Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO® (Respiratory Syncytial Virus Vaccine), a bivalent RSV vaccine, for preventing lower respiratory tract disease (LRTD) caused by RSV in individuals aged 18 to 59 who are at increased risk for the disease. This approval broadens the vaccine’s indications, which previously included only those aged 60 and older, and it remains the only RSV vaccine authorized for pregnant individuals at 32 to 36 weeks of gestation to protect infants from birth to 6 months.
“RSV poses a significant threat to younger adults with chronic conditions,” said Aamir Malik, Chief U.S. Commercial Officer and Executive Vice President at Pfizer. “With this approval, we’re proud to offer the only RSV vaccine for adults aged 18 to 49 at increased risk, complementing our existing indications for older adults and pregnant women.”
The FDA’s decision was based on data from the pivotal Phase 3 MONeT trial (NCT05842967), which assessed the safety, tolerability, and immunogenicity of ABRYSVO in at-risk adults. Pfizer plans to publish the trial results in a peer-reviewed journal and present them at an upcoming conference.
In the U.S., approximately 9.5% of adults aged 18 to 49 have underlying chronic conditions—such as obesity, diabetes, and COPD—that increase their risk for RSV-related LRTD. This figure rises to 24.3% for those aged 50 to 64.
About RSV
Respiratory syncytial virus (RSV) is a highly contagious virus that can cause severe respiratory illness. It primarily affects individuals with chronic conditions like cardiovascular disease, lung disease, and severe obesity, increasing their risk of severe RSV.
About ABRYSVO
Pfizer is the only company with an RSV vaccine for adults aged 60 and older, as well as for adults aged 18 and older at increased risk of RSV-LRTD, and for infants through maternal immunization. ABRYSVO is a bivalent, unadjuvanted vaccine designed to offer broad protection against RSV, targeting the virus’s fusion protein, which is essential for neutralizing antibodies.
The FDA approved ABRYSVO for adults 60 and older in May 2023, followed by its recommendation for use in at-risk adults aged 60-74 and those aged 75 and older in June 2024. The vaccine was also authorized in August 2023 for pregnant individuals to protect infants from RSV.
Indications for ABRYSVO
ABRYSVO® is indicated in the U.S. for:
- Preventing LRTD caused by RSV in individuals 60 years and older.
- Preventing LRTD in individuals 18 to 59 years at increased risk for RSV.
- Protecting infants from birth through 6 months of age through maternal immunization for pregnant individuals at 32 to 36 weeks of gestation.
Important Safety Information
ABRYSVO should not be administered to individuals with a history of severe allergic reactions to any of its components. For pregnant individuals, the vaccine should only be given at 32 to 36 weeks of gestation to reduce the risk of preterm birth. Common side effects include fatigue, headache, pain at the injection site, and muscle pain in adults, while pain at the injection site, nausea, and headache were noted in pregnant individuals. Infants born to vaccinated mothers experienced slightly higher rates of low birth weight and jaundice compared to those born to unvaccinated mothers.
