在COVID-19 mRNA疫苗接种后对不良事件的监测
Nicola P Klein1, Ned Lewis1, Kristin Goddard1
1Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California, Oakland.
JAMA
|September 3, 2021
概括
与晚期相比,COVID-19疫苗安全监测发现疫苗接种后21天内严重的健康结果没有显著增加. 对mRNA疫苗的持续监测确保了公众的持续信任,并为政策决策提供了信息.
科学领域:
- 公共卫生
- 疫苗学
- 流行病学
背景情况:
- 确保COVID-19疫苗的安全性是保持公众信任和为健康政策提供信息的首要任务.
- 强大的安全监测系统对于监测接种疫苗的人和检测潜在的不良事件至关重要.
研究的目的:
- 使用大量多样化的人口对COVID-19疫苗安全数据进行临时分析.
- 监测mRNA COVID-19疫苗接种后发生的23种严重健康结果.
- 为了比较疫苗接种后21天和晚期 (22至42天) 的特定结果的风险.
主要方法:
- 使用疫苗安全数据链接, 监测超过1000万个适合接种疫苗的人.
- 每周更新的雇员管理数据,并对所选结果进行医疗记录审查.
- 使用波桑回归方法比较风险间隔 (接种疫苗后21天) 和比较间隔 (接种疫苗后22-42天) 的严重结果发病率.
主要成果:
- 在接种疫苗后1至21天内,与22至42天后相比,选择性严重结果的发生率没有显著增加.
- 缺血性中风,尾炎和急性心肌梗塞等特定结果显示,风险和比较间隔之间的发病率没有显著差异.
- 确认过敏症的发生率很低,BNT162b2的病例为每百万4. 8例,mRNA-1273的病例为每百万5. 1例.
结论:
- 临时安全监测数据表明,mRNA COVID-19 疫苗在疫苗接种后的早期没有与监测的严重结果的显著更高发生率有关.
- 虽然一些结果的置信区间很宽,表明需要更多的数据,但目前的发现支持这些疫苗的安全性.
- 持续的安全监测对于进一步完善疫苗安全的理解和解决任何新出现的问题至关重要.
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