本站小编 免费考研网 发布于2018-07-31 0次阅读
摘要 :   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 crosed a moral line, and the nation deserves a clear explanation.  此次疫苗事件突破...



  The vaccine case has crossed a moral line, and the nation deserves a clear explanation.



  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.


  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.



  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.


  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.


  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.



  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。



  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.





  It was also revealed that Changsheng Bio-tech was linked to a substandard adsorbed diphtheria-pertussis-tetanus, or ADPT, vaccine for infants.





  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.








  The substandard ADPT vaccine may reduce the expected immune effects, but won’t post safety threats to people’s health.



  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.


  A plan for reinoculation of those affected was worked out in February.






  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.


  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.


  The authorities need to release whatever information they know about the incident to the public as soon as possible.


  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.




  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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