欧盟批准辉瑞肺炎疫苗Prevenar 13（沛儿13）用于18岁及以上成人群体

2015年3月5日讯/生物谷BIOON/--辉瑞（Pfizer）重磅疫苗产品Prevenar13（沛儿13）近日在欧盟监管方面收获大好消息。欧盟委员会（EC）已批准扩大Prevenar13适应症，用于18岁及以上成人群体，预防由13种血清型肺炎链球菌株导致的肺炎。Prevenar13的产品特性概要（SPC）也已更新，纳入了辉瑞具有里程碑意义的CAPiTA（社区获得性肺炎成人免疫试验）研究的疗效数据，表明接种Prevenar13显著降低了65岁及以上成人群体中疫苗型社区获得性肺炎（CAP）的首次流性发作，包括非侵入性/非菌血症性CAP和侵入性肺炎球菌病（IPD）。
Prevenar13在一些国家被称为沛儿13，是全世界使用最广泛的肺炎球菌结合疫苗（PCV），累计疫苗接种已超过7.5亿个剂量，该产品也是全世界最畅销的疫苗，2014年的全球销售额高达45亿美元，是辉瑞的第2号旗舰产品。目前，Prevenar13已获全球120多个国家批准。
CAPiTA（成人社区获得性肺炎免疫试验）研究是迄今为止在老年群体中开展的史上最大的双盲随机安慰剂对照疫苗疗效研究，涉及约8.5万名65岁及以上受试者。研究数据表明，与安慰剂组相比，Prevenar13免疫组疫苗型CAP首次发作减少45.56%（p=0.0006）、非菌血症性/非侵入性疫苗型肺炎球菌CAP首次发作减少45.00%（p=0.0067）、疫苗型IPD首次发作减少75.00%。该项研究中Prevenar13的安全性与既往研究一致。其他数据还显示，接种Prevenar13的受试者，在免疫之后长达4年的时间内，疫苗型CAP、非菌血症性/非侵入性疫苗型CAP、疫苗型IPD首次发作均减少。该研究是首次在成人群体中明确证明疫苗型肺炎球菌CAP流性发作显著降低的研究，更重要的是，显著降低了非菌血症性/非侵入性疫苗型肺炎球菌CAP的流性发作。
Prevenar13（沛儿13）是由辉瑞开发的一款13价肺炎链球菌结合型疫苗，是目前唯一一种获FDA和欧盟批准用于全年龄段（从婴儿期至成年期）的肺炎球菌疫苗，用于预防13株肺炎链球菌菌株（1,3,4,5,6A,6B,7F,9V,14,18C,19A,19F,23F）导致的肺炎球菌性肺炎和侵入性疾病。
Prevenar13于2009年首次在欧洲获批用于婴幼儿，目前在120多个国家被批准用于这种适应症。此外，Prevenar13在90多个国家被加速批准用于50岁及以上成年人，以解决老年群体中的医疗需求。作为加速审批的要求，辉瑞开展了CAPiTA来验证Prevenar13的临床利益。在美国和欧洲，Prevenar13也被批准用于更大年龄的儿童及6至17岁的青少年。2013年，Prevenar13在欧洲也被批准用于18至49岁成年人。
英文原文：PfizerReceivesEuropeanApprovalforNewIndicationforPrevenar13forPreventionofVaccine-TypePneumococcalPneumoniainAdults
LabelAlsoUpdatedtoIncludeDataFromtheCommunity-AcquiredPneumoniaImmunizationTrialinAdults(CAPiTA)
Tuesday,March3,2015-8:35amESTPfizerInc.(NYSE:PFE)announcedtodaythattheEuropeanCommissionapprovedanexpandedindicationfortheuseofPrevenar13*(pneumococcalpolysaccharideconjugatevaccine[13-valent,adsorbed])forthepreventionofpneumoniacausedbythe13pneumococcalserotypesinthevaccineinadultsaged18yearsandolder.TheSummaryofProductCharacteristicshasalsobeenupdatedtoincludeefficacydatafromPfizer’slandmarkCommunity-AcquiredPneumoniaImmunizationTrialinAdults(CAPiTA),whichdemonstratedstatisticallysignificantreductionsinfirstepisodesofvaccine-typepneumococcalcommunity-acquiredpneumonia(CAP),includingnon-invasive/non-bacteremicCAP,andinvasivepneumococcaldisease(IPD)inadultsaged65andolder.
“WewelcometheapprovalofthisnewindicationforPrevenar13intheEU,whichwillenablehealthcareprofessionalstohelpadultsreducetheirriskofpneumococcalpneumoniacausedbythe13serotypesinthevaccine.Thisisparticularlyimportantforolderadultsandthosewithmedicalconditionsthatmaymakethemmorevulnerabletothisserious,debilitatingandpotentiallydeadlydisease,”saidReneReinert,VicePresident,PfizerVaccinesMedicalandScientificAffairs,Europe.“PfizerlooksforwardtoworkingwithvaccinetechnicalcommitteesinEuropetodiscussthisnewindicationandtheCAPiTAdata,aswellaspotentialupdatestorecommendationsfortheuseofPrevenar13inadults.”
Streptococcuspneumoniae,alsoknownaspneumococcus,isthemostcommonbacterialcauseofcommunity-acquiredpneumonia.1Pneumococcalpneumoniaisoneoftheleadingcausesofdeathandhospitalizationworldwide.2,3Pneumococcalpneumoniacanbeclassifiedasnon-invasive,whenbacteriacauseinfectioninthelungsbutarenotdetectedinthebloodconcurrently,orinvasive,whenbacteriaalsoenterthebloodstream(bacteremicpneumonia)oranothernormallysterilesiteinthebody.4Foreveryonecaseofinvasivepneumococcalpneumoniainadults,itisestimatedthatatleastthreecasesofnon-invasivepneumococcalpneumoniaoccur.5Whilenon-invasiveformsofpneumococcaldiseasearetypicallymorecommon,theinvasivetypesofdiseasearegenerallymoresevere.6
PfizerconductedtheCAPiTAstudy(Community-AcquiredPneumoniaImmunizationTrialinAdults)aspartofitsregulatorycommitmentstoglobalregulatoryauthorities.TheresultshavebeensubmittedtotheU.S.FoodandDrugAdministrationandregulatoryagenciesinothermajormarkets,includingAustraliaandCanada,forinclusionintheproduct’slabeling.
AboutCAPiTA(Community-AcquiredPneumoniaImmunizationTrialinAdults)
Thisstudyisoneofthelargestdouble-blind,randomized,placebo-controlledvaccineefficacytrialseverconductedinolderadults.Thestudyachieveditsprimaryandsecondaryobjectives.Itinvolvedapproximately85,000subjectsaged65yearsandolderandwasconductedbyJuliusClinical,anacademicresearchorganizationaffiliatedwiththeUniversityMedicalCenterUtrecht(UMCU)intheNetherlands.Fifty-ninesentinelhospitalswereusedforthesurveillanceofCAPandIPD.
AboutPrevenar13
WiththisapprovalforPrevenar13,itisnowindicatedintheEUforactiveimmunizationforthepreventionofinvasivediseaseandpneumoniacausedbyStreptococcuspneumoniaeinadults≥18yearsofageandtheelderly.Prevenar13wasfirstintroducedforuseininfantsandyoungchildreninDecember2009inEuropeandisnowapprovedforsuchuseinmorethan120countriesworldwide,includingtheUnitedStatesandJapan.Itisthemostwidelyusedpneumococcalconjugatevaccine(PCV)intheworld,andmorethan750milliondosesofPrevenar7-valent/Prevenar13havebeendistributedworldwide.Inaddition,Prevenar13isapprovedforuseinadults50yearsofageandolderinmorethan90countries,andisalsoapprovedintheUnitedStates,EuropeanUnion(EU)andothercountriesforuseinolderchildrenandadolescentsaged6to17years.
INDICATIONSFORPREVNAR13®
Prevnar13®isavaccineapprovedintheU.S.foradults50yearsofageandolderforthepreventionofpneumococcalpneumoniaandinvasivediseasecausedby13Streptococcuspneumoniaestrains(1,3,4,5,6A,6B,7F,9V,14,18C,19A,19F,and23F).ThisindicationisbaseduponimmuneresponsestothevaccineForchildren6weeksthrough17yearsofage,Prevnar13®isapprovedintheU.S.forthepreventionofinvasivediseasecausedbythe13vaccinestrains,andforchildren6weeksthrough5yearsforthepreventionofotitismediacausedby7ofthe13strainsPrevnar13®isnot100%effectiveandwillonlyhelpprotectagainstthe13strainsincludedinthevaccineEffectivenesswhengivenlessthan5yearsafterapneumococcalpolysaccharidevaccineisnotknown
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