Pfizer Gets FDA Breakthrough Therapy Designation for Maternal RSV Vaccine
The FDA has granted Breakthrough Therapy designation to Pfizer’s respiratory syncytial vaccine (RSV) candidate, RSVpreF, for the prevention of RSV-associated lower respiratory tract illness in infants from birth up to six months of age by active immunization of pregnant women.
If the vaccine gets the FDA’s approval, it will be the first available to prevent RSV-associated lower respiratory tract in infants.
The FDA based its decision on positive phase 2b study results from a study in healthy pregnant women who were vaccinated in weeks 28 to 36 of gestation and their infants.
Pfizer has not yet released the clinical trial data from the study.