FDA advisory panel's vote to approve Merck's COVID-19 therapeutic was 'surprisingly close'

Greg P. | 8:05 AM on December 01, 2021

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 (@LizHighleyman) December 1, 2021

The panel said the drug “should be restricted to high-risk unvaccinated adults, as in the clinical trial”:

https://twitter.com/benryanwriter/status/1465802254959718406

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