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对非活化脊髓灰质炎疫苗的安全评价
Deng Yan1, Leng Yunji1, Liu Jiawei1
1Institute of Medical Biology, Chinese Academy of Medical Sciences, Kunming, Yunnan, China.
Human vaccines & immunotherapeutics
|February 9, 2026
概括
不活化脊髓灰质炎疫苗 (sIPV) 在实际使用中显示出出色的安全性,与国家IPV相比,不良事件发生率明显较低. 这支持它在正在进行的脊髓灰质炎根除工作中的关键作用.
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:
- 脊髓灰质炎仍然是全球健康威胁,需要有效的疫苗接种策略.
- 从Sabin菌株开发非活化脊髓灰质炎疫苗 (sIPV) 的发展为预防脊髓灰质炎提供了潜在的进步.
- 营销后监测对于在现实环境中评估疫苗安全至关重要.
研究的目的:
- 评估sIPV在中国市场营销后的实际使用过程中的安全性.
- 将sIPV免疫接种后不良事件 (AEFI) 的发生率与国家IPV和其他销售疫苗进行比较.
- 评估与sIPV疫苗接种相关的AEFI的特征和结果.
主要方法:
- 追溯分析2015-2025年中国的多来源数据,包括AEFI监测系统和疫苗接种数据库.
- 使用千平方和费舍尔精确测试的sIPV和国家IPV (2018-2022) 之间的安全指标的统计比较.
- 分析AEFI发病率,时间和解决方案后管理超过5000万个sIPV剂量.
主要成果:
- 在50111746个sIPV剂量中报告了12788例AEFI病例 (每10万剂量25.52).
- 与全国IPV相比,sIPV的发烧症,接种部位红血症/胀以及接种部位硬化报告发生率明显较低.
- 与全国IPV相比,sIPV的严重AEFI发病率明显低,大多数事件发生在3天内并完全消失.
结论:
- sIPV在现实应用中表现出卓越的安全性,其特点是低AEFI率.
- 这些发现支持在中国的疫苗接种计划中继续使用sIPV,并为消除脊髓灰质炎做出贡献.
- 建议进行持续监测,以监测罕见的不良事件,并确定疫苗安全性的任何区域差异.
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