A panel of independent advisors Thursday recommended the U.S. Food and Drug Administration give full approval to COVID-19 treatment Paxlovid, produced by Pfizer. Photo by Kches16414/Wikimedia Commons
March 16 (UPI) -- A panel of independent advisers Thursday recommended the U.S. Food and Drug Administration give full approval to COVID-19 treatment Paxlovid, which is produced by Pfizer.
The Antimicrobial Drugs Advisory Committee voted 16 to 1 in favor of the recommendation, following Thursday's meeting.
The committee said it found the benefits of the co-packaged, two-drug oral medication outweighed the risks.
Up until now, the investigational medicine had only been authorized for emergency use by the FDA, which was granted in 2021.
A final decision from the FDA is expected in May. The agency typically follows the recommendations of its independent advisory panels, but is not required to do so.
A report released ahead of Thursday's hearing found the drug to be safe and effective when used to treat adults at risk of severe COVID-19 symptoms, including hospitalization or death.
Over 11 million people across the globe have taken the New York-based biopharmaceutical company's combination of nirmatrelvir and ritonavir so far.
The report found rebound rates for patients who took Paxlovid were between 10% and 16%.
"I'd say besides oxygen, Paxlovid has probably been the single most important tool in this epidemic, and it continues to be," committee member Dr. Richard Murphy said during Thursday's meeting, where he was among those to vote in favor of the drug's authorization.
"We still have many groups that stand to benefit from the use of Paxlovid, including unvaccinated persons, undervaccinated persons, elderly, immunocompromised, and the other treatment options that we have have significant disadvantages."
Last month, results of a new study showed Paxlovid to be effective against the COVID-19 BA.4 and BA.5 subvariants.
Pfizer's mid and late-stage clinical trials included some 6,000 patients across 21 countries.