Pfizer received full approval from the federal Food and Drug Administration (FDA) today, Thursday, for its oral pill paxlovid which has been treated with the highest amount against the coronavirus.
At the moment, more than 11 million Paxlovid prescriptions have been filled since the FDA approved its emergency use in late 2021. The state of emergency was based on initial studies and was intended to be temporarily suspended for subsequent investigations.
Among those guidelines, the FDA has granted full approval to adults with COVID-19 who face a high risk of serious illness that can lead to hospitalization or death. This group often includes older adults and common diseases such as diabetes, asthma and severe pain.
SALE
Continue to view the contents
The decision allows Pfizer’s drug to remain on the market indefinitely and be marketed in a similar way to other drugs.
The pill also continues to be available to children ages 12 to 17 under individual emergency authorization.
The US government has ordered millions of doses of Paxlovid and will take them back to patients at no cost, the FDA said in a statement. More than 14,000 new cases of COVID-19 were reported each week last month, although many cases in the United States are no longer reported to health authorities.
Paxlovid is the fourth covid-19 drug to receive full FDA approval and the first to be a pill. Previously proven therapies are intravenous or injectable drugs that are usually given in clinics or hospitals.
Pfizer initially studied Paxlovid in the highest risk of COVID-19 patients: unvaccinated adults with other health problems and no evidence of prior coronavirus infection. In that group, the FDA said the drug reduced the risk of hospitalization or death by 86% when given soon after the onset of symptoms.
But this does not reflect the current situation of the US population, in which more than 95% of people are protected by at least one dose of the vaccine, a previous infection, or both.
In more recent studies of people who had COVID-19, Paxlovid continued to significantly reduce the chance of hospitalization or death by more than 85%.
As Paxlovid became more widely used in 2021, doctors and patients reported cases of recurrence of symptoms of COVID-19 several days after treatment with the drug. But the FDA said Thursday that there is “no clear link” between Pfizer’s drug and the reported cases.
That conclusion was supported by an independent group of FDA advisers, who voted to recommend full approval of the drug at a meeting earlier this year.
