U.S. health regulators have given full approval to Pfizer’s COVID-19 pill Paxlovid.
More than 11 million prescriptions for Paxlovid have been dispensed since the Food and Drug Administration allowed emergency use in late 2021. The emergency status was based on early studies and was intended to be temporary pending follow-up research.
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.U.S.
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. 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%.
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