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NYTimes reporting that the White House has blocked the release of the FDA's "EUA+" vaccine guidance on the standards for it to grant an emergency authorization for a vaccine.
https://www.nytimes.com/2020/10/05/us/politics/coronavirus-vaccine-guidelines.html
A few thoughts below...
https://www.nytimes.com/2020/10/05/us/politics/coronavirus-vaccine-guidelines.html
A few thoughts below...
1) FDA has already communicated with sponsors
2) FDA already has this authority. "Guidance" just tells people how to expect FDA to interpret that authority
3) This may raise the stakes of Azar over-ruling FDA if the agency asks for additional data. (Still unlikely)
2) FDA already has this authority. "Guidance" just tells people how to expect FDA to interpret that authority
3) This may raise the stakes of Azar over-ruling FDA if the agency asks for additional data. (Still unlikely)
4) CBER director Peter Marks has been talking about what he wants to see for a while now. Some of the EUA standards are in another guidance. Marks has also asked for ~2 months of safety data follow-up.
5) Expect the Advisory Committee meeting on the 22nd to weigh in on this.
5) Expect the Advisory Committee meeting on the 22nd to weigh in on this.
6) If the sole reason for the hold on this guidance is the 2-month follow-up, that sure looks like the White House is pushing this solely for a vaccine "win" by Election Day
7) Key Q: Will companies wait the additional weeks before submitting to enhance likelihood of an EUA?
7) Key Q: Will companies wait the additional weeks before submitting to enhance likelihood of an EUA?
7 ctd) Because if I'm a company, I'm less willing to piss off the FDA than I am the White House.
8) The pressure on the FDA in the coming weeks is going to ramp up every. single. day. Especially once a vaccine is submitted for an EUA.
8) The pressure on the FDA in the coming weeks is going to ramp up every. single. day. Especially once a vaccine is submitted for an EUA.
And maybe the most important question of all:
9) How fast can the FDA review an application for authorization? Assuming they're already reviewing lots of this data pre-submission (like it does for some cancer drugs), could it be weeks? Days?
9) How fast can the FDA review an application for authorization? Assuming they're already reviewing lots of this data pre-submission (like it does for some cancer drugs), could it be weeks? Days?
With additional reporting on the FDA guidance by my Politico colleague @adamcancryn:
The big detail is that the White House is trying to say that it's the vaccine makers asking for this.
Number of companies willing to confirm that: 0 https://www.politico.com/news/2020/10/05/white-house-fda-vaccine-standards-426605
The big detail is that the White House is trying to say that it's the vaccine makers asking for this.
Number of companies willing to confirm that: 0 https://www.politico.com/news/2020/10/05/white-house-fda-vaccine-standards-426605
