GSK announced that the US Food and Drug Administration (FDA) has approved Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) for use in individuals aged 10 through 25 years. The vaccine targets five major serogroups of Neisseria meningitidis (A, B, C, W, and Y) which commonly cause invasive meningococcal disease (IMD).

The vaccine combines the antigenic components of GSK’s two well-established meningococcal vaccines, Bexsero (Meningococcal Group B Vaccine) and Menveo (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine). The regulatory application was supported by positive results from two phase III trials [NCT04502693; NCT04707391], which evaluated the vaccine’s safety, tolerability, and immune response in over 4,800 participants aged 10-25 years. The safety data demonstrated that the vaccine has a safety profile consistent with GSK’s licensed meningococcal vaccines.

Tony Wood, Chief Scientific Officer, GSK, said: “We are excited about the opportunities ahead to help improve meningococcal vaccination coverage in the United States, especially for IMD caused by serogroup B. Building on our global leadership in meningococcal vaccination and our longstanding commitment to address unmet need in disease prevention, we aim to help protect more teens and young adults at a life stage when they are at an increased risk.” 

Judy Klein, President and Founder of Unity Consortium, a non-profit organization focused on adolescent health and immunization in the US, said: “The consequences of IMD 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 one vaccine and making it easier for adolescents to get the coverage they need.”