FDA expands approval of Pfizer's RSV vaccine to high-risk adults 18 and older

The FDA has approved Pfizer's RSV vaccine, Abrysvo, for adults aged 18 to 59 who are at increased risk for lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV).

The nod expands the vaccine's indication, which previously covered individuals aged 60 and older, making Abrysvo the only RSV vaccine available for adults under 60 with heightened risk factors such as chronic health conditions.

The FDA's decision was based on Pfizer's phase 3 MONeT trial data, which evaluated the vaccine’s safety and efficacy in adults with underlying conditions that increase their risk for severe RSV disease. These conditions include chronic obstructive pulmonary disease (COPD), diabetes, heart failure, and asthma, among others. ABRYSVO aims to reduce the risk of RSV-related complications in this vulnerable population.

Pfizer’s vaccine remains the only RSV immunization approved for both older adults and pregnant individuals.