WHOCOVID-19 疫苗接种区域会议

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RegionalmeetingonCOVID-19vaccination

ReorientingandenhancingCOVID-19vaccinationintheSEAsiaRegionNewDelhi,India,3July2024

SEA-Immun-158

RegionalMeetingonCOVID-19vaccination

ReorientingandenhancingCOVID-19vaccinationintheSEAsiaRegionNewDelhi,India,3July2024

worldHealthorganization

REGioNAOFFicEFORSouth-EastAsia

RegionalMeetingonCOVID-19vaccinationSEA-Immun-158

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Contents

PageNo

Abbreviations V

1.Background 1

2.ObjectivesOfTheMeeting 4

3.OrganizationOfTheMeeting 4

4.ProceedingsOfTheMeeting 5

5.TechnicalSessions 7

6.KeyConclusionsAndActionPoints 9

Annexures

1.

Agenda 12

2.

MessageFromTheDirectorForCommunicableDiseases 13

3.

ListOfParticipants 15

v

Abbreviations

AEFIadverseeventfollowingimmunization

BCGbacilleCalmette–Guérinvaccine

BeSDbehaviouralandsocialdriversofvaccineuptake

CDSCommunicableDiseasesandSurveillanceDepartmentofWHO

COVID-19coronavirusdisease

CSOcivilsocietyorganization

eJRFelectronicJointReportingForm

EPIExpandedProgrammeonImmunization

EUAemergencyuseauthorization

EULemergencyuselisting

GACVSGlobalAdvisoryCommitteeonVaccineSafety

GaviCDSGavi,COVID-19Vaccinedeliveryfundingsupport

GISAIDGlobalInitiativeonSharingAllInfluenzaData

IHRInternationalHealthRegulations

ITAGImmunizationTechnicalAdvisoryGroup

IVDimmunizationandvaccinesdevelopment

MAmarketauthorization

MoHMinistryofHealth

NDVPNationalDeploymentandVaccinationPlan

NGOnongovernmentalorganization

PHCprimaryhealthcare

PHEICPublicHealthEmergencyofInternationalConcern

PSPQProgrammaticSuitabilityforPQ

PQprequalification

RIroutineimmunization

SAGEStrategicAdvisoryGroupofExpertsonImmunization

SARS-CoV-2severeacuterespiratorysyndromecoronavirus2

SCMSeniorCountryManager

SEAsiaSouth-EastAsia

SRAstringentregulatoryauthority

VAEDvaccine-associatedenhanceddisease

vi

VE

vaccineeffectiveness

VOI

variantsofinterest

VUM

variantundermonitoring

VVM

vaccinevialmonitor

WCO

WorldHealthOrganizationcountryoffice

WHE

WorldHealthOrganizationHealthEmergenciesProgramme

WHO

WorldHealthOrganization

WHO-SEARO

WHORegionalOfficeforSouth-EastAsia

UNICEF

UnitedNationsChildren’sFund

UNICEF

ROSA

UnitedNationsChildren’sFundRegionalOfficeforSouthAsia

1

1.Background

CurrentepidemiologyofCOVID-19disease,globallyandintheRegion

TheepidemiologyofCOVID-19diseasehaschangedfromthepandemicperiodtothepost-pandemicperiod.Aglobalsummaryofthedatabetween1Januaryand10September2023showedthatthehighestproportionsofCOVID-19deathsoccurredinpersonsaged65yearsandabove,withthisgrouprepresentingbetween43.6%and92.3%indifferentWHOregions.

IntheSouth-East(SE)AsiaRegion,theproportionofdeathsamongthetotalduetoCOVID-19diseaseamongthoseaged65yearsandabove,rangedfrom49.2%to100%in2020–2021(eightreportingcountries),and43.6%to59.5%in2022–2023(threereportingcountries).Theagegroupof65yearsandabovestillrepresentsthegroupsmostaffectedbyCOVID-19deaths.

CurrentWHOglobalrecommendations

Atthe15thmeetingoftheIHREmergencyCommittee,theWHODirector-Generalannouncedtheterminationofthepublichealthemergencyofinternationalconcern(PHEIC)on5May2023,andissuedtemporaryrecommendationstoallStatesParties.

On2November2023,WHOpublishedandupdatedthe“WHOSAGERoadmapforprioritizingusesofCOVID-19vaccines”document

1

andthe“Goodpracticestatementontheuseofvariant-containingCOVID-19vaccines”toaccountfornovelmonovalentXBBvariantvaccines,on2November2023.

2

TheupdatedroadmapprovidedforconsiderationofnovelmonovalentXBBvaccinesinrelationtotimingandfrequencyofrevaccinationintervals,andprimaryimmunizationschedules(considerationofsimplifiedposology).

Giventhatmostofthepopulationhashadatleastonesevereacuterespiratorysyndromecoronavirus(SARS-CoV-2)infection,theroadmapalsorecommendsasimplifiedvaccineschedule.Termssuchas“initialdoses”insteadofprimaryseriesarenowusedtoreflectthefactthatmostofthepopulationhasbeenprimed.Insteadofboosterdoses,WHOnowalsorefersto“re-vaccination”.Theroadmapalsoproposesthefollowingprioritygroups:

highpriority-usegroups:oldestadultsandolderadultswithmultiplecomorbidities,andpersonswithsevereimmunocompromisingconditions.

mediumpriority-usegroups:healthyadults(18to49or18to59years)andchildrenandadolescentsaged6monthsto17yearswithsevereobesityoracomorbidity.

lowpriority-usegroups:healthychildrenandadolescentsaged6monthsto

17years;and

subpopulationswithspecialconsiderations:pregnantwomenandadolescentsandhealth-careworkerswithdirectpatientcontact.

1

/publications/i/item/WHO-2019-nCoV-Vaccines-SAGE-Prioritization-2023.1

2

/publications/i/item/WHO-2019-nCoV-Vaccines-SAGE-Variants-2022

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StatusofCOVID-19vaccinationintheRegion

Starting13January2021,10countriesintheSEAsiaRegionintroducedCOVID-19vaccinesandcollectivelyadministeredmorethan3.36billiondosesofCOVID-19vaccinesreachinghighcoverages.

SinceAugust2023,theMemberStatesoftheRegionfaceseveralchallengeswithCOVID-19vaccination.AscountriesconsiderifandhowtocontinueCOVID-19vaccineroll-out,theymustaddressseveralcurrentchallengesandmusthaveaccesstoadequateinformationonthefollowingaspectsfordecision-making:

(1)WHOSAGEpolicyrecommendationsandGaviCOVID-19vaccinesupport

•WhatarethevaccinessupportedthroughtheGaviCOVID-19vaccineprogramme?

•WhatistheavailabilityofthecurrentlylicensedCOVID-19vaccines?

•Incaseofanyoutbreaks,whatoptionsareavailableforcountriestoaccesstovaccines–isthereaglobalstockpile,andhowcancountrieshaveaccesstothis?

(2)CurrentlandscapeofCOVID-19vaccines

•WhatisthecurrentpolicyofWHOonCOVID-19vaccineauthorizationatthegloballevelandatthecountrylevel?

•WhatisthecurrentpolicyofWHO(targetproductprofile)onvaccinecomposition?

•WhatisthecurrentlandscapeofCOVID-19vaccines,including:

oWhichvaccineshavemovedfromemergencyuselisting(EUL)toprequalification(PQ)?

oWhichvaccinesarestillEULandwhenisthetimelineforthemtoreceivePQorphaseout?

oWhichvaccinesusedduringthepandemicarenolongerbeingmanufacturedafterexpirationofEUL?

oWhataretherecent/newCOVID-19vaccinesandwhichonesareinthepipeline?

oHowdothesecomparewithordifferfromvaccinesusedduringthepandemicresponseintermsofformulations/variantstargeted?

oWhenwillthesevaccineshavevaccinevialmonitors(VVM)?

(3)COVID-19vaccinesafetymonitoringandresponse

•WhatdoweknowaboutthesafetyofcurrentlyornewgenerationCOVID-19vaccines?

•HowdoesthesafetyofCOVID-19vaccinespost-PHEICcomparewiththoseusedduringthepandemicperiod?

•ArethenewgenerationCOVID-19vaccinessafe/saferforSAGEhigh-riskgroups/subpopulationswithspecialconsiderations?

•WhatshouldcountriescontinuetodotomonitorCOVID-19vaccinesafety?

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(4)COVID-19vaccineeffectiveness(VE)

•WhatisknownabouttheeffectivenessofnewgenerationCOVID-19vaccinesorthosecurrentlyinuse?

•IsthereadequateinformationontheVEofCOVID-19vaccinesinthePHEICperiodandhowdoesitcomparewiththeVEofvaccinesusedinthepandemicperiod?

•Howdoestheeffectivenessofthesenewvaccinesinthehigh-riskgroups/specialsubpopulations,comparewithothergroups?

•HowdoesVE(benefits)currentlycomparewithrisksofvaccination?

(5)Demandgenerationandriskcommunication,

•WhatarethecurrentcommunicationchallengeswithCOVID-19vaccination?

•Howcandemandgenerationbetailoredtomeettheinformationneedsofhigh-riskgroupsandspecialsubpopulations?

•Howcandemandgenerationbeintegratedintocurrentroutineimmunizationandprimaryhealthcare(PHC)communication?

•Whatshouldcountriesplanforinresponsetoacuteeventsintheirriskcommunicationplans?

•Howcancountriesbestidentifybarrierstovaccinationincludingvaccinehesitancyanddeliverystrategy?

•WhatarethekeytakeawaystopromoteCOVID-19vaccinationinhigh-riskgroups/specialsubpopulations?

(6)MonitoringCOVID-19vaccinedeliveryandtransitionofreporting

InviewoftherecentchangestoCOVID-19vaccinepoliciesandprogrammesundertheupdatedWHO“RoadmapforprioritizingusesofCOVID-19vaccines”,WHOandpartnershaverevisedtheminimumsetofCOVID-19vaccination-relateddatarequestedforreportingtoWHO.Theisarevisedfrequencyofreportingfrommonthlytoquarterly.ThisprocesswasaimedateffortstoreducethereportingburdenofMemberStates.CountriesoftheSEAsiaRegionneedtobebriefedonthesechanges.

(7)IntegrationofCOVID-19vaccinationintoPHC/RIactivities

CountriesthatarecurrentlyconductingCOVID-19vaccinationorplantodosoarefacedwiththeissueofhowtointegratetheseactivitiesintotheirroutineimmunization(RI)activitiesandotherPHCactivities.Countrieshavevariouslevelsofsuccessinintegrationandmustaddressthechallengesexistinginitsimplementationrelatedtoavailabilityofvaccinationstaff,addedworkloadandincreasedtimeofvaccinationservices,aswellasoperationalcostsfortheintegration.Moreover,itisuncertainhowfarcountriesshouldpushforthisintegrationagendaespeciallywithvaccinesbeingwithdrawnandunavailabilityofCOVID-19vaccines.SharingtheexperienceandpublisheddocumentsoncountrieswhichhavesuccessfullyintegratedCOVID-19inRIorotherPHCservicesishelpfultothecountries.

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2.Objectivesofthemeeting

Thegeneralobjectiveofthemeetingwastoprovidetechnicalsupporttoinformdecision-makingontheneedandstrategiesforcontinuedCOVID-19vaccinationroll-outandtomakethetransitioninCOVID-19vaccinationmonitoring.

Thespecificobjectiveswereto:

•Briefparticipantsonthefollowingtopics:

oCurrentepidemiologyofCOVID-19diseaseintheRegion.

oStatusofCOVID-19vaccinationintheRegion.

oCurrentlandscapeofCOVID-19vaccinesandlicensing/marketingauthorization.

oCOVID-19vaccinesafety–monitoringandresponse.

oCOVID-19vaccineeffectivenessupdates.

oDemandgenerationandriskcommunication.

oMonitoringandreportingofCOVID-19vaccinedelivery.

oPromotingintegrationofCOVID-19vaccinationintoPHC/RIactivities.

•IdentifywaysforwardtosupportCOVID-19vaccinationintheMemberStates.

3.Organizationofthemeeting

Themeetingwasheldvirtually.AllsessionsoftheworkshopweremadelivethroughZoom.Thelinksweresharedwithallrelevantpartnersandstakeholdersbeforethemeeting.ItwasattendedbyofficialsfromministriesofhealthincludingNationalImmunizationProgrammetechnicalofficersanddatamanagers–Bangladesh(02),Bhutan(02),India(03),Indonesia(03),Maldives(03),Nepal(03),SriLanka(02),Thailand(03)andTimor-Leste(02).

FromWHOcountryoffices,theimmunizationandWHEtechnicalfocalpersonsanddatamanagersattendedasfollows:Bangladesh(04),Bhutan(01),India(03),Indonesia(02),Maldives(03),Myanmar(03),Nepal(03),SriLanka(02),Thailand(01)andTimor-Leste(06)

Representativesofpartneragenciesattended.FromtheUNICEFcountryofficesinMemberStatesoftheSEAsiaRegion,thefollowingattended:Bangladesh(2),Bhutan(1),DPRKorea(1),India(2),Indonesia(2),Myanmar(1),Nepal(1),SriLanka(1)andTimor-Leste(1).AlsoattendingwereparticipantsfromUNICEFheadquarterssupplydivisionandUNICEFregionaloffices(6),andfromGavi,theVaccineAlliance(02).

FromWHOheadquarters,seventechnicalofficersattended.ThesecretarialsupportwasprovidedbytheWHORegionalOffice.ThelistofparticipantsisprovidedinAnnexure3.

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ThefacilitatorsincludedcamefromGavitheVaccineAlliance(02)andUNICEF(01);fromWHOheadquarters(07)andfromtheWHORegionalOfficeforSouth-EastAsia(02).

Theone-daymeetingwasorganizedaroundthefollowing10agendaitems(seeAnnexure1fortheagendaofthemeeting):

RegionaloverviewofCOVID-19diseaseepidemiology.

RegionaloverviewofCOVID-19vaccination,challengesandthewayforward.

SAGEroadmapoverview.

GaviCOVAXprogrammesupportandCOVID-19availability.

CurrentlandscapeofCOVID-19vaccinesandvaccinelicensing.

COVID-19vaccineeffectiveness.

COVID-19vaccinesafetymonitoringandresponse.

Demandgenerationandriskcommunicationresponse.

COVID-19vaccinationmonitoringtransition.

IntegrationofCOVID-19vaccinationintoPHC/RIactivities.

4.Proceedingsofthemeeting

Pre-meetingpreparatoryactivities

Toensurethesuccessfulconductoftheworkshop,allMemberStatesandtherepresentingparticipantswereprovidedwiththemeetingagenda,PRSEAHinformationnote,meetinglinks,andadministrativeannouncements.

Participantswerealsoprovidedwithotherreferencedocumentsreferredtoduringandafterthemeeting.Theseincluded:

(1)WHOSAGERoadmapforprioritizingusesoftheCOVID-19vaccines.AvailableontheSAGEwebsite:

/publications/i/item/WHO-

2019-nCoV-Vaccines-SAGE-Prioritization-2023.1

(2)Goodpracticestatementontheuseofvariant-containingCOVID-19vaccine.Publishedon2November2023andfoundinthislink:

/publications/i/item/WHO-2019-nCoV-Vaccines-SAGE-

Variants-2022.1

(3)WHO’simplicationontheEmergencyUseListingofCOVID-19vaccinesafterthePublicHealthEmergencyofInternationalConcernwasdeclaredover;21June2024.

(4)WHO’sresultsofCOVID-19vaccineeffectivenessstudies:anongoingsystematicreview;updated13June2024.

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Openingsession

TheworkshopwasopenedbyDrSumanRijal,DirectorCDS.Hewelcomedtheparticipantsanddeliveredtheopeningremarks.

DrSumanRijalthenrequestedDrVinodBura,CoordinatorIVD,tooutlinetheobjectivesofthemeetingandtofurthercoordinatethemeeting.

Technicalsessions

ThetechnicalsessionscoveredvarioussubjectsincludingtheRegionaloverviewofCOVID-19diseaseepidemiology,theRegionaloverviewofCOVID-19vaccination,challengesandthewayforward,apresentationontheSAGEroadmapoverview,GaviCOVAXprogrammesupportandCOVID-19availability,currentlandscapeofCOVID-19vaccinesandvaccinelicensing,COVID-19vaccineeffectiveness,COVID-19vaccinesafetymonitoringandresponse,demandgenerationandriskcommunicationresponse,COVID-19vaccinationmonitoringtransitionandintegrationofCOVID-19vaccinationintoPHC/RIactivities

Themeetingchatwasretrieved,andthequestionsandanswersweresharedwithparticipants.Thesewereasfollows:

OnCOVID-19policies

Additionaldocumentshared:thisisthelinktotheWHOresource,summarizingthelatestonCOVID-19vaccines/vaccinationtosupportcountrydecision-making:

/publications/m/item/considerations-to-inform-country-covid-19-

vaccination-decision-making

Question:AreCOVID-19vaccinescontraindicatedforHIVpatients?WhichCOVID-19vaccinesarerecommendedfortheimmunocompromisedpatientsasperSAGE?

Response:COVID-19vaccinesarestronglyrecommendedinpatientswithHIV,especiallyiftheyareimmunocompromised.

OnCOVID-19vaccineprocurementsupport

Question:IunderstandthatGAVIwilldiscontinuetheCOVID-19programme.Isthisfrom1January2025onwards?

Response:Thecountryrequestfortheyear2024willbeviablefor2025andtheprogrammerunsthrough2025.CountriesshouldworkwiththeirUNICEFcounterpartstoplanthetimingofdeliveries.

OnCOVID-19vaccinationdemandgeneration

Question:ThepublicperceptionforgettingCOVID-19vaccinehasbeenbadlyaffectedafterthepandemicsituationhasscaleddown.Whilehealthpromotionwillplayaroletoaddresstheaboveissue,whatistheexperienceofothercountriesinpromotingdemandinsuchsituations?

Response.(Thisquestionwasaddressedinthepresentation.)Thisreportprovidessomecountryexamples:

/global-vaccine-demand-

event-final-report-2/

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TherearealsootherusefulresourcesintheDemandHubwebsiteknowledgebase,inthecategoryforCOVID-19:

/knowledge-

base/?_category=covid-19

OnCOVID-19vaccinesafetymonitoring

Question:Therateestimatesofseriousadverseevents.Doweknowforhowlongpopulationshavegenerallybeenfollowedtocapturetheseevents?

Response:ThereisnouppertimelimitforAEFIreporting–allcasesthatarebroughttothenoticeofthehealthsystem(evenafteroneormoreyears)canbereported.ThisisdonetoaddresslatereportedAEFIcases,e.g.BCGlymphadenitis,VAED,etc.

Closingsession

Intheclosingsession,DrVinodBurathankedallthefacilitatorsfortheinformationprovidedandtheparticipantsfortheirattendanceandattention.HerequestedtheparticipantstoexploitthedetailedmaterialtobesharedwiththemandtoreverttotheRegionalOfficefocalpersonforanyfurtherclarificationandsupportneeded.

5.Technicalsessions

Thetechnicalsessionshadpresentationsinthefollowingareas:

RegionaloverviewofCOVID-19diseaseepidemiology:Inthissessionthefollowingitemswerecovered:numberofconfirmedCOVID-19casesintheWHOSEAsiaRegion(asof1July2024),incidenceofconfirmedCOVID-

19casesanddeathsinMemberStatesoftheSEAsiaRegion,distributionofCOVID-19cases(confirmedandprobable)byagegroups,2020–2021and2022–2023,epidemiologicalassumptionsofpossiblescenariosofthepandemictrajectory,WHO’sconceptfortransitionfromacutepandemicresponsetosustainedcontrol,SARS-CoV-2andinfluenzadetectionsfromsentinelsitesintheSEAsiaRegion,globalprevalenceofSARS-CoV-2variantsasof17June2024,numberandproportionofSARS-CoV-2variantsofinterest(VOI)andvariantundermonitoring(VUM)sequencessubmittedtotheGlobalInitiativeonSharingAllInfluenzaData(GISAID),wastewatermonitoringforSARS-CoV-2viralactivityinIndia,COVID-19deathsbyagegroups,andpopulationimmunityasatrajectorydeterminant(seroprevalenceestimates).

RegionaloverviewofCOVID-19vaccination,challenges:ThisincludedatimelineofCOVID-19vaccinationroll-outandrecommendationsoftheImmunizationTechnicalAdvisoryGroup(ITAG),resultsoftheJanuary2024surveyofCOVID-19vaccinationpoliciesandstrategiesinMemberStates,includingtheirpoliciesonhigh-riskgroups,revaccination,intervals,COVID-

19vaccinetypesandsourceofvaccines,andintegrationwiththeExpandedProgrammeonImmunization(EPI)andPHCactivities.ItalsocoveredtheQ12024electronicJointReportingForm(Ejrf)COVID-19vaccinationdataandthecurrentchallengeswithCOVID-19vaccination.

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SAGEroadmapoverview:SAGEMeeting(March2024):KeymessagesandexplanationoftheWHOinterimrecommendationsfortheoptimaluseofCOVID-19vaccines.

GaviCOVAXprogrammesupportandCOVID-19availability:ThisincludedapresentationbyGavi,theVaccineAllianceontheStatusofCOVID-19programme,2025applicationprocessandkeydates,andapresentationbyUNICEFondeliveriesthroughUNICEFtocountriesoftheSEAsiaRegionin2024andvaccinessupportedthroughtheGaviCOVID-19vaccineprogrammein2024and2025.

CurrentlandscapeofCOVID-19vaccinesandvaccinelicensing:ExplainedthenotionsofWHOrequalification(PQ)andWHOEmergencyUseListing(EUL)assessment,EmergencyUseListingprinciples,ProgrammaticSuitabilityforPQ(PSPQ)forCOVID-19vaccines,andthehighlightsofCOVID-19vaccinesunderEUL.

COVID-19vaccineeffectiveness:ExplainedthenotionofeffectivenessofCOVID-19vaccinesandpresented599COVID-19vaccineeffectivenesscovering52countries,whichhavebeenincludedinalivingsystematicreviewasof26June2024.PresentedtheglobalvariantdistributionduringtheCOVID-19pandemic,andansweredthefollowingquestions:WhatistheeffectivenessofaCOVID-19vaccineagainstJN.1withinthreemonthsafteratleastonerevaccination(previouslybooster)/,byoutcome?WhatistheeffectivenessofaCOVID-19vaccineintheJN.1periodovertime?WhatistheeffectivenessofaCOVID-19vaccineagainstJN.1versusXBBwithinthreemonths?WhatistheeffectivenessofaCOVID-19vaccineagainstseverediseaseduringOmicroninpopulationsofspecialinterest?Itconcludedthatcurrently,comparedtothePHEICperiod,protectionagainstalloutcomesislowerforOmicronthanforDelta.Secondly,despiteantigenmismatch,XBBboostersprotectagainstJN.1symptomaticandseveredisease,anddeathbutlessthanthatagainstXBB.Thirdly,protectionwanessomewhatby3–4months,andolderadults,children,immunocompromisedandhealth-careworkersareprotectedagainstseverediseaseduringOmicronbuttherearefewstudiesonhealth-careworkersandimmunocompromised.

COVID-19vaccinesafetymonitoringandresponsehadtwobroadtopics:COVID-19vaccineadversereactionsandtheSEAsiaRegionalAEFISurveillancePerformance.AEFIreportedtoVigibase–COVID-19vaccine,RateestimatesofseriousadverseeventsforwhichthereisalikelycausallinkwithaCOVID-19vaccineplatform,WHOGACVSandSAGErecommendationsonsafetyofallvaccinesagainstCOVID-19,EstimatedobservedratesofmyocarditisandmyopericarditisfollowingBNT162b2andmRNA-1273vaccinesbyagegroup,dosenumberandsex,WHOGACVSandSAGErecommendationsonmRNAvaccines,OtheradverseeventsofspecialinterestfollowingmRNACOVID-19vaccines.ThepresentationonSEARAEFISurveillancePerformance.AEFIreportedtoVigibaseincludedcountriesreportingseriousadverseeventsintoVigibasein2020,2021and2022,thechallengesandopportunitiesfortheSEAsiaRegion.

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Demandgenerationandriskcommunicat