Real-World Evidence Confirms High Effectiveness of Pfizer

Real-World Evidence Confirms High Effectiveness of Pfizer-BioNTech COVID-19 Vaccine and Profound Public Health Impact of Vaccination One Year ... Skiptomaincontent Real-WorldEvidenceConfirmsHighEffectivenessofPfizer-BioNTechCOVID-19VaccineandProfoundPublicHealthImpactofVaccinationOneYearAfterPandemicDeclaredThursday,March11,2021-06:45amDramaticallylowerCOVID-19diseaseincidenceratesobservedinindividualsfullyvaccinatedwiththePfizer-BioNTechvaccine,basedonreal-worlddatagatheredbytheIsraelMinistryofHealth DatasuggestPfizer-BioNTechvaccinepreventsasymptomaticSARS-CoV-2infectionLatestdataanalysisfindsunvaccinatedindividualswere44timesmorelikelytodevelopsymptomaticCOVID-19and29timesmorelikelytodiefromCOVID-19Findingsrepresentthemostcomprehensivereal-worldevidencetodatedemonstratingtheeffectivenessofaCOVID-19vaccineDataareofglobalimportancetoothercountriesasvaccinationcampaignscontinueworldwideJERUSALEM&NEWYORK&MAINZ,Germany--(BUSINESSWIRE)-- TheIsraelMinistryofHealth(MoH),PfizerInc.(NYSE:PFE)andBioNTechSE(Nasdaq:BNTX)todayannouncedreal-worldevidencedemonstratingdramaticallylowerincidenceratesofCOVID-19diseaseinindividualsfullyvaccinatedwiththePfizer-BioNTechCOVID-19Vaccine(BNT162b2),underscoringtheobservedsubstantialpublichealthimpactofIsrael’snationwideimmunizationprogram.ThesenewdatabuilduponandconfirmpreviouslyreleaseddatafromtheMoHdemonstratingthevaccine’seffectivenessinpreventingsymptomaticSARS-CoV-2infections,COVID-19cases,hospitalizations,severeandcriticalhospitalizations,anddeaths.ThelatestanalysisfromtheMoHprovesthattwoweeksafterthesecondvaccinedoseprotectionisevenstronger–vaccineeffectivenesswasatleast97%inpreventingsymptomaticdisease,severe/criticaldiseaseanddeath.Thiscomprehensivereal-worldevidencecanbeofimportancetocountriesaroundtheworldastheyadvancetheirownvaccinationcampaignsoneyearaftertheWorldHealthOrganization(WHO)declaredCOVID-19apandemic. Thispressreleasefeaturesmultimedia.Viewthefullreleasehere:https://www.businesswire.com/news/home/20210311005482/en/ Findingsfromtheanalysiswerederivedfromde-identifiedaggregateIsraelMoHsurveillancedatacollectedbetweenJanuary17andMarch6,2021,whenthePfizer-BioNTechCOVID-19VaccinewastheonlyvaccineavailableinthecountryandwhenthemoretransmissibleB.1.1.7variantofSARS-CoV-2(formerlyreferredtoastheU.K.variant)wasthedominantstrain.Vaccineeffectivenesswasatleast97%againstsymptomaticCOVID-19cases,hospitalizations,severeandcriticalhospitalizations,anddeaths.Furthermore,theanalysisfoundavaccineeffectivenessof94%againstasymptomaticSARS-CoV-2infections.Foralloutcomes,vaccineeffectivenesswasmeasuredfromtwoweeksaftertheseconddose. “Israel’sstronghealthsystemandanunprecedentedsocietalmobilizationandawarenessallowedustoachievehighnationaluptakeoftheCOVID-19vaccineinashortperiodoftime.Thankstoourcomprehensivepublichealthsurveillanceprogram,wehavebeenabletodocumenttheremarkablesuccessofthenationwidevaccinationcampaignwiththeCOVID-19vaccine.Incidenceratesinthefullyvaccinatedpopulationhavemassivelydroppedcomparedtotheunvaccinatedpopulation,showingamarkeddeclineinhospitalizedcasesduetoCOVID-19,”saidProfessorYeheskelLevy,IsraelMinistryofHealthDirector.“ThisclearlydemonstratesthepoweroftheCOVID-19vaccinetofightthisvirusandencouragesustocontinueevenmoreintensivelywithourvaccinationcampaign.Weaimtoachieveevenhigheruptakeinpeopleofallages,whichgivesushopeofregainingnormaleconomicandsocialfunctioninthenotsodistantfuture.” “Weareextremelyencouragedthatthereal-worldeffectivenessdatacomingfromIsraelareconfirmingthehighefficacydemonstratedinourPhase3clinicaltrialandshowingthesignificantimpactofthevaccineinpreventingseverediseaseanddeathsduetoCOVID-19,”saidLuisJodar,Ph.D.,SeniorVicePresident&ChiefMedicalOfficer,PfizerVaccines.“ThefindingswhichsuggestthatthevaccinemayalsoprovideprotectionagainstasymptomaticSARS-CoV-2infectionsareparticularlymeaningfulaswelooktodisruptthespreadofthevirusaroundtheglobe.Altogether,thesedataarecriticaltounderstandingtheroleofvaccinationincombattingthepandemicandprovidehopetoothercountriesdealingwiththisdevastatingdisease,whichhasnowafflictedtheworldformorethanayear.” “WhenwestartedourdevelopmentlastyearinJanuary,ouraimwastomakeadifferenceforpeopleworldwideandtohelpendthispandemic.OneyearafterthedeclarationofapandemicbytheWHO,wenowseethatweareontherighttracktoaccomplishourgoals,”saidUgurSahin,M.D.,Co-FounderandCEOofBioNTech.“Thereal-worlddatareportedfromIsraeldemonstratethatBNT162b2isexceptionallyeffectiveinfightingSARS-CoV-2.OurvaccinehasbeeneffectiveinpreventingCOVID-19cases,aswellasprofoundlyreducingtherateofCOVID-19relatedseverediseases,hospitalizationsanddeaths.Thesefindingsarealsoimportant,asthedataweregeneratedatatimewhentheSARS-CoV-2variantB.1.1.7wasthedominantstrain.” InJanuary,PfizerandtheIsraelMoHenteredintoacollaborationagreementtomonitorthereal-worldimpactofthePfizer-BioNTechCOVID-19Vaccine.Detailedfindingsfromthiscollaborationalsowillbesubmittedtoapeer-reviewedjournal. AbouttheIsraelMoHVaccinationProgramandAnalysis FollowingtheauthorizationforemergencyuseofthePfizer-BioNTechCOVID-19VaccineinIsraelonDecember6,2020,theIsraelMoHlaunchedanationalvaccinationprogramtargetingindividualsage16yearsorolder–atotalof6.4millionpeople,representing71%ofthepopulation.ThevaccinationprogramstartedatthebeginningofalargesurgeofSARS-CoV-2infectionsinIsrael,whichlaterresultedinanationallockdownstartingonJanuary8,2021. ThisMoHanalysisusesde-identifiedaggregateIsraelMoHpublichealthsurveillancedatafromJanuary17throughMarch6,2021(analysisperiod);thestartoftheanalysisperiodcorrespondstosevendaysafterindividualsbeganreceivingseconddosesofthePfizer-BioNTechCOVID-19Vaccine.MoHregularlycollectscomprehensive,real-timedataonSARS-CoV-2testing,COVID-19casesincludingdateofsymptomonset,andvaccinationhistorythroughanationallynotifiablediseaseregistryandthenationalmedicalrecorddatabase. Vaccineeffectivenessestimates–adjustedtoaccountforvariancesinage,genderandtheweekspecimenswerecollected–weredeterminedforthepreventionofsixlaboratory-confirmedSARS-CoV-2outcomescomparingunvaccinatedandfully-vaccinatedindividuals:SARS-CoV-2infections(includessymptomaticandasymptomaticinfections);asymptomaticSARS-CoV-2infections;COVID-19cases(symptomaticonly);COVID-19hospitalizations;severe(respiratorydistress,including>30breathsperminute,oxygensaturationonroomair<94%,and/orratioofarterialpartialpressureofoxygentofractionofinspiredoxygen<300mmmercury)andcritical(mechanicalventilation,shock,and/orheart,liverorkidneyfailure)COVID-19hospitalizations;andCOVID-19deaths. TheMoHanalysiswasconductedwhenmorethan80%oftestedspecimensinIsraelwerevariantB.1.1.7,providingreal-worldevidenceoftheeffectivenessofBNT162b2forpreventionofCOVID-19infections,hospitalizations,anddeathsduetovariantB.1.1.7.However,thisanalysiswasnotabletoevaluatevaccineeffectivenessagainstB.1.351(formerlyreferredtoastheSouthAfricanvariant)duetothelimitednumberofinfectionscausedbythisstraininIsraelatthetimetheanalysiswasconducted. Thevaccineeffectivenessestimatesalignwiththe95%vaccineefficacyofBNT162b2againstCOVID-19demonstratedinthepivotalRandomizedClinicalTrial(RCT)ofBNT162b2.However,thisobservationalanalysisdiffersfromtheRCTinseveralaspects.Vaccineeffectivenessestimatesmaybeaffectedbydifferencesbetweenvaccinatedandunvaccinatedpersons(i.e.,differenttest-seekingbehaviorsorlevelsofadherencetopreventivemeasures).IntheRCT,randomizationminimizedtheimpactofdifferencesbetweenvaccinatedandunvaccinated.Despiteeffortstoadjustfortheseeffectsintheavailabledataset,thepossibilityremainsofunmeasureddistortions.Forexample,findingsfromtheMaccabiHMOindicatethatneighborhoodmaybeanimportantfactor.Furthervaccineeffectivenessanalysesinvestigatingtheeffectofadditionalcovariatessuchaslocation,comorbidities,race/ethnicity,andlikelihoodofseekingSARS-CoV-2testingarewarranted. AboutthePfizer-BioNTechCOVID-19Vaccine(BNT162b2) ThePfizer-BioNTechCOVID-19Vaccine,whichisbasedonBioNTechproprietarymRNAtechnology,wasdevelopedbybothBioNTechandPfizer.Thevaccinehasnowbeengrantedaconditionalmarketingauthorization,emergencyuseauthorizationortemporaryauthorizationinatotalofmorethan60countries.BioNTechistheMarketingAuthorizationHolderintheEuropeanUnion,andtheholderofemergencyuseauthorizationsorequivalentinIsrael,theUnitedStates,UnitedKingdom,Canadaandothercountriesinadvanceofaplannedapplicationforfullmarketingauthorizationsinthesecountries. ThePfizer-BioNTechCOVID-19VaccinehasnotbeenapprovedorlicensedbytheU.S.FoodandDrugAdministration(FDA),buthasbeenauthorizedforemergencyusebyFDAunderanEmergencyUseAuthorization(EUA)topreventCoronavirusDisease2019(COVID-19)foruseinindividuals16yearsofageandolder.TheemergencyuseofthisproductisonlyauthorizedforthedurationofthedeclarationthatcircumstancesexistjustifyingtheauthorizationofemergencyuseofthemedicalproductunderSection564(b)(1)oftheFD&CActunlessthedeclarationisterminatedorauthorizationrevokedsooner.PleaseseeEmergencyUseAuthorization(EUA)FactSheetforHealthcareProvidersAdministeringVaccine(VaccinationProviders)andFullEUAPrescribingInformationavailableatwww.cvdvaccine-us.com. AUTHORIZEDUSEINTHEU.S.: ThePfizer-BioNTechCOVID19VaccineisauthorizedforuseunderanEmergencyUseAuthorization(EUA)foractiveimmunizationtopreventcoronavirusdisease2019(COVID-19)causedbysevereacuterespiratorysyndromecoronavirus2(SARS-CoV-2)inindividuals16yearsofageandolder. IMPORTANTSAFETYINFORMATIONFROMU.S.FDAEMERGENCYUSEAUTHORIZATIONPRESCRIBINGINFORMATION: DonotadministerPfizer-BioNTechCOVID-19Vaccinetoindividualswithknownhistoryofasevereallergicreaction(e.g.,anaphylaxis)toanycomponentofthePfizer-BioNTechCOVID-19Vaccine. AppropriatemedicaltreatmentusedtomanageimmediateallergicreactionsmustbeimmediatelyavailableintheeventanacuteanaphylacticreactionoccursfollowingadministrationofPfizer-BioNTechCOVID-19Vaccine. MonitorPfizer-BioNTechCOVID-19VaccinerecipientsfortheoccurrenceofimmediateadversereactionsaccordingtotheCentersforDiseaseControlandPreventionguidelines(https://www.cdc.gov/vaccines/covid-19/). Immunocompromisedpersons,includingindividualsreceivingimmunosuppressanttherapy,mayhaveadiminishedimmuneresponsetothePfizer-BioNTechCOVID-19Vaccine. ThePfizer-BioNTechCOVID-19Vaccinemaynotprotectallvaccinerecipients. Inclinicalstudies,adversereactionsinparticipants16yearsofageandolderincludedpainattheinjectionsite(84.1%),fatigue(62.9%),headache(55.1%),musclepain(38.3%),chills(31.9%),jointpain(23.6%),fever(14.2%),injectionsiteswelling(10.5%),injectionsiteredness(9.5%),nausea(1.1%),malaise(0.5%),andlymphadenopathy(0.3%). Severeallergicreactions,includinganaphylaxis,havebeenreportedfollowingthePfizer-BioNTechCOVID-19Vaccineduringmassvaccinationoutsideofclinicaltrials. Additionaladversereactions,someofwhichmaybeserious,maybecomeapparentwithmorewidespreaduseofthePfizer-BioNTechCOVID-19Vaccine. AvailabledataonPfizer-BioNTechCOVID-19Vaccineadministeredtopregnantwomenareinsufficienttoinformvaccine-associatedrisksinpregnancy. DataarenotavailabletoassesstheeffectsofPfizer-BioNTechCOVID-19Vaccineonthebreastfedinfantoronmilkproduction/excretion. TherearenodataavailableontheinterchangeabilityofthePfizer-BioNTechCOVID-19VaccinewithotherCOVID-19vaccinestocompletethevaccinationseries.IndividualswhohavereceivedonedoseofPfizer-BioNTechCOVID-19VaccineshouldreceiveaseconddoseofPfizer-BioNTechCOVID-19Vaccinetocompletethevaccinationseries. VaccinationprovidersmustreportAdverseEventsinaccordancewiththeFactSheettoVAERSathttps://vaers.hhs.gov/reportevent.htmlorbycalling1-800-822-7967.Thereportsshouldincludethewords"Pfizer-BioNTechCOVID-19VaccineEUA"inthedescriptionsectionofthereport. VaccinationprovidersshouldreviewtheFactSheetforInformationtoProvidetoVaccineRecipients/CaregiversandMandatoryRequirementsforPfizer-BioNTechCOVID-19VaccineAdministrationUnderEmergencyUseAuthorization. PleaseseeEmergencyUseAuthorization(EUA)FactSheetforHealthcareProvidersAdministeringVaccine(VaccinationProviders)includingFullEUAPrescribingInformationavailableatwww.cvdvaccine-us.com. AboutPfizer:BreakthroughsThatChangePatients’Lives AtPfizer,weapplyscienceandourglobalresourcestobringtherapiestopeoplethatextendandsignificantlyimprovetheirlives.Westrivetosetthestandardforquality,safetyandvalueinthediscovery,developmentandmanufactureofhealthcareproducts,includinginnovativemedicinesandvaccines.Everyday,Pfizercolleaguesworkacrossdevelopedandemergingmarketstoadvancewellness,prevention,treatmentsandcuresthatchallengethemostfeareddiseasesofourtime.Consistentwithourresponsibilityasoneoftheworld'spremierinnovativebiopharmaceuticalcompanies,wecollaboratewithhealthcareproviders,governmentsandlocalcommunitiestosupportandexpandaccesstoreliable,affordablehealthcarearoundtheworld.Formorethan170years,wehaveworkedtomakeadifferenceforallwhorelyonus.Weroutinelypostinformationthatmaybeimportanttoinvestorsonourwebsiteatwww.Pfizer.com.Inaddition,tolearnmore,pleasevisitusonwww.Pfizer.comandfollowusonTwitterat@Pfizerand@PfizerNews,LinkedIn,YouTubeandlikeusonFacebookatFacebook.com/Pfizer. PfizerDisclosureNotice TheinformationcontainedinthisreleaseisasofMarch11,2021.Pfizerassumesnoobligationtoupdateforward-lookingstatementscontainedinthisreleaseastheresultofnewinformationorfutureeventsordevelopments. Thisreleasecontainsforward-lookinginformationaboutPfizer’seffortstocombatCOVID-19,thecollaborationbetweenBioNTechandPfizertodevelopaCOVID-19vaccine,theBNT162mRNAvaccineprogramandthePfizer-BioNTechCOVID-19Vaccine(BNT162b2)(includingqualitativeassessmentsofavailabledata,potentialbenefits,expectationsforclinicaltrials,theanticipatedtimingofregulatorysubmissions,regulatoryapprovalsorauthorizations,acollaborationwiththeIsraelMoHtomonitorthereal-worldimpactofBNT162b2andanticipatedmanufacturing,distributionandsupply),involvingsubstantialrisksanduncertaintiesthatcouldcauseactualresultstodiffermateriallyfromthoseexpressedorimpliedbysuchstatements.Risksanduncertaintiesinclude,amongotherthings,theuncertaintiesinherentinresearchanddevelopment,includingtheabilitytomeetanticipatedclinicalendpoints,commencementand/orcompletiondatesforclinicaltrials,regulatorysubmissiondates,regulatoryapprovaldatesand/orlaunchdates,aswellasrisksassociatedwithpreclinicalandclinicaldata(includingtheinvitroandPhase3dataandthereal-worldevidence),includingthepossibilityofunfavorablenewpreclinical,clinicalorsafetydataandfurtheranalysesofexistingpreclinical,clinicalorsafetydata;theabilitytoproducecomparableclinicalorotherresults,includingtherateofvaccineeffectivenessandsafetyandtolerabilityprofileobservedtodate,inadditionalanalysesofthePhase3trialandadditionalstudiesorinlarger,morediversepopulationsuponcommercialization;theabilityofBNT162b2topreventCOVID-19causedbyemergingvirusvariants;theriskthatmorewidespreaduseofthevaccinewillleadtonewinformationaboutefficacy,safety,orotherdevelopments,includingtheriskofadditionaladversereactions,someofwhichmaybeserious;theriskthatpreclinicalandclinicaltrialdataaresubjecttodifferinginterpretationsandassessments,includingduringthepeerreview/publicationprocess,inthescientificcommunitygenerally,andbyregulatoryauthorities;whetherandwhenadditionaldatafromtheBNT162mRNAvaccineprogramwillbepublishedinscientificjournalpublicationsand,ifso,whenandwithwhatmodificationsandinterpretations;whetherregulatoryauthoritieswillbesatisfiedwiththedesignofandresultsfromtheseandanyfuturepreclinicalandclinicalstudies;whetherandwhenaBiologicsLicenseApplicationforBNT162b2maybefiledintheU.S.andwhetherandwhenotherbiologicslicenseand/oremergencyuseauthorizationapplicationsmaybefiledinparticularjurisdictionsforBNT162b2oranyotherpotentialvaccinesthatmayarisefromtheBNT162program,andifobtained,whetherorwhensuchemergencyuseauthorizationorlicenseswillexpireorterminate;whetherandwhenanyapplicationsthatmaybependingorfiledforBNT162b2(includingapotentialBiologicsLicenseApplicationintheU.S.)orothervaccinesthatmayresultfromtheBNT162programmaybeapprovedbyparticularregulatoryauthorities,whichwilldependonmyriadfactors,includingmakingadeterminationastowhetherthevaccine’sbenefitsoutweighitsknownrisksanddeterminationofthevaccine’sefficacyand,ifapproved,whetheritwillbecommerciallysuccessful;decisionsbyregulatoryauthoritiesimpactinglabelingormarketing,manufacturingprocesses,safetyand/orothermattersthatcouldaffecttheavailabilityorcommercialpotentialofavaccine,includingdevelopmentofproductsortherapiesbyothercompanies;disruptionsintherelationshipsbetweenusandourcollaborationpartnersorthird-partysuppliers;risksrelatedtotheavailabilityofrawmaterialstomanufactureavaccine;challengesrelatedtoourvaccine’sultra-lowtemperatureformulation,two-dosescheduleandattendantstorage,distributionandadministrationrequirements,includingrisksrelatedtostorageandhandlingafterdeliverybyPfizer;theriskthatwemaynotbeabletosuccessfullydevelopothervaccineformulations;theriskthatwemaynotbeabletocreateorscaleupmanufacturingcapacityonatimelybasisormaintainaccesstologisticsorsupplychannelscommensuratewithglobaldemandforourvaccine,whichwouldnegativelyimpactourabilitytosupplytheestimatednumbersofdosesofourvaccinewithintheprojectedtimeperiodsaspreviouslyindicated;whetherandwhenadditionalsupplyagreementswillbereached;uncertaintiesregardingtheabilitytoobtainrecommendationsfromvaccinetechnicalcommitteesandotherpublichealthauthoritiesanduncertaintiesregardingthecommercialimpactofanysuchrecommendations;uncertaintiesregardingtheimpactofCOVID-19onPfizer’sbusiness,operationsandfinancialresults;andcompetitivedevelopments. AfurtherdescriptionofrisksanduncertaintiescanbefoundinPfizer’sAnnualReportonForm10-KforthefiscalyearendedDecember31,2020andinitssubsequentreportsonForm10-Q,includinginthesectionsthereofcaptioned“RiskFactors”and“Forward-LookingInformationandFactorsThatMayAffectFutureResults”,aswellasinitssubsequentreportsonForm8-K,allofwhicharefiledwiththeU.S.SecuritiesandExchangeCommissionandavailableatwww.sec.govandwww.pfizer.com. AboutBioNTech BiopharmaceuticalNewTechnologiesisanextgenerationimmunotherapycompanypioneeringnoveltherapiesforcancerandotherseriousdiseases.TheCompanyexploitsawidearrayofcomputationaldiscoveryandtherapeuticdrugplatformsfortherapiddevelopmentofnovelbiopharmaceuticals.Itsbroadportfolioofoncologyproductcandidatesincludesindividualizedandoff-the-shelfmRNA-basedtherapies,innovativechimericantigenreceptorTcells,bi-specificcheckpointimmuno-modulators,targetedcancerantibodiesandsmallmolecules.BasedonitsdeepexpertiseinmRNAvaccinedevelopmentandin-housemanufacturingcapabilities,BioNTechanditscollaboratorsaredevelopingmultiplemRNAvaccinecandidatesforarangeofinfectiousdiseasesalongsideitsdiverseoncologypipeline.BioNTechhasestablishedabroadsetofrelationshipswithmultipleglobalpharmaceuticalcollaborators,includingGenmab,Sanofi,BayerAnimalHealth,Genentech,amemberoftheRocheGroup,Regeneron,Genevant,FosunPharma,andPfizer.Formoreinformation,pleasevisitwww.BioNTech.de. BioNTechForward-lookingStatements Thispressreleasecontains“forward-lookingstatements”ofBioNTechwithinthemeaningofthePrivateSecuritiesLitigationReformActof1995.Theseforward-lookingstatementsmayinclude,butmaynotbelimitedto,statementsconcerning:BioNTech’seffortstocombatCOVID-19;thecollaborationbetweenBioNTechandPfizerregardingaCOVID-19vaccine;ourexpectationsregardingthepotentialcharacteristicsofBNT162b2inourPhase2/3trialand/orincommercialusebasedondataobservationstodate,includingreal-worlddatagathered;theabilityofBNT162b2topreventCOVID-19causedbyemergingvirusvariants;theexpectedtimepointforadditionalreadoutsontrialdataofBNT162b2inourPhase2/3trial;thenatureoftheclinicaldata,whichissubjecttoongoingpeerreview,regulatoryreviewandmarketinterpretation;thetimingforsubmissionofdatafor,orreceiptof,anymarketingapprovalorEmergencyUseAuthorization;ourcontemplatedshippingandstorageplan,includingourestimatedproductshelflifeatvarioustemperatures;andtheabilityofBioNTechtosupplythequantitiesofBNT162tosupportclinicaldevelopmentand,ifapproved,marketdemand,includingourproductionestimatefor2021.Anyforward-lookingstatementsinthispressreleasearebasedonBioNTechcurrentexpectationsandbeliefsoffutureevents,andaresubjecttoanumberofrisksanduncertaintiesthatcouldcauseactualresultstodiffermateriallyandadverselyfromthosesetforthinorimpliedbysuchforward-lookingstatements.Theserisksanduncertaintiesinclude,butarenotlimitedto:theabilitytomeetthepre-definedendpointsinclinicaltrials;competitiontocreateavaccineforCOVID-19;theabilitytoproducecomparableclinicalorotherresults,includingourstatedrateofvaccineeffectivenessandsafetyandtolerabilityprofileobservedtodate,intheremainderofthetrialorinlarger,morediversepopulationsuponcommercialization;theriskthatmorewidespreaduseofthevaccinewillleadtonewinformationaboutefficacy,safety,orotherdevelopments,includingtheriskofadditionaladversereactions,someofwhichmaybeserious;theabilityofBNT162b2topreventCOVID-19causedbyemergingvirusvariants;theabilitytoeffectivelyscaleourproductionscapabilities;andotherpotentialdifficulties. Foradiscussionoftheseandotherrisksanduncertainties,seeBioNTech’sQuarterlyReportfortheThreeandNineMonthsEndedSeptember30,2020,filedasExhibit99.2toitsCurrentReportonForm6-KfiledwiththeSEConNovember10,whichisavailableontheSEC’swebsiteatwww.sec.gov.Allinformationinthispressreleaseisasofthedateoftherelease,andBioNTechundertakesnodutytoupdatethisinformationunlessrequiredbylaw. Viewsourceversiononbusinesswire.com:https://www.businesswire.com/news/home/20210311005482/en/Pfizer: MediaRelations AmyRose +1(212)733-7410 [email protected] InvestorRelations ChuckTriano +1(212)733-3901 [email protected]BioNTech: MediaRelations JasminaAlatovic +49(0)613190841513 [email protected] InvestorRelations SylkeMaas,Ph.D. +49(0)613190841074 [email protected]Source:PfizerInc.ShowHide