In response to the rabies vaccine production violations of Changchun Changsheng company, disease control departments in many places have successively responded. Now the vaccine event has aroused public outrage. In addition to DPT vaccine, Changchun Changsheng rabies vaccine seems to have problems. Let's get to know.
On July 15, the State Food and Drug Administration issued the notice on illegal production of freeze-dried human rabies vaccine by Changchun Changsheng Biotechnology Co., Ltd. according to the clues, the State Drug Administration organized flight inspection on Changchun Changsheng Biotechnology Co., Ltd. and found that the production of freeze-dried human rabies vaccine by the enterprise was in serious violation of the drug, such as record fraud Product production quality management standard.
The Circular of the State Food and Drug Administration pointed out that all batches of products involved in the flight inspection have not yet been delivered or put on the market, and all products have been effectively controlled.
Since July 16, many disease control departments have responded. According to the incomplete statistics of surging journalists, as of July 22, at least 20 disease control departments of provinces, autonomous regions and municipalities directly under the central government had made a voice on the Changchun Changsheng vaccine incident.
The CDC, including Shanghai, Henan, Hainan, Chongqing, Shandong, Shanxi, Guangxi, Hebei and eight provinces, made it clear that the use of Changchun Changsheng rabies vaccine would be stopped or suspended.
The Centers for Disease Control in Hunan, Fujian and Guangdong said there were no batches of rabies vaccine involved in the province.
In addition, the disease control departments in Tibet, Beijing, Tianjin and Jiangxi said they did not purchase the rabies vaccine products of Changchun Changsheng company or the batches involved in the purchase.
On July 17, Changchun Changsheng company issued a statement saying that the quality of all the listed human rabies vaccine products of the company met the national registration standards, and there was no adverse reaction caused by product quality problems. Please rest assured.
However, Changchun Changsheng also said in the statement that after the inspection team found problems, the company sealed all batches of vaccines involved in the first time to avoid flowing to the market. In order to ensure the drug safety, the company is recalling all batches of freeze-dried human rabies vaccine (Vero cell) within the validity period.
As of July 22, many provinces and cities introduced the recall. Henan Province said that by 12:00 on July 17, the number of Changchun Changsheng rabies vaccines reported and sealed in Henan Province was 141380.8 (5 per person), which is estimated to account for more than 90% of the total market of Changchun Changsheng rabies vaccine in Henan. According to Guangxi CDC, Changchun Changsheng company took the initiative to recall by itself, which was the company's behavior. By July 18, 2018, there had been 93384 recalls in 58 counties (cities, districts) in Guangxi.
In the briefing of CDCs around the world, a lot of information about vaccines was also introduced.
Jiangsu CDC introduced that since 2006, China has implemented a batch issuance system for all listed vaccines, i.e. mandatory inspection and audit for each batch of vaccines at the time of ex factory listing or import. Under this system, every batch of biological products produced by an enterprise can only be listed after sampling, submission for inspection, data audit and inspection are qualified. The inspection is unqualified or the audit is unqualified Those that meet the requirements shall not be listed or imported.
Many centers for Disease Control and prevention have reminded that if the freeze-dried human rabies vaccine of Changchun Changsheng company has been inoculated and the whole vaccination has not been completed, another brand of freeze-dried human rabies vaccine can be used to continue to complete the whole vaccination according to the original procedure.
Shanxi CDC also reminded that not only dogs can carry rabies virus, but also cats, bats, foxes, raccoons and other animals may carry rabies virus, and emergency treatment should be done after being bitten by any of them.
On July 22, Premier Li Keqiang made a comment on the vaccine incident, according to chinagov.cn: the vaccine incident broke through the moral bottom line of people, and must give the people of the whole country a clear account.
In his instructions, Li Keqiang asked the State Council to immediately send an investigation team to thoroughly investigate the whole process and chain of all vaccine production and sales and find out the truth as soon as possible. No matter which enterprises and people are involved, they will resolutely punish and never tolerate. We will resolutely crack down on all illegal and criminal acts that endanger people's lives and safety, severely punish the illegal elements in accordance with the law, and resolutely hold accountable for dereliction of duty and dereliction of duty. We will return to the people a safe, secure and trustworthy living environment as soon as possible.
Attachment: Notice of violation of regulations of Changchun Changsheng rabies vaccine by provinces, municipalities and autonomous regions
1. Shanghai: Changchun Changsheng rabies vaccine has been completely stopped
In July 16th, the Shanghai Municipal Center for Disease Control and prevention, the official WeChat public No. "Shanghai disease control" announced that Shanghai had already suspended the Changchun Changsheng rabies vaccine. Further information needs to wait for the follow-up notification from the state drug administration departments and vaccine manufacturers.
Shanghai CDC said that if you have been vaccinated with some doses of Changchun Changsheng rabies vaccine, you can choose other brands of rabies vaccine with the same 'five needle method'.
2. Henan: suspend the use and seal up all rabies vaccines of Changchun Changsheng
On July 17, Henan Darun biopharmaceutical Co., Ltd., which is responsible for the promotion, storage and transportation of Changchun Changsheng vaccine in Henan, told reporters that at 5:00 p.m. on July 15, the company had informed all county-level disease control centers in Henan that are using Changchun Changsheng rabies vaccine, and asked them to suspend the use and store all Changchun Changsheng vaccines in place hydrophobia vaccine.
According to the above report, as of 12:00 p.m. on July 17, the number of Changchun Changsheng rabies vaccines reported for storage in Henan Province was 141380.8 (5 per person), which is estimated to account for more than 90% of the total market of Changchun Changsheng rabies vaccine in Henan.
On July 18, the official wechat @ Henan disease control of Henan Provincial Center for Disease Control and Prevention released a message that there was no vaccine involved in Henan. In a question and answer article released by @ Henan CDC, Henan CDC said that the announcement of the State Food and Drug Administration pointed out that all batches of products involved in the flight inspection have not yet been delivered and marketed, and all products have been effectively controlled. Therefore, people who have already injected other batches of rabies vaccine produced by the manufacturer need not worry.
3. Hainan: Changchun Changsheng rabies vaccine has been completely stopped
On July 17, according to haikou.com, the freeze-dried human rabies vaccine produced by Changchun Changsheng Biotechnology Co., Ltd. has been stopped in Hainan. The supply of freeze-dried human rabies vaccine from other manufacturers is sufficient, which can ensure the normal development of prevention and treatment of rabies exposure in Hainan.
According to the report, Hainan Provincial Center for Disease Control and prevention reminded that if the enterprise's freeze-dried human rabies vaccine has been inoculated, but the whole vaccination has not been completed, another brand of freeze-dried human rabies vaccine can be used to continue to complete the whole vaccination according to the original procedure; if the whole vaccination has been completed, it will wait for further notice from the State Drug Administration, and it is not recommended to re vaccinate at present.
4. Chongqing: suspend the use of Changchun Changsheng rabies vaccine and store it locally
In July 18th, the Chongqing Municipal Center for Disease Control and prevention, WeChat public number, released by Chongqing CDC, said that since July 15th, Chongqing has suspended the use and sealed up Changchun Changsheng Biotechnology Co., Ltd., freeze-dried Purified Hamster Kidney Cell Rabies Vaccine.
5. Shandong: the rabies vaccine produced by Changchun Changsheng company has been completely stopped
On July 18, Shandong Provincial Center for Disease Control and Prevention official wechat @ Shandong disease control released a message that Shandong Province has completely stopped using the human rabies vaccine produced by Changchun Changsheng Biotechnology Co., Ltd. for further information, it needs to wait for the follow-up notice from the State Drug Administration and vaccine manufacturers.
On July 23, @ Shandong disease control said that 252600 unqualified DPT vaccines (batch No.: 201605014-01) produced by Changchun Changsheng company and flowing into Shandong had been identified, and no suspected abnormal reaction of vaccination was found among children involved.
6. Shanxi: Changchun Changsheng rabies vaccine has been stopped
On July 19, the official website of Shanxi Provincial Center for Disease Control and prevention announced that according to the notice of the State Drug Administration and the emergency notice of Changchun Changsheng Biotechnology Co., Ltd., all vaccination sites in the province have stopped using Changchun Changsheng rabies vaccine.
Shanxi CDC also reminded that not only dogs can carry rabies virus, but also cats, bats, foxes, raccoons and other animals may carry rabies virus, and emergency treatment should be done after being bitten by any of them.
7. Guangxi: 93384 recalled in 58 counties (cities, districts)
In July 19th, the Guangxi disease control and Prevention Center's WeChat public No. @ Guangxi disease control announced that there was no vaccine in Guangxi.
Guangxi CDC mentioned that there are 11 rabies vaccine manufacturers entering the second type vaccine procurement system of Guangxi Public Resources Trading Center. By July 18, 2018, the distribution volume of rabies vaccine in the procurement system was 1.5 million, and the distribution volume of the enterprise (Changchun Changsheng) was 480000, accounting for about 32%.
According to Guangxi CDC, it is the company's behavior that Changchun Changsheng company voluntarily recalls itself. As of July 18, 2018, there have been 93384 recalls in 58 counties (cities, districts) in Guangxi.
In addition, according to local media on July 20, the freeze-dried human rabies vaccine produced by Changchun Changsheng Biotechnology Co., Ltd. has been completely stopped in Guangxi. The disease control department of the autonomous region will pay close attention to the progress of the incident and timely announce the relevant treatment.
8. Fujian: no involved batches of rabies vaccine
On July 19, according to Fuzhou news network, the CDC of Fujian Province responded that there was no batch of rabies vaccine involved in Fujian Province.
According to the above report, the CDC of Fujian Province said that according to the procurement catalogue of class II vaccine of Fujian Province in 2018, rabies vaccines of 10 manufacturing enterprises including Changchun Changsheng entered the procurement catalogue of our province, and some of them were purchased in some counties and regions. However, due to the fact that all batches of products involved in flight inspection have not yet been delivered and marketed, all products have been effectively controlled.
9. Qinghai: if the whole vaccination procedure is not completed, rabies vaccine from other manufacturers can be used to continue the vaccination according to the original vaccination procedure
In July 19th, the Qinghai Provincial Center for Disease Control and prevention WeChat public No. @ Qinghai disease control news, it is understood that the State Drug Administration is organizing the investigation of enterprises. According to the work specification for prevention and treatment of rabies exposure, if the whole vaccination procedure is not completed, rabies vaccine from other manufacturers can be used to continue the vaccination according to the original vaccination procedure.
10. Hunan: there is no vaccine involved in Hunan
On July 20, the official micro blog of Hunan disease prevention and control center @ Hunan disease control news, according to the announcement of the State Drug Administration and the involved companies, all the involved batches of products in this inspection have not yet been delivered and marketed, and all the products have been effectively controlled. On July 16, Changchun Changsheng, the involved enterprise, issued an announcement that: in order to ensure the safety of drug use, Changchun Changsheng is facing All batches of freeze-dried human rabies vaccine within the validity period shall be recalled.
According to Hunan CDC, there is no vaccine involved in Hunan.
According to the requirements of the technical guidelines, rabies vaccination should be completed on time. Try to use the same brand of rabies vaccine. If it can not be achieved, use different brands of qualified rabies vaccine to continue to complete the whole vaccination according to the original procedures.
11. Jiangsu: all vaccines in Jiangsu Province are approved