Abrysvo FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 22, 2023.
FDA Approved: Yes (First approved May 31, 2023)
Brand name: Abrysvo
Generic name: respiratory syncytial virus vaccine
Dosage form: Injection
Company: Pfizer Inc.
Treatment for: RSV
Abrysvo (respiratory syncytial virus vaccine) is a vaccine used for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV).
- Abrysvo is indicated for:
- active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age.
- active immunization for the prevention of LRTD caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. - RSV is a contagious virus and a common cause of respiratory illness. It can potentially cause severe illness in young infants, older adults, and individuals with certain chronic medical conditions.
- Abrysvo is a bivalent recombinant protein subunit vaccine that consists of equal amounts of stabilized prefusion F (preF) antigens from the two major RSV subgroups: RSV A and RSV B. Prefusion F is a key form of the viral fusion protein (F) that RSV uses to enter human cells. Research has demonstrated that antibodies specific to the prefusion form were highly effective at blocking virus infection, suggesting a prefusion F-based vaccine may confer optimal protection against RSV.
- Abrysvo is administered as an intramuscular injection.
- Warnings and precautions associated with Abrysvo include the potential risk of preterm birth. Abrysvo should only administered to pregnant individuals 32 through 36 weeks gestational age.
- Common side effects (≥10%) in pregnant individuals include pain at the injection site, headache, muscle pain, and nausea.
Common side effects (≥10%) in adults 60 years of age and older include fatigue, headache, pain at the injection site, and muscle pain.
Development timeline for Abrysvo
Further information
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