Two new coronavirus vaccines in China start clinical trials

- May 13, 2020-

On April 11, the staff conducted impurity testing on samples of the new inactivated coronavirus vaccine in the quality inspection department of Sinopharm's China Bio-New Crown Vaccine Production Base.

The reporter learned on April 14 from the State Council Joint Prevention and Control Mechanism Scientific Research Group that two of China ’s new inactivated coronavirus vaccines have been approved by the State Drug Administration to initiate a phase one or two combined clinical trial, becoming the first to adopt clinical research approval A new coronavirus vaccine based on the "inactivated" technical route.

Prior to this, the adenovirus vector vaccine of the Academy of Military Medical Sciences of the Academy of Military Sciences has been approved for clinical trials.

What does this mean that China's vaccine research and development is in progress? What are the characteristics of different vaccines?

The effect needs to continue to be evaluated. The inactivated vaccine process is more mature

The two new inactivated coronavirus vaccines approved for clinical trials this time were developed by Sinopharm Group Wuhan Biological Products Research Institute and Beijing Kexing Zhongwei Biotechnology Co., Ltd. in conjunction with relevant scientific research institutions.

It is understood that both units urgently carried out research and development work in January, completed the preparation of the first batch of vaccines at the end of February and early March and fully entered the animal safety and effectiveness evaluation process.

Generally speaking, animal experiments must be completed before initiating a phase 1 clinical trial to confirm that viral proteins can be delivered to key parts of the immune system so that the immune system can recognize the virus. This process can be achieved by using inactivated or inactivated viruses, recombination or extraction of viral proteins.

The relevant person in charge of Sinopharm Group stated that the inactivated vaccine approved for clinical trials this time is a vaccine that kills the virus by physical or chemical methods, but still retains the activity of the virus to cause human immune response. This technical route vaccine has a long-term research foundation, has mature production technology, controllable quality standards, and wide protection. It has been widely used in the prevention of infectious diseases such as hepatitis A, influenza, hand, foot and mouth disease, and poliomyelitis.

According to the relevant national laws and regulations, the relevant enterprises have been prepared for emergency use. Taking Sinopharm Group as an example, its clinical trial batch production of new coronavirus vaccines exceeded 50,000 doses, and after batch production, each batch output exceeded 3 million doses, with an annual production capacity of more than 100 million doses, and has the capacity to produce large-scale inactivated vaccines. .

However, clinical trials are divided into Phase I, Phase II, and Phase III, and the sample size is constantly expanding. The safety and effectiveness of vaccines need to be continuously verified and then "passed" in order. According to previous news released by the World Health Organization, this time usually takes more than a year.

On April 10, the staff tested the illuminance in the new coronavirus inactivated vaccine production workshop that has not yet been put into production at Sinopharm's China Bio-New Crown Vaccine Production Base. Xinhua News Agency reporter Zhang Yuwei photo

1 billion yuan in funds, "wartime rhythm" Vaccine research and development started at high speed

In an emergency, vaccine research and development entered a "wartime rhythm."

It is understood that Sinopharm China Biotechnology established a scientific research leadership team led by Yang Xiaoming, the chief scientist of the vaccine project of the "863" program of the Ministry of Science and Technology, on January 19, and quickly arranged 1 billion yuan in research and development funds and deployed 3 research institutes in Development of new coronavirus vaccines on two technical routes.

Among them, the inactivated vaccine was developed by Sinopharm Group China Bio-Wuhan Biological Products Research Institute and Wuhan Institute of Virology, Chinese Academy of Sciences, Wuhan, and Sinopharm Group China Bio-Beijing Bioproducts Research Institute and China Disease Control and Prevention Center, Beijing Institute of Viral Disease Prevention and Control. The genetic engineering vaccine is led by the Chinese Academy of Biotechnology.

According to the relevant person in charge of Sinopharm Group, scientific researchers have successively completed the production and quality control of a series of new coronavirus vaccines including vaccine strain screening, virus seed bank establishment, antibody preparation and identification, detection method establishment, production process research, compatibility and formulation screening , Quickly develop and complete the effectiveness and safety evaluation of animals.

At the same time, the scientific research team of Kexing Zhongwei relied on the experience of SARS vaccine development in Zhejiang Provincial Center for Disease Control and Prevention, Institute of Laboratory Animals, Chinese Academy of Medical Sciences, Chinese Center for Disease Control and Prevention, Institute of Biophysics, Chinese Academy of Sciences, and Military Medical Research With the cooperation and vigorous support of the Institute of Microbiology and Epidemiology, the research and development of new coronavirus vaccines has also continued to accelerate.

The relevant person in charge of Kexing Zhongwei said that the company has adjusted the vaccine development target to respond to the global epidemic. Existing research data shows that the vaccine has a good cross-neutralization response to different new coronavirus strains at home and abroad, providing data support for the use of vaccines worldwide.

When the epidemic situation is urgent, the State Food and Drug Administration is also preparing for emergency review and approval, organizing an early team of experts to intervene and follow up the research and development process at the same time, and accelerate the approval process on the premise that the standards are not lowered, the procedures are not reduced, and the vaccine is safe and effective.

Simultaneously launch 5 technical routes and enter clinical trials

Vaccines are essential for epidemic prevention and control, and safety requirements are also the first priority. Since the outbreak, the research team of the Joint Defense and Joint Control Mechanism of the State Council has set up a special vaccine research and development team, and laid out a total of 5 technical routes based on inactivated vaccines, recombinant protein vaccines, adenovirus vector vaccines, attenuated influenza virus vector live vaccines, and nucleic acid vaccines.12 Research and development tasks to ensure the overall success rate of new coronavirus vaccine research and development.

Prior to this, the adenovirus vector vaccine of the Academy of Military Medical Sciences of the Academy of Military Sciences has been approved for clinical trials.

At the press conference of the Joint Defense and Joint Control Mechanism of the State Council in mid-March, Wang Junzhi, an academician of the Chinese Academy of Engineering, once said that the progress of China's new coronavirus vaccine research and development is generally in the forefront of the world. Clinical Trials.

Wang Junzhi said that without reducing standards and ensuring safety and effectiveness, Chinese scientists are racing to speed up vaccine development.