FDA Grants Priority Review To Pfizer’s RSV Vax With May Decision Timeline

By Lia DeGroot / December 8, 2022 at 12:54 PM
FDA has granted priority review designation to Pfizer’s respiratory syncytial virus (RSV) vaccine candidate for people ages 60 and older, with a goal of making an approval decision by May 2023, the company announced Wednesday (Dec. 7) . Pfizer said in August that it planned to submit its application for FDA approval "in the coming months.” The company is in the race to develop the first FDA-approved RSV vaccine. FDA also granted priority review to GlaxoSmithKline’s RSV vaccine candidate in...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.