The investigation into a vaccine scandal involving China’s second-largest rabies vaccine maker has made important progress, the investigating team from the State Council said on Friday.
国务院调查小组周五表示,针对中国第二大狂犬病疫苗生产商的疫苗丑闻调查取得了重要进展。
The investigators said they had provisionally concluded that Changchun Changsheng Life Sciences had produced rabies vaccines illegally.
调查人员表示,他们暂时认定长春长生生命科学公司非法生产狂犬病疫苗。
Sixteen suspects, including the company’s chairwoman Gao Junfang, had been detained up to Wednesday. The bank accounts of executives and those suspected of direct involvement in the scandal have also been frozen.
截至周三,包括该公司董事长高俊芳在内的16名嫌疑人已被拘留。高管和涉嫌直接卷入丑闻的高管的银行账户也已被冻结。
The probe was set up after the company was accused of counterfeiting production data and changing the parameters for the equipment processing the vaccine in violation of good pharmaceutical manufacturing practices.
该公司被控伪造生产数据,并违反制药生产惯例,改变了疫苗生产设备的参数。
The investigators said the vaccine maker’s violation of laws and regulations include:
调查人员表示,疫苗制造商违反法律法规的行为包括:
Blending undiluted vaccine solutions from different batches for sub-packaging;
混合不同批次的未稀释疫苗溶液用于分包装;
Re-concentrating and re-purifying blended vaccine solutions;
重新浓缩和净化混合疫苗溶液;
Using expired preparations for individual batches of products;
对个别批次的产品使用过期的制剂;
Forging production data, and conducting in advance challenge experiments on mice that should be carried out after vaccines had been produced.
伪造生产数据,并提前对小鼠进行挑战性实验,这些实验应该在疫苗生产后进行。
According to a reporter with the People’s Daily at the investigation scene, a total of 60 computer hard drives, which the company allegedly attempted to damage and dispose of, were retrieved by authorities. Further investigation is ongoing.
据《人民日报》在调查现场的一名记者说,当局找回了总共60个电脑硬盘,据称该公司试图损坏和处理这些硬盘。进一步的调查还在继续。
Chinese drug regulators conducted unannounced inspections at Changchun Changsheng Life Sciences from July 6 to 8 during which violations were discovered and vaccine production immediately suspended.
7月6日至8日,中国药品监管部门在长春长生生命科学公司进行了突击检查,发现违规行为,疫苗生产立即暂停。
According to the Chinese Center for Disease Control and Prevention, there were 516 cases of rabies in humans in China in 2017 and the human morbidity of rabies in the country is declining each year.
根据中国疾病控制和预防中心的数据,2017年中国有516例狂犬病病例,并且中国的狂犬病发病率每年都在下降。
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