The first recombinant Ebola virus vaccine was approved by CFDA

October 19, 2017, the State Food and Drug Administration approved the "recombinant Ebola virus vaccine (adenovirus vector)" new drug registration application. The vaccine is independently developed by China, with completely independent intellectual property rights of innovative recombinant vaccine products, by the Academy of Military Medical Sciences Institute of Bioengineering and Kangxinuo biological joint-stock research and development company.

In 2014, the most serious Ebola epidemic in the West Africa had erupted at least 1.13 million people, and the World Health Organization has classified it as one of the most serious diseases of humanity. China's approval of the Ebola virus vaccine using the international advanced replication-defective virus carrier technology and serum-free high-density suspension culture technology, which can stimulate the human body immunity and humoral immunity not only ensuring safety, but also with good immunogenicity. In addition, the vaccine also broke the technical bottleneck of virus carrier vaccine freeze-dried preparations. Prior to this, there are only two countries, United States and Russia, in which Ebola virus vaccine are available. Compared with foreign liquid dosage form Ebola vaccine, China's freeze-dried dosage form Ebola virus vaccine with more excellent stability, especially in Africa and other high-temperature areas for transport and use, with more prominent advantages.

Since January 2015, the food and drug administration immediately launched a special examination and approval procedures, set up a special working group, simultaneously conduct on-site inspection and technical evaluation and sample inspection, approved the clinical trial of this product on February 13th of the same year. On October 19, 2017, the food and Drug Administration approved the registration of this variety, and issued a new drug certificate and drug approval number.

In the future, in order to further promote the pharmaceutical industry restructuring and technological innovation, approve more new drugs and medicine as soon as possible to better meet the public medical needs, enable 1.3 billion people can enjoy the deep well-being of healthy, Chinese Food and Drug Administration will also be the same Relevant departments to further deepen reform, to promote the improvement of laws and regulations, to develop detailed supporting documents, strengthen the system convergence, strengthen the effect of monitoring, to ensure a solid and orderly reform.