ACIP endorses GSK pentavalent meningococcal vaccine for concurrent MenACWY and MenB use

The Advisory Committee on Immunization Practices (ACIP) has issued updated guidance supporting the use of a second pentavalent meningococcal vaccine, MenACWY-CRM/MenB-4C (Penmenvy; GSK), when both quadrivalent meningococcal conjugate (MenACWY) and serogroup B meningococcal (MenB) vaccines are indicated at the same clinical encounter for persons 10 years or older. The recommendations were published in the Morbidity and Mortality Weekly Report and reflect evidence reviewed by ACIP between January 2024 and March 2025.¹

Meningococcal disease is a serious bacterial infection caused by Neisseria meningitidis. Although uncommon in the United States, invasive disease can progress rapidly and is associated with substantial morbidity and mortality. Serogroups B, C, W, and Y account for most US cases.²

FDA licensure of GSK pentavalent MenACWY-CRM/MenB-4C vaccine

In February 2025, the FDA licensed MenACWY-CRM/MenB-4C for the prevention of invasive meningococcal disease caused by serogroups A, B, C, W, and Y in persons aged 10 to 25 years. The vaccine contains the same antigenic components as 2 previously licensed GSK products: MenACWY-CRM (Menveo) and MenB-4C (Bexsero).

MenACWY-CRM/MenB-4C is the second pentavalent meningococcal vaccine approved in the United States, following licensure of MenACWY-TT/MenB-FHbp (Penbraya; Pfizer) in 2023. Both products share the same age indication and are intended for use when MenACWY and MenB vaccines are otherwise recommended concurrently.

Evidence review of immunogenicity and safety for pentavalent meningococcal vaccines

ACIP evaluated evidence addressing 3 policy questions: use of MenACWY-CRM/MenB-4C when both MenACWY and MenB are indicated, when MenACWY alone is indicated, and when MenB alone is indicated. The committee applied the Evidence to Recommendations framework and the Grading of Recommendations, Assessment, Development, and Evaluation approach.

Critical outcomes included short-term immunity, serious adverse events, and disease caused by serogroups A, B, C, W, and Y. Important outcomes included persistence of immunity, nonserious adverse events, and potential interference with other routinely recommended vaccines.

Short-term and persistent immune responses to MenACWY-CRM/MenB-4C

Immunogenicity data were derived from 7 randomized controlled trials conducted across multiple countries, including the United States. Participants were healthy adolescents and young adults aged 10 to 25 years who had not previously received MenB vaccination.

One month after receipt of a single dose targeting serogroups A, C, W, and Y, participants who received MenACWY-CRM/MenB-4C were similarly likely to achieve seroprotective antibody titers as those who received MenACWY-CRM alone. After completion of a 2-dose MenB series administered 6 months apart, immune responses to 3 of 4 serogroup B antigens were comparable between recipients of the pentavalent vaccine and those who received MenB-4C alone.

Participants who received MenACWY-CRM/MenB-4C were less likely to have seroprotective antibody titers against the PorA antigen. The authors noted that “the clinical implications of the reduced PorA response are unknown,” citing limitations in correlates of protection and variability in circulating serogroup B strains.

Data on long-term immunity were limited. No studies evaluated persistence of immunity for serogroups A, C, W, or Y. Two years after vaccination, persistence of serogroup B antibody responses was similar between pentavalent and MenB-only recipients, though the certainty of evidence was low.

Safety profile and adverse event findings from randomized trials

Serious adverse events possibly related to vaccination were rare and occurred at similar frequencies across pentavalent and comparator groups. Among nearly 8000 participants, 6 serious adverse events were assessed as possibly related to vaccination, with no pattern suggesting increased risk associated with MenACWY-CRM/MenB-4C.

Nonserious adverse events, including injection site reactions and systemic symptoms, were more common after receipt of the pentavalent vaccine compared with MenACWY alone. Rates of nonserious adverse events were similar between recipients of the pentavalent vaccine and those receiving MenB-containing regimens.

Cost-effectiveness of pentavalent meningococcal vaccination strategies

ACIP reviewed economic modeling conducted by the CDC and GSK to assess resource use across vaccination scenarios. Use of the pentavalent vaccine in place of separate MenACWY and MenB vaccines when both were indicated at the same visit was estimated to be cost saving.

Other scenarios, such as replacing MenACWY or MenB alone, were associated with higher costs per quality-adjusted life-year gained, reinforcing ACIP’s recommendation to limit use of MenACWY-CRM/MenB-4C to situations in which both vaccine components are indicated concurrently.

ACIP recommendations for use when MenACWY and MenB are concurrently indicated

ACIP recommended that MenACWY-CRM/MenB-4C may be used when both MenACWY and MenB are indicated at the same visit for healthy persons aged 16 to 23 years when shared clinical decision-making favors MenB vaccination. The recommendation also applies to persons 10 years or older who are at increased risk for meningococcal disease, including those with functional or anatomic asplenia or persistent complement deficiencies.

Indications for MenACWY and MenB vaccination have otherwise not changed from previous guidance.

Clinical guidance on interchangeability and dosing intervals

MenB vaccines from different manufacturers are not interchangeable. When MenACWY-CRM/MenB-4C is used, all remaining MenB doses should be completed with MenB-4C. Clinicians are advised to verify vaccination history to ensure series completion with a single manufacturer.

For healthy adolescents receiving the pentavalent vaccine based on shared clinical decision-making, the MenB series should be completed with MenB-4C administered 6 months after the pentavalent dose.

Implications for meningococcal vaccination in routine and risk-based schedules

The addition of MenACWY-CRM/MenB-4C provides clinicians with a second pentavalent option for patients who are recommended to receive MenACWY and MenB vaccines at the same visit. ACIP noted that appropriate product selection and adherence to manufacturer-specific MenB schedules remain essential to ensure valid series completion.

References

1. Amin AB, Collins JP, Dong X, et al. Use of the GSK MenACWY-CRM/MenB-4C pentavalent meningococcal vaccine among persons aged ≥10 years: recommendations of the Advisory Committee on Immunization Practices - United States, 2025. MMWR Morb Mortal Wkly Rep. 2026;75(1):7-14. doi:10.15585/mmwr.mm7501a2
2. Rubis A, Schillie S. Chapter 8: meningococcal disease. In: Manual for the Surveillance of Vaccine-Preventable Diseases. CDC. 2024. https://www.cdc.gov/surv-manual/php/table-of-contents/chapter-8-meningococcal-disease.html