Notice of the General Office of the Ministry of Agriculture on Adjusting the Viruses of Highly Pathogenic Avian Influenza Vaccines

　　In order to improve the matching between the vaccine and epidemic strains and better prevent and control avian influenza, after research, our department decided to adjust the production of highly pathogenic avian influenza vaccine. The relevant matters are hereby notified as follows.

　　First, the vaccine variety.After adjustment, the vaccines are bivalent inactivated vaccine (Re-6 strain +Re-8 strain) and trivalent inactivated vaccine (Re-6 strain +Re-7 strain +Re-8 strain) of recombinant avian influenza virus H5 subtype, which are used to prevent avian influenza caused by H5 subtype avian influenza virus.

　　Second, seed poison distribution and filing.Before December 18, 2015, the National Avian Influenza Reference Laboratory organized the distribution of Re-8 strains of seed viruses, and sent 5 strains of Re-8 strains of seed viruses to the National Microbial Virus Collection Center for filing, and provided the seed virus identification report. The national center for the preservation of microbial strains should do a good job of preservation in strict accordance with relevant state regulations.

　　Third, the production and inspection of vaccines.After receiving the seed virus, the highly pathogenic avian influenza vaccine production enterprises should organize production and inspection activities in accordance with the relevant provisions on veterinary drug management and the product production inspection regulations and quality standards issued by our department, and send three batches of samples of trivalent inactivated recombinant avian influenza virus H5 subtype (Re-6 strains +Re-7 strains +Re-8 strains) to China Veterinary Drug Supervision Institute for efficacy inspection. Self-inspection of enterprises and inspection by China Veterinary Drug Control Institute are carried out simultaneously. Only after passing the inspection by China Veterinary Drug Control Institute can the batch be issued.

　　Fourth, the vaccine was discontinued and used.Since January 1st, 2016, vaccine manufacturers stopped producing bivalent inactivated vaccine of H5 subtype of recombinant avian influenza virus (Re-6 strain +Re-7 strain) and inactivated vaccine of recombinant avian influenza virus (Re-6 strain of H5N1 subtype), except for products exclusively for export. The products previously produced can continue to be sold and used within the product validity period.

　　5. Approval number of veterinary drug products.All production enterprises shall declare the approval number of veterinary drug products as soon as possible in accordance with the relevant provisions of the Measures for the Administration of Approval Number of Veterinary Drug Products.

　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　 General office of agriculture department

　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　 　 December 10, 2015