New Dosing Interval and Schedule for the Bexsero MenB-4C Vaccine: Updated Recommendations of the Advisory Committee on Immunization Practices - United States, October 2024.

Abstract

Two meningococcal serogroup B vaccines are licensed for use in the United States. In August 2024, the Food and Drug Administration (FDA) changed the label for the meningococcal serogroup B MenB-4C vaccine (Bexsero) from a 2-dose schedule (intervals of 0 and ≥1 month) to a 2-dose schedule (0 and 6 months) and added a 3-dose schedule (0, 1-2, and 6 months), based on new immunogenicity data. On October 24, 2024, the Advisory Committee on Immunization Practices (ACIP) voted to update its recommendations for the MenB-4C dosing interval and schedule to align with the new FDA label. ACIP recommends extending the interval for the 2-dose series of MenB-4C from 0 and ≥1 month to 0 and 6 months for healthy adolescents and young adults aged 16-23 years based on shared clinical decision-making and has added a recommendation for a 3-dose series with doses administered at 0, 1-2, and 6 months for persons aged ≥10 years at increased risk. The updated ACIP recommendations for MenB-4C align with existing ACIP recommendations for the other FDA-licensed meningococcal serogroup B vaccine, MenB-FHbp (Trumenba).