20 October 2023 - The FDA’s decision is based on data from Phase 2 and Phase 3 trials, which demonstrated that Penbraya has robust immunogenicity non-inferior to Trumenba + Menveo for all serogroups and was well-tolerated with a favourable safety profile.
Pfizer announced today that the US FDA has approved Penbraya (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides coverage against the most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age.