FDA refuses Moderna's application for new mRNA flu vaccine
apnews.com
apnews.com
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.
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.
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.