ABRYSVO
STN: 125769; 125768
Proper Name: Respiratory Syncytial Virus Vaccine
Tradename: ABRYSVO
Manufacturer: Pfizer Inc.
Indication:
ABRYSVO is a vaccine 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.
Product Information
- Package Insert - ABRYSVO (STN 125769/26)
- Package Insert - ABRYSVO (STN 125768)
- Demographic Subgroup Information – Respiratory Syncytial Virus Vaccine (ABRYSVO)
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
Supporting Documents
- August 21, 2023 Approval Letter - ABRYSVO (STN 125769/26)
- August 21, 2023 Approval Letter - ABRYSVO (STN 125768)
- May 31, 2023 Approval Letter - ABRYSVO
- May 31, 2023 Summary Basis for Regulatory Action - ABRYSVO
- Approval History, Letters, Reviews, and Related Documents - ABRYSVO