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FDA Approves GSK's Pentavalent Meningococcal Vaccine Penmenvy
The ACIP of the CDC will meet on February 26 to vote on recommendations for appropriate incorporation of Penmenvy into the routine vaccination schedule.
GSK announced that the FDA has approved Penmenvy, the company’s pentavalent meningococcal vaccine, for individuals aged 10 through 25 years. The vaccine provides coverage against five major serogroups of Neisseria meningitidis (A, B, C, W, and Y), addressing a critical need for broader meningococcal protection in adolescents and young adults, the company stated in a news release February 15. Penmenvy is the second "5-in-1" vaccine to receive the FDA greenlight, following the agency's approval in 2023 of Penbraya, developed by Pfizer.
Penmenvy combines antigenic components from GSK's previously approved vaccines, Bexsero (targeting serogroup B) and Menveo (targeting serogroups A, C, W, and Y). Approval was based on positive outcomes from two phase 3 clinical trials (NCT04502693; NCT04707391) involving more than 4,800 participants. The vaccine demonstrated a safety profile consistent with GSK’s existing 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,” Tony Wood, chief scientific officer at GSK, said in the company's news release. "We aim to help protect more teens and young adults at a life stage when they are at an increased risk.”
Invasive meningococcal disease (IMD) is a rare but severe condition that can lead to death within 24 hours despite treatment. Even when treatment is administered, approximately 1 in 6 people with IMD will die.2 Adolescents and young adults are at heightened risk due to social behaviors that facilitate bacterial transmission, such as living in close quarters, kissing, and sharing drinks or utensils. IMD can cause long-term complications, including brain damage, hearing loss, and limb amputations.2
While the Centers for Disease Control and Prevention (CDC) recommends vaccination against meningococcal serogroups A, C, W, Y, and B, uptake remains suboptimal, particularly for MenB. Only about 13% of eligible US adolescents receive the full two-dose MenB series, while 32% receive at least one dose. GSK currently supplies approximately 75% of MenB doses administered in the United States.3,4
“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," Judy Klein, president and founder of the Unity Consortium, said in the announcement. She highlighted the public health implications for the approval. "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.”1
The CDC's Advisory Committee on Immunization Practices (ACIP) is scheduled to vote on February 26, 2025, regarding recommendations for Penmenvy's use in adolescents and young adults. If adopted, the decision could further integrate the vaccine into routine immunization programs, simplifying administration and increasing coverage against multiple meningococcal serogroups.
GSK's MenABCWY vaccine is administered as an intramuscular injection. It is supplied as a lyophilized MenACWY component requiring reconstitution with a liquid MenB component before use. The vaccine is indicated for active immunization to prevent invasive meningococcal disease caused by serogroups A, B, C, W, and Y.1
