Recently, the event of long-term biological vaccine has exploded the circle of friends and caused parents' strong concerns. What is the core fact of the event? Vaccinated or not?
Yesterday, Changchun Changsheng, a subsidiary of the company, was punished by Jilin Provincial Food and Drug Administration for failing to meet the requirements of the test of "combined absorption of acellular pertussis vaccine" (referred to as "pertussis").
Curiously, the regulatory authorities filed a case for investigation as early as October 2017. The company also said that the production workshop of baibaipo has been shut down at present, but this important information has not been disclosed in the previous announcement and 2017 annual report. Nearly nine months ago.
A senior industry analyst said that this may be because the rabies vaccine incident was turned out by the media and found that it had not published the punishment results for a long time and was urged. (it is understood that in the annual report of 2015, the company issued about 5.62 million copies of Baidu batch, ranking the first among the six vaccine products sold by the company. However, in the annual reports of 2016 and 2017, the batch issuance volume of baibaipo was not disclosed. With the exposure of the decision on administrative punishment, the mystery of the disappearance of important products of Changsheng biology may be revealed layer by layer, and the listed companies are afraid to escape the suspicion of violating the regulations. )
Changsheng biology announced that on July 18, 2018, Changchun Changsheng Biotechnology Co., Ltd., a wholly-owned subsidiary of Changsheng Biology (hereinafter referred to as "Changchun Changsheng") received the decision on administrative penalty from Jilin food and drug administration.
In the special sampling test of national drugs, the "adsorbed acellular pertussis combined vaccine" (batch No.: 201605014-01) produced by Changchun Changsheng was inspected by China food and Drug Control Institute, and the test results [titer determination] did not meet the requirements.
The above-mentioned drugs produced by Changchun Changsheng are in conformity with the provisions of item 6, paragraph 3, Article 49 of the drug administration law of the people's Republic of China, and other cases that do not conform to the provisions of the drug standards shall be punished as inferior drugs. Changchun's behavior violates the first paragraph of Article 49 of the drug administration law of the people's Republic of China, which prohibits the production and sale of inferior drugs. 'and filed on October 27, 2017.
According to the investigation, there are 253338 drugs produced in this batch, 552 of which are sampled by Jilin Provincial Drug Inspection Institute and sold to 252600 centers for Disease Control and prevention of Shandong Province. Now 186 drugs are in stock at a price of 3.40 yuan / piece. The illegal income of this batch of drugs is 858840.00 yuan in total and the value of goods is 861349.20 yuan in total.
Rabies vaccine counterfeiting has evaporated the market value of nearly 10 billion yuan of long-lived organisms, which has been concerned recently, mainly due to the problem of rabies vaccine counterfeiting. Because of the fake rabies vaccine, the food and drug administration took back Changchun Changsheng's GMP certificate. Changchun Changsheng was asked to stop the production of rabies vaccine. The company also started a comprehensive recall of rabies vaccine.
On July 15, the State Food and Drug Administration issued a notice, and the State Food and Drug Administration organized a flight inspection on Changchun Changsheng. It was found that the production of freeze-dried human rabies vaccine in the enterprise had record fraud and other serious violations of the "drug production quality management specifications".
According to the inspection results, the State Food and Drug Administration promptly ordered Jilin food and drug administration to take back Changchun Changsheng's relevant GMP certificate. Jilin food and drug administration has withdrawn Changchun Changsheng's GMP certificate, and Changchun Changsheng has stopped the production of rabies vaccine as required.
Then, Changchun Changsheng recalled all batches of freeze-dried human rabies vaccine (Vero cell) within the validity period.
After the event, the stock price of Changsheng biology has been down and stopped for five consecutive wordboards. Today, the latest stock price after opening is 14.5 yuan, down 40.94%. The market value has evaporated by 9.789 billion yuan, and now the latest market value is 14.1 billion yuan.
In fact, after the rabies vaccine fraud, many open-ended public funds have lowered the valuation of longevity biology in advance, which is mainly reduced to 16.11 yuan and 14.5 yuan, corresponding to 4 and 5 falls.
Parents flipped over their children's vaccine books
According to Nanfang +, from the CDC of Guangdong Province, among the 12 rabies vaccines available in Guangdong Province, Changchun Changsheng freeze-dried human rabies vaccine (Vero cell) is one. However, Guangdong Provincial Center for Disease Control and Prevention said Guangdong did not purchase the pertussis vaccine of the batch number 201605014-01 produced by Changchun Changsheng.
However, the related batches of rabies vaccine products produced by the company have not yet been delivered and marketed, and all products have been effectively controlled. Therefore, no batches of vaccines were involved in Guangdong Province, and no adverse reactions were found after rabies vaccination.
But most people are still uneasy. If the vaccine is not in the batch involved, it cannot guarantee the quality completely. Under the ferment of public opinion these days, the sense of trust in Changchun Changsheng has gone bankrupt in the minds of parents.
These two days, many parents began to go home and look at their children's vaccine books. They found that many of the vaccines the children were vaccinated with were produced by the manufacturers of immortality, and there were more than one type, all of which included diphtheria, hepatitis A, varicella and other vaccine types.
Zheng Huizhen, director of the Institute of immunology, Guangdong Center for Disease Control and prevention, said that many studies at home and abroad have shown that the protection effect of one dose of vaccination is between 20% and 90%, with an average level of 70%, while the protection effect of two doses of vaccination is close to 100%.
According to the immunization planning center of China Center for Disease Control and prevention: parents or guardians of children can check the vaccination record of DPT on the children's vaccination certificate and compare it with the published vaccine manufacturers and batch numbers to determine whether they have received the unqualified DPT vaccine of the corresponding batch number. You can also consult the vaccination unit, and the vaccination unit will assist in querying the batch number of the DPT vaccine to determine whether the unqualified DPT vaccine of the corresponding batch number has been inoculated. You can also call 12320 health hotline for consultation.
Vaccinated or not?
Changchun Changsheng and other top vaccine manufacturers in China have been exposed many problems, shaking people's trust in domestic vaccines. But is that why there is no vaccine at all?
Of course, we can't 'stop eating because of choking' because of some batches of vaccines in some companies, which will harm our own and family's health. Historically, there have been large-scale 'vaccine boycotts' in the UK, leading to outbreaks without exception.
This year marks the 40th anniversary of China's implementation of the immunization program. Mao Qun'an, head of the relevant departments and bureaus of the National Health Commission, said that through 40 years of efforts, the implementation of the immunization program has achieved remarkable results.
In 2000, China achieved the goal of polio eradication. In 2014, the HBsAg carrier rate of children under 5 years old dropped to 0.32%. In 2017, the incidence rate of hepatitis a dropped from 5.98/10 million before the national immunization program to 1.37/10 million, a decrease of 77.1%. The incidence rate of infectious diseases dropped to the lowest level in history.
As with food, there are certain preparation risks for vaccines. In the process of production, transportation and storage, problems in any link may lead to 'problematic vaccines'.
The vaccine needs to be vaccinated, but after the vaccine incident, how and how to vaccinate has become a worry for many people.
How to pick up the broken confidence?
These days, the public is immersed in a variety of question marks and exclamation marks.
Recently, the 21st century economic reporter has been in a variety of consultations. A friend from Shanghai asked if the batch of long-lived creatures that had been beaten by baibaipo had any impact; Another friend said that he just spent more than 1000 yuan to get the rabies vaccine and immunoglobulin of immortality. He didn't know whether they were effective. How to continue with the next few shots? Or whether those unqualified vaccines were really controlled and didn't hit him? Why is immortality the only choice for vaccination? Can it be imported?
At the same time, a series of related vaccine events, such as the chairman / General Manager / chief financial officer of Changsheng biological Co., Ltd. being the same person, how to go public, privatization, past events of operators, rabies vaccine fraud, and the wave of hepatitis B vaccine death, were uncovered. This is not a long time since the outbreak of Shandong vaccine case.
Things ferment so far, is no longer a matter of living creatures. What disease control experts are most worried about is that in the circle of friends, many friends have asked about imported vaccines, and on some social networks, some people are also questioning the necessity of vaccination.
A friend commented that over the years, the little trust accumulated by domestic vaccines is being destroyed. After the Shandong vaccine case, a number of experts told the 21st century economic reporter that the development of domestic vaccines is not easy, and the supervision is also very strict. There is a set of formal process for batch issuance, including the subsequent strict supervision of the transportation process. In fact, vaccines are very important for disease prevention. For example, the vaccination of hepatitis B vaccine has greatly reduced the number of hepatitis B patients in China.
However, the problem has come back.
Some people have made a comparison with foreign pharmaceutical companies, especially vaccine manufacturers. They have very few reports of this kind. Even if they report it, they will see heavy punishment.
In January 2018, Philippine Minister of health DUKAI said: 'according to the dengue observation report released by the epidemiological Department on January 10, there are 17 cases, four of which died of dengue shock. 'Sanofi dengue vaccine had to refund unused vaccine payments and the € 87 million collected in the fourth quarter. On February 5, the Philippine house of Representatives held the fourth hearing on the dengue vaccine incident, during which members asked officials of the Philippine Ministry of health whether Sanofi had criminal responsibility.
In Japan, the head of an enterprise told the 21st century economic reporter that the cost of its fake and shoddy products is very high. For example, once the fake and shoddy products are found, the head of the enterprise is punished and almost ruined, and is not allowed to enter the industry again, so the people in Japan have a high degree of trust in the products produced by their own country.
A number of industry insiders interviewed before pointed out that in terms of quality supervision, we should learn from Japan and other countries, and we should impose heavy penalties on intentional fraud and other acts, and enter into the penalty. For the 21st century economic news reporter, the person concerned about the vaccine incident said that the punishment of the long-lived organism Baibai break just published before was 3.4428 million yuan, which involves the safety of human life. Compared with the punishment of the banking and financial industry, the punishment is also very light.
Different from drugs, because vaccines play a preventive role, whether they work or not is a long-term process, and all trust can only be based on the qualification of vaccines themselves, so how to grasp this checkpoint is a question worthy of deep thinking. How will the confidence that is about to break be picked up?