The World'S R & D Speed, China'S New Crown Vaccine Is About To Enter The Three Phase Of Clinical Trials.

Editor's note

Yesterday, the global confirmed diagnosis of new crown pneumonia exceeded 9 million. The World Health Organization says the virus has spread steadily across the globe. In the absence of specific drugs, vaccines become the only hope for humans to contain the spread of the disease.

Is there any significant progress in the development of new crown vaccines at home and abroad? When is the fastest time for mass production? Can the vaccine meet the global supply demand in time? Today we will bring you the latest research progress in this special report.

On June 23rd, the global confirmed case of new crown pneumonia exceeded 9 million.

Just three days ago, Professor Zhang Wenhong, director of infectious diseases department of Huashan Hospital Affiliated to Fudan University, pointed out on the social platform that 10 days later, the world's new crown pneumonia patients will break through 10 million and speed up the research and development of vaccine products will become the key way to solve this global disaster.

At present, many countries in the world are accelerating the development of new crown vaccine, among which the United States, Britain and China are making the fastest progress. According to who data, more than 100 teams worldwide are competing to develop new crown vaccine. It is also reported that there are 6 kinds of vaccines for clinical research in China, of which 3 vaccines will soon enter the 3 phase of clinical trials. On the night of June 23rd, Chinese bio Group officially announced that its new crown inactivated vaccine will soon begin its international clinical phase III study in the United Arab Emirates.

Zheng Zhongwei, the head of the special research team on vaccine development and joint control, said that according to the severity of the epidemic, according to the twentieth provision of the Chinese vaccine law, emergency use of the vaccine can be initiated when there is a particularly serious public health event.

Accessibility is another important issue after the successful development of vaccines. In this regard, Liang Yingyu, chief executive of Qiming venture capital, pointed out that the demand for the new crown pneumonia vaccine is huge. No matter which country is first developed, it is difficult for the production capacity to meet the global demand in a short time. Only through cooperation with different countries, the authorization of Technology and production is the best way to instantly increase productivity and avoid bottlenecks. Developing countries can effectively control costs on the basis of local production and ensure that people can enjoy the fruits of joint development of vaccines at affordable prices.

China speeds up vaccine market

According to real-time statistics of Johns Hopkins University, as of 8:33 Beijing time, the number of confirmed cases in the world has exceeded 9 million, and the cumulative death rate is over 470 thousand. According to the statistical data of the time of June 23rd,

Medical experts worry that in the northern hemisphere, because of the arrival of winter, Asian countries with better control of the new crown pneumonia situation may have a new outbreak of the outbreak of new crown pneumonia. However, the countries with severe epidemics in Europe and the United States are likely to aggravate the severity of the epidemic due to the arrival of winter, so they call on all countries to speed up the research and development of the new crown vaccine.

According to published data, University of Oxford and AstraZeneca pharmaceutical company cooperate in the development of AZD1222 vaccine the fastest progress, has now entered the three phase of clinical; the United States has a vaccine called mRNA1273 is about to enter the three phase of clinical, and a vaccine called INO-4800 has entered the first phase of clinical.

In June 19th, the Ministry of science and technology and the National Health Protection Commission informed that China's scientific research team laid out 12 research and development tasks according to the 5 vaccine technology routes, and 5 new crown vaccines were approved for clinical trials, accounting for 40% of the total number of clinical trials in the world.

In June 22nd, according to sci-tech daily, the new type of coronavirus inactivated vaccine developed by the Institute of medical biology of the Chinese Academy of Medical Sciences entered the phase II clinical trial in Honghe Prefecture, Yunnan province in the afternoon of June 20th. This is the fourth new inactivated vaccine for coronary disease in China, which has entered the two phase of clinical trials.

Among them, the inactivated vaccine of Kexing Zhongwei will launch the III phase clinical trial in Brazil in July, and a total of 9000 volunteers will be recruited. Vaccine expert Tao Li Na told reporters on twenty-first Century economic report that if the progress is successful, the test will see the obvious effect within two months. "Optimistic estimate that about October this inactivated vaccine can be approved".

Liang Yingyu, chief executive of Qiming venture capital, believes that in order to speed up the listing of vaccines, we should consider adopting an open and transparent system as long as the pharmaceutical factory can prove that the vaccine reaches a minimum preventive rate, and clearly shows the ingredients and effectiveness, that is, allowing vaccines that have proved harmless to go public.

The twentieth provision of China's vaccine law stipulates that the urgent need for vaccines for major public health emergencies or other vaccines that are urgently needed by the health and Health Department of the State Council should be approved by the drug regulatory authorities under the State Council.

At the same time, relevant state departments and R & D enterprises are preparing for the mass production of the new crown vaccine.

In June 18th, the five departments of the national health and Health Committee, the Ministry of science and technology, Ministry of industry and information technology, the State Administration of market supervision and the State Administration of Drug Administration jointly issued the general requirements for Biosafety in the vaccine production workshop as a temporary emergency standard to promote the production of the new crown vaccine.

Enterprises are also actively preparing for mass production.

At present, the Beijing Biological Products Research Institute workshop has a batch production of over 3 million agents, and its annual production capacity reaches 100 million -1.2 billion after mass production. In addition, the construction of the new crown inactivated vaccine workshop of the Wuhan Institute of biological products is expected to be completed by the end of June and early July.

In addition, according to the twenty-first Century economic report reporter learned from Kexing biology, Kexing Zhongwei is building a new crown vaccine production workshop in Daxing District, Beijing, and is expected to supply 100 million doses of new crown vaccine every year after commissioning. Kang Xin, who works with Academician Chen Wei, is also actively preparing for capacity.

At the same time, some studies have shown that some new crown viruses are mutating. In June 22nd, Dr. Xu Younong, deputy director of disease biology at the global health drug research and development center, told the twenty-first Century economic analysis reporter that because the new crown virus is integrated into the cells through the spike protein and the angiotensin converting enzyme 2 (ACE2) receptor on the cell surface, the antibody that blocks the spike protein is the core of the development vaccine. Up to now, the variation of spike protein is very small, and some mutations in the spike protein (including D614G) have not changed the interaction between the receptor binding domain and ACE2, so it will not affect the current vaccine research and development strategy.

However, once the mutation of the important antigen sites in the receptor binding domain of the spike protein affects its interaction with ACE2, the current vaccine will fail, that is, the vaccine induced antibody can not effectively neutralize the new crown virus with this mutation.

On June 18th, Zhang Yuntao, vice president of biology in China, told China news agency Xinhua that the inactivated vaccine of Chinese biological crown was not affected by virus mutation. It was first launched in 2021.

Vaccine accessibility has become the focus of attention

Another issue that must be concerned is the accessibility of vaccines after the successful development of vaccines.

Liang Yingyu said that the demand for the new crown pneumonia vaccine is huge. No matter which country is developed first, it is difficult for the production capacity to meet the global demand in a short time. Only through cooperation with different countries, the authorization of technology and production is the best way to improve productivity and avoid supply bottlenecks.

At the 2020 fiscal summer summit held in June 22nd, Gavi Seth CEO Berkeley said that if we want to overcome the new crown disease and revive the economy, the only realistic way is to develop effective vaccines and international cooperation so that the vaccine will benefit the whole world, no matter poverty or wealth.

If the vaccine is successful, market demand for the new crown vaccine will exceed the previous experience of the pharmaceutical industry. Berkeley stressed that it is now imperative to respond in the same seriousness to the obstacles faced by the production, procurement and distribution of vaccines on an unprecedented scale.

In fact, when the world calls for the advent of the new crown vaccine, it is also necessary to discuss the issue of equitable distribution and accessibility of vaccines.

In June 17th, Zhang Li, director of the global innovation and immunization Alliance (Gavi) strategic innovation and new investor center, told the twenty-first Century business reporter at the Gates foundation global health and development media seminar that if each country signed a bilateral agreement with all manufacturers, it would inevitably lead to low income countries and countries without resources that could not get the vaccine, especially the initial vaccine.

According to the introduction, in response to these challenges, the global alliance for vaccines and immunization recently set up a "new crown vaccine vaccine pre market procurement commitment mechanism" (AMC) to purchase new crown pneumonia vaccine for low-income countries.

Zhang Li said that the initial financing target of the pre market procurement mechanism is US $2 billion, which can guarantee a new crown vaccination for health care workers in 78 recipient countries. At the global vaccine summit 4 this month, the mechanism has raised nearly $600 million.

Zhang Li introduced the Ebola virus as an example. In order to encourage Ebola vaccine to go public as soon as possible, Gavi set up a pre purchase commitment. That is to say, how much quantity should be promised by the enterprise first, and at the same time, it provides funds for the enterprise to make the related work directly for the final approval and listing. At least, the enterprise knows that the R & D cost in front is borne by the enterprise.

"In 2017, we signed a pre purchase commitment with Merck at the time. So far, Ebola vaccine has already made 500 thousand doses of vaccine reserves, and now the Ebola virus in West Africa is showing signs of rebound, at least ensuring that all front-line medical staff can vaccinate the vaccine, which is very important." Zhang Li said.

In addition, Zhang Li also referred to the international immunization financing mechanism, that is, to issue bonds in the capital market in the name of vaccine, which is supported by the sovereign state finally, which is the commitment made by the state in 20 or 30 years in the whole debt repayment process.

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