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China's development of new coronavirus vaccine begins animal trials and enters clinical practice as soon as April

via:CnBeta     time:2020/2/10 14:22:40     readed:174

Chinese scientific research team announced that the latest development of the new coronavirus vaccine has begun animal testing.This is only two weeks from the CDC's successful separation of the first strain of the new coronavirus in January 24th. The outbreak of new coronavirus pneumonia has killed more than 900 people as of February 10th, and the death toll exceeds SARS. To this end, scientists around the world are actively developing vaccines against new coronaviruses.

Author: Tong LAN

Recently, the Chinese scientific research team announced that the newly developed vaccine for the new coronavirus has started animal testing. This is only two weeks from the CDC's successful separation of the first strain of the new coronavirus in January 24th.

Two weeks to complete development

The first financial reporter learned from many sources that the vaccine was jointly designed and developed by China CDC, Shanghai Tongji University Medical College and Shanghai biotechnology company, s microorganism, which provided samples for vaccine production. On Sunday, samples of the new vaccine were administered to more than 100 healthy mice.

China's CDC officials confirmed the progress of the new coronavirus vaccine to the first financial reporter, but stressed: "this is still a very early stage, and there are still many steps to be taken to help people."

According to the microbiological aspect, by the end of January, the R & D personnel started the two week vaccine development after obtaining the new coronavirus antigen from CDC. The vaccine was developed on the basis of mRNA (messenger RNA) platform. MRNA was transcribed from DNA single strand. Like DNA, it also carries genetic information and can guide protein synthesis. In addition, 9 to 12 different antigens were used in animal trials of the vaccine.

The first financial reporter contacted Tongji University and Sri Lanka microbiological Department on February 10. As of the publication, the two sides have not replied to the vaccine research and development process and details.

Professor Liu Zhongmin, Dean of the Oriental Hospital Affiliated to Tongji University, said in an interview with CCTV: "the mouse test is only a preliminary screening of the candidate vaccine. After the search for the effective virus antibody, the toxicity test will be carried out, which will use monkeys and other large animals to ensure the safety of the vaccine in human clinical trials.

At the same time, in order to ensure the objectivity of the vaccine, the mouse test of the same vaccine sample was carried out simultaneously in China CDC and CFDA.

"The development of mRNA vaccine is really fast, but it will take a while for it to be really used, because there are still many steps to be taken," an official from China CDC told first financial reporter. "

Professor Liu Zhongmin also said that mRNA based vaccine development is one of the most effective and advanced methods so far, greatly reducing the cycle of vaccine development.

Vaccine safety is a major responsibility. The research and development of vaccines requires a high level of basic research facilities, which must be completed under the extremely high requirements of biosafety, and the laboratory must reach P3 or P4 level. Even so, the risk of live toxicity research is still very high. Moreover, after the animal test is completed, the clinical safety and effectiveness evaluation should be carried out.

According to the available public information, the first financial reporter, at present, the institutions with P3 laboratory in Shanghai include Shanghai public health center and Fudan University, etc. Informed sources told the first financial reporter, Shanghai public health center has also launched a new coronavirus related vaccine research and development work.

Subversive mRNA platform

The traditional vaccine development is a long process, but thanks to the development of new technologies, the vaccine development cycle has also been shortened from the past few years to several months.

MRNA vaccine simulates the process of natural virus infection, inducing human cells to produce the same protein as the pathogen surface, activating the immune response of human body, which is like building a "pharmaceutical factory" in human body.

However, it is necessary to enter the clinical trial. According to the trial cycle and the patient's situation, the clinical trial cycle may vary from several months to several years.

If animal trials go well, the new vaccine will enter human clinical trials as soon as April this year. Industry insiders believe that the research and development progress of Sri Lanka microorganism is likely to be based on the standard of American biotechnology company Moderna.

According to the official statement of Barney Graham, deputy director of NIH vaccine research center of National Institutes of health, the partner of Moderna, the vaccine of Moderna will also enter human clinical trials as soon as April. "This is a vaccine exploration for the unknown new virus, and it will force the reform of the process system. Let's look forward to how fast we can push forward." NIH also said it was ready to scale up vaccine production in the future.

First financial reporter checked the background information of Si microorganism and found that the core competitiveness of the biotechnology company founded in 2016 lies in the mRNA synthesis platform and LPP nano delivery platform, which are currently used in the research and development of mRNA vaccine.

Dr. Li Hangwen, the founder and CEO of s microorganism, served as an assistant professor in Roswell cancer center and Oriental Hospital Affiliated to Shanghai Tongji University.

It is understood that compared with traditional vaccines, mRNA vaccine technology has great advantages in efficacy, R & D speed, production scalability and safety. A variety of viral antigens can be integrated into a single mRNA, which can produce complex multi antigen vaccines that are difficult to achieve by traditional technology.

Previously, the mRNA vaccine of the microbes was intended to be applied in the field of tumor immunotherapy. However, after the outbreak of the new coronavirus pneumonia, the company accelerated the development of the vaccine.

The development of the vaccine also requires a lot of money. Notably, on February 7, it was reported that Shanghai Junshi Bio had announced a capital contribution of 10 million yuan to participate in the A-round financing of the mRNA drug platform Si Microbes and received a 2.86 percent stake in it. Junshi bio ceo li ning confirmed the investment to the first financial reporter.

It is widely believed in the industry that the mRNA drug platform is expected to become a disruptive iterative product. At present, the head enterprises of therapeutic vaccines all over the world take mRNA vaccine as an important research and development direction, such as Moderna, curevac, biontech, etc.

Global vaccine competition

Although most scientists believe that "far water cannot save near fire", by the time the vaccine is considered safe, the epidemic may have eased. But researchers in the world including the United States, Britain, France, Australia and other countries are still actively investing in the development of new coronavirus vaccine. A vaccine race against the virus has begun.

Since the outbreak of the new coronavirus pneumonia in 2017, the CEPI, a government enterprise cooperation institution set up in 2017, has invested 9 million US dollars in four start-ups and research institutions including Moderna, Inovio, research team of Australia, etc., supporting the development of new coronavirus vaccine.

Richard Hatchett, CEO of the agency, told CFI that their goal is to enter human clinical trials within four months.

In addition to mRNA methods, DNA based vaccines can also be developed rapidly. Innovio, an American biological enterprise, launched its R & D program the day after Chinese scientists released the genome sequence of the new coronavirus to a public database. They designed a DNA vaccine against the spike protein of the new coronavirus and a vaccine against the spike protein within two days.

According to Joseph Kim, CEO of inovio, the company develops vaccines based on the gene sequence of the virus, which is more efficient and faster than the traditional laboratory practice of using virus entities for testing.

On January 28, inovio cooperated with AI diweixin, a biopharmaceutical company based in Suzhou, to develop the vaccine with the latest DNA vaccine technology, and said it would strive to promote the vaccine to the clinical trial stage in China in the shortest time.

"Vaccine development is a very difficult work. On the one hand, it needs strong technology. Although the technical difficulties have been largely overcome, on the other hand, it also needs strong funds. "Professor Peter Hotez, Professor of National Tropical medical school, Baylor School of medicine, Rockefeller University, Houston, USA, who has been engaged in the research of coronavirus for a long time, told the first financial reporter," it can be seen from the failure of vaccine research and development of SARS that once the epidemic passed, the investment in vaccine research and development was obviously insufficient. The difficulty of vaccine research and development is very high, and it is difficult to continue without financial support. "

A person in charge of the Pasteur Institute of Chinese Academy of Sciences also told the first financial reporter: "there are many difficulties that will hinder scientists from developing vaccines. For example, when the epidemic passes, no enterprise will do industrial production. "But he still said that the vaccine reserve is of positive significance for the prevention and control of similar viruses in the future.

Take Ebola virus as an example. When the virus first broke out in West Africa in 2014, there was no vaccine available. However, when the Ebola epidemic broke out again in Congo in 2019, more than 200000 people were injected with Ebola vaccine, timely inhibiting the spread of the epidemic.

In this outbreak, the world has shown unprecedented support for basic scientific research. Richard Hatchett, CEO of the Alliance for epidemic prevention and innovation, told CFI: "we hope that one of these teams will bring hope."

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