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Summaryoforalevidence:DrJohnWoodandDrJames
Robertson,NationalInstituteforBiologicalStandardsand
Control(NIBSC)
27 April 2006
DrJohnWoodandDrJamesRobertsonarePrincipalScientistsintheDivisionofVirologyatNIBSC.DrWood
andDrRobertsonleadtheNIBSC’sinfluenzagroupandtheirresponsibilitiesincludethecontroland
standardisationofinfluenzavaccines.OnbehalfoftheWorldHealthOrganisation(WHO)theNIBSCis
involvedintheserologicaltestingofvaccinetrials;thepreparationanddistributionofinfluenzavirusesto
vaccinemanufacturers;andthecoordinationofEUstrainselectionprocess.
Membersoftheworkinggrouppresentwere:SirJohnSkehel,ProfessorGlynisBreakwell,ProfessorNeil
Ferguson,ProfessorBarryFurr,DrJohnMcCauley,ProfessorAndrewMcMichael,ProfessorKarlNicholson,Dr
GeoffreySchildandRichardStubbins.
Key points
NIBSCisagovernmentfundedagencywhichactsasaninterfacebetweenpublichealthandthevaccine
industrytocontrolandstandardisebiologicalproducts.Reversegeneticstechnologyisusedtomodifyvirulent
strainsbeforetheyaregiventovaccinemanufacturers.TheNIBSCalsosuppliesindustrywithstandardsand
reagentstomeasurevaccinepotencyandisresponsiblefortheofficialtestingofnewvaccines.Insummary,
theNIBSCisinvolvedinmanystagesofthelifecycleofseasonalvaccineproductionandisconstantlylooking
atnewmethodstospeeduppandemicvaccineproduction.
Obtaining sera
DrsRobertsonandWoodtoldthegrouptheyfacenorestrictionsinobtainingsuppliesofseraaftervaccine
manufactureshavecompletedtheirtrialsofseasonalinfluenzavaccines.However,H5N1serahavebeen
morecloselyguarded.TheyhavejustbegunaprojectwithProfessorMariaZambon(HealthProtection
Agency,HPA)toexaminevaccinecrossreactivityinH5N1butthishasjuststartedasithasbeenhardto
obtainthenecessarypermission.Vaccinemanufacturesarereluctanttoreleasetheirseraincaseregulators
requiremoreexperimentsinthefuture.
Pandemic vaccines
DrsRobertsonandWoodconsiderthatpandemicvaccinedevelopmentintheEUhasbeenslowdueto
limitedpublicfunding.ThisisincontrasttothesituationintheUSA.DrWoodtoldthegroupthattheNIBSC
collaboratewiththevaccineindustry,forexampleonanH9N2vaccine.TheEMEAhavehelpedtopersuade
industrytoinvestinpandemicvaccineswiththeintroductionofthemockupfilesandbywaivingthe
regulatoryfeesandseveralpandemicvaccinesarenowinclinicaltrials.However,thisisaslowprocessand
theybelievethatpublicfunding(fromDepartmentofHealth(DH)ortheEU)shouldhavebeenusedtokick
starttheprocessasindustrywouldnotinitiallyreleasefundstodevelopaproductwhichmaynotbe
marketable.
arecurrentlynotupandrunning.DrMcCauleytoldthegroupthattheInstituteofAnimalHealthhas16-18
roomsavailableforexperimentsusingferrets.
Use of live vaccines
DrsWoodandRobertsonwereaskedtheiropiniononprimingthepopulationforapandemicusinglive
vaccinesandiftheyconsiderittobeagoodidea.Howeverthetimingiscritical;ifliveH5N1vaccinesare
usednowitwouldbeconsideredtoodangerous,butifapandemicisimminenttheriskmaybejustified.A
stockpileoflivevaccine,withthecleavagesiteremoved,couldbeusedtoprimethepopulationinadvanceof
thepandemicreachingtheUK.Evenwithoutanexactmatchinvirusstrain,itispredictedthatthiswould
provideabroadimmunitytothepopulation.
Surge capacity
AprocessevaluationiscurrentlybeingconductedatNIBSCtoidentifyareastoimprovesurgecapacityina
pandemic.ItisanticipatedthattheInstitute’sessentialfunctionswillbepreservedbutsomefunctionswillbe
minimised.
TheNIBSCisnotinvolvedwithdiagnosticsforinfluenza,oranyotherinfectiousdisease.