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李克强就疫苗事件作出批示:必须给全国人民一个明明白白的交代

 近日,长春长生生物科技有限公司(下称“长春长生”)“狂犬病疫苗生产记录造假”及“百白破疫苗效价不符合规定”两起事件备受关注。

李克强总理就疫苗事件作出批示:

The vaccine case has crossed a moral line, and the nation deserves a clear explanation.
此次疫苗事件突破人的道德底线,必须给全国人民一个明明白白的交代。

李克强在批示中要求,

The State Council should immediately send a group to thoroughly investigate the production and selling chain of vaccine, to uncover the truth as soon as possible, and any wrongdoing will be severely punished regardless of who is involved.
国务院要立刻派出调查组,对所有疫苗生产、销售等全流程全链条进行彻查,尽快查清事实真相,不论涉及到哪些企业、哪些人都坚决严惩不贷、绝不姑息。

Any illegal acts that could harm the people's lives should be severely cracked down and people behind it punished in accordance with law. Any dereliction of duty in the supervision authority should be held accountable, and we should give the people a living environment that is safe, trustworthy and credible.
对一切危害人民生命安全的违法犯罪行为坚决重拳打击,对不法分子坚决依法严惩,对监管失职渎职行为坚决严厉问责。尽早还人民群众一个安全、放心、可信任的生活环境。

针对“狂犬病疫苗生产记录造假”事件,昨日,国家药监局在官网通报最新调查进展。

A child is vaccinated in hospital in Southwest China's Guizhou province on April 25, 2018. [Photo/VCG]

According to the investigation, the company counterfeited the vaccine’s production and inspection data, and changed the parameters for equipment and processing the vaccine.
通报说,现已查明,企业编造生产记录和产品检验记录,随意变更工艺参数和设备。

目前,已责令企业停止生产(terminate the production),收回药品生产质量管理规范(Good Manufacturing Practices,GMP)证书,同时会同吉林省局已对企业立案调查,涉嫌犯罪的移送公安机关追究刑事责任(the cases of those suspected of violating laws will be transferred to public security departments)。

GMP(Good Manufacturing Practices),中文含义是“生产质量管理规范”或“良好作业规范”、“优良制造标准”。

Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. 
“良好作业规范”是监管部门审批和发放食品饮料、化妆品、药品、膳食补充剂以及医疗设备时要遵照的规范要求。

These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user.
这些规范是生产方确保所有批次产品保证高质量并且有效的基本要求,每个行业的具体规范或有不同,但GMP的核心目标是防止产品对终端用户产生有害影响。

国家药监局表示,已部署全国疫苗生产企业进行自查,确保企业按批准的工艺组织生产,严格遵守GMP生产规范,所有生产检验过程数据要真实、完整、可靠,可以追溯。

国家药监局将组织对所有疫苗生产企业进行飞行检查(unannounced inspections),对违反法律法规规定的行为要严肃查处。

【起因】

事情的起因是7月15日,国家药监局宣布发现长春长生生物科技有限责任公司生产的狂犬病疫苗造假。

The State Drug Administration has launched an investigation of Changchun Chang­sheng Bio-tech Co, which was found to have fabricated production records for freeze-dried rabies vaccines for human use.
国家药品监督管理局组织对长春长生生物科技有限责任公司开展检查,发现长春长生“冻干人用狂犬病疫苗”生产存在记录造假等严重违反《药品生产质量管理规范》的行为。

据《中国证券报》报道,接近长生生物的一位疫苗业资深人士说,此次事发是因为长生生物内部生产车间的老员工实名举报。

一波未平,一波又起。

7月20日,吉林省食药监局又宣布对去年11月份发现的长生生物子公司长春长生的疫苗造假事件进行处罚,公告称,长春长生生产的一批约25万支百白破疫苗效价指标不合格。

It was also revealed that Changsheng Bio-tech was linked to a substandard adsorbed diphtheria-pertussis-tetanus, or ADPT, vaccine for infants. 
随后又发现,长春长生生产的“吸附无细胞百白破联合疫苗”效价指标不合格。

吉林省药监局对长春长生给予行政处罚:

没收库存的剩余“吸附无细胞百白破联合疫苗”186支、没收违法所得85.88万元。同时,处违法生产药品货值金额三倍罚款258.4万元,罚没款总计344.29万元。

根据长生生物的公告,在被查之前该批次约25万支疫苗几乎已全部销售到山东省疾病预防控制中心。

Changsheng Bio-tech Co, parent company of Changchun Changsheng Bio-tech Co, revealed in November that 252,600 doses of the substandard ADPT vaccine that couldn't meet the standard of immunity results were all sold to Shandong province.
长生生物去年11月称,25.26万支效价指标不合格的百白破疫苗已全部销售往山东省。

现在网友们最关心的是,这批疫苗有多少流入市场,是否有孩子因为问题疫苗患病、健康受损。

据山东《大众日报》报道,7月22日,记者从山东省疾控中心获悉,长春长生公司生产的流入山东的不合格百白破疫苗流向已全部查明,流向济南、淄博、烟台、济宁、泰安、威海、日照、莱芜等8个市。

这批疫苗已接种247359支,涉及儿童215184人,后续补种工作陆续开展

报道称,监测显示,山东省接种该批次疫苗的儿童未发现疑似预防接种异常反应发生率增高。

山东省卫生计生委要求各级疾控机构和预防接种单位密切关注,及时发现问题,妥善处置,确保每一名接种过不合格百白破疫苗的儿童获得补种。

中国疾病预防控制中心有关专家也称:

The substandard ADPT vaccine may reduce the expected immune effects, but won’t pose safety threats to people’s health.
不合格的百白破疫苗可能影响免疫保护效果,但接种安全性风险没有增加。

另外,国家药监局22日称:

The state drug administration confirmed on Sunday that it was discovered in October that one batch of Changsheng’s ADPT vaccine was substandard, and its production of ADPT has been suspended since then.
去年10月,原食药监总局抽样检验中发现该企业生产的1批次百白破疫苗效价不合格,该产品目前仍在停产中。

A plan for reinoculation of those affected was worked out in February.
有关补种工作原国家卫计委会同原食药监总局已于今年2月进行了部署。

疫苗事关生命健康,质量安全容不得半点瑕疵,不能有一丝侥幸。

《中国日报》昨日发表中英文社论,其中提到:

唯有公开透明的处理方式,才能有效化解“问题疫苗”引发的公共卫生危机。

这次“问题疫苗”事件,不仅引起公众恐慌,更因为涉事公司已有过生产不合格疫苗的劣迹而可能引发公众对于监管体系的质疑。

The government should launch an investigation into the case, not only about how the company tampered with the vaccines but also about how the loopholes in supervision have allowed problematic vaccines into the market. 
面对汹汹舆论,监管部门有必要不仅严查涉事企业,更反思整个监管体系,亡羊补牢,防止“问题疫苗”流入市场的悲剧重现。

Given social media’s power in spreading rumors and alarm about anything, transparency and the truth are the most effective way to keep people’s worries at bay.
更重要的,新媒体时代舆情传播以秒计算,有关部门切不可做鸵鸟,而应与时间和谣言赛跑,知无不言、言无不尽,防止谣言的出现,让公众看到自己保护公共卫生安全的决心。

The authorities need to release whatever information they know about the incident to the public as soon as possible.
事已至此,唯有公开透明的处理方式,才能有效化解“问题疫苗”引发的公共卫生危机。

It is not just to pacify the public in the wake of this particular incident. It is also for a thorough overhaul of the industry as vaccines are directly related to people’s health, particularly children.
这不仅是为了平息舆论,更是为了整顿整个疫苗行业。毕竟这一行业关系着全国人民的生命健康,尤其牵涉着少年儿童,牵涉着祖国的未来。


【相关词汇】

fabricate:伪造

freeze-dried: 经过冷冻干燥的

rabies ['reɪbiːz]:狂犬病

vaccine [væk'sin]:疫苗

diphtheria [dɪp'θɪərɪr]:白喉

pertussis [pə'tʌsɪs]:百日咳

tetanus ['tɛtənəs]:破伤风

 

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