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活疫苗才能赶走病毒?FDA前疫苗评审主管余力:现有应急疫苗保护力不够;中国疫苗审批比美国更严格

作者:李傲华 2020-12-14 19:10:35

  YULIBIAOSHI,JINJISHIYONGSHOUQUANBINGBUDENGYUWANZHENGDESHANGSHIPIZHUN。YIJINGHUODEJINJISHIYONGSHOUQUANDEYIMIAO,JIEXIALAIHAIYAOTIJIAOWANZHENGDELINCHUANGSHUJU,HAIYOUCMCZHILIANGKONGZHIDEJIEGUO,CAINENGWANCHENGSHANGSHIZHUCESHENQING。

  全球新冠疫苗超级竞技已经从研发阶段正式走向了审批、落地。

  DANGDISHIJIANZHOUYI(12YUE14RI),SHOUPIHUIRUIXINGUANYIMIAOJIANGZAIMEIGUOZHENGSHIKAISHIJIEZHONG。TELANGPUZHENGFUDE“QULVJISUXINGDONG”FUZERENGustave PernaBIAOSHI,ZHOUYIJIANGYOU145GEFENFAZHANDIANJIESHOUYIMIAO,ZHOUER(15RI)SONGDA425GEZHANDIAN,ZHOUSAN(16RI)SONGDA66GEZHANDIAN。GAIYIMIAOYU12YUE11RIZHENGSHIHUODEFDADEJINJISHIYONGSHOUQUAN(EUA)。

  ModernaDEXINGUANYIMIAOYEYUJIJIANGYU12YUE17RIJIESHOUFDASHENHE。NIANDIQIAN,MEIGUOHUOJIANGYOULIANGKUANYIMIAOKEYIHUODEJINJISHOUQUAN。

  GUOCHANYIMIAOFANGMIAN,GUOYAOJITUANZHONGGUOSHENGWUDEMIEHUOXINGUANYIMIAOJINRIXIANGJIZAIALIANQIU、BALINZHENGSHIHUOPI。ERZAI11YUE25RI,GUOYAOJITUANFUZONGJINGLISHISHENGYIBIAOSHI,GUOYAOJITUANYIJINGXIANGGUOJIAYAOJIANJUTIJIAOLEXINGUANYIMIAODESHANGSHISHENQING。

  CONGJINRULINCHUANGDAODAGUIMOJIEZHONGBUZUYINIANSHIJIAN,JIANGUANBUMENRUHEBAOZHENGXINGUANYIMIAODEANQUANXINGHEYOUXIAOXING?ZHONGGUOHESHINENGYINGLAISHOUKUANSHANGSHIDEXINGUANYIMIAO?MEIGUODEYIMIAOSHENPINGHEZHONGGUOYOUHEBUTONG?

  WEIRAOZHESHANGSHUWENTI,12YUE12RI,ZAIYOUZHONGGUOSHENGWUGONGCHENGXUEHUIHESHANGTUXINXILIANHEZHUBANDECOVID-19YIMIAO/KANGTIYANFAYUCHANYEHUALUNTANSHANG,SHIDAICAIJINGZHUANFANGLEFDAQIANYIMIAOPINGSHENZHUGUAN(CMC)HEGAOJIPINGSHENGUANYUAN、SICHUANANKEKANGSHENGWUYIYAOYOUXIANGONGSIDONGSHIZHANGYULI。

  TUPIANLAIYUAN:COVID-19YIMIAO/KANGTIYANFAYUCHANYEHUALUNTANGUANFANG JINJISHIYONG≠ZHENGSHIHUOPI

  SHIDAICAIJING:FDASHOUYUYIKUANYIMIAOJINJISHIYONGQUAN(EUA),YIBANJIYUNAXIEYINSUKAOLV?JINJISHIYONGHEZHENGSHIDESHENPIYOUNAXIEBUTONG?

  YULI:SHOUXIANYAOKAOLVDEKENDINGSHIYIMIAODUIYUYIQINGKONGZHIYOUSHENMEHAOCHU,NENGJIBINGRENDAILAIDUOSHAOLIYI。

  JINJISHIYONGSHOUQUANDEYIMIAOKEYIWEIJIXUYIMIAODERENYUANTIGONGJISHIDEBAOHU。DANSHIZHEIZHONGSHOUQUANBUDENGTONGYUTONGGUOLEBLA(SHENGWUZHIPINZHIZHAOSHENQING)DESHANGSHISHENPI,LIANGZHEHAISHIBUYIYANGDE。

  JINJISHIYONGSHIJIYUMUQIANYIYOUDEBUFENLINCHUANGSHUJUDUIYIMIAOJINXINGYIGECHUBUDELEJIE,GENJUYIMIAODEANQUANXING、YOUXIAOXINGSHUJUYIJIYIMIAODESHENGCHANLAICHULI,ZAIZHENGSHIDESHANGSHIZHUCESHENPIQIAN,DUITESHUDERENQUNZUOYIGEBAOHU。

  SHANGSHIZHUCEZEYAOSHEJIDAOFANGFANGMIANMIAN,BAOKUODUIYIMIAOZHONGZI,YEJIUSHISHENGCHANDECAILIAOLAIYUAN、SHENGCHANGUOCHENGJINXINGJIANKONGHEJIANCE,SHENZHIYIMIAOZUIHOUDEBAOZHUANGHEGUANGGAO,QUANBUDOUYAOJINXINGSHENCHASHENPI,ZHEISHIYIGEBIJIAOHAOSHIDEGUOCHENG。

  YIJINGHUODEJINJISHIYONGSHOUQUANDEYIMIAO,JIEXIALAIHAIYAOTIJIAOWANZHENGDELINCHUANGSHUJU,HAIYOUCMCZHILIANGKONGZHIDEJIEGUO,CAINENGWANCHENGSHANGSHIZHUCESHENQING。

  MUQIANHUOPIDEYIMIAOGUJIDOUMEIYOUWANQUANWANCHENGSANQIJIEGUO,LIZHENGSHISHANGSHISHENPIHAIYOUYIDUANJULI。ZHEISHIHOUJIYUBUFENYIMIAOJINJISHOUQUAN,YOULIYUYIQINGFANGKONGHEYIMIAOSHIYAN。

  时代财经:在正常情况下,FDA对一款疫苗的审批要需要多长时间?

  YULI:IND(XINYAOYANJIUSHENQING)ZHISHAOXUYAOYIGEYUE,WANZHENGDEBLAZHUCESHENQINGXUYAOYINIANDESHIJIAN,JISHISHIJIASUSHENPIYEXUYAOBANNIANDESHIJIAN,YINWEISHENPISHEJIDAOHENDUOBUTONGFANGMIANDECAILIAO,SHIGENJUTONGJIXUE、BINGLIXUEDENGJIWANFENLINCHUANGSHUJUDECHULAIDEJIEGUO。

  疫苗安全如何保障

  SHIDAICAIJING:ZAIXINGUANYIMIAOZHIQIAN,LISHISHANGHAIMEIYOUGUOCHENGGONGDEmRNAYIMIAO。DUIYUmRNADENGXINDEYIMIAOJISHU,FDAZENYANGQUPINGGUTADEANQUANXINGHEYOUXIAOXING?

  YULI:mRMAYIMIAOSHIYIGEBUFENDEHESUANYIMIAO,BUSHIYIGEWANZHENGDEBINGDU,MEIYOUZHIBINGXING,ZHEIYIDIANSHIKEYIKENDINGDE,YIBANBUHUIYOUTAIDADEANQUANXINGWENTI,CHUFEIZAIZHIZUOGUOCHENGZHONGSHOUDAOWURAN,CHUNHUACHULIBUGOUHAO,DAOZHICHUXIANZHILIANGWENTI。

  TONGCHANGLAIJIANG,mRNAYIMIAOSHIBUDAKENENGHUIYOUYANZHONGDEDULIFANYING,CONGZHIBINGXINGLAISHUOHAISHIBIJIAOANQUANDE。

  ZHIQIANMEIYOUPIZHUNGUOmRNAYIMIAOZHUYAOSHIKAOLVDAOTADEXIAOJIAWENTI。DANJINGLILE30DUONIANDEFAZHAN,HESUANYIMIAOJISHUZAILIAOXIAOFANGMIANYOUSUOGAIJIN。RUGUOZHEICImRNAYIMIAONENGGOUXIANSHICHUHAODEXIAOJIA,HAISHINENGGOUJIESHOUDE。

  ModernaHEBioNTechDEBAOHULVFENBIEDADAO94.1%HE95%,DANSHIGUANCHADESHIJIANHAIBUGOUZHANG,CONG10YUEFENDAOXIANZAIHAIBUDAO3GEYUEDESHIJIAN。RUGUOANZHAOZHONGGUODEBIAOZHUN,YIMIAODEBAOHUQIZHISHAOYAOBANNIAN,ZHEIDOUHAIMEIYOUDAOBIAOZHUNSHIJIAN,ZHISHIYIGEZHONGQIDESHUJU。

  BUGUOXINGUANYIMIAOZHUYAOHAISHIWEILEMANZUYINGJIXUQIU,YIMUQIANYIQINGDEXINGSHILAIKAN,MEIYOUYIMIAOSHIWUFAKONGZHIYIQINGDE。XINGUANYIMIAOYEBUSHIDAYIZHENJIUNENGZHONGSHENMIANYI,JIEZHONGHOUDUANQINEIHAIYOUFABINGKENENGXING,SHUOMINGZHEIGEYIMIAOMUQIANHAISHIYOUQUEXIANDE。

  SHIDAICAIJING:HUIRUIYIMIAOZAIYINGGUODAGUIMOJIEZHONGHOU,CHUXIANLEYIXIEBULIANGSHIJIAN,ZHEIHUIYINGXIANGDAOFDADUIHUIRUIYIMIAODEPINGGUMA?

  余力:在以后的BLA上市注册批准当中,FDA会对这些做出严格的评审。

  YINWEIBUGUANSHIINDHAISHISHANGSHIZHUCE,DOUYOULINCHUANGYISHENGTUANDUIDUIZHEIXIESHUJUZUOPINGGU,KAOLVBINGRENLIYINENGFOUDADAOYUQI、YIJIFUZUOYONGDEYANZHONGCHENGDUDENG。

  SHIDAICAIJING:DIYIPIXINGUANYIMIAOYIJINGLUXUHUOPI。NINRENWEIDIYIPIYIMIAOJIEZHONGYIHOU,QUANQIUYIQINGJIUNENGDEDAOBIJIAOHAODEKONGZHIMA?

  余力:我只能说希望如此。

  YENEIYOUYIZHONGGUANDIANRENWEI,MEIYOUHUOYIMIAODEHUA,SHIGANBUZOUZHEIGEBINGDUDE。XIANZAIDEYINGJIYIMIAODEBAOHULIKENENGBUTAIGOU,MIANYICHIJIUXINGBIJIAOCHA,KANGTIHEXIBAOMIANYIFANYINGBUNENGDADAOZHONGSHENBAOHUDEXIAOGUO,SUOYIBINGDUZAIRENQUNZHONGRENGRANYOUCHIXUCHUANBODEKENENG。

  HUOYIMIAODEBAOHULIBIJIAOQIANG,MIANYIXITONGHUIYOUJIYIFANYING,JIEZHONGYIHOU,JISHIZAIYUDAOGANRAN,MIANYIXITONGYENENGLIJIJINXINGBAOHU。

  SHIDAICAIJING:XIANZAIYIJINGYOUYIPIYINGJIDEYIMIAOLE,FDAJIEXIALAIHUIBUHUISHOUJINJINJISHIYONGSHENPI,YAOQIUYIHOUSHENQINGDEYIMIAOSHUJUYAOGENGHAOYIXIE?

  YULI:BUHUIDE。ZHIYAOYIMIAODEANQUANXINGHAO,HUOZHEYUQINENGGOUDUIYIQINGFANGKONGQIDAOZUOYONG,JINJISHENPIDOUHUITONGGUO。ZHIYUNAYIKUANYIMIAOGENGHAO,SHIYOUSHICHANGJUEDINGDE,BUSHIFDASHUOLESUANDE。

  MEIGUOCAIQUDECELVESHIZHEIYANG,XIANQUEDING4TIAOJISHULUXIAN,ZAIMEITIAOLUXIANLIMIAN,TIAOXUAN2GELINCHUANGSHIYANBIJIAOKUAIDE,ZHIYAOYOUYIKUANZUGOUHAODEYIMIAOJIUXINGLE。

  不过他们的4条路线里并不包括灭活疫苗。

  MIEHUOYIMIAOSHENGCHANBIJIAOMAFAN,XUYAOYONGDAOP4CHEJIAN。QISHIYIKAISHI,WOMENGUOJIAYEXIANGZUOHUOYIMIAO,DANSHIHUOYIMIAOJIANDUGUOCHENGFEICHANGHAOSHI,XUYAOP3、P4SHIYANSHI,CHENGGONGLVYEBIJIAODI,SUOYIZUIHOUJIUBUKAOLVLE,JIZHONGLILIANGZUOMIEHUOYIMIAO。

  中国疫苗何时获批?

  时代财经:我国的疫苗审批要求和FDA有什么不同?

  余力:我们的审批的要求要更严格一些。

  ZAIINDSHENCHADESHIHOU,WOGUOWANGWANGHUITIQIANDUISHENGCHANGMP、SHENGCHANDEWENDINGXINGDENGJINXINGSHENHE。DANZAIMEIGUO,ZHEIXIEYIBANSHIBLADESHENHENEIRONG。YINWEIZAIINDQIAN,YIMIAOHAIMEIYOUJINGGUOLINCHUANGSHIYAN,BUZHIDAOLINCHUANGHUICHUXIANSHENMEJIEGUO,SUOYICHANPINDESHENGCHANCHENGXUHAIMEIYOUGUDING,KEYIZAIGAI。DANSHIGUONEISHIBUYUNXUZAIGAIDE,INDSHISHENMEYANGDESHENGCHANCHENGXU,BLAJIUSHISHENMEYANGDESHENGCHANCHENGXU。

  SHIDAICAIJING:ZHONGGUOSHENGWUDEMIEHUOYIMIAOSHANGGEYUEYIJINGTIJIAOSHENQINGLE,NINYUJIDAGAISHENMESHIHOUCAIHUIZAIGUONEIHUOPINI?

  YULI:ZHEIJIUBUZHIDAOLE,YAODENGGUANFANGXIAOXI。ZHEIGEWENTIWOYEKUNHUO,YINWEIXIANZAICHUYUYIMIAOJINGSAI,BIEDEGUOJIAYIMIAOYIJINGNACHULAI,WEISHENMEZHONGGUOHAIMEICHULAI,WOGUJIKENENGSHISANQISHUJUMUQIANHAIMEIYOUCHULAI。

  WOZHIDAOGUOWAIXINGUANSHIYANCAIQULEYIGEBIJIAOGAOXIAODEFANGFA,JIUSHIJISUOYOUSHOUSHIZHEDESHOUJIANZHUANGYIGEAPP,JIEZHONGYIHOUJIUXUYAOMEITIANJILUDIANZIRIJI,JIANGFUZUOYONGDENGSHUJUZHIJIECHUANSONGDAOJIANGUANZHONGXINQU,ZHEIYANGZAIGUANCHAQIJIESHUHOU,JIUKEYILIJIHUODEJIWANRENDELINCHUANGSHUJU。

  YIQIANLINCHUANGSHIYANYAOKAOSUIFANGDENGJI,GUANLIRENYUANZAISHURUDAODIANNAOLIJINXINGFENXI,ZHEIBUFENGONGZUOJIUZHANLEZHENGGELINCHUANGSHIYANDESANFENZHIYI,GUOCHENGFEICHANGMAFAN。ERLIYONGXIANZAIDEWANGLUOJISHU,KEYIHENKUAIBASHUJUXINXIDOUNADAO,BUZHIDAOWOGUODELINCHUANGSHIYANYOUMEIYOUCAIQUZHEIZHONGFANGFA,DANWOTUICEZHEIKENENGJIUSHIGUOWAILINCHUANGSHIYANZUODEKUAIDEYUANYIN。

  SHIDAICAIJING:YOUGUANDIANRENWEI,YAOMANZUGUONEIDEYIMIAOXUQIU,ZHUYAOHAISHIYAOKANGUOCHANDEYIMIAO,BUYAOTAIZHIWANGGUOWAIYIMIAOHUIFENPEIDAOZHONGGUOSHICHANG。NINZENMEKANDAIZHEIGEGUANDIAN?

  YULI:NEISHIDANGRANDE。CONGZHENGZHIDEJIAODULAIKAOLV,WOMENYEKENDINGBUHUIBAYIMIAOJINEIXIEDUIWOMENTAIDUBUYOUHAODEXIFANGGUOJIA。BUGUOZHEIGEHAISHIYAOKANYIMIAOZUIZHONGDECHANNENG,RUGUOCHANNENGZUGOUCHONGZU,NEIYESHIKENENGHUIZAIGUONEIXIAOSHOUDE。

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