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

The company said Tuesday that Pfizer Inc. has applied to the Food and Drug Administration to allow its antiviral pills to treat people who are not immunized with COVID-19 and are at risk of severe disease.

The drug, which will be sold under the brand name Paxlovid, could become available within weeks if permission is granted. It is meant to be dispensed from pharmacies and taken at home.

Paxilvid is the second antiviral pill to show effectiveness against Covid, in a new class of treatments for the disease that is expected to reach far more patients than other infusion drugs.

In a major clinical trial, baxlovid was found to significantly reduce the risk of hospitalization or death when administered to unvaccinated high-risk volunteers soon after they developed symptoms. It appears to be more effective than a similar offering from Merck, known as molnupiravir, that could be allowed as soon as possible in early December.

Both pills are intended for the elderly, people with obesity or medical conditions that put them at increased risk of severe disease from COVID-19.

For now, the company is seeking permission to give its pills only to unvaccinated people, Pfizer spokesperson Kit Longley said, but the company may make modifications to this line later, depending on data from clinical trials.

Merck, which applied for a license for molnupiravir last month, said it was up to the Food and Drug Administration to decide whether to allow the pill to be used in vaccinated people in addition to unvaccinated people.

The US Food and Drug Administration has not yet said whether it will hold a meeting of expert advisors to recommend whether to allow Pfizer’s treatment. The panel of experts advising the agency on antimicrobial drugs is due to meet at the end of this month to discuss Merck’s drug.

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

Australia and Britain have already closed off some of these supplies. A supply deal to the United States has not yet been announced.

Pfizer said on Tuesday it had reached an agreement to allow other manufacturers to make and sell the contraceptive pills cheaply for use in 95 developing countries.

Pfizer is designed to stop the coronavirus from replicating by blocking the activity of a key enzyme that the coronavirus uses to replicate itself inside cells. Merck’s pills work differently, by introducing errors into the virus’s genetic code, a mechanism that has raised concerns that some scientists could cause genetic mutations that cause reproductive harm. This difference may give Pfizer an advantage between doctors and patients, because it doesn’t carry the same safety concerns as Merck’s pills.

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