GSK Announces FDA PDUFA Date for 5-in-1 Meningococcal Vaccine Based on Acceptance of BLA

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GSK today announced the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine. The federal agency has set a PDUFA date for a decision of February 14, 2025.¹

The MenABCWY vaccine combines the antigenic components of 2 well-established GSK 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).¹ The new combination vaccine 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 globally¹ and do so with 2 injections 6 months apart vs separate MenB and MenACWY vaccinations given separately as 4 or 5 doses between ages 11 and 18 years.² 

The data
The vaccine candidate met all 11 primary endpoints specified in its pivotal phase 3 randomized, multicountry clinical trial. The trial evaluated the vaccine in 3650 healthy individuals aged 10 to 25 years in 2 doses, 6 months apart.¹ Among the multiple primary endpoints met were immunologic noninferiority to a single dose of Menveo and noninferior immune responses against 110 diverse MenB invasive strains when compared with 2 doses of the company’s MenB vaccine Bexero. The 110 strains represent 95% of MenB strains circulating in the US, according to GSK.¹

MenABCWY was well tolerated, with a safety profile consistent with Bexsero and Menveo, the company said.¹

“These statistically significant phase 3 data are a very encouraging step toward reducing the incidence of meningococcal disease,” Tony Wood, PhD, GSK chief scientific officer, said in a company statement at the time the results were announced.³

Meningococcal disease
According to the National Foundation for Infectious Diseases, IMD is unpredictable but serious and can cause life-threatening complications, including death in as few as 24 hours.⁴ Even when treatment is administered, approximately 1 in 6 people with IMD will die. Among those who do recover, there may be serious and permanent sequelae, including brain damage, kidney damage, hearing loss, and amputation.⁴

Although anyone can get IMD, certain groups are at increased risk including infants younger than age 1 year, adolescents and young adults aged 16 to 23 years, college students living in congregate housing, and individuals who are immunocompromised.⁴

Recommendations for meningococcal vaccination against all 5 serogroups have been in place in the US since 2015 however annual rates continue to be low, with some part of the poor uptake related to the complex schedule.⁵ Vaccination against MenB is subject to shared clinical decision making between health care provider and patient recommended by the CDC; fewer than 12% of US adolescents have received the 2 required doses.⁶ 

“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.³

References
1. 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/
2. Administering meningococcal vaccines. Centers for Disease Control and Prevention. Reviewed November 20, 2023. Accessed April 16, 2024. https://www.cdc.gov/vaccines/vpd/mening/hcp/administering-vaccine.html
3. GSK announces positive pivotal phase III data for 5-in-1 Meningococcal ABCWY vaccine candidate. News release. GSK. March 14, 2023. Accessed April 16, 2024. https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-pivotal-phase-iii-data-for-5-in-1-meningococcal-abcwy-vaccine-candidate/
4. Meningococcal disease. National Foundation for Infectious Diseases. Last reviewed December 2023. Accessed April 16, 2024. https://www.nfid.org/infectious-disease/meningococcal/
5. Meningococcal disease: clinical information. Centers for Disease Control and Prevention. Reviewed February 7, 2022. Accessed April 16m 2024. https://www.cdc.gov/meningococcal/clinical-info.html.
6. Thompson MJ et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet. 2006;367(9508):397-403. doi:10.1016/S0140-6736(06)67932-4