New crown vaccine related national technical standards released

According to this website, the drug evaluation center of the State Drug Administration has recently issued five guiding principles, which shall be implemented from the date of promulgation. These guidelines provide reference national technical standards for clinical research and development of new coronal vaccine in China.

novel coronavirus novel coronavirus infection is known as a “public health emergencies of international concern” since January 31, 2020. The international community and the rest of the world are adopting positive policies and incentives to encourage the development of new vaccines for the prevention of coronavirus. In order to strengthen the guidance of clinical evaluation of new coronal vaccine and promote the launch of new crown vaccine as soon as possible, these guiding principles are formed by referring to the characteristics of target products released by who. According to the current research and development of
recombinant vaccines and vaccines, the main types include viral vaccines and inactivated vaccines. Data show that all age groups are susceptible to NCV, and mass vaccination is needed to form a population immune barrier and block transmission. Therefore, the candidate vaccine should be suitable for all ages, including pregnant and lactating women; at least, it should be suitable for adults, including the elderly.

the drug evaluation center believes that, as an innovative vaccine, when considering the approval of clinical evaluation criteria for marketing, comprehensive consideration should be given to the epidemic situation, transmission capacity, prevention and treatment means, and public health needs at that time.

vaccine is a special drug for healthy people to prevent diseases, so the safety of vaccine itself should be the most basic bottom line, which usually needs to be observed in large-scale clinical trials. Under the background of global epidemic situation, on the one hand, new coronal vaccine needs rapid research and development of various technical routes, on the other hand, because of the expectation of universal vaccination, it needs clear clinical safety and effectiveness evidence.

the guiding principle is clear. In order to speed up the development and marketing process of the new crown vaccine, it is allowed to enter the phase III clinical trial before determining the most appropriate immunization procedure and dose. We can consider changing the immune program during the phase III clinical trial or optimizing it after marketing. The protective effect of new coronal vaccine should be evaluated by phase III clinical protective efficacy test. At the same time, the safety risk of vaccine products and the risk of vaccination should be evaluated. If the vaccine has sufficient protective effect and acceptable safety, it is qualified to be approved for marketing. After the vaccine comes into market, we should continue to observe the safety and clinical protection effect under the condition of large-scale vaccination, and continue to study the protection persistence.

in addition, with the deepening of research, the awareness of diseases and pathogens is increasing and improving, and the guiding principles will continue to be improved and timely updated. 20