Vaccine is a biological product for preventing and controlling the occurrence and prevalence of infectious diseases, and it is of great significance to protect human health. The reporter learned from National Medical Products Administration that at present, China is the largest vaccine producer in the world, with 45 vaccine manufacturers, which can produce 63 kinds of vaccines and prevent 34 kinds of infectious diseases, with an annual production capacity of more than 1 billion doses. It is one of the few countries and regions in the world that can solve all planned immunization vaccines on their own.
Taking children’s vaccines as an example, at present, China’s children’s immunization program covers 12 vaccine-preventable diseases, basically covering all key vaccine types recommended by the World Health Organization, and individual vaccines such as Japanese encephalitis are included in children’s immunization programs before other countries and regions. Since the implementation of immunization program in 1978, the R&D and production capacity of vaccine manufacturers in China has been continuously improved, and polio caused by wild strains has been eliminated, and diseases such as hepatitis B, measles, diphtheria, pertussis, tetanus, tuberculosis and Japanese encephalitis have been controlled. In particular, domestic inactivated enterovirus 71 vaccine (hand, foot and mouth disease vaccine) and recombinant hepatitis E vaccine are the first in the world.
However, many parents still hesitate when choosing to vaccinate domestic vaccines. "There is no obvious difference between domestic and imported vaccines in terms of quality standards, safety and use." Wang Huaqing, chief expert of China CDC, said that both domestic vaccines and imported vaccines must strictly follow the requirements of the State Drug Administration, strictly carry out pre-marketing clinical research, and the production meets GMP requirements. Each batch of vaccines can only be put on the market after passing the strict batch issuance inspection. Judging from the current domestic vaccination situation, domestic vaccines account for more than 95% of the actual vaccination in the country.
"Before the vaccine is put on the market, it is necessary to implement a strict batch issuance system, which is an important barrier in the process of vaccine delivery and circulation, that is, the drug inspection agency should inspect and review its data according to the standards, which is equivalent to adding another weight to vaccine safety besides ordinary drugs ‘ Insurance ’ 。” Wang Youchun, vice president of China Institute of Food and Drug Control, said that as early as 2006, China had managed the batch issuance of all vaccines. At present, among the more than 190 member countries of the World Health Organization, only more than 30 countries have the full supervision function of vaccines recognized by the World Health Organization.
At the same time, in order to understand the quality status of vaccines on the market, find out quality problems and hidden dangers, and take corresponding risk control measures in time, since 2008, the national drug regulatory authorities have carried out evaluation sampling tests on some vaccines every year, that is, the vaccine products are selected from three aspects: production, circulation and use for quality inspection and result analysis. Statistics show that at present, China issues about 5000 batches and 700 million dosage units of vaccines every year. From 2006 to 2017, a total of 317 batches of unqualified vaccines were refused, with about 19 million people. Judging from the sampling inspection, the country has sampled 944 batches of vaccine products since 2008, with a qualified rate of 99.6%.
In fact, China’s vaccine management not only follows the most stringent standards, but also the formed vaccine supervision system has passed the evaluation of the national supervision system of the World Health Organization. "This assessment is not only a comprehensive consideration of the ability of a national vaccine regulatory agency, but also the basis and premise for vaccine manufacturers in this country to apply for WHO product pre-certification and enter international procurement channels." For example, Wang Youchun said that domestic vaccines such as live attenuated Japanese encephalitis vaccine produced by Chengdu Institute of Biological Products, oral type I and type III polio vaccine produced by Beijing Beishengyan Biological Company, influenza vaccine produced by Hualan Biological Company and inactivated hepatitis A vaccine produced by Beijing Kexing Biological Company have successively passed the product pre-certification of the World Health Organization, and have been successively purchased by UNICEF and Global Alliance for Vaccine Immunization for disease prevention and control in other countries.
With the increasingly strict supervision, in recent years, the quality standards of vaccines listed in China have reached the requirements of the World Health Organization for vaccine products, and the key indicators of some varieties are even higher than those in Europe and America. Wang Youchun said that at present, China has established a coverage vaccine "research and development — Production — Circulation — "Vaccination" has a complete vaccine supervision system, legal system and standard management, a scientific and rigorous vaccine registration and approval system has been established, and good manufacturing practice, which is in line with the international advanced level, and strict quality management standards for drug business have been implemented. (Economic Daily-China Economic Net reporter Ji Leilei)
