Beyond the antivaxx stuff MAHA is either banal or fake
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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.
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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.
The whole reason we call them illegal aliens is because they’re subject to our laws.
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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.
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?
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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.
Education is extremely important.
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You seem confident that the FDA can reverse a written decision on the spot, but are unable to expedite a meeting on the spot.
@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.
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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.
@Horace said in Beyond the antivaxx stuff MAHA is either banal or fake:
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.
As I said they likely promised a post marketing study. FDA last week said they would not review the submission because they (really he) didn’t accept the previously agreed upon study design. Now FDA says they will review the submission based on the previously agreed upon study design.
If that’s a non-back track, I would welcome more non-back tracks on vaccine policy in the future.
The whole reason we call them illegal aliens is because they’re subject to our laws.
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@jon-nyc said in Beyond the antivaxx stuff MAHA is either banal or fake:
It's a silly question. It depends on the concrete vaccine, and it is not about whether it's more dangerous than the disease, it's about the likelihood of getting infected compared to the likelihood of undesirable side effects.
For instance, for most people in the US, a yellow fever vaccination would not make sense because there is a significant side effect risk and the likelihood of getting infected is very low.
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@Horace said in Beyond the antivaxx stuff MAHA is either banal or fake:
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.
As I said they likely promised a post marketing study. FDA last week said they would not review the submission because they (really he) didn’t accept the previously agreed upon study design. Now FDA says they will review the submission based on the previously agreed upon study design.
If that’s a non-back track, I would welcome more non-back tracks on vaccine policy in the future.
@jon-nyc said in Beyond the antivaxx stuff MAHA is either banal or fake:
@Horace said in Beyond the antivaxx stuff MAHA is either banal or fake:
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.
As I said they likely promised a post marketing study.
No "likely" about it. That's what happened, as I assume you've read.
FDA last week said they would not review the submission because they (really he) didn’t accept the previously agreed upon study design. Now FDA says they will review the submission based on the previously agreed upon study design.
If that’s a non-back track, I would welcome more non-back tracks on vaccine policy in the future.
It's a compromise, likely due at least partially to political pressures of one sort or another, of which we have no direct evidence. But it's a compromise. The FDA's encouragement to have a sit down intentionally left the door open to a compromise.
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@klaus Right but those are pretty accurately accessed by public heath professionals which is why you don’t see yellow fever vaccines in the recommended panel.
I would caution you against assuming there’s even an ounce of rationality behind the anti-vax movement. It’s one part naturalistic fallacy, two parts resentment, and three parts conspiratorial thinking.
The whole reason we call them illegal aliens is because they’re subject to our laws.
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@klaus Right but those are pretty accurately accessed by public heath professionals which is why you don’t see yellow fever vaccines in the recommended panel.
I would caution you against assuming there’s even an ounce of rationality behind the anti-vax movement. It’s one part naturalistic fallacy, two parts resentment, and three parts conspiratorial thinking.
@jon-nyc said in Beyond the antivaxx stuff MAHA is either banal or fake:
@klaus Right but those are really accurately accessed by public heath professionals which is why you don’t see yellow fever vaccines in the recommended panel.
I would caution you against assuming there’s even an ounce of rationality behind the anti-vax movement. It’s one part naturalistic fallacy, two parts resentment, and three parts conspiratorial thinking.
There are plenty of coherent arguments that the COVID vaccine was on the wrong side of risk/reward for a large section of the populace who were economically forced to take it.
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@klaus Right but those are pretty accurately accessed by public heath professionals which is why you don’t see yellow fever vaccines in the recommended panel.
I would caution you against assuming there’s even an ounce of rationality behind the anti-vax movement. It’s one part naturalistic fallacy, two parts resentment, and three parts conspiratorial thinking.
said in Beyond the antivaxx stuff MAHA is either banal or fake:
@klaus Right but those are pretty accurately accessed by public heath professionals which is why you don’t see yellow fever vaccines in the recommended panel.
The one exception to this, sort of, is late adolescent males and the Covid vaccine. I say ‘sort of’ because it took a while for the data to come in so some delay is to be expected, also how the benefit-risk shakes out is highly dependent on things like severity of the current wave, brand of vaccine, dosing interval, etc. Still, when there was a reasonable amount of data available to show it was borderline or worse there were still public health officials who were afraid to address it lest they fuel vaccine hesitancy more broadly. A friend of mine was a lonely but ultimately effective voice in preventing a major university from requiring Covid vaccines in incoming freshman for this very reason.
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Anybody who would say that, say, the polio vaccine is worse than the disease is just insane. Like, that person should go into a mental institution immediately.
For Covid vaccines, there are some grey areas, as you say.
@Klaus said in Beyond the antivaxx stuff MAHA is either banal or fake:
Anybody who would say that, say, the polio vaccine is worse than the disease is just insane. Like, that person should go into a mental institution immediately.
That's like 99% of Trump voters, man.
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Now it looks like Prasad was just sidelined on the decision (no doubt due to pressure described above), so the leaders of CBER that he had overruled just withdrew his letter in a meeting with Moderna and issued a new letter agreeing to review the original submission. So basically ex post ante. I suspect the White House itself was involved.
