Wheldrake Kate, Sisnowski Jana, AHoure Michele, Anagnostou Nicholas, Almond Sara, Flood Louise
Communicable Disease Control Branch, Department for Health and Wellbeing, SA Health, Australia.
Communicable Disease Control Branch, Department for Health and Wellbeing, SA Health, Australia; Southern Adelaide Local Health Network, Australia.
Vaccine. 2025 May 22;56:127158. doi: 10.1016/j.vaccine.2025.127158. Epub 2025 May 2.
South Australia (SA)'s ongoing statewide Meningococcal B Vaccination Program (the Program) provides 4CMenB (Bexsero) to children aged six weeks to 12 months, and young people aged 15 to 17 years. This retrospective study aimed to evaluate the safety profile of 4CMenB, using routinely collected data on adverse events following immunisation (AEFI). The study population was all participants in the Program, as well as those who received 4CMenB through the National Immunisation Program (NIP), from the Program's commencement on 1 October 2018 to 30 June 2022. Information about AEFIs was collated and classified according to the Australian Product Information (PI) for 4CMenB and the internal Meningococcal B Immunisation Program Vaccine Safety Plan (the Safety Plan). The total number of 4CMenB vaccines distributed (and not subsequently discarded) during the study period for both the Program and the NIP was 437,462 vaccines. A total of 306 AEFI notifications were received during the study period, equating to a reporting rate of 69.9 notifications per 100,000 doses. Most reported AEFI were known, common, non-serious adverse events (85 % of reports), followed by serious AEFI (13 %) and suspected unexpected serious adverse reactions (SUSAR) (2 %). The most frequently reported non-serious AEFI clinical features were rash (14 %), injection site reaction (14 %), nausea/vomiting/diarrhoea (11 %) and fever (11 %). Of the serious AEFI, the most frequently reported were hypotonic-hyporesponsive events (HHE) (n = 12; 30 %), various problems requiring inpatient hospital admission (n = 10; 25 %), and high fever greater than 40 °C (n = 6; 15 %). There were five episodes of anaphylaxis or anaphylactoid reaction, four episodes of seizure and two episodes of febrile convulsion. No specific new safety signal was ascertained from review of serious AEFI and SUSAR. A high proportion (83 %) of children under two years with reported AEFI were administered prophylactic acetaminophen. Our findings from prolonged, population-based analysis of AEFI complement the existing safety data on the 4CMenB vaccine and may be used to inform the implementation of 4CMenB vaccination programs at scale in other jurisdictions.
南澳大利亚州（SA）正在进行的全州范围的B型脑膜炎球菌疫苗接种计划（该计划）为6周龄至12个月龄的儿童以及15至17岁的青少年提供4CMenB（Bexsero）疫苗。这项回顾性研究旨在利用常规收集的免疫接种后不良事件（AEFI）数据，评估4CMenB疫苗的安全性。研究人群包括该计划的所有参与者，以及从2018年10月1日该计划启动至2022年6月30日期间通过国家免疫计划（NIP）接种4CMenB疫苗的人群。根据澳大利亚4CMenB产品信息（PI）和内部B型脑膜炎球菌疫苗接种计划疫苗安全计划（安全计划），对AEFI信息进行了整理和分类。在研究期间，该计划和NIP分发（且未随后丢弃）的4CMenB疫苗总数为437,462剂。在研究期间共收到306份AEFI报告，报告率为每10万剂69.9份报告。大多数报告的AEFI是已知的、常见的、非严重不良事件（占报告的85%），其次是严重AEFI（13%）和疑似意外严重不良反应（SUSAR）（2%）。最常报告的非严重AEFI临床特征为皮疹（14%）、注射部位反应（14%）、恶心/呕吐/腹泻（11%）和发热（11%）。在严重AEFI中，最常报告的是低张性低反应事件（HHE）（n = 12；30%）、各种需要住院治疗的问题（n = 10；25%）以及体温高于40°C的高热（n = 6；15%）。有5次过敏反应或类过敏反应发作、4次癫痫发作和2次热性惊厥发作。通过对严重AEFI和SUSAR的审查，未确定任何特定的新安全信号。报告AEFI的2岁以下儿童中，很大一部分（83%）接受了预防性对乙酰氨基酚治疗。我们通过对AEFI进行长期的基于人群的分析得出的结果补充了4CMenB疫苗现有的安全性数据，可用于为其他司法管辖区大规模实施4CMenB疫苗接种计划提供参考。
