CDE's new standard for vaccine research and development has helped China's five technical routes to oversteed.

Author . . . On the second Friday, August 14, 2020, it seemed to be a tradition, and the State Drug Administration issued a series of circulars on five guiding principles, including the Technical Guidelines for the Development of Vaccines for the Prevention of New Coronavirus (Trial) (2020). No. 21 of this year), this weekend pharmaceutical people have a bad time ah, since the date of publication (August 14, 2020), this paper on the current new coronavirus vaccine research and development of five new guidelines policy background and main content of the initial interpretation.
1. Since January 31, 2020, when the disease caused by the new coronavirus infection was listed as a "public health emergency of international concern" by the World Health Organization (WHO), the international community and other countries around the world have taken active policies and incentives to encourage the development of new coronavirus vaccine prevention vaccines and standardize the guidance for the clinical evaluation of new crown vaccines. Product quality standards, promote the launch of new coronary vaccines as soon as possible, CDE refers to the target product characteristics issued by WHO, the organization has formulated the New Coronavirus Prevention Vaccine Research And Development Technical Guidelines (Trial), New Coronavirus Prevention MRNA Vaccine Pharmacological Research Technical Guidelines (Trial), New Coronavirus Prevention Vaccine Non-Clinical Effectiveness Research and Evaluation Technical Points (Trial), New Coronavirus Prevention Vaccine Clinical Research Technical Guidelines (Trial) Guidelines for clinical evaluation of vaccines for the prevention of new coronavirus (trial) are heeded and approved by the State Drug Administration and are heeded for implementation as of the date of publication (August 14, 2020).
II, the new standard of the new crown vaccine to help China's 5 technical routes overcarrying the current clinical application of the vaccine is mainly divided into virus inactivated vaccine, genetically engineered recombinant vaccine, viral vector vaccine, nucleic acid vaccine (proton DNA, mRNA, etc.), anti-virus influenza virus vector vaccine 5 categories.
Under the leadership of the leading group of the CPC Central Committee in response to the outbreak, the State Council's joint prevention and control mechanism for responding to the epidemic has set up a scientific research team involving 12 departments, including the Ministry of Science and Technology and the National Health and Safety Commission, which has made vaccine research and development a top priority, and China's new crown vaccine research and development has laid out five technical routes to advance simultaneously, including virus inactivated vaccines, genetic engineering recombinant vaccines, viral vector vaccines, nucleic acid vaccines (granulated DNA, mRNA, etc.) Virus vector vaccine, each technical route by a number of units to form a joint force, from enterprises to universities, research institutes to high-level biosecurity laboratories, the Academy of Military Sciences Institute of Military Medicine, the Chinese Academy of Sciences, the Chinese Academy of Medical Sciences, the Chinese Center for Disease Control and Prevention, Tsinghua University, Sichuan University, Fudan University and other top national academic institutions and high-tech enterprises in the field of life sciences to fully invest in the "battle", the launch of the "new coronavirus vaccine research and development guidelines" Such 5 guidelines apply to the current research and development of new crown vaccine in China involving all technical route candidates for clinical research.
2.1 Virus Vector Vaccines 2.1.1 Principle: The protected antigen gene of the target pathogen (e.g. SARS-CoV-2) is inserted into the virus genome, and the high purity harmless virus is injected into the body, which induces the generation of the induced body.
the long and time-consuming technology path of this kind of vaccine, the technical requirements for carrier selection, operation and production are high, but the successful research and development has confirmed the reliable safety and effectiveness of the vaccine.
2.1.2 New developments in China's new crown vaccine: Adenovirus vector (Ad5-nCoV) vaccine developed using recombinant technology was developed jointly by the Institute of Bioengineering of the Institute of Military Medicine of the Academy of Military Sciences and Concinosen, and was prepared using genetic engineering methods to replicate defective type 5 glands Virus as a vector, the SARS-CoV-2S antigen gene recombined into an inactivated adenovirus genome, using the expression of protective antigen gene recombinant adenovirus, the vaccine Phase II clinical trial was launched on April 12, is the world's first phase II clinical trial of the new crown vaccine.
2.2 Virus Inactivated Vaccines 2.2.1 Principle: Inactivated vaccines are the most traditional classical technical route: to culture new coronavirus in-body and then inactivate it so that it is not toxic, but the "corpse" of these viruses can still stimulate the body to produce antibodies, so that immune cells remember what the virus looks like.
2.2.2 New developments in China's new crown vaccine: (1) In April, the State Drug Administration approved a clinical trial of the SARS-CoV-2 inactivated vaccine jointly applied by the Wuhan Institute of Biological Products of China Pharmaceutical Group China Biotechnology Co., Ltd. and the Wuhan Institute of Virus Research of the Chinese Academy of Sciences; On the 8th, the new coronavirus inactivated vaccine I./II, jointly developed by the China Bio-Beijing Biological Products Research Institute and the Viral Disease Prevention and Control Institute of the Chinese Center for Disease Control and Prevention, showed that the safety after vaccination is good, and the vaccinators in different procedures and after vaccination have produced high-titration antibodies.
the same day, The International Clinical (Phase III. Phase III) of China Bio-New Corona inactivated vaccine was launched.
(2) approved a clinical trial application for an inactivated virus vaccine developed by Beijing Cosing Zhongwei Biotechnology Co., Ltd. in April.
On May 6, qinchuan team of the Institute of Medical Experimental Animals of the Chinese Academy of Medical Sciences led a team of researchers to publish the results of the world's first animal trial of the new crown vaccine in the internationally renowned journal Science, confirming that the new crown inactivated vaccine developed by Beijing-based Koxing Zhongwei Bio is safe and effective in the rhesus monkey model, the first publicly reported results of the new crown vaccine animal experiment.
Phase I./II. Clinical Study was launched on April 16 in Yanning County, Xuzhou City, Jiangsu Province.
2.3 Genetically Engineered Recombination Vaccine 2.3.1 Principle: Using genetically engineered recombination technology, this kind of recombination protein vaccine is achieved by inducing the immune response of the body by expressing the immunogenic protein in the shell of the virus through bacteria or yeast, because the technology is also more suitable for large-scale production, so it is a relatively active research and development field.
2.3.2 New developments in China's new crown vaccine: On June 19th, the new crown recombination protein vaccine developed by Gao Fu and Yan Jinghua of the Institute of Microbiology of the Chinese Academy of Sciences and Anhui Zhifeilong Coma Biopharmaceutical Co., Ltd. was approved for phase I clinical trials.
2.4 Nucleic acid vaccine 2.4.1 Principle: Nucleic acid vaccine includes mRNA vaccine and DNA vaccine, is the code s protein gene, mRNA or DNA directly into the human body, using human cells in the human body to synthesize S protein, stimulate the body to produce antibodies.
, it's the equivalent of handing over a detailed virus file to the body's immune system.
2.4.2 China's new crown vaccine progress: June 26 Watson Bio released news that China's first new crown mRNA vaccine into phase I. clinical trials, approved clinical 3 groups of research, each group of 56 people, approved to enter clinical trials of the new coronavirus mRNA vaccine trial organizers areChinese the PLA Academy of Military Sciences Military Medical Research Institute, Suzhou Aibo Biotech Co., Ltd., Yunnan Watson Biotechnology.
2.5 "Detox influenza virus vector vaccine" principle 2.5.1 principle: anti-virus influenza virus vector vaccine is the use of approved influenza virus vaccine as a vector, carrying the new coronavirus S protein, together stimulate the human body to produce antibodies against both viruses.
simply put, this vaccine is a low-toxic influenza virus wearing the new crown virus S protein "hat" formed by the fusion virus, can be stone two birds, both anti-flu and anti-new crown.
2.5.2 China's new crown vaccine progress: it is still in the early stages of research and development, the relevant research and development institutions have not been retrieved reports.
3. Covering the whole process of new crown vaccine research and development scientific supervision guarantees from the selection of new crown strains to the registration of new crown vaccine products, about ten processes, including laboratory animal safety and ability research, to clinical human safety, ability research, to large-scale production of research validation stage, all research processes have very strict standards and norms.
Guidelines for the Development and Development of Vaccines for New Coronavirus Prevention (Trial), Technical Guidelines for The Pharmacology of mRNA Vaccines for New Coronavirus Prevention (Trial), Technical Points for Research and Evaluation of Non-Clinical Effectiveness of Vaccines for New Coronavirus Prevention (Trial), and Technical Guidelines for Clinical Research on Vaccines for New Coronavirus Prevention (Trial) and "Clinical Evaluation Guidelines for New Coronavirus Prevention Vaccines (Trial)", covering the supervision of the new crown vaccine throughout the whole process of research and development, production, pre-market and post-market, and established a complete set of national regulatory system from the research, production to use of the new coronavirus, the realization of the source-to-end quality control and supervision model, for the establishment of other drug standards system provides a reference idea.
five guiding principles highlights: (1) The guiding principles of the Technical Guidelines for Vaccine Research and Development for the Prevention of New Coronavirus (Trial) are divided into five parts: foreword, pharmaceutical research (including research on the production of bacteria (toxic) species, cellular substings, The main raw materials, production processes, etc. a total of 11 content), non-clinical research, clinical research and reference technical guidelines, non-clinical research requires that preclinical research samples should be able to represent clinical trial samples, clinical research can use a more flexible method of clinical trial design, in order to shorten the clinical trial process, speed up the purpose of clinical research.
(2) The guiding principles of the Technical Guidelines for The Pharmaceutical Research of mRNA Vaccines for The Prevention of New Coronavirus (Trial) include template design, transcription of template prosurpris construction and bacterial library research materials, production process, quality characteristics research, quality standards, stability studies, sources, selection basis and quality standards of packaging materials and containers for direct contact products, etc., and clarify the contents of mRNA vaccine pharmacological research, especially the consideration of the clinical stage.
(3) "Technical Points for Research and Evaluation of Non-Clinical Effectiveness of New Coronavirus Prevention Vaccines (Trial)" is applicable to guide the evaluation of the pharmacoetics of new coronavirus vaccines in emergency situations.
that if there is a difference between non-clinical study samples and clinical samples, the necessary bridding studies should be conducted to assess the effects of pharmaceutical changes on the effectiveness and safety of the subjects.
(4) The Technical Guidelines for Clinical Research of New Coronavirus Prevention Vaccines (Trial) cover the main clinical research processes from first trial, exploratory trial to corroroidative trial, as well as some important preclinical studies and the necessary post-market research processes.
(5) The Guidelines for Clinical Evaluation of Vaccines for New Coronavirus Prevention (Trial) set out specific requirements for evaluating the safety and effectiveness of vaccines, requiring candidates for new coronavirus vaccines to be best applied to all ages, including pregnant and lactating women; Protection for 1 year or more is provided for at least 6 months, and in placebo-controlled trials, the protection effectiveness of the target population is preferably more than 70% (point estimate), at least 50% (point estimate), and 95% confidence interval lower limit is not less than 30%.
, China's new crown vaccine to look forward to the spread of the global new crown epidemic, including China, many countries are "race to the bottom" to develop a new crown pneumonia vaccine.
On May 18, 2020, the President of the People's Republic of China announced at the opening ceremony of the video conference of the 73rd World Health Assembly that China will make China's contribution to the realization of the accessibility and affordability of vaccines in developing countries as a global public product when the research and development of the new crown vaccine is completed and put into use.
Technical Guidelines for the Research and Development of Vaccines for New Coronavirus Prevention (Trial) developed by CDE Organization, Technical Guidelines for Pharmaceutical Research on mRNA Vaccines for New Coronavirus Prevention (Trial), Technical Points for Research and Evaluation of Non-Clinical Effectiveness of Vaccines for New Coronavirus Prevention (Trial), and New Coronary The implementation of the five guiding principles of the Technical Guidelines for Clinical Research on Vaccines for Virus Prevention (Trial) and the Guidelines for Clinical Evaluation of Vaccines for New Coronavirus Prevention (Trial) has been implemented to promote the market of the new crown vaccine as soon as possible, and the Chinese-made new crown vaccine is about to be "bright sword" in the face of the new crown virus, the common enemy of mankind.
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