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