FDA Approves GSK's Penmenvy Vaccine for Meningococcal Disease

The US Food and Drug Administration (FDA) has approved GSK's Penmenvy vaccine for individuals aged 10 to 25, targeting five major serogroups of Neisseria meningitidis that cause invasive meningococcal disease. This combination vaccine integrates components from GSK's existing vaccines, Bexsero and Menveo, which enhances the immune response against serogroups A, B, C, W, and Y. The approval follows positive results from two phase III trials involving over 4,800 participants, demonstrating a safety profile consistent with previously licensed meningococcal vaccines. Meningococcal disease cases have surged since 2021, surpassing pre-pandemic levels, with 438 confirmed cases reported in 2023. Experts believe that the single-injection format of Penmenvy could simplify vaccination and improve coverage among adolescents. The approval is seen as a significant step in addressing the unmet need for effective meningococcal disease prevention in young adults.