Document text
BNT162b2
5.3.6 Cumulative Analysis of Po st-authorization Adverse Event Reports
CONFIDENTIAL
Page 1CUMULATIVE ANALYSIS OF POST -AUTHORIZATION ADVERSE EVENT
REPORTS OF
PF-07302048 (BNT162B 2)
RECEIVED THROUGH 30 SEPTEMBER 2021
IN INDIVIDUALS AGED BETWEEN 12 AND 15 YE ARS OF AGE
Report Prepared by:
Worldwide Safety
Pfizer
The information contained in this document is proprietary and confidential. Any disclosure, reproduction,
distribution, or other dissemination of this information outside of Pfizer, its Affiliates, its Licensee s, or
Regulatory Agencies is strictly prohibited. Except as may be otherw ise agreed to in writing, by accepting or
reviewing these materials, you agree to hold such information in confidence and not to disclose it to others
(except where required by applic able law ), nor to use it for unauthorized purposes.
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Page 2TABLE OF CONTENTS
LIST OF TABLES ................................ ................................ ................................ ..................... 3
LIST OF FIGURES ................................ ................................ ................................ ................... 3
LIST OF ABBREVIATION S................................ ................................ ................................ ....4
1. METHODOLO GY................................ ................................ ................................ ................ 5
2. RESUL TS................................ ................................ ................................ .............................. 5
2.1. Safet y Database ................................ ................................ ................................ ......... 5
2.1.1. General Overview ................................ ................................ ......................... 5
2.1.2. Summary of Safety Concerns in the US Pharmacovigilance Plan ............... 8
3. SUMMARY AND CONCL USION ................................ ................................ .................... 15
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Page 3LIST OF TABLES
Table 1. Selected Case Characteristics of Post -Marketing Reports I nvolving
Individuals 12 – 15 Years of Age Received Cumulatively through
30 September 2021 ................................ ................................ ..................... 6
Table 2. Medic al History and Co- Suspect Medications of Post -Marketing
Reports I nvolving Individuals 12 – 15 Years of Age Received
Cumulatively through 30 September 2021 ................................ ................. 6
Table 3. Adverse Events Reported in ≥2% Cases in 12 -15 Years of Age ................ 7
Table 4. Safety Concerns ................................ ................................ .......................... 8
Table 5. Important Identified Risk Anaphy laxis –Post-Marketing Reports
Received Cumulatively through 30 September 2021 on 12 – 15
Years o f Age Individuals ................................ ................................ ............ 9
Table 6. Important Identified Risk My ocarditis and Pericarditis –Post-
Marketing Reports Received Cumulatively through
30September 2021 on 12 – 15 Years of Age Individuals........................ 10
Table 7. Important Potential Risk Vaccine -Associated Enhanced Diseas e
(VAED), including Vaccine -Associated Enhanced Respiratory
Disease (VAERD) -Post-Marketing Reports Received Cumulatively
through 30 September 2021 on 12 –15 Years of Age Individuals .......... 13
Table 8. Description of Missing Information ................................ ......................... 14
LIST OF FIGURES
Figure 1. Total Number of BNT162b2 AEs by System Organ Classes and
Event Seriousness ................................ ................................ ....................... 7
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Page 4LIST OF ABBREVIATIONS
Acronym Term
AE adverse event
AER adverse event report
BC Brighton Collaboration
COVID -19 coronavirus disease 2019
HLT (MedDRA) high level t erm
LLT lower level term
MAH marketing authorisation holder
MedDRA medical dictionary for regulatory activities
MHRA Medicines and Healthcare products Regulatory Agency
MC medically confirmed
PT (MedDRA) preferred term
PM post-marketing
SARS -CoV -2 severe acute respiratory syndrome coronavirus 2
SOC (MedDRA) system organ class
UK United Kingdom
US United States
VAED vaccine -associated enhanced disease
VAERD vaccine -associated enhanced respiratory disease
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Page 51.METHODOLOGY
Pfizer is responsible for the management post -authorization safety data on behalf of the
MAH BioNTech according to the Pharmacovigilance Agreement in place. Data from
BioNTech are included in the report when applicable.
Pfizer’s safety database contains c ases of AEs reported spontaneousl y to Pfizer, cases
reported b y 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 s tudies regardless of causality assessment.
The limitations of post -marketing adverse drug event reporting should be considered when
interpreting these data:
Reports are submitted voluntarily , and the magnitude of underreporting is unknown.
Some of the fact ors that may influence whether an event is reported include: length of
time since marketing, market share of the drug, publicity about a drug or an AE,
seriousness of the reaction, regulatory actions, awareness b y health professionals and
consumers of adve rse drug event reporting, and litigation.
Because man y external factors influence whether or not an AE is reported, the
spontaneous reporting s ystem y ields reporting proportions not incidence rates. As a
result, it is generall y not appropriate to make betw een-drug comparisons using these
proportions; the spontaneous reporting sy stem should be used for signal detection
rather than h ypothesis testing.
In some reports, clinical information (such as medical history , validation of diagnosis,
time from drug use to onset of illness, dose, and use of concomitant drugs) is missing
or incomplete, and follow- up information may not be available.
An accumulation of AERs does not necessarily indicate that a particular AE was
caused b y the drug; rather, the event may be due to an underl ying disease or some
other factor(s) such as past medical history or concomitant medication.
2.RESULTS
2.1. Safety Database
2.1.1. General Overview
Cumulatively ,out of the 629,5251total reports received through 30September 2021 ,there
was a total of 3320 post-marketing reports containing 10,050 events occurred in paediatric
individuals aged between 12 and 15 years of age .
Table 1and Table 2presents the main characteristics of the 12-15 year of age cases .
1Using the RMP search criteria.
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Page 6Table 1. Selected Case Characteristics of Post- Marketing Reports Involving
Individuals 12 – 15 Years of Age Received Cumulatively through 30
September 2021
Characteristics No. of Cases
N (%)
No. of Cases 3320
Gender Female 1601 (48.2)
Male 1619 (48.8)
Unknown/No Data 100(3.0)
Age (years) N 3320a
Min-Max 12 –15
Mean 13.6
Median 14
Country of
occurrence
(≥2% of all cases)United States (US) 1606 (48.4)
France 214 (6.4)
Italy 206 (6.2)
Japan 160 (4.8)
Denmark 154 (4.6)
Canada 142 (4.3)
Germ any 103 (3.1)
Netherlands 99 (3.0)
Spain 97 (2. 9)
Case Seriousness Serious 1215 (36.6)
Non-serious 2105 (63.4)
Case Outcome Resolved/Resolving 557 (16.8)
Resolved w ith sequelae 19 (0.6)
Not resolved 693 (20.9)
Fatal 18 (0.5)
Unknown 1211 (36.5)
Medically
ConfirmedYes 1490 (44.9)
No 1830 (55.1)
a.There w ere 813 reports in individuals aged 12 years (24.49%), 739 report in individuals aged 13 years
(22.26%), 839 reports in individuals aged 14 years (25.27%), and 929 reports in individuals aged 15 years
(27.98%).
Table 2. Medical History and Co -Suspect Medications of Post -Marketing Reports
Involving Individuals 12 –15 Years of Age Received Cumulatively through
30 September 2021
Medical history was available in 976 cases; the m ost frequently reported ( ≥2%) medical history SOC s
included : Imm une system disorders (368), Respiratory, thoracic and mediast inal disorders (228), Infections
and infestations (198), Psychiatric disorders (188), Nervous system disorders (143), Congenital, familial and
genetic disorders (90), Skin and subcutaneous tissue disorders (89) and Surgical and medical procedures (67).
Regardless the SOC, the most frequently (>40 occurrences) reported PTs included Asthma (161), COVID -19
(110), Food allergy (82), Seasonal allergy (74), Drug hypersensitivity (64), Hypersensitivity (63), Attention
deficit hyperactivity disorder (59).
Co-suspec t medications were reported in 47 cases; those reported at least tw ice, included :COVID -19
Moderna (mRNA 1273) vaccine ( 8), Sodium chloride (6), adalimumab (5), Human papillomavirus vaccine
and Johnson & Johnson vaccine (3 each), ciprofloxacin, COVID -19 As traZeneca vaccine and fluoxetine (2
each).
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Page 7Figure 1shows the events grouped b y SOCs ; the SOCs that contained the greatest number
(≥5%) of events included General disorders and administration site conditions ( 2545 AEs),
Nervous s ystem disorders (1606), Injury , poisoning and procedural complications (1131),
Gastrointestinal disorders (830), Skin and subcutaneous tissue disorders (599),
Musculoskeletal and connective tissue disorders ( 584), Respiratory , thoracic and mediastinal
disorders ( 495), Cardiac disorders (362), Investigation (350), Infections and infestations
(229), Psychiatric disorders (188) andVascular disorders (167).
Figure 1.Total Number of BNT162b2 AEs by System Organ Classes and Event
Seriousness
Table 3shows the most commonly (≥2%) reported MedDRA (v. 24.0) PTs.
Table 3. Adverse Events Reported in ≥2% Cases in 12 -15Years of Age
Cumulatively through
30Septem ber2021
MedDRA SOC MedDRA PT n (%a)
Blood and lymphatic system disorders
Lymphadenopathy 90(2.71)
Cardiac disorders
Myocarditis 154(4.64)
Gastrointestinal disorders
Nausea 269(8.1)
Vomiting 196(5.9)
Diarrhoea 82(2.47)
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Page 8Table 3.Adverse Events Reported in ≥2% Cases in 12 -15Years of Age
Cumulatively through
30Septem ber2021
MedDRA SOC MedDRA PT n (%a)
General disorders and administration
site conditions
Pyrexia 578 (17.41)
Fatigue 346(10.42 )
Malaise 190 (5.72)
Chest pain 178 (5.39)
Chills 164(4.94)
Vaccination site pain 158(4.76)
Pain 146(4.4)
Asthenia 98(2.95)
Injury, poisoning and procedural
complications
Poor quality product administered 274 (8.25)
Overdose 81 (2.44)
Product preparation error 80 (2.41)
Expired product administered 77 (2.32)
Off label use 76 (2.29)
Product storage error 71 (2.14)
Musculoskeletal and connective tissue
disorders
Pain in extremity 227 (6.84)
Myalgia 93 (2.8)
Nervous system disorders
Headache 520 (15.66)
Dizziness 184 (5.54)
Syncope 148 (4.46)
Loss of consciousness 100 (3.1)
Product issues
Product temperature excursion issue 140 (4.22)
Respiratory, thoracic and mediastinal
disorders
Dyspnoea 118 (3.55)
Oropharyngeal pain 70 (2.11)
Skin and subcutaneous tissue disorders
Rash 127 (3.83)
Urticaria 117(3.52)
Total num ber of events 10050
a.Adverse Event Reporting Proportion: n/N*100; n: number of Adverse Events; N: Number of Cases
2.1.2. Summary of Safety Concerns in the US Pharmacovigilance Plan
Table 4.Safety C oncernsa
Important identified risks Anaphylaxis
Myocarditis and Pericarditis
Important potential risks Vaccine- Associated Enhanced Disease (VAED), Including Vaccine -
associated Enhanced Respiratory Disease (VAERD)
Missing inform ation Use in Pregnancy and Lactation
Use in Paediatric Individuals <5 Years of Age
Vaccine Effectiveness
a.According to BLA US -PVP version 1.2 .
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Page 9Table 5. Important Identified Risk Anaphylaxis –Post- Marketing Reports
Received Cumulatively through 30 September 2021 on 12 – 15 Years of
Age Individuals
Search criteria: MedDRA PTs Anaphylactic reaction, Anaphylactic shock, Anaphylactoid reaction,
Anaphylactoid shock.
Distribution of Event by Outcome*
N (% )
PT # of
Events
(% of
Total
PTs)# Serious
Events
(% of
PT)# Events w ith
Criterion of
Hospitalization
(% of PT)Fatal Resolved /
ResolvingResolved
with
SequelaeNot
ResolvedUnknown /
No Data
All PTs 46 (100) 46 (100) 15 (32.6) 0 32 (69.6) 0 2 (4.3) 12 (26.1)
Anaphylactic
reaction41 (89.1) 41 (100) 14 (34.1) 0 29 (70.7) 0 1 (2.4) 11 (26.8)
Anaphylactic
shock4 (8.7) 4 (100) 1 (25) 0 3 (75) 0 1 (25) 0
Anaphylactoid
reaction1 (2.2) 1 (100) 0 0 0 0 0 1 (100)
*For the outcome count, the multiple LLTs that code to the same PT within a case or the PTs duplicated during migration from legacy
databases (possibly with different outcome), are counted and presented individually. Therefore, for selected PTs the total c ount of
event outcomes may exceed from t he total number of events.
Number of relevant cases : 43(1.3% of 3 320cases, the total 12-15 years old PM dataset).
Medically Confirmed (MC) cases ( 33),Non-MC cases (10).
Country of incidence: Japan (1 8), US ( 8), Belgium (3), France, Germany and UK (2 each), Brazil,
Denmark, Finland, Ireland, Israel, Italy, Portugal and Romania (1 each) .
Subjects’ gender: female ( 25), male (18).
Subjects’ age in years (n =43), range: 12-15,mean 13.5, median 13.
Time to event onset (n =43), range:<24 hours to 7days.
<24 hours: 3 7 events;
1 day: 3 events;
2-7 days: 3events .
Duration of relevant event (n = 12out of 32occurrences with outcome of resolved/resolved w ith
sequelae).
<24 hours: 10events;
1 day: 0 events;
2 days: 2events.
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Page 10Table 6. Important Identified Risk Myocarditis and Pericarditis – Post-Marketing
Reports Received Cumulatively through 30 September 2021 on 12 – 15
Years of Age Individuals
Overall, there were 180 potentially relevant cases of Myocarditis and Pericarditis; 154 cases reported
myocarditis and 61 cases reported pericarditis (in 35of these cases, the subjects developed both myocarditis
and pericarditis).
Myocarditis
Search criteria: MedDRA PTs Autoimmune myocarditis; Eosinophilic myocarditis; Giant cell
myocarditis; Hypersensitivity myocarditis; Immune -mediated myocarditis; Myocarditis.
Number of relevant cases: 154 (4.6% of 3320 cases, the total 12 -15 years old PM d ataset).
These 154 cases w ere individually revie wed and assessed according to Brighton Collaboration (BC)
Myocarditis Case Definition and Level of Certainty Classification (version 1.5.0, 16 July 2021), as per
table below:
Brighton Collaboration Level Num ber of cases
BC 1 14
BC 2 9
BC 3 0
BC 4 130
BC 5 1
Total 154
Level 1 indicates a definitive case with the highest level of diagnostic certainty of
myocarditis, level 2 indicates a probable case, and level 3 indicates a possible case.
Level 4 is defined as “reported event of myocarditis with insufficient evidence to
meet the case definition” and Level 5 as not a case of myocarditis.
Distribution of Event by Outcome*
N (% )
PT # of
Events (%
of Total
PTs)# Serious
Events (%
of PT)# Events with
Criterion of
Hospitalization
(% of PT)Fatal Resolved /
ResolvingResolved
with
SequelaeNot
ResolvedUnknown /
No Data
All PTs 154 (100) 153 (99.4) 111 (72.1) 0 79 (51.3) 0 17 (11) 58 (37.7)
Myocarditis 154 (100) 153 (99.4) 111 (72.1) 0 79 (51.3) 0 17 (11) 58 (37.7)
*For the outcome count, the multiple LLTs that code to the same PT within a case or the PTs duplicated during migration from legacy
databases (possibly with different outcome), are counted and presented individually. Therefore, for selected PTs the total c ount of
event outcomes may exceed from t he total number of events.
MC cases ( 128), Non-MC cases ( 26).
Country of incidence: Hong Kong (39), US (26), Germany (1 8), France (17), Italy ( 8), Israel (7), Austr ia
and Spain (6 each ), Denmark and Japan (5 each), Canada (3), Czech Republic and Latvia (2 each) and 1
case each from 10 other countries.
Subjects’ gender: female ( 20), male (131) and unknown ( 3).
Subjects’ age in years (n =154), range: 12 -15, mean 13.9, median 14.
Relevant c ardiac medical history: Arrhythmia (2), Aortic dilatation, Atrial fibrillation, Heart disease
congenital, Marfan’s syndrome, Myocardial infarction, Myocardial ischaemia, Myocarditis, Palpitations,
Ventricular tachycardia (1 each).
COVID -19 m edical history: COVID -19 (6), Asymptomatic COVID -19 and SARS -CoV- 2 test positive
(1 each).
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Page 11Table 6. Important Identified Risk Myocarditis and Pericarditis – Post-Marketing
Reports Received Cumulatively through 30 September 2021 on 12 – 15
Years of Age Individuals
Myocarditis was reported:
oafter the 1st dose in 36 cases ;
oafter the 2nd dose in 106 cases ;
oin 12 cases it was unknown after w hich dose myocarditis occurred.
Time to event onset (n =108), range:<24 hours to 42days.
<24 hours: 6 events;
1 day: 30events;
2-4days: 54 events;
5-14 days: 11events;
15-30 days: 5 events;
31-42days: 2 events.
Duration of relevant event (n = 8 out of 34occurrences w ith outcome of resolved/resolved w ith
sequelae).
1-2 days: 4 events;
5-6days: 4 events.
Pericarditis
Search criteria: MedDRA PTs: Autoimmune pericarditis; Pericarditis; Pericarditis adhesive; Pericarditis
constrictive; Pleuropericarditis.
Number of relevant cases 61 (1.2% of 3320 cases, the total 12 -15 years old PM dataset).
These 61 cases w ere individually reviewed and assessed according to BC Pericarditis Case Definition
and Level of Certainty Classification (version 1.0.0, 15 July 2021), as per table below :
Brighton Collaboration Level Number of cases
BC 1 1
BC 2 4
BC 3 0
BC 4 56
BC 5 0
Total 61
Level 1 indicates a definitive case with the highest level of diagnostic certainty of
myocarditis, level 2 indicates a probable case, and level 3 indicates a possible case.
Level 4 is defined as “reported event of myocarditis with insufficient evidence to
meet the case definition” and Level 5 as not a case of myocarditis.
Distribution of Event by Outcome*
N (% )
PT # of
Events
(% of
Total
PTs)# Serious
Events (%
of PT)# Events with
Criterion of
Hospitalization
(% of PT)Fatal Resolved /
ResolvingResolved
with
SequelaeNot
ResolvedUnknown /
No Data
All PTs 61 (100) 61 (100) 17 (27.9) 0 18 (29.5) 1 (1.6) 9 (14.8) 33 (54.1)
Pericarditis 61 (100) 61 (100) 17 (27.9) 0 18 (29.5) 1(1.6) 9 (14.8) 33 (54.1)
*For the outcome count, the multiple LLTs that code to the same PT within a case or the PTs duplicated during migration from legacy
databases (possibly with different outcome), are counted and presented individually. Therefore, for selected PTs the total c ount of
event outcomes may exceed from t he total number of events.
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Page 12Table 6. Important Identified Risk Myocarditis and Pericarditis – Post-Marketing
Reports Received Cumulatively through 30 September 2021 on 12 – 15
Years of Age Individuals
MC cases ( 52), Non-MC cases ( 9).
Country of incidence: Hong Kong (29), Italy (7), France (6), US (4), Canada (3), Australia, Belgium,
Germ any, Japan (2 each) and 1 case each from 4 other countries.
Subjects’ gender: female ( 13), male (48).
Subjects’ age in years (n =61), range: 12 -15, mean14, median 1 4.
Relevant cardiac medical history: Aortic valve incompetence, Cardiac aneurysm, Cardiac septal defect
repair, DiGeorge’s syndrome, Fallot’s tetralogy, Heart disease congenital, Pericarditis (1 each).
COVID -19 m edical history: COVID -19 (3).
Pericarditis w as reported:
oafter the 1st dose in 14cases ;
oafter the 2nd dose in 38cases ;
oin 9 cases it was unknown after w hich dose pericarditis occurred.
Time to event onset (n =32), range:<24 hours to 31days.
<24 hours: 1event;
1 day: 6 events;
2-4days: 16events;
5-14 days: 5 events;
15-31days: 4events .
Duration of relevant event (n = 2 out of 12occurrences w ith outcome of resolved/resolved w ith
sequelae); 1 event resolved after 3 day sand 3 hours and the second one after 6 days.
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Page 13Table 7.Important Potential Risk Vaccine -Associated Enhanced Disease (VAED),
including Vaccine -Associated Enhanced Respiratory Disease (VAERD) -
Post-Marketing Reports Received Cumulatively through
30September 2021 on 12 –15 Years of Age Individuals
Search criteria:
oPT=Vaccine associated enhanced respiratory disease; Vaccine associated enhanced disease OR
oStandard Decreased Therapeutic Response Search (Drug ineffective OR Vaccination failure) AND
1 among the following PTs: Dyspnoea; Tachypnoea; Hypoxia; COVID -19 pneumonia; Respiratory
failure; Acute respiratory distress syndrome; Cardiac failure ; Cardiogenic shock; Acute myocardial
infarction; Arrhythmia; Myocarditis; Vomiting; Diarrhoea; Abdominal pain; Jaundice; Acute
hepatic failure; Deep vein thrombosis; Pulmonary embolism; Peripheral ischaemia ; Vasculitis;
Shock; Acute kidney injury; Renal failure; Altered state of consciousness; Se izure;
Encephalopathy; Meningitis; Cerebrovascular accident; Thrombocytopenia; Disseminated
intravascular coagulation; Chillblains; Erythema multiforme; Multiple organ dysfunction
syndrome; Multisystem inflammatory syndrome in children.
Number of cases 2 (0.06% of 3320 cases, the total 12 -15 years old PM dataset).
MC cases (2), No n-MC cases ( 0).
Distribution of Event by Outcome*
N (%)
PT # of
Events
(% of
Total
PTs)#
Serious
Events
(% of
PT)# Events with
Criterion of
Hospitalization
(% of PT)Fatal Resolved
/
ResolvingResolved
with
SequelaeNot
ResolvedUnknown
/ No Data
All PTs 6 (100) 6 (100) 6 (100) 0 4 (66.7) 0 0 2 (33.3)
Diarrhoea 1 (16.7)1 (100) 1 (100) 0 1 (100) 0 0 0
Drug ineffective 1 (16.7) 1 (100) 1 (100) 0 0 0 0 1 (100)
Multisystem
inflammatory
syndrome in
children1 (16.7) 1 (100) 1 (100) 0 1 (100) 0 0 0
Seizure 1 (16.7) 1 (100) 1 (100) 0 1 (100) 0 0 0
Vaccination
failure1 (16.7) 1 (100) 1 (100) 0 0 0 0 1 (100)
Vom iting 1 (16.7) 1 (100) 1 (100) 0 1 (100) 0 0 0
Of the 2 cases retrieved with the above criteria, both cases were determined to be non -contributory and are
not further discussed.
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Page 14Table 8.Description of Missing Information
Topic Description
Use in
Pregnancy
and
LactationSearch criteria: Pregnancy cases are identified as cases where:
-Patient Pregnant Flag is “Yes”;
-If there is a value for Pregnancy Outcome, Birth Outcome, or Congenital Anomaly;
-If Delivery Notes are available;
-If any of the valid events on the case contains one of the follow ing:"
oSOC Pregnancy, puerperium and perinatal conditions, or
HLT Exposures associated with pregnancy, delivery and lactation; Lactation
disorders, or
PT Exposure via body fluid.
Number of cases: 1 serious case from UK (0.03% of 3320 cases, the total 12 -15 years
old PM dataset).
A 12 -year-old was pregnant (gestation week unknown) at the time of first dose; she had
miscarriage 2 w eeks after vaccine administration. No additional information was available
for this case.
There w ere no cases indicative of breastfeeding.
Use in
Paediatric
Individuals
<5 years of
AgeNumber of cases: 56(0.01% of the 629,525 cases, the total PM dataset ).
MC cases ( 23), Non-MC cases ( 33).
Country of incidence: UK (14), US (13), Italy (7), South Africa ( 4), Japan and Spain (3
each), Germany, Lithuania and Netherlands (2 each) and 1 case each from other 6
countries.
Cases Seriousness: serious ( 14), non- serious (42).
Subjects’ gender: female ( 28), male (24), unknown/no data ( 4).
Subjects’ age in years (n = 55),range: 0.02 -4.75, mean 1.8, median 3.
Case outcome: fatal ( 2)2, resolved/resolving ( 23), not resolved (1 6), and unknown ( 15).
Of the 172reported events, those reported more than three times were as follows:
Product administered to patient of inappropriate age ( 21), Off label use (17), Product use
issue (15), Pyrexia ( 11), Fatigue, Headache, Myalgia and Nausea (4 each).
Vaccine
EffectivenessNumber of cases: 29(0.9 % of the 3320 cases, the total 12 -15 years old PM dataset ).
MC cases (14), No n-MC cases (15).
Number of lack of efficacy events: 29[PTs: Drug ineffective ( 20) and Vaccination
failure (9)].
Country of incidence: US ( 14), Austria and Brazil (2 each) and 1 case each from other
11 countries .
2Both cases contained minimal information with unknown medical history, concomitant medications and
clinical course; for both cases it w as unknown if an autopsy was performed. The first case, from UK, involved
a 5-month-old m ale boy who received the first dose on 17 April 2021 and died on 02 May 2021. A
SARS -CoV- 2 test negative was reported on an u nknown date. The second case, from Saudi Arabia, involved a
2-year-old girl who had been hospitalized since 14 February 2021 ( she may have gotten sick from first shot )and
received the second dose on 25 February 2021. The patient died on 03 Mar ch 2021.
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BNT162b2
5.3.6 Cumulative Analysis of Po st-authorization Adverse Event Reports
CONFIDENTIAL
Page 15Table 8.Description of Missing Information
Topic Description
Vaccine
Effectiveness
(Con t’d)COVID -19 infection was suspected in 3cases, confirmed in 26cases (including 1 case
of asymptomatic COVID -19).
COVID -19 infection (suspected or confirmed) outcome was reported as
resolved/resolving ( 6), not resolved ( 1) or unknown ( 22) at the time of the reporting .
Drug ineffective cases ( 20)
Drug ineffective event seriousness: serious ( 19), non -serious ( 1).
Lack of efficacy term was reported:
oafter the 1st dose in 12cases
oafter the 2nd dose in 7cases
oin 1case it was unknown after which dose the lack of efficacy occurred.
Latency of lack of efficacy term reported after the first dose was known for 3cases: after
5, 13 and 15 days, respectively.
Latency of lack of efficacy term reported after the second dos e was known for 2cases:
after 2 and 5 days, respectively.
Latency of lack of efficacy term reported in cases where the number of doses
administered w as not provided, w as known in 1case: after 5 days.
Vaccination failure cases ( 9)
Vaccination failure seriousness: all serious .
Lack of efficacy term was reported in all cases after the 2nd dose .
Latency of lack of efficacy was known for all 9 cases: in 1 case after 10 days and in the
other 8 cases betw een 23 and 92 days.
COVID -19 (8) and Asymptomatic COVID -19 (1) were the reported vaccine preventable
infections that occurred in these 9cases.
3.SUMMARY AND CONCLUSION
Review of the cumulative available post- marketing data in individuals aged between 12 and
15 years,did not identify any additional or unexpected risks associated with for BNT162b2
and confirms the favorable benefit risk balance observed in the clinical study .Post-marketing
surveillance activities will continue .
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