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    Home > Active Ingredient News > Drugs Articles > Crossing WHO-PQ certification domestically produced new crown vaccine to ensure vaccine supply in developing countries

    Crossing WHO-PQ certification domestically produced new crown vaccine to ensure vaccine supply in developing countries

    • Last Update: 2021-11-03
    • Source: Internet
    • Author: User
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    According to reports, as of the end of September this year, China has exported nearly 1.
    5 billion doses of COVID-19 vaccine (including stock solution) to 112 countries and regions around the world, equivalent to 1/6 of the current global vaccine production.
    China has become the global COVID-19 vaccine supply.
    The workhorse
    .

    Major supplier of COVID-19 vaccine in developing countries

    Major supplier of COVID-19 vaccine in developing countries

    From a global perspective, there will be a total of 20 countries or regions with vaccine production or research and development capabilities in 2020, mainly in regions with strong comprehensive technical strengths such as Europe, America, Japan, India, and China, and populations such as Indonesia, Bangladesh, and Brazil.
    More countries
    .

    As a major supplier of global public goods, China has made China's contribution to achieving the availability and affordability of the new crown vaccine in developing countries
    .

    From the perspective of export regions, the main export destinations of domestic new crown vaccines are in Southeast Asia and the Middle East.
    They are ranked in descending order of vaccine export value.
    The top 5 countries and regions are Indonesia, Turkey, Brazil, Mexico and Pakistan
    .


    Among them, the export value of Indonesia, the largest exporter, exceeded 6 billion yuan from January to July


    Two vaccine companies exporting to developing countries

    Two vaccine companies exporting to developing countries

    On May 7, 2021, the World Health Organization (WHO) announced the approval of the emergency use authorization of the new crown vaccine of the Beijing Institute of China National Pharmaceutical Group, allowing the vaccine to be promoted worldwide
    .


    The Phase III clinical data submitted by Sinopharm Beijing to the WHO are the results of the trial (NCT04510207) of 45,000 participants over 18 years old in the UAE, Bahrain, Egypt and other countries.


    The virus-inactivated Covid-19 vaccine developed by Beijing is the first Chinese Covid-19 vaccine to be included in the WHO emergency use list and the sixth vaccine in the world to be included in the WHO emergency use list
    .

    Beijing Kexing Zhongwei submitted an application for inclusion in the emergency use list to the WHO in mid-October last year, and submitted clinical research data, non-clinical research data, quality and pharmaceutical research data, etc.
    , in accordance with the requirements of the WHO, for the WHO to assess the safety of the vaccine.
    , Effectiveness and product quality are continuously evaluated
    .

    In early June, the new crown inactivated vaccine developed by Beijing Kexing Zhongwei Biotechnology passed the WHO review and was officially included in the emergency use list.
    After the Beijing Institute of China National Pharmaceutical Group, it entered the COVAX plan of the WHO and provided China's new crown vaccine.
    The supply of vaccines has brought China's plan to respond to the epidemic for the vast number of vaccine-scarce developing countries
    .

    WHO-PQ certification standard

    WHO-PQ certification standard

    The full name of WHO-PQ certification is the World Health Organization Supplier Pre-certification.
    This certification activity was launched in 2001 to expand the access to selected priority drugs, ensure the treatment, efficacy and safety of drugs purchased by international funds, and serve development.
    Patients in China
    .

    The threshold for the export of new crown vaccines to developing countries

    The threshold for the export of new crown vaccines to developing countries

    The listing of domestic vaccines mainly needs to pass GMP certification, and the threshold standards for export to developing countries need to pass WHO-PQ certification
    .

    The WHO emergency use list procedure refers to the technical review procedure for including new products or products that have not passed the pre-certification into the scope of procurement in response to public health emergencies
    .


    After the global outbreak of the new crown epidemic, WHO revised the emergency use procedure guidelines and reviewed the emergency use list as a prerequisite for countries to provide vaccines for the "New Coronary Pneumonia Vaccine Implementation Plan" (COVAX)


    According to reports, the immunization strategy advisory group (SAGE) under the WHO is responsible for reviewing evidence and making recommendations on policies and dosages related to the new crown vaccine.
    According to the process, the new crown vaccine is evaluated by a special meeting of SAGE, and SAGE submits the final recommendations to the WHO
    .


    The SAGE review is based on the summary of the clinical trial data of the new crown vaccine in China and abroad


    Up to now, only the two vaccine manufacturers of China National Pharmaceutical Group Beijing Institute and Beijing Kexing Zhongwei have passed the WHO-PQ certification for the new crown vaccine, and the products are exported to overseas developing countries
    .


    In addition, Kangxinuo, Clover, and Zhifei are in the application stage of WHO-PQ certification, and the application progress of the first two is relatively fast


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