FDA Approves Pfizer's PENBRAYA Vaccine for Meningococcal Disease

The U.S. Food and Drug Administration (FDA) has approved Pfizer Inc.'s PENBRAYA™ (meningococcal groups A, B, C, W and Y vaccine) on October 20, 2023. The vaccine is the first and only pentavalent vaccine providing coverage against the most common serogroups causing invasive meningococcal disease (IMD) in adolescents and young adults aged 10 through 25. PENBRAYA combines components from two meningococcal vaccines to protect against serogroups A, B, C, W, and Y.

Pfizer stated the vaccine aims to simplify vaccination schedules in the U.S. by reducing the total number of doses needed for comprehensive protection against the five leading serogroups. The company believes fewer doses may lead to more adolescents receiving timely vaccinations, thereby decreasing the incidence of IMD and its severe long-term consequences.

The FDA's decision follows Phase 2 and Phase 3 clinical trials. These studies demonstrated that PENBRAYA has robust immunogenicity and was well-tolerated with a favorable safety profile. The vaccine's immunogenicity was found to be non-inferior to a combination of the currently U.S.-licensed vaccines Trumenba® and Menveo® across all targeted serogroups.

Meningococcal disease is an uncommon but serious illness that can be fatal within 24 hours or lead to life-altering disabilities for survivors. The CDC's Advisory Committee on Immunization Practices (ACIP) is scheduled to meet to discuss recommendations for the vaccine's appropriate use.