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65万余支不合格百白破疫苗流入三省 食药监总局要求立即停用

2017-11-04 佚名 新华网

国家食品药品监督管理总局新闻发言人3日对媒体说,分别由长春长生生物科技有限公司和武汉生物制品研究所有限责任公司生产的各一批次共计65万余支百白破疫苗效价指标不符合标准规定,食药监总局已责令企业查明流向,并要求立即停止使用不合格产品。据介绍,上述不合格疫苗对人体安全性没有影响。

国家食品药品监督管理总局新闻发言人3日对媒体说,分别由长春长生生物科技有限公司和武汉生物制品研究所有限责任公司生产的各一批次共计65万余支百白破疫苗效价指标不符合标准规定,食药监总局已责令企业查明流向,并要求立即停止使用不合格产品。据介绍,上述不合格疫苗对人体安全性没有影响。

该发言人说,经检查,长春长生生物科技有限公司生产的批号为201605014-01的疫苗共计252600支,全部销往山东省疾病预防控制中心;武汉生物制品研究所有限责任公司生产的批号为201607050-2的疫苗共计400520支,销往重庆市疾病预防控制中心190520支,销往河北省疾病预防控制中心210000支。

食药监总局已会同国家卫生计生委组织专家研判,并向有关省市发出通知,责令企业查明流向,责令疫苗生产企业报告2批次不合格疫苗出厂检验结果,对留样重新检验,认真查找效价不合格原因。调查组将对两个企业开展调查,并进行现场生产体系合规性检查。将抽取两家企业生产所有在有效期内的百白破疫苗样品进行检验,检验结论需6至8周作出。

发言人提示,该2批次百白破疫苗效价指标不合格,可能影响免疫保护效果,但是对人体安全性没有影响。国家卫计委和有关省份卫生计生部门正在组织专家对接种这两批次疫苗的保护效果进行评估,根据评估结果采取相应措施妥善处理;要求相关省份卫生计生部门及时调配疫苗,保证免疫接种正常开展。

发言人介绍,2008年以来,国家药品抽检计划共抽检疫苗产品944批次,合格率99.6%。这次2批次百白破疫苗效价指标不合格的原因和结论,需要根据企业自查、调查组调查和有效期内疫苗样品检验结果综合分析后做出,我们将及时向社会公布有关信息。

据介绍,百白破疫苗是预防百日咳、白喉、破伤风的有效手段。自上世纪70年代纳入计划免疫以来,百日咳、白喉、破伤风发病率持续下降,从2007年至今没有白喉病例报告,百日咳年发病率已降至目前的0.5/10万以下。

该发言人强调,药品生产企业需对上市药品质量承担全部法律责任。所有药品生产企业必须按照国家批准的工艺标准生产,严格执行药品生产质量管理规范,确保生产经营行为持续合规,全过程所有数据真实、完整、可追溯。所有疫苗产品必须在检验合格后申报批签发,企业需对出厂产品检验报告、产品留样的真实性承担法律责任。

据了解,食药监总局将继续加强上市产品抽样检验和生产现场有因检查,及时查处发现的质量安全问题,涉嫌犯罪的移交公安机关追究刑事责任。

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    2018-03-02 cmsvly
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  5. [GetPortalCommentsPageByObjectIdResponse(id=2076241, encodeId=a9cb20e624174, content=<a href='/topic/show?id=b4351011422b' target=_blank style='color:#2F92EE;'>#食药监#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101142, encryptionId=b4351011422b, topicName=食药监)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aad0444, createdName=cmsvly, createdTime=Fri Mar 02 21:04:00 CST 2018, time=2018-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1705885, encodeId=76601e05885fe, content=<a href='/topic/show?id=76e510114468' target=_blank style='color:#2F92EE;'>#食药监总局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101144, encryptionId=76e510114468, topicName=食药监总局)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a73b31099952, createdName=lilili1114, createdTime=Mon Feb 26 03:04:00 CST 2018, time=2018-02-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1668947, encodeId=6b07166894e3c, content=<a href='/topic/show?id=1086203266c' target=_blank style='color:#2F92EE;'>#不合格#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=20326, encryptionId=1086203266c, topicName=不合格)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f77c26479803, createdName=echonoir, createdTime=Thu Mar 15 00:04:00 CST 2018, time=2018-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1840436, encodeId=c245184043683, content=<a href='/topic/show?id=186b8e937c6' target=_blank style='color:#2F92EE;'>#药监总局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87937, encryptionId=186b8e937c6, topicName=药监总局)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=19ad38, createdName=lq1767, createdTime=Tue Dec 19 14:04:00 CST 2017, time=2017-12-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1752924, encodeId=75dd1e5292457, content=<a href='/topic/show?id=c38de1891f5' target=_blank style='color:#2F92EE;'>#百白破#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71891, encryptionId=c38de1891f5, topicName=百白破)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3c6a36593474, createdName=fzwish20012, createdTime=Wed Jun 06 00:04:00 CST 2018, time=2018-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=258616, encodeId=446625861673, content=非常好的文章.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=1, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7LIiaRZTzJ3SEfiauCzTMPW7YvPPYLNJBXG9oh6Al1icq2VQQkIHWxqXehcicTS62YKJVBhxeth3wggw/0, createdBy=7ce01621306, createdName=天涯183, createdTime=Sat Nov 04 12:41:25 CST 2017, time=2017-11-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=258585, encodeId=8cfe2585851d, content=又是山东出事.问题不小呀, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c4a5105539, createdName=lovetcm, createdTime=Sat Nov 04 11:22:45 CST 2017, time=2017-11-04, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=2076241, encodeId=a9cb20e624174, content=<a href='/topic/show?id=b4351011422b' target=_blank style='color:#2F92EE;'>#食药监#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101142, encryptionId=b4351011422b, topicName=食药监)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aad0444, createdName=cmsvly, createdTime=Fri Mar 02 21:04:00 CST 2018, time=2018-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1705885, encodeId=76601e05885fe, content=<a href='/topic/show?id=76e510114468' target=_blank style='color:#2F92EE;'>#食药监总局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101144, encryptionId=76e510114468, topicName=食药监总局)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a73b31099952, createdName=lilili1114, createdTime=Mon Feb 26 03:04:00 CST 2018, time=2018-02-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1668947, encodeId=6b07166894e3c, content=<a href='/topic/show?id=1086203266c' target=_blank style='color:#2F92EE;'>#不合格#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=20326, encryptionId=1086203266c, topicName=不合格)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f77c26479803, createdName=echonoir, createdTime=Thu Mar 15 00:04:00 CST 2018, time=2018-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1840436, encodeId=c245184043683, content=<a href='/topic/show?id=186b8e937c6' target=_blank style='color:#2F92EE;'>#药监总局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87937, encryptionId=186b8e937c6, topicName=药监总局)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=19ad38, createdName=lq1767, createdTime=Tue Dec 19 14:04:00 CST 2017, time=2017-12-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1752924, encodeId=75dd1e5292457, content=<a href='/topic/show?id=c38de1891f5' target=_blank style='color:#2F92EE;'>#百白破#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71891, encryptionId=c38de1891f5, topicName=百白破)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3c6a36593474, createdName=fzwish20012, createdTime=Wed Jun 06 00:04:00 CST 2018, time=2018-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=258616, encodeId=446625861673, content=非常好的文章.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=1, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7LIiaRZTzJ3SEfiauCzTMPW7YvPPYLNJBXG9oh6Al1icq2VQQkIHWxqXehcicTS62YKJVBhxeth3wggw/0, createdBy=7ce01621306, createdName=天涯183, createdTime=Sat Nov 04 12:41:25 CST 2017, time=2017-11-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=258585, encodeId=8cfe2585851d, content=又是山东出事.问题不小呀, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c4a5105539, createdName=lovetcm, createdTime=Sat Nov 04 11:22:45 CST 2017, time=2017-11-04, status=1, ipAttribution=)]
    2017-11-04 天涯183

    非常好的文章.学习了

    0

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    2017-11-04 lovetcm

    又是山东出事.问题不小呀

    0

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