I don't have a strong view on whether this vaccine should be approved.
I do have a strong view that "we agreed to your trial design, then rejected your filing for the trial design" is not how a functioning regulatory process works.
The stated rationale -- wrong comparator vaccine for seniors -- is thin when you read the details. Moderna says FDA agreed to their trial design in 2024.
As recently as August, FDA indicated they'd review the filing and assess comparator issues during that process. Now it's a refusal-to-file.
I did some research and found a refusal-to-file letters hit about 4% of submissions.
For vaccines specifically, after years of sponsor-FDA dialogue, it's genuinely rare. The FDA didn't cite safety concerns. Didn't cite efficacy concerns. Just: wrong comparator.
Meanwhile Prasad's internal memo last year killed the streamlined flu approval process that's worked for decades — prompting a dozen former FDA commissioners to publicly object.
EU, Canada, and Australia accepted the same application. Not to claim they can't be wrong but...American biotech, built here, approved everywhere else first.
Try building a house, especially in California. You hire an engineer to draw up plans that comply with all regulations, and file a permit with the county. They wait several months, point out some random thing, and request proof that it is compliant. Your engineer shows the math, citing the building code that says to use it, and you give that to the county. Several months later, the same thing happens again.
I know a contractor that, after retiring, bought a lot and submitted plans to build his dream house. Ten years later, the county gave in and approved his permit, but he was too old to build the house. There's a big difference between 65 and 75.
Anything that is not automatic ministerial approval is common law, not civil law, and it lets the government do whatever they feel like doing, regardless of what the laws actually say.
I want to believe the FDA did a non-political thing here, and it's an argument about marginal benefits in the 40,000 patient survey, against methodology issues had they used the vax recommended for over 65s. Just 'you didn't test best in breed with your new better in breed'
But, I suspect thats not whats going on. I truly suspect, even though its conspiracy theory, they wanted a flex as the vaccine approvals board, and this is the flex they chose.
I don't respect this approvals board. I think its stacked. I'm not a med, an epidemiologist or a bio person. What do I know, it's down to news and public disclosures.
I don't have a strong view on whether this vaccine should be approved.
I do have a strong view that "we agreed to your trial design, then rejected your filing for the trial design" is not how a functioning regulatory process works.
The stated rationale -- wrong comparator vaccine for seniors -- is thin when you read the details. Moderna says FDA agreed to their trial design in 2024.
As recently as August, FDA indicated they'd review the filing and assess comparator issues during that process. Now it's a refusal-to-file.
I did some research and found a refusal-to-file letters hit about 4% of submissions.
For vaccines specifically, after years of sponsor-FDA dialogue, it's genuinely rare. The FDA didn't cite safety concerns. Didn't cite efficacy concerns. Just: wrong comparator.
Meanwhile Prasad's internal memo last year killed the streamlined flu approval process that's worked for decades — prompting a dozen former FDA commissioners to publicly object.
EU, Canada, and Australia accepted the same application. Not to claim they can't be wrong but...American biotech, built here, approved everywhere else first.
Doesn't feel like a win.
Try building a house, especially in California. You hire an engineer to draw up plans that comply with all regulations, and file a permit with the county. They wait several months, point out some random thing, and request proof that it is compliant. Your engineer shows the math, citing the building code that says to use it, and you give that to the county. Several months later, the same thing happens again.
I know a contractor that, after retiring, bought a lot and submitted plans to build his dream house. Ten years later, the county gave in and approved his permit, but he was too old to build the house. There's a big difference between 65 and 75.
Anything that is not automatic ministerial approval is common law, not civil law, and it lets the government do whatever they feel like doing, regardless of what the laws actually say.
I want to believe the FDA did a non-political thing here, and it's an argument about marginal benefits in the 40,000 patient survey, against methodology issues had they used the vax recommended for over 65s. Just 'you didn't test best in breed with your new better in breed'
But, I suspect thats not whats going on. I truly suspect, even though its conspiracy theory, they wanted a flex as the vaccine approvals board, and this is the flex they chose.
I don't respect this approvals board. I think its stacked. I'm not a med, an epidemiologist or a bio person. What do I know, it's down to news and public disclosures.
[dupe] https://news.ycombinator.com/item?id=46968424