Pfizer asks FDA to grant emergency authorization for its COVID-19 pill

Pfizer is asking federal regulators to authorize its experimental COVID-19 pill, which the drugmaker says can protect people from the most severe symptoms of the disease. 

Pfizer on Tuesday said it is seeking Emergency Use Authorization for the antiviral pill, called Paxlovid, from the Food and Drug Administration. Earlier this month, the company said Pavlovid cut the risk of hospitalization and death by nearly 90% in people with mild to moderate coronavirus infections. 

The pharmaceutical giant, which also produces a coronavirus vaccine, earlier on Tuesday announced that it has signed a deal with a U.N.-backed group to allow other manufacturers to make the COVID-19 pill, a move that could make the treatment available to more than half of the world’s population. 

“The overwhelming efficacy achieved in our recent clinical study of Paxlovid, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19,” Pfizer CEO Albert Bourla said in a statement. 

Pfizer said it would grant a license for the antiviral pill to the Geneva, Switzerland-based Medicines Patent Pool, which would let generic drug companies produce the pill for use in 95 countries, making up about 53% of the world’s population.

Other drugmakers are also developing a pill to treat COVID-19. An FDA panel is scheduled to meet on November 30 to weigh a potential emergency use authorization for molnupiravir, an antiviral drug developed by Merck and Ridgeback Biotherapeutics that recently won authorization in the United Kingdom.

Merck says its drug halved the risk that adult COVID-19 patients with underlying health conditions ended up in the hospital or died from the disease. 

This is a developing story.