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New Dosing Interval and Schedule for the Bexsero MenB-4C Vaccine: Updated Recommendations of the Advisory Committee on Immunization Practices - United States, October 2024.
Morbidity and Mortality Weekly Report ( IF 25.4 ) Pub Date : 2024-12-12 , DOI: 10.15585/mmwr.mm7349a3
Sarah Schillie,Jamie Loehr,Wilbur H Chen,Charlotte A Moser,Gabrielle Cooper,Cheryl Isenhour,Lucy A McNamara

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).

中文翻译:


Bexsero MenB-4C 疫苗的新给药间隔和时间表:免疫实践咨询委员会的更新建议 - 美国,2024 年 10 月。



两种 B 群脑膜炎球菌疫苗已获准在美国使用。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,将脑膜炎球菌血清型 B MenB-4C 疫苗 (Bexsero) 的标签从 2 剂方案(间隔 0 和 ≥1 个月)更改为 2 剂方案(0 和 6 个月),并增加了 3 剂方案(0、1-2 和 6 个月)。2024 年 10 月 24 日,免疫实践咨询委员会 (ACIP) 投票更新了其对 MenB-4C 给药间隔和时间表的建议,以与新的 FDA 标签保持一致。ACIP 建议根据共同的临床决策,将 16-23 岁健康青少年和年轻人的 2 剂 MenB-4C 系列接种间隔从 0 个月和 ≥1 个月延长至 0 和 6 个月,并增加了 3 剂系列的建议,对于 ≥10 岁风险较高的人群,剂量分别为 0、1-2 和 6 个月。更新的 MenB-4C 的 ACIP 建议与 FDA 批准的另一种 B 群脑膜炎球菌疫苗 MenB-FHbp (Trumenba) 的现有 ACIP 建议一致。
更新日期:2024-12-12
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