First Volunteers Complete Vaccination Uncovering The Story Behind the Development of the World's First New Crown Inactivated Vaccine

On April 12, the new coronary inactivated vaccine, developed by the China Biological Wuhan Institute of Biological Products of The State Pharmaceutical Group, obtained a clinical trial license from the State Drug Administration and launched the relevant clinical trials simultaneouslyThis is the world's first new crown inactivated vaccine approved for clinical trialsin addition,, the inactivated vaccine developed by Beijing Kexing Zhongwei Biotechnology Co., Ltdwas approved on April 13 and clinical trials were conducted on april 16approvetwo clinical trials at once
inactivated vaccine is a vaccine that kills the virus physically or chemically while preserving the immunogenicity of the virus and enables the recipient to produce an immune responseCompared with other types of vaccines, inactivated vaccines have the advantages of advanced research and development technology, mature production process, controllable quality standards and good protection effect, and are the most effective vaccine development path for new outbreaks of infectious diseasesSince the outbreak of new coronary pneumonia, in order to improve the success rate of vaccine research and development, China's vaccine emergency response from 5 technical routes to advance simultaneously, inactivated vaccine is one of themBecause of the sufficient preclinical research data and good results, the State Drug Administration approved a one-time trial of the new coronavirus inactivated vaccine developed by Wuhan Institute of Biological Products, which also means that the progress of the vaccine will be further acceleratedJanuary 5, the Chinese Academy of Sciences Wuhan virus successfully isolated the new coronavirus strain, the new coronain vaccine research and development work beganOn January 19th, China Pharmaceutical Group Set up a leading group on scientific research and research, laid out three research institutes and developed new crown vaccines on two technical routesInactivated vaccines are developed by Wuhan Institute of Biological Products and Wuhan Virus Institute of the Chinese Academy of Sciences, Beijing Institute of Biological Products and Cdc Virus Disease Prevention and Control Institute in Wuhan and Beijing, respectively, while geneticengineering vaccines are led by the China Biotechnology Research InstituteThe scientific research team established the third seed bank in the shortest time, completed the virus inactivation verification, process and formula research, animal immunogenicity research, safety evaluation program design, etc., and urgently started the follow-up registration related work in accordance with scientific principles, to ensure effective quality and safety, clear and orderly development plan, and accelerated progress in approval and declarationFebruary 1, China Bio, China Pharmaceutical Group, as the lead unit, obtained the Ministry of Science and Technology National Key Research and Development Program "Public Safety Risk Prevention and Control and Emergency Technical Equipment" key special "2019-nCoV inactivated vaccine" project emergency project, scientific research team overtime to move forwardFebruary 14, the scientific research team obtained the purification antigen;" conservation studies continued until April 7, and trials in animals such as rhesus monkeys proved that vaccines have good protective effects Wang Zexuan, director of the Viral Vaccine Research Office at Wuhan Institute of Biological Products, said preclinical safety evaluation is an essential step in vaccine development From March 8 to April 7, the research team carried out animal safety evaluation work, the results of the results are very good, animals did not have any abnormal reactions or adverse reactions the poison is the basis for the development and preparation of vaccines The scientific research team carried out the construction of the poison seed bank simultaneously, in accordance with the relevant regulations, on February 28 set up a three-stage poison seed bank, began clinical registration batch production of vaccines, and on March 18 completed the production of three batches of vaccines April 4, Wuhan Institute of Biological Products production of inactivated vaccine self-test qualified, April 9, obtained the China Food and Drug Research Institute of the inspection of the qualified report On April 10, the Wuhan Institute of Biological Products submitted the final version of the declaration as required, and on April 12, the vaccine was licensed by the State Drug Administration for clinical trials it will take about 10 years to speed up vaccine development " in the past, an innovative vaccine Zhang Yuntao, vice president of China Biology at China Pharmaceutical Group, said Vaccines are special drugs for healthy people, and in addition to having a suitable production process, it is important to evaluate their preclinical safety and effectiveness The Ebola virus broke out in Africa in 2014, but it wasn't until five years later that the first Ebola vaccine was approved in the United States and the European Union Why is the development of this new crown inactivated vaccine so rapidly ? Zhang Yuntao said that three reasons compressed the time of the new crown vaccine research and development: first, the continuous combat of scientific researchers, hard work, second, multi-line and raise the success rate of vaccine research and development, and third, the country in the standard does not reduce, the process does not reduce the situation, accelerate the review and approval of vaccines 'fast' is important, but it must also be 'good' "This is the National Pharmaceutical Group China Biological President, Party Secretary Yang Xiaoming in this new crown vaccine research and development "blitz" often stressed a sentence He said that in the advanced production process, China Pharmaceutical Group China bio-new crown vaccine production base used in the production of research and development processes, testing quality standards, testing means, are international lying leading to carry out research and development of the new crown inactivated vaccine, is at the critical stage of the outbreak prevention and control of the fight against the war, the location of the scientific research team is the first line of epidemic prevention and control of Wuhan, the degree of difficulty can be imagined Before the Spring Festival, Fang Xijing, a researcher at the Wuhan Institute of Biological Products, returned to his home in Huainan, Anhui Province On January 23rd, Wuhan announced the closure of the city, and on February 1st, the development of vaccines was urgently launched This makes Fang Xi anxious - she is responsible for the work, the key link in quality control in order to return to work as soon as possible, Fang Xijing first contact the company to issue a certificate of epidemic prevention work, many times contact the residential community for the return to Wuhan application At 6 a.m on February 19th, she boarded the G1741 high-speed rail Affected by the outbreak, the high-speed rail does not stop in Wuhan, need to Yueyang and then find a way back to Wuhan When the conductor learned of her work, he made a technical stop in Wuhan At 11 o'clock that night, Fang Xijing rushed to the laboratory and immediately put himself into intense scientific research like Fang Xijing, the members of Wuhan Institute of Biological Products in the field overcome a lot of resistance, experienced a variety of twists and turns, from all directions to Wuhan one after another Around February 20, the research backbone of the institute basically to Qi, together into this battle without smoke, with the virus, and time race the unknown and spread of the new coronavirus, increasing the difficulty and urgency of research and development Even more difficult and dangerous, all operations dealing with live viruses must be done in a high-security biological laboratory In the face of the severe situation, Wang Zexuan faced up to the difficulties, and took the initiative to ask Yu to undertake the responsibility of researchand and development of the new crown inactivated vaccine "Only by understanding the characteristics of a virus and mastering the laws of all aspects of it can we race against its changes in a race against time." "At the same time as organizing the specific work of research and development projects every day, Wang Ze was obliviously engaged in the research of relevant literature, often exploring the war "epidemic" at two or three o'clock in the morning, followed by the next day because of the tight time of vaccine research and development, heavy task, scientific research team in the local research and development link, from the previous "series" to "parallel", improve the efficiency of research and development, but also means higher work intensity and more concentrated input For example, in the evaluation of the effectiveness of vaccines, effectiveness tests have previously been conducted on different types of animals on a case-by-case basis In parallel, different types of animals are tested for effectiveness at the same time "We work more than 16 hours a day, which is the equivalent of two or three days a day Wang said as research and development institutions battled around the clock, the State Drug Administration also launched a series of special approval mechanisms, opening up a fast track for vaccine research and development in the past, research and development institutions need to prepare the declaration materials after a one-time submission, can now be rolled submission materials, the State Drug Administration to review simultaneously to improve the speed of approval In addition, the relevant departments also held a number of special technical communication meetings, the vaccine to obtain approval when many drug regulatory departments to solve the concerns in the research and development process, greatly shorten the approval time to make China's contribution to the cause of world public health
At present, China has three new crown vaccines approved for clinical trials Among them, The adenovirus vector recombinant new coronavirus vaccine developed by Chen Wei's team completed the vaccination of the first phase of clinical trial stoicism at the end of March, and began recruiting volunteers for Phase II clinical trials on April 9, the world's first new coronavaccine vaccine to launch phase II clinical studies " in addition to adenovirus vector vaccines and inactivated vaccines, the development of three other vaccine technology routes is also accelerating Wu Yuanbin, Director of the Department of Social Development Science and Technology of the Ministry of Science and Technology, said that the vaccine for detoxifying influenza virus vector strains has completed the construction of vaccine strains and the establishment of quality inspection methods, quality process research and quality verification are under way, pilot production, animal attack testing and safety evaluation experiments are also carried out at the same time; " vaccines on the above-mentioned technical route are expected to be declared for clinical trials in April and May Wu Yuanbin said vaccine development into clinical trials is a significant development At the same time, Wang Junzhi, a member of the Chinese Academy of Engineering, also stressed that the clinical trial is divided into three phases, its objectives and significance, programs, the time required is not the same Therefore, "even if we are in an emergency situation, the evaluation criteria for the safety and effectiveness of the vaccine cannot actually be reduced throughout the evaluation process" vaccine is the key to the prevention and control of this outbreak, and many countries around the world are racing to develop new coronavirus vaccines As of April 8, 115 new crown vaccines were being developed, 78 of which had been confirmed for trial and five were in clinical trials, according to a study published by the Alliance for Innovation in Epidemiological Prevention " next step, Chinese biology will go all out, race against time, accelerate scientific research, and strive to complete the clinical trial of the new crown inactivated vaccine as soon as possible, as soon as possible to prepare a safe and effective new crown vaccine, on the basis of emergency use, large-scale market, to meet domestic and international needs, in order to overcome the outbreak of new coronapneumonia, to ensure the safety of human public health to make new contributions "China Pharmaceutical Group's China biology-related person-in-charge said currently, the outbreak of new coronary pneumonia has affected more than 200 countries and regions around the world Public health security is a common challenge facing mankind, no country can stay out of the way, and China is actively advocating global cooperation in vaccine research and development China has made every effort to develop a new crown vaccine and made new breakthroughs, not only to prevent and control the outbreak in its own country, but also to contribute to the cause of world public health.