More than 11 million prescriptions for Paxlovid have been dispensed since the
The FDA granted full approval for adults with COVID-19 who face high risks of severe disease, which can lead to hospitalization or death. That group typically includes older adults and those with common medical conditions like diabetes, asthma and obesity.
The decision allows
The pill is still available for children ages 12 to 17 under a separate emergency authorization.
The
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 IV or injectable drugs, typically given at clinics or hospitals.
But that doesn’t reflect the
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.
That conclusion was backed by an independent panel of FDA advisers, who voted to recommend the drug's full approval at a meeting earlier this year.
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