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Medical Network October 23, 2017 On October 19, 2017, the State Food and Drug Administration approved the application for registration of a new drug for “recombinant Ebola virus vaccine (adenovirus vector)â€. The vaccine is an innovative recombinant vaccine product independently developed by China and with completely independent intellectual property rights. It is jointly developed by the Institute of Biotechnology of the Academy of Military Medical Sciences and Kangxi Bio-investment Company.
In 2014, the most serious Ebola outbreak in West Africa broke out in West Africa, killing at least 113,000 people, and the World Health Organization listed it as one of the most harmful diseases to humans. China's approved Ebola virus vaccine uses internationally advanced replication-defective virus vector technology and serum-free high-density suspension culture technology, which can simultaneously stimulate human cellular immunity and humoral immunity, while ensuring safety. Good immunogenicity. In addition, the vaccine also broke through the technical bottleneck of the viral vector vaccine lyophilized preparation. Prior to this, only the United States and Russia had available Ebola virus vaccines available worldwide. Compared with the foreign liquid dosage form Ebola vaccine, China's lyophilized Ebola virus vaccine has better stability, especially when transported and used in high temperature areas such as Africa.
Under the background of deepening the reform of the drug review and approval system and actively encouraging drug innovation, the Food and Drug Administration has given high attention and strong support to the research and development and registration of Ebola virus vaccine in China. Since accepting the application for clinical trial of this product in January 2015, the General Administration of Food and Drug Administration immediately launched a special approval process, set up a special working group, and conducted on-site verification, technical review and sample inspection simultaneously, and approved this on February 13 of the same year. Clinical trial of the product. The World Health Organization has repeatedly invited China's drug regulatory authorities and research and development teams to Geneva to participate in the Ebola epidemic prevention and control topic, and included the vaccine in the World Health Organization's Ebola virus disease vaccine quality, safety and effectiveness. guide. In April 2017, the variety was formally declared for production registration, and the General Administration of Food and Drug Administration immediately included the application in the priority review process. During the technical review process, several communication meetings and expert meetings were organized to address issues in the registration process. Applicants conduct sufficient communication to provide guarantee for the smooth development of product R&D registration. On October 19, 2017, the Food and Drug Administration officially approved the registration application for the variety, and issued the new drug certificate and drug approval number.