SummaryofthePneumococcalConjugateVaccine(PCV)ProductAssessment
April2017
ThissummaryisbasedonareviewoftechnicalandprogrammaticevidencethatmayhelpcountriesmakePCVproductchoices.Two
productsareavailable:PCV-10andPCV-13.Thisdocumentdoesnotprovideanyrecommendationforproductchoiceandhasnot
yetundergoneformalWHOguidelinereview,soisnotaformalrecommendationfromWHO.Thefullreportcanbefoundhere.
PCVContext&Background
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BothPCV-10andPCV-13havedemonstratedhigheffectivenessandimpactagainstinvasivepneumococcaldisease,pneumonia
andotheroutcomesinarangeofsettings.
VaccineCharacteristics
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ThevaccineformulationofPCV-13includesthreemoreserotypes(3,6A,19A)thanPCV-10.
BothPCV10andPCV13haveaccruedextensivepost-introducitonsafetysurveillancedataandhaveexcellentsafetyprofiles.
PCVPerformance&ImpactConsiderations
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PCV-10andPCV-13haveshowncomparablediseaseimpactfollowinguseinroutineusesettings.
Bothvaccineshaveshownhighefficacyagainstoverallvaccineserotypedisease.Theefficacyforindividualvaccineserotypes
variesquitewidely,withmostserotypeshavinghighefficacy,butsomedemonstratingmodestorlimitedefficacy.
AvailabledataindicatingthatPCV-10providescrossprotectionagainsttwooftheadditionalserotypes(6Aand19A)foundin
PCV-13haspromptedregulatoryagencies,suchastheEuropeanMedicinesAgency,tolabelPCV-10forprotectionagainstthese
types.ThereisinsufficientevidenceavailabletoevaluatetheeffectofPCV-10onserotype3;giventhattheserotypeisnot
includedinthevaccine,efficacyispresumedtobeabsent.
PCV-13wasfoundtobeefficaciousagainstserotypes6Aand19A;thereisinconsistentevidenceofPCV-13onserotype3.
ThereisalmostnodataonPCV-10andPCV-13interchangeabilityorperformanceofmixedproductregimensinindividual
children.ThecurrentWHOpositionpaperindicatesthatimmunizationshouldbecompletedusingthesameproduct.Ifthisis
notpossible,theotherPCVproductshouldbeusedtocompletetheregimen.
Economic&FinancialConsiderations
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StudiesreviewedconcludedthatPCV-10andPCV-13weremorecost-effectivecomparedwithPCV-7ornovaccine.
ComparisonsofeconomicmodelresultsforPCV-10versusPCV-13 aredifficulttomake.Theyvaryacrossstudiesandmaybe
impactedbyuncertaintiesonserotypereplacement(i.e.theincreaseofnon-vaccinetypeincidenceofdiseaseasvaccine-type
diseaseisreducedfollowinguseofthevaccine),herdeffects(i.e.,reduceddiseaseamongunimmunizedpersonsduetoreduced
transmission),cross-protectionfromvaccine-relatedserotypes,andprotectionagainstacuteotitismediafromnon-typeable
Haemophilusinfluenzae(relatedtotheproteincarrierinPCV-10).
Gavi-supportedcountriestakeonahigherlevelofvaccineco-financingastheytransitionoutofGavisupport,thusthecostof
PCV-10orPCV-13inthepost-Gaviperiodshouldbeconsidered.
ProgrammaticConsiderations
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Thedosingscheduleandnumberofdosesrecommendedarethesameforeachproduct.
ThecurrentPCV-10presentation—2-dosevialswithoutpreservative—isexpectedtobereplacedby4-dosevialswith
preservativein2018.PCV-13iscurrentlyavailableinboth1-doseand4-dosevialswithpreservative.
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Thecoldchainvolumeper4dosevialofPCV-10(2.4cm )istwothirdsthatofPCV-13(3.6cm ).
Trainingisrequiredforuseofbothproductspriortointroduction,andifaproductswitchisundertaken.Ifaproductand/or
presentationswitchoccurs,healthworkersmustberetrained,particularlyonthemulti-dosevialpolicyregardinghowlongthe
productcanbekeptafteropening,andtoavoidmissedopportunitiesorexcesswastage.
SupplyConsiderations
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AccordingtoUNICEF,supplyavailabilityforbothPCVproductsissufficienttomeetdemand.BothPCVsuppliers(PfizerandGSK)
haveincreasedproductioncapacitytomeetexistingandnewlyapprovedGavi-countrydemand.
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