ACIP recommends extending interval for two-dose series and adding three-dose series in accordance with FDA label
By Elana Gotkine HealthDay Reporter
THURSDAY, Dec. 12, 2024 (HealthDay News) — The Advisory Committee on Immunization Practices (ACIP) recommendations have been updated for the meningococcal serogroup B MenB-4C vaccine (Bexsero), in accordance with the updated U.S. Food and Drug Administration label. The updated recommendations have been published in the Dec. 12 issue of the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.
Sarah Schillie, M.D., from the CDC in Atlanta, and colleagues present the updated recommendations of the ACIP for the Bexsero MenB-4C Vaccine.
Based on new immunogenicity data, the FDA changed the label for the Bexsero MenB-4C vaccine from a two-dose schedule at intervals of zero and at least one month to a two-dose schedule at intervals of zero and six months, and added a three-dose schedule (zero, one to two, and six months) in August 2024. The authors note that ACIP voted to update its recommendations for the MenB-4C dosing interval and schedule to align with the new FDA label on Oct. 24, 2024. For healthy adolescents and young adults aged 16 to 23 years, ACIP recommends extending the interval for the two-dose series from zero and at least one month to zero and six months, based on shared clinical decision-making, and added a recommendation for the three-dose series for those aged 10 years and older at increased risk. The updated recommendations align with those of the other FDA-licensed meningococcal serogroup B vaccine, MenB-FHbp (Trumenba).
“These changes were prompted by new immunogenicity data and were not due to safety concerns,” the authors write. “This report only updates recommendations for the dosing interval and schedule for MenB-4C; other previously published meningococcal vaccination guidance remains unchanged.”
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