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Friesein Profile picture
@Friesein
Aug 24 • 3 tweets • 2 min read • Read on X
Novavax Approval Update ✔️

We now have an update from Novavax clarifying one of the reasons for the FDA approval delay.

Yesterday, Novavax quietly updated their press release on the JN.1 update with a statement from their CEO, John C. Jacobs. In the statement, Jacobs said that they were working to provide "additional information" requested by the FDA.

“Novavax is working expeditiously to provide the additional information the U.S. FDA requires to complete its review and we are grateful for their ongoing efforts and strong partnership. Novavax’s intent is to provide access to our vaccine as a choice for consumers this season.”

While we don't know what specific information was requested, it's at least helpful to understand that the company does expect approval in the near future. In an earlier update, Novavax said that they anticipated being available in U.S. pharmacies "at the start of the fall vaccination season this September".August 22, 2024 Updated August 23, 2024 Novavax and the U.S. Food and Drug Administration (FDA) are working together productively as the U.S. FDA continues its review of data in consideration of an Emergency Use Authorization (EUA) of Novavax’s 2024-2025 formula COVID-19 vaccine (NVX-CoV2705). “Novavax is working expeditiously to provide the additional information the U.S. FDA requires to complete its review and we are grateful for their ongoing efforts and strong partnership,” said John C. Jacobs, President and Chief Executive Officer, Novavax. “Novavax’s intent is to provide access to ...
See the quoted post for a link to the updated press release from Novavax (thanks @tthiking for sending this my way).

Here's my earlier post on expected September availability:

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More from @Friesein

Friesein Profile picture
Aug 22
Potentially bad news on Novavax approval.

Take this with a grain of salt, as this is an unconfirmed rumor from a message board, but it looks like Novavax approval will likely be delayed.

This is in line with reporting from WP and NPR, which I will share later in the thread. See next post for text
Full text from above image for accessibility (wouldn't fit in ALT text):

"Unfortunately it appears at the moment that Novavax will lag behind the green light that will be given to Moderna and Pfizer this weekend. This is the decision of Peter Marks. Though Marks himself didn't personally mention it in his interview with NPR, the NPR interviewer made the statement in his opening remarks.

Obviously Mark's didn't want to actually say it and have to give a verbal reason as to why. And it's NPR so the interviewer didn't bother to question him. Marks does have an email and I know of two people that have written him and he actually responded.... Not on this subject but on his "cold and warm" milk philosophy.

There can be no legit reasoning behind it other than Marks wants to exit the FDA and be hired by either Pfizer or Moderna. Former FDA head Stephen Hahn who held up Novavax was hired by Flagship Pioneering the venture capitalist firm that created Moderna... Noubar Afeyan is Founder of Flagship and Co-Founder and Board chairman of Moderna.....

Scott Gottlieb FDA head before Hahn is on the board of Pfizer.... He had nothing to do with Covid. ... Point is all these people in charge leave the government for that big paycheck in the Pharma Industry."
From the NPR audio clip, not in the article text: "The Novavax vaccine, which is expected to get the FDA stamp of approval later, targets JN.1."

npr.org/sections/shots…
Read 8 tweets
Friesein Profile picture
Aug 18
Parents: The FDA is putting you in an extraordinarily unfair position on COVID vaccine selection.

Right as school is starting, they're going to force you to choose between vaccinating your child with mRNA now or waiting an unspecified amount of time for Novavax.

The mRNA option offered is a bit too specific, and should have been targeted to JN.1 instead of KP.2 (the mutational trunk, not a branch). The WHO presented reasoning in favor of selecting JN.1 instead of a KP sub-lineage since it was broader and more likely to be a common denominator with future variants. The VRBPAC committee agreed with this rationale and voted accordingly.

During the meeting, Dr. Peter Marks (director of the CBER) had tried and failed to propose selection of KP.2, knowing that only the mRNA providers would be able to meet that goal. The committee didn't agree with his reasoning.

Instead of adopting the WHO guidance and committee vote, the committee was circumvented and a press release was issued after the committee vote to select JN.1, announcing that providers would be able to target KP.2 instead at their discretion.

Then after doing all of this, as they have done before, they delayed approval of Novavax for an unknown reason, right as school starts.

To add to the frustration, Novavax's JN.1 vaccine has shown to be more efficient at neutralizing KP.3.1.1 (the dominant strain that is fueling the current wave) than other outdated KP lineages, but it is sitting in a warehouse unused. The fact that we do not already have access to this vaccine, and the fact that FDA will likely not make it available for at least another month (after school has started) is, frankly, negligence at best.

No parent should have to choose between a potentially more effective vaccine and a less effective one because the less effective one happens to be available. We are on the third formulation of Novavax's COVID vaccine, and every single time the FDA has tipped the scale so that mRNA comes out before Novavax. This needs to stop.

We need access to the best remedies and prevention for COVID as soon as possible. Novavax would have been ready to provide the updated vaccine in July if FDA were able to meet that deadline. Safety is not the driving factor in these delays. The clinical characteristics and safety profile of Novavax remains the same in spite of an altered strain selection.

If you are angry, just as I am, I am asking you to write and call the FDA to express your frustration. I will provide contact details on the following tweets. Let's put them in the hot seat. Make them explain why they're playing games with our kids' safety and limiting our choices.

If we do not get a satisfactory answer, then other options should be pursued.Slide Title: "Novavax JN.1 vaccine induces broad cross neutralization to variants including KP.3 and KP.3.1.1." Bar graphs demonstrating that KP.3.1.1 has a pseudovirus neutralization GMT value of 4106. Neutralization of all other variants is within the same order of magnitude, ranging between 1875 and 5081).
Here is the latest data showing that Novavax is even more effective at neutralizing KP.3.1.1 (the dominant strain driving the current COVID outbreak) than other outdated KP lineages, which is pretty incredible.

Here is some FDA contact info so you can demand access to Novavax at the same time mRNA is available.

They are not going to give this to us without being forced to. Let's put them in the hot seat. Make them explain why they're risking our kids' safety.

Read 6 tweets
Friesein Profile picture
Aug 16
I have a sinking feeling that we're going to ignore obvious signs of mpox airborne transmission all over again.

They'll say "but there's no peer reviewed-studies" and ignore any contradictory evidence.

It terrifies me. The stakes are much higher this time. This is not a game. "MPXV was previously detected in the air of health centre consulting rooms,4 and we showed high virus levels in the air of indoor public spaces, presumably exhaled from people who were infected with MPXV. This finding suggests that MPXV exposure occurs beyond skin or sexual contact..." Sanchiz et al. (2023) "MPXV and SARS-CoV-2 in the air of nightclubs in Spain"
People, we are seeing mpox high viral loads in air samples. How much more evidence do you need?

Are you seeing the pattern here?

Read 11 tweets
Friesein Profile picture
Jul 27
2 years after being infected with COVID-19, one study showed that 17.8% of infected patients studied had lung damage and 23.9% had kidney damage.

Most of the patients were classified as having had "non-severe" infections. They also excluded patients with pre-existing conditions. Graphical abstract titled "Long COVID at One- and Two-year revisits". See study link in next tweet for textual abstract.
Here's the study, for anyone interested: cell.com/iscience/fullt…
This finding makes sense considering that there are over 100 proteins in the liver and kidneys alone that are cleaved by the 3CL protease.

You could think of it as a tiny pair of scissors necessary for viral replication--but it also damages our bodies.

Read 5 tweets
Friesein Profile picture
Jul 20
People don't want to shatter the fragile coping they've set up for themselves.

Pushing past it would force them to acknowledge that they're harming themselves/their children with every reinfection. The mental burden is too heavy.

So they hide behind a thin veil of ignorance. 🧵
As a parent, I'll openly admit that accepting the reality of COVID's long term effects is extremely difficult.

Working from there, if you're being responsible, you can either seek to reduce or remove the risk. Removing the risk is not an option for many.

So they ignore it.
This is where the conversation often stops for parents, sadly.

Rather than acknowledging that there's an unsolved problem which requires government intervention to solve, they revert to thinking about COVID with a pre-2019 mentality.

But Pandora's box is already open.
Read 11 tweets
Friesein Profile picture
Jul 4
A neurologist reports that they're being inundated with patients showing signs of rapid onset late-stage neurological disease.

Their caseload almost doubled since COVID mitigations were dropped. Now they're seeing stage 3 Parkinson's patients in their 20s.

This is not normal.
No mask, no entry sign with prohibition symbol
This shouldn't come as a surprise though.

We've removed all policies aimed at reducing transmission and shifted to actively encouraging infection.

One study showed that Lewy bodies developed in the brains of every animal infected with COVID-19.

The point is, we as a society need to change course, and fast.

The consequences of inflicting neurological damage across the population are almost too devastating to even complete.

Yet the mutilation continues without a hint of concern from the people it's being done to.
Read 5 tweets

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