4hw.com.cn: Recently, the vaccine has become a topic of concern for the whole people and has exploded the circle of friends. Due to the continuous exposure of rabies vaccine and DPT vaccine, the domestic vaccine enterprise Changsheng biology company has fallen into a deep storm of public opinion.
On the 25th, an article called "the king of vaccines" was swiped in the circle of friends to let the topic of vaccines explode again. At the same time, everyone's distrust of domestic vaccines reached the peak.
In the past two days, many parents are searching for their children's vaccine books in panic to see if they have been vaccinated by Changchun Changsheng company. They found that almost all kinds of vaccines, including DPT, hepatitis A and varicella, have entered their children's bodies.
Can we believe the domestic vaccine?
We found that the DPT vaccine was unqualified last year
Eight months later, he exposed the fake rabies vaccine
The incident started on July 15.
On the same day, the State Food and Drug Administration issued an urgent notice that the production of freeze-dried human rabies vaccine of Changchun Changsheng Biotechnology Co., Ltd. had serious violations such as record fraud and illegal production of freeze-dried human rabies vaccine.
The State Food and drug administration has asked Jilin food and drug administration to take back the GMP certificate of the enterprise, ordered to stop the production of rabies vaccine, instructed the enterprise to strictly implement the main responsibility, comprehensively investigate the risk potential, and actively take control measures to ensure the public drug safety. On the same day, Changchun Changsheng Biotechnology Co., Ltd. also issued an emergency notice, demanding that the company immediately stop using, store the company's freeze-dried human rabies vaccine on the spot, and start the recall procedure. On July 16, Dongguan suspended the use of freeze-dried human rabies vaccine of Changchun Changsheng Biotechnology Co., Ltd. The Changchun rabies vaccine was also stored in Shanghai.
Wave after wave
On the evening of July 19, Changsheng biology announced that its subsidiary Changchun Changsheng Biotechnology Co., Ltd. (hereinafter referred to as "Changchun Changsheng", Changchun Changsheng Biotechnology Co., Ltd. is a wholly-owned subsidiary of the listed company Changsheng Biotechnology Co., Ltd.) had received the decision on administrative punishment from Jilin food and drug administration.
According to the decision, Changchun Changsheng's "adsorptive acellular pertussis combined vaccine" (batch No.: 201605014-01) "titer determination" item does not meet the requirements. If the titer index is unqualified, it means that the immunization effect of diphtheria, tetanus and pertussis may be affected.
Therefore, the punishment for Changchun Changsheng is:
1. 186 pieces of 'adsorbed acellular pertussis combined vaccine' (batch No.: 201605014-01) were confiscated.
2. Confiscate the illegal income of 858840.00 yuan.
3. Impose a fine of 2584047.60 yuan for three times the value of illegally produced drugs. The total amount of fines and confiscations is 3442887.60 yuan.
Here we need to draw a point: this batch of unqualified DPT vaccines was not newly found, but was found in the random inspection last November, only recently Jilin Provincial Drug Administration implemented administrative punishment. At that time, this batch of vaccines had all been sold to Shandong, with a total of 252600 vaccines, which had been delivered to more than 250000 children.
There are still three big questions to be solved
One question: Why did it take nearly nine months for the punishment decision to be announced?
On July 20, Jilin food and Drug Administration released the decision on its official website, and the date of signing was July 18.
The decision was made nearly nine months after the old case was filed, and only three days after the rabies vaccine incident.
What's the reason for such a time arrangement? The reporter called several persons in charge of Jilin food and Drug Administration many times on the night of the 21st, and no one answered or hung up the reporter's call.
Second, is there any concealment from the living creatures?
According to the measures for the administration of information disclosure of listed companies: when the company is suspected of violating laws and regulations and investigated by the competent authorities, and the investors have not yet learned about it, the listed company shall immediately disclose the cause, current status and possible impact of the event. But it wasn't until three days ago that evergreen broke its silence, disclosed the penalties and admitted that the baibaipo workshop had been shut down.
According to another report of Shanghai Securities News, in the 2015 annual report of Changsheng biology, the company issued about 5.62 million copies of "one hundred white broken batches", ranking the first among the six vaccine products sold by the company. According to the company's annual reports in 2016 and 2017, Changchun Changsheng's products on sale include DPT vaccine, etc., but the batch issuance volume of the vaccine has not been disclosed. Another change is that Baipo has also disappeared from the company's picture list of products on sale in the past two years.
When did the company stop producing DPT vaccine? The announcement didn't say.
On the evening of the 21st, no one answered the external calls from the aspect of longevity biology.
On July 20, the Shenzhen Stock Exchange issued a letter of concern, asking Changsheng biology to make a supplementary explanation on the proportion of products involved in the company's revenue, the specific impact on the company and the company's proposed response measures after the production of Baipo production workshop has been stopped; in addition, the company is required to explain whether there is any information disclosure not in time and other matters such as the company's production and operation.
Gao Li, a spokesman for the CSRC, also talked about information disclosure of listed companies at the regular press conference of the CSRC on the same day. She said that with the continuous strengthening of supervision and law enforcement, the quality of financial information disclosure of listed companies has greatly improved in recent years, but the quality of other types of major events still needs to be improved. For major events that may have a greater impact on the stock exchange price of listed companies, information disclosure obligations should be disclosed in a timely manner according to law, fully explaining the cause of the event and the current status And possible impacts. In the next step, CSRC will do a good job in relevant work and crack down on various types of information disclosure violations.
Gao Li: the information disclosure obligations stipulated in the securities law, the measures for the administration of information disclosure of listed companies and other legal rule systems are various and rich in content. For any major event that may have a significant impact on the trading price of listed companies, the information disclosure obligations shall be disclosed in a timely manner according to law, fully explaining the cause, current status and possible impact of the event 。
Third, is the punishment of Jilin food and drug administration too light?
According to the punishment decision, for pertussis pertussis vaccine, the illegal income of 858800 yuan will be confiscated and a fine of 2584000 yuan will be imposed for three times the value of illegally produced drugs.
A total of 250000 problematic vaccines was fined 3.4429 million yuan. There were many questions.
But the punishment decision also specifies the basis for punishment -- according to the drug administration law, those who produce and sell substandard drugs shall be confiscated of the drugs illegally produced and sold and their illegal income, and a fine of not less than one time but not more than three times the value of the drugs illegally produced and sold shall be concurrently imposed; those who use substandard drugs mainly for pregnant women, infants and children shall be given a heavier punishment within the scope of punishment.
However, on the other hand, the drug administration law also stipulates that those who produce or sell inferior drugs, if the circumstances are serious, shall be ordered to stop production, suspend business for rectification or cancel the drug approval documents and relevant licenses; if the case constitutes a crime, they shall be investigated for criminal responsibility according to law.
A number of people in the legal field told reporters that within the existing legal framework, triple punishment is indeed a 'heavier punishment'; as for whether the 'circumstances are serious', it is difficult to determine that there is no evidence to support the impact of pertussis vaccine. However, they also said that at present, China's handling of similar violations is relatively light and the warning is not enough.
A senior lawyer suggested that similar behaviors should be capped with ten times of punishment, but he also confessed that the current drug administration law has only been revised for 15 years, and it is unlikely to be revised again in a short time.
It is understood that DPT combined vaccine is a kind of children's vaccine. According to Baidu Encyclopedia's explanation: DPT vaccine is a combination of pertussis (P), diphtheria (d) and neonatal tetanus (T). It is made up of pertussis vaccine, refined diphtheria and tetanus toxoid in proper proportion, and is used to prevent three kinds of diseases: pertussis, diphtheria and tetanus. DPT is one of the vaccines in the national immunization program. The subjects of DPT are children (3-24) months old. The incidence of adverse reactions is the highest among all vaccines.
Changchun Changsheng has a variety of vaccines
According to the official website of Changchun Changsheng company, the company has two types of vaccine, i.e. freeze-dried live attenuated hepatitis A vaccine, adsorbed cell-free pertussis combined vaccine, and four types of vaccine, i.e. live attenuated varicella vaccine, freeze-dried human rabies vaccine (Vero cell), influenza virus split vaccine, acyw135 group meningococcal polysaccharide vaccine, which are products of domestic vaccine enterprises One of the most abundant private enterprises.
According to the 2017 financial report of Changsheng biology, Changchun Changsheng, a wholly-owned subsidiary of Changsheng biology, is currently mainly selling products including: freeze-dried live attenuated varicella vaccine, freeze-dried human rabies vaccine (Vero cell), influenza virus split vaccine, acyw135 group meningococcal polysaccharide vaccine. The sales volume of rabies vaccine involved accounts for nearly a quarter of the domestic market.
Shenzhen Stock Exchange launched condemnation
Changchun Changsheng Biotechnology Co., Ltd. is a wholly-owned subsidiary of the listed company Changsheng Biotechnology Co., Ltd. According to the information disclosed by Shenzhen Stock Exchange, Changchun Changsheng's rabies vaccine sales accounted for nearly a quarter of the domestic market.
On July 20, 2018, the official website of the Shenzhen Stock Exchange issued the launch of public condemnation of longevity.
The Shenzhen stock exchange took regulatory measures as soon as possible, according to the public censure of the Shenzhen Stock Exchange. First, it asked about the situation of Changsheng biological company by telephone and asked for immediate disclosure and response to the notified matters; The second is to send two consecutive letters of concern to Changsheng biological company, urging the company to verify the specific situation of the products involved, whether the disclosure of major events is timely and the impact of administrative penalties on the company; the third is to require Changsheng biological company to disclose the progress in time and fulfill the obligation of information disclosure according to the on-site supervision of the drug regulatory department.
At present, Gao Junfang is the chairman, general manager and chief financial officer of Changsheng biological company, and Zhang Minghao is the vice chairman of Changsheng biological company. According to the 2017 annual report of Changsheng biology company, as of December 31, 2017, Gao Junfang, her son Zhang Minghao and husband Zhang Youkui jointly held 36.66% of the company's equity, which is the actual controller of Changsheng biology company.
In the latest articles of association of Shenzhen Stock Exchange issued by Shenzhen Stock Exchange on July 20, 2018, Nandu reporter saw that Article 24 stipulates that if a member violates the articles of association and business rules, and the circumstances are serious, the exchange may impose the following disciplinary sanctions alone or concurrently: (I) circulate a Notice of approval; (II) publicly condemn; (III) collect punitive liquidated damages; (IV) suspend or limit the trading authority; （5） Cancel the trading authority; (6) report to the CSRC to identify the member directors, supervisors and senior managers as inappropriate candidates; (7) cancel the membership. '
Parents flipped over their children's vaccine books
If the vaccine is not in the batch involved, it cannot guarantee the quality completely. But most people are still uneasy. 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 that the children were vaccinated with were produced by the manufacturers of immortality, and there were more than one kind, including all kinds of vaccines, including diphtheria, hepatitis A, chicken pox and so on. According to China Center for Disease Control and Prevention