A key Food and Drug Administration advisory panel has recommended approving Merck’s antiviral COVID-19 pill for at-risk adults, paving the way for potential emergency authorization by the end of this year.
The Antimicrobial Drugs Advisory Committee voted 13-10 to recommend authorization of the pill, known as molnupiravir. Merck found in clinical trials that the pill reduced the chance of hospitalization and death in at-risk COVID-19 patients by 30 percent.
The FDA could authorize molnupiravir within days for at-risk Americans, i.e. the elderly and other adults with co-morbidities for COVID-19.
Additionally, the FDA may authorize a similar pill from Pfizer in the coming weeks, which that company found to reduce risk of hospitalization and death by 89-percent in at-risk patients.
The news comes after the discovery of the Omicron coronavirus variant, with over 30 mutations to the virus’s spike protein, which allows the virus to attach to human cells. The high number of mutations has led to speculation that the variant could more easily evade immunity provided by available coronavirus vaccines.
“I think it’s going to be a material drop” in immunity, Moderna CEO Stéphane Bancel told the Financial Times on Tuesday. “I just don’t know how much because we need to wait for the data.”
However, Merck’s antiviral pill targets the mechanism used by the coronavirus to replicate, meaning it could remain effective against new variants. Molnupiravir was tested against a number of existing coronavirus variants including Gamma and Delta.
“We expect, based on what we know about the Omicron variant, that molnupiravir would be effective against this particular variant,” Dr. Nicholas Kartsonis, senior vice president for clinical research at Merck, told the FDA panel on Tuesday.