In the face of the novel coronavirus epidemic, a scientific research institute and a biopharmaceutical enterprise launched an emergency research and development project of novel coronavirus inactivated vaccine. The project team has established an efficient virus culture system, optimized the virus inactivation process, and adopted formaldehyde inactivation and aluminum adjuvant adsorption technology to ensure the safety and immunogenicity of the vaccine; Through multiple clinical trials, the safety and efficacy of the vaccine in different age groups have been verified, with a neutralizing antibody conversion rate of 99.6% and a protective efficacy of 79.3% after vaccination.  

The identification process is strictly carried out in accordance with the relevant regulations of the National Medical Products Administration. The identification team is composed of 11 experts in the fields of virology, immunology, clinical medicine, etc., to comprehensively review the research and development process, production technology, quality standards, clinical trial data, etc. of the vaccine. Experts unanimously agree that the vaccine development technology route is scientifically feasible, the production process is stable and controllable, the quality meets national standards, the safety and effectiveness have been fully verified, and the achievements have reached the international advanced level.  

The vaccine has been approved for market by the National Medical Products Administration, with a cumulative production and supply of over 1 billion doses. It has shown good safety and immune efficacy in large-scale vaccination in China, with an adverse reaction rate of less than 0.03%. The relevant technology has applied for 16 invention patents, including 3 PCT international patents and 1 national standard, making important contributions to the global fight against the epidemic. At the same time, it has driven the upgrading of domestic vaccine production processes and enhanced the international competitiveness of China's biopharmaceutical industry.