Vaccine safety management:foreign experience
10.3760/cma.j.issn.1008-5734.2018.04.011
- VernacularTitle:疫苗安全管理:国外经验
- Author:
Haodong CAI
1
;
Yuqin WANG
;
Yuzhen LI
Author Information
1. 100015,首都医科大学附属北京地坛医院
- Publication Type:Journal Article
- Keywords:
Vaccines;
Safety;
Public health administration;
Adverse Drug Reaction Reporting Systems;
United States
- From:
Adverse Drug Reactions Journal
2018;20(4):296-301
- CountryChina
- Language:Chinese
-
Abstract:
Vaccination is one of the most successful public health achievements of human history. However,like any drug,no vaccine is absolutely safe. As the incidence of vaccine-preventable diseases has been effectively controlled by vaccines,the safety of vaccines inoculated in healthy people has attracted more and more attention. The United States is the earliest country to start vaccine safety management. After some major vaccine safety incidents,vaccine safety management has gradually developed and improved. Vaccine safety regulator in the United States mainly consists of 4 federal agencies:the Food and Drug Administration (FDA),the Centers for Disease Control and Prevention (CDC),the National Institutes of Health (NIH), and the Health Resources & Services Administration (HRSA). FDA is mainly responsible for pre-market registration and approval of vaccines,and supervision and inspection of vaccine manufacturers. CDC is mainly responsible for making immunization planning, monitoring of vaccine adverse reactions, and management of free vaccine projects of government. NIH is mainly responsible for vaccine research and development. HRSA is mainly responsible for vaccine accident compensation. In addition,the experience of European Medicines Agency in limitation of validity period of vaccine license and vaccine quality management and the experiences in safety management of vaccines in Canada,Britain,Australia and New Zealand, including＂cold chain＂ management,surveillance of vaccine adverse events,etc. are worthy of learning.
