The U.S. Food and Drug Administration has approved meningococcal groups A, B, C, W, and Y vaccine (Penmenvy) for patients aged 10 to 25 years.

The pentavalent vaccine targets five major serogroups of Neisseria meningitidis—A, B, C, W, and Y—responsible for most of the invasive meningococcal disease (IMD) cases, according to a press release from GSK. The approval is supported by data from two phase III trials (ClinicalTrials.gov identifiers NCT04502693, NCT04707391), which assessed safety, tolerability, and immunogenicity in over 4,800 participants. The vaccine demonstrated a safety profile consistent with existing GSK meningococcal vaccines.

The novel vaccine combines antigenic components from meningococcal group B vaccine (Bexsero) and meningococcal groups A, C, Y, and W-135 oligosaccharide diphtheria CRM197 conjugate vaccine (Menveo) into a single formulation. The vaccine’s broad serogroup coverage reduces the number of required injections. Although meningococcal B is the leading cause of IMD in this population, fewer than 13% of eligible patients complete the recommended two-dose series, and approximately 32% receive at least one dose. GSK manufactures approximately 75% of meningococcal B vaccine doses administered in the United States, and meningococcal B–containing vaccinations must be completed with the same manufacturer’s vaccine.

“We are excited about the opportunities ahead to help improve meningococcal vaccination coverage, especially for IMD caused by serogroup B,” emphasized Tony Wood, Chief Scientific Officer at GSK.

Judy Klein, President of the Unity Consortium, underscored the clinical significance of expanding meningococcal vaccine availability. “The consequences of IMD can be devastating. We welcome new tools to help protect more adolescents,” she highlighted.

The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is scheduled to vote on February 26, 2025, regarding recommendations for the vaccine’s use in adolescents and young adults.