USFDA gives go-ahead to Pfizer's Covid pill

WION Web Team
New DelhiUpdated: Dec 23, 2021, 12:11 AM IST
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Pfizer Photograph:(Reuters)

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Pfizer's Covid treatment using pills has previously been authorized in the European Union.

US Food and Drug Administration on Wednesday gave a go-ahead to Pfizer's Covid pill for its use among high-risk people aged 12 and above.

"Today's authorization introduces the first treatment for Covid-19 that is in the form of a pill that is taken orally -- a major step forward in the fight against this global pandemic," said FDA scientist Patrizia Cavazzoni.

Paxlovid, Pfizer's treatment is a combination of two pills taken over five days. The treatment was shown to be safe and reduced the risk of hospitalizations and deaths among at-risk people by 88 percent. The clinical trial included 2,200 people.

In an unusual move, the FDA did not convene its customary panel of independent experts to review in depth data surrounding Pfizer's pill ahead of authorization.

Pfizer's treatment has previously been authorized in the European Union.

The US has already paid for 10 million courses.

The authorization comes as cases are surging across the United States, driven by Omicron, the most infectious variant seen to date.

The highly-mutated variant is better able to bypass immunity conferred by prior infection, and health authorities are urging the public to get boosted with mRNA vaccines in order to restore a higher degree of protection.

Unlike vaccines, the Covid pill does not target the ever-evolving spike protein of the coronavirus, which it uses to invade cells. It should in theory be more variant proof, and Pfizer has said preliminary studies have backed up that hypothesis.

Authorization is still awaited for another Covid pill, developed by Merck, which is also taken over five days and has been shown to reduce the same outcomes by 30 percent among high-risk people.

(With inputs from agencies)