China : National Technical Standards on New Coronavirus Vaccine, Effective Protection Period must be at least 6 Months after Injection

The China's clinical research and development of new coronavirus vaccine has national technical standards that can be referred to. On August 15, the Drug Evaluation Center of the National Medical Products Administration issued the 'Guiding Principles for the Research and Development of New Coronavirus Vaccines (Trial)' and other guidelines, which will be implemented on the date of issuance.

Screenshot of the State Food and Drug Administration of China website

According to the Center for Drug Evaluation, since January 31, 2020, since the disease caused by the new coronavirus infection was listed as a 'public health emergency of international concern' by the World Health Organization, the international community and countries around the world have taken positive measures. Policies and incentives to encourage the development of vaccines for the prevention of new coronaviruses. In order to strengthen the guidance on the clinical evaluation of the new coronavirus vaccine and promote the launch of the new coronavirus vaccine as soon as possible, this guiding principle has been formed with reference to the characteristics of the target product issued by the WHO.

According to reports, the new coronavirus vaccine is an innovative vaccine. When considering the clinical evaluation criteria for approval for marketing, it needs to be combined with the prevailing disease epidemic situation, transmission capacity, prevention and treatment methods, and public health needs.

The new coronavirus vaccine that is clinically needed should be used for active immunization of all susceptible people. It can prevent the occurrence or reduce the severity of the disease caused by the new coronavirus infection. It is best to prevent the new coronavirus infection and have long-term protection. When a new coronavirus virus outbreak occurs, the new coronavirus vaccine can be used together with other prevention and control measures to contain or stop the outbreak.

At present, the research and development of new coronavirus vaccines mainly include virus inactivated vaccines, genetic engineering recombinant vaccines, viral vector vaccines, nucleic acid vaccines (plasmid DNA, mRNA), etc.

According to the Drug Evaluation Center, data shows that people of all ages are susceptible to the new coronavirus and require large-scale vaccination to form a herd immune barrier and block transmission. Therefore, the candidate new coronavirus vaccine is best suitable for all ages, including pregnant and lactating women; at least it should be suitable for adults, including the elderly.

The Center for Drug Evaluation proposed that, in combination with safety considerations, vaccine clinical research should be carried out in different age groups. First obtain preliminary safety data from adults, and start clinical trials for the elderly after maintaining reasonable intervals; minors need to conduct independent clinical trials based on the safety and effectiveness results of adults and the elderly; children under 6 should be based on other populations by comprehensive consideration of the research results.

For the development of clinical trials in the minor population, it may be considered to be divided into different age subgroups (for example, 12 to 17 years old, 6 to 11 years old) for sequential entry.
Regarding the population of 3 to 5 years old, it should be determined based on the safety and effectiveness research results of the population ≥ 6 years old, combined with the development of the epidemic situation and clinical needs. If this group of people needs to carry out clinical trials, they should make full use of the research results of people ≥ 6 years of age to reduce invalid doses and procedures.

For people under 3 years of age, the risk of exposure to the new coronavirus in this population is relatively low and the clinical manifestations are light, and they can rely on the immune barrier established by the entire population for prevention. At the same time, considering the innovation of the new coronavirus vaccine and the unknown risk, the current risks are comprehensively considered the benefits and ethical factors, it is not recommended to enroll people under 3 years old to carry out clinical trials.

As an innovative vaccine, the new coronavirus vaccine, the focus of Phase I clinical trials is to investigate the safety and tolerability of the vaccine, so the safety of the subjects should be considered first. In Phase II clinical trials, adequate immunization doses and immunization procedures (dose times, intervals) should be explored.

In order to ensure that the new coronavirus vaccine that is widely used on the market can produce the expected effect, the Center for Drug Evaluation has proposed that its protective effect on the target population should preferably reach more than 70%, and at least 50%.

The vaccine should preferably provide protection for 1 year or more, and at least 6 months of protection. Its protection durability research can accumulate data through continuous human trials or animal studies after the market.

The Center for Drug Evaluation has proposed that after the vaccine is marketed, the safety and clinical protection effects in the case of large-scale vaccination should continue to be observed, and the durability of protection should continue to be studied.