This is really quite bad.

[cremevax@infosec.exchange]

This is really quite bad. The FDA’s Prasad succeeded in creating enough regulatory roadblocks such that Pfizer gave up on its #covid #covid19 vaccine trial for healthy adults.

reuters.com

(www.reuters.com)

[matthewconroy@mathstodon.xyz]

@cremevax Goddammit.

[tweetsjen@hear-me.social]

@cremevax the #MAHA effect is chipping away at our #vaccines in multiple ways. "FDA's stricter trial requirements and low U.S. vaccine uptake hinder study progress. Pfizer and BioNTech cite slow enrollment, not safety concerns, for stopping trial. Moderna's study faces similar struggles, sources say"

#Covid #Covid19 #CovidIsNotOver

[cremevax@infosec.exchange]

@DavidPenington I wouldn’t say that the Pfizer covid vax has been killed — not yet, anyway.

But by imposing new, large trial requirements for an annual strain revision for a given population subset, the FDA is doing its best to make up-to-date Covid vaccines uneconomical to produce. If they are successful, then that impacts vaccine access for everyone.

But! FDA decisions are not set in stone. See for example the pending Moderna mRNA flu application, about which they originally said they wouldn’t even look at the application, promptly ate shit on, and then decided to review after all. Trump is only getting weaker, and therefore is more susceptible to pushback — before the midterms at least.

Double-reverse: FDA now says it will review Moderna’s mRNA flu vaccine

CIDRAP (www.cidrap.umn.edu)