＂Seamless Supervision and Whole-process Monitoring＂ —— The journey of disease control department to analyze a vaccine
Xinhua News Agency, Beijing, April 25th Title: "Seamless Supervision and Whole Process Monitoring" —— The journey of disease control department to analyze a vaccine
Xinhua News Agency reporters Shuai Cai, Yu Yong and Zi Qiang
April 25th is the 32nd National Child Vaccination Day. 40 years ago, China began to implement planned immunization. 40 years’ practice has proved that immunization program is one of the public health measures with significant cost-effectiveness and wide influence in various health work, which has contributed to effectively protecting children’s health.
Many people have this question: How are vaccines produced, transported and stored? Is the quality supervision of the whole process in place? The reporter learned from the disease control departments in Hunan, Zhejiang, Yunnan and other places that at present, China has established and improved the working mechanism of immunization planning with government-led, departmental cooperation and social participation, and implemented timely monitoring of all aspects of vaccine storage, transportation and vaccination to ensure vaccine quality and vaccination safety.
At present, China’s vaccines are divided into two categories. The first category is vaccines provided by the government to citizens free of charge, and the second category is other vaccines that are planted by citizens at their own expense and voluntarily. The reporter learned from the Hunan Provincial Center for Disease Control and Prevention that the health department is responsible for bidding and purchasing the first type of free vaccine, and the CDC collects it uniformly. When the CDC staff receives the vaccine, they need to carry a refrigerator and put enough ice cubes to ensure that the temperature of the refrigerator meets the requirements for vaccine storage, and then put the vaccine in the refrigerator and transport it to the hospital. After the vaccine is distributed to the hospital by the CDC, the hospital will store the vaccine in the freezer according to the required storage temperature, and fill in the Registration Form for Vaccine Entry and Exit as required.
Zhang Shujun, head of the Immunization Planning Department of the Hunan Provincial Center for Disease Control and Prevention, said that Hunan’s disease control department stipulates that doctors need to confirm whether infants have serious organ diseases, fever caused by acute infectious diseases, and allergies to vaccine ingredients before vaccinating infants. Doctors will vaccinate infants in strict accordance with operational requirements.
Yi Luzhen, deputy director of the Hunan Provincial Health Planning Commission, said that in order to ensure the safety of vaccines, Hunan has established a supervision system for the whole process of vaccine batch issuance, transportation, storage and vaccination to ensure seamless supervision of vaccine safety and quality; Implement the "double insurance" system for vaccine batch issuance: on the one hand, drug inspection institutions should test the vaccine indicators in the laboratory according to standards; On the other hand, drug inspection institutions should strictly review the quality control of the production process submitted by enterprises.
Xie Shuyun, director of the Institute of Immunization Planning of Zhejiang CDC, told reporters that with the deepening of the concept of vaccination, the public is paying more and more attention to vaccine safety. Domestic vaccines have very strict process requirements from research and development, production to approval and listing.
"The first is animal experiments. After reaching certain standardization and effectiveness, they will enter human trials. Human trials are divided into phase I, phase II and phase III. After the test results demonstrate that the vaccine is safe and effective, it can be approved and produced. Before production and marketing, each batch of vaccine should be sampled. After the vaccine was approved by the State Food and Drug Administration, the corresponding enterprises began to produce and market. " Xie Shuyun said.
According to the introduction of Zhejiang Provincial Center for Disease Control and Prevention, in Zhejiang, the first-class vaccines are purchased by the provincial CDC through a centralized procurement platform, and then distributed step by step through the provincial, municipal and county disease control departments. In order to ensure the effectiveness of vaccination, the provincial finance of Zhejiang Province has continuously increased its financial input. Over the past three years, it has continuously invested more than 50 million yuan for cold chain facilities and equipment such as refrigerated trucks, cold storage and refrigerators in CDC and grass-roots vaccination units at all levels. The second-class vaccines are purchased by county CDC through centralized procurement platform, and then supplied to vaccination clinics within their jurisdiction. In terms of transportation, the vaccine is mainly transported to the county-level CDC by production enterprises or transportation enterprises with cold chain qualifications.
Lin Lu, deputy director of the Yunnan Provincial Health Planning Commission, told the reporter that Yunnan Province has established a vaccination service network from the province to the village, with nearly 20,000 vaccination sites in the province, with a service radius of 5 kilometers, which is convenient for citizens to vaccinate. A class of vaccines used in Yunnan are monitored from the factory to the inoculation point, and the transportation, distribution and storage of vaccines are monitored regularly.
"Now many parents are used to taking their children to big hospitals for vaccination. In fact, the vaccines of big hospitals and community health service centers are all from the disease control system, so parents don’t have to go far." Wang Meituan, director of the Neonatal Department of Changsha Central Hospital, reminded.
The reporter learned that at present, monitoring systems for abnormal reactions of suspected vaccination have been established in Hunan, Zhejiang, Yunnan and other places. In view of the abnormal reaction after vaccination, the disease control department will organize a special investigation and invite experts from immunology, epidemiology, clinic and pharmacy to consult. If it is determined that it is indeed an abnormal clinical reaction caused by vaccine, the vaccinator will receive corresponding compensation.