Submit comments on Paxlovid to the FDA (deadline Nov 29th).

post by AllAmericanBreakfast · 2021-11-27T18:44:27.615Z · LW · GW · 1 comments


  They accept public comment at the meeting.
1 comment

1,000 Americans are dying daily from COVID-19. Paxlovid is 89% effective against it. Pfizer submitted an EUA on Paxlovid to the FDA on Nov. 16th. The FDA has yet to schedule a meeting to review this EUA request, 11 days later. Thousands of lives are at stake over this delay.

For molnupiravir, they only took 3 days to schedule a meeting, but they scheduled that meeting for 7 weeks out, on Nov. 30th. Here is a link to the announcement.

They accept public comment at the meeting.

And as far as I can tell, it doesn't have to be about molnupiravir. It can be about Paxlovid. 

Last I checked, they had 23 comments, including mine.

From their website,

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

The deadline to have comments considered by the committee has already passed, but "comments received after that date but by November 29, 2021, will be taken into consideration by FDA."

This might be one method to express any thoughts you might have about the review of Paxlovid's EUA, as well as on molnupiravir.

The FDA still hasn't scheduled a meeting to review Paxlovid. It scheduled its meeting for molnupiravir 7 weeks out. But it scheduled its review of the vaccines just 3 weeks after the submission. One suggestion, if you submit a comment, is to urge the FDA to schedule its review ASAP and to make the timeline 3 weeks (or less) rather than 7.

Note that Dr. Marty Makary of Johns Hopkins, who routinely conducts and evaluates clinical trials, has said that this review should take no more than a few hours, even for the 43,000 cases in the vaccine trials. This trial is less than 2,000 cases. 



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comment by WingKelp · 2021-11-28T21:06:17.497Z · LW(p) · GW(p)

From the submitted public comments on the government website, I learned that Molnupiravir's mechanism of actions seems to be inducing mutations in the virus.  Some of the comments bring up the possibility that this might lead to greater probability of new variants emerging.  I'm not sure how probable this is, but it seems something worth considering.