预防用疫苗说明书安全性有关内容的思考

doi:10.19803/j.1672-8629.2021.04.08

摘要/Abstract

摘要： 目的阐述我国预防用疫苗说明书中相关安全性内容的一般考虑,期望为疫苗研发企业和疫苗使用等相关人员提供参考和借鉴;分析疫苗说明书撰写、修订、管理和使用等方面存在问题,希望业界重视疫苗安全性相关项目的起草修订工作,共同推动我国疫苗说明书内容的完善,以利于指导疫苗的临床合理使用。结果结合目前境内疫苗临床试验和临床实践的现状和境内外相关法规的要求,分析疫苗说明书安全性信息撰写等方面尚存在的问题。明确了预防用疫苗说明书中撰写“禁忌”“注意事项”和“特殊人群”相关安全性内容的具体要求和考虑;明确了疫苗说明书中安全性部分撰写的目的不是为了限制疫苗的使用,而是为了在确保安全的前提下更好地充分发挥疫苗的有效性,更好地发挥疫苗的公共卫生价值。结论疫苗说明书的不断完善既是监管要求,又是不断丰富科学认知的过程。要改变我国疫苗说明书中安全性相关项目的撰写和修订工作存在的种种不足,需要各部门联合联动,共同努力。

关键词: 疫苗, 说明书, 禁忌, 注意事项, 特殊人群

Abstract: Objective We explaine the considerations of "contraindications" "precautions" and "special groups" in vaccine instructions , to provide reference for vaccine enterprises and vaccine users; and analyze the problems with drafting, revision, management and use of vaccine instructions, to promote the improvement of the content of vaccine instructions in China, so as to guide the rational clinical use of vaccines. Results Based on the requirements of related regulations at home and abroad, given the current clinical research on vaccines and clinical practice in China, this paper explained the considerations of "contraindications" "precautions" and "special groups" in vaccine instructions, and explained the purpose of the safety section in the vaccine instructions is not to restrict the use of the vaccine, but to give full play the vaccine public health value under controllable security. Conclusion The improvement of vaccine instructions is not only a regulatory requirement, but also a process of continuously enriching scientific cognition. In order to change the problem of safety-related items in the vaccine instructions, it is necessary for all departments to make joint efforts.

Key words: vaccine, instructions, contraindication, precaution, special groups

中图分类号:

R978.7

王远征, 刘波, 邓霞, 高晨燕, 杨焕. 预防用疫苗说明书安全性有关内容的思考[J]. 中国药物警戒, 2021, 18(4): 334-337.

WANG Yuanzheng, LIU Bo, DENG Xia, GAO Chenyan, YANG Huan. Considerations of Security Items in Vaccine Package Instructions[J]. Chinese Journal of Pharmacovigilance, 2021, 18(4): 334-337.

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