The FDA’s advisory committee voted unanimously that available data supported the vaccine’s efficacy for giving the shot to women in their second or third trimesters of pregnancy to prevent lower respiratory tract infection and severe disease in infants up to 6 months of age.
Tag Archive for: maternal RSV vaccine
The U.S. Food and Drug Administration’s staff reviewers said on Tuesday the safety data for Pfizer Inc.’s experimental respiratory syncytial virus (RSV) vaccine in pregnant women was “generally favorable”.
Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) deemed there were enough data to support Pfizer’s respiratory syncytial virus (RSV) vaccine RSVpreF in adults aged 60 and older.
Pfizer notched another score in the race for an RSV vaccine Tuesday, as it announced the FDA has accepted the Biologics License Application for its maternal RSV vaccine and granted the candidate priority review.
