关键词: 重组禽流感病毒H5亚型灭活疫苗, 生产现状, 质量分析, 工艺改进

Abstract: This paper introduces the types and use of the recombinant Avian Influenza virus H5 subtype inactivated vaccine, which is mainly used for highly pathogenic Avian Influenza prevention and control, as well as the main branches of the highly pathogenic Avian Influenza epidemic strains in China. As the antigenicity of virus continues to mutate, the vaccine strain needs to be replaced, therefore, the vaccine that matches the corresponding branch must be used to achieve the desired control effect. At present, the current domestic production of recombinant Avian Influenza virus H5 subtype inactivated vaccine is that there are 10 manufacturers, 2 of them are produced by suspension cell technology, and the remaining 8 manufacturers all adopt chicken embryo technology for vaccine production. According to the situation of these products reported by the manufacturers, the compulsory immunized recombinant avian influenza virus H5 subtype trivalent inactivated vaccine (Re-6 strain +Re-7 strain +Re-8 strain), which was against the highly pathogenic avian influenza stipulated by the Ministry of agriculture from 2016 to 2017, was taken as an example in this paper. Subsequently, focusing on the safety and efficacy of the vaccine, the qualities of the 488 batches inspection data from four recombinant Avian Influenza inactivated vaccine manufacturers were analyzed. The antibody titer comparison of Re-6, Re-7 and Re-8 strain show that the geometric mean titer (GMT) of all batch vaccines is at least 1 titer above the national standard, while the antibody titer of Re-6 and Re-8 strain (GMT) are at least 2 titers above the national standard. Even though the titer of the product exceeds the national standard, the antibody level is still uneven, and the manufacturer with higher GMT of 3 components shall have 1.5 titers higher than the manufacturer with lower ones. The difference between batches of the manufacturer is still relatively significant. Although there are factors for the continuous maturation and optimization of the production process, it also indicates that the manufacturer’s production process is not very stable. The overall level of the antibody titer GMT from the 4 manufacturer in 2017 is higher than that in 2016, indicating the production process has been continuously matured and optimized and the quality of products has been further strictly controlled. The formaldehyde and bacterial endotoxin contained in the Avian Influenza inactivated vaccine in China are the direct cause of vaccine side effects. Therefore, by improving the production process, the side effects of the vaccine can be reduced by reducing the content of formaldehyde and bacterial endotoxin in the vaccine. Nucleic acid vaccine is the frontier technology of the current research and development of Avian Influenza vaccine, which is the most promising vaccine and also a hot spot in the research of Avian Influenza vaccine. In addition, universal vaccines with cross protective and broad-spectrum immunogenicity can effectively solve the problem of antigen drift, which is an important research direction of influenza vaccine at the present stage.