It's Time to Get Novavax Its Full Approval.
The FDA is a mess, but when it comes to Novavax, that's not a new problem.
I said it was coming, and now we are here.
For the last few months, I have been warning folks that we would have to make a push for Novavax in April, just like our previous pushes over the last few years.
You are welcome to read more about Novavax's benefits in this petition we previously prepared, but you might want to come back to that later.
Petition and effectiveness data → https://tinyurl.com/mt4yysh7
Simply put, Novavax creates a superior COVID vaccine, and the simple fact is that no one in power seems to want people protected from COVID anymore…
Unfortunately, the answer to why that is is an overly complex question I’m covering in an extended article series. Rather than bore you with long-winded explanations, we should get directly to our current key problems.
While I said we would need to make a push for Novavax in April…
Unfortunately, Novavax did not make it clear that the actual deadline we were faced with was April 1st. We learned that as the news rolled out on April 2nd, the “FDA missed a critical approval day for Novavax” and asked for more information instead.
No one likes being blindsided and had approval gone through, it’d all be fine.
Now, the FDA giving Novavax trouble is not new, and many folks thought this was happening because of the current takeover and firings occurring at the FDA.
Some are saying that Peter Marks leaving is delaying the process, and removing Peter Marks was the first thing the new FDA director, Marty Makary, did.
While that may be true, Peter Marks was, in large part, behind Novavax being delayed.
He was even the focus of our push last year to get COVID vaccines approved early, where he ultimately tried to withhold Novavax’s approval as long as possible.
It was only a week last year, but it was months in previous years.
It appears to be more of the same nonsense from the same people who were also undermining COVID protections while projecting expertise on the matter the last four years. They conveyed expertise, but that expertise was never backed with action… But it’s worse than that…
They were never experts; Peter Marks is an oncologist, not even a vaccine expert.
That’s not to say the oncoming leadership is a greater expert, but new problems don’t erase the old ones or clear those same people of their past transgressions.
Peter Marks consistently overstated the effectiveness of mRNA, often stating that it would protect from infection even though that data was never presented to him.
He also created all the confusion with the JN.1 and KP.2 vaccines last year. He chose to override the expert decision to focus on JN.1, and ultimately, his choice to override it was a failure with lowered effectiveness rates released in a recent MMWR.
For the sake of a clear argument, here is the actual effectiveness data that the CDC presented to all of us when he made that claim.
You can even check the entire slide deck if you want.
If you notice, nowhere do the protective qualities even come close to Marks’ claims. They also are not even measuring preventing infection… It’s just measuring trips to the emergency department and urgent care.
If you were part of this conversation, you know this confusion was created to make Novavax seem like the “older product,” but ultimately, it was the better choice.
Misleading the public was pretty much the most consistent thing about Peter Marks.
He lied to the public regularly, and because of this, many people died. One could even argue that his deceptions created the space for the response we are seeing now with entire health agencies being erased overnight.
Republicans would never have come to power over this if we simply told the truth.
This time, it’s coming from Sara Brenner. Her Wikipedia page shows she was a holdover from Trump's first presidency. She became the interim FDA director after Cardiff, the previous director, left and before the new director was fully in his position.
But more importantly, she represents an FDA that prioritizes less protective vaccines and treatments for the benefit of corporate interests. Multiple sources have stated that it’s “very unusual” for someone in her position to pull something like this.
As far as I can tell, with Marks on his way out (his official last day is the fifth), someone else has to throw a wrench in the process like they have done the entire time.
I cannot stress enough that it’s the same people.
Do I automatically think the Republicans are going to do better? No.
However, they might actually be better on this singular issue.
All of the Republicans who have taken over health agencies are on the record of pointing out Novavax as the better COVID vaccine…
This is good… in theory, but it certainly doesn’t rectify all the other bad things happening at these health agencies. They are all also on the record as saying mRNA will be under examination to stay available on the market, which is a problem.
I don’t expect mRNA as a product to pass this scrutiny, as emergency use authorization has always been seen as critical for its approval.
If we had mRNA removed and everyone could get Novavax, that would be much better for handling COVID, but we run into several issues:
All under-12 COVID vaccines are mRNA and under EUA, which means that the Republicans can wipe them out in one day. So, no COVID vaccines for kids.
These people are all also on the record saying that it is not necessary to vaccinate kids for COVID… and before you get mad, our previous administration did not offer proper vaccination for kids either, so they aren’t that far off from each other.
At the very least, we need Novavax approved for under twelve as part of the move from EUA to BLA… That’s emergency use authorization to biological license application… You can think of that last A as approval, and it’s the same thing.
People will ultimately not respond well to being forced to do something like that. A challenge with creating any strategy for people is that they don’t like being forced to do anything. In the same way the anti-vaxxers didn’t want to be forced to get mRNA, the mRNA folks will not be happy about being forced to get Novavax, even if it is better. (On a side note, I can’t wait to hear them call Novavax the Trump vaccine. /s)
So, right now, as much as this is about getting Novavax its BLA approved…
It is also about getting Novavax approved for kids.
And then convince everyone that Novavax is, in fact, better.
… about this.
On the surface, trying to get Republicans to allow the use of Novavax for kids seems like an impossible issue… They are against vaccines, especially for kids, and their supporters are going to go on a vast bemoaning fest if a new vaccine gets approved.
However, we just had another study about Novavax, and it shows promising data that supports the use of Novavax being priotized as the pediatric COVID-19 vaccine.
This concerns a little idea called the “IgG4 class switch,” where harmful IgG is prioritized over helpful IgG1. That means IgG1 becomes IgG4, and this process suppresses both IgG2 and Fc effector functions that trigger T cells.
When antivaxxers talk about mRNA shots being immunosuppressive, they are referring to this effect. While their version is severely dramatized, it’s a real issue. They’re not talking about vaccine injury, which can also be suppressive…
They mean IgG4.
Unfortunately, this is one of the more overly complicated aspects of all of this.
It's a bit funny, even, but we learned from this study that when they talk about mRNA having higher overall antibodies, they include the bad ones, too.
Which seems counter-intuitive to me… Yes, it’s more, but is it actually better?
The reality is that this class switch is entirely harmful, and the only other vaccine on the market that does it is the DTaP. Specifically, the acellular antigen we switched to in the 90s causes a similar class switch, but it does it in adults and children.
![Screenshot from NIH article dated May 17, 2023. Highlighted text says: "The HIV [113] and malaria trials [115], and studies with the Pertussis vaccine informed us that repeated vaccination was linked to reduced protection from infection, and this poor response was directly related to a higher IgG4 production. Moreover, it was suggested that this class switch might contribute to breakthrough infections due to impaired fc-mediated antiviral responses...IgG4 production induced by repeated vaccination does not in any way constitute a protective mechanism..."](https://substackcdn.com/image/fetch/f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F97b2c048-8967-4373-ba86-f245efaf265c_1355x258.webp "Screenshot from NIH article dated May 17, 2023. Highlighted text says: \"The HIV [113] and malaria trials [115], and studies with the Pertussis vaccine informed us that repeated vaccination was linked to reduced protection from infection, and this poor response was directly related to a higher IgG4 production. Moreover, it was suggested that this class switch might contribute to breakthrough infections due to impaired fc-mediated antiviral responses...IgG4 production induced by repeated vaccination does not in any way constitute a protective mechanism...\"")
If you get multiple DTaP at any point, by the second one, you are experiencing a nonbeneficial IgG class switch… It’s well documented. High IgG4 is also associated with autoimmune disorders and cancer. Generally, it should be avoided.
Technically, the DTaP vaccine is fine, but not really; we should prioritize using vaccines that do not have this effect. Last year, we advocated for improvements in the pertussis antigen in a presentation to VRBAC (FDA) over this precise issue.
I want to make it abundantly clear that the DTaP vaccine is critical to get, and the three antigens represented in the vaccine are historically the most deadly bacterias to humans.
What matters here for Novavax is that mRNA creates this same class switch, but it does it primarily in first exposures. So, by administering DTaP and mRNA together to infants, we risk sending them into an IgG4 spiral because the mRNA version of the same response can last for over a year, much longer than the DTaP version.
We have not measured the combined effects, but we can assume it’s not desirable.
These are children too young to identify symptoms or changes, so if something goes wrong, doctors just shrug and write you a prescription for medication if they can.
And we know for a fact that the class switch is associated with more COVID infections and greater risks. And more infections mean more Long COVID.
Now, you might have many thoughts about this position; I admit it’s dangerously close to a few toxic positions that are actually just pushing to imply vaccines are unsafe or unnecessary… That couldn’t be further from accurate to my position.
After two years of working on this issue and creating FDA presentations on these matters, I've reached these conclusions. We’ve also worked on it extensively on our twice-weekly calls, so we didn’t come to this conclusion errantly.
This could represent a significant change in our vaccines.
The new study was interesting because it again showed that Novavax’s adjuvant overcomes these adverse effects of this class switch by promoting IgG2 and Fc effectors, the same two that are suppressed by the class switch effect.
That could mean if we use Novavax as the primary child vaccine in the early stages of life and it is administered with DTaP, then the combo might reduce the risk from DTaP’s IgG4 class switch effect until we can replace the antigen with something without that response.
At the very least, fixing this would be a win for everyone involved, and they can point to an actual problem with our vaccines without removing the ones we badly need.
This is simply a better way to protect our children and is a core argument for the approval of Novavax’s BLA and expansion for pediatric use.
People want to protect their kids and should have the best protection available.
However, we might need to remind the FDA that we need to protect kids from COVID.
We need to pressure the new and old FDA members to approve Novavax’s BLA and expand usage to children under twelve.
The best part about this situation is that there isn’t a pediatric Novavax COVID vaccine, so there is no additional vaccine for which to seek approval.
It’s the same vaccine on the shelves right now, and if the FDA simply gave the green light, we could start vaccinating kids with a far more protective vaccine immediately.
What’s our timeline? I think we have until the end of the month to get this straightened out before it starts affecting Novavax’s Sanofi deal, but that might have shorter deadlines than I realize. At the same time, we should be putting pressure on the FDA to extend the shelf life of their current product.
Other countries have extended it to nine months, just like the original vaccine, and should that extension be added in the US, their April batch will stay on the shelves.
Call to Action
So, we have three points in total:
Novavax’s BLA approval.
Expansion for pediatric use.
Expiration date moved from three to six or nine months.
We make this happen, and it will improve on every country’s availability.
If you have any questions, we will be doing a show on Thursday the third, the same day this article is going out, to discuss and open dialogue on this action.
If you have them, it’s a good time to show up with your Novavax questions.
But right now, you can start contacting people at the FDA. If this doesn’t work in the first few days, then we will open it up to HHS, too, which we’ve never had to do before.
However, if we are going to call the FDA and wait on the HHS…
Might as well throw the CDC into this message heap.
ACIP (CDC) public comment
We also have an ACIP meeting where the same points should be made…
The public comment period is open until the 11th; the meeting is on the 15th & 16th.
https://www.regulations.gov/docket/CDC-2025-0017/document
Contact these FDA numbers and emails with the three points listed.
Here are your points of contact to start with:
(The list has shrunk considerably since our last push for action.)
General
ocod@fda.hhs.gov
cberocod@fda.hhs.gov
CBERVRBPAC@fda.hhs.gov
(800) 835-4709 (240) 402-8010
Sara Brenner - Principal Deputy Commissioner
Sara.Brenner@fda.hhs.gov
Scott Steele - Acting Director, CBER: ← Peter Marks’s replacement
Scott.Steele@fda.hhs.gov
Scott.Steele@rochester.edu
Julia C. Tierney, Acting Center Director
Julia.Tierney@fda.hhs.gov
David Kaslow- Deputy Director, Vaccine Research
David.Kaslow@fda.hhs.gov
301-796-7114
Tod Merkel - Associate Research Director:
tod.merkel@fda.hhs.gov
240-402-9746
Robin Levis - Deputy Director, Vaccine Research
robin.levis@fda.hhs.gov
240-402-9665
Christophe Joneckis - Regulatory Director
Christopher.Joneckis@fda.hhs.gov
240-402-8083
Karin Bok - Deputy Director, Office of Vaccine Review
Karin.Bok@fda.hhs.gov
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As usual, incredibly helpful. Thank you!