The 5-in-1 meningococcal ABCWY vaccine candidate has an assigned Prescription Drug User Fee Act action date of February 14, 2025.
The FDA has announced that it accepted a biologics license application for a 5-in-1 meningococcal ABCWY vaccine candidate (GSK), assigning a Prescription Drug User Fee Act action date of February 14, 2025.
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The vaccine candidate combines antigenic components of GSK’s well-established meningococcal vaccine with the efficacy and safety profiles, according to the press release. The 2 vaccines that were used included meningococcal group b vaccine (Bexsero) and meningococcal groups A, C, Y, and W-135 (oligosaccharide diphtheria CRM197 conjugate vaccine) (Menveo). The proposed vaccine candidate is intended to target the 5 groups of Neisseria meningitidis, which cause most invasive meningococcal disease cases, according to the press release.
The submission was based on the phase 3 MenABCWY trial, which was a controlled, observer-blind trial that evaluated the safety, tolerability, and immunogenicity of the vaccine candidate. Approximately 3650 individuals aged 10 through 25 were enrolled starting in August 2020 in the United States, Canada, Czech Republic, Estonia, Finland, Turkey, and Australia.
The trial assessed the safety profile and immunological vaccine effectiveness against 110 MenB strains. Further, investigators aimed to determine whether the vaccine candidate had a non-inferiority immune response for those who received 2 doses of the investigational vaccine compared to those who received 2 doses of the meningococcal group b vaccine and 1 dose of the meningococcal group A, C, Y, and W vaccine, according to the press release.
Investigators found that the trial met all primary endpoints, which included the non-inferiority endpoint compared to the currently approved vaccines from GSK. Furthermore, the vaccine demonstrated a well-tolerated safety profile consistent with the 2 other vaccines.
Trial Name: Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults
ClinicalTrial.gov ID: NCT04502693
Sponsor: GlaxoSmithKline
Completion Date: Septemeber 2022
GSK hopes that by combining the protection of both vaccines into fewer doses, it could help to increase the series completion and vaccine coverage to reduce the overall burden of invasive meningococcal disease, according to the press release. Currently in the United States, meningococcal vaccine is recommended for all 5 serogroups and has been in place since 2025. However, the annual immunization rates have remained low due to the complect dosing schedule, according to the press release. MenB is the most common group of invasive meningococcal disease-causing bacteria in the United States for adolescents and young adults, accounting for more than half of cases in this age group from 2017 to 2021, according to the press release. Approximately just under 12% of United States adolescents have had the 2 required doses.
According to the press release, invasive meningococcal disease is an unpredictable serious illness that can cause life-threatening complication, and despite treatment, approximately 1 in 6 individuals with invasive meningococcal disease will die, with some in as little as 24 hours. Additionally, 1 in 5 survivors may suffer long-term consequences, including brain damage, amputations, hearing loss, and nervous system problems. Those who are in their late teens and early adulthood are at high risk for contracting invasive meningococcal disease, according to the press release.
Currently, the meningococcal group b vaccine is licensed or received approval in 55 countries, which included the United States and European Union, and is used in 16 national immunization programs worldwide. Further, the oligosaccharide diphtheria CRM197 conjugate vaccine has received approval in over 60 countries, including the United States, and more than 72 million doses have been distributed since 2010 worldwide.
Reference
GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA. News release. GSK. April 16, 2024. Accessed April 16, 2024. https://www.gsk.com/en-gb/media/press-releases/gsk-s-5-in-1-meningococcal-abcwy-vaccine-candidate-accepted-for-regulatory-review-by-us-fda/
