文章来源：http://www.bioon.com/industry/mdnews/609476.shtml
關鍵詞：輝瑞,肺炎,疫苗,Prevenar13,沛兒132015年3月5日訊/生物谷BIOON/--輝瑞（Pfizer）重磅疫苗產品Prevenar13（沛兒13）近日在歐盟監管方面收獲大好消息。歐盟委員會（EC）已批準擴大Prevenar13適應癥，用于18歲及以上成人群體，預防由13種血清型肺炎鏈球菌株導致的肺炎。Prevenar13的產品特性概要（SPC）也已更新，納入了輝瑞具有里程碑意義的CAPiTA（社區獲得性肺炎成人免疫試驗）研究的療效數據，表明接種Prevenar13顯著降低了65歲及以上成人群體中疫苗型社區獲得性肺炎（CAP）的首次流性發作，包括非侵入性/非菌血癥性CAP和侵入性肺炎球菌病（IPD）。Prevenar13在一些國家被稱為沛兒13，是全世界使用最廣泛的肺炎球菌結合疫苗（PCV），累計疫苗接種已超過7.5億個劑量，該產品也是全世界最暢銷的疫苗，2014年的全球銷售額高達45億美元，是輝瑞的第2號旗艦產品。目前，Prevenar13已獲全球120多個國家批準。CAPiTA（成人社區獲得性肺炎免疫試驗）研究是迄今為止在老年群體中開展的史上最大的雙盲隨機安慰劑對照疫苗療效研究，涉及約8.5萬名65歲及以上受試者。研究數據表明，與安慰劑組相比，Prevenar13免疫組疫苗型CAP首次發作減少45.56%（p=0.0006）、非菌血癥性/非侵入性疫苗型肺炎球菌CAP首次發作減少45.00%（p=0.0067）、疫苗型IPD首次發作減少75.00%。該項研究中Prevenar13的安全性與既往研究一致。其他數據還顯示，接種Prevenar13的受試者，在免疫之后長達4年的時間內，疫苗型CAP、非菌血癥性/非侵入性疫苗型CAP、疫苗型IPD首次發作均減少。該研究是首次在成人群體中明確證明疫苗型肺炎球菌CAP流性發作顯著降低的研究，更重要的是，顯著降低了非菌血癥性/非侵入性疫苗型肺炎球菌CAP的流性發作。Prevenar13（沛兒13）是由輝瑞開發的一款13價肺炎鏈球菌結合型疫苗，是目前唯一一種獲FDA和歐盟批準用于全年齡段（從嬰兒期至成年期）的肺炎球菌疫苗，用于預防13株肺炎鏈球菌菌株（1,3,4,5,6A,6B,7F,9V,14,18C,19A,19F,23F）導致的肺炎球菌性肺炎和侵入性疾病。Prevenar13于2009年首次在歐洲獲批用于嬰幼兒，目前在120多個國家被批準用于這種適應癥。此外，Prevenar13在90多個國家被加速批準用于50歲及以上成年人，以解決老年群體中的醫療需求。作為加速審批的要求，輝瑞開展了CAPiTA來驗證Prevenar13的臨床利益。在美國和歐洲，Prevenar13也被批準用于更大年齡的兒童及6至17歲的青少年。2013年，Prevenar13在歐洲也被批準用于18至49歲成年人。（生物谷Bioon.com）英文原文：PfizerReceivesEuropeanapprovalforNewIndicationforPrevenar13forPreventionofVaccine-TypePneumococcalPneumoniainAdultsLabelAlsoUpdatedtoIncludeDataFromtheCommunity-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.6PfizerconductedtheCAPiTAstudy(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.AboutPrevenar13WiththisapprovalforPrevenar13,itisnowindicatedintheEUforactiveimmunizationforthepreventionofinvasivediseaseandpneumoniacausedbyStreptococcuspneumoniaeinadults≥18yearsofageandtheelderly.Prevenar13wasfirstintroducedforuseininfantsandyoungchildreninDecember2009inEuropeandisnowapprovedforsuchuseinmorethan120countriesworldwide,includingtheUnitedStatesandJapan.Itisthemostwidelyusedpneumococcalconjugatevaccine(PCV)intheworld,andmorethan750milliondosesofPrevenar7-valent/Prevenar13havebeendistributedworldwide.Inaddition,Prevenar13isapprovedforuseinadults50yearsofageandolderinmorethan90countries,andisalsoapprovedintheUnitedStates,EuropeanUnion(EU)andothercountriesforuseinolderchildrenandadolescentsaged6to17years.INDICATIONSFORPREVNAR13Prevnar13isavaccineapprovedintheU.S.foradults50yearsofageandolderforthepreventionofpneumococcalpneumoniaandinvasivediseasecausedby13Streptococcuspneumoniaestrains(1,3,4,5,6A,6B,7F,9V,14,18C,19A,19F,and23F).ThisindicationisbaseduponimmuneresponsestothevaccineForchildren6weeksthrough17yearsofage,Prevnar13isapprovedintheU.S.forthepreventionofinvasivediseasecausedbythe13vaccinestrains,andforchildren6weeksthrough5yearsforthepreventionofotitismediacausedby7ofthe13strainsPrevnar13isnot100%effectiveandwillonlyhelpprotectagainstthe13strainsincludedinthevaccineEffectivenesswhengivenlessthan5yearsafterapneumococcalpolysaccharidevaccineisnotknown(責任編輯：yixin.zhang)
關鍵字標籤：輝瑞威而剛
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