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中国刚上市美国早退市,宫颈癌疫苗希瑞适是否是“淘汰品”?

2017-08-08 许雯 凤凰资讯

8月1日,GSK有关负责人向封面新闻证实,其生产的2价疫苗希瑞适确实已不再供应美国市场,但他表示希瑞适在美国下架是因为政策原因,并非网传“过时的淘汰品”。有舆论认为,希瑞适在美国退市因销量不佳,GSK有关人士对此种说法也给予了否认。

7月31日,国内首个获批宫颈癌疫苗——英国制药企业葛兰素史克(GSK)生产的疫苗希瑞适(Cervarix)正式上市。不过,这款刚在中国上市的宫颈癌疫苗已在美国退市。

中国上市美国退市希瑞适是“过时的淘汰品”?

目前全球应用的宫颈癌疫苗有两种,分别为默沙东生产的4价和9价疫苗佳达修,以及葛兰素史克的2价疫苗希瑞适。2016年7月,希瑞适获得中国食品药品监督管理总局的上市许可,也由此成为国内首个获批的预防宫颈癌疫苗。今年5月,默沙东4价宫颈癌疫苗佳达修也获得中国食药监总局上市批准,成为国内第二个获批上市的宫颈癌疫苗。

美国疾病控制预防中心2016年4月起只采购9价宫颈癌疫苗。2016年底前,2价及4价疫苗已不再供应美国市场。2价、4价、9价指的是疫苗针对的病毒亚型的种类数。其中,希瑞适属于2价疫苗,针对16型和18型两种病毒亚型;4价则增加针对6型、11型两种病毒亚型;而9价在4价的基础上,新增了31、33、45、52、58病毒亚型。

希瑞适在美退市为何却在中国上市?

8月1日,GSK有关负责人向封面新闻证实,其生产的2价疫苗希瑞适确实已不再供应美国市场,但他表示希瑞适在美国下架是因为政策原因,并非网传“过时的淘汰品”。有舆论认为,希瑞适在美国退市因销量不佳,GSK有关人士对此种说法也给予了否认。

“9价宫颈癌疫苗采取2剂接种程序,而2价和4价疫苗采用3剂免疫接种程序。美国疾控中心只采购9价宫颈癌疫苗, 主要是其两剂的免疫程序有助于提升接种率。”GSK有关负责人解释称。

接种疫苗能否告别宫颈癌,宫颈癌疫苗适合所有人吗?

一般认为青春期女性是接种首选人群,最好在有性生活之前完成接种。美国妇产科医师协会(ACOG)建议9-26岁的女性均可接种,而26岁以上的男性或女性无需接种。美国CDC免疫实践委员会(ACIP)推荐11或12岁时进行接种,13-26岁已有性生活的女性也可补种。世界卫生组织(WHO)推荐的接种人群为9-12岁。而美国食品药品监督管理局(FDA)批准HPV疫苗的应用年龄为9-26岁。

总体来说,由于国家和地区不同和初次性行为的年龄不同,各组织机构建议的免疫年龄也有所不同。封面新闻了解到,希瑞适在中国注册用于9到25岁女性的接种。而已获批但还未正式上市的4价疫苗佳达修则将适用人群延伸至了20-45岁。

值得注意的是,接种了疫苗并不意味着可以完全告别宫颈癌,仍需进行定期筛查。北京妇产医院妇科瘤科主任医师吴玉梅说,宫颈癌相关的病毒亚型有很多,所以接种了2价和4价疫苗后,也只能预防70%的宫颈癌发生率。此外还有12种HPV病毒可引起宫颈癌。9价疫苗增加了病毒亚型之后,预防率大约能提高到85%以上,但都不是100%预防宫颈癌。

针对消费者普遍关心的价格问题,GSK有关负责人向封面新闻表示,希瑞适目前已中标省份的中标价是统一的人民币580/支,但各省接种者最终付费价格会不同。希瑞适采用3剂免疫接种程序,按照目前的价格,全部接种完毕约花费1740元。

下一步,希瑞适是否有望纳入政府免疫计划社会公众免费接种。GSK有关负责人向封面新闻表示,正积极努力通过与政府相关部门合作,提升中国公众对像希瑞适这样的创新疫苗的可及性。

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    2017-08-09 一闲
  2. [GetPortalCommentsPageByObjectIdResponse(id=1408049, encodeId=3a2114080496d, content=<a href='/topic/show?id=92194628826' target=_blank style='color:#2F92EE;'>#宫颈#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46288, encryptionId=92194628826, topicName=宫颈)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=11102737131, createdName=一闲, createdTime=Wed Aug 09 23:51:00 CST 2017, time=2017-08-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=231770, encodeId=553e231e70a3, content=谢谢分享,学习了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160914/IMG57D82E721DB581755.jpg, createdBy=4fc81933929, createdName=明天会更好!, createdTime=Wed Aug 09 10:34:06 CST 2017, time=2017-08-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1663732, encodeId=a0261663e3274, content=<a href='/topic/show?id=6a124631390' target=_blank style='color:#2F92EE;'>#宫颈癌疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46313, encryptionId=6a124631390, topicName=宫颈癌疫苗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=077725685033, createdName=12498adam48暂无昵称, createdTime=Thu Oct 05 14:51:00 CST 2017, time=2017-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=231409, encodeId=bee0231409a0, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Tue Aug 08 09:24:40 CST 2017, time=2017-08-08, status=1, ipAttribution=)]
    2017-08-09 明天会更好!

    谢谢分享,学习了!

    0

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  4. [GetPortalCommentsPageByObjectIdResponse(id=1408049, encodeId=3a2114080496d, content=<a href='/topic/show?id=92194628826' target=_blank style='color:#2F92EE;'>#宫颈#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46288, encryptionId=92194628826, topicName=宫颈)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=11102737131, createdName=一闲, createdTime=Wed Aug 09 23:51:00 CST 2017, time=2017-08-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=231770, encodeId=553e231e70a3, content=谢谢分享,学习了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160914/IMG57D82E721DB581755.jpg, createdBy=4fc81933929, createdName=明天会更好!, createdTime=Wed Aug 09 10:34:06 CST 2017, time=2017-08-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1663732, encodeId=a0261663e3274, content=<a href='/topic/show?id=6a124631390' target=_blank style='color:#2F92EE;'>#宫颈癌疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46313, encryptionId=6a124631390, topicName=宫颈癌疫苗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=077725685033, createdName=12498adam48暂无昵称, createdTime=Thu Oct 05 14:51:00 CST 2017, time=2017-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=231409, encodeId=bee0231409a0, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Tue Aug 08 09:24:40 CST 2017, time=2017-08-08, status=1, ipAttribution=)]
    2017-08-08 明月清辉

    谢谢分享,学习了

    0

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