China's new crown vaccine research and development leads the world
Written and written by: Reporter Zhang Jiaxing Planning: Liu Li
At the opening speech of the 73rd World Health Assembly video conference at the opening meeting of the 73rd World Health Assembly on May 18, President Xi Jinping announced that after the completion of the development and use of the new Chinese crown vaccine, it will be used as a global public product to achieve vaccine accessibility in developing countries. And contribute to China’s contribution.
This solemn commitment to the world's attention-
Can China's new crown vaccine become the ultimate weapon against the new crown virus? When will China's new crown vaccine get to the front line in the new crown pneumonia outbreak battle?
From the central government to scientists and scientific research organizers, the research and development of China's new crown vaccine always adheres to people first, life first, scientific deployment, and race against viruses.
"The most important sign of vaccine success is safety, effectiveness and accessibility." Wang Zhigang, Minister of Science and Technology, pointed out that in the entire vaccine development process, China's new crown vaccine research and development always adhere to the importance of safety, effectiveness and accessibility. Position and insist on international cooperation.
Academician Wang Junzhi of the Chinese Academy of Engineering said that the successful development of vaccines is the key to the human's fundamental victory in the face of major infectious diseases. The people at home and abroad are eagerly awaiting. The central government attaches great importance to it. Thousands of scientists in related fields from all over the country go all out. Strictly follow the relevant laws and technical requirements, on the one hand, make every effort to compete against time, on the one hand, adhere to the scientific law, on the premise of ensuring the safety and effectiveness of vaccines, accelerate the application of vaccine research.
As of July 2, the World Health Organization (WHO) official website statistics show that the number of candidate vaccines currently approved for clinical trials has reached 18, of which 7 are from China. Whether it is the first in the world to publish the effective evaluation results of live vaccines in non-human primate models, or to publish the human clinical data of the world's first new crown vaccine, China's vaccine research and development work is leading the world.
Practice President Xi Jinping's solemn promise that the Chinese New Crown Vaccine will "sword" in front of the new enemy's common enemy, the New Crown Virus, and write the "Chinese answer sheet" of people first and life first with "safe, effective and accessible", with rigorous scientific practice Give a clear answer to China's new crown vaccine "OK"!
Decades of accumulation of scientific and technological innovations: order a thousand troops to compete
On March 2nd, General Secretary Xi Jinping pointed out that the vaccine, as a special product for healthy people, is very important for the prevention and control of the epidemic, and the safety requirements are also the first. It is necessary to accelerate the development of vaccines for various existing technical routes, and at the same time closely follow the progress of foreign research and development, strengthen cooperation, and strive to promote the clinical trials and marketing of vaccines as soon as possible.
Under the leadership of the Central Leading Group for Epidemic Response Work, the State Council has established a scientific research team with 12 departments including the Ministry of Science and Technology and the National Health and Health Commission to respond to the epidemic joint prevention and control mechanism. According to the request of Vice Premier Liu He of the State Council, scientific research The group established 10 key work special classes and 2 research groups, including vaccine special classes.
The sound of the "starting gun" running against the virus is still in my ears.
"The scientific research team takes the research and development of vaccines as the top priority, and has laid out five technical routes to advance simultaneously. The National Science and Technology Plan focuses on supporting 12 vaccine research and development tasks." said Wu Yuanbin, director of the Department of Social Development and Technology of the Ministry of Science and Technology. There are five main technical routes for the development of new crown vaccines in my country, including inactivated vaccines, genetically engineered subunit vaccines (recombinant protein vaccines), adenovirus vector vaccines, nucleic acid vaccines based on mRNA and DNA, and attenuated influenza virus vector vaccines.
On January 22, the Ministry of Science and Technology's "New Coronavirus Infected Pneumonia Outbreak Technology Response" first batch of emergency research projects was launched, and rapid realization of vaccine research and development is one of the important tasks.
At a critical moment when public health emergencies are coming, why can China's vaccine R&D and deployment be able to "make a single order and compete with thousands of soldiers"?
Yang Xiaoming, Chairman of Sinopharm Group, said: "Over the past decade or so, national scientific and technological investment and accumulation have made China's vaccine research and development technology, platform, and system gradually be in line with international standards. Vaccine development from R&D to production is a long chain. China's institutional advantages will be Consolidate the strengths of all parties to minimize the process under the premise of safety and effectiveness."
"Vaccines need to be produced on a large scale. No matter how good the vaccine is, it cannot be widely used, and it is difficult to form an immune protection barrier for the population." Yang Xiaoming said, with the support of the National 863 Program and Science and Technology Support Program, " During the tenth five-year plan, the eleventh five-year plan, and the twelfth five-year plan, various professional research institutes and professional certification institutions, including state-owned enterprises, private enterprises, and universities, including China Biotechnology, have formed comprehensive vaccine technology research and development Large platform system.
Come prepared. Due to past innovation and accumulation, each Chinese team involved in R&D has its own "diamond diamond".
Zhang Linqi, a professor at Tsinghua University School of Medicine, said that each company has its own high-level recruits and will choose a good partner to join in the vaccine development work based on the previous technology platform and accumulation of each laboratory.
"We have selected 5 vaccine technical routes, and each technical route has 2 to 3 teams for R&D." Lu Shan, the project specialist of the vaccine R&D team and the deputy director of the China Biotechnology Development Center, said that 5 were supported in emergency research Among the 12 technical routes, each technical route is formed by multiple units, from enterprises to universities, scientific research institutes to high-level biosecurity laboratories, Academy of Military Medical Sciences, Chinese Academy of Sciences, Chinese Academy of Medical Sciences, National top academic institutions such as China Center for Disease Control, Tsinghua University, Sichuan University, Fudan University and high-tech enterprises in the field of life sciences have fully invested in the "fight" to start R&D work around the clock.
After the establishment of the first batch of emergency research projects, after a few days of preparation and exploration, the scientific research team needs to give a back-to-back time at the internal meetings at the end of January and early February: when will your vaccine be submitted to the clinic? Test application.
It is absolutely high speed to develop a brand new virus vaccine in about half a year and push it into the clinical trial stage. However, most teams only gave themselves less than 3 months, with the end of April as the deadline.
The discussion about "when there will be a vaccine" is still one after another, but Lin Yuan envy the fish and withdraw from the battle has never been in the dictionary of Chinese scientific researchers. They know that the discussion will not produce results, and only work hard!
After the outbreak of the New Coronary Pneumonia epidemic, military medical experts made up of troops transferred to Wuhan on January 26 went to Wuhan to carry out scientific research. Chen Wei, academician of the Chinese Academy of Engineering and researcher of the Academy of Military Medical Sciences, is one of them.
"I came to Wuhan at the time, made the worst plan, the most adequate plan, and prepared to fight for the longest time." Chen Wei said.
On the basis of the world's first Ebola vaccine, Academician Chen Wei's team continued to promote the development of a new coronavirus adenovirus vector vaccine independently developed by my country in the field of anti-epidemic.
The mastery of cutting-edge vaccine development technology has greatly accelerated the vaccine development process. In response to the new coronavirus, our vaccine research and development team is courageous and "swordsman". On the basis of rigorous and sufficient preclinical research, the recombinant new corona vaccine successfully passed the clinical research registration review. On March 16, the first clinical trial of the world's first new crown vaccine was launched, and 108 healthy adults were successively injected with the world's first new crown vaccine. On April 12, the Phase II clinical trial was launched, which was the only new crown vaccine that entered the Phase II clinical trial in the world at that time.
In response to the new coronary pneumonia epidemic, the Sinopharm Zhongsheng team quickly innovated ideas and raced against the virus. On the one hand, the team constantly detects whether different virus strains are excellent and high-yield, and quickly builds a virus stock; on the other hand, it studies in parallel a large number of process parameters such as inactivation processes and conditions, subsequent purification processes, formulated adjuvants, and vaccine dosage forms.
"On the evaluation of the safety and effectiveness of inactivated vaccines in animals, the research team used nearly 7 animals, including two kinds of monkeys, three kinds of mice, as well as rabbits and guinea pigs, for immunization. Originality and safety tests." Yang Xiaoming told reporters from Science and Technology Daily that only through strict production techniques, testing techniques, and quality control techniques can we produce safe and effective vaccines for public use.
The epidemic of the new coronary pneumonia raged, and the concept of "only counting people's health accounts" urged the development of inactivated vaccines to speed up without reducing procedures and standards. All preclinical data are recorded. Due to the sufficient and good research data, on April 12, the world’s first inactivated vaccine was approved for phase I/II clinical trials, which will greatly speed up its market progress.
The vaccine research and development team of Beijing Kexing Zhongwei Biotechnology Co., Ltd. spent an extraordinary Spring Festival. They formally launched a new coronavirus vaccine development project called "Operation Crown" on January 28, and entered Zhejiang on January 30. The P3 laboratory of the CDC conducts virus isolation, cultivation and inactivation.
Supported by the advanced inactivated vaccine production technology platform, Kexing Zhongwei's new crown inactivated vaccine was tested in animals in March and entered the phase I clinical trial in mid-April. Yin Weidong, chairman, president and CEO of Kexing Holdings, recalled: "Before the phase I clinical trial, a large expert group review meeting was held at 10 pm. After my report, the expert group asked a full 50 minutes. Many questions were about vaccine safety. Sexual."
What experts are most concerned about is that the test time is so short. Have you lowered the standard and omitted the process? Yin Weidong said that the process design of the experiment is to improve efficiency on the basis of ensuring safety principles. The test results and data are "iron certificates". The data are reported by internationally certified laboratories, and these reports follow international standards. In fact, some domestic indicators of vaccine safety are even higher than WHO standards. On April 13, the State Food and Drug Administration approved the new coronavirus inactivated vaccine developed by Kexing Zhongwei to enter clinical research.
Subsequently, several inactivated vaccines in China were approved for clinical research. On June 28, the new coronavirus jointly developed by the Chinese Center for Disease Control and Prevention (Viral Disease Institute) and the China National Pharmaceutical Group Beijing Institute of Biological Products Phase I/II clinical blinding of inactivated vaccine. The results show that the vaccine has good safety and immunogenicity. At the same time, Sinopharm Group took the lead in building the world's largest new crown vaccine production workshop, with an annual production capacity of 100 million doses after mass production.
On June 19, the New Coronavirus mRNA Candidate Vaccine (ARCoV) jointly researched by the Academy of Military Medical Sciences and Suzhou Aibo officially passed the clinical trial approval of the State Drug Administration and became the first mRNA approved for clinical trials in China. vaccine.
Subsequently, the new crown recombinant protein vaccine jointly developed by the Institute of Microbiology of the Chinese Academy of Sciences and Anhui Zhifeilong Kema Biopharmaceutical Co., Ltd. was also approved for phase I clinical trials. Another technical route for the development and deployment of China's new crown vaccine has entered the clinic.
"The layout of multiple technical routes for vaccines in China is very forward-looking, because vaccines with different technical routes have their own advantages and disadvantages and are highly complementary in clinical use." Suzhou Aibo Biotechnology Co., Ltd. CEO InBev said that in the prevention and treatment of epidemics, vaccines of different technical routes can play an advantage. In layman's terms, a person may be given different vaccines at different times, or people of different ages and physical conditions may be given different vaccines.
People's health first, clinical application after vaccine development needs more scientific research. Different publics have different situations. Once a vaccine is not suitable under certain conditions, another alternative vaccine can be used as a "starter". These have been considered early in the development of China's new crown vaccine.
Give full play to the advantages of the new national system: focus on advantages and attack
The outbreak of the new coronary pneumonia, the scientific research force must "concentrate its superior forces" in order to effectively attack the new virus and effectively break new problems.
To overcome the new scientific problems brought about by the new coronavirus, it is necessary to organize interdisciplinary and interdisciplinary scientific research teams to coordinate resource coordination and scientific research security. This is a systematic work that involves a wide range of requirements and is difficult. In this process, it is critical to take advantage of the new nationwide system, which can be twisted into a string of "strength" and the mainspring can be tightened to "accelerate".
"During the research and development of vaccines, the scientific research team further strengthens scientific research, adjusts the organization and management methods, strengthens services to R&D institutions, especially strengthens research and examination linkages, and accelerates the vaccine research and development process." Wu Yuanbin introduced that vaccine research and development follows the research and development There are many steps required for regularity, and strengthening services and organizations will speed up the process.
Vaccine R&D work has progressed smoothly overall, largely due to my country's institutional advantages. The vaccine research and development team can fully integrate the resources of all parties and coordinate the advantages of all parties. For example, research institutions isolate and obtain viruses from samples provided by medical institutions, medical institutions and scientific research institutions cooperate well, and scientific research institutions and enterprises cooperate well. Every step of the vaccine research and development process has to undergo strict identification and verification by the Food and Drug Administration, the China Provincial Procuratorate, and the Drug Evaluation Center, and the joint cooperation of relevant government departments is very important. With regard to the organization of vaccine research and development, the Ministry of Science and Technology has provided project support in a timely manner, and provided scientific and technological resources and financial security.
Why can the vaccine R&D chain advance in time under the premise of a lot of links? Zheng Zhongwei, director of the Medical and Health Technology Development Research Center of the National Health and Health Commission, explained that during the entire R&D process, the participating institutions, including R&D units, laboratory animal units, drug verification and drug review units, carried out a reasonable parallel: experimental animal institutions prepared in advance The animal model of the new Coronary Pneumonia is improved, and the R&D institutions are guaranteed at the first time; the special research team effectively connects the R&D institutions and the experimental animal institutions; the drug inspection and review institutions participate in the R&D process inspection and process approval for the first time Link.
"The country particularly emphasizes that scientific research units are not counted as economic income accounts, but only as people's health accounts, and they have been granted special funds to protect them, and they have also made a commitment to the construction of a future vaccine reserve system." Zheng Zhongwei said that this is a national emergency. An effective practice for scientific research.
"Scientific research institutes, such as the Chinese Center for Disease Control and Prevention, Wuhan Institute of Virology, Chinese Academy of Sciences, etc., were the first to isolate new coronavirus strains. The Laboratory Animal Institute of the Chinese Academy of Medical Sciences was the first to have animal models. Has a complete vaccine production and R&D system." Lu Shan explained that in the process of teaming up different vaccine R&D projects, the scientific research team insisted on the internship of General Secretary Jin Ping about "accelerating the establishment of an enterprise-based vaccine R&D and combination of production, education and research. The instruction of "industrialization system" has promoted close cooperation between upstream and downstream units of the vaccine industry chain, and implemented them one by one from the funding of funds to the coordination of test guarantees, so as not to be delayed by one second due to organizational management approval.
Through organizing and coordinating work, the special class mobilizes all aspects of the game, and uses limited resources to "blade". "We have issued a number of documents to strengthen overall management in the form of national tasks, coordinate and mobilize resources of all parties, and prioritize limited resources to guarantee key scientific research tasks." Lu Shan said, for example, due to the suspension of wildlife trading during the epidemic, experimental use The monkey has also become the speed limit link of the project unit. To this end, through the coordination of units such as the Forest and Grass Bureau in the animal model class, monkeys for scientific research can be guaranteed, and air transportation and other units must also be coordinated.
Faced with the test of the new coronary pneumonia epidemic, the State Food and Drug Administration has formulated a special review work plan for anti-new coronary pneumonia drugs, and the drug review center has established a "working research and review linkage, with development and submission, with submission and review" review mechanism R&D and evaluation are connected in parallel, and the evaluation is completed when the research and development is over, and the vaccine is pushed to the clinic as soon as possible.
In accordance with the requirements of emergency testing, the Chinese People's Procuratorate intervened in vaccine research and development in advance, and communicated the vaccine quality standards and inspection-related issues with the R&D unit for new vaccines that were developed in an emergency. According to Li Changgui, Director of the Respiratory Virus Vaccine Office of the Biological Products Laboratory of the Chinese People's Procuratorate, the team used technology reserves to prepare and purify multiple new coronavirus antibodies, and provided them to multiple inactivated vaccine manufacturers to establish antigen content detection methods to promote vaccines. The research and development process has laid the foundation for ensuring vaccine quality.
In the vaccine emergency review process, the communication and communication mechanism established by the drug review center with the applicant was fully enlarged and utilized. "Up to hundreds of communication before and after, collected and summarized the key issues and concentration issues that the R&D unit needs to pay attention to, and pointed out early, you can avoid R&D and detours." Wang Tao, chief reviewer of the drug review center, previously accepted the media The interview stated that the review will be communicated wherever R&D is reached. Telephone conferences, written feedback, emails, WeChat, and in-depth research and development of the company, and other methods, whether it is late at night or early morning, the relevant departments will reply to the company's email and WeChat within 24 hours.
Early intervention, full communication, research and review linkage...Under the guarantee of an innovative mechanism, the emergency approval of the clinical trial of the new crown inactivated vaccine product can be completed within 24 hours, and this process may normally take 60 working days.
Establish animal models in one go: "Assay" vaccine helps lead
"Animal models are the new crown'patients' developed in the laboratory." Professor Qin Chuan, director of the Institute of Medical Laboratory Animals of the Chinese Academy of Medical Sciences, always uses this popular phrase to explain animal models that people are not familiar with.
In the development of vaccines, animal models are veritable "behind-the-scenes heroes." It is difficult to understand why a mouse or a monkey is so important. Vaccine development must be tested by a special "animal patient" in the laboratory of animal models to be constantly improved. Animal models are known as the "touchstone" for clinical trials of vaccines and drugs.
Since the outbreak of the New Coronary Pneumonia, the Institute of Medical Laboratory Animals of the Chinese Academy of Medical Sciences has responded quickly. On December 31, 2019, a three-level laboratory for animal biosafety was launched based on bioinformatics analysis, pathogen-sensitive animal analysis, animal infection experiments, and comparative medicine. A series of studies such as analysis, a few days later, on January 7, 2020, completed the analysis of susceptible animals, and urgently formulated an experimental plan. Immediately after getting the virus on January 23, an animal infection experiment was conducted. After a series of analysis of indicators, respectively On January 29th and February 14th, we first completed the construction of two animal models of transgenic mouse model and rhesus monkey model, and passed the identification of the Ministry of Science and Technology on February 18th. The entire development process can be said to be "all in one go" At that time, it was still in the stage of conception of animal model experiment in the world.
The Wuhan Institute of Virology, Chinese Academy of Sciences began building mouse and rhesus monkey models on January 23, and the rhesus monkey model it built passed the technology together with the rhesus monkey model of the Institute of Experimental Animals, Chinese Academy of Medical Sciences on February 18 Ministry identification, its mouse model passed the identification on March 21. The Institute of Medical Biology, Chinese Academy of Medical Sciences began constructing rhesus monkey and cynomolgus monkey models on February 22, and was evaluated by an expert team on March 21, which can be used for the study of pathogenic characteristics, pathogenic mechanisms, transmission routes, etc., and Evaluation of drugs and vaccines.
"One of the important reasons why this vaccine development is so fast is that we have developed animal models at the world's leading speed and accelerated the vaccine development process. The reason for the rapid establishment of animal models and the completion of vaccine animal model evaluation depends on the pre-stage The basis of work, the cultivation of a professional team for the development of animal models of human diseases, and the innovation of this research." Qin Chuan said.
In the face of a completely new virus, why can the construction of animal models be “at one go”? Qin Chuan explained, "The selection of new coronavirus susceptible animals, the development of pathogen detection reagents, and the determination of pathological judgment standards all require continuous exploration and are likely to fail, but because we have cultivated a group since SARS The professional team, after 17 years of accumulation of animal models of infectious diseases, based on the innovation of the theoretical system of comparative medicine theory, solved these technical problems in the first time."
Relevant information shows that the "Establishment and Application of Animal Model System for Major Human Infectious Diseases" project jointly completed by the Institute of Medical Laboratory Animals of the Chinese Academy of Medical Sciences, the University of Hong Kong and Beijing Kexing Biological Products Co., Ltd. won the National Science and Technology Progress in 2019 Second prize, the project established 104 species of experimental animal species and genetically engineered animal strains related to pathogen susceptibility and immunity, 95 animal models of major infectious diseases, and a multi-species animal model for a single infectious disease The integrated system has completed the standardization of vaccine and drug evaluation technologies.
The professional national team, quick response, and profound accumulation have made the Chinese animal model complete the charge as soon as the "Pioneer Team" when the "Assembly Number" of the new coronary pneumonia epidemic sounded.
The strong support of animal models enables the preclinical animal experiments of vaccines to be started quickly and carried out in parallel, greatly reducing the time required for the vaccine to enter the clinic, and "snatching" time for the development of vaccines in China.
On May 6, "Science" published a paper by the Chinese scientific research team "Rapid Development of New Coronavirus Inactivated Vaccine", which is the first non-human primate model evaluation result of the effectiveness of the inactivated vaccine published in the world. It provides the "China Plan" for the development of animal models internationally and provides an important reference for the development of vaccines internationally.
On the basis of completing national tasks, animal models in my country also provide support for vaccine research and development in other countries. Vaccine companies in the United States, Germany and other countries have come here to carry out vaccine cooperation between China and foreign countries to solve problems with international vaccine research and development.
Strictly regulate the whole process of vaccine development: the procedure does not reduce the standard and does not decrease
"From the selection of the strain to the registration of the product, there are about ten processes, including the research of seedling production in laboratory research, animal safety and effectiveness, to the clinical study of human safety and effectiveness, In the research verification stage of large-scale production, all research processes have very strict standards and specifications." Zheng Zhongwei emphasized that these standards and specifications not only ensure the safety and effectiveness of preclinical research, but also ensure clinical research and production links. Safety and effectiveness.
"There are strict laws, regulations and technical standards for the launch of vaccines at home and abroad. Pharmaceutical research, efficacy research and safety research must be completed before the vaccine enters clinical trials." Wang Junzhi, academician of the Chinese Academy of Engineering, said that for each vaccine research and development China has corresponding technical regulations to follow. These regulations and technical requirements are consistent with international standards such as WHO. Chinese scientists are working in accordance with relevant regulations and technical requirements and in accordance with scientific laws to ensure the safety and effectiveness of vaccines. Under the premise of sex, accelerate the application of vaccine research.
Taking animal testing and pre-clinical clinical review as an example, on January 8th, an experimental animal welfare ethics committee composed of veterinarians, scientific researchers, management personnel, and public representatives urgently reviewed animal experiment programs. Since the animal models have been waiting in line, the preparatory work including animal ethics review has been completed in accordance with relevant technical regulations, and the vaccine development chain has been rapidly launched. In addition, in the clinical trial application process, the program must be approved by a third-party ethics committee and approved by a national drug review clinical expert before it can be launched.
"To speed up the development of vaccines, the premise is that the procedures are not reduced and the standards are not reduced. In the actual development process of the new crown vaccine, the standards will even be higher than before." Liu Peicheng, director of brand and public relations of Kexing Holdings Biotechnology Co., Ltd., told the Science and Technology Daily reporter The reason why it is fast is that the research and development process changed many of the previous series things into parallel. For example, in the past animal experiments, mice were first made of rats, then rabbits, monkeys, and some small animals were obtained. Data, experiments can reduce some possibilities, and then do it on large animals. Counting people’s health accounts now, to seize the time from the possible harm caused by the virus, it is necessary to simultaneously verify several possibilities, different dosage forms, different immunization procedures, etc., and verify them on all animals at the same time. This is for companies. It will increase the investment, but can improve the development speed without reducing the standard.
The development of the world's first adenovirus vector vaccine into clinical trials not only has the speed of "blitzkrieg", but also has a solid verification process. Lu Shan introduced that the vaccine research and development team established a daily report system. The records show that the world’s first adenoviral vector vaccine developed by academician Chen Wei’s team has entered the clinical trial. In terms of safety evaluation, it has been used on rats, guinea pigs, cynomolgus monkeys and other animals. Carried out tests for acute poison, long poison and allergic reaction. In terms of the effectiveness evaluation of the vaccine, the vaccine has carried out immunogenicity tests on three kinds of animals: mice, guinea pigs, and cynomolgus monkeys. The vaccine is not challenged in order to observe the immunogenicity of the vaccine. Rhesus monkeys carried out a challenge test to verify the immune effect of the vaccine.
Thanks to the rigorous vaccine development process, the clinical trial results of vaccines in my country have all performed well. On May 22, the Lancet published online the results of the Phase I clinical trial of Academician Chen Wei’s team. 108 subjects all developed specific antibodies or cellular immune responses after vaccination. Clinical trials confirmed that the vaccine was used in healthy adults It has good immunogenicity and safety, which is the human clinical data of the world's first new crown vaccine.
On June 14th, the Phase I/II clinical study of the new coronavirus inactivated vaccine developed by Kexing Zhongwei was unblinded. The preliminary results showed that the vaccine had good safety and immunogenicity. Reports show that a total of 743 subjects in Phase I/II clinical studies have completed vaccination, and no serious adverse reactions have been reported. After 14 days of full immunization, the neutralizing antibody positive conversion rate exceeded 90%.
On June 16, the Phase I/II clinical trials of the new inactivated coronavirus vaccine developed by Sinopharm Wuhan Institute of Biological Products of China National Pharmaceutical Group were unblinded. Up to now, there have been 1120 subjects in Phase I/II clinical research, all of which have been completed. 2 Needle inoculation. The results of the blinding show that the safety after vaccination is good, and there are no serious adverse reactions. After different procedures and different doses of vaccination, the vaccine group vaccinated all produced high-titer antibodies. After two doses (28 days), the positive antibody conversion rate reached 100%.
In the key link of vaccine review and approval, in accordance with conventional procedures, clinical investigators should apply to the National Drug Administration to submit a series of data and information such as drug efficacy tests and animal tests, and clinical trials can only be conducted after approval. Clinical samples must be qualified by the China Food and Drug Administration. "Under the current joint defense and joint control mechanism, the review and approval of relevant departments and the production link are jointly promoted." The person in charge of the relevant department said that the review department has strict approval procedures, carried out early intervention work, and entered all aspects of R&D and testing. Suggestions and guidance. For example, the technical standards department of the China Food and Drug Inspection Institute and the evaluation center of the State Administration of Drug Administration follow up in real time, synchronously guide and provide technical support to ensure that the scientific research data meets the standards.
"For vaccine applications that have been fully prepared for application and approved through scientific and feasibility evaluation, a special expert group can be invited to assess and review whether they can be included in the special approval process." Wang Tao, chief reviewer of the Drug Administration Center of the State Food and Drug Administration, said, The review and approval of the new crown candidate vaccine must be time-consuming, respect scientific, and not lower standards, to ensure the safety and effectiveness of pre-clinical research evaluation projects, and fully protect the safety of the subjects.
China's new crown vaccine needs to undergo rigorous scientific testing before it can enter clinical trials, which reflects the responsibility and ability of a big country that is responsible for people's health.
Beneficial community of human destiny: Strengthen international cooperation to play the most beautiful "harmony"
In response to the new coronary pneumonia epidemic, WHO released the draft of a new randomized clinical trial of the new crown vaccine called "Unity" in April, hoping to mobilize global forces to accelerate research and development, accelerate clinical trials, accelerate the search for safe and effective vaccines, and accelerate the return to normal life. Road.
At the press conference of the State Council Office on June 7, Ma Zhaoxu, Vice Minister of Foreign Affairs, made it clear again: "China attaches great importance to international cooperation in vaccine research and development, and has participated in the WHO Global Initiative on Drugs and Vaccine Research and Development. The video conference of the Unity Test' vaccine development plan."
With the spread of the epidemic, people gradually realized that the development of effective vaccines is difficult to achieve by only one country. To vigorously practice the spirit of solidarity and cooperation, we must actively build a community of human destiny. On June 11, WHO Director General Tan Desai said at a regular press conference that the new crown vaccine should be provided as a global public product to all people in need. He also called on leaders of all countries to make political commitments to adopt the same procedures and guidelines to develop new crown vaccines.
"Strengthening international cooperation, enterprises are the main body." Lu Shan said that in order to promote the pace of enterprises going out, the scientific research team is also approaching different international organizations to promote international cooperation in vaccine research and development.
"China's new crown vaccine research and development is in line with international standards, which has laid the foundation for companies to go out and carry out international cooperation in phase III clinical trials." InBev stated that they had received an "olive branch" from a non-profit organization at an international conference, but individual companies Docking is still relatively difficult.
"The transnational cooperation of vaccines is relatively complicated in the implementation process." Liu Peicheng explained that going out of China's vaccines is not a simple clinical research implementation process. It is necessary to consider the current and subsequent epidemic situation in the location of clinical research, as well as the clinical research of the cooperative unit. Many issues such as qualifications and experience.
In addition, international cooperation must respect the laws and culture of the host country and respect the choice of the government and people. To this end, relevant departments have organized several online seminars and invited foreign peer experts from relevant international organizations to communicate with China's vaccine R&D team.
Related vaccine R&D cooperation plans are steadily advancing. Kang Xinuo Bio-stock Company issued an announcement on May 18 that the vaccine jointly developed by the company and the Institute of Bioengineering (Academician Chen Wei) of the Military Medical Research Institute of the Chinese Academy of Military Sciences has been approved by the Health Canada to conduct clinical trials. On June 11th, China Kexing Holdings Biology and Brazil's Butantan Institute announced the signing of a clinical development cooperation agreement to advance the clinical trial of the new coronavirus inactivated candidate vaccine Kelford developed by the company to clinical phase III in Brazil...
On June 7, at the press conference of the State Council Office, in response to a reporter's question about "how China can make domestic vaccines as a global public product, as President Xi Jinping promised," Minister of Science and Technology Wang Zhigang responded: Chinese scientists and others Scientists from all countries hope to contribute to the community of human destiny in health. In the next step, if Chinese vaccines are developed and clinically tested, when they are ready for use, we will seriously implement President Xi Jinping’s commitment at the 73rd World Health Assembly and provide it as a public product to the world.