Last call for Public Comment to VRBPAC.

Deadline is 11:59 eastern on the 9th, that's today. But this is only the beginning of addressing a larger issue at the FDA and CDC regarding our vaccines.

Oct 10, 2024

This is a last minute call for immediate action and it will only take a few mins.

Deadline is in just a few hours.

The FDA called a meeting with little time to produce a presentation or even plan a public comment push on a looming problem. When normally meetings are announced months in advance, this was only put on the calendar on the 19th of last month.

And this matters because after our last presentation on Pertussis, which was only on the 20th, we understood a little better why the FDA and CDC are being so problematic about prioritizing more protective vaccines.

It’s not that we’ve hit a limit with our vaccine technology, but rather it is the desired outcome, and that’s not something you just say without some sources.

And I do have a heavily sourced article that I was trying to finish before the public comment deadline tonight but there was simply not enough time to get it right.

But while we’re working on this, we’ve realized the problem here has a lot more to do with the CDC. Their public comment is still open for a bit longer than a week.

So, expect that article soon.

The issue at hand here is not Novavax or COVID but actually H5N1.

Well, actually, it’s about a larger issue with the approach from both the CDC and FDA.

But instead of getting into the complexity of the larger problem now, we are going to simplify the talking point to something we can easily agree on because we simply don’t have time for the complex discussion this matter demands…

We need to get some comments up before the deadline.

So, what am I asking for?

I’m asking you to write a public comment before midnight eastern tonight to simply ask the FDA to work with manufacturers to create H5N1 vaccines that stop transmission and prioritize their use after development.

We need to stop H5N1 before it enters the general population.

Not wait until it enters the population to act.

But all the FDA oversees on this matter is the protective level of the vaccines while actual administration of the vaccines is up to the CDC…

So, for this comment it is simply a matter of expectation of protective levels of the new vaccines… The current general influenza protective levels are too low for H5N1.

If they will treat COVID like the flu, then you had better believe they will treat H5N1 like any other influenza. Real world effectiveness of flu vaccines is too low for the flu, it’s way too low for COVID, and that’s way too low to stop transmission of H5N1.

We need to prevent this from spreading to the general population and that means the new H5N1 vaccines need to prioritize stopping transmission.

Then we need to make sure the CDC is using them in a preventative manner.

But even talking about stopping transmission is seen as “disruptive” at the CDC and FDA. And that’s a fundamental idea that needs to change.

So, until we can change that, go be disruptive.

Here’s your link https://www.regulations.gov/document/FDA-2024-N-4189-0001

Demand the FDA to work with manufacturers to create H5N1 vaccines that stop transmission and prioritize their use after development.
They need to understand that stopping transmission is the expectation of the public, not simply reducing symptoms.