GSK 5-in-1 Meningococcal Vaccine Given a PDUFA

GSK announced the FDA has accepted for review a Biologics License Application (BLA) for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine, and the federal agency has provided a PDUFA action date for a decision on February 14, 2025.¹ The vaccine combines the antigenic components of its 2 well-established meningococcal vaccines with demonstrated efficacy and safety profiles, Bexsero (Meningococcal Group B Vaccine) and Menveo (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine).This latest addition to the vaccine family, MenABCWY, will target the 5 groups of the bacteria Neisseria meningitidis (Men A, B, C, W and Y) that cause most invasive meningococcal disease (IMD) cases globally.¹

What the Data Showed
The vaccine candidate met all 11 primary endpoints of its phase 3 clinical trial, including the non-inferiority of the vaccine candidate for all five Neisseria meningitides serogroups (A, B, C, W, and Y) compared to licensed meningococcal vaccines Bexsero and Menveo in terms of an immune response. The vaccine was administered to participants in 2 doses at six months apart in healthy individuals between the ages of 10-25 years old.²

The phase 3 trial randomized, controlled, observer-blind, multi-country trial to evaluate the safety, tolerability, and immunogenicity of GSK’s MenABCWY vaccine candidate. It is part of a comprehensive program to generate clinical evidence on the benefits of meningococcal immunization. The trial had approximately 3650 participants aged 10-25 were enrolled in the US, Canada, Czech Republic, Estonia, Finland, Turkey, and Australia.²

MenABCWY was well tolerated, with a safety profile consistent with Bexsero and Menveo.²

“These statistically significant phase 3 data are a very encouraging step toward reducing the incidence of meningococcal disease,” GSK Chief Scientific Officer Tony Wood, PhD, said in a statement at the time.²

The Impact of Meningococcal Disease
According to the Centers for Disease Control and Prevention (CDC), IMD is an unpredictable but serious illness that can cause life-threatening complications.³ Some patients with IMD can die in as little as a few hours. Most people, however, do recover from bacterial meningitis. Those who do recover can have permanent disabilities, such as brain damage, hearing loss, and learning disabilities.³

Although anyone can get IMD, those who are in their late teens and early adulthood are amongst the groups at higher risk of contracting it.^4,5

The potential FDA approval could help impact this aforementioned group that is susceptible to this infection. “In the US, routine use of a 5-in-1 meningococcal vaccine with a 2-dose regimen in adolescents at 16 to 18 years of age, just before this disease’s incidence peak, could drive significant public health impact,” Wood added.²

References
1. GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA. GSK press release. 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/

2. GSK Achieves Primary Endpoints Meningococcal ABCWY Vaccine for Phase 3 Trial. Contagion. March 15, 2024. Accessed April 16, 2024.
https://www.contagionlive.com/view/gsk-achieves-primary-endpoints-meningococcal-abcwy-vaccine-for-phase-3-trial

3. Bacterial Meningitis. CDC. Accessed April 16, 2024.
www.cdc.gov/meningitis/bacterial.html

4. McNamara LA, Blain A. Meningococcal Disease Roush SW, Baldy LM, Hall MAK, eds. Manual for the Surveillance of Vaccine-Preventable Diseases. Centers for Disease Control and Prevention. Reviewed January 5, 2022. Accessed April 16, 2024.

5. Pingali C, Yankey D, Elam-Evans LD, et al. Vaccination Coverage Among Adolescents Aged 13-17 Years - National Immunization Survey-Teen, United States, 2022. MMWR Morb Mortal Wkly Rep. 2023;72(34):912-919. Published 2023 Aug 25. doi:10.15585/mmwr.mm7234a3