5-in-1 Meningococcal Vaccine Fetches FDA Approval

GSK’s meningococcal groups A, B, C, W, and Y vaccine (Penmenvy) has been approved by the FDA for use in individuals aged 10 through 25 years.¹

Combining the antigenic components of GSK’s 2 other meningococcal vaccines, meningococcal group B vaccine (Bexsero) and meningococcal groups A, C, Y, and W-135 vaccines (Menveo), the regulatory application followed positive results from 2 phase 3 trials, which evaluated the vaccine’s safety, tolerability, and immune response in more than 4800 participants. The safety data demonstrated that the vaccine has a safety profile consistent with GSK’s licensed meningococcal vaccines.

Integrating GSK’s MenABCWY vaccine into healthcare provider practices could simplify meningococcal vaccination delivery and help protect more US adolescents against these 5 common disease-causing serogroups—A, B, C, W, and Y—for which the Centers for Disease Control and Prevention has issued recommendations.

Judy Klein, president and founder of Unity Consortium, a nonprofit organization focused on adolescent health and immunization in the United States, said in a statement: “The consequences of invasive meningococcal disease can be devastating for those who contract it, for their families and friends. We welcome new tools to help protect more adolescents from meningococcal disease. Pentavalent MenABCWY vaccines could help address the disease by providing protection against the five vaccine-preventable serogroups in 1 vaccine and making it easier for adolescents to get the coverage they need.”

Reference

1. GSK. Penmenvy, GSK’s 5-in-1 meningococcal vaccine, approved by US FDA to help protect against MenABCWY [press release]. February 15, 2025. Accessed April 9, 2025. www.gsk.com/en-gb/media/press-releases/penmenvy-gsk-s-5-in-1-meningococcal-vaccine-approved-by-us-fda-to-help-protect-against-menabcwy/