Vaccine preparedness for influenza pandemic: global influenza vaccine strain updates and regulatory system
10.3760/cma.j.cn112309-20240504-00159
- VernacularTitle:应对流感流行的疫苗准备：全球流感疫苗株更新机制和监管体系
- Author:
Yang PAN
1
;
Shuang LU
Author Information
1. 国家药品监督管理局药品审评中心生物制品临床部，北京 100076
- Keywords:
Influenza;
Influenza vaccine;
Vaccine strain;
Regulation
- From:
Chinese Journal of Microbiology and Immunology
2024;44(11):978-984
- CountryChina
- Language:Chinese
-
Abstract:
Influenza is one of the most common respiratory infectious diseases worldwide, and vaccination against influenza is the most effective means of prevention and control. Due to the antigenic drift of influenza viruses, the World Health Organization (WHO) recommends the vaccine strains for the next influenza season based on global surveillance data. This guidance informs the industry′s vaccine production efforts. Based on the vaccine recommendation issued by the WHO, regulatory authorities in various countries, including China, have formulated corresponding regulatory requirements to ensure the safety, effectiveness, and quality of vaccines. This review summarizes the regular vaccine recommendation mechanisms for seasonal influenza, the regulatory requirements and typical pathways of some national regulatory authorities, the selection of vaccines during influenza pandemics, and the regulatory authorities′ response experiences. Besides, the current challenges and the future of development are discussed in this article, aiming to provide reference for the research, development, and regulation of influenza vaccines and other similar vaccines in the future.
