FDA Approves GSK's Pentavalent Meningococcal Vaccine

The US Food and Drug Administration (FDA) has approved GSK's pentavalent meningococcal vaccine, Penmenvy, for children and young adults aged 10 to 25 years. This new vaccine provides protection against five meningococcal serogroups by combining components from two of GSK’s existing vaccines: Bexsero (serogroup B) and Menveo (serogroups A, C, W, and Y).

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.”

Integrating GSK’s MenABCWY vaccine into healthcare provider practices could simplify meningococcal vaccination delivery and help protect more US adolescents against these five common disease-causing serogroups – A, B, C, W, and Y – for which the US Centers for Disease Control and Prevention (CDC) have issued recommendations. Although MenB is the leading cause of IMD among this population, less than 13% receive the recommended two-dose vaccination series; around 32% receive at least one dose. Three of every four MenB doses currently administered in the US are manufactured by GSK, positioning the company well to lead in the US market as MenB-containing vaccinations must be completed with the same manufacturer’s MenB vaccine.

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.”

At its meeting on February 26, 2025, the CDC’s Advisory Committee on Immunization Practices (ACIP) is expected to vote on recommendations for the appropriate use of GSK’s MenABCWY vaccine in adolescents and young adults.

About IMD

IMD is an uncommon but serious illness that can lead to death for up to one in six of those who contract it in as little as 24 hours from onset, despite treatment. IMD is easily misdiagnosed, with early symptoms often mistaken for the flu. Approximately one in five survivors may experience long-term consequences such as brain damage, amputations, hearing loss, and nervous system problems. Although anyone can get IMD, adolescents and young adults between the ages of 16 and 23 years are one of the groups at highest risk due to common behaviors that help transmit the bacteria that cause IMD such as living in close quarters like college dormitories, kissing and sharing drinks, utensils, or smoking devices.