A report by the Food and Drug Administration on Wednesday said that Paxlovid was safe and effective. The drug is up for full approval on Thursday. Photo courtesy Wikimedia Commons
March 15 (UPI) -- A U.S. Food and Drug Administration advisory panel will discuss whether to recommend Pfizer's COVID-19 treatment Paxlovid for full approval during a meeting Thursday.
The drug is safe and effective for treating adults who are at risk for severe effects from the virus, including hospitalization or death, the FDA said in a report released in advance of the meeting.
Paxlovid is currently available under emergency use authorization that was granted in 2021.
More than 11 million people worldwide have taken Paxlovid for COVID-19, the FDA said in its report, which found that the drug does not cause rebound symptoms.
Concerns about rebound cases arose after some patients, including President Joe Biden and his former medical adviser Anthony Fauci, reported testing positive or experiencing symptoms after completing treatment with the drug.
The agency found that the rebound rates for patients who took Paxlovid were 10% to 16%, which was about the same for those who took a placebo.
"It has been challenging to determine the direct contribution of Paxlovid treatment to virologic or symptomatic rebound from published reports," the FDA said.
The agency also said that, based on the available virology data, "Paxlovid is likely to retain clinical efficacy" in adults with COVID-19 caused by the Omicron variant who are at high risk of progression to severe disease.
More than 90% of U.S. adults have either received a COVID-19 vaccine or had some immunity from a prior infection.