5-in-1 Meningococcal ABCWY Vaccine Candidate Receives FDA Approval for Meningococcal Disease

GSK’s 5-in-1 meningococcal ABCWY (MenABCWY, Penmenvy; GSK) vaccine has received FDA approval for use in individuals aged 10 through 25 years, indicated to target 5 groups of the bacteria Neisseria meningitidis (Men A, B, C, W, and Y) that account for most invasive meningococcal disease (IMD) cases globally.¹

Image credit: Bernard Chantal | stock.adobe.com

The 5-in-1 MenABCWY vaccine combines the antigenic components of Meningococcal Group B vaccine (Bexsero; GSK) and Meningococcal (Groups A, C, Y, and W-135) oligosaccharide diphtheria CRM₁₉₇ conjugate vaccine (Menveo; GSK). Both meningococcal vaccines are well-established with tolerable safety and efficacy profiles. Combining the vaccines into fewer shots simplifies immunization, increases vaccination coverage, and reduces the risk of infection and outbreaks.¹

“The consequences of IMD can be devastating for those who contract it, for their families and friends. 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 5 vaccine-preventable serogroups in 1 vaccine and making it easier for adolescents to get the coverage they need,” Judy Klein, president and founder of Unity Consortium, said in a news release.²

According to the CDC, IMD is a severe bacterial infection caused by the bacterium Neisseria meningitidis, often leading to meningitis or sepsis. The bacteria typically live in the back of the nose and throat but can spread to other areas of the body and cause infection. IMD is spread through close or lengthy contact among individuals that share respiratory and throat secretions.³ Although anyone can get IMD, individuals in their late teens and early adulthood face a higher risk of contracting the infection. However, MenB is the most common IMD-causing bacteria among US adolescents and young adults.¹

The CDC recommends meningococcal vaccination for all preteens and teens; children 2 months through 10 years old at increased risk; and adults 19 years and older at increased risk.⁴

“We are excited about the opportunities ahead to help improve meningococcal vaccination coverage in the United States, especially for IMD caused by serogroup B," Tony Wood, chief scientific officer, GSK, said in a news release.²

The approval is based on results from 2 phase 3 trials (NCT04502693; NCT04707391) that evaluated the safety, tolerability, and immunogenicity of the MenABCWY vaccine candidate among 4800 healthy adolescents and young adults.^{1,2, 5}

Individuals aged 10 to 25 years were included in the randomized, controlled, observer-blind, multi-country trial (NCT04502693) study from the US, Canada, Czech Republic, Estonia, Finland, Turkey, and Australia. The study’s objective was to assess the immunological vaccine effectiveness against a panel of 110 MenB strains and to demonstrate non-inferiority of the immune responses among individuals that received 2 doses of the MenABCWY vaccine candidate, 6 months apart. The researchers compared the responses to the control group of individuals that received 2 doses of the Meningococcal Group B vaccine and 1 dose of the Meningococcal Groups A, C, Y, and W vaccine.^1,5

The results demonstrated that the MenABCWY vaccine candidate was well tolerated with a safety profile consistent with both vaccines. All primary end points were met, including non-inferiority to 1 dose of Meningococcal Groups A, C, Y, and W vaccine and non-inferior immune response against 110 diverse strains of MenB, compared to 2 doses of the Meningococcal Group B vaccine.¹

"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," Wood said.²

REFERENCES

1. GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA. GSK. News release. Published April 16, 2024. Accessed February 13, 2025. 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. PENMENVY, GSK’s 5-in-1 Meningococcal Vaccine, Approved by US FDA to Help Protect Against MenABCWY. Business Wire. News release. Published February 17, 2025. Accessed February 17, 2025. https://www.businesswire.com/news/home/20250214551710/en/PENMENVY-GSK%E2%80%99s-5-in-1-Meningococcal-Vaccine-Approved-by-US-FDA-to-Help-Protect-Against-MenABCWY

3. About Meningococcal Disease. CDC. News release. Published February 1, 2024. Accessed February 13, 2025. https://www.cdc.gov/meningococcal/about/index.html

4. Meningococcal Vaccination. CDC. News release. Published June 26, 2024. Accessed February 13, 2025. https://www.cdc.gov/meningococcal/vaccines/index.html

5. Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults. ClinicalTrials.gov. Updated March 5, 2024. Accessed February 13, 2025. https://clinicaltrials.gov/study/NCT04502693?tab=results