在新西兰的奥特罗亚新西兰BNT162b2 mRNA COVID-19 疫苗 (Pfizer-BioNTech) 后发生的不良事件
Muireann Walton1,2, Vadim Pletzer1,2, Thomas Teunissen1
1Ministry of Health New Zealand, 133 Molesworth Street, Wellington, 6011, New Zealand.
Drug safety
|August 9, 2023
概括
新西兰新西兰新西兰新西兰
科学领域:
- 疫苗学 疫苗学 疫苗学
- 公共卫生 公共卫生
- 流行病学 流行病学
背景情况:
- 新西兰于2021年2月启动了使用BNT162b2 mRNA COVID-19疫苗的最大免疫计划.
- 该研究的重点是符合条件的5岁及以上人口.
研究的目的:
- 调查12个特别感兴趣的不良事件 (AESI) 和BNT162b2疫苗之间的关联.
- 评估新西兰人口在初级和二级剂量后的疫苗安全性.
主要方法:
- 利用国家电子健康记录来比较观察到的AESI疫苗接种后率与历史背景率 (2014-2019).
- 计算标准化发病率 (SIR) 和风险差异,以量化疫苗接种与AESI之间的关联.
主要成果:
- 接种BNT162b2疫苗显示了与肌肉/心膜炎的统计学意义上的关联,特别是在第二剂后.
- 在第一剂后,在20-39岁的年龄组中,单个器官皮肤血管炎 (SOCV) 的SIR增加.
- 对于其他10个AESI,没有发现SIR的统计显著增加.
结论:
- 接种BNT162b2疫苗与肌肉/心膜炎显著相关,这与国际研究结果一致.
- 该疫苗与其他被调查的AESI没有联系,除了特定人口中的SOCV,这为整体疫苗安全提供了保证.
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