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    A New Global Vaccine Is Needed For The Vaccine.

    2020/6/30 7:48:00 1

    New CrownVaccineArmySpecial NeedsDrugsApprovalGlobalEpidemicVaccine

    In June 29th, Kang Xi no announced that the new recombinant coronavirus vaccine (adenovirus vector Ad5-nCoV), which was jointly developed by the military medical research and Bioengineering Research Institute of the Academy of military science, was approved by the Health Bureau of the Logistics Department of the Central Military Commission in June 25, 2020. Approval of the Ministry shall not extend the scope of vaccination.

    The vaccine completed the two phase of the trial in June 11th. Industry vaccine experts told the twenty-first Century economic report reporter that according to the twentieth provisions of the Chinese vaccine act, the use of the new crown vaccine is "special approval" for conditional use.

    In June 28th, the world's new crown pneumonia patients exceeded 10 million. Zhang Wenhong, director of infectious diseases department of Huashan Hospital Affiliated to Fudan University, pointed out that accelerating the speed of research and development of vaccine products will become the key way to solve this global disaster.

    In June 29th, Wu Zunyou, chief expert of epidemiology at the China Center for Disease Control and prevention, said in a media interview that the overall progress of vaccine research and development is better, but there are still many uncertainties. At present, China should also maintain its original prevention and control strategy, namely, external defense input and internal defense rebound. As long as the global epidemic is not controlled, it will always pose a threat to China's prevention and control.

    According to the vaccine law, "special approval".

    The I phase and II phase clinical trials of the new recombinant coronavirus vaccine (Ad5-nCoV) have been carried out in China, and the phase I clinical trial has been completed in June 11, 2020. Continuing trials showed that Ad5-nCoV has potential to prevent diseases caused by SARS-CoV-2.

    According to the regulations of the PLA on the implementation of the drug administration law of the People's Republic of China, the Ad5-nCoV is limited to the internal use of the army at the present stage, and the scope of vaccination shall not be expanded without the approval of the Ministry of insurance after the Military Commission.

    Industry experts stressed that, in the face of a major public health event, in accordance with the provisions of the vaccine law, under the premise of full demonstration and informed consent, the vaccine can be used urgently in a certain scope and time limit to protect some high-risk groups.

    Zheng Zhongwei, head of the vaccine development and development team of the joint defense and joint control mechanism, said that the listing of vaccines should be carried out in strict accordance with the provisions of the drug administration law. On the other hand, according to the severity of the epidemic, according to the twentieth provision of China's vaccine law, the emergency use of the vaccine can be initiated when there is a particularly serious public health event.

    The specific provisions are as follows: in response to the urgent need for major public health emergencies or other vaccines identified by the health and Health Department of the State Council, if the assessment is more effective than the risk, the drug regulatory agency of the State Council may apply for conditional approval of the vaccine registration application.

    In the event of a particularly serious public health emergency or other serious public health threats, the Department of health and health under the State Council shall put forward suggestions for the urgent use of vaccines according to the prevention and control of infectious diseases. After the organization and demonstration of the drug supervision and Administration Department of the State Council, it can be used urgently within a certain scope and time limit.

    Urgent demand for vaccines

    In fact, in addition to the two phase clinical trial of Conchino's new crown vaccine, China has completed the two phase clinical trial of the two biological inactivated new crown vaccines and the Kexing biological inactivated vaccine recently.

    According to WHO, there are more than 200 vaccine candidates worldwide, of which 15 are undergoing human clinical trials.

    The reason why countries are accelerating vaccine development is closely related to the growing global epidemic. In June 28th, the new crown pneumonia epidemic data of Johns Hopkins University in the United States showed that the number of confirmed cases of new crown pneumonia in the world exceeded 10 million, and the cumulative death toll exceeded 500 thousand. From June 22nd to June 28th, the number of new cases increased by 1 million in 6 days.

    To this end, the vaccine has become a key way to solve this global epidemic.

    Wu Zunyou pointed out that "we have expectations for vaccines, but we can not put all our policies on vaccines, and regard vaccines as the only and only measures."

    According to Wu Zunyou analysis, except for the new crown virus, other coronavirus such as SARS, Middle East respiratory syndrome, etc., after human infection, the generation of antibodies is not very long, not like measles, poliomyelitis, human infection can produce long-term protection. There is still much uncertainty about whether the new crown vaccine can produce long-term immunity.

    "If the new human immune system is not protected for a long time after the infection of the new crown pneumonia virus, it is very likely that there will be a vaccine similar to influenza, that is, regular vaccination is needed. It may be 3 months, 6 months, 1 years or 2 years without a shot to permanently solve the problem." Wu Zunyou pointed out.

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