Attacks on Public Health Put Our Kids' COVID Protection at Risk: Part 1 of 3
It's Time to Not Only Step Up and Protect our Vaccines, But Also Get Access to Better Ones. Call the FDA and Demand Expanded Access to Novavax for Kids Under 12.
Disclaimer: Nothing in here is Medical, Legal, or Investment advice…
I’m a strategist, giving you the tools to create your best strategy.
Table of Contents
Intro: We need to do better…
We’ve all seen the headlines.
Why Novavax?
You probably think you’re reading this wrong.
The best COVID vaccine for kids has been sitting on the shelves this whole time…
Has Novavax been properly tested for children?
Let’s talk about our immune system.
Is Novavax safe to use after multiple mRNA vaccines?
Is a two-shot series really necessary? - Coming soon
IgG4: Does this matter? And should you care? - Coming soon
What was the government’s goal then? - Coming soon
Novavax’s phase 3 was called “PREVENT-19.” - Coming soon
What does efficacy mean? - Coming soon
Do they have equal efficacy or not? - Coming soon
Novavax Timing. - Coming soon
Novavax for Long COVID - Coming soon
So, for pediatric Novavax, what’s the holdup? - Coming soon
Who is actually more concerned about safety? - Coming soon
So, what the heck is going on here? - Coming soon
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.
![Screenshot from the Canadian "Guidance on the use of COVID-19 vaccines for 2025 to summer 2026," dated January 10th, 2025. Text says: "Unique to the COVID-19 vaccine context is that acceptability and access to COVID-19 vaccines have been influenced by earlier preferential recommendations for mRNA vaccines. The preferential recommendation is no longer in place (see NACI Updated guidance on the use of protein subunit COVID19 vaccine [Novavax Nuvaxovid]). Product preferences may continue to exist within the population because of the past products they received, and considerable public awareness that developed during the pandemic"](https://substackcdn.com/image/fetch/f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F0b8d6031-d069-4f88-bbd0-27af40ae0c35_1456x340.jpeg "Screenshot from the Canadian \"Guidance on the use of COVID-19 vaccines for 2025 to summer 2026,\" dated January 10th, 2025. Text says: \"Unique to the COVID-19 vaccine context is that acceptability and access to COVID-19 vaccines have been influenced by earlier preferential recommendations for mRNA vaccines. The preferential recommendation is no longer in place (see NACI Updated guidance on the use of protein subunit COVID19 vaccine [Novavax Nuvaxovid]). Product preferences may continue to exist within the population because of the past products they received, and considerable public awareness that developed during the pandemic\"")
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…
![Screenshot from The Lancet article published January 11th, 2023. Highlighted text says: "Each dose of 0.5 ml of NVX-CoV2373/SII-NVX-CoV2373 contains 5 μg SARS-CoV-2 recombinant spike protein antigen and 50 μg Matrix M adjuvant." Entire text includes non-highlighted portions and says: "Study vaccines In the Phase 2 part, SII-NVX-CoV2373 (DS manufactured by Novavax and DP fill and finished by SIIPL) or placebo were used. In the Phase 3 part, SII NVX-CoV2373 [DS and DP manufactured by SIIPL (COVOVAXTM)] or NVX-CoV2373 (NUVAXOVIDTM) manufactured by Novavax were used. Each dose of 0.5 ml of NVX-CoV2373/SII-NVX-CoV2373 contains 5 μg SARS-CoV-2 recombinant spike protein antigen and 50 μg Matrix M adjuvant. The other ingredients are 25 mM phosphate buffer (pH 7.2), 300 mM sodium chloride and 0.01% (v/v) polysorbate 80."](https://substackcdn.com/image/fetch/w_1456,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fd95d1f5e-8ffe-46a8-96bf-8bfb1a38d070_1600x411.png "Screenshot from The Lancet article published January 11th, 2023. Highlighted text says: \"Each dose of 0.5 ml of NVX-CoV2373/SII-NVX-CoV2373 contains 5 μg SARS-CoV-2 recombinant spike protein antigen and 50 μg Matrix M adjuvant.\" Entire text includes non-highlighted portions and says: \"Study vaccines In the Phase 2 part, SII-NVX-CoV2373 (DS manufactured by Novavax and DP fill and finished by SIIPL) or placebo were used. In the Phase 3 part, SII NVX-CoV2373 [DS and DP manufactured by SIIPL (COVOVAXTM)] or NVX-CoV2373 (NUVAXOVIDTM) manufactured by Novavax were used. Each dose of 0.5 ml of NVX-CoV2373/SII-NVX-CoV2373 contains 5 μg SARS-CoV-2 recombinant spike protein antigen and 50 μg Matrix M adjuvant. The other ingredients are 25 mM phosphate buffer (pH 7.2), 300 mM sodium chloride and 0.01% (v/v) polysorbate 80.\"")
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…
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:
![An image of a screenshot from wikipedia with highlighted text Cellular immunity protects the body through: T-cell mediated immunity or T-cell immunity: activating antigen-specific cytotoxic T cells that are able to induce apoptosis in body cells displaying epitopes of foreign antigen on their surface, such as virus-infected cells, cells with intracellular bacteria, and cancer cells displaying tumor antigens; Macrophage and natural killer cell action: enabling the destruction of pathogens via recognition and secretion of cytotoxic granules (for natural killer cells)[3] and phagocytosis (for macrophages);[4] and Stimulating cells to secrete a variety of cytokines that influence the function of other cells involved in adaptive immune responses and innate immune responses](https://substackcdn.com/image/fetch/w_1456,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fa8582f29-670d-4c62-9a2a-33cf71dfdb14_1446x570.png "An image of a screenshot from wikipedia with highlighted text Cellular immunity protects the body through: T-cell mediated immunity or T-cell immunity: activating antigen-specific cytotoxic T cells that are able to induce apoptosis in body cells displaying epitopes of foreign antigen on their surface, such as virus-infected cells, cells with intracellular bacteria, and cancer cells displaying tumor antigens; Macrophage and natural killer cell action: enabling the destruction of pathogens via recognition and secretion of cytotoxic granules (for natural killer cells)[3] and phagocytosis (for macrophages);[4] and Stimulating cells to secrete a variety of cytokines that influence the function of other cells involved in adaptive immune responses and innate immune responses")
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.
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.
B cells that haven’t been exposed to an antigen
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
Dormant B cells that respond to familiar antigens
Transforms into plasma cells when reactivated
Creates long-lasting immunity to pathogens
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…
CD8+ cytotoxic T cells kill cells infected with pathogens.
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…
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.
It has been two months since your last COVID shot.
That you are immunocompromised.
The CDC guidelines state that the minimum interval is two months.
CDC guidelines also state that no paperwork is required.
Bonus: Insurance will cover all ACIP-approved shots.
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.
This is the end of Part 1… but not the end of our journey…
Below is a call to action and a list of numbers to start calling.
DO NOT wait for Part 2 or 3 to start taking action.
The aim is to release future Parts soon, but we don’t even know if the FDA and CDC won’t have already been chopped up for bits and sent down to the border or worse in those two weeks. At this rate, we’re going to find it in a barrel somewhere in TJ.
SO, START MAKING CALLS NOW!
If you would like to follow any of my socials, not recommended, or make a donation, definitely recommended… then the links are in the button below.
Also, here is a quick plug for our show Brace for Impact. We are currently on Twitter/X spaces on Tuesdays and Thursdays around 6:00 pm PST, but the time is not set in stone.
We’re aiming to leave TwiX soon, but no final landing spot has been chosen yet.
You’re also welcome to join our Discord, but be prepared for a small test to enter.
See you in Part 2.
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
Excellent work!
As to why Canada would want Novavax to manufacture in Canada, well, Novavax has new vaccine technology that could make Canada a world leader. America treated Novavax like garbage, why not relocate?