Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine...

23
Quality & Regulation Biologics Challenges for registration of vaccines in receiving countries by Dr. Nora Dellepiane Workshop: Global Registra8on and Vaccine Shortage Taipei, Taiwan 6 to 10 March 2017

Transcript of Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine...

Page 1: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

Quality&

Regulation

Biologics

Challenges for registration of Challenges for registration of

Challenges for registration of vaccines in receiving countries

byDr.NoraDellepianeWorkshop:GlobalRegistra8onandVaccineShortage

Taipei,Taiwan6to10March2017

Page 2: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

Quality&

Regulation

Biologics

Outline of the presentation

•  Somede'initions•  Maincausesbehindvaccineshortages•  MarketsegmentationanduseofaPvswPcontainingvaccines

•  WHOpositionpaperonpertussisvaccines•  CountriesroleinaddressingaPvaccineshortages

•  Increaseddemand'lexibility•  ExampleofEMA(shortageofaPvaccine)•  Optionsfor'lexibilities•  References

Page 3: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

VaccineSecurity

ü  VaccineSecurity,de'inedasthe“sustained,uninterruptedsupplyofaffordablevaccinesofassuredquality”,isrecognisedasakeycomponentofsuccessfulnationalimmunisationprogrammes.

ü  Overthepastcoupleofyears,manycountries,acrossregionsandincomegroups,havereportedshortagesofvaccines

ü  Shortagessometimescausecriticaldisruptionsintimelyimmunisationservices.

Page 4: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

Quality&

Regulation

Biologics

Good Manufacturing Practice (GMP)

Shortage vs Stock outs ü  Vaccineshortage:thereisavaccineshortagewhenavaccinecannotbeobtainedbyacountryinsuf'icientamounttomeetitsneeds.Thelackofvaccineavailabilitycanbeglobal(severalcountriesimpacted)orlocal(onecountrycannotacquirethevolumeitneeds).

ü  Vaccinestockout:thereisastockoutofvaccinewhenstocksatthenationalordistrictlevelshavebeendepleted.

Ashortagemayormaynotleadtoastockout,ifthecountryhasenoughdosesinstocktobridgethelackofsupplyforsometime.Stockoutsofvaccinesarenotnecessarilyrelatedtoavaccineshortage,butmayalsobecausedbypooruseofavailabledoseswithinthecountry(e.g.poorstockmanagementorsupplychainissues).

Page 5: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

Quality&

Regulation

Biologics

Main causes behind vaccine shortages

ü  Supply:Supplyfactorsrelatetotheproductionofvaccinesaswellasmarketconditions(suchasthenumberofproductsavailableandthenumberofmanufacturersactiveoneachvaccinemarket).Supplyfactorsin'luenceavailabilityofvaccines.

ü  Demand:Demandfactorsrelatetothe'lexibilityandpredictabilityofdemand.Demandpredictabilityreliesonthecapacityofacountrytoaccuratelyforecastitsdemand.Demand'lexibilityreliesonprocessesbeinginplacetoensurethatacountryisabletosecurethesupplyitneeds.Demandfactorsin'luenceaccesstotimelysupply.

ü  Information:Informationfactorsrelatetothelackofinformationavailableatthegloballevelonsupplyanddemand,whichmaycontributetoamisalignmentofsupplyanddemand.

Page 6: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

Quality&

Regulation

Biologics

Main causes behind vaccine shortages Category Factors DescriptionSupply Production

issues•  BatchfailuresduetocomplexityofproductionofBiologicalProducts•  LongandcomplexproductionprocessandQCtesting•  CapacityofNRAs,workload

Limitedsupplierbase

•  InvestmentforproductionofBiologicsishigh,andthereforehighlyrelatedtomarketattractiveness•  Preferenceformorepro'itablemarkets.Ex.BCG•  Cannibalisationbetweenvaccines:pentavs.DTwPandDTaPbasedpentavs.hexa•  Limitednumberofmanufacturers(mergers)andlessproducingcountries(60to14)•  Localproduction(less'lexibilitytomarket'luctuations,publicsectormorerisky,etc)

Demand Littledemand'lexibility

•  Safetyconcerns•  Inef'icientandunharmonizedregistrationproceduresmaydetermanufacturerstopursueregistration•  Limitedinfooninterchangeabilityofproductslimitsavailability•  Singleawardtendersorrestrictiontospeci'icproductcategories(aPratherthanwP)•  Lowelasticityofdemandresources

Lackofdemandpredictability

•  WeakcountrydecisionmakingmechanismsincludinglackofNITAGs•  Poorpoliticalcommitmentand'inancing•  Vaccinehesitancy(resultofantivaccinationlobbying)•  Weakprocuringsystemsincludingforplanning,forecasting,budgetingandtendering)•  Weaksupplychainandstockmanagement•  Unaffordability(particularlyinMICs)•  Emergencyoutbreaksandsurveillance(Stockpilingmayreducevaccineavailabilityforroutine

immunization•  Goodsurveillancecanaccelerateresponsetoanoutbreakandthuslimittheincreaseindemand

Page 7: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

Quality&

Regulation

Biologics

Main causes behind vaccine shortages

Category Factors DescriptionInformation Supply

information•  Limitedglobalinformationavailabilityoncurrentandfuturesupplycapacityandthereforevaccinesatriskofshortage

Demandinformation

•  Limitedglobalinformationondemandevolutionparticularlyfornon-GAVIcountries

•  Lackorlimitedinformationonnewpoliciesandchangesinschedulerecommendationsimplementedincountries.Thesechangesimpactcountrydemandpatternsandmaythereforedisruptthebalancebetweensupplyanddemand.

Timelycommunication

•  Lackoftimelycommunicationbetweensupplyanddemand,particularlyforself-procuringcountries

•  Lackofwarningsystemsatgloballevelincaseofshortage•  Lackofclarityonmechanismusedbymanufacturerstoallocatesupplyincaseofashortagemayleadtomisunderstandinganddistrust

Page 8: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

Quality&

Regulation

Biologics

Market segmentation

SegmentationofthevaccinemarketbetweenHIC,MIC,LMICandLICaffectsanumberofvaccinecategories.Someexamplesinclude.•  UntilrecentlyIPVwasusedinHICandsomeMICsandOPVusedintherestoftheworld.Thissegmentationisnolongerapplicableinviewofthechangesinschedulestargetedateradicationofpoliodiseases

•  aPbasedcombinationsusedmostlyinHIC(andfewMICs)andwPbasedcombinationsusedintherestoftheworld

•  FuturepotentialformarketsegmentationwithregardstoGardasil9-valentandGardasil4-valent(Merck)

Marketsegmentationisamechanismappliedbymanufacturersinordertoincreaserevenuesandcost-recoveryfromvaccinedevelopmentinthosemarketsthatcanaffordit.

Page 9: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

Quality&

Regulation

Biologics

Impact of market segmentation for aP

ü  CommonknowledgeaboutpertussisvaccinesindicatesthataPcontainingvaccinesareusuallylessreactogenicandequallyeffectivetowPcontainingvaccines

ü ThisleadssometimestotheimpressionthatcountriesusingwPcontainingvaccinesaretreated“assecondclasscountries”

ü Howeveracloserlookattheissuemayallowtohaveaclearerperspectiveofthesituation:

Page 10: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

Quality&

Regulation

Biologics

WHO position paper on pertussis vaccines Whole cell pertussis containing vaccines •  ThewPvaccinesareproducedfromculturesofselectedB.pertussisstrainsthataresubsequentlykilled,usuallybyheatingortreatmentwithformalin.

•  ThemethodsusedforproductionvaryamongmanufacturersandthereforewPvaccinesarerelativelyheterogeneous.

•  TheimpactofthevaryingamountsofbiologicallyactivePT,lipopolysaccharide,TCTorACTonvaccineeffectivenessisunclear.

•  AllwPvaccinesarecombinedwithdiphtheriatoxoidandtetanustoxoid(DTwP).SomewPvaccinesarealsocombinedwithHaemophilusin2luenzaetypeb(Hib),andhepatitisB(HepB).Combinationsincludinginactivatedpoliovirus(IPV)areindevelopment.

•  AllwPvaccinescontainaluminiumsaltsasadjuvant,andsomehavethiomersalorphenoxyethanoladdedaspreservativesinmultidosevials.

Page 11: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

Quality&

Regulation

Biologics

WHO position paper on pertussis vaccines (2)

Whole cell pertussis containing vaccines •  TheimmuneresponsetowPvaccinesisdirectedagainstanarrayofbacterialantigens.

•  Signi'icantdifferencesintheimmuneresponsestovariousantigenshavebeenobservedwithdifferentwPvaccines.

•  Immunogenicitydataaredif'iculttointerpretandcompareforwPvaccinesanddatafromclinicaltrialsshowedthathighlyef'icaciouswPvaccinesdidnotnecessarilyinducethehighestmeasurableantibodytitres.

•  Thereisnoestablishedimmunologicalcorrelateofprotectionagainstpertussisdisease,althoughthepresenceofantibodytoPTisbelievedtoplayaroleinprotectionagainstseverediseaseininfants.

•  DifferentwPvaccinesmayhavedifferentantigeniccontentandmethodsofproductionandcontrol,leadingtovariationsinpost-vaccinationimmuneresponses.

Page 12: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

Quality&

Regulation

Biologics

WHO position paper on pertussis vaccines (3)

Whole cell pertussis containing vaccines ü  Anupdatedsystematicreviewofimmunogenicityindicatesthat3-doseschedulesand2+1schedules(atages3,5and10–13months)ofwPgivenininfancyareeffectiveagainstpertussisdiseaseinthe'irst5yearsoflife.

ü  Dataoneffectivenessareonlyavailableforschedulesinitiatedataround2–3monthsofage.

ü  LittleisknownabouttheeffectivenessofwPvaccinesinolderagegroupsbecause,thereactogenicityofwPvaccinewasconsideredtoohighforroutineuseinolderchildren,adolescentsandadults.

Page 13: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

Quality&

Regulation

Biologics

WHO position paper on pertussis vaccines (4)

Acellular pertussis containing vaccines ü  Thesevaccinescontainoneormoreofthefollowingpuri'iedantigens:PT,FHA,PRN,andFIMtypes2and3.

ü  Vaccinesdifferinthenumberofcomponentsü  1componentPTonlyü  2componentsPTandFHAü  3componentsPT,FHA,andPRNü  5componentsPT,FHA,PRN,andFIMtypes2and3

ü  Theydifferalsoinconcentrationoftheantigencomponents,thebacterialcloneusedinproduction,methodsofpuri'icationanddetoxi'ication(glutaraldehyde,formaldehyde,H2O2orgenetic),adjuvants,andtheuseofpreservatives,suchasthiomersalandphenoxyethanol.

ü  TheexactcontributionoftheindividualaPantigenstoprotectionisnotclear.

Page 14: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

Quality&

Regulation

Biologics

WHO position paper on pertussis vaccines (5)

Immunogenicity,ef=icacyandeffectivenessofpertussiscontainingvaccinesü  Arandomizedcontrolledtrialcomparing3-componentand5-componentaP-containingvaccineswithawPvaccineconcludedthattheef'icaciesofthewPvaccineandtheaPvaccinesweresimilaragainstculture-con'irmedpertussiswithatleast21daysofparoxysmalcough

ü  InastudyinGermany,a4-componentaPvaccinehadanef'icacyof83%(95%,CI:76%–88%)againsttypicalpertussis.

ü  InastudyinItaly,ef'icaciesof84%(95%,CI:76%–89%)and84%(95%,CI:76%–90%)againsttypicalpertussiswerereportedfor2different3-componentaPvaccinescomparedwithapoorlyef'icaciouswPvaccine

ü  Inarandomizeddouble-blindtrialinSenegal,a2-componentDTaPvaccinewascomparedwithaDTwPvaccine.Absoluteef'icacyestimatesderivedfromthisstudyshowedthattheaPvaccineprovidedlessprotectionthanthewPvaccine:74%(95%,CI:51%–86%)versus92%(95%,CI:81%–97%)usingtheWHOcasede'inition,althoughthedifferencewasnotstatisticallysigni'icant.

Page 15: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

Quality&

Regulation

Biologics

WHO position paper on pertussis vaccines (6)

Ef=icacyandeffectivenessofacellularpertussiscontainingvaccinesü  Asystematicreviewof3large,double-blindrandomizedcontrolledtrialsofaP

vaccinesconcludedthatmulticomponentaPvaccineshavehigherprotectiveef'icacythan1-componentand2-componentaPvaccinesagainstbothtypicalwhoopingcoughandmildpertussisdisease.

ü  Asystematicreviewthatincluded49randomizedcontrolledtrialsand3cohortstudiesconcludedthat1-componentand2-componentaPvaccineshadlowerabsoluteef'icaciesthanvaccineswith≥3components:(67%–70%ef'icacyversus80%–84%).

ü  However,inobservationalstudiesofvaccineeffectivenessconductedafterlong-termlarge-scaleuseoflicensed2-componentaP-containingvaccinesandof1-componentaPvaccineintheDanishnationalimmunizationprogramme,alloftheseaP-containingvaccinesdemonstratedhigheffectivenessinpreventingpertussisirrespectiveofspeci'icantigencontent.

Hence,thehigheref=icacynumbersformulti-componentvaccinescomparedtothe1-componentand2-componentvaccinesintherandomizedclinicaltrialsshouldbeinterpretedwithcaution.

Page 16: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

Quality&

Regulation

Biologics

WHO position paper on pertussis vaccines (7)

ComparisonoftheeffectivenessofwP-containingandaP-containingvaccinesü  ExperienceintheUKsuggeststhatthelowerimmunogenicityoftheHibantigenintheDTaP–HibcombinationmaybeclinicallyrelevantcomparedwiththeDTwP–Hibcombinationvaccinewhenschedulesdonotincludeaboosterdoseinthesecondyearoflife.

ü  RecentmathematicalmodellingstudiesfromAustralia,EnglandandWales,andtheUSA,aswellasdatafromababoonmodelofpertussisthatcloselyresemblesthehumandisease,supportthehypothesisthattransitionfromwPtoaPvaccinesmaybeassociatedwithdiseaseresurgence.

•  Inthebaboonmodel,theaPvaccinesstudiedprotectedagainstdiseasebuthadlimitedimpactoninfectionortransmissionofpertussistootheranimals,whereasDTwPvaccineswereeffectiveinpreventinginfectionandtransmission.

•  Itisplausiblethatinhumans,asinnonhumanprimates,asymptomaticormildlysymptomaticinfectionsinDTaP-immunizedpersonsmayresultintransmissionofB.pertussistoothersandmaydrivepertussisoutbreaks.

Page 17: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

Quality&

Regulation

Biologics

WHO position paper on pertussis vaccines (8)

ComparisonoftheeffectivenessofwP-containingandaP-containingvaccines(continued)

•  Thebaboonstudysuggestsasigni'icantroleofTh1andTh17cellsintheimmuneresponsetonaturalinfectionandtoDTwPvaccine.ThemodelsuggeststhatbothTh1andTh17memoryresponsesareneededtoproducesterilizingmucosalimmunity.InbaboonstheaPvaccinesinducehigherTh2,butlowerTh1andTh17responses,andarelesseffectiveinclearingthepertussisorganismsandpreventingtransmission.Correspondingstudiesinhumansareneeded.

ü  Althoughthereasonsfortheresurgenceofpertussiswerefoundtobecomplexandvariedbycountry,theshorterdurationofprotectionandprobablelowerimpactofaPvaccinesoninfectionandtransmissionarelikelytoplaycriticalroles.

Page 18: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

Quality&

Regulation

Biologics

WHO position paper on pertussis vaccines (9)

Durationofprotectionandneedforboosterdosesü  ThereislimitedevidenceonthedurationofclinicalprotectionconferredbywPvaccines.

Availabledatasuggestthatdurationofimmunityacquiredaftera3-doseseriesofwPvaccineisestimatedtorangefrom4to12years.

ü  Forthevaccinescurrentlyinuse,a2014systematicreviewindicatesamaximumannuallossofprotectionof13%andaminimumlossof2%followingaprimaryvaccinationserieswithwPcontainingvaccines.

ü  InSweden,a2-doseprimaryaPimmunizationserieswithaboosteratage12monthsprovidedprotectionagainstpertussisforapproximately5years

ü  ThereisincreasingevidencethatprotectionfollowingboosterdosesofaPvaccineswanesfasterinindividualsprimedwithaPratherthanwithwPvaccines

ü  OngoingpassivesurveillanceintheUSAhasdemonstratedanincreaseintheincidenceofpertussisamongchildrenaged7–10yearswhohadbeenvaccinatedwith5dosesofaPvaccine.

ü  Dataalsosuggestafasterwaningofprotectionfollowingrepeatedboosterdoses.Incontrast,wPvaccineusedforatleastthe1stdosefollowedbyaPvaccinesprovideslonger-lastingprotectionirrespectiveofthesubsequentdoses.

Page 19: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

Quality&

Regulation

Biologics

Example of aP containing vaccines: Countries role in

addressing aP vaccine shortage

Category Factors CountriesroleSupply Productionissues Norole

Limitedsupplierbase NoroleDemand Littledemand'lexibility Increasedemand=lexibility

Lackofdemandpredictability Reviewstatusofdemandforecastingandplanning

Information Supplyinformation NoroleDemandinformation Timelycommunicationto

procuringagencyaboutdemand,changeinschedules,vaccinesnewlyintroducedintheNIP

Timelycommunication Noadditionalrole

Page 20: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

Quality&

Regulation

Biologics

Increased demand flexibility. The EMA example of aP vaccine shortage

Background:•  Earlyin2015,therewasashortageofacellularpertussis-containingcombinationvaccinesforuseinEUimmunisationprogrammes

•  Theshortage,currentlyaffectingsomeoftheEU/EEAMemberStateshaddirectconsequencesforthedeliveryofnationalvaccinationprogrammes,withsomecountrieshavingtorevisetheirchildhoodvaccinationpolicy.

•  Discontinuingordelayingprimaryvaccinationschemeswouldhavedramaticconsequences,inparticularforthepreventionofpertussisandinvasivediseaseduetoHaemophilusin'luenzaetypebininfantsandyoungchildren.

•  Asmuchaspossible,theinfantandyoungchildrenimmunisationscheduleshouldbe

preservedinordertoensuretheearlyandadequateprotectionofnewborns.Preferenceshouldbegiventotheuseofcombinedvaccineswiththehighestnumberofantigens. •  Priorityshouldbegiventopreservingtheinfantprimaryimmunisationschedule('irstyearoflife)overthe'irsttoddlerboosterdose(secondyearoflife).

•  Ifapplicable,the'irsttoddlerboosterdoseshouldbeprioritisedovertheschool-entryboosterdose.

Page 21: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

Quality&

Regulation

Biologics

Options for flexibilities due to vaccine shortage

•  Possibleadjustmentstotheprimaryimmunisationseries(0–2years)

•  Priorityshouldbegiventopreservingtheinfantprimaryimmunisationschedule('irstyearoflife)overthe'irsttoddlerboosterdose(secondyearoflife).

•  Ifapplicable,the'irsttoddlerboosterdoseshouldbeprioritisedovertheschool-entryboosterdose.

•  Optionsforvaccinesubstitutionintheimmunisationschedule•  Buildingstockpilestoensureimmunisationprogrammesaremaintainedduringfutureshortages.

Page 22: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

Quality&

Regulation

Biologics

References

•  Pertussisvaccinepositionpaper.WorldHealthOrganizationWeeklyEpidemiologicalRecord35,2015,90,433-460.http://www.who.int/wer

•  Pre-emptingandrespondingtovaccinesupplyshortagesSAGEApril2016http://www.who.int/immunization/sage/meetings/2016/april/en/

•  RapidRiskAssessment.Shortageofacellularpertussis-containingvaccinesandimpactonimmunisationprogrammesintheEU/EEAhttp://ecdc.europa.eu/en/publications/Publications/vaccine-shortage-rapid-risk-assessment-october-2015.pdf

Page 23: Challenges for registration of vaccines in receiving countries · Vaccine Security ü Vaccine Security, deined as the “sustained, uninterrupted supply of affordable vaccines of

Thankyou MerciCпасибо

شكراً GraciasGrazieDankeSchönObrigado


VACCINE INFOR MATION - nicd.ac.za · Section 2 – Vaccines included in the expanded programme on Immunization of South Africa Vaccines first given at birth Polio vaccine Page 08

VACCINE INFOR MATION - nicd.ac.za · Section 2 – Vaccines included in the expanded programme on Immunization of South Africa Vaccines first given at birth Polio vaccine Page 08

Vaccines and other positive things Vaccine design Current vaccines Developing new approaches Cancer vaccines Possible role of the immune system in suppressing.

Vaccines and other positive things Vaccine design Current vaccines Developing new approaches Cancer vaccines Possible role of the immune system in suppressing.

Vaccine hesitancy, vaccine refusal and the anti-vaccine ......Vaccine hesitancy, vaccine refusal and the anti-vaccine movement: influence, impact and implications Expert Rev. Vaccines

Vaccine hesitancy, vaccine refusal and the anti-vaccine ......Vaccine hesitancy, vaccine refusal and the anti-vaccine movement: influence, impact and implications Expert Rev. Vaccines

Implementing New Vaccines and Vaccine Recommendations

Implementing New Vaccines and Vaccine Recommendations

COVID Vaccines: Approaches to vaccine trial design

COVID Vaccines: Approaches to vaccine trial design

Vaccine Education Module: Vaccines Updated: April 2013.

Vaccine Education Module: Vaccines Updated: April 2013.

TAKEDA VACCINES · 2018. 10. 11. · vaccines for people in Japan . 2018 . Global vaccine business established . Global pivotal Phase 3 clinical trial of dengue vaccine candidate

TAKEDA VACCINES · 2018. 10. 11. · vaccines for people in Japan . 2018 . Global vaccine business established . Global pivotal Phase 3 clinical trial of dengue vaccine candidate

Seasonal and Pandemic Influenza Vaccines : Vaccine Development and Production

Seasonal and Pandemic Influenza Vaccines : Vaccine Development and Production

Vaccines herd immunity anti vaccine movt

Vaccines herd immunity anti vaccine movt

CD ANALYSIS IN VACCINE DEVELOPMENT › assets › blog › pdf › AP Vaccine... · 2020-05-07 · CD ANALYSIS IN VACCINE DEVELOPMENT VACCINES PREVENT DISEASE Vaccines prevent disease

CD ANALYSIS IN VACCINE DEVELOPMENT › assets › blog › pdf › AP Vaccine... · 2020-05-07 · CD ANALYSIS IN VACCINE DEVELOPMENT VACCINES PREVENT DISEASE Vaccines prevent disease

Vaccine standardization in the context of PQOutline WHO standards for vaccines Vaccines of assured quality Written and measurement standards –40 years analysis Basis for vaccine

Vaccine standardization in the context of PQOutline WHO standards for vaccines Vaccines of assured quality Written and measurement standards –40 years analysis Basis for vaccine

New vaccines EMA perspective€¦ · New vaccines –EMA perspective ... Yellow fever vaccine virus or attenuated Dengue virus 2 as ... Dengue vaccine) VSV vectors (Ebola)

New vaccines EMA perspective€¦ · New vaccines –EMA perspective ... Yellow fever vaccine virus or attenuated Dengue virus 2 as ... Dengue vaccine) VSV vectors (Ebola)

From vaccines shortages to sustainable vaccine supply€¦ · From vaccines shortages to sustainable vaccine supply Michel Stoffel, chair of RA WG at Vaccines Europe VHPB (Lisbon),

From vaccines shortages to sustainable vaccine supply€¦ · From vaccines shortages to sustainable vaccine supply Michel Stoffel, chair of RA WG at Vaccines Europe VHPB (Lisbon),

Vaccines- Introduction Vaccines- History Immunological Adjuvants Types DNA Vaccines Viral Vectors Mucosal Vaccines Peptide Vaccines Subunit Vaccines Vaccine.

Vaccines- Introduction Vaccines- History Immunological Adjuvants Types DNA Vaccines Viral Vectors Mucosal Vaccines Peptide Vaccines Subunit Vaccines Vaccine.

 · anidulafungin, influenza H1N1 vaccine, influenza H5N1 vaccines, influenza seasonal vaccine, methoxy polyethylene glycol-epoetin beta, vaccinia smallpox vaccine Full text with

 · anidulafungin, influenza H1N1 vaccine, influenza H5N1 vaccines, influenza seasonal vaccine, methoxy polyethylene glycol-epoetin beta, vaccinia smallpox vaccine Full text with

Moderna’s other vaccines: CMV vaccine (mRNA-1647)

Moderna’s other vaccines: CMV vaccine (mRNA-1647)

COVID-19 Vaccines: An overview of COVID-19 vaccine · 16/12/2020  · The push for COVID -19 vaccines • Given the benefits of vaccines, global efforts for a vaccine for COVID -19

COVID-19 Vaccines: An overview of COVID-19 vaccine · 16/12/2020  · The push for COVID -19 vaccines • Given the benefits of vaccines, global efforts for a vaccine for COVID -19

Transporting Refrigerated Vaccine (PDF) - EZIZ · VACCINE FOR CHILDREN (WC) PROGRAM Refrigerated Vaccine Transport Log VACCINES Do Not FREEZE! Refrigerate Upon Arrival

Transporting Refrigerated Vaccine (PDF) - EZIZ · VACCINE FOR CHILDREN (WC) PROGRAM Refrigerated Vaccine Transport Log VACCINES Do Not FREEZE! Refrigerate Upon Arrival

Vaccines and The National Vaccine Injury Compensation Program

Vaccines and The National Vaccine Injury Compensation Program

Decade of Vaccines Global Vaccine Action Plan SAGE ...

Decade of Vaccines Global Vaccine Action Plan SAGE ...