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`INTERVENORS’ EXHIBIT 2
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`MAR O 2 ZO
`pPLE0)
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`USDISIRIGT COURT
`DISTRICT OF DELAWARE
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`BNT162b2
`5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
`
`§.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT
`REPORTSOF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021
`
`Report Prepared by:
`
`Worldwide Safety
`
`Pfizer
`
`The information contained in this documentis proprietary and confidential. Any disclosure, reproduction,
`distribution, or other dissemination of this information outside of Pfizer, its Affiliates, its Licensees, or
`Regulatory Agenciesis strictly prohibited. Except as may be otherwise agreed to in writing, by accepting or
`reviewing these materials, you agree to hold such information in confidence and not to discloseit to others
`(except where required by applicable law), nor to use it for unauthorized purposes.
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`BNT162b2
`5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
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`TABLE OF CONTENTS
`
`LIST OF TABLES0.0... ee ceecccescceeeeeseeessneeseesneeseevsceenecsnssonseaeessneeaeenaeenaeensereaeeeieseaaseresseeesarendaees 3
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`LIST OF FIGURESoo eceeccsccsscnsccseesnecsscnscsnsracessevsssssensessseaeceaseaeessereseasessesseesaseaeeasoneceaseaae 3
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`APPENDICES ..........ccceessccseccesesersorsecesceserssersscnserscerecevecevscssneesseessesesserseserssraccesseseasecsscessentaeeasens 3
`
`LIST OF ABBREVIATIONS oo ee ccsscscesceccsencereceeesaceseteceeneeseseneeecssecessecesaneenseeeeneeaeenes® 4
`
`L INTRODUCTION ooo ices rseccceceenceeceescansascensessessesssessessseseeseeseesssosesseeseeseaea 5
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`2. METHODOLOGY 0... cceccccsccssecssceesceesnecensesasensesensenaeenseecsecaaeseseassaeeaneseeessnesecesseeecesenseneeeeatens 5
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`3. RESULTS000. ee cecceeeeceeceeceeceseeaesansecesseaeeseeaecacaeaceceescerseceseeaneaaeaceacenseseessesecsesateeseeceeeeeeeeaeens 6
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`3.1. Safety Databasecc sccsssscssceseesserasessesscescesesneseesssseseeeasenessasrsspssereceesonacenseae 6
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`3.1.1. General OVErVieW 0. ceecescesceececenetaceaeeaeeseeaseaenarsersesserseeserseeaeeseeeaeraees 6
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`3.1.2. Summary of Safety Concerns in the US Pharmacovigilance Plan............... 9
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`3.1.3. Review of Adverse Events of Special Interest (AESTs) .............eseeeeeeeeeees 16
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`3.1.4. Medication error ..........cccccceccceceecccecceecseeesscesececeseneessaeeseeeeseseersnseneeeeseaeenaaes 26
`
`4, DISCUSSION..0.... eee eeeseeseeseteecseeseessscaseenecnansaeesateacescenssssecsessessauesecaeenacesesenseseteseseseaseasenees 28
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`5. SUMMARY AND CONCLUSION....o. ee eceeeecssereesessesaecseseseesesserscrsensenapasssessossessasoes29
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`BNT162b2
`5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
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`Table I.
`
`Table 2.
`
`Table 3.
`
`Table 4.
`
`Table 5.
`
`Table 6.
`
`Table 7.
`
`Table 8.
`
`LIST OF TABLES
`
`General Overview: Selected Characteristics of All Cases Received
`During the Reporting Interval ccc eeeeeeeeeseeceseeceeceseeaseeeeeesetseeseeeeteees 7
`
`Events Reported in =2% CaseS......ceceesessscsesseceecseeeseeseeeeseenenesneeeneeneeenes 8
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`Safety CONCEINS 20... ececceesesccesceeceecenseesetoesseensceeneeeescesaeeeeesaseneeaeeeneeaenaes9
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`Important Identified Risk.............ccccscesseceeesereesesceeecceesneersceceeseuecsneenaees 10
`
`Important Potential Risk 000... csesseeseceeeeeeeeeeseeecceseceesacesseeeetseaeeeaaeneaes 1
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`Description of Missing Information 2.0.0.0... eeseessescceeeceeeeeeeeneeeeeeeaeeeess 12
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`AESIs Evaluation for BNT162b2..........cccssscsssessecssecceeeseccessenetetseeeneeans 16
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`MEPTsbyseriousness with or without harm co-association
`(Through 28 February 2021) 00... ceceesseessessersseeseeeceeecceesceeenecsueeeaeeees27
`
`Figure |.
`
`Total Number of 13vPnC AEs by System Organ Classes and Event
`SETIOUSNIESS 00.0... ecscessessenenensesesessceseaenssesseeseeesereseseeeseeseseasesseseesesaeaeaenaas 8
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`LIST OF FIGURES
`
`APPENDIX 1 LIST OF ADVERSE EVENTSOF SPECIAL INTEREST..........cceeceesceeeeee 30
`
`APPENDICES
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`BNT162b2
`5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
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`LIST OF ABBREVIATIONS
`
`
`
`
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`
`
`
`
`
`
`
`
`
`
`
`B
`
`
`
`
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`
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`emergency use authorisation
`edDRA) High Group Level Term
`
`marketing authorisation holder
`activities
`medical dictionary
`for regulatory
`Medicines and Healthcare products Regulatory Agenc
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`vaccine adverse event reporting system
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`BNT162b2
`§.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
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`1. INTRODUCTION
`
`Reference is made to the Request for Comments and Advice submitted 04 February 2021
`regarding Pfizer/BioNTech’s proposalfor the clinical and post-authorization safety data
`package for the Biologics License Application (BLA) for our investigational COVID-19
`Vaccine (BNT162b2). Further reference is made to the Agency’s 09 March 2021 response to
`this request, and specifically, the following request from the Agency.
`
`‘Monthly safety reports primarilyfocus on events that occurred during the reporting interval
`and include information not relevant to a BLA submission such aslinelists ofadverse events
`by country. We are most interested in a cumulative analysis ofpost-authorization safety data
`to support yourfuture BLA submission. Please submit an integrated analysis ofyour
`cumulative post-authorization safety data, including U.S. andforeign post-authorization
`experience, in your upcoming BLA submission. Please include a cumulative analysis ofthe
`Important Identified Risks, Important Potential Risks, and areas ofImportant Missing
`Information identified in your Pharmacovigilance Plan, as well as adverse events ofspecial
`interest and vaccine administration errors (whether or not associated with an adverse event).
`Please also include distribution data and an analysis ofthe most common adverse events. In
`addition, please submit your updated Pharmacovigilance Plan with your BLA submission.”
`
`This documentprovides an integrated analysis of the cumulative post-authorization safety
`data, including U.S. and foreign post-authorization adverse event reports received through 28
`February 2021.
`
`2. METHODOLOGY
`
`Pfizer is responsible for the managementpost-authorization safety data on behalf of the
`MAHBioNTechaccording to the Pharmacovigilance Agreementin place. Data from
`BioNTechare included in the report when applicable.
`
`Pfizer’s safety database contains cases of AEs reported spontaneously to Pfizer, cases
`reported by the health authorities, cases published in the medical literature, cases from
`Pfizer-sponsored marketing programs, non-interventional studies, and cases of serious AEs
`reported from clinical studies regardless of causality assessment.
`
`The limitations of post-marketing adverse drug event reporting should be considered when
`interpreting these data:
`
`e Reports are submitted voluntarily, and the magnitude of underreporting is unknown.
`Someofthe factors that may influence whetheran event is reported include: length of
`time since marketing, market share of the drug, publicity about a drug or an AE,
`seriousnessof the reaction, regulatory actions, awareness by health professionals and
`consumers of adverse drug event reporting, andlitigation.
`
`e Because many external factors influence whetheror not an AEis reported, the
`spontaneous reporting system yields reporting proportions not incidence rates. As a
`result, it is generally not appropriate to make between-drug comparisonsusing these
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`5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
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`proportions; the spontaneous reporting system should be used forsignal detection
`rather than hypothesis testing.
`
`®
`
`In some reports, clinical information (such as medical history, validation of diagnosis,
`time from drug useto onsetofillness, dose, and use of concomitant drugs) is missing
`or incomplete, and follow-up information may not be available.
`
`e Anaccumulation of adverse event reports (AERs) does not necessarily indicate that a
`particular AE was caused bythe drug; rather, the event may be due to an underlying
`disease or some otherfactor(s) such as past medical history or concomitant
`medication.
`
`e Among adverse event reports received into the Pfizer safety database during the
`cumulative period, only those having a complete workflow cycle in the safety database
`(meaning they progressed to Distribution or Closed workflow status) are included in the
`monthly SMSR. This approach prevents the inclusion ofcases that are not fully processed
`hence not accuratelyreflecting final information. Due to the large numbers of
`spontaneous adverse event reports received for the product, the MAH hasprioritised the
`processing of serious cases, in order to meet expedited regulatory reporting timelines and
`ensure these reports are available for signal detection and evaluation activity. The
`increased volume of reports has not impacted case processing for serious reports, and
`compliance metrics continue to be monitored weekly with promptaction taken as needed
`to maintain compliance with expedited reporting obligations. Non-serious cases are
`entered into the safety database no later than 4 calendar days from receipt. Entrance into
`the database includes the coding ofall adverse events; this allow for a manual reviewof
`events being received but may not include immediate case processing to completion.
`Non-serious cases are processed as soon as possible and nolater than 90 days from
`receipt. Pfizer has also taken a multiple actions to help alleviate the large increase of
`adverse event reports. This includes significant technology enhancements, and process
`and workflow solutions, as well as increasing the numberofdata entry and case
`
`processing colleagues. To date, Pfizer has onboarded approximately "| additional full-
`
`time employees (FTEs). More are joining each month with an expected total of more than
`
`additional resources by the end of June 2021.
`
`3. RESULTS
`
`3.1. Safety Database
`
`3.1.1. General Overview
`
`
`doses of BNT162b2 were shipped worldwide
`It is estimated that approximately
`from the receipt of the first temporary authorisation for emergency supply on 0! December
`2020 through 28 February 2021.
`
`Cumulatively, through 28 February 2021, there was a total of 42,086 case reports (25,379
`medically confirmed and 16,707 non-medically confirmed) containing 158,893 events. Most
`cases (34,762) were received from United States (13,739), United Kingdom(13,404)Italy
`(2,578), Germany (1913), France (1506), Portugal (866) and Spain (756); the remaining
`7,324 were distributed among 56 other countries.
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`BNT162b2
`5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
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`Table | below presents the main characteristics of the overall cases.
`
`Table 1. General Overview: Selected Characteristics of All Cases Received During
`the Reporting Interval
`
`
`
`
`
`
`
`Age range (years):
`0.01 -107 years
`Mean = 50.9 years
`
`n= 34952
`
`
`
`19582
`
`Recovered with sequelae
`Not recovered at the time of report
`
`(N=42086
`
`Relevant cases
`29914
`9182
`2990
`
`11361
`1223
`9400
`
`
`
`
`
`Case outcome:
`
`
`in 46 cases reported age was <16-year-old and in 34 cases <12-year-old.
`
`a.
`
`As shown in Figure 1, the System Organ Classes (SOCs) that contained the greatest number
`(22%) of events, in the overall dataset, were General disorders and administrationsite
`conditions (51,335 AEs), Nervous system disorders (25,957), Musculoskeletal and
`connective tissue disorders (17,283), Gastrointestinal disorders (14,096), Skin and
`subcutaneoustissue disorders (8,476), Respiratory, thoracic and mediastinal disorders
`(8,848), Infections and infestations (4,610), Injury, poisoning and procedural complications
`(5,590), and Investigations (3,693).
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`BNT162b2
`5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
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`Figure 1. Total Number of BNT162b2 AEs by System Organ Classes and Event
`Seriousness
`
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`
`Table 2 shows the most commonly (=2%) reported MedDRA(v. 23.1) PTs in the overall
`dataset (through 28 February 2021),
`
`Table 2.
`
`Events Reported in >2%Cases
`
`MedDRA SOC
`
`MedDRA PT
`
`Cumulatively Through 28
`
`AEs (AERP%)
`N = 42086
`
`Blood and lymphatic system
`disorders
`
`Cardiac disorders
`
`Gastrointestinal disorders
`
`Lymphadenopath
`
`7666 (18.2%)
`7338 (17.4%
`
`5181
`
`(12.3%)
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`o=©— c
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`

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`BNT162b2
`5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
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`Table 2.
`
`Events Reported in >2% Cases
`
`‘epmaee
`
`February
`
`2021
`
`“Nee
`N = 42086
`
`
`
`
`poPain
`poMalaiseid28976.9%)
`
`Ppt~—“=‘C‘S*S*™*C~C~C~CCCCCCSStent—“(i‘“‘;S™S™S™C*drSC‘“‘CS™SC*C‘éBSSAM)
`Drug ineffective
`2201 (5.2%
`Vaccination site erythema
`930 (2.2%
`Vaccination site swelling
`913 (2.2%
`Influenza like illness
`835 (2%
`
`Infections and infestations
`PoC(i‘iCVI19274.6%)
`Injury,
`poisoning and procedural complications
`Pofflabetse880%)
`
`
`PC“ttstCt~‘“‘(CNC*dProduceissueCCdEC82%)
`Musculoskeletal and connective tissue disorders
`poMyaigigSTH)
`poPainimextremity895909.4%)
`poAthratigig8525(8.4%)
`
`poHeadache1013124.1%)
`
`poDizziness3720(8.8%)
`poParaesthesia500(3.6%)
`poypoaesthesia9992.49)
`Respiratory,
`thoracic and mediastinal disorders
`Dyspnoea
`Cough
`Oropharyngeal pain
`
`PPrritus18474%)
`Ppts—“‘CS™SCSCSC~*ORcshee —“(i‘“‘C*drS14043.3%)
`POErythema104425%)
`
`Pp—C“‘(SC*é*dCyppeerhidrosis,Cd900 (2.1%
`POrticarig8622.1%)
`
`
`|Totalnumberofeventsss|C(is‘C:CSCidz 93473
`
`
`
`
`
`
`
`
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`
`
`
`
`2057 (4.9%
`1146 (2.7%
`948 (2.3%
`
`3.1.2. Summary of Safety Concerns in the US Pharmacovigilance Plan
`
`Table3.
`
`Safety concerns
`
`Importantidentified risks
`
`Anaphylaxis
`
`Vaccine Effectiveness
`
`Importantpotential risks
`
`Missing information
`
`Vaccine-Associated Enhanced Disease (VAED), Including Vaccine-associated
`Enhanced Respiratory Disease (VAERD)
`Use in Pregnancy andlactation
`Use in Paediatric Individuals <12 Years of Age
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`BNT162b2
`5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
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`Table 4.
`
`Important Identified Risk
`
`
`
`ES
`
`Post Authorization Cases Evaluation (cumulative to 28 Feb 2021)
`Total Numberof Cases in the Reporting Period (N=42086)
`
`Important
`Identifted
`Risk
`
`A axis|Since the first temporary authorization for emergency supply under Regulation 174 in the UKnaphyl
`
`
`
`
`(01 December 2020) and through 28 February 2021, 1833 potentially relevant cases were retrieved from
`the Anaphylactic reaction SMQ (Narrow and Broad) searchstrategy, applying the MedDRA algorithm.
`These cases were individually reviewed and assessed according to Brighton Collaboration (BC)
`definition and level of diagnostic certainty as shown in the Table below:
`
`[BCS0
`
`1833
`
`Level | indicates a case with the highest level of diagnostic certainty of anaphylaxis,
`whereas the diagnostic certainty is lowest for Level 3. Level 4 is defined as “reported
`event of anaphylaxis with insufficient evidence to meetthe case definition” and Level
`5 as not a case of anaphylaxis.
`
`There were 1002 cases (54.0% ofthe potentially relevant cases retrieved), 2958 potentially relevant
`events, from the Anaphylactic reaction SMQ (Broad and Narrow)search strategy, meeting BC Level | to
`4:
`
`Country of incidence: UK (261), US (184), Mexico (99), Italy (82), Germany (67), Spain (38), France
`(36), Portugal (22), Denmark (20), Finland, Greece (19 each), Sweden (17), Czech Republic ,
`Netherlands (16 each), Belgium,Ireland (13 each), Poland (12), Austria (11); the remaining 57 cases
`originated from 15 different countries.
`Relevant event seriousness: Serious (2341), Non-Serious (617);
`Gender: Females (876), Males (106), Unknown (20);
`Age (n=961) ranged from 16 to 98 years (mean = 54.8 years, median = 42.5 years);
`Relevant even outcome”: fatal (9), resolved/resolving (1922), not resolved (229), resolved with sequelae
`(48), unknown (754);
`Mostfrequently reported relevant PTs (=2%), from the Anaphylactic reaction SMQ (Broad and Narrow)
`search strategy: Anaphylactic reaction (435), Dyspnoea (356), Rash (190), Pruritus (175), Erythema
`(159), Urticaria (133), Cough (115), Respiratory distress, Throat tightness (97 each), Swollen tongue
`(93), Anaphylactic shock (80), Hypotension (72), Chest discomfort (71), Swelling face (70), Pharyngeal
`swelling (68), and Lip swelling (64).
`
`Conclusion: Evaluation of BC cases Level | - 4 did not reveal any significant new safety information.
`Anaphylaxis is appropriately described in the product labeling as are non-anaphylactic hypersensitivity
`events. Surveillance will continue.
`Different clinical outcome may be reported for an event that occurred more than once to the same individual.
`There were 4 individuals in the anaphylaxis evaluation who died on the same day they were vaccinated.
`Although these patients experienced adverse events (9) that are potential symptomsof anaphylaxis, they all had serious
`underlying medical conditions, and one individual appearedto also have COVID-19 pneumonia, that likely contributed to
`their deaths
`
`a b
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`Important
`Potential
`
`Risk
`
`
`Vaccine-
`No post-authorized AE reports have been identified as cases of VAED/VAERD,therefore,there is no
`Associated
`observed data at this time. An expected rate of VAEDisdifficult to establish so a meaningful
`
`
`Enhanced
`observed/expected analysis cannot be conductedat this point based on available data. The feasibility of
`Disease
`conducting such an analysis will be re-evaluated on an ongoing basis as data on the virus grows and the
`(VAED),
`vaccine safety data continues to accrue.
`
`including
`
`Vaccine-
`Thesearchcriteria utilised to identify potential cases of VAEDforthis report includes PTs indicating a
`Associated
`lack of effect of the vaccine and PTspotentially indicative of severe or atypical COVID-19*.
`Enhanced
`
`
`Respiratory|Since the first temporary authorization for emergency supply under Regulation 174 in the UK (01
`Disease
`December 2020) and through 28 February 2021, 138 cases [0.33% ofthe total PM dataset], reporting 317
`
`(VAERD)
`potentially relevant events were retrieved:
`
`
`
`
`
`
`
`
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`
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`
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`5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
`
`Table 5.
`
`ImportantPotential Risk
`
`
`
`Post Authorization Cases Evaluation (cumulative to 28 Feb 2021)
`Total Numberof Cases in the Reporting Period (N=42086)
`
`
`
`
`
`Country of incidence: UK (71), US (25), Germany (14), France, Italy, Mexico, Spain, (4 each), Denmark
`(3); the remaining 9 cases originated from 9 different countries;
`Cases Seriousness: §38;
`Seriousnesscriteria for the total 138 cases: Medically significant (71, of which 8 also serious for
`disability), Hospitalization required (non-fatal/non-life threatening) (16, of which 1 also serious for
`disability), Life threatening (13, of which 7 were also serious for hospitalization), Death (38).
`Gender: Females (73), Males (57). Unknown (8);
`Age (n=132) ranged from 21 to 100 years (mean = 57.2 years, median = 59.5);
`Case outcome: fatal (38), resolved/resolving (26), not resolved (65), resolved with sequelae (1), unknown
`(8);
`Of the 317 relevantevents, the most frequently reported PTs (=2%) were: Drug ineffective (135),
`Dyspnoea (53), Diarrhoea (30), COVID-19 pneumonia (23), Vomiting (20), Respiratory failure (8), and
`Seizure (7).
`
`
`
` Conclusion: VAED maypresentas severe or unusualclinical manifestations of COVID-19. Overall, there
`
`
`
`
`
`
`
`
`
`were 37 subjects with suspected COVID-19 and 101 subjects with confirmed COVID-19 following one
`or both doses ofthe vaccine; 75 of the 101 cases were severe, resulting in hospitalisation,disability,
`life-threatening consequences or death. None of the 75 cases could be definitively considered as
`VAED/VAERD.
`In this review of subjects with COVID-19 following vaccination, based on the current evidence,
`VAED/VAERDremainsa theoreticalrisk for the vaccine. Surveillance will continue.
`Search criteria: Standard Decreased Therapeutic Response Search AND PTs Dyspnoea; Tachypnoea; Hypoxia;
`a.
`COVID 19 pneumonia; Respiratory Failure, Acute Respiratory Distress Syndrome; Cardiac Failure; Cardiogenic shock;
`Acute myocardial infarction; Arrhythmia; Myocarditis; Vomiting; Diarrhoea; Abdominalpain; Jaundice;
`Acute hepatic failure; Deep vein thrombosis; Pulmonary embolism; Peripheral Ischaemia; Vasculitis; Shock;
`Acute kidney injury; Renalfailure; Altered state of consciousness: Seizure; Encephalopathy; Meningitis;
`Cerebrovascular accident; Thrombocytopenia; Disseminated intravascular coagulation; Chillblains;
`Erythema multiforme; Multiple organ dysfunction syndrome; Multisystem inflammatory syndrome in children.
`
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`5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
`
`Table 6.
`
`Description of Missing Information
`
`Information
`
`Use in
`Pregnancy
`andlactation
`
`Post Authorization Cases Evaluation (cumulative to 28 Feb 2021)
`Total Number of Cases in the Reporting Period
`(N=42086
`
`Numberofcases: 413 (0.98% of the total PM dataset); 84 serious and 329 non-serious;
`Country of incidence: US (205), UK (64), Canada (31), Germany (30), Poland (13), Israel
`(11); Italy (9), Portugal (8), Mexico (6), Estonia, Hungary andIreland, (5 each), Romania (4),
`Spain (3), Czech Republic and France (2 each), the remaining 10 cases were distributed among
`10 other countries.
`
`Pregnancy cases: 274 cases including:
`
`Breast feeding mother cases (6): 1 serious case reported 3 clinical events that occurred in a mother during breast feeding (PT
`
`270 mother cases and 4 foetus/baby cases representing 270 unique pregnancies(the 4
`foetus/baby cases were linked to 3 mother cases; | mother case involved twins).
`Pregnancy outcomesfor the 270 pregnancies were reported as spontaneous abortion (23),
`outcome pending (5), premature birth with neonatal death, spontaneous abortion with
`intrauterine death (2 each), spontaneous abortion with neonatal death, and normal outcome(1
`each). No outcome was provided for 238 pregnancies (note that 2 different outcomes were
`reported for each twin, and both were counted).
`
`146 non-serious mother cases reported exposure to vaccine in utero without the occurrence of
`any Clinical adverse event. The exposure PTs coded to the PTs Maternal exposure during
`pregnancy (111), Exposure during pregnancy (29) and Maternal exposure timing unspecified
`(6). Trimester of exposure was reported in 21 of these cases: Ist trimester (15 cases), 2nd
`trimester (7), and 3rd trimester(2).
`124 mother cases, 49 non-serious and 75 serious, reported clinical events, which occurred in
`the vaccinated mothers. Pregnancy related events reported in these cases coded to the PTs
`Abortion spontaneous (25), Uterine contraction during pregnancy, Premature rupture of
`membranes, Abortion, Abortion missed, and Foetal death (1 each). Otherclinical events which
`occurred in more than 5 cases coded to the PTs Headache (33), Vaccinationsite pain (24).
`Pain in extremity and Fatigue (22 each), Myalgia and Pyrexia (16 each), Chills (13) Nausea
`(12), Pain (11), Arthralgia (9), Lymphadenopathy and Drug ineffective (7 each), Chest pain,
`Dizziness and Asthenia (6 each), Malaise and COVID-19 (5 each). Trimester of exposure was
`reported in 22 ofthese cases: Ist trimester (19 cases), 2nd trimester (1 case), 3rd trimester (2
`cases).
`4 serious foetus/baby cases reported the PTs Exposure during pregnancy, Foetal growth
`restriction, Maternal exposure during pregnancy, Premature baby (2 each), and Death neonatal
`(1). Trimester of exposure was reported for 2 cases (twins) as occurring during the Ist
`trimester.
`
`Breast feeding baby cases: 133, of which:
`
`116 cases reported exposure to vaccine during breastfeeding (PT Exposure via breast milk)
`without the occurrence of any clinical adverse events;
`17 cases, 3 serious and 14 non-serious, reported the following clinical events that occurred in
`the infant/child exposed to vaccine via breastfeeding: Pyrexia (5), Rash(4), Infantirritability
`(3), Infantile vomiting, Diarrhoea, Insomnia, and Illness (2 each), Poor feeding infant,
`Lethargy, Abdominal discomfort, Vomiting, Allergy to vaccine, Increased appetite, Anxiety,
`Crying, Poor quality sleep, Eructation, Agitation, Pain and Urticaria (1 each).
`
`Maternal exposure during breast feeding): these events coded to the PTs Chills, Malaise, and
`Pyrexia
`1 non-serious case reported with very
`
`limited information and without associated AEs.
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`Case 1:22-cv-00252-MSG Document 60-4 Filed 03/02/23 Page 14 of 39 PagelD #: 1251
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`5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
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`Table 6. Description of Missing Information
`
`a I
`
`Total Numberof Cases in the Reporting Period (N=42086
`
`nformation
`
`Use in
`Paediatric
`Individuals
`<12 Years of
`
`Age
`
`In 4 cases (3 non-serious; | serious) Suppressed lactation occurred in a breast feeding women
`with the following co-reported events: Pyrexia (2), Paresis, Headache, Chills, Vomiting, Pain
`in extremity, Arthralgia, Breast pain, Scar pain, Nausea, Migraine, Myalgia, Fatigue and
`Breast milk discolouration (1 each).
`Conclusion: There were no safety signals that emerged from the review ofthese cases of use in
`pregnancy and while breast feeding.
`
`Paediatric individuals <12 years of age
`Numberofcases: 344 (0.1% ofthe total PM dataset), indicative of administration in paediatric
`subjects <12 years of age;
`Country of incidence: UK (29), US (3), Germany and Andorra (1 each);
`Cases Seriousness: Serious (24), Non-Serious (10):
`Gender: Females (25), Males (7), Unknown(2);
`Age (n=34) ranged from 2 months to 9 years, mean = 3.7 years, median = 4.0;
`Case outcome: resolved/resolving (16), not resolved (13), and unknown (5).
`Ofthe 132 reported events, those reported more than once were as follows: Product
`administeredto patient of inappropriate age (27, see Medication Error), Offlabel use (11),
`Pyrexia (6), Product use issue (5), Fatigue, Headache and Nausea (4 each), Vaccination site
`pain (3), Abdominal pain upper, COVID-19, Facial paralysis, lymphadenopathy, Malaise,
`Pruritus and Swelling (2 each).
`
`Conclusion: No new significant safety information was identified based on a review of these cases
`compared with the non-paediatric population.
`
`Vaccine
`
`Company conventions for coding cases indicative of lack of efficacy:
`
`Effectiveness Post Authorization Cases Evaluation (cumulative to 28 Feb 2021)
`
`The coding conventions for lack ofefficacy in the context ofadministration of the COVID-19 vaccine
`were revised on 15 February 2021, as shown below:
`PT “Vaccination failure” is coded when ALLofthe following criteria are met:
`©
`The subject has received the series of two doses perthe dosing regimen in local
`labeling,
`Atleast 7 days have elapsed since the second dose of vaccine has been administered.
`co
`The subject experiences SARS-CoV-2 infection (confirmed laboratory tests).
`o
`PT “Drug ineffective” is coded when either of the following applies:
`©
`Theinfection is not confirmed as SARS-CoV-2 through laboratory tests
`(irrespective of the vaccination schedule). This includes scenarios where LOEis
`stated or implied, e.g., “the vaccine did not work”, “I got COVID-19”.
`It is unknown:
`=* Whether the subject has received the series of two doses per the dosing
`regimenin local labeling;
`How manydayshave passed since the first dose (including unspecified
`numberof dayslike” a few days”, “some days”, etc.);
`If 7 days have passed since the second dose;
`=
`The subject experiences a vaccine preventableillness 14 days after receiving the
`first dose up to and through 6 days after receipt ofthe second dose.
`
`o
`
`o
`
`=
`
`Note: after the immune system as had sufficient time (14 days) to respond to the vaccine, a report of
`COVID-19 is considered a potential lack of efficacy evenif the vaccination course is not complete.
`
`Summary ofthe coding conventions for onset of vaccine preventable disease versus the vaccination
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`Case 1:22-cv-00252-MSG Document 60-4 Filed 03/02/23 Page 15 of 39 PagelD #: 1252
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`BNT162b2
`§.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
`
`Table 6. Description of Missing Information
`
`Post Authorization Cases Evaluation (cumulative to 28 Feb 2021)
`Information
`Total Number of Cases in the Reporting Period (N=42086
`
`Ist dose (day 1-13) From day 14 post Ist dose to|Day 7 post 2nd dose
`day 6 post 2nd dose
`Code “Drugineffective”
`
`Code “Vaccination failure”
`
`Code only the events
`describing the SARS-CoV-2
`infection
`Scenario Not considered
`LOE
`
`therefore for the above 1649 cases where lack of efficacy was reported after the Ist dose or the
`
`Scenario considered LOEas
`“Drug ineffective”
`
`Scenario considered LOE as
`“Vaccination failure”
`
`Lack ofefficacy cases
`Numberofcases: 1665" (3.9 % ofthe total PM dataset) of which 1100 were medically
`confirmed and 565 non medically confirmed;
`Numberoflack of efficacy events: 1665 [PT: Drug ineffective (1646) and Vaccinationfail