COVID-19 pill Paxlovid moves closer to full FDA approval

Pfizer’s COVID-19 pill Paxlovid won another vote of confidence from U.S. health advisers Thursday, clearing the way for its full regulatory approval by the Food and Drug Administration.

The medication has been used by millions of Americans since the FDA granted it emergency use authorization in late 2021. The agency has the final say on giving Pfizer’s drug full approval and is expected to decide by May.

A panel of outside experts voted 16-1 that Paxlovid remains a safe and effective treatment for highrisk adults with COVID-19 who are more likely to face hospitalization and death due to the virus.

“We still have many groups that stand to benefit from Paxlovid, including unvaccinated persons, undervaccinated persons, the elderly and the immuno-compromised,” said Dr. Richard Murphy of the Department of Veteran Affairs.

The FDA said using Paxlovid in high-risk patients could prevent 1,500 COVID-19 deaths and 13,000 hospitalizations per week.

The panel’s positive vote was widely expected, given that Paxlovid has been the go-to treatment against COVID-19, especially since an entire group of COVID-19 antibody drugs has been sidelined as the virus mutated.

The U.S. continues reporting about 4,000 deaths and 35,000 hospitalizations weekly, the FDA noted.

The agency asked its panel of independent medical experts to address several lingering questions, including which people currently benefit from treatment and whether the drug plays a role in cases of COVID-19 rebound.

The panel agreed with assessments by both the FDA and Pfizer that found no clear link between the use of Paxlovid and returning symptoms, but said more information is needed from studies and medical records data.