Pfizer Asks F.D.A. to Authorize Covid Pill For High-Risk Unvaccinated People

Both pills are geared toward older people or people who have obesity or medical conditions that put them at elevated risk for getting severely ill from Covid.

A spokesman for Pfizer, Kit Longley, said that for now, the company is seeking authorization for its pill to be given only to unvaccinated people, but the company might submit amendments to that provision later, depending on the data from clinical trials. The F.D.A. has final say on who will be eligible to receive the pill.

Merck, which applied for authorization for molnupiravir last month, said it would be up to the F.D.A. to decide whether to authorize its pill for use in vaccinated people in addition to unvaccinated people.

The F.D.A. has not yet said whether it would convene a meeting of expert advisers to recommend whether to authorize Pfizer’s treatment. A panel of experts that advises the agency on antimicrobial drugs is scheduled to meet at the end of this month to discuss Merck’s drug.

Supplies of Pfizer’s treatment, which is taken as a regimen of 30 pills over five days, will be very limited at first. Pfizer said it could produce enough of the pills by the end of the year to treat 180,000 people. The company expects to expand manufacturing to produce at least 50 million treatment courses next year, including 21 million or more by the end of June.

Article source: https://www.nytimes.com/2021/11/16/business/pfizer-covid-pill-paxlovid-unvaccinated.html