CFDA approved the world's first Sabin polio vaccine

On January 14, 2015, the State Food and Drug Administration approved the production registration application of the world's first Sabin vaccine (single vaccine) The vaccine is developed by the Institute of medical biology, Chinese Academy of Medical Sciences It is produced by using the current live attenuated poliomyelitis vaccine production strain (Sabin strain), by culturing and harvesting the virus in the Vero cell bioreactor, and combining with the inactivated vaccine production process The vaccine is mainly used to prevent poliovirus infection in children by injection, and its listing will play a crucial role in the complete eradication of polio in China Polio is an acute infectious disease caused by poliovirus type Ⅰ, Ⅱ and Ⅲ It is also the second infectious disease to be eliminated within a time limit after smallpox The promotion of its eradication plan has been listed as one of the most important work of the World Health Organization At present, countries mainly use polio inactivated vaccine for injection (IPV) and oral Sabin strain of live attenuated polio vaccine (OPV) for prevention Since 1963, most countries in the world have adopted live attenuated polio vaccine as the main means of immunization because of its simplicity, low cost and convenient transportation The prevention and control of poliomyelitis in China began in the 1960s Through the promotion of live attenuated polio vaccine in China, the occurrence of the disease has been effectively controlled In 2000, China was recognized as a polio free country by the World Health Organization Although the live attenuated poliomyelitis vaccine has strong immunity and long action time, it is a live attenuated vaccine, but it still has potential risk of disease, sometimes it can directly cause the related cases of vaccine strains, or the related cases can be caused by the derivative strains formed by the circulation of vaccine strains Although the incidence of this situation is very low, only about 1 / 2.5-1 / 5 million, if the live attenuated polio vaccine is used alone, the two parallel goals of wild poliovirus eradication and vaccine derived poliovirus eradication proposed by the World Health Organization in the final phase strategic plan for polio eradication (2013-2018) cannot be achieved The use of polio inactivated vaccine can avoid the above situation Therefore, using polio inactivated vaccine instead of live attenuated vaccine will become the necessary way to eliminate polio in the world At present, only a few foreign enterprises use wild poliovirus strains to produce inactivated polio vaccine, and its products are widely used in developed countries One of the products is listed as class II vaccine in China, but the quantity is limited and the price is high In order to ensure that the national commitment of polio eradication made by China to who is fulfilled, it is expected that the annual demand for polio vaccine will reach tens of millions of doses in the future As a major innovative product with completely independent intellectual property rights, the approved Sabin polio vaccine has successfully achieved the progress from "made in China" to "created in China" It not only fills the gap in the field of production of polio vaccine in China, but also breaks the monopoly of production technology of polio vaccine in developed countries, which will have a positive impact on polio eradication in China and even in the world, especially in developing countries It is understood that the vaccine will be gradually incorporated into China's EPI program The World Health Organization also recently sent a letter to the relevant departments of China, proposing to introduce the Sabin vaccine produced in China into the global polio eradication action plan In the process of research and development, evaluation and registration of the vaccine, relevant organizations and departments at home and abroad have paid great attention to it As the world's first Sabin polio vaccine (single vaccine), its evaluation and registration is difficult, influential and responsible In order to comprehensively evaluate the safety and effectiveness of the innovative vaccine, the State Food and drug administration made scientific deployment and overall arrangement, and all relevant units worked closely and seamlessly together Under the framework of laws and regulations, the work process was optimized and the work efficiency was improved The technical review and on-site inspection were ensured by means of full follow-up, open door review, forward-looking guidance and procedure linkage , inspection and testing, administrative approval and other works are completed efficiently, fairly and transparently The technical department of our bureau adheres to the concept of scientific supervision and open vision, conducts professional review according to procedures, holds expert seminars and consultation meetings for many times, and invites representatives and experts from the World Health Organization, the United States CDC, Japan niid, the European Union EMA, the United Kingdom NIBSC and other international organizations, as well as experts and enterprise representatives from the national health and Family Planning Commission and China's infectious disease prevention and control and vaccine research and development field to participate in the meeting Discussion and review On the basis of fully learning from the experience of innovative drug R & D and evaluation at home and abroad, all relevant departments strictly control the work to ensure the scientific, objective and comprehensive registration review