Paxlovid, COVID-19 treatment pill, advances towards full FDA approval

Pfizer’s COVID-19 pill Paxlovid received a vote of confidence from a U.S. health advisory panel on Thursday, paving the way for its full regulatory approval from the Food and Drug Administration.

The FDA granted the drug emergency use authorization in late 2021, and is expected to decide on full approval by May. The panel voted 16-1 that Paxlovid remains a safe and effective treatment for high-risk adults with COVID-19, who are more likely to face hospitalization and death due to the virus.

The U.S. government has purchased more than 20 million doses of Paxlovid, allegedly in order to help prevent severe cases of the virus. The panel also discussed the possibility of cases of COVID-19 rebound, with the FDA stating that there was no clear link between the use of Paxlovid and returning symptoms.

The panel warned of the dangers of overprescribing, noting that Paxlovid made no meaningful difference in otherwise healthy adults, whether or not they had been previously inoculated. It was reportedly said to reduce the chance of hospitalization or death in high-risk adults by between 60% and 85%.

The panel also stressed the importance of managing potentially dangerous drug interactions between Paxlovid and other commonly used medications. Ultimately, they found that the decision to prescribe Paxlovid should be made on a case-by-case basis.

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