The inactivated enterovirus 71 vaccine (human diploid cells), a new biological product, was approved by CFDA for marketing

On December 3, the State Food and Drug Administration approved the registration application for the production of enterovirus 71 inactivated vaccine (human diploid cells), a new class 1 new preventive biological product independently developed by the Institute of medical biology, Chinese Academy of Medical Sciences The advent of the vaccine is of great significance to effectively reduce the incidence rate of children's hand foot mouth disease, especially to reduce the severe and fatal cases of the disease and protect the health of children in China Hand foot mouth disease (HFMD) is an infectious disease caused by enterovirus infection, which occurs in infants under 5 years old Some of the children infected by enterovirus 71 (EV71) can cause nervous system infection symptoms and lead to cardiopulmonary failure, even death Since the disease appeared in China in 1981, there have been many large-scale outbreaks or epidemics, which seriously threaten the life and health of hundreds of millions of children In May 2008, HFMD was officially included in the national legal infectious disease class C case report management In recent years, the number of HFMD patients in China has always been in the forefront of legal infectious diseases Currently, there is a lack of specific treatment drugs, and severe and death cases occur frequently The development and use of vaccines are crucial to prevent and control the epidemic of HFMD Since 2008, the Institute of medical biology of Chinese Academy of Medical Sciences has started the research and development of EV71 inactivated vaccine, which is supported by the national major science and technology special project of new drug development by the health and Family Planning Commission Based on the study of the biological characteristics and infection mechanism of EV71, the adaptive passage, immunogenicity, safety and genetic characteristics of EV71 on human diploid cells were studied from the perspective of virus isolation In the absence of similar vaccine R & D and marketing at home and abroad, the product has broken through the bottleneck of key technologies for large-scale production and quality control of vaccine diploid cells, established a technology system for large-scale production, as well as a quality control and quality standard system, and laid the foundation for the production of safe, effective and quality controlled vaccine products The clinical trial results of ten thousand subjects showed that the vaccine was safe and the protective rate for EV71 induced hand foot mouth disease could reach 97.3% This suggests that the vaccine can obviously reduce the incidence rate of HFMD after listing and has good clinical benefits The food and Drug Administration focused on the R & D and registration of the vaccine and accelerated the review of EV71 vaccine registration Because the vaccine is a brand-new viral vaccine, there is no data support for comparison and reference in its research and development and evaluation process; at the same time, because the basic research on EV71 virus is relatively weak at home and abroad, the pathogenesis, immune type, infection incubation period and other aspects of clinical death of the disease are under research and exploration, and these issues are the technical evaluation and inspection of the vaccine And so on According to the characteristics of the vaccine research and development and regulatory needs, the food and Drug Administration organized and coordinated the national health and Family Planning Commission and other relevant departments to work together, and gave priority to the review, approval, verification, inspection and other work of the vaccine through early intervention, close follow-up, coordination and linkage At the same time, we should establish a working mechanism with the participation of multiple units, such as the Chinese Academy of inspection, the drug Audit Center, the verification center and the China CDC According to the progress of product research and development and registration, we should organize dozens of work coordination meetings, expert argumentation meetings and academic seminars, and invite experts from the World Health Organization to participate in the discussion on the trial scheme and clinical data of the vaccine, and carefully analyze the epidemic Difficulties and challenges in vaccine research and development and evaluation, in-depth product quality control research, comparative research and standardization research, accurate and efficient completion of clinical serum samples and pathogenic samples testing; guide research and development institutions to improve key indicators and risk control measures, and scientifically promote and accelerate the process of EV71 vaccine research and development and registration under the premise of ensuring safety The successful marketing of EV71 inactivated vaccine is of great public health significance to prevent and control the epidemic of HFMD in children caused by EV71 virus, reduce the incidence of severe cases, improve the emergency response ability to deal with sudden infectious diseases in China, and protect people's health and life safety Since the issuance of the State Council's opinions on the reform of the review and approval system for pharmaceutical and medical devices (GF [2015] No.44), the food and drug administration has earnestly implemented the relevant requirements, closely focused on the overall situation of ensuring public health and promoting industrial transformation and upgrading, with the improvement of drug quality as the core, with the focus on solving the registration backlog, and with the guidance of encouraging the creation of new drugs as the guide, and accelerated the establishment of More scientific and efficient review and approval system On the basis of self-examination and verification of drug clinical trial data to ensure the authenticity and integrity of the test data, we should actively encourage the creation of new drugs through innovation system, priority review, simplification of procedures, strengthening of communication and other measures, so as to truly form a review and approval mechanism conducive to stimulating innovation Tips: Enterovirus 71 is a kind of human enterovirus, EV71 for short It often causes hand foot mouth disease, viral angina in children, and myocarditis, pulmonary edema, encephalitis, etc in severe children These diseases are collectively referred to as enterovirus EV71 infection diseases Most of the cases occurred in children, especially infants under 3 years old A few of them were seriously ill and even died EV71 infection can occur all year round, and it is common from April to September The incubation period of the disease is 2-7 days The source of infection includes the patients and the recessive ones, which are mostly transmitted by air (droplets), diet and close contact Infected children will have chickenpox like herpes on the skin of hands, feet or oral mucosa, which is called hand foot mouth disease EV71 is a global infectious disease EV71 was first confirmed in the United States in 1972 In Australia, Sweden, Bulgaria, Hungary and other countries, EV71 with the central nervous system as the main clinical feature has been epidemic Japan is an Asian country with a high incidence of EV71 infection There have been many large-scale epidemics in history In the late 1990s, EV71 began to ravage East Asia Since 1997, the disease has been in large-scale outbreak in Malaysia, Singapore and other places, resulting in an increase in deaths due to the complications of central nervous system symptoms, which has attracted the attention and vigilance of all countries in the world The disease has been found in Shanghai since 1981, and has been reported in more than ten provinces (cities) such as Beijing, Hebei, Tianjin, Fujian, Jilin, Shandong, Anhui, Hubei and Guangdong From May 2008 to June 2015, 12.8 million HFMD cases and 3296 deaths were reported in China It has become one of the diseases with the highest incidence of infectious diseases in China for several consecutive years The situation of epidemic prevention and control is not optimistic At present, there is no targeted treatment drug for the disease Prevention is an effective means to reduce and control EV71 infection The development and use of vaccine is the first choice to prevent and control the disease.