Pfizer's Paxlovid gets thumbs-up for full approval from FDA advisory committee

An FDA advisory committee has recommended Pfizer’s COVID-19 oral antiviral Paxlovid for full approval, concluding that the benefits of the treatment outweigh the risks.

The treatment is for people age 12 and older who have been infected and are at risk for progressing to a severe form of the disease.

The committee voted 16-1 for approval after hearing efficacy data that “were clear and convincing,” according to panelist Sankar Swaminathan, M.D., of the University of Utah School of Medicine.

The FDA now will decide whether to take its usual step to accept the recommendation of the committee.

Paxlovid was endorsed on an emergency-use basis in December 2021. More than 12 million doses have been delivered by Pfizer in the U.S., including more than 10 million that have been prescribed. Pfizer’s sales of Paxlovid reached $18.9 billion in 2022.

During the FDA’s Antimicrobial Drugs Advisory Committee meeting on Thursday, Pfizer presented data from a study that showed that Paxlovid reduces the risk of death and hospitalization by 86% in non-hospitalized, high-risk patients who were unvaccinated.

“I’d say besides oxygen, Paxlovid has probably been the single-most important treatment tool in this epidemic,” said Richard Murphy, M.D., of the VA White River Junction Medical Center in Vermont.

“We still have many groups who stand to benefit from the use of Paxlovid including unvaccinated persons, under vaccinated persons, elderly, immunocompromised. The other treatment options have significant disadvantages.”  

The committee also discussed the concerns with Paxlovid, including the uncertainty of drug interactions and cases of Paxlovid rebound—experienced most notably by President Joe Biden and former National Institute of Allergy and Infectious Diseases Director Anthony Fauci, M.D.

The lone dissenting vote on the panel was from patient representative Terry Gillespie, who expressed her frustrations of not being prescribed Paxlovid despite contracting COVID “four or five” times with one hospitalization, having one lung and being overweight.

“I’m kinda concerned about doctors knowing actually when to prescribe it to someone like me,” Gillespie said. “I normally can’t breathe well, but when I call and doctor and say, ‘Hey, I think I have COVID. I’ve tested for COVID,' it’s never offered.”  

Pfizer applauded the vote and pointed to the 4,000 to 5,000 hospital admissions and 500 to 600 deaths caused by the virus daily in the U.S. as of January. There are 200 million adults in the U.S. at high risk of severe COVID, Pfizer added.