Proper Name: Meningococcal Groups A, B, C, W, and Y Vaccine
Manufacturer: Pfizer Ireland Pharmaceuticals
- PENBRAYA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. PENBRAYA is approved for use in individuals 10 through 25 years of age.
- Package Insert - PENBRAYA
- Demographic Subgroup Information - Meningococcal Groups A, B, C, W, and Y Vaccine (PENBRAYA)
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.
- November 17, 2023 Summary Basis for Regulatory Action - PENBRAYA
- October 20, 2023 Approval Letter - PENBRAYA
- Approval History, Letters, Reviews, and Related Documents – PENBRAYA