中国免疫规划在过去的数十年中已取得了众多瞩目的成就,但依然面临着持续的挑战。近年来,各地疫苗安全事件不时发生,尤以第二类疫苗为甚。文章分析了其中的原因,如疫苗供应制度设计存在缺陷、监管不力、冷链管理存在薄弱环节、疫苗接种单位设立不规范、多联疫苗开发不足、免疫预防违法成本低、司法救济制度缺失等,提出了制定《中华人民共和国人体免疫预防法》,确立我国免疫预防的基本法律规范,将免疫预防纳入的科学化、制度化、规范化和法制化管理轨道等建议。 China’s immunization program has made remarkable achievements in the past few decades but it still faces ongoing challenges. In recent years, vaccine safety incidents have taken place from time to time, especially in the second type of vaccine. The article analyzes the reasons, such as the deficiencies of vaccine supply system design, ineffective supervision, weak links in cold chain management, the establishment of vaccination units is not standardized, lack of development of polyvalent vaccines, low immunization prevention costs, the lack of judicial relief system, Put forward the formulation of “the People’s Republic of China on Prevention of Human Immunity,” the establishment of the basic laws and regulations of China’s immunoprophylaxis, immunization prevention included in the scientific, institutionalized, standardized and legalized management track and other recommendations.