国家免疫咨询委员会 (NACI) 关于重组流感疫苗的补充声明的摘要
Anabel Gil1, Angela Sinilaite1, Jesse Papenburg2,3,4,5
1Centre for Immunization Readiness, Public Health Agency of Canada, Ottawa, ON.
概括
复合四价流感疫苗 (RIV4) 的Supemtek是成人安全有效的选择. 它表现出与传统疫苗相比较的免疫性,并可能提供对流感A的增强保护.
科学领域:
- 疫苗学 疫苗学 疫苗学
- 免疫学 免疫学 免疫学
- 公共卫生 公共卫生
背景情况:
- 再组合蛋白技术为流感疫苗制造提供了一种新的方法,与基于蛋和细胞培养方法不同.
- 苏佩姆特克是加拿大第一个也是唯一一个被批准用于18岁及以上成年人使用的重组四价流感疫苗 (RIV4).
- 本次审查侧重于支持RIV4疗效,有效性,免疫性和安全性的证据,以及国家免疫咨询委员会 (NACI) 的建议.
研究的目的:
- 审查关于RIV4 (Supemtek) 疗效,有效性,免疫性和安全性的证据.
- 总结NACI关于Supemtek在成年人流感疫苗接种中的使用建议.
- 评估RIV4作为传统流感疫苗的替代品.
主要方法:
- 一个系统的文献综述和成人RIV4的元分析.
- 方法遵循一个预先定义的书面协议.
- 在评估证据和制定建议时,使用了NACI的基于证据的流程.
主要成果:
- 十项研究被纳入了证据综合.
- 一个RCT建议RIV4可以在50岁以上的成年人中提供更好的抗流感A疫苗,而不是以蛋为基础的疫苗.
- 来自多个RCT和市场推广后研究的数据证实Supemtek在成年人中是安全的,耐受性良好和免疫原性的.
结论:
- 公平的证据支持Supemtek在18岁及以上的成年人中的有效性,安全性和非劣质免疫性.
- NACI建议Supemtek作为年度成人疫苗接种季节性流感疫苗中的一个潜在选择.
- RIV4代表了传统的以蛋为基础的流感疫苗的安全和免疫替代品.
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