Experts: It is recommended to smooth the fast-track approval channel for the Vaccine of the Ami kerong variant

People's Daily health client Xu Tingting Wang Zhuo

In order to be prepared, the mainland has deployed vaccine research and development units to carry out the research and development of the Aomi Kerong variant vaccine. Zhang Boli, academician of the Chinese Academy of Engineering, Professor Shao Yiming, member of the expert group of the vaccine research and development special class of the Scientific Research Group of the Joint Prevention and Control Mechanism of the State Council, and Wang Hongguang, director of the International Bioeconomy Center of the Biomedical Interdisciplinary Research Institute of Tsinghua University, and many other experts suggested that the rapid approval channels should be smoothed and the approval of the Marketing of the Aomi Kerong mutant vaccine should be accelerated.

Residents were vaccinated in an orderly manner, pictured by Xinhua News Agency.

The continuous mutation of the virus has put forward higher requirements for vaccines, and the Vaccine of the Semikron variant has made positive progress

Zheng Zhongwei, head of the vaccine research and development working group of the scientific research group and director of the Science and Technology Development Center of the National Health Commission, introduced at the press conference that so far, the research and development of the single and multivalent vaccines for the Olmi kerong variant strain has made positive progress, and the preclinical research has been completed relatively quickly, and the declaration materials for clinical trials are being submitted to the national drug regulatory department on a rolling basis.

In November 2021, when the WHO announced that the Aumecreon variant was listed as a variant that needs "attention", Lizhu Group launched the vaccine research and development of the Omnikron variant for the first time, and it is currently progressing smoothly, and it is undergoing monoclonal cell line screening, which can be mass-produced as needed. Livzon Group said it is actively promoting the conditional listing application of the vaccine.

In terms of inactivated vaccine research and development, Since the end of 2021, the University of Hong Kong has introduced the Olmikeron strain, completed the vaccine production, process verification and animal testing, and submitted the clinical registration declaration data and rolling modification of the New Coronavirus Inactivated Vaccine of the Semikron strain at the first time, and once approved, the clinical research will be started immediately.

In terms of mRNA vaccine research and development, Lin Jinzhong, professor of the School of Life Sciences of Fudan University and director of the Shanghai Zhangjiang mRNA International Innovation Center, told reporters that after the outbreak of the new crown epidemic, the mRNA vaccine, one of the five vaccine technology paths deployed by the state, has made important progress, and the phase III clinical trial of the first-generation prototype strain mRNA jointly developed by the Academy of Military Sciences, Aibo Biology and Yunnan Watson has come to an end. In 2021, in response to the virus mutation, a broad-spectrum polyvalent mRNA vaccine from Yunnan Watson and Fudan University is also applying for clinical trials. This novel COVID-19 broad-spectrum mRNA vaccine adopts an innovative antigen design, which has a good anti-epidemic effect on many existing variants, including Omilon.

"In fact, the development of a broad-spectrum mRNA vaccine for COVID-19 predates the spread of the now-circulating Omilon strain." Professor Lin Jinzhong introduced that animal experiments and small-scale population trials have shown that the vaccine can produce a broad spectrum of neutralizing antibody capabilities for strains such as The currently circulating Aomi Kerong. Since the NEW CROWN variant strain basically originated from the alpha or beta strain, the probability of maintaining the effectiveness of the new strain in the future is also relatively high.

Experts suggest that smooth and fast approval channels should be used to speed up the listing approval process

"The first echelon of the new crown vaccine is to solve the problem of whether there is enough and not enough, and the second echelon must solve the problem of good or bad." The main goal of the NEW CROWN vaccine initially determined by the World Health Organization is to prevent the onset of disease, especially hospitalization, severe illness and death, as the epidemic develops, the virus continues to mutate, society has put forward higher requirements for vaccines, and research is facing more challenges. In view of the immune escape of the vaccine by the mutant strain, it is necessary to strengthen the immunization strategy of the vaccine in a timely manner, including accelerating the promotion of the enhancement of the needle and the development of a new generation of vaccines for the mutant strain, maintaining the leading edge of the first echelon vaccine on the mainland, and accelerating the promotion of the second echelon vaccine, by building a higher and stronger vaccine immunity barrier, reducing the pressure on public health prevention and control measures. Professor Shao Yiming, a member of the expert group of the vaccine research and development special class of the scientific research group of the joint prevention and control mechanism of the State Council, revealed to the People's Daily health client reporter.

Lin Jinzhong told reporters that the epidemic has prompted the mainland to develop and accumulate technology from the bottom, and the industry, education and research have cooperated closely, mastered the independent production and core processes of some key raw materials, and basically realized independent control while researching and developing, improving and producing. At present, domestic mRNA vaccines can technically benchmark foreign vaccines, have advanced and controllable nature, and can also ensure safety and efficacy after marketing.

Zhang Boli, an academician of the Chinese Academy of Engineering, told reporters that the same vaccine technology route in the past has been relatively mature, and safety can be guaranteed, such as overseas clinical trials according to conventional procedures will miss the precious time window. Approval of the Omiljun strain vaccine should be expedited.

Specifically, there are several aspects of work to be done:

Keep and accelerate the flow of various approval channels. Shao Yiming suggested that in the vaccine approval policy in the early days of the epidemic in the mainland, it is very important to open the approval channel for emergency use. At present, the research and development of various vaccines for mutant strains in the second echelon still needs the support of national policies, continue to open up the approval channel for emergency use of national vaccines, and let the vaccines of the new technology path serve the people of the whole country and the people of the world as soon as possible.

Strengthen mechanism and institutional innovation. Academician Zhang Boli suggested that with reference to the wartime experience of Wuhan's anti-epidemic war, the special affairs special office should optimize and simplify the relevant procedures, which can be used as a reinforcing needle for universal vaccination to passively form a herd immunity barrier of Theomilon virus. Wang Hongguang, director of the International Bioeconomy Center of the Institute of Biomedical Interdisciplinary Research of Tsinghua University, suggested that the rapid response system jointly built by the government, industry, academia and research should be kept in normal condition to promote the rapid development of biomedical industries such as vaccines.

Ensure that the entire vaccine industry chain is independent and controllable. Shao Yiming pointed out that the core technology, raw materials, and even packaging materials, any of which is broken, will affect the vaccine research and development process. The joint prevention and control mechanism of the State Council, led by the Ministry of Industry and Information Technology, should realize high-quality domestic substitution on the basis of the previous work, from the core technology, raw materials, key equipment to packaging materials and other whole industrial chains.