The new crown vaccine has national technical standards, and the effective protection period should be at least 6 months after injection

China’s new crown vaccine clinical research and development has reference to the national technical standards. The reporter learned on August 15 that the drug evaluation center of the State Food and drug administration has issued and implemented the guiding principles since the date of promulgation. The novel coronavirus novel coronavirus infection has been classified as “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 coronavirus vaccine for preventive use, the

said. In order to strengthen the guidance for clinical evaluation of new coronal vaccine and promote its marketing as soon as possible, this guiding principle is formed by referring to the characteristics of target products released by who.

it was introduced 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, public health needs, etc.

the new coronavirus vaccine needed in clinic should be used for active immunization of all susceptible population, which can prevent the occurrence of disease caused by new coronavirus infection or reduce the severity of disease. It is better to prevent the infection of new coronavirus and have long-term protection. When a new coronavirus outbreak occurs, the new coronavirus vaccine can be used together with other prevention and control measures to stop or stop the outbreak.

at present, the research and development of new crown vaccine mainly includes virus inactivated vaccine, genetic engineering recombinant vaccine, virus vector vaccine, nucleic acid vaccine, etc.

according to the drug evaluation center, 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 proposed that, in combination with safety considerations, vaccine clinical research should carry out trials in different age groups step by step. Firstly, the preliminary safety data should be obtained from adults, and the elderly clinical trial should be started after reasonable interval; minors should conduct clinical trials independently based on the safety and effectiveness results of adults and the elderly; children under 6 years old should be comprehensively considered based on the research results of other populations.

for the clinical trial of minors, we can divide them into different age subgroups and sequential penetration groups.

for the population aged 3 to 5, it should be determined by the safety and effectiveness research results of the population aged ≥ 6 years, and further comprehensive evaluation should be made in combination with the development of epidemic situation and clinical needs. If the population needs to carry out clinical trials, we should fully learn from the research results of people aged ≥ 6 years, and explore the reduction of ineffective dose and procedure.

for people under 3 years old, the exposure risk of new coronavirus is relatively low and the clinical manifestations are light, and can rely on the immune barrier established by the whole population for prevention. Meanwhile, considering the innovation and unknown risk of the new coronavirus vaccine, and considering the current risk / benefit and ethical factors, it is not recommended to enroll the population under 3 years old for clinical trial.

as an innovative vaccine, the focus of phase I clinical trial is to investigate the safety and tolerance of the vaccine, so the safety of the subjects should be considered first. In phase II clinical trials, adequate dose and procedure should be considered.

in order to ensure that the widely used new crown vaccine on the market can produce the expected effect, the drug evaluation center proposed that the protection effect of the new crown vaccine on the target population should be more than 70%, and at least 50%.

the vaccine should be able to provide protection for 1 year or more, at least for 6 months. The study of its protection durability can accumulate data through continuous human trials or animal studies after marketing.

the drug evaluation center proposed that after the vaccine was put into the market, it should continue to observe the safety and clinical protection effect under the condition of large-scale vaccination, and continue to study the protection persistence. PARRENT&CHILDREN