The first recombinant Ebola virus vaccine was approved at an advanced speed

On October 19, 2017, the State Food and Drug Administration approved the new drug registration application of "recombinant Ebola virus vaccine (adenovirus vector)" Source | CFDA this vaccine is an innovative recombinant vaccine product independently researched and developed by our country with completely independent intellectual property rights It is jointly developed by the Institute of bioengineering of the Academy of Military Medical Sciences and kangxinuo biological Co., Ltd In 2014, the most serious Ebola outbreak ever broke out in West Africa, killing at least 11300 people, which was listed as one of the most serious diseases to human beings by the World Health Organization The approved vaccine of Ebola virus disease in China adopts the international advanced replication defective virus vector technology and serum-free high-density suspension culture technology, which can simultaneously stimulate human cell immunity and humoral immunity, while ensuring safety, it also has good immunogenicity In addition, the vaccine also broke through the technical bottleneck of freeze-dried preparation of virus vector vaccine Prior to that, only the United States and Russia had available Ebola vaccine Compared with the foreign liquid form of Ebola vaccine, the freeze-dried form of Ebola vaccine in China has better stability, especially when it is transported and used in high temperature areas such as Africa Under the background of deepening the reform of 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, development and registration application of Ebola virus vaccine in China Since the acceptance of the clinical trial application of this product in January 2015, the food and drug administration immediately launched a special approval procedure, established a special working group to conduct on-site verification, technical review and sample inspection simultaneously, and approved the clinical trial of this product on February 13 of the same year The World Health Organization has invited China's drug regulatory authorities and research and development teams to Geneva for many times to participate in the thematic discussion on the prevention and control of Ebola epidemic, and included the vaccine in the World Health Organization's guidelines on the quality, safety and effectiveness of Ebola virus vaccine In April 2017, the variety officially applied for production registration, and the food and drug administration immediately incorporated the application into the priority review procedure In the process of technical review, the State Food and Drug Administration organized and held many communication meetings and expert meetings to fully communicate with the applicant regarding the problems in the process of application and registration, so as to ensure the smooth development of product R & D registration On October 19, 2017, the food and Drug Administration officially approved the application for registration of this variety, and issued a new drug certificate and drug approval number In the past two years, the General Administration of food and drug administration has earnestly implemented the opinions of the State Council on the reform of the review and approval system for pharmaceutical and medical devices and the opinions of the general office of the CPC Central Committee and the general office of the State Council on deepening the reform of the review and approval system to encourage the innovation of pharmaceutical and medical devices, formulated a series of reform policies to encourage the innovation of pharmaceuticals, and continuously improved the standards and transparency of review and approval, The effective purification of the R & D registration ecological environment, the priority approval of a batch of innovative drugs and medical devices, and the successful approval of the recombinant Ebola virus vaccine are the concrete embodiment of the implementation of relevant policies, and an important practice of deepening the reform of drug review and approval system and encouraging drug innovation Its approval not only provides a strong guarantee for the prevention and control of major public health events, but also promotes and leads the research and development of vaccines for major infectious diseases in China, which is conducive to actively promoting the construction of national public health system It shows that the strength of scientific and technological innovation in the field of biomedicine in China has leapt up, which has important strategic significance for national biosafety It also provides a new means for China to effectively control the epidemic situation when the global public health events break out, and highlights the image of China as a big country taking the international responsibility on its own initiative   In the future, in order to further promote the structural adjustment and technological innovation of the pharmaceutical industry, make more new and good drugs come into the market as soon as possible, better meet the public medical needs, and enable 1.3 billion people to enjoy the profound well-being of a healthy China, the food and Drug Administration will further deepen the reform with relevant departments, promote the improvement of laws and regulations, formulate detailed supporting documents, strengthen the system connection, and strengthen We will monitor the effectiveness of the reform and ensure that the reform is carried out in a solid and orderly manner.