A bad dose hits Chinese vaccine player
The Chinese government has detained all the vaccines involved, avoided giving patients a problem vaccine, and stopped the Changchun Changsheng Biotechnology Co., Ltd’s vaccine production when it conducted a flight inspection of the production site of the company and it was found that the company had record fraud during the production of the batch of rabies vaccine.
to the seriousness of this issue and to timely discover and eliminate potential risks in the production of vaccines, the CFDA has conducted comprehensive and
thorough risk investigation in less than six weeks. The results of the investigation showed that the existing vaccine varieties
in the production enterprises are normal, and no problems affecting the quality and
safety of the vaccine have been found.
On July 5, based on the clues, the China State Food and Drug Administration (CFDA), China’s drug regulator and the Jilin Provincial Bureau, conducted a flight inspection of Changchun Changsheng Biotechnology Co., Ltd, engaged in research, development, production and sale of human vaccine products. The company’s main products include live attenuated freeze-dried varicella vaccine, freeze-dried human rabies vaccine (Vero cells), freeze-dried live attenuated hepatitis A vaccine, influenza lysis vaccine, DTP vaccine, adsorption of cell-free diphtheria combined vaccine and ACYW Group 135 meningococcal polysaccharide vaccine. The company distributes its products in the domestic market as well as overseas markets.
Again on July 15, both the agencies formed an investigation team to conduct comprehensive investigations and issued the “Notice on July 22 on Changchun Changsheng Biotechnology Co., Ltd.’s illegal production of freeze-dried human rabies vaccine.”
It has been found that the company fabricates production records and product inspection records, and arbitrarily changes process parameters and equipment. The above acts are a serious violation of the relevant provisions of the Drug Administration Law of the People’s Republic of China and the Regulations on the Quality Management of Pharmaceutical Production. The drug regulator has ordered enterprises to stop production, recover the GMP certificate for drugs, and recall unused rabies vaccines. The CFDA and the Jilin Provincial Bureau have filed investigations on enterprises, and the suspected crimes have been transferred to the public security
organs for criminal responsibility.
The person in charge of the investigations said that it was the second time in a year that the quality of the company’s product was found to be not of good quality. In October last year, the original food and drug supervision bureau found in the sampling test that the batch of Baibai broken vaccine produced by the company was unqualified, and the product is still in production. The former National Health and Safety Commission and the original food medicine are related to the replanting work. The General Administration of Supervision has deployed in February this year.
According to the relevant regulations on vaccine management, the vaccines for sale and marketing of all enterprises must be submitted to the China Food and Drug Control Research Institute for approval. The safety of all batches of vaccines should be tested during the batch issuance process, and the effectiveness of a certain proportion of batches of vaccines should be tested. The company has been legally tested for the sale and use of vaccines, and no quality problems have been found. In order to further confirm the effectiveness of the vaccines already in the market, a laboratory evaluation of samples has been initiated.
Reacting to the developments, on the afternoon of July 23, the nation’s drug regulator held an enlarged meeting to convey the spirit of the important instructions of Xi Jinping, President of China on the Jilin Changchun Longevity Vaccine Case and to study and implement the measures. Li Li, secretary of the party group and deputy director, presided over the meeting. Xu Jinghe, a member of the party group and deputy director, attended the meeting. The director Jiao Hong attended the meeting and the person in charge of the relevant department of the bureau was also present.
According to the reports, the meeting pointed out that the important instructions of Xi Jinping, President of China and attaches great importance to the health of the people, and further investigates and handles cases, investigates potential risks, improves the vaccine management system, and responds to society. Concerns, pointed out the direction, and provided compliance. The CFDA should conscientiously implement the spirit of the important instructions of the incumbent General Secretary Ping Ping and the instructions of Premier Li Keqiang, firmly establish the “four awarenesses”, improve the
political position, enhance political acumen, and have a high sense of responsibility and mission, in accordance with the “four awarenesses”. The most stringent requirements are to fully protect the overall safety of the people in drug use and social security and stability.
The meeting decided that first, on the basis of the preliminary work, further increase the number of personnel, enrich the strength of the investigation and handling work leading group, and fully cooperate with the investigation team of the State Council.
The second is to conduct a thorough investigation of the entire process of production and sales of all Changchun Changsheng vaccines, to find out the truth as soon as possible, and to lock up evidence clues. The third is to persistently attack with heavy punches, severely punish those who are not punished, and use them to be effective. The fourth is to solve the hot issues of concern to the people and do a good job in solving problems. The fifth is to make a comprehensive investigation of the national vaccine production enterprises, and strictly investigate the risks. The sixth is to systematically analyze the vaccine life cycle supervision system, analyze the crux of the problem one by one, and study and improve the vaccine management system in China.
The State Council investigation team investigated that the company’s production of unqualified
Baibai broken vaccine involves the same batch of 201605014-01 and 201605014-02 the batch number of products totalled 499,800.
The investigation found that company produced a total of 252,600 batches of 201605014-01 Baibai Breaking Vaccine, all of which were sold to Shandong Province, 247,359 pieces have been used, and 5,241 losses and storages have been used. Batch number 201605014-02 Baibai broken vaccine has a total of 247,200, of which 223,800 are sold to Shandong, and more than 10,000 are sealed; 23,400 are sold to Anhui, and 3,277 are lost and sealed.
On August 7, CFDA issued a circular stating that the National Health Committee and the State Food and Drug Administration have formulated Vaccination programme in all localities, where rabies vaccines from Changchun Changsheng Company were administered.
The children who were inoculated with the batch number 201605014-01 unqualified DTP (diphtheria-tetanus-pertussis) vaccine produced by the company have been replanted according to the replanting work notice on February 6 this year. As of now, 76.2 per cent of the total number of children to be rehabilitated has been completed. The followup doses that have not been replanted need to be
determined according to the actual vaccination situation of the affected children.
The National Health Commission and the CFDA have made arrangements for the replanting of children who have been inoculated with Changchun Changsheng Company’s batch number 20160501402.
In order to comprehensively evaluate the risk of vaccination of Changbai Changsheng Co., Ltd., the China Food and Drug Administration Institute used the rapid vaccine test method for all batches of DTP vaccine during the validity period of the company for
antigen detection. No abnormalities were found.
At present, an in-depth investigation into the suspected violations of law by company for the production of unqualified DTP vaccine is underway. The violations of laws and regulations and personnel shall be severely punished according to the law, and the local governments and competent authorities with supervisory responsibilities shall be held accountable for their dereliction of duty, default, oversight and inaction.
According to the investigation team, since
April 2014, Changchun Changsheng Company has seriously violated the relevant regulations on the quality management regulations for pharmaceutical production and the national drug standards in the process of producing rabies vaccine. Some batches are mixed with expired stock solution, and the date and batch number are not truthfully filled. Some batches are marked backwards with the date of manufacture. Currently, the recall is in progress. The vaccines involved in the case were sold abroad, and the notification and recall work was initiated.
In order to assess the safety and effectiveness risks of the vaccines that have been marketed, the State Council investigation team has established an expert group consisting of experts in virology, vaccinology, epidemiology, clinical medicine, vaccination, health emergency, and quality control. In-depth investigation and analysis were conducted. Experts comprehensively evaluated and recommended that the vaccination unit has not completed the vaccination programme, and the vaccination unit will continue to continually administer other qualified vaccines.
According to the characteristics of rabies, those who have completed the vaccination program do not need to replant. If the recipient has the willingness to replant, the inoculation unit can replenish the seed free of charge after notifying the prevention and control knowledge, the protection of the vaccine, and the precautions after inoculation.
According to the World Health Organization’s report on rabies published in April 2018, the incubation period for rabies is usually 1-3 months, rarely more than 1 year.
After continuing its investigation in this case revealed many loopholes such as the lack of supervision by the former State Food and Drug Administration and the State Drug Administration, the lack of supervision and guidance, and the oversight of the company. On August 17, 2018, it was decided by the State Administration of Market Supervision to dismiss six senior officials in the administration. The dismissed ones include Ding Jianhua, Director of the Drug and Cosmetics Supervision Department of the State Food and Drug Administration (the State Drug Administration) and Director of the Food and Drug Inspection and Inspection Center; Dong Runsheng, deputy director of the Drug and Cosmetics Supervision Department of the former State Food and Drug Administration (the State Drug Administration); Sun Jinglin, deputy director of the Department of Drug and Cosmetic Supervision of the former State Food and Drug Administration (National Drug Administration) (November 2014 to April 2017, deputy director of the Food and Drug Inspection and Inspection Center of the former State Food and Drug Administration) Dismissal; Ye Guoqing, the director of the Special Drug Supervision Division of the Drug and Cosmetics Supervision Department of the former State
Food and Drug Administration (the State Drug Administration); Guo Xiuxia, an investigator of the Special Drug Supervision Department of the Drug and Cosmetic Supervision Department of the former State Food and Drug Administration (National Drug Administration) and Wang Youchun, vice president of China Food and Drug Administration Research Institute.
Li Bo, the dean (Director) of the China Food and Drug Administration Research Institute (formerly
the State Food and Drug Administration General Administration of Medical Device Standards Management), was asked to make an in-depth examination in the case.
The investigation team, on August 23 has suspected of serious violations of the law by Wang Lifeng, former director of the Drug and Cosmetics Registration and Management Department of the State Food and Drug Administration, and is currently undergoing disciplinary review and surveillance investigations.
According to the monitoring by the Chinese Center for Disease Control and Prevention, the incidence of rabies in China has gradually declined in recent years.
In order to timely discover and eliminate potential risks in the production of vaccines, the
State Food and Drug Administration has sent 45 inspection teams from July 23 to August 9, and has 45 vaccine production enterprises in the country (excluding Changchun Changsheng Biotechnology Co., Ltd.) to conduct comprehensive and thorough risk investigation. According to the drug production quality management standard (drug GMP) criteria, the results of the investigation showed that the existing vaccine varieties in the production enterprises are normal, and no problems affecting the quality and safety of the vaccine have been found.
According to CFDA release on September 7, after investigation, among the 45 vaccine manufacturers, 38 vaccine manufacturers can organize production according to the requirements of drug GMP, and establish a relatively complete quality management system; staffing, facilities and equipment meet production requirements, and production and design capacity match. The quality of the vaccine can be controlled in accordance with the requirements of the Chinese Pharmacopoeia and the drug registration standards. Seven vaccine production enterprises have been suspended for more than three years due to the expiration of the license, the failure to apply for replacement, the poor management of the company, and the renovation of the workshop. No products are circulating in the market.
The State Food and Drug Administration said that it will resolutely implement the central government’s decision on the investigation and handling of the vaccine case of Jilin Changchun Changsheng Company, effectively strengthen the supervision of vaccine quality, timely identify and eliminate potential risks, and ensure the safety of the people. It is necessary to implement the daily supervision responsibility of the provincial drug regulatory authorities for vaccine manufacturers, maintain the high pressure on the supervision of vaccine products; implement the main responsibility of enterprises, further improve the quality management system, establish a quality and safety traceability system, and implement a product risk reporting system; Guidelines for the issuance of vaccines for batches of vaccines, especially for rabies vaccines, rabies vaccines, polio vaccines, etc., which are more complex in production processes and quality control, comprehensively enhance risk control; increase the intensity of flight inspections and follow-up inspections, and timely strictly investigate and deal with violations of laws and regulations.
The Food and Drug Administration has deployed national vaccine production enterprises to conduct self-inspection to ensure that enterprises organize production according to the approved technology, strictly abide by GMP production standards, and all production inspection process data should be true, complete, reliable and traceable. The State Food and Drug Administration will organize the flight inspection of all vaccine production enterprises, and seriously investigate and deal with violations of laws and regulations.