How to ensure vaccine safety: An evaluation of China’s vaccine regulation system

Abstract

Vaccination is the most economic and effective measure to deal with infectious diseases and protect public health. Nowadays, due to the spread of COVID-19 and the ensuing pandemic, safe, effective vaccines are in urgent need. However, due to concerns about vaccine safety, there is still reluctance to vaccinate. In China, in response to the Changchun Changsheng Vaccine incident, the National People’s Congress Standing Committee passed the Vaccine Administration Law in 2019, which marks China’s first comprehensive piece of legislation on vaccine regulation. The law establishes a regulatory system covering the entire life cycle of vaccines, introduces the vaccine marketing authorization holder system, stipulates the legal responsibilities of all parties, and further clarifies the compensation system for any individuals who exhibit abnormal reactions to vaccination. In addition, it emphasizes the use of modern technology to build a national vaccine electronic platform for tracing. To balance vaccine efficacy and safety, it is necessary to further improve the vaccine risk management mechanism, promote cooperation between government and non-governmental actors, and avoid improper interventions in the vaccine market.