新冠疫苗的副作用

Youallcontinuetopasswhateveryoufeellikepassing.But,we

arepayingattentionnow.Weknowyouwanttocompilea

databaseofeveryone'sDNAandinformationatyourwill.Ifyou

makethesechanges,thesewillbecareerendingforyou.The

publicwillwinlegally,ethicallyandconstitutionallyandyouwill

dojailtime.

Yetyoustillhaverefusedtodisclosethedangersofthepast

ChiefMedicalofficersLACKofdisclosureofwhatheknows

(attachedPFIZERcourtorderedreleaseofhundredsofpagesof

adverseeventsoftheCOVIDvaccineheisstillpushingcausing

death,nervedisorders,permanentheartdamage,miscarriage,

spontaneousabortionknownsinceFebruary2021)

Thisisgovernmentoverreach.Wehavearighttoprotectthe

medicalinformationofourchildrenifwesochoose.Wehavea

constitutionalrighttoareligiousexemptionforamedical

procedureortreatmentthatwedonotwantwhichyouall

somehowthinkyoucanjustgetaroundwhichisillegal.We

havearighttodenyabodilyinvasivetestwedonotwant.We

havearighttodenyanypublicinformationorDNAfrombeing

sharedinanydatabaseoranywhereunlessweapproveand

consentwithoutcoercion.Anylawyoumakeregardingthisis

invalid.

Youshouldallgodosomethingelseormovetoanother

countrybeforeyougetfoundoutwithyourdisgusting

acceptanceofmoneyoverhumans.Truthalwaysprevailsand

itwillbeepic.

Dotherightthing.Protecthumans,protectprivacy,protect

freedomandforGodsakeyouarethehealthboardsoactually

trytohelpsomebody!

ElizabethHammack,

BNT162b2

5.3.6CumulativeAnalysisofPost-authorizationAdverseEventReports

5.3.6CUMULATIVEANALYSISOFPOST-AUTHORIZATIONADVERSEEVENT

REPORTSOFPF-07302048(BNT162B2)RECEIVEDTHROUGH28-FEB-2021

ReportPreparedby:

WorldwideSafety

Pfizer

Theinformationcontainedinthisdocumentisproprietaryandconfidential.Anydisclosure,reproduction,

distribution,orotherdisseminationofthisinformationoutsideofPfizer,itsAffiliates,itsLicensees,or

RegulatoryAgenciesisstrictlyprohibited.Exceptasmaybeotherwiseagreedtoinwriting,byacceptingor

reviewingthesematerials,youagreetoholdsuchinformationinconfidenceandnottodiscloseittoothers

(exceptwhererequiredbyapplicablelaw),nortouseitforunauthorizedpurposes.

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TABLEOFCONTENTS

LISTOFTABLES3

LISTOFFIGURES3

APPENDICES3

LISTOFABBREVIATIONS4

1.INTRODUCTION5

2.METHODOLOGY5

3.RESULTS6

3.1.SafetyDatabase6

3.1.1.GeneralOverview6

3.1.2.SummaryofSafetyConcernsintheUSPharmacovigilancePlan9

3.1.3.ReviewofAdverseEventsofSpecialInterest(AESIs)16

3.1.4.Medicationerror26

4.DISCUSSION28

5.SUMMARYANDCONCLUSION29

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LISTOFTABLES

Table1.GeneralOverview:SelectedCharacteristicsofAllCasesReceived

DuringtheReportingInterval7

Table2.EventsReportedin≥2%Cases8

Table3.Safetyconcerns9

Table4.ImportantIdentifiedRisk10

Table5.ImportantPotentialRisk11

Table6.DescriptionofMissingInformation12

Table7.AESIsEvaluationforBNT162b216

Table8.MEPTsbyseriousnesswithorwithoutharmco-association

(Through28February2021)27

LISTOFFIGURES

Figure1.TotalNumberof13vPnCAEsbySystemOrganClassesandEvent

Seriousness8

APPENDICES

APPENDIX1LISTOFADVERSEEVENTSOFSPECIALINTEREST30

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LISTOFABBREVIATIONS

AcronymTerm

AEadverseevent

AESIadverseeventofspecialinterest

BCBrightonCollaboration

CDCCentersforDiseaseControlandPrevention

COVID-19coronavirusdisease2019

DLPdatalockpoint

EUAemergencyuseauthorisation

HLGT(MedDRA)HighGroupLevelTerm

HLT(MedDRA)HighLevelTermMAHmarketingauthorisationholder

MedDRAmedicaldictionaryforregulatoryactivities

MHRAMedicinesandHealthcareproductsRegulatoryAgency

PCRPolymeraseChainReactionPT(MedDRA)PreferredTermPVPpharmacovigilanceplan

RT-PCRReverseTranscription-PolymeraseChainReaction

RSIreferencesafetyinformationTMEtargetedmedicallyevent

SARS-CoV-2severeacuterespiratorysyndromecoronavirus2

SMQstandardisedMedDRAquery

SOC(MedDRA)SystemOrganClass

UKUnitedKingdomUSUnitedStates

VAEDvaccine-associatedenhanceddisease

VAERDvaccine-associatedenhancedrespiratorydisease

VAERSvaccineadverseeventreportingsystem

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1.INTRODUCTION

ReferenceismadetotheRequestforCommentsandAdvicesubmitted04February2021

regardingPfizer/BioNTech’sproposalfortheclinicalandpost-authorizationsafetydata

packagefortheBiologicsLicenseApplication(BLA)forourinvestigationalCOVID-19

Vaccine(BNT162b2).FurtherreferenceismadetotheAgency’s09March2021responseto

thisrequest,andspecifically,thefollowingrequestfromtheAgency.

“Monthlysafetyreportsprimarilyfocusoneventsthatoccurredduringthereportinginterval

andincludeinformationnotrelevanttoaBLAsubmissionsuchaslinelistsofadverseevents

bycountry.Wearemostinterestedinacumulativeanalysisofpost-authorizationsafetydata

tosupportyourfutureBLAsubmission.Pleasesubmitanintegratedanalysisofyour

cumulativepost-authorizationsafetydata,includingU.S.andforeignpost-authorization

experience,inyourupcomingBLAsubmission.Pleaseincludeacumulativeanalysisofthe

ImportantIdentifiedRisks,ImportantPotentialRisks,andareasofImportantMissing

InformationidentifiedinyourPharmacovigilancePlan,aswellasadverseeventsofspecial

interestandvaccineadministrationerrors(whetherornotassociatedwithanadverseevent).

Pleasealsoincludedistributiondataandananalysisofthemostcommonadverseevents.In

addition,pleasesubmityourupdatedPharmacovigilancePlanwithyourBLAsubmission.”

Thisdocumentprovidesanintegratedanalysisofthecumulativepost-authorizationsafety

data,includingU.S.andforeignpost-authorizationadverseeventreportsreceivedthrough28

February2021.

2.METHODOLOGY

Pfizerisresponsibleforthemanagementpost-authorizationsafetydataonbehalfofthe

MAHBioNTechaccordingtothePharmacovigilanceAgreementinplace.Datafrom

BioNTechareincludedinthereportwhenapplicable.

Pfizer’ssafetydatabasecontainscasesofAEsreportedspontaneouslytoPfizer,cases

reportedbythehealthauthorities,casespublishedinthemedicalliterature,casesfrom

Pfizer-sponsoredmarketingprograms,non-interventionalstudies,andcasesofseriousAEs

reportedfromclinicalstudiesregardlessofcausalityassessment.

Thelimitationsofpost-marketingadversedrugeventreportingshouldbeconsideredwhen

interpretingthesedata:

•Reportsaresubmittedvoluntarily,andthemagnitudeofunderreportingisunknown.

Someofthefactorsthatmayinfluencewhetheraneventisreportedinclude:lengthof

timesincemarketing,marketshareofthedrug,publicityaboutadrugoranAE,

seriousnessofthereaction,regulatoryactions,awarenessbyhealthprofessionalsand

consumersofadversedrugeventreporting,andlitigation.

•BecausemanyexternalfactorsinfluencewhetherornotanAEisreported,the

spontaneousreportingsystemyieldsreportingproportionsnotincidencerates.Asa

result,itisgenerallynotappropriatetomakebetween-drugcomparisonsusingthese

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proportions;thespontaneousreportingsystemshouldbeusedforsignaldetection

ratherthanhypothesistesting.

•Insomereports,clinicalinformation(suchasmedicalhistory,validationofdiagnosis,

timefromdrugusetoonsetofillness,dose,anduseofconcomitantdrugs)ismissing

orincomplete,andfollow-upinformationmaynotbeavailable.

•Anaccumulationofadverseeventreports(AERs)doesnotnecessarilyindicatethata

particularAEwascausedbythedrug;rather,theeventmaybeduetoanunderlying

diseaseorsomeotherfactor(s)suchaspastmedicalhistoryorconcomitant

medication.

•AmongadverseeventreportsreceivedintothePfizersafetydatabaseduringthe

cumulativeperiod,onlythosehavingacompleteworkflowcycleinthesafetydatabase

(meaningtheyprogressedtoDistributionorClosedworkflowstatus)areincludedinthe

monthlySMSR.Thisapproachpreventstheinclusionofcasesthatarenotfullyprocessed

hencenotaccuratelyreflectingfinalinformation.Duetothelargenumbersof

spontaneousadverseeventreportsreceivedfortheproduct,theMAHhasprioritisedthe

processingofseriouscases,inordertomeetexpeditedregulatoryreportingtimelinesand

ensurethesereportsareavailableforsignaldetectionandevaluationactivity.The

increasedvolumeofreportshasnotimpactedcaseprocessingforseriousreports,and

compliancemetricscontinuetobemonitoredweeklywithpromptactiontakenasneeded

tomaintaincompliancewithexpeditedreportingobligations.Non-seriouscasesare

enteredintothesafetydatabasenolaterthan4calendardaysfromreceipt.Entranceinto

thedatabaseincludesthecodingofalladverseevents;thisallowforamanualreviewof

eventsbeingreceivedbutmaynotincludeimmediatecaseprocessingtocompletion.

Non-seriouscasesareprocessedassoonaspossibleandnolaterthan90daysfrom

receipt.Pfizerhasalsotakenamultipleactionstohelpalleviatethelargeincreaseof

adverseeventreports.Thisincludessignificanttechnologyenhancements,andprocess

andworkflowsolutions,aswellasincreasingthenumberofdataentryandcase

(b)(4)

processingcolleagues.Todate,Pfizerhasonboardedapproximatelyadditionalfull-timeemployees(FTEs).Morearejoiningeachmonthwithanexpectedtotalofmorethan

(b)(4)

additionalresourcesbytheendofJune2021.

3.RESULTS

3.1.SafetyDatabase

3.1.1.GeneralOverview

ItisestimatedthatapproximatelydosesofBNT162b2wereshippedworldwide

(b)(4)

fromthereceiptofthefirsttemporaryauthorisationforemergencysupplyon01December

2020through28February2021.

Cumulatively,through28February2021,therewasatotalof42,086casereports(25,379

medicallyconfirmedand16,707non-medicallyconfirmed)containing158,893events.Most

cases(34,762)werereceivedfromUnitedStates(13,739),UnitedKingdom(13,404)Italy

(2,578),Germany(1913),France(1506),Portugal(866)andSpain(756);theremaining

7,324weredistributedamong56othercountries.

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Table1belowpresentsthemaincharacteristicsoftheoverallcases.

Table1.GeneralOverview:SelectedCharacteristicsofAllCasesReceivedDuring

theReportingInterval

CharacteristicsRelevantcases(N=42086)

Gender:Female29914

Male9182

NoData2990Agerange(years):≤17175a

0.01-107years18-304953

Mean=50.9years31-5013886

n=3495251-647884

65-743098≥755214Unknown6876

Caseoutcome:Recovered/Recovering19582

Recoveredwithsequelae520

Notrecoveredatthetimeofreport11361

Fatal1223Unknown9400

a.in46casesreportedagewas<16-year-oldandin34cases<12-year-old.

AsshowninFigure1,theSystemOrganClasses(SOCs)thatcontainedthegreatestnumber

(≥2%)ofevents,intheoveralldataset,wereGeneraldisordersandadministrationsite

conditions(51,335AEs),Nervoussystemdisorders(25,957),Musculoskeletaland

connectivetissuedisorders(17,283),Gastrointestinaldisorders(14,096),Skinand

subcutaneoustissuedisorders(8,476),Respiratory,thoracicandmediastinaldisorders

(8,848),Infectionsandinfestations(4,610),Injury,poisoningandproceduralcomplications

(5,590),andInvestigations(3,693).

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Figure1.TotalNumberofBNT162b2AEsbySystemOrganClassesandEvent

Seriousness

Table2showsthemostcommonly(≥2%)reportedMedDRA(v.23.1)PTsintheoverall

dataset(through28February2021),

Table2.EventsReportedin≥2%Cases

CumulativelyThrough28

February2021

MedDRASOCMedDRAPTAEs(AERP%)

N=42086

Bloodandlymphaticsystemdisorders

Lymphadenopathy1972(4.7%)Cardiacdisorders

Tachycardia1098(2.6%)Gastrointestinaldisorders

Nausea5182(12.3%)

Diarrhoea1880(4.5%)

Vomiting1698(4.0%)

Generaldisordersandadministrationsiteconditions

Pyrexia7666(18.2%)

Fatigue7338(17.4%)

Chills5514(13.1%)

Vaccinationsitepain5181(12.3%)

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Table2.EventsReportedin≥2%Cases

CumulativelyThrough28

February2021

MedDRASOCMedDRAPTAEs(AERP%)

N=42086

Pain3691(8.8%)

Malaise2897(6.9%)

Asthenia2285(5.4%)

Drugineffective2201(5.2%)

Vaccinationsiteerythema930(2.2%)

Vaccinationsiteswelling913(2.2%)

Influenzalikeillness835(2%)

Infectionsandinfestations

COVID-191927(4.6%)Injury,poisoningandproceduralcomplications

Offlabeluse880(2.1%)

Productuseissue828(2.0%)

Musculoskeletalandconnectivetissuedisorders

Myalgia4915(11.7%)

Paininextremity3959(9.4%)

Arthralgia3525(8.4%)

Nervoussystemdisorders

Headache10131(24.1%)

Dizziness3720(8.8%)

Paraesthesia1500(3.6%)

Hypoaesthesia999(2.4%)

Respiratory,thoracicandmediastinaldisorders

Dyspnoea2057(4.9%)

Cough1146(2.7%)

Oropharyngealpain948(2.3%)

Skinandsubcutaneoustissuedisorders

Pruritus1447(3.4%)

Rash1404(3.3%)Erythema1044(2.5%)Hyperhidrosis900(2.1%)Urticaria862(2.1%)

Totalnumberofevents93473

3.1.2.SummaryofSafetyConcernsintheUSPharmacovigilancePlan

Table3.Safetyconcerns

ImportantidentifiedrisksAnaphylaxis

ImportantpotentialrisksVaccine-AssociatedEnhancedDisease(VAED),IncludingVaccine-associated

EnhancedRespiratoryDisease(VAERD)

MissinginformationUseinPregnancyandlactation

UseinPaediatricIndividuals<12YearsofAge

VaccineEffectiveness

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Table4.ImportantIdentifiedRisk

TopicDescription

ImportantPostAuthorizationCasesEvaluation(cumulativeto28Feb2021)

IdentifiedTotalNumberofCasesintheReportingPeriod(N=42086)

Risk

AnaphylaxisSincethefirsttemporaryauthorizationforemergencysupplyunderRegulation174intheUK

(01December2020)andthrough28February2021,1833potentiallyrelevantcaseswereretrievedfrom

theAnaphylacticreactionSMQ(NarrowandBroad)searchstrategy,applyingtheMedDRAalgorithm.

ThesecaseswereindividuallyreviewedandassessedaccordingtoBrightonCollaboration(BC)

definitionandlevelofdiagnosticcertaintyasshownintheTablebelow:

BrightonCollaborationLevelNumberofcases

BC1290BC2311BC310BC4391BC5831Total1833

Level1indicatesacasewiththehighestlevelofdiagnosticcertaintyofanaphylaxis,

whereasthediagnosticcertaintyislowestforLevel3.Level4isdefinedas“reported

eventofanaphylaxiswithinsufficientevidencetomeetthecasedefinition”andLevel

5asnotacaseofanaphylaxis.

Therewere1002cases(54.0%ofthepotentiallyrelevantcasesretrieved),2958potentiallyrelevantevents,fromtheAnaphylacticreactionSMQ(BroadandNarrow)searchstrategy,meetingBCLevel1to

4:

Countryofincidence:UK(261),US(184),Mexico(99),Italy(82),Germany(67),Spain(38),France

(36),Portugal(22),Denmark(20),Finland,Greece(19each),Sweden(17),CzechRepublic,

Netherlands(16each),Belgium,Ireland(13each),Poland(12),Austria(11);theremaining57cases

originatedfrom15differentcountries.

Relevanteventseriousness:Serious(2341),Non-Serious(617);Gender:Females(876),Males(106),Unknown(20);

Age(n=961)rangedfrom16to98years(mean=54.8years,median=42.5years);

Relevantevenoutcomea:fatal(9)b,resolved/resolving(1922),notresolved(229),resolvedwithsequelae

(48),unknown(754);

MostfrequentlyreportedrelevantPTs(≥2%),fromtheAnaphylacticreactionSMQ(BroadandNarrow)

searchstrategy:Anaphylacticreaction(435),Dyspnoea(356),Rash(190),Pruritus(175),Erythema

(159),Urticaria(133),Cough(115),Respiratorydistress,Throattightness(97each),Swollentongue

(93),Anaphylacticshock(80),Hypotension(72),Chestdiscomfort(71),Swellingface(70),Pharyngeal

swelling(68),andLipswelling(64).

Conclusion:EvaluationofBCcasesLevel1-4didnotrevealanysignificantnewsafetyinformation.

Anaphylaxisisappropriatelydescribedintheproductlabelingasarenon-anaphylactichypersensitivity

events.Surveillancewillcontinue.

aDifferentclinicaloutcomemaybereportedforaneventthatoccurredmorethanoncetothesameindividual.

bTherewere4individualsintheanaphylaxisevaluationwhodiedonthesamedaytheywerevaccinated.

Althoughthesepatientsexperiencedadverseevents(9)thatarepotentialsymptomsofanaphylaxis,theyallhadserious

underlyingmedicalconditions,andoneindividualappearedtoalsohaveCOVID-19pneumonia,thatlikelycontributedto

theirdeaths

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Table5.ImportantPotentialRisk

TopicDescription

Important

Potential

Risk

Vaccine-

Associated

Enhanced

Disease

(VAED),

including

Vaccine-

Associated

Enhanced

Respiratory

Disease

(VAERD)

PostAuthorizationCasesEvaluation(cumulativeto28Feb2021)

TotalNumberofCasesintheReportingPeriod(N=42086)

Nopost-authorizedAEreportshavebeenidentifiedascasesofVAED/VAERD,therefore,thereisno

observeddataatthistime.AnexpectedrateofVAEDisdifficulttoestablishsoameaningful

observed/expectedanalysiscannotbeconductedatthispointbasedonavailabledata.Thefeasibilityof

conductingsuchananalysiswillbere-evaluatedonanongoingbasisasdataonthevirusgrowsandthe

vaccinesafetydatacontinuestoaccrue.

ThesearchcriteriautilisedtoidentifypotentialcasesofVAEDforthisreportincludesPTsindicatinga

lackofeffectofthevaccineandPTspotentiallyindicativeofsevereoratypicalCOVID-19a.

SincethefirsttemporaryauthorizationforemergencysupplyunderRegulation174intheUK(01

December2020)andthrough28February2021,138cases[0.33%ofthetotalPMdataset],reporting317

potentiallyrelevanteventswereretrieved:

Countryofincidence:UK(71),US(25),Germany(14),France,Italy,Mexico,Spain,(4each),Denmark

(3);theremaining9casesoriginatedfrom9differentcountries;

CasesSeriousness:138;

Seriousnesscriteriaforthetotal138cases:Medicallysignificant(71,ofwhich8alsoseriousfor

disability),Hospitalizationrequired(non-fatal/non-lifethreatening)(16,ofwhich1alsoseriousfor

disability),Lifethreatening(13,ofwhich7werealsoseriousforhospitalization),Death(38).

Gender:Females(73),Males(57),Unknown(8);

Age(n=132)rangedfrom21to100years(mean=57.2years,median=59.5);

Caseoutcome:fatal(38),resolved/resolving(26),notresolved(65),resolvedwithsequelae(1),unknown

(8);

Ofthe317relevantevents,themostfrequentlyreportedPTs(≥2%)were:Drugineffective(135),

Dyspnoea(53),Diarrhoea(30),COVID-19pneumonia(23),Vomiting(20),Respiratoryfailure(8),and

Seizure(7).

Conclusion:VAEDmaypresentassevereorunusualclinicalmanifestationsofCOVID-19.Overall,there

were37subjectswithsuspectedCOVID-19and101subjectswithconfirmedCOVID-19followingone

orbothdosesofthevaccine;75ofthe101casesweresevere,resultinginhospitalisation,disability,

life-threateningconsequencesordeath.Noneofthe75casescouldbedefinitivelyconsideredas

VAED/VAERD.

InthisreviewofsubjectswithCOVID-19followingvaccination,basedonthecurrentevidence,

VAED/VAERDremainsatheoreticalriskforthevaccine.Surveillancewillcontinue.

a.Searchcriteria:StandardDecreasedTherapeuticResponseSearchANDPTsDyspnoea;Tachypnoea;Hypoxia;

COVID19pneumonia;RespiratoryFailure;AcuteRespiratoryDistressSyndrome;CardiacFailure;Cardiogenicshock;

Acutemyocardialinfarction;Arrhythmia;Myocarditis;Vomiting;Diarrhoea;Abdominalpain;Jaundice;

Acutehepaticfailure;Deepveinthrombosis;Pulmonaryembolism;PeripheralIschaemia;Vasculitis;Shock;

Acutekidneyinjury;Renalfailure;Alteredstateofconsciousness;Seizure;Encephalopathy;Meningitis;

Cerebrovascularaccident;Thrombocytopenia;Disseminatedintravascularcoagulation;Chillblains;

Erythemamultiforme;Multipleorgandysfunctionsyndrome;Multisysteminflammatorysyndromeinchildren.

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Table6.DescriptionofMissingInformation

TopicDescription

Missing

Information

PostAuthorizationCasesEvaluation(cumulativeto28Feb2021)

TotalNumberofCasesintheReportingPeriod(N=42086)

Usein

Pregnancy

andlactation

•Numberofcases:413a(0.98%ofthetotalPMdataset);84seriousand329non-serious;

•Countryofincidence:US(205),UK(64),Canada(31),Germany(30),Poland(13),Israel

(11);Italy(9),Portugal(8),Mexico(6),Estonia,HungaryandIreland,(5each),Romania(4),

Spain(3),CzechRepublicandFrance(2each),theremaining10casesweredistributedamong

10othercountries.

Pregnancycases:274casesincluding:

•270mothercasesand4foetus/babycasesrepresenting270uniquepregnancies(the4

foetus/babycaseswerelinkedto3mothercases;1mothercaseinvolvedtwins).

•Pregnancyoutcomesforthe270pregnancieswerereportedasspontaneousabortion(23),

outcomepending(5),prematurebirthwithneonataldeath,spontaneousabortionwith

intrauterinedeath(2each),spontaneousabortionwithneonataldeath,andnormaloutcome(1

each).Nooutcomewasprovidedfor238pregnancies(notethat2differentoutcomeswere

reportedforeachtwin,andbothwerecounted).

•146non-seriousmothercasesreportedexposuretovaccineinuterowithouttheoccurrenceof

anyclinicaladverseevent.TheexposurePTscodedtothePTsMaternalexposureduring

pregnancy(111),Exposureduringpregnancy(29)andMaternalexposuretimingunspecified

(6).Trimesterofexposurewasreportedin21ofthesecases:1sttrimester(15cases),2nd

trimester(7),and3rdtrimester(2).

•124mothercases,49non-seriousand75serious,reportedclinicalevents,whichoccurredin

thevaccinatedmothers.PregnancyrelatedeventsreportedinthesecasescodedtothePTs

Abortionspontaneous(25),Uterinecontractionduringpregnancy,Prematureruptureof

membranes,Abortion,Abortionmissed,andFoetaldeath(1each).Otherclinicaleventswhich

occurredinmorethan5casescodedtothePTsHeadache(33),Vaccinationsitepain(24),

PaininextremityandFatigue(22each),MyalgiaandPyrexia(16each),Chills(13)Nausea

(12),Pain(11),Arthralgia(9),LymphadenopathyandDrugineffective(7each),Chestpain,

DizzinessandAsthenia(6each),MalaiseandCOVID-19(5each).Trimesterofexposurewas

reportedin22ofthesecases:1sttrimester(19cases),2ndtrimester(1case),3rdtrimester(2

cases).

•4seriousfoetus/babycasesreportedthePTsExposureduringpregnancy,Foetalgrowth

restriction,Maternalexposureduringpregnancy,Prematurebaby(2each),andDeathneonatal

(1).Trimesterofexposurewasreportedfor2cases(twins)asoccurringduringthe1st

trimester.

Breastfeedingbabycases:133,ofwhich:

•116casesreportedexposuretovaccineduringbreastfeeding(PTExposureviabreastmilk)

withouttheoccurrenceofanyclinicaladverseevents;

•17cases,3seriousand14non-serious,reportedthefollowingclinicaleventsthatoccurredin

theinfant/childexposedtovaccineviabreastfeeding:Pyrexia(5),Rash(4),Infantirritability

(3),Infantilevomiting,Diarrhoea,Insomnia,andIllness(2each),Poorfeedinginfant,

Lethargy,Abdominaldiscomfort,Vomiting,Allergytovaccine,Increasedappetite,Anxiety,

Crying,Poorqualitysleep,Eructation,Agitation,PainandUrticaria(1each).

Breastfeedingmothercases(6):

•1seriouscasereported3clinicaleventsthatoccurredinamotherduringbreastfeeding(PT

Maternalexposureduringbreastfeeding);theseeventscodedtothePTsChills,Malaise,and

Pyrexia

•1non-seriouscasereportedwithverylimitedinformationandwithoutassociatedAEs.

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Table6.DescriptionofMissingInformation

TopicDescription

Missing

Information

PostAuthorizationCasesEvaluation(cumulativeto28Feb2021)

TotalNumberofCasesintheReportingPeriod(N=42086)

•In4cases(3non-serious;1serious)Suppressedlactationoccurredinabreastfeedingwomen

withthefollowingco-reportedevents:Pyrexia(2),Paresis,Headache,Chills,Vomiting,Pain

inextremity,Arthralgia,Breastpain,Scarpain,Nausea,Migraine,Myalgia,Fatigueand

Breastmilkdiscolouration(1each).

Conclusion:Therewerenosafetysignalsthatemergedfromthereviewofthesecasesofusein

pregnancyandwhilebreastfeeding.

Usein

Paediatric

Individuals

<12Yearsof

Age

Paediatricindividuals<12yearsofage

•Numberofcases:34d(0.1%ofthetotalPMdataset),indicativeofadministrationinpaediatric

subjects<12yearsofage;

•Countryofincidence:UK(29),US(3),GermanyandAndorra(1each);

•CasesSeriousness:Serious(24),Non-Serious(10);

•Gender:Females(25),Males(7),Unknown(2);

•Age(n=34)rangedfrom2monthsto9years,mean=3.7years,median=4.0;

•Caseoutcome:resolved/resolving(16),notresolved(13),andunknown(5).

•Ofthe132reportedevents,thosereportedmorethanoncewereasfollows:Product

administeredtopatientofinappropriateage(27,seeMedicationError),Offlabeluse(11),

Pyrexia(6),Productuseissue(5),Fatigue,HeadacheandNausea(4each),Vaccinationsite

pain(3),Abdominalpainupper,COVI