大流行流感疫苗研发和质量管理中一些问题的探讨

季节性流感疫苗是公认的预防流行性感冒的有力武器,主要预防人流感病毒同型变异株造成的流行和感染.而大流行流感通常由新的流感病毒亚型引起,因此,大流行流感疫苗是一种全新的预防性疫苗.比较季节性流感和大流行流感的产生原因,进而从毒种制备、生产基质、抗原含量、佐剂、免疫效果评价、质控方法、生物安全等各个方面阐述大流行流感疫苗研制中面临的技术问题,同时介绍国外在质量管理方面的技术法规.

Issues in Developing the Pandemic Influenza Vaccine and Related Regulatory Activities

The seasonal flu vaccine has been commonly recognized for it's effectiveness against the Human influenza caused by the epidemic viruses.While the pandemic influenza is the result of emergence of new virus subtype,so the pandemic influenza vaccine is different from seasonal flu vaccine.This article reviews the distinct aspects of pandemic vaccine,such as the virus strain preparation,production substrate,antigen content,adjuvant,effectiveness evaluation,quality control,bio-safety issue,as well as the regulatory activities involved.