Schillie Sarah, Loehr Jamie, Chen Wilbur H, Moser Charlotte A, Cooper Gabrielle, Isenhour Cheryl, McNamara Lucy A
MMWR Morb Mortal Wkly Rep. 2024 Dec 12;73(49):1124-1128. doi: 10.15585/mmwr.mm7349a3.
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).
两种B型脑膜炎球菌疫苗已在美国获得使用许可。2024年8月，美国食品药品监督管理局（FDA）根据新的免疫原性数据，将B型脑膜炎球菌MenB-4C疫苗（Bexsero）的标签从2剂接种程序（间隔0个月和≥1个月）改为2剂接种程序（0个月和6个月），并增加了3剂接种程序（0个月、1 - 2个月和6个月）。2024年10月24日，免疫实践咨询委员会（ACIP）投票决定更新其关于MenB-4C接种间隔和程序的建议，以与FDA的新标签保持一致。ACIP建议，基于共同的临床决策，将16 - 23岁健康青少年和年轻成年人的MenB-4C 2剂系列接种间隔从0个月和≥1个月延长至0个月和6个月，并增加了一项建议，即对于≥10岁的高危人群，采用0个月、1 - 2个月和6个月接种3剂的程序。ACIP对MenB-4C的更新建议与ACIP对另一种FDA许可的B型脑膜炎球菌疫苗MenB-FHbp（Trumenba）的现有建议一致。
