China is at the forefront of the five-way new crown vaccine

The world’s first vaccine law is issued, achieving full traceability
China is at the forefront of the five-way release of the new crown vaccine (Big Health Watch·New crown vaccine is coming ②)

On April 2, 2020, the world’s first new crown vaccine was approved for phase I and II clinical trials.

On June 23, 2020, the world’s first new crown vaccine started phase III clinical trials.

On June 24, 2020, after strict review procedures, emergency use was approved in accordance with laws and regulations.

Starting in July 2020, a number of vaccines have successively carried out phase III clinical trials overseas.

On December 30, 2020, the new coronavirus inactivated vaccine of Sinopharm, China Bio-Beijing Company was approved to be listed conditionally, and the first domestic vaccine was officially listed conditionally.

“China’s vaccine research and development work has always been in the world’s first phalanx!” Zeng Yixin, deputy director of the National Health Commission and head of the vaccine research team of the Joint Prevention and Control Mechanism Research Group of the State Council, said at a press conference a few days ago.

“In terms of time, China was the first to launch the research and development of the new crown vaccine, the first to enter clinical trials, and the first to enter phase III clinical trials. At the same time, domestic vaccines were approved and officially listed with conditions.” Feng Dujia, President of China Vaccine Industry Association In an interview with our reporter, “In terms of quantity, according to the data released by the World Health Organization, as of December 2020, there are 202 new crown vaccine candidates worldwide, of which 47 have entered the clinic. There are 14 in China, of which Five vaccines have entered phase III clinical trials. In addition to the vaccines that have been conditionally marketed, several other vaccines are also expected to be put on the market in the near future.”

Feng Duojia said: “Regardless of time or quantity, China’s vaccine research and development has not fallen behind. This is also a manifestation of ability.”

5 technical routes are advanced simultaneously, not for the first run

In order to maximize the success rate of new coronavirus vaccine research and development, China has laid out five technical routes: inactivated vaccines, recombinant protein vaccines, adenovirus vector vaccines, and attenuated influenza virus vector vaccines and nucleic acid vaccines.

As of December 31, 2020, 5 technical routes and 14 vaccines have entered clinical trials, of which 3 technical routes and 5 vaccines have entered phase III clinical trials, including 2 inactivated vaccines of Sinopharm Sinopharm and Beijing Kexingzhong The inactivated vaccine of Weiwei Company, the adenovirus vector vaccine jointly developed by the Academy of Military Medicine and Cansino, and the recombinant protein vaccine jointly developed by the Institute of Microbiology of the Chinese Academy of Sciences and Zhifei Biological Company. There are also a batch of pre-clinical drugs that are accelerating.

“These 5 technical routes cannot simply say which one is better.” Zheng Zhongwei, leader of the vaccine research and development team of the State Council Joint Prevention and Control Mechanism Scientific Research Group, said that to evaluate a vaccine, we must comprehensively consider its safety and effectiveness. Availability, accessibility, and affordability. “For example, the research and development of China’s new crown inactivated vaccine, from the selection and breeding of the virus, the determination of the inactivation process, to the level of biosafety assurance technology for large-scale P3 plants, and the quality standards of the vaccine, are in an international leading position. .”He said.

“Because China’s new crown epidemic is well controlled, the conditions for conducting Phase III clinical trials are not available in China.” Zheng Zhongwei introduced that after completing Phase I and Phase II clinical trials, Chinese vaccine research and development units will adopt international cooperation methods to cooperate with overseas Countries or regions jointly carry out phase III clinical trials. “Although we started phase III clinical trials earlier, since the countries and regions where the phase III clinical trials are carried out are not the most epidemic areas in the world, it is necessary to obtain the phase III clinical trials. The number of infected cases is not the fastest.”

Yang Xiaoming, chairman of Sinopharm Group China Biotech, said that in order to ensure the safety and effectiveness of the vaccine, they carried out various experimental studies in strict accordance with scientific procedures and laws and regulations. “We did not omit any step for the sake of speed.” Yang Xiaoming said, “We are the world’s first inactivated COVID-19 vaccine approved for clinical trials, but we did not deliberately fight for’the world’s first COVID-19 vaccine approved for marketing’. Although we have always been in the world’s first phalanx of vaccine research and development, we have never rushed and rushed forward for the first place.”

Change from series to parallel, join hands in battle

It usually takes 8-10 years to develop a vaccine from project approval to market launch. Now in less than a year, China has developed a new coronavirus vaccine and put it on the market conditionally. How can it be done without reducing procedures, lowering standards, and ensuring safety?

According to Zheng Zhongwei, the vaccine research and development process was “in series” under normal conditions in the past. In response to this new crown pneumonia epidemic, all participating units have adopted a reasonable “parallel connection”, concentrated their superior forces, and carried out backups of R&D supplies regardless of cost; experimental shopping institutions prepared in advance Good animal experimental models provide guarantees for R&D institutions in the first time; drug inspection and review agencies participate in the entire R&D, inspection and approval process in accordance with relevant national emergency laws and regulations, and “connect” the original normal The working mode has become a “parallel” working mode.

“The state places special emphasis on requiring scientific research units not to be counted as economic income accounts, but only as people’s health accounts, and special funds are guaranteed.” Zheng Zhongwei emphasized, “This is also an effective practice of the national system in scientific research under emergency conditions. .”

“In the emergency R&D process, we have a good foundation and strong organization and coordination capabilities.” Feng Duojia said that after decades of development, the vaccine industry has laid a solid foundation in technology and talent accumulation and has a complete industrial system. Construction. “Because vaccines require a combination of industry, academia, and research. China has the advantages of a nationwide system and strong organizational and coordination capabilities. Everyone cooperates closely with each other, between companies, between companies and institutions, and between researchers. Therefore, vaccines are not just a single family. What companies can do must be a general battle, which is our advantage.” He said.

Liang Xiaofeng, executive vice president and secretary-general of the Chinese Preventive Medicine Association, said in an interview with our reporter that the scientific and technological workers in this vaccine research and development will not rest on weekends and holidays. “Thank you for the work of Chinese scientists, medical workers and vaccine production. People, it is because of their hard work that the new crown vaccine can be produced so quickly. I hope everyone respects their labor. Your vaccination is a respect for science.”

Every dose of the new crown vaccine has an electronic ID card

The new crown vaccine has gone through a series of strict procedures from research and development to marketing. According to Wang Tao, chief reviewer of the Center for Drug Evaluation of the National Food and Drug Administration, clinical trials are an inevitable stage of drug and vaccine research and development. Clinical trials are divided into phase I, II, and III clinical trials in chronological order. Phase III is the most critical clinical trial. , Obtain data through large-scale clinical trials to determine that the vaccine can meet the nationally recognized standards of protection efficacy. It is also necessary to complete commercial-scale production process verification, establish controllable quality standards, and prove that the vaccine to be marketed has acceptable safety, clear effectiveness, and quality controllability. After these standards are met, the applicant submits a listing application, and the State Food and Drug Administration completes the technical review as soon as possible to ensure that a safe, effective, and controllable vaccine will be launched as soon as possible.

Chen Shifei, deputy director of the State Food and Drug Administration, introduced that in the production supervision process, the State Food and Drug Administration and the provincial drug regulatory authorities have jointly strengthened the quality supervision of the new crown virus vaccine, organized the National Vaccine Inspection Center to carry out regular inspections of vaccine manufacturers, and carried out non-productive inspections Regular spot checks are organized to organize the National Drug Evaluation Center to cooperate with health departments to monitor suspected abnormal reactions to vaccination. “Every batch of vaccines that leave the factory will be issued by the drug regulatory authority.” Chen Shifei said that the batch issuing agency will implement strict data review and laboratory testing for each batch of vaccines.

“We have also strengthened the entire chain of vaccine supervision.” Chen Shifei said that the State Food and Drug Administration in conjunction with the National Health Commission has established a vaccine information traceability system, which has basically realized the full traceability management of the vaccines on the market. At present, Sinopharm Group Sino Biotech has started the large-scale production of the new crown vaccine. Each dose of vaccine has an “electronic ID card” that traces the flow of the vaccine throughout the entire process. Where the vaccine is received and who is vaccinated will be recorded.

“China is the first country in the world to promulgate a vaccine management law, which clearly implements the most stringent management of vaccines. From production to circulation, from raw and auxiliary materials to final products, quality supervision is carried out without blind spots in the whole process. Each batch of vaccines has to go through Double verification by the enterprise and the national drug regulatory department.” Feng Duojia said, “We must have enough confidence in our domestic vaccine.”

Wang Meihua

Wang Meihua

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