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CENTER FOR VACC INE I NNOVAT ION AND ACCE S S
PATH/GabeBienczycki
Dynamicsofvaccineuptakeindevelopingcountrymarkets:Achievingimpactthroughsuccessfulpartnership-acasestudywithJEvaccinesDebbieAtherlyPhD,GlobalHeadPolicy,Access,&IntroducOonOctober26,2016
DCVMNAnnualGeneralMeeOngBuenosAires,ArgenOna
CENTERFORVACCINEINNOVATIONANDACCESSCENTERFORVACCINEINNOVATIONANDACCESSCENTERFORVACCINEINNOVATIONANDACCESS 2
Workinmorethan70countries.150millionpeoplereachedeachyearonaverage.PATHsnapshot
6billionvaccinevialmonitorsensuringthatvaccinesarepotentwhengiven
6.3millionpeoplereachedwithriceforOfiedwithcriOcalmicronutrients
6.2millionlivessavedwithPATH-pioneeredapproachestomalariacontrol
Weharnessour
entrepreneurialinsight,
scienOficandpublic
healthexperOse,and
passionforhealth
equity…
…tosavethelives
ofwomenandchildren.
CENTERFORVACCINEINNOVATIONANDACCESSCENTERFORVACCINEINNOVATIONANDACCESSCENTERFORVACCINEINNOVATIONANDACCESS 3
PATH’sCenterforVaccineInnovaOonandAccess(CVIA)CVIA’sprimaryobjecOveistoacceleratethedevelopmentandintroducOonoflifesavingvaccinesforopOmalpublichealthimpactintheworld’slowestresourcesebngs.Wefocusonvaccinesthatprotectwomenandchildrenfromtheleadingcausesofdiseaseanddeath.
DISEASEAREAS
RespiratoryInfecConsandMaternalImmunizaConpneumococcus•meningococcus•groupBstreptococcus•B.pertussis•influenzavirus•respiratorysyncyOalvirus
EntericandDiarrhealDiseasesrotavirus•enterotoxigenicEscherichiacoli•Shigellassp.•poliovirus
MalariaPlasmodiumfalciparum•Plasmodiumvivax
ZoonoCc,Emerging,andSexuallyTransmiLedInfecConshumanpapillomavirus•JapaneseencephaliOsvirus•denguevirus•yellowfevervirus•outbreaks
CENTERFORVACCINEINNOVATIONANDACCESSCENTERFORVACCINEINNOVATIONANDACCESSCENTERFORVACCINEINNOVATIONANDACCESS 4
RESEARCH/DESIGN DEVELOP/VALIDATE APPROVE/RECOMMEND INTRODUCE/OPTIMIZE SCALE-UP/APPLY
• IdenOfypotenOalvaccineleadsandapproaches
• ConductiniOalcandidateevaluaOons
• AddresscountryneedsandprioriOesinproductdevelopment
• Assessproofofconcept/efficacyinlow-resourcesebngs
• Generateevidenceforregulatoryreviewandapproval
• Supportqualitymanufacturingandadequatesupply
• FacilitateWorldHeathOrganizaOonprequalificaOonandregulatoryapprovalatnaOonallevel
• Enableevidence-baseddecisionmakingforpublicfinancingandglobalandnaOonalpolicies
• Supportcountriesonplanning,preparaOon,andintroducOon
• Capturelearningsfromearlyadopters
• Ensuresustainablesupply
• Facilitatewide-scaleuse• Measureimpact
OurworkspanstheenOrevaccinedevelopmentanddeliveryspectrum
PATH/AaronJoelSantosPATH/MaghewDakinPATH/WillBoase
CENTERFORVACCINEINNOVATIONANDACCESSCENTERFORVACCINEINNOVATIONANDACCESSCENTERFORVACCINEINNOVATIONANDACCESS 6
JapaneseencephaliOs(JE):AbriefintroducOon
• JE:mosquito-borneflavivirus;closelyrelatedtodengueandWestNileviruses.
• LeadingviralcauseofencephaliOsinAsia.
• Nearly3billionpeopleliveinJE-endemicregions.
• Childrenandruralpoorsufferthegreatestdiseaseburden.
SolomonT,DungNM,KneenR,GainsboroughM,VaughnDW,KhanhVT.JapaneseencephaliOs.JNeurolNeurosurgPsychiatry.2000Apr;68(4):405-15.
CENTERFORVACCINEINNOVATIONANDACCESSCENTERFORVACCINEINNOVATIONANDACCESSCENTERFORVACCINEINNOVATIONANDACCESS 7
CENTERFORVACCINEINNOVATIONANDACCESSCENTERFORVACCINEINNOVATIONANDACCESSCENTERFORVACCINEINNOVATIONANDACCESS 8
OurPartnershipwithChengduInsOtuteofBiologicalProducts(CDIBP)• PartneredonpivotalclinicaltrialstoestablishvaccinesafetyandimmunogencityoutsideofChina
• ProvidedtechnicalandfinancialsupporttopursueWHOprequalificaOonandmeetrigorousinternaOonalstandardsofquality,safety,andefficacy
• Assistedinthedesignandfinancingofanewmanufacturingfacilitytoensurehigh-quality,adequate,stablevaccinesupply,whilescalingupproducOonforinternaOonalexport
• ProvideconOnuedtechnicalandmanufacturingsupporttoadvancevaccineavailabilityandmaintaingoodmanufacturingpracOcestandards
• Establishedalow,public-sectorvaccinepriceforJE-endemiccountriesthroughourcollaboraOveagreement
• MonitorJEvaccinesupplytomeetcountrydemand
CENTERFORVACCINEINNOVATIONANDACCESSCENTERFORVACCINEINNOVATIONANDACCESSCENTERFORVACCINEINNOVATIONANDACCESS 9
HistoricMoment:JEVaccineWHOPrequalificaOon
CENTERFORVACCINEINNOVATIONANDACCESSCENTERFORVACCINEINNOVATIONANDACCESSCENTERFORVACCINEINNOVATIONANDACCESS 10
OtherKeyWins• A180percentincreaseofCDIBP’sJEvaccineannualproducOon
capacityasresultofanewlyconstructed,GMP-compliantfacility
• CDIBPcanproduce70milliondosesperyearonaverage,versusthe25milliondosesperyearproducedintheolder,recently-reOredfacility
• WithinmonthsofWHOPQ,GaviopenedafundingwindowtosupportJEvaccinaConcatch-upcampaignsforchildrenlessthan15yearsofage
• From2003–2017,anesCmated308millionchildrenoutsideofChinawillbevaccinatedbyCDIBP’svaccine
• ThroughrecentnegoOaOonsofafairpublichealthpricethatreflectsactualvaccineproducOoncostatCDIBP,weincreasedthelikelihoodofvaccineuptakebyallcountrieswithahighJEburden,notjustGavicountries.ItalsoensuredsustainablevaccineproducOonunOl2033.CDIBP’sJEvaccineremainsoneofthemostcosteffecCvevaccinesonthemarket.
CENTERFORVACCINEINNOVATIONANDACCESSCENTERFORVACCINEINNOVATIONANDACCESSCENTERFORVACCINEINNOVATIONANDACCESS 11
KeyMilestonesinJEControlandPrevenOon
2006FirstWHOJEpositionpaperpublished,whichrecommendedreplacingolder,moreexpensivevaccineswithnewgenerationJEvaccines,giventheiradvantageoussafetyprofileandaffordability.
2012Newmanufacturingfacilitycomplete;dosecapacityraisedfrom25Mto70M.
2013WHO“Prequalification”statusobtainedforCD-JEV,whichmeansasafe,effectivevaccineismorewidelyaffordableandaccessible.
2015WHOJEpositionpaperupdated:StronglyendorsesintegratingvaccineintoallnationalimmunizationscheduleswhereJEisrecognizedasapublichealthpriority.
2006India
2007NepalThailand
2008DPRK
2002SouthKoreaSriLanka
2015LaosCambodia
2016Nepal
2017MyanmarVietnamIndonesiaPhilippines
2018Bangladesh
2014Gaviapplicationsopen,whichprovidesfinancingforCD-JEVintroductionforlowandlower-middleincomecountries.
CountryintroductionsofCD-JEV
1988China Vaccinedevelopmentandmanufacturing
PartneracCviCesCountryvaccineintroducCon/expansion
CENTERFORVACCINEINNOVATIONANDACCESSCENTERFORVACCINEINNOVATIONANDACCESSCENTERFORVACCINEINNOVATIONANDACCESS 12
China|1988
DPRK|2008
SouthKorea|2002Nepal|2007
JEvaccina=onexpanded2016
MyanmarExpectedintroduc=on2017
BangladeshExpectedintroduc=on2018India|2006
ConOnuestoexpand
SriLanka|2002
Thailand|2007
PhilippinesExpectedintroduc=on2017
IndonesiaExpectedintroduc=on2017
VietnamExpectedexpansion2017
Laos|2015
Cambodia|2016
Country-financedintroducOonofCD-JEVfollowedbyGavi-supportedexpansion
CountriesthathaveintroducedCD-JEV
AnOcipatedGavi-supportedJEvaccineintroducOonorprogramexpansion
Note:YearscorrespondtoyearthatCD-JEVwasincorporatedintochildhoodvaccinaOonprograms