A US reporter said that China stole vaccine technology, and Foreign Ministry spokesperson Hua Chunying responded that this was ridiculous. In this race against time to develop vaccines, how did the Chinese R&D team perform? Text/Reporter Zhao Tianyu Editor/Chen Yongjie New Media Editor/Chen Xuanzhi As the COVID-19 pandemic rages around the world, vaccine research and development has become the focus of attention of all countries. At the regular press conference of the Ministry of Foreign Affairs on July 17, a reporter asked about the US officials' claim that China attempted to steal US vaccine research and medical research data. Foreign Ministry spokesperson Hua Chunying responded that it was ridiculous for some people in the US to claim that China launched a cyber attack to steal US vaccines. Hua Chunying said, "China is in the lead in the development of COVID-19 vaccines. China has first-class scientific researchers and does not need to steal to gain a leading position. At present, China's scientific research team has laid out a number of vaccine development tasks according to five technical routes. Vaccines with independent intellectual property rights in China have successfully entered clinical trials. China National Biotec Group Beijing Institute of Biological Products has taken the lead in building the world's largest COVID-19 vaccine production workshop. The China Food and Drug Administration and other competent departments are also making every effort to promote the development and marketing of COVID-19 vaccines. At the same time, China is actively strengthening cooperation with relevant countries in vaccine research and development, production and distribution." Because the question was so ridiculous, Hua Chunying couldn't help laughing out loud when answering it. In fact, Chinese President Xi Jinping made a solemn commitment at the opening ceremony of the 73rd World Health Assembly video conference held on May 18 that once China's new crown vaccine is developed and put into use, it will be a global public product and will make China's contribution to achieving the accessibility and affordability of vaccines in developing countries. Why did the Foreign Ministry spokesperson say that China is in the leading position in the development of COVID-19 vaccines? What practical actions is China taking to make vaccines a global public product? More than half of the vaccines approved for clinical trials worldwide are from China As of July 2, statistics from the World Health Organization (WHO) official website 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 to publish the evaluation results of the effectiveness of live vaccines in non-human primate models in the world, or to publish the world's first human clinical data of the new crown vaccine, China's vaccine research and development work is in the lead internationally. In the process of vaccine development, the advantages of the new national system were once again demonstrated. At least a dozen scientific research institutes and enterprises in China have played their respective advantages and carried out vaccine development around five technical routes, including inactivated vaccines, recombinant protein vaccines, attenuated influenza virus vector vaccines, adenovirus vector vaccines, and nucleic acid vaccines, under unified coordination and leadership, greatly increasing the possibility of successful vaccine development. The reporter found that among the 7 new coronavirus vaccines approved for clinical trials in China, 4 were inactivated vaccines, and the other 3 were adenovirus vector vaccines, RNA vaccines and recombinant subunit new coronavirus vaccines. Adenovirus vector vaccine: Academician Chen Wei's team leads the way Among the seven COVID-19 vaccines that have entered clinical trials, which one is the fastest? The leading one is the adenovirus vector vaccine jointly developed by China CanSino Biologics Co., Ltd. and the Institute of Bioengineering, Academy of Military Medical Sciences, Academy of Military Sciences (Academician Chen Wei's team). Adenovirus vector vaccines are also called non-replicating virus vector vaccines. This technology uses a modified harmless adenovirus as a vector, inserts the S protein gene of the new coronavirus (regarded as the key protein for the new coronavirus to intervene in human cells), and makes an adenovirus vector vaccine to stimulate the body to produce antibodies. It is reported that the team has cooperated in the development of adenovirus vector vaccines for Ebola. The adenovirus vector vaccine for the new coronavirus uses the same adenovirus type 5 replication-deficient vector, except that the new coronavirus S protein is inserted into it. ▲Academician Chen Wei's team continues to advance the development of my country's independently developed adenovirus vector vaccine for the new coronavirus on the front line of the fight against the epidemic (Picture from the Internet) The vaccine started Phase I clinical trials on March 16, with 108 volunteers enrolled; subsequently, based on the safety data of Phase I clinical trials, Phase II clinical trials were started on April 12, with 508 volunteers enrolled. On May 22, the results of the Phase I clinical trial of the vaccine were published in The Lancet, showing that a single dose of the vaccine can produce virus-specific antibodies and T cells within 14 days, making the vaccine potential for further research. According to the latest announcement from CanSino, the Phase II clinical trial of the vaccine was unblinded on June 11, and the data confirmed that it has good safety and high levels of humoral and cellular immune responses. Previously, the vaccine received approval for clinical trials from the Canadian Ministry of Health on May 15, and its Phase III clinical trials will be conducted in Canada. According to an announcement released by CanSino Biologics, the vaccine can already be injected and used within the Chinese military. On June 25, the Health Bureau of the Logistics Support Department of the Central Military Commission approved it as a special drug for the military, with a validity period of one year. Inactivated vaccine: the first to enter Phase III clinical trials The development of inactivated vaccines is also not far behind. The most traditional classic technical route of inactivated vaccines is to culture the new coronavirus in vitro and then inactivate it to make it non-toxic, but the "corpses" of these viruses can still stimulate the human body to produce antibodies and make immune cells remember the appearance of the virus. The preparation method of inactivated vaccines is simple and fast, with the advantages of short development time, no infectious toxicity, and safe use. It is a common means to deal with the spread of acute diseases. However, it also has problems such as large vaccination doses, short immunity period, and single immunity pathway. In particular, it may cause antibody-dependent enhancement effect (ADE), aggravating viral infection and leading to failure of vaccine development. In terms of inactivated vaccines, Sinopharm Group China National Biotec Group (hereinafter referred to as "Sinopharm") and Beijing Sinovac Biotech Co., Ltd. (Beijing Sinovac) have obvious advantages. The Beijing Institute of Biological Products and the Wuhan Institute of Biological Products under Sinopharm have respectively launched the research of the inactivated COVID-19 vaccine, and have completed the Phase I/II clinical trials and unblinding respectively. On June 16, the Phase I/II clinical trial of the inactivated COVID-19 vaccine developed by the Wuhan Institute of Biological Products of China National Biotec Group was unblinded, with a 100% antibody conversion rate and no serious adverse reactions. Subsequently, the inactivated vaccine of the Beijing Institute of Sinopharm was also unblinded on June 28. Due to the early unblinding time, the vaccine developed in Wuhan has started overseas Phase III clinical trials in the UAE on June 23. This is the world's first Phase III clinical trial of an inactivated new coronavirus vaccine and the first time that a Chinese new coronavirus vaccine has been conducted clinically overseas. On July 1, a research and development laboratory and production workshop complex with an annual production capacity of 100 million doses of inactivated COVID-19 vaccines was completed in Wuhan. The project will provide safe and reliable hardware support for the scientific research and large-scale production of inactivated COVID-19 vaccines. ▲China is leading in the field of inactivated COVID-19 vaccines. The picture shows the virus culture and inactivation area of the inactivated COVID-19 vaccine production workshop of Sinopharm Group China National Biotec Group's COVID-19 vaccine production base, which has not yet been put into production (Photo courtesy of Xinhua News Agency) ▲The virus culture and inactivation area of the new coronavirus inactivated vaccine production workshop at the Sinopharm Group China Biological COVID-19 vaccine production base, which has not yet been put into production (picture from the Internet) The COVID-19 vaccine "Kerlaifu" developed by Beijing Sinovac was unblinded in the Phase I/II clinical trial on June 14, and preliminary results showed that the vaccine has good safety and immunogenicity. The latest report shows that on July 3, the Brazilian health regulator, the National Health Surveillance Agency, approved the above-mentioned vaccine to conduct Phase III clinical research in Brazil on July 3. This study was applied for by Sinovac's partner, the Butantan Institute, and will be carried out in 12 research centers in 6 states in Brazil. It plans to recruit nearly 9,000 volunteers. After obtaining ethical approval from each research center, volunteers will start to be enrolled this month. After the vaccine is proven to be effective, it will be registered in Brazil and the Butantan Institute will be authorized to produce the vaccine locally for local epidemic prevention and control in Brazil and Latin America. In addition to the above two leading units, the inactivated vaccine research and development of the Institute of Medical Biology of the Chinese Academy of Medical Sciences (hereinafter referred to as "Institute of Biology") is also progressing steadily. On June 21, the institute announced that the inactivated new coronavirus vaccine independently developed by it entered Phase II clinical trials in Honghe Prefecture, Yunnan Province on the afternoon of June 20. The reporter noted that this is the fourth inactivated new coronavirus vaccine in my country to enter Phase II clinical trials. Nucleic acid vaccine: has entered clinical trials in Hangzhou Nucleic acid vaccines are also a major technical route for my country's vaccine research and development. Nucleic acid vaccines include RNA vaccines and DNA vaccines. They use a specific delivery system to directly inject RNA or DNA expressing antigen targets into the human body, use human cells to synthesize viral proteins in the human body, and stimulate the body to produce antibodies. In layman's terms, this is equivalent to handing over a detailed record of the virus to the human immune system. The vaccine does not require the synthesis of proteins or viruses, the process is simple, and the safety is relatively high. However, due to the relatively new technology, there is no successful precedent yet. In terms of nucleic acid vaccines, the nucleic acid vaccine developed by the Military Medical Research Institute of the Chinese Academy of Military Sciences started Phase I clinical trials at Hangzhou Shulan Hospital on June 25. It is the first RNA vaccine approved for clinical trials in China. Previous animal experiments on the vaccine showed that the vaccine can not only induce high levels of neutralizing antibodies in mice and crab-eating macaques, but also induce protective T cell immune responses. Recombinant protein vaccine: Phase II clinical trial has been initiated Among other vaccine types, protein subunit vaccines are also a direction. Protein subunit vaccines, also known as recombinant protein vaccines, use genetic engineering methods to mass-produce the S protein, which is most likely to be used as an antigen for the new coronavirus, and inject it into the human body to stimulate the body to produce antibodies. It is equivalent to not producing a complete virus, but producing many key components of the new coronavirus separately, and giving them to the human immune system to recognize. On June 23, Chongqing Zhifei Bio released an announcement that the recombinant novel coronavirus vaccine (CHO cells) jointly developed by its subsidiary Zhifei Longcoma and the Institute of Microbiology, Chinese Academy of Sciences has officially entered clinical trials. The vaccine has started Phase II clinical trials on July 10 to evaluate the safety and immunogenicity of the vaccine. It is reported that the antigen of the vaccine is a structurally designed S protein receptor domain (RBD) dimer antigen with a unique structure, which brings a high level of protection to the vaccine. Adhere to the five routes of international cooperation and open to the outside world In response to the COVID-19 outbreak, the WHO released a draft plan for an international randomized clinical trial of a COVID-19 vaccine called the Solidarity Trial in April, hoping to mobilize global forces to accelerate research and development, clinical trials, and the search for safe and effective vaccines, and to accelerate the return to normal life. According to WHO data, more than 100 teams around the world are currently competing to develop COVID-19 vaccines, and 150 COVID-19 vaccines are under development. In the future, more and more vaccines will enter the clinical trial stage. "The most important signs of vaccine success are safety, effectiveness and accessibility." Wang Zhigang, Minister of Science and Technology of China, pointed out that throughout the vaccine development process, China's new crown vaccine research and development has always placed safety, effectiveness and accessibility in a very important position, and insisted on carrying out international cooperation. Public health security is a common challenge facing mankind, and all countries need to work together to respond. The Guidelines for Application for International Cooperation Projects in Response to the COVID-19 Epidemic in 2020 under the National Key R&D Program issued by the Ministry of Science and Technology of China on July 6 show that in order to strengthen international cooperation in scientific research on epidemic prevention and control, China plans to deploy international cooperation projects in response to the COVID-19 epidemic. This international cooperation plans to deploy 11 research tasks in four areas, including drugs, vaccines, testing reagents, and traditional Chinese medicine to combat COVID-19. It plans to support no more than 37 projects, and the project implementation period will not exceed 2 years. ▲On June 23, the launch ceremony of the Sinopharm Group China National Biotec Group's COVID-19 inactivated vaccine international clinical trial (Phase III) in the United Arab Emirates was held simultaneously in Beijing, Wuhan, China, and Abu Dhabi, UAE, via video conference. The UAE Minister of Health issued a clinical trial approval document to Sinopharm. At the ceremony, China and the UAE signed the relevant clinical cooperation agreement on the spot, marking the official launch of the world's first international clinical trial (Phase III) of the COVID-19 inactivated vaccine (picture from the Internet) It is reported that at present, China's five technical routes are open to the outside world. Chinese companies have carried out technical cooperation with companies in Canada, the United Kingdom, Germany, Brazil and other countries. China has also carried out scientific research cooperation with international organizations such as the World Health Organization, the Coalition for Epidemic Preparedness Innovations, and the Global Vaccine Immunity Alliance. The Chinese research team published papers in international journals such as The Lancet to share research progress and results. The Ministry of Science and Technology stated that this deployment aims to strengthen scientific research cooperation with relevant countries, especially those with high incidence of the epidemic, and relevant international organizations through international scientific and technological innovation cooperation, share scientific research data and information, jointly solve key and difficult problems in scientific research on epidemic prevention and control, and contribute wisdom and strength to promoting the building of a community with a shared future for mankind. As Foreign Ministry spokesperson Hua Chunying said, China will continue to work with relevant countries to strengthen and advance cooperation in vaccine research and development, production and distribution, and make our contribution to the world's quick victory over the epidemic and safeguarding the lives, safety and health of people around the world. Produced by: Science Central Kitchen Produced by: Beijing Science and Technology News | Science Plus Client Reproduction without authorization is prohibited |
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