Discussion surrounding Merck’s newly-authorized COVID-19 pill, molnupiravir, has mostly concerned the risk it might pose to pregnant women. But some experts worry it could also lead to the outbreak of a new variant of the virus it’s designed to treat.
The Food and Drug Administration (FDA) granted emergency use authorization to two antiviral pills to treat COVID-19 this week, one from Pfizer (paxlovid) and another from Merck (molnupiravir). The Pfizer EUA was generally lacking in controversy, but the authorization of molnupiravir was far more contentious.
The FDA’s Antimicrobial Drugs Advisory Committee (ADAC) voted at the end of November to recommend authorization of molnupiravir, but it was by a narrow 13-10 margin. Even the members who voted in favor did so with qualifiers: some said the pill shouldn’t be given to pregnant women, and others were skeptical of its efficacy.
“I don’t think I would want to take this drug, not knowing the effect it could have on my unborn child,” Dr. Roblena Walker, CEO of public health non-profit EMAGAHA Inc. and ADAC member, said at the time. She voted yes.
Some of the members who voted against recommending authorization expressed more serious concerns, that rather than help solve the pandemic with its 30% efficacy rate, molnupiravir could cause the breakout of a new variant.