Behind the Shanxi vaccine incident

Following the Shanxi vaccine case, the problem rabies vaccine once again aroused strong public concern.

The harm is great and the impact is far ahead. 265,438+/kloc-0,000 vaccines have been marketed, and most of them have been used. Relevant information shows that people should be injected with rabies vaccine within 24 hours after being bitten by dogs. After the expiration, the disease prevention effect will be greatly weakened, and the longer the time, the worse the effect. This means that patients injected with the above vaccines will face serious consequences if they are really infected with rabies virus-rabies is still an incurable disease and usually dies within 6 days of onset.

However, the truth of the incident is still unclear. In the case of Dalian Jingang problem vaccine, the problem is that the company illegally added nucleic acid to pass the inspection by the drug supervision department. However, whether and to what extent the added substances affect the quality of vaccines is controversial in the industry. As for what happened to Yanchang Company and Foer Company's vaccines, the State Administration of Pharmaceutical Products is still vague. According to the notice of the State Administration of Medical Products, the problems between Yanchang Company and Foer Company are different in nature. The former has been involved in illegal crimes and many employees of the company have been arrested. However, Foer Company only violated the rules and found no illegal problems.

Some insiders believe that there are various quality problems in the rabies vaccine on the market at present, both due to poor control and deliberate fraud. If the relevant details are not published, then people will not know what is wrong with the vaccine, which is irresponsible to the public, especially the 200,000 problem vaccinators.

Vaccines are issued in batches in China, and drug supervision departments have resident supervisors in vaccine production enterprises. After any batch of vaccine is produced, it must be sampled by the resident supervisor and tested by the relevant departments of the State Administration of Pharmaceutical Products before it can be listed. According to industry insiders, this batch of problematic vaccines from Jiangsu Yanchang and Hebei Fuer should also undergo batch sampling inspection. However, the State Administration of Medical Products found problems in the re-sampling, and the previous sampling inspection was quite suspicious.

It is reported that the investigation of the two enterprises involved is mainly carried out by the local drug supervision department. Some insiders have questioned this: the registration, GMP certification, quality inspection after production and batch issuance of vaccines are all the responsibility of the State Administration. Why did you hand it over to the local branch office for investigation after the problem appeared?

In fact, because there is news that the enterprises involved have been shut down for several months.

There are various indications that this important public safety incident is likely to go away without the further exposure of the media.

How did the problem vaccine come out?

The quality of some domestic vaccines is not up to standard, which has aroused people's concern about the quality of vaccines. In fact, vaccine quality problems have been exposed before.

In 2007, a vicious incident caused by counterfeit rabies vaccine occurred in Daxing County, Beijing: on August 9, Li, a villager in Daxing District, was bitten by a dog. In order to prevent rabies, Li spent five times in 200 yuan to inject rabies vaccine in village clinics without relevant qualifications. 10 years1On October 26th, Li suddenly felt unwell. He was diagnosed with rabies by Beijing You 'an Hospital and died two days later. After investigation by the police, the vaccine used in the village clinic is a fake rabies vaccine purchased from abnormal channels. Vaccine distributor was sentenced to 10 year. However, it has never been reported who the dealer went to, who produced the fake vaccine, how it came out and how much it sold.

In the eyes of the industry, Li's death fully shows that there are serious problems in the production, circulation and vaccination of rabies vaccine in China. According to its disclosure, there is a "batch number" phenomenon in the vaccine production process, that is, in order to save costs, manufacturers manipulate and produce several batches of vaccines under one batch number, which is actually a problem vaccine. However, because the dealers can't identify it, it flows into the market. Once there is a problem, the manufacturer firmly denies that the batch of vaccine has been produced, and the release of the vaccine becomes a mystery. In addition, according to the insider, even if Li is injected with the real rabies vaccine, he may be living as hell. This is because for patients bitten by dogs, if they are really infected with rabies virus, they must be injected with immunoglobulin in addition to rabies vaccine. However, due to the high cost of immunoglobulin, many low-income people can't afford it, so it is actually impossible to get rabies vaccine just for peace of mind.

In 2008, the Ministry of Health and the Ministry of Agriculture jointly issued a document, revealing that from 2004 to 2006, 8,403 cases of rabies deaths were reported nationwide, the highest among the reported deaths of various legal infectious diseases. It is worth mentioning that it is reported that the total number of rabies cases in China is only 1996. It has increased 20 times in ten years, and during this period, the sales of rabies vaccine as a paid vaccine have been increasing. No one knows how many people who died of rabies were vaccinated against rabies like Li.

Mutual shirking of supervisory responsibilities

As a special medicine, vaccine is nominally subject to the strictest supervision. However, this is not the case in law or in reality. Southern Weekend reporter inquired about 200 1 and found the newly revised Drug Law. Although the law defines vaccines as medicines, the whole law does not mention vaccines. Only article 104 stipulates that the state applies special management to the circulation of preventive biological products (including vaccines). The specific measures shall be formulated by the State Council. In June, 2005, hospitals all over the country promulgated and implemented the Regulations on the Administration of Vaccine Circulation and Vaccination, which made vaccine supervision have laws to follow. However, some insiders believe that this regulation formulated under the auspices of the health department is obviously insufficient in vaccine quality supervision.

In fact, if there are loopholes in the supervision of vaccines in production, the problems in circulation may be even greater. According to the Regulations on the Administration of Vaccine Circulation and Vaccination, the competent health department is responsible for the supervision and management of vaccination, and the drug supervision and administration department is responsible for the supervision and management of vaccine quality and circulation. However, there are doubts about how to distinguish between "vaccination" and "quality circulation". A drug supervisor told Southern Weekend that the main body of "circulation" usually refers to production enterprises and operating enterprises. After the vaccine enters the disease control system, it actually enters the hands of the government and enters the "vaccination" link. Drug supervision departments should not be involved.

This statement is called "shirking responsibility" by the health system, because even if the vaccine reaches the disease control department, as long as it is not vaccinated, it belongs to the "circulation" link.

No matter who is right or wrong, the fact is that drug supervision departments rarely intervene in vaccine supervision after entering the disease control system. According to Chen, a reporter from Southern Weekend, the drug supervision department did not dare to seal the vaccine of the disease control department. "It has to do this, and the disease control department will lose its temper as soon as it says it affects the control of the' epidemic'."

In the Shanxi vaccine incident, the Shanxi provincial drug supervision department never intervened, but in the State Administration of Pharmaceutical Products, the quality of the vaccine was sampled and tested after the coordination of the Ministry of Health. However, whether to destroy vaccines that are out of the "cold chain" management in a responsible attitude towards people's health or to continue to use them after sampling inspection and qualified quality has caused great controversy in the industry.

From public welfare to profit-making

A former staff member of the disease control system in Hebei Province said that with the emergence of paid vaccines, the former public welfare organization epidemic prevention system actually became a vaccine distributor. ...

□ Our reporter Chai Huiqun

The work of planned immunization in China began in 1970s. It is characterized by compulsory universal vaccination with administrative power and strong planning, so it is called "planned immunization". China has made great achievements in planned immunization, such as successfully eradicating smallpox and polio, which has been highly praised by the World Health Organization.

Hebei province is considered as one of the birthplaces of national planned immunization. According to a former staff member of the Provincial Center for Disease Control and Prevention, free initial vaccine is an important national policy implemented by the state to improve the quality of the population. Planned immunization is mainly aimed at children. Provincial Epidemic Prevention Station (predecessor of CDC) formulates immunization plan according to the number of newborns every year and reports it to the provincial government. The provincial finance fully allocates funds. The epidemic prevention station buys vaccines from several major domestic products, generally measles, BCG, polio and DTP, and then allocates them through the epidemic prevention system.

According to the former staff member, at that time, the country attached great importance to planned immunization, and from the chairman to the secretary of the provincial party Committee, they all had the experience of personally feeding sugar pills to their children. In order to improve the vaccination rate, the epidemic prevention department has explored a set of experiences, such as asking local leaders to take the lead, closely cooperating with the publicity and education departments, making vaccination books, and linking vaccination with children's admission to the park.

The staff of the epidemic prevention station are at the front line. At that time, people from the provincial epidemic prevention station had to travel to every county in the province, the city epidemic prevention station had to travel to every township and the county epidemic prevention station had to travel to every village. Over the years, the number of newborns in China has three figures, one from the family planning department, one from the public security department and one from the epidemic prevention department. "The figures of the epidemic prevention department are the most accurate." This person said.

During decades of planned immunization, a planned immunization system consisting of provincial, municipal and county disease control systems has also been established. What the former staff did not expect was that with the emergence of paid vaccines, the epidemic prevention system as a non-profit organization has also become a marketing network for paid vaccines.

In the impression of this former staff member, Hebei Province probably started charging for vaccination after the mid-1980s. At first, it was only used to subsidize vaccinators and give them an injection of 30 cents to encourage their enthusiasm. Later, the sugar pill (polio vaccine) inoculated in the provincial epidemic prevention station received a dime, which became one dollar in the city and two dollars in the county. Later, the vaccine itself began to charge, and there was a distinction between "planned vaccines" and "unplanned vaccines" (that is, the precursors of the first and second vaccines stipulated in the Vaccine Regulations, our reporter's note). One of the earliest unplanned vaccines was rabies vaccine. Vaccines, whether unplanned or on the market, enter and exit through the network of the disease control system, and unplanned vaccines have become the "small treasury" of disease control departments at all levels.

L, an immunology staff member of a former epidemic prevention station in Hebei Province, recalled the process of vaccination in those years: probably at the end of 1968+0980, a brother of an epidemic prevention station in a neighboring county came to me and asked me if there were any sugar pills here. My work here is over, only one box is left. I said you should accept it. He asked me how much it cost. I said this is its price. He said that we have collected money there, so I can't use yours for nothing. Let me give you 200 yuan. This incident also inspired me. Later, I thought, is it possible to borrow vaccines to collect some money to make up for the expenses of the epidemic prevention station? Later, I had a meeting with the head of the department of the county epidemic prevention station. As a result, as soon as I faltered, they patted their thighs and said it was long overdue!

The former staff member believes that at the beginning of vaccine charging, it really mobilized the enthusiasm of vaccination in disease control systems at all levels, which was acceptable to the people. Vaccination rates have even increased because of fees. "If you don't collect money, the people feel that it is not a good thing. They don't want to play (vaccine) and collect money. He thinks this is a good thing, but he will fight. "

The former staff member admitted that there was fierce opposition from a group of old epidemic prevention workers about vaccine charges, but with the rise of market economy, the resistance to vaccine charges is getting smaller and smaller. The boundary between "planned" and "unplanned" began to blur. For example, DTP vaccine should be free, but cell-free DTP is charged. It is worth mentioning that although the vaccine began to be charged, the compulsory immunization model of the government to promote free vaccines was retained, such as issuing documents through the health authorities, using the news media to create momentum, and cooperating with the education department to link vaccination with children's admission to the park.

According to the former staff, after the emergence of paid vaccines, the disease control system actually became a vaccine distributor, while some grassroots vaccinators became vaccine salesmen, trying their best to let vaccinators use paid vaccines. For example, the most common thing is to emphasize that class II vaccine is more effective and safer than class I vaccine. In fact, if there is an abnormal reaction during the vaccination of the first class vaccine, the government is responsible, and the second class vaccine can only be responsible for the problem. The promotion of the second-class vaccine at the grassroots level sometimes comes to the point of making jokes. He still remembers that when he was working in an epidemic prevention station, he received a phone call asking if there was a plague epidemic. He said no, the provincial epidemic prevention station did not receive any information about the plague epidemic. Later, I learned that there were several cases of hemorrhagic fever transmitted by rats in the local area. In order to promote vaccines, some people call hemorrhagic fever a plague to scare people into getting vaccinated.

A similar example is vaccination against leprosy. Leprosy vaccine refers to the abbreviation of measles and rubella combined vaccine, which has nothing to do with leprosy, but it is distorted below that leprosy will occur if leprosy vaccine is not planted. People are not afraid of measles and leprosy, so measles and leprosy vaccine appears in the form of "leprosy combined vaccine".