FDA approves GSK's meningococcal ABCWY vaccine

FDA approves GSK's meningococcal ABCWY vaccine | Image Credit: © Calin - © Calin - stock.adobe.com.

The FDA has approved meningococcal ABCWY (MenABCWY, Penmenvy; GSK) vaccine for use in individuals aged 10 to 25 years, according to an announcement from GSK.¹

The vaccine targets 5 groups of the bacteria Neisseria meningitidis (A,B,C,W, AND Y) that cause the most invasive meningococcal disease cases (IMD) globally. The vaccine combines antigenic components of the meningococcal group B vaccine (Bexsero) and meningococcal groups A, C, Y, and W-135 Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (Menveo).²

“We are excited about the opportunities ahead to help improve meningococcal vaccination coverage in the United States, especially for IMD caused by serogroup B," said Tony Wood, chief scientific officer, GSK. "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 

The biologics license application (BLA) submission and acceptance was based on data from a randomized, controlled, observer-blind, multi-country phase 3 trial (NCT04502693) that evaluated safety, tolerability, and immunogenicity of the vaccine candidate.²

Approximately 3650 participants aged 10 to 25 years from 7 countries, including the United States and Canada, were enrolled in the study. The trial’s main objective was to assess immunological vaccine effectiveness against a panel of 110 MenB strains and to demonstrate non-inferiority of the immune responses of participants who received 2 doses of meningococcal ABCWY 6 months apart. These results were compared to responses of individuals who received 2 doses of meningococcal group B vaccine and 1 does of meningococcal groups A, C, Y, and W vaccine.²

The trial met all primary endpoints and was "well tolerated with a safety profile consistent with both vaccines,” GSK stated when the BLA was accepted by the FDA.²

"The meningococcal bacteria, especially the B strain, are quite contagious, especially in college settings," Russell Libby, MD, FAAP, founder and president of Virginia Pediatric Group, told Contemporary Pediatrics. Libby is also a contributing member of the Contemporary Pediatrics editorial advisory board.

"The onset of symptoms can be subtle and the progression rapid and severe," said Libby. "Being able to vaccinate for all likely infectious strains in a 2 shot series makes it more likely more young adults will be protected."

MenB is the most common group of IMD-causing bacteria in US adolescents and young adults, making up more than half of the IMD cases in the age group in the United States from 2017 to 2021. GSK states less than 12% of adolescents in the United States have had the 2 required doses protection against MenB.²

“The consequences of IMD can be devastating for those who contract it, for their families and friends," said Judy Klein, president and founder of Unity Consortium, a non-profit organization focused on adolescent health and immunization in the United States. "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.”¹

References:

1. GSK. Penmenvy, GSK’s 5-in-1 meningococcal vaccine, approved by US FDA to help protect against MenABCWY. GSK. February 14, 2025. Accessed February 14, 2025. https://www.gsk.com/en-gb/media/press-releases/penmenvy-gsk-s-5-in-1-meningococcal-vaccine-approved-by-us-fda-to-help-protect-against-menabcwy/

2. Fitch, J. FDA accepts BLA for meningococcal ABCWY vaccine, target action date set. Contemporary Pediatrics. April 16, 2025. Accessed February 12, 2025. https://www.contemporarypediatrics.com/view/fda-accepts-bla-for-meningococcal-abcwy-vaccine-target-action-date-set