What challenges will China’s immunization program face in the next 40 years?

On July 22, the person in charge of the State Food and Drug Administration reported on the illegal production of freeze-dried human rabies vaccine by Changchun Changsheng Biotechnology Co., Ltd. Affected by this rabies vaccine case, many people have wavered on the safety and necessity of vaccination.

In fact, since my country began implementing planned immunization in 1978, it has reduced the incidence and death of vaccine-targeted diseases by popularizing childhood immunization. On July 13, the National Health Commission's "Reply to Questions on the 40th Anniversary of the Immunization Program" mentioned many related achievements and remarkable disease prevention and control effects. For example, in 2000, my country was certified as polio-free; hepatitis B surface antigen carriers and 1992 It dropped by 97% year-on-year.

40 Years of Immunization Program

At present, vaccines in our country are mainly divided into two categories, which can be simply called "Class I vaccines" and "Class II vaccines."

Class I vaccines are provided free of charge by the government to citizens. At present, my country's Class I vaccines mainly include hepatitis B vaccine, BCG vaccine, and live attenuated oral polio vaccine. Because this type of vaccine is provided free of charge, the provincial and municipal governments bear its funding, and they are budgeted, tendered and procured by the provincial governments. Depending on the manufacturer purchased, the price will be slightly different. After the purchase is completed, it will be uniformly distributed to each vaccination point.

Category II vaccines refer to vaccines that are voluntarily received by citizens at their own expense. This type of vaccine is no longer centrally purchased by the government, but is purchased by each vaccination site on its own. The pricing of this type of vaccine is usually based on market rules.

Not long ago, at the 40th anniversary event of China’s immunization program, Mao Qun’an, director of the Bureau of Disease Control of the National Health Commission, pointed out that current epidemic monitoring shows that the incidence of infectious diseases targeted by multiple vaccines has dropped to historically low levels. . "In 2017, the central government's investment in immunization planning reached 3.564 billion, and local governments also spent a lot of money to support this work. In the next step, we will introduce timely, safe and effective second-category immunization programs that meet the urgent needs of the people and are financially affordable. Vaccines are included in the immunization program to enhance the general public’s sense of access. In fact, since my country began to implement planned immunization in 1978, the popularization of vaccination has directly or indirectly saved countless lives. Greatly reduced infectious disease morbidity and mortality.

Wang Huaqing, chief expert on the immunization program at the Chinese Center for Disease Control and Prevention, pointed out that it has been 40 years since my country began carrying out planned immunization for children, covering 12 types of vaccine-preventable diseases. From 4 vaccines to protect against 6 diseases to 14 vaccines against 15 diseases, my country has ended smallpox, achieved polio-free status, and controlled diseases such as hepatitis B, measles, diphtheria, whooping cough, tetanus, and Japanese encephalitis.

On July 13, the National Health Commission's "Responses to Questions on the 40th Anniversary of the Immunization Program" also pointed out that the disease prevention and control effects are significant. In 2000, my country was certified as polio-free; after promoting neonatal hepatitis B vaccination, the hepatitis B virus surface antigen carrying rate among children under 5 years old dropped from 9.67% in 1992 to 0.32% in 2014. Hepatitis B surface antigen carriers were the same as those in 1992. A year-on-year decrease of 97%.

There are still challenges in China’s immunization program

In the past 40 years, China’s quality vaccine R&D, management and production capabilities have also been continuously improved. Xu Miao, deputy director of the Institute of Biological Inspection of the China Institute of Food and Drug Control, also emphasized that my country's planned immunization work mainly relies on vaccines produced in my country. For example, the EV71 vaccine is an innovative vaccine developed by China and is currently the only vaccine that can be used to prevent severe hand, foot and mouth disease. On March 22, 2016, the world’s first EV71 vaccine was successfully administered in Beijing.

Previously, a person in charge of the Beijing Food and Drug Administration told a reporter from the 21st Century Business Herald that the vaccine quality standard system consists of two parts: Chinese Pharmacopoeia standards and drug registration standards, both of which have mandatory legal effect.

At the same time, batch release of drugs is also very strict. The China Institute of Food and Drug Control (hereinafter referred to as the China Institute for Food and Drug Control) opened to the media on May 24. It is understood that during the batch release data review process, staff conducted trend analysis on the test results of key items of vaccine quality, and compared the data submitted by the company with the test results of the China National Institute of Inspection and Quarantine. Once abnormal deviations are discovered, the company will be asked to provide feedback. If necessary, on-site verification at the company may be initiated and experts will be organized to conduct risk assessments.

However, the safety of all batches of vaccines is checked, that is, each batch of vaccines is checked for sterility and abnormal toxicity. These two inspection items are undertaken by the authorized drug testing agency in the jurisdiction where the production company is located, and the results are summarized in Issued uniformly by the Central People's Procuratorate. However, batches with only 5% effectiveness will be checked, because if every vaccine and every test item is checked when the batch is issued, it will take too long and affect the validity period of the vaccine.

The batch that Changchun Changsheng was put under investigation on October 27, 2017 was not included in the 5% sampling inspection, but was included in the national special drug inspection. The "adsorbed acellular diphtheria-tetanus pertussis combined vaccine" produced by Changchun Changsheng "(Batch number: 201605014-01), after inspection by China Institute of Food and Drug Control, the test result "potency determination" did not meet the regulations.

In the context of domestically produced vaccines being the main force in my country’s immunization program, how to ensure the safety and effectiveness of vaccines is a very important issue.

At the same time, the National Health Commission also pointed out that there are still some challenges in China’s immunization planning system. Due to the large differences between regions, the intensity of financial support, personnel quality and service management level, and the people's understanding of vaccine scientific knowledge are also different. The differences between urban and rural areas and income differences make the demand multi-layered and diversified, which all reflect the immunization planning work. problems of unbalanced and inadequate development.

The challenges are specifically reflected in the following aspects: First, insufficient investment; second, shortage of talents, whose quality cannot fully meet demand; third, vaccine products are not rich enough, and domestic enterprises are struggling in the research and development of new vaccines, multi-vaccines and The listing lags behind international companies; fourth, the incidence of vaccine-preventable diseases for individual groups in some regions is still at a high level, and the burden on patients with chronic hepatitis and other diseases is heavy; fifth, there is still a certain gap between the level of vaccination services and the needs of the masses.