喜讯！辉瑞肺炎疫苗临床试验大获成功！

2015年3月21日讯/生物谷BIOON/--辉瑞公司公布了其肺炎疫苗Prevenar13临床试验CAPiTA结果，数据已经在三月份的《新英格兰医学》杂志上发表。（相关阅读：欧盟批准辉瑞肺炎疫苗Prevenar13（沛儿13）用于18岁及以上成人群体）
肺炎链球菌是细菌性肺炎最常见的感染源，而Prevenar13是辉瑞公司开发的用于预防13种肺炎链球菌致病的疫苗。该疾病也是在全球范围内导致住院和死亡的主要原因。肺炎球菌病也同样可以导致儿童而不感染和其它多种疾病。
CAPiTA研究是近来有辉瑞公司与荷兰乌特勒支大学医学中心和JuliusClinical合作开展的，该研究用于评估Prevenar13对于第一阶段的肺炎球菌肺炎、侵入性肺炎球菌病和非细菌性获得性肺炎在65岁以上成年中的预防效果。受试者体质非常虚弱，因为他们脆弱的免疫系统已经无法保护他们免受肺炎和其它危及生命的细菌感染。
辉瑞公司宣布该疫苗已经达到了首次和第二次的研究目标，因为其可以保护病人在血液和其它无菌区域免于危险的感染。该实验共招募84496个受试者，其中一半接受Prevenar13，另一半给予安慰剂。试验结果表明该疫苗可以降低45.6%肺炎球菌肺炎的发生。
Prevenar13已经成为了全球范围内使用最广泛的用于预防肺炎链球菌感染的疫苗。全球已经有7.5亿份Prevenar疫苗售出，在历史上已成为第二大高利润的疫苗。该疫苗也同样是辉瑞第二大产生高收入的产品，在2014年为公司带来45亿美金的销售。目前在全球已有超过120个国家批准该疫苗上市，欧洲与今年2月批准，美国FDA也已经批准其用于6周到17岁的儿童和49岁以上的成年人。
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生物谷推荐英文原文报道：
PfizerInc.PublishesPrevenar13DataFromCAPiTAStudy
PfizerInc.(NYSE:PFE)announcedthattheresultsfromtheCommunity-AcquiredPneumoniaImmunizationTrialinAdults(CAPiTA),conductedtoevaluateitsblockbustervaccinePrevenar13,havebeenpublishedintheMarchissueoftheNewEnglandJournalofMedicine.
Prevenar13isavaccinedevelopedbyPfizerforprotectionagainst13strainsofpneumococcaldisease,whichisknowntobethemostcommoncauseofpneumoniaduetobacteria.Thediseaseisalsoknowntobetheleadingcauseofhospitalizationsanddeathsworldwide.Pneumococcaldiseasecanalsoleadtoearinfectionsandvariousotherdiseasesinchildren.
TheCAPiTAstudywasrecentlyconductedbyPfizerincollaborationwiththeUniversityMedicalCentreUtrecht,situatedinNetherlands,andJuliusClinicaltoevaluatetheimmunizationefficacyofPrevenar13againstfirststageofvaccine-typepneumococcalCommunity-AcquiredPneumonia(CAP)andInvasivePneumococcalDisease(IPD),andnon-bacteremic/non-invasiveCAPinadults65andolder.
Patientsamongthesaidagegroupareparticularlymorevulnerable,astheirweakeningimmunesystemsarenotabletoprotectthemagainstpneumoniaandotherlife-threateningbacterialinfections.
Pfizerannouncedthatthevaccinemetbothprimaryandsecondaryendpointsspecifiedforthestudy,asitprovedtoprotectthepatientsfromthesaidagegroupfromthethreateninginfectionsfoundinthebloodstreamsandothersterileregionsofthebody.
Asmanyas84,496peoplewereenrolledintheCAPiTAstudy,halfofwhomweregivenadoseofPrevenar13,whiletheotherhalfweregivenaplaceboshot.Inthestudy,PrevenarprovedtoreducetheCAPinfectionsbyasmuchas45.6%.
Pfizerfurthersaidthatmoredangerousbutlesscommonbloodstreamandvariousotherinvasivebacterialinfectionswereshowntooccurin75%fewerpatientswhowerereceivingtheactualvaccineshots,incomparisontothepatientswhoweregiventhedummyshots.
PfizerwasrequiredtoconductCAPiTAbyregulatorybodiesofvariouscountriesglobally.
Prevenar13iswellknowntobethemostcommonlyandwidelyusedvaccineworldwideforprotectionagainstpneumococcalinfections.Globally,asmanyas750milliondosesofPrevenar13aredistributedanditstandstobethesecond-mostlucrativevaccinedruginrecordedhistory.Thevaccineisalsothesecond-highestrevenue-generatingproductforPfizer,bringing$4.5billioninsalesin2014.Prevenar13isalreadyapprovedinover120countries.ThemostrecentapprovalgrantedtothevaccinecameinFebruary2015astheEuropeanCommissiongaveagreenlightfortheexpandeduseofthedrugtobeadministeredinadultsforprotectionagainstvaccine-typepneumococcalpneumonia.Followingtheapproval,theSummaryofProductCharacteristicsforPrevenar13wasupdatedastheefficacydatawasincludedinit.
TheUSFoodandDrugAdministration(FDA)hasapprovedthevaccineforuseinchildrenagedsixweeksto17yearsandinadultsaged49andabove.TherecentlypublishedresultsforPrevenar13havealsobeensubmittedtotheFDA.Theresultshavefurtherbeensubmittedtoregulatorybodiesofothermajormarketsglobally,suchasCanadaandAustralia,fortheadditionoftheindicationtotheapproveduseofthevaccine.
TheNewEnglandJournalofMedicinehasrecentlyreceivedalotoflimelightfromthemedia,asthedatapublishedinthejournalhasresultedinsignificantupwardmovementfortherelevantstocks.Thejournalrecentlypublisheddatafortwodrugswhichbelongtothenewgenerationofcholesterol-loweringdrugsknownasPCSK9inhibitors;amongthesedrugs,onewasdevelopedbyAmgen,Inc.(NASDAQ:AMGN),whiletheotherdrugwasdevelopedbySanofiSA(ADR)(NYSE:SNY)andRegeneronPharmaceuticalsInc(NASDAQ:REGN).Stocksofallthreecompaniessoaredonthebackofthepositivedatafromtherecentstudiesthatwerepublishedinthesaidjournal.
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