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Breaking-News >> TodayHistory July 15, 2018: The beginning and end of the fraud of longevity rabies vaccine
On July 15, 2018 (June 3, 2018 in the lunar calendar), the whole story of the fraud of longevity rabies vaccine. Vaccination against rabies is the most effective way to prevent rabies. Usually, there are 5 rabies vaccines each and must be vaccinated on the 1st, 3rd, 7th, 14th, and 30th days of the bite. If the vaccination is ineffective, the consequences will be unimaginable. At present, the incidence of rabies in my country ranks second in the world, and it is increasing year by year. According to a document on rabies vaccines updated by the World Health Organization in 2010, about 55,000 people die of rabies every year around the world. Event Development On July 15, 2018, the State Food and Drug Administration issued a notice. The State Food and Drug Administration organized an unannounced inspection of Changchun Changsheng Biotechnology Co., Ltd.(hereinafter referred to as Changchun Changsheng) based on clues and found that the company's freeze-dried human rabies vaccine production There were serious violations of the Good Manufacturing Practice such as false records. On July 16, the State Food and Drug Administration requested the Jilin Province Food and Drug Administration to withdraw the company's "GMP Certificate"(Certificate No.: JL20180024), ordered it to stop the production of rabies vaccines, and instructed the company to strictly implement its main responsibilities, comprehensively investigate potential risks, and proactively take control measures to ensure the safety of public medication. On the evening of July 19, Changsheng Biotech issued an announcement on the Shenzhen Stock Exchange stating that on July 18, Changchun Changsheng Biotech Co., Ltd., a wholly-owned subsidiary of Changsheng Biotech Co., Ltd., received the "Jilin Province Food and Drug Administration Administrative Penalty Decision"(hereinafter referred to as the "Punishment Decision"), and was fined a total of more than 3.44 million yuan by the Jilin Food and Drug Administration. The "Punishment Decision" stated that during the national drug special random inspection, the "adsorbed cell-free DPT combined vaccine" produced by Changchun Changsheng Biotechnology Co., Ltd. was inspected by China National Institute for Food and Drug Control, and the inspection results [titer determination] did not meet the requirements. On the evening of July 22, Premier Li Keqiang issued instructions on the vaccine incident: This vaccine incident broke through people's moral bottom line and must be given a clear explanation to the people of the country. The consequences of "breach of trust" are more serious than "failure". On July 15, 2018, the State Food and Drug Administration issued a notice stating that the State Food and Drug Administration organized an unannounced inspection of Changchun Changsheng Biotechnology Co., Ltd.(hereinafter referred to as Changchun Changsheng) based on clues and found that the company had serious violations of the "Good Manufacturing Practice" such as false records in the production of freeze-dried rabies vaccine for human use. As soon as the announcement came out, everyone who heard it felt horrified! What's even more terrifying is that this company's rabies vaccine sales rank second in the country! In 2017 alone, the company produced 3.55 million doses of rabies vaccines! In other words, in 2017 alone, 3.55 million people may have received this rabies vaccine! How many such human vaccines has this company produced in recent years! Who can guarantee that there are no problems with the other rabies vaccines they produce! Once rabies attacks, there is almost no cure! Injecting the company's fake rabies vaccine, what would that mean! It means death! Moreover, once an effective vaccine is not injected within a period of time after you may be infected with the rabies virus, re-injection of the vaccine will lose its effect! What could be more terrible than the behavior of this kind of company! Why do Sudan red, gutter oil, poisoned milk powder, poisoned rice and other similar incidents continue to challenge people's views? One of the reasons is that the cost of this kind of crime is too low! Most of them are just fines! Compared with the huge benefits he has gained, a little fine is like a drop in the bucket! There are also some people who question that domestic vaccines are inferior to imported vaccines, but the "signs" are getting higher and higher. Many people believe that the quality of domestic vaccines is unreliable and are "superstitious" about imported vaccines. Foreign problem vaccines Are there really no problems with foreign problem vaccines? At the end of 2017, 8 batches of Pasteur's imported five-combination vaccines were unqualified and were not allowed to be marketed. Pasteur Company made a mistake similar to Changchun Changsheng this time. It changed the supplier of excipients without reporting, and actually led to unqualified vaccine titer being scrapped. The current domestic five-combination vaccine is seriously suspended, which is caused by this incident. The consequences continue to this day. In 2013, the Japanese government announced free cervical cancer vaccination for 2.61 million girls from grade 6 to grade 1 of high school, but reports of serious side effects surged within two months. The Ministry of Health, Labor and Welfare had to suspend the promotion of cervical cancer vaccination. However, vaccination has caused many young girls to be disabled. In 2013, the families of the victims established the "National Liaison Association for Cervical Cancer Vaccine Victims" and began to actively fight. In 1996, the hepatitis B vaccine produced in Japan used sera from patients with AIDS and hepatitis as raw materials, causing some recipients to become sick. After the incident, Japan's Ministry of Health and Welfare and the manufacturers did not inform the public, but joined forces to cover up the truth, causing more vaccinators to become innocent victims. In 1955, there was a polio vaccine accident in the United States. When Cutter Laboratories in Berkeley, California was producing a polio vaccine, it did not kill all the viruses because the use of formalin was not thorough enough to inactivate the corresponding viruses. As a result, of the 120,000 children who received the vaccine, 40,000 were infected, and 56 of them developed paralytic polio, giving this acute infectious disease that seriously endangers children's health a chance to spread again among young children. In the end, 113 people were paralyzed for life and 5 people died. Even this is true in developed countries, and the rate of vaccine safety accidents in many developing countries that do not have medical research and development can be seen. Therefore, it is absolutely not advisable to blindly believe that "imported vaccines are absolutely safe". It is scientific to have a rational attitude to distinguish them. The vaccine accident that broke out in China this time is an indisputable fact, but killing the existence of domestic vaccines with a stick will frustrate the intentions of those "anti-vaccinationism"! In recent years, the West's "anti-vaccinism" has been transformed into a conspiracy theory that has been aghast heard of in the East, increasing public panic about vaccines. Coupled with the campaign of some interested people named themselves "scholars", the "vaccine scare" is still a serious worldwide problem today. Severe Punishment and Morality Premier Li Keqiang issued instructions on the vaccine incident: This vaccine incident broke through people's moral bottom line and must be given a clear explanation to the people of the country. In his instructions, Li Keqiang requested that the State Council should immediately dispatch an investigation team to conduct a thorough investigation of all vaccine production and sales processes, find out the truth as soon as possible, and resolutely punish and never tolerate any companies or people involved. We will resolutely crack down on all illegal and criminal acts that endanger the safety of people's lives, resolutely severely punish lawbreakers in accordance with the law, and resolutely and severely hold accountable for dereliction of duty in supervision. Give the people a safe, secure and trustworthy living environment as soon as possible. It can be seen that the government has paid close attention to the adverse impact of this incident. For now, regarding the development status of the whole matter, it is not difficult to find that public opinion's demands focus on several points: First, whether the punishment of the enterprises involved is reasonable. There are many voices questioning that the fine of 3 million yuan will not serve as a deterrent. The second is whether the vaccines that have been produced also have safety hazards? The follow-up test results are the focus of everyone's attention. Third, for the safety of the entire domestic vaccine, we need to use a "booster" dose and the supervision of the regulatory authorities is in place. All in all, excessive remarks abound on the Internet, and they need to be treated rationally and scientifically to prevent interested people from taking advantage of the opportunity to create chaos. Changchun Changsheng Company was fined 9.1 billion yuan. On October 16, 2018, the State Food and Drug Administration and the Food and Drug Administration of Jilin Province respectively imposed multiple administrative penalties on Changchun Changsheng Company. The State Food and Drug Administration revoked the drug approval certificate for Changchun Changsheng Company's rabies vaccine (Sinopharm Zun Zi S20120016); revoked the biological product batch issuance certificate of the product involved in the case and imposed a fine of 12.03 million yuan. The Food and Drug Administration of Jilin Province revoked its "Drug Production License"; confiscated illegally produced vaccines and illegal income of 1.89 billion yuan, and imposed a fine of 7.21 billion yuan three times the value of illegal production and sales, with a total of 9.1 billion yuan in fines; 14 directly responsible supervisors and other directly responsible persons involved in the case were imposed administrative penalties that were prohibited from engaging in drug production and operation activities in accordance with the law. Those suspected of committing a crime shall be investigated for criminal responsibility by the judicial organ in accordance with the law. News raw data sources → https://www.abtool.cn/today_detail/1e9l.html 17WorldNews[2025.09.12-17:19] 访问:73
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