首页 新闻快报 海关总署:已立即暂停采购和使用长春长生各类疫苗

海关总署:已立即暂停采购和使用长春长生各类疫苗

长春长生问题疫苗事件发生后,海关总署高度重视,立即对全系统国际旅行卫生保健中心(以下简称保健中心)的疫苗采购和使用情况进行了认真全面核查。经查,海关系统保健中心从未采购和使用长春长生生物科技有限公司(以下简称长春长生)和武汉生物制品研究所有限责任公司生产的狂犬病和百白破涉事问题疫苗。

为保证海关系统保健中心预防接种工作安全,切实保护广大出入境人员健康,我署已决定立即暂停采购和使用长春长生生产的各类疫苗。

延伸阅读:如何确认孩子接种了问题疫苗?

因狂犬病疫苗深陷舆论漩涡的长春长生生物科技公司因一纸罚单,再受质疑。因生产的一批次百白破疫苗效价不符合规定,日前,吉林省食药监管理局开出344万元的罚单。不少家长回家翻出疫苗接种本,确认是否给孩子接种过问题疫苗。

据不完全统计,截至目前,已有北京、广东、青岛等多地疾控部门表示,未使用长春长生问题百白破疫苗。

实际上,问题百白破疫苗在2017年11月就已被监管部门发现。除长春长生外,武汉生物制品研究所生产的一批次百白破疫苗也存在同样的问题。后经官方调查,长春长生的问题百白破疫苗全部销往山东,武汉生物制品研究所的问题疫苗则分别销往重庆和河北。

原国家食药监总局新闻发言人曾在去年11月表示,这次2批次百白破疫苗效价指标不合格的原因和结论,将在调查后及时向社会公布有关信息。但截至目前,未有检验结果相关信息披露。

中国疾病预防控制中心免疫规划中心相关负责人表示,儿童家长或监护人可以查看儿童预防接种证上的百白破疫苗接种记录,与公布的疫苗生产企业和批号进行对照,判断是否接种了相应批号的不合格百白破疫苗。

也可以咨询接种单位,由接种单位协助查询所接种百白破疫苗的批号,判断是否接种了相应批号的不合格百白破疫苗。还可以拨打12320卫生热线咨询。

释疑1:问题疫苗如何发现的?

我国对疫苗等生物制品采取批签发制度。具体来说,按照我国《药品管理法》等法律法规要求,疫苗生产企业必须对每一批上市疫苗安全性、有效性等进行全部项目检验,自检合格后报中国食品药品检定研究院(中检院,下同)签发上市。

按照官方披露的消息,问题百白破疫苗是中检院在抽检中发现。2017年11月3日,原食品药品监管总局披露称,近日接到中检院报告,在药品抽样检验中检出长春长生生物科技有限公司、武汉生物制品研究所有限责任公司生产的两批次百白破疫苗效价指标不符合标准规定。

释疑2:批签发制度下,百白破疫苗效价指标为何依旧不合格?

根据原国家食药监局新闻发言人的解释,按照相关规定,中检院对企业报请批签发的疫苗,逐批进行安全性指标检验,对效价有效性指标按国际通行做法随机抽取5%进行检验。

“经查批签发记录,该2批次疫苗安全性指标符合标准,效价有效性指标不在抽样检验范围内。”发言人说。

发言人表示,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,将及时向社会公布有关信息。同时,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6-8周作出。

但截至目前,未有检验结果相关信息披露。

释疑3:接种了问题百白破疫苗会影响免疫效果吗?

效价,是疫苗对人体保护力大小的指标。中疾控表示,该两批次百白破疫苗效价指标不合格,可能影响免疫保护效果。

那么,效价指标不合格的百白破疫苗安全吗?中疾控相关负责人表示,中国食品药品检定研究院对企业报请批签发的疫苗,逐批进行安全性指标检验,经查批签发记录,该两批次疫苗安全性指标符合标准。接种该两批次疫苗安全性风险没有增加。

释疑4:家长如何确认儿童是否接种了问题疫苗?

据原国家食药监总局消息,长春长生生物科技有限公司生产的批号为201605014-01、武汉生物制品研究所有限责任公司生产的批号为201607050-2的百白破疫苗效价指标不符合标准规定。

经调查,长春长生生物科技有限公司生产的该批次疫苗共计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该批次疫苗共计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。

中国疾病预防控制中心免疫规划中心相关负责人表示,儿童家长或监护人可以查看儿童预防接种证上的百白破疫苗接种记录,与公布的疫苗生产企业和批号进行对照,判断是否接种了相应批号的不合格百白破疫苗。

也可以咨询接种单位,由接种单位协助查询所接种百白破疫苗的批号,判断是否接种了相应批号的不合格百白破疫苗。还可以拨打12320卫生热线咨询。

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