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BNT162b2 (COVID-19 Vaccine, mRNA) 

Vaccine –in Individuals 5 to <12 Years of Age

November 2nd Alejandra Gurtman, MD 2021

Vice President

Vaccine Clinical Research and Development 

Pfizer Inc
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Presentation Agenda

Introduction

Clinical Data • Phase 2/3 Immunogenicity and Safety

• Efficacy Analysis
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Pfizer/BNT Received Emergency Use Authorization of 

10ug Dose of BNT162 in Children 5 to <12 Years of Age

10ug dose level was selected as optimal to 

elicit robust immune responses with an 

acceptable safety profile

Proposed Indication and Schedule 

Active immunization to 

prevent COVID-19 

caused by SARS-CoV-2 

in individuals 5 to <12 

years of age

Administered 

intramuscularly as a 

primary series of 

2 doses (0.2 mL each), 

3 weeks apart
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BNT162b2 – Meets EUA Guidance 

for 5 to <12 Years of Age

Meets all 

safety data 

expectations for 

follow up 

durations and 

subject number

Clear and Compelling Data

Vaccine’s 

benefits 

outweigh its 

risks

Plans for active 

safety follow up 

under EUA

90.7% 

efficacy was 

observed

Meets 

Immunobridging

criteria 

comparing 5 to 

<12 yo to 16 to 

25 yo subjects
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Clinical Data
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Pfizer-BioNTech Pediatric COVID-19 Vaccine 

BNT162b2: Study Overview: 5 to <12 Years

Phase 1 Phase 2/3

90

clinical 

trial

sites

48

PARTICIPANTS

5 to <12 yrs

Identification of 

preferred dose 

level(s)

~Additional 1500 BNT162b2 and 750 placebo recipients 

most with ≥2 weeks post dose 2 safety data

2:1 

randomization

~1500 BNT162b2

750 placebo

Non-inferior immune responses 

have been established to infer 

vaccine efficacy

Children

5 to <12 years

of age

16–25-year-olds 

from the pivotal 

Phase 3 study

Compared

to

Although not required for 

EUA approval, COVID-19 

surveillance was conducted 

permitting evaluation of 

vaccine efficacy

10 μg 20 μg 30 μg
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NON-SERIOUS AEs ICD to Visit 4 (1-Month follow-up)

Phase 2/3 Timelines of Participants 

5 to <12 Years of Age Through 6 Months Post-dose 2

COVID-19/MIS-C Visit: triggered if a participant reports experiencing a COVID-19/MIS-C Symptom reported on 

the Illness diary or reported directly by the participants → potential COVID-19 Illness visit 

(telehealth/in-person visit + nasal swab) must be scheduled (optimally within 3 Days after illness onset)

UP TO 2-YEARS

7 DAY 

Reactogenicity

V1

Dose

1

V2

Dose

2

V3

7d

V4

1mo

V5

6mo

7 DAY 

Reactogenicity

Blood draws for Immunogenicity

21 days

SERIOUS AEs ICD to Visit 5 (6-Month follow-up) 
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Safety Data for 5 to <12 Year Olds

to Support EUA Application

0 10 20 30 40 50 60 70 80 90 100

Days of follow-up

Additional 

follow-up time

to 3.3 months

XX,XXX

XX,XXX

Median follow-up time 2.3 months

Median follow-up time 2.4 weeks

Initial enrollment group 

2268 participants

Safety expansion group 

2379 participants
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Demographics for 5 to <12 Year Olds

Phase 2/3 Safety Population Initial Enrollment Group (N=2268)

BNT162b2 (10μg)

N=1518 

Placebo

N=750 

Sex, n (%)

Male 799 (52.6) 383 (51.1)

Female 719 (47.4) 367 (48.9)

Race, n (%)

White 1204 (79.3) 586 (78.1)

Black or African American 89 (5.9) 58 (7.7)

American Indian or Alaska native 12 (0.8) 3 (0.4)

Native Hawaiian or other Pacific Islander <1% <1%

Asian 90 (5.9) 47 (6.3)

Multiracial 109 (7.2) 49 (6.5)

Not reported <1% <1%

Ethnicity, n (%)

Hispanic/Latino 319 (21.0) 159 (21.2)

Non-Hispanic/non-Latino 1196 (78.8) 591 (78.8)

Not reported <1% <1%

Age at vaccination

Mean (SD) 8.2 (1.93) 8.1 (1.97)

Min, Max (5, 11) (5, 11)

Obese, n (%) Yes 174 (11.5) 92 (12.3)

Comorbiditiesa, n (%) Yes 312 (20.6) 152 (20.3)

a. Participants who had at least one of the prespecified comorbidities based on MMWR 69(32);1081-1088 and/or obesity (BMI ≥ 95th percentile

b. Obese is defined as a body mass index (BMI) at or above the 95th percentile according to the growth chart. Refer to the CDC growth charts at 

https://www.cdc.gov/growthcharts/html_charts/bmiagerev.htm. 
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Local Reactions, by Maximum Severity, Within 7 Days 

After Each Dose in 5 to <12 and 16-25 Year Olds

Redness and swelling severity definition: Mild= >2-5cm, Moderate= >5-10 cm; Severe= >10 cm; Grade 4= necrosis

Pain at injection site severity definition: Mild=no interference; Moderate=some interference; Severe=prevents daily activity; Grade 4=ER visit or hospitalization 

Dose 1: 5-<12yrs N=2260; 16-25 yrs N=1064 Dose 2: 5-<12 yrs N=2242 16-25 yrs N=984

14.7%

5.7% 6.4% 0.9%

10.5%

2.7% 8.3%

1.1%

74.1%

31.3%

83.4%

15.9%

0%

20%

40%

60%

80%

100%

10 μg Placebo 30 μg Placebo 10 μg Placebo 30 μg Placebo 10 μg Placebo 30 μg Placebo

Redness Swelling Pain at Injection Site

Mild Moderate Severe Grade 4

Dose 1

Dose 2

18.5%

5.4% 5.7% 0.2%

15.3%

2.7% 6.8% 0.2%

71.0%

29.5%

77.5%

12.1%

0%

20%

40%

60%

80%

100%

10 μg Placebo 30 μg Placebo 10 μg Placebo 30 μg Placebo 10 μg Placebo 30 μg Placebo

5-<12 16-25 5-<12 16-25 5-<12 16-25

5-<12 16-25 5-<12 16-25 5-<12 16-25
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Systemic Events, by Maximum Severity, Within 7 Days 

After Dose 2 in 5 to <12 and 16-25 Year Olds 

Fatigue, headache, chills, muscle pain, joint pain severity definition: Mild=no interference; Moderate=some interference; Severe=prevents daily activity; Grade 4=ER visit or hospitalization

Vomiting severity definition: Mild=1-2 time in 24h; Moderate=>2times in 24h; Severe=Requires IV hydration; Grade 4=ER visit or hospitalization

Diarrhea severity definition: Mild=2-3 times in 24h; Moderate=4-5 times in 24h; Severe=6 or more times in 24h; Grade 4=ER visit or hospitalization 

Dose 2: 5-<12 yrs N=2242 16-25 yrs N=984

6.5%

17.2%

39.4%

65.6%

28.0%

60.9%

9.8%

40.0%

1.9% 2.7% 5.3% 8.0% 11.7%

40.8%

5.2%

21.9%

0%

20%

40%

60%

80%

100%

5-<12

10μg

16-25

30μg

5-<12

10μg

16-25

30μg

5-<12

10μg

16-25

30μg

5-<12

10μg

16-25

30μg

5-<12

10μg

16-25

30μg

5-<12

10μg

16-25

30μg

5-<12

10μg

16-25

30μg

5-<12

10μg

16-25

30μg

Fever Fatigue Headache Chills Vomiting Diarrhea Muscle Pain Joint Pain

Fever: 38.0 °C-38.4 °C 38.4 °C-38.9 °C 38.9 °C-40.0 °C >40.0 °C

Systemic Events: Mild Moderate Severe Grade 4

1.2% 0.4%

24.3% 23.2% 18.6% 23.8%

4.3% 4.4% 0.8% 1.8% 4.7% 5.2% 7.4% 9.7% 3.6% 4.0%

0%

20%

40%

60%

80%

100%

5-<12

10μg

16-25

30μg

5-<12

10μg

16-25

30μg

5-<12

10μg

16-25

30μg

5-<12

10μg

16-25

30μg

5-<12

10μg

16-25

30μg

5-<12

10μg

16-25

30μg

5-<12

10μg

16-25

30μg

5-<12

10μg

16-25

30μg

BNT162b2

Placebo
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Subjects Reporting Local Reactions, by Maximum Severity, Within 7 Days 

After Each Dose in 5 to <12 Year Olds by Baseline SARS-CoV-2 Status

Mild Moderate Severe Grade 4

Redness Swelling Pain at Injection Site

15.0%

7.7% 14.7%

5.6% 8.3% 3.1%

10.7%

2.6%

72.9%

23.1%

74.2%

32.1%

0%

20%

40%

60%

80%

100%

10 μg Placebo 10 μg Placebo 10 μg Placebo 10 μg Placebo 10 μg Placebo 10 μg Placebo

Positive Negative Positive Negative Positive Negative

9.9% 3.1%

19.3%

5.6% 6.9% 0.0%

16.1%

3.0%

58.0%

17.2%

72.2%

30.6%

0%

20%

40%

60%

80%

100%

10 μg Placebo 10 μg Placebo 10 μg Placebo 10 μg Placebo 10 μg Placebo 10 μg Placebo

Positive Negative Positive Negative Positive Negative

Redness and swelling severity definition: Mild= >2-5cm, Moderate= >5-10 cm; Severe= >10 cm; Grade 4= necrosis

Pain at injection site severity definition: Mild=no interference; Moderate=some interference; Severe=prevents daily activity; Grade 4=ER visit or hospitalization 

Dose 1: Positive N=198; Negative N=2062 Dose 2: Positive N=195; Negative N=2047 Dose 1 Dose 2
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Systemic events: Mild Moderate Severe Grade 4

Fever: 38.0 °C-38.4 °C 38.4 °C-38.9 °C 38.9 °C-40.0 °C >40.0 °C

Fever Fatigue Headache Chills Vomiting Diarrhea Muscle

Pain

Joint

Pain

Fatigue, headache, chills, muscle pain, joint pain severity definition: Mild=no interference; Moderate=some interference; Severe=prevents daily activity; Grade 4=ER visit or hospitalization

Vomiting severity definition: Mild=1-2 time in 24h; Moderate=>2times in 24h; Severe=Requires IV hydration; Grade 4=ER visit or hospitalization

Diarrhea severity definition: Mild=2-3 times in 24h; Moderate=4-5 times in 24h; Severe=6 or more times in 24h; Grade 4=ER visit or hospitalization 

Dose 1 Positive N=198; Negative N=2062 Dose 2: Positive N=195; Negative N=2047

3.8% 2.4%

30.8% 33.9%

24.8% 22.2%

3.8% 4.7% 4.5% 2.0% 6.8% 5.8% 11.3% 8.9% 3.8% 3.3%

0%

20%

40%

60%

80%

100%

Pos. Neg. Pos. Neg. Pos. Neg. Pos. Neg. Pos. Neg. Pos. Neg. Pos. Neg. Pos. Neg.

Subjects Reporting Systemic Events, by Maximum Severity, Within 7 Days 

After Dose 1 and Dose 2 in 5 to <12 Year Olds by Baseline SARS-CoV-2

Status

Dose 1

3.1% 6.9%

28.2%

40.5%

25.2% 28.2%

7.6% 10.0%

2.3% 1.8% 3.8% 5.4% 6.1% 12.2%

3.8% 5.3%

0%

20%

40%

60%

80%

100%

Pos. Neg. Pos. Neg. Pos. Neg. Pos. Neg. Pos. Neg. Pos. Neg. Pos. Neg. Pos. Neg.

Dose 2
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Adverse Events
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Overall Adverse Events from Dose 1 to Data Cutoff Date: 

5 to <12 Year Olds

11.6

3.0 0.1 0.0 0.0 0.0

9.6

2.1 0.1 0.0 0.0 0.0

0

20

40

60

80

100

Any AE Related AE Any SAE Related SAE Withdrawal

Due to AE

Death

BNT162b2 10 μg (N=1518) Placebo (N=750) Initial enrollment 

group: 

Median follow-up 

time 2.3 months

Cutoff date 

September 6, 2021

Safety expansion 

group: 

Median follow-up 

time 2.4 weeks

Cutoff date 

October 8, 2021

Proportion of Subjects (%) Reporting at Least 1 AE

7.2 3.5 0.2 0.0 0.1 0.0 6.3 1.8 0.0 0.0 0.0 0.0

0

20

40

60

80

100

Any AE Related AE Any SAE Related SAE Withdrawal

Due to AE

Death

BNT162b2 10 μg (N=1591) Placebo (N=788)
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Adverse Events ≥1.0% by System Organ Class for 5 to <12 Year Olds 

from Dose 1 to Cutoff Date Initial Enrollment Group (N=2268)

a. Predominantly reflect nausea, vomiting and diarrhea

b. Predominantly reflect local reactions at the injection site and systemic reactions of fever and fatigue

Lymphadenopathy 0.9% in BNT162b2 group

11.6

1.9

1.8

1.8

1.7

1.6

1.4

9.6

2.1

0.7

1.7

1.3

1.7

0.8

0 20 40 60 80 100

Percent of Subjects Reporting ≥1 AE

Any adverse events

Infections and infestations

Injury, poisoning and 

procedural complications

Gastrointestinal disordersa

General disorders and 

administration site conditionsb

Skin and subcutaneous 

tissue disorders

Respiratory, thoracic and

mediastinal disorders

BNT162b2 10μg (N=1518) Placebo (N=750)

Data Cutoff September 6, 2021
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Adverse Events ≥1.0% by System Organ Class for 5 to <12 Year Olds 

from Dose 1 to Cutoff Date Safety Expansion Group (N= 2379)

1. Predominantly reflect local reactions at the injection site and systemic reactions of fatigue 

Lymphadenopathy 0.4% in the BNT162b2 group

7.2

2.3

1.0

0.9

0.5

6.3

1.8

0.5

1.3

1.0

0 20 40 60 80 100

Percent of Subjects Reporting ≥1 AE

Any adverse events

General disorders and 

administration site conditions1

Skin and subcutaneous 

tissue disorders

Respiratory, thoracic and 

mediastinal disorders

Injury, poisoning and 

procedural complications

BNT162b2 10μg (N=1591) Placebo (N=788)

Data Cutoff October 8, 2021
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Overall Adverse Events from Dose 1 to 1 Month Post Dose 2 in 

5 to <12 Year Olds by Baseline SARS-CoV-2 Status

8.3 1.5 0.0 0.0 0.0 0.0 4.6 0.0 0.0 0.0 0.0 0.0

0

20

40

60

80

100

Any AE Related AE Any SAE Related SAE Withdrawal

Due to AE

Death

BNT162b2 10 μg (N=133) Placebo (N=65)

Baseline 

SARS-CoV-2 

Positive

Baseline 

SARS-CoV-2 

Negative

Proportion of Subjects (%) Reporting at Least 1 AE

11.2

3.2 0.0 0.0 0.0 0.0

9.6

2.3 0.1 0.0 0.0 0.0

0

20

40

60

80

100

Any AE Related AE Any SAE Related SAE Withdrawal

Due to AE

Death

BNT162b2 10 μg (N=1385) Placebo (N=685)
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Serious Adverse Events from Dose 1 to Cutoff Date 

in 5 to <12 Year Olds

• Initial enrollment group (all unrelated):

– One participant in the BNT162b2 group reported a SAE of an upper 

limb fracture

– One participant in the Placebo group reported a SAE of abdominal 

pain and a SAE of pancreatitis related to trauma 

• Expansion Safety group (all unrelated; all in the BNT162b2 

group)

– One participant reported a SAE of infective arthritis

– One participant reported a SAE of epiphyseal fracture

– One participant reported a SAE of ingestion of a foreign body
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Adverse Events of Special Interest

Initial Enrollment Group and Safety Expanded Group

• FDA AESIs:

– No anaphylaxis

– No myocarditis/pericarditis

– No Bell’s palsy (or facial paralysis/paresis)

– No appendicitis 

• CDC Defined AESIs:

– Potential hypersensitivity (angioedema, and predominantly rash 

and urticaria)

– Arthritis (infective)

– Vasculitis 
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Safety Conclusions for 5 to <12 Year Olds

• Reactogenicity was mostly mild to moderate, and short lived

• Observed mild to moderate local reactions (redness, swelling) captured 

by ediary were more common and systemic reactions (including fever) 

less common than those in 16-25 year olds

• The observed AE profile in this study did not suggest any safety 

concerns for BNT162b2 vaccination in children 5 to <12 years of age
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Immunogenicity and Efficacy
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BNT162b2 (10μg)

5 to <12 Years

BNT162b2 (30μg)

16-25 years 5 to <12 / 16-25 years

Assay

Dosing/Sampling 

Time Point n

GMT 

(95% CI) n

GMT 

(95% CI)

GMR

(95% CI)

Met Immunobridging 

(Y/N)

SARS-CoV-2 

neutralization assay -

NT50 (titer)

2 / 1 Month 264

1197.6

(1106.1, 

1296.6)

253

1146.5

(1045.5, 

1257.2)

1.04

(0.93, 1.18) Y

Immunobridging Criteria Between 5 to <12 and 16-25 Years of Age 

Were Met Both for GMR and for Seroresponse

Immunobridging is declared if the lower bound of the 95% confidence interval of the GMR is > 0.67 and the GMR is ≥0.8

BNT162b2 (10μg)

5 to <12 Years

BNT162b2 (30μg)

16-25 years

Difference in %

5 to <12 / 16-25 years

Assay

Dosing/Sampling 

Time Point N

n (%)

(95% CI) N

n (%)

(95% CI)

%

(95% CI)

Met Immunobridging 

(Y/N)

SARS-CoV-2 

neutralization assay -

NT50 (titer)

2 / 1 Month 264 262 (99.2)

(97.3, 99.9) 253 251 (99.2)(97.2, 99.9)

0.0

(-2.0, 2.2) Y

Seroresponse defined as achieving a ≥4 fold rise from baseline (before Dose 1)

Immunobridging is declared if the lower bound of the 95% confidence interval for the percentage difference is greater than -10
CC-24 NT50 = 50% neutralizing titers

Geometric Mean Titers (NT50), By Baseline SARS-CoV-2 Status –

Subjects 5 to <12 Years – Evaluable Immunogenicity Population

Immunogenicity Subset –

11.5

59.8

10.1

1300.3

3270.0

1211.3

1

10

100

1,000

10,000

N=294

All SARS-Co-V-2 Positive

Day 1 1M PD2

N=294 N=21

GMFR

(95% CI)

113.1

(104.4, 122.6)

54.7

(35.3, 84.7)

NT50 (titer) GMT

N=4 N=21 N=273 N=273

Day 1 1M PD2 Day 1 1M PD2

BNT162b2 10 μg BNT162b2 10 μg

119.6

(110.8, 129.2)

SARS-Co-V-2 Negative

BNT162b2 10 μg
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Geometric Mean Titers (NT50), by Age Subgroup – Subjects 5 to <12 

Years – Evaluable Immunogenicity Population

Immunogenicity Subset – Without Evidence of Prior Infection up to 1 Month Post Dose 2 NT50 (titer) GMT

10.1 10.0 10.0 10.3

1197.6 1164.1 1236.1 1191.5

1

10

100

1,000

10,000

BNT162b2 10 μg

All 5-6 Years

N=131

9-11 Years

N=264

Day 1 1M PD2

N=264 N=59 N=59 N=74 N=74 N=131

7-8 Years

BNT162b2 10 μg

Day 1 1M PD2

BNT162b2 10 μg

Day 1 1M PD2

BNT162b2 10 μg

Day 1 1M PD2

NT50 = 50% neutralizing titers
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10.0 10.0

365.3 294.9

1

10

100

1,000

Neutralization of Both Reference Strain and Delta Variant of Concern are 

Comparable – Randomly Selected Subset

Phase 2/3 - Subjects 5 to <12 Years of Age

N=34

Delta Strain (B.1.617.2)

BNT162b2 (10 μg)

Reference Strain (USA-WA1/2020)

BNT162b2 (10 μg)

Day 1 1M PD2 Day 1 1M PD2

N=34

N=34

N=34

GMFR

(95% CI)

36.5

(27.9, 47.8)

29.5

(21.5, 40.5)

Plaque Reduction Neutralization

NT50 (titer) GMT
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High Efficacy was Observed in 5 to <12 Year Olds Descriptive Analysis 

of First COVID-19 Occurrence From 7 Days After Dose 2

BNT162b2 (10 μg)

N=1305

Placebo

N=663

Efficacy Endpoint n

Surveillance 

Time (n) n

Surveillance 

Time (n)

VE 

(%) (95% CI)

First COVID-19 occurrence 

≥7 days after Dose 2 3 0.322 (1273) 16 0.159 (637) 90.7 (67.7, 98.3)

Subjects WITHOUT Evidence of Infection Prior to 7 Days After Dose 2

No severe cases of COVID-19 were reported

No cases of MIS-C were reported

Total surveillance time: 1000 person-years for all subjects within each group at risk for the endpoint
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0.000

0.005

0.010

0.015

0.020

0.025

0.030

0 14 28 42 56 70 84 98 112 126

Cumulative Incidence of 

COVID-19 Occurrence

Cumulative Incidence of COVID-19 After Dose 1: 

5 to <12 Years of Age 

Days After Dose 1

BNT162b2 (10 μg)

Placebo
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Immunogenicity and Efficacy Conclusions

• Immunobridging success criteria were met for 5 to <12 year 

olds at 10 μg dose level

• BNT162b2-immune sera effectively neutralized both 

USA-WA1/2020 (reference strain) and the highly transmissible 

B.1.617.2 (Delta) variant of concern

• BNT162b2 as a two dose series is highly protective against 

COVID-19 in 5 to <12 year olds when Delta variant was 

prominent
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Ongoing and Active Pharmacovigilance 

and Pharmacoepidemiology (Pediatric)

Pharmacovigilance

• Detect unexpected safety events rapidly 

• Spontaneous report collection 

• Active follow-up

• Frequent signal detection and evaluation

Proactive Risk

Mitigation

• Labeling

• Educational materials

• Vial differentiation

Pharmacoepidemiology 

Studies

5 Studies that include pediatric patients:

• 3 studies of >175M health records

• 2 studies of post-vaccination myocarditis
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Acknowledgments

Pfizer and 

BioNTech 

wish to thank:

• The clinical trial participants and 

their families

• Sites, Investigators, CRO, our 

partners and their staff

• FDA guidance to assess this urgent 

medical need