Pfizer Pentavalent Meningococcal Vaccine Approved

FDA has approved Pfizer’s Penbraya (meningococcal groups A, B, C, W and Y vaccine), a pentavalent vaccine that protects against the most common serogroups causing meningococcal disease in adolescents and young adults aged 10 through 25 years of age. The company says the vaccine “combines the components from two meningococcal vaccines, Trumenba (meningococcal group B vaccine) and Nimenrix (meningococcal groups A, C, W-135, and Y conjugate vaccine) to help protect against the five most common meningococcal serogroups that cause the majority of invasive meningococcal disease (IMD) globally.”

The approval was based on positive results from Phase 2 and Phase 3 trials, including a randomized, active-controlled non-inferiority Phase 3 trial (NCT04440163) that assessed the safety, tolerability, and immunogenicity of the pentavalent vaccine candidate compared to currently U.S. licensed meningococcal vaccines, the company says.