The new coronavirus vaccine is the ultimate weapon against the epidemic and is highly anticipated. How is the development of our new coronavirus vaccine progressing? Is the safety guaranteed? When will it be ready for use? To address these questions, relevant institutions and experts have recently answered your questions.
With the global pandemic of New Coronavirus, the vaccine has become the ultimate anti-epidemic weapon expected by the public. At present, three new crown vaccines have been opened for clinical trials in China, and the progress of new crown vaccine development is in the international advanced ranks.
5 lines in parallel.
3 vaccines opened clinical trials
Wu Yuanbin, director of the Department of Social Development Science and Technology of the Ministry of Science and Technology, introduced the new crown pneumonia epidemic at the beginning, the scientific research and development group will be one of the main directions of vaccine development. In order to enhance the success rate of vaccine development to a greater extent, after sorting out and analyzing different technical bases and possibilities, they laid out five technical lines, namely inactivated virus vaccine, nucleic acid vaccine, recombinant protein vaccine, adenovirus vector vaccine, and attenuated influenza virus vector vaccine; at the same time, a special vaccine R&D team was set up to strengthen the relevant organizational coordination, as well as the corresponding scientific research institutions to collaborate and work overtime, striving to carry out Vaccine research and development.
What is the current progress of China's new crown vaccine development? In this regard, Wu Yuanbin revealed, "At present, three vaccines have been approved to enter clinical trials in China."
These three vaccines are the adenovirus vector vaccine of Chen Wei's academician team, Wuhan and Beijing's two inactivated vaccines. Among them, Chen Wei academician team of adenovirus vector vaccine the first approved to enter clinical research, has completed a phase I clinical trial subjects inoculation at the end of March, and April 9 began recruiting volunteers for the second phase of clinical trials, which is to start the second phase of clinical research of the new crown vaccine varieties. In addition, the State Drug Administration has recently approved two inactivated vaccines to enter clinical trials.
"At present, of the five routes, in addition to the adenovirus vector vaccine and inactivated vaccine that have entered clinical trials, the vaccines of the other three technical routes are also being accelerated." Wu Yuanbin revealed that the attenuated influenza virus vector vaccine has completed the construction of the vaccine strain and the establishment of quality control methods, and is carrying out quality process research and quality identification, while pilot production, animal attack experiments and safety evaluation experiments are also being carried out at the same time. The recombinant protein vaccine has completed virulent strain construction, and is conducting cell and virulent strain identification and genetic stability investigation, animal attack experiments and safety evaluation experiments. The nucleic acid vaccine has also entered the stage of animal efficacy and safety evaluation, and the preparation of clinical samples and quality verification work are being carried out simultaneously.
According to the preliminary analysis and arrangement of the Ministry of Science and Technology, the vaccines of the above technical lines are expected to be declared for clinical trials one after another in April and May. Vaccine emergency approval, how to ensure safety? Three new coronavirus vaccines entered clinical trials through emergency approval, can safety be guaranteed at such a fast pace?
"Vaccines are special drugs used for healthy people, and safety is the first priority." Wang Junzhi, an academician of the Chinese Academy of Engineering, introduced that in the emergency approval process, China always adheres to the policy of respecting science, following the law, and taking safety and effectiveness as fundamental, and insists on special cases, in which many R&D steps are changed from tandem to parallel, research and review are linked, and R&D materials are submitted on a rolling basis, and are reviewed and evaluated as they are delivered; on the premise that the standards are not lowered, the efficiency of R&D and review are greatly improved through seamless integration Efficiency.
"The safety of vaccines is mainly determined by preclinical studies, so our new crown vaccine in terms of safety, efficacy and other related animal experiments, to be completed in accordance with relevant regulations and technical requirements." Wang Junzhi introduced that this includes acute toxicity experiments, repeated toxicity experiments, immunogenicity experiments and even animal attack toxicity protection tests. All these experiments must meet the requirements and meet the required standards before approval on the clinical. "To fully ensure the safety of subjects after going to the clinic, this is our goal."
In addition, the two vaccines newly approved to enter the clinical trial stage are both inactivated New Coronavirus vaccines. Inactivated vaccines are composed of complete viruses, which have to be inactivated in the preparation process by physicochemical methods to inactivate their pathogenicity, and also by inactivation verification, and still maintain the immunogenicity of the virus, and prepare the vaccine candidates through the preparation process such as purification process. The organism is vaccinated with the candidate vaccine to stimulate the immune response and produce antibodies to achieve protection.
Inactivated vaccine is a mature technology route, China's inactivated vaccine R & D preparation base is better, has successfully developed and prepared inactivated H1N1 influenza vaccine, inactivated hepatitis A vaccine, inactivated EV71 hand, foot and mouth disease vaccine, Sabin strain IPV polio vaccine and many other inactivated vaccines.
Wang Junzhi introduced, the new inactivated vaccine preparation process of the new coronavirus, is China isolated to the virus strains; and live virus to go through large-scale culture, China through the joint prevention and control mechanism to coordinate R & D units, the use of P3 laboratory mass culture of live virus, so that R & D has the basic conditions; early intervention of experts from various departments, the whole guidance, especially to guide enterprises to complete the necessary pre-clinical animal experiments; production of three batches of clinical trial samples, all of which had to be tested and qualified by the China Academy of Food and Drug Administration; the declaration materials were submitted on a rolling basis, approved in accordance with the special approval procedures of the State Drug Administration and in compliance with the relevant technical requirements, and met the requirements for emergency approval of clinical trials and were approved to enter clinical trials.
"Even in emergency situations, the evaluation standards for vaccine safety and efficacy throughout the review process cannot be lowered." Wang Junzhi said. How long does a phase III clinical trial take? When will the vaccine be available?
When will the new coronavirus vaccine be available for use? Wu Yuanbin said that the R&D work needs to adhere to the basic premise of science, safety and effectiveness, as this is a special product for healthy people. Therefore, despite the fact that vaccine R&D is an emergency project, special emphasis is placed on science and procedure.
At present, the fastest developed adenovirus vector vaccine in China has already started phase II clinical trials, and after that, phase III clinical trials will be conducted, which will be based on the results of clinical trials before the final determination of whether to put it into use. The two inactivated vaccines just recently approved for clinical trials are traditional technology processes, with relatively mature production processes, controllable quality standards and a wide range of protection, and have internationally accepted standards for judging safety and efficacy, which will also provide conditions for accelerating the use of vaccines.
From clinical trials to market, vaccines need to go through the test of phase III clinical trials. So what is the process of Phase III clinical trials? Roughly how long does it take?
"Generally speaking, a typical clinical trial is divided into three phases, that is, three stages. These three phases have different objectives and meanings, and take different amounts of time depending on the design plan for research and development, but they must be carried out in compliance with the Code for Quality Management of Drug Clinical Trials. For example, comply with the regulations related to informed consent of subjects and so on." Wang Junzhi introduced.
Among them, 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, as well as to understand the results of its preliminary safety. This phase generally has a relatively small population size of tens or 100 or so.
Phase II is the expansion of the sample size and target population to further confirm the initial efficacy and safety results in the population and to determine the immunization schedule and dose. This phase typically involves hundreds or more subjects.
"It should be noted that Phase I and Phase II clinical trials are done by healthy volunteers, which are relatively easy to recruit and take about a few months depending on the different immunization procedures and protocols." Wang Junzhi said.
To really determine the effectiveness of the vaccine, it is in phase III clinical trials. For infectious diseases, an epidemic cycle generally needs to be observed to determine its rate of protection for susceptible people. Phase III clinics require much larger sample sizes, which are in the thousands, and in some cases, tens of thousands of people. The scientific basis for the approval of the vaccine for the market can only be obtained after the phase III clinic is completed.
Wang Junzhi said, "At present, the society is highly concerned about vaccines, and we are looking forward to seeing breakthroughs in China's vaccine research and development as soon as possible, so that a safe and effective vaccine can be marketed as soon as possible."
