U.S. Department of Health & Human Services
Protecting the Nation’s Health through Immunization
2010 National Vaccine PlanProtecting the Nation’s Health through Immunization
U.S. Department of Health & Human Services
Department of Health & Human Services | The 2010 National Vaccine Plan
Department of Health & Human Services | The 2010 National Vaccine Plan
Table of ContentsAcronyms 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 ObjectivesAppendix 2: 1994 National Vaccine Plan Objectives and ProgressAppendix 3: Federal Government Agencies Involved in ImmunizationAppendix 4: Relevant Federal Strategic Plans and InitiativesAppendix 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
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ACA AffordableCareAct(comprisedofthePatientProtectionandAffordableCareActandtheHealthCareandEducationReconciliationActof2010)
ACF AdministrationforChildrenandFamilies
ACIP AdvisoryCommitteeonImmunizationPractices
AEFI AdverseEventFollowingImmunization
AIDS AcquiredImmuneDeficiencySyndrome
AHRQ AgencyforHealthcareResearchandQuality
ASPR AssistantSecretaryforPreparednessandResponse
BARDA BiomedicalAdvancedResearchandDevelopmentAuthority
CDC CentersforDiseaseControlandPrevention
CICP CountermeasuresInjuryCompensationProgram
CMS CentersforMedicareandMedicaidServices
DoD DepartmentofDefense
DHS DepartmentofHomelandSecurity
DoJ DepartmentofJustice
EHR ElectronicHealthRecords
FDA FoodandDrugAdministration
GAVI GlobalAllianceforVaccinesandImmunizations
GHI GlobalHealthInitiative
HBV HepatitisBVirus
HHS U.S.DepartmentofHealthandHumanServices
Hib Haemophilusinfluenzaetypeb
HIV HumanImmunodeficiencyVirus
HP HealthyPeople
HPV Humanpapillomavirus
HRSA HealthResourcesandServicesAdministration
Acronyms and Abbreviations
IHS IndianHealthService
IIS ImmunizationInformationSystems
IOM InstituteofMedicine
NGO Non-GovernmentalOrganization
NIH NationalInstitutesofHealth
NVAC NationalVaccineAdvisoryCommittee
NVP NationalVaccineProgram
NVPO NationalVaccineProgramOffice
ONC OfficeoftheNationalCoordinatorforHealthInformationTechnology
P .L . PublicLaw
TB Tuberculosis
UNICEF UnitedNation’sChildren’sFund(formerlyUnitedNationsInternationalChildren’sEmergencyFund)
USAID U.S.AgencyforInternationalDevelopment
VA DepartmentofVeteransAffairs
VICP NationalVaccineInjuryCompensationProgram
VPD Vaccine-PreventableDisease
WHO WorldHealthOrganization
Department of Health & Human Services | The 2010 National Vaccine Plan
7Department of Health & Human Services | The 2010 National Vaccine Plan
“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
9Department of Health & Human Services | The 2010 National Vaccine Plan
Executive SummaryThe20thcenturycouldbeconsideredthecenturyofvaccines.ThelifespansofAmericansincreasedbymorethanthirtyyearsinlargepartbecauseofvaccines,andmortalityfrominfectiousdiseasesintheUnitedStatesdecreased14-fold.(2)Deathordisabilityfrommanyonce-commondiseasesisnowrareintheU.S.AchildbornintheU.S.todaycannowbeprotectedagainst17seriousdiseasesandconditionsthroughimmunization.Thewidespreaduseofvaccineshashelpedtoeradicatesmallpoxworldwideandeliminatepolio,measlesandrubellaintheU.S.Globally,vaccinationsaves2to3millionlivesperyear.(3)
Vaccineshavetheuniquequalityofprotectingbothindividualsandcommunities.However,theyhavebeensoeffectiveformanyyearsinpreventingandeliminatinganumberofseriousinfectiousdiseasesthatthesignificantcontributionsthatvaccinesmaketooursocietyanditshealthmayhavefadedfrompublicconsciousness.Beforethedevelopmentandwidespreaduseofsafeandeffectivevaccines,infectiousdiseasesthreatenedthelivesofmillionsofchildrenandadultsinthiscountryandabroad.Whatwereoncereferredtoasthecommondiseasesofchildhoodarenowvaccine-preventablediseases(VPDs).IntheU.S.,childrenarenolongercrippledcasesbypolionorkilledbyinfectionssuchasdiphtheriaorHaemophilus influenzaetypeB(Hib).Vaccinesalsohelppreventcancerscausedbyhumanpapillomavirus(HPV)andhepatitisBvirus(HBV).
The2010NationalVaccinePlanprovidesavisionfortheU.S.vaccineandimmunizationenterpriseforthenextdecade.ThePlanarticulatesacomprehensivestrategytoenhanceallaspectsofvaccinesandvaccinationincluding:researchanddevelopment,supply,financing,distribution,safety,informeddecisionmakingbyconsumersandhealthcareproviders,VPDsurveillance,vaccineeffectivenessandusemonitoring,andglobalcooperation.TheactionscontainedinthestrategiesofthePlanareconditionalandaresubjecttotheavailabilityofresources.
ThescopeofthePlanisbroadandaddressesvaccinesandkeyvaccine-relatedissuesfortheU.S.anditsglobalpartners.Itprovidesastrategicapproachforpreventinginfectiousdiseasesandimprovingthepublic’shealththroughvaccinationforthecomingdecade.Althoughvaccinesarebeingdevelopedtotreatdiseasesandconditions(therapeuticvaccines)andfornon-infectiousdiseases,thefocusofthisPlanisonvaccinesforthepreventionofinfectiousdiseasesasguidedbythelawthatestablishedtheNationalVaccineProgram(NVP).(4)
2. AmericanAcademyofPediatrics.Prologue.In:PickeringLK,ed.RedBook:2009ReportoftheCommitteeonInfectiousDiseases.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,andrequiredtheNationalVaccineProgramtofocusonpreventionofinfectiousdiseasesandadversereactionstovaccines.
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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,suchasimprovementsinregulatoryscience,thedevelopmentofmedicalcountermeasuresforemergencies,andglobalhealthpartnershipsareembeddedwithinthePlan.StrategiesofthisPlanwillalsobecoordinatedwiththosedevelopedthroughotherfederalefforts.OneexampleistheNationalPrevention,HealthPromotionandPublicHealthCouncil,establishedinthe2010AffordableCareAct(ACA).TheCouncilwillcoordinatefederalprevention,wellness,andpublichealthactivities,anddevelopanationalstrategytoimprovethenation’shealth.
InconjunctionwithotherfederaleffortsliketheNationalPreventionandHealthPromotionStrategy,HealthyPeople(HP)2020,andthePublicHealthEmergencyMedicalCountermeasuresEnterpriseReview,the2010NationalVaccinePlanprovidesthestrategicguidancetobuildastrongerpreventivehealthsystem.Itwillhelpbridgedisparitiesinuseof,andaccesstovaccines,andwillprovideinnovativestrategiestoguidethenation’svaccineenterpriseacrossthenextdecadeandbeyond.
Department of Health & Human Services | The 2010 National Vaccine Plan 11Department of Health & Human Services | The 2010 National Vaccine Plan
Purpose and BackgroundThepurposeofthe2010NationalVaccinePlanistoprovidestrategicdirectionforthecoordinationofthevaccineandimmunizationenterprisefortheNVP.TheProgram’sgoalsaretopreventinfectiousdiseasesandtheirsequelaeandreduceadversereactionstovaccinesintheU.S.ThePlanwillachievethisthroughcoordinatedimplementationofastrategicvisionimplementedbyvaccineandimmunizationstakeholdersacrossandoutsideofthefederalgovernment.
BackgroundFederalinvolvementinvaccinationprogramstargetingcivilianandmilitarypopulationshasarichhistorythatincludesresearchanddevelopment,assuringsafetyandeffectiveness,supportingdelivery,anddevelopingmechanismsforreportingadverseeventsfollowingimmunization.Recognizingtheneedforincreasedcoordinationoftheseactivities,theNVPwasestablishedbyCongressin1986.(5)CongresscalledforthedevelopmentofaNationalVaccinePlantoguideactivitiesinpursuitofprogramgoals.TheinitialPlan,completedin1994,definedactivitiestoachievetheprogram’smissionthroughcoordinatedactionbyfederalagencies,stateandlocalgovernments,andprivatesectorpartnersincludingmanufacturersandhealthcareproviders.
Thenation’svaccineenterprisehasmadeconsiderableprogresssincethefirstNationalVaccinePlan.Throughroutinevaccination,achildborntodaycanbeprotectedagainst17diseasesandconditionswhileonebornin1995couldbeprotectedagainstonlynine.Growingscientificknowledgecoupledwithadvancesinbiotechnologyprovidespossibilitiesfornewandimprovedvaccines.Manyofthefinancialbarriersthatoncelimitedwidespreaduseofvaccineshavebeenovercome.Amyriadofenhancedtoolsareavailableforcommunicatingaccurateinformationaboutvaccinesandforensuringthatvaccinesaresafeandeffective.Abroadrangeofpublicandprivatestakeholdershavebecomeessentialtothevaccineenterprise.
Ironically,thepublichealthvictorywitnessedfromtheuseofvaccineshascreatedapublichealthchallenge:becausevaccineshavereducedtheimpactandawarenessofmanyinfectiousdiseases,somehavebeguntoquestionthevalueandneedforvaccines.Inaddition,thelong-termeffects(e.g.,cancer)ofsomeVPDs(e.g.,HBVandHPV)maynotbevisibletothepublic,thusdiminishingtheperceivedvalueofvaccination.Thus,thisPlancomesatacriticaltimeforthisnationanditshealthasitengagesontheseissuesandasthereisanincreasedfocusontheimportanceofpreventivehealthfortheU.S.anditscitizens.
5. P.L.99-660
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Mission, Perspective, and ScopeThe2010NationalVaccinePlanprovidesastrategicapproachforpreventinginfectiousdiseasesandimprovingthepublic’shealththroughvaccination.
ThescopeofthePlanisbroad,includingvaccinesandvaccine-relatedissuesfortheU.S.andglobalcommunities.AsguidedbythestatutethatestablishedtheNVP,thefocusforthisPlanispreventionofinfectiousdiseasesandadversereactionstovaccines.(6)ThePlanincorporatescurrentinitiatives,suchasthelongrecognizedneedtodevelopvaccinesagainsthumanimmunodeficiencyvirus/acquiredimmunedeficiencysyndrome(HIV/AIDS),tuberculosis(TB),andmalaria,andprogramstoenhancemedicalcountermeasures,regulatoryscience,andvaccineproduction.Aten-yearhorizonwassetforthePlantoalignwithHP2020goals(seeAppendix1formoredetails(7)).
2010 National Vaccine Plan StructureThe2010NationalVaccinePlanprovidesacomprehensiveapproachtoreduceinfectiousdiseasesandtheirsequelaeandreduceadversereactionstovaccinesthroughcoordinatedeffortsoffederal,state,local,multinationalandnon-governmentalstakeholders.Recognizingthatsuccessisfacilitatedbycarefulplanningthatincludesdefiningspecificactivities,milestonesandmeasurableoutcomes,animplementationplanwillbedevelopedbasedonthisplanandreleasedin2011.Withaten-yearhorizon,thisframeworkrecognizesandanticipatesthatemergingscience,newopportunities,andchangingcircumstanceswillguidethecourseofthePlan.Annualmonitoringofprogressandamid-coursereviewwillpromotebothaccountabilityandflexibility.
ThePlanisbuiltaroundfivebroadgoals:
Goal 1:Developnewandimprovedvaccines.
Goal 2:Enhancethevaccinesafetysystem.
Goal 3:Supportcommunicationstoenhanceinformedvaccinedecision-making.
Goal 4:Ensureastablesupplyof,accessto,andbetteruseofrecommendedvaccinesintheUnitedStates.
Goal 5:Increaseglobalpreventionofdeathanddiseasethroughsafeandeffectivevaccination.
Eachgoalissupportedbyobjectivesthatwillbepursuedthroughadefinedsetofstrategies.Reachinggoalsandobjectivesgenerallyrequiresactionbymanystakeholdersinthevaccineandimmunizationenterprise.TheImplementationPlan,tobewrittenduring2011,willdescribetheactionstepsandmeasurableindicatorsforkeyPlanobjectivesandstrategies.
6. P.L.99-660
7. PleasenotethattheAppendicescanbefoundontheNationalVaccinePlanwebsiteatwww.hhs.gov/nvpo/vacc_plan/index.AsthePlanisa“livingdocument,”theAppendiceswillbeupdatedonanongoingbasis.
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Progress Since the 1994 PlanThe2010NationalVaccinePlanbuildsonthemanyachievementsofthevaccineandimmunizationenterprisepriortoandsincetheestablishmentoftheNVPin1986andthecompletionofthefirstNationalVaccinePlanin1994.Newvaccineshavebeenlicensedtoexpandthenumberofinfectionsthatcanbeprevented,andmoreeffectivelyandsafelypreventsomediseasesforwhichearliergenerationvaccinesalreadyexisted.Inaddition,federalimmunizationfinancingprogramshavereducedoreliminatedmanyfinancialbarrierstovaccination,particularlyforchildren.ThenumberofinfectionscausedbyVPDshasdecreasedsignificantlywhilevaccinationcoverageintheU.S.hasincreased,andcoverageformanyvaccineshasreachedrecordlevels.Morerobustsystemshavebeendevelopedtoidentifyadverseeventsfollowingimmunizationandtoassesspotentialassociationsofthoseeventswithvaccination.Globally,theU.S.hasworkedwithmultilateralandbilateralpartnersandnon-governmentalorganizations(NGOs)incontributingtoimprovementsinchildhealthstatusandthepreventionofhundredsofthousandsofchilddeathseachyearthroughimprovedvaccinecoverageandintroductionofnewvaccines.Ofthefourteenanticipatedoutcomesincludedinthe1994NationalVaccinePlan,mostweresubstantiallyorfullyachieved(seeAppendix2).
Unfortunately,manyofthechallengesthatstimulatedestablishmentoftheNVPandthedevelopmentofthe1994NationalVaccinePlanremainrelevanttoday.Vaccineshortagesandinterruptionshaveoccurredformanyroutinelyrecommendedvaccines.Despiteimprovedvaccinationcoverageamongchildren,recentVPDoutbreaksintheU.S.serveasremindersthatthesediseasesstilloccur.Amongolderadultsbothvaccinationcoverageandtheeffectivenessofsomeroutinelyrecommendedvaccinesremainsub-optimal.Disparitiesexistinadultvaccinationratesbetweenracialandethnicgroups.Asthecostofvaccinationhasincreased,financialbarrierstovaccinationhaveemergedforhealthdepartments,healthcareproviders,andthepublic.Significantscientificchallengesremaininthedevelopmentofsafeandeffectivevaccinesagainstexistingglobalhealththreats,suchasHIV,TBandmalaria.Vaccinesthathavebeendevelopedandareinuseinindustrializedcountrieshavethepotentialtomakemajorcontributionstohealthindevelopingcountries,butarecurrentlyunderusedinmanyplaces.Additionally,emerginginfectionsandthepersistentthreatofnaturalandintentionalinfectiousdiseaseposenewchallengesforvaccinedevelopmentandregulation,manufacturing,vaccinedeliveryandaccessintheU.S.andabroad.
U.S. Immunization FrameworkDiseasepreventionandenhancedvaccinesafetyareultimateoutcomesofasuccessfulvaccinationprogram.Identifyingobjectivesandstrategiesthatleadtoandsustaintheseoutcomesisfacilitatedbyunderstandingthemanyprocessesordeterminantsoftheseoutcomes.
ToprotectindividualsandcommunitiesfromVPDs,vaccinesmustbeadministeredtothepublic.Vaccinationbeginswiththeidentificationofpublichealthpriorities,whichareinformedbydiseasesurveillancedataandinformationonthepublichealthburdenofthediseasesthatvaccinescaneffectivelyandsafelyprevent.Vaccineresearchandlicensurefollows.AfterthelicensureofavaccineandtheAdvisoryCommitteeonImmunizationPractices(ACIP)andmedicalorganizations’recommendationforitsuse,avaccinemustbedistributed,stored,andhandledappropriately.Vaccinepaymentandreimbursementpoliciesareimportantforensuringreceiptanduseofthevaccine.Communicationsandpublicandprovideroutreachhelpsupportinformeddecision-makingaboutvaccination.Attitudes,vaccinationcoverageandtheeffectivenessofdiseasepreventionalsoareinfluencedbyissuesrelatedtovaccinesafetyandeffectiveness.
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Development of the 2010 National Vaccine PlanThe2010NationalVaccinePlan,underthecoordinationoftheU.S.DepartmentofHealthandHumanServices(HHS)NationalVaccineProgramOffice(NVPO),istheproductofdeliberation,analysis,andinputfrommultiplefederalagencies,anditincorporatesbroadpublicandstakeholderinput.NVPOistheprincipalcoordinatingofficefortheNVPandisresponsibleforprovidingleadership,facilitatingcoordination,andmonitoringprogressofthe2010NationalVaccinePlanduringimplementation.
Relevantfederalgovernmentagencies(seeAppendix3)identifiedkeyobjectivesandstrategiesaspathwaystosuccessforeachofthefivegoals.NVPOconsultedwiththeNationalVaccineAdvisoryCommittee(NVAC),federalagencies,domesticandinternationalstakeholders,andthepublicregularlyaboutthedevelopmentofthePlan.AnationalstakeholdermeetingwasconvenedtodiscussthefirstdraftofthePlan.Inadditiontothenationalstakeholdermeeting,NVPOobtainedinputthroughseveralmechanisms:
•CommentsgatheredbyanInstituteofMedicine(IOM)committee(8)atfivepublicmeetingsthatfocusedonthedifferentgoalsinthePlan;
•TheIOMcommittee’sfinalreport;(9)
•Inputfromfederalvaccineadvisorycommitteemembers;
•Meetingswithdomesticandinternationalstakeholders;and
•InputfromthepublicinthreepublicmeetingsandthroughpubliccommentinresponsetoanoticeintheFederalRegister.
AdditionalinformationaboutthedevelopmentoftheNationalVaccinePlanisavailableatwww.hhs.gov/nvpo/vacc_plan/index.
Coordination with Other Federal InitiativesThe2010NationalVaccinePlanwillsupportrelevantstrategichealthprioritiesandkeyinteragencycollaborationsforthenationissuedbytheSecretaryofHHS,whichincludethefollowing:topromoteearlychildhoodhealthanddevelopment,toacceleratetheprocessofscientificdiscoverytoimprovepatientcare,andtoimproveglobalhealth.(10)GlobalhealthplaysanimportantroleinthenationalsecurityoftheU.S.populationandpopulationsworldwide,andassuchthePlanisofimporttoallagenciesinvolvedinglobalhealthactivities,includingtheDepartmentofStateandtheU.S.AgencyforInternationalDevelopment(USAID).U.S.involvementinglobalvaccineissuescanreduceworldwidetransmissionofVPDs,strengthenhealthsystems,andfosterbilateralandinternationalpartnerships.
Inaddition,the2010NationalVaccinePlanhasdirectrelevancetothegoalsoftheACA,thecomprehensivehealthcarereformlawenactedinMarch2010,whichexpandsaccesstopreventivecare,includingvaccines,byrequiringhealthplanstocoverpreventiveserviceswithoutchargingadeductible,copayment,orcoinsurance.IndividualsenrolledinthesenewgrouporindividualhealthplanswillhaveaccesstothevaccinesrecommendedbytheACIPpriorto
8. HHSrequestedtheformationofanIOMcommitteespecificallytogatherpublicinputandproviderecommendationsonprioritiesforthe2010NationalVaccinePlan.
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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September2009withnoco-paymentsorothercost-sharingrequirementswhenthoseservicesaredeliveredbyanin-networkprovider.ThesenewhealthplanswillberequiredtocovernewACIPrecommendationsmadeafterSeptember2009withoutcost-sharinginthenextplanyearthatoccursoneyearafterthedateoftherecommendation.Inadditiontoexpandingaccesstoimmunizationunderthepreventiveservicesrules,theACAincludesthefollowingimmunization-relatedprovisions:
•Providesauthoritytostatestopurchaseadultvaccineswithstatefundsfromfederally-negotiatedcontracts.
•ReauthorizestheSection317ImmunizationGrantProgram,whichmakesavailablefederallypurchasedvaccinesandgrantstoall50states,theDistrictofColumbia,fivelargeurbanareas,andterritoriesandprotectoratestoprovideimmunizationservicestoprioritypopulations.
•RequiresaGeneralAccountabilityOfficestudyandreporttoCongressaboutMedicarebeneficiaryaccesstorecommendedvaccinesundertheMedicarePartDbenefit.
Moreinformationaboutthenewpreventiveservicesrequirementscanbefoundat:www.healthcare.gov/center/regulations/prevention/recommendations.
StrategiesidentifiedinthePlanwillbecoordinatedwiththoseintheNationalHealthSecurityStrategy,theGlobalHealthInitiative(GHI),theNationalStrategyforPandemicInfluenza,andothernationalstrategicplansthatrelatetoimmunizationandvaccines.Inparticular,thisworkwillbecoordinatedwiththeNationalPrevention,HealthPromotionandPublicHealthCouncil’spriorities,whichwillintegratefederalprevention,wellness,andpublichealthactivities,anddeveloptheNationalPreventionandHealthPromotionStrategytoimprovethenation’shealth.AlloftheseeffortswillcomplementtheNationalStrategyforQualityImprovementinHealthCare,alsodescribedintheACA.
ThePlanalignswithqualityofcareimprovementinitiativesundertheChildren’sHealthInsuranceProgramReauthorizationActandcomplementstheCentersforMedicareandMedicaid(CMS)’sworktoimproveaccesstoandmeasurementofmandatoryhealthcareservicesdeliveredchildrenenrolledinMedicaidthroughtheEarlyandPeriodicScreening,Diagnostic,andTreatmentProgram.ThePlanalsosupportstheGHI,whichfocusesonimprovingthehealthofwomen,newborns,andchildrenworldwidethroughstrengthenedhealthsystemsandthroughcoordinated,results-oriented,country-ledapproaches.Additionally,thePlancomplementsotherinitiativesincludingtheU.S.President’sEmergencyPlanForAIDSRelief,whichassistscountriesinstrengtheningtheirhealthsystemsandprovidingcomprehensiveprevention,care,andtreatmenttocombattheglobalepidemicofHIV/AIDSanddiplomaticeffortstobuildglobalpartnershipsinpreparationforpandemicinfluenzaandotherpandemicdiseases.ForafulllistofrelevantplanspleaseseeAppendix4.
Understandingtheextensivescopeofthevaccineandimmunizationenterprise,thePlanalsoencompassesrelevantstrategicvisionswithinotherfederalagencies.TheseincludetheHP2020objectivesaswellasthefullspectrumofstrategiesarticulatedintheefforttodevelopmedicalcountermeasuresagainstbioterroristthreats,thethreatofpandemics,andnewandemerginginfectiousdiseasethreats.(11)
11. Forexample,seeBARDAstrategicplanatwww.hhs.gov/aspr/barda/phemce/enterprise/strategy/index.
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Implementation Opportunities and ChallengesManyfactorsmayaffectachievementofthe2010NationalVaccinePlan.Opportunitiesmayemergethatfacilitaterapidprogressandachievementofobjectivessoonerthananticipated.Scientific,technological,healthcarefinancing,orcommunicationsadvancesalsocouldemerge,enablingrapidachievementofthevisionlaidforthbythePlan,supersedingitsobjectivesandgoals.Conversely,existingchallengesandbarriersmaybemoredifficulttoovercomethananticipatedandnewchallengesmaysurface.
The2010NationalVaccinePlanwillrelyonsoundscienceandincludesmeasurablegoals,timelines,andaccountabilitymeasuresfortheelementsthathavebeenidentifiedashighestpriorityasnotedinTable1.TheseprioritiestakeintoaccountthesuggestionsoftheIOM,theNVAC,andtheagenciesinvolvedindeveloping,implementingandevaluatingthe2010NationalVaccinePlan.Theseprioritiesalsoprovidestrategicactionstepstoensurethatthenationhasarobustimmunizationprogram;theyarenothoweverintendedtobeacomprehensivelistofallactivitiesrelatedtovaccinesandimmunizations.TheactionsdescribedinthePlanareconditional,serveasaguidelineforfuturedevelopment,andaresubjecttotheavailabilityofresources.
IndicatorsfortrackingprogressinmeetingeachoftheseprioritiesareunderdevelopmentandwillbeincludedinanImplementationPlantobereleasedin2011.Theseindicatorswillrepresentthefederalgovernment’splanformeasuringprogresstowardmeetingthePlan’sgoalsandincludeimmediate,short-term,andlonger-termactions.In2011,NVPOwillconsultwithfederalagenciestoimplementtheseprioritiesanddevelopindicatorsfor2012andbeyondandupdatethemasnecessary.Additionally,asfederalagenciesbegintoimplementthePlanandasdiscussionscontinuewithstakeholders,newindicatorsmayalsobedeveloped.
Implementingthe2010NationalVaccinePlandoesnotfalltothefederalgovernmentalone.Thesuccessofthisplanwillrequirestates,tribalandlocalgovernments,componentsofthehealthcaredeliverysystem,communitiesandotherstakeholderstoworktogethertoensureacoordinatedandcomprehensiveimmunizationprogram.SeeAppendix5foralistofimmunizationstakeholders.TheprioritiesandthePlanareintendedtoserveasacatalystforallstakeholderstodeveloptheirownimplementationplansforachievingthegoalsofthe2010NationalVaccinePlan.
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Table 1:National Vaccine Plan Priorities for Implementation
A . Developacatalogueofpriorityvaccinetargetsofdomesticandglobalhealthimportance(Goal 1) .
B . Strengthenthesciencebaseforthedevelopmentandlicensureofnewvaccines(Goals 1 and 2).
C . Enhancetimelydetectionandverificationofvaccinesafetysignalsanddevelopavaccinesafetyscientificagenda(Goal 2) .
D .Increaseawarenessofvaccines,vaccine-preventablediseases,andthebenefits/risksofimmunizationamongthepublic,providers,andotherstakeholders(Goal 3).
E .Useevidence-basedsciencetoenhancevaccine-preventablediseasesurveillance,measurementofvaccinecoverage,andmeasurementofvaccineeffectiveness(Goal 4).
F . Eliminatefinancialbarriersforprovidersandconsumerstofacilitateaccesstoroutinelyrecommendedvaccines(Goal 4).
G . Createanadequateandstablesupplyofroutinelyrecommendedvaccinesandvaccinesforpublichealthpreparedness(Goal 4).
H . Increaseandimprovetheuseofinteroperablehealthinformationtechnologyandelectronichealthrecords(Goal 4).
I .Improveglobalsurveillanceforvaccine-preventablediseasesandstrengthenglobalhealthinformationsystemstomonitorvaccinecoverage,effectiveness,andsafety(Goal 5).
J . Supportglobalintroductionandavailabilityofnewandunder-utilizedvaccinestopreventdiseasesofpublichealthimportance(Goal 5).
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Goal 1:Develop new and improved vaccines
IntroductionThegreatestandmostrapidchangesinhealthoccurredduringthelastcentury,primarilyattributedtoahigherstandardofliving,improvedpublichealthmeasures,andtheapplicationofscience-basedmedicine.Inadditiontocleanwater,sanitation,andtheuseofantibiotics,vaccinesareanessentialpartofthesepublichealthachievements.Vaccineresearchanddevelopmentaswellastheimplementationofeffectivevaccinedeliveryprogramshasledtotheeradicationandeliminationofseveralonce-commonseriousinfectiousdiseases.
Discoverybeginswiththerecognitionofaninfectiousdiseaseburdenandtheopportunitytopreventitthroughimmunization.Basicscientificresearchbringsideasforwardintotheproductdevelopmentpathwaytowardtheultimategoaloftranslatingtheseideasintosafeandeffectivemedicalproducts.Safetyandefficacytestingareconductedateverystepofthisproductdevelopmentpathway.Bothbasicandtargetedresearchisthebasisforthedevelopmentofvaccinecandidatesandnewvaccineplatformsthatoffergreaterflexibilityinvaccinedevelopmentandproduction.Newtools,suchasefficientantigenidentificationtechniques,coupledwithaprofoundlygreaterunderstandingoftheimmuneresponseareavailabletodefinebasicmechanismsofdiseasetosupportdesignanddevelopmentofnovelandimprovedvaccines.Determining“proofofconcept”regardingimmunogenicityandsafetyfollows–initiallyinpre-clinicalstudiesinanimalsandtheninhumanstofurtherevaluatesafetyandefficacy.Finally,researchersconductscientificcharacterizationofthevaccineandtheprocessforproducingit,includingscalingthemanufacturingprocesstocommerciallevelsbeforevaccinesaremovedintohumantesting.
Vaccinesaredevelopedthroughpublic-privatepartnerships–includingresearchers,government,manufacturers,purchasers,andpolicy-makers–whohavebeensuccessfulatbringingnewvaccinestolicensureforbroaduse.Thesepartnershipsarecentraltothesuccessofvaccineinnovations.Throughtargetedinvestmentsinscienceandtechnology,suchpartnershipshaveledtothedevelopmentofhundredsofvaccinecandidatesatvariousstagesofmaturityinthedevelopmentpipeline.TheGlobalHIVEnterpriseisanexampleofunprecedentedcollaborationamongorganizationsworldwide,includingtheNationalInstitutesofHealth(NIH),theInternationalAIDSVaccineInitiative,USAID,theBillandMelindaGatesFoundation,andmanyothersworkingtogethertoacceleratethedevelopmentofapreventiveHIVvaccine.
Becausevaccinedevelopmentistime-andresource-intensive,establishingandunderstandingprioritiesfordevelopmentandencouragingcollaborationbetweenstakeholdersisessentialinaddressingthechallengesofdevelopingnewandimprovedvaccines.Fosteringcontinuedinvestmentfromallsectorsiscriticalastechnologicalapproachesanddiseasethreatsexpandamidincreasingcoststodevelop,license,anddelivervaccines.
TheaimofGoal1istodevelopnewandimprovedvaccinesandtoaddresstheupstreamresearchanddevelopmentaspectsofvaccinesfordomesticandglobalhealthpriorities.Theresearchneedsofotheraspectsofthevaccineenterprise(e.g.,programimplementation,distributionlogistics,communication)areincludedwithinothergoalsinthePlan.
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Objectives
Objective 1.1Prioritizenewvaccinetargetsofdomesticandglobalpublichealthimportance.
Strategies:1.1.1Developandimplementaprocessforprioritizingandevaluatingnewvaccinetargetsofdomesticandglobalpublichealthimportance.Thiscatalogueofvaccinetargets(includingimprovedvaccines)shouldincludeananalysisofbarrierstodevelopment.
1.1.2Conductandimprovediseasesurveillanceofexistingpathogensandoptimizemethodstodetectnewpathogenstocontinuouslyinformtheprioritiesforpotentialnewvaccines.
Objective 1.2Supportresearchtodevelopandmanufacturenewvaccinecandidatesandimprovecurrentvaccinestopreventinfectiousdiseases.
Strategies:1.2.1Conductandsupportexpandedvaccineresearchtomeetmedicalandpublichealthneeds.Establishsurveillancesystemsorstudiestobetterassessdiseaseburdeninspecifictargetpopulationsincludingneonates,infants,children,olderadults,pregnantwomen,immunocompromisedindividuals,andotherat-riskindividuals.
1.2.2Advanceresearchanddevelopmenttowardnewand/orimprovedvaccinesthatpreventinfectiousdiseasesandtheirsequelae,includingthosethatprotectagainstemerging,re-emerging,andimportantbiodefense-relatedpathogens.
1.2.3Advancethescienceofneonatalandmaternalimmunityincludingimmunizationandthedevelopmentofimmunologicalmodelstostudymaternalimmunizationandeffectsonoffspring.
1.2.4Developaprocessthatidentifiescurrentvaccinesthatwouldbenefitfromimprovedperformancecharacteristics(e.g.,effectiveness,safety,numberofdoses,stability,and/orvaccineadministrationcharacteristics)thatcanbeusedintheevaluationandlicensureprocess.
1.2.5Developnewapproachestovaccinemanufacturing(e.g.,rapid,flexible,andcost-effective)tomeetdemandsforefficient,expandablevaccineproductioncapacitywhilealsomeetingneedsrelatedtootherpublichealthemergencythreatssuchasinternationalemergingdiseases.
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Objective 1.3Supportresearchonnovelandimprovedvaccinedeliverymethods.
Strategies:1.3.1Developandevaluatenewandimprovedalternatedeliverymethodsofvaccineadministrationtooptimizetheprotectiveimmuneresponse,safety,effectiveness,and/orefficiency(e.g.,numberofdoses).
1.3.2Expandknowledgeregardingtheinductionandmaintenanceofvaccineimmuneresponsesviadifferentroutesofadministration(e.g.,mucosalsurfaces).
Objective 1.4Increaseunderstandingofthehostimmunesystem.
Strategies1.4.1Definethecapacityandqualityofinnateandadaptivehumanimmuneresponsetoinfectionsamongdiversegender,ethnic,racial,age(childhood,adolescence,andadulthood),andhealthconditionstatus(e.g.,autoimmunecompromisedindividuals)populationsinordertoadvancetheunderstandingofimmuneprotection.
1.4.2Gainabetterunderstandingofhowinductionandrecallofimmunememorymayinformthedevelopmentofvaccinesthatprovidelife-longprotection.
1.4.3Supportdevelopmentofimmunomodulatorsincludingvaccineadjuvantsthatfacilitatetheappropriatecell-mediatedandantibodyresponsesforprotectionagainstpathogenswithdistincteffectorrequirements.
1.4.4Expandknowledgeofhost-relatedfactorsthatimpactseverityofdiseaseandvaccine-inducedhostimmuneresponse,andusethisinformationtoinformvaccinedevelopment.
1.4.5Developadatabaseofgene-expressionandimmunologicresponsestoselectedcurrentlylicensedvaccineswithafocusonsignalsthatcorrelatewithmechanismofaction,protection,safety,andadverseevents.Utilizethiscompendiumtoinformdevelopmentofnewcandidatevaccinesandadjuvants.
1.4.6Studymucosalimmunityfollowingvaccinationinordertobetterunderstandvaccinemechanismsandtoprovidenew,potentiallymorerelevant,correlatesofprotectionagainstrespiratory,enteric,genital,andurinarypathogens.
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Objective 1.5Supportproductdevelopment,evaluation,andproductiontechniquesofvaccinecandidatesandthescientifictoolsneededfortheirevaluation.
Strategies1.5.1Supportappliedresearchtodeveloprapidandcost-efficientproduction,andoptimizeformulationsandstabilityprofilesofcurrentlyavailablevaccines.
1.5.2Supportresearchonanddevelopmentofmoreflexibleandagileapproachestoproductdevelopment,manufacturingproductiontechniquesincludingmulti-usetechnologiessuchasplatforms,andqualitytestingprocedures(e.g.,potencyandsafetytesting).
1.5.3Improveaccesstopilotlotmanufacturingfacilitiesthatproduceclinicalgradematerialforevaluatingpromisingvaccinecandidates.
1.5.4Supporttranslationalresearchthatacceleratesthedevelopmentofinformationthatcanbeusedintheevaluationandlicensureprocess.
1.5.5Establishandstrengthenpublicandprivatepartnershipstoaddressurgentneedsinvaccineresearchanddevelopment.
Objective 1.6Improvethetools,standards,andapproachestoassessthesafety,efficacy,andqualityofvaccines.
Strategies1.6.1Improveassaydevelopmentforcharacterizationofnovelcellsubstrates.
1.6.2Improveeffortstodevelop,refine,andvalidatenewbiomarkersandcorrelatesofimmunity.
1.6.3Developandimprovemethodstobetterassessvaccineefficacyandsafetyincludingassessmentofnewtechnologiesanddevelopmentofbetteranimalmodels.
1.6.4Improvemethodsforassessingandevaluatingvaccinequality,potency,safety,andeffectiveness.
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Goal 2:Enhance the vaccine safety system
IntroductionTheU.S.hasarobustvaccinesafetysystem.Thegoalofthissystemistoidentifyinatimelymannerandminimizetheoccurrenceofadverseeventsfromvaccines.Pastsuccessesandchallengesofferinsightsintoareaswheretheexistingvaccinesafetysystemcanbeenhanced.Advancesininformationtechnologyenhancetheabilitytoconductactivesurveillance.Improvementsinunderstandingofimmunologyandgenomicscreateopportunitiestobettercomprehendtheimmuneresponseandbiologicalmechanismsimportantforunderstandingthesafetyofvaccines.
Vaccinesafetyisakeyelementofanyimmunizationprogram.ThevisionofGoal2istospecificallyaddresssafety-relatedissues,strengthenthesystemthatmonitorsthesafetyofvaccinesthroughoutproductionanduse,andadvancethesafetyprofileofvaccines.(12)Specifically,thisgoalaimstopreventadverseeventsandfullycharacterizethesafetyprofileofvaccinesinatimelymanner.
Vaccinesafetyscienceisoftenchallengingbecauseitmayrequirestudyingveryrareoutcomes.However,toolshavebeendevelopedthathelpdetectandquantifyexceedinglyrareevents.Importantly,avaccinesafetymonitoringsystemshouldhavethecapacitytodistinguishapotentialincreasedriskofavaccineadversereactionfromanadverseeventfollowingimmunization(13)thatisoccurringbecauseofotherdiseasesorexposures.Everyday,peoplesufferfromheartattacks,severeheadachesandotherhealthproblemsandsomeofthesewillnaturallycoincidewithvaccination.Moreover,astheabilityofepidemiologytoruleoutaveryrareeventisdifficult,newtechnologiesandmulti-disciplinaryresearchcanhelpelucidatebiologicalmechanismsandsubpopulationsatincreasedriskforadverseeventsandhelpaddressthesescientificchallenges.
Severalimportantvaccinesafetyissuesareaddressedinothergoalsofthe2010NationalVaccinePlan.Forexample,Goal1addressesvaccineresearchanddevelopmentthatincludestheimportanceofsafetyassessmentsinpre-clinicalandclinicalvaccineevaluation.Issuesrelatedtoeducation,riskcommunications,behavioralscienceresearch,andstakeholderengagementonvaccinesafetyareincludedinGoal3.Becausevaccinesafetyisanimportantcomponentofeveryimmunizationprogram,whetherintheU.S.orglobally,itisalsofeaturedinGoals4and5.
12. ThroughoutGoal2,thefollowingtermsarefrequentlyused:“signal”and“vaccineadversereaction.”Thesetermsasaredefinedas:
Signal:Whiletherearemultipledefinitionsofsignals,inthisdocumentasignalreferstoa concernthatavaccineadverseeventcouldbetemporallyoccurringmoreoftenthananticipatedbasedonchancealone(i.e.,thattheeventcouldberelatedtothereceiptofthevaccine).Asignalisnotproofofcausation;ratheritrepresentstheneedforfurtherevaluation.Signalsmayarisefromavarietyofsources,includingfrompre-licensureclinicaltrials,caseseries,surveillance,clinicalexperience,theliterature,expertcommitteereviews,themediaand/orthepublic.
Vaccine adverse reactionisanadverseeventcausedbyavaccine.Vaccineadversereactionsaredefinedasminor,suchasasorearmorlowgradefever,orcanbemoreseveresuchasanaphylaxis.Vaccineadversereactionsaredichotomizedaslocal(e.g.,sorearm,swellingatsiteofinjection)orsystemic(e.g.,fever,irritability).
13. Adverse event following immunization (AEFI)isanadverseeventtemporallyassociatedwithanimmunizationthatmayormaynotbecausallyrelatedtotheimmunization.Theterm“vaccineadverseevent”isalsocommonlyusedtoconveythesamemeaning.
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Objectives
Objective 2.1Ensurearobustvaccinesafetyscientificsystemthatfocusesonhighpriorityareas.
Strategies:2.1.1Develop,prioritize,andregularlyupdateanationalvaccinesafetyscientificagenda.
2.1.2Retaincurrentandrecruitadditionalhighlytrainedvaccinesafetyscientistsandclinicians.
2.1.3Improvelaboratory,epidemiological,andstatisticalmethodsusedinvaccinesafetyresearch.
Objective 2.2Facilitatethetimelyintegrationofadvancesinmanufacturingsciencesandregulatoryapproachesrelevanttomanufacturing,inspection,andoversighttoenhanceproductqualityandpatientsafety.
Strategies:2.2.1Facilitatetheenhancementofvaccinemanufacturingsciencesandqualitysystems,includingproductiontechnologies,in-processcontrolsandtesting,andidentificationofbestpracticesinpreventivequalitysystemsandoversight.
2.2.2Develop,implement,andperiodicallyreassessrisk-basedscientificapproachestoidentifyinspectionalprioritiesandbestpractices.
2.2.3DevelopnewscientificmethodsforbothindustryandtheFoodandDrugAdministration(FDA)forproductqualitytesting.
2.2.4Assurethatregulations,guidancedocuments,policies,andproceduresthatarerelevanttovaccinemanufacturing,laboratorytesting,andqualitycontrolincorporatethemostcurrentrelevantscientificinformationtopromoteandenhanceproductsafety.
Objective 2.3Enhancetimelydetectionandverificationofvaccinesafetysignals.
Strategies2.3.1Improvetheeffectivenessandtimelinessofsignalidentificationandassessmentthroughcoordinateduseofpassiveandactivesurveillancesystems,andfromprovidersandthepublic.
2.3.2ImprovetheprocessforassessingAEFIsignalstodeterminewhichsignalsshouldbeevaluatedfurtherinepidemiologicalandclinicalstudies.
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Objective 2.4:Improvetimelinessoftheevaluationofvaccinesafetysignals,especiallywhen1)ahigh-prioritynewvaccinesafetyconcernemergesor2)whenanewvaccineisrecommended,vaccinationrecommendationsareexpanded,orduringpublichealthemergenciessuchasinaninfluenzapandemicorothermassvaccinationcampaign.
Strategies2.4.1Expandcollaborationwithclinical,laboratory,genetic,statistical,andbioinformaticsexpertstoconductclinicalresearchstudiestoinvestigatetheroleofhostgeneticsinAEFIs.
2.4.2Increasethesize,representativeness,andutilityofthepopulationunderactivesurveillanceforseriousAEFIsthatcanbeincludedintimely,highquality,rigorouslyconductedepidemiologicalstudiestoassessvaccinesafetyquestions.
Objective 2.5ImprovecausalityassessmentsofvaccinesandrelatedAEFIs.
Strategies2.5.1Builduponnewscientificdevelopmentsinareassuchasgenetics,systemsbiologyandbioinformatics,andimmunologytodevelopandvalidatetoolswhichaidin(orenable)theidentificationofindividualriskfactorsforAEFIsforwhichacausalrelationshiphasbeenestablished.
2.5.2AssesstheevidenceforacausalrelationshipbetweencertainvaccinesandspecificclinicallyimportantAEFIsand,astheneedarises,conductanindependentreviewofavailableevidence.
Objective 2.6Improvescientificknowledgeaboutwhyandamongwhomvaccineadversereactionsoccur.
Strategies2.6.1Identifyhostriskfactorsthatmaybeassociatedwithincreasedriskforspecificvaccineadversereactionsthroughbasic,clinical,orepidemiologicalresearch.
2.6.2Identifythebiologicalmechanism(s)forvaccineadversereactions.
2.6.3AssesswhethertheriskofspecificAEFIsisincreasedinspecificpopulationssuchaspregnantwomen,prematureinfants,olderadults,thosewithimmunocompromisingorothermedicalconditions,basedongenderorrace/ethnicity,orotherat-riskindividuals.
2.6.4DeveloparobustsystemtoenhancecollectionofmedicalhistoriesandbiologicalspecimensfromselectedpersonsexperiencingseriousAEFIstoenhancestudyofbiologicalmechanismsandindividualriskfactors.
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Objective 2.7Improveclinicalpracticetoprevent,identifyandmanagevaccineadversereactions.
Strategies2.7.1Improvetraining,availabilityof,andaccesstovaccinesafetyclinicalandcommunicationexpertstoprovideconsultationtohealthcareprovidersandpublichealthpractitioners.
2.7.2Developanddisseminateevidence-basedguidelinesforvaccinationorrevaccination,asappropriate,especiallyforpersonswhomaybeatincreasedriskforvaccineadverseevents.Usethisinformationtoclarifycontraindicationsandprecautionstovaccination.
Objective 2.8Enhancecollaborationofvaccinesafetyactivities.
Strategies2.8.1Improvecollaboration,suchasdatasharingarrangements,acrossfederalagencies,departments,andwithnon-federalpartners.
2.8.2Improveinformationanddatasharingwithinternationalpartners(e.g.,nationalvaccinesafetyprograms)consistentwithethicalandhumansubjectsprotectionsandapplicablelaw,includingconfidentialityprotections.
2.8.3DevelopadditionalstandardcasedefinitionsforAEFIsforuseinimmunizationsafetysurveillanceandresearch,vaccinesafetystandardssuchasconceptdefinitions,standardizedabbreviations,andstandardizedstudydesigns.
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Goal 3:Support communications to enhance informed vaccine decision-making
IntroductionHHSiscommittedtoprovidingaccurate,timely,transparent,complete,andaudience-appropriateinformationaboutimmunizationsandvaccines.Thisinformationisdesignedforparentsmakingvaccinationdecisionsfortheirchildren(birththroughage18);adultsconsideringvaccinesforthemselves;publichealthpartners;providers;policy-makersandothers.
Communicationtoolsandchannelsusedtodisseminateimmunizationandvaccineinformationspanabroadspectrum:publicationofevidence-basedrecommendations;useofmassmediaandnewmedia;providereducationandtraining;andsupportofpartnerorganizationsandstateimmunizationprogramsthroughprovisionofresources,trainings,updates,andannouncements.
Currentcommunicationeffortsareinformedbyresearchaswellastheprinciplesofeffectiveriskcommunication,socialmarketing,andsocialmobilization.Researchshouldbeenhancedtobetterunderstandthenatureofinformeddecision-makingandtheelementsthatsupportsuchdecisions.Improvedcommunicationsresearchcanfacilitatedevelopmentofmoretargetedmessagesandmethodsforclearlyandeffectivelycommunicatingaboutthebenefitsandrisksofvaccines,andtoaddressinformationneedsuniquetovariousaudiences.Thecombinedeffortsofcommunicationscientists,healthservicesresearchers,andotherscanenhancethedevelopmentandimplementationoflong-term,sustainableplansforgatheringreliablereal-timedataaboutfacilitatorsofandbarrierstovaccineacceptance,translatingthosedataintopracticalsolutions.Thisresearchalsoenhanceseffortstopromotetheadoptionofvaccinerecommendationstopreventdiseaseandimprovethepublic’shealth.
The2010NationalVaccinePlanrecognizestheimportanceofcommunicationactivitiesthatarestrategic,science-based,transparent,andculturallyappropriate.CommunicationstrategiesshouldreflectthehealthliteracylevelandEnglishproficiencyofspecifictargetpopulationgroups,aswellasconsiderationsoftheaccessibilityofinformationtoindividualswithhearing,visual,cognitive,orotherlimitations.Relatedtothesegoalsaretherolesandresponsibilitiesofvariousstakeholdersengagedinvaccinecommunicationsandeducation.Policy-makers,suchasfederal,state,andlocallegislators;healthdepartments;employers;third-partypayorsandothers,arecriticalstakeholdersinthevaccineenterprise.Collaboratingwithpublichealthdecisionmakersacrossthehealthsectoriscriticaltorealizingthefullvisionoftheplan.Healthcareproviders,advocacygroups,thepublichealthcommunity,andcommunityandfaith-basedorganizationscanserveasstrongandcredibleimmunizationadvocatesabouttheriskofVPDs,thebenefitsofvaccination,recommendedschedules,thesupplyandfinancingofvaccines,andthepossiblerisksassociatedwithvaccination.Public-privatecollaborationoncommunicationandeducationactivitieswillbecriticaltoachievingthegoalandobjectivessetforthbythePlan.
WhilethefocusofGoal3isoncommunicationandeducationissuesrelevanttoinformeddecision-making,theseissuesarealsorelevanttoeachoftheothergoalsofthe2010NationalVaccinePlan.Topic-specificcommunicationsandeducationactivitiesaredescribedinGoals2,4,and5.
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Objectives
Objective 3.1Utilizecommunicationapproachesthatarebasedonongoingresearch.
Strategies3.1.1Conductresearchregularlytounderstandthepublic’sknowledge,beliefs,andconcernsaboutvaccinesandVPDs.
3.1.2Conductresearchonfactorsthataffectdecision-makingaboutvaccinationforindividualsandfamilies,providers,andpolicy-makers.
3.1.3Identify,develop,andtesteducationalstrategiesthatbetterenablepolicy-makerstoread,understand,anduseinformationaboutvaccinebenefitsandrisks.
3.1.4Evaluatetheeffectivenessofmessagesandmaterialsinaddressingtheinformationneedsandconcernsofthepublicandunder-immunizedpopulations.
3.1.5Developevidence-basedtoolstoassistindividuals,parents,andproviderswithrelevantinformationtomakeinformeddecisionsregardingvaccination.
Objective 3.2:Buildandenhancecollaborationsandpartnershipsforcommunicationefforts.
Strategies3.2.1Strengthenexistingpartnershipsandcoalitionsandbuildrelationshipswithnewpartnerstosupportrelevantimmunizationsacrossthelifespan.
3.2.2Usecross-agencyandintra-agencycollaborationtoinformdevelopmentofcommunicationresearchagendas,protocols,campaignsandmessages.
3.2.3Collaboratewithpartnersandstakeholderstocommunicatevaccinebenefits,risks,andrecommendationsinaccessibleformatsandinculturallyappropriatelanguages,methods,andliteracylevels.
3.2.4Utilizestateandlocalvenuestoeducateonvaccineandimmunizationissuestoexpandthereachofmessagesoutsideofthetraditionalclinicalsetting.
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Objective 3.3Enhancedeliveryoftimely,accurate,andtransparentinformationtopublicaudiencesandkeyintermediaries(suchasmedia,providers,andpublichealthofficials)aboutwhatisknownandunknownaboutthebenefitsandrisksofvaccines.
Strategies 3.3.1Enhancecommunicationofnewfindingsaboutvaccineeffectiveness,safety,andadministrationstudiestothepublic,partnersandprovidersinaclear,transparentandtimelymanner.
3.3.2Respondinarapid,coordinated,consistent,andeffectivemannertoemergingvaccineissuesandconcerns(e.g.,supply,safety,orpublichealthemergencies).
3.3.3Rapidlyandeffectivelydisseminatecommunicationsresearchfindingsthroughpeer-reviewedjournals,conferences,media,andpartnercommunicationstofacilitateimplementationofevidence-basedstrategies.
Objective 3.4Increasepublicawarenessofthebenefitsandrisksofvaccinesandimmunization,especiallyamongpopulationsatriskofunder-immunization.
Strategies3.4.1Develop,implement,andevaluatealong-termstrategiccommunicationsplanandprogramaimedateducatingparents,caregiversofchildren,adolescents,andadultsaboutVPDs;thebenefitsandrisksofvaccines;andvaccinerecommendations.
3.4.2Maintaincurrent,easilyaccessible,evidence-basedonlineinformationonVPDsandvaccines,includingbenefitsandrisksandthebasisofimmunizationrecommendations,forallaudiencegroups.
3.4.3Evaluatenewmedia(suchasmobiletechnologiesandsocialmedia)andutilizeitappropriatelytoreachtargetaudienceswithaccurateandtimelyinformationaboutvaccinesandtorespondtoemergingconcernsandissues.
3.4.4Enhanceawarenessoftheimportanceofimmunizationaspartofpreventivehealthcareamongparents,adolescents,andadults.
3.4.5CollaboratewiththeeducationcommunitytoassessopportunitiestointegrateinformationonVPDs,recommendedvaccines,preventivehealthcare,andpublichealthinexistingeducationalcurricula.
3.4.6Developanddisseminatevaccinecommunicationtools/materialsthatareaccessibleandculturallyandliteracy-levelappropriateforgroupsatriskofunder-immunization.
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Objective 3.5:Assurethatkeydecision-andpolicy-makers(e.g.,third-partypayers,employers,legislators,communityleaders,hospitaladministrators,healthdepartments)receiveaccurateandtimelyinformationonvaccinebenefitsandrisks;economics;andpublicandstakeholderknowledge,attitudes,andbeliefs.
Strategies3.5.1Develop,disseminate,andevaluatebroad-basededucationtoolsforkeygroupsonthevalue,risks,andcost-effectivenessofvaccines;thebasisofimmunizationrecommendations;businesscaseevidenceandguidance;vaccinepolicydevelopment;thestandardsofimmunizationpracticeandadministration;andvaccinesasacomponentofpreventivehealthcare.
3.5.2Selectandimplementamodelforsustainedcommunityengagementtoinformvaccinepolicyandprogramactivities.
3.5.3Providevaccineprogrammanagersandpolicy-makersinformationonthedirectandindirectcostsandbenefitsofvaccination.Thisincludes,butisnotlimitedto,informationonfederalandstateprogramsthatofferlow-costvaccines.
3.5.4Providepolicy-makerswithdatanecessarytomakeinformeddecisionsontheutilizationofvaccinesinmassvaccinationprogramsforpublichealthemergencies.
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Goal 4:Ensure a stable supply of, access to, and better use of recommended vaccines in the United States
IntroductionVPDincidenceintheU.S.isatornearrecord-lowlevelsformostdiseasesagainstwhichchildrenareroutinelyimmunized;infantandchildvaccinationratesareapproachingormeetrecordlevels.However,coveragelevelsarebelowHP2020targetsformanyvaccinestargetedtoadolescentsandadults,andsubstantialdisparitiesexistamongracialandethnicgroupsinadultandadolescentvaccinationlevels.Limitedknowledgeaboutrecommendedvaccinesandattitudestowardsvaccinesexistamongthepublic,healthcareprofessionals,andhealthpolicy-anddecision-makers.Lackofhealthcareaccessandfinancialbarriersalsocontributetothesedisparitiesandneedtobeaddressedinstrategiesmovingforward.Researchonhowbesttoovercomesuchbarrierswilldictatestrategiesandpractices.Ongoingpartnershipsamongnational,state,local,tribal,private,andpublicentitiesareneededtosustainandimprovevaccineuseandtheconcomitantindividualandpublichealthbenefits.
EnsuringareliableandsteadysupplyofallvaccinesiscriticalintheU.S.,whereshortagesofseveralcommonlyusedvaccineshaveoccurredsince2000(e.g.,Hib,hepatitisA,andinfluenza).New21st-centuryvaccinesupplyconcerns,suchasvaccinesforpandemicinfluenza,emergingdiseasesandbioterrorismthreats,presentdifferentchallengesforsustainabilityandmayrequiresurgemanufacturingcapacitycomparedwithtraditionalvaccinepathways.
Immunizationinformationsystems(IIS)andelectronichealthrecords(EHR)maybecomeincreasinglyimportantcomponentsofimmunizationprograms.Jointlytheycanleadtomuchbetterimmunizationrecordkeepingforchildrenandadults,therebyreducingthebarrierofunknownimmunizationstatusandthereceiptofadditionalunneededdosesofvaccinesandenhancingefficiencyandcost-effectivenessofnationalimmunizationefforts.
StrongpublichealthsurveillancetomonitorandevaluateVPDsandtheeffectivenessoflicensedvaccinesprovidesthelinkbetweenvaccinationpolicyandhealthoutcomes.Suchpublichealthsurveillanceisakeycomponentofstrategiestoovercomebarriersandimproveuseofexistingvaccines.
Challengespersisttoimprovevaccinationratesandtoincorporatenewvaccinesintochildandadolescentvaccinationschedules.Between2005and2010,sixnewvaccinesorvaccinerecommendationswereaddedforchildrenandadolescentsbytheACIPandtheCentersforDiseaseControlandPrevention(CDC):
•meningococcalconjugatevaccine
•tetanus,diphtheria,acellularpertussisvaccine
•HPVvaccine
•rotavirusvaccine
•universalinfluenzavaccination
•13-valentpneumococcalconjugatevaccine.
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Barrierstoimprovedvaccineuptakeincludepersistentcost,awarenessandaccessproblems;lackofknowledgeofnecessaryvaccines;andlimiteduseofevidence-basedstrategiestoimprovevaccineuptake,suchasreminder-recallsystems.Communityhealthcenters,othercommunityimmunizationsites(e.g.,pharmaciesandstores)andschool-locatedclinicsoffervenuesforimprovingvaccineuptake,inadditiontotraditionalprovidersites.
Goal4identifiesnineobjectivesandrelatedstrategiestostrengthenournation’svaccinationprogramandovercomebarriers.EnhancingcommunicationandeducationactivitiesaboutvaccinationisakeyapproachtoovercomemanyofthecurrentchallengesidentifiedinGoal4,andisaddressedindetailinGoal3.
Objectives
Objective 4.1EnsureconsistentandadequatesupplyofvaccinesfortheU.S.
Strategies4.1.1DeterminebarrierstohavingmultiplesuppliersforeachvaccinelicensedandrecommendedforroutineuseintheU.S.
4.1.2Promoteharmonizationofinternationalvaccineregulatorystandardsforlicensure.
4.1.3Improvevaccinequalityandavailabilitythroughbettermanufacturingandproductionoversight.
4.1.4Optimizeuse,content,anddistributionofvaccinestockpilesandancillarysupplies.
4.1.5Improvethedevelopmentof,communicationof,andtrackingofadherencetorecommendedchangesinvaccineuseduringnationalvaccineshortages.
Objective 4.2EnsureconsistentandstabledeliveryofvaccinesfortheU.S.
Strategies4.2.1Improvevaccineordering,distributionandtrackingsystemsforroutineuse,forpublichealthemergencies,andformanagementofdeliverydisruptions.
4.2.2Enhancepublicsectorinfrastructuretosupportandsustainadultimmunizationactivities,includingaddressingdisparitiesinvaccinationratesamongracialandethnicminoritiesandunvaccinatedrefugeesresettlingtotheU.S.
4.2.3Expandaccesstovaccinationatmedicalcaresitesforchildren,adolescents,andadults,suchasbyincreasinghoursofoperationandestablishingspecificvaccinationclinicsatselectedtimesoftheyear(e.g.,“backtoschool”campaigns).
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4.2.4Expandaccesstovaccinationinnon-healthcaresettings,suchasretailoutlets,schools,workplaces,andcommunitycenters.
4.2.5Develop,monitor,andevaluatepoliciespromotingvaccinationforpatientsinlong-termcarefacilitiesandhospitals.
4.2.6Develop,implement,andevaluateemployer-basedimmunizationprograms,whichshouldincludefreevaccines,convenientaccess,education,andcompliancemonitoring,toincreasethecoverageofemployees,includinghealthcareworkers,withrecommendedvaccines.
4.2.7Implement,monitor,andevaluateevidence-basedinterventionsdesignedtoraiseandsustainhighvaccinationcoverageacrossthelifespan.
4.2.8Monitorandevaluatetheimpactofstateimmunizationlawsandregulationsonvaccinecoverage,includingchildcare,pre-school,school,collegeprematriculationrequirements,employerrequirements,andtheroleofexemptions,insurancemandates,andimmunizationinformationsystemsrequirements.
4.2.9Prepare,practice,andevaluatemassvaccinationactivities,includingvaccineadministration,forscenariossuchasanoutbreakofaVPD,forabiologicalattack,forthecriticalworkforceinadvanceofaninfluenzapandemic,andfortheentirepopulation,priortoandduring,aninfluenzapandemic.
Objective 4.3Reducefinancialbarrierstovaccination.
Strategies4.3.1IdentifyandregularlymonitorfinancialbarrierstoreceiptofACIP-recommendedandCDC-adoptedvaccines.
4.3.2Ensurethatout-of-pocketcostsforpurchaseandadministrationofACIP-recommendedandCDC-adoptedvaccinesdonotrepresentasignificantfinancialbarrier.
4.3.3Strengthentheabilityofstatestopurchase,andexpandaccessto,ACIP-recommendedandCDC-adoptedvaccinesforthosewhoqualifyforpubliclysupportedvaccinations.
4.3.4Develop,implement,andevaluatestrategiestoreducethefinancialburdenonvaccinationprovidersforpurchaseofinitialandongoingvaccineinventories.
Department of Health & Human Services | The 2010 National Vaccine Plan 33Department of Health & Human Services | The 2010 National Vaccine Plan
Objective 4.4Maintainandenhancethecapacitytomonitorimmunizationcoverageforvaccinesroutinelyadministeredtoallagegroups.
Strategies4.4.1Identify,implement,andevaluatecost-effectiveandrapidmethods,suchastheuseofIISorinternetpanelsurveys,forassessingvaccinationcoveragebycategories,includingagegroups,groupsatriskofunderimmunization,bytypeofvaccine,andtypeoffinancing.
4.4.2Improvethecompletenessof,useof,andcommunicationbetween,IISandEHRtomonitorvaccinationcoverage.
4.4.3Supporttheadoptionofnationalcertified,interoperablehealthinformationtechnologyandEHRforimmunization.
4.4.4Supportandimproveexistingsurveysassessingimmunizationcoverage(e.g.,theNationalImmunizationSurveyandtheBehavioralRiskFactorSurveillanceSystem),toincludemorerepresentativesamplesandtimelyreportingofdata.
Objective 4.5EnhancetrackingofVPDsandmonitoringoftheeffectivenessoflicensedvaccines.
Strategies4.5.1StrengthenepidemiologicandlaboratorymethodsandtoolstodiagnoseVPDs,assesspopulationsusceptibility,andcharacterizevaccineeffectivenessandtheimpactofvaccinationcoverageonclinicalandpublichealthoutcomes.
4.5.2Monitorcirculatingstrainsofrelevantvaccine-preventableandpotentiallyvaccine-preventablepathogens,includingemergingandre-emergingdiseases.
4.5.3ImprovemonitoringofdiseaseburdenanddetermineepidemiologicandclinicalcharacteristicsofcasesofVPDsandpotentialVPDsbysupportingtraditionalsurveillanceanduseofhealthinformationtechnology,interoperabledatastandards,andnewdataresources.
4.5.4Developandmaintaincapacitytorapidlyestimatetheeffectivenessofnewvaccines,suchaspandemicandpre-pandemicinfluenzavaccines.
4.5.5Assurerapidandcomprehensiveidentification,investigation,andresponsetovaccine-preventablediseaseoutbreaks.
34 Department of Health & Human Services | The 2010 National Vaccine Plan Department of Health & Human Services | The 2010 National Vaccine Plan
4.5.6Assuretimelyevaluationtoassessvaccineeffectiveness,durationofprotection,andindirect(communityandherd)protectionbycurrentandnewlyrecommendedvaccines.
Objective 4.6Educateandsupporthealthcareprovidersinvaccinationcounselingandvaccinedeliveryfortheirpatientsandthemselves.
Strategies4.6.1ExpandandimplementtrainingandeducationofhealthcareprovidersonVPDs,includingdiagnosis,modesoftransmission,preventionandcontrol,andreportingrequirements.
4.6.2Expandandimplementtrainingandeducationofimmunizationprovidersatalllevelsoftheireducationontheproperuseandadministrationofvaccines;theproperstorageandhandlingofvaccines;thebasisofimmunizationrecommendations;thesafetyofvaccines;reportingofAEFIs;understandingofthevaccinesafetysystem;andonthestandardsofimmunizationpractice(e.g.,vaccineeducationmodulesinprimarycareandcontinuingmedicaleducationprograms).
4.6.3Developaplantoreduceandultimatelyeliminateerrorsinvaccineadministration(e.g.,wrongvaccine,dose,injectionsite,ortiming).
4.6.4 Promoteandsupporteducationalandtechnicalassistancetoimprovebusinesspracticesassociatedwithprovidingimmunizations,suchaseducatingprovidersandenrollingnewprovidersintotheVaccinesforChildrenprogram,includingnon-traditionalproviders.
4.6.5ExpandtheincorporationofvaccinationsandtheuseofIISintoqualityimprovementprogramssuchastheHealthcareEffectivenessDataandInformationSet.
4.6.6Supportadequatereimbursementforvaccinecounseling,administration,storageandhandlingbyprovidersunderpublicsectorandprivatehealthplans.
4.6.7Supportresearchtoevaluatethecapacity(accommodatingtheincreasednumberofpatientvisitsrequiredtoreceiverecommendedvaccines)ofhealthcareproviderstoimplementvaccinerecommendationsforallagegroups.
4.6.8Develop,implement,andevaluatecomprehensiveprogramstoensurehealthcareprofessionalsareappropriatelyimmunizedwithrecommendedvaccines.
Department of Health & Human Services | The 2010 National Vaccine Plan 35Department of Health & Human Services | The 2010 National Vaccine Plan
Objective 4.7Maintainastrong,science-based,transparentprocessfordevelopingandevaluatingimmunizationrecommendations.
Strategies4.7.1Obtainbroad-basedinputfromthepublicandstakeholderscontributingtonewimmunizationpoliciesandtheassessmentofexistingpolicies.
4.7.2Assesstheimpactofnewvaccinesandvaccinerecommendationsontheoverallimmunizationschedule,includingprogrammaticimplementation,safety,andefficacy.
4.7.3Evaluatethecost-effectivenessandcomparativeeffectivenessofproposedandexistingimmunizationrecommendations.
Objective 4.8StrengthentheNationalVaccineInjuryCompensationProgram(VICP)andCountermeasuresInjuryCompensationProgram(CICP).
Strategies4.8.1IncreaseknowledgeabouttheVICPandCICPamongallstakeholders.
4.8.2Assuretheprogramsareresponsivetoevolvingscience,includingregularlyupdatingtheirVaccineInjuryTables.
4.8.3Continuetoensurefairandefficientcompensationforvaccine-relatedinjuries.
4.8.4Examinealternativeapproaches,andevaluateandimplementthosedeemedoptimal,foradjudicationofVICPclaimsforillnessesnotincludedintheVaccineInjuryTabletotheextentpermittedbyapplicablelaw.
Objective 4.9Enhanceimmunizationcoveragefortravelers.
Strategies4.9.1Definethepopulationsatriskforacquiringinternationaltravel-relatedVPDs,andidentifyandaddressbarrierstotheirreceivingimmunizations.
4.9.2Assessoverallimmunizationstatusduringtravel-relatedimmunizationclinics.
36 Department of Health & Human Services | The 2010 National Vaccine Plan Department of Health & Human Services | The 2010 National Vaccine Plan
Goal 5: Increase global prevention of death and disease through safe and effective vaccination
IntroductionInfectiousdiseasesaretheleadingcauseofdeathamongchildrengloballyandcontributesubstantiallytodiseaseanddisabilityamongpersonsofallages.Immunizationprogramshavebeenremarkablysuccessfulinpreventingmillionsofchildhooddeaths,eradicatingsmallpox,andeliminatingcirculationofpolioandmeaslesfrommanycountriesaroundtheworld.However,substantialchallengesremain.Manydiseasesforwhichsafeandeffectivevaccinesareavailableposeacontinuedburden,asdoestheunderutilizationofvaccinesinmostcountries(e.g.,pneumococcal,rotavirusandHPV)anddiseasesforwhichvaccinesarebeingdeveloped(e.g.,HIV,TB,andmalaria).Globallymobilepopulationsincludingrefugees,andstatelessandinternallydisplacedpersonsareoftendifficulttoreachandmaynotbeincludedinnationalimmunizationprograms.AchievingtheUnitedNations’MillenniumDevelopmentGoalsofreducingtheunder-fiveyearmortalityratebytwothirdsby2015willrequiresubstantiveaction,includingincreasingtheproportionofoneyear-oldchildrenimmunizedagainstmeasles.
Thegoalsofglobalvaccinationaretocontrol,eliminate,oreradicateinfectiousdiseasesinawaythatstrengthenshealthsystemsandissustainableasnewvaccinesareintroduced.Successinglobalimmunizationrequiresactionbythefullrangeofstakeholdersinvolvedinthevaccineandimmunizationenterprise:researchanddevelopment,regulationandmanufacturing,andprogramimplementationandmonitoring.NewpartnershipssuchastheGlobalAllianceforVaccinesandImmunizations(GAVI)haveledtoincreasedsupportforimmunizationworldwide,spurringintroductionofnewvaccinesinlowincomecountriesandexpandedvaccinationcoverage.U.S.governmentalandNGOshavecontributedtoprogressthroughvaccineresearchanddevelopment,participationinmultilateralandbilateralpartnerships,technicalassistance,andprogramsupport.
GiventhebreadthofglobalimmunizationactivitiesinGoal5,someoftheobjectivesandstrategiesrelevanttothistopicareincludedelsewhereinthisPlan.Forexample,allvaccineresearchanddevelopmentissuesareincludedunderGoal1becausetheapproachandstakeholdersnecessarytoachievetheseobjectivesarelargelythesameintheU.S.andtherestoftheworld.Similarly,issuesrelatedtovaccinesafety,communicationsandprogramimplementationareincludedunderthisgoal,aswellasunderothergoalsofthePlan,asthereareuniqueintellectualperspectivesforthem.WhilemanyoftheobjectivesintheseareasaresimilarfortheU.S.andabroad,thestrategiesdifferinternationallybecauseU.S.stakeholdersfocusonpartnershipsandprovidingassistanceratherthanondirectimplementation.
Intheeraofglobalpandemicsandmasstravel,thepublichealthofU.S.citizensiscloselyrelatedtodiseasesoccurringinothercountries.EventhoughmanyVPDssuchaspolio,measles,andrubellahavebeeneliminatedinthiscountry,theU.S.remainsvulnerabletoimportationsaslongasthesediseasescontinuetopersistelsewhere.Supportforoverseas(pre-departure)vaccinationofmobilepopulations,includingrefugeesandimmigrantsmigratingtotheU.S.,willreducethelikelihoodofimportation.Supportfordevelopingandintroducingnewvaccinestoaddressdiseasesinothercountriesandassistingwithstrengtheningandenhancingcapacityoftheirimmunizationprogramscontributestowardprovidingan“umbrellaofprotection”fortheU.S.andfulfillingtheU.S.government’sbroadercommitmenttoglobalpublichealth.
MeetingthiscommitmenttosupportglobalimmunizationisalsoreflectedinotherfederalpublichealthinitiativesanddevelopmentinitiativesbeyondthePlan.TheGHI–currentlyledbytheU.S.
Department of Health & Human Services | The 2010 National Vaccine Plan 37Department of Health & Human Services | The 2010 National Vaccine Plan
DepartmentofState,USAID,andtheCDC,withactiveengagementofotheragencies,includingtheDepartmentofDefense(DoD),NIH,andtheHealthResourcesServicesAdministration(HRSA)–andFDA’sglobalvaccineregulatorycapacitybuildingeffortsthroughtheWorldHealthOrganization(WHO)aretwoexamplesoffederalinitiativesthatincorporateimmunizationasacomponentofabroadU.S.interesttoimprovematernalandchildhealth.Additionally,theCDChasaGlobalImmunizationStrategicFrameworkthatfocusesonhowtheagencywillsupportimmunizationprogramsaroundtheworld.TheseandotherinitiativesareconsistentwiththeobjectivesoutlinedinthePlan.
Objectives
Objective 5.1SupportinternationalorganizationsandcountriestoimproveglobalsurveillanceforVPDsandstrengthenhealthinformationsystemstomonitorvaccinecoverage,effectiveness,andsafety.
Strategies5.1.1AchievesustainableWHOcertificationqualitysurveillanceforeradicationoftargetedVPDs.
5.1.2ExpandandimprovesustainablesurveillancesystemsforalldiseaseshavingWHO-recommendedvaccinesanddiseasesforwhichvaccineintroductionisbeingconsidered.
5.1.3Strengthenalllevelsofgloballaboratorynetworks(includingnational,regional,andglobalreferencelaboratories)tosustainandimproveVPDdiagnosisinordertoestablishbaselinediseaseburden,detectoutbreaks,detectnewlyemergingvariantsofVPDs,andmonitortheimpactofnewvaccines.Thislaboratorycapacityshouldalsobedevelopedforsurveillanceofpotentialpublichealthemergenciesofinternationalconcern.
5.1.4EnhanceassessmentsofemergingvariantsorstrainsofVPDagents.
5.1.5Developnewdiagnostictests,toolsandprocedurestoimprovebothfield-basedandlaboratoryconfirmationofdiagnoses.
Objective 5.2Supportinternationalorganizationsandcountriestoimproveandsustainimmunizationprogramsasacomponentofhealthcaredeliverysystemsandpromoteopportunitiestolinkimmunizationdeliverywithotherpriorityhealthinterventions,whereappropriate.
Strategies5.2.1Providetechnicalsupporttocountries,multilateralinstitutions,andotherpartnerstostrengthenkeycomponentsofimmunizationprogrammanagementandimplementation,includingepidemiologicalanalysis,comprehensiveplanning,vaccinedistributionandsafeadministration,monitoring,informationsystems,andprogramevaluation.
38 Department of Health & Human Services | The 2010 National Vaccine Plan Department of Health & Human Services | The 2010 National Vaccine Plan
5.2.2Providetechnicalsupporttocountriesandmultilateralinstitutionsasappropriatetointroduce,sustain,andmonitorrecommendedsafeinjectionpracticesforallvaccinations,includingtheuseofautodisablesyringesorneedle-freedevices.
5.2.3Improvecoveragemonitoringofvaccinesandotherhealthserviceslinkedwiththevaccinationprogramandtheuseofinformationatdistrictandlocallevels.
5.2.4IntroduceandimproveprogramsthatevaluateAEFIs.
5.2.5Developstandardizedmethodsformonitoringandevaluatingtheefficiency,effectivenessandimpactofcombinedinterventionstoimprovecoverage,andsupportlinkingdeliveryofimmunizationandotherhealthservicesinwaysthatdonotjeopardizeimmunizationcoverage.
5.2.6Encourageestablishmentofprograms,asappropriate,forvaccinationbeyondthetraditionalinfanttargetagegroups(e.g.,amongolderchildren,adolescents,adults,andhealthcareproviders),includingunvaccinatedmobilepopulationsofvariousagegroupssincetheepidemiologyinsomemobilepopulationsmaydifferfromotherpopulationswherethediseasesarenormallyspreadingincertainage-groups.
5.2.7Providetechnicalsupporttocountries,multilateralinstitutionsasappropriate,andotherpartnerstodevelopsustainablevaccinefinancingmechanismsandadequateglobalsuppliesofvaccines,includingthrougheconomicandsupplyanddemandanalyses.
Objective 5.3Supportinternationalorganizationsandcountriestointroduceandmakeavailablenewandunderutilizedvaccinestopreventdiseasesofpublichealthimportance.
Strategies 5.3.1Strengthencapacityatthecountrylevel,andinmultilateralinstitutionsasappropriate,tomakeinformeddecisionsonintroductionofnewvaccinesbasedonevaluationofepidemiology,financialsustainability,safety,andprogrammaticconsiderations,includingsupporttonationaladvisorycommittees.
5.3.2Collaboratewithglobalorganizationsandpartnerstoaccelerateclinicaltestingandlicensureindevelopingcountriesofvaccinesalreadylicensedindevelopedcountries,whereappropriate.
5.3.3SupporttheintegrationofnewandunderutilizedvaccinesintoeachGAVI-eligiblecountry’smulti-yearnationalplanofactionandprovidetrainingandlogisticalsupportnecessarytosuccessfullyincorporatenewvaccinesintoroutineprograms.
5.3.4Supportpost-licensureevaluationsofnewvaccineswithregardtoimmunizationprograms,diseasepatterns,andvaccinesafety.
Department of Health & Human Services | The 2010 National Vaccine Plan 39Department of Health & Human Services | The 2010 National Vaccine Plan
5.3.5Workwithglobalpartnerstoestablishaninternationalsystemthatfacilitatesrapidresponsetoemerginginfectionsthroughthedevelopmentofvaccinereferencestrainsandcandidatevaccines.
5.3.6Workwithglobalpartnerstosecureandmaintainadequatestockpiles/strategicreservesofvaccinestomaintainuninterruptedsupplyandforemergencyresponsetooutbreaks.
5.3.7Supportanddevelopmechanismsforrapidlymakingvaccinesavailabletodevelopingcountriesforpublichealthemergenciessuchaspandemicinfluenza,includingexploringoptionsforsharingofvaccinesandtieredpricing.
Objective 5.4Supportinternationalorganizationsandcountriestoimprovecommunicationofevidence-basedandculturallyandlinguisticallyappropriateinformationaboutthebenefitsandrisksofvaccinestothepublic,providers,andpolicy-makers.
Strategies5.4.1Supportappropriateeconomicstudiestoinformkeydecision-andpolicy-makers’understandingofthebenefitsandcostsofimmunization.
5.4.2Supportthedevelopmentofcapabilitiestocommunicatevaccinebenefitsandrisksandtorespondtoemergingvaccinesafetyissues.
5.4.3Supportnationalsystemstoimprovereportingofadverseevents.
5.4.4Assistcountriestodevelopandimplementsustainablecommunicationresearchtogathertimelyandreliabledatafromthepublicandprovidersonknowledge,attitudesandbeliefsaboutthebenefitsandrisksofvaccines.
5.4.5AssistcountriestodevelopcommunicationplanstoincreaseproviderandpublicawarenessofVPDsandpromoteimmunizationrecommendations,especiallyamongpopulationsatriskofunder-immunization.
5.4.6ProvidetechnicalassistanceandtrainingtobehavioralandcommunicationsscientistsandpromotetheirparticipationonTechnicalAdvisoryGroups.
5.4.7Supportandparticipatewithpartnerstocreateandimplementaglobalvaccineadvocacystrategy.
40 Department of Health & Human Services | The 2010 National Vaccine Plan Department of Health & Human Services | The 2010 National Vaccine Plan
Objective 5.5Supportthedevelopmentofregulatoryenvironmentsandmanufacturingcapabilitiesthatfacilitateaccesstosafeandeffectivevaccinesinallcountries.
Strategies5.5.1PromoteandsupporttheeffortsofWHOandotherglobalpartnerstodevelopandharmonizeinternationalstandardsforvaccinedevelopmentandlicensure.
5.5.2PromoteandsupporttheeffortsofWHOandotherstoimproveregulatorycapacityincountrieswithlimitedinfrastructurestoassurevaccinequality,evaluatenewvaccineswhenappropriate,andassurethatclinicaltrialsareconductedinaccordancewithGoodClinicalPractices.
5.5.3Providetechnicalassistancetodevelopingcountryvaccinemanufacturerstosupportdevelopmentandproductionofsafeandeffectivevaccines.
Objective 5.6Buildandstrengthenmultilateralandbilateralpartnershipsandothercollaborativeeffortstosupportglobalimmunizationanderadicationprograms.
Strategies5.6.1Participateinestablishingglobalimmunizationpriorities,goalsandobjectivesandprovidetechnicalassistanceatglobal,regional,andnationallevels.
5.6.2Strengtheninternationalcollaborationsforbasicandappliedresearchandrelatedtrainingofnextgenerationresearchers,especiallyindiseaseendemicareas,toincludeimprovingthestabilityandperformanceofcurrentvaccines.
5.6.3ContributetodevelopmentandimplementationofaplanestablishingthescientificbasisforVPDeradication/elimination,identifyingoptimalvaccinationapproaches,anddevelopingstrategiestominimizerisksinthepost-eradicationperiod.
5.6.4Participateinregionalimmunizationinitiatives,suchasthoseadoptedbythePanAmericanHealthOrganizationandotherWHOregions.
5.6.5Strengthenvaccinationofgloballymobilepopulationsthroughtargetedprograms(e.g.,pre-departurevaccinationofUSboundrefugees).
Department of Health & Human Services | The 2010 National Vaccine Plan 41Department of Health & Human Services | The 2010 National Vaccine Plan
Monitoring and EvaluationNVPOwillberesponsibleforassuringcoordinationandformonitoringfederalactionsandaccomplishmentsonthe2010NationalVaccinePlanonanongoingbasis.NVPOandNVACwillreporttheirfindingstotheAssistantSecretaryforHealthannually.Thisreportwillincludeasummaryofprogress,identifyareaswhereprogressislagging,andproposecorrectiveactionwhereneeded.ThereportalsowillbepresentedatanNVACmeeting,whichisopentothepublicandisattendedbymanystakeholdersnotrepresenteddirectlyontheCommittee.
KeyfederalstakeholdersinglobalimmunizationincludeCDC,theDepartmentofStateandUSAID.ManyoftheglobalimmunizationtargetsincludedinthePlanwereestablishedbyinternationalorganizations(e.g.,WHO)inconsultationwithU.S.stakeholders.However,theroleofthosestakeholdersinachievingthesetargetsmostofteninvolvesprovidingtechnicalassistanceandsupportratherthandirectimplementation.
ManyfactorsmayaffecttheabilitytoachieveNationalVaccinePlanobjectives.Opportunitiesmayemergethatfacilitaterapidprogressandachievementofobjectivessoonerthananticipated.Scientific,technological,healthcarefinancing,orcommunicationsadvancesalsocouldemergeandenablerapidachievementofthevisionlaidforthbythePlan,supersedingitsobjectivesandgoals.Ontheotherhand,existingchallengesandbarriersmaybemoredifficulttoovercomethananticipatedandnewchallengesmayemerge.Forexample,arangeofscientificandtechnicalissuesmaydelaydevelopmentandlicensureofnewvaccines;safetyconcernsmayaffectvaccineuptake;financialconstraintsmayaffectvaccinationdelivery.Recognizingtheseuncertainties,NVPOwillcoordinateamid-coursereviewofthePlanafterfiveyearsallowingchangestobemadewhichrespondtotherealityoftheenvironment.Modifiedindicators,strategies,actions,andmilestoneswillguidesubsequentannualevaluationthroughtheoverallten-yearhorizonofthePlan.
ConclusionTheoverridinggoalofthisplanistoinvigoratenationalcoordinationandplanningonvaccinesandimmunizations.HHSwillleadthisnationaleffort,leveragingexistingresourcesandexpertise,tomaximizethecontrolofVPDsinthiscountryandwithglobalpartners.Giventhatthisisintendedtobenotjustafederalplanbutrepresentanationalstrategy,itwillrequirethepartnershipofstakeholdersinvolvedinallaspectsofthevaccineenterprise.Thegoals,objectives,andstrategiesoutlinedinthisdocument,whenfullyimplemented,willmarkedlyenhancethecontrolofVPDsandthehealthofthepublicinthisnation.
42 Department of Health & Human Services | The 2010 National Vaccine Plan Department of Health & Human Services | The 2010 National Vaccine Plan
Obj
ectiv
eFederal
HHS
DH
S
DoD
DoJ
Dep
t. of
Sta
te
USA
ID
VAACF
AH
RQ
ASP
R (B
ARD
A)
CDC
CMS
FDA
HRS
A
IHS
NIH
NVP
O
ON
C
Goal 1: Develop new and improved vaccines
1 .1 1 .2 1 .3 1 .4 1 .5 1 .6
Goal 2: Enhance the vaccine safety system
2 .1 2 .2 2 .3 2 .4 2 .5 2 .6 2 .7 2 .8
Goal 3: Support communications to enhance informed vaccine decision-making
3 .1 3 .2 3 .3 3 .4 3 .5
Goal 4: Ensure a stable supply of, access to and better use of recommended vaccines in the United States
4 .1 4 .2 4 .3 4 .4 4 .5 4 .6 4 .7 4 .8 4 .9
Goal 5: Increase global prevention of death and disease through safe and effective vaccination
5 .1 5 .2 5 .3 5 .4 5 .5 5 .6
Table 2: National Vaccine Plan Objectives: Responsible Stakeholders
Department of Health & Human Services | The 2010 National Vaccine Plan 43Department of Health & Human Services | The 2010 National Vaccine Plan
Obj
ectiv
e
Non-federalH
ealth
car
e pr
ovid
ers
Hea
lth c
are
syst
em
Publ
ic a
nd p
riva
te h
ealth
ca
re p
lans
Stat
e, lo
cal,
and
trib
al
gove
rnm
ents
Aca
dem
ia
Adv
ocac
y or
gani
zatio
ns
Phila
nthr
opic
or
gani
zatio
ns
Vacc
ine
man
ufac
ture
rs
UN
ICEF
WH
O
Goal 1: Develop new and improved vaccines
1 .1 1 .2 1 .3 1 .4 1 .5 1 .6
Goal 2: Enhance the vaccine safety system
2 .1 2 .2 2 .3 2 .4 2 .5 2 .6 2 .7 2 .8
Goal 3: Support communications to enhance informed vaccine decision-making
3 .1 3 .2 3 .3 3 .4 3 .5
Goal 4: Ensure a stable supply of, access to and better use of recommended vaccines in the United States
4 .1 4 .2 4 .3 4 .4 4 .5 4 .6 4 .7 4 .8 4 .9
Goal 5: Increase global prevention of death and disease through safe and effective vaccination
5 .1 5 .2 5 .3 5 .4 5 .5 5 .6