Type2 Vaccine-Derived Poliovirus (VDPV2) and Type 2 Wild Poliovirus (WPV2)

MONOVALENTORALPOLIOVACCINETYPE2(mOPV2)VACCINEREQUESTFORM

for the response to

type2 vaccine-derived poliovirus (VDPV2) and type 2 wild poliovirus (WPV2)

Version 2, Dec 2016

Introduction

Followingglobal withdrawal of oral polio vaccinetype 2 (OPV2) from national immuniza tionprogrammes,aconfirmedtype2eventwillbeconsideredapublichealthemergencyofinternationalconcern(PHEIC).TheWorldHealthOrganization(WHO),incollaborationwiththeUnitedNationsChildren’sFund(UNICEF)SupplyDivisionandvaccinemanufacturers,hasestablishedastockpileofmOPV2thatcanbeprovidedrapidlytoMemberStatesfollowingdetectionofapoliovirustype2.Inlinewiththeguidelinesforatype2outbreakresponseinthisprotocol,countriesshouldfilethisrequestformformOPV2forsupplementaryimmunizationactivities(SIA).TheAdvisoryGrouponmOPV2provisionwillreviewtherequestandmakerecommendationstotheWHO Directorof the Polio ProgrammewhowilladvisetheWHODirector-GeneraltoauthorizethereleaseofmOPV2.

Inmostsituations,detectionofatype2vaccine-derivedpoliovirus(VDPV2)ortype2wildpoliovirus (WPV2)willinitiallyrequireasmall-scalerapidvaccinationresponseusingmOPV2within14daysofreceivingthelaboratorysequencingresults.Thescope,thenumberofdosesandthevaccinetyperequiredforfurthersupplementaryimmunizationactivitiesSIAswilldependonlocalriskfactorsandadditionalfieldandlaboratoryinvestigations.(See“Respondingtoapolioviruseventandoutbreak:SOPforpoliovirustype2”1. Inorder toensurean efficientand rapidprocess,thevaccinewillberequestedintwostages:

•Stage1coversonlymOPV2requiredforthefirstroundofsupplementaryimmunizationactivities (SIA)andshouldbefiledwithWHOwithin24hoursofreceivingthevalidatedsequencingresults.

•Stage2coversmOPV2requirementsforallfurtherplannedSIAsroundsandshouldbefiledwithWHOonlyafterconductingfurtherinvestigation,finalclassificationoftheisolateifnecessary,andcompletedresponseplan.Aimtosubmitthisstage2requestbyday14followingreceiptofthesequencingresults.IfIPVisrequired as part of the outbreak response plan,please use the separate request form forIPV,syringesandsafetyboxes.

The signed vaccine requestform and requireddocumentation should be sentto:

theAdvisoryGrouponmOPV2ProvisionSecretariatat:

20AvenueAppia,1211

Geneva27,Switzerland

Fax:+41227914198

Email:

CC: WHO country office, UNICEF Supply Division (; )

1 Responding to apoliovirus event and outbreak- Standard Operating Procedures (SOPs).

Checklist

1. Request form completed and signed / Yes
2. Vaccine acceptance letter signed and attached / Yes / Pending
3. Laboratory reports initial case (stage 1) / Yes / Pending
4. Field investigation reports / Yes / Pending
5. Laboratory reports of additional cases (stage 2) / Yes / Pending
6. Immunization response plan / Yes / Pending
7. Authorization from the national regulatory authority or ministry of health to import and use mOPV2 / Yes / Pending
8. If pending, then expected date of receiving formal acceptance / ___/____/____
9. Risk assessment report / Yes / Pending
10. Map with dots representing the location of the case(s) or site of environmental sampling / Yes / Pending
11. Other(specify):

NoticeforrecipientcountriesofmOPV2

WHOuse and release ofmOPV2

WHOwillprioritizetherequestsforvaccinesfromtheglobalmOPV2stockpilebasedontherecommendationsoftheAdvisory Group on mOPV2 provision composed of EradicationandtheOutbreakManagementGroup(EOMG) members and independents experts.ThedecisionandtheAdvisory Group on mOPV2 provision recommendationwillbebased onepidemiologicalconsiderations,thelaboratoryinformationprovided,thetotalnumberofdosesrequestedfromWHO,thetotalnumberofdosesintheWHOmOPV2stockpile,andtheprioritizationoftherequestsreceivedbyWHObasedoncountries’needs.Inthisregard,itshouldbenotedthatthesubmissionofthisrequestformdoesnotautomaticallymeanthatWHOwillsupplyanyvaccinetothe requestingcountry,orthatWHOwillsupplythequantitiesrequested,orthatWHOwillsupplythevaccinebytherequesteddeliverydate.Thedecisionwhethertosupplyanyvaccinetothecountry,andinwhichquantities,willbetakenbytheWHODirector-GeneralinitssolediscretionbasedontherecommendationsoftheAdvisory Group on mOPV2 provision andtheabove-mentionedconsiderations.Detailsregardinganysupplyofvaccine,includingthequantitiesandlogistics,suchasanticipated deliverytimelinesanddestinations,willbecommunicatedbyWHOtothegovernmentat thecontactdetailsindicatedinthisrequestform.Theministerofhealthmustcompleteandsignthe vaccine request form, then returnthecompletedsigned requestformalongwiththerequiredacceptance letter authorizingtheimportationanduseofmOPV2(seebelow).

Country acceptance to authorizeimportationanduseofmOPV2

mOPV2hasbeenprequalifiedbyWHOandapprovedbyastringentnationalregulatoryauthoritywithjurisdictionoverthefacilitywherethevaccinehasbeenmanufactured.mOPV2isintendedforemergencyuseasaresponsetoatype2outbreakoreventfollowingtOPVwithdrawal,andhasnotbeenlicensedinthecountry.Countriesthatareexperiencingatype 2outbreakorevent,andthatarerequestingforthereleaseofmOPV2supplyfromtheglobalmOPV2stockpile,arestronglyadvisedtoauthorizetheimportationbasedonWHOpre- qualificationand/orprovideanemergencywaiverforuseofthevaccinefortheemergencyresponse. Any delays in authorizing its importation and use will delay the procurement and delivery of the vaccine to the country, thereby delaying the required 14 day outbreak response inlinewiththeGPEISOPs for Responding to poliovirus event and outbreak. To enableUNICEFtoissuea purchaseordertothemanufacturer,thecountrymustsubmitalettertoauthorizeimportationanduseofthevaccine.InAnnexAisprovidedatemplateletterwhichshouldbecompleted andcopiedonaMinistryofHealthletterhead.Thisacceptance letterforauthorizationtoimportandusemOPV2mustbesignedbyadesignatepersonintheministryofhealthornationalregulatory authority.

UNICEF will provide this letter to the manufacturer to initiate packing of the goods andclearthevaccineconsignmentfordispatch.Thelettertoauthorizethemanufacturertosendthevaccinemustbeprovidedatthetimeofsubmissionofthedulysignedandfilledvaccine requestformtoavoiddelaystosupplythevaccineinordertostartthefirst roundofsupplementaryimmunizationactivitieswithin14days.

Waiver for special shipping documentation and/or pre-inspection requirements

Inordertomeetdeliverytimelinestothecountry,thesupplierwillonlyincludethestandardlistofdocuments requiredforinternationalvaccineshipment:thepackinglist,shippinginvoice,andstandardlot releasecertificateprovidedbythenational regulatoryauthorityoftheproducingcountry.Countriesare requestedtowaivenon-standarddocumentation requirements(suchasoriginalcertificatesoforigin,consularlegalisationandstampsinspecificcolors),aswellaspre-inspection requirements.Shouldacountrycontinueto requireadditional,non-standarddocumentation,providedthatthemanufacturerisableandwillingtoprovidesuchadditionaldocuments,orpre-inspection,thenthecountryacceptsthe responsibilityforanydelaysindeliveryofthevaccine.

Physical inspection of consignment after delivery

PhysicalinspectionandverificationofthemOPV2consignmentshallbemadebythecon- signeenamedinthis requestformand/oritsdesignatedauthorized representative,usingthe vaccine arrival report (VAR) accompanying the shipment. The VAR should be returned within 24hoursafterdeliverytoensuretimelyactioniftheconsignmentdoesnotconformtothe requirements.Iftheconsignee,inconsultationwiththeWHOcountryoffice, reasonablydeterminesthat,intermsoftheaspectssetoutinthe VAR,allorpartofthevaccineconsignmentdoesnotconformtothe requirements,theconsigneeshallimmediatelynotifyWHO andUNICEFofthenon-conformity.

Generalinformation

Dateofthe request:stage1:
Dateofthe request:stage2:
Country:
Outbreak-affectedregion/state:
Outbreak-affectedareas(towns/districts):
Extendedareawithhigh-risk
subpopulation region/state:
Extendedareawithhigh-risk
subpopulation(towns/districts):
Requestinggovernmentministry/department:
Contactdetailsoffocalpeopleinrequestinggovernmentministry/department
(name,telephone,email):
NAME / PHONE / EMAIL
Nameandtitleofthepersonwhofillsthisform:
NAME / TITLE

Signatureofpersonwhocompletesthisform:

Consigneeinthecountry
Consigneeorganization*
Contactname
Telephone
Fax
Email
Address
PObox
Town
Country

*Thegovernmentwillbe responsibleforhandlingtherapidimportationandcustomsclearanceofthevaccineintothecountry,unlessUNICEFisexceptionallynamedinthepurchaseorderastheconsigneeforcustomsclearancepurposes.

Vaccinationplanandvaccinesuppliesrequirements

Notice: SeeGPEI SOPs Respondingtoapolioviruseventandoutbreaktodeterminethetypeofvaccine,sizeoftargetpopulationandnumberofsupplementaryimmunizationactivitiesrecommendedforeachsituation.

1-Firststageofvaccinedeploymentincaseoftype2detection(first supplementaryimmunizationactivity):SIAround1inrapid-responsearea(startingdate//__)

Immunization plan for SIA round 1

ProvinceDistrict / City/town/locality / Targetagegroup / Targetpopulation(number)

mOPV2 requirement for SIA round 1

Totaltargetpopulation(number) / Numberofdoses / Wastagefactor / TotalmOPV2doses
1 / 1.15*

* If different wastage factor is used please provide supportive document e.g.vaccine wastage studies or monitoring exercise conducted in selected provinces/districts

2 Responding to apoliovirus event and outbreak- Standard Operating Procedures (SOPs).

2-Secondstageofvaccinedeploymentaftertype2detection(alladditionalsupplementaryimmunizationactivities):SIAround2inoutbreak-affectedarea(startingdate//____)

Immunization plan for SIA 2

TargetageTargetpopulationProvinceDistrictCity/town/locality group (number)
Outbreak-affectedarea(includesrapid-responseareaplussurroundings)
Total
Extendedareawithhigh-risksubpopulation(ifrequired–seeProtocol)
Total

mOPV2 requirement for SIA 2 in outbreak-affected area

Targetpopulation(number) / Wastagefactor / TotalmOPV2doses
1.15

3-SIAround3(startingdate//____)

Immunization plan for SIA round 3

TargetProvinceDistrictCity/town/locality agegroup / Targetpopulation(number)

mOPV2 requirement for SIA round 3

Targetpopulation(number) / Wastagefactor / TotalmOPV2doses
1.15

4-SIAround4(startingdate//____)

Immunization plan for SIA round 4

ProvinceDistrict / City/town/locality / Targetagegroup / Targetpopulation(number)

mOPV2 requirement for SIA round 4

Targetpopulation(number) / Wastagefactor / TotalmOPV2doses
1.15

5-SIAround5(startingdate//____)

Immunization plan for SIA round 5

ProvinceDistrict / City/town/locality / Targetagegroup / Targetpopulation(number)

mOPV2requirementforSIAround5

Targetpopulation(number) / Wastagefactor / TotalmOPV2doses
1.15

Caseidentificationandlaboratoryinvestigationreporting

1-Firststageofvaccinedeploymentincaseoftype2detection(SIA1)

Laboratoryreportingforhumanspecimens

Address of laboratory for virus isolation:
TEL / FAX
Name of responsible person:
Email:
Ifdifferent,addressoflaboratoryforsequencing:
TEL / FAX
Name of responsible person:
Email:

Case identification

Province: / District:
EPID no. / Patient name / Village/locality / Gender / Date of birth
DD/MM/YYYY / Age
(months) / Total
doses of
OPV / Total
doses
of IPV
received / Date of
paralysis
onset / Date of
last stool
collection
samples
M / F

Laboratory report

Province: / District:
EPID no. / Specimen
ID / Source / Polio type 2 category / Nucleotide
Changes / EPID no.
Of VDPV
Closest
match / Comment
AFP / Contact / Healthy / Other / Pending classification / cVDPV2 / aVDPV / iVDPV2 / WPV2

Reporting laboratory for environmental sample

Address of laboratory for virus isolation:
TEL / FAX
Nameofresponsibleperson: / Email:

Laboratory report

Environ-mental
sample
site code / Environ-
mental
sample
collec-tion site
name / EPID no. / Speci-
men ID / Date collected
(DD/MM/YY) / VDPV2 category / Nucleotide
changes / Date of classification
(DD/MM/YY) / EPID no.
of VDPV
closest
match / Comment
Pending classification / cVDPV2 / aVDPV / iVDPV2 / WPV2

2- Secondstageofvaccinedeploymentincaseoftype2detectionSIA2–4+(additionalinformationobtainedsincestage1request)

Case identification

Reporting laboratory for human sample(s)

Address of laboratory for virus isolation:
TEL / FAX
Nameofresponsibleperson: / Email:
Ifdifferent,addressoflaboratoryforsequencing:
TEL / FAX
Nameofresponsibleperson: / Email:

Laboratory report

Province: / District:
EPID no. / Specimen
ID / Source / VDPV2 Category / Nucleotide
Changes / EPID no. of
VDPV closestmatch / Comment
AFP / Contact / Healthy / Other / Pending classification / cVDPV2 / aVDPV / iVDPV2 / WPV2

Reporting laboratory for environmental sample(s)

Address of laboratory for virus isolation:
TEL / FAX
Nameofresponsibleperson: / Email:

Laboratory investigation reporting of environmental sample(s)

Riskassessment

DPT3coverageatnationallevelinpastthreeyears:

2013 / 2014 / 2015

DPT3 coverageinaffected districtinpastthree years:

2013 / 2014 / 2015

Below, characteristicsofthecurrentlyaffecteddistrict(orsubnationallevel):

High birth rate: / Yes / No / NA
Populationdensity: / Urban / Rural / Mixed
DatelastpolioSIA:(dd/mm/yyyy):
Targetage:
Vaccine used (check all that apply): / tOPV / bOPV / IPV / mOPV2
Totaltargetpopulation(number):
Estimated population coverage: / %
Otherpopulationcharacteristicsintheaffecteddistrict:
Refugee camps: / Yes / No / NA
Ongoing conflict: / Yes / No / NA
Displacedpopulation: / Yes / No / NA
History of immunizationrefusals: / Yes / No / NA
Recentclustersofadverseeventsfollowing immunization: / Yes / No / NA
Largepopulationmovementsacrossborders: / Yes / No / NA
Others(pleasespecify):

Termsandconditions

ThegovernmentacceptsandagreesthatthesupplyofvaccinefromtheWHOmOPV2stockpilewillbesubjecttothefollowingtermsandconditions:

i.Your government represents and warrants that mOPV2 (hereinafter also “the vaccine”) has been authorized by your government for importation and use in humans in the control of an outbreak or event of poliovirus type 2 in your country.

ii.The vaccine is being supplied to the government exclusively for emergency use under the control of the government, to respond to a WHO-confirmed outbreak of type 2 poliovirus in the country and reported as a public health emergency of international concern. In this connection, the government confirms that it has full knowledge of the known side-effects of the vaccine.1

iii.The vaccine has been licensed by a stringent national regulatory authority in the country of manufacturing and has been prequalified by WHO.2,3 Specifically, the manufacturer of the vaccine has warranted and represented to WHO and UNICEF that for the duration of its shelf-life, the vaccine has been manufactured in accordance with current good manufacturing practices and conforms to the specifications approved by a functional regulatory authority with jurisdiction over the facility where the vaccine has been manufactured; and is of even quality, free from faults and defects in design, material, manufacture and technique.

iv.Except as explicitly otherwise provided herein, the government of the country shall be solely responsible for, and accepts, any and all liability for the use of the vaccine. Specifically, the government of the country agrees to indemnify, defend and hold harmless WHO and UNICEF as well as their officers, employees and agents, for any and all costs, expenses and claims of any kind arising from, as a result of, or in connection with the supply, distribution and/or use of the vaccine in the country, by or on behalf of the government or otherwise.

v.It is understood and agreed that neither WHO, UNICEF nor the manufacturer will accept any liability or responsibility whatsoever for the use of the vaccine in the country if the vaccine has not been authorized by your government for such use.

vi.To the extent that these terms and conditions limit potential liabilities associated with the supplies of the vaccine by or on behalf of WHO and UNICEF, the government expresslyacknowledges that these terms and conditions are for the benefit of WHO and for the benefit of UNICEF, and, therefore, that these terms and conditions create benefits and rights that are directly enforceable not only by WHO, but also by UNICEF on its own behalf (as third-party beneficiary to the terms of this request form).

vii.Ownershipof,andriskofdamagetoandlossof,thevaccinewilltransfertothegovernmentuponavailabilityofthe vaccine FCA Brussels Airport for loading by the UNICEF designated freight forwarder; however, UNICEF will take out insurance covering the value of the goods during the transport to the recipient country. The government will be responsible for handling the rapid importation and customs clearance of the vaccine into the country (unless it has exceptionally been agreed that UNICEF will handle suchimportation andcustoms clearance).The governmentwill alsobe responsiblefor thephysical inspection of the vaccine quantity, using the vaccine arrival report(VAR)4 accompanying the shipment, within 24 hours after delivery in the country, adhering to the terms set out in the section “Important notice” of the request form. The government will then be responsible for arranging for any subsequent storage and transportation of the vaccine (under appropriate conditions, including compliance with cold chain requirements5) and ensure its rapid delivery and administration to patients.

WHOvaccine reactionratesinformationsheets.Geneva: WorldHealthOrganization;2016(
VaccinePQ.Geneva:WorldHealthOrganization;2016(

viii.Thegovernmentagreesandwillensurethat:

•thevaccinesuppliedhereunderwillnotbeusedforanypurposeotherthanasprovidedinthisrequestform;

•thevaccinesuppliedhereunderwillonlybeprovidedtopeopleinthecountrywhohavebeenprioritizedinaccordancewiththecountry’soutbreakresponseplan;

•thevaccinesuppliedhereunderwillnotbeexportedorotherwisemadeavailableforuseoutsidethecountry;

•thevaccinesuppliedhereunderwillbeproperlymanagedandstoredduringanoutbreakresponse;

•anyremainingopenandunopenedvialwillbesecurelydisposedofincompliancewithWHOguidelinesonsafedisposalofOPVtype2.6

ix.Inaddition,bearinginmindthattheaforesaidquantityisbeingprovidedtothegovernmentfreeofcharge,thegovernmentwillensurethatthevaccinesuppliedbyWHO willnotbesoldbutwillonlybeprovidedtothetargetedpopulationinthecountryfreeofcharge.

x.Thelabellingandinnerpackagingofthevaccine,aswellasleafletsandouterpackaging,maybeinEnglishand/orotherlanguages.Thepackagingandinsertleafletswillnotbespeciallytranslatedoradaptedtomeetcertainspecificationsorrequirementsbycountriesoutsideof thestandardpackaging andinsertleaflets.

xi.Thegovernmentexplicitlyacceptsandagreeswiththeuseofstandardpackaging,labellingandleafletsasdescribedabove.Thegovernmentwilldistributeanyrelevantleafletstohealth-careprofessionalswhoadministerthevaccine.

xii.The government confirms that it shall ensure that all health-care practitioners and others administering the vaccine to the population of the country:

•arefullyawareof,understandandwillensureadherencetoallrecommendationsfortheproperhandling,administrationanduseofthevaccineascontainedintheabove-mentionedleafletsandtheattachedinformationpackage;

•implementsurveillanceofadverseeventsfollowingimmunizationascontainedin“Globalmanualonsurveillanceofadverseeventsfollowingimmunization”;7

•willhaveputintoplacearecallprocedureasdescribedin“Annex5:gooddistributionpracticesforpharmaceuticalproducts”;8

•willinformallpeopletowhomthevaccinemaybeadministeredofallpossiblesafetyconcerns towhichthevaccinemaygiverise,includingitspossibleside-effectsandknownadverseevents.

xiii.YourgovernmentagreestonotifyWHO,inwriting,assoonas reasonablypossible,ofanyinformation receivedbyitontheoccurrenceofanyseriousadverseevents,anunexpectedlyhighoccurrenceofadverseeventsandanysignificantsafetyinformation with respecttotheuseofthevaccine. Yourgovernmentagreestotransmitsuchinformation by mail to the World Health Organization, Department of Global Vaccine Safety,20 AvenueAppia,1211Geneva27,Switzerland,.

ThepurposeoftheUnitedNationsprequalificationassessmentistoprovideassurancethatcandidatevaccinesmeet WHO recommendationsonquality,safetyandefficacy,includingcompliancewithWHO’s recommendedstandardsforgoodmanufacturingpracticesandgoodclinicalpractice;andthatcandidatevaccinesmeettheoperationalpackagingandpresentationspecificationsofthe relevantUnitedNationsagency.Theaimistoensurethatvaccinesprovided throughtheUnitedNationsforuseinnationalimmunizationservicesindifferentcountriesaresafe,effectiveandsuitableforthetargetpopulationsatthe recommendedimmunizationschedulesandwithappropriateconcomitantproducts(WHOExpertCommitteeonBiologicalStandardization.Sixty-first report.WHO TechnicalReportSeries978.Geneva: WorldHealthOrganization;2013).
See
Vaccinesandbiologicals:ensuringthequalityofvaccinesatcountrylevel.Geneva:WorldHealthOrganization;2002(
Guidance forimplementingthe switch.Geneva:World HealthOrganization;2015 (

xiv.NeitherWHOnoranydirectorindirectsupplierofthevaccinetoWHOorthecountry(includingbutnotlimitedtothemanufacturerand/orUNICEF)willbeliableorheld responsibleforanydelayorfailureinthesupplyofthevaccineasa resultofforcemajeureoractbygovernmentorotherauthoritiesthatmaypreventor restrictWHO and/orany(directorindirect)supplierofthevaccinetoWHOorthecountry(includingbutnotlimitedtothemanufacturerand/orUNICEF)insupplyinganddeliveringthevaccine,orthatmayprecludeor restrictthefreemovementofthevaccinetotheagreedsiteofdelivery.Inaddition,neitherWHOnorany(directorindirect)supplierofthevaccinetoWHOorthecountry(includingbutnotlimitedtothemanufacturer and/orUNICEF)willbeliableorheld responsibleforclosureofairlines,airports,bordersorotherelementsofthetransportationsystemthatmaylimitthefreemovement ofgoodswithinorbetweencountries

xv.Anymatter relatingtotheinterpretationandapplicationofthis requestform,whichisnotcoveredbyitsterms,willbe resolvedby referencetothelawsofFrance,excludingtheconflictoflawrules.

xvi.Alldisputes relatingtotheinterpretationorapplicationofthepresent requestformthatcannotbe resolvedamicablywillbefinallysettledbyarbitrationtobeconductedinaccordancewiththeRulesofArbitrationoftheInternationalChamberofCommercebyoneormorearbitratorsappointedinaccordancewithsaidRules.ThelanguageofarbitrationshallbeEnglish.Theplaceofarbitrationshallbeagreedbymutualconsent oftheparties,or,intheabsencethereof,shallbeParis,France.Thepartiesshallacceptthearbitralawardasthefinalandbindingadjudicationoftheirdispute.Itisunderstoodandagreedthatexceptfortheenforcementofanyarbitralawardasaforesaid,nothingcontainedinthisrequestformwillbedeemedtosubmitthegovernmenttoanynationalcourtjurisdiction

xvii.Itisfurtheragreedandunderstoodthat:

•thetermsandconditionscontainedinthisrequestformarenotaimedatestablishinganinternationaltreaty,arenotsubjecttointernationallawandarenotintendedtogiverisetoanyrightsorobligationsatinternationallaw;

•nothinginthisrequestformshallbedeemedtoconstituteawaiverofanyprivilegesorimmunitiesenjoyedbyWHOand/orUNICEF,and/orassubmittingWHOand/orUNICEFtoanynationalcourtjurisdiction.

xviii.Thegovernmentagreesthatanysupplyofvaccinesandothermaterials,aswellasanyothersupportandassistancethatmaybeprovidedbyWHOtothecountryinfurtheranceofthisrequestform,willbeprovidedinaccordancewiththetermsoftheagreementfortechnicaladvisorycooperationorassistanceconcludedwiththegovernment

Thetermsandconditionscontainedinthisrequestformareirrevocableandcannotbeamendedorchanged,exceptbymutualagreementofthegovernmentandWHO,including UNICEF,insofarasthebenefitsandrightsof UNICEF in this request form are concerned.

Globalmanualonsurveillanceofadverseeventsfollowingimmunization.Geneva: WorldHealthOrganization;2014(
Annex 5: good distribution practices for pharmaceutical products. WHO Technical Report Series 957. Geneva: World Health Organization; 2010 ( GoodDistributionPracticesTRS957Annex5.pdf)

AnnexA:templateacceptanceletter

[insertletterheadofthecompetentauthority(ministryofhealth)ornationalregulatoryauthority]

[Note: countries should not specify the number of doses in this acceptance letter otherwise suppliers will need to round down the quantities due to the supplier regulatory requirement]

Date://

Subject:acceptanceletterforauthorizingoftheimportationanduseofmOPV2

Onbehalfofthegovernmentof[country],Iherebyconfirmthegovernment’sacceptanceofandagreementwiththetermsandconditionsofthemOPV2vaccinerequestformforresponsetoatype2vaccine-derivedpoliovirus(VDPV2)andwildpoliovirus(WPV2).

IconfirmthatthemOPV2vaccinemanufacturedbyGlaxoSmithKlineBiologicalsinBelgium,andlicensedbytheBelgianNationalRegulatoryAuthority,andprequalifiedbyWHO,isauthorizedforimportingbythegovernmentof [country]foruseinhumansfortherapidcontrol/preventionofpoliovirustype2.

ThisletteristoconfirmtheacceptanceofandauthorizationfortheimportationanduseofthemOPV2vaccinefromGlaxoSmithKlineBiologicalsinthecountrytorespondtothecurrentoutbreakofpoliotype2,andthatprovisionhasbeenmadefortherapidcustomclearanceofthevaccineandimmunization-relatedsuppliesintothecountryallowingformassimmunizationcampaignstobepromptlyimplemented.

Bestregards,

Signed:

Name:

Title: [ministerordesignatewithdelegatedauthoritytosignfortheminister]

Date:

AnnexB:guidingnotestofilltherequestform

1-Checklist

BeforesendingtherequisitiontoWHOheadquarters,makesureyouhaveallthedocumentstosupporttherequisition.Thischecklististohelptoinventoryallthedocumentsattachedtotherequisition.Forthestage1request,ifthefullfieldinvestigation,immunizationresponse planandriskassessment havenotyetbeen completed,tick“pending”.

2-General information

Thevaccinerequestformwillbefilledintwostages:

Stage1

OnceGPLNITDandsequencingresultsareavailable,arapidresponsemustbeinitiatedwithin 14daysusingmOPV2foraminimumtargetpopulationof500000peopleintheaffectedarea.IncaseofVDPV2,theministryofhealthdoesnotneedtowaitforfurtherfieldassessmentorlaboratoryinvestigationtoconfirmacVDPV2,iVDPV2orVDPV2.IftheisolateisaWPV2,thevaccinesandimmunization-relatedsuppliescanbeorderedforbothstagesatonceaftertheinitialrapidassessmentconductedbytherapidresponseteamshowsthereisevidenceofindividualexcretion(foranenvironmentalsample)and/orevidenceofnoexposuretowildvirusinalaboratoryorproductionfacility(acuteflaccidparalysis/humancaseorpositiveevidenceofvirusexcretion).Pleaseenterthedateofcompletionintheformforstage1.

Stage2

Upontheavailabilityoffurtherfieldinvestigationandlaboratorydata(includingGPLNITDandsequencingresultsfromadditionalcontacts,andimmunoglobulintesting)toenablefinalclassificationoftheVDPV2isolate,thestage2requestformcanbecompletedforVDPV2.Bythetimethefirstroundofsupplementaryimmunizationactivitystarts(within14daysfollowinginitialGPLN results),the governmentshould beableto completestage 2of theform inordertoreceivethevaccineontimetoconductround2andsubsequentrounds.(Note:thesecondroundisexpectedtostartwithin30daysfollowingtheinitialGPLNITDandsequencingresults.)Pleaseenterthedatetherequisitionformforstage2iscompleted.IfbothstagescanbefilledwithresultsofinitialGPLNITDandsequencing,thenwritedownthesamedate.

3-Consignee in the country

Theconsigneeorganizationistheministryofhealthorother responsibleministry(unless UNICEF is exceptionally named in the purchase order as the consignee). It will be the responsibilityoftheconsigneetomakeprovisionforthepaymentofthevalue-addedtax(VAT)orhaveataxwaiverinplaceinordertoavoiddelaysinclearingthevaccine.

Insigningthisform,theministryofhealthorother responsibleministryshouldhaveaconfirmationthatthevaccinewillbeclearedrapidlythroughcustomsoncetheconsignmentisinthecountry.AformalacceptanceletterforthemOPV2vaccinesignedbythecompetentauthorityinthe recipientcountryshouldbeattachedtothe requestform.AnnexAprovidesatemplateofacceptanceletterformOPV2. Withoutthisletter,themanufacturerwillnotaccept to dispatchthe vaccine. Itis thereforevery important tohave this lettersigned at thetimethe requestformissenttoWHOtoavoiddelaysofthevaccinedeliveryandtostartimplementingthefirst roundofsupplementaryimmunizationactivities.

4-Vaccine and immunization supplies requirements

Stage 1

The requisitionforthesupplementaryimmunizationactivity round1rapid response roundshould reachWHOheadquarterswithin48hoursafterGPLNITDandsequencing resultsareavailable.Pleaseentertheplannedstartdateofthefirst roundofsupplementaryimmunizationactivities.

Stage 2

EnterthemOPV2 requirementsforeachofthesubsequentsupplementaryimmunizationactivitiesas appropriate. The wastage factor for mOPV2 is 1.15. If you want touse anotherwastagefactor,pleaseprovidejustification,suchasvaccinewastagestudiesormonitoringexerciseinselectedareas.

5-Case identification and laboratory investigation

The tablesforhumansampleandenvironmental samplesarethesameinstages1 and2.

Paragraph A: case identification

Makesureallinformationfortheidentificationofthecaseisfilledinthetable,includingthenameoftheprovinceandthedistrict.

ParagraphB:laboratoryreportingforhumansamples

IfITDandsequencingarenotconductedinthesamelaboratory,thenenterthedetailsofthelaboratorythatperformedvirusisolationandthedetailsofthelaboratorythatperformedthesequencing.Headquartersmayneedtocontacteachlaboratoryforfurtherenquiry.Itisthere-foreimportanttorecordallthecontactdetailsoftheresponsiblepeopleforeachlaboratory.

Whenfillingthedatainthetable,use“–”whendataarenotavailableorapplicable.Indoing so,youconfirmthedataarenotyetavailableorarenotapplicableratherthanbeingamissingdataentry.

Ifyoufillthecolumnlabelled“EPIDno.oftheclosestmatch”withanEPIDnumber,thegovernment confirms circulation of VDPV2 and therefore the government should be able tocompletestages1and2ofthevaccinerequestform.Ifyouareexpendingfurtherfindingsoffieldassessmenttoconfirmcirculationofthevirus,donotwaitandsendtherequisitionstage1.

ParagraphC:laboratoryreportingforenvironmentalsample

Writedownthefulladdressofthelaboratoryandcontactdetailsofthepersonforfurtherenquiryifneeded.Makesureallthecolumnisfilledwithrelevantdataor“–”whennotavail-ableorapplicableforeachsample.Completelaboratoryreportsmustbeattachedandsentalongwiththeform.

6-Risk assessment

Thispartoftherequisitionformistobefilledoncethefieldassessmenthasbeenconductedandisavailable,usuallywithin14daysfollowingthelaboratorynotificationoftype2polio- virusisolatesequencingresults.Provideinformationascompletelyaspossibleandattachthefieldassessment report to be sent along with the request form.