US FDA Approves GSK's Penmenvy 5-in-1 Meningococcal Vaccine

LONDON, UK I February 15, 2025 I GSK plc has announced that the US Food and Drug Administration (FDA) has approved Penmenvy, a vaccine for individuals aged 10 to 25 years. This vaccine targets the five major serogroups of Neisseria meningitidis, which are A, B, C, W, and Y, and are known causes of invasive meningococcal disease (IMD).

Penmenvy combines components from two established GSK vaccines: Bexsero, which targets meningococcal group B, and Menveo, which targets groups A, C, Y, and W-135. The approval was backed by successful phase III trials that assessed the vaccine's safety, tolerability, and immune response in over 4,800 participants within the specified age range. The safety profile aligns with those of GSK's existing licensed meningococcal vaccines.

Tony Wood, GSK's Chief Scientific Officer, expressed enthusiasm about enhancing meningococcal vaccination coverage in the U.S., particularly against serogroup B which poses a significant risk. This effort is part of GSK's broader commitment to addressing unmet needs in disease prevention. By making the MenABCWY vaccine available to healthcare providers, GSK aims to streamline vaccination processes and extend protection to more adolescents against the five serogroups recommended by the U.S. Centers for Disease Control and Prevention (CDC).

Despite being the most common cause of IMD among young people, MenB vaccination rates remain low, with less than 13% completing the recommended two-dose series. Currently, GSK supplies three-quarters of the MenB doses administered in the U.S., asserting a strong market position as the vaccine must be completed with the same manufacturer's product.

Judy Klein, President and Founder of Unity Consortium, a non-profit organization focusing on adolescent health and immunization in the U.S., emphasized the severe impact of IMD on individuals and their families. She welcomed the introduction of the pentavalent MenABCWY vaccine as a significant advancement. This vaccine simplifies the immunization process, offering protection against five vaccine-preventable serogroups in a single product, thus facilitating better coverage for adolescents.

The CDC's Advisory Committee on Immunization Practices (ACIP) is anticipated to review and vote on the appropriate use of GSK's MenABCWY vaccine for adolescents and young adults in an upcoming meeting.

IMD is a rare but serious condition that can lead to death within 24 hours of onset despite treatment. The disease is often misdiagnosed in its early stages, with symptoms resembling those of the flu. Survivors may suffer long-term effects such as brain damage, hearing loss, and amputations. Adolescents and young adults between 16 and 23 years are particularly susceptible due to behaviors that facilitate bacterial transmission, like living in close quarters, and sharing drinks or smoking devices.

The MenABCWY vaccine is administered intramuscularly and comes as a lyophilized powder that is reconstituted with a liquid component at the time of use. It is approved in the U.S. for preventing IMD caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals aged 10 to 25 years.

GSK's MenB vaccine, Bexsero, is approved in over 55 countries and used in 18 national immunization programs worldwide. Over 110 million doses have been distributed since 2015, demonstrating its efficacy and safety in protecting against MenB strains. Menveo, the MenACWY vaccine, is also widely approved and has seen over 80 million doses distributed globally since 2010. Both vaccines show strong immunogenicity and well-characterized safety profiles.

GSK continues its mission as a global biopharma leader, combining science, technology, and talent to advance disease prevention and ensure better health outcomes.