FDA Approves Penmenvy Vaccine for Meningococcal Disease Prevention

The U.S. Food and Drug Administration (FDA) has approved Penmenvy, a vaccine for meningococcal groups A, B, C, W, and Y, for use in individuals aged 10 to 25 years. The vaccine targets five major serogroups of Neisseria meningitidis, the bacteria responsible for invasive meningococcal disease (IMD).
The approval is based on data from two phase 3 clinical trials (NCT04502693; NCT04707391) that assessed the vaccine’s safety, tolerability, and immune response in more than 4,800 participants. Penmenvy combines elements from two existing GSK meningococcal vaccines, Bexsero and Menveo, to enhance immune protection against multiple strains.

One study (NCT04502693) examined the effectiveness of two or three doses of Bexsero along with two doses of Penmenvy in healthy adolescents and young adults. The trial included 3,651 individuals, with primary endpoints focusing on safety and immune response. Researchers reported immune response rates of 78.7% for a 0-to-2-month schedule, 81.8% for a 0-to-6-month schedule, and 83.2% for a 0-to-2-to-6-month schedule. No significant differences in immunogenicity were observed between the dosing schedules, and the vaccine was well tolerated.
The second trial (NCT04707391) evaluated the vaccine’s safety and immunogenicity in individuals aged 15 to 25 years who had previously received the MenACWY vaccine. The primary endpoint assessed the noninferiority of MenABCWY compared with the MenACWY-CRM197-glycoconjugate vaccine. Secondary endpoints included the percentage of participants with human serum bactericidal antibody (hSBA) titers above the lower limit of quantification (≥ LLOQ) for serogroups ACWY. The results showed noninferiority of MenABCWY, with hSBA titers ≥ LLOQ ranging from 97.9% to 98.9% following one dose and 99.5% to 100% after two doses. The MenACWY-CRM group had response rates between 96.8% and 99%. The vaccine was well tolerated.

According to the U.S. Centers for Disease Control and Prevention (CDC), cases of meningococcal disease have increased significantly since 2021, surpassing pre-pandemic levels. In 2023, 438 confirmed and probable cases were reported in the United States.
The CDC’s Advisory Committee on Immunization Practices is expected to vote on recommendations regarding the vaccine’s use in adolescents and young adults.