An FDA health panel is endorsing Merck's COVID-19 pill for emergency use authorization.
Members of the FDA's Antimicrobial Drugs Advisory Committee were split in their vote to recommend molnupiravir, which can reduce the relative risk someone will progress to severe disease or death by about 30%. The absolute reduction in risk of severe disease or death was 3% -- 9.7% of people who took placebo died, compared to 6.8% of those given molnupiravir.
It could become the first U.S. authorized at-home treatment for COVID. It would treat adults with mild to moderate COVID symptoms who are at risk for severe disease or hospitalization. The FDA will likely follow the committee's advice. It could be authorized in the United States within days, and available within weeks. However, there's no official word yet on when the pill will be available. Most members said they hoped Merck would be asked to continue gathering safety data on the pill.
"I see this as an incredibly difficult decision and as already been stated, there are many, many more questions than answers," said Dr. Lindsey Baden, director of clinical research division of infectious diseases at Brigham and Women's Hospital in Boston, who voted yes.
"Overall, I trust our practitioners that if we educate them properly, they can deploy this properly," Baden added.