世界經(jīng)濟(jì)論壇-區(qū)域化疫苗生產(chǎn)合作框架：通過區(qū)域化生產(chǎn)生態(tài)系統(tǒng)加強(qiáng)疫苗獲取的框架（英）-2024.1

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4Images:GettyImagesContentsForeword46ExecutiveSummaryIntroduction7Context7RegionalizedVaccineManufacturingCollaborative(RVMC)RVMCFrameworkOverviewPillar1BusinessArchetypesPathtoImplementation8811111112Step1SelectBusinessArchetypeandPositioningStrategyStep2Assemble,Test

andScaleMinimumViableBusinessModelPillar2HealthyRegionalMarketsPathtoImplementation1313131415Step1AggregateDemandStep2AttractSupplyStep3BuildandShapeHealthyMarketsbasedonGavi’sHealthyMarketsFrameworkStep4OptimizeandSustainRegionalMarketsPillar3FinancialModels161717171718191919PathtoImplementationStep1ConductProjectFeasibilityStudiesStep2De-riskFinancialReturnsStep3DevelopTargeted

FinancialInstrumentsPillar4R&DandManufacturingInnovationPathtoImplementationStep1EstablishRegionalVaccineManufacturingInnovationStrategyStep2PrioritizeandResourceaPortfolioofTechnologiesStep3CreateandExecuteInnovationProgrammesPillar5Technology

Transfer

andWorkforceDevelopmentPathtoImplementation2121222222Step1ContextualizeandCustomizetheTech

TransferProcessfortheRegion’s

CapabilitiesStep2Train

theLocalManufacturingWorkforcetoReceivetheTechnology2424Step3EmbedRegulatory&QA/QCSkillsRegionalizedVaccineManufacturingCollaborative2Pillar6SupplyChainandInfrastructurePathtoImplementation252525Step1DesignEnd-to-EndVaccineSupplyChainsRight-SizedtotheRegionalMarketStep2DiversifyVaccineManufacturingOperationsStep3EstablishInboundSupplyChainsandLogistics262627Step4EstablishOutboundSupplyChainDistributionNetworksStep5ImplementEnd-to-EndSupplyChainInformationSystems,DataIntegrationandDigitalAutomation28Pillar7ProductRegulation2929PathtoImplementation:HarmonizeSafetyandQualityRegulationsAcrossMemberStatesPillar8PolicyandGovernancePathtoImplementation323232Step1SetGovernanceStrategyandEstablishRegionalInitiativesStep2ImplementRegionalPolicyFrameworkConclusionandOutlookRecap33343434353636383941Supply:AccesstoTechnologyDemand:AccesstoMarketsCapital:AccesstoFinancingLookingAheadAcronymsAcknowledgementsEndnotesDisclaimerThisdocumentispublishedbytheWorldEconomicForumasacontributiontoaproject,insightareaorinteraction.The?ndings,interpretationsandconclusionsexpressedhereinarearesultofacollaborativeprocessfacilitatedandendorsedbytheWorldEconomicForumbutwhoseresultsdonotnecessarilyrepresenttheviewsoftheWorldEconomicForum,northeentiretyofitsMembers,Partnersorotherstakeholders.?2024WorldEconomicForum.Allrightsreserved.Nopartofthispublicationmaybereproducedortransmittedinanyformorbyanymeans,includingphotocopyingandrecording,orbyanyinformationstorageandretrievalsystem.RegionalizedVaccineManufacturingCollaborative3January2024RegionalizedVaccineManufacturingCollaborativeAFrameworkforEnhancingVaccineAccessThroughRegionalizedManufacturingEcosystemsForewordVictorDzauNationalAcademyofMedicines(NAM)Sinceitsinception,theRegionalizedVaccineManufacturingCollaborative(RVMC)hasanactionablevisiontoexpandpartnerships,bringtogetherpublicandprivatestakeholdersandbuildaroadmapforregionstogrowproductionanddistributioncapabilitiessustainably,establishinglocalcapacitiestorespondatscaleintimesofcrisis.advocatedthecreationofregionallybasedvaccinemanufacturingecosystems.RegionalsystemscancomplementexistingglobalnetworksandaddresstheissuesofinequitythatcametoprominenceduringtheCOVID-19pandemic.Inlaunchingthismodel,weenvisiontheRVMCasaresourceforglobalstakeholders,afacilitatorforimplementationandaconnectorforregionshopingtolearnfromongoingeffortsaroundtheworld.Aftermorethanayearofcollaborativediscussionsandgatherings,RVMCisatanin?ectionpoint.TheprovisionalframeworkwedescribebelowpresentsRichardHatchettCoalitionofEpidemicPreparednessInnovations(CEPI)COVID-19underscoredtherisksthatepidemicsandpandemicspresenttomodernsocietywhilehighlightingthatvaccinesareourmostimportantcountermeasureagainstsuchthreats.Indeed,theabilitytoproducevaccinesurgentlyandatscaleisafoundationofsociety’s

preparedness.Inassemblingtheframeworkpresentedhere,RVMChasconsultedwithdozensofsubjectmatterexpertsandpolicy-makersfromaroundtheworld.Theirinsighthashelpedusunderstandthecomplexchallengesthatmustbenavigatedtoestablishandsustainregionalcapacity.RegionalizedVaccineManufacturingCollaborative4ShyamBishenWorldEconomicForumTherearemanylearningsfromCOVID19In2022,WorldEconomicForumjoinedforceswiththeNationalAcademyofMedicineandCEPItobringaboutacollaborationbetweenprivateandpublicsectortotacklethisissueandhelpbuildregionalmanufacturingcapacity.Theregionalizedvaccinemanufacturingcollaborative(RVMC)waslaunchedduringWEFannualmeetinginDavosinMayof2022.RVMChasdoneanexcellentjobinconsultingvariousstakeholdersanddevelopingthisframeworkfordiversi?edvaccinemanufacturingwhichmayalsobeappliedtotherapeuticsandothermedicalcountermeasures.pandemic.Thegood:pandemicbroughtremarkableprogressfordevelopmentanddeliveryofmedicalcountermeasures.Vaccinesweredevelopedinrecordtimeofaround10months.TheBad:therewasalackofearlyaccesstovaccinesinmanypartsoftheworld,particularlyindevelopingcountries.Thisismainlyduetoabsenceofmanufacturingcapacityinseveralregionsoftheworld.Thus,asustainedefforttoincreasediversi?edmanufacturingintheglobalagendaisneededtoreducerelianceonafewnationsorthebusinessplansofahandfulofcommercialentities.GregRehDeloitteHealthequitystartswithequitablevaccineaccess.workingwiththeForumtoprogressthegoalsoftheRVMC,collaboratingonaframeworkfordevelopingasustainable,regionalvaccinemanufacturingecosystem.Ourvisionofhealthequityisbuiltontheconvictionthatnocountryshouldbewithoutlife-savingvaccines,andastrategyofvaccineproductionautonomyisvitaltoensuringaccessnowandinthefuture.COVID-19broughttolightmanyinequitiesinthedeliveryofhealthcarearoundtheworld.Vaccineinequity,inparticular,stemmedfromalackofdistributedvaccinemanufacturingcapacity.DeloittehaslongbeencommittedtohealthequityandisRegionalizedVaccineManufacturingCollaborative5ExecutiveSummaryTheCOVID-19pandemicrevealedtheglobalcommunity’s

strengthsandweaknessesinrespondingtothemostseriousinfectiousdiseaseoutbreakofourtime.Internationalcollaborationdeliveredsafeandeffectivevaccinesinunderasustainableandtransparentinroutinetimesandduringapandemic.Regionalpooledpurchasingcreatesscaleef?cienciesandnegotiatingpowerforvolumediscounts,wideraccesstovaccinesandafasterresponsetopandemics.year.1savingnearly15millionlives.2Yet,

manystillandrecordedperished,with6.6millioncon?rmeddeathsapproximately20millionexcessdeathsasofDecember2022.3–Pillar3:FinancialModels.De-risk?nancingandstructureanecosystemthatattractssustainedprivate,donorandpublicpartnershipinvestmentthroughoutthelifecycleofavaccinemanufacturingfacility.Regionalprogrammesgeneratecostbene?tsfourtimeshigherthaninvestmentsmadeatanationallevel.4Almostayearafterthe?rstCOVID-19vaccinewasapprovedforuse,high-incomecountriesachievedavaccinationratetwicethatoflower-middle-incomecountriesandtwentytimesthatoflower-incomecountries.5Manyfactorscontributedtothis,but––Pillar4:R&DandManufacturingInnovation.Developandadvanceregionalvaccinemanufacturingtechnologycapabilitiestoaddressfuturepandemics.Regionalizationimprovesaccesstosuchtechnologiesandcapabilities.thereisaclearcorrelationbetweenratesofvaccineadministrationandregionalaccesstovaccinedevelopmentandproductioncapacity.Africa,forexample,whichimportsover99%ofitsvaccines,waslastinthequeue.6TheRegionalizedVaccine

ManufacturingPillar5:Technology

Transfer

andWorkforceDevelopment.Ef?ciently,effectively,andrepeatablyenableregionstointroduceandoperateright-sizedvaccinemanufacturingcapacityatscale.To

compete,regionsmusthaveincentivestructuresinplaceforretentionofaquali?edworkforcesothatvaccinemanufacturerscantrainanddeploythelocalworkforce.Collaborative(RVMC),aninitiativeattheWorldEconomicForum,wasestablishedinMay2022.Itsmandateistohelpaddressgapsinglobalvaccineequitybycreatingsustainableregionalvaccinemanufacturingnetworkscapableofproducingenoughvaccinesforregionalself-suf?ciencyduringbothnormaltimesandwhenpandemicsdemandproductionsurges.Theframeworkdescribedinthisdocumentpresentsregionswithaneconomicallyviablepathwaytothatvaccineself-suf?ciencyandsecurity.–Pillar6:SupplyChainandInfrastructure.Ef?cientlyoperatearesilient,responsive,andequitableregionalized,end-to-endvaccinemanufacturingbase,supplychainnetworkandindustrialinfrastructuretomeetnormalandpandemicvaccinedemand.Networkedregionalvaccinesupplychainsclosetopointsofneedamongmemberstatesthataremutuallydependentononeanotherforvaccinesaremuchmorerobustandequitable.TheRVMCFrameworkassemblesbestpracticeandrecommendedimplementationprogrammesthatincorporateregionallyrelevantandactionablestrategicoptionsthatcancreatesustainable,regionalvaccinemanufacturingnetworks.Theeightpillarsoftheframeworkaredesignedtoofferregionsawayofaddressingissuesandopportunities.Toestablishregionalvaccinemanufacturinginatrulyself-sustainingway,regionswillneedtoworkonachievingtheaimsofeachpillar:––Pillar7:Product

Regulation.Enablefasteraccesstomarketsforvaccinemanufacturersthrough

mutualrecognition

andsharedsubmissionprocedures

withoutcompromising

thequality,

safety,

oref?cacyof

vaccines.

Harmonizedregulations

canaccelerateaccessandreduce

thecostofregionally

manufactured

vaccines.–Pillar1:BusinessArchetypes.Developsustainablecommercialbusinessoperationsforregionallyscaledvaccinemanufacturingecosystems.Right-sizingthecurrentglobal-scaledbusinessmodelmayreduceresourcerequirementsbyone-thirdandtimetomarketby50%.Pillar8:PolicyandGovernance.Leadandimplementcross-bordermechanismstoraiseandresolveissuesfairlyacrossa

regionalvaccinemarket.Focusedleadershiponregionalvaccineproductionisneededtogatherthenecessarypublicandprivatecross-borderagreements.–Pillar2:HealthyMarkets.UsingGavi’sHealthyMarketsFramework,createanef?cient,uni?edregionalvaccinemarketthatisscaled,RegionalizedVaccineManufacturingCollaborative6IntroductionContextTheCOVID-19pandemicrevealedsigni?cantshortcomingsintheglobalcommunity’s

abilitytouniteforthegoodofhumanityacrossnationalbordersandideologicaldifferences.WhilevaccinesweredevelopedwithunprecedentedrapidityGlobalsystemslackthe?exibilitytorampupmanufacturingcapabilitieseffectivelyanddistributevaccinestoemergingmarketsduringglobalpandemics.Additionally,theylackthepoliticalauthoritytomakerapiddecisionsanddriveandsaved15millionlives,7inequitableaccesstoequitableallocation.COVAXwasanunprecedentedglobalcoordinationmechanismwhichraised$12.5Banddistributed~2Bdoses,1.75Bofwhichwenttothe92poorestcountries.Notwithstandingitsphenomenalsuccess,themechanismcontainedfatal?aws:ittooktoolongtoraise?nancingandvaccinedeploymentwasdelayedbyexportbansandothergeopoliticaltensions,includingvaccinenationalism.Thislackofequitablevaccineaccessunderscorestheneedforstrategicautonomyandself-reliance,anchoredindistributed,regionallybasedvaccinemanufacturingecosystemsthatcomplementexistingglobalsystems.13vaccineproductionanddistributionwasresponsibleforneedlessdeathsandprolongedtheacutephaseofthepandemic.RapidCOVID-19vaccinedevelopmentcoupledwithsocialmeasurestoreducetransmissionpreventedmuchhigherdeathtolls,butthepandemicstillhadextremeglobalimpacts.AsofDecember2022,6.6millioncon?rmeddeathsand20millionexcessdeaths,

alongwith$14to89$28trillionofeconomicdamageglobally,10

wereattributedtotheCOVID-19outbreak.ByDecember2021,oneyearafterthe?rstCOVIDvaccinewasapprovedforuse,high-incomecountries(>$12,000grossnationalincomepercapita)reporteddoublethenumberofdosesperpopulationthanlower-middle-incomecountries($1,000to$4,000grossnationalincomepercapita)and20-timesmorethanlower-incomecountries(<$1,000grossnationalincomepercapita).11

AsCOVID-19vaccineswereinitiallyproducedonlyintheUnitedStates,EuropeanUnion,Russia,ChinaandIndia,thisinequitywasdirectlycorrelatedwiththegeographicfootprintofvaccinemanufacturingfacilities.12

Forexample,Africa,whichimportsover99%ofitsvaccines,waslastinthequeuetoreceivethem,whiletheUnitedStatesandtheEuropeanUnion,whichproducedlargequantitiesofvaccinedomestically,securedsupplyagreementsforenoughdosestoinoculatetheirpopulationsmanytimesoverbeforedistributingvaccinestootherregions.Countrieswanttohavegreaterhealthsecuritywithcontrolovervaccinemanufacturingproductionwithintheirborders.Unfortunately,withafewexceptions,onlyregions(inotherwords,coalitionsofcountries)canachievethenecessaryscaleofdemand,investmentandcapabilitytomaintainviableandsustainablevaccineproduction.Furthermore,newvaccinetechnologies(forexample,mRNAandother’programmablevaccine’approaches)thatwereprovenduringtheresponsetoCOVID-19offerbreakthroughopportunitiestoimprovepandemicpreparednessandhealth.Effectiveregionscanspeeduptheacceptanceandapplicationoftheserevolutionaryprogrammablevaccinetechnologiesacrosscountryborderstocontrolthespreadofneglectedandnewinfectiousdiseasevectorsandoutbreaks.14RegionalizedVaccineManufacturingCollaborative7RegionalizedVaccine

ManufacturingCollaborative(RVMC)RVMCisaninitiativeattheWorldEconomicForumthataimstoreducethegapsinglobalvaccineequityandenhanceaccesstovaccinesforallpopulations.Itwillachievethisbyestablishingsustainableregionalvaccinemanufacturingnetworkscapableofproducingenoughvaccinesforregionalself-suf?ciencyduringbothnormaltimesandwhenpandemicsdemandproductionsurges.GlobalHealthSecurityandDiplomacy,WorldTrade

Organization,WorldHealthOrganizationandWellcomeTrust.RVMChasworkedtoidentifyopportunitiestoaccelerateongoingregionalcapacity-buildingefforts,buildpoliticalsupportforregionalization,promoteregionalcross-learning,linkregionaleffortstoglobalfora

andinitiatives(suchastheG7,G20,AfricanUnionandJohannesburgProcess),anddocumentleadingpracticesthatincreasevaccinemanufacturingcapacity,improveequitableaccessandrespondtopandemicandroutineneeds.TheresultofayearofmultilateraldiscussionsistheRVMCFramework:anend-to-endapproachforestablishingself-sustainingregionalvaccinemanufacturingecosystems.LaunchedattheForum’s

AnnualMeetinginDavosinMay2022,RVMCisco-chairedbytheCoalitionforEpidemicPreparednessInnovations(CEPI)andtheUSNationalAcademyofMedicine.SteeringcommitteemembersincludeleadersfromtheAfricaCentersforDiseaseControlandPrevention,AspenPharmacare,BiologicalE,DevelopingCountriesVaccineManufacturersNetwork,GavitheVaccineAlliance,GlobalHealthInnovationTechnologyFund,InternationalFinanceCorporation,MinistryofForeignAffairsinNorway,MinistryofHealthinSingapore,MinistryofHealthinIndonesia,MinistryofHealthinBrazil,Moderna,PanAmericanHealthOrganization,USStateDepartment’sBureauforByusingthisframework,regionscanassesstheirstatusandleveragebestpracticetocreateactionplansforeffectivelyandef?cientlyimplementingregionalinitiatives.RVMC

FrameworkOverviewDe?ningRegionalInitiativesandcreatesupplychainsthataresusceptibletosingle-point-of-failuredisruption,asseenduringrecentpandemicsforMpoxandCOVID.Regionalcoalitionsthatbringtogethernationswithsimilardiseasetargets,healthneedsandgovernanceprioritieswillbene?tfromcoordinatingacross-bordervaccinemanufacturingecosystem.Creatingacommonregionalvaccinemarketbypoolingdemandandmanufacturingcapacityenablesregionalinitiativestoachieveascalethatwouldotherwisebeunattainable.Effectivelyfunctioningregionsalsominimizethetimeandcomplexitiesofdecision-making,anddeliverfasterresponsestohealthemergencies,suchaspandemics.

Thesize,complexityandscopeofregionalinitiativeswillvaryaccordingtotheneedsoftheirmembercountries.Anyofthepillarsintheframeworkcanserveasastartingpointtokickstartregionalinitiatives.Conversely,local,country-speci?cmanufacturingcanprovideincreased?exibility,fasterspeedtomarket,lowervaccinationhesitancyandgreaterresilience,butfewcountriesactingalonecansupporta

completevaccinemanufacturingecosystem

that

can

compete

against

a

global

model.Thisdocumentoutlinesbestpracticeforapplyingtheframeworktosupporttheexpansionofcompetitive,localvaccinemanufacturingcapacity.Itshowsthatit’s

possibletopoolmarketssuppliedbyregionalsupplychainsandright-sizedmanufacturingtechnologiesandmaintainaresponsivenessand?exibilitythat’s

notpossibleinglobaloperations.WorldBankanalysis17

showsthatregionalinvestmentinvaccinemanufacturing,R&Dandregulationcapacitybuildingwillcostlessthan1%oftotalgovernmenthealthexpenditurewhilereturningcost-bene?tratiosfourtimeshigherthannational-levelinvestments.Collaborativeregionalgovernancecanimproveaccesstotechnology,?nancing,andmarketstoenablesustainableincreasesinvaccinemanufacturing.Bene?tsofRegionalVaccineManufacturingEcosystemsGlobalvaccinemanufacturersbene?tfromeconomiesofscalebyconcentratingproductioninafewlocationswithwell-developedinfrastructure.However,

thismodelcancontributetoinequalityRegionalizedVaccineManufacturingCollaborative8EightPillarsoftheRVMCFrameworkImplementationofthepillarsmustbesynchronizedandadaptedtoregionalneedsandambitions.Regionallycontextualizedroadmapswillneedtofocusoneconomicsustainabilityandinnovationtoensureequity.Asregionsexecuteagainsttheirroadmapsandadvancealongtheirrespectivejourneystowardsmaturity,theycanalsoapplythelessonslearnedforvaccinemanufacturingtootherindustries,turningregionalself-suf?ciencyforpandemicresponseintomoregeneralandtrulysustainableeconomicdevelopment.Theeightpillarsoftheframeworkarethebuildingblocksofaregionalecosystem,designedtoshowregionshowtoaddresstheissuesandopportunitiestheymayface.To

establishregionalvaccinemanufacturinginatrulyself-sustainingway,regionswillneedtoworkonachievingtheaimsofallthesepillars:Pillar1:BusinessArchetypesDevelopsustainablecommercialandpublicsectorbusinessoperationsforregionallyscaledvaccinemanufacturingecosystems.UsingGavi’s

HealthyMarketsFramework,createincentivestodirectthe?owofcapitaltowardregionalmanufacturingcapacityandachieveanef?cient,uni?edregionalmarketthatisscaled,sustainableandtransparentinbothroutinetimesandduringapandemic.Pillar2:HealthyMarketsPillar3:FinancialModelsDe-risk?nancingandstructureanecosystemthatattractssustainedprivate,donorandpublicpartnershipinvestmentthroughoutthelifecycleofavaccinemanufacturingfacility.Managetheportfolioofbasic,clinical,andappliedmanufacturingandtranslationalresearchrequiredtointegrateprocesses,continuouslyimproveyields,assurequality,andpromoteinnovationtoachievetheregionalvaccineplatformcoverage,scale,compliance,andoptimizationnecessarytobecompetitive.Pillar4:R&DandManufacturingInnovationEf?ciently,effectively,andrepeatablyenableregionstointroduceandoperateright-sizedvaccinemanufacturingcapacityatscale.To

compete,regionsmusthaveincentivestructuresinplaceforretentionofaquali?edworkforcesothatvaccinemanufacturerscantrainanddeploythelocalworkforce.Pillar5:Technology

Transfer

andWorkforceDevelopmentPillar6:SupplyChainandInfrastructureEf?cientlyoperatearesilient,responsive,andequitableregionalized,end-to-endvaccinemanufacturingandsupplychainecosystemtomeetnormalandpandemicvaccinedemand.Pillar7:ProductRegulationEnablefasteraccesstomarketsforvaccinemanufacturersthroughmutualrecognitionandsharedsubmissionprocedureswithoutcompromisingquality,safety,oref?cacyofvaccines.Pillar8:PolicyandGovernanceLeadandimplementcross-bordermechanismstoaddresschallengesandopportunitiesthroughacollaborativeregionalpolicyframework.RegionalizedVaccineManufacturingCollaborative9FIGURE1

EightPillarRVMCFrameworkPolicyandBusinessGovernanceArchetypesProductRegulationHealthyMarketsPillarsSupplyChainandInfrastructureFinancialModelsTechnology

TransferandWorkforceDevelopmentR&DandManufacturingInnovationRegionalizedVaccineManufacturingCollaborative

10BusinessArchetypesPillar

1OneofthebiglessonslearnedduringtheCOVIDresponsewasthatvaccineproductionisscaledandcon?guredforeitherglobalornationalsupplychains.Therefore,toestablishregionalproduction,currentbusinessmodelsmustberight-sized.Manufacturersmustachieveaminimalviableregionalproductiontomanagethetrade-offbetweenagilityandscalethatresultedininequitablevaccineaccessduringtheresponsetoCOVID.Thissectionputsforwardoptionsthataddresstheseissues,enablingregionstocon?gurevaccinemanufacturingandright-sizeoperationsfortheirmarkets.PathtoImplementationStep1:SelectBusinessArchetypeandPositioningStrategyTo

date,thebiopharmaindustryhasemployedanarchitecturethatcapitalizesonlow-cost,globallyscaledmanufacturingandsupply-chainmodels.IFCscenario-modellingstudies17

suggestthatright-sizedregionalmodelscanbeestablishedatcostsbetweentwoand?ve-timeslowerthan–andattwicethespeedof–globalmodels,whileaccessingregionalmarketscanreturnthreetosixtimesmorethanfragmentedcountrymarketscantoday.bioprocessingfacilitiesorexpandingexistingones,andpositioningthemselvestoimproveuponorexpandtraditionaloperations.Aregionshouldsupportadiversesetofbusinessarchetypes(listedinTable

1below).Thishelpsthemovercomeanydisadvantagesofpursuingasinglearchetypeandenablesthemtoaddressspeci?cmarketneedseffectively,maximizingtheircompetitiveness.Oncechosen,thearchetypeemployedisnot?xed:thecon?gurationcanevolveinaccordancewiththebusiness’s

roadmap,shiftingtechnology,markets,andcompetitors’landscapes.Choosingacoremanufacturingbusinessarchetypeprovidesastartingpointtoright-sizeoperations.Regionsshouldevaluatethefeasibilityofeachoption,includingcommissioningnewvaccineandTABLE

1

BusinessArchetypesforSelectCapabilitiesandFunctionsArchetypeRoleStrategicAdvantagesLow-costmanufacturingandworkforce,

anddirectcontrol

overmanufacturingandqualityoperations.ItavoidsR&D,clinicaltrialsandB2Cmarketingexpenses.CMOsProducers

actascontractorsandsynthesizevaccinesdevelopedbylargerpharmaceutical?rmswhoprovidetheIPandprotocols

fora

setcost.(Contractmanufacturingorganizations)AsCMO,pluslimitedlate-stagedevelopmentresearchcapabilities,suchasdevelopingsecond-generationproducts

orbeingcontractedforR&Dtasksbylargerpharmaceutical?rms.Canincluderevenue

sharing.CDMOsAccesstoclinicalpatientpopulationsformore

ef?cientclinicaltrialsandregulatory

approvals.

Mayofferpreferential

accesstoregional

markets.(Contractdevelopmentmanufacturing

organizations)Bytargetingregional

patientpopulationsandavoidingentrenched

competitors,specialtybiopharmacompaniescanachievepro?tabilityevenwithlowermanufacturingvolumes.Concentrateondevelopingandcommercializingnichevaccinesoringredientstoaddress

speci?cdiseasesandprioritiesofregional

markets.Locally/RegionallyfocusedbiopharmaCompaniescanspecializeinbiosimilarsatlowercoststhanexistingbrandedvaccines.Avoids

marketingandR&Dcostsandleveragesestablishedprocesses,

low-costscaledsupplychainsandreduced

regulatory

burdens.BiosimilarsCompaniescanobtainlicensesfrom

NIHorsimilaragenciesandfurtherdevelopvaccinestocommercialization.Produces

rawmaterials,excipientsandadjuvantswithlocallysourced

andmore

secure

andresponsive

supplychains.AncillaryproductsandservicesHighenoughdemandforregionally

sourced

rawmaterialstocommandprivilegedaccesstomarkets.RegionalizedVaccineManufacturingCollaborative

11Notethatalthoughthearchetypesabovefocusonminimizingcapitalrequirementstoestablishaminimumviablebusiness,therearealsorelativelystraightforwardwaysofusingpublicsectorsupporttosecureend-to-endcapabilities,suchasFiocruz,andstate-ownedenterprises.Furthermore,established,individualmanufacturersmaydecidetooffercombinationsandhybridsofthearchetypesinTable

1thataretunedtoregionalrequirementstocreatesustainablecompetitiveadvantage.Step2:Assemble,Test