COMIRNATY (COVID-19 mRNA VACCINE) RISK …

1 BNT162b2 Risk management plan 25 November 2021 CONFIDENTIAL Page 1 COMIRNATY (COVID-19 mRNA VACCINE) RISK management plan RMP Version number: Data lock point for this RMP: See below 12-15 years of age13 March 2021 (Pfizer Clinical Database) 18 June 2021 (Pfizer Safety Database) 16 years and older 23 October 2020 (BioNTech Clinical Database) 13 March 2021 (Pfizer Clinical Database) 18 June 2021 (Pfizer Safety Database) 5 to < 12 years of age 06 September 2021 (Pfizer Clinical Database) 18 June 2021 (Pfizer Safety Database) Date of final sign off: 25 November 2021 Rationale for submitting an updated RMP (v ): This Type II variation includes an updated COMIRNATY EU RMP that merges versions and : Rationale for submitting an updated RMP (v ): This Type II variation includes anupdated COMIRNATY EU RMP that merges versions (myocarditis/pericarditis) and (tris-sucrose adult formulation). The updated EU RMP v was submitted on 12 November 2021.

2 Rationale for submitting an updated RMP (v ): This Type II variation supportsextension of the indication to children 5 to <12 years of age. Following receipt of thePRAC Rapporteur s preliminary assessment report and the Request for SupplementaryInformation on 16 November 2021, with regard to the RMP v submitted in October2021 (procedure number EMEA/H/C/005735/X/0077), an updated draft added non-interventional post-approval safety studies that include paediatric subject aged 5 to < 12years old, as requested. The updated EU RMP v was submitted on 19 of significant changes in this RMP: BNT162b2 Risk management PlanNovember 2021 CONFIDENTIALPage 2 RMP Part/ModuleMajor Change (s)RMP v v IPRODUCT(S) OVERVIEWC hange to include the new paediatric population aged 5 to < 12-year-oldAddition of data related to the tris-sucrose adult formulation PART IISAFETY SPECIFICATIONPART SIEpidemiology of the Indication(s) and Target PopulationsChange to include the new paediatric population aged 5 to < 12-year-oldNo changes madePART SIINon-Clinical Part of the Safety SpecificationNo changes changes madePART SIIIC linical Trial ExposureChange to include the new paediatric population aged 5 to < 12-year-oldNo changes madePART SIVP opulations Not Studied in Clinical TrialsChange to include the new paediatric population aged 5 to < 12-year-oldNo changes madePART SVPost-Authorisation ExperienceNo changes changes SVIA dditional EU Requirements for the Safety SpecificationNo changes changes SVIII dentified and Potential RisksChange to include the new paediatric population aged 5 to < 12-year-oldNo changes madePART SVIIIS ummary of the Safety ConcernsNo changes changes IIIPHARMACOVIGILANCE plan (INCLUDING POST AUTHORISATION SAFETY STUDIES)

3 Routine Pharmacovigilance Additional Pharmacovigilance Activitiesand Summary Table of Additional Pharmacovigilance ActivitiesAddition of data related to the new paediatric population aged 5 to < 12-year-old and of tri/sucrose paediatric formulationRemoval of study C4591018 Milestone for study C4591024 updatedInclusion of new protocol number C4591030 Non-interventional post-approval safety studies updated to include paediatric subjects aged5 to < 12 years oldInclusion of study C4591007 Milestone changed for study C4591001 Addition of data related to the tris-sucrose adult formulation PART IVPLANS FOR POST AUTHORISATION EFFICACY STUDIESNo changes changes VRISK MINIMISATION MEASURES (INCLUDING EVALUATION OF THE EFFECTIVENESS OF RISK MINIMISATION ACTIVITIES)BNT162b2 Risk management PlanNovember 2021 CONFIDENTIALPage 3 RMP Part/ModuleMajor Change (s)RMP v v Routine Risk Minimisation Additional Risk Minimisation Summary of Risk Minimisation MeasuresAddition of data related to the new paediatric population aged 5 to < 12-year-oldInclusion of study C4591007No changes VISUMMARY OF THE RISK management PLANI The Medicine and What It Is Used ForII Risks Associated With the Medicine and Activities to Minimise or Further Characterise the RisksAddition of data related to the new paediatric population aged 5 to < 12-year-oldNon-interventional post-approval safety studies updated to include paediatric subjects aged 5 to < 12 years oldInclusion of study C4591007 Milestone changed for study C4591001No changes VIIANNEXES TO THE RISK management PLANA nnex 2: Studies/milestones updated Annex 3.

4 Studies updatedAnnex 8: Changes to reflect the updatesAnnex 8: Changes to reflect the updatesBNT162b2 Risk management PlanNovember 2021 CONFIDENTIALPage 4 Other RMP versions under evaluation: RMP version number: on: 15 November 2021 Procedure number: EMEA/H/C/005735/II/0087 RMP version (updated version) Submitted on: 19 November 2021 Procedure number: EMEA/H/C/005735/X/0077 Details of the currently approved RMP RMP version number: with (combined) procedurenumbers: EMEA/H/C/005735/X/0044/G, EMEA/H/C/005735/IB/0069/G and EMEA/H/C/005735/N/0079 Date of approval: 12 November 2021 QPPV name1:Barbara De BernardiQPPV oversight declaration: The content of this RMP has been reviewed and approved by the marketing authorisation applicant s QPPV. The electronic signature is available on file. 1 QPPV namewill not be redacted in case of an access to documents request; see HMA/EMA Guidance document on the identification of commercially confidential information and personal data within the structure of the marketing-authorisation application.

5 Available on EMA website management PlanNovember 2021 CONFIDENTIALPage 5 LIST OF ABBREVIATIONSA bbreviationDefinition of TermACIPA dvisory Committee onImmunisation PracticesAEadverse eventAESI adverse event of special interestA:Galbumin:globulinALC-0315((4-h ydroxybutyl)azanediyl)bis(hexane-6,1-diy l)bis(2-hexyldecanoate)ALC-01592 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamideA RDS acute respiratory distress syndromeBALB/cbagg albinoBCBrighton CollaborationBMIbody mass indexBPblood pressureCD4, CD8cluster of differentiation-4,8 CDCC enters for Disease Control and PreventionCIconfidence intervalCLLchronic lymphocytic leukaemiaCOPD chronic obstructive pulmonary diseaseCOVID-19coronavirus disease 2019 CSRclinical study reportCTclinical trialDART developmental and reproductive toxicologyDCAdata capture aidDHPCD irect Healthcare Professional CommunicationDLPdata-lock pointDoDDepartment of DefenseECDCE uropean Center for Disease ControlEDemergency departmentEEAE uropean Economic AreaeGFRestimated glomerular filtration rateEHRelectronic health recordsEMAE uropean Medicines AgencyEUAemergency use authorisationEUEuropean UnionFDA(US)

6 Food and Drug AdministrationGLPgood laboratory practiceHbA1cglycated haemoglobinHBVhepatitis b virusHCVhepatitis c virus HIVhuman immunodeficiency virusIAinterim analysisICUintensive care unitBNT162b2 Risk management PlanNovember 2021 CONFIDENTIALPage 6 AbbreviationDefinition of TermIFNinterferonIL-4interleukin-4 IMintramuscular(ly)IMDindex of multiple deprivationINDinvestigational new drugLNPlipid nanoparticleMAHmarketing authorisation holderMedDRAM edical Dictionary for Regulatory ActivitiesmRNAmessenger ribonucleic acidMERS-CoVMiddle East respiratory syndrome-coronavirusMHSM ilitary Health SystemMIS-Cmultisystem inflammatory syndrome in childrenNDAnew drug applicationNHLBIN ational Heart, Lung and Blood InstituteNHPnonhuman primateNIHN ational Institutes of HealthNICEN ational Institute for Health and Care ExcellenceNSCLCnon-small-cell lung carcinomaOCSoral corticosteroidsPCproduct complaintPKpharmacokineticPHNP ediatric Heart NetworkPRACP harmacovigilance risk assessment committeeRArheumatoid arthritisRBCred blood cellRMPrisk management planRNAribonucleic acidRRrelative riskSAEserious adverse eventSARS severe acute respiratory syndromeSARS-CoV-1severe acute respiratory syndrome coronavirus 1 SARS-CoV-2severe acute respiratory syndrome coronavirus 2siRNAsmall-interfering RNASMQ standardised MedDRA querySmPCsummary of product characteristicsSPEACS afety Platform for Emergency vACcinesTESSyTheEuropean Surveillance SystemTh1T helper cell type 1Th2T helper cell type 2 TMEtargeted medical eventTNFtumour necrosis factorUKUnited KingdomUSUnited StatesV8variant 8 BNT162b2 Risk management PlanNovember 2021

7 CONFIDENTIALPage 7 AbbreviationDefinition of TermV9variant 9 VAC4 EUVaccine monitoring Collaboration for EuropeVAED vaccine-associated enhanced diseaseVAERD vaccine-associated enhanced respiratory diseaseWBCwhite blood cellsWHOW orld Health OrganisationWOCBP women of child-bearing potentialBNT162b2 Risk management PlanNovember 2021 CONFIDENTIALPage 8 TABLE OF CONTENTSLIST OF OF OF I. PRODUCT(S) II. SAFETY SI. Epidemiology of the Indication(s) and Target Population (s)..17 Module SII. Non-Clinical Part of the Safety SIII. Clinical Trial SIV. Populations Not Studied in Clinical Exclusion Criteria in Pivotal Clinical Studies Within the Development Limitations to Detect Adverse Reactions in Clinical Trial Development Limitations in Respect to Populations Typically Under-Represented in Clinical Trial Development SV. Post-Authorisation Post-Authorisation Method Used to Calculate SVI. Additional EU Requirements for the Safety SVII.

8 Identified and Potential Identification of Safety Concerns in the Initial RMP Risks not Considered Important for Inclusion in the List of Safety Concerns in the Risks Considered Important for Inclusion in the List of Safety Concerns in the New Safety Concerns and Reclassification with a Submission of an Updated of Important Identified Risks, Important Potential Risks, and Missing Presentation of Important Identified Risks and Important Potential Presentation of the Missing SVIII. Summary of theSafety management PlanNovember 2021 CONFIDENTIALPage 9 PART III. PHARMACOVIGILANCE plan (INCLUDING POST-AUTHORISATION SAFETYSTUDIES).. Routine Pharmacovigilance Additional Pharmacovigilance Summary Table of Additional Pharmacovigilance and Planned Additional Pharmacovigilance IV. PLANS FOR POST AUTHORISATION EFFICACY V. RISK MINIMISATION MEASURES (INCLUDING EVALUATION OF THE EFFECTIVENESS OFRISK MINIMISATION ACTIVITIES).

9 Routine Risk Minimisation Additional Risk Minimisation Summary of Risk Minimisation VI. SUMMARY OF THE RISK management The Medicine and What It Is Used Risks Associated With the Medicine and Activities to Minimise or Further Characterise the List of Important Risks and Missing Summary of Important Post-Authorisation Development Studies which are Conditions of the Marketing Other Studies in Post-Authorisation Development VII. ANNEXES TOTHE RISK management PlanNovember 2021 CONFIDENTIALPage 10 LIST OF TABLEST able 1. Incidence, Prevalence, and Mortality of COVID-19 as of 15 August 2. Distribution of Cases (n=29,346,352) by Age, Sex, Race, and Cross-Tabulated Age and Sex- United States as of 14 August of Deaths (n=513,204) by Age, Sex, Race, and Cross-Tabulated Age and Sex - United States as of 14 August incidence and rate ratios, by age group among persons aged <25 years across three periods of 2020 in 16 jurisdictions.

10 23 Table of 135,794 US individuals under age 25 tested for COVID-19 by 08 September 6. Risk for COVID-19 Infection, Hospitalisation, and Death by Age Group and by Ratios and 95% Confidence Intervals for COVID-19-related Death .. and Symptoms among 291 Paediatric (age <18 years) and 10,944 Adult (age 18 64 years) Patients with laboratory confirmed COVID-19 United States, February 12 April 2, among COVID-19 Patients in EU/EEA, by Severity of Disease. Case-based Data from TESSy Reported 12 August in Individuals tested for COVID-19 in the Providence St. Joseph Health System States of California, Oregon, and Washington, 01 March 31 December Safety Findings and Relevance to Human to BNT162b2 by Age Group and Dose (C4591001) Blinded Placebo-Controlled Follow-up to BNT162b2 by Age Group and Dose (C4591001) Open-Label Follow-up Period Subjects Who Originally Received to BNT162b2 by Age Group and Dose (C4591001) Open-Label Follow-up Period Subjects Who Originally Received Placebo and Then Received BNT162b2 After to BNT162b2 by Age Group and Dose(BNT162-01).