How does a Vaccine Work?

On March 17, 2010, there were media reports that nearly a hundred children in Shanxi died or were disabled after being vaccinated ^[1-2] , which caused widespread concern from government departments and society. The incident was called the Shanxi vaccine incident

Shanxi vaccine incident

On March 17, 2010, there were media reports that nearly 100 children in Shanxi were injected.

From the northernmost part of Shanxi

How to get JE after getting JE vaccine

Several children I saw during the interview,

On the 17th, there were media reports that nearly 100 children in Shanxi were injected.

March 2010, Shanxi

On March 17, some media reported to our province

China Broadcasting Network Beijing April 7 (Reporter Liu Tiansi) According to

Following the Shanxi vaccine case, the problem rabies vaccine has once again attracted strong public attention.

The magnitude of the damage is far greater than the former. 210,000 vaccines have been put on the market, and most of them have been used. According to relevant data, rabies vaccine should generally be injected within 24 hours after a person is bitten by a dog. When it expires, the disease prevention effect will be greatly weakened, and the effect will be worse as time goes by. This means that patients who are vaccinated against the above-mentioned problems will face serious consequences if they are infected with rabies virus-rabies is still incurable and usually dies within 6 days of onset.

However, the truth of the incident is still unclear. In the Dalian Golden Port Vaccine Case, the problem was that the company illegally added nucleic acids to pass the inspection by the drug regulatory department. However, there is much controversy in the industry as to whether and to what extent the added substances affect vaccine quality. As for what went wrong with the vaccines of the extension company and the company, the State Drug Administration has so far been unclear. According to the notice of the State Administration of Drug Administration, the nature of the problems between the extension company and the company is different. The former has already involved illegal crimes, and many people in the company have been arrested. However, Fore Company only violated the rules and found no illegal problems.

Some people in the industry believe that there are various quality problems in the rabies vaccine on the market, both for reasons of poor control and for intentional counterfeiting. If the relevant details are not released, then people cannot know what is wrong with the vaccine, which is irresponsible to the public, especially the 200,000 problem vaccine recipients.

The vaccine is issued in China in batches. The drug regulatory department has factory-resident supervisors in the vaccine manufacturing enterprises. After any batch of vaccines is produced, they must be spot-checked by the factory supervisors and tested by the relevant departments of the State Drug Administration before they can be listed on the market. According to industry insiders, this batch of problem vaccines from Jiangsu Yanan and Hebei Foul should also undergo batches of random inspections. However, the National Drug Administration found problems again during the random inspections, and the previous random inspections were quite suspicious.

It is reported that the investigation and prosecution of the two companies involved in the case are handled by the local drug regulatory department. Some people in the industry have questioned this: The registration, GMP certification, and post-production quality inspection and batch issuing are all under the responsibility of the National Bureau. Why is it submitted to the local bureau for investigation after a problem?

In fact, it was said that the companies involved had been stopped for months.

All signs show that if it is not for the further exposure of the media, this major public safety incident may not be left.

How does the vaccine emerge?

The quality of some domestic vaccines is not up to standard, which has aroused national concern about vaccine quality. In fact, vaccine quality issues have long been exposed.

In 2007, a vicious incident caused by a fake rabies vaccine occurred in Daxing County, Beijing: On August 9, Li Shuqi, a villager in Daxing District, was bitten by a dog. In order to prevent rabies infection, Li spent 200 yuan five times to get rabies vaccines in village medical offices without relevant qualifications. On October 26, Li suddenly felt unwell. She was diagnosed with rabies by Beijing You'an Hospital and died two days later. After investigation by the police, the vaccine used by the village infirmary was a fake rabies vaccine purchased from abnormal channels. The vaccine dealer was sentenced to 10 years. However, there has been no report on who the dealer is from, who produced the fake vaccine, how it was released, and how much it was sold.

In the opinion of an industry insider, the death of Li Shuqi 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 "set number" phenomenon in the vaccine production process, that is, in order to save costs, manufacturers through the hands and feet to produce several batches of vaccine under a batch number, which is really a problem vaccine. However, because the distributor could not identify it, it flowed into the market. Once a problem occurred, the manufacturer firmly denied that the batch of vaccine had been produced, and the emergence of the problem vaccine became a mystery. In addition, in the industry's opinion, even if Li Shuqi was injected with a real rabies vaccine, he may not escape. This is because for patients who have been bitten by dogs, if they are really infected with rabies virus, In addition to rabies vaccine, immunoglobulins must be injected to work. However, due to the high cost of immunoglobulins, many low-income people can't afford it, so only rabies vaccines are used for peace of mind, but in fact it can't help.

In 2008, the Ministry of Health and the Ministry of Agriculture jointly issued a document revealing that from 2004 to 2006, a total of 8,403 rabies deaths were reported nationwide, the highest number of deaths reported by various infectious diseases. It is worth mentioning that there are reports that the total number of rabies cases in China in 1996 was only 159. A decade has seen a 20-fold increase, during which rabies vaccine sales as a paid vaccine have been increasing. No one knows how many rabies deaths have been vaccinated against rabies like Li Shuqi.

Mutual responsibility for supervision

As a special medicine, vaccines are nominally subject to the strictest regulations. However, this is not the case in law or in reality. Southern Weekend reporter inquired about the newly revised Drug Law of 2001 and found out. Although the law characterizes vaccines as pharmaceuticals, none of the entire law mentions vaccines. Only Article 104 stipulates that the state applies special management to the circulation of preventive biological products (including vaccines, Southern Weekend reporter's note). Specific measures shall be formulated by the State Council. In June 2005, the State Council promulgated and implemented the "Regulations on the Administration of Vaccine Circulation and Vaccination", so that vaccine surveillance can be implemented in accordance with the law. However, some people in the industry believe that the regulation formulated by the health department is obviously insufficient in the supervision of vaccine quality.

In fact, if there are loopholes in the supervision of vaccine production, then 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 regulatory department is responsible for the supervision and management of vaccine quality and circulation. However, there are doubts about the division between "vaccination" and "quality circulation". A pharmacist told a Southern Weekend reporter that the "circulation" subject usually refers to manufacturing and operating companies. After the disease control system, it actually arrived in the hands of the government and entered the "vaccination" link, and drug supervision departments should not intervene.

This statement was referred to by the health system personnel as "dodge responsibility" of the drug regulatory department, because even if the vaccine has reached the disease control department, as long as it has not been vaccinated, it is a "circulation" link.

No matter who is right or wrong, the fact is that drug regulatory agencies rarely intervene in vaccine surveillance after it has entered the disease control system. According to whistleblower Chen Taoan to Southern Weekend reporters, the drug supervision department did not dare to seal the vaccine of the disease control department. temper".

In the Shanxi vaccine case, the Shanxi Provincial Drug Supervision Department has never intervened, and the State Drug Administration has also spot-checked the quality of the vaccine with the coordination of the Ministry of Health. However, whether to destroy vaccines that have been managed out of the "cold chain" in a manner that is responsible for people's health, or to continue to use the vaccines after they have been approved for quality inspection, they have caused great controversy in the industry.

From public benefit to profit

A former CDC staff member in Hebei Province said that with the advent of fee-based vaccines, they had been used as a public welfare institution's epidemic prevention system, but in fact became vaccine distributors ...

Reporter Chai Huiqun

China's immunization efforts began in the 1970s. Its characteristic is that the use of administrative forces to force the promotion of vaccination has a strong program color, so it is called "planned immunization." Great achievements have been made in China's immunization efforts, such as the successful elimination of smallpox and polio, which has been highly evaluated by the World Health Organization.

Hebei Province is considered one of the birthplaces of national immunization efforts. According to a former staff member of the provincial Centers for Disease Control and Prevention, the initial vaccines were free of charge, an important national policy implemented by the country to improve the quality of the population. Planned immunization is mainly aimed at children. Provincial epidemic prevention stations (predecessors of the CDC) make immunization plans based on the number of newborns each year and report them to the provincial government. The provincial government has fully funded the vaccines. The epidemic stations purchase vaccines from several major domestic products, usually measles. , BCG, Polio, Baibai Po, and then dial down through the epidemic prevention system.

According to the former staff member, the country attached great importance to the immunization work at that time. From the state president to the provincial party secretary, they all had the experience of feeding the children with sugar pills. In order to improve the vaccination rate, the epidemic prevention department has found out a whole set of experience. For example, it requires the main local leaders to take the lead, and the publicity and education departments to cooperate closely to produce a vaccination book and link the vaccination to the schooling of children.

The staff of the epidemic prevention station was on the front line. In that year, the people at the provincial epidemic prevention station had to travel to every county in the province, the municipal epidemic prevention station had to travel to every township, and the county epidemic prevention station had to travel to every village. For many years, the number of newborns in China has three figures, one for the family planning department, one for the public security department, and the other is the epidemic prevention department. "The number of epidemic prevention departments is the most accurate," said the person.

During decades of immunization work, an immunization system composed of provincial, city and county disease control systems has also been established. What the former staff did not expect was that with the advent of fee-based vaccines, as a public health agency's epidemic prevention system, it also became a marketing network for fee-based vaccines.

In the impression of the former staff member, Hebei Province started to charge vaccination since the mid-1980s. It was initially only used to subsidize the vaccinating doctors and gave them three cents to encourage the enthusiasm of the vaccinating doctors. Later, the provincial epidemic prevention station collected a dime vaccination fee for sugar pill (poliomyelitis vaccine) vaccination. As a result, it became one yuan in the city and two yuan in the county. Later, the vaccine itself also began to charge fees, with the distinction between "planned vaccines" and "unplanned vaccines" (that is, the predecessors of the first-class vaccines and second-class vaccines specified in the Vaccine Regulations, our reporter noted). One of the earliest unplanned vaccines was the rabies vaccine. Both unplanned vaccines and in-market vaccines are imported and exported through the CDC network, and unplanned vaccines have become "small vaults" for disease control departments at all levels

A staff member of the immunization department of the former epidemic prevention station of a city in Hebei province recalled the process of vaccine charges in the past: probably in the late 1980s, a brother from an epidemic prevention station in a neighboring county came to me and asked if there were sugar pills here. I The work here is over. There is exactly one box left. I say you take it. He asked me how much it cost. I said that this is what the money is for. He said that we have collected the money, I can't use yours for nothing, give you two hundred dollars. This incident also inspired me. Then I thought, can we borrow some money from the vaccine to make up for the cost of the epidemic prevention station? Later, I held a meeting with the head of the county epidemic prevention station, but as soon as I mentioned it, they patted their thighs and said that it should be closed already!

The former staff member believed that at the beginning of the vaccine charge, it was indeed possible to mobilize the enthusiasm of the vaccination work of the disease control systems at all levels, and the people could accept it, and the vaccination rate even increased because of the increase in fees. "If you don't collect money, people think it's not a good thing. They don't want to get vaccinated. If they collect the money, he thinks it's a good thing, but they will fight it."

The former staff member acknowledged that a number of veteran epidemic prevention workers had fiercely opposed the charges for vaccines, but with the rise of the market economy, the resistance to vaccine charges has become smaller and smaller. The line between "on-plan" and "out-of-plan" has begun to blur. For example, Bai Bai Po vaccine is free of charge, but cell-free Bai Bai Po is charged. It is worth mentioning that although the vaccine has begun to charge, the government's compulsory immunization model to promote free vaccines has been retained. For example, through the health authority's post, using the news media to build momentum, and cooperating with the education department, the vaccination and children are enrolled in school. Hook etc.

According to the former staff member, after the emergence of fee-based vaccines, the CDC has in fact become a distributor of vaccines, while some of the most basic vaccination staff have become vaccine salespeople, and they have tried every means to allow vaccinators to use fee-based vaccines. For example, the most common is to emphasize that the second-class vaccine is more effective and safer than the first-class vaccine. In fact, if an abnormal reaction occurs when the first-class vaccine is administered, the government is responsible for it. The business is responsible. The promotion of the second-class vaccines at the grassroots level sometimes reaches the point of a joke. He still remembers that when he was working at the epidemic prevention station, he received a call saying that it was not plague. He said nothing, the provincial epidemic prevention station did not receive any information on the plague situation. I later learned that there had been several cases of hemorrhagic fever transmitted by rats in the local area. Some people described the hemorrhagic fever as a plague in order to sell vaccines and scared the people to vaccinate.

A similar example is the vaccination of leprosy. Leprosy vaccine is the abbreviation for measles and rubella combined vaccine. It has nothing to do with leprosy, but it has disappeared below, saying that if you do nt have a leprosy vaccine, you will get leprosy. People are not afraid of measles and leprosy, so measles and leprosy vaccines appear as "leprosy vaccines."