GSK’s Penmenvy Meningococcal Vaccine Approved by FDA
- By Rachel Maier, MS
GSK’s Penmenvy (meningococcal groups A, B, C, W and Y vaccine) has been approved by the U.S. Food and Drug Administration (FDA) for use in individuals aged 10 through 25 years. The vaccine targets five major serogroups of Neisseria meningitidis, 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).
Approval was supported by positive results from two Phase III trials [NCT04502693; NCT04707391] that evaluated the vaccine’s safety, tolerability and immune response in more than 4,800 participants aged 10 to 25 years. The safety data demonstrated that the vaccine has a safety profile consistent with GSK’s licensed meningococcal vaccines.
“We are excited about the opportunities ahead to help improve meningococcal vaccination coverage in the United States, especially for IMD caused by serogroup B,” said Tony Wood, chief scientific officer at GSK. “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.”
According to GSK, integrating GSK’s MenABCWY vaccine into healthcare provider practices could simplify meningococcal vaccination delivery and help protect more U.S. adolescents against these five common disease-causing serogroups for which the Centers for Disease Control and Prevention has issued recommendations.
References
Penmenvy, GSK’s 5-in-1 Meningococcal Vaccine, Approved by US FDA to Help Protect Against MenABCWY. GSK press release, Feb. 15, 2025. Accessed at 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.
