FDA advisory committee votes in support of safety and effectiveness of Paxlovid

Pfizer announced that the U.S. Food and Drug Administration’s Antimicrobial Drugs Advisory Committee, or AMDAC, voted 16 to 1 that available data support the safety and effectiveness of Paxlovid for the treatment of mild-to-moderate COVID-19 in adult patients who are at high risk for progression to severe illness. The AMDAC’s vote, while not binding, will be considered by the FDA when making its decision regarding the potential approval of Paxlovid, the company noted. "We believe it is critical for adults who are at high risk of progression to severe COVID-19 to have access to safe and effective treatment options, like Paxlovid, to help prevent avoidable hospitalizations and deaths. We are encouraged by the AMDAC’s positive vote today. The outcome is well supported by the strong safety and efficacy data seen both in our clinical trials and in a growing base of real-world evidence, showing that Paxlovid helps to reduce the risk of hospitalization or death for high-risk adult patients regardless of vaccination status," said James Rusnak, Senior Vice President and Chief Development Officer, Internal Medicine, Anti-infectives and Hospital, Pfizer.