FDA Approves Pfizer's Respiratory Syncytial Virus Vaccine Abrysvo For Adults Below 60 Years

On Tuesday, the FDA approved Pfizer Inc’s (NYSE:PFE) Abrysvo  (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, to prevent lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 who are at high risk.

Abrysvo now offers the broadest RSV vaccine indication for adults, which previously included those 60 years and older.

Additionally, it remains the only RSV immunization approved for pregnant individuals at 32 through 36 weeks of gestation to protect infants from birth up to 6 months of age.

The FDA’s decision is based on inferred efficacy from the pivotal Phase 3 MONeT study, which ...