The FDA granted full approval for adults with COVID-19 who face high risks of severe disease, which can lead to hospitalization or death.
The decision allows Pfizer’s drug to remain on the market indefinitely and to be marketed similarly to other drugs.The U.S. government has stockpiled millions of doses of Paxlovid and patients will continue to receive it at no charge, the FDA said in a statement. More than 14,000 new COVID-19 cases were reported each week last month, although most U.S. cases are no longer reported to health authorities.
Paxlovid is the fourth drug for COVID-19 to receive full FDA approval and the first one that is a pill. The previously approved therapies are Pfizer originally studied Paxlovid in the highest-risk COVID-19 patients: unvaccinated adults with other health problems and no evidence of prior coronavirus infection. In that group, the FDA said the drug lowered the risk of hospitalization or death by 86% when given shortly after symptoms emerged.
But that doesn’t reflect the U.S. population today, where more than 95% of people have protection from at least one vaccine dose, a prior infection or both.In more recent studies of people who have had COVID-19, Paxlovid still significantly decreased the chance of hospitalization or death by more than 85%.
As Paxlovid became widely used in 2021, doctors and patients reported cases of COVID-19 symptoms returning several days after treatment with the drug. But the FDA said Thursday “there is not a clear association,” between Pfizer’s drug and rebound cases., who voted to recommend the drug’s full approval at a meeting earlier this year.
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