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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


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.

5Department of Health & Human Services | The 2010 National Vaccine Plan

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


“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


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.

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

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


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.


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.


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.


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.


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.


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).


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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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).


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.


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.


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.


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.


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.


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.


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.


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.


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).


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.


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


5 .1 5 .2 5 .3 5 .4 5 .5 5 .6

Table 2: National Vaccine Plan Objectives: Responsible Stakeholders


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


5 .1 5 .2 5 .3 5 .4 5 .5 5 .6

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