The FDA’s Antimicrobial Drugs Advisory Committee voted 16-1 that the benefits of Pfizer’s Covid-19 pill Paxlovid outweigh the risks in adults with mild to moderate disease.
The vote followed hours of discussion on topics ranging from effectiveness in people who have already been vaccinated or infected to drug-drug interactions (DDIs). Pfizer submitted a request to convert its EUA to full approval back in June, but the FDA extended its review period by three months to consider additional submitted data, the company announced in December. The current PDUFA action date for an FDA decision is May 2023.
Only one committee member voted against the question: “Is the overall benefit-risk assessment favorable to Paxlovid (nirmatrelvir and ritonavir tablets) when used to treat mild to moderate COVID-19 in adults who are at high risk of progression to severe COVID-19, including hospitalization or death?”
While members who voted yes agreed that efficacy and safety have been demonstrated, they added that it is important to understand who is at high risk and who will benefit from the drug. They also reiterated the need to monitor DDIs, as well as ongoing and future studies by Pfizer on symptomatic rebound and the drug’s impact on immunosuppressed, pediatric and pregnant patients.
Patient representative Terry Gillespie, who voted no, said she has a lung and has had Covid four or five times. Gillespie said she was never offered Paxlovid by doctors and is “concerned that doctors actually know when to prescribe it to someone, for example, like me.”
Commenting on the strength of evidence for the use of Paxlovid in patients who have already been vaccinated or previously infected, committee members said more data is needed.
“I just agree with those who said the evidence is not as compelling as in those who are unvaccinated,” committee member Paige Waterman said. “I don’t think we’re ever going to have a fully vaccinated population, whatever fully vaccinated means, although along with previous infection that would give us decent numbers. I agree with the points about individualizing decisions. As we say, doctors need to recognize indications. Who meets these criteria?”
If given full approval, Paxlovid’s EUA will remain in place so that adolescents aged 12 and over can continue to be treated with the drug. In the United States, more than 10 million courses of Paxlovid have been prescribed to date, according to Pfizer.
Although the FDA does not have to follow an adcomm’s recommendations, it typically does. Pfizer has an ongoing trial of Paxlovid in children and plans to file a supplemental NDA for approval in children.