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联合疫苗的有效性、安全性及制剂问题。

Efficacy, safety, and formulation issues of the combined vaccines.

作者信息

Tafreshi Say-Yed Hesameddin

机构信息

Vaccine R&D Unit, Research and Production Complex, Pasteur Institute of Iran , Alborz, Iran.

出版信息

Expert Rev Vaccines. 2020 Oct;19(10):949-958. doi: 10.1080/14760584.2020.1843434. Epub 2020 Nov 16.

Abstract

Controlling the preventable infectious diseases is the main goal of vaccination. Among the vaccines, combined vaccines are of great importance for their social, public health, and economic values. It is stated that the combined vaccines are as efficient and safe as the monovalent vaccines. However, a concern has raised about the efficacy and safety of the combined vaccines due to the outbreaks of vaccine-preventable diseases and occurrence of serious adverse events. A retrospective literature search was conducted in the Google Scholar and PubMed databases to evaluate the efficacy and safety of the combined vaccines from 1980 to 2020 using appropriate keywords. Several studies have shown efficacy and safety issues related to the combined vaccines. Different factors contribute to the inefficacy and lack of safety in the vaccines including formulation problems, limited data in the pre-licensure studies and challenges related to imperfection of the post-licensure surveillance systems. For surmounting the mentioned obstacles, there is a need to provide new formulations of the vaccines, revise the vaccines҆ safety and efficacy acceptance standards in the pre-licensure studies, improvement of post-licensure surveillance systems, and education of healthcare staff.

摘要

控制可预防的传染病是疫苗接种的主要目标。在各类疫苗中,联合疫苗因其社会、公共卫生和经济价值而具有重要意义。据称,联合疫苗与单价疫苗一样有效且安全。然而,由于疫苗可预防疾病的爆发和严重不良事件的发生,人们对联合疫苗的有效性和安全性产生了担忧。在谷歌学术和PubMed数据库中进行了回顾性文献检索,使用适当的关键词评估1980年至2020年联合疫苗的有效性和安全性。多项研究表明了联合疫苗存在有效性和安全性问题。导致疫苗无效和缺乏安全性的因素有很多,包括配方问题、上市前研究数据有限以及与上市后监测系统不完善相关的挑战。为克服上述障碍,需要提供新的疫苗配方,在上市前研究中修订疫苗的安全性和有效性接受标准,改进上市后监测系统,并对医护人员进行教育。

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