By Fineline Cube 
Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has amended the marketing authorization for Abrysvo, its bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine. The expanded indication now includes the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 18 through 59 years, in addition to those aged 60 and older.
Expanded Indication
Abrysvo now offers the broadest RSV vaccine indication in the EU, covering:
- Active immunization of individuals 18 years and older to prevent LRTD caused by RSV.
- Passive protection against LRTD caused by RSV in infants from birth through 6 months of age following maternal immunization during pregnancy.
Clinical Trial Basis
The approval is supported by positive results from the pivotal Phase 3 MONeT trial (NCT05842967), which demonstrated the vaccine’s efficacy in preventing severe RSV-related illness in higher-risk adults.-Fineline Info & Tech