Pfizer Granted FDA Breakthrough Therapy Designation for RSV Vaccine Candidate

 Pfizer Inc. (NYSE:PFE) today announced that its respiratory syncytial virus (RSV) vaccine candidate, PF-06482077 or RSVpreF, received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for prevention of RSV-associated lower respiratory tract illness in infants from birth up to six months of age by active immunization of pregnant women.

The FDA decision is informed by the results of the Phase 2b proof-of-concept study of RSVpreF (NCT04032093), a global, double-blinded, placebo-controlled study that assessed the safety and immunogenicity of RSVpreF in healthy pregnant women ages 18 through 49 years old, who were vaccinated between 28- and 36-weeks gestation, and their infants. Pfizer will publish outcomes from this clinical trial at a future date.

https://www.businesswire.com/news/home/20220302005162/en/Pfizer-Granted-FDA-Breakthrough-Therapy-Designation-for-Respiratory-Syncytial-Virus-RSV-Vaccine-Candidate-for-the-Prevention-of-RSV-in-Infants-from-Birth-up-to-Six-Months-of-Age-by-Active-Immunization-of-Pregnant-Women