Merck’s Covid Pill Is Authorized by F.D.A. for High-Risk Adults


Dr. Dean Li, a Merck executive, said on Thursday that preliminary laboratory studies suggested that the drug was equally effective against Omicron as it was against earlier versions of the virus. The company and independent researchers have been running experiments on how well the drug can stop the Omicron variant from replicating.

The pills from Merck and Pfizer can be taken at home and are expected to reach many more people globally than monoclonal antibody treatments, which are typically given via intravenous infusions by a health care provider.

Until this week, the antibody drugs have been the only authorized treatment option for Covid patients who are at high risk of becoming severely ill. But Omicron has wreaked havoc on the country’s supply of the antibodies.

On Thursday, the federal government paused distribution of the treatments from Regeneron and Eli Lilly, saying it was unlikely they would work against Omicron. Those treatments represented nearly all of the country’s supply. The only antibody treatment that remains potent against the new variant, from GlaxoSmithKline and Vir Biotechnology, is in very limited supply for now.

In that context, the value of Merck’s pill has increased, experts said.

“Anything that keeps people out of the hospital, even incremental, has a role,” said Dr. Nahid Bhadelia, director of the Center for Emerging Infectious Diseases Policy and Research at Boston University.

In early November, the Delta variant started fueling a rise in coronavirus cases, particularly in the Midwest and the Northeast. Omicron, which rapidly became the dominant form of new cases in the United States, is now driving the surge.

Merck’s treatment is meant to be taken as 40 pills over five days. The company is ready to ship the first 378,000 courses for the United States within days. Merck is expected to fulfill the federal government’s full order of enough pills for 3.1 million people, at a cost of about $700 a person, by the end of January.



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