Everything you care about about the COVID-19 vaccine developed in China is here

The joint prevention and control mechanism of The State Council held press conferences on March 17 and April 14, respectively, at which authoritative experts answered questions about China's self-developed COVID-19 vaccine. Are COVID-19 vaccines approved for clinical studies safe? How long before the vaccine enters clinical study? Xinhua reporters will answer your questions based on the content of the press conference.

Q1: What is the progress of the COVID-19 vaccine in China?

Wu YuanBIN, DIRECTOR OF THE DEPARTMENT OF SOCIAL DEVELOPMENT OF THE Ministry OF Science AND Technology, SAID THAT THE 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 for clinical trials, among which the adenoviral vector vaccine has been approved for clinical trials. The subjects of phase I clinical trials were vaccinated at the end of March, and the volunteers of Phase II clinical trials began to be recruited on April 9, which is the novel coronavirus vaccine that has started phase II clinical trials worldwide.

On April 12, the National Food and Drug Administration approved an inactivated COVID-19 vaccine jointly applied by the Wuhan Institute of Biological Products of China and the Wuhan Institute of Virology of the Chinese Academy of Sciences, which has also entered clinical trials. On Friday, it also approved clinical trials of an inactivated vaccine developed by Beijing Kexing Zhongwei Biotechnology Co., LTD.

Q2. What are the approval criteria for a vaccine to enter clinical trials?

Wang Junzhi, academician of the Chinese Academy of Engineering: The two newly approved vaccines are actually inactivated vaccines against the novel coronavirus. Inactivated vaccine is composed of complete virus. The preparation process of inactivated vaccine requires physical and chemical methods to inactivate its pathogenicity, and inactivation verification, while still maintaining the immunogenicity of the virus. The candidate vaccine can be prepared through purification process and other preparation processes. Candidate vaccines inoculated into the body can stimulate the body's immune response, produce antibodies, to achieve protective effect.

At the beginning of the epidemic, China's first isolated strains, then live virus passes through mass culture, and through the zone spreading mechanism to coordinate research and development unit, the use of our country to establish the biological safety of relatively high production conditions, namely P3 laboratory, it can be a large number of cultivation of live virus, make our research and development have a basic requirement. Experts from various departments intervened early and guided the whole process, especially the enterprises to complete the necessary pre-clinical animal experiments. After completion, there will be three batches of clinical trial samples produced to pass the inspection of the China Institute for Food and Drug Control. In this process, all the materials shall be submitted on a rolling basis, and shall be examined and approved according to the special approval procedures of the State Food and Drug Administration and relevant technical requirements. The result of the examination and approval is that the requirements for emergency approval of clinical trials are met, and the application shall be approved to enter clinical trials.

Q3: Why is the development of COVID-19 vaccines in China progressing at such a fast pace?

Wang Junzhi: The vaccine itself is a kind of special medicine used for healthy people. It is safe. Therefore, in the process of emergency approval, we always adhere to the principle of respecting science, following rules, and taking safety and effectiveness as the fundamental principle. We adhere to the principle of special affairs and special affairs. In this process, many R&D steps are changed from series to parallel, research and review linkage, and R&D materials are submitted on a rolling basis, followed by review and evaluation. Under the premise that the standard is not lowered, the efficiency of research and development and the efficiency of evaluation are greatly improved through seamless connection.

Q4: Can the safety of vaccines approved for clinical trials be ensured?

Wang Junzhi: There are strict laws, regulations and technical standards for the marketing and application of vaccines at home and abroad. The process, technical characteristics and requirements of preclinical studies of various vaccines are different. Pharmaceutical studies, efficacy studies and safety studies must be completed before vaccines enter clinical trials.

In general, qualified vaccine samples must be produced and proven to be safe and effective in animal studies before they can enter clinical trials. For each link of vaccine research and development, the country has corresponding technical regulations to follow, and these regulations and technical requirements are consistent with international standards such as WHO.

Q5. How many steps are left before the COVID-19 vaccine is available for all?

Wang Junzhi: Generally speaking, clinical trials are divided into three phases, that is, three phases. The goals and significance of the three phases are different, and the time required is also different according to the design of research and development.

A key phase of clinical trial is to observe the safety of the use, mainly through a few easy feeling healthy volunteers as the subjects of different doses of the vaccine will be to determine the safety profile and understand its preliminary results, are generally in the relatively small size, are dozens of people, or about one hundred people, this is a phase of clinical trial must do.

Phase II clinical trials are to expand the sample size and target population, in order to further confirm the results of the initial efficacy and safety of the vaccine in the population, and determine the immunization procedure and dose, which must be completed in phase II clinical trials. The average number of subjects is in the hundreds, and phase II trials are in the hundreds or more. It should be pointed out that phase I and Phase II clinical trials are conducted by healthy volunteers, which are relatively easy to recruit. Depending on different immunization procedures and different protocols, it may take several months.

To truly determine the effectiveness of the vaccine, there are still phase 3 clinical trials, which require a larger sample size. For general infectious diseases, it is generally necessary to observe an epidemic cycle to determine the protection rate of the susceptible population. The scale of these trials is many thousands, and some even tens of thousands of people. The scientific basis for vaccine approval is generally the final results of phase III clinical trials. Under normal circumstances, there are three parts.

Question six: What is the status of China's vaccine research and development in the world?

Wang Junzhi: Successful vaccine research and development is the key to mankind's fundamental victory in the face of major infectious diseases. People at home and abroad are eagerly awaited, and the central government attaches great importance to it. Thousands of scientists in related fields across the country have gone all out to make positive progress in China's vaccine research and development, which fully demonstrates our institutional advantages.

So far, five technical direction vaccines are overall progress smoothly, sure of 9 task have been completed before the clinical research (that is, the study of the efficacy, safety animals, most of the work, most of the research and development team can complete preclinical studies in April, and gradually start clinical trials, some team progress faster. It should be said that the development of COVID-19 vaccine in China is currently among the most advanced in the world and will not be slower than that in other countries.