Drug Approval | March 24, 2022
Pfizer granted USFDA Breakthrough Therapy Designation for RSV vaccine candidate
The FDA decision is primarily informed by the positive results of a proof-of-concept, Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age
