Penbraya FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 30, 2023.
FDA Approved: Yes (First approved October 20, 2023)
Brand name: Penbraya
Generic name: meningococcal groups A, B, C, W, and Y vaccine
Dosage form: Injection
Company: Pfizer Inc.
Treatment for: Meningococcal Disease Prophylaxis
Penbraya (meningococcal groups A, B, C, W, and Y vaccine) is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals 10 through 25 years of age.
- Meningococcal disease is a serious illness caused by Neisseria meningitidis bacteria that can cause long-term disabilities, or in severe cases, death.
- Penbraya is a pentavalent vaccine that provides coverage against the most common serogroups (A, B, C, W, and Y) that cause meningococcal disease.
- Penbraya combines the components from two meningococcal vaccines, Trumenba (meningococcal group B vaccine) and Nimenrix* (meningococcal groups A, C, W-135, and Y conjugate vaccine).
- FDA approval of Penbraya was based on the positive results from Phase 2 and Phase 3 trials, including a randomized, active-controlled and observer-blinded Phase 3 trial assessing the safety, tolerability, and immunogenicity of the pentavalent vaccine candidate compared to currently U.S. licensed meningococcal vaccines, with the goal of determining immunologic noninferiority. The Phase 3 trial (NCT04440163) evaluated more than 2,400 patients from the U.S. and Europe.
- Penbraya is administered by intramuscular injection. Two doses are given 6 months apart.
- Common adverse reactions include pain at the injection site, fatigue, headache, muscle pain, injection site redness, injection site swelling, joint pain, and chills.
* Nimenrix is licensed for use in the European Union. Nimenrix is not licensed in the U.S.
Development timeline for Penbraya
Further information
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