I will be live-blogging the ACIP meeting on new booster doses September 1 and 2

10 am to 5 pm, no human data, pretend scientific meeting

https://live.childrenshealthdefense.org/acip-meeting-recommendations-to-covid-19-booster-framework-liveblog-by-dr-meryl-nass

As usual, my application to speak during the public comment period was rejected. The public comments are likely to be the only time any real science gets mentioned.

Please pay attention to this rollout and urge your friends and family to WAIT or better yet avoid them altogether—they should not be the first guinea pigs for these shots. A former FDA Commissioner, Jane Henney, M.D., said she never used any medicine until it had been on the market a year or two, which is what it takes to understand its safety and efficacy profile.

Here is the “Fact Sheet” for the new “bivalent” Pfizer vaccine. It has plenty of clinical trial data—only none of the clinical trials were conducted with the vaccine that was authorized today. This is yet another bait and switch, a charade in which the FDA and CDC pretend are following some science they found somewhere. Here is a big download on all things Moderna.

The same thing was done with anthrax vaccine—it was licensed based on data obtained from a different anthrax vaccine. When we brought suit against the license, Judge Emmet Sullivan revoked the anthrax vaccine license in 2004. Then FDA waited about 18 months, till the coast was clear, and then rubber-stamped the anthrax vaccine license without requiring a single clinical trial. On appeal, the FDA won on the basis that it had “deference”—in other words, FDA is the regulatory agency and it can do whatever it wants, and you are not allowed to question its interpretation of the scientific evidence.

This “deference” doctrine probably makes it very easy for the judges to rule—avoiding the merits of the case at all costs.

The older, original Wuhan strain booster EUAs were revoked today for those 12 and over (Pfizer) and for those 18 and older (Moderna). The plan is to exclusively use the new totally experimental shots. This worries me. They REALLY want these shots rolled out and into arms, and don’t want the old vaccine to interfere with that. Why?

From MSN:

… Because of high levels of immunity from prior vaccination and infection, it would be impossible for the companies to test the new boosters in nearly as many people as the original shots.

The FDA asked the drugmakers to update the shots in late June, with the goal of having the shots tested and distributed by the fall. Moderna has finished enrollment for its new booster with 512 participants. Pfizer said it began human testing late this month.

Both companies are expected to release results later this year.

The FDA's decision to consider Covid boosters without human data is in line with how it evaluates modified vaccines for influenza each year. Clinical studies in humans aren't required for the approval of seasonal influenza vaccines, even when they're reformulated for strain changes, said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief.

Still, the flu vaccine isn’t a fair comparison, said Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia.

The FDA’s policy on influenza shots is based on decades of experiences with strain changes where the flu vaccines behaved generally in the same way. The U.S. is still on its first iteration of the Covid vaccines, and the mRNA technology has only been in widespread use since late 2020.

The agency is making “huge assumptions” in its consideration of the new Covid boosters, Offit said, adding that it’s possible the new shots may not be any more effective than the existing vaccines…