On the development of novel coronavirus vaccine in China

Are novel coronavirus vaccines approved for clinical research safe for China's independently developed novel coronavirus vaccines?How long before the vaccine enters the clinical study?

Question 1: What is the progress of the novel coronavirus vaccine developed in China?

Wu Yuanbin, Director of Science and Technology Department of Social Development, Ministry of Science and Technology: The scientific research team has laid out five technical routes: inactivated virus vaccine, nucleic acid vaccine, recombinant protein vaccine, adenovirus vector vaccine and attenuated influenza virus vector vaccine.At present, three vaccines have been approved to enter clinical trials, among which the adenovirus vector vaccine was the first approved to enter clinical studies, and the vaccination of the subjects in phase I clinical trials was completed by the end of March, and the volunteers in phase II clinical trials were recruited on April 9, which is the first COVID-19vaccine variety in the world to initiate phase II clinical studies.

On April 12, the State Food and Drug Administration approved the inactivated novel coronavirus vaccine jointly applied by China Institute of Biological Products and Wuhan Institute of Virology, Chinese Academy of Sciences, and entered clinical trials.On the 13th, the inactivated vaccine developed by Beijing Kexing Zhongwei Biotechnology Co., Ltd. was approved for clinical trial.

Question 2: What are the approval criteria for a vaccine to enter the clinical trial phase?

Academician Wang Junzhi, Chinese Academy of Engineering: Both newly approved vaccines are actually inactivated novel coronavirus vaccines.Inactivated vaccines are composed of complete viruses. The preparation process of inactivated vaccines requires physical and chemical methods to inactivate their pathogenicity, but also through inactivation verification, and still maintain the immunogenicity of the viruses. Candidate vaccines are prepared by purification process and other preparation processes.Vaccination of candidate vaccines into the body can stimulate the immune response of the body, produce antibodies, and achieve protective effects.

At the beginning of the epidemic, the viral strains were first isolated in China. At that time, the live viruses had to be cultured on a large scale. Through the joint defense and control mechanism, the R&D units were coordinated, and the production conditions with high biosafety established in China, namely the P3 laboratory, were utilized, so that a large number of live viruses could be cultured, which enabled our R&D to have a basic condition.Experts from all departments intervened early and guided the whole process, especially guided the enterprises to complete the necessary animal experiments before clinical treatment.After completion, there are three batches of clinical trial samples produced, which must pass the inspection of China Institute for Food and Drug Control.In this process, all materials are submitted by rolling submission at the same time, and approved according to the special approval procedure of the State Drug Administration and relevant technical requirements. The result of the approval is that the requirements for emergency approval of clinical trials are met and approved to enter clinical trials.

Question 3: Why is the research and development progress of COVID-19 vaccine in China so fast?

Wang Junzhi: Vaccine itself is a special drug for healthy people, and safety is the first.Therefore, in the process of emergency approval, we always adhere to the principle of respecting science, following laws, taking safety and effectiveness as the fundamental principle, and insisting on special affairs. In this process, many R&D steps are changed from tandem to parallel, research and review linkage, rolling submission of R&D materials, followed by review and follow-up.On the premise that the standards are not reduced, the efficiency of R&D and review is greatly improved through seamless connection.

Question 4: Is the safety of the vaccine approved for clinical trial guaranteed?

Wang Junzhi: There are strict laws, regulations and technical standards for the marketing and application of vaccines at home and abroad.Various types of vaccines have different processes, technical characteristics and requirements in preclinical research. When a vaccine enters a clinical trial, it must complete pharmaceutical research, effectiveness research and safety research.

In general, qualified vaccine samples must be produced before entering clinical trials after proving safety and effectiveness in animal experiments.For every link of vaccine research and development, the state has corresponding technical regulations that can be followed, and these regulations and technical requirements are consistent with international standards such as WHO.

Question 5: How far is the COVID-19 vaccine from universal vaccination?

Wang Junzhi: Generally speaking, clinical trials are divided into three stages, that is, three stages. The objectives and significance of the three stages are different. According to the design of R&D, the schemes are different and the time required is different.

Phase I clinical trials focus on observing the safety of use, mainly through a small number of susceptible healthy volunteers as subjects to determine the human tolerance to different doses of the vaccine and understand the results of its preliminary safety. Generally, the number of people is relatively small, all of them are tens or 100 people, which is necessary for phase I clinical trials.

Phase II clinical trial is to expand the sample size and target population, in order to further confirm the preliminary efficacy and safety results of the vaccine in the population, and determine the immunization procedure and immune dose, which must be completed in phase II clinical trial.There are hundreds of subjects in general and hundreds or more in Phase II clinical trials.It should be pointed out that Phase I and Phase II clinical trials are all conducted by healthy volunteers, which are relatively easy to recruit. According to different immunization procedures and different schemes, it takes about several months.

There are still three phase clinical trials to determine the effectiveness of the vaccine. The sample size required for phase III clinical trials is larger. For general infectious diseases, it is generally necessary to observe an epidemic cycle to determine its protection rate for susceptible populations. Its scale is thousands, some even tens of thousands of people.Generally, the final results of the phase III clinical trials are the scientific basis for the approval and marketing of vaccines.Usually it goes through these three parts.

Question 6: What is the international level of vaccine R&D in China?

Wang Junzhi: Successful vaccine research and development is the key to the fundamental success of human beings in the face of major infectious diseases. People at home and abroad look forward to it and the central government attaches great importance to it. Thousands of scientists in relevant fields all over the country have devoted their efforts to promoting the positive progress of vaccine research and development in China, which fully reflects our institutional advantages.

Up to now, the overall progress of vaccines in the five major technical directions has been smooth. Most of the nine tasks identified in the first batch have completed the preclinical research (that is, the effectiveness and safety study of animals). Most R&D teams can complete the preclinical research in April and gradually start the clinical trials. Some teams have made faster progress.It should be said that the research and development progress of the COVID-19vaccine in China is currently in the international advanced rank on the whole, and will not be slower than that abroad.