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

by AllAmericanBreakfast2 min read27th Nov 20215 comments

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COVID-19 pandemic
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1,000 Americans are dying daily from COVID-19, and perhaps 7,000-8,000 per day throughout the world. 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. 

Timeline:

  • Nov. 9th, 2020: Pfizer announces preliminary data on its vaccine showing high efficacy, and plans to seek EUA.
  • Nov. 20th, 2020 (12 days later): Pfizer and Moderna vaccines submitted for EUA to the FDA
  • Dec. 11th (3 weeks later): Comirnaty (Pfizer-BioNTech COVID-19 Vaccine) issued EUA by the FDA
  • It also took Pfizer 2 weeks from preliminary data announcement on effectiveness of Paxlovid to submit for an EUA. If it takes 3 weeks to approve, then we should have an EUA issued in about 10 days, perhaps the end of the first week of December.
  • Oct. 11th, 2021: Merck submits EUA for molnupiravir.
  • Oct. 14th, 2021 (3 days later): FDA announces meeting scheduled to discuss EUA for molnupiravir on Nov. 30th, 2021.
  • Nov. 5th, 2021: Pfizer releases preliminary data on Paxlovid and announces it plans to submit an EUA to the FDA.
  • Nov. 16th, 2021 (11 days after preliminary data released): Pfizer submits an EUA to the FDA. Once the FDA
  • Nov. 30th, 2021 (7 weeks later): FDA plans to hold molnupiravir EUA meeting.

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5 comments, sorted by Highlighting new comments since Today at 1:35 AM
New Comment

I submitted the following:

Thousands of people are dying daily around the world from covid-19. In this context, it is important that the FDA move as quickly as possible to approve Paxlovid, since approving this highly effective drug sooner will save many lives. Recent news about the Omicron variant only makes this more urgent, as it becomes important to approve Paxlovid and scale up distribution before the brunt of a new, Omicron-driven covid wave hits the USA. The pandemic is not standing still; doing your best to protect American citizens means scheduling a meeting on Paxlovid for as soon as possible.

For talking points, see my blog post containing responses to the common objections to the FDA quickly doing an EUA.  


I plan to submit something based off that post. I also hope to be able to secure a spot to give an oral presentation when the committee meets again for the Paxlovid EUA application. (The deadline for oral presentations for the Molnupiravir EUA meeting passed quite a while ago). 

This seems like a good idea.

I submitted the following comment:

I urge the FDA to schedule its review of Paxlovid and to make the timeline 3 weeks or less, as it did with the COVID vaccine.

1000 people are dying of COVID in the US every day. With an efficacy of 89%, Paxlovid could prevent many of these deaths. The earlier Paxlovid is approved, the more lives will be saved.

Thank you for your consideration.

I wasn't sure what topic to put it under so I chose "Drug Industry - C0022." 

Thank you for taking action!