美国疫苗企业Harrisvaccines公司9月21日宣布：他们已经被美国农业部授予禽流感疫苗的有条件许可证。这是自2015年在北美爆发的高致病性禽流感以来的第一个有条件许可证。美国农业部通常给予有条件的许可证，以满足紧急或未满足的需求。有条件许可的产品必须有一个合理的预期的有效性，安全性和效力。据Harrisvaccines的副总裁JoelHarris所说：当禽流感被在2015的春天被证实的时候，Harrisvaccines应用它的快速反应技术，为爱荷华和中西部的家禽和蛋生产商带来一个解决方案。Harris说：有条件的使用许可证不允许公司在现今出售疫苗，但在美国发现禽流感的时候，公司可以更好的使用疫苗。
据悉，Harrisvaccines公司总部设在美国爱荷华州，专注于动物健康，以及提高动物生产力的疫苗。该公司主要运用RNA技术（SirraVaxSM）生产猪，牛，马，和水产类的疫苗，以及针对特异性疾病的防治产品。SirravaxRP技术提供了一个平台，简化了疫苗的研制。对于不同的疾病疫苗而言，疫苗平台和生产过程中是完全相同的，惟一的区别是在疫苗基因。病原体本身从未进入疫苗的生产。一种电子基因序列的特定病原菌鉴定的蓝图是用来启动疫苗的生产工艺。据悉，RNA平台包括一个“复制”功能，复制包含任何特定的病毒或病菌病毒非结构基因和目的基因（GOI）。这种复制是通过一个过程，用电引入细胞线，被称为电穿孔。结构基因使细胞产生传播缺陷粒子包含非结构基因。这些颗粒然后收获并纯化制成RNA颗粒疫苗。一旦注入到动物的体内，使用动物的细胞产生编码的GOI抗原；这个过程诱导的细胞免疫应答和抗体反应。
此前Harrisvaccines公司已经利用其SirraVaxSM技术分别于2012年9月取得猪流感疫苗的生产批准文号；2014年3月取得美国农业部(USDA)批准的
轮状病毒疫苗的生产执照；6月获得美国农业部动植物健康检验局（APHIS）颁发的一款用于帮助控制猪流行性腹泻病毒（P
EDV）的疫苗颁发了有条件的许可。
HARRISVACCINESRECEIVESUSDACONDITIONALLICENSEFORAVIANINFLUENZAVACCINE,RNA
Firstconditionallicenseawardedsincetheoutbreakinearly2015
AMES,Iowa,September21,2015–Ames,Iowa-basedvaccineproducer,Harrisvaccines,todayannouncedithasbeengrantedUnitedStatesDepartmentofAgriculture(USDA)conditionallicensureofthecompany’sAvianInfluenzaVaccine,RNA.Thisisthefirstconditionallicenseforhighlypathogenicavianinfluenza(HPAI)grantedsincetheoutbreakbeganinspring2015.
ThisisalsothefirstUSDAconditionallicensegrantedforanavianinfluenzavaccineutilizingtherapidresponse,SirraVaxSMplatformtechnology.Thistechnologyallowsforthevaccinetobeeasilyupdatedtomatchcurrentandfuturestrainsofavianinfluenza.ThisisanimportantfirststepinimplementingavaccinestrategybytheUSDA.Initially,however,producerswillhavetowaitforUSDAauthorizationbeforeacquiringthevaccine.TheUSDAhascalledforasolicitationtocreateavaccinestockpileforH5avianinfluenzaforthefall;Harrisvaccinesiscurrentlypursuingthisopportunity.
“Thecreation,testing,andregulatoryapprovalofthevaccinewasarealjointeffortbytheUSDA’sAgricultureResearchService,theCenterforVeterinaryBiologics,andHarrisvaccines,”saidDr.MarkMogler,HeadofResearchandDevelopmentatHarrisvaccines.“TheARS’SoutheastPoultryResearchLaboratoryprovidedboththegeneneededtopreparethevaccineatHarrisvaccinesandtheproperfacilitiesforefficacytestinginchickens.”
“Thethreatposedbyavianinfluenzaisextraordinarytobothproducersandconsumers,”saidDr.HankHarris,FounderandCEOofHarrisvaccines.“Gettingavaccineinthefieldthatmatches100percenttotheH5N2strainiscrucialtoongoingcontainmentefforts.Thisvaccineisalsocompatiblewithdiagnosticteststhatcandifferentiateinfectedfromvaccinatedbirds(DIVA).Thi
smakesourvaccineanimportanttoolforeradicationeffortsandmayalleviateanyconcernswithtradingpartnersabroad.”
“USDAtestingofouravianinfluenzavaccineprovidedboththeefficacyandsafetydatanecessaryforapprovalbytheUSDACenterforVeterinaryBiologics,”saidJodiFrench,HeadofManufacturingandUSDALiaisonforHarrisvaccines.“Furtherefficacyandpotencystudiesinchickensandturkeysareongoing.”
“WhenH5wasconfirmedinthespringofthisyear,ourteamimmediatelyappliedourrapidresponsetechnologytobringasolutiontoIowaandMidwestpoultryandeggproducers,”saysJoelHarris,VicePresidentofHarrisvaccines.“Althoughwecannotsellthevaccinetoday,weareinabetterpositiontoapplythisrobustandrapidlyproducedvaccine,ifandwhenthevirusreemergesonceagain.”
Avianinfluenzaisafast-moving,highlycontagiousdiseasethathasdevastatedproducersacrossthenationthisyear.Todate,nearly50millionchickensandturkeyshavebeenlosttothisvirus.InIowaalone,avianinfluenzahasimpacted31millionbirds.Theimpactisstaggering,andonMay1,2015,IowaGovernorTerryBranstaddeclaredastateofemergencyinIowaduetotheoutbreak.Eggpricessincetheoutbreakhaveskyrocketednearly200percentandproducersstruggletorepopulateasreemergencelooms.Reportsestimateamorethan$2.5billiondecreaseinoutputandanimpactonmorethan15,000jobsnationwide.
"IamencouragedtoseeanewandpromisingvaccinereceiveUSDAlicensure,"saidDaveRettig,CEOofRembrandtEnterprises."TheimpactofavianinfluenzaonthelayerindustryinIowahasbeendevastating.Weneedtocontinuemovingtowardlong-termsolutionswhichincludeavaccinestrategythatcanbemobilizedquicklyandtailoredtothevirusstrainsimpactingourfarms."
TheUSDAgenerallygrantsconditionallicensesinordertomeetanemergencyorunmetneed.Aconditionallylicensedproductmustshowareasonableexpectationofefficacy,safety,andpotency.Furtherefficacyandpotencytestingisongoing.HarrisvaccineshasreceivedUSDAlicensureinthepastusingSirraVaxSMtechnologyfor:PorcineEpidemicDiarrheaVaccine,RNA(June2014),SwineInfluenzaVaccine,RNA(September2012),andAutogenousVaccine,RNAforRotavirusC(January2013).
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