Pfizer Asks FDA to Authorize Covid Pill for Unvaccinated People


Pfizer applied to the Food and Drug Administration for permission. The company said on Tuesday it’s antiviral pill to treat unvaccinated people who are at high risk of becoming seriously ill with Covid-19.

The drug, which will be sold under the brand name Paxlovid, will be available within weeks if allowed. It is intended to be distributed by pharmacies and taken at home.

Paxlovid is the second antiviral pill to show efficacy against Covid in a new class of disease treatment that is expected to reach many more patients than other drugs typically given by infusion.

In a major clinical trial, Paxlovid sharply reduce the risk hospitalization or death when given to high-risk unvaccinated volunteers soon after they begin to show symptoms. It appears to be more effective than a similar offering from Merck known as molnupiravir. this authorization may be granted Like early December.

Both pills are intended for older people or people with obesity or medical conditions that put them at risk of getting seriously ill from Covid.

Pfizer spokesperson Kit Longley said the company is currently seeking permission for its pills to be given only to unvaccinated people, but the company may introduce changes to that provision later, based on data from clinical trials.

Merck, which applied for authorization For molnupiravir last month, he said it would be up to the FDA to decide whether the pill should be allowed to be used in vaccinated people in addition to unvaccinated people.

The FDA has yet to announce whether it will hold a meeting of expert advisors to recommend whether the Pfizer treatment should be allowed. A panel of experts advising the agency on antimicrobial drugs meeting is scheduled To discuss Merck’s medication later this month.

The resources of Pfizer therapy, taken as a 30-pill regimen for five days, will initially be very limited. Pfizer said it could produce enough pills to treat 180,000 people by the end of the year. The company expects to expand production to produce at least 50 million treatment courses next year, including 21 million or more by the end of June.

Australia and the UK have already locked down some of these materials. A supply deal for the US has not yet been announced.

Pfizer said on Tuesday had an agreement Allowing other manufacturers to manufacture and sell the pill cheaply for use in 95 developing countries.

Pfizer’s drug is designed to stop the coronavirus from multiplying by blocking the activity of an important enzyme that the coronavirus uses to replicate within cells. Merck’s pill works differently by adding errors to the virus’s genetic code; This is a mechanism that has raised concerns among some scientists that Merck’s drug may trigger genetic mutations that cause reproductive damage. This difference may give the Pfizer pill an advantage among physicians and patients, as it does not pose the same safety concerns as the Merck pill.



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