In a 13-to-10 vote, advisors for the Food and Drug Administration narrowly supported authorizing Merck’s Thor-inspired antiviral pill molnupiravir for use against severe COVID-19.
The FDA’s panel of advisors—the Antimicrobial Drugs Advisory Committee (AMDAC)—struggled in an all-day meeting Tuesday to weigh the drug’s risks, its modest benefits, and the limited available data. The latest analysis suggests that the pill is only 30 percent effective at preventing hospitalization and death from COVID-19 in people at high risk of severe disease. Meanwhile, the drug has the worrisome potential to cause mutations, leading advisors to agonize over whether it should be offered to pregnant people.
Molnupiravir’s final data and today’s vote is a significant disappointment from the early fanfare around the drug, which initially promised to be an easy-to-use oral drug to effectively prevent severe COVID-19. “Our prediction from our in vitro studies and now with this data is that molnupiravir is named after the right [thing]… this is a hammer against SARS-CoV-2 regardless of the variant,” Merck’s head of research and development, Dean Li, said last month.