Things are moving very fast, while somehow simultaneously moving very slowly.

For vaccine access in general, it’s moving very quickly… It’s difficult even to keep up.

However, if you are a regular reader waiting for Novavax, it’s moving slower than ever.

And everywhere I look, influencers are making it more complicated than it needs to be, which is, in fact, a conversation worth having about the power of influencers in general. Let’s put a pin in that for later, because we’re talking about the state of vaccines.

It’s not really a statement about influencers having power, but the ineptness of the people in power because of either nepotism, cronyism, or whatever “ism” that gives jobs to an acquaintance instead of someone who is equipped to do the work, which allows for social media “entrepreneurs” to drive the conversation.

Stories about how COVID vaccines will be limited have gone far beyond reality and are concocted to boost influencers’ subscriber base, while not providing accurate information or effective strategies.

This has even affected state governments and major corporations.

As this is the “People’s Strategist Newsletter,” that’s what we’re going to do…

Discuss a strategy that will actually be good for people.

We’re going to take a moment to cut fact from fiction and help you, the reader, navigate this situation. At the very least, trust me when I say, there’s a lot more we can do right now than is being advertised.

Things have been moving so fast that I wrote a rough draft on Monday, and by Wednesday, it was absolutely not up-to-date anymore.

We’re going to explain what’s going on and what you can do to help…

While also giving you a few tools that haven’t been on the chessboard yet.

Before we start, I would like to note that nothing in here is defending, in support of, or somehow being okay with how RFK Jr. is dismantling our public health systems.

We’re both trying to make it work now while also moving toward long-term solutions.

Sometimes, finding a functional solution in a time of crisis appears similar to an acceptance of the pressure we face, when there is still an opportunity to alleviate it.

I assure you that is not the case here.

Our group not only helped shut down RFK Jr.’s restructuring budget at appropriations but also played a crucial role in accelerating the yearly COVID vaccine release over the last two years, aiming to align the release with the school year and transition from a seasonal to a year-round strategy. This will be important later.

We’re a bit over four years into using these vaccines, and not only are we still learning how to use them, but, as Congress has been a dilapidated mess, none of this is legislated into law, which is why they even have the room to remove the vaccines in the first place, potentially. This wiggle room should not be ignored.

The idea of yearly vaccines is more of a courtesy than a required act, and last year, vaccines were released nationwide before ACIP issued an “official” recommendation.

That is, after all, what this debate is about: ACIP recommendations.

The only thing that makes it so your insurance will pay for these vaccines is if they are “ACIP recommended,” which is a legal requirement for insurance providers based on laws written by Congress. That’s really the only thing here that legally matters.

This is part of the Affordable Care Act, or as it is colloquially known, “Obamacare.”

So, it should be no wonder that Republicans might try to undermine it.

EDIT: Both New York, Minnesota, and Nevada have now allowed access in precisely the manner I lay out here. New York did it through the Governor’s office, and Nevada did it through the State Pharmacy Board. Hopefully, that will help alleviate some of the doubts people have about whether I am presenting the correct interpretation.

They would only have the power to do that if my interpretation is correct.

Make no mistake, ACIP is a hot mess with new members being appointed to drive around in that clown car in the last few days, with a meeting rapidly approaching in just a few weeks. Senator Cassidy is calling for this meeting to be postponed.

Though he kinda started this fire.

At the same time, Bernie Sanders is calling for RFK Jr.’s resignation, and over a thousand HHS staff are doing the same. While we should postpone this meeting for self-explanatory reasons, even if we did, it wouldn’t solve the recommendation issue.

Meanwhile, the actual limits are coming from CVS and Walgreens, which are the primary distributors of mRNA. However, in a confusing twist, they are requiring people to obtain a doctor’s prescription to access the vaccines in specific states.

Obviously, we all assume this is tied to specific legal requirements, right?

Buuuutttt… there’s a “small” inconsistency, and by small I mean enormous.

And I don’t mean that a prescription is explicitly never required for access.

They are limiting different states.

CVS is limiting access in the following states: CO, FL, GA, KY, LA, ME, NY, NC, PA, UT, VA, WV, MA, NV, MN, and DC: 15 states and the District of Columbia. So, 16.

Walgreens is limiting access in the following states: AZ, CO, GA, IN, LA, MO, MT, NM, NY, OR, SC, UT, VA, WA, WV, and WI…. also 16, but all states this time.

Do you see the problem here?

In total, it’s Arizona, Colorado, Florida, Georgia, Kentucky, Louisiana, Indiana, Maine, Missouri, New Mexico, New York, North Carolina, Pennsylvania, South Carolina, Utah, Virginia, West Virginia, Massachusetts, Nevada, Minnesota, Wisconsin, and DC…. making 21 states and DC.

There’s no consistency.

This is hypothetically tied to various state laws, which limit vaccinations to ONLY ACIP-recommended vaccines. The more I think about this, the more I hate it.

The reason it’s inconsistent is that none of this is based on CLEAR law; it seems it’s an issue with state liability for administering the vaccines outside of the ACIP recommendations, so the threat is purely from the states themselves.

Some states are already taking action to this effect.

New Mexico issued a public health order.

Pennsylvania is taking a clear stance on the issue and breaking from ACIP recommendations.

The problem is that this is already leading to significant confusion because these health orders do not force insurance to cover them. That means that while you can access them, you may have to pay out of pocket.

This will limit access to those who need these vaccines the most.

It will also limit access for programs that distribute vaccines to children at no cost.

If this plan is our new neutral, then the antivaxxers win.

This all comes down to a liability issue, which, even if every state changes its laws or makes exemptions in some way, as they should, does not necessarily answer the question of whether insurance will cover it.

The strange thing is that a doctor’s prescription doesn’t negate that liability, so I am still unclear why Walgreens or CVS sees that as a solution. Especially since federal protections for administering these vaccines were extended for several years.

It’s already been stated that some insurance companies will choose how to cover them plan by plan, but that can quickly become case by case.

If you haven’t noted, everyone is making things up on the fly, and this is what the antivaxxers want… whether it be altering access, or confusing people in general.

Ultimately, their goal is to limit access to vaccines, which will reduce demand, and over time, capitalism wins because there’s too much waste, and it will be viewed as not profitable… Which, to be clear, is a silly plan, but that’s who we’re dealing with.

And as silly as it sounds, this is a problem we’ve already faced in multiple countries with Novavax, where access was limited and not advertised. Then they turned around to say there was no demand. The problem now is that pro-vaccine advocates are doing the heavy lifting for the antivaxxers, telling people they can’t access these vaccines…

When that is not actually true, if we followed regulations as they stand.

Currently, we need to address the immediate accessibility of these vaccines, the long-term recommendation issue, and ensure that insurance coverage remains consistent throughout. While also figuring out how to get RFK Jr. out of a job.

We will almost certainly have to deal with some limits on access during that time.

Fortunately, we have enough wiggle room to make it work in the meantime.

While you might not like our access to COVID vaccines being limited to “wiggle room,” this is what folks seeking Novavax have had to deal with under both administrations… But that’s not what we’re going to talk about right now.

The idea you should focus on, as I explain everything else, is how close we are to removing RFK Jr. altogether because it’s not just the Democrats with a bone to pick.

Almost no one is aware that RFK Jr.’s HHS restructuring bill got shut down in appropriations with a vote of 26-3 to move on without his changes.

He’s coming off a major “L.” The Republicans aren’t happy with him either.

He’s basically pulling this off because he’s viewed as Trump’s pet.

… Changing paces, what if I told you that all COVID vaccines are automatically ACIP-recommended regardless of the year-to-year recommendation?

RFK Jr. said, “Talk to your doctor,” which has been interpreted as get a prescription, but that’s a simple misunderstanding of the niche regulation.

Say what you want about him, the FDA Director already understands the solution.

I’m not a fan of this guy, but what he said is not inherently false.

It’s one thing to hear it from me; it’s another to listen to it from the guy in charge, and once everyone understands how this works, we can push for clarity.

It sounds made up, but the process that allows this was a safeguard established by a combination of our group’s efforts over the last few years to make it as easy as possible for people to start Novavax with three in a year to receive maximum protection, and the former ACIP to protect all COVID vaccines in general.

If you haven’t questioned me up to this point, then I’m sure that’s what did it.

However, we have the receipts in the form of presentations we gave to prove it.

The problem we are facing is that the “vaccine skeptics” feel that ACIP recommendations become soft mandates when getting all the ACIP-required vaccines becomes a requirement of your job.

When they talk about “mandates,” I think that’s what they are referring to.

And I say “I think” because it’s like trying to translate stupid.

The point is that if we can find a way for Walgreens and CVS to accept this form of recommendation and make it the primary method for people to receive COVID vaccines, then they will be instantly covered by insurance, and access won’t be limited.

Most importantly, this process uses a “self-attest” system.

If we use the self-attest system, it would be ACIP-recommended enough to be covered by insurance, but not ACIP-recommended enough to become a “soft mandate…”

And somehow, oddly offers more access than we had in the previous administration.

Under these guidelines, anyone would be able to receive a COVID vaccine as long as it is two months after a previous one. Unless someone is starting with Novavax for the first time, then no one needs a COVID vaccine that often.

Accepting this strategy would mean that all COVID vaccines are covered by insurance, available to you as frequently as you want, as long as it’s been two months since the last one, all while using a self-attest system, and not creating a soft mandate.

So, let’s get moving before you have time to second-guess the decision to read further.

Let’s start with the ‘Shared Clinical Decision-Making Guidelines.’

Do you need a prescription?
Do you need to claim you are immunocompromised?

You can do those things if you’d like, and in some cases, it may make things easier.

However, not everyone has easy access to a doctor, and due to HIPAA, you cannot be required to disclose your health status except under certain circumstances…

These guidelines were designed with that in mind to remove those circumstances.

There is a chance you will be handed a piece of paper that may require a box to click, stating you are immunocompromised or at risk of severe COVID. Still, hopefully, we can narrow the question down to “are you using the shared clinical decision-making guidelines?” But as we are all aware, they reuse old documents for way longer than they should, so that’s just a thing we may have to deal with.

To clarify, it has been discussed at great length at VRBPAC meetings that stating you are immunocompromised, even if you are not, is specifically how the rules were set up to allow access to additional Novavax doses. It’s not really lying because it’s intended to be used that way, only to make it easier for pharmacists to allow access.

It sounds ridiculous, but making things “idiot proof” involves bending definitions.

Putting all COVID vaccines on this list last year was part of our solution for the problem of allowing for a new priming series. So, in a way, we are recycling solutions, but it works out now so that it helps everyone who wants COVID vaccines, rather than just those who want a new priming series of Novavax for maximum protection.

We’ve presented a total of five times at VRBPAC:

• VRBPAC Meeting: June 15th, 2023 - COVID

• VRBPAC Meeting: March 5th, 2024 - Influenza.

• VRBPAC Meeting: June 5th, 2024 - COVID

• VRBPAC Meeting: Sept. 20th, 2025 - Pertussis

• VRBPAC Meeting: May 22nd, 2025 - COVID

We fought to change the requirement to claim immunocompromised, and later, the documentation removed the requirement to claim immunocompromised altogether. However, it does still exist in some documentation from last year, leading to confusion.

Here are the guidelines for the 2024-2025 season, which serve as the basis for RFK Jr.’s claims that anyone will have access to these vaccines.

Even if you hate RFK Jr. and hate this process, you want these rules preserved.

Before you proceed, please note that these guidelines apply to children who are NOT moderately or severely immunocompromised.

So, not the group at risk of severe COVID who maintain a general recommendation.

This essentially means these rules apply to everyone in some capacity.

Will documentation be required?

No. Well, at least it shouldn’t be if they were following the regulations as they stand.

These are the rules for immunocompromised people, but it explicitly says that you can “self-confirm,” also known as “self-attest,” which means it’s on the honor system.

“You do NOT need documentation to receive a COVID-19 vaccine you are eligible for.”

This is where wording from different documents can become confusing, but it is overwhelmingly stated that you can self-attest to a status that allows for COVID vaccine access. It makes that clear in all eligibility capacities…

It’s a strange fight for eligibility when you are in charge of deciding for yourself.

Essentially, you are deciding your own eligibility, after discussing it with “whoever is in charge of your healthcare”… probably you, and they even dramatically capitalized “NOT” to emphasize the fact that you do not need documentation or a prescription.

Technically, the complete list of “healthcare providers” is “primary care physicians, specialists, physician assistants, nurse practitioners, registered nurses, and pharmacists,” but, again, no documentation is currently required.

That means that access to these specific people is not a limitation.

But will insurance cover it?

Yes, absolutely.

We’ve been doing this for a year already, so that folks can access a new priming series.

“With respect to the individual involved” sounds an awful lot like shared clinical decision making, but at this point, I’d be happy to get an objective opinion.

Didn’t RFK Jr. already tell us the recommendations were changed?

Technically, he has only expressed his intention to change the recommendation, but the actual ACIP recommendations haven’t been changed since 2024.

There is an interim guidance page, but it’s incomplete, and many links are dead.

Now, that being where things stand now, does not mean that’s where they will be, but we will get to that in a moment, because more than COVID vaccines are at risk.

For right now, this all comes down to CVS and Walgreens establishing the status quo that all COVID vaccines are administered according to the shared clinical decision-making guidelines. Ensuring that insurance pays for it, and access will be available regardless of variant changes. As long as the FDA approves the variant selection and batches, then CDC meetings should not hinder access to the public.

Accepting this now would benefit us in the future, regardless of who is in charge, while also providing a specific point of pressure to ensure access.

This would also go a long way to help us be more nimble and respond to COVID as it mutates, regardless of how the CDC sets up its meetings earlier in the year.

This way, it would only require approval from the FDA to change variants without needing Congressional members to actually do their jobs.

We’ve already determined these platforms safe, though at variable levels of protection, so reapproving them every time the variant changes is more theatre than safety.

And it’s all just a matter of groups like CVS and Walgreens setting the new status quo.

If we adopt this now, it will allow more access, the antivaxxers get their dog and pony show that vaccines are being limited, and vaccine skeptics lose their soft mandates.

It’s weird because it’s possible everyone wins.

This probably doesn’t match up with what other influencers are saying.

Which is why it’s essential to keep track of the misleading claims being said and have the correct response for each individual issue:

1. A doctor’s prescription will be required.

• At no point has any regulator made that claim; however, there has been confusion over whether shared clinical decision-making requires a conversation with your doctor or your “healthcare provider,” which is a broader interpretation. Many are interpreting this as requiring the creation of documentation of this conversation in the form of a prescription, and that is explicitly not the case. So, unless they change the shared clinical decision-making guidelines (which badly needs an abbreviation), that is incorrect at every step and should not limit access.

2. Around 24 states and DC are limiting access by prescription under the pretense that these are not ACIP-recommended vaccines. In some cases, state liability laws will come into effect, preventing their distribution. States are trying to find workarounds that alter their state laws in relation to ACIP.

• This is simply wrong at every level. I cannot express how incorrect this is. Under the shared clinical decision-making guidelines, these remain as ACIP-recommended vaccinations. No additional changes should be necessary. Changing state rules to follow ACIP guidelines is a slippery slope, potentially leading to red states limiting the enforcement of laws that mandate insurance coverage for vaccines. We’re better off trying to fix ACIP than we are trying to alter every individual state’s laws. Anything more than an Executive Order to protect liability is going too far to enable distribution because it might negatively affect other aspects of access.

3. Insurance will not cover these vaccines.

• This is obviously incorrect, again, unless the guidelines are changed. Altering the greater recommendation will not impact this unless they are removed from the shared clinical decision-making guidelines. I have been personally holding people’s hands through this process for over a year.

4. We don’t know what criteria will allow access to vaccines.

• This is a bit of a no-brainer if you read this far. However, since people will still be in doubt for various reasons, here’s the list of conditions that allow anyone access, according to the recommendations they claim to want to make. This is not a list of conditions that allow access, but rather a list of high-risk conditions that put you at the highest risk for severe COVID. Also, important to note two things: 1. This is not an exhaustive list; it simply indicates who should automatically have access. 2. You are not required to disclose any condition to access these vaccines. Also, bonus, while they are trying to limit vaccines to pregnant people, pregnancy is still listed as a high-risk condition for severe COVID.

5. In two weeks, the illegitimate ACIP is meeting again, and they may alter the recommendation. Vaccine companies are waiting to distribute based on how that meeting might go.
   

   This is a genuine concern.

We should start by stating that the removed ACIP had the fewest conflicts of interest of any recent ACIP, as our group informally removed all but one ACIP member by contacting them directly at their academic email addresses.

They even expressed their frustration with us during a meeting.

To say the former ACIP represented twenty years of corporate malfeasance, as RFK Jr. has, is an absurd claim, given that all the members were replaced the previous year.

And it’s not just this last ACIP… Conflicts of Interest (COIs) are at a historic low for both the ACIP (CDC) and VRBPAC (FDA).

So, what are our options?

We get CVS and Walgreens to change their policy, then what?

Not everyone will understand the shared clinical decision-making guidelines, and while they will enable access, these additional steps will still reduce uptake.

We could try to bend the rules in all the states, or we could try to fix ACIP.

We could also do both.

As far as states are concerned, getting the Governors to sign Executive Orders that will protect pharmacists from the liability of state laws will likely enable access…

So, will contacting the State Pharmacy Board.

Or states like New Mexico are implementing rules that allow access in other ways.

The most important thing a state can do is remove limitations for any group to access all COVID vaccines regardless of federal stipulations.

Really, this process only exists for clarity, and it’ll be easier to resolve this statewide.

Since the shared clinical decision-making guidelines are so intentionally ambiguous, it’s questionable if this is necessary at all. However, it is something that news agencies will discuss, letting people know that these vaccines are accessible. While some people are surprised by this problem, we were aware that it could be a concern.

This is one of the reasons we advocated for not updating vaccines this year, as they had already been approved. Technically, it’s not a new vaccine, and it would likely have a more streamlined approval process to remain on the market.

Not only that, but it was also the best variant option.

Just a quick side step on whether JN.1 is actually the best variant choice… but don’t worry, I’m going to explain the process to reinstate ACIP, impeach RFK Jr., and put all this madness to an end. You can read our entire 2025 VRBPAC presentation here.

Last year, we were in the same boat, choosing between what is known as a “leaf on the tree” or the “trunk of the tree,” the former referring to a random variant, and the latter referring to the primary variant from which all the current subvariants emerged. You can read our entire 2024 VRBPAC presentation here.

There is a common misconception that we want to get as close as possible to a circulating variant; however, several issues arise.

With the primary problem being that aiming for a current variant means that it will likely have circulated out by the time manufacturing can be complete, even for mRNA, and that brings us to the second problem, where the new variant will likely have immune evasion to the antibodies created by both the previous variant and the vaccines you just released.

The point that is repeatedly emphasized is that each individual variant has less in common with the other variants than it does with the parent variant.

And though we did not use JN.1 mRNA in the US, we did use it internationally.

This provided us with some stark data on the matter, with the JN.1 mRNA far outperforming the KP.2 vaccines. It’s not even close.

JN.1 is in blue.

However, this is from last year. What about variants now?

Here’s a demonstration of the current variants. This was presented at the May VRBPAC meeting. You can see that XFG, NB.1.8.1, and LP.8.1 are all within 1-2 antigenic units, which is a standardized measurement of antigenic distance.

What you might miss in this chart, though, is that the actual vaccine sera responses do not line up directly with the variants themselves, and all of the responses end up closer to JN.1 than they do their intended target.

This is really important to note because people often seem to think that it’s like driving to a location in the real world; do you want to drive and park two blocks away?

No, of course not, I want to park as close as possible.

Well, in immunology, you are parking “two blocks” away, regardless. Which means we are better off planning for the walk than denying that it’s part of the process.

Also, sticking with JN.1 would have let us skip all this needless drama; we could have updated everyone’s memory response, and we could also begin the process to move to a year-round COVID response instead of a seasonal one, as COVID does not peak in the winter season alone and is actually far more likely to peak in the summer than more traditional respiratory viruses, as we are seeing now.

Seasonality, as observed during the winter season, when we are more susceptible to infection, does not significantly impact COVID-19 spread, with waves regularly occurring during warmer months.

It’s worth noting that VRBPAC in 2024 took place in June, whereas VRBPAC in 2025 occurred in May. If we continue to move up VRBPAC next year, then we can have vaccines out before the school year starts. This means we need VRBPAC in April to plan for a July/August release, rather than May for an August/September release.

You can watch the previous VRBPAC meeting, starting with my public comment presentation, and observe the conversation our presentation started regarding not updating the vaccines this year.

Ultimately, only three of the nine members thought updating was the right choice.

Maybe it was four, but no consensus was reached on the concept.

It was ultimately Vinay Prasad’s CBER that made the call to update to LP 8.1.

So, try to remember that when folks in the COVID-conscious community discuss LP.8.1 as the better choice because it is “more updated,” they are actually following through with Vinay Prasad’s plan from the new CBER.

Which is funny because Prasad is making the same mistake that Peter Marks made last year, which goes to show that it doesn’t matter who is in charge; they still make the same mistake because the same groups are pulling the strings.

Okay, Don, get back to the Impeaching RFK Jr. talk.

I completely understand if you are not up-to-date with our group’s work and therefore might share opinions with this individual.

We are a bit further along with this than this perspective might suggest…

On a side note, this highlights the issue of influencers exploiting the trust they’ve built with their followers and manipulating the parasocial relationships created on social media. This person is totally unaware of the work we have done while following me at the same time. The larger influencers are, for some reason, pretending this all didn’t happen, and consequently, neither does this individual.

I should point to Taylor Lorenz’s recent article on the pay-to-play political influencers and how this is not an abnormal event unique to politics.

While much of her article is framed as influenced by the Democratic Party, it’s actually about influence OVER the Democratic Party. This type of influence exists in any high-dollar situation, and COVID vaccines are technically higher on the economic ladder than control of the Democratic Party.

In other words, pay-to-play influencers for topics related to COVID are likely to be even more common and require even fewer disclosures.

Instead of pointing fingers, let’s take a look at the work.

Here are the previous articles on these actions, but please note that we are also hosting ‘Brace for Impact’ to activate our listeners twice a week with calls to action.

Brace for Impact is Tuesdays and Thursdays, starting between 6 and 7 pm Pacific.

January 29th, 2025

• Attacks on Public Health Put Our Kids’ COVID Protection at Risk: Part 1 of 3

March 25, 2025

• RFK Jr. is Limiting Public Comment, and it Could Be the Beginning of the End of Public Engagement in Federal Matters.

April 3, 2025

• It’s Time to Get Novavax Its Full Approval.

April 16, 2025

• We Need Your Help Keeping COVID Vaccines Covered by Insurance.

May 12, 2025

• Novavax Call to Action: Less Than Two Days to Act on First Steps.

June 20, 2025

• It’s Time to Call the Senate; It’s Not Just About Novavax Anymore, We Have to Protect All Vaccines

June 24, 2025

• Open This Right Now. RFK Jr. Lied To the Senate. Now He Wants To Lie To the House. It’s Time for an Investigation.

July 1, 2025

• Two Calls to Action; Both Critical and Both in Congress. Time Is Not Our Friend

July 8, 2025

• We Have Just a Few More Days to Stop RFK Jr. by Means of the House Energy & Commerce Committee

August 8, 2025

• While Taking a Victory Lap, We Have a Call To Action That’s Giving Us More Time to Act.

What does this all mean?

We were taking a victory lap because, after a multi-month process, we were able to protect public comment and also shut down RFK Jr.’s HHS restructuring budget in the appropriations committee. This was not covered by any major media group that we have identified, other than STAT News.

On the surface, this might not seem like a big deal, but it’s a huge deal.

The appropriations committee, like all committees, is controlled by Republicans.

That means that the Republicans had to decide that his plan was a bad idea.

And only three Republicans on the committee voted against moving forward without his additions. Meaning that only three Republicans on the committee supported his changes, but he only lost that support after events unfolded in Congress.

So, what happened?

Well, RFK Jr. perjured himself multiple times in Congressional hearings.

We’ve already seen Bill Clinton famously impeached for perjury, and make no mistake about it, committing perjury to Congress is grounds for impeachment.

Now, this, combined with the reality that Republicans voted against his restructuring budget, means that there are enough combined House members who are against what RFK Jr. is doing to push for formal impeachment.

Will it happen?… Well, it could.

It also becomes leverage for the upcoming ACIP meeting, especially given RFK Jr.’s practice of altering recommendations without consulting an expert first.

RFK Jr. has more congressional hearings coming up and multiple ethics complaints.

I expect to see him perjure himself more because, as far as I can tell, he doesn’t seem to know where he is from meeting to meeting. Watching him deny conversations we had observed him having a few weeks earlier was a new one for me personally.

The truth is that getting him impeached will take a minute, but the tools to make it happen are available to us, and we should get started.

Okay, but what about ACIP?

Senator Cassidy is currently advocating for the next ACIP meeting to be postponed.

You’ve already seen this, but it’s a long article, so it’s probably good to revisit it.

However, this will disrupt access in multiple states until either the ACIP can meet and officially recommend them or the individual Governor signs Executive Orders limiting liability to people who administer the vaccines, or a similar act is taken by public health officials, as in New Mexico.

Alternatively, we could establish a new status quo with the major corporations.

Although concerns remain about insurance coverage, leaning into Shared Clinical Decision Making is the best approach for at least the remainder of this year.

Though that’s a short-term plan, and while that’s helpful, we need a real solution.

This is where the Senate bill to legalize ACIP comes into play.

Legalizing ACIP and reinstating former members should be extended to include reinstating the former CDC Director, as well as preventing such firings in the future.

The bill is co-sponsored by U.S. Senators Angela Alsobrooks (D-Md.), Martin Heinrich (D-N.M.), Ben Ray Luján (D-N.M.), Jeff Merkley (D-Ore.), and Raphael Warnock (D-Ga.).

As the CDC Director is now Senate-confirmed, the White House should not have the ability to fire a CDC Director without proper cause that is presented to the Senate.

Republican Senators who are unwilling to impeach RFK Jr. for perjuring himself may be more willing to enforce the ACIP membership directly.

However, the issue is that Trump would have to sign that bill into law.

Perhaps we get lucky and Vance signs it into law.

This is why impeachment of RFK Jr. should be a reasonable possibility, because it doesn’t require the President’s signature.

We need to do all of this because we are not only having troubles with COVID vaccines, but two workgroups of fringe antivaxxers have been set up to call into question various vaccines. This is just their first stop.

One workgroup is focused on COVID vaccines, and while I would like a greater conversation about vaccine injury from mRNA, this is not the group we want to lead it.

Even as a proponent of Novavax, in this situation where it is likely to leave Novavax in a stronger position, this is not how or who we want doing this.

The second group focuses on Childhood vaccines in general and makes recommendations to Congress every two years. This itself is not something to be afraid of, because we are on the verge of improving several vaccines typically received by the entire population during childhood.

However, that’s not what the people selected are focused on; we should be worried.

But where does that leave us?

We have two weeks to get ACIP put on hold, take the state’s route, reinstate the former ACIP, or get the current ACIP to recommend them broadly.

While at the same time, open up access to COVID vaccines without an ACIP meeting.

However, we actually have one option that could help us more than the others.

CVS and Walgreens are dominating this conversation based on incorrect information. Most importantly, a prescription is NEVER required, and they are not following ACIP recommendations as they stand. These vaccines remain ACIP-recommended from year to year due to the shared clinical decision-making guidelines.

Additionally, we should push through the bill to legalize ACIP membership so it can’t be used as a political weapon, all while starting RFK Jr.’s impeachment proceedings.

However, these are niche regulations that not everyone seems to be aware of.

COVID vaccines of all types remain ACIP-recommended, regardless of the year of the vaccine or the individual yearly approval, as long as access is through the shared clinical decision-making guidelines, which could be how all COVID vaccines are accessed from this point forward.

It’s almost a better system, to be honest, as it allows for additional vaccines.

Also, please note that RFK Jr. did not establish this method. The previous administration set it up as a tool to protect access to these lifesaving vaccines.

While we should and will contact the House about Impeachment, we should also contact the Senate about both passing the ACIP bill and impeachment.

And although some think going state by state is a good plan, it’s certainly a viable approach, but it comes with a lot of risks… and more importantly…

Red states are on the list, and they are unlikely to go along with that strategy.

So, we should go to the source of the problem, and it’s not RFK Jr. for once.

CVS and Walgreens are setting limitations not required by any regulator.

That’s our first stop.

We should first contact CVS and Walgreens’ help lines and inform them that they are not following the current guidelines, nor are they allowed to require prescriptions for COVID-19 vaccines. While also making a huge mistake by not ordering Novavax.

We should also share this information with members of Congress so they can put pressure on CVS and Walgreens to distribute them properly. The same is true of State leaders who are being asked to write unnecessary E.O.s or public health orders.

This should still happen and will reduce liability, but red states will not comply.

If you want to go the extra mile, contact your state reps to confirm that access is allowed via the shared clinical decision-making guidelines without documentation.

That should immediately open up access.

Then we work with the HELP committee to try to get the meeting postponed.

At the same time, pressuring a combination of Congressional committees to initiate impeachment proceedings based on RFK Jr. continuously perjuring himself to Congress, which is likely to continue at today’s Senate hearing.

While simultaneously pushing through the bill to legalize and reinstate ACIP in the Senate, adding the reinstatement of the removed Senate-approved CDC Director.

All while you all are making public comments to the illegitimate ACIP.

We want to complete all this before these two workgroups can meet and further alter the recommendations. And it all starts with calling CVS and Walgreens, while ramping up for the continuous run of RFK Jr. committing crimes in Congress.

We should also use this time to push CVS and Walgreens to order Novavax.

In the past, Novavax had a short shelf life, resulting in significant waste.

With the expansion to six months and single-use vials, that problem is gone.

However, just like everything else, they don’t know if we won’t tell them.

So, now that you’ve seen the thought process, let’s break it down into something a little less complicated.

Fix pharmacy barriers at the corporate level:

• Contact CVS & Walgreens to remove non-required limitations, considering that the ACIP recommendations have remained the same; access constraints have not been implemented at this time, and are unlikely to alter the shared guidelines.

CVS: 1-800-746-7287
Walgreens: 1-800-925-4733

Don’t forget to mention that they should order Novavax.

CVS is limiting access in the following states: CO, FL, GA, KY, LA, ME, NY, NC, PA, UT, VA, WV, MA, NV, MN, and DC.

Walgreens is limiting access in the following states: AZ, CO, GA, IN, LA, MO, MT, NM, NY, OR, SC, UT, VA, WA, WV, and WI.

The two groups, having different lists of states with limitations, clearly demonstrate that there is no rhyme or reason to this.

We will update numbers as we start finding new ones to call.

Lock in state-by-state access:

• Contact your state health officer/board of pharmacy (and legislators) to confirm COVID vaccine access under shared clinical decision-making.

• Use them to add pressure to the push at CVS and Walgreens.

The 21 states (and DC) in question are Arizona, Colorado, Florida, Georgia, Kentucky, Louisiana, Indiana, Maine, Missouri, New Mexico, New York, North Carolina, Pennsylvania, South Carolina, Utah, Virginia, West Virginia, Massachusetts, Nevada, Minnesota, Wisconsin, and DC.

Edit: 21 is down to 16 as of 9/8.

We may add them later, but for now, you’ll need to look it up.

Contact the Governor’s Office, the State Pharmacy Board, and the state’s public health leadership to inform them of the correct regulation in your state.

Flood the public record for ACIP:

• Submit written and oral comments for the Sept 18–19 ACIP meeting.

• ACIP public comment page: https://www.regulations.gov/commenton/CDC-2025-0454-0001 Public comment is open from 9/2/2025 to 9/13/2025 at midnight.

• Emphasize the illegitimacy of this committee, as well as a pharmacist’s authority to order COVID vaccines, shared clinical decision making for access, and avoiding added gatekeeping that isn’t required by regulators (i.e., the same stuff you talked to your state legislators, state health officials, and corporate pharmacies about in steps 1 and 2).

• Push for the recommendation to remain as wide as possible, so as not to overcomplicate access, while leaving the shared clinical decision-making guidelines intact.

Congressional oversight:

• Hold RFK Jr. accountable for all the stupid things he says to Congress.

• Advocate to push through the bill for Senate oversight of ACIP, including reinstating the previous ACIP members, and adding the reinstatement of the removed Senate-approved CDC Director.

• Advocate to Congressional Committees and eventually the Judicial Committee to initiate impeachment proceedings of HHS Secretary RFK, with an eye on upcoming hearings where we anticipate him to continue perjuring himself.

• Contacting the committee he’s meeting with on Thursday to lead RFK Jr. to explain how people will be able to get the vaccine.

Show how RFK doesn’t know where he is from meeting to meeting.

Be prepared for him to perjure himself. Don’t get caught slackjawed.

And most importantly, call CVS and Walgreens.

CVS: 1-800-746-7287
Walgreens: 1-800-925-4733

Thank you for taking the time to protect our public health.

Next Article: Is Novavax the Better COVID Vaccine?

If you are a new reader and want to follow up with some of my work…

• The Risk of Long COVID Explained: Feb. 11th, 2022.

• The Benefits of Novavax Explained: Nov. 26th, 2022.

• Americans Should Be Able to Get Novavax: Sept. 11th, 2023

• Our Continued Success Requires Us Building on What’s Worked: Feb. 15th, 2024

Amidst this, I started doing a show multiple times a week in early 2023. We formed a group and consistently did the show to push successful direct action.

This led to presentations and direct contact with members for further action…

The COVID presentations employed an “inside/outside” strategy. We did the presentation “inside” the meeting, but also had the public contact from the “outside” with not only public comments but direct contact via academic emails to members.

If you are unclear, VRBPAC is a committee of the FDA and, with that, the HHS.

Our work has been cited in a few articles.

• WebMD: Sept. 11th, 2024

• Medpage Today: Nov. 18th, 2024

• Reuters: April 24th, 2025

• Boing Boing: April 25th, 2025

• Boing Boing: June 17th, 2025

Brace for Impact is on Twitter and X on Tuesdays and Thursdays at 6:00 pm PST.

You’re also welcome to join our Discord, but be prepared for a small test to enter.

Discord

However, I need first to point out that we have a new call to action at the WHO, where they are seeking public comments regarding the “WHO Strategic and Operational Plan for Coronavirus Disease Threat Management (2025–2030).”

Technically, this should be closed, but the WHO tends to leave these open longer.

The gateway to comment said it ended a few hours ago, but as of writing, it is still open, and there is also an email associated with it that could be used to reach them.

You can download the document and find the comment link here.

The link to comment is at the bottom of the page, or you can use this.

And here is the provided email… covid19@who.int

I’ll provide some talking points at the end of the article.

I didn’t want this to get lost because what I’m about to tell you is kinda wild.

Back to the last few calls to action.

These are listed in reverse order, from most recent to oldest.

• We Have Just a Few More Days to Stop RFK Jr. by Means of the House Energy & Commerce Committee

• Two Calls to Action; Both Critical and Both in Congress. Time Is Not Our Friend

• Open This Right Now. RFK Jr. Lied To the Senate. Now He Wants To Lie To the House. It's Time for an Investigation

• It's Time to Call the Senate; It's Not Just About Novavax Anymore, We Have to Protect All Vaccines.

Then we had a pivot to the appropriations committee, while I didn’t publish an article we did discuss this on a call…

And believe it or not…
It worked.

Trust me when I say I am as surprised as you are reading this now.

It actually worked, and almost no one reported on it.

Things are also heating up for RFK Jr., as there have been requests from the House Oversight and Ethics Committee for documents that would be related to what he perjured himself over.

That said, there have been so many requests from Oversight and Ethics regarding his behavior that even finding that link became a bit of a challenge.

So, let’s not assume the two Committees are on the same page, but we’re close.

That means we need to contact the Oversight and Ethics members and request a full investigation into his perjury at the Energy and Commerce Committee and the Senate HELP Committee as well.

However, the former is the more egregious. So, we’ll focus on that.

It’s very straightforward; he’s either lying to Congress or he doesn’t know where he is.

Both mean he should not be responsible for public health in any capacity.

There is bipartisan support for stopping RFK Jr.’s madness, as it was Republican leadership that led to the exclusion of his MAHA restructuring of the HHS.

That means there may also be bipartisan support for his potential perjury.

We should at least find out.

As you will see, there are a large number of members. If you are overwhelmed, start with those who are also in the Health and Financial Services subcommittee, as they are most likely to be closely aligned with the other health-related subcommittees.

House Oversight and Ethics Contacts

Committee Chair:
Rep. Jamie Comer (R-KY-01)
Phone 202-225-3115
Fax 202-225-3547

Majority - (R)

Rep. Gary Palmer (R-AL-06)
Phone 202-225-4921
Fax 202-225-2082

Rep. Eli Crane (R-AZ-02)
Phone 202-225-3361
Fax N/A

Rep. Andy Biggs (R-AZ-05)
Phone 202-225-2635
Fax 202-226-4386

Rep. Paul Gosar (R-AZ-09) Health and Financial Services Subcommittee
Phone 202-225-2315
Fax N/A

Rep. Lauren Boebert (R-CO-04)
Phone 202-225-4761
Fax 202-225-5870

Rep. Anna Luna (R-FL-13) Health and Financial Services Subcommittee
Phone 202-225-5961
Fax 202-225-9764

Rep. Byron Donalds (R-FL-19)
Phone 202-225-2536
Fax 202-226-3547

Rep. Brian Jack (R-GA-03)
Phone 202-225-5901
Fax 202-225-2515

Rep. Marjorie Greene (R-GA-14)
Phone 202-225-5211
Fax 202-225-8272

Rep. Clay Higgins (R-LA-03)
Phone 202-225-2031
Fax 202-225-5724

Rep. Eric Burlison (R-MO-07)
Phone 202-225-6536
Fax 202-225-5604

Rep. Nick Langworthy (R-NY-23)
Phone 202-225-3161
Fax 202-226-6599

Rep. Virginia Foxx (R-NC-05)
Phone 202-225-2071
Fax 202-225-2995

Rep. Jim Jordan (R-OH-04)
Phone 202-225-2676
Fax 202-226-0577

Rep. Mike Turner (R-OH-10)
Phone 202-225-6465
Fax 202-225-6754

Rep. Scott Perry (R-PA-10)
Phone 202-225-5836
Fax N/A

Rep. Nancy Mace (R-SC-01)
Phone 202-225-3176
Fax 202-225-3407

Rep. William Timmons (R-SC-04)
Phone 202-225-6030
Fax 202-226-1177

Rep. Tim Burchett (R-TN-02)
Phone 202-225-5435
Fax 202-225-6440

Rep. Pat Fallon (R-TX-04)
Phone 202-225-6673
Fax 202-225-3332

Rep. Pete Sessions (R-TX-17) Health and Financial Services Subcommittee
Phone 202-225-6105
Fax 202-225-0350

Rep. Brandon Gill (R-TX-26) Health and Financial Services Subcommittee
Phone 202-225-7772
Fax 202-225-2919

Rep. Michael Cloud (R-TX-27)
Phone 202-225-7742
Fax 202-226-1134

Rep. John McGuire (R-VA-05) Health and Financial Services Subcommittee
Phone 202-225-4711
Fax 202-225-5681

Rep. Glenn Grothman (R-WI-06) Chair: Health and Financial Services Subcommittee
Phone 202-225-2476
Fax 202-225-2356

Minority (D):

Rep. Yassamin Ansari (D-AZ-03)
Phone 202-225-4065
Fax N/A

Rep. Lateefah Simon (D-CA-12) Health and Financial Services Subcommittee
Phone 202-225-2661
Fax N/A

Rep. Ro Khanna (D-CA-17)
Phone 202-225-2631
Fax 202-225-2699

Rep. Robert Garcia (D-CA-42) Ranking Member
Phone 202-225-7924
Fax N/A

Rep. Dave Min (D-CA-47)
Phone 202-225-5611
Fax 202-225-7926

Rep. Maxwell Frost (D-FL-10)
Phone 202-225-2176
Fax 202-225-0999

Rep. Raja Krishnamoorthi (D-IL-08) Health and Financial Services Subcommittee, Ranking Member
Phone 202-225-3711
Fax 202-225-7830

Rep. Kweisi Mfume (D-MD-07)
Phone 202-225-4741
Fax 202-225-3178

Rep. Ayanna Pressley (D-MA-07)
Phone 202-225-5111
Fax 202-225-9322

Rep. Stephen Lynch (D-MA-08)
Phone 202-225-8273
Fax 202-225-3984

Rep. Rashida Tlaib (D-MI-12)
Phone 202-225-5126 Fax

Rep. Wesley Bell (D-MO-01) Health and Financial Services Subcommittee
Phone 202-225-2406
Fax 202-226-3717

Rep. Melanie Stansbury (D-NM-01)
Phone 202-225-6316
Fax 202-225-4975

Rep. Shontel Brown (D-OH-11)
Phone 202-225-7032
Fax 202-225-1339

Rep. Summer Lee (D-PA-12)
Phone 202-225-2135
Fax N/A

Rep. Jasmine Crockett (D-TX-30)
Phone 202-225-8885
Fax 202-226-1477

Rep. Greg Casar (D-TX-35)
Phone 202-225-5645
Fax N/A

Rep. Suhas Subramanyam (D-VA-10)
Phone 202-225-5136
Fax 202-225-0437

Rep. Emily Randall (D-WA-06) Health and Financial Services Subcommittee
Phone 202-225-5916
Fax 202-226-3575

Rep. Eleanor Norton (D-DC-01)
Phone 202-225-8050
Fax 202-225-3002

I hope you will make calls, because, so far, this is working.

WHO public comment talking points

These talking points are from our newly minted staff member, whom we are happy to have on board….

You can find his post from yesterday here.

If you are looking for help, you might find it in the comments.

I suggest taking a quick look at the document before trying to fill it out, as the format is slightly different from what we are used to.

But generally speaking, we want these talking points to fit into their questionnaire-style public comment format, and you can decide what fits bits.

And by no means limit yourself to these points. If you think one is missing, leave it in the comments. I’m sure our list is incomplete, but the format is very different.

Main points

1. Recognize airborne transmission as the primary mode of COVID-19 spread and the primary mode of the spread of all respiratory pathogens.

2. Make clean indoor air a core component of infection prevention.

3. Center Long COVID prevention, treatment, and research.

4. Acknowledge COVID-19 as a vascular, multi-system disease with long-term impacts from viral persistence

5. Define COVID-19 as a respiratory-transmitted disease (RTD), not a respiratory disease

6. Ensure public access to adequate respiratory protection (eg, N95 respirators or better)

7. Ensure public access to effective vaccines for COVID-19 (eg, Novavax)

Thank you for taking the time to protect our public health.

If you are a new reader and want to follow up with some of my work…

• The Risk of Long COVID Explained: Feb. 11th, 2022.

• The Benefits of Novavax Explained: Nov. 26th, 2022.

• Americans Should Be Able to Get Novavax: Sept. 11th, 2023

• Our Continued Success Requires Us Building on What's Worked: Feb. 15th, 2024

Amidst this, I started doing a show multiple times a week in early 2023. We formed a group and consistently did the show to push successful direct action.

This led to presentations and direct contact with members for further action…

• VRBPAC Meeting: June 15th, 2023 - COVID

• VRBPAC Meeting: March 5th, 2024 - Influenza.

• VRBPAC Meeting: June 5th, 2024 - COVID

• VRBPAC Meeting: Sept. 20th, 2025 - Pertussis

• VRBPAC Meeting: May 22nd, 2025 - COVID

The COVID presentations employed an “inside/outside” strategy. We did the presentation “inside” the meeting, but also had the public contact from the “outside” with not only public comments but direct contact via academic emails to members.

If you are unclear, VRBPAC is a committee of the FDA and, with that, the HHS.

Our work has been cited in a few articles.

• WebMD: Sept. 11th, 2024

• Medpage Today: Nov. 18th, 2024

• Reuters: April 24th, 2025

• Boing Boing: April 25th, 2025

• Boing Boing: June 17th, 2025

Brace for Impact is on Twitter and X on Tuesdays and Thursdays at 6:00 pm PST.

You’re also welcome to join our Discord, but be prepared for a small test to enter.

Discord

This is a vast government agency for many things…

But most importantly, its structure is mandated by Congress.

This is what the agency looked like before…

And this is what the proposed agency would look like, as demonstrated by the current HHS website…

From thirty-five offices to twenty-nine.

And the thing is, that might seem small, but he’s not allowed to do this at all…

As outlined in a recent ruling by a Judge in Rhode Island regarding an earlier change.

Only Congress has the power to alter these agencies. Congress sets them up, and then the Executive branch can decide how to run them, but can’t alter them.

Which brings us to this call to action.

Currently, the Energy and Commerce Committee in the House is debating whether to accept RFK Jr.’s budget, which includes funding for this illegal restructuring.

The last hearing didn’t go so well, and he clearly purjured himself.

We need the Energy and Commerce Committee to stop RFK Jr.’s budget.

The court ruling creating the injunction only applied to the original attempt at restructuring in March. It does not stop this budgetary process…

It should, but it won’t because the court has no direct power over Congress.

However, the Committee members should vote according to this ruling because RFK Jr. is attempting to subvert the power of Congress through this budget.

Technically, the Committee has until the middle of this week to request more information from RFK Jr., but they should shut him down entirely.

We need as many people as possible to contact the Energy and Commerce members in the House to oppose approving his budget because he lacks the legal authority to restructure the HHS and is subverting the powers of Congress.

Also, contact the Senate HELP Committee to start an investigation into his actions.

CALL TO ACTION

Message to House Committee members:

RFK Jr.’s budget for significant HHS changes should not be approved, as it is not legal, and an investigation into his actions at HHS, CDC, and ACIP has been conducted.

He has already lied to Congress and cannot be treated as acting in good faith. We can assume he will continue to lie to Congress, as we saw last month.

An investigation must be held into his impropriety.

His HHS budget should not be approved while the investigation is ongoing.

We are requesting coordination with the Senate HELP Committee on these matters.

Contact for House Committee on Energy and Commerce:

Chairman Buddy Carter (R-GA): Phone: (202) 225-5831 Fax: 202-226-2269

Vice chairman Neal Dunn, MD (R-FL): Phone: (202) 225-5235 Fax: 202-225-5615

Alexandria Ocasio-Cortez (D-NY): Phone: 202-225-3965 Fax: (202)-225-1909

Diana DeGette (D-CO): Phone: (202) 225-4431 Fax: 202-225-5657

Morgan Griffith (R-VA): Phone: (202) 225-3861 Fax: 202-225-0076

Gus Bilirakis (R-FL): Phone: (202) 225-5755 Fax: 202-225-4085

Dan Crenshaw (R-TX): Phone: (202) 225-6565 Fax: 202-225-5547

Troy Balderson (R-OH): Phone: (202) 225-5355 Fax: 202-226-4523

Diana Harshbarger (R-TN): Phone: (202) 225-6356 Fax: 202-225-5714

Mariannette Miller-Meeks (R-IA): Phone: (202) 225-6576

Kat Cammack (R-FL): Phone: (202) 225-5744 Fax: (202)-225-3973

Jay Obernolte (R-CA): Phone: (202) 225-5861 Fax: (202)-225-2908

John James (R-MI): Phone: (202) 225-4961 Fax: N/A

Cliff Bentz (R-OR): Phone: (202) 225-6730 Fax: (202)-225-5774

Erin Houchin (R-IN): Phone: (202) 225-5315 Fax: (202)-226-6866

Nick Langworthy (R-NY): Phone: (202) 225-3161 Fax: (202)-226-6599

Tom Kean (R-NJ): Phone: (202) 225-5361 Fax: (202)-225-9460

Michael Rulli (R-OH): Phone: (202) 225-5705 Fax: (202)-225-5907

Brett Guthrie (R-KY): Phone: (202) 225-5705 Fax: (202)-226-2019

Raul Ruiz (D-CA): Phone: (202) 225-5330 Fax: (202)-225-1238

Debbie Dingell (D-MI): Phone: (202) 225-4071 Fax: (202)-226-0371

Robin Kelly (D-IL): Phone: (202) 225-0773 Fax: (202)-225-4583

Nanette Diaz Barragán (D-CA): Phone: (202) 225-8220 Fax: (202)-226-7290

Kim Schrier (D-WA): Phone: (202) 225-7761 Fax: (202)-225-4282

Lori Trahan (D-MA): Phone: (202) 225-3411 Fax: (202)-226-0771

Marc Veasey (D-TX): Phone: (202) 225-9897 Fax: (202)-225-9702

Lizzie Fletcher (D-TX): Phone: (202) 225-2571 Fax: (202)-226-3805 or (202)-225-4381

Jake Auchincloss (D-MA): Phone: (202) 225-5931 Fax: (202)-225-0182

Troy Carter (D-LA): Phone: (202) 225-6636 Fax: (202)-225-1988

Greg Landsman (D-OH): Phone: (202) 225-2216 Fax: (202)-225-3012

Frank Pallone (D-NJ): Phone: (202) 225-4671 Fax: (202)-225-9665

John Joyce (R-PA): Phone: (202) 225-2431 Fax: N/A

Senate HELP Committee.

Message for Senate Committee:

We are requesting a thorough investigation into RFK Jr.’s actions to subvert the powers of Congress by illegally restructuring the HHS, his removal of ACIP members, and his alleged misleading of the Senate regarding his intentions.

We are also requesting coordination with the House Committee on Energy and Commerce to prevent the approval of his HHS budget and changes until the investigation is completed.

His decisions have been made in bad faith and must be treated as such.

Senate HELP Committee Contact:

Chair Bill Cassidy (R-LA): (202) 224-5824 Fax (202)-224-6161

Bernie Sanders (I-VT): (202) 224-5141 Fax (202)-228-0776

Patty Murray (D-WA): (202) 224-2621 Fax (202)-224-0238

Tammy Baldwin (D-WI): (202) 224-5653 Fax (202)-224-9787

Christopher Murphy (D-CT): (202) 224-4041 Fax (202)-224-9750

Tim Kaine (D-VA): (202) 224-4024 Fax (202)-228-6363

Maggie Hassan (D-NH): (202) 224-3324 Fax (202)-228-0581

Ed Markey (D-MA); (202) 224-2742 Fax (202)-228-0769

Lisa Blunt Rochester (D-DE): (202) 224-2441 Fax (202)-228-2190

Susan M. Collins (R-ME): (202) 224-2523 Fax (202)-224-2693

Lisa Murkowski (R-AK): (202) 224-6665 Fax (202)-857-0322

Markwayne Mullin (R-OK): (202) 224-4721 Fax (202)-228-0380

Tim Scott (R-SC): (202) 224-6121 Fax (202)-228-5143

Jon Husted (R-OH): (202)-224-3353 Fax (202)-224-9075

Josh Hawley (R-MO): (202) 224-6154 Fax (202)-228-0526

Angela D. Alsobrooks (D-MD): (202) 224-4524 Fax (202)-228-0629

Ashley Moody (R-FL): (202) 224-3041 Fax (202)-224-0104

John Hickenlooper (D-CO): (202) 224-5941 Fax: N/A

Andy Kim (D-NJ): (202) 224-4744 Fax: N/A

Roger Marshall (R-KS): (202) 224-4774 Fax: N/A

Tommy Tuberville (R-AL): (202) 224-4124 Fax: N/A

Jim Banks (R-IN) :(202) 224-4814 Fax: N/A

Rand Paul (R-KY): (202) 224-4343 Fax: N/A

If you find any missing fax numbers, please share them in the comments.

Thank you for taking the time to protect our public health.

If you are a new reader and want to follow up with some of my work…

• The Risk of Long COVID Explained: Feb. 11th, 2022.

• The Benefits of Novavax Explained: Nov. 26th, 2022.

• Americans Should Be Able to Get Novavax: Sept. 11th, 2023

• Our Continued Success Requires Us Building on What's Worked: Feb. 15th, 2024

Amidst this, I started doing a show multiple times a week in early 2023. We formed a group and consistently did the show to push successful direct action.

This led to presentations and direct contact with members for further action…

• VRBPAC Meeting: June 15th, 2023 - COVID

• VRBPAC Meeting: March 5th, 2024 - Influenza.

• VRBPAC Meeting: June 5th, 2024 - COVID

• VRBPAC Meeting: Sept. 20th, 2025 - Pertussis

• VRBPAC Meeting: May 22nd, 2025 - COVID

The COVID presentations employed an “inside/outside” strategy. We did the presentation “inside” the meeting, but also had the public contact from the “outside” with not only public comments but direct contact via academic emails to members.

If you are unclear, VRBPAC is a committee of the FDA and, with that, the HHS.

Our work has been cited in a few articles.

• WebMD: Sept. 11th, 2024

• Medpage Today: Nov. 18th, 2024

• Reuters: April 24th, 2025

• Boing Boing: April 25th, 2025

• Boing Boing: June 17th, 2025

Discord

Both are a bit of a long shot, but neither is impossible.

Currently, two things are happening; of course, there are more than just these…

1. The Big Ugly Reconciliation Bill is moving through the Senate.

2. The House Energy and Commerce Committee is voting on RFK Jr.'s budget for restructuring the HHS.

Even though the Senate is voting on the Bill, the House bill and the Senate bill differ, and the two must be reconciled. This will take a bit.

I wrote several articles about reconciliation bills in early 2020.

Phase 1 & 2 → https://bit.ly/35z5Dh9
Phase 3 → https://bit.ly/38BWwhD
Phase 3.5 → https://bit.ly/3nBX0bR
Phase 4 → https://bit.ly/38NStz1
Phase 4.1 → https://bit.ly/38TxYAO
Phase 4.2 → https://bit.ly/2NJicR9
Phase 4.3 → https://bit.ly/3d2wJ54

Bottom line, in the hopes of saving you a lot of reading?

The Senate hopes to have the Bill passed by July 4th, but that’s far from reaching Trump’s desk. Not to diminish the risk that the Bill creates, though, and it should ultimately be stopped completely.

This bill is poised to alter the balance of power in our government.

It’s terrifying stuff.

However, just to add an additional layer of overwhelming hardship, this situation is somewhat akin to a challenge mode from a Democrat’s perspective.

This will come down entirely to the Republicans, as they currently control both houses of Congress. While calling Republicans and begging them not to let us die is a long shot, there have been more than a few moments in modern history when a Republican vote stopped their agenda.

And while that Bill still has quite a bit of process…

Stopping the budget to restructure the HHS does not.

The Energy and Commerce Committee only had nine days to submit questions for RFK Jr. after the hearing last Tuesday. Assuming that those are not all business days, that puts us at two, maybe three, days to push the Committee to not move forward with his budget until an investigation can be completed.

We had already called for an investigation last week before the meeting, and based on what we know now, an investigation by both the Senate and House is badly needed.

Congress typically has a method for extending the previous budget when a new one cannot be agreed upon. This is referred to as a “Continued Resolution” regarding the larger budget, and I am sure a similar mechanism exists for such instances.

The HHS budget and the reconciliation bill share many similarities, albeit on different scales. Both attempt to radically alter the fabric of how we interact with our government, while creating the perception of reducing waste and streamlining processes. Ultimately, only the former is true.

In the same way folks are trying to mislead us about the state of the reconciliation bill, RFK Jr. is trying to mislead Congress about his intentions with HHS changes.

This clip should bring you up to speed.
Also, follow our YouTube account.

RFK Jr. is not operating in good faith.

Talk about a headline that needs less of an explanation, right?

If you are a regular reader, you are probably wondering about my thoughts on the clown committee of an ACIP meeting that took place last week.

And to be honest, they chickened out, and it was a nothing-burger.

Not because they did the right thing, but because of the pressure they are experiencing from all the people, including everyone who responded to our previous calls to action, who have a problem with what we all know they are trying to do.

Thimerosal, for example, should have been sunsetted years ago, as it is only in 6% of our adult influenza vaccines after agreeing to remove it twenty-six years ago.

That’s a quarter of a century on a century-old product. It doesn’t matter if it is safe or whatever talking point you heard; this was low-hanging fruit for a committee under tons of scrutiny.

And it’s a preservative, not an antigen or adjuvant… We have better options now.

As for everything else, the only thing of great concern is that they expressed plans to revisit various childhood vaccines to argue for their necessity.

… Spoilers: They are necessary.

This means future ACIP meetings will almost certainly be VERY problematic.

And, hey, I agree with some of their arguments because that’s how antivaxxers’ arguments work. Just a shred of truth, but no real solutions. I agree that we give a lot of vaccines very early, and that’s only necessary with our capitalist cycle that forces new mothers back into the workforce and children into daycare.

Hep B at birth is one of the ones they are focused on.

Does Hep B spread easily at home? Well, not really.

Can Hep B spread like wildfire at daycares? … I don’t have words to express the issue.

Of course, tons of information will tell you it’s not a thing… because of vaccinations.

Therefore, we vaccinate automatically at birth because it overall reduces the risk of severe disease. Remember, it’s a multi-step vaccine as well. So, we’re throwing a hot dog down the hallway, trying our best to limit the risk of an infant being hospitalized.

Is this the absolute best way to handle things? Probably not.

But a sick child, and worse, an infant, is the worst imaginable thing for a parent.

Even then, I’m still willing to reexamine things like this, given that we can change other aspects that the committee cannot control, perhaps with the help of Congress.

However, the reality is that this is the world we live in, and this Committee is not responsible for matters that Congress should address to improve everyone’s life.

Should we change that? Yes, absolutely.

Is that the role of this Committee? Not even a little bit.

Do none of these people actually care about making people’s lives better?

Making people’s lives better is completely left out of their equation.

The ACIP Committee makes decisions based on what will cut disease and save lives, primarily through the lens of reducing hospitalizations.

While I think that doesn’t go far enough, that’s further than these new clowns want.

These new committee members appear to be committed to creating an environment that benefits wellness influencers the most. That’s the wrong environment.

When the wrong environment is fostered, we all lose.

This is why we need to support Senator Rochestor’s Bill to reform ACIP by reinstating the former approved members and making it illegal to change it in this way later.

While this may not solve our problems right now, it could be a lot of help later.

So, when it comes to the reconciliation bill, please take action wherever you see it.

Calling House members or Senators is likely going to be the call to action.

But for the HHS budget that will restructure the entire agency?

We only have a few days.

Please contact these representatives in any way you can.

Since we included Fax lines, we have also included a free online fax service.

https://faxzero.com/fax_senate.php allows 50 free faxes with a trial account.

If you are having trouble writing your message, imagine you’re arguing with someone on social media. It’s basically the same thing.

CALL TO ACTION

Message to House Committee members:

RFK Jr.’s budget for significant HHS changes cannot be approved until an investigation into his actions at HHS, CDC, and ACIP has been conducted.

He has already lied to Congress and cannot be treated as acting in good faith. We can assume he will continue to lie to Congress, as we saw last week.

An investigation must be held into his impropriety.

His HHS budget should be put on hold until the investigation is concluded.

We are requesting coordination with the Senate HELP Committee on these matters.

Contact for House Committee on Energy and Commerce:

Chairman Buddy Carter (R-GA): Phone: (202) 225-5831 Fax: 202-226-2269

Vice chairman Neal Dunn, MD (R-FL): Phone: (202) 225-5235 Fax: 202-225-5615

Alexandria Ocasio-Cortez (D-NY): Phone: 202-225-3965 Fax: (202)-225-1909

Diana DeGette (D-CO): Phone: (202) 225-4431 Fax: 202-225-5657

Morgan Griffith (R-VA): Phone: (202) 225-3861 Fax: 202-225-0076

Gus Bilirakis (R-FL): Phone: (202) 225-5755 Fax: 202-225-4085

Dan Crenshaw (R-TX): Phone: (202) 225-6565 Fax: 202-225-5547

Troy Balderson (R-OH): Phone: (202) 225-5355 Fax: 202-226-4523

Diana Harshbarger (R-TN): Phone: (202) 225-6356 Fax: 202-225-5714

Mariannette Miller-Meeks (R-IA): Phone: (202) 225-6576

Kat Cammack (R-FL): Phone: (202) 225-5744 Fax: (202)-225-3973

Jay Obernolte (R-CA): Phone: (202) 225-5861 Fax: (202)-225-2908

John James (R-MI): Phone: (202) 225-4961 Fax: N/A

Cliff Bentz (R-OR): Phone: (202) 225-6730 Fax: (202)-225-5774

Erin Houchin (R-IN): Phone: (202) 225-5315 Fax: (202)-226-6866

Nick Langworthy (R-NY): Phone: (202) 225-3161 Fax: (202)-226-6599

Tom Kean (R-NJ): Phone: (202) 225-5361 Fax: (202)-225-9460

Michael Rulli (R-OH): Phone: (202) 225-5705 Fax: (202)-225-5907

Brett Guthrie (R-KY): Phone: (202) 225-5705 Fax: (202)-226-2019

Raul Ruiz (D-CA): Phone: (202) 225-5330 Fax: (202)-225-1238

Debbie Dingell (D-MI): Phone: (202) 225-4071 Fax: (202)-226-0371

Robin Kelly (D-IL): Phone: (202) 225-0773 Fax: (202)-225-4583

Nanette Diaz Barragán (D-CA): Phone: (202) 225-8220 Fax: (202)-226-7290

Kim Schrier (D-WA): Phone: (202) 225-7761 Fax: (202)-225-4282

Lori Trahan (D-MA): Phone: (202) 225-3411 Fax: (202)-226-0771

Marc Veasey (D-TX): Phone: (202) 225-9897 Fax: (202)-225-9702

Lizzie Fletcher (D-TX): Phone: (202) 225-2571 Fax: (202)-226-3805 or (202)-225-4381

Jake Auchincloss (D-MA): Phone: (202) 225-5931 Fax: (202)-225-0182

Troy Carter (D-LA): Phone: (202) 225-6636 Fax: (202)-225-1988

Greg Landsman (D-OH): Phone: (202) 225-2216 Fax: (202)-225-3012

Frank Pallone (D-NJ): Phone: (202) 225-4671 Fax: (202)-225-9665

John Joyce (R-PA): Phone: (202) 225-2431 Fax: N/A

Senate HELP Committee.

Message for Senate Committee:

We are requesting a thorough investigation into RFK Jr.’s actions regarding ACIP and his alleged misleading of the Senate regarding his intentions. We are also requesting coordination with the House Committee on Energy and Commerce to prevent the approval of his HHS budget and changes until the investigation is completed.

We also request that the investigation include his unilateral changes to COVID vaccine recommendations without proper oversight from the ACIP, his removal of the Federal oversight officer, and his limitation of public comment, both oral and written.

His decisions have been made in bad faith and must be treated as such.

Senate HELP Committee Contact:

Chair Bill Cassidy (R-LA): (202) 224-5824 Fax (202)-224-6161

Bernie Sanders (I-VT): (202) 224-5141 Fax (202)-228-0776

Patty Murray (D-WA): (202) 224-2621 Fax (202)-224-0238

Tammy Baldwin (D-WI): (202) 224-5653 Fax (202)-224-9787

Christopher Murphy (D-CT): (202) 224-4041 Fax (202)-224-9750

Tim Kaine (D-VA): (202) 224-4024 Fax (202)-228-6363

Maggie Hassan (D-NH): (202) 224-3324 Fax (202)-228-0581

Ed Markey (D-MA); (202) 224-2742 Fax (202)-228-0769

Lisa Blunt Rochester (D-DE): (202) 224-2441 Fax (202)-228-2190

Susan M. Collins (R-ME): (202) 224-2523 Fax (202)-224-2693

Lisa Murkowski (R-AK): (202) 224-6665 Fax (202)-857-0322

Markwayne Mullin (R-OK): (202) 224-4721 Fax (202)-228-0380

Tim Scott (R-SC): (202) 224-6121 Fax (202)-228-5143

Jon Husted (R-OH): (202)-224-3353 Fax (202)-224-9075

Josh Hawley (R-MO): (202) 224-6154 Fax (202)-228-0526

Angela D. Alsobrooks (D-MD): (202) 224-4524 Fax (202)-228-0629

Ashley Moody (R-FL): (202) 224-3041 Fax (202)-224-0104

John Hickenlooper (D-CO): (202) 224-5941 Fax: N/A

Andy Kim (D-NJ): (202) 224-4744 Fax: N/A

Roger Marshall (R-KS): (202) 224-4774 Fax: N/A

Tommy Tuberville (R-AL): (202) 224-4124 Fax: N/A

Jim Banks (R-IN) :(202) 224-4814 Fax: N/A

Rand Paul (R-KY): (202) 224-4343 Fax: N/A

If you find any missing fax numbers, please share them in the comments.

Thank you for taking the time to protect our public health.

If you are a new reader and want to follow up with some of my work…

• The Risk of Long COVID Explained: Feb. 11th, 2022.

• The Benefits of Novavax Explained: Nov. 26th, 2022.

• Americans Should Be Able to Get Novavax: Sept. 11th, 2023

• Our Continued Success Requires Us Building on What's Worked: Feb. 15th, 2024

Amidst this, I started doing a show multiple times a week in early 2023. We formed a group and consistently did the show to push successful direct action.

This led to presentations and direct contact with members for further action…

• VRBPAC Meeting: June 15th, 2023 - COVID

• VRBPAC Meeting: March 5th, 2024 - Influenza.

• VRBPAC Meeting: June 5th, 2024 - COVID

• VRBPAC Meeting: Sept. 20th, 2025 - Pertussis

• VRBPAC Meeting: May 22nd, 2025 - COVID

The COVID presentations employed an “inside/outside” strategy. We did the presentation “inside” the meeting, but also had the public contact from the “outside” with not only public comments but direct contact via academic emails to members.

If you are unclear, VRBPAC is a committee of the FDA and, with that, the HHS.

Our work has been cited in a few articles.

• WebMD: Sept. 11th, 2024

• Medpage Today: Nov. 18th, 2024

• Reuters: April 24th, 2025

• Boing Boing: April 25th, 2025

• Boing Boing: June 17th, 2025

Discord

This one is for TODAY, June 24th, 2025, and needs immediate action.

Business starts at 9 am Eastern time, but you can leave a voicemail or fax earlier.

Please share widely because this is a pivot, and we need to turn up the pressure.

This is one of the final steps in a long journey to shut down ACIP and possibly start the process to shut down RFK Jr. completely, or at least rein him in.

If you didn’t know, our push to get Senator Cassidy to acknowledge the meeting should be halted was successful. You can read the earlier article here.

Also, quick reminder that we have our Brace for Impact show today, you can RSVP here.

But this does not shut down the meeting on its own.

Technically, the Senate has no mechanism to stop the meeting other than to launch an investigation that causes RFK Jr. to shut the meeting down preemptively…

So, there is a good chance the meeting will still happen, but we need to invalidate it at every level so the recommendations can’t have real-world consequences.

Some insurance groups have already said they won’t let it affect them paying for vaccines, but I trust them as far as I can throw them.

Also, a Senate bill is in motion to reverse the decision and prevent this in the future.

However, stopping the meeting entirely would be better.

That can only happen if the House and Senate are willing to join together to start the investigative process, creating enough pressure that RFK Jr. will be forced to act.

This is more or less where we have gotten ourselves with one day to spare.

To be fair, I don’t hate everything that RFK Jr. is proposing; we are already seeing positive changes in our food. While those changes should stay, other proposed changes lack the rigorous science that his claims about food hold.

By the way, if you didn’t know that most of our commercialized food is unhealthy, talk to literally anyone from any other country for just a few minutes about their food.

If he wants to make these changes, he should use the process and prove the science.

The process that many call too slow, which is very slow, is actually good.

Yes, it could be streamlined, but not at the cost of limiting the public’s voice.

Democracy isn’t voting once every four years; it involves even small daily decisions.

And remember, one of his first acts as HHS Secretary was to limit public comments.

Not only that, we haven’t spoken to anyone approved for oral comments for this ACIP meeting, which means they might not have approved anyone at all. We shall see.

I have this feeling that they only approved people who would approve of them, so they would sing their praises while they tear down years of work on vaccines.

This brings me to the idea that this process needs to be slowed down, and we can’t let them slip through harmful regulations because everyone is distracted by war.

So, let’s stay focused on our call to action.

We already have acknowledgment that this meeting should not be allowed to affect recommendations, and the HELP committee has added a hearing for Wednesday morning that will begin the process to approve the nominated CDC Director.

Her name is Susan Moranaz, and she seems alright, at least better than the last one they tried to get approved. This is at the same time as Day 1 of ACIP.

Though worth pointing out, she does not have a medical degree, which would be a first since 1953. However, she’s not what we’re here to talk about.

RFK Jr. has been called in for a different hearing, but this time in the House.

The Committee on Energy and Commerce, the oldest committee in the House, is meeting with RFK Jr. to discuss his budget plans for HHS.

This budget includes significant changes to many health systems.

But why is this happening?

In previous meetings, RFK Jr. was allowed to operate in what is known as “good faith.” He wanted to make significant changes, but promised to do it as the phrase says … in good faith, which is why the Senate and House permit his actions.

However, his shake-up at ACIP after promising Cassidy he would not do that exact thing proves that he is NOT OPERATING IN GOOD FAITH…

That’s the tip of the iceberg at this point, and he’s trying to sink the ship.

Consequently, the House Committee should treat him as such.

This is significant because it’s the difference between being a hostile witness and not.

He should not be allowed to make these changes at HHS.

His budget should be on hold until his actions are investigated.

And some of these changes are significant; you can read them here.

Someone operating in bad faith cannot be allowed to make changes like these.

CALL TO ACTION

There are two rounds of phone calls here.

First is the House committee, which meets first thing TODAY.

Then we want to continue contacting Senate HELP members to start an investigation.

Since we included Fax lines, we have also included a free way to fax online.

https://faxzero.com/fax_senate.php allows 50 free faxes with a trial account.

Message to House Committee members:

RFK Jr.’s budget for significant HHS changes cannot go through until an investigation into his actions at ACIP is conducted. He has already lied to Congress and cannot be treated as acting in good faith. We can assume he will continue to lie to Congress, so an extra level of scrutiny and hearings must be applied to his Committee hearings if he continues to act as a bad-faith actor.

His HHS budget should be put on hold until an investigation can be concluded. We are asking for coordination with the Senate HELP committee on these matters.

Contact for House Committee on Energy and Commerce:

Chairman Buddy Carter (R-GA): Phone: (202) 225-5831 Fax: 202-226-2269

Vice chairman Neal Dunn, MD (R-FL): Phone: (202) 225-5235 Fax: 202-225-5615

Alexandria Ocasio-Cortez (D-NY): Phone: 202-225-3965 Fax: (202)-225-1909

Diana DeGette (D-CO): Phone: (202) 225-4431 Fax: 202-225-5657

Morgan Griffith (R-VA): Phone: (202) 225-3861 Fax: 202-225-0076

Gus Bilirakis (R-FL): Phone: (202) 225-5755 Fax: 202-225-4085

Dan Crenshaw (R-TX): Phone: (202) 225-6565 Fax: 202-225-5547

Troy Balderson (R-OH): Phone: (202) 225-5355 Fax: 202-226-4523

Diana Harshbarger (R-TN): Phone: (202) 225-6356 Fax: 202-225-5714

Mariannette Miller-Meeks (R-IA): Phone: (202) 225-6576

Kat Cammack (R-FL): Phone: (202) 225-5744 Fax: (202)-225-3973

Jay Obernolte (R-CA): Phone: (202) 225-5861 Fax: (202)-225-2908

John James (R-MI): Phone: (202) 225-4961 Fax: N/A

Cliff Bentz (R-OR): Phone: (202) 225-6730 Fax: (202)-225-5774

Erin Houchin (R-IN): Phone: (202) 225-5315 Fax: (202)-226-6866

Nick Langworthy (R-NY): Phone: (202) 225-3161 Fax: (202)-226-6599

Tom Kean (R-NJ): Phone: (202) 225-5361 Fax: (202)-225-9460

Michael Rulli (R-OH): Phone: (202) 225-5705 Fax: (202)-225-5907

Brett Guthrie (R-KY): Phone: (202) 225-5705 Fax: (202)-226-2019

Raul Ruiz (D-CA): Phone: (202) 225-5330 Fax: (202)-225-1238

Debbie Dingell (D-MI): Phone: (202) 225-4071 Fax: (202)-226-0371

Robin Kelly (D-IL): Phone: (202) 225-0773 Fax: (202)-225-4583

Nanette Diaz Barragán (D-CA): Phone: (202) 225-8220 Fax: (202)-226-7290

Kim Schrier (D-WA): Phone: (202) 225-7761 Fax: (202)-225-4282

Lori Trahan (D-MA): Phone: (202) 225-3411 Fax: (202)-226-0771

Marc Veasey (D-TX): Phone: (202) 225-9897 Fax: (202)-225-9702

Lizzie Fletcher (D-TX): Phone: (202) 225-2571 Fax: (202)-226-3805 or (202)-225-4381

Jake Auchincloss (D-MA): Phone: (202) 225-5931 Fax: (202)-225-0182

Troy Carter (D-LA): Phone: (202) 225-6636 Fax: (202)-225-1988

Greg Landsman (D-OH): Phone: (202) 225-2216 Fax: (202)-225-3012

Frank Pallone (D-NJ): Phone: (202) 225-4671 Fax: (202)-225-9665

John Joyce (R-PA): Phone: (202) 225-2431 Fax: N/A

Senate HELP Committee.

Message for Senate Committee:

We are asking for a full investigation into RFK Jr.’s actions regarding ACIP and misleading the Senate on his intentions. We are also asking for coordination with the House Committee on Energy and Commerce to prevent his HHS budget and changes from being approved until the investigation can be completed.

This ACIP meeting needs to be shut down or made nonbinding, and the former members should be reinstated until new members can be vetted and approved.

We also ask the investigation to include his unilateral changes to COVID vaccine recommendations without proper ACIP oversight, his removal of the Federal oversight officer, and limiting public comment, both oral and written.

These are bad faith decisions and must be treated as such.

Senate HELP Committee Contact:

Chair Bill Cassidy (R-LA): (202) 224-5824 Fax (202)-224-6161

Bernie Sanders (I-VT): (202) 224-5141 Fax (202)-228-0776

Patty Murray (D-WA): (202) 224-2621 Fax (202)-224-0238

Tammy Baldwin (D-WI): (202) 224-5653 Fax (202)-224-9787

Christopher Murphy (D-CT): (202) 224-4041 Fax (202)-224-9750

Tim Kaine (D-VA): (202) 224-4024 Fax (202)-228-6363

Maggie Hassan (D-NH): (202) 224-3324 Fax (202)-228-0581

Ed Markey (D-MA); (202) 224-2742 Fax (202)-228-0769

Lisa Blunt Rochester (D-DE): (202) 224-2441 Fax (202)-228-2190

Susan M. Collins (R-ME): (202) 224-2523 Fax (202)-224-2693

Lisa Murkowski (R-AK): (202) 224-6665 Fax (202)-857-0322

Markwayne Mullin (R-OK): (202) 224-4721 Fax (202)-228-0380

Tim Scott (R-SC): (202) 224-6121 Fax (202)-228-5143

Jon Husted (R-OH): (202)-224-3353 Fax (202)-224-9075

Josh Hawley (R-MO): (202) 224-6154 Fax (202)-228-0526

Angela D. Alsobrooks (D-MD): (202) 224-4524 Fax (202)-228-0629

Ashley Moody (R-FL): (202) 224-3041 Fax (202)-224-0104

John Hickenlooper (D-CO): (202) 224-5941 Fax: N/A

Andy Kim (D-NJ): (202) 224-4744 Fax: N/A

Roger Marshall (R-KS): (202) 224-4774 Fax: N/A

Tommy Tuberville (R-AL): (202) 224-4124 Fax: N/A

Jim Banks (R-IN) :(202) 224-4814 Fax: N/A

Rand Paul (R-KY): (202) 224-4343 Fax: N/A

If you find any missing fax numbers, please share them in the comments.

Thank you for taking the time to protect our public health.

One more thing…

If you are a New York City voter, vote for Zohran Mamdani, but don’t rank Cuomo.

If you are a new reader and want to follow up with some of my work…

• The Risk of Long COVID Explained: Feb. 11th, 2022.

• The Benefits of Novavax Explained: Nov. 26th, 2022.

• Americans Should Be Able to Get Novavax: Sept. 11th, 2023

• Our Continued Success Requires Us Building on What's Worked: Feb. 15th, 2024

Amidst this, I started doing a show multiple times a week in early 2023. We formed a group and consistently did the show to push successful direct action.

This led to presentations and direct contact with members for further action…

• VRBPAC Meeting: June 15th, 2023 - COVID

• VRBPAC Meeting: March 5th, 2024 - Influenza.

• VRBPAC Meeting: June 5th, 2024 - COVID

• VRBPAC Meeting: Sept. 20th, 2025 - Pertussis

• VRBPAC Meeting: May 22nd, 2025 - COVID

The COVID presentations were based on an “inside/outside” strategy. We did the presentation “inside” the meeting, but also had the public contact from the “outside” with not only public comments but direct contact via academic emails to members.

If you are unclear, VRBPAC is a committee of the FDA and, with that, the HHS.

Our work has been cited in a few articles.

• WebMD: Sept. 11th, 2024

• Medpage Today: Nov. 18th, 2024

• Reuters: April 24th, 2025

• Boing Boing: April 25th, 2025

• Boing Boing: June 17th, 2025

Discord

The People's Strategist is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.

(Original article begins here.)

I’m not going to waste anyone’s time.

RFK Jr.’s plans for the upcoming ACIP are… well, it’s just a “who’s who” of anti-vaxxer conspiracies with a stacked kangaroo court of sycophants, after having dismantled all the safeguards, oversight, and expertise typically required to make these decisions.

We need to call Senators on the HELP committee to shut down the upcoming ACIP.

You probably already know that RFK Jr. fired the entire ACIP and stacked the committee with ideologues who are not being adequately approved by any measure.

It should take months to approve these roles, and there’s no way to do it this fast.

But there is also no Senate-approved CDC director, a requirement only started in 2022.

RFK Jr. also removed the oversight officer; his scheduler will handle that role instead.

So, he has removed all the oversight mechanisms, leaving him as the sole power.

Usually, I would have to spend a lot of time convincing you, the reader, that there is a problem. However, not only is this straightforward, but MANY articles are being published to explain this problem in great detail this time.

I don’t think this will harm Novavax access, but it’s not just about that…

And it never was.

So, what’s going on?

Although what they're trying to do is a huge problem, technically, they can do it.

However, how they are trying to do it is the bigger issue.

It’s like a kid caught lying, and they tell more lies to cover up the last one, until they end up just creating an alternate dimension to live in…

And that’s really true here.

First, they made the COVID recommendation without ACIP, and rather than just secure ACIP voting, they wiped the whole committee and went full anti-vaxxer.

And make no mistake, this meeting is set to be two days of anti-vaxxer tropes.

This meeting cannot happen, and that doesn’t give us many options as the public.

The closest we can come to directly affecting some oversight mechanism is to pressure the HELP committee and its surrounding Senate members to call an immediate hearing regarding RFK Jr. and his changes being made for ACIP.

We’ve already had people calling all week, and some appetite exists for this.

There are people in power already calling for this, but it just needs a bit more.

The HELP committee is currently led by Bill Cassidy, the same Cassidy who is not only one of four physicians in the Senate, but also who RFK Jr. promised that he would not radically change ACIP.

I’m unsure if that’s perjury, but I can confidently say he lied.

We want to contact Cassidy’s office, other members of the HELP committee, and your personal sitting Senator.

If you are contacting someone on a specific committee, anyone can call any Senator. However, if it is a more general vote, you want to call your own.

But no one’s stopping you from calling them all anyway.

We call these lines Today and Monday, and on Saturday and Sunday, we will fax.
(Fax numbers are still being verified at the time of publishing.)

Contacts to the Senate HELP Committee Members:

Bill Cassidy (R-LA, Chairman) (202) 224-5824

Bernie Sanders (I-VT) (202) 224-5141

Patty Murray (D-WA) (202) 224-2621

Tammy Baldwin (D-WI) (202) 224-5653

Christopher Murphy (D-CT) (202) 224-4041

Tim Kaine (D-VA) (202) 224-4024

Maggie Hassan (D-NH) (202) 224-3324

John Hickenlooper (D-CO) (202) 224-5941

Ed Markey (D-MA) (202) 224-2742

Andy Kim (D-NJ) (202) 224-4744

Lisa Blunt Rochester (D-DE) (202) 224-2441

Angela Alsobrooks (D-MD) (202) 224-4524

Rand Paul (R-KY) (202) 224-4343

Susan M. Collins (R-ME) (202) 224-2523

Lisa Murkowski (R-AK) (202) 224-6665

Markwayne Mullin (R-OK) (202) 224-4721

Roger Marshall (R-KS) (202) 224-4774

Tim Scott (R-SC) (202) 224-6121

Josh Hawley (R-MO) (202) 224-6154

Tommy Tuberville (R-AL) (202) 224-4124

Jim Banks (R-IN) (202) 224-4814

Jon Husted (R-OH) (202)-224-3353

Ashley Moody (R-FL) (202) 224-3041

Fax Numbers (update) + Extra numbers

Here is a online fax option that lets you contact Senators for free.
https://faxzero.com/fax_senate.php

Bernie Sanders (I-VT) (202) 224-5141 Fax 202-228-0776

Patty Murray (D-WA) (202) 224-2621 Fax 202-224-0238

Tammy Baldwin (D-WI) (202) 224-5653 Fax 202-224-9787

Christopher Murphy (D-CT) (202) 224-4041 Fax 202-224-9750

Tim Kaine (D-VA) (202) 224-4024 Fax 202-228-6363

Maggie Hassan (D-NH) (202) 224-3324 Fax 202-228-0581

Ed Markey (D-MA) (202) 224-2742 Fax 202-228-0769

Lisa Blunt Rochester (D-DE) (202) 224-2441 Fax 202-228-2190

Bill Cassidy (R-LA) (202) 224-5824 Fax 202-224-6161

Susan M. Collins (R-ME) (202) 224-2523 Fax 202-224-2693

Lisa Murkowski (R-AK) (202) 224-6665 Fax 877-857-0322

Markwayne Mullin (R-OK) (202) 224-4721 Fax 202-228-0380

Tim Scott (R-SC) (202) 224-6121 Fax 202-228-5143

Jon Husted (R-OH) (202)-224-3353 Fax 202-224-9075

Josh Hawley (R-MO) (202) 224-6154 Fax 202-228-0526

Angela D. Alsobrooks (D-MD) (202) 224-4524 Fax 202-228-0629

Ashley Moody (R-FL) (202) 224-3041 Fax 202-224-0104

Still unconfirmed or no fax: John W. Hickenlooper (D-CO) Andy Kim (D-NJ) Roger Marshall (R-KS) Tommy Tuberville (R-AL) Jim Banks (R-IN)

Item points.

1. The ACIP meeting must be immediately cancelled.

2. Sign on and support Rochester’s bill to reinstate the former members.

3. A hearing must be called for RFK Jr to appear by Tuesday of next week.

4. An investigation must be opened into the firings (Bernie/AMA supported).

Here’s an example of what the faxes have looked like…

You can tell it’s a real fax based on how crooked it is, lol.

ACTION ITEMS FOR PHONE CALLS

First, call Bill Cassidy’s office and ask him to call an immediate hearing before next week's ACIP meeting so RFK Jr. can explain why he misled the Senator.

Then, call the rest of the HELP committee and ask them to pressure Bill Cassidy to schedule an immediate hearing with RFK Jr. before the ACIP meeting.

The presentations for the meeting should be done, and RFK Jr. should explain to the Senator what they plan to vote on.

Right now, their focus appears to be on removing former recommendations.

While a few of the products could be phased out with replacements, this is certainly not the right way to make this change, nor are these the right people to do it.

I’ve spent the last two years advocating for improvements in vaccine policy, and this is by no means the right way to do anything regarding vaccine policy.

But folks are distracted right now.

Folks are rightfully distracted by the Middle East conflict, but it’s much easier to stop the meeting than fix the aftermath. If other countries follow these kangaroo court recommendations, there could be lasting ramifications.

Even if we rectify it at home, that might not fix it in other countries.

These proposed changes could set a precedent for other countries while limiting insurance company coverage here at home. We’ve already seen it happen.

We can predict what the proposed changes are likely to be because these people have publicly expressed their unqualified opinions numerous times.

The thing to focus on is how wildly unqualified they are.

And when comparing the two committees, these are specifically unqualified people.

The Charter also requires an explicit membership overlap to build on previous committees' work. That means specifically not wiping the committee in one move in the exact way that just happened.

So, wiping the whole committee shows a great deal of intention.

What has the response been?

The AMA has called for the reinstatement of the former members.

Bernie has called for an immediate investigation into RFK Jr.’s actions.

22 Senators signed a letter about the matter.

RFK Jr. first responded with papers with fake citations.

Then he fixed the citations, but now the people he nominated don’t actually work at the places he said they did… It just keeps going and going.

We have information on every member, and there’s not enough time to discuss how bad they are. However, this has spawned some progress in at least one way.

A bill is being pushed to reverse what’s happening but also require cause to remove ACIP members in the future, removing the power to alter the committee with a heavy hand, and codifying the ACIP, making it illegal to try this in the future.

While well-intentioned and needed, Congress does not have the “appetite” for this type of bill, especially not in this climate.

Not only that, even if there were, it wouldn’t come in time to change something next week, but it does fit nicely into a “backup plan” scenario.

So, we should certainly try, but hopefully we can get this stopped first.

We did not come to this decision lightly.

I have been generally patient with the changes at HHS, even willing to work around the new COVID vaccine policies as long as specific regulations stayed in place.

But as we looked into these members, it just got worse and worse.

Also, claims are being made that “this needed to happen for a long time,” meaning an overhaul at ACIP. This is nonsense because, through our activism, we helped reset the entire committee just last year.

RFK Jr. was already coming into a mostly clean slate with one member rolling over to lead the group. He has the right to change the committee, but like many of his claims, there is no truth to the idea of long-term corruption from the members.

They simply hadn’t been there long enough, and the rules were updated to be more stringent in 2022, so even his understanding of what is possible is wrong.

The removed ACIP members shared their thoughts in a recent publication.

As far as I can tell, the corruption RFK Jr. describes happens at the FDA and CBER.

I don’t even disagree that there are problems with approvals; that’s been our whole thing here for the last few years, as we tried to get a better COVID vaccine approved.

However, how he describes the process is not how it functions.

And now they have released the agenda for a three-day meeting, laying out two of the days. I'm not sure if that means we get a surprise day or if they don’t realize it was planned for three days… It’s anyone's guess at this point.

However, what they have laid out reads like a complete nightmare…

They are primarily revisiting already approved vaccines. I expected this from them, but didn’t expect them to try to finish it in their first meeting with a stacked group.

He knows that he could never get this done in a normal situation, so he had to rig it.

I have already said that some of their complaints about certain aspects of vaccines have the tiniest merit of truth. So, if we can phase them out, we might as well.

For the MMRV vaccine, for example, they are likely to discuss that the risk of AE doubles when MMR is combined with Varicella to make the MMRV vaccine.

This is true.

But it’s the difference of 4 in 10,000 or 9 in 10,000. These are exceedingly rare cases.

There may be an argument to improve upon those vaccines or phase in a new one. However, they aren’t going to discuss phasing out or replacing current vaccines; this is going to be about restricting children's access to current vaccines.

To be fair, the conversation about Thimerosal will likely be a phasing-out process, as only around 6% of influenza vaccines still use the quantity that raises concerns.

However, that’s really just a small part of the problems for next week..

Seeing the agenda item list as it stands is just a lineup of all the things the anti-vaxxer community has been talking about for decades. Going after adjuvants with mercury or aluminum is precisely what I warned about in my Influenza presentation last year.

On one hand, it might be funny to watch these idiots try to explain themselves in a professional setting like a bunch of children playing house…

On the other hand, there will be real-world consequences if this goes through.

Please take a moment and call the Senators.

We are also leaving public comment until the close of business today.

Link for Public Comment

We will follow up with fax numbers for Senators on Saturday.

If you are a new reader and want to follow up with some of my work…

• The Risk of Long COVID Explained: Feb. 11th, 2022.

• The Benefits of Novavax Explained: Nov. 26th, 2022.

• Americans Should Be Able to Get Novavax: Sept. 11th, 2023

• Our Continued Success Requires Us Building on What's Worked: Feb. 15th, 2024

Amidst this, I started doing a show multiple times a week in early 2023. We then formed a group and consistently did the show to push direct action.

This led to presentations and direct contact with members for further action…

• VRBPAC Meeting: June 15th, 2023 - COVID

• VRBPAC Meeting: March 5th, 2024 - Influenza.

• VRBPAC Meeting: June 5th, 2024 - COVID

• VRBPAC Meeting: Sept. 20th, 2025 - Pertussis

• VRBPAC Meeting: May 22nd, 2025 - COVID

The COVID presentations were based on an “inside/outside” strategy. We did the presentation “inside” the meeting, but also had the public contact from the “outside” with not only public comments but direct contact via academic emails to members.

If you are unclear, VRBPAC is a committee of the FDA and, with that, the HHS.

Our work has been cited in a few articles.

• WebMD: Sept. 11th, 2024

• Medpage Today: Nov. 18th, 2024

• Reuters: April 24th, 2025

• Boing Boing: April 25th, 2025

• Boing Boing: June 17th, 2025

Discord

There are just a few days until the first steps and weeks for the following steps.

If you want clarity on where we are, here is a clip from our show, Brace for Impact, with a direct quote from Novavax’s investor call.

You can also cut through all that garbage from the WSJ by reading this accurate article on where Novavax actually is. Spoilers: It’s not as bad as they made it out to be.

We need to move fast, and our moves now are critical.

What happens with these earlier moves will decide the effectiveness of our later actions. We can do it, but I have to cover some of the *eyeroll* old stuff first.

I hate writing this part of the article, where I try to prove why you should listen to me by demonstrating all our work. At this point, there is so much material that simply explaining it creates a text wall as long as most other writers’ articles alone.

This is what you need to know about us…

I, and now we, have been working on Novavax access for four years. During that time, our group's actions have played a pivotal role in ensuring vaccine access worldwide.

Or at least protecting whatever we could hold on to.

Some folks complain that I don’t post sources, but they only look at my Twitter.

I first wrote articles… These are the main ones.

• The Risk of Long COVID Explained: Feb. 11th, 2022.

• The Benefits of Novavax Explained: Nov. 26th, 2022.

• Americans Should Be Able to Get Novavax: Sept. 11th, 2023.

• Our Continued Success Requires Us Building on What's Worked: Feb. 15th, 2024.

Amidst this, I started doing a show multiple times a week in early 2023. We then formed a group and consistently did the show to push direct action.

This led to presentations and direct contact with members for further action…

• VRBPAC Meeting: June 15th, 2023 - COVID

• VRBPAC Meeting: March 5th, 2024 - Influenza.

• VRBPAC Meeting: June 5th, 2024 - COVID

• VRBPAC Meeting: Sept. 20th, 2025 - Pertussis

The COVID presentations were based on an “inside/outside” strategy. We did the presentation “inside” the meeting, but also had the public contact from the “outside” with not only public comments but direct contact via academic emails to members.

If you are unclear, VRBPAC is a committee of the FDA and, with that, the HHS.

Our work has been cited in a few articles.

• WebMD: Sept. 11th, 2024

• Medpage Today: Nov. 18th, 2024

• Reuters: April 24th, 2025

This has not been limited to Novavax; it has encompassed all types of public health pushes for better quality safety measures across the board.

We’ve been lucky to have more success than other groups.

And we need to do it again.

This is where I say some hokey crap like “we need your help to do it…”… but we don’t.

If you want to help, that’s fantastic, but we already have enough people; while we could use more, we have enough.

If you are already convinced, great; if you aren’t, I won’t be trying anymore.

Not here at least.

I have an extremely detailed article coming up; you’ll just have to wait for that.

So, here’s the deal.

We have a bunch of things happening at once, and they are moving very quickly.

As in, right now, quickly.

After months of silence and cancelled meetings, we finally got our VRBPAC meeting to pick COVID variants for later this year.

Important note: This means we will have updated vaccines this year, or at least the process is starting. Influenza vaccines were settled on earlier this year, so let’s put that fear aside. However, it’s looking like an “updated” vaccine might not be what this moment calls for.

Typically, we would have at least a month's warning. However, because of public pressure, this meeting was only dropped on us last week, and they have decided to try to make our work less effective by playing games with how public comment works.

We can submit public comments until the 23rd, the day after the meeting.

However, you only have until May 14th at noon Eastern time to submit public comments supporting Novavax and have it shown to the committee.

I’m releasing this on May 12th, so there’s not much time to submit comments.

You can post your public comment here → https://www.federalregister.gov/documents/2025/05/08/2025-08083/vaccines-and-related-biological-products-advisory-committee-notice-of-meeting-establishment-of-a#open-comment

(This information will all be posted again at the bottom.)

That’s less than two days to get a comment before the committee.

Did that freak you out? Good.

It definitely should… However, we already have a plan for this.

While they are limiting the comments that will be shown to committee members, we have those members’ emails and will contact them directly.

So, this won’t stop us much… that all being said, comment right now.

The basic demands for the FDA are as follows…

These were our earlier demands, which have evolved a bit over time.

As we get closer to the meeting, this will change slightly.

These demands will likely include permission for Novavax to stay with JN.1.

I don’t know what Novavax will do and have not communicated with them.

This is not being said out of convenience, but rather a firm grasp on the situation.

Also, the new FDA and HHS are making strange demands for placebo testing that could inhibit vaccine availability this year.

At the same time, mRNA manufacturers will likely need to update to closer variants as they don’t have the same range as Novavax, which puts them in a tough spot.

For the record, placebo testing is required to prove that treatments work. The multi-phase trials process for vaccines is already designed to demonstrate effectiveness.

While their interpretations could use work, generally, this process works well.

Vaccines, or biologics, use a process different from traditional pharmaceutical products, but our new glorious leaders don’t seem to understand this basic concept.

Ironically, the antivaxxers are the control every year, proving the effectiveness of even mRNA.

The bar for treatments and vaccines is extremely low because until recently, that has been our limitation, but because of Operation Warp Speed, that’s all changed.

So, the place we speak to as success might feel lower than it should, and it has been at times. However, this testing has been done, and Novavax specifically has placebo testing. So, while this shouldn’t be limiting for us, they will just move the bar again.

Novavax may present data showing they can make a new vaccine fine, and I don’t doubt they are capable of it, but we likely don’t need it.

I’ve said at multiple meetings that Novavax only requires updates every two years… and Yunlong Cao of the Sato lab has said that antibodies last for about two years.

Sticking with an already heavily tested JN.1 when the vast majority, if not all, variants are JN.1 makes the most sense even without these unethical demands.

Choosing a closer variant is especially challenging because of new developments.

We have an XBB + JN.1 recombinant, NB.1.8.1, making a lot of noise out of Hong Kong that is now hitting the ground in California.

Technically, it’s an XBB recombinant that creates XDE, which then creates a recombinant with JN.1 to create XDV, which among its subvariants is NB.1.8.1.

So, not confusing at all.

However, it’s important to remember that the XBB recombinant is likely a persistent variant that recombined with an active JN.1 infection that is only now landing in the US, but it only has JN.1 variants to meet.

It likely being a persistent variant is important because there is very little XBB around.

Future recombinant processes will likely occur with more JN.1 subvariants, moving it closer to JN.1 overall and within the range of multiple vaccines.

This process has been steadily happening, with charts like these showing up.

The takeaway is that they are all JN.1 subvariants acting like they live in the panhandle. While that can be confusing, it can be more easily explained linearly.

I spent way longer on this than I want to admit…

It’s a little less scary when you look at it that way.

Typically, we would think variants grow out. Instead, this is a lot of “cousin relations.”

When we would typically talk about targeting the “trunk of the tree” instead of some random leaf or branch, like KP.2, this is quickly becoming more of a stump.

The point is that we can expect many more recombinants as we allow infections to run rampant, which creates a rare, predictable moment for variants.

In the same way all variants are JN.1; the same could be said about many of the currently evolving variants being XEC. We see things like XFL, but it’s just a product of multiple XEC subvariants all “inbreeding,” which is still under the JN.1 umbrella.

It’s important to note that the jump from XBB.1.5 to JN.1 was the most significant antigenic jump in the pandemic. At this stage, further recombinants will likely bring them closer together, not further apart.

We have substantial testing showing JN.1 Novavax still works on all variants.

With an even improved response toward the newest ones.

These results show a response for XEC that is EXTREMELY close to JN.1.

This was demonstrated again by one of the top antibody labs in the world.

Also, independently of Novavax… Don’t forget to look at the XBB response, because even with the largest antigenic jump ever, it still covers it going backward, even though the XBB vaccine had trouble going forward to JN.1.

The Sato Lab’s work shows up at everyone’s meetings because it’s the best.

And, to be clear, these results were achieved with a single shot of JN.1.

Notably, it shows a high response against XBB.1.5 variants, which means it should show high effectiveness against the mutant recombinant variant on its way.

One of these new crossover variants will likely be next year's variants for Novavax. In the same way we saw BA.2.86 coming when we were picking XBB.1.5, we needed to wait for BA.2.86.1 to evolve, which we now call JN.1.

However, this did not occur on a seasonal cycle, because COVID does not need the benefit of reduced immune systems during cold weather to proliferate.

Bottom line? COVID is a year-round problem, especially if folks want to claim it’s endemic inappropriately.

The decision to change variants should be made earlier next year.

We should move the variant meeting to March and plan variant shifts in early August to meet the demands created by the start of school.

Plus, with this platform, they can pivot variants with a single shot.

Knowing that it can do this with a single shot is significant, considering we have not even tapped the potential for Novavax to reach even more variants.

But how does this work?

A benefit of Novavax is that each shot increases the range of your existing antibodies.

I can’t make it clear enough that the benefits of the products are perfectly tuned for this moment. Each shot brings your antibodies closer to evolving variants.

So, whether you have received Novavax or need to start, you’re in a good spot.

People who need protection this year break down into two groups…

1. Those who have already received a Novavax priming series.

2. Those who have not.

Unlike mRNA, those who have received Novavax would only need a single booster and would build on their previous vaccinations.

Those who have not received a full series of Novavax should start over with a full series of three shots. The first two should be eight weeks apart, and the third should be six months after the second. This has been well tested at this point.

Getting at least two is the goal, but three is better… and that data is coming up.

As JN.1 can be ready to go immediately, it will give people plenty of time to adequately vaccinate before next season. They will also need fewer shots in the long run while retaining greater protection in the process.

This multi-shot mechanism is responsible for two things we have seen with Novavax.

1. This effect has already allowed the original prototype vaccine to maintain efficacy against Omicron simply by using a third shot. (This is well proven; Novavax measured better in every way, so much that I question why we use mRNA at all.)

   

2. This is also the mechanism behind multiple shots helping with persistent virus. (This is not yet well proven, but we proved it enough to open up Novavax access two years ago in our first presentation.)

My theory for persistent virus, which we used to seek timing approval, is that your antibodies evolve from the initial variant you are exposed to. While that variant will continue to shift during initial infection, the antibodies created at the start of your infection do not. They are locked into that initial exposure at the start of this infection.

So, a variant, which is rarely more fit, can evolve to be just outside your antibodies' range. Not by intention, but just by the nature of how many virions are produced and how quickly. It’s the infinite monkeys and typewriters theorem in the real world.

COVID produces an overwhelming amount of copies, and it does it poorly.

So, it’s bound to create at least a single virion with immune evasion, but they should be very close to each other… just outside the antibodies’ reach.

Over time, they will get further apart, making your antibodies even less effective.

This is why, mechanically, increasing the range of your antibodies will assist your immune system in identifying and removing persistent viruses. Also, this antigenic range will likely increase over time, which is why speed plays a factor.

Even though persistence is not the only driver of Long COVID, it is a primary driver, and it needs to be dealt with first before we can even tell what other symptoms are left. While multiple Novavax will be and has been a solution for some people, it will not be a solution for ALL people.

But I digress, let’s stay on vaccines…

Last year, we successfully pushed for vaccines to be released earlier, and we need COVID vaccine recommendations to happen even earlier in general.

The availability should align with the start of the school year, and a vaccine with more robust protection will work continuously through the winter season.

COVID is not a seasonal virus and requires year-round protection.

Novavax achieves more robust year-round protection if folks get at least two.

This chart also means that the response never wanes to zero if you get two shots.

That is testing to 400 days after it has already plateaued for 200 days. This is why I say that folks need fewer shots: You are maintaining that baseline.

Other available COVID vaccines have not achieved this.

The end of Novavax’s response has never been captured in any study.

That means everyone needs access to a new priming series without jumping through the “immunocompromised hoop.” In previous years, they created special access for folks with Long COVID to access more shots to fight persistence, but as Long COVID is not a clearly defined term, they used immunocompromised instead.

This also opens up access for many more people.

But, back to the shots…

It has an even more robust response with three shots; this actually shows four.

So, this is not a one-time trick; it maintains between continuous shots.

While some claim that Novavax and mRNA have the same response, that’s only when measuring two mRNA against two Novavax. I have a pretty intense breakdown comparison in the larger article coming up, but it is demonstrated above.

mRNA cannot achieve that response and goes no further than the initial first increase… Novavax then goes on to achieve 4- 5x that and maintains it. Let’s also note that it’s wildly effective in adolescents, specifically with an even higher response than adults.

So, Novavax and mRNA are not the same protective levels…

Novavax is 4 -5x better, has fewer AE, pivots immune memory with one shot, improves other aspects of your immune system… It’s better by every marker.

But how does this affect where we are now?

mRNA does not meet the protective levels to claim it is protective because it does not protect from the long-term effects, only short-term effects.

And you are welcome to fight with me on this, but we got that information from the FDA and CDC, and the people we are fighting have access to that data now.

There is no point in trying to misrepresent what’s going on here…

This is important because while mRNA does not meet protective levels for these characters to claim a recommendation should be allowed, Novavax is far superior in its protective levels and does meet the requirements they have put forward.

As much as they claim COVID is not harmful to children, current data points do not support that. They seem very stuck in an early 2021 mindset that has no place in the current conversation, probably also why they keep going on about mandates.

Recommendations don’t mean mandates; we just want insurance to cover the shots.

However, maintaining the idea that mRNA and Novavax have the same protective levels could only result in losing both. Novavax meets their demands, but not mRNA.

And I understand this is a tough bridge to get folks to cross.

So, while we don’t need to convince new folks, we do need to reach all the convinced ones. Whatever you can do to get the word out, do it.

If you disagree with anything I’ve said here, please push what you agree with. I’ll provide a detailed breakdown at the end of each step.

Luckily, even though the public comment that will be given to the committee closes on the 14th, we still have a week to contact members directly. So, there’s still time for folks to get their mind right on whether to send in a comment.

First is public comment, then we contact members directly until the meeting.

But it doesn’t stop there… RFK Jr. appointed Vinay Prasad, who makes wild claims about how COVID does not harm kids, vaccines are ineffective, requiring unethical placebo trials for vaccines, and other wrong and awful statements, to lead CBER, which is essentially in charge of all vaccine approvals.

He’s not only a eugenicist but also callous and evil about it, so trying to reach him other than by a brute force-style attack on all forms of communication will be unlikely to be effective. Ironically, not too different from the previous head of CBER, Marks.

However, that doesn’t mean we are without options.

RFK Jr. is on unsteady ground and is about to get grilled by the HELP committee.

So, our opportunity here is to work with the HELP committee to pressure RFK over Prasad's appointment. We might as well throw in this Surgeon General they are trying to appoint, too.

That means we need to send the HELP committee as much ammunition as possible because they may not be aware of Prasad's awful statements, and there are a lot.

This is not a person who is quietly evil; he has a podcast where he’s wildly cruel.

Here’s a page dedicated to refuting the terrible things he’s said.

Like I said, RFK Jr. is already on thin ice.

Among many of his promises was that he would not limit or eliminate vaccines. His appointment of not only Beth Hoeg, a notorious anti-vaxxer, but also a second, even worse one, as the leader of vaccines in general at CBER is not the sign he should be sending to the Senators.

But approving Novavax for both adults and kids would go a long way to prove otherwise.

The simple fact is that just like how his call for placebo testing on vaccines is unethical, it is also unethical not to allow access to beneficial vaccines.

This is where we are with Novavax, considering Novavax's expansion is just that: an expansion of usage for the existing product.

Kids and Adults use the exact same vaccine, and other countries are already opening up access. Even if you don’t want to agree with the evidence showing Novavax is better, we can at least agree that it is comparable, and as many folks cannot take mRNA, the same is true of kids. We need a non-mRNA alternative for children, too.

This is an ongoing accessibility issue. The current stance of the federal government is unethical when you consider the best vaccine for kids, or even the only vaccine certain kids can get, is just sitting on the shelves going to waste while they are unprotected.

Kids who need an mRNA alternative are likely to need these vaccines the most.

… just a quick sidebar before we get to the action plan.

There will be some debate about whether what I’m saying is totally ridiculous, with mRNA advocates talking about how this or that variant is the best choice.

And that was fun in previous years, but this year it hits a bit differently.

We already have a glimmer of the plan for mRNA’s future, which is a “second-gen vaccine,” but really, it’s just the old bivalent, but now with less antigen.

This was the only COVID vaccine asked to present at the last rushed ACIP meeting.

What’s funny, but also not funny, about this is that they significantly reduced the antigen, but this did not lead to an equal reduction in Adverse Events.

That tip there with the stripes? Those are Grade 3 Adverse Events.

If Novavax had a consistent Grade 3 response, we would never have made it here.

The bivalent failed rather famously, and the proof is in how quickly we moved back to monovalent vaccines. The data was clear then, and the data is clear now.

You can look at the entire slide deck here, but when mRNA advocates try to give us a hard time for suggesting we stick with JN.1… Remember, they plan to go back to the bivalent… and good luck trying to figure that mess out.

Trying to pick a single variant is hard enough, but two?!?! That’s a lot of money riding on not only one but TWO games of Pin the Tail on the Donkey.

So, if they try to give you any trouble, just remind them that’s their position already.

We cannot, under any circumstances, let them move us back to bivalent COVID vaccines. Will we do multi-valent-style “combo” vaccines, with COVID and influenza? Yeah, probably, and that’s the “multi-valent” style vaccine RFK Jr. would mean in a world where people are prepared to do their jobs in the best interests of the people.

Unfortunately, we are not in that world… Not yet, at least.

Here’s a direct breakdown of actions:

First, all contact should be friendly and polite. This push does not support hating on or attacking these people through this process. That will not help.

Step 1

First: VRBPAC public comment & Contact Senate HELP members.

Deadline: Both are on May 14th, noon Eastern.

VRBPAC

VRBPAC demands:

Previous Demands

1. Immediate approval of Novavax’s BLA

2. Streamline approval of pediatric expansion

3. Expand the expiration date

New Demands

1. Move COVID variant selection to early in the year to align release with the school year, treating COVID as a year-round virus instead of a seasonal one. With greater protection from Novavax, it will last year-round instead of a few months.

2. Choosing JN.1 for Novavax is a very reasonable choice; it not only circumvents many of the roadblocks being erected by new leadership but is also a safe choice. Choosing JN.1 will also give adequate space to change approval timing next year.

3. Recommend a new priming series be available when switching to Novavax; the immunocompromised rules have proven effective, but this is the best way to use this product. This is the protection available, and folks should have access.

4. Clarity on changes to the Pediatric Vaccine Application made recently. Novavax reported changes to testing for the supplemental to their BLA for pediatric expansion. However, it’s unclear what those changes are.

5. Under no circumstances should we recommend moving back to bivalent COVID vaccines; these failed miserably last time and would be a huge step back.

VRBPAC Public Comment Link → https://www.regulations.gov/commenton/FDA-2025-N-1146-0001

You can also send public comment directly through the federal register → https://www.federalregister.gov/documents/2025/05/08/2025-08083/vaccines-and-related-biological-products-advisory-committee-notice-of-meeting-establishment-of-a#open-comment

I’m 90% sure they all go to the same place, and regulations.gov is friendlier.

We will follow up with direct contact after this next step.

Senate HELP Committee & HHS

Deadline: May 14th

HELP Committee Demands: (there are more questions we want asked)

1. Specifically, the hiring of Vinay Prasad and the current Surgeon General nominee.

2. Hold up on Novavax approval; it has already been delayed a month and a half.

3. COVID variant hearings were only held after immense public pressure.

4. Why have there been changes to approval for pediatric vaccines at the FDA?

5. Does he plan to limit vaccines or not approve new ones?

6. Does he think COVID is dangerous for children?

7. Will he approve the Novavax expansion for children?

8. Does he believe Long COVID is real?

9. Are we studying Monoclonal Antibodies and infusion antivirals for LC?

10. Does his concern for chronic illness include those caused by airborne pathogens?

HELP Senate Committee Members:

Bernie Sanders (I-VT) (202) 224-5141

Patty Murray (D-WA) (202) 224-2621

Tammy Baldwin (D-WI) (202) 224-5653

Christopher Murphy (D-CT) (202) 224-4041

Tim Kaine (D-VA) (202) 224-4024

Maggie Hassan (D-NH) (202) 224-3324

John W. Hickenlooper (D-CO) (202) 224-5941

Ed Markey (D-MA) (202) 224-2742

Andy Kim (D-NJ) (202) 224-4744

Lisa Blunt Rochester (D-DE) (202) 224-2441

Angela D. Alsobrooks (D-MD) (202) 224-4524

Bill Cassidy (R-LA) (202) 224-5824

Rand Paul (R-KY) (202) 224-4343

Susan M. Collins (R-ME) (202) 224-2523

Lisa Murkowski (R-AK) (202) 224-6665

Markwayne Mullin (R-OK) (202) 224-4721

Roger Marshall (R-KS) (202) 224-4774

Tim Scott (R-SC) (202) 224-6121

Josh Hawley (R-MO) (202) 224-6154

Tommy Tuberville (R-AL) (202) 224-4124

Jim Banks (R-IN) (202) 224-4814

Jon Husted (R-OH) (202)-224-3353

Ashley Moody (R-FL) (202) 224-3041

HHS

When you are done contacting those Senators, contact the HHS.

Use the same or similar talking points.

Contacts: 1-877-696-6775

More TBD

Step 2

Contacting VRBPAC and ACIP members.

VRBPAC

Deadline: May 22 for final public comment and direct contact with members.

VRBPAC Demands: (same as before)

Previous Demands

1. Immediate approval of Novavax’s BLA

2. Streamline approval of pediatric expansion

3. Expand the expiration date

New Demands

1. Move COVID variant selection to early in the year to align release with the school year, treating COVID as a year-round virus instead of a seasonal one. With greater protection from Novavax, it will last year-round instead of a few months.

2. Choosing JN.1 for Novavax is a very reasonable choice; it circumvents many of the roadblocks being erected by new leadership and is also a safe choice. Choosing JN.1 will also give adequate space to change approval timing next year.

3. Recommend a new priming series be available when switching to Novavax; the immunocompromised rules have proven effective, but this is the best way to use this product. This is the protection available, and folks should have access.

4. Clarity on changes to the Pediatric Vaccine Application made recently. Novavax reported changes to testing for the supplemental to their BLA for pediatric expansion. However, it’s unclear what those changes are.

5. Under no circumstances should we recommend moving back to bivalent COVID vaccines; these failed miserably last time and would be a huge step back.

FDA - VRBPAC voting members for contact

• Hana M. El Sahly: hanae@bcm.edu

• Adam C. Berger: adam.berger@nih.gov

• Henry H. Bernstein: hbernstein@northwell.edu

• Archana Chatterjee: archana.chatterjee@rosalindfranklin.edu

• (New) Anna Durbin: adurbin1@jhu.edu

• Hayley Gans: hagans@stanford.edu

• Robert S. Janssen: N/A

• Luis Jódar: luis.jodar@pfizer.com ← wtf @pfizer

• CAPT Sarah Meyer: vif6@cdc.gov

• Arnold S. Monto: asmonto@umich.edu

• (New) Flor M. Munoz-Rivas: florm@bcm.edu

• Michael R. Nelson: mrn8d@virginia.edu

• Paul A. Offit: Not him

• (NEW) Saad B. Ome: saad.omer@yale.edu

• Stanley M. Perlman: stanley-perlman@uiowa.edu

• Jay M. Portnoy: jportnoy@cmh.edu

• Eric J. Rubin: erubin@hsph.harvard.edu

All three new members specifically have an expertise in pediatrics.

ACIP

Deadline: ACIP Event date June 25th- 26th.

We will follow up with the ACIP public comment when it opens.

ACIP Demands:

1. Activists fought hard for the COVID vaccine recommendations with earlier ACIP committees. Please do not erase that work by removing the recommendation. The recommendation exists primarily to require insurance companies to cover them at no cost; losing this would be very expensive.

2. Recommend a new priming series for people switching to Novavax so that it is easily available. If folks want access, they should have access.

3. Recommend pediatric Novavax expansion so we can have a pediatric mRNA alternative. Some folks cannot get mRNA, and they often need a COVID vaccine the most. They need an alternative; it is unethical to do otherwise when the vaccine is immediately available. It is called an expansion because it expands usage to include pediatric use; other countries are ahead of us on this.

4. Clarity on changes to the Pediatric Vaccine Application made recently.

5. Under no circumstances should we recommend moving back to bivalent COVID vaccines; these failed miserably last time and would be a huge step back.

CDC - ACIP voting Members for contact

• Chair: Helen Keipp Talbot: keipp.talbot@vumc.org

• Edwin Jose Asturias: edwin.asturias@ucdenver.edu

• Noel T. Brewer: ntb@unc.edu

• Oliver Brooks: olibro@aol.com

• Lin H. Chen: lchen@hms.harvard.edu

• Helen Y. Chu: helenchu@uw.edu

• Sybil Cineas: Sybil Cineas@brown.edu

• Denise J Jamieson: denise-jamieson@uiowa.edu

• Mini Kamboj: kambojm@mskcc.org

• George Kuchel: kuchel@uchc.edu

• Jamie Loehr: Dr.Jamie.Loehr@Gmail.com

• Yvonne Maldonado: bonniem@stanford.edu

• Charlotte A. Moser: moser@email.chop.edu

• Robert Schechter: R.Schechter@cdph.ca.gov

• Albert C Shaw: albert.shaw@yale.edu

• Karyn Lyons: Karyn.Lyons@Illinois.gov

• Jane Zucker: jzucker@health.nyc.gov

Discord

There are a lot of bad things going on right now.

And that is truly unfortunate.

However, today we have a rare opportunity to “gently” fix an issue.

There’s no two ways about it, antivaxxers and science deniers have taken over.

And public health is hanging on by a thread.

Assuming you are reading this on April 16th, 2025, ACIP (CDC) is meeting today.

It’s a two-day meeting, and yesterday, they discussed two concerning things.

1. There was a discussion about moving to a risk-based approval system for COVID vaccines in the future.

This is an insane problem, and I used "insane" correctly, as we have already solved it.

Over the last two years, the public has fought for that recommendation because, ultimately, it’s the only thing forcing insurance companies to pay for the shots.

Cutting the recommendation won’t limit access to previously approved vaccines, but it will give insurance companies a reason not to pay.

This means you pay out of pocket.

We already covered the general idea that uptake is so low that if people want access to these vaccines, they should have access. No one is being forced to take them, so recommendations do not directly increase uptake the way mandates might.

2. There was a discussion about reintroducing the Bivalent.

The Bivalent was a failure in every way.

It does make sense to use multivalent vaccines, but even that terminology is not universally defined with the utmost clarity. We use that phrasing for the influenza vaccines, but each antigen is different enough that even though they are all influenza, they do not disrupt each other’s memory response.

With COVID, it does… It disrupts our immune memory response, giving sub-par protection, and this isn’t even a fringe idea… Moderna’s data says the same thing.

Trying to pass this off as a success is the most “polished turd” I’ve ever seen.

However, we had a pretty significant development in understanding why these low levels of protection have been prioritized over Novavax’s superior protection…

…Prepare for the plot to thicken…

After years of denial, it turns out that the NIH controls the mRNA patent.

Both BioNTech and Moderna are paying royalties after losing their court cases.

So, here’s what we’re going to do right now.

We’re going to be calm and patient with the ACIP members because all but two of them are brand new, and they are holding on by a thread as much as we are.

We are going to POLITELY email them at their public academic emails and remind them that some of the matters being discussed are settled issues.

We all need to find a way to placate the children who are trying to drive the car off the cliff, and, for the time being, these members are on our side.

There’s no script, and I don’t want to spam them thousands of times.

We just want to clarify that these are settled issues. We need to find a way to avoid revisiting them, as changing them might cause harm, and we need to do this without harming the member’s position.

We already got all the new members on ACIP last year, and we don’t want them to replace our current ACIP members with a bunch of sycophants.

In the next few days, you can look forward to a very large and definitive article on the science of Novavax’s effectiveness versus other COVID vaccines that should help in rallying the public on this issue.

But right now, we gotta deal with this.

Okay, that’s it, go get ‘em.

… And remember, be professional. These people could be our friends.

And feel free to point out that Novavax’s BLA should be approved for all ages.

CDC - ACIP voting Members for contact

Chair: Helen Keipp Talbot: keipp.talbot@vumc.org

Edwin Jose Asturias: edwin.asturias@ucdenver.edu

Noel T. Brewer: ntb@unc.edu

Oliver Brooks: olibro@aol.com

Lin H. Chen: lchen@hms.harvard.edu

Helen Y. Chu: helenchu@uw.edu

Sybil Cineas: Sybil Cineas@brown.edu

Denise J Jamieson: denise-jamieson@uiowa.edu

Mini Kamboj: kambojm@mskcc.org

George Kuchel: kuchel@uchc.edu

Jamie Loehr: Dr.Jamie.Loehr@Gmail.com

Yvonne Maldonado: bonniem@stanford.edu

Charlotte A. Moser: moser@email.chop.edu

Robert Schechter: R.Schechter@cdph.ca.gov

Albert C Shaw: albert.shaw@yale.edu

Karyn Lyons: Karyn.Lyons@Illinois.gov

Jane Zucker: jzucker@health.nyc.gov

Bonus: Contact notorious antivaxxer Tracy Beth Hoeg.

She’s the holdup on Novavax, or at least she has been positioned to be the holdup.

She is not our friend or on our side.

You are welcome to be less nice, but these are also publicly available emails.

tracy.hoeg@ucsf.edu

tbhoeg@mit.edu

I don’t want anyone to “harass” anyone, but sending emails to this public email address for the foreseeable future might be helpful in getting full vaccine protection.

For the last few months, I have been warning folks that we would have to make a push for Novavax in April, just like our previous pushes over the last few years.

You are welcome to read more about Novavax's benefits in this petition we previously prepared, but you might want to come back to that later.

Petition and effectiveness data → https://tinyurl.com/mt4yysh7

Simply put, Novavax creates a superior COVID vaccine, and the simple fact is that no one in power seems to want people protected from COVID anymore…

Unfortunately, the answer to why that is is an overly complex question I’m covering in an extended article series. Rather than bore you with long-winded explanations, we should get directly to our current key problems.

While I said we would need to make a push for Novavax in April…

Unfortunately, Novavax did not make it clear that the actual deadline we were faced with was April 1st. We learned that as the news rolled out on April 2nd, the “FDA missed a critical approval day for Novavax” and asked for more information instead.

No one likes being blindsided and had approval gone through, it’d all be fine.

Now, the FDA giving Novavax trouble is not new, and many folks thought this was happening because of the current takeover and firings occurring at the FDA.

Some are saying that Peter Marks leaving is delaying the process, and removing Peter Marks was the first thing the new FDA director, Marty Makary, did.

While that may be true, Peter Marks was, in large part, behind Novavax being delayed.

He was even the focus of our push last year to get COVID vaccines approved early, where he ultimately tried to withhold Novavax’s approval as long as possible.

It was only a week last year, but it was months in previous years.

It appears to be more of the same nonsense from the same people who were also undermining COVID protections while projecting expertise on the matter the last four years. They conveyed expertise, but that expertise was never backed with action… But it’s worse than that…

They were never experts; Peter Marks is an oncologist, not even a vaccine expert.

That’s not to say the oncoming leadership is a greater expert, but new problems don’t erase the old ones or clear those same people of their past transgressions.

Peter Marks consistently overstated the effectiveness of mRNA, often stating that it would protect from infection even though that data was never presented to him.

He also created all the confusion with the JN.1 and KP.2 vaccines last year. He chose to override the expert decision to focus on JN.1, and ultimately, his choice to override it was a failure with lowered effectiveness rates released in a recent MMWR.

For the sake of a clear argument, here is the actual effectiveness data that the CDC presented to all of us when he made that claim.

You can even check the entire slide deck if you want.

If you notice, nowhere do the protective qualities even come close to Marks’ claims. They also are not even measuring preventing infection… It’s just measuring trips to the emergency department and urgent care.

If you were part of this conversation, you know this confusion was created to make Novavax seem like the “older product,” but ultimately, it was the better choice.

Misleading the public was pretty much the most consistent thing about Peter Marks.

He lied to the public regularly, and because of this, many people died. One could even argue that his deceptions created the space for the response we are seeing now with entire health agencies being erased overnight.

Republicans would never have come to power over this if we simply told the truth.

This time, it’s coming from Sara Brenner. Her Wikipedia page shows she was a holdover from Trump's first presidency. She became the interim FDA director after Cardiff, the previous director, left and before the new director was fully in his position.

But more importantly, she represents an FDA that prioritizes less protective vaccines and treatments for the benefit of corporate interests. Multiple sources have stated that it’s “very unusual” for someone in her position to pull something like this.

As far as I can tell, with Marks on his way out (his official last day is the fifth), someone else has to throw a wrench in the process like they have done the entire time.

I cannot stress enough that it’s the same people.

Do I automatically think the Republicans are going to do better? No.

However, they might actually be better on this singular issue.

All of the Republicans who have taken over health agencies are on the record of pointing out Novavax as the better COVID vaccine…

This is good… in theory, but it certainly doesn’t rectify all the other bad things happening at these health agencies. They are all also on the record as saying mRNA will be under examination to stay available on the market, which is a problem.

I don’t expect mRNA as a product to pass this scrutiny, as emergency use authorization has always been seen as critical for its approval.

If we had mRNA removed and everyone could get Novavax, that would be much better for handling COVID, but we run into several issues:

1. All under-12 COVID vaccines are mRNA and under EUA, which means that the Republicans can wipe them out in one day. So, no COVID vaccines for kids.

2. These people are all also on the record saying that it is not necessary to vaccinate kids for COVID… and before you get mad, our previous administration did not offer proper vaccination for kids either, so they aren’t that far off from each other.

3. At the very least, we need Novavax approved for under twelve as part of the move from EUA to BLA… That’s emergency use authorization to biological license application… You can think of that last A as approval, and it’s the same thing.

4. People will ultimately not respond well to being forced to do something like that. A challenge with creating any strategy for people is that they don’t like being forced to do anything. In the same way the anti-vaxxers didn’t want to be forced to get mRNA, the mRNA folks will not be happy about being forced to get Novavax, even if it is better. (On a side note, I can’t wait to hear them call Novavax the Trump vaccine. /s)

So, right now, as much as this is about getting Novavax its BLA approved…

It is also about getting Novavax approved for kids.

And then convince everyone that Novavax is, in fact, better.

… about this.

On the surface, trying to get Republicans to allow the use of Novavax for kids seems like an impossible issue… They are against vaccines, especially for kids, and their supporters are going to go on a vast bemoaning fest if a new vaccine gets approved.

However, we just had another study about Novavax, and it shows promising data that supports the use of Novavax being priotized as the pediatric COVID-19 vaccine.

This concerns a little idea called the “IgG4 class switch,” where harmful IgG is prioritized over helpful IgG1. That means IgG1 becomes IgG4, and this process suppresses both IgG2 and Fc effector functions that trigger T cells.

When antivaxxers talk about mRNA shots being immunosuppressive, they are referring to this effect. While their version is severely dramatized, it’s a real issue. They’re not talking about vaccine injury, which can also be suppressive…

They mean IgG4.

Unfortunately, this is one of the more overly complicated aspects of all of this.

It's a bit funny, even, but we learned from this study that when they talk about mRNA having higher overall antibodies, they include the bad ones, too.

Which seems counter-intuitive to me… Yes, it’s more, but is it actually better?

The reality is that this class switch is entirely harmful, and the only other vaccine on the market that does it is the DTaP. Specifically, the acellular antigen we switched to in the 90s causes a similar class switch, but it does it in adults and children.

If you get multiple DTaP at any point, by the second one, you are experiencing a nonbeneficial IgG class switch… It’s well documented. High IgG4 is also associated with autoimmune disorders and cancer. Generally, it should be avoided.

Technically, the DTaP vaccine is fine, but not really; we should prioritize using vaccines that do not have this effect. Last year, we advocated for improvements in the pertussis antigen in a presentation to VRBAC (FDA) over this precise issue.

I want to make it abundantly clear that the DTaP vaccine is critical to get, and the three antigens represented in the vaccine are historically the most deadly bacterias to humans.

What matters here for Novavax is that mRNA creates this same class switch, but it does it primarily in first exposures. So, by administering DTaP and mRNA together to infants, we risk sending them into an IgG4 spiral because the mRNA version of the same response can last for over a year, much longer than the DTaP version.

We have not measured the combined effects, but we can assume it’s not desirable.

These are children too young to identify symptoms or changes, so if something goes wrong, doctors just shrug and write you a prescription for medication if they can.

And we know for a fact that the class switch is associated with more COVID infections and greater risks. And more infections mean more Long COVID.

Now, you might have many thoughts about this position; I admit it’s dangerously close to a few toxic positions that are actually just pushing to imply vaccines are unsafe or unnecessary… That couldn’t be further from accurate to my position.

After two years of working on this issue and creating FDA presentations on these matters, I've reached these conclusions. We’ve also worked on it extensively on our twice-weekly calls, so we didn’t come to this conclusion errantly.

This could represent a significant change in our vaccines.

The new study was interesting because it again showed that Novavax’s adjuvant overcomes these adverse effects of this class switch by promoting IgG2 and Fc effectors, the same two that are suppressed by the class switch effect.

That could mean if we use Novavax as the primary child vaccine in the early stages of life and it is administered with DTaP, then the combo might reduce the risk from DTaP’s IgG4 class switch effect until we can replace the antigen with something without that response.

At the very least, fixing this would be a win for everyone involved, and they can point to an actual problem with our vaccines without removing the ones we badly need.

This is simply a better way to protect our children and is a core argument for the approval of Novavax’s BLA and expansion for pediatric use.

People want to protect their kids and should have the best protection available.

However, we might need to remind the FDA that we need to protect kids from COVID.

We need to pressure the new and old FDA members to approve Novavax’s BLA and expand usage to children under twelve.

The best part about this situation is that there isn’t a pediatric Novavax COVID vaccine, so there is no additional vaccine for which to seek approval.

It’s the same vaccine on the shelves right now, and if the FDA simply gave the green light, we could start vaccinating kids with a far more protective vaccine immediately.

What’s our timeline? I think we have until the end of the month to get this straightened out before it starts affecting Novavax’s Sanofi deal, but that might have shorter deadlines than I realize. At the same time, we should be putting pressure on the FDA to extend the shelf life of their current product.

Other countries have extended it to nine months, just like the original vaccine, and should that extension be added in the US, their April batch will stay on the shelves.

Call to Action

So, we have three points in total:

1. Novavax’s BLA approval.

2. Expansion for pediatric use.

3. Expiration date moved from three to six or nine months.

We make this happen, and it will improve on every country’s availability.

If you have any questions, we will be doing a show on Thursday the third, the same day this article is going out, to discuss and open dialogue on this action.

Brace for Impact: March 3rd, 2025

If you have them, it’s a good time to show up with your Novavax questions.

But right now, you can start contacting people at the FDA. If this doesn’t work in the first few days, then we will open it up to HHS, too, which we’ve never had to do before.

However, if we are going to call the FDA and wait on the HHS…

Might as well throw the CDC into this message heap.

ACIP (CDC) public comment

We also have an ACIP meeting where the same points should be made…

The public comment period is open until the 11th; the meeting is on the 15th & 16th.

https://www.regulations.gov/docket/CDC-2025-0017/document

Contact these FDA numbers and emails with the three points listed.

Here are your points of contact to start with:

(The list has shrunk considerably since our last push for action.)

General

ocod@fda.hhs.gov

cberocod@fda.hhs.gov

CBERVRBPAC@fda.hhs.gov

(800) 835-4709 (240) 402-8010

Sara Brenner - Principal Deputy Commissioner

Sara.Brenner@fda.hhs.gov

Scott Steele - Acting Director, CBER: ← Peter Marks’s replacement

Scott.Steele@fda.hhs.gov

Scott.Steele@rochester.edu

Julia C. Tierney, Acting Center Director

Julia.Tierney@fda.hhs.gov

David Kaslow- Deputy Director, Vaccine Research

David.Kaslow@fda.hhs.gov

301-796-7114

Tod Merkel - Associate Research Director:

tod.merkel@fda.hhs.gov

240-402-9746

Robin Levis - Deputy Director, Vaccine Research

robin.levis@fda.hhs.gov

240-402-9665

Christophe Joneckis - Regulatory Director

Christopher.Joneckis@fda.hhs.gov

240-402-8083

Karin Bok - Deputy Director, Office of Vaccine Review

Karin.Bok@fda.hhs.gov

Discord

The goal here is to get folks on the phone banks to contact Florida voters to go vote.

Here is the phone bank → https://www.mobilize.us/mobilize/event/750460/

Anyone from anywhere can call in and help with GOTV.

But we only have about an hour to act… and as long as they are in line before 7 p.m. Eastern, they can cast a vote.

Florida is a state drenched in politics, but, for some reason, they have to be told to vote on election day, or they don’t show up.

There are two races in Florida today, but only one is winnable.

And this race has not only a great candidate but also the worst imaginable republican.

In FL- Congressional - 6, the Democrat caught the Republican sleeping. Not only is the Republican a vile person for so many reasons, but the Democrat is actually a pretty decent guy, at least so far.

This race is just as much about keeping the Republican out as it is about electing the Democrat. So, that probably means I’m asking you to elect some “vote blue no matter who” neoliberal, right? Wrong.

This candidate is actually great.

He doesn’t have some big Super PAC backing him, he doesn’t take AIPAC money, and in the past, he has been an ardent voice for protecting Palestinians.

He not only received a green check from the AIPAC tracker, but Bernie Sanders also endorsed him on Saturday. Maybe that resonates with you, maybe it doesn’t, but this would be a huge improvement over the Republican candidate.

How bad is the Republican candidate?

He keeps an Israeli flag in his office instead of an American one.

He brags about pictures of dead babies in Gaza.

I have trouble saying the things this guy says because they are so awful.

You are welcome to look them up. Many people are talking about the terrible things the Republican candidate has said, but not enough are telling people how to help.

Jump on the phone banks and remind voters to go vote.

https://www.mobilize.us/mobilize/event/750460/

I spoke to the campaign manager on Wednesday after a friend from Florida called me to speak to him and see how I could help. I made my contact later that night to my congressional contact and had just started making a push on behalf of the candidate.

Luckily, the endorsements have rolled in since…

This is a traditionally Republican district, but the party preference is split in a way that is favorable to a democratic challenger in this environment of outrage against what Republicans have been doing.

And Josh has outraised his challenger by at least 10 to 1.

Last I checked, Josh had raised over $12 million, and Randy Fine had raised only one.

Please consider phone banking on this race.

Florida elections are funny in that despite being a place constantly under political pressure, everyone forgets about election day.

https://www.mobilize.us/mobilize/event/750460/

If you want to read more about the race, you can do so on the Ballotpedia page.

If you are reading this, then you have about an hour to make calls so folks can get in line before the polls close.

They can vote if they are in line before 7 pm Eastern.

I have more info on Novavax, mask bans, and the HHS coming up, but we’re going to focus on this for the moment… and that moment is over in about an hour and a half.

https://www.mobilize.us/mobilize/event/750460/

Don’t forget that at 6 p.m. Pacific, we will be doing our twice-weekly “Brace for Impact” show. We’ll be talking about all the things missing from this article, including the results of this race tonight.

April 1st Brace for Impact

So, if you are seeing this late, just tune in, and you can get ahead on what’s next.

Public comment was first established in 1946, and since then, it has served as a method for the public to stay engaged in federal matters or decision-making.

Yes, the public can give comments with varying degrees of success; at times, commenting can seem ineffective. However, our group successfully petitioned VRBPAC and ACIP members for greater Novavax access in the last two years.

More importantly, the public comment process requires the federal government to announce its actions, creating a timeline of events leading up to whatever change is being implemented. This creates the space for potential intervention.

Petition to protect public comment

If public comment is removed completely, then the federal government can take any action, and we won’t even know it’s happening because they don’t have to announce it.

First, they came for the waivers.

Right now, it’s only the Richardson waiver, which is a waiver of a waiver, forcing groups with Congressional exemptions for public comment to do it regardless.

However, like Roe v. Wade, this was never codified, and the HHS secretary has almost total control over its implementation. However, it is being challenged in court.

Immediately after taking office, RFK Jr. moved to have this waiver removed.

Not only does the waiver force public comment on groups who previously were not required to do it, but the waiver also had a stipulation to use the rule that allowed meetings to be canceled or not held in specific environments to be used less.

This was explicitly pointed out in RFK Jr’s official statement.

So, even if it’s protected by Congress, they are stating their plan to use the rule that allows them to skip meetings more often… and it won’t be loud when it happens.

To that point, this has quietly escalated.

Underfunding has been a Republican strategy for decades.

This will undoubtedly lead to cuts in the staff that maintains public comment for these various groups. Over 1,000 agencies use public comment, and only some are under the HHS’s control, but that’s more than you’d think.

This could have far-reaching negative impacts on our government and the actions it takes; we won’t even know what its done until after we are penalized for not following some new rule.

If they can get away with this without objection, other agencies could follow suit.

And we’ve already had a significant flu shot meeting happen without the normal process, and now we aren’t learning from last season and instead are doing this behind closed doors. Even if you don’t use public comment, the news you read comes from it, and you want it to be there even if you aren’t going to use it.

These meetings are more than just choosing next year’s variant and agreeing with the WHO; they also review data to see how effective last year’s vaccines were.

I have advocated for improved responses from our Influenza vaccines at VRBPAC meetings, and even if they are less effective than I’d like them to be…

This is a direct attack on our democracy and foreshadows actions to come.

The good news is that as of today, March 31st, 2025, the CDC has updated regulations.gov for the next ACIP meeting.

Comments close April 11th, 2025.

So, they are starting to move forward with meetings, but the moment we go to sleep on this, they will begin to cut more and more meetings, and we won’t even know it.

With over 1000 committees using public comment, it will be very hard to know that every group is allowing public comments; they could start cutting them, and no one would know because there would be no public comment for the process.

Please sign and share our petition to protect public comment.

Our options for fighting back are limited, but as new methods become available or the problem escalates further, we will contact you for actions.

The best thing we can do is educate ourselves and each other about the issue.

Petition to protect public comment

Discord

We need to call the state representatives introducing it and shut it down.

It’s so important that we stand against “mask bans” every time they show their ugly face, but let’s call this what it is… a ban on personal respiratory protection.

There’s a lot of propaganda surrounding the idea of whether respirators work or not, with tricky language being used to make them seem less effective.

Although, what this really comes down to is a personal freedom issue…

Folks should have the freedom to use personal respiratory protection.

We can talk about how it’s inclusionary, or that sucking down other people’s lung juice is just gross… but in the end, what matters is that folks should have that right.

In Maryland they are introducing a bill to ban masks entirely.

There’s been talk about respiratory protection being used to hide criminal activity…

However, it’s been demonstrated many times that it doesn’t inhibit finding criminals.

We need to step up against any attempt to ban personal respiratory protection.

This time it’s calling Maryland representatives.

Article on the bill: https://archive.is/0gjvL

Bill information: https://mgaleg.maryland.gov/mgawebsite/Legislation/Details/HB1081 / https://mgaleg.maryland.gov/mgawebsite/Legislation/Details/SB0709

Full text: https://mgaleg.maryland.gov/2025RS/bills/hb/hb1081F.pdf

Here are the five state representatives putting the bill up…

Delegate Joe Vogel

Phone: 410-841-3103
Toll-free in MD: 1-800-492-7122 ext. 3103

Delegate Karen Toles

Phone: 410-841-3524
Toll-free in MD: 1-800-492-7122 ext. 3524

Delegate Ryan Spiegel

Phone: 410-841-3792
Toll-free in MD: 1-800-492-7122 ext. 3792

Delegate Karen Simpson

Phone: 410-841-3436
Toll-free in MD: 1-800-492-7122 ext. 3436

Delegate Adrian Boafo

Phone: 410-841-3047
Toll-free in MD: 1-800-492-7122 ext. 3047

You can find the full list of delegates and judiciary committee below.

Maryland Delegates

MD Judiciary Committee

They say they are already receiving a lot of calls so it’s a good time to call them some more. We have to stand against these mask bans and other attacks on public health.

Thank you to everyone who makes calls.

“We’ve all seen the headlines” has even more meaning than it did when I released Part 1 of my most recent series a few days ago…

If you didn’t catch it, you can read it here.

Part 2 is close but needs a lot of work and we simply cannot wait that long to start taking more action to protect public health.

There will be more calls for direct action, but while everyone focuses on the Treasury and whatever DOGE is up to, btw they had their computer access limited finally, though that fight is far from over…

We need to make sure our public health doesn’t disappear into the shadows while everyone is distracted.

It is already on the edge of being done away with entirely.

There is a petition and call to action attached to this article…

That means all you have to do is like this article before sharing either it or the petition… it’s up to you.

Let’s get the word out… we need our elected Democrats to stand up and fight for what they say they believe in.

And if they won’t….

Well, if they won’t then “replace your representative” is going to become the new “contact your representative.”

The petition can be found here —> Action Network Petition

Getting immediate signatures on this petition will help get the ball rolling.

Thank you.

I’m a strategist, giving you the tools to create your best strategy.

Table of Contents

Intro: We need to do better…

1. We’ve all seen the headlines.

2. Why Novavax?

3. You probably think you’re reading this wrong.

4. The best COVID vaccine for kids has been sitting on the shelves this whole time…

5. Has Novavax been properly tested for children?

6. Let’s talk about our immune system.

7. Is Novavax safe to use after multiple mRNA vaccines?

8. Is a two-shot series really necessary? - Coming soon

9. IgG4: Does this matter? And should you care? - Coming soon

10. What was the government’s goal then? - Coming soon

11. Novavax’s phase 3 was called “PREVENT-19.” - Coming soon

12. What does efficacy mean? - Coming soon

13. Do they have equal efficacy or not? - Coming soon

14. Novavax Timing. - Coming soon

15. Novavax for Long COVID - Coming soon

16. So, for pediatric Novavax, what’s the holdup? - Coming soon

17. Who is actually more concerned about safety? - Coming soon

18. So, what the heck is going on here? - Coming soon

19. The EUA is the solution, not the problem. - Coming soon
    End - That means we need to start contacting the FDA
    (Chapters are subject to change)

We need to do better…

And that’s precisely what we’re here to do.

In a world where our children are essentially swimming in COVID and becoming adorable little vectors for spread, we should reach for a higher level of protection whenever possible…

And while they might be minor, the COVID spread created by our kids is not.

This article provides supplementary information for a call to action demanding the FDA expand access to Novavax’s COVID vaccine for pediatric use.

Though, it’s probably a good time to call the FDA to protect vaccines in general.

The harsh reality is that children are a primary source of COVID transmission in our households, with many adult infections starting at home. This is happening because we have done almost nothing to limit the spread of airborne pathogens in our schools.

Even if you don’t have kids, their parents are your coworkers showing up sick…

And with the Republicans attacking remote work, things are only going to get worse in that regard… that and you’ll have to deal with that manager who keeps harassing you. Not to mention, it’s a serious disability justice issue.

Limiting spread includes not only clean air but also adequate vaccine protection…

And as we learn more about the cumulative damage COVID infections cause, vaccines that only protect from hospitalization and death are not sufficient to reduce the risk of long-term damage to our families.

At the same time, Republicans are poised to destroy public health in general, with a special focus on vaccines…

Meanwhile, mRNA, a long-time target, is already in their sights.

At the moment, there is no pediatric COVID option other than mRNA.

We need the FDA to use the emergency use authorization currently granted to Novavax to expand kids' access to the current vaccine, which is available right now.

At the very least, we have to pose the idea that if they are going to get rid of mRNA, we still need to have a pediatric COVID-19 vaccine available.

And this problem is not limited to America…

In Alberta, Canada, there’s a push to eliminate COVID vaccines entirely.

We’re going to walk through how the FDA can approve this and why that’s even possible in the first place with the vaccine itself… and the roadblocks in the way.

We should probably act before they dismantle the FDA entirely.

Trump has already ordered a 90-day halt to all messaging from public health agencies, and we are already seeing things like H5N1 trackers not being updated.

This is especially bad with a new clade of bird flu being discovered in California.

We did get one map updated recently… the general influenza chart…

It says the week of January 18, 2025, but it was updated in just the last few days.

It’s not looking good, either.

I find it super interesting that all those disclaimers explaining the data only show up when you copy over the image and are unavailable on the website.

Should also point out that it’s not just Influenza and COVID to watch out for…

We are also experiencing our largest tuberculosis (TB) outbreak in recorded history.

That’s not since forever, but since modern recording, which is still a big deal.

This problem was under control and is now out of control… This is the consequence of improperly informing the public of the risk of COVID infections.

If you didn’t know, TB is considered an AIDS-defining illness, and this is likely happening because of immune damage from excessive COVID exposure…

We won’t be getting to that until Part 3.

Though, this does make a strong argument for improving our COVID vaccines.

It’s important to remember that unless you get tested regularly, no one knows who is immunocompromised, and this matters for Novavax access.

These articles might soon be all the public health we have left.

Which is a scary proposition…

However, we still need to be able to get the best information available one way or another.

This piece also doubles as an explanation of the science behind timing Novavax for the optimal response. Folks have been asking me to write this article for years…

Everyone who has gotten mRNA and stayed up on their boosters always wants to know if they need just one or a two-shot series; we will answer that question.

By the end of Part 2, we’ll all agree on the best available vaccine strategy.

I’ve been promising sources on this for far too long, and over the last few months, there’s been an absolute deluge of new data to go through…

And now, keeping track of every terrible thing Trump has done… It’s hard to keep up.

If it feels like homework while reading this, that makes sense…

It felt like homework while I was writing it.

You don’t get an A on your report card or a certificate of completion at the end, but we could get a better COVID vaccine for our children out of it…

While also putting us one step closer to having an actual plan for COVID prevention.

That seems good, right?

We will walk through the answers to most of the questions I get asked the most. So, if it seems like a subject might be out of the way, it gets asked.

We’re taking the scenic tour on this one.

If I missed your question, add it in the comments.

Also, I want to apologize for all the Twitter/X links; I know some folks aren’t going to like that. I wrote 98% of this before the owner of it decided to send his “message of love.” I will try to avoid using TwiX links in future articles.

On that note…

Let’s get to some good news.

We’re starting with good news for anyone worried about Novavax’s survival.

Folks are frequently coming to me with concerns that the company might not survive when the situation, from my perspective, has been steadily improving…

However, that might not be reflected in its stock price.

It’s common for the same folks to have questions about the new, shorter expiration dates and what that might mean for timing their priming series.

Novavax has updated its website to show distributed batches that won’t expire until the end of March.

Those are batch numbers and expiration dates, which expire at the END of the month.

I expect that to continue without disruption now that the CDC recommends COVID vaccines twice a year for many groups, which includes anticipating that the same twice-a-year recommendation will be extended to other groups in the summer.

Though, that depends on the new administration and how much concerted effort we can direct at the latest FDA and CDC leadership…

If left to their own devices, I would expect that not to happen.

But… regarding Novavax..?

I expect they will keep their primary product on the shelves for now.

The shorter expiration dates are annoying, though pretty standard for moving from multi-dose vials that often led to unnecessarily wasted shots to single-dose packs that, besides the boxes and syringes themselves, have almost no waste.

This also removes the risk of a pharmacist not preparing the shot correctly.
So, it’s better for a few reasons.

If you didn’t know, there were five and ten-dose vials at different points. Except once opened, any unused doses had to be destroyed at the end of the day…

So, if demand was low, they had to discard whatever was left over daily.

When a pharmacy only gets 10 vials, if only one person gets a shot that day, then nine shots are wasted to administer just one dose.

It wasn’t a great system when only the unvaccinated were allowed it at initial rollout.

They later cut a vial to five doses, and that was still four doses being wasted.

All of this made getting access challenging on a lot of different levels.

Luckily, it’s not an issue anymore. Instead, now, there are new and different problems to deal with.

The new shorter shelf life is still a concern.

Here’s the specific language from the FDA regarding expiration dates. You are welcome to look at the document, but the critical language is in these two paragraphs.

I don’t expect you to read any of it, so I didn’t highlight anything.

Though, it’s there if you want it…

It would have been a giant mess if I had highlighted the important parts.

First off, DP stands for “drug product,” which, for some reason, folks always ask about.

The definition is not clearly stated in their document either.

The most important takeaway from those two very confusing paragraphs is that this arrangement was entered into on August 28th, 2024, which, at the time of this writing, was five months ago…

And the short expiration dates are based on Novavax's inability to provide longer shelf-life data…

Because, you know… their 2024-25 vaccine hadn’t existed that long yet.

This agreement started only 84 days after the VRBPAC meeting to recommend JN.1 on June 5th, 2024, and they would have needed to submit data around then…

That’s like asking for 10 years of experience right out of college; it’s simply not a realistic expectation, and it’s always spun as a bad thing.

By now, there’s been plenty of time for Novavax to submit more information, and toward the end of the above screenshot, the FDA says they will revise the expiration date after they get more data. However, that might have been lip service…

We will get into that in just a bit. Remember that the original vaccine only had a nine-month expiration date, so don’t expect it to extend longer.

At the Jefferies London Health Conference in November, Novavax stated that Japan and Europe have already extended it to nine months.

Hopefully, we will see that here in the States as well.

Though… it might take a bit of pressure.

Let’s talk timetables.

I’m going to explain everything… probably too much…

The TL;DR is the FDA could approve pediatric Novavax access tomorrow if they wanted to, and it would be in line with how the other COVID vaccine manufacturers have been treated.

Except for mRNA, they were approving an additional product, so it was actually more complicated. In a perfect world, Biden’s FDA would have approved it months ago for this winter season, and it was within their power. Sadly, they had other priorities in mind.

Instead, we must push the new FDA to seek the same approval via EUA.

It’s a bit confusing, but this approval breaks down into two different, yet overlapping, processes. The expectation is that the FDA will decide to move Novavax from emergency approval to standard approval in the Spring.

If this happens, it would mean they are off the EUA…

And would finally start the process for standard approval of pediatric expansion.

However, that’s entirely dependent on what Trump’s FDA will do.

If this happens, even if there are no issues from the new FDA, the process to get pediatric Novavax actually takes longer…

How would getting general approval make it take longer?

Suppose Novavax gets general approval in the spring, which I hope they do. In that case, they apply for pediatric usage in the appropriate amount of time, and that’s for non-emergency approval… that means the earliest we would see expansion is the next winter season.

Not terrible, though that would take longer than what we could do with the EUA.

If the EUA is used, we could get expansion immediately by using the emergency status granted by the EUA process. It can be simple to some, but still pretty convoluted.

Don’t worry; there’s a whole section to explain what this all means.

Personally? I would like it sooner, and we will try to make it happen sooner…

Then, pediatric Novavax would be available while general approval goes through.

And as long as Novavax is under EUA, the FDA can make it happen faster.

So, until then, we should push VERY hard on the new FDA in any way we can. At the very least, this action will help move that general approval later this year.

At the same time, taking this action could do a lot to protect our vaccines.

Don’t be confused about my intentions here; I’m not against general approval; getting full approval would be fantastic. We should help make it happen when we get there.

However, knowing a summer surge is coming, we shouldn’t wait until next winter for our kids to have the best vaccine protection available.

Even if you don’t have kids, children are a significant source of transmission, and we are simply not giving our youths under twelve the maximum protection available.

That leads to viral spread in our communities, negatively affecting us all.

If any of this works, we can get pediatric Novavax access as soon as possible or as late as next season.

Either way, that’s good news.

There’s actually more good news.

Novavax got the rug pulled out from under them after developing a successful vaccine… That’s not the good news.

That left the company with debts and outstanding contracts that had investors worried… That’s really not good news, either.

The GOOD news is their new leadership team consolidated those debts and entered into multi-year arrangements to pay them off…

They had a pretty good 2024 when you look at the numbers.

And all of this is a good sign that they plan to stick around.

Even if folks are concerned about another company buying them, until these debts are handled, that’s not an attractive purchase. The decision to enter into these multi-year arrangements is a testament to the confidence in their product.

That confidence is not misplaced.

It’s not all debt consolidation, too; Novavax just hit a significant milestone in its relationship with Sanofi regarding the success of its pediatric COVID-19 trials.

Sanofi has entered into an arrangement to license Novavax’s products, including milestones where Sanofi gives Novavax different payment levels.

Novavax reaching this $50 million milestone associated with their pediatric trials is essentially a “twofer” as that’s both speaking to the long-term sustainability of the company AND the success of their pediatric testing…

And that’s why we’re here.

We don’t know the precise details of this particular milestone, yet we can certainly say that it at least bodes well for the product and its manufacturer.

At the same time, Republicans have been saying very troubling things about vaccines in general, and we need to talk about it.

And though that might seem like the least of our concerns regarding the troubling things Republicans are saying, the adverse long-term effects of lowered vaccination rates will stick around regardless of who is in power for, possibly, generations.

So, let’s get this started.

That’s right… We haven’t even started yet.

… If you feel like screaming, just get it out now.

… …

Do you feel better?

Okay, so… go make some tea, grab your favorite warm blanket, and get ready to read some genuinely frustrating data with obnoxiously good sources about an unobtainable protein-based pediatric COVID vaccine…

That might also help stop transmission in adults, too.

1. We’ve all seen the headlines.

And if you haven’t… don’t worry, you’ll be seeing them soon.

Republican attacks on public health have put access to COVID vaccines in jeopardy.

We need an alternative to mRNA for children because a primary focus of the Republican attacks is aimed at mRNA specifically…

And at the moment, we only have mRNA for children under twelve.

By the time you’re reading this, Trump and his goons have taken control, and they seem prepared to change how vaccines are approved or which are even allowed…

Or, for that matter, if we get public health at all.

To complicate things further, as summer waves become more commonplace, it’s increasingly apparent that a flu-style seasonal approach for COVID isn’t working…

That means we need to improve on our vaccine response in general.

Trump unquestioningly handing over control of the FDA to people not friendly to vaccines when we need to adopt better COVID vaccine practices… creates a problematic environment, though there’s a lot of that going on right now.

On one hand, we do need to rethink our COVID vaccine strategy…

On the other, there is reasonable fear we might see access to mRNA limited…

Or even possibly removed altogether. While they could go much further than that even.

When we should be seizing the opportunity to upgrade our vaccine protection for kids, we’re instead being faced with the possibility of everyone under twelve losing access to COVID vaccines entirely…

And this is not the time to go back.

We ask that you sign the petition…

Then call the FDA, just like we did to get earlier vaccine approval for JN.1 updates.

Getting a shift in a major policy like that was a huge win…

And we need to do it again.

There are several contact options.

We will update contacts as needed, so leave a comment if you have a suggestion or if one of them becomes unusable. While the leaders are changing, most of the lower positions aren’t.

We will see how many staff they fire, but that’s another reason to start calling ASAP.

This article is to show you, the reader, all the data you would want to see (and some you might not) before you’d think this is necessary or even possible…

• Is it safe? Is it effective? Can we just use the same vaccine on kids?

• Is approval like this even something the FDA can do?

• And can our kids get a priming series after multiple mRNA?

We’re going to cover it all so you feel comfortable making calls.

The petition can be found here → https://tinyurl.com/mt4yysh7

You might want to hang on to that; maybe you even want to share it later, because…

Remember when I said we were going to see all those headlines?

Well, you don’t have to turn on the news to see them…

There are some very concerning things being said.

Trump’s pick for HHS, Robert Kennedy Jr., has had troubling positions for a while now, whether it be about Polio or COVID vaccines.

And it doesn’t stop there…

Comments from the writers of the Great Barrington Declaration (GBD) are even more unsettling.

While the GBD itself is more of an announcement of intention, the signers are also referred to informally by the same name. They represent a primary US “doctor” group that has been pushing to normalize infections while minimizing the risk of COVID…

Especially to children.

This chart demonstrates perfectly how wrong they were about immunity.

A signing member, Jay Bhattacharya, has been nominated to lead the NIH.

Here’s an example of his opinions…

To paraphrase from the article…

If they have it their way, which it looks like they might, unethical infection-based immunity could be the only option for our kids.

Here, see for yourself… and to be clear, this is wrong…

His basic assumption is that infection creates “long-lasting protection” from severe disease, completely ignoring the cumulative risk of multiple bouts of COVID.

He’s advocating for short-lived and unethical infection-based immunity as the primary source of infection control, if we can even call it that when we know that these infections make you more vulnerable, not less…

Except, allowing rampant infections is not infection control at all…

It’s not great.

The only silver lining of this negativity was that most of it was framed in the past context of mRNA mandates.

Well, until you get to Florida.

This is an actual real screenshot from the official Florida Public Health…

There are many things wrong with the above statement.

Honestly, I don’t know where to start, but to be clear, that’s not how any of that works. That being said…

Florida Surgeon General Joseph Ladapo is possibly up for a major health position.

At the very least, he appears to be in the circle of people taking control of public health… and he was the lead medical advisor in Florida while Trump was living at Mar-a-Lago…

The joke about ‘Making America Florida Again’ is especially not funny right now…

Ladapo tweeted this on November 27th, 2024:

Notice that he points explicitly at “mRNA COVID shots,” singling out mRNA.

With that, somehow… It’s not all bad news.

Just in August 2024, on Chris Cuomo’s show, Trump’s former CDC Director, Dr. Robert Redfield, said he prefers Novavax.

“I wish the country would switch more rapidly (to Novavax) … and in my clinical practice I use the protein vaccine. So, I know exactly how much spike protein you get. Your body is not becoming a manufacturing plant, right, okay. I give you a certain amount of spike protein that’s not able to replicate, not able to reproduce itself, and I know the decay curve in the human body and that’s the vaccine I use now. It’s made by Novavax.”

RFK himself has made similar statements…

While I admit it was a few years ago, that’s still a silver lining in so much tragedy.

If you notice the date of that tweet, that’s showing approval way back in 2022, and yet, almost no one has heard of Novavax still…

Watching Novavax as they’ve been trying to make it work has been a wild ride. After experiencing so many regulatory delays, you can assume that if there were any actual problems, the FDA would be making a massive deal of it…

We’ll revisit that later.

2. Why Novavax?

Well, for starters, its initial data was extremely strong…

That shows 100% efficacy against moderate and severe disease and an overall efficacy of 89.7% and 90.4% in general efficacy between two different studies…

What does that actually mean?

Though officials will say all these vaccines have equal efficacy, that doesn’t directly equate to real-world effectiveness… I will explain that too.

At the same time, Novavax was also put under much more scrutiny than some other COVID vaccines…

Much more scrutiny.

I want to take a second to speak to the folks who are not my regular readers; if you are a regular reader, you can skip this part and jump down to the “four main points.”

… They gone? … Okay.

Our group has pushed for greater access to Novavax for over two years.

When we started, it was looked at as inferior by “experts” on social media, and access was limited to just those who had never been vaccinated for COVID previously.

Folks would have to cross state lines or even lie about their names to get access.

It was really something at the time.

None of the data supported these limitations; it was simply a matter of improper prioritization by the FDA and CDC... for reasons that are “officially” unknown.

Af reasonster outcry from the public, Novavax is now looked at equally by the government.

But… how did we do it?

By consistently engaging with VRBPAC (FDA) and ACIP (CDC) members directly, we were able to open up access based on the available science.

We can’t take all the credit, but while VRBPAC has responded positively to our engagement, ACIP members did not care for it, and almost all of the members left.

Here’s a clip from our Brace For Impact show on the subject:

However, since ACIP has almost entirely new members, and we have contacted them since they started, that’s the new status quo.

Generally speaking, they seem like alright folks.

However, there's a lot of material to cover regarding why you will listen to me and what I’m going to share with you right now.

And no… I will not explain my overuse of ellipses…

Just think of it as a healthy pause for your blood pressure with all this disturbing data.

I have three articles that cover Novavax; you are welcome to read them.

- The Benefits of Novavax Explained: Nov 26th, 2022.

- Americans Should Be Able to Get Novavax: Sept 11th, 2023.

- Our Continued Success Requires Us Building on What's Worked: Feb 15th, 2024.

And two presentations to the FDA on this specifically…

- VRBPAC Meeting: June 15th, 2023.

- VRBPAC Meeting: June 5th, 2024.

Now, you can read all of those, and they are full of sources… though…

It primarily comes down to four main points:

1) Year-round protection without gaps (persistent immunity)

2) A more effective upper respiratory tract response

3) Increasing the breadth of protective antibodies with additional shots

4) Fewer Adverse Events (AE)

Does lower AE equate to “real-world” safety?

In early 2024, a study was released showing the safety profile after administering one hundred thousand doses, twenty-five thousand of which were their first doses…

And what did we learn?

Novavax produced an amount of AE that was on par with mRNA, except…

The actual AE it produced had a lower risk.

3. You probably think you’re reading this wrong.

You’re probably thinking… “this data seems pretty good…”

It could even be better than mRNA.

And you’d think our former regulatory bodies would be excited to boost vaccines with this much of an improved response, right?

Well… not exactly…

I cannot explain what a struggle it’s been to keep Novavax approved and available. It has taken a significant effort from the public to keep the product alive…

Many countries have even lost access entirely, sometimes with no apparent reason.

However, some countries are starting to see potential access again.

So, there is some hope; we are looking at Australia working on its deal to allow Novavax for their next season.

And their winter is in what would be the summer for the northern hemisphere.

Watching the WHO have to remind the CDC presenters of that during their once-a-year presentation was definitely a more memorable moment than it should have been.

Here are the details of the deal down under:

This was announced on December 12th, 2024.

This means Australia has 3 million doses available at no additional cost, and they have organized potential delivery through the end of 2029.

All the Australian government has to do is tell Novavax when to drop them off.

Regarding the UK, there’s been talk of Sanofi distributing there…

Sources are limited, but we have this from the 2nd quarter 2024 earnings call.

It’s right there in the first example of a lunar cycle.

In the meantime, Germany and Austria have it and allow vaccine tourism.

When it comes to not primarily white countries, a few countries have it, but the product is likely to see Sanofi distribution unless Novavax has preexisting purchasing agreements, such as India, Japan, and South Korea.

When it comes to Canada, that’s a bit more complicated because Canada wants the vaccine made on Canadian soil. I’m not quite sure what the fix for this is.

It seems like it’s either a complex regulatory issue or… Canada is just being petty.

While working on this project, they updated their recommendation so that mRNA is no longer the preferential COVID vaccine, specifically citing Novavax, and that mRNA was unfairly given preferential treatment.

We did the same thing here in the States.

While Canadians have had to cross the border to access Novavax, it looks like maybe this won’t be a problem much longer, as Canada appears ready to implement the same regulations that allowed Americans access.

Now, all they have to do is buy it.

This was just updated on January 10th, 2025:

The language is almost identical to the US with at least one notable exception…

The timing.

This is likely happening because of the efforts of activists who watched us gain access here in America. A concerted push in Canada started just a few months ago, and I can’t help but feel that their work and these changes are related.

Canada is putting the interval at three months, which is technically pretty close and, at one time, was acceptable. It isn’t too bad, but they’ll need to push for two months.

The three-month interval has been a long-standing Canadian rule since 2022, but we don’t know if waiting that long creates the proper priming effect. It might, but we don’t know.

Plus, they even acknowledge the need for a second vaccine to mitigate waning:

The brutal truth is…

If you want access to this vaccine in your region, you’ll probably have to fight for it.

All this work we do adds up and will ultimately save lives.

This is why we keep pushing…

Even when the gains are negligible, at least we are moving forward.

Now, while dealing with all of this, you’d think it’d be hard to find space to push the FDA on pediatric access too…

…

Yeah, probably.

But we’ve been trying anyway.

A year and a half ago, we were already pushing the FDA to alter the required pediatric testing parameters to something that reflected the population they’d be vaccinating:

So far, there’s been no progress on the issue…

That might change with a new FDA.

Don’t we want another pediatric COVID vaccine?

It really seems like the FDA is sending Novavax around in circles for no good reason while leaving them in EUA, preventing them from even asking for help on the matter.

EUA stands for “Emergency Use Authorization,” and the process is how all the COVID vaccines came to market faster. The EUA gives the FDA incredible control over what the company can or can’t do with its product and how it’s manufactured. That last bit will be significant later on.

This is essentially regulatory capture, but how it’s supposed to work, with the regulatory body having capture over the companies they regulate. Instead, it’s being used to limit the public’s access to a beneficial product, not the other way around.

What we are used to seeing instead is companies having regulatory capture over the regulatory bodies themselves… we will be covering that in Part 2.

The premise of the problem with pediatric Novavax is that the FDA wants Novavax to test with child subjects that are both infection and vaccine-naive, based on a deal made in 2022…

This is not the majority group they will ultimately be vaccinating.

While also requiring additional steps that other companies weren’t faced with. Even with all these data requirements, Novavax is successfully producing these studies, but the FDA isn’t even seeing that data yet because of a bad deal over the approval process.

As far as I can tell, the FDA has not been open to altering this arrangement with Novavax.

This was like making a plan with Darth Vader, and Novavax is just hoping they don’t hear, “I am altering the deal. Pray I don’t alter it any further.”

But the EUA is a double-edged lightsaber; it can limit Novavax in many ways…

Though… it can also expedite approvals in ways that are normally not available.

The FDA can use this process to expand access to Novavax for under twelve…

This was the same process used to bring pediatric mRNA to market.

As of October 24th, 2024, both mRNA vaccines for under twelve were still under EUA.

This means even the mRNA companies will have to file for full approval while the Republicans are in control, making its future seem bleak.

So… can we just use the adult vaccine for kids, too?

It’s probably a good time to mention that I’m not associated or in communication with Novavax. Nor do I, as of the time of this writing, have any significant investment in the company either.

Except… I do have two children who need to get vaccinated.

So, there’s my conflict of interest.

4. The best COVID vaccine for kids has been sitting on the shelves this whole time…

Novavax is the same shot for all ages.

If we want to guarantee access to a pediatric COVID vaccine, the FDA must expand Novavax access to include children.

We need the FDA to act now!

With the way Republicans are talking…

They might remove childhood vaccinations altogether.

It will take a significant effort from the public to stop them. And even if that’s successful, there’s still reasonable concern they won’t allow mRNA regardless…

With its current EUA status, the FDA has complete control over pediatric mRNA.

This could leave us with no way to vaccinate our children against COVID.

I said as much at the December 12th, 2024 VRBPAC meeting…

Even if some of the Republicans have said nice things about Novavax, we can’t count on what’s going to happen now that they are in control of public health…

Or at least what’s left of it.

And many of the Republicans are on the record saying vaccinating kids for COVID is unnecessary. A few are even saying all vaccines are unnecessary.

This is as much about Novavax's approval as it is protecting vaccines.

There are many reasons to approve a new pediatric protein-based COVID vaccine…

However… It’s actually a bit simpler than a complicated approval.

It’s not even approval of a new vaccine; it’s simply expanding access.

Doses of mRNA can be more complicated than you’d think, with even the experts tripping up while trying to explain the difference between the adult and pediatric dosing at VRBPAC meetings…

However, with Novavax, it’s all the same shot.

If you and your teenager went to get it, they would come from the same box.

So, we know the vaccine for children over twelve is the same vaccine adults use, but what about those under twelve?

It’s still the same vaccine.

To demonstrate… Here’s an example of adult and pediatric testing using the same vaccine with the exact dosing.

This is from the adult vaccine trials…

And this is from the pediatric trials.

See? They used the same vaccine for both successful trials.

Also, that’s our first glimpse of pediatric Novavax data.

What does all this mean?

That means, for the FDA, it’s a more straightforward expansion of existing access to the vaccine that is not only available… it also has a special emergency approval.

We don’t need a complicated approval process for a new vaccine…

It’s just an expansion of existing usage under emergency authorization.

Which is the current status quo for all COVID vaccines for children under twelve.

The most protective pediatric COVID vaccine is just sitting there on the shelves while our kids get infected repeatedly.

It’s frustrating what a simple solution this is for such a complicated problem.

The FDA could snap their fingers, and this would be almost instantly available.

The fingers that need to snap belong to the head of CBER (Center for Biologics Evaluation and Research), Peter Marks, at the FDA.

Why would a group seeking approval or expansion of a vaccine focus on Marks?

From Marks’ own Wikipedia page…

On his own wiki page, he’s called the “Chief Regulator of vaccines.”

So, I hope we’re clear on why we’re putting our focus where we are.

And he has no plans to leave his position, having served under Trump already.

In the Summer of 2024, he was also the single person that threw out the JN.1 recommendation in favor of KP.2…

Even though both science and now history support that JN.1 was preferred.

One more thing: he’s a hematologist oncologist… not an immunologist, epidemiologist, or whatever else might be more closely related to vaccine science.

That makes him a specialist in blood cancer, which is just more fuel for the antivaxxer fire where they are claiming vaccines cause cancer. He was also the focus of our previous successful action last year to get COVID vaccines released earlier.

It took two days from the point we decided to focus on him to the final Novavax approval for 2024. This included a direct statement from Marks just a few days after mRNA was approved early.

In 2023, it was over a month between mRNA and Novavax approvals.

Focusing on Marks has become a tried-and-true method, as many readers are familiar with, but I wanted to make sure I made the point for all the new folks.

Marks can kill any product that needs him to sign off on it… and all he has to do is just sit on his approval longer than their funding allots.

On the surface, it looks like the company failed, not that he withheld his approval for an unwarranted amount of time.

That gives him total control of way too much.

Many company or product failures are attributed to Marks holding his approval or not communicating properly with management teams…

Except… the claims are purely anecdotal. However, we aren’t waiting on anyone else.

And when Marks isn’t carefully deliberating which products not to approve…

He’s out giving speaking engagements, which I’m sure he does for charity.

And while he’s the chief regulator of vaccines, he is not his own boss.

The whole FDA is getting a new boss.

Two bosses, actually.

With Trump taking control of public health, new leadership is being approved for all the primary leadership roles.

RFK is going through the nomination process to lead HHS, which is the top…

While Dorothy Fink has been appointed to that same position in the interim.

The power structure breaks down like this:

Be warned, the chart below is probably one of the worst ways to display that structure imaginable, but there it is. This isn’t even the worst version of it…

We'll be talking about the FDA commisisioner in a few minutes. I thought it was the commissioner this whole time, but here we are. It turns out we were wrong.

That was sarcasm for their misspelling, but it does kinda explain the job they’ve been doing.

Anyways, RFK Jr. is nominated for the top HHS Secretary position…

While Martin “Marty” Makary has been nominated to oversee the FDA.

This nomination appears to be happening so he can ban abortion drugs… and that’s a fight all by itself. Please help where you can.

He’s also expressed some horrible positions on COVID:

That’s an article where some of his claims are being fact-checked.

Both of these people are potentially about to be Marks’ new bosses.

So, while they are super problematic and under normal circumstances I would never suggest ever trying to work with folks who talk about things the way they do…

This time, though, that’s where the power is, and they are already coming for mRNA.

So, if we want to protect our kids from infection, we have to work it out.

Though, we shouldn’t just rush into doing something potentially dangerous…

Would expanding Novavax for kids be safe?

We saw one study; do we have more?

5. Has Novavax been properly tested for children?

This is a more complicated question than it should be, with most problems arising from how the FDA keeps Novavax locked into their EUA.

Do we have data out there showing it to be safe and well-tolerated?

Yes, we do.

While the sample group was small, it was well-balanced.

What about Adverse Events?

In this particular study, it did well…

Not only are the Adverse Events within safe ranges, but we are also seeing a similar 180-day antibody response as we’ve seen in adults.

This is the same study from the last chapter, and it alone is not enough.

There needs to be a greater examination of the available data while still recognizing that the “E” in “EUA” stands for EMERGENCY.

At the same time, everything is moving very fast…

So fast that other countries are getting ahead of us on pediatric access, even though Americans paid for Novavax via Operation Warp Speed.

Japan has recently approved Novavax for those six and older.

Japan is generally considered to be more ardent than the US when it comes to safety.

So, for them to approve it, it at least implies the data they saw met higher expectations than what we have here in the States.

Japan’s approval data isn’t readily available (if you have access to it, please let us know), so we have to look for even more safety testing.

Because at the very least, from this, we can say that Novavax does have sufficient data to support expansion to at least six years old. But in the US, we aren’t even in a place where that data would be submitted yet… Don’t worry, I’ll explain…

However, we can at least assume that the safety data does exist.

We’ll need to go through all the mechanics and identify as much risk as we can…

Which means going through all the different aspects that make up this situation.

So, let’s start with the adjuvant…

The adjuvant is new… Do we know if it’s safe for children?

The adjuvant is called “Matrix-M.”

Its name is so close to sounding like an X-Men character that I wouldn’t be surprised if they had to get licensing from Disney.

Though, if they had to, which they did not, I’m sure they would have agreed because the safety of this new adjuvant has been widely tested.

Wait a sec, what is an adjuvant?

A vaccine generally breaks down into two parts…

Antigens and Adjuvants.

The adjuvant helps kick-start the immune response.

The antigen is a piece of the pathogen that essentially kick-starts the response.

It works kind of like ammunition, with the adjuvant being the gunpowder and the antigen being the bullet, but don’t worry, there’s no actual gunpowder involved.

Honestly, maybe if we use more gun metaphors, the Republicans won’t try to get rid of them.

As far as adjuvants are concerned, we’ve generally used some variety of aluminum for the last few decades, and that’s fed some of the anti-vaccine rhetoric in that time.

Here’s a historical breakdown of adjuvants and how they’ve changed over the years.

It’s an incomplete list, but it’s still interesting and helps you more easily understand that even vaccines have their own version of the “march of technology.”

Unfortunately, risk is still part of the deal.

As long as the side effects of the adjuvant or antigen are significantly less than the side effects of the pathogen, then it’s generally considered a net gain.

However, that can and should be improved over time.

And our long-term aim should be reducing that risk entirely.

The best way to offset the risk ratio is to aim for consistent protection…

Even if a vaccine comes with a warning, the benefits of the vaccine have to outweigh any of the adverse effects from exposure.

There will always be some risk in exposure to a dangerous antigen, but we reduce the risk significantly this way. Though, we don’t remove it altogether, and at times, we can even trade risks…

The overarching goal should be a net gain of lowered risk overall.

So, when it comes to COVID, we need the response to last. We can’t have inconsistent protection that leaves us vulnerable at random times.

Never before have we successfully vaccinated for a coronavirus…

But a new adjuvant might just change that.

Taking a look back at point #1 from the four main points in Chapter 2:

This chart demonstrates consistent year-round protection without gaps.

Persistent immunity is an unfortunate phrasing considering the connections between persistent virus and Long COVID, but we can work on that later.

The chart above shows both the original version and the BA.1 update comparatively ending up in roughly the same place, even though the newer version started with a slightly lower response…

mRNA was not able to do this between versions.

Consistent protection, without gaps, needs to be a priority.

And the improvement that allows that could lead to improvements in all our vaccines, but there’s a lot more resistance to improving our vaccines than you’d think.

Most of us who grew up within the safety net created by vaccines can’t truly understand the pain that was experienced by earlier generations caused by simply living in a world without them.

And when we did get good vaccines, it took multiple attempts to get it right.

Even after our first pass at vaccination, COVID still gives us a glimpse into the harsh reality of how vulnerable we are to these microscopic pathogens.

Some might consider it a failure to continue seeing negative outcomes after only the first attempt at vaccination. However, anyone who would say otherwise would have to be familiar with the reality of trial and error. Failures of this type should be expected.

Thinking we’d get it right on our first try seems the most unrealistic of all positions.

The art of creating vaccines is finding only the necessary parts of the pathogen to get an optimal immune response while leaving out the parts that create risk…

Then, adjuvants activate the immune response in the same way the more harmful parts, which have been removed, would have.

This allows us to get the correct immune response with the lowest risk.

Naturally, it will take a few tries to get it right.

Improving vaccine technology, whether it be the antigen or adjuvant, is an ongoing process. As a result, it’s far too easy to confuse folks by misrepresenting different aspects of vaccine history.

While there has been a lot of talk about Novavax’s vaccine using “older” technology…

That’s only part of the story.

We aren’t getting the whole picture.

It’s true that protein-based is a more traditional platform when compared to mRNA; that’s their intended context when it’s said that Novavax uses older tech…

However, the Saponin-based adjuvant is a significant advancement.

Saponin-based adjuvants have long been viewed as the future, as we could move away from the various aluminum-based adjuvants currently used.

Well, that future is now—in this case, the same adjuvant used in this COVID vaccine has already been used in another, one meant for pediatric use…

And it had some really great results.

The R/21 Oxford malaria vaccine significantly improved over prior vaccines, increasing real-world effectiveness from 36% after four shots to 75% with only three.

That’s doubling effectiveness with fewer shots.

Doubling protection with fewer vaccines is a huge improvement and means that the youngest can gain full protection faster…

Because this malaria vaccine is for ages 6 months and older.

And saw extensive pediatric testing.

That testing group is ten times larger than the previous study.

That vaccine was so successful that it led to an agreement with The Bill and Melinda Gates Foundation to find additional uses for the adjuvant.

Novavax has already demonstrated that the adjuvant has benefits when simply added to any existing antigen, which is exactly what happened here with the Oxford/R21.

That means there’s still room for improvements in the R/21 malaria vaccine if improvements are made in the antigen.

We still don’t know if this malaria vaccine triggers an IgG4 class switch like earlier malaria vaccines, but if it does, then improvement in the antigen might fix that.

That means there’s still significant room for improvement in this malaria vaccine.

Despite all these benefits, there has been a great effort to try to shut Novavax down…

At one time, it was the top shorted stock on the American stock exchange. Folks don’t believe me when I say the problem with Novavax is that it’s TOO good…

But there it is.

Novavax as a company represents significant changes to BOTH antigen and adjuvant and risks shaking up existing markets. Naturally, some folks don’t like that.

And I’m sure at least one of our Big Pharma companies would LOVE to pick them up at a discount… but really? There’s nothing “old tech” about it besides the antigen being protein-based instead of mRNA.

There’s an even more complex piece to this puzzle.

The Matrix-M adjuvant does something we see with saponins in general: modulating an immune system for an up-regulated interferon-I response…

On the surface, up-regulating type I interferon genes might seem insignificant…

But it’s not… It was through the excellent work of Dr. Akiko Iwasaki that we got confirmation that folks with a high interferon-I response were more likely to either not get infected at all or experience what they were calling an “abortive infection.”

Don’t get mad at me; I don’t name these things.

This interferon-I idea is complex and relates to many different parts of our immune system… You should probably refresh that cup of tea before we continue.

We’re going to really get into the thick of it, like we traveled through Europe and couldn’t find a razor for several weeks…

6. Let’s talk about our immune system

It’s time to have “the” talk… uh, no, not that talk. The other talk.

This was originally supposed to be my follow-up article to my Long COVID piece, but let’s just say that never happened because, as it turns out, this is all very complicated.

If we want to understand our immune system, we start by breaking it down into two parts: the Adaptive and Innate immune systems.

Having both is common among vertebrates.

So, if you have backbone, then you’re included… naturally, most politicians don’t make the cut.

And as far as naming things after what they do, this is about as far as we get into this whole thing making literal sense, except maybe with interferons themselves.

Our adaptive system adapts to your environment…

Our innate immune system is what you naturally have and is also called the “nonspecific immune system” by some, which means it’s not variant-specific.

These two systems continue breaking down into other groups…

The adaptive immune system can be cut into the Humoral and Cellular systems.

Rather than try to reinvent the wheel myself, I’ll just use someone else’s explanation.

First, humoral immunity…

“Humoral immunity is also called antibody-mediated immunity. With assistance from helper T cells, B cells will differentiate into plasma B cells that can produce antibodies against a specific antigen. The humoral immune system deals with antigens from pathogens that are freely circulating, or outside the infected cells. Antibodies produced by the B cells will bind to antigens, neutralizing them, or causing lysis (dissolution or destruction of cells by a lysin) or phagocytosis.”

Humoral immunity is called that because it uses organic compounds called humors.

I’m not even kidding… I don’t actually have a joke for this. You’d think I would, as it’s super low-hanging fruit, but no. You’re just going to have to adapt to it.

But when we talk about what the FDA and CDC ask about for vaccines, they are primarily talking about neutralizing antibodies, and those are part of the humoral system. These are produced by B lymphocytes with the right memory response.

While they do talk about T cells, there’s a lot of confusion about how they work…

And that’s pretty much as much of the immune system the government cares about.

However, there’s still a lot more to explain.

We haven’t even gotten to innate immunity yet…

We’re still covering the first half of humoral immunity, which is cellular immunity…

“Cellular immunity occurs inside infected cells and is mediated by T lymphocytes. The pathogen's antigens are expressed on the cell surface or on an antigen-presenting cell. Helper T cells release cytokines that help activated T cells bind to the infected cells’ MHC-antigen complex and differentiate the T cell into a cytotoxic T cell. The infected cell then undergoes lysis.”

While Cellular immunity sounds like an immunity system inside the cell and, in a perfect world, would protect your cells… that would actually be called “intracellular immunity,” which, honestly, we should be putting a lot more focus into than we are…

Cellular immunity doesn’t really create a happy ending for the infected cell…

The process actually involves destroying a lot of infected cells, all of them really.

Or at least… as many as it can find…

Not being able to find certain infected cells is basically how persistence works.

Here are a few examples of different versions of cellular immunity:

One of the things in there is that T cells destroy the cell to get at the pathogen.

It’s great we can do all this… and automatically no less… however..

This cell death is ultimately your death.

My editor says I should put a trigger warning because this is tough for some folks.

While it feels like we have an unlimited amount of cells, and it is hard to conceptualize how many cells are in your body, it is actually a finite amount.

When we talk about “dying of old age,” it’s a colloquial way of saying that you’ve had so many cells die that there are not enough to keep your body functional.

Even if cancer or a car crash or that bad relationship doesn’t get you, eventually, your body will simply not have enough cells to continue on…

Anything that creates an effect that reduces our cells’ capacity to divide or makes them lose their ability to function optimally… leads to autoimmune disorders.

And we know COVID leads to autoimmune disorders.

So, COVID destroys enough cells that it creates the same effect as simply living an entire life… SARS-CoV-2 is closer to a weeping angel than any character I can think of in fiction because it uses what would be your future to replicate itself…

While COVID sends you on a time travel to your new future, except it just ages your body while everything else stays the same… and the Hulk isn’t there to wind you back.

This is why we talk about stress, or accidents, or anything that causes inflammation as if it can age you… You’re aging somewhat unnaturally when you are experiencing inflammation because cells are being destroyed, and they need to be replaced…

If they even can be replaced at all.

And while we can manage this in normal terms, infections, especially COVID, advance this process even faster than having a bad day, and it can create permanent lifelong changes in the mechanics of your body because it can destroy so many cells.

This creates vast dysfunction, not only through damage, but persistence, which also is just more damage and dysfunction.

I wrote a whole article about syncytial formation, so that’s it until later.

But that cell death process, that’s the clock ticking in the back of your head.

So, we want to limit this as much as we can.

I, for one, want to save all my cell death for enjoyable memories, you know, things I will regret temporarily instead of being sick for a month before it disables me more.

Apologizing profusely to all the folks who this already happened to.

What’s the whole picture here?

Your adaptive immune system is in effect once you are infected… and while that’s all very important for limiting disease and death…

This protection alone is not enough to stop sequelae.

Sequelae is any long-term change to your body chemistry where you can experience many types of disabling effects. Also, stop being self-ableist. Any change that directly leads to you being less able is a disability… don’t be afraid of it, just support helping other folks more.

Technically, sequelae is the plural of sequels, which is “a pathological condition resulting from a disease, injury, therapy, or other trauma. Derived from the Latin word meaning sequel.” So, if it feels like round 2… It’s right in the name.

I’ve personally experienced sequelae from infection at least three times; it’s not fun.

When we talk about sequelae in the context of SARS2, we call that Long COVID.

This is why we want to stop a pathogen before it fully infects us, and the innate immune system is where we should be focusing our energy.

The innate immune system is made up of our front-line defenders, and though they are often thought of in the context of mucosal immunity, generalizations like that are never the whole picture. That being said, a lot of this is happening in your mucous.

Because of this, we know a lot less about the innate immune system than our adaptive one because it’s just easier to measure the effect of exposure to an antigen.

We’re going to get really into this in Part 2.

We can, of course, measure innate immune responses, but how we affect it is still new.

But the basic idea that we need to understand for this purpose is that we present antigen to the innate immune system, and it then activates the adaptive immune response… though, it’s rare to modulate the innate immune system for any long period.

Here’s some reading on modulating the innate immune system from 2023 if you’re interested in the subject. Nothing conclusive, but nice facts on the subject.

I’m sure if we look more, we’ll find examples of it, but this modulation limitation is one of the reasons saponin-based adjuvants have been sought out for so long.

While the innate immune system is a bit more complicated and less understood…

We do see the effects of it all over… not only can it stop infection entirely, in some cases, but it can also help our adaptive immune system be more effective by helping those cells simply not hurt each other as much.

When studying innate immune responses, this is how many things Novavax measured… all the things in red saw an increase in effect from Matrix-M alone.

To be clear again, this is the Matrix-M adjuvant with no antigen.

For the purpose of this explanation, we’re focusing on one particular part of the innate immune system… a cytokine called interferon-I.

There are actually three different types of this cytokine: alpha, beta, and omega.

They are represented by the Greek alphabet in the literature.

“Type I IFNs, which include IFNα, -β, and -ω, are rapidly activated during viral infection and considered “antiviral” partly because IFNα receptor-deficient mice are highly susceptible to viral infections (1). Type II IFN, which is represented only by IFNγ, also inhibits growth of viral and other pathogenic infections.”

All three have slightly different processes depending on which one they are…

Though, some have what I’d call pretty important functions…

It’s specifically interferon-I alpha and beta that regulate memory T cells.

These cytokines can be released by a number of cells, making them functional parts of our immune systems… and the stronger this reaction at the start, the faster we stop infection. In a perfect world, we stop the virus before it proliferates…

When our masks and nasal sprays fail, then our innate immune system takes over…

And that’s where Matrix-M’s effects really shine.

The antigen modulates your adaptive immune system by creating powerful antibodies, but the adjuvant modulates your innate immune system to have a higher interferon-I response, among other things.

This is measured both in our blood and lymph nodes but not in muscle.

Interferon-I can be produced by macrophages, dendritic cells, fibroblasts, epithelial cells, stromal cells, and more. Whatever gets infected has a different response.

Ultimately, this initial response sets the stage for everything that’s about to happen.

It kinda seems like it rolls out the red carpet for the rest of our immune response…

But really it sets the stage for a battle that is about to take place.

If we are trying to avoid having our cells destroyed, macrophages play a pretty big role in all this by activating interferon-I without being infected…

I’ve been talking about boosting macrophages as the solution to stopping COVID for a while now, and it looks like that might be a reasonable course of action.

It’s been quite the two and a half years, and the only thing that’s changed is Trump is back.

If you notice, that last chart shows the interaction that leads to managing our T cells…

Interleukins, which are referred to by “IL” and come in at least seventeen variations, play an important role in this process.

It’s essentially the postal service for your immune system, and if it stops working, then nothing works right. If communications stop or are improperly sent…

The pathogen wins.

Think of it as an electric signal in your body, just like any other feeling, except it’s using organic proteins. This can be interrupted, and we don’t know what to do about that.

While whichever front-line defender is fighting off a pathogen with interferon-I, it also sends off interleukins like the “beacons of Gondor” to activate the part of the immune system that creates interferon-II.

Which is represented only by interferon gamma, a potent antiviral.

Interferon Gamma was only discovered sixty years ago, in 1965.

Technically, there’s a third type of interferon… interferon III. I know, very original name, but for this article, we aren’t going to delve into it. All you need to know is that it was only discovered in 2003, and it overlaps a lot with interferon-I.

All of this science is very new in a historical sense, so just like our long history of improving antigens and adjuvants, there’s a lot of room to improve our thinking on this.

At the same time interferon II is being activated, different interleukins go on to activate lymphocytes. These are white blood cells we call B and T cells.

Specifically, it’s interleukin 1 (IL-1), interleukin 2 (IL-2), interleukin 10 (IL-10), and interleukin 12 (IL-12) that activate lymphocytes.

Let’s quickly roll through the different types of B and T cells…
Which is the least confusing part of this.

Also, grammar side note, only hyphenate T cells if it’s an adjective like T-cell destroyer or T-cell macerater, which both would be really good examples of phrases to describe what syncytial pathogens do to T cells… and yeah, we will get there in later parts.

What are the different types of B cells?

There are four main types of B cells: naive, transitional, plasma, and memory.

Naive B cells

• B cells that haven’t been exposed to an antigen

Plasma B cells

• Activated B cells that produce antibodies to fight antigens

• Also known as plasmacytes or effector cells

• Can release up to 2,000 antibodies per second

Memory B cells

• Dormant B cells that respond to familiar antigens

• Transforms into plasma cells when reactivated

• Creates long-lasting immunity to pathogens

Follicular B cells

• A subset of B cells that circulate in the blood and lymphoid organs

• Produce high-affinity antibodies during infections

The B cells are responsible for creating IgG… or immunoglobulin, which come in a few types, but we’ll get into that later… and neutralizing antibodies.

T-cells and B-cells work together to activate each other.

The important part for right now is the idea of T-dependent B cell activation which uses helper T cells that are designated by Th1 in the literature..

And when we talk about T cells, that’s slightly easier than dealing with B cells.

Of course, there are more types of T cells, but for our purposes, this is what matters.

There are two main types…

1. CD8+ cytotoxic T cells kill cells infected with pathogens.

2. CD4+ helper T cells coordinate other lymphocytes to act.

The thing about T cells is that all types of them are finite.

You do not have an unlimited amount of T cells.
Technically, no cell is infinite, but your supply of CD8+ is particularly low.

A healthy ratio is three to one CD4+ to CD8+.

That means we should have 3x as many CD4+ than CD8+…

So, do we want T cells on the front lines spewing cytotoxic goop or T cells coordinating other cells that don’t have the same limitations?

T cells are like the officer, and though they can seem kinda snobby, sending them out into the front lines is advancing a type of cell death that we can never come back from.

There’s no easier way to say it: increased T cells are associated with living longer.

Even when there is a T cell replacement, it’s associated with longer lifespans.

That means there is a direct correlation between our T cells and our lifespan.

Types of T cells can also include effector cells, which include many types of cells.

For the sake of time, and how overwhelming this already is, we’re going to skip these for now.

However, T and B cells are both just different types of white blood cells.

Here’s the whole break down of how these form from blood stem cells.

This is why stem cell treatments work, but there are a variety of types of stem cells.

The other cells coming from lymphoblasts, besides B and T cells, are natural killer cells.

Interferon gamma or IFN-γ, the sole interferon II, is primarily produced by natural killer (NK) cells, though they can be produced by NK T cells too.

Because it’s a bit confusing, there are both NK T cells and natural killer cells that are not T cells, and the latter is mostly responsible for our interferon gamma response. Here, we’re talking about the NK cells, not T cells, though NK T cells produce interferon-gamma as well.

I know, it’s really simple.

We need this organic antiviral, IFN-γ, but NK cells can be cytotoxic to CD8 T cells.

This is where we circle back around to our interferon-I response…

From the same study…

A strong interferon-I response stops your cells from hurting each other…

More or less, an interferon-I secretion protects your CD8+ T cells from NK cells.

They don’t attack each other directly, so much as their cytokines can be cytotoxic to each other. After all, the whole point of this process is to destroy infected cells, so this stops it from destroying non-infected cells, too.

However, if a pathogen gains control of that cell, then it can use that process to hurt us.

This interferon modulation is likely the same process that activates your lymph nodes. At the same time, mRNA does have this effect from using antigen alone, but Novavax does it better by having both the antigen and adjuvant each doing it.

At the same time, mRNA responses focus on CD8+, while Novavax produces more CD4+, though it does produce CD8+ as well, but in lower numbers.

And I feel like we already covered why focusing on CD4+ is better than CD8+…

We’ll get into that more in later parts. If you listen to my VRPBAC comment, it’ll make sense.

For now, it’s important to remember this whole process uses your lymph nodes…

This is also likely why some AE can be swollen lymph nodes, which happened to me on my third shot, but traditionally, AE does go up for your third shot in most cases.

So, word to the wise: stay hydrated whenever getting vaccinated to help avoid this.

This is happening because Matrix-M creates such a strong modulating response.

Though they don’t explain the chain of events, we see the increased interferon gamma response, which is associated with an improved interferon-I response. They call it a milieu.

An often-overlooked fact is that this process plays a crucial role in fighting cancer.

Will long-term modulation of our interferon-I processes help us fight cancer, too?

It’s way too soon to say, but it’s all very interesting how it’s all connected.

It’s not clear how long this modulation lasts, if it’s just short-lived to help boost the antigen response process, or if it achieves more long-term changes; we will need more data. At worst, successive exposures to Matrix-M could see benefits.

Even if there is a chance it might help fight cancer, don’t we want that?

It might surprise you that some people in the business of public health don’t actually want that.

If we want to understand interferon-I improvements, then we have to understand that it’s the start of a cascade effect that kicks off our entire immune response.

But when it comes to a strong interferon-I response protecting from infection with COVID directly, here’s the good doctor explaining it herself:

And as much as we might not like the term “abortive infection”…

In this case, though, it does make sense.

An abortive infection is when you contract the virus and become infected, but instead of going through an infectious stage, you will have 1-2 days of not feeling well, then just get better while possibly never testing positive.

While in that context, the effect doesn’t stop infection entirely…

It will almost certainly make cutting the line of transmission much easier.

However, there is a context of this effect where it aborts your infection entirely…

And we probably shouldn’t tell the Republicans about this, or they might try to ban it.

It’s interesting, though, that Novavax wasn’t prioritized because it actually fits really well into what the government wanted out of mRNA… but couldn’t achieve.

If you are familiar with the folks who get Novavax, then you will know this “abortive infection” concept is a commonly shared story; where they don’t test positive or maybe one day of a faint line, while others who were exposed with them do.

They ultimately feel like they are going to get sick for a few days before recovering.

Here’s an example that just popped up on our Discord on January 22nd, 2025:

I have read a similar message more times than I can remember.

And in some cases, the same exposure does not lead to any change at all for those with Novavax compared to those without. However, I want to make clear that this effect is not consistent or understood enough to go about your day without a respirator.

It’s just hard to tell because how do we measure when nothing happens other than with unethical controlled exposures? And we’re not doing that.

It’s likely the adjuvant is causing this effect, as the same effect has been shown in pigs even when administering the adjuvant alone, and we see the same outcome we’d expect in human data if it were present there.

And you might be thinking… “Sir, that is pig data. Shouldn’t we use mice or primates?”

Pigs are over 80% similar to humans for immune parameters; mice are under 10%.

… really makes you wonder why use mice data at all, eh? It is faster, but it’s not really good for anything other than preliminary data and not enough for human approvals.

And though we have difficulty explaining why it’s happening…

The protective effect we are trying to diagnose is certainly measurable in studies.

Looking back at point #2 from the four main points in Chapter 2:

This demonstrates reduced viral load in the upper respiratory tract on days 2 and 4 compared to mRNA. “Vaccines that reduce viral loads early during infection are likely to help reduce transmission” seems like kind of an important point.

And while the interferon-I response is very important, it’s not the whole picture either when it comes to what’s creating this protection… more on that in Part 2.

Though, from a protecting against Long COVID perspective, which is always my personal aim, this is as good of a reaction, that includes an infection, we can expect.

Except, on a side note, this effect is not monitored by the CDC or FDA and is not a consideration when the vast majority of folks discuss these products’ benefits.

I’d go so far as to say less than 1% of people who talk about vaccines consider this.

That means when it comes to the “which is better” argument, the idea that one of them has a potentially infection-blocking effect which does not include measuring antibodies, and this effect is not variant-specific, nor is it even limited to COVID…

This effect is not even a matter up for consideration.

And we see this effect in multiple places.

Here’s a qualified expert explaining a recent study where the effect was observed:

Novavax reduces SARS-CoV-2 in the upper respiratory tract six times better than mRNA and six HUNDRED times better than being unvaccinated.

If this isn’t just the interferon-I response, does this mean this is mucosal immunity or sterilizing immunity, or what’s the difference?

Don’t worry, we’ll get there.

So, how does Novavax’s COVID vaccine work?

Does it run on magic? Should we expect an Owl before we can get it?

Novavax has a great video that breaks it down as the “mechanisms of action.”

Here’s the transcript:

COVID‑19 is caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). SARS-CoV-2 uses its spike protein to bind to an ACE2 receptor on the airway epithelial cell and enters the cell.

This spike protein is the target of many vaccines, that work in different ways allowing the immune system to build a defense against the virus.

Novavax COVID‑19 Vaccine, Adjuvanted, is a protein sub-unit vaccine produced using established technology that has also been used in some seasonal influenza, HPV and Hepatitis B vaccines. Novavax COVID‑19 Vaccine, Adjuvanted presents the spike protein part of the virus to the immune system. The vaccine is composed of multiple trimers of recombinant spike proteins, stabilized in the prefusion conformation, and bound to a polysorbate 80 core, and are highly immunogenic.

The vaccine is also formulated with Matrix-M a proprietary adjuvant that includes saponin extracted from the bark of the Quillaja saponaria Molina tree.

Matrix-M enhances the magnitude of the immune response and promotes recruitment of various types of immune cells to draining lymph nodes, which may facilitate a more robust, long-lasting response.

Studies have shown that Novavax COVID‑19 Vaccine, Adjuvanted elicits an immune response, inducing both antibody-producing B-cells and multi-functional CD4+ and CD8+ T-cells. When challenged with the real virus, the antibodies block SARS-CoV-2 binding to the ACE receptor. Multi-functional T-cells produce multiple cytokines and are associated with an enhanced immune response to clear the virus. And effector memory T-cells target infected cells.

… It’s a great video, but it’s a lot to read as text.

As far as immune responses go, the last paragraph is the important part. But there was some bizarre language about how the antigen works…

And no, when I say bizarre, I am not referring to how “adjuvanted” was repeated.

I meant the part talking about “trimers of recombinant protein.” The process of creating an antigen is similar, though completely different, to recombinant variants.

This refers to breaking down spike protein into pieces and then recombining only the parts we’d need. In this case, it also removes the furin cleavage site.

This is a really cool process that makes antigen in a way that’s at least relatively new…

Calling this “old tech” is intentionally doing not only the product but also the public a serious disservice. It’s almost like they don’t want you to know about the advancements.

Here’s an infographic on how the vaccine is made:

And for all those with egg allergies, you can see no egg is involved in the process.

Around 7-9 of these recombined spike proteins are then stabilized on a circular body.

The antigen is the blue dot with the red spike proteins in the image below:

Here’s what they look like under an electron microscope…

So, they do actually look like they are rendered:

The study above shows a few important things…

#1) It shows how the actual adjuvant and antigen look as described. Both are much larger than COVID virions, which have a diameter of about 1nm. These are about 40nm.

#2) It shows the changes made to the spike protein so it has fewer dangerous parts.

This language is going to be new to most folks, so bear with me.

“Linear diagram of the sequence and structure elements of the FL SARS-CoV-2 spike protein showing the S1 and S2 ectodomain. Structural elements include a cleavable signal sequence (SS, white), NTD (blue), RBD (green), SD1 and SD2 (light blue), protease cleavage site 2′ (S2′, arrow), fusion peptide (FP, red), heptad repeat 1 (HR1, yellow), central helix (CH, brown), heptad repeat 2 (HR2, purple), TM domain (black), and CT (white). The native furin cleavage site was mutated (RRAR→QQAQ) to be protease resistant and stabilized by introducing two proline (2P) substitutions at positions K986P and V987P to produce SARS-CoV-2 3Q-2P-FL spike. A, Ala; D, Asp; E, Glu; K, Lys; L, Leu; N, Asn; P, Pro; Q, Gln; R, Arg; S, Ser; V, Val. (B) Representative negative-stain EM images and 2D classes of SARS-CoV-2 3Q-2P-FL, formulated in PS 80 detergent in the presence of Matrix-M adjuvant. In the raw micrograph, spike rosettes are circled in yellow and Matrix-M adjuvant cages are circled in white. 2D classes showing individual spikes, higher-order spike nanoparticles, and Matrix-M cages of different sizes. Matrix-M does not appear to interact with the spike nanoparticles.”

This demonstrates the significant advances in both antigen and adjuvant…

This is why calling this “old tech” is so misleading.

I know to almost everyone that reads like stereo instructions, so let’s talk about it.

What does “native furin cleavage site was mutated … to be protease resistant” mean?

This not only explains how the native furin cleavage site was essentially removed by making that particular genetic coding resistant to protease, which is a crucial part of cell invasion where the spike is cleaved by a protease for the purpose of infection…

With this protease resistance, it can’t be cleaved. This removes the concern of the spike entering cells we don’t want it to or building up in places that could be harmful…

Plus, they managed to do this while not negatively impacting our immune response.

mRNA does not have this safety feature.

But also, interestingly, it explains that Matrix-M does not appear to interact with the spike nanoparticles directly, which means your body absorbs it, and you gain an immune-modulating effect that affects whatever antigen is in your body at the time.

This last bit is really important because it shows that if one coadministered other weaker vaccines with Novavax, it should make their effects stronger and last longer…

In the same way that Matrix-M has shown benefit by simply swapping adjuvants.

This also creates a mechanism for fighting persistent viruses when we combine the antigen-targeting conserved epitopes and the adjuvant effect that increases the breadth of your antibodies. Or at least, that’s what I told the FDA that ultimately opened up access. The theory has advanced a lot in 18 months.

So far, it seems to check out… with some limits.

We will get to that in Part 3. It was Part 2 originally, but it just got too long.

It really shows that this represents significant increases in our ability to not only make safer but better vaccines too… and this antigen is like the Ferrari of antigens.

This represents the next generation of vaccines and is a “market disruptor”…

That’s the real problem here; more on that in Part 2.

Adding more antigen isn’t better unless it’s the right antigen.

It seems that our immune system responds better to less antigen in the vaccine overall but instead more spike protein on the individual parts of antigen.

mRNA, for example, has three spike protein heads, and that might not be enough to get the long-term immune response everyone was hoping for.

I should also point out that mRNA does not have an adjuvant, and, again, they did not remove the furin cleavage site, so it’s not a recombinant spike protein like Novavax.

Recombinant… just like two variants creating a new one, is all the parts of spike protein recombined into a new spike protein, but without the furin cleavage site.

It’s basically just a bunch of amino acids, which are also the building blocks for all life, and as they don’t need to function like an actual spike protein- nor do we want that- they can be recombined for an immune response without the same risk.

These amino acids combine to make what are known as epitopes.

For Novavax specifically, they try their best to target what are known as “conserved epitopes.” These epitopes are recognized as whole parts for the purpose of your immune response, and a specific conserved epitope is targeted.

Here’s an example of that process in action, where the same epitope is seen across all variants that also share a vaccine response. This data is from 2022 but is still relevant.

It’s not about this actual vaccine but rather their methods as a whole.

There’s a lot of argument about why or how this happens, but Novavax advertises its product as targeting the entire Spike 2 protein, while mRNA only targets part of it.

It’s generally referred to as the “full-length SARS-CoV-2 spike protein,” which is bad labeling again, as it makes it sound like it puts us at greater risk, not less.

However, this is believed to be why Novavax is more long-lasting.

Back to mRNA…

They had hoped this would be the outcome with mRNA, and it just didn’t pan out.

There’s no Y-axis on this chart, but you get the general idea.

The idea is that even if you have a lot of individual antigens, if there is not enough antigen on the individual parts, then you won’t get the ideal immune response.

Also, when comparing the two available vaccine platforms, we don’t know how much antigen is created by mRNA, but it’s believed to be within safe levels…

With Novavax, we know exactly how much spike protein is in each dose.

mRNA is already expecting a lot more out of our immune system than we would normally by simply not using an adjuvant…

It actually defies a lot of tried-and-true methodology.

What happens when Novavax just increases antigen?

The chart below shows that significantly increasing the volume of antigen in Novavax did not improve the response. Below is data from early in their process showing comparative results in 2.5, 5, and 25 micrograms, giving roughly equal outcomes.

This is why five micrograms is the current standard antigen dose for Novavax.

Quick sidebar: This chart also shows the deceptive nature of “natural immunity.”

Not to be deceptive myself, that’s non-human primate data in Novavax against convalescent human data in red… these three things are comparable between groups.

These are relatively small testing groups, with each dot representing a single person.

Charts B, C, and D include convalescent data for folks who just had COVID while unvaccinated… this is from 2020 before vaccines existed. Their data was gathered four to six weeks after testing positive.

B is Anti-Spike Immunoglobulin titer.

C is human ACE2 binding inhibition.

D is actual live virus neutralization.

Technically, C is the dodgiest with macaque ACE2 binding against human ACE2…

But even those are technically considered almost identical.

Also, they are all logarithmic scales, or log charts, in multiples of ten. So, though things look close being between two and three, it’s actually ten times that distance.

In all three charts, all versions of Novavax perform better than natural infection.

What’s interesting though is how there is a mean of all the groups with far outliers both at the top and bottom, where one or two people have responses comparable to Novavax vaccination… although, with far more people on the bottom with no response at all, with the exception of chart B showing the Anti-S IgG titers.

So, while some rare people do have an excellent immune response to COVID from infection, they are the exception, not the rule. Also, now we know this doesn’t last.

This is a great example of survivor’s bias, where the person who does have that high response assumes it’s that way for everyone, and it couldn’t be further from the truth.

And because these are log charts, the distance is even further than it looks.

Now, putting our focus back on Chart A, which is why I showed it in the first place.

They are demonstrating using three different quantities of antigen…

At 25 micrograms, that’s 5x the antigen, and there was no significant increase… so, a 5x increase doesn’t add up to a 5x benefit…

What it comes down to is a quality-over-quantity issue.

And more does not make it better; it will likely only increase your risk of AE.

However, it should be said that Novavax is currently testing a vaccine with only a marginally higher antigen, and it’s showing promising results.

I was fortunate enough to participate in a workshop with the former lead Novavax scientist, and it was a question I asked him that appears to have spawned the product.

I’ll update this later with a clip of the Q&A; it is available in the link, but this is a great example of how important it is to get involved with anything you can.

7. Is Novavax safe to use after multiple mRNA?

I’d like to say that if it was not safe to get a protein-based vaccine after multiple mRNA, then that would be a damning condemnation of mRNA in general…

As many of our existing vaccines are protein-based.

Luckily, that is not the case.

The FDA has already approved Novavax doses, regardless of mRNA history.

This was the fight in 2023, where we were initially successful. Before that, folks who had gotten mRNA were prevented from access to the product entirely.

Novavax has released many studies on getting their vaccine after mRNA, but just recently, they released a study again demonstrating that receiving two doses after multiple mRNA was safe and effective.

Though, technically, this study had them at 180 days apart.

Which is also the general recommendation for many groups already vaccinated.

Current guidelines for children are based on similar safety data.

I’m saying current now, but with Trump, who knows how long this will last?

This is from the current CDC guidelines for 12 - 18 years old:

The current guidelines for adolescents that have already received three or more COVID vaccines is two shots, six months apart, with the initial 2024-25 version being administered at least eight weeks after the last previous version.

This makes it very clear that it is considered safe AND within current regulations to get the additional shots on the same timeline that you would a new priming series.

Technically, this is under the immunocompromised section, but we will get to that.

But quickly, if they are saying it is safe for immunocompromised folks, then we can only assume it is also safe for immunocompetent folks too…

So, the distinction is not about safety, but rather necessity…

And as there isn’t a shortage of COVID vaccines, there’s nothing to worry about.

But that timing is them saying that getting two shots eight weeks apart and then a third six months later is not only safe but allowed in specific circumstances.

Just in this case, it would be an XBB.1.5 vaccine, then a JN.1 eight weeks later, then they can get another JN.1 six months after that.

Even though the variants don’t match in that example…

That’s the same timing for a priming series.

But here’s a flow chart explaining the general recommendation, as it stands…

If you have already received your mRNA vaccines, you might have missed that the chart shows that Novavax requires one less dose compared to the others.

If that sounds familiar, it's because it should. It’s just like with the malaria vaccine.

That would mean that vaccinating kids with Novavax would require fewer pharmacy visits for a better and faster response.

That’s right, not only would the protection be better, but they could get it quicker.

That last block they all end at is a relatively new concept called “shared clinical decision-making.” It does, for some reason, seem to confuse the pharmacists.

And by relatively new, it was started in 2013 and is now 12 years old…

So, the program is just old enough to get a Novavax shot.

Currently, five vaccines fall under shared clinical decision-making guidelines.

COVID vaccines being added to this already obscure list is new, and that’s leading to some folks being denied access. This issue should just be temporary.

However, making sure insurance companies pay for them is rapidly becoming more of a concern, and somehow, CVS has managed to blend these two problems into one.

There will be more on that in Part 2.

But the barrier between the CDC and FDA, simply by being two different agencies, leaves too much opportunity to muck things up.

If it seems like I’m talking about the FDA and CDC as somewhat interchangeable… I’m not.

The process for approval can be a bit confusing.

First, you see FDA approvals, but then CDC regulations..?

Or is it recommendations? Or is it both?

How does that work?

The FDA approves safety and efficacy, then the CDC sets out plans for actual usage based on that FDA approval.

That means FDA approval leads to the CDC setting usage guidelines…

The confusing part is a feature, not a bug, and there’s a reason we call it “red tape.”

But understanding this means we can nail down the hold-up with pediatric approval to the FDA specifically. The process simply hasn’t reached the CDC yet.

And while the official recommendation has been prioritizing a seasonal approach, the CDC created the self-attesting immunocompromised process as a middle ground for those who think they require more access.

The current data does support wider use, hence, “shared clinical decision-making.”

It’s set up so the people who know they need more can get more… and that can make a person ask a lot of questions, like, if it’s necessary, then why aren’t they making a wider general recommendation? And the reason is mostly political.

I’m sure that will only get worse under Trump, but maybe we can play it in our favor.

This shared clinical decision-making language is now fairly standard practice for CDC guidelines in general, allowing for a higher level of vaccine protection while not requiring documentation.

It’s really not any different than getting it normally, other than it’s essentially a coded phrase that’s supposed to give you access to the additional vaccines.

It’s just that sometimes the pharmacists don’t know about it yet.

Sometimes, they are even the last ones to find out.

I’ll have all the information you need to talk to your pharmacist at the end.

This process was created because we were able to present the appropriate data showing that the benefit was greater than the risk and that the demand was there.

So, science supports it, and the people want it…

But politically? Getting these federal agencies, as part of Biden’s executive branch, to clearly recommend wider usage of Novavax was nearly impossible.

That means, to get them to recommend an additional priming series as necessary?

Now… that was actually impossible.

It breaks down like this…

Getting the last administration to admit that we need to do an entirely new priming series would mean them also recognizing and acknowledging that mRNA did not meet the demands set out by the WHO for COVID vaccines.

When it comes to your Novavax timing, unless your mRNA was within the last two months, then it’s simply not relevant to our process of protecting you now.

mRNA simply doesn’t create lasting protection the way they told us it would.

Even though that same administration promised that the earlier vaccines were enough for long-term protection… and they even had the audacity to say they’d stop infection…

There was never even a moment where we had that level of protection.

The goal was just to convince the public to accept mass infection…

And we will use their own charts to prove it.

*sigh*

I accepted a long time ago that Biden was never gonna fix this problem.

It’s highly unlikely his administration would ever admit to that type of failure…

Especially after they created the problem themselves.

Which, again, is only a failure because of unrealistic expectations.

And I’m 100% certain that it will only be more complicated with Trump.

Instead, we get these immunocompromised rules.

There have even been attempts to “liberalize” the term more directly by members of VRBPAC in the hopes it would make it clearer that access was available.

This rule has been in place for an entire year.

The immunocompromised rules for COVID vaccines have been in place since 2023. It has been specifically discussed at committee meetings regarding how it was set up to allow access for anyone who wants additional doses.

But I’m sure this requires a lot of paperwork, right?

No paperwork is required.

The self-attesting option was also discussed at the same VRBPAC meeting.

If you haven’t noticed, self-attest, self-confirm, and self-identify are used interchangeably. They all mean the same thing, but it’s new, so it's still inconsistently said.

Now, the CDC has made it extra clear…

This is a very recent version of CDC guidelines explaining that no documentation is required for access to these doses. So recently, we caught a typo before they did.

Now, as soon as you stop giggling about “COVID-129,” we can see pretty clearly that a person can “self-confirm” for access to additional doses…

And yes, that’s the actual CDC making typos. There’s actually a second one coming up.
See if you can find it. But after the FDA’s “commisisisioner”… it’s just kinda normal now.

Letting these things slide is more of a sign of cognitive Long COVID than folks realize.

But how does this let folks get a new priming series?

What is a priming series?

Here’s the specific language that opens the door for it…

Let’s not forget that anyone can self-confirm as immunocompromised because no documentation is required.

As we’ve seen, the minimum time to access doses is eight weeks, not six months.

And the same rules that allow for additional doses are in effect for minors as well.

Clearly, they are not concerned about the risk to kids from switching to Novavax.

And just in case you are wondering about how clear the rules are on allowing access when you are self-attesting as immunocompromised…

They have made it explicitly clear multiple times. Here’s one more:

The CDC has made it as clear as possible that both children and adults can get a two-shot series after mRNA without explicitly recommending a new priming series.

On their way out, the Biden administration’s CDC gave us a bit more clarity.

They clarified the language even more on requirements for access.

Also, don’t miss that below the highlighted text, it shows the recommended and minimum interval, with two months being the minimum even though it’s not the recommendation.

They have made it AS CLEAR AS POSSIBLE that you can both get them two months apart to complete a priming series and are not required to show any documentation to self-attest as moderately immunocompromised for access.

And technically, anyone could be moderately immunocompromised… We have no idea who is or who isn’t without what might be expensive testing for many.

While working with your doctor or provider is completely on the honor system…

Plus, the laws protecting the pharmacists and manufacturers from liability were just extended by executive order until 2029.

At the same time, we’re talking about the COVID vaccine with the lowest AE.

That means anyone should be able to access Novavax shots as long as they are at least two months apart… On the upside, you only need the two-shot series once.

But as of this moment, you likely need to self-attest as immunocompromised.

And it is clearly stated in these regulations that anyone is allowed to do that.

Also, bonus… don’t forget to stay hydrated whenever getting vaccinated…

I cannot stress enough how important this is, and it will reduce AE overall.

And you know someone is going to complain about me saying hydration will cut AE.

Let’s get to brass tacks.

How does one get access to multiple Novavax?

Here’s what you need to say to the pharmacist if it comes to that…
And the less you say, the better… being chatty can make all of this much harder.

1. It has been two months since your last COVID shot.

2. That you are immunocompromised.

3. The CDC guidelines state that the minimum interval is two months.

4. CDC guidelines also state that no paperwork is required.

5. Bonus: Insurance will cover all ACIP-approved shots.

6. If you are at CVS and there is an issue, ask for a manual override.

Hopefully, they won’t ask questions at all, so just don’t say anything you don’t need to.

And while this is not medical advice, this is advice on getting already-approved access.

These are the two links you’ll need if they ask for a source…

Here’s one…

And here is the other… from the same page even…

Hope that helps you make it happen.

In Part 2, we’re walking through, in clear terms, why the additional shots are needed.

But remember, when you’re getting the extra shots so you can have more protection…

No child in America under twelve can experience the same level of protection you are getting… even though the vaccine for them is just rotting away on the shelf…

We need to push until all ages can reach the same level of protection.

And according to Novavax’s SEC filings, the ball is in the FDA’s court to act faster.

So, let’s keep pushing.

Discord

Call to action.

We are calling on the FDA to use the powers granted by EUA to fast-track approval of an emergency expansion of Novavax’s COVID vaccine for pediatric use…

And for new access not to be limited by previous mRNA.

It really seems like the FDA doesn’t want your children to have the best available protection from COVID…

If they did, then you wouldn’t have had to spend a huge chunk of your day reading what would otherwise be an erroneous article.

So, be mad at them, at least, for creating a situation where you need to read all of this.

And you can tell them that when you call…

We need to start contacting the FDA.

We have a few different contacts to focus on here...

General Contact: 1-800-835-4709

Director of CBER - Peter Marks, MD, PhD​
204-402-8116
240-402-8000
Peter.Marks@fda.hhs.gov

This is the main person holding it up. Reminder: He also held up Lucira, which helped Pfizer buy the company after they went bankrupt due to a lack of approval.

CBER is the Center for Biologics Evaluation and Research…

They are responsible for approval.

Office of Vaccines Research and Review

OFFICE DIRECTOR - David Kaslow, MD
Organization: DHHS/FDA/CBER/CBER/OVRR
301-796-7114
David.Kaslow@fda.hhs.gov

OVRR, Associate Director for Research - Tod Merkel, PhD
Organization: DHHS/FDA/CBER/CBER/OVRR
240-402-9746
Tod.Merkel@fda.hhs.gov

OVRR, Regulatory Review Branch 1
SUPERVISORY BIOLOGIST - Jon Daugherty, PhD
Organization: DHHS/FDA/CBER/CBER/OVRR/DRMRR/RRB1
301-796-2640
Jon.Daugherty@fda.hhs.gov

OVRR, Regulatory Review Branch 2
SUPERVISORY BIOLOGIST - Rakesh Pandey, PhD
Organization: DHHS/FDA/CBER/CBER/OVRR/DRMRR/RRB2
301-796-2640
Rakesh.Pandey@fda.hhs.gov

OVRR, Regulatory Review Branch 3
SUPERVISORY CHEMIST - Elizabeth M. Sutkowski, PhD
Organization: DHHS/FDA/CBER/CBER/OVRR/DRMRR/RRB3
301-796-1536
E-mail Elizabeth.Sutkowski@fda.hhs.gov

OVRR, Clinical Review Branch 1
SENIOR ADVISOR FOR THERAPEUTICS - Maria Allende, MD
Organization: DHHS/FDA/CBER/CBER/OVRR/DCTR
301-796-2952
Maria.Allende@fda.hhs.gov

OVRR, Clinical Review Branch 2
SUPERVISORY PHYSICIAN - Andrea Hulse (James), MD
Organization: DHHS/FDA/CBER/CBER/OVRR/DCTR/CRB2
301-796-2640
Andrea.Hulse@fda.hhs.gov

OVRR, Clinical Review Branch 3
SUPERVISORY PHYSICIAN - Anuja Rastogi, MD, MHS
Organization: DHHS/FDA/CBER/CBER/OVRR/DCTR/CRB3
301-796-1544
Anuja.Rastogi@fda.hhs.gov

OFFICE OF THE CENTER DIRECTOR, Chief, Executive Operations Staff
SUPERVISORY MANAGEMENT OFFICER - Debra Fisher, MBA
Organization: DHHS/FDA/CBER/CBER/OD/EOS
240-402-3003
Debra.Fisher@fda.hhs.gov

OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY
Special Assistant to the Director
CONSUMER SAFETY OFFICER - Mona G. Atkinson, MS, MBA
Organization: DHHS/FDA/CBER/CBER/OCBQ
301-796-4215
Mona.Atkinson@fda.hhs.gov

MANAGEMENT OFFICER - Gloria Grantham
Organization: DHHS/FDA/CBER/CBER/OD/EOS
Gloria.Grantham@fda.hhs.gov

And a few more emails to try:​

cberocod@fda.hhs.gov

OCOD@fda.hhs.gov

commissioner@fda.hhs.gov

Just like the last rush job, this action has a short shelf life.

This goes out the morning of the 14th with the event on the 14th and 15th.

We don’t need a lot of people to write letters, we just need enough.

If you are a part of the COVID Conscious Community (CCC) then you have undoubtedly heard about HICPAC.

In Nov 2023, there was a big push to reverse a decision for the official CDC recommendation to include both surgical masks and respirators offering equal protection.

It was an all hands on deck moment for the community, and it wasn’t just a single event where we expressed outrage; it included a 60-day comment period as well.

We were ultimately successful, with the CDC sending back the guidelines.

We have continued our activism, pushing on HICPAC for preferable guidance.

And over the next two days they meet to finally revisit these recommendations that haven’t been changed since 2007…

But according to the 2007 documents the last change was brought on by the original SARS from 2003, but they were unable to lock in the best practices.