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9价HPV疫苗在中国8天火速过审

来源: 南方日报网络版     时间: 2019年07月23日 16:59:25
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(因)(此)(,劳)(动)(节)(前)(的)(这)(条)(消)(息)(,无)(疑)(是)(给)(16-26岁)(女)(性)(送)(上)(了)(一)(份)(最)(贴)(心)(的)(的)(健)(康)(大)(礼)(。
什)(么)(是)(HPV疫)(苗)(?
HPV是)(“人)(乳)(头)(状)(瘤)(病)(毒)(”英)(文)(名)(字)(的)(缩)(写)(,HPV家)(族)(中)(有)(100多)(号)(成)(员)(,其)(中)(一)(部)(分)(被)(称)(为)(高)(危)(型)(HPV。
虽)(然)(90%以)(上)(的)(宫)(颈)(癌)(是)(由)(HPV引)(起)(的)(,但)(是)(HPV病)(毒)(本)(身)(并)(不)(可)(怕)(。
据)(统)(计)(,美)(国)(妇)(女)(一)(生)(中)(感)(染)(过)(一)(种)(HPV的)(可)(能)(性)(高)(达)(40%-80%,但)(是)(超)(过)(80%的)(HPV感)(染)(8个)(月)(内)(会)(自)(然)(清)(除)(,只)(有)(少)(数)(持)(续)(高)(危)(型)(HPV感)(染)(2年)(以)(上)(才)(有)(可)(能)(致)(癌)(。
所)(以)(,对)(大)(多)(数)(人)(而)(言)(,感)(染)(了)(HPV病)(毒)(不)(用)(过)(于)(紧)(张)(害)(怕)(。
▲图)(片)(来)(源)(:摄)(图)(网)((图)(文)(无)(关)()
目)(前)(全)(球)(上)(市)(的)(HPV疫)(苗)(有)(二)(价)(、四)(价)(、九)(价)(三)(种)(,“价)(”代)(表)(了)(疫)(苗)(可)(预)(防)(的)(病)(毒)(种)(类)(。目)(前)(二)(价)(和)(四)(价)(疫)(苗)(已)(获)(准)(在)(内)(地)(上)(市)(,能)(够)(防)(控)(84.5%宫)(颈)(癌)(风)(险)(,而)(九)(价)(疫)(苗)(可)(以)(预)(防)(92.1%的)(宫)(颈)(癌)(。疫)(苗)(通)(常)(分)(3次)(注)(射)(给)(药)(,共)(6个)(月)(,才)(能)(生)(效)(。
火)(速)(过)(审)(,有)(条)(件)(上)(市)(
国)(家)(药)(监)(局)(相)(关)(负)(责)(人)(向)(媒)(体)(介)(绍)(了)(九)(价)(疫)(苗)(火)(速)(过)(审)(的)(经)(过)(:
收)(到)(九)(价)(HPV疫)(苗)(进)(口)(注)(册)(申)(请)(后)(,国)(家)(药)(监)(局)(将)(其)(纳)(入)(优)(先)(审)(评)(程)(序)(,多)(次)(就)(产)(品)(在)(境)(外)(临)(床)(数)(据)(及)(上)(市)(后)(安)(全)(监)(测)(情)(况)(与)(企)(业)(沟)(通)(交)(流)(;
并)(基)(于)(之)(前)(四)(价)(HPV疫)(苗)(获)(批)(数)(据)(的)(基)(础)(,有)(条)(件)(接)(受)(境)(外)(临)(床)(试)(验)(数)(据)(,与)(境)(外)(临)(床)(数)(据)(相)(桥)(接)(,在)(最)(短)(时)(间)(内)(,有)(条)(件)(批)(准)(了)(产)(品)(的)(进)(口)(注)(册)(。
据)(中)(国)(政)(府)(网)(报)(道)(,李)(克)(强)(总)(理)(4月)(11日)(上)(午)(来)(到)(上)(海)(复)(旦)(大)(学)(附)(属)(华)(山)(医)(院)(,考)(察)(民)(生)(迫)(切)(需)(求)(的)(药)(品)(供)(应)(及)(价)(格)(。当)(地)(有)(关)(负)(责)(人)(向)(总)(理)(汇)(报)(:目)(前)(我)(国)(HPV疫)(苗)(需)(求)(量)(很)(大)(,二)(价)(疫)(苗)(供)(应)(基)(本)(可)(以)(保)(障)(,四)(价)(疫)(苗)(供)(应)(需)(提)(前)(预)(约)(,而)(九)(价)(疫)(苗)(内)(地)(尚)(未)(上)(市)(,需)(求)(者)(必)(须)(数)(次)(往)(返)(境)(外)(地)(区)(和)(国)(家)(才)(能)(接)(种)(。
李)(克)(强)(当)(即)(要)(求)(,有)(关)(部)(门)(一)(定)(要)(加)(快)(审)(批)(,保)(障)(供)(应)(,让)(有)(意)(愿)(的)(群)(众)(尽)(早)(就)(近)(用)(上)(最)(新)(HPV等)(防)(癌)(疫)(苗)(。
2017年)(12月)(,原)(国)(家)(食)(品)(药)(品)(监)(督)(管)(理)(总)(局)(发)(布)(《临)(床)(急)(需)(药)(品)(有)(条)(件)(批)(准)(上)(市)(的)(技)(术)(指)(南)((征)(求)(意)(见)(稿)()》,给)(予)(了)(有)(条)(件)(上)(市)(的)(定)(义)(:
临)(床)(急)(需)(药)(品)(有)(条)(件)(批)(准)(上)(市)(是)(指)(对)(用)(于)(治)(疗)(严)(重)(危)(及)(生)(命)(且)(尚)(无)(有)(效)(治)(疗)(手)(段)(的)(疾)(病)(的)(创)(新)(药)(,在)(规)(定)(申)(请)(人)(必)(须)(履)(行)(特)(定)(获)(得)(正)(规)(批)(准)(的)(条)(件)(下)(,基)(于)(以)(下)(情)(况)(而)(批)(准)(上)(市)(:
应)(用)(替)(代)(终)(点)(指)(标)(或)(中)(间)(临)(床)(终)(点)(指)(标)(的)(临)(床)(研)(究)(结)(果)(可)(以)(预)(测)(该)(产)(品)(很)(可)(能)(具)(有)(疗)(效)(和)(临)(床)(获)(益)(而)(给)(予)(有)(条)(件)(批)(准)(上)(市)(;
根)(据)(早)(期)(或)(中)(期)(临)(床)(试)(验)(数)(据)(,可)(合)(理)(预)(测)(或)(判)(断)(其)(临)(床)(获)(益)(且)(较)(现)(有)(治)(疗)(手)(段)(具)(有)(明)(显)(优)(势)(,允)(许)(在)(完)(成)(确)(证)(性)(临)(床)(试)(验)(前)(有)(条)(件)(批)(准)(上)(市)(;
境)(外)(已)(批)(准)(上)(市)(的)(罕)(见)(病)(治)(疗)(药)(品)(。
不)(建)(议)(女)(性)(超)(龄)(接)(种)(疫)(苗)(
小)(编)(注)(意)(到)(,由)(于)(官)(方)(和)(民)(间)(的)(大)(力)(宣)(传)(和)(推)(广)(,宫)(颈)(癌)(疫)(苗)(近)(两)(年)(成)(了)(知)(名)(度)(最)(高)(的)(疫)(苗)(之)(一)(,二)(价)(和)(四)(价)(疫)(苗)(在)(上)(市)(后)(都)(出)(现)(了)(供)(不)(应)(求)(的)(状)(况)(。
据)(香)(港)(文)(汇)(报)(报)(道)(,内)(地)(游)(客)(与)(疫)(苗)(有)(关)(的)(投)(诉)(,由)(2016年)(的)(4宗)(激)(增)(到)(2017年)(的)(392宗)(。究)(其)(原)(因)(,主)(要)(是)(去)(年)(赴)(港)(接)(种)(疫)(苗)(的)(内)(地)(游)(客)(人)(数)(暴)(增)(,使)(得)(香)(港)(一)(度)(出)(现)(疫)(苗)(短)(缺)(的)(情)(况)(。
不)(过)(,新)(华)(网)(曾)(经)(发)(文)(提)(醒)(,疫)(苗)(虽)(好)(,但)(一)(定)(要)(根)(据)(自)(己)(的)(年)(龄)(和)(身)(体)(状)(况)(决)(定)(是)(否)(接)(种)(。
HPV疫)(苗)(接)(种)(一)(般)(有)(年)(龄)(限)(制)(,各)(个)(国)(家)(和)(机)(构)(对)(适)(合)(接)(种)(HPV疫)(苗)(的)(年)(龄)(建)(议)(有)(差)(异)(。全)(球)(范)(围)(内)(宽)(泛)(规)(定)(为)(9-45岁)(,而)(美)(国)(食)(药)(监)(局)((FDA)批)(准)(的)(年)(龄)(是)(9-26岁)(。美)(国)(疾)(控)(中)(心)((CDC)则)(推)(荐)(11-12岁)(的)(女)(孩)(接)(种)(HPV疫)(苗)(。
目)(前)(,在)(内)(地)(上)(市)(的)(两)(种)(HPV疫)(苗)(分)(别)(为)(葛)(兰)(素)(史)(克)((GSK)的)(二)(价)(希)(瑞)(适)(和)(默)(沙)(东)(的)(四)(价)(佳)(达)(修)(。
GSK二)(价)(HPV疫)(苗)(被)(获)(准)(“在)(中)(国)(内)(地)(注)(册)(用)(于)(9到)(25岁)(女)(性)(接)(种)(”;默)(沙)(东)(旗)(下)(四)(价)(HPV疫)(苗)(获)(批)(用)(于)(20至)(45岁)(的)(女)(性)(接)(种)(。药)(监)(局)(最)(新)(批)(准)(的)(九)(价)(HPV疫)(苗)(适)(用)(于)(16到)(26岁)(的)(女)(性)(,用)(于)(预)(防)(HPV引)(起)(的)(宫)(颈)(癌)(等)(癌)(前)(病)(变)(或)(不)(典)(型)(病)(变)(。
此)(外)(,根)(据)(CDC网)(站)(介)(绍)(,年)(龄)(限)(制)(并)(非)(绝)(对)(,关)(键)(在)(于)(是)(否)(进)(入)(性)(成)(熟)(期)(。
美)(国)(疾)(控)(中)(心)(认)(为)(,进)(入)(性)(活)(跃)(期)(之)(前)(的)(11-12岁)(女)(孩)(在)(感)(染)(HPV病)(毒)(之)(前)(就)(接)(种)(疫)(苗)(,是)(最)(理)(想)(的)(安)(排)(,但)(并)(不)(意)(味)(着)(已)(经)(有)(性)(生)(活)(史)(的)(女)(性)(就)(不)(能)(接)(种)(疫)(苗)(。HPV疫)(苗)(对)(于)(无)(性)(生)(活)(史)(的)(女)(性)(效)(果)(最)(佳)(;有)(性)(生)(活)(的)(女)(性)(感)(染)(HPV的)(几)(率)(大)(幅)(上)(升)(,从)(药)(物)(经)(济)(学)(角)(度)(来)(说)(年)(龄)(越)(大)(、效)(果)(越)(差)(、越)(不)(划)(算)(。
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