Heavy! Sinopharm Zhongsheng New Crown Vaccine Obtained Emergency Use Authorization by WHO

May 11, 2021

On May 7, the Director-General of the World Health Organization (WHO) Tan Desai announced that the new coronavirus inactivated vaccine (Vero cell) developed and produced by the Beijing Institute of Biological Products of Sinopharm Group has obtained the emergency use authorization of the WHO and is included Global "Emergency Use List" (EUL). This vaccine is a safe and effective high-quality vaccine certified by the WHO. This is the first emergency use certification of China's new crown vaccine approved by the WHO, and the first new crown vaccine approved by the WHO in a non-Western country. In order to realize the availability of China's new crown vaccine as a global public product, especially in developing countries. Accessibility and affordability have taken another leap forward. This also indicates that the quality, safety, effectiveness, and accessibility of Sinopharm’s China Bio-New Crown Vaccine meets the requirements of the relevant WHO standards. It will, to a greater extent and in a broader scope, contribute to the global fight against the new crown pneumonia epidemic. A community of human health and health, contributing more Chinese power.

The WHO issued an emergency use license to the Sinopharm China Biotech Covid-19 Vaccine and included it in the "emergency use list" in accordance with the WHO prequalification mechanism to respond to emergency public health situations. This mechanism is set up to accelerate the availability of vaccines needed in public health emergencies, and aims to evaluate data such as vaccine quality, safety and effectiveness, and assist the proposed procurement agencies and member states to use approved vaccines. In June 2020, the new coronavirus nucleic acid detection kit of Sinopharm Sinopharm Shanghai Genuo Biotechnology Co., Ltd. was also approved to be included in the WHO emergency use list. Being able to be included in the WHO "emergency use list" is a manifestation of the quality level and comprehensive strength of a country and enterprise's medical vaccine research and development and production.

Up to now, China has a total of five vaccines approved by the World Health Organization, of which three are developed and produced by Sinopharm Group China Biotech. In addition to the new crown inactivated vaccine approved by the Beijing Institute of Biological Products of Sinopharm Group, in 2013, the live attenuated Japanese encephalitis vaccine of the Chengdu Institute of Biological Products of Sinopharm Group became the first in China to pass the WHO pre-certification. Vaccine products. In 2017, the Bivalent Live Attenuated Polio Vaccine (bOPV) of the Beijing Institute of Biological Products of Sinopharm Group also passed the WHO pre-certification.

In April 2021, after strict inspection by EU inspectors, Sinopharm China Bio-New Crown Inactivated Vaccine became the first vaccine product approved for use in the EU and GMP certified in China's history. Based on the mature inactivated vaccine research and development technology platform and advanced technology and quality control system, Sinopharm Group China Biotechnology completed the preclinical research of the new crown inactivated vaccine in 98 days. Based on the good results of domestic I/II clinical trials, Sinopharm's China Bio-New Crown Vaccine was approved by the UAE Ministry of Health and Prevention on June 23, 2020. It is the first phase III clinical trial in the world to be launched, which is also the first time that a Chinese original vaccine has been launched. A large-scale multi-center phase III clinical study was carried out internationally, with 63,000 volunteers enrolled in the group, covering 125 national populations, creating a number of world firsts. It is the world's most invested and fastest-growing clinical research on the new crown vaccine.

On December 9, 2020, the UAE Ministry of Health and Prevention released the Phase III clinical trial data of Sinopharm's China Bio-New Crown Vaccine and approved the vaccine to become the world's first officially registered new crown vaccine. The results of clinical trials show that the vaccine has a protective effect of 86%, a neutralizing antibody conversion rate of 100%, a prevention rate of 100% for moderate infections, and a prevention rate of 100% for severe and critical infections. Real-world research results after mass vaccination show that the effective rate of reducing the hospitalization of vaccinators is 93%, and the effective rate of reducing the demand for intensive care unit is 95%. On December 30, 2020, the State Food and Drug Administration approved the first conditional listing of the new crown vaccine of Sinopharm Beijing Institute of Biological Products in China, and the review determined that the protective effect of the vaccine during the phase III clinical trial was 79.34%. On May 3, 2021, WHO announced the evaluation report on the new crown inactivated vaccine of Sinopharm Beijing Institute of Biological Products. The review found that the effectiveness of the new crown inactivated vaccine of Sinopharm Beijing Institute of Biological Products was 78.1%, which was as high as 78.1%. 90%, the safety is good, no safety problems were found in the clinical trial data.

Up to now, Sinopharm’s China Bio-New Crown Vaccine has been approved for registration or emergency use in 70 countries and regions and international organizations around the world. More than 100 countries and international organizations have put forward procurement requirements. The domestic and international supply of more than 200 million doses has covered 196 inoculations. It is the most widely used, most effective, safest, and most acclaimed new coronavirus vaccine in the world. Sinopharm Group China Biotech not only has the only new crown vaccine approved for marketing in many countries, but also the only company in the world that has 2 technical routes (inactivated vaccines, genetically recombined new crown vaccines) and independently developed 3 new crown vaccines (Beijing Biological Products Research) The new crown inactivated vaccine, the Wuhan Institute of Biological Products, the new crown inactivated vaccine, and the Sinopharm Zhongsheng Biotechnology Research Institute (recombinant new crown vaccine).

It is worth pointing out that as early as April 2020, the Beijing Institute of Biological Products of Sinopharm Group China established a special working group to start the preparation of general technical documents (CTD documents) related to the emergency use of new crown vaccines. During the period, the Beijing Institute of Biological Products of Sinopharm Group and the WHO review expert team have always maintained active communication. Remote video conferences will be held in August and November 2020 to discuss the development, production, preclinical and clinical trials of the new crown vaccine. Communicate the situation and submit CTD documents to WHO on December 28, 2020. After 4 months of rigorous review, on-site inspection, technical review, and related responses, the WHO finally authorized the first Chinese new crown vaccine for emergency use, and included the new crown inactivated vaccine of the Sinopharm Beijing Institute of Biological Products in the "emergency list" .

In order to resolutely implement President Xi Jinping’s important announcement of China's new crown vaccine as a global public product, Sinopharm Group China Biotech has given full play to the role of the central enterprise national team, main force, and pillar, and is the first to build a large-scale P3 high-level biosafety production facility for the new crown vaccine in the world. On the basis of this, the six major biological products research institutes in Beijing, Wuhan, Changchun, Lanzhou, Chengdu, Shanghai and the Sinopharm Zhongsheng Biotechnology Research Institute continue to expand production and packaging capacity, with an annual production capacity of more than 3 billion doses, becoming the world’s largest new crown The vaccine R&D and production base and the largest supplier, and the only biomedical company in the world that independently developed three new crown vaccines on two technical routes, actively contributing China's strength to the global fight against the epidemic.

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Ms. Yi

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