Emergency notification by the State Food and Drug Administration | Famous enterprise rabies vaccine fraud!

Medical Network July 16 news, the thunderstorm, the State Food and Drug Administration yesterday informed that the rabies vaccine produced by the listed pharmaceutical company subsidiary has recorded illegal activities such as fraud.

July 15, country drug According to the official website of the Supervisory Authority, according to the clue, the State Drug Administration organized a flight inspection of Changchun Changsheng Biotechnology Co., Ltd. enterprise 'Freeze-dried human rabies vaccine' production has serious violations of the "Good Manufacturing Practices".

The State Food and Drug Administration has requested the Jilin Food and Drug Administration to withdraw the drug from the enterprise. GMP Certificate (Certificate No.: JL20180024), ordered to stop the production of rabies vaccine, instructs enterprises to strictly implement the main responsibility, comprehensively investigate potential risks, take the initiative to take control measures to ensure the safety of public medication.

At present, the investigation team of the Jilin Food and Drug Administration has been stationed in the enterprise to investigate the relevant violations. The State Food and Drug Administration sent a special inspection team to Jilin to supervise the investigation and disposal.

Fortunately, all the batch products involved in this flight inspection have not been shipped and sold, and all products have been effectively controlled.

According to public information, Changchun Changsheng was founded on August 18, 1992. It is a national high-tech enterprise engaged in research, development, production and sales of human vaccines. In December 2015, Changsheng Bio was listed on the Shenzhen Stock Exchange through asset restructuring.

The parent company Changsheng Life Annual Report stated that Changchun Changsheng is China's first batch of vaccine companies that independently develop and sell influenza vaccines and human rabies vaccines (Vero cells). It is one of the few companies in China that can simultaneously produce viruses and bacterial vaccines. It is licensed to use cell factory technology to produce vaccines for live attenuated hepatitis A vaccine. The quality of vaccine products ranks among the top in the industry.

According to the daily economic news report, on the same day, informed sources revealed that Changchun Changsheng Biotechnology Co., Ltd. (hereinafter referred to as 'Changchun Changsheng', a wholly-owned subsidiary of the listed company Changsheng Biological) issued an urgent notice, requiring the provincial promotion team to immediately Inform the district/county disease control agencies and vaccination units within the jurisdiction, immediately stop using the company's rabies vaccine, and immediately seal the company's rabies vaccine.

According to the report, the news has been confirmed by a staff member of Changchun Changsheng Medical Consultation Department. At the same time, the staff stressed that: It is not our drug regulatory department that finds out that there is a problem, it is our own behavior, and may be afraid of our previous quality indicators. Some questions, so we have to recall and check the status of the existing indicators in the market. We are not sure what the specific reasons are, probably because of the safety considerations of the products, and how big the batch size is currently not clear.

The 2017 annual report of Changsheng Biology shows that the number of batches of vaccines and second-class vaccines of the company is 5.77 million and 10.11 million, respectively. The main products of the company are freeze-dried human rabies vaccine (Vero cells), freeze-dried varicella attenuated. The number of live vaccines, influenza split vaccines, freeze-dried hepatitis A live attenuated vaccines was 3.55 million, 3.6 million, 2.57 million, and 2.72 million, from the number of batches issued, The rabies vaccine and varicella vaccine have already ranked second in the country.

It is understood that rabies vaccine belongs to the second class vaccine. China is currently the number one producer and user of global rabies vaccine, with an annual production and sales volume of more than 15 million. More than 80% of the world's rabies vaccine is consumed in China.

'Human rabies' is mainly caused by bites, scratches or mucosal infections of diseased animals. It can also be transmitted through respiratory aerosols under certain conditions. The infected animal's saliva contains rabies virus. The infected animals are mainly dogs (more than 90 %), followed by the cat.

The typical clinical manifestation of rabies is water-induced disease. Therefore, rabies is also called water-threatening disease. Initially, it is sensitive to sound, light, wind and other sensation, and the throat has a tight feeling. When entering the excitement period, it can be extremely horrible, fearful of water, fear of wind. , paroxysmal pharyngeal spasm, dyspnea, etc., the last episode of seizures and various paralysis, can quickly die due to respiratory and circulatory failure. Once rabies is ill, the mortality rate is 100%. Patients usually die within 3 to 6 days. In breathing or circulatory failure.

China has a relatively complete reporting and statistical system for rabies deaths. The rabies deaths reported in the infectious disease reporting system are basically vaccinated against rabies after being bitten by mad animals.

(Source: 2016 China Health Statistics Yearbook)

The immune effect of the injection of rabies vaccine is directly related to the time of injection. After the bite, the earlier the injection, the better the immune effect and the greater the chance of protection. If the vaccine is fraudulent, it is conceivable that the effect of this protection Will be greatly reduced.

For the problem vaccine, I believe that everyone is most impressed. It is the Shandong illicit vaccine case that broke out in March 2016. Since then, the state's supervision of the second class vaccine has been continuously strengthened.

On April 25, 2016, the State Council issued a decision on amending the Regulations on the Administration of Vaccine Circulation and Vaccination, clarifying that the vaccination unit should not directly purchase the second-class vaccine from the enterprise, and the state establishes a traceability system for the whole process.

On February 7, 2017, the General Office of the State Council issued the “Opinions on Further Strengthening Vaccine Circulation and Vaccination Management”, clearly promoting the promotion of quality management and standard production capacity of vaccine manufacturers, and continuously improving vaccines. product quality.

It is reported that in response to the flight inspection, Changchun Changsheng found violations of laws and regulations in production quality management. The special inspection team of the State Food and Drug Administration clearly stated that 'it will not be tolerated, and will be seriously investigated and punished according to laws and regulations. Transferred to the public security organs for severe punishment'.