In the Phase 3 trial, GSK's vaccine met all 11 primary endpoints, providing expanded options for preventing invasive meningococcal disease in individuals aged 10-25 years.
GSK is a biopharma company focused on developing medicines and vaccines to address health challenges.
GSK plc announced that the US Food and Drug Administration (FDA) has approved Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) for individuals aged 10 through 25 years. This vaccine is designed to protect against five major serogroups of Neisseria meningitidis (A, B, C, W, and Y), which cause invasive meningococcal disease (IMD).1
MenABCWY combines the protective components of two of GSK’s existing vaccines: the meningococcal Group B vaccine Bexsero and the meningococcal (Groups A, C, Y, and W-135) oligosaccharide diphtheria CRM₁₉₇ conjugate vaccine Menveo. The approval of MenABCWY makes it the second pentavalent meningococcal vaccine available, joining Penbraya by Pfizer, which also targets the same five meningococcal serogroups.1
In its international, observer-blinded Phase 3 clinical trial (NCT04502693), MenABCWY demonstrated promising results. The study involved 3,650 participants aged 10 to 25 years across the US, Canada, and other countries. The vaccine met all 11 primary endpoints and was shown to be noninferior to the combination of Bexsero and Menveo in terms of immunological effectiveness.2
Specifically, MenABCWY produced strong immune responses against a panel of 110 diverse MenB strains, covering 95% of the circulating strains in the US It was well tolerated, with no major safety concerns, and demonstrated a robust immune response across all five meningococcal serogroups (A, B, C, W, and Y). These results position MenABCWY as a significant tool in reducing the incidence of invasive meningococcal disease, particularly among adolescents and young adults at higher risk.2
MenABCWY is administered as two intramuscular (IM) injections, given six months apart, following a dosing regimen similar to Penbraya. The approval of MenABCWY is expected to enhance protection for primary care and pediatric populations, providing an effective option to prevent meningococcal disease in a broader age group.1
In the press release, Tony Wood, chief scientific officer at 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.”1
GSK's Penmenvy vaccine has been FDA-approved for individuals aged 10-25 to protect against five meningococcal serogroups (A, B, C, W, and Y).
MenABCWY, combining elements of Bexsero and Menveo, showed strong immune responses and met all primary endpoints in its Phase 3 trial.
The approval of MenABCWY provides enhanced protection against meningococcal disease for adolescents and young adults, especially in high-risk settings like dormitories.
IMD is a serious, often rapidly progressing disease that can lead to death in as little as 24 hours. It is frequently misdiagnosed in its early stages, as its symptoms can resemble those of the flu,1 but can lead to deadly infections like meningitis (brain and spinal cord inflammation) and bloodstream infections.3 Adolescents and young adults, especially those in close living environments such as dormitories, are at higher risk for contracting the disease.1
The CDC's Advisory Committee on Immunization Practices (ACIP) will meet on February 26, 2025, to discuss recommendations for the vaccine's use in the target age group.1
