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Pfizer’s Covid-19 Pill Authorized in U.S.


JackSeal

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U.S. health regulators cleared use of a Covid-19 pill from Pfizer Inc., the first drug that newly infected patients can now take at home to stay out of the hospital.

The authorization by the U.S. Food and Drug Administration on Wednesday permits doctors to prescribe the medicine to high-risk patients age 12 and older early in the course of disease, shortly after they develop symptoms.

The FDA said the drug, named Paxlovid, worked safely and would be an important tool in reducing hospital admissions and death.

The pill arrives as the Omicron variant spreads across the U.S. Researchers expect antivirals like Paxlovid would be effective against the new strain because of the way they work, but are waiting for studies to confirm their suspicion.

Paxlovid is expected to be available at pharmacies and hospitals in the coming days. Initial supplies will be limited, until Pfizer can ramp up production.

Pfizer will ship tens of thousands of treatment courses in the U.S. before the end of this year, and hundreds of thousands at the start of 2022, a spokeswoman said. The U.S. government has agreed to pay $5.29 billion to purchase 10 million treatment courses that Pfizer will deliver by the end of next year.

Pfizer said it aims to make 120 million treatment courses next year, up from its previous projection of 80 million.

The pill’s key advantage over most existing treatments is that patients can easily take them at home, unlike antibody therapies or the antiviral Veklury that usually require administration at a clinic or hospital.

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