About the new crown vaccine developed in China, all your concerns are here

Source: Pharmaceutical Network

The joint defense and joint control mechanism of the State Council held press conferences on March 17 and April 14, respectively. Authoritative experts answered relevant information about the new coronavirus vaccine independently developed by China. Is it safe to obtain a new coronavirus vaccine for clinical research approval? How long will it take for the vaccine to enter clinical research? Xinhua News Agency reporters sorted out and answered your concerns according to the content of the press conference.

Question 1: Where has the new crown vaccine developed in China progressed?

Wu Yuanbin, Director of the Department of Social Development Science and Technology of the Ministry of Science and Technology: The scientific research team has arranged five technical routes such as 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, of which the first adenoviral vector vaccine is approved for clinical research. The vaccination of the first phase of clinical trials has been completed at the end of March, and recruitment began on April 9. Volunteers in Phase II clinical trials, this is the world's first new crown vaccine variety to initiate Phase II clinical studies.

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

Question 2: What are the approval criteria for vaccines to enter clinical trials?

Wang Junzhi, academician of the Chinese Academy of Engineering: The two newly approved vaccines actually belong to the inactivated new coronavirus vaccine. The inactivated vaccine is composed of a complete virus. The process of its preparation must be inactivated by physical and chemical methods. It must also be verified by inactivation, and it still maintains the immunogenicity of the virus. It is prepared through purification processes and other preparation processes. Candidate vaccine. Candidate vaccination into the body can stimulate the body's immune response, produce antibodies, and achieve protection.

At the beginning of the epidemic, the earliest virus strains were isolated in China. At that time, live viruses had to be cultivated on a large scale, and the R & D units should be coordinated through the joint prevention and control mechanism, and the production conditions established in China with relatively high biological safety, that is, P3 laboratories, can be Cultivating live viruses will make our research and development a basic condition. Experts from various departments intervened early and guided the whole process, especially guiding enterprises to complete the necessary pre-clinical animal experiments. After the completion, there are three batches of samples for clinical trials that have to pass the inspection by the China Food and Drug Administration. In this process, all the materials are submitted by rolling submission at the same time, according to the special approval procedures of the State Food and Drug Administration, and in accordance with the relevant technical requirements for approval. The result of the approval is that it meets the requirements for emergency approval of clinical trials and is approved to enter clinical trials. .

Question 3: Why is the research and development progress of China's new crown vaccine so fast?

Wang Junzhi: The vaccine itself is a special medicine for healthy people, and safety is the first priority. Therefore, in the emergency approval process, we always adhere to the principle of respecting science, following the rules, taking safety and effectiveness as the fundamental policy, and adhering to special tasks. In this process, many R & D steps are changed from serial to parallel, research and review linkage, and rolling submission of R & D Materials, follow up with review and evaluation. On the premise of not lowering the standards, through seamless connection, the efficiency of research and development and the efficiency of review are greatly improved.

Question 4: Can the safety of vaccines approved for clinical trials be guaranteed?

 Wang Junzhi: There are strict laws, regulations and technical standards for the market application of vaccines at home and abroad. The preclinical research process, technical characteristics and requirements of various types of vaccines are different. In the clinical trials of vaccines, pharmaceutical research, efficacy research and safety research must be completed.

In general, qualified vaccine samples must first be produced and proven safe and effective in animal experiments before they can enter clinical trials. The country has corresponding technical regulations for each link of vaccine research and development. These regulations and technical requirements are consistent with international standards such as WHO.

Question 5: How close is the new crown vaccine from universal vaccination?

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

The focus of the first phase of clinical trials is to observe the safety of use, mainly to determine the tolerance of the human body to different doses of the vaccine and understand its preliminary safety results through a small number of susceptible healthy volunteers as subjects, generally the relative number of people They are relatively small, with dozens or a hundred people. This is a phase one clinical trial that must be done.

The second-phase clinical trial is to expand the sample size and target population. The purpose is to further confirm the preliminary effectiveness and safety of the vaccine in the population, and to determine the immunization procedure and immunization dose. This is necessary in the second-phase clinical trial. Done. Generally, the number of subjects is hundreds, and the second-phase clinical trials are hundreds or more. It should be noted that the Phase I and Phase II clinical trials are conducted by healthy volunteers, which are relatively easy to recruit. Depending on the immunization procedures and different protocols, it may take several months.

There are three phases of clinical trials to really determine the effectiveness of the vaccine. The third phase requires a larger sample size. For general infectious diseases, it is generally necessary to observe an epidemic cycle to determine its protection rate for susceptible people. Its scale is Thousands, some even tens of thousands. It is generally the scientific basis for the approval of the vaccine to obtain the final results of the phase III clinical trials. Under normal circumstances to go through these three parts.

Question 6: What is the international level of vaccine research and development in China?

Wang Junzhi: The successful research and development of vaccines is the key to the fundamental victory of mankind in the face of major infectious diseases. The people at home and abroad are looking forward to it. The central government attaches great importance to it. Progress has fully demonstrated our institutional advantages.

Up to now, the vaccines of the five major technical directions have generally been progressing smoothly. The first nine tasks identified have completed most of the preclinical research (that is, animal efficacy and safety studies). Most of the R & D teams have Can complete pre-clinical research, and gradually start clinical trials, and some teams progress faster. It should be said that the progress of China's new crown vaccine research and development is currently at the forefront of the world, and it will not be slower than abroad.