FDA批准赛诺菲四联疫苗Quadracel用于4-6岁儿童

2015年3月26日讯/生物谷BIOON/--法国制药巨头赛诺菲(Sanofi)旗下疫苗事业部赛诺菲巴斯德(SanofiPasteur)近日宣布，FDA已批准四联疫苗Quadracel（吸附无细胞百白破-灭活脊髓灰质炎，DTaP-IPV）用于4-6岁儿童的主动免疫，预防严重威胁健康的4大疾病：百日咳、白喉、破伤风、脊髓灰质炎。
赛诺菲巴斯德美国科学和医疗事务部副总裁DavidP.Greenberg医师表示，Quadracel此次获FDA批准，为医疗保健机构提供了一种新的联合疫苗，将潜在减少4-6岁儿童疫苗注射次数。
为保护婴儿和儿童免受这几种严重威胁健康的疾病，美国疾病控制和预防中心（CDC）推荐4-6岁儿童接种第5针百白破（DTaP）疫苗系列以及第4针灭活脊髓灰质炎病毒（IPV）疫苗系列。Quadracel疫苗可用于DTaP系列的第5针接种及IPV系列的第4或第5针。（附件：美国疾病控制和预防中心（CDC）发布的2015年美国《0-18岁人群免疫接种建议》）
Quadracel的获批，是基于一项关键性多中心随机对照III期研究的数据，该研究在此前已接种DAPTACEL和/或Pentacel（DTaP-IPV/Hib）的4-6岁儿童中开展，比较了Quadracel疫苗（DTaP-IPV）与DAPTACEL（DTaP）联合IPOL（IPV）疫苗的免疫原性和安全性。结果表明，Quadracel疫苗与分别单独接种DAPTACEL及IPOL疫苗具有相似的安全性及免疫原性。
CDC：RecommendedImmunizationScheduleforPersonsAged0Through18YearsinUnitedStates,2015英文原文：FDAapprovesQuadracelvaccinetoprotectyoungchildrenfromlife-threateningdiseases
SanofiPasteur,thevaccinesdivisionofSanofi(EURONEXT:SANandNYSE:SNY),announcedtodaythattheU.S.FoodandDrugAdministration(FDA)hasapproveduseofQuadracel?(DiphtheriaandTetanusToxoidsandAcellularPertussisAbsorbedandInactivatedPoliovirus;DTaP-IPV)vaccineforactiveimmunizationagainstdiphtheria,tetanus,pertussisandpoliomyelitisinchildren4through6yearsofage.
"TheFDAapprovalofQuadracelvaccineprovideshealthcareproviderswithanewcombinationvaccine,potentiallyreducingthenumberofvaccineinjectionschildrenaged4through6wouldneed,"saidDavidP.Greenberg,M.D.,VicePresident,U.S.ScientificandMedicalAffairs,SanofiPasteur."Ourgoalistohelpremovebarrierstotimelyimmunizationandwethinkthiscombinationvaccinecouldhelpensurechildrenaregettingvaccinatedinlinewithcurrentrecommendations."
Toprotectinfantsandchildrenfromlife-threateningdiseases,theCentersforDiseaseControlandPrevention(CDC)recommendchildren4through6yearsofagereceiveboththeirfifthdoseofthediphtheria,tetanusandacellularpertussis(DTaP)vaccineseriesandtheirfourthdoseofinactivatedpoliovirus(IPV)vaccineseries.1QuadracelvaccinecanbeadministeredasafifthdoseintheDTaPseriesandasafourthorfifthdoseintheIPVseriesinchildren4through6yearsofage.
ThisFDAapprovalisbasedondatafromapivotalmulticenter,randomized,controlled,PhaseIIIstudydesignedtocomparethesafetyandimmunogenicityofQuadracelvaccine(DTaP-IPV)withDAPTACEL(DTaP)andIPOL(IPV)vaccinesinchildren4through6yearsofagewhowerepreviouslyvaccinatedwithDAPTACELand/orPentacel(DTaP-IPV/Hib)vaccines.ResultsshowQuadracelvaccinehassimilarsafetyandimmunogenicityprofilesascomparedtothoseofseparatelyadministeredDAPTACELandIPOLvaccines.
AboutQuadracelVaccine
Indication
Quadracelvaccineisgivenforactiveimmunizationagainstdiphtheria,tetanus,pertussis,andpoliomyelitis.AsingledoseofQuadracelvaccineisapprovedforuseinchildren4through6yearsofageasafifthdoseinthediphtheria,tetanus,pertussisvaccination(DTaP)series,andasafourthorfifthdoseintheinactivatedpoliovirusvaccination(IPV)series,inchildrenwhohavereceived4dosesofPentacel®(DiphtheriaandTetanusToxoidsandAcellularPertussisAdsorbed,InactivatedPoliovirusandHaemophilusbConjugate[TetanusToxoidConjugate]Vaccine)and/orDAPTACEL®(DiphtheriaandTetanusToxoidsandAcellularPertussisVaccineAdsorbed).
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