During a week that has seen a new COVID variant emerge and suddenly throw the efficacy of American vaccines and remedies into question, the FDA's outside advisors have only narrowly approved of Merck's molnupiravir, opening the door for the agency to approve the drug for use among high-risk patients only.
The Antimicrobial Drugs Advisory Committee, as the panel is known, voted 13 to 10 in support of the FDA approving the drug, which was first introduced to the public a couple of months ago with "blockbuster" experimental results from a very limited trial that, according to some critics, glossed over safety risks presented by the drug.
By granting its blessing to the drug, the committee will allow Merck to start selling it widely in the US by the end of the year.
As far as omicron is concerned, Merck plans to study whether molnupiravir is effective against the new variant panic of the moment. The company is working to collect samples of the new strain to do so. Nick Kartsonis, who oversees Merck’s vaccine clinical research, confirmed as much to the panel.
"We expect, based on what we know about the Omicron variant, that molnupiravir would be effective against this particular variant," he said.
Evaluating molnupiravir against omicron, Kartsonis said, will take longer than assessing COVID-19 antibody drugs because Merck needs to collect a broader set of data covering the entire genome of the virus, rather than select pieces.
As we have explained, molnupiravir targets the machinery the virus uses to replicate, rather than the spike protein, the structure that helps the virus infiltrate cells. Omicron has mutations to the spike protein, which researchers say could help it evade protections provided by vaccines and drugs trained to target the virus's spike protein.
Just last week, the company said that a final analysis had found the drug to be about 30% effective at reducing the risk of hospitalization and death in high-risk people, lower than the 50% efficacy first announced in October after a preliminary look at the data.
While the FDA isn't obligated to follow the ADAC's recommendation, it typically does.