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U.S. Department of Health & Human Ser vices

Protecting the Nation's Health through Immunization

U.S. Department of Health & Human Ser vices

2010 National Vaccine Plan

Protecting the Nation's Health through Immunization

Table of Contents

Acronyms and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Purpose and Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Table 1: National Vaccine Priorities for Implementation . . . . . . . . . . . . . . . . . . . . . . . . 17 Goal 1: Develop new and improved vaccines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Goal 2: Enhance the vaccine safety system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Goal 3: Support communications to enhance informed vaccine decision-making . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Goal 4: Ensure a stable supply of, access to and better use of recommended vaccines in the United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Goal 5: Increase global prevention of death and disease through safe and effective vaccination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Monitoring and Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Table 2: National Vaccine Plan Objectives: Stakeholders and Responsibilities . . . . . . . . . . 42 Appendices: ( 1) Appendix 1: Healthy People 2020 Immunization-related Objectives Appendix 2: 1994 National Vaccine Plan Objectives and Progress Appendix 3: Federal Government Agencies Involved in Immunization Appendix 4: Relevant Federal Strategic Plans and Initiatives Appendix 5: Stakeholders in the United States National Vaccine System

1. PleasenotethattheAppendicescanbefoundontheNationalVaccinePlanwebsiteatwww.hhs.gov/nvpo/vacc_ plan/index.AsthePlanisa"livingdocument,"theAppendiceswillbeupdatedonanongoingbasis. Department of Health & Human Services | The 2010 National Vaccine Plan

Acronyms and Abbreviations

ACA AffordableCareAct(comprised ofthePatientProtectionand AffordableCareActandthe HealthCareandEducation ReconciliationActof2010) AdministrationforChildrenand Families AdvisoryCommitteeon ImmunizationPractices AdverseEventFollowing Immunization AcquiredImmuneDeficiency Syndrome AgencyforHealthcareResearch andQuality AssistantSecretaryfor PreparednessandResponse BiomedicalAdvancedResearch andDevelopmentAuthority CentersforDiseaseControland Prevention CountermeasuresInjury CompensationProgram CentersforMedicareand MedicaidServices DepartmentofDefense DepartmentofHomelandSecurity DepartmentofJustice ElectronicHealthRecords FoodandDrugAdministration GlobalAllianceforVaccinesand Immunizations GlobalHealthInitiative HepatitisBVirus U.S.DepartmentofHealthand HumanServices Haemophilusinfluenzaetypeb HumanImmunodeficiencyVirus HealthyPeople Humanpapillomavirus HealthResourcesandServices Administration IHS IIS IndianHealthService ImmunizationInformation Systems IOM InstituteofMedicine NGO Non-GovernmentalOrganization NIH NationalInstitutesofHealth NVAC NationalVaccineAdvisory Committee NVP NationalVaccineProgram NVPO NationalVaccineProgramOffice ONC OfficeoftheNationalCoordinator forHealthInformationTechnology P .L . PublicLaw TB Tuberculosis UNICEF UnitedNation'sChildren's Fund(formerlyUnitedNations InternationalChildren's EmergencyFund) USAID U.S.AgencyforInternational Development VA DepartmentofVeteransAffairs VICP NationalVaccineInjury CompensationProgram VPD Vaccine-PreventableDisease WHO WorldHealthOrganization

ACF ACIP AEFI AIDS AHRQ ASPR BARDA CDC CICP CMS DoD DHS DoJ EHR FDA GAVI GHI HBV HHS Hib HIV HP HPV HRSA

Department of Health & Human Services | The 2010 National Vaccine Plan

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"To raise new questions, new possibilities, to regard old problems from a new angle, requires creative imagination and marks real advance in science." - Albert Einstein

Department of Health & Human Services | The 2010 National Vaccine Plan

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Executive Summar y

The20thcenturycouldbeconsideredthecenturyofvaccines.ThelifespansofAmericans increasedbymorethanthirtyyearsinlargepartbecauseofvaccines,andmortalityfrominfectious diseasesintheUnitedStatesdecreased14-fold.(2)Deathordisabilityfrommanyonce-common diseasesisnowrareintheU.S.AchildbornintheU.S.todaycannowbeprotectedagainst17 seriousdiseasesandconditionsthroughimmunization.Thewidespreaduseofvaccineshas helpedtoeradicatesmallpoxworldwideandeliminatepolio,measlesandrubellaintheU.S. Globally,vaccinationsaves2to3millionlivesperyear.(3) Vaccineshavetheuniquequalityofprotectingbothindividualsandcommunities.However,they havebeensoeffectiveformanyyearsinpreventingandeliminatinganumberofseriousinfectious diseasesthatthesignificantcontributionsthatvaccinesmaketooursocietyanditshealthmay havefadedfrompublicconsciousness.Beforethedevelopmentandwidespreaduseofsafeand effectivevaccines,infectiousdiseasesthreatenedthelivesofmillionsofchildrenandadultsinthis countryandabroad.Whatwereoncereferredtoasthecommondiseasesofchildhoodarenow vaccine-preventablediseases(VPDs).IntheU.S.,childrenarenolongercrippledcasesbypolionor killedbyinfectionssuchasdiphtheriaorHaemophilus influenzaetypeB(Hib).Vaccinesalsohelp preventcancerscausedbyhumanpapillomavirus(HPV)andhepatitisBvirus(HBV). The2010NationalVaccinePlanprovidesavisionfortheU.S.vaccineandimmunizationenterprise forthenextdecade.ThePlanarticulatesacomprehensivestrategytoenhanceallaspectsof vaccinesandvaccinationincluding:researchanddevelopment,supply,financing,distribution, safety,informeddecisionmakingbyconsumersandhealthcareproviders,VPDsurveillance, vaccineeffectivenessandusemonitoring,andglobalcooperation.Theactionscontainedinthe strategiesofthePlanareconditionalandaresubjecttotheavailabilityofresources. ThescopeofthePlanisbroadandaddressesvaccinesandkeyvaccine-relatedissuesfortheU.S. anditsglobalpartners.Itprovidesastrategicapproachforpreventinginfectiousdiseasesand improvingthepublic'shealththroughvaccinationforthecomingdecade.Althoughvaccinesare beingdevelopedtotreatdiseasesandconditions(therapeuticvaccines)andfornon-infectious diseases,thefocusofthisPlanisonvaccinesforthepreventionofinfectiousdiseasesasguidedby thelawthatestablishedtheNationalVaccineProgram(NVP).(4)

2. AmericanAcademyofPediatrics.Prologue.In:PickeringLK,ed.RedBook:2009ReportoftheCommitteeon InfectiousDiseases.28thed.ElkGroveVillage,IL:AmericanAcademyofPediatrics;2009:1-2. 3. WorldHealthOrganizationandUnitedNationsChildren'sFund.GlobalImmunizationVisionandStrategy,2006-2015.Geneva,Switzerland:WorldHealthOrganizationandUnitedNationsChildren'sFund;2005. Availableatwww.who.int/vaccines/GIVS/english/GIVS_Final_17Oct05.pdf. 4. PublicLaw(P.L.)99-660establishedtheNationalVaccineProgram,andrequiredtheNationalVaccineProgramto focusonpreventionofinfectiousdiseasesandadversereactionstovaccines. Department of Health & Human Services | The 2010 National Vaccine Plan

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ThePlanhasfivebroadgoals: Goal 1: Developnewandimprovedvaccines. Goal 2: Enhancethevaccinesafetysystem. Goal 3: Supportcommunicationstoenhanceinformedvaccinedecision-making. Goal 4: Ensureastablesupplyof,accessto,andbetteruseofrecommendedvaccinesintheUnitedStates. Goal 5: Increaseglobalpreventionofdeathanddiseasethroughsafeandeffectivevaccination. Existingnationalandglobalvaccine-relatedinitiatives,suchasimprovementsinregulatory science,thedevelopmentofmedicalcountermeasuresforemergencies,andglobalhealth partnershipsareembeddedwithinthePlan.StrategiesofthisPlanwillalsobecoordinatedwith thosedevelopedthroughotherfederalefforts.OneexampleistheNationalPrevention,Health PromotionandPublicHealthCouncil,establishedinthe2010AffordableCareAct(ACA).The Councilwillcoordinatefederalprevention,wellness,andpublichealthactivities,anddevelopa nationalstrategytoimprovethenation'shealth. InconjunctionwithotherfederaleffortsliketheNationalPreventionandHealthPromotion Strategy,HealthyPeople(HP)2020,andthePublicHealthEmergencyMedicalCountermeasures EnterpriseReview,the2010NationalVaccinePlanprovidesthestrategicguidancetobuilda strongerpreventivehealthsystem.Itwillhelpbridgedisparitiesinuseof,andaccesstovaccines, andwillprovideinnovativestrategiestoguidethenation'svaccineenterpriseacrossthenext decadeandbeyond.

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Department of Health & Human Services | The 2010 National Vaccine Plan

Purpose and Background

Thepurposeofthe2010NationalVaccinePlanistoprovidestrategicdirectionforthecoordination ofthevaccineandimmunizationenterprisefortheNVP.TheProgram'sgoalsaretoprevent infectiousdiseasesandtheirsequelaeandreduceadversereactionstovaccinesintheU.S.The Planwillachievethisthroughcoordinatedimplementationofastrategicvisionimplementedby vaccineandimmunizationstakeholdersacrossandoutsideofthefederalgovernment.

Background

Federalinvolvementinvaccinationprogramstargetingcivilianandmilitarypopulationshasarich historythatincludesresearchanddevelopment,assuringsafetyandeffectiveness,supporting delivery,anddevelopingmechanismsforreportingadverseeventsfollowingimmunization. Recognizingtheneedforincreasedcoordinationoftheseactivities,theNVPwasestablishedby Congressin1986.(5)CongresscalledforthedevelopmentofaNationalVaccinePlantoguide activitiesinpursuitofprogramgoals.TheinitialPlan,completedin1994,definedactivitiesto achievetheprogram'smissionthroughcoordinatedactionbyfederalagencies,stateandlocal governments,andprivatesectorpartnersincludingmanufacturersandhealthcareproviders. Thenation'svaccineenterprisehasmadeconsiderableprogresssincethefirstNationalVaccine Plan.Throughroutinevaccination,achildborntodaycanbeprotectedagainst17diseasesand conditionswhileonebornin1995couldbeprotectedagainstonlynine.Growingscientific knowledgecoupledwithadvancesinbiotechnologyprovidespossibilitiesfornewandimproved vaccines.Manyofthefinancialbarriersthatoncelimitedwidespreaduseofvaccineshavebeen overcome.Amyriadofenhancedtoolsareavailableforcommunicatingaccurateinformation aboutvaccinesandforensuringthatvaccinesaresafeandeffective.Abroadrangeofpublicand privatestakeholdershavebecomeessentialtothevaccineenterprise. Ironically,thepublichealthvictorywitnessedfromtheuseofvaccineshascreatedapublichealth challenge:becausevaccineshavereducedtheimpactandawarenessofmanyinfectiousdiseases, somehavebeguntoquestionthevalueandneedforvaccines.Inaddition,thelong-termeffects (e.g.,cancer)ofsomeVPDs(e.g.,HBVandHPV)maynotbevisibletothepublic,thusdiminishing theperceivedvalueofvaccination.Thus,thisPlancomesatacriticaltimeforthisnationand itshealthasitengagesontheseissuesandasthereisanincreasedfocusontheimportanceof preventivehealthfortheU.S.anditscitizens.

5. P.L.99-660 Department of Health & Human Services | The 2010 National Vaccine Plan

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Mission, Perspective, and Scope

The2010NationalVaccinePlanprovidesastrategicapproachforpreventinginfectiousdiseases andimprovingthepublic'shealththroughvaccination. ThescopeofthePlanisbroad,includingvaccinesandvaccine-relatedissuesfortheU.S.and globalcommunities.AsguidedbythestatutethatestablishedtheNVP,thefocusforthisPlan ispreventionofinfectiousdiseasesandadversereactionstovaccines.(6)ThePlanincorporates currentinitiatives,suchasthelongrecognizedneedtodevelopvaccinesagainsthuman immunodeficiencyvirus/acquiredimmunedeficiencysyndrome(HIV/AIDS),tuberculosis(TB), andmalaria,andprogramstoenhancemedicalcountermeasures,regulatoryscience,andvaccine production.Aten-yearhorizonwassetforthePlantoalignwithHP2020goals(seeAppendix1 formoredetails(7)).

2010 National Vaccine Plan Structure

The2010NationalVaccinePlanprovidesacomprehensiveapproachtoreduceinfectiousdiseases andtheirsequelaeandreduceadversereactionstovaccinesthroughcoordinatedeffortsof federal,state,local,multinationalandnon-governmentalstakeholders.Recognizingthatsuccessis facilitatedbycarefulplanningthatincludesdefiningspecificactivities,milestonesandmeasurable outcomes,animplementationplanwillbedevelopedbasedonthisplanandreleasedin2011. Withaten-yearhorizon,thisframeworkrecognizesandanticipatesthatemergingscience,new opportunities,andchangingcircumstanceswillguidethecourseofthePlan.Annualmonitoring ofprogressandamid-coursereviewwillpromotebothaccountabilityandflexibility. ThePlanisbuiltaroundfivebroadgoals: Goal 1: Developnewandimprovedvaccines. Goal 2: Enhancethevaccinesafetysystem. Goal 3: Supportcommunicationstoenhanceinformedvaccinedecision-making. Goal 4: Ensureastablesupplyof,accessto,andbetteruseofrecommendedvaccinesintheUnitedStates. Goal 5: Increaseglobalpreventionofdeathanddiseasethroughsafeandeffectivevaccination. Eachgoalissupportedbyobjectivesthatwillbepursuedthroughadefinedsetofstrategies. Reachinggoalsandobjectivesgenerallyrequiresactionbymanystakeholdersinthevaccineand immunizationenterprise.TheImplementationPlan,tobewrittenduring2011,willdescribethe actionstepsandmeasurableindicatorsforkeyPlanobjectivesandstrategies.

6. P.L.99-660 7. PleasenotethattheAppendicescanbefoundontheNationalVaccinePlanwebsiteatwww.hhs.gov/nvpo/vacc_ plan/index.AsthePlanisa"livingdocument,"theAppendiceswillbeupdatedonanongoingbasis.

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Department of Health & Human Services | The 2010 National Vaccine Plan

Progress Since the 1994 Plan

The2010NationalVaccinePlanbuildsonthemanyachievementsofthevaccineand immunizationenterprisepriortoandsincetheestablishmentoftheNVPin1986andthe completionofthefirstNationalVaccinePlanin1994.Newvaccineshavebeenlicensedtoexpand thenumberofinfectionsthatcanbeprevented,andmoreeffectivelyandsafelypreventsome diseasesforwhichearliergenerationvaccinesalreadyexisted.Inaddition,federalimmunization financingprogramshavereducedoreliminatedmanyfinancialbarrierstovaccination,particularly forchildren.ThenumberofinfectionscausedbyVPDshasdecreasedsignificantlywhile vaccinationcoverageintheU.S.hasincreased,andcoverageformanyvaccineshasreached recordlevels.Morerobustsystemshavebeendevelopedtoidentifyadverseeventsfollowing immunizationandtoassesspotentialassociationsofthoseeventswithvaccination.Globally, theU.S.hasworkedwithmultilateralandbilateralpartnersandnon-governmentalorganizations (NGOs)incontributingtoimprovementsinchildhealthstatusandthepreventionofhundredsof thousandsofchilddeathseachyearthroughimprovedvaccinecoverageandintroductionofnew vaccines.Ofthefourteenanticipatedoutcomesincludedinthe1994NationalVaccinePlan,most weresubstantiallyorfullyachieved(seeAppendix2). Unfortunately,manyofthechallengesthatstimulatedestablishmentoftheNVPandthe developmentofthe1994NationalVaccinePlanremainrelevanttoday.Vaccineshortagesand interruptionshaveoccurredformanyroutinelyrecommendedvaccines.Despiteimproved vaccinationcoverageamongchildren,recentVPDoutbreaksintheU.S.serveasremindersthat thesediseasesstilloccur.Amongolderadultsbothvaccinationcoverageandtheeffectivenessof someroutinelyrecommendedvaccinesremainsub-optimal.Disparitiesexistinadultvaccination ratesbetweenracialandethnicgroups.Asthecostofvaccinationhasincreased,financialbarriers tovaccinationhaveemergedforhealthdepartments,healthcareproviders,andthepublic. Significantscientificchallengesremaininthedevelopmentofsafeandeffectivevaccinesagainst existingglobalhealththreats,suchasHIV,TBandmalaria.Vaccinesthathavebeendeveloped andareinuseinindustrializedcountrieshavethepotentialtomakemajorcontributionstohealth indevelopingcountries,butarecurrentlyunderusedinmanyplaces.Additionally,emerging infectionsandthepersistentthreatofnaturalandintentionalinfectiousdiseaseposenew challengesforvaccinedevelopmentandregulation,manufacturing,vaccinedeliveryandaccessin theU.S.andabroad.

U.S. Immunization Framework

Diseasepreventionandenhancedvaccinesafetyareultimateoutcomesofasuccessful vaccinationprogram.Identifyingobjectivesandstrategiesthatleadtoandsustainthese outcomesisfacilitatedbyunderstandingthemanyprocessesordeterminantsoftheseoutcomes. ToprotectindividualsandcommunitiesfromVPDs,vaccinesmustbeadministeredtothepublic. Vaccinationbeginswiththeidentificationofpublichealthpriorities,whichareinformedbydisease surveillancedataandinformationonthepublichealthburdenofthediseasesthatvaccinescan effectivelyandsafelyprevent.Vaccineresearchandlicensurefollows.Afterthelicensureofa vaccineandtheAdvisoryCommitteeonImmunizationPractices(ACIP)andmedicalorganizations' recommendationforitsuse,avaccinemustbedistributed,stored,andhandledappropriately. Vaccinepaymentandreimbursementpoliciesareimportantforensuringreceiptanduseofthe vaccine.Communicationsandpublicandprovideroutreachhelpsupportinformeddecisionmakingaboutvaccination.Attitudes,vaccinationcoverageandtheeffectivenessofdisease preventionalsoareinfluencedbyissuesrelatedtovaccinesafetyandeffectiveness.

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Development of the 2010 National Vaccine Plan

The2010NationalVaccinePlan,underthecoordinationoftheU.S.DepartmentofHealthand HumanServices(HHS)NationalVaccineProgramOffice(NVPO),istheproductofdeliberation, analysis,andinputfrommultiplefederalagencies,anditincorporatesbroadpublicand stakeholderinput.NVPOistheprincipalcoordinatingofficefortheNVPandisresponsiblefor providingleadership,facilitatingcoordination,andmonitoringprogressofthe2010National VaccinePlanduringimplementation. Relevantfederalgovernmentagencies(seeAppendix3)identifiedkeyobjectivesandstrategiesas pathwaystosuccessforeachofthefivegoals.NVPOconsultedwiththeNationalVaccineAdvisory Committee(NVAC),federalagencies,domesticandinternationalstakeholders,andthepublic regularlyaboutthedevelopmentofthePlan.Anationalstakeholdermeetingwasconvenedto discussthefirstdraftofthePlan.Inadditiontothenationalstakeholdermeeting,NVPOobtained inputthroughseveralmechanisms: ·CommentsgatheredbyanInstituteofMedicine(IOM)committee(8)atfivepublicmeetings thatfocusedonthedifferentgoalsinthePlan; ·TheIOMcommittee'sfinalreport;(9) ·Inputfromfederalvaccineadvisorycommitteemembers; ·Meetingswithdomesticandinternationalstakeholders;and ·Inputfromthepublicinthreepublicmeetingsandthroughpubliccommentinresponsetoa noticeintheFederalRegister. AdditionalinformationaboutthedevelopmentoftheNationalVaccinePlanisavailableat www.hhs.gov/nvpo/vacc_plan/index.

Coordination with Other Federal Initiatives

The2010NationalVaccinePlanwillsupportrelevantstrategichealthprioritiesandkeyinteragency collaborationsforthenationissuedbytheSecretaryofHHS,whichincludethefollowing:to promoteearlychildhoodhealthanddevelopment,toacceleratetheprocessofscientificdiscovery toimprovepatientcare,andtoimproveglobalhealth.(10)Globalhealthplaysanimportantrolein thenationalsecurityoftheU.S.populationandpopulationsworldwide,andassuchthePlanisof importtoallagenciesinvolvedinglobalhealthactivities,includingtheDepartmentofStateand theU.S.AgencyforInternationalDevelopment(USAID).U.S.involvementinglobalvaccineissues canreduceworldwidetransmissionofVPDs,strengthenhealthsystems,andfosterbilateraland internationalpartnerships. Inaddition,the2010NationalVaccinePlanhasdirectrelevancetothegoalsoftheACA,the comprehensivehealthcarereformlawenactedinMarch2010,whichexpandsaccessto preventivecare,includingvaccines,byrequiringhealthplanstocoverpreventiveserviceswithout chargingadeductible,copayment,orcoinsurance.Individualsenrolledinthesenewgroup orindividualhealthplanswillhaveaccesstothevaccinesrecommendedbytheACIPpriorto

8. HHSrequestedtheformationofanIOMcommitteespecificallytogatherpublicinputandprovide recommendationsonprioritiesforthe2010NationalVaccinePlan. 9. Availableatwww.iom.edu/Reports/2009/Priorities-for-the-National-Vaccine-Plan. 10. U.S.DepartmentofHealthandHumanServices.Secretary'sStrategicInitiatives&KeyInter-AgencyCollaborations. Availableatwww.hhs.gov/secretary/about/priorities.

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Department of Health & Human Services | The 2010 National Vaccine Plan

September2009withnoco-paymentsorothercost-sharingrequirementswhenthoseservicesare deliveredbyanin-networkprovider.ThesenewhealthplanswillberequiredtocovernewACIP recommendationsmadeafterSeptember2009withoutcost-sharinginthenextplanyearthat occursoneyearafterthedateoftherecommendation.Inadditiontoexpandingaccessto immunizationunderthepreventiveservicesrules,theACAincludesthefollowingimmunizationrelatedprovisions: ·Providesauthoritytostatestopurchaseadultvaccineswithstatefundsfromfederallynegotiatedcontracts. ·ReauthorizestheSection317ImmunizationGrantProgram,whichmakesavailablefederally purchasedvaccinesandgrantstoall50states,theDistrictofColumbia,fivelargeurbanareas, andterritoriesandprotectoratestoprovideimmunizationservicestoprioritypopulations. ·RequiresaGeneralAccountabilityOfficestudyandreporttoCongressaboutMedicare beneficiaryaccesstorecommendedvaccinesundertheMedicarePartDbenefit. Moreinformationaboutthenewpreventiveservicesrequirementscanbefoundat: www.healthcare.gov/center/regulations/prevention/recommendations. StrategiesidentifiedinthePlanwillbecoordinatedwiththoseintheNationalHealthSecurity Strategy,theGlobalHealthInitiative(GHI),theNationalStrategyforPandemicInfluenza,andother nationalstrategicplansthatrelatetoimmunizationandvaccines.Inparticular,thisworkwillbe coordinatedwiththeNationalPrevention,HealthPromotionandPublicHealthCouncil'spriorities, whichwillintegratefederalprevention,wellness,andpublichealthactivities,anddevelopthe NationalPreventionandHealthPromotionStrategytoimprovethenation'shealth.Allofthese effortswillcomplementtheNationalStrategyforQualityImprovementinHealthCare,also describedintheACA. ThePlanalignswithqualityofcareimprovementinitiativesundertheChildren'sHealthInsurance ProgramReauthorizationActandcomplementstheCentersforMedicareandMedicaid(CMS)'s worktoimproveaccesstoandmeasurementofmandatoryhealthcareservicesdeliveredchildren enrolledinMedicaidthroughtheEarlyandPeriodicScreening,Diagnostic,andTreatmentProgram. ThePlanalsosupportstheGHI,whichfocusesonimprovingthehealthofwomen,newborns, andchildrenworldwidethroughstrengthenedhealthsystemsandthroughcoordinated,resultsoriented,country-ledapproaches.Additionally,thePlancomplementsotherinitiativesincluding theU.S.President'sEmergencyPlanForAIDSRelief,whichassistscountriesinstrengtheningtheir healthsystemsandprovidingcomprehensiveprevention,care,andtreatmenttocombatthe globalepidemicofHIV/AIDSanddiplomaticeffortstobuildglobalpartnershipsinpreparation forpandemicinfluenzaandotherpandemicdiseases.Forafulllistofrelevantplanspleasesee Appendix4. Understandingtheextensivescopeofthevaccineandimmunizationenterprise,thePlanalso encompassesrelevantstrategicvisionswithinotherfederalagencies.TheseincludetheHP2020 objectivesaswellasthefullspectrumofstrategiesarticulatedintheefforttodevelopmedical countermeasuresagainstbioterroristthreats,thethreatofpandemics,andnewandemerging infectiousdiseasethreats.(11)

11. Forexample,seeBARDAstrategicplanatwww.hhs.gov/aspr/barda/phemce/enterprise/strategy/index. Department of Health & Human Services | The 2010 National Vaccine Plan

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Implementation Opportunities and Challenges

Manyfactorsmayaffectachievementofthe2010NationalVaccinePlan.Opportunitiesmay emergethatfacilitaterapidprogressandachievementofobjectivessoonerthananticipated. Scientific,technological,healthcarefinancing,orcommunicationsadvancesalsocouldemerge, enablingrapidachievementofthevisionlaidforthbythePlan,supersedingitsobjectivesand goals.Conversely,existingchallengesandbarriersmaybemoredifficulttoovercomethan anticipatedandnewchallengesmaysurface. The2010NationalVaccinePlanwillrelyonsoundscienceandincludesmeasurablegoals, timelines,andaccountabilitymeasuresfortheelementsthathavebeenidentifiedashighest priorityasnotedinTable1.TheseprioritiestakeintoaccountthesuggestionsoftheIOM,the NVAC,andtheagenciesinvolvedindeveloping,implementingandevaluatingthe2010National VaccinePlan.Theseprioritiesalsoprovidestrategicactionstepstoensurethatthenationhasa robustimmunizationprogram;theyarenothoweverintendedtobeacomprehensivelistofall activitiesrelatedtovaccinesandimmunizations.TheactionsdescribedinthePlanareconditional, serveasaguidelineforfuturedevelopment,andaresubjecttotheavailabilityofresources. Indicatorsfortrackingprogressinmeetingeachoftheseprioritiesareunderdevelopmentandwill beincludedinanImplementationPlantobereleasedin2011.Theseindicatorswillrepresentthe federalgovernment'splanformeasuringprogresstowardmeetingthePlan'sgoalsandinclude immediate,short-term,andlonger-termactions.In2011,NVPOwillconsultwithfederalagencies toimplementtheseprioritiesanddevelopindicatorsfor2012andbeyondandupdatethem asnecessary.Additionally,asfederalagenciesbegintoimplementthePlanandasdiscussions continuewithstakeholders,newindicatorsmayalsobedeveloped. Implementingthe2010NationalVaccinePlandoesnotfalltothefederalgovernmentalone.The successofthisplanwillrequirestates,tribalandlocalgovernments,componentsofthehealthcare deliverysystem,communitiesandotherstakeholderstoworktogethertoensureacoordinated andcomprehensiveimmunizationprogram.SeeAppendix5foralistofimmunization stakeholders.TheprioritiesandthePlanareintendedtoserveasacatalystforallstakeholdersto developtheirownimplementationplansforachievingthegoalsofthe2010NationalVaccinePlan.

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Department of Health & Human Services | The 2010 National Vaccine Plan

Table 1:

National Vaccine Plan Priorities for Implementation

A . B . C . Developacatalogueofpriorityvaccinetargetsofdomesticandglobal healthimportance(Goal 1) . Strengthenthesciencebaseforthedevelopmentandlicensureof newvaccines(Goals 1 and 2). Enhancetimelydetectionandverificationofvaccinesafetysignalsanddevelopa vaccinesafetyscientificagenda(Goal 2) . Increaseawarenessofvaccines,vaccine-preventablediseases,and thebenefits/risksofimmunizationamongthepublic,providers,and otherstakeholders(Goal 3). Useevidence-basedsciencetoenhancevaccine-preventabledisease surveillance,measurementofvaccinecoverage,andmeasurement ofvaccineeffectiveness(Goal 4). Eliminatefinancialbarriersforprovidersandconsumerstofacilitate accesstoroutinelyrecommendedvaccines(Goal 4). Createanadequateandstablesupplyofroutinelyrecommended vaccinesandvaccinesforpublichealthpreparedness(Goal 4). Increaseandimprovetheuseofinteroperablehealthinformation technologyandelectronichealthrecords(Goal 4). Improveglobalsurveillanceforvaccine-preventablediseases andstrengthenglobalhealthinformationsystemstomonitorvaccine coverage,effectiveness,andsafety(Goal 5). Supportglobalintroductionandavailabilityofnewandunder-utilized vaccinestopreventdiseasesofpublichealthimportance(Goal 5).

D .

E .

F . G . H .

I .

J .

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Goal 1:

Develop new and improved vaccines

Introduction

Thegreatestandmostrapidchangesinhealthoccurredduringthelastcentury,primarily attributedtoahigherstandardofliving,improvedpublichealthmeasures,andtheapplicationof science-basedmedicine.Inadditiontocleanwater,sanitation,andtheuseofantibiotics,vaccines areanessentialpartofthesepublichealthachievements.Vaccineresearchanddevelopmentas wellastheimplementationofeffectivevaccinedeliveryprogramshasledtotheeradicationand eliminationofseveralonce-commonseriousinfectiousdiseases. Discoverybeginswiththerecognitionofaninfectiousdiseaseburdenandtheopportunityto preventitthroughimmunization.Basicscientificresearchbringsideasforwardintotheproduct developmentpathwaytowardtheultimategoaloftranslatingtheseideasintosafeandeffective medicalproducts.Safetyandefficacytestingareconductedateverystepofthisproduct developmentpathway.Bothbasicandtargetedresearchisthebasisforthedevelopmentof vaccinecandidatesandnewvaccineplatformsthatoffergreaterflexibilityinvaccinedevelopment andproduction.Newtools,suchasefficientantigenidentificationtechniques,coupledwith aprofoundlygreaterunderstandingoftheimmuneresponseareavailabletodefinebasic mechanismsofdiseasetosupportdesignanddevelopmentofnovelandimprovedvaccines. Determining"proofofconcept"regardingimmunogenicityandsafetyfollows­initiallyinpreclinicalstudiesinanimalsandtheninhumanstofurtherevaluatesafetyandefficacy.Finally, researchersconductscientificcharacterizationofthevaccineandtheprocessforproducingit, includingscalingthemanufacturingprocesstocommerciallevelsbeforevaccinesaremovedinto humantesting. Vaccinesaredevelopedthroughpublic-privatepartnerships­includingresearchers,government, manufacturers,purchasers,andpolicy-makers­whohavebeensuccessfulatbringingnew vaccinestolicensureforbroaduse.Thesepartnershipsarecentraltothesuccessofvaccine innovations.Throughtargetedinvestmentsinscienceandtechnology,suchpartnershipshave ledtothedevelopmentofhundredsofvaccinecandidatesatvariousstagesofmaturityinthe developmentpipeline.TheGlobalHIVEnterpriseisanexampleofunprecedentedcollaboration amongorganizationsworldwide,includingtheNationalInstitutesofHealth(NIH),theInternational AIDSVaccineInitiative,USAID,theBillandMelindaGatesFoundation,andmanyothersworking togethertoacceleratethedevelopmentofapreventiveHIVvaccine. Becausevaccinedevelopmentistime-andresource-intensive,establishingandunderstanding prioritiesfordevelopmentandencouragingcollaborationbetweenstakeholdersisessential inaddressingthechallengesofdevelopingnewandimprovedvaccines.Fosteringcontinued investmentfromallsectorsiscriticalastechnologicalapproachesanddiseasethreatsexpandamid increasingcoststodevelop,license,anddelivervaccines. TheaimofGoal1istodevelopnewandimprovedvaccinesandtoaddresstheupstreamresearch anddevelopmentaspectsofvaccinesfordomesticandglobalhealthpriorities.Theresearch needsofotheraspectsofthevaccineenterprise(e.g.,programimplementation,distribution logistics,communication)areincludedwithinothergoalsinthePlan.

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Objectives

Objective 1.1

Prioritizenewvaccinetargetsofdomesticandglobalpublichealthimportance.

Strategies:

1.1.1 Developandimplementaprocessforprioritizingandevaluatingnewvaccinetargetsofdomestic andglobalpublichealthimportance.Thiscatalogueofvaccinetargets(includingimproved vaccines)shouldincludeananalysisofbarrierstodevelopment. 1.1.2 Conductandimprovediseasesurveillanceofexistingpathogensandoptimizemethodstodetect newpathogenstocontinuouslyinformtheprioritiesforpotentialnewvaccines.

Objective 1.2

Supportresearchtodevelopandmanufacturenewvaccinecandidatesandimprovecurrent vaccinestopreventinfectiousdiseases.

Strategies:

1.2.1 Conductandsupportexpandedvaccineresearchtomeetmedicalandpublichealth needs.Establishsurveillancesystemsorstudiestobetterassessdiseaseburdeninspecific targetpopulationsincludingneonates,infants,children,olderadults,pregnantwomen, immunocompromisedindividuals,andotherat-riskindividuals. 1.2.2 Advanceresearchanddevelopmenttowardnewand/orimprovedvaccinesthatprevent infectiousdiseasesandtheirsequelae,includingthosethatprotectagainstemerging,reemerging,andimportantbiodefense-relatedpathogens. 1.2.3 Advancethescienceofneonatalandmaternalimmunityincludingimmunizationandthe developmentofimmunologicalmodelstostudymaternalimmunizationandeffectsonoffspring. 1.2.4 Developaprocessthatidentifiescurrentvaccinesthatwouldbenefitfromimprovedperformance characteristics(e.g.,effectiveness,safety,numberofdoses,stability,and/orvaccineadministration characteristics)thatcanbeusedintheevaluationandlicensureprocess. 1.2.5 Developnewapproachestovaccinemanufacturing(e.g.,rapid,flexible,andcost-effective)to meetdemandsforefficient,expandablevaccineproductioncapacitywhilealsomeetingneeds relatedtootherpublichealthemergencythreatssuchasinternationalemergingdiseases.

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Objective 1.3

Supportresearchonnovelandimprovedvaccinedeliverymethods.

Strategies:

1.3.1 Developandevaluatenewandimprovedalternatedeliverymethodsofvaccineadministrationto optimizetheprotectiveimmuneresponse,safety,effectiveness,and/orefficiency(e.g.,numberof doses). 1.3.2 Expandknowledgeregardingtheinductionandmaintenanceofvaccineimmuneresponsesvia differentroutesofadministration(e.g.,mucosalsurfaces).

Objective 1.4

Increaseunderstandingofthehostimmunesystem.

Strategies

1.4.1 Definethecapacityandqualityofinnateandadaptivehumanimmuneresponsetoinfections amongdiversegender,ethnic,racial,age(childhood,adolescence,andadulthood),andhealth conditionstatus(e.g.,autoimmunecompromisedindividuals)populationsinordertoadvancethe understandingofimmuneprotection. 1.4.2 Gainabetterunderstandingofhowinductionandrecallofimmunememorymayinformthe developmentofvaccinesthatprovidelife-longprotection. 1.4.3 Supportdevelopmentofimmunomodulatorsincludingvaccineadjuvantsthatfacilitatethe appropriatecell-mediatedandantibodyresponsesforprotectionagainstpathogenswithdistinct effectorrequirements. 1.4.4 Expandknowledgeofhost-relatedfactorsthatimpactseverityofdiseaseandvaccine-induced hostimmuneresponse,andusethisinformationtoinformvaccinedevelopment. 1.4.5 Developadatabaseofgene-expressionandimmunologicresponsestoselectedcurrentlylicensed vaccineswithafocusonsignalsthatcorrelatewithmechanismofaction,protection,safety,and adverseevents.Utilizethiscompendiumtoinformdevelopmentofnewcandidatevaccinesand adjuvants. 1.4.6 Studymucosalimmunityfollowingvaccinationinordertobetterunderstandvaccinemechanisms andtoprovidenew,potentiallymorerelevant,correlatesofprotectionagainstrespiratory,enteric, genital,andurinarypathogens.

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Objective 1.5

Supportproductdevelopment,evaluation,andproductiontechniquesofvaccinecandidatesand thescientifictoolsneededfortheirevaluation.

Strategies

1.5.1 Supportappliedresearchtodeveloprapidandcost-efficientproduction,andoptimize formulationsandstabilityprofilesofcurrentlyavailablevaccines. 1.5.2 Supportresearchonanddevelopmentofmoreflexibleandagileapproachestoproduct development,manufacturingproductiontechniquesincludingmulti-usetechnologiessuchas platforms,andqualitytestingprocedures(e.g.,potencyandsafetytesting). 1.5.3 Improveaccesstopilotlotmanufacturingfacilitiesthatproduceclinicalgradematerialfor evaluatingpromisingvaccinecandidates. 1.5.4 Supporttranslationalresearchthatacceleratesthedevelopmentofinformationthatcanbeused intheevaluationandlicensureprocess. 1.5.5 Establishandstrengthenpublicandprivatepartnershipstoaddressurgentneedsinvaccine researchanddevelopment.

Objective 1.6

Improvethetools,standards,andapproachestoassessthesafety,efficacy,andqualityofvaccines.

Strategies

1.6.1 Improveassaydevelopmentforcharacterizationofnovelcellsubstrates. 1.6.2 Improveeffortstodevelop,refine,andvalidatenewbiomarkersandcorrelatesofimmunity. 1.6.3 Developandimprovemethodstobetterassessvaccineefficacyandsafetyincludingassessment ofnewtechnologiesanddevelopmentofbetteranimalmodels. 1.6.4 Improvemethodsforassessingandevaluatingvaccinequality,potency,safety,andeffectiveness.

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Goal 2:

Enhance the vaccine safety system

Introduction

TheU.S.hasarobustvaccinesafetysystem.Thegoalofthissystemistoidentifyinatimely mannerandminimizetheoccurrenceofadverseeventsfromvaccines.Pastsuccessesand challengesofferinsightsintoareaswheretheexistingvaccinesafetysystemcanbeenhanced. Advancesininformationtechnologyenhancetheabilitytoconductactivesurveillance. Improvementsinunderstandingofimmunologyandgenomicscreateopportunitiestobetter comprehendtheimmuneresponseandbiologicalmechanismsimportantforunderstandingthe safetyofvaccines. Vaccinesafetyisakeyelementofanyimmunizationprogram.ThevisionofGoal2istospecifically addresssafety-relatedissues,strengthenthesystemthatmonitorsthesafetyofvaccines throughoutproductionanduse,andadvancethesafetyprofileofvaccines.(12)Specifically,this goalaimstopreventadverseeventsandfullycharacterizethesafetyprofileofvaccinesinatimely manner. Vaccinesafetyscienceisoftenchallengingbecauseitmayrequirestudyingveryrareoutcomes. However,toolshavebeendevelopedthathelpdetectandquantifyexceedinglyrareevents. Importantly,avaccinesafetymonitoringsystemshouldhavethecapacitytodistinguish apotentialincreasedriskofavaccineadversereactionfromanadverseeventfollowing immunization(13)thatisoccurringbecauseofotherdiseasesorexposures.Everyday,people sufferfromheartattacks,severeheadachesandotherhealthproblemsandsomeofthesewill naturallycoincidewithvaccination.Moreover,astheabilityofepidemiologytoruleoutaveryrare eventisdifficult,newtechnologiesandmulti-disciplinaryresearchcanhelpelucidatebiological mechanismsandsubpopulationsatincreasedriskforadverseeventsandhelpaddressthese scientificchallenges. Severalimportantvaccinesafetyissuesareaddressedinothergoalsofthe2010NationalVaccine Plan.Forexample,Goal1addressesvaccineresearchanddevelopmentthatincludesthe importanceofsafetyassessmentsinpre-clinicalandclinicalvaccineevaluation.Issuesrelatedto education,riskcommunications,behavioralscienceresearch,andstakeholderengagementon vaccinesafetyareincludedinGoal3.Becausevaccinesafetyisanimportantcomponentofevery immunizationprogram,whetherintheU.S.orglobally,itisalsofeaturedinGoals4and5.

12. ThroughoutGoal2,thefollowingtermsarefrequentlyused:"signal"and"vaccineadversereaction."Thesetermsas aredefinedas: Signal:Whiletherearemultipledefinitionsofsignals,inthisdocumentasignalreferstoa concernthatavaccine adverseeventcouldbetemporallyoccurringmoreoftenthananticipatedbasedonchancealone(i.e.,thatthe eventcouldberelatedtothereceiptofthevaccine).Asignalisnotproofofcausation;ratheritrepresentstheneed forfurtherevaluation.Signalsmayarisefromavarietyofsources,includingfrompre-licensureclinicaltrials,case series,surveillance,clinicalexperience,theliterature,expertcommitteereviews,themediaand/orthepublic. Vaccine adverse reactionisanadverseeventcausedbyavaccine.Vaccineadversereactionsaredefinedasminor, suchasasorearmorlowgradefever,orcanbemoreseveresuchasanaphylaxis.Vaccineadversereactionsare dichotomizedaslocal(e.g.,sorearm,swellingatsiteofinjection)orsystemic(e.g.,fever,irritability). 13. Adverse event following immunization (AEFI)isanadverseeventtemporallyassociatedwithanimmunizationthat mayormaynotbecausallyrelatedtotheimmunization.Theterm"vaccineadverseevent"isalsocommonlyusedto conveythesamemeaning.

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Objectives

Objective 2.1

Ensurearobustvaccinesafetyscientificsystemthatfocusesonhighpriorityareas.

Strategies:

2.1.1 Develop,prioritize,andregularlyupdateanationalvaccinesafetyscientificagenda. 2.1.2 Retaincurrentandrecruitadditionalhighlytrainedvaccinesafetyscientistsandclinicians. 2.1.3 Improvelaboratory,epidemiological,andstatisticalmethodsusedinvaccinesafetyresearch.

Objective 2.2

Facilitatethetimelyintegrationofadvancesinmanufacturingsciencesandregulatory approachesrelevanttomanufacturing,inspection,andoversighttoenhanceproductquality andpatientsafety.

Strategies:

2.2.1 Facilitatetheenhancementofvaccinemanufacturingsciencesandqualitysystems,including productiontechnologies,in-processcontrolsandtesting,andidentificationofbestpracticesin preventivequalitysystemsandoversight. 2.2.2 Develop,implement,andperiodicallyreassessrisk-basedscientificapproachestoidentify inspectionalprioritiesandbestpractices. 2.2.3 DevelopnewscientificmethodsforbothindustryandtheFoodandDrugAdministration(FDA) forproductqualitytesting. 2.2.4 Assurethatregulations,guidancedocuments,policies,andproceduresthatarerelevantto vaccinemanufacturing,laboratorytesting,andqualitycontrolincorporatethemostcurrent relevantscientificinformationtopromoteandenhanceproductsafety.

Objective 2.3

Enhancetimelydetectionandverificationofvaccinesafetysignals.

Strategies

2.3.1 Improvetheeffectivenessandtimelinessofsignalidentificationandassessmentthrough coordinateduseofpassiveandactivesurveillancesystems,andfromprovidersandthepublic. 2.3.2 ImprovetheprocessforassessingAEFIsignalstodeterminewhichsignalsshouldbeevaluated furtherinepidemiologicalandclinicalstudies.

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Objective 2.4:

Improvetimelinessoftheevaluationofvaccinesafetysignals,especiallywhen1)ahigh-priority newvaccinesafetyconcernemergesor2)whenanewvaccineisrecommended,vaccination recommendationsareexpanded,orduringpublichealthemergenciessuchasinaninfluenza pandemicorothermassvaccinationcampaign.

Strategies

2.4.1 Expandcollaborationwithclinical,laboratory,genetic,statistical,andbioinformaticsexpertsto conductclinicalresearchstudiestoinvestigatetheroleofhostgeneticsinAEFIs. 2.4.2 Increasethesize,representativeness,andutilityofthepopulationunderactivesurveillancefor seriousAEFIsthatcanbeincludedintimely,highquality,rigorouslyconductedepidemiological studiestoassessvaccinesafetyquestions.

Objective 2.5

ImprovecausalityassessmentsofvaccinesandrelatedAEFIs.

Strategies

2.5.1 Builduponnewscientificdevelopmentsinareassuchasgenetics,systemsbiologyand bioinformatics,andimmunologytodevelopandvalidatetoolswhichaidin(orenable)the identificationofindividualriskfactorsforAEFIsforwhichacausalrelationshiphasbeen established. 2.5.2 Assesstheevidenceforacausalrelationshipbetweencertainvaccinesandspecificclinically importantAEFIsand,astheneedarises,conductanindependentreviewofavailableevidence.

Objective 2.6

Improvescientificknowledgeaboutwhyandamongwhomvaccineadversereactionsoccur.

Strategies

2.6.1 Identifyhostriskfactorsthatmaybeassociatedwithincreasedriskforspecificvaccineadverse reactionsthroughbasic,clinical,orepidemiologicalresearch. 2.6.2 Identifythebiologicalmechanism(s)forvaccineadversereactions. 2.6.3 AssesswhethertheriskofspecificAEFIsisincreasedinspecificpopulationssuchaspregnant women,prematureinfants,olderadults,thosewithimmunocompromisingorothermedical conditions,basedongenderorrace/ethnicity,orotherat-riskindividuals. 2.6.4 Developarobustsystemtoenhancecollectionofmedicalhistoriesandbiologicalspecimens fromselectedpersonsexperiencingseriousAEFIstoenhancestudyofbiologicalmechanismsand individualriskfactors.

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Objective 2.7

Improveclinicalpracticetoprevent,identifyandmanagevaccineadversereactions.

Strategies

2.7.1 Improvetraining,availabilityof,andaccesstovaccinesafetyclinicalandcommunicationexpertsto provideconsultationtohealthcareprovidersandpublichealthpractitioners. 2.7.2 Developanddisseminateevidence-basedguidelinesforvaccinationorrevaccination,as appropriate,especiallyforpersonswhomaybeatincreasedriskforvaccineadverseevents.Use thisinformationtoclarifycontraindicationsandprecautionstovaccination.

Objective 2.8

Enhancecollaborationofvaccinesafetyactivities.

Strategies

2.8.1 Improvecollaboration,suchasdatasharingarrangements,acrossfederalagencies,departments, andwithnon-federalpartners. 2.8.2 Improveinformationanddatasharingwithinternationalpartners(e.g.,nationalvaccinesafety programs)consistentwithethicalandhumansubjectsprotectionsandapplicablelaw,including confidentialityprotections. 2.8.3 DevelopadditionalstandardcasedefinitionsforAEFIsforuseinimmunizationsafetysurveillance andresearch,vaccinesafetystandardssuchasconceptdefinitions,standardizedabbreviations, andstandardizedstudydesigns.

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Goal 3:

Support communications to enhance informed vaccine decision-making

Introduction

HHSiscommittedtoprovidingaccurate,timely,transparent,complete,andaudience-appropriate informationaboutimmunizationsandvaccines.Thisinformationisdesignedforparentsmaking vaccinationdecisionsfortheirchildren(birththroughage18);adultsconsideringvaccinesfor themselves;publichealthpartners;providers;policy-makersandothers. Communicationtoolsandchannelsusedtodisseminateimmunizationandvaccineinformation spanabroadspectrum:publicationofevidence-basedrecommendations;useofmassmedia andnewmedia;providereducationandtraining;andsupportofpartnerorganizationsandstate immunizationprogramsthroughprovisionofresources,trainings,updates,andannouncements. Currentcommunicationeffortsareinformedbyresearchaswellastheprinciplesofeffective riskcommunication,socialmarketing,andsocialmobilization.Researchshouldbeenhancedto betterunderstandthenatureofinformeddecision-makingandtheelementsthatsupportsuch decisions.Improvedcommunicationsresearchcanfacilitatedevelopmentofmoretargeted messagesandmethodsforclearlyandeffectivelycommunicatingaboutthebenefitsandrisksof vaccines,andtoaddressinformationneedsuniquetovariousaudiences.Thecombinedeffortsof communicationscientists,healthservicesresearchers,andotherscanenhancethedevelopment andimplementationoflong-term,sustainableplansforgatheringreliablereal-timedataabout facilitatorsofandbarrierstovaccineacceptance,translatingthosedataintopracticalsolutions. Thisresearchalsoenhanceseffortstopromotetheadoptionofvaccinerecommendationsto preventdiseaseandimprovethepublic'shealth. The2010NationalVaccinePlanrecognizestheimportanceofcommunicationactivitiesthatare strategic,science-based,transparent,andculturallyappropriate.Communicationstrategiesshould reflectthehealthliteracylevelandEnglishproficiencyofspecifictargetpopulationgroups,aswell asconsiderationsoftheaccessibilityofinformationtoindividualswithhearing,visual,cognitive,or otherlimitations.Relatedtothesegoalsaretherolesandresponsibilitiesofvariousstakeholders engagedinvaccinecommunicationsandeducation.Policy-makers,suchasfederal,state, andlocallegislators;healthdepartments;employers;third-partypayorsandothers,arecritical stakeholdersinthevaccineenterprise.Collaboratingwithpublichealthdecisionmakersacross thehealthsectoriscriticaltorealizingthefullvisionoftheplan.Healthcareproviders,advocacy groups,thepublichealthcommunity,andcommunityandfaith-basedorganizationscanserveas strongandcredibleimmunizationadvocatesabouttheriskofVPDs,thebenefitsofvaccination, recommendedschedules,thesupplyandfinancingofvaccines,andthepossiblerisksassociated withvaccination.Public-privatecollaborationoncommunicationandeducationactivitieswillbe criticaltoachievingthegoalandobjectivessetforthbythePlan. WhilethefocusofGoal3isoncommunicationandeducationissuesrelevanttoinformed decision-making,theseissuesarealsorelevanttoeachoftheothergoalsofthe2010National VaccinePlan.Topic-specificcommunicationsandeducationactivitiesaredescribedinGoals2,4, and5.

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Objectives

Objective 3.1

Utilizecommunicationapproachesthatarebasedonongoingresearch.

Strategies

3.1.1 Conductresearchregularlytounderstandthepublic'sknowledge,beliefs,andconcernsabout vaccinesandVPDs. 3.1.2 Conductresearchonfactorsthataffectdecision-makingaboutvaccinationforindividualsand families,providers,andpolicy-makers. 3.1.3 Identify,develop,andtesteducationalstrategiesthatbetterenablepolicy-makerstoread, understand,anduseinformationaboutvaccinebenefitsandrisks. 3.1.4 Evaluatetheeffectivenessofmessagesandmaterialsinaddressingtheinformationneedsand concernsofthepublicandunder-immunizedpopulations. 3.1.5 Developevidence-basedtoolstoassistindividuals,parents,andproviderswithrelevant informationtomakeinformeddecisionsregardingvaccination.

Objective 3.2:

Buildandenhancecollaborationsandpartnershipsforcommunicationefforts.

Strategies

3.2.1 Strengthenexistingpartnershipsandcoalitionsandbuildrelationshipswithnewpartnersto supportrelevantimmunizationsacrossthelifespan. 3.2.2 Usecross-agencyandintra-agencycollaborationtoinformdevelopmentofcommunication researchagendas,protocols,campaignsandmessages. 3.2.3 Collaboratewithpartnersandstakeholderstocommunicatevaccinebenefits,risks,and recommendationsinaccessibleformatsandinculturallyappropriatelanguages,methods,and literacylevels. 3.2.4 Utilizestateandlocalvenuestoeducateonvaccineandimmunizationissuestoexpandthereach ofmessagesoutsideofthetraditionalclinicalsetting.

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Objective 3.3

Enhancedeliveryoftimely,accurate,andtransparentinformationtopublicaudiencesandkey intermediaries(suchasmedia,providers,andpublichealthofficials)aboutwhatisknownand unknownaboutthebenefitsandrisksofvaccines.

Strategies

3.3.1 Enhancecommunicationofnewfindingsaboutvaccineeffectiveness,safety,andadministration studiestothepublic,partnersandprovidersinaclear,transparentandtimelymanner. 3.3.2 Respondinarapid,coordinated,consistent,andeffectivemannertoemergingvaccineissuesand concerns(e.g.,supply,safety,orpublichealthemergencies). 3.3.3 Rapidlyandeffectivelydisseminatecommunicationsresearchfindingsthroughpeer-reviewed journals,conferences,media,andpartnercommunicationstofacilitateimplementationof evidence-basedstrategies.

Objective 3.4

Increasepublicawarenessofthebenefitsandrisksofvaccinesandimmunization,especially amongpopulationsatriskofunder-immunization.

Strategies

3.4.1 Develop,implement,andevaluatealong-termstrategiccommunicationsplanandprogram aimedateducatingparents,caregiversofchildren,adolescents,andadultsaboutVPDs;the benefitsandrisksofvaccines;andvaccinerecommendations. 3.4.2 Maintaincurrent,easilyaccessible,evidence-basedonlineinformationonVPDsandvaccines, includingbenefitsandrisksandthebasisofimmunizationrecommendations,forallaudience groups. 3.4.3 Evaluatenewmedia(suchasmobiletechnologiesandsocialmedia)andutilizeitappropriately toreachtargetaudienceswithaccurateandtimelyinformationaboutvaccinesandtorespondto emergingconcernsandissues. 3.4.4 Enhanceawarenessoftheimportanceofimmunizationaspartofpreventivehealthcareamong parents,adolescents,andadults. 3.4.5 Collaboratewiththeeducationcommunitytoassessopportunitiestointegrateinformationon VPDs,recommendedvaccines,preventivehealthcare,andpublichealthinexistingeducational curricula. 3.4.6 Developanddisseminatevaccinecommunicationtools/materialsthatareaccessibleandculturally andliteracy-levelappropriateforgroupsatriskofunder-immunization. 28

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Objective 3.5:

Assurethatkeydecision-andpolicy-makers(e.g.,third-partypayers,employers,legislators, communityleaders,hospitaladministrators,healthdepartments)receiveaccurateandtimely informationonvaccinebenefitsandrisks;economics;andpublicandstakeholderknowledge, attitudes,andbeliefs.

Strategies

3.5.1 Develop,disseminate,andevaluatebroad-basededucationtoolsforkeygroupsonthevalue,risks, andcost-effectivenessofvaccines;thebasisofimmunizationrecommendations;businesscase evidenceandguidance;vaccinepolicydevelopment;thestandardsofimmunizationpracticeand administration;andvaccinesasacomponentofpreventivehealthcare. 3.5.2 Selectandimplementamodelforsustainedcommunityengagementtoinformvaccinepolicy andprogramactivities. 3.5.3 Providevaccineprogrammanagersandpolicy-makersinformationonthedirectandindirectcosts andbenefitsofvaccination.Thisincludes,butisnotlimitedto,informationonfederalandstate programsthatofferlow-costvaccines. 3.5.4 Providepolicy-makerswithdatanecessarytomakeinformeddecisionsontheutilizationof vaccinesinmassvaccinationprogramsforpublichealthemergencies.

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Goal 4:

Ensure a stable supply of, access to, and better use of recommended vaccines in the United States

Introduction

VPDincidenceintheU.S.isatornearrecord-lowlevelsformostdiseasesagainstwhichchildren areroutinelyimmunized;infantandchildvaccinationratesareapproachingormeetrecord levels.However,coveragelevelsarebelowHP2020targetsformanyvaccinestargetedto adolescentsandadults,andsubstantialdisparitiesexistamongracialandethnicgroupsin adultandadolescentvaccinationlevels.Limitedknowledgeaboutrecommendedvaccines andattitudestowardsvaccinesexistamongthepublic,healthcareprofessionals,andhealth policy-anddecision-makers.Lackofhealthcareaccessandfinancialbarriersalsocontributeto thesedisparitiesandneedtobeaddressedinstrategiesmovingforward.Researchonhowbest toovercomesuchbarrierswilldictatestrategiesandpractices.Ongoingpartnershipsamong national,state,local,tribal,private,andpublicentitiesareneededtosustainandimprovevaccine useandtheconcomitantindividualandpublichealthbenefits. EnsuringareliableandsteadysupplyofallvaccinesiscriticalintheU.S.,whereshortagesofseveral commonlyusedvaccineshaveoccurredsince2000(e.g.,Hib,hepatitisA,andinfluenza).New 21st-centuryvaccinesupplyconcerns,suchasvaccinesforpandemicinfluenza,emergingdiseases andbioterrorismthreats,presentdifferentchallengesforsustainabilityandmayrequiresurge manufacturingcapacitycomparedwithtraditionalvaccinepathways. Immunizationinformationsystems(IIS)andelectronichealthrecords(EHR)maybecome increasinglyimportantcomponentsofimmunizationprograms.Jointlytheycanleadtomuch betterimmunizationrecordkeepingforchildrenandadults,therebyreducingthebarrierof unknownimmunizationstatusandthereceiptofadditionalunneededdosesofvaccinesand enhancingefficiencyandcost-effectivenessofnationalimmunizationefforts. StrongpublichealthsurveillancetomonitorandevaluateVPDsandtheeffectivenessoflicensed vaccinesprovidesthelinkbetweenvaccinationpolicyandhealthoutcomes.Suchpublichealth surveillanceisakeycomponentofstrategiestoovercomebarriersandimproveuseofexisting vaccines. Challengespersisttoimprovevaccinationratesandtoincorporatenewvaccinesintochild andadolescentvaccinationschedules.Between2005and2010,sixnewvaccinesorvaccine recommendationswereaddedforchildrenandadolescentsbytheACIPandtheCentersfor DiseaseControlandPrevention(CDC): ·meningococcalconjugatevaccine ·tetanus,diphtheria,acellularpertussisvaccine ·HPVvaccine ·rotavirusvaccine ·universalinfluenzavaccination ·13-valentpneumococcalconjugatevaccine. 30

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Barrierstoimprovedvaccineuptakeincludepersistentcost,awarenessandaccessproblems;lack ofknowledgeofnecessaryvaccines;andlimiteduseofevidence-basedstrategiestoimprove vaccineuptake,suchasreminder-recallsystems.Communityhealthcenters,othercommunity immunizationsites(e.g.,pharmaciesandstores)andschool-locatedclinicsoffervenuesfor improvingvaccineuptake,inadditiontotraditionalprovidersites. Goal4identifiesnineobjectivesandrelatedstrategiestostrengthenournation'svaccination programandovercomebarriers.Enhancingcommunicationandeducationactivitiesabout vaccinationisakeyapproachtoovercomemanyofthecurrentchallengesidentifiedinGoal4,and isaddressedindetailinGoal3.

Objectives

Objective 4.1

EnsureconsistentandadequatesupplyofvaccinesfortheU.S.

Strategies

4.1.1 Determinebarrierstohavingmultiplesuppliersforeachvaccinelicensedandrecommendedfor routineuseintheU.S. 4.1.2 Promoteharmonizationofinternationalvaccineregulatorystandardsforlicensure. 4.1.3 Improvevaccinequalityandavailabilitythroughbettermanufacturingandproductionoversight. 4.1.4 Optimizeuse,content,anddistributionofvaccinestockpilesandancillarysupplies. 4.1.5 Improvethedevelopmentof,communicationof,andtrackingofadherencetorecommended changesinvaccineuseduringnationalvaccineshortages.

Objective 4.2

EnsureconsistentandstabledeliveryofvaccinesfortheU.S.

Strategies

4.2.1 Improvevaccineordering,distributionandtrackingsystemsforroutineuse,forpublichealth emergencies,andformanagementofdeliverydisruptions. 4.2.2 Enhancepublicsectorinfrastructuretosupportandsustainadultimmunizationactivities, includingaddressingdisparitiesinvaccinationratesamongracialandethnicminoritiesand unvaccinatedrefugeesresettlingtotheU.S. 4.2.3 Expandaccesstovaccinationatmedicalcaresitesforchildren,adolescents,andadults,suchasby increasinghoursofoperationandestablishingspecificvaccinationclinicsatselectedtimesofthe year(e.g.,"backtoschool"campaigns).

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4.2.4 Expandaccesstovaccinationinnon-healthcaresettings,suchasretailoutlets,schools, workplaces,andcommunitycenters. 4.2.5 Develop,monitor,andevaluatepoliciespromotingvaccinationforpatientsinlong-termcare facilitiesandhospitals. 4.2.6 Develop,implement,andevaluateemployer-basedimmunizationprograms,whichshouldinclude freevaccines,convenientaccess,education,andcompliancemonitoring,toincreasethecoverage ofemployees,includinghealthcareworkers,withrecommendedvaccines. 4.2.7 Implement,monitor,andevaluateevidence-basedinterventionsdesignedtoraiseandsustain highvaccinationcoverageacrossthelifespan. 4.2.8 Monitorandevaluatetheimpactofstateimmunizationlawsandregulationsonvaccinecoverage, includingchildcare,pre-school,school,collegeprematriculationrequirements,employer requirements,andtheroleofexemptions,insurancemandates,andimmunizationinformation systemsrequirements. 4.2.9 Prepare,practice,andevaluatemassvaccinationactivities,includingvaccineadministration, forscenariossuchasanoutbreakofaVPD,forabiologicalattack,forthecriticalworkforcein advanceofaninfluenzapandemic,andfortheentirepopulation,priortoandduring,aninfluenza pandemic.

Objective 4.3

Reducefinancialbarrierstovaccination.

Strategies

4.3.1 IdentifyandregularlymonitorfinancialbarrierstoreceiptofACIP-recommendedandCDCadoptedvaccines. 4.3.2 Ensurethatout-of-pocketcostsforpurchaseandadministrationofACIP-recommendedandCDCadoptedvaccinesdonotrepresentasignificantfinancialbarrier. 4.3.3 Strengthentheabilityofstatestopurchase,andexpandaccessto,ACIP-recommendedandCDCadoptedvaccinesforthosewhoqualifyforpubliclysupportedvaccinations. 4.3.4 Develop,implement,andevaluatestrategiestoreducethefinancialburdenonvaccination providersforpurchaseofinitialandongoingvaccineinventories.

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Objective 4.4

Maintainandenhancethecapacitytomonitorimmunizationcoverageforvaccinesroutinely administeredtoallagegroups.

Strategies

4.4.1 Identify,implement,andevaluatecost-effectiveandrapidmethods,suchastheuseofIISor internetpanelsurveys,forassessingvaccinationcoveragebycategories,includingagegroups, groupsatriskofunderimmunization,bytypeofvaccine,andtypeoffinancing. 4.4.2 Improvethecompletenessof,useof,andcommunicationbetween,IISandEHRtomonitor vaccinationcoverage. 4.4.3 Supporttheadoptionofnationalcertified,interoperablehealthinformationtechnologyandEHR forimmunization. 4.4.4 Supportandimproveexistingsurveysassessingimmunizationcoverage(e.g.,theNational ImmunizationSurveyandtheBehavioralRiskFactorSurveillanceSystem),toincludemore representativesamplesandtimelyreportingofdata.

Objective 4.5

EnhancetrackingofVPDsandmonitoringoftheeffectivenessoflicensedvaccines.

Strategies

4.5.1 StrengthenepidemiologicandlaboratorymethodsandtoolstodiagnoseVPDs,assesspopulation susceptibility,andcharacterizevaccineeffectivenessandtheimpactofvaccinationcoverageon clinicalandpublichealthoutcomes. 4.5.2 Monitorcirculatingstrainsofrelevantvaccine-preventableandpotentiallyvaccine-preventable pathogens,includingemergingandre-emergingdiseases. 4.5.3 Improvemonitoringofdiseaseburdenanddetermineepidemiologicandclinicalcharacteristics ofcasesofVPDsandpotentialVPDsbysupportingtraditionalsurveillanceanduseofhealth informationtechnology,interoperabledatastandards,andnewdataresources. 4.5.4 Developandmaintaincapacitytorapidlyestimatetheeffectivenessofnewvaccines,suchas pandemicandpre-pandemicinfluenzavaccines. 4.5.5 Assurerapidandcomprehensiveidentification,investigation,andresponsetovaccine- preventablediseaseoutbreaks.

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4.5.6 Assuretimelyevaluationtoassessvaccineeffectiveness,durationofprotection,andindirect (communityandherd)protectionbycurrentandnewlyrecommendedvaccines.

Objective 4.6

Educateandsupporthealthcareprovidersinvaccinationcounselingandvaccinedeliveryfortheir patientsandthemselves.

Strategies

4.6.1 ExpandandimplementtrainingandeducationofhealthcareprovidersonVPDs,including diagnosis,modesoftransmission,preventionandcontrol,andreportingrequirements. 4.6.2 Expandandimplementtrainingandeducationofimmunizationprovidersatalllevelsoftheir educationontheproperuseandadministrationofvaccines;theproperstorageandhandlingof vaccines;thebasisofimmunizationrecommendations;thesafetyofvaccines;reportingofAEFIs; understandingofthevaccinesafetysystem;andonthestandardsofimmunizationpractice(e.g., vaccineeducationmodulesinprimarycareandcontinuingmedicaleducationprograms). 4.6.3 Developaplantoreduceandultimatelyeliminateerrorsinvaccineadministration(e.g.,wrong vaccine,dose,injectionsite,ortiming). 4.6.4 Promoteandsupporteducationalandtechnicalassistancetoimprovebusinesspractices associatedwithprovidingimmunizations,suchaseducatingprovidersandenrollingnew providersintotheVaccinesforChildrenprogram,includingnon-traditionalproviders. 4.6.5 ExpandtheincorporationofvaccinationsandtheuseofIISintoqualityimprovementprograms suchastheHealthcareEffectivenessDataandInformationSet. 4.6.6 Supportadequatereimbursementforvaccinecounseling,administration,storageandhandlingby providersunderpublicsectorandprivatehealthplans. 4.6.7 Supportresearchtoevaluatethecapacity(accommodatingtheincreasednumberofpatient visitsrequiredtoreceiverecommendedvaccines)ofhealthcareproviderstoimplementvaccine recommendationsforallagegroups. 4.6.8 Develop,implement,andevaluatecomprehensiveprogramstoensurehealthcareprofessionals areappropriatelyimmunizedwithrecommendedvaccines.

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Department of Health & Human Services | The 2010 National Vaccine Plan

Objective 4.7

Maintainastrong,science-based,transparentprocessfordevelopingandevaluatingimmunization recommendations.

Strategies

4.7.1 Obtainbroad-basedinputfromthepublicandstakeholderscontributingtonewimmunization policiesandtheassessmentofexistingpolicies. 4.7.2 Assesstheimpactofnewvaccinesandvaccinerecommendationsontheoverallimmunization schedule,includingprogrammaticimplementation,safety,andefficacy. 4.7.3 Evaluatethecost-effectivenessandcomparativeeffectivenessofproposedandexisting immunizationrecommendations.

Objective 4.8

StrengthentheNationalVaccineInjuryCompensationProgram(VICP)andCountermeasuresInjury CompensationProgram(CICP).

Strategies

4.8.1 IncreaseknowledgeabouttheVICPandCICPamongallstakeholders. 4.8.2 Assuretheprogramsareresponsivetoevolvingscience,includingregularlyupdatingtheirVaccine InjuryTables. 4.8.3 Continuetoensurefairandefficientcompensationforvaccine-relatedinjuries. 4.8.4 Examinealternativeapproaches,andevaluateandimplementthosedeemedoptimal,for adjudicationofVICPclaimsforillnessesnotincludedintheVaccineInjuryTabletotheextent permittedbyapplicablelaw.

Objective 4.9

Enhanceimmunizationcoveragefortravelers.

Strategies

4.9.1 Definethepopulationsatriskforacquiringinternationaltravel-relatedVPDs,andidentifyand addressbarrierstotheirreceivingimmunizations. 4.9.2 Assessoverallimmunizationstatusduringtravel-relatedimmunizationclinics.

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Goal 5:

Increase global prevention of death and disease through safe and effective vaccination

Introduction

Infectiousdiseasesaretheleadingcauseofdeathamongchildrengloballyandcontribute substantiallytodiseaseanddisabilityamongpersonsofallages.Immunizationprogramshave beenremarkablysuccessfulinpreventingmillionsofchildhooddeaths,eradicatingsmallpox,and eliminatingcirculationofpolioandmeaslesfrommanycountriesaroundtheworld.However, substantialchallengesremain.Manydiseasesforwhichsafeandeffectivevaccinesareavailable poseacontinuedburden,asdoestheunderutilizationofvaccinesinmostcountries(e.g., pneumococcal,rotavirusandHPV)anddiseasesforwhichvaccinesarebeingdeveloped(e.g., HIV,TB,andmalaria).Globallymobilepopulationsincludingrefugees,andstatelessandinternally displacedpersonsareoftendifficulttoreachandmaynotbeincludedinnationalimmunization programs.AchievingtheUnitedNations'MillenniumDevelopmentGoalsofreducingtheunderfiveyearmortalityratebytwothirdsby2015willrequiresubstantiveaction,includingincreasing theproportionofoneyear-oldchildrenimmunizedagainstmeasles. Thegoalsofglobalvaccinationaretocontrol,eliminate,oreradicateinfectiousdiseasesinaway thatstrengthenshealthsystemsandissustainableasnewvaccinesareintroduced.Successin globalimmunizationrequiresactionbythefullrangeofstakeholdersinvolvedinthevaccine andimmunizationenterprise:researchanddevelopment,regulationandmanufacturing,and programimplementationandmonitoring.NewpartnershipssuchastheGlobalAlliancefor VaccinesandImmunizations(GAVI)haveledtoincreasedsupportforimmunizationworldwide, spurringintroductionofnewvaccinesinlowincomecountriesandexpandedvaccination coverage.U.S.governmentalandNGOshavecontributedtoprogressthroughvaccineresearch anddevelopment,participationinmultilateralandbilateralpartnerships,technicalassistance,and programsupport. GiventhebreadthofglobalimmunizationactivitiesinGoal5,someoftheobjectivesand strategiesrelevanttothistopicareincludedelsewhereinthisPlan.Forexample,allvaccine researchanddevelopmentissuesareincludedunderGoal1becausetheapproachand stakeholdersnecessarytoachievetheseobjectivesarelargelythesameintheU.S.andthe restoftheworld.Similarly,issuesrelatedtovaccinesafety,communicationsandprogram implementationareincludedunderthisgoal,aswellasunderothergoalsofthePlan,asthereare uniqueintellectualperspectivesforthem.Whilemanyoftheobjectivesintheseareasaresimilar fortheU.S.andabroad,thestrategiesdifferinternationallybecauseU.S.stakeholdersfocuson partnershipsandprovidingassistanceratherthanondirectimplementation. Intheeraofglobalpandemicsandmasstravel,thepublichealthofU.S.citizensiscloselyrelated todiseasesoccurringinothercountries.EventhoughmanyVPDssuchaspolio,measles,and rubellahavebeeneliminatedinthiscountry,theU.S.remainsvulnerabletoimportationsaslong asthesediseasescontinuetopersistelsewhere.Supportforoverseas(pre-departure)vaccination ofmobilepopulations,includingrefugeesandimmigrantsmigratingtotheU.S.,willreducethe likelihoodofimportation.Supportfordevelopingandintroducingnewvaccinestoaddress diseasesinothercountriesandassistingwithstrengtheningandenhancingcapacityoftheir immunizationprogramscontributestowardprovidingan"umbrellaofprotection"fortheU.S.and fulfillingtheU.S.government'sbroadercommitmenttoglobalpublichealth. Meetingthiscommitmenttosupportglobalimmunizationisalsoreflectedinotherfederalpublic healthinitiativesanddevelopmentinitiativesbeyondthePlan.TheGHI­currentlyledbytheU.S. 36

Department of Health & Human Services | The 2010 National Vaccine Plan

DepartmentofState,USAID,andtheCDC,withactiveengagementofotheragencies,including theDepartmentofDefense(DoD),NIH,andtheHealthResourcesServicesAdministration (HRSA)­andFDA'sglobalvaccineregulatorycapacitybuildingeffortsthroughtheWorldHealth Organization(WHO)aretwoexamplesoffederalinitiativesthatincorporateimmunizationasa componentofabroadU.S.interesttoimprovematernalandchildhealth.Additionally,theCDC hasaGlobalImmunizationStrategicFrameworkthatfocusesonhowtheagencywillsupport immunizationprogramsaroundtheworld.Theseandotherinitiativesareconsistentwiththe objectivesoutlinedinthePlan.

Objectives

Objective 5.1

SupportinternationalorganizationsandcountriestoimproveglobalsurveillanceforVPDsand strengthenhealthinformationsystemstomonitorvaccinecoverage,effectiveness,andsafety.

Strategies

5.1.1 AchievesustainableWHOcertificationqualitysurveillanceforeradicationoftargetedVPDs. 5.1.2 ExpandandimprovesustainablesurveillancesystemsforalldiseaseshavingWHO-recommended vaccinesanddiseasesforwhichvaccineintroductionisbeingconsidered. 5.1.3 Strengthenalllevelsofgloballaboratorynetworks(includingnational,regional,andglobal referencelaboratories)tosustainandimproveVPDdiagnosisinordertoestablishbaselinedisease burden,detectoutbreaks,detectnewlyemergingvariantsofVPDs,andmonitortheimpactofnew vaccines.Thislaboratorycapacityshouldalsobedevelopedforsurveillanceofpotentialpublic healthemergenciesofinternationalconcern. 5.1.4 EnhanceassessmentsofemergingvariantsorstrainsofVPDagents. 5.1.5 Developnewdiagnostictests,toolsandprocedurestoimprovebothfield-basedandlaboratory confirmationofdiagnoses.

Objective 5.2

Supportinternationalorganizationsandcountriestoimproveandsustainimmunizationprograms asacomponentofhealthcaredeliverysystemsandpromoteopportunitiestolinkimmunization deliverywithotherpriorityhealthinterventions,whereappropriate.

Strategies

5.2.1 Providetechnicalsupporttocountries,multilateralinstitutions,andotherpartnerstostrengthen keycomponentsofimmunizationprogrammanagementandimplementation,including epidemiologicalanalysis,comprehensiveplanning,vaccinedistributionandsafeadministration, monitoring,informationsystems,andprogramevaluation.

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5.2.2 Providetechnicalsupporttocountriesandmultilateralinstitutionsasappropriatetointroduce, sustain,andmonitorrecommendedsafeinjectionpracticesforallvaccinations,includingtheuse ofautodisablesyringesorneedle-freedevices. 5.2.3 Improvecoveragemonitoringofvaccinesandotherhealthserviceslinkedwiththevaccination programandtheuseofinformationatdistrictandlocallevels. 5.2.4 IntroduceandimproveprogramsthatevaluateAEFIs. 5.2.5 Developstandardizedmethodsformonitoringandevaluatingtheefficiency,effectiveness andimpactofcombinedinterventionstoimprovecoverage,andsupportlinkingdeliveryof immunizationandotherhealthservicesinwaysthatdonotjeopardizeimmunizationcoverage. 5.2.6 Encourageestablishmentofprograms,asappropriate,forvaccinationbeyondthetraditionalinfant targetagegroups(e.g.,amongolderchildren,adolescents,adults,andhealthcareproviders), includingunvaccinatedmobilepopulationsofvariousagegroupssincetheepidemiologyinsome mobilepopulationsmaydifferfromotherpopulationswherethediseasesarenormallyspreading incertainage-groups. 5.2.7 Providetechnicalsupporttocountries,multilateralinstitutionsasappropriate,andotherpartners todevelopsustainablevaccinefinancingmechanismsandadequateglobalsuppliesofvaccines, includingthrougheconomicandsupplyanddemandanalyses.

Objective 5.3

Supportinternationalorganizationsandcountriestointroduceandmakeavailablenewand underutilizedvaccinestopreventdiseasesofpublichealthimportance.

Strategies

5.3.1 Strengthencapacityatthecountrylevel,andinmultilateralinstitutionsasappropriate,tomake informeddecisionsonintroductionofnewvaccinesbasedonevaluationofepidemiology, financialsustainability,safety,andprogrammaticconsiderations,includingsupporttonational advisorycommittees. 5.3.2 Collaboratewithglobalorganizationsandpartnerstoaccelerateclinicaltestingandlicensurein developingcountriesofvaccinesalreadylicensedindevelopedcountries,whereappropriate. 5.3.3 SupporttheintegrationofnewandunderutilizedvaccinesintoeachGAVI-eligiblecountry'smultiyearnationalplanofactionandprovidetrainingandlogisticalsupportnecessarytosuccessfully incorporatenewvaccinesintoroutineprograms. 5.3.4 Supportpost-licensureevaluationsofnewvaccineswithregardtoimmunizationprograms, diseasepatterns,andvaccinesafety. 38

Department of Health & Human Services | The 2010 National Vaccine Plan

5.3.5 Workwithglobalpartnerstoestablishaninternationalsystemthatfacilitatesrapidresponse toemerginginfectionsthroughthedevelopmentofvaccinereferencestrainsandcandidate vaccines. 5.3.6 Workwithglobalpartnerstosecureandmaintainadequatestockpiles/strategicreservesof vaccinestomaintainuninterruptedsupplyandforemergencyresponsetooutbreaks. 5.3.7 Supportanddevelopmechanismsforrapidlymakingvaccinesavailabletodevelopingcountries forpublichealthemergenciessuchaspandemicinfluenza,includingexploringoptionsforsharing ofvaccinesandtieredpricing.

Objective 5.4

Supportinternationalorganizationsandcountriestoimprovecommunicationofevidence-based andculturallyandlinguisticallyappropriateinformationaboutthebenefitsandrisksofvaccinesto thepublic,providers,andpolicy-makers.

Strategies

5.4.1 Supportappropriateeconomicstudiestoinformkeydecision-andpolicy-makers'understanding ofthebenefitsandcostsofimmunization. 5.4.2 Supportthedevelopmentofcapabilitiestocommunicatevaccinebenefitsandrisksandto respondtoemergingvaccinesafetyissues. 5.4.3 Supportnationalsystemstoimprovereportingofadverseevents. 5.4.4 Assistcountriestodevelopandimplementsustainablecommunicationresearchtogathertimely andreliabledatafromthepublicandprovidersonknowledge,attitudesandbeliefsaboutthe benefitsandrisksofvaccines. 5.4.5 Assistcountriestodevelopcommunicationplanstoincreaseproviderandpublicawarenessof VPDsandpromoteimmunizationrecommendations,especiallyamongpopulationsatriskof under-immunization. 5.4.6 Providetechnicalassistanceandtrainingtobehavioralandcommunicationsscientistsand promotetheirparticipationonTechnicalAdvisoryGroups. 5.4.7 Supportandparticipatewithpartnerstocreateandimplementaglobalvaccineadvocacy strategy.

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39

Objective 5.5

Supportthedevelopmentofregulatoryenvironmentsandmanufacturingcapabilitiesthat facilitateaccesstosafeandeffectivevaccinesinallcountries.

Strategies

5.5.1 PromoteandsupporttheeffortsofWHOandotherglobalpartnerstodevelopandharmonize internationalstandardsforvaccinedevelopmentandlicensure. 5.5.2 PromoteandsupporttheeffortsofWHOandotherstoimproveregulatorycapacityincountries withlimitedinfrastructurestoassurevaccinequality,evaluatenewvaccineswhenappropriate,and assurethatclinicaltrialsareconductedinaccordancewithGoodClinicalPractices. 5.5.3 Providetechnicalassistancetodevelopingcountryvaccinemanufacturerstosupport developmentandproductionofsafeandeffectivevaccines.

Objective 5.6

Buildandstrengthenmultilateralandbilateralpartnershipsandothercollaborativeeffortsto supportglobalimmunizationanderadicationprograms.

Strategies

5.6.1 Participateinestablishingglobalimmunizationpriorities,goalsandobjectivesandprovide technicalassistanceatglobal,regional,andnationallevels. 5.6.2 Strengtheninternationalcollaborationsforbasicandappliedresearchandrelatedtrainingofnext generationresearchers,especiallyindiseaseendemicareas,toincludeimprovingthestabilityand performanceofcurrentvaccines. 5.6.3 ContributetodevelopmentandimplementationofaplanestablishingthescientificbasisforVPD eradication/elimination,identifyingoptimalvaccinationapproaches,anddevelopingstrategiesto minimizerisksinthepost-eradicationperiod. 5.6.4 Participateinregionalimmunizationinitiatives,suchasthoseadoptedbythePanAmericanHealth OrganizationandotherWHOregions. 5.6.5 Strengthenvaccinationofgloballymobilepopulationsthroughtargetedprograms(e.g.,predeparturevaccinationofUSboundrefugees).

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Monitoring and Evaluation

NVPOwillberesponsibleforassuringcoordinationandformonitoringfederalactionsand accomplishmentsonthe2010NationalVaccinePlanonanongoingbasis.NVPOandNVAC willreporttheirfindingstotheAssistantSecretaryforHealthannually.Thisreportwillinclude asummaryofprogress,identifyareaswhereprogressislagging,andproposecorrectiveaction whereneeded.ThereportalsowillbepresentedatanNVACmeeting,whichisopentothepublic andisattendedbymanystakeholdersnotrepresenteddirectlyontheCommittee. KeyfederalstakeholdersinglobalimmunizationincludeCDC,theDepartmentofStateandUSAID. ManyoftheglobalimmunizationtargetsincludedinthePlanwereestablishedbyinternational organizations(e.g.,WHO)inconsultationwithU.S.stakeholders.However,theroleofthose stakeholdersinachievingthesetargetsmostofteninvolvesprovidingtechnicalassistanceand supportratherthandirectimplementation. ManyfactorsmayaffecttheabilitytoachieveNationalVaccinePlanobjectives.Opportunities mayemergethatfacilitaterapidprogressandachievementofobjectivessoonerthananticipated. Scientific,technological,healthcarefinancing,orcommunicationsadvancesalsocouldemerge andenablerapidachievementofthevisionlaidforthbythePlan,supersedingitsobjectivesand goals.Ontheotherhand,existingchallengesandbarriersmaybemoredifficulttoovercomethan anticipatedandnewchallengesmayemerge.Forexample,arangeofscientificandtechnical issuesmaydelaydevelopmentandlicensureofnewvaccines;safetyconcernsmayaffectvaccine uptake;financialconstraintsmayaffectvaccinationdelivery.Recognizingtheseuncertainties, NVPOwillcoordinateamid-coursereviewofthePlanafterfiveyearsallowingchangestobemade whichrespondtotherealityoftheenvironment.Modifiedindicators,strategies,actions,and milestoneswillguidesubsequentannualevaluationthroughtheoverallten-yearhorizonofthe Plan.

Conclusion

Theoverridinggoalofthisplanistoinvigoratenationalcoordinationandplanningonvaccines andimmunizations.HHSwillleadthisnationaleffort,leveragingexistingresourcesand expertise,tomaximizethecontrolofVPDsinthiscountryandwithglobalpartners.Giventhat thisisintendedtobenotjustafederalplanbutrepresentanationalstrategy,itwillrequirethe partnershipofstakeholdersinvolvedinallaspectsofthevaccineenterprise.Thegoals,objectives, andstrategiesoutlinedinthisdocument,whenfullyimplemented,willmarkedlyenhancethe controlofVPDsandthehealthofthepublicinthisnation.

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Table 2:

National Vaccine Plan Objectives: Responsible Stakeholders

Federal HHS

ASPR (BARDA)

Dept. of State

Objective

USAID

AHRQ

NVPO

HRSA

ONC

CMS

DoD

DHS

CDC

FDA

ACF

DoJ

NIH

IHS

Goal 1: Develop new and improved vaccines

1 .1 1 .2 1 .3 1 .4 1 .5 1 .6 2 .1 2 .2 2 .3 2 .4 2 .5 2 .6 2 .7 2 .8 3 .1 3 .2 3 .3 3 .4 3 .5 4 .1 4 .2 4 .3 4 .4 4 .5 4 .6 4 .7 4 .8 4 .9 5 .1 5 .2 5 .3 5 .4 5 .5 5 .6

Goal 2: Enhance the vaccine safety system

Goal 3: Support communications to enhance informed vaccine decision-making

Goal 4: Ensure a stable supply of, access to and better use of recommended vaccines in the United States

Goal 5: Increase global prevention of death and disease through safe and effective vaccination

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Department of Health & Human Services | The 2010 National Vaccine Plan

VA

Non-federal

Public and private health care plans

Advocacy organizations

Vaccine manufacturers

State, local, and tribal governments

Health care providers

Health care system

Philanthropic organizations

Objective

Academia

UNICEF

Goal 1: Develop new and improved vaccines

1 .1 1 .2 1 .3 1 .4 1 .5 1 .6 2 .1 2 .2 2 .3 2 .4 2 .5 2 .6 2 .7 2 .8 3 .1 3 .2 3 .3 3 .4 3 .5 4 .1 4 .2 4 .3 4 .4 4 .5 4 .6 4 .7 4 .8 4 .9 5 .1 5 .2 5 .3 5 .4 5 .5 5 .6

Goal 2: Enhance the vaccine safety system

Goal 3: Support communications to enhance informed vaccine decision-making

Goal 4: Ensure a stable supply of, access to and better use of recommended vaccines in the United States

Goal 5: Increase global prevention of death and disease through safe and effective vaccination

WHO

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