Beyond the antivaxx stuff MAHA is either banal or fake

[jon-nyc]

Say it ain’t so Bobby.

[jon-nyc]

Thanks magats.

[jon-nyc]

FDA flatly declines to even review Moderna’s new flu vaccine citing vague concerns about the control arm which they previously approved.

[jon-nyc]

[jon-nyc]

“Im not afraid of a germ. I used to snort cocaine off of toilet seats.”

Says the man in charge of health policy in the Trump administration.

[Horace]

Difficult to imagine that the toilet seat was the best option available.

[jon-nyc]

I was thinking about that. If you need a flat surface and can’t risk openly using the sink area of a public bathroom. Still can’t you find a sheet of paper or something?

[Doctor Phibes]

"I'm not afraid of children dying, I used to sell them drugs"

[jon-nyc]

Moderna will no longer invest in Phase 3 vaccine trials for infectious diseases and is shelving their Epstein-Barr, Herpes, and Shingles programs.

Good job, Trump voters, good job.

Well played, Senator Cassidy. Great legacy, Doctor.

[jodi]

Jesus. And WTF, RFK.

[Axtremus]

The alternative would never!

[Horace]

Could easily lay some blame at the feet of the self-righteous covid hawks who couldn't get enough of jamming vaccines down everybody's throat. Like it or not, this is part of the backlash, and it's hardly obvious that any of that was a good idea, now or at the time. To whatever extent this is even a blameworthy event. Not everybody is hyper focused on private industry finding profitable cures for rare diseases.

[jon-nyc]

[jon-nyc]

Prasad walked it back.

[Horace]

It's not quite that stark an about face. The refusal letter prominently encouraged Moderna to come and have a sit down with the FDA to resolve the issue. Maybe that happened. "Massive pushback caused the FDA to relent" is a crafted narrative, unless more evidence was provided in the paywall section.

[jon-nyc]

Zero chance they had a their type A meeting in the time since this unfolded. Far more lijkely is Senators applied pressure (ie, the system worked) and FDA got some face saving vague promise for a post marketing study.

[Horace]

You seem confident that the FDA can reverse a written decision on the spot, but are unable to expedite a meeting on the spot.

[jon-nyc]

said in Beyond the antivaxx stuff MAHA is either banal or fake:

Far more lijkely is Senators applied pressure ...

And administration friendly investors. (A16Z has a biotech fund after all). What was particularly insidious about this decision was indication that the FDA couldn’t be trusted to keep to its own written word. How are you supposed to invest hundreds of millions into a p3 trial when the FDA backtracks on its own written approval of the design after the funds have been spent?

[Horace]

Anyway, the official story is that Moderna made changes to their application, and the FDA accepted the revised version. Everything else is narrative. But the implication that the FDA simply reversed is not accurate. Moderna did make changes to the app. According to my exhaustive google search.

[jon-nyc]

@Horace said in Beyond the antivaxx stuff MAHA is either banal or fake:

You seem confident that the FDA can reverse a written decision on the spot, but are unable to expedite a meeting on the spot.

Meetings take a lot of preparation, presentations, data, etc. Writing a letter agreeing to review a submission in the future is trivial and was clearly done regardless of what else happened.