By a vote of 13-10, an FDA advisory panel voted to approve molnupiravir, Merck’s new treatment for COVID-19:
BREAKING: The FDA panel on Merck's Covid-19 antiviral, molnupiravir, voted 13 to 10 that the drug's known and potential benefits outweigh the known/potential risks of the drug for treatment of mild/moderate Covid in adults within 5 days of sypmtom onset in high-risk patients.🧵
— Benjamin Ryan (@benryanwriter) November 30, 2021
This was a “surprisingly close vote”:
FDA advisory panel votes in favor of the Merck COVID pills. Surprisingly close vote.
Expect FDA to sign off soon.
Hoping Pfizer's Paxlovid gets reviewed soon! https://t.co/NcOahkRBsn
— Ashish K. Jha, MD, MPH (@ashishkjha) November 30, 2021
Shouldn’t it be a bigger deal that the drug barely passed this step?
#Molnupiravir, the first oral antiviral for COVID-19, reduces risk of hospitalization or death if started within five days, but FDA advisors expressed concerns about its modest effectiveness & potential risks.@pozmagazine @MonicaGandhi9 @JamesEKHildreth https://t.co/TUjmQLfrRy
— Liz Highleyman (@LizHIVHep) December 1, 2021
The panel said the drug “should be restricted to high-risk unvaccinated adults, as in the clinical trial”:
Those who voted yes on authorization for the oral antiviral for Covid-19 are stressing that molnupiravir should be restricted to high-risk unvaccinated adults, as in the clinical trial.
— Benjamin Ryan (@benryanwriter) November 30, 2021
The panel’s concerns “included male fertility and birth defects, bone growth, embryonic loss, and enhancement of escape mutations”:
The FDA advisory committee voted 13 to 10 to recommend emergency approval of #molnupiravir .
Concerns against included male fertility and birth defects, bone growth, embryonic loss, and enhancement of escape mutations.
Not great, considering cost ($700) and "efficacy". pic.twitter.com/vWSLOaPQXi
— Ryan Radecki, MD MS (@emlitofnote) December 1, 2021
Merck is recommending that pregnant women do not take the drug:
Merck does not recommend molnupiravir for women who are pregnant or breastfeeding. However, the drug co. does not think a full-out contraindication is warranted, because there may be circumstances in which the potential benefits of the drug outweigh the risk for such women. 6/
— Benjamin Ryan (@benryanwriter) November 30, 2021
And it’s not being recommended for children:
Research in rats suggest that molnupiravir may impact bone growth plates. For this reason, and because of a lack of data in human children, Merck's oral antiviral for Covid-19 is not recommended for people younger than 18, out of concern that it could impact kids' growth. 9/
— Benjamin Ryan (@benryanwriter) November 30, 2021
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