125742 45 S211 M5 c4591001 interim ado mth6 demographics

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 12 15 Documents

227

Document text

16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1005 
10051317/ 
BNT162b2 (30 μg) 12 Female 145.54 51.18 24.1 White    Non-Hispanic/non-
Latino 20OCT2020 
C4591001 1005 
10051328/ 
BNT162b2 (30 μg) 14 Female 160.02 57.09 22.2 White    Non-Hispanic/non-
Latino 20OCT2020 
C4591001 1005 
10051339/ 
Placebo 14 Female 161.29 54.64 21 White    Non-Hispanic/non-
Latino 21OCT2020 
C4591001 1005 
10051410/ 
Placebo 13 Female 152.4 35.45 15.2 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1005 
10051412/ 
BNT162b2 (30 μg) 14 Female 157.48 93.73 37.7 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1005 
10051413/ 
BNT162b2 (30 μg) 15 Male 193.04 105.45 28.2 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1005 
10051414/ 
Placebo 13 Female 170.18 76.09 26.2 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1005 
10051415/ 
Placebo 15 Male 164.59 51.45 19 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1005 
10051417/ 
Placebo 13 Female 157.48 48.64 19.6 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1005 
10051418/ 
BNT162b2 (30 μg) 15 Female 162.56 54.73 20.7 White    Non-Hispanic/non-
Latino 16DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 1
FDA-CBER-2022-5812-0224305
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1005 
10051419/ 
Placebo 15 Female 162.56 53.91 20.4 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1005 
10051420/ 
BNT162b2 (30 μg) 12 Female 166.37 49.09 17.7 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1005 
10051421/ 
Placebo 13 Male 174.24 54.18 17.8 Black or African American    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1005 
10051422/ 
Placebo 12 Male 152.4 38.18 16.4 Black or African American    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1005 
10051424/ 
BNT162b2 (30 μg) 13 Male 156.21 38.09 15.6 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1005 
10051425/ 
BNT162b2 (30 μg) 13 Female 168.15 64.45 22.7 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1005 
10051427/ 
Placebo 14 Female 162.56 59.82 22.6 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1005 
10051428/ 
BNT162b2 (30 μg) 15 Female 170.18 67.68 23.3 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1005 
10051429/ 
BNT162b2 (30 μg) 14 Male 156.97 42.45 17.2 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1005 
10051430/ 
Placebo 15 Male 185.42 71.73 20.8 White    Non-Hispanic/non-
Latino 22DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 2
FDA-CBER-2022-5812-0224306
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1005 
10051431/ 
BNT162b2 (30 μg) 14 Male 180.34 98.18 30.1 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1005 
10051436/ 
BNT162b2 (30 μg) 15 Female 168.91 51.55 18 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1005 
10051437/ 
Placebo 15 Female 160.02 66.09 25.8 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1005 
10051438/ 
Placebo 13 Male 154.69 35.91 15 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1005 
10051439/ 
BNT162b2 (30 μg) 14 Male 180.34 74.09 22.7 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1005 
10051440/ 
Placebo 12 Male 164.59 71 26.2 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1005 
10051441/ 
BNT162b2 (30 μg) 15 Female 154.94 61.82 25.7 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1005 
10051444/ 
Placebo 15 Male 170.18 79.82 27.5 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1005 
10051445/ 
Placebo 14 Female 175.26 60.82 19.8 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1005 
10051447/ 
BNT162b2 (30 μg) 14 Female 170.18 77.27 26.6 White    Non-Hispanic/non-
Latino 11JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 3
FDA-CBER-2022-5812-0224307
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1005 
10051448/ 
Placebo 12 Female 160.02 59.45 23.2 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1005 
10051449/ 
BNT162b2 (30 μg) 14 Male 178.31 82.82 26 White    Hispanic/Latino  11JAN2021 
C4591001 1005 
10051450/ 
Placebo 14 Male 168.91 61.18 21.4 Asian  Other Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1005 
10051451/ 
BNT162b2 (30 μg) 15 Female 153.67 41.55 17.6 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1006 
10061183/ 
Placebo 14 Male 166.37 97.73 35.2 Multiracial    Hispanic/Latino  30NOV2020 
C4591001 1006 
10061184/ 
BNT162b2 (30 μg) 15 Male 166.37 54.18 19.5 White    Non-Hispanic/non-
Latino 30NOV2020 
C4591001 1006 
10061188/ 
Placebo 12 Female 152.4 45.18 19.4 Asian    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1006 
10061189/ 
BNT162b2 (30 μg) 15 Male 173.99 59.23 19.5 Asian    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1006 
10061190/ 
BNT162b2 (30 μg) 15 Male 171.45 75.45 25.6 White    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1006 
10061191/ 
BNT162b2 (30 μg) 15 Female 162.56 62.73 23.7 White    Hispanic/Latino  02DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 4
FDA-CBER-2022-5812-0224308
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1006 
10061196/ 
Placebo 12 Male 167.64 57.59 20.4 White    Hispanic/Latino  02DEC2020 
C4591001 1006 
10061200/ 
Placebo 15 Male 173.99 79.55 26.2 White    Non-Hispanic/non-
Latino 03DEC2020 
C4591001 1006 
10061201/ 
BNT162b2 (30 μg) 12 Male 162.56 74.27 28 White    Non-Hispanic/non-
Latino 03DEC2020 
C4591001 1006 
10061203/ 
BNT162b2 (30 μg) 13 Female 161.29 50.09 19.2 White    Non-Hispanic/non-
Latino 03DEC2020 
C4591001 1006 
10061206/ 
Placebo 12 Male 161.29 63.59 24.4 White    Non-Hispanic/non-
Latino 04DEC2020 
C4591001 1006 
10061207/ 
Placebo 14 Male 172.72 54.64 18.3 White    Non-Hispanic/non-
Latino 04DEC2020 
C4591001 1006 
10061209/ 
BNT162b2 (30 μg) 13 Male 170.69 57.73 19.8 White    Non-Hispanic/non-
Latino 04DEC2020 
C4591001 1006 
10061212/ 
Placebo 14 Female 161.29 49.91 19.1 White    Non-Hispanic/non-
Latino 04DEC2020 
C4591001 1006 
10061213/ 
BNT162b2 (30 μg) 12 Male 166.37 52.82 19 White    Non-Hispanic/non-
Latino 04DEC2020 
C4591001 1006 
10061214/ 
Placebo 14 Male 175.26 90.27 29.3 Black or African American    Hispanic/Latino  04DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 5
FDA-CBER-2022-5812-0224309
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1006 
10061219/ 
Placebo 14 Male 193.8 82.64 22 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1006 
10061220/ 
BNT162b2 (30 μg) 15 Male 176.53 70.73 22.6 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1006 
10061221/ 
BNT162b2 (30 μg) 15 Female 160.02 58.5 22.8 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1006 
10061223/ 
Placebo 15 Male 152.4 37.09 15.9 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1006 
10061224/ 
BNT162b2 (30 μg) 14 Female 160.02 68.18 26.6 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1006 
10061226/ 
Placebo 15 Female 161.29 49.64 19 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1006 
10061227/ 
BNT162b2 (30 μg) 15 Female 162.56 55.55 21 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1006 
10061228/ 
Placebo 12 Female 161.29 46.73 17.9 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1006 
10061229/ 
Placebo 15 Female 160.78 49.64 19.2 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1006 
10061230/ 
BNT162b2 (30 μg) 14 Female 166.37 60.77 21.9 Multiracial    Non-Hispanic/non-
Latino 08DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 6
FDA-CBER-2022-5812-0224310
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1006 
10061231/ 
BNT162b2 (30 μg) 12 Female 151.77 52 22.5 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1006 
10061232/ 
Placebo 13 Female 168.91 47.45 16.6 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1006 
10061233/ 
Placebo 15 Male 173.99 46.64 15.4 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1006 
10061234/ 
BNT162b2 (30 μg) 13 Male 167.64 48.82 17.3 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1006 
10061235/ 
Placebo 15 Male 182.88 60.18 18 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1006 
10061236/ 
BNT162b2 (30 μg) 15 Female 156.21 49.27 20.1 Asian    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1006 
10061237/ 
Placebo 14 Male 170.18 66.95 23.1 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1006 
10061239/ 
Placebo 14 Female 172.72 65.18 21.8 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1006 
10061241/ 
BNT162b2 (30 μg) 14 Female 159.51 48.09 18.9 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1006 
10061242/ 
BNT162b2 (30 μg) 15 Male 172.72 52.27 17.5 White    Non-Hispanic/non-
Latino 09DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 7
FDA-CBER-2022-5812-0224311
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1006 
10061243/ 
BNT162b2 (30 μg) 13 Female 183.13 69.18 20.6 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1006 
10061244/ 
BNT162b2 (30 μg) 15 Male 163.83 53.64 19.9 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1006 
10061245/ 
Placebo 15 Male 162.56 49.36 18.6 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1006 
10061247/ 
Placebo 13 Female 165.1 61.45 22.5 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1006 
10061248/ 
Placebo 13 Male 166.37 51 18.4 White    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1006 
10061249/ 
BNT162b2 (30 μg) 15 Female 158.75 133.09 52.7 White    Hispanic/Latino  11DEC2020 
C4591001 1006 
10061250/ 
Placebo 13 Male 168.91 84.91 29.7 White    Hispanic/Latino  11DEC2020 
C4591001 1006 
10061252/ 
BNT162b2 (30 μg) 14 Male 156.21 38.09 15.6 White    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1006 
10061253/ 
Placebo 14 Male 180.34 63.18 19.4 White    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1006 
10061254/ 
BNT162b2 (30 μg) 14 Female 165.1 95.45 34.9 White    Non-Hispanic/non-
Latino 11DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 8
FDA-CBER-2022-5812-0224312
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1006 
10061256/ 
BNT162b2 (30 μg) 15 Female 163.83 70 26 White    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1006 
10061257/ 
Placebo 15 Female 163.07 53.32 20 Asian    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1006 
10061258/ 
BNT162b2 (30 μg) 14 Male 183.39 67.64 20.1 Native Hawaiian or other 
Pacific Islander   Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1006 
10061259/ 
Placebo 15 Female 163.83 45.45 16.9 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1006 
10061260/ 
Placebo 12 Female 153.67 37.36 15.8 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1006 
10061261/ 
BNT162b2 (30 μg) 14 Male 160.02 43.45 16.9 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1006 
10061262/ 
Placebo 15 Male 175.51 70.55 22.9 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1006 
10061263/ 
BNT162b2 (30 μg) 12 Female 147.32 37.55 17.3 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1006 
10061264/ 
BNT162b2 (30 μg) 13 Male 176.53 82.36 26.4 White    Hispanic/Latino  14DEC2020 
C4591001 1006 
10061265/ 
BNT162b2 (30 μg) 13 Male 154.94 36.45 15.2 White    Non-Hispanic/non-
Latino 15DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 9
FDA-CBER-2022-5812-0224313
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1006 
10061266/ 
Placebo 15 Female 165.35 69 25.2 Multiracial    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1006 
10061267/ 
Placebo 15 Female 165.61 61.68 22.4 Asian  Other Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1006 
10061269/ 
BNT162b2 (30 μg) 14 Male 167.64 48.09 17.1 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1006 
10061270/ 
Placebo 15 Female 167.64 59.82 21.2 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1006 
10061271/ 
BNT162b2 (30 μg) 14 Male 156.21 48.09 19.7 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1006 
10061272/ 
BNT162b2 (30 μg) 13 Female 172.72 67.27 22.5 Black or African American    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1006 
10061273/ 
Placebo 13 Male 172.72 71.27 23.8 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1006 
10061274/ 
BNT162b2 (30 μg) 14 Female 173.23 44.91 14.9 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1006 
10061276/ 
Placebo 15 Female 162.56 54.73 20.7 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1006 
10061277/ 
Placebo 13 Female 172.09 71.86 24.2 White    Non-Hispanic/non-
Latino 17DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 10
FDA-CBER-2022-5812-0224314
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1006 
10061278/ 
BNT162b2 (30 μg) 13 Male 163.07 42 15.8 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1006 
10061279/ 
Placebo 13 Female 160.02 80.73 31.5 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1006 
10061280/ 
BNT162b2 (30 μg) 15 Male 172.72 89.73 30 White    Hispanic/Latino  17DEC2020 
C4591001 1006 
10061282/ 
BNT162b2 (30 μg) 13 Male 171.45 54.09 18.4 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1006 
10061283/ 
Placebo 15 Male 170.94 57 19.5 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1006 
10061284/ 
Placebo 14 Male 182.88 98.27 29.3 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1006 
10061285/ 
Placebo 14 Female 161.29 48.36 18.6 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1006 
10061286/ 
BNT162b2 (30 μg) 14 Male 180.34 53.82 16.5 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1006 
10061287/ 
Placebo 13 Male 165.1 47 17.2 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1006 
10061288/ 
BNT162b2 (30 μg) 15 Female 167.64 64.36 22.9 White    Non-Hispanic/non-
Latino 21DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 11
FDA-CBER-2022-5812-0224315
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1006 
10061289/ 
BNT162b2 (30 μg) 13 Female 153.67 53.64 22.7 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1006 
10061290/ 
BNT162b2 (30 μg) 15 Female 151.13 50.55 22.1 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1006 
10061291/ 
Placebo 13 Male 151.13 35.55 15.5 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1006 
10061292/ 
Placebo 15 Female 168.91 52.27 18.3 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1006 
10061293/ 
BNT162b2 (30 μg) 15 Male 181.61 86.36 26.1 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1006 
10061294/ 
Placebo 14 Female 166.37 71.91 25.9 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1006 
10061295/ 
Placebo 12 Male 166.37 47.45 17.1 White    Non-Hispanic/non-
Latino 24DEC2020 
C4591001 1006 
10061296/ 
Placebo 14 Male 173.99 51.82 17.1 White    Hispanic/Latino  29DEC2020 
C4591001 1006 
10061297/ 
BNT162b2 (30 μg) 12 Female 157.48 56.5 22.7 White    Hispanic/Latino  29DEC2020 
C4591001 1006 
10061298/ 
Placebo 13 Female 167.64 75.45 26.8 White    Non-Hispanic/non-
Latino 29DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 12
FDA-CBER-2022-5812-0224316
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1006 
10061299/ 
BNT162b2 (30 μg) 14 Male 168.91 52.59 18.4 White    Non-Hispanic/non-
Latino 31DEC2020 
C4591001 1006 
10061300/ 
BNT162b2 (30 μg) 15 Male 170.18 52.45 18.1 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1007 
10071409/ 
BNT162b2 (30 μg) 13 Male 154 36.2 15.3 Asian    Non-Hispanic/non-
Latino 22OCT2020 
C4591001 1007 
10071414/ 
Placebo 14 Male 166.5 46.4 16.7 White    Non-Hispanic/non-
Latino 22OCT2020 
C4591001 1007 
10071415/ 
Placebo 12 Male 142 32 15.9 White    Non-Hispanic/non-
Latino 22OCT2020 
C4591001 1007 
10071417/ 
BNT162b2 (30 μg) 15 Male 191.8 100.2 27.2 White    Non-Hispanic/non-
Latino 22OCT2020 
C4591001 1007 
10071428/ 
Placebo 12 Male 160 41.8 16.3 Asian    Non-Hispanic/non-
Latino 22OCT2020 
C4591001 1007 
10071429/ 
Placebo 13 Female 159 47.7 18.9 White    Non-Hispanic/non-
Latino 22OCT2020 
C4591001 1007 
10071467/ 
BNT162b2 (30 μg) 15 Female 159 55.1 21.8 White    Non-Hispanic/non-
Latino 30NOV2020 
C4591001 1007 
10071469/ 
BNT162b2 (30 μg) 14 Male 126 39.6 24.9 White    Non-Hispanic/non-
Latino 30NOV2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 13
FDA-CBER-2022-5812-0224317
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1007 
10071471/ 
BNT162b2 (30 μg) 14 Male 175 62.5 20.4 White    Non-Hispanic/non-
Latino 30NOV2020 
C4591001 1007 
10071472/ 
Placebo 13 Female 159 50 19.8 White    Non-Hispanic/non-
Latino 30NOV2020 
C4591001 1007 
10071475/ 
BNT162b2 (30 μg) 15 Female 167 57.4 20.6 White    Non-Hispanic/non-
Latino 30NOV2020 
C4591001 1007 
10071476/ 
BNT162b2 (30 μg) 13 Female 159 54 21.4 White    Non-Hispanic/non-
Latino 30NOV2020 
C4591001 1007 
10071478/ 
Placebo 14 Male 191 93.6 25.7 White    Non-Hispanic/non-
Latino 30NOV2020 
C4591001 1007 
10071480/ 
Placebo 14 Male 175.5 95.9 31.1 White    Non-Hispanic/non-
Latino 30NOV2020 
C4591001 1007 
10071481/ 
Placebo 12 Female 162 47.6 18.1 White    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1007 
10071482/ 
BNT162b2 (30 μg) 13 Female 165.5 53 19.3 White    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1007 
10071483/ 
Placebo 15 Female 169 50.8 17.8 White    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1007 
10071484/ 
Placebo 13 Female 168.5 55.3 19.5 White    Non-Hispanic/non-
Latino 01DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 14
FDA-CBER-2022-5812-0224318
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1007 
10071485/ 
BNT162b2 (30 μg) 14 Female 163.5 59.6 22.3 White    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1007 
10071488/ 
BNT162b2 (30 μg) 14 Female 175 78.4 25.6 White    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1007 
10071490/ 
BNT162b2 (30 μg) 13 Male 175 57.4 18.7 White    Hispanic/Latino  01DEC2020 
C4591001 1007 
10071492/ 
Placebo 13 Female 157 47.7 19.4 White    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1007 
10071494/ 
BNT162b2 (30 μg) 15 Male 189.5 79.1 22 White    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1007 
10071495/ 
Placebo 15 Male 165 60.6 22.3 White    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1007 
10071496/ 
Placebo 14 Female 167 46.2 16.6 Asian    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1007 
10071497/ 
BNT162b2 (30 μg) 12 Male 151 39 17.1 Asian    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1007 
10071499/ 
Placebo 14 Male 170 50.9 17.6 White    Non-Hispanic/non-
Latino 03DEC2020 
C4591001 1007 
10071500/ 
BNT162b2 (30 μg) 15 Female 163.3 51.3 19.2 White    Non-Hispanic/non-
Latino 03DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 15
FDA-CBER-2022-5812-0224319
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1007 
10071504/ 
BNT162b2 (30 μg) 15 Male 186 90.2 26.1 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1007 
10071505/ 
Placebo 12 Female 153 53.8 23 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1007 
10071506/ 
BNT162b2 (30 μg) 15 Female 175 69.8 22.8 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1007 
10071507/ 
Placebo 13 Male 177.5 59.7 18.9 Asian    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1007 
10071508/ 
BNT162b2 (30 μg) 14 Female 168 54.5 19.3 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1007 
10071509/ 
Placebo 15 Female 162.5 71.5 27.1 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1007 
10071511/ 
Placebo 15 Male 177 75.6 24.1 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1007 
10071512/ 
BNT162b2 (30 μg) 15 Female 169.5 59.7 20.8 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1007 
10071514/ 
BNT162b2 (30 μg) 12 Male 151 37.9 16.6 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1007 
10071515/ 
Placebo 12 Male 170.5 61.7 21.2 White    Non-Hispanic/non-
Latino 08DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 16
FDA-CBER-2022-5812-0224320
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1007 
10071516/ 
Placebo 15 Male 173 52.2 17.4 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1007 
10071517/ 
BNT162b2 (30 μg) 12 Male 148 38.1 17.4 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1007 
10071518/ 
BNT162b2 (30 μg) 15 Male 176 95.8 30.9 White    Hispanic/Latino  08DEC2020 
C4591001 1007 
10071519/ 
Placebo 15 Male 177.5 65.6 20.8 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1007 
10071520/ 
Placebo 13 Male 179 63.3 19.8 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1007 
10071521/ 
BNT162b2 (30 μg) 13 Male 171 61.1 20.9 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1007 
10071522/ 
Placebo 15 Female 168 74.9 26.5 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1007 
10071523/ 
BNT162b2 (30 μg) 13 Female 148.5 40.3 18.3 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1007 
10071524/ 
Placebo 15 Male 175 63.4 20.7 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1007 
10071525/ 
BNT162b2 (30 μg) 13 Male 168.5 70.4 24.8 White    Non-Hispanic/non-
Latino 08DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 17
FDA-CBER-2022-5812-0224321
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1007 
10071526/ 
BNT162b2 (30 μg) 14 Female 172 55 18.6 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1007 
10071527/ 
Placebo 12 Male 168 46.7 16.5 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1007 
10071528/ 
Placebo 14 Female 170 70 24.2 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1007 
10071529/ 
BNT162b2 (30 μg) 14 Female 155.4 45.9 19 Multiracial    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1007 
10071530/ 
BNT162b2 (30 μg) 12 Female 160 64.9 25.4 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1007 
10071531/ 
Placebo 14 Female 166.5 71.4 25.8 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1007 
10071533/ 
Placebo 14 Male 181.9 93.2 28.2 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1007 
10071535/ 
BNT162b2 (30 μg) 15 Male 181.9 73.9 22.3 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1007 
10071536/ 
BNT162b2 (30 μg) 13 Female 165 49.1 18 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1007 
10071537/ 
BNT162b2 (30 μg) 13 Male 175 77.7 25.4 White    Non-Hispanic/non-
Latino 09DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 18
FDA-CBER-2022-5812-0224322
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1007 
10071539/ 
Placebo 15 Male 164.5 47.8 17.7 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1007 
10071540/ 
Placebo 13 Male 157 49.6 20.1 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1007 
10071541/ 
Placebo 15 Male 172 62.6 21.2 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1007 
10071542/ 
BNT162b2 (30 μg) 13 Female 168 59.1 20.9 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1007 
10071543/ 
Placebo 14 Male 162 57.3 21.8 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1007 
10071544/ 
BNT162b2 (30 μg) 12 Male 146 38 17.8 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1007 
10071546/ 
BNT162b2 (30 μg) 15 Male 184.4 82.3 24.2 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1007 
10071547/ 
Placebo 14 Male 171.5 59.8 20.3 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1007 
10071550/ 
BNT162b2 (30 μg) 13 Female 163.5 40.4 15.1 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1007 
10071551/ 
Placebo 13 Male 162 51.3 19.5 White    Non-Hispanic/non-
Latino 10DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 19
FDA-CBER-2022-5812-0224323
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1007 
10071552/ 
Placebo 15 Female 167 58.7 21 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1007 
10071554/ 
Placebo 14 Female 171 71.7 24.5 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1007 
10071555/ 
BNT162b2 (30 μg) 12 Male 157.5 42.5 17.1 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1007 
10071557/ 
BNT162b2 (30 μg) 15 Female 160 50.8 19.8 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1007 
10071558/ 
BNT162b2 (30 μg) 14 Female 165.5 61.9 22.6 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1007 
10071559/ 
Placebo 14 Female 170 62 21.5 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1007 
10071560/ 
Placebo 12 Female 160 43 16.8 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1007 
10071561/ 
BNT162b2 (30 μg) 12 Female 153 43 18.4 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1007 
10071562/ 
Placebo 12 Female 161 56.7 21.9 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1007 
10071563/ 
Placebo 12 Male 160 71.5 27.9 White    Non-Hispanic/non-
Latino 14DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 20
FDA-CBER-2022-5812-0224324
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1007 
10071564/ 
BNT162b2 (30 μg) 14 Female 161 53.8 20.8 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1007 
10071565/ 
BNT162b2 (30 μg) 14 Male 175 54 17.6 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1007 
10071566/ 
BNT162b2 (30 μg) 15 Male 178 74.6 23.5 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1007 
10071567/ 
BNT162b2 (30 μg) 14 Male 163 40.2 15.1 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1007 
10071568/ 
Placebo 14 Male 170.2 63.6 22 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1007 
10071569/ 
Placebo 12 Female 164.4 62.6 23.2 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1007 
10071570/ 
Placebo 15 Female 168.5 103.8 36.6 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1007 
10071571/ 
BNT162b2 (30 μg) 14 Female 160 49.3 19.3 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1007 
10071572/ 
BNT162b2 (30 μg) 12 Female 161.3 63.2 24.3 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1007 
10071573/ 
Placebo 12 Male 162 49.2 18.7 White    Non-Hispanic/non-
Latino 15DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 21
FDA-CBER-2022-5812-0224325
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1007 
10071574/ 
BNT162b2 (30 μg) 15 Male 181 67.4 20.6 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1007 
10071575/ 
BNT162b2 (30 μg) 15 Male 175 68.3 22.3 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1007 
10071576/ 
Placebo 15 Female 169 53.8 18.8 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1007 
10071577/ 
Placebo 15 Male 169 63 22.1 Multiracial    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1007 
10071578/ 
Placebo 12 Male 146 40.1 18.8 Multiracial    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1007 
10071579/ 
BNT162b2 (30 μg) 12 Female 161 42 16.2 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1007 
10071580/ 
BNT162b2 (30 μg) 14 Female 163 55.3 20.8 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1007 
10071581/ 
Placebo 15 Male 175 64.8 21.2 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1007 
10071582/ 
BNT162b2 (30 μg) 12 Male 165.7 58 21.1 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1007 
10071583/ 
Placebo 15 Male 173 87.4 29.2 White    Non-Hispanic/non-
Latino 17DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 22
FDA-CBER-2022-5812-0224326
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1007 
10071584/ 
BNT162b2 (30 μg) 15 Male 188 68.7 19.4 White    Hispanic/Latino  17DEC2020 
C4591001 1007 
10071585/ 
Placebo 12 Male 168 89.4 31.7 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1007 
10071586/ 
Placebo 13 Male 165 69.1 25.4 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1007 
10071587/ 
BNT162b2 (30 μg) 14 Female 154.9 56.3 23.5 Asian    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1007 
10071588/ 
BNT162b2 (30 μg) 13 Male 147 40.4 18.7 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1007 
10071589/ 
Placebo 12 Male 145 31.7 15.1 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1007 
10071590/ 
BNT162b2 (30 μg) 14 Male 165 59.9 22 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1007 
10071591/ 
Placebo 13 Male 161 50.1 19.3 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1007 
10071592/ 
BNT162b2 (30 μg) 13 Male 155 40 16.6 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1007 
10071593/ 
Placebo 15 Male 201.7 100 24.6 White    Non-Hispanic/non-
Latino 28DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 23
FDA-CBER-2022-5812-0224327
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1007 
10071594/ 
BNT162b2 (30 μg) 14 Female 174 55.7 18.4 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1007 
10071595/ 
Placebo 13 Female 162 49.4 18.8 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1007 
10071596/ 
Placebo 13 Male 160 36.9 14.4 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1007 
10071597/ 
BNT162b2 (30 μg) 14 Female 159 37.2 14.7 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1007 
10071599/ 
BNT162b2 (30 μg) 14 Male 166 42.5 15.4 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1007 
10071600/ 
Placebo 12 Female 150 39.2 17.4 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1007 
10071601/ 
Placebo 15 Male 176.5 65.2 20.9 Asian  Other Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1007 
10071602/ 
BNT162b2 (30 μg) 14 Male 165 47.1 17.3 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1007 
10071603/ 
Placebo 13 Male 164 56.3 20.9 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1007 
10071604/ 
Placebo 15 Female 172 77.1 26.1 White    Non-Hispanic/non-
Latino 29DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 24
FDA-CBER-2022-5812-0224328
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1007 
10071605/ 
BNT162b2 (30 μg) 12 Male 154 38.8 16.4 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1007 
10071606/ 
BNT162b2 (30 μg) 13 Female 151 45.2 19.8 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1007 
10071607/ 
Placebo 14 Female 163 67.4 25.4 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1007 
10071608/ 
Placebo 12 Male 149 36.4 16.4 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1007 
10071609/ 
BNT162b2 (30 μg) 12 Male 162.5 56.6 21.4 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1007 
10071610/ 
BNT162b2 (30 μg) 15 Female 161 87.8 33.9 American Indian or Alaska 
Native    Hispanic/Latino  29DEC2020 
C4591001 1007 
10071612/ 
BNT162b2 (30 μg) 14 Male 159 47.9 18.9 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1007 
10071613/ 
Placebo 13 Male 166.1 51.2 18.6 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1007 
10071614/ 
Placebo 14 Male 170 56.3 19.5 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1007 
10071615/ 
BNT162b2 (30 μg) 12 Male 155 45.9 19.1 White    Non-Hispanic/non-
Latino 29DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 25
FDA-CBER-2022-5812-0224329
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1007 
10071616/ 
BNT162b2 (30 μg) 15 Male 170.5 66.5 22.9 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1007 
10071617/ 
Placebo 15 Female 167 62.3 22.3 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1007 
10071618/ 
Placebo 13 Male 165 60.4 22.2 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1007 
10071619/ 
BNT162b2 (30 μg) 12 Male 155 39.5 16.4 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1007 
10071620/ 
BNT162b2 (30 μg) 12 Female 155.5 57.1 23.6 White    Hispanic/Latino  30DEC2020 
C4591001 1007 
10071621/ 
Placebo 14 Male 149 39.5 17.8 White    Hispanic/Latino  30DEC2020 
C4591001 1007 
10071622/ 
BNT162b2 (30 μg) 15 Male 162 59 22.5 White    Hispanic/Latino  30DEC2020 
C4591001 1007 
10071623/ 
Placebo 13 Male 163 45 16.9 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1007 
10071624/ 
Placebo 13 Male 170 55.5 19.2 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1007 
10071625/ 
Placebo 13 Female 167 48.3 17.3 White    Non-Hispanic/non-
Latino 30DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 26
FDA-CBER-2022-5812-0224330
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1007 
10071626/ 
BNT162b2 (30 μg) 14 Male 156.5 43 17.6 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1007 
10071627/ 
BNT162b2 (30 μg) 14 Male 182 74.6 22.5 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1007 
10071628/ 
BNT162b2 (30 μg) 14 Male 183 55.7 16.6 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1007 
10071629/ 
Placebo 15 Female 156 61.8 25.4 Asian  Other Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1007 
10071630/ 
Placebo 13 Male 153 51.9 22.2 Asian  Other Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1007 
10071631/ 
BNT162b2 (30 μg) 12 Male 166 57.4 20.8 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1007 
10071632/ 
Placebo 13 Female 177 58.8 18.8 White    Hispanic/Latino  30DEC2020 
C4591001 1007 
10071633/ 
BNT162b2 (30 μg) 12 Male 156 47.3 19.4 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1007 
10071634/ 
BNT162b2 (30 μg) 14 Male 174 55.8 18.4 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1007 
10071635/ 
Placebo 13 Male 165 50.7 18.6 White    Non-Hispanic/non-
Latino 04JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 27
FDA-CBER-2022-5812-0224331
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1007 
10071636/ 
BNT162b2 (30 μg) 12 Female 162 71.6 27.3 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1007 
10071638/ 
BNT162b2 (30 μg) 13 Female 166.5 65.9 23.8 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1007 
10071639/ 
Placebo 13 Male 176 70.8 22.9 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1007 
10071640/ 
Placebo 14 Female 162 48.7 18.6 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1007 
10071641/ 
BNT162b2 (30 μg) 13 Female 168 53.4 18.9 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1007 
10071642/ 
BNT162b2 (30 μg) 15 Male 170 45 15.6 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1007 
10071643/ 
Placebo 12 Male 148 38.6 17.6 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1007 
10071644/ 
BNT162b2 (30 μg) 13 Male 160 35 13.7 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1007 
10071645/ 
Placebo 14 Male 181 70.7 21.6 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1007 
10071646/ 
Placebo 12 Male 147 31.8 14.7 White    Non-Hispanic/non-
Latino 04JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 28
FDA-CBER-2022-5812-0224332
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1007 
10071647/ 
BNT162b2 (30 μg) 12 Male 162.5 62.4 23.6 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1007 
10071648/ 
Placebo 15 Male 176.5 60.5 19.4 Asian  Other Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1007 
10071649/ 
BNT162b2 (30 μg) 14 Female 184 66.8 19.7 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1007 
10071650/ 
Placebo 13 Male 159.5 77.2 30.3 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1007 
10071651/ 
BNT162b2 (30 μg) 12 Male 160 44.6 17.4 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1007 
10071652/ 
Placebo 12 Female 164 55 20.4 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1007 
10071653/ 
BNT162b2 (30 μg) 14 Male 174 82.1 27.1 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1007 
10071654/ 
Placebo 12 Female 150.2 39.8 17.6 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1007 
10071655/ 
Placebo 14 Male 167 45.4 16.3 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1007 
10071656/ 
BNT162b2 (30 μg) 14 Female 157.5 51.4 20.7 White    Non-Hispanic/non-
Latino 06JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 29
FDA-CBER-2022-5812-0224333
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1007 
10071658/ 
Placebo 13 Female 164 68.4 25.4 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1007 
10071659/ 
BNT162b2 (30 μg) 15 Female 153 48.8 20.8 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1007 
10071660/ 
Placebo 12 Male 150 33.7 15 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1007 
10071661/ 
BNT162b2 (30 μg) 13 Female 174 63.9 21.1 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1007 
10071662/ 
Placebo 15 Female 175.5 63.6 20.6 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1008 
10081751/ 
Placebo 13 Female 157.48 68.45 27.5 White    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1008 
10081752/ 
Placebo 15 Male 167.64 56.45 20 Asian    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1008 
10081753/ 
BNT162b2 (30 μg) 14 Male 168.91 55 19.2 Asian    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1008 
10081754/ 
BNT162b2 (30 μg) 12 Male 163.83 41.91 15.6 White    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1008 
10081755/ 
BNT162b2 (30 μg) 15 Female 167.64 53.82 19.1 White    Non-Hispanic/non-
Latino 02DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 30
FDA-CBER-2022-5812-0224334
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1008 
10081756/ 
Placebo 15 Female 162.56 47.18 17.8 White    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1008 
10081757/ 
Placebo 12 Male 165.1 47.45 17.4 White    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1008 
10081758/ 
BNT162b2 (30 μg) 15 Female 160.02 70.82 27.6 White    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1008 
10081760/ 
BNT162b2 (30 μg) 13 Female 166.37 62.64 22.6 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1008 
10081761/ 
Placebo 15 Female 165.1 91.36 33.4 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1008 
10081763/ 
Placebo 14 Male 175.26 93.45 30.4 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1008 
10081764/ 
BNT162b2 (30 μg) 13 Female 160.02 64.64 25.2 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1008 
10081767/ 
Placebo 15 Male 176.53 55.82 17.9 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1008 
10081768/ 
Placebo 14 Female 171.45 56.82 19.3 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1008 
10081769/ 
BNT162b2 (30 μg) 15 Male 174.63 50.73 16.6 White    Non-Hispanic/non-
Latino 08DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 31
FDA-CBER-2022-5812-0224335
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1008 
10081770/ 
BNT162b2 (30 μg) 14 Female 175.26 59.55 19.3 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1008 
10081771/ 
BNT162b2 (30 μg) 12 Female 161.29 60.36 23.2 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1008 
10081773/ 
Placebo 13 Male 177.8 61.27 19.3 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1008 
10081774/ 
BNT162b2 (30 μg) 12 Female 167.64 58 20.6 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1008 
10081775/ 
Placebo 14 Male 165.1 49.82 18.2 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1008 
10081777/ 
BNT162b2 (30 μg) 15 Female 170.18 47 16.2 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1008 
10081780/ 
Placebo 15 Female 162.56 61.91 23.4 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1008 
10081781/ 
Placebo 13 Female 149.86 55 24.4 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1008 
10081785/ 
BNT162b2 (30 μg) 13 Female 163.83 65.55 24.4 Asian    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1008 
10081788/ 
Placebo 13 Female 165.1 50.36 18.4 White    Non-Hispanic/non-
Latino 14DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 32
FDA-CBER-2022-5812-0224336
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1008 
10081789/ 
BNT162b2 (30 μg) 15 Male 180.34 64.91 19.9 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1008 
10081790/ 
Placebo 12 Female 161.29 62.45 24 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1008 
10081791/ 
BNT162b2 (30 μg) 12 Male 167.01 50.36 18 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1008 
10081792/ 
BNT162b2 (30 μg) 13 Female 175.26 57.45 18.7 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1008 
10081793/ 
Placebo 14 Male 189.87 70.45 19.5 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1008 
10081794/ 
Placebo 12 Female 154.94 39.82 16.6 Asian    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1008 
10081795/ 
BNT162b2 (30 μg) 14 Male 172.72 57.55 19.2 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1008 
10081796/ 
Placebo 15 Female 164.47 54.09 20 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1008 
10081797/ 
BNT162b2 (30 μg) 14 Female 154.31 60.91 25.5 American Indian or Alaska 
Native    Hispanic/Latino  15DEC2020 
C4591001 1008 
10081798/ 
Placebo 13 Female 149.86 41.18 18.3 White    Non-Hispanic/non-
Latino 15DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 33
FDA-CBER-2022-5812-0224337
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1008 
10081799/ 
BNT162b2 (30 μg) 13 Female 161.93 62.91 23.9 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1008 
10081800/ 
BNT162b2 (30 μg) 14 Female 167.64 47.91 17 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1008 
10081801/ 
Placebo 15 Female 172.72 70.45 23.6 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1008 
10081802/ 
BNT162b2 (30 μg) 13 Male 156.85 41 16.6 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1008 
10081803/ 
Placebo 15 Male 194.31 146.64 38.8 Black or African American    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1008 
10081804/ 
Placebo 14 Female 157.48 51.36 20.7 Asian    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1008 
10081805/ 
BNT162b2 (30 μg) 12 Female 164.47 63.73 23.5 Asian  Other Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1008 
10081806/ 
BNT162b2 (30 μg) 14 Female 173.99 56.45 18.6 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1008 
10081807/ 
Placebo 12 Female 172.72 80.55 26.9 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1008 
10081808/ 
Placebo 13 Male 167.01 48.82 17.5 Asian  Other Non-Hispanic/non-
Latino 18DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 34
FDA-CBER-2022-5812-0224338
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1008 
10081809/ 
Placebo 13 Female 167.64 54.73 19.4 Asian    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1008 
10081810/ 
BNT162b2 (30 μg) 13 Female 162.56 63.27 23.9 White    Hispanic/Latino  18DEC2020 
C4591001 1008 
10081811/ 
BNT162b2 (30 μg) 15 Female 154.94 62.82 26.1 White    Hispanic/Latino  18DEC2020 
C4591001 1008 
10081812/ 
Placebo 14 Male 169.55 63.64 22.1 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1008 
10081813/ 
BNT162b2 (30 μg) 12 Male 161.29 54.91 21.1 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1008 
10081814/ 
BNT162b2 (30 μg) 13 Female 151.13 47.27 20.7 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1008 
10081815/ 
Placebo 12 Female 167.64 59.64 21.2 Black or African American    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1008 
10081816/ 
BNT162b2 (30 μg) 13 Female 165.74 61 22.2 Black or African American    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1008 
10081817/ 
Placebo 13 Female 149.23 47.09 21.1 Asian  Other Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1008 
10081818/ 
BNT162b2 (30 μg) 15 Male 165.1 48.55 17.8 White    Non-Hispanic/non-
Latino 18DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 35
FDA-CBER-2022-5812-0224339
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1008 
10081819/ 
Placebo 12 Male 161.29 47.27 18.1 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1008 
10081820/ 
Placebo 14 Female 173.36 58.82 19.5 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1008 
10081821/ 
BNT162b2 (30 μg) 13 Male 157.48 41.73 16.8 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1008 
10081822/ 
Placebo 13 Female 173.99 56 18.5 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1008 
10081823/ 
BNT162b2 (30 μg) 14 Male 165.1 51.73 18.9 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1008 
10081824/ 
BNT162b2 (30 μg) 12 Male 151.77 32.36 14 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1008 
10081825/ 
Placebo 12 Female 151.77 40 17.3 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1008 
10081826/ 
BNT162b2 (30 μg) 14 Male 170.82 58.73 20.1 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1008 
10081827/ 
BNT162b2 (30 μg) 15 Female 180.34 55.91 17.2 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1008 
10081828/ 
Placebo 14 Female 168.91 67.91 23.7 White    Non-Hispanic/non-
Latino 21DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 36
FDA-CBER-2022-5812-0224340
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1008 
10081829/ 
Placebo 13 Male 177.17 49.73 15.8 Asian    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1008 
10081830/ 
Placebo 13 Male 168.91 49 17.1 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1008 
10081831/ 
BNT162b2 (30 μg) 15 Male 167.64 70.91 25.2 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1008 
10081832/ 
BNT162b2 (30 μg) 15 Female 162.56 114.27 43.1 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1008 
10081833/ 
Placebo 13 Male 157.48 60 24.1 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1008 
10081834/ 
Placebo 13 Male 156.85 47.73 19.4 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1008 
10081835/ 
BNT162b2 (30 μg) 14 Male 161.93 49.27 18.8 Asian    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1008 
10081836/ 
Placebo 14 Female 169.55 65.75 22.8 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1008 
10081837/ 
Placebo 12 Male 147.32 40.82 18.8 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1008 
10081838/ 
BNT162b2 (30 μg) 15 Male 152.4 59 25.3 White    Non-Hispanic/non-
Latino 22DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 37
FDA-CBER-2022-5812-0224341
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1008 
10081839/ 
BNT162b2 (30 μg) 15 Female 164.47 64.09 23.6 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1008 
10081840/ 
Placebo 15 Female 166.37 59.09 21.3 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1008 
10081841/ 
BNT162b2 (30 μg) 14 Male 176.53 76.18 24.4 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1008 
10081842/ 
Placebo 12 Female 152.4 40.09 17.2 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1008 
10081843/ 
BNT162b2 (30 μg) 15 Male 185.42 73.64 21.4 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1008 
10081844/ 
Placebo 12 Male 168.91 59.55 20.8 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1008 
10081845/ 
Placebo 13 Female 160.02 50.91 19.8 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1008 
10081846/ 
BNT162b2 (30 μg) 15 Female 161.29 50.18 19.2 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1008 
10081847/ 
BNT162b2 (30 μg) 14 Female 161.93 91.09 34.7 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1008 
10081848/ 
BNT162b2 (30 μg) 13 Male 158.75 40.91 16.2 White    Non-Hispanic/non-
Latino 23DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 38
FDA-CBER-2022-5812-0224342
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1008 
10081849/ 
Placebo 12 Male 162.56 47 17.7 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1008 
10081850/ 
BNT162b2 (30 μg) 15 Female 153.67 48.18 20.4 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1008 
10081851/ 
Placebo 13 Female 165.1 53.82 19.7 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1008 
10081852/ 
Placebo 15 Male 193.04 100.73 27 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1008 
10081853/ 
Placebo 14 Female 168.28 57.45 20.2 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1008 
10081854/ 
BNT162b2 (30 μg) 15 Male 164.47 42.73 15.8 Asian  Other Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1008 
10081855/ 
BNT162b2 (30 μg) 14 Male 164.47 53.18 19.6 Asian  Other Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1008 
10081856/ 
Placebo 14 Female 157.48 53.55 21.5 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1008 
10081857/ 
BNT162b2 (30 μg) 13 Female 156.21 45.09 18.4 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1008 
10081858/ 
Placebo 15 Male 170.18 64.36 22.2 White    Non-Hispanic/non-
Latino 28DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 39
FDA-CBER-2022-5812-0224343
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1008 
10081859/ 
BNT162b2 (30 μg) 15 Female 168.91 68.18 23.8 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1008 
10081860/ 
BNT162b2 (30 μg) 14 Male 168.28 62 21.8 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1008 
10081861/ 
Placebo 14 Male 167.64 52.82 18.8 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1008 
10081862/ 
BNT162b2 (30 μg) 12 Female 168.28 54.09 19.1 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1008 
10081863/ 
Placebo 13 Female 160.02 42.82 16.7 Asian  Other Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1008 
10081864/ 
BNT162b2 (30 μg) 12 Female 148.59 34.73 15.7 Asian  Other Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1008 
10081865/ 
BNT162b2 (30 μg) 13 Female 163.2 55.73 20.9 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1008 
10081866/ 
Placebo 13 Male 156.21 51.55 21.1 White    Hispanic/Latino  29DEC2020 
C4591001 1008 
10081867/ 
Placebo 13 Female 160.02 50.64 19.7 White    Hispanic/Latino  29DEC2020 
C4591001 1008 
10081868/ 
BNT162b2 (30 μg) 15 Female 165.1 61.91 22.7 White    Non-Hispanic/non-
Latino 29DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 40
FDA-CBER-2022-5812-0224344
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1008 
10081869/ 
Placebo 14 Female 166.37 68.27 24.6 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1008 
10081870/ 
BNT162b2 (30 μg) 14 Male 157.48 58 23.3 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1008 
10081871/ 
Placebo 14 Female 180.34 77.64 23.8 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1008 
10081872/ 
Placebo 15 Male 173.99 50.55 16.7 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1008 
10081873/ 
BNT162b2 (30 μg) 13 Female 157.48 63.36 25.5 Black or African American    Hispanic/Latino  30DEC2020 
C4591001 1008 
10081874/ 
BNT162b2 (30 μg) 12 Male 165.1 78 28.6 White    Hispanic/Latino  30DEC2020 
C4591001 1008 
10081875/ 
Placebo 15 Female 170.18 59.36 20.5 White    Hispanic/Latino  30DEC2020 
C4591001 1008 
10081876/ 
BNT162b2 (30 μg) 12 Male 154.31 36.64 15.4 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1008 
10081877/ 
Placebo 14 Male 179.07 63 19.6 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1008 
10081878/ 
BNT162b2 (30 μg) 15 Female 168.28 62.73 22.1 White    Non-Hispanic/non-
Latino 30DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 41
FDA-CBER-2022-5812-0224345
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1008 
10081879/ 
Placebo 14 Male 161.93 76.18 29 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1008 
10081880/ 
Placebo 14 Female 163.83 48.73 18.1 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1008 
10081881/ 
Placebo 12 Female 167.64 49.55 17.6 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1008 
10081882/ 
BNT162b2 (30 μg) 15 Male 190.5 74.36 20.4 White    Non-Hispanic/non-
Latino 31DEC2020 
C4591001 1008 
10081883/ 
BNT162b2 (30 μg) 15 Female 172.09 68.45 23.1 White    Non-Hispanic/non-
Latino 31DEC2020 
C4591001 1008 
10081884/ 
Placebo 15 Female 161.29 106.41 40.8 White    Non-Hispanic/non-
Latino 31DEC2020 
C4591001 1008 
10081885/ 
BNT162b2 (30 μg) 14 Male 149.86 36.55 16.2 White    Hispanic/Latino  31DEC2020 
C4591001 1008 
10081886/ 
BNT162b2 (30 μg) 12 Female 144.78 29 13.8 White    Hispanic/Latino  31DEC2020 
C4591001 1008 
10081887/ 
Placebo 12 Female 165.1 43.91 16.1 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1008 
10081888/ 
Placebo 14 Male 174.63 59.91 19.6 White    Non-Hispanic/non-
Latino 04JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 42
FDA-CBER-2022-5812-0224346
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1008 
10081889/ 
BNT162b2 (30 μg) 14 Female 181.61 78.36 23.7 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1008 
10081890/ 
BNT162b2 (30 μg) 13 Male 182.88 90.91 27.1 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1008 
10081891/ 
Placebo 14 Male 165.74 56.27 20.4 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1008 
10081892/ 
Placebo 14 Male 163.2 70.45 26.4 American Indian or Alaska 
Native    Hispanic/Latino  04JAN2021 
C4591001 1008 
10081893/ 
BNT162b2 (30 μg) 14 Female 160.02 66.18 25.8 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1008 
10081894/ 
BNT162b2 (30 μg) 13 Female 172.72 56.27 18.8 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1008 
10081895/ 
BNT162b2 (30 μg) 14 Female 157.48 40.91 16.5 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1008 
10081896/ 
Placebo 15 Male 188.6 84.91 23.8 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1008 
10081897/ 
BNT162b2 (30 μg) 13 Female 160.02 44.45 17.3 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1008 
10081898/ 
Placebo 12 Female 160.02 56.09 21.9 White    Non-Hispanic/non-
Latino 05JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 43
FDA-CBER-2022-5812-0224347
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1008 
10081899/ 
Placebo 15 Female 167.64 68.36 24.3 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1008 
10081900/ 
BNT162b2 (30 μg) 13 Female 169.55 72.18 25.1 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1008 
10081901/ 
Placebo 15 Male 178.44 90.45 28.3 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1008 
10081902/ 
Placebo 14 Male 177.8 67.45 21.3 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1008 
10081903/ 
BNT162b2 (30 μg) 12 Male 147.32 38.64 17.8 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1008 
10081904/ 
Placebo 12 Male 168.28 82 28.9 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1008 
10081905/ 
BNT162b2 (30 μg) 15 Female 180.98 59.45 18.1 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1008 
10081906/ 
BNT162b2 (30 μg) 14 Female 158.75 58.64 23.2 Asian    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1008 
10081907/ 
Placebo 14 Female 157.48 59.09 23.8 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1008 
10081908/ 
BNT162b2 (30 μg) 12 Female 167.64 53.45 19 White    Non-Hispanic/non-
Latino 06JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 44
FDA-CBER-2022-5812-0224348
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1008 
10081909/ 
Placebo 14 Male 170.18 54.18 18.7 Asian    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1008 
10081910/ 
BNT162b2 (30 μg) 14 Male 171.45 54.91 18.6 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1008 
10081911/ 
Placebo 14 Male 154.94 47.73 19.8 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1008 
10081912/ 
BNT162b2 (30 μg) 12 Male 152.4 57.09 24.5 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1008 
10081913/ 
Placebo 13 Male 171.45 54.45 18.5 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1008 
10081914/ 
Placebo 14 Male 176.53 94.45 30.2 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1008 
10081915/ 
BNT162b2 (30 μg) 13 Female 149.86 57.64 25.6 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1008 
10081916/ 
BNT162b2 (30 μg) 15 Male 180.34 85.45 26.2 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1008 
10081917/ 
Placebo 13 Male 174.63 71.27 23.3 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1008 
10081918/ 
BNT162b2 (30 μg) 12 Female 147.32 39.36 18.1 White    Non-Hispanic/non-
Latino 07JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 45
FDA-CBER-2022-5812-0224349
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1008 
10081919/ 
Placebo 14 Female 160.66 52.82 20.4 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1008 
10081920/ 
BNT162b2 (30 μg) 13 Female 166.37 59.36 21.4 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1008 
10081921/ 
Placebo 15 Male 186.69 64.82 18.6 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1008 
10081922/ 
BNT162b2 (30 μg) 12 Male 151.13 46 20.1 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1008 
10081923/ 
Placebo 12 Female 162.56 42.09 15.9 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1008 
10081924/ 
Placebo 12 Female 160.02 41.27 16.1 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1008 
10081925/ 
BNT162b2 (30 μg) 13 Female 162.56 55.91 21.1 Black or African American    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1008 
10081926/ 
Placebo 14 Female 162.56 47.27 17.8 Asian  Other Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1008 
10081927/ 
BNT162b2 (30 μg) 14 Female 161.93 44.09 16.8 Asian  Other Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1008 
10081928/ 
BNT162b2 (30 μg) 13 Female 163.83 74.09 27.5 White    Non-Hispanic/non-
Latino 08JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 46
FDA-CBER-2022-5812-0224350
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1008 
10081929/ 
BNT162b2 (30 μg) 12 Female 151.13 41.55 18.1 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1008 
10081930/ 
Placebo 12 Female 160.02 42.09 16.4 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1008 
10081931/ 
Placebo 12 Male 157.48 55.5 22.3 Asian    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1008 
10081932/ 
Placebo 14 Female 157.48 52.09 21 Asian    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1008 
10081933/ 
Placebo 12 Male 165.1 49.36 18.1 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1008 
10081934/ 
BNT162b2 (30 μg) 13 Female 145.42 36.64 17.3 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1008 
10081935/ 
BNT162b2 (30 μg) 15 Male 167.64 72.73 25.8 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1008 
10081936/ 
Placebo 14 Male 165.1 54.09 19.8 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1008 
10081937/ 
BNT162b2 (30 μg) 13 Female 161.29 51.73 19.8 Asian  Other Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1008 
10081938/ 
Placebo 15 Female 171.45 69.18 23.5 White    Non-Hispanic/non-
Latino 11JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 47
FDA-CBER-2022-5812-0224351
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1008 
10081940/ 
BNT162b2 (30 μg) 14 Male 172.09 70.73 23.8 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1008 
10081941/ 
Placebo 12 Female 155.58 41 16.9 Asian    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1008 
10081942/ 
Placebo 15 Male 178.44 70.09 22 Asian    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1008 
10081943/ 
BNT162b2 (30 μg) 15 Male 180.34 63.45 19.5 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1009 
10091204/ 
Placebo 13 Male 171.45 51.18 17.4 White    Non-Hispanic/non-
Latino 15OCT2020 
C4591001 1009 
10091205/ 
BNT162b2 (30 μg) 15 Male 160.02 52.55 20.5 White    Non-Hispanic/non-
Latino 15OCT2020 
C4591001 1009 
10091208/ 
Placebo 15 Male 184.15 53.91 15.9 White    Non-Hispanic/non-
Latino 15OCT2020 
C4591001 1009 
10091209/ 
BNT162b2 (30 μg) 13 Female 149.86 43.27 19.2 White    Non-Hispanic/non-
Latino 15OCT2020 
C4591001 1009 
10091212/ 
Placebo 13 Female 151.13 41.73 18.2 White    Non-Hispanic/non-
Latino 16OCT2020 
C4591001 1009 
10091213/ 
Placebo 15 Male 179.07 58.55 18.2 White    Non-Hispanic/non-
Latino 16OCT2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 48
FDA-CBER-2022-5812-0224352
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1009 
10091216/ 
BNT162b2 (30 μg) 12 Female 160.02 56.18 21.9 White    Non-Hispanic/non-
Latino 16OCT2020 
C4591001 1009 
10091218/ 
BNT162b2 (30 μg) 13 Female 162.56 59.91 22.6 White    Non-Hispanic/non-
Latino 16OCT2020 
C4591001 1009 
10091220/ 
Placebo 15 Male 179.58 53.18 16.5 White    Non-Hispanic/non-
Latino 19OCT2020 
C4591001 1009 
10091221/ 
BNT162b2 (30 μg) 14 Female 162.56 47.73 18 White    Non-Hispanic/non-
Latino 19OCT2020 
C4591001 1009 
10091223/ 
BNT162b2 (30 μg) 14 Male 161.29 70.91 27.2 White    Non-Hispanic/non-
Latino 19OCT2020 
C4591001 1009 
10091226/ 
Placebo 15 Male 172.72 73.64 24.6 White    Non-Hispanic/non-
Latino 20OCT2020 
C4591001 1009 
10091227/ 
BNT162b2 (30 μg) 15 Male 172.72 58.18 19.5 White    Non-Hispanic/non-
Latino 20OCT2020 
C4591001 1009 
10091229/ 
Placebo 12 Female 166.37 57 20.5 White    Non-Hispanic/non-
Latino 20OCT2020 
C4591001 1009 
10091231/ 
BNT162b2 (30 μg) 15 Male 167.64 57.82 20.5 Asian    Non-Hispanic/non-
Latino 20OCT2020 
C4591001 1009 
10091233/ 
Placebo 12 Male 151.13 34.09 14.9 White    Non-Hispanic/non-
Latino 21OCT2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 49
FDA-CBER-2022-5812-0224353
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1009 
10091234/ 
BNT162b2 (30 μg) 13 Male 162.56 50.64 19.1 White    Hispanic/Latino  21OCT2020 
C4591001 1009 
10091237/ 
Placebo 14 Female 157.48 60.36 24.3 White    Non-Hispanic/non-
Latino 21OCT2020 
C4591001 1009 
10091238/ 
Placebo 15 Male 180.34 65.91 20.2 White    Non-Hispanic/non-
Latino 21OCT2020 
C4591001 1009 
10091240/ 
BNT162b2 (30 μg) 13 Male 162.56 68.64 25.9 White    Non-Hispanic/non-
Latino 21OCT2020 
C4591001 1009 
10091246/ 
Placebo 13 Male 157.48 35 14.1 White    Non-Hispanic/non-
Latino 22OCT2020 
C4591001 1009 
10091247/ 
BNT162b2 (30 μg) 12 Male 170.18 70.18 24.2 White    Non-Hispanic/non-
Latino 22OCT2020 
C4591001 1009 
10091249/ 
Placebo 15 Female 158.75 70.91 28.1 White    Non-Hispanic/non-
Latino 22OCT2020 
C4591001 1009 
10091250/ 
BNT162b2 (30 μg) 13 Female 161.29 54.09 20.7 White    Non-Hispanic/non-
Latino 22OCT2020 
C4591001 1009 
10091265/ 
BNT162b2 (30 μg) 14 Male 181.61 119.27 36.1 White    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1009 
10091266/ 
Placebo 15 Female 165.1 77.55 28.4 White    Non-Hispanic/non-
Latino 01DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 50
FDA-CBER-2022-5812-0224354
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1009 
10091267/ 
Placebo 13 Male 144.78 49.82 23.7 White    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1009 
10091269/ 
BNT162b2 (30 μg) 15 Male 172.72 55.36 18.5 White    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1009 
10091270/ 
BNT162b2 (30 μg) 12 Male 157.48 49.55 19.9 White    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1009 
10091272/ 
BNT162b2 (30 μg) 12 Male 160.02 43.18 16.8 White    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1009 
10091273/ 
Placebo 15 Male 167.64 40.36 14.3 White    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1009 
10091274/ 
Placebo 12 Male 152.4 41.82 18 White    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1009 
10091275/ 
Placebo 15 Male 180.34 63.73 19.6 White    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1009 
10091277/ 
Placebo 13 Male 166.37 82.27 29.7 White    Hispanic/Latino  03DEC2020 
C4591001 1009 
10091280/ 
BNT162b2 (30 μg) 12 Female 157.48 40.55 16.3 White    Non-Hispanic/non-
Latino 03DEC2020 
C4591001 1009 
10091281/ 
BNT162b2 (30 μg) 14 Male 163.83 42.73 15.9 White    Non-Hispanic/non-
Latino 03DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 51
FDA-CBER-2022-5812-0224355
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1009 
10091282/ 
Placebo 14 Male 180.34 65.45 20.1 White    Non-Hispanic/non-
Latino 03DEC2020 
C4591001 1009 
10091283/ 
Placebo 13 Female 166.37 55.27 19.9 White    Non-Hispanic/non-
Latino 03DEC2020 
C4591001 1009 
10091284/ 
BNT162b2 (30 μg) 15 Male 179.07 58.55 18.2 White    Non-Hispanic/non-
Latino 03DEC2020 
C4591001 1009 
10091287/ 
BNT162b2 (30 μg) 15 Female 172.72 47.27 15.8 White    Non-Hispanic/non-
Latino 04DEC2020 
C4591001 1009 
10091288/ 
BNT162b2 (30 μg) 13 Male 162.56 49.09 18.5 White    Non-Hispanic/non-
Latino 04DEC2020 
C4591001 1009 
10091289/ 
BNT162b2 (30 μg) 13 Female 165.1 60.45 22.1 White    Non-Hispanic/non-
Latino 04DEC2020 
C4591001 1009 
10091292/ 
Placebo 15 Male 175.26 62.55 20.3 White    Non-Hispanic/non-
Latino 04DEC2020 
C4591001 1009 
10091293/ 
Placebo 14 Male 158.12 45.55 18.2 White    Non-Hispanic/non-
Latino 04DEC2020 
C4591001 1009 
10091294/ 
Placebo 15 Female 170.18 51.55 17.8 White    Hispanic/Latino  07DEC2020 
C4591001 1009 
10091295/ 
BNT162b2 (30 μg) 12 Female 144.78 28.73 13.7 White    Non-Hispanic/non-
Latino 07DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 52
FDA-CBER-2022-5812-0224356
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1009 
10091296/ 
Placebo 14 Male 171.45 58.73 19.9 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1009 
10091297/ 
BNT162b2 (30 μg) 14 Male 157.48 51.82 20.8 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1009 
10091298/ 
BNT162b2 (30 μg) 14 Male 170.18 66.91 23.1 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1009 
10091300/ 
BNT162b2 (30 μg) 13 Male 163.32 55.36 20.7 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1009 
10091301/ 
Placebo 15 Female 165.74 58.64 21.3 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1009 
10091303/ 
Placebo 13 Female 162.56 48.55 18.3 White    Hispanic/Latino  08DEC2020 
C4591001 1009 
10091304/ 
BNT162b2 (30 μg) 13 Male 165.74 53.36 19.4 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1009 
10091305/ 
Placebo 15 Female 170.18 61.27 21.1 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1009 
10091306/ 
Placebo 14 Female 170.18 62.82 21.6 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1009 
10091307/ 
BNT162b2 (30 μg) 15 Female 165.1 97 35.5 White    Non-Hispanic/non-
Latino 09DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 53
FDA-CBER-2022-5812-0224357
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1009 
10091308/ 
Placebo 13 Male 166.37 43.36 15.6 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1009 
10091309/ 
BNT162b2 (30 μg) 13 Male 160.02 52.45 20.4 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1009 
10091310/ 
BNT162b2 (30 μg) 15 Female 162.56 61.64 23.3 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1009 
10091311/ 
Placebo 13 Male 168.91 34.18 12 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1009 
10091312/ 
Placebo 12 Male 157.48 45.91 18.5 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1009 
10091313/ 
BNT162b2 (30 μg) 15 Male 172.72 73.91 24.7 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1009 
10091314/ 
Placebo 15 Male 180.34 60.64 18.6 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1009 
10091315/ 
BNT162b2 (30 μg) 13 Male 180.34 63.36 19.4 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1009 
10091316/ 
Placebo 15 Male 177.8 66.82 21.1 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1009 
10091317/ 
Placebo 13 Female 153.67 67.45 28.5 White    Non-Hispanic/non-
Latino 10DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 54
FDA-CBER-2022-5812-0224358
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1009 
10091318/ 
BNT162b2 (30 μg) 14 Female 170.18 52 17.9 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1009 
10091319/ 
BNT162b2 (30 μg) 15 Male 175.9 52.55 16.9 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1009 
10091320/ 
Placebo 14 Male 168.91 61.18 21.4 White    Hispanic/Latino  10DEC2020 
C4591001 1009 
10091321/ 
BNT162b2 (30 μg) 12 Female 161.29 48.18 18.5 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1009 
10091322/ 
BNT162b2 (30 μg) 12 Male 154.94 42.36 17.6 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1009 
10091323/ 
Placebo 15 Female 166.37 61.64 22.2 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1009 
10091324/ 
Placebo 15 Female 177.8 71.73 22.6 White    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1009 
10091325/ 
BNT162b2 (30 μg) 12 Male 161.29 42.27 16.2 White    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1009 
10091326/ 
Placebo 12 Female 167.64 47.64 16.9 White    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1009 
10091328/ 
BNT162b2 (30 μg) 13 Female 149.86 44 19.5 White    Non-Hispanic/non-
Latino 11DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 55
FDA-CBER-2022-5812-0224359
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1009 
10091329/ 
Placebo 13 Female 154.94 57.82 24 White    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1009 
10091330/ 
Placebo 13 Female 154.94 49.09 20.4 White    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1009 
10091331/ 
BNT162b2 (30 μg) 13 Female 167.64 61.91 22 White    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1009 
10091332/ 
BNT162b2 (30 μg) 15 Female 181.61 84.45 25.5 White    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1009 
10091333/ 
BNT162b2 (30 μg) 14 Male 175.26 71.73 23.3 White    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1009 
10091334/ 
Placebo 13 Female 149.86 47.18 21 White    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1009 
10091335/ 
BNT162b2 (30 μg) 15 Female 169.55 59.09 20.5 White    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1009 
10091336/ 
Placebo 13 Male 158.24 49.09 19.6 White    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1009 
10091337/ 
Placebo 12 Male 158.75 45.64 18.1 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1009 
10091338/ 
Placebo 15 Female 171.45 52 17.7 White    Non-Hispanic/non-
Latino 14DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 56
FDA-CBER-2022-5812-0224360
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1009 
10091339/ 
BNT162b2 (30 μg) 14 Female 166.37 56.82 20.5 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1009 
10091340/ 
BNT162b2 (30 μg) 15 Female 165.1 107.36 39.3 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1009 
10091341/ 
Placebo 13 Male 153.67 38 16.1 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1009 
10091342/ 
BNT162b2 (30 μg) 15 Male 175.26 61.64 20 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1009 
10091343/ 
BNT162b2 (30 μg) 13 Female 142.24 40.45 20 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1009 
10091344/ 
Placebo 15 Male 175.26 65.91 21.4 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1009 
10091345/ 
BNT162b2 (30 μg) 12 Male 153.67 58 24.5 Multiracial    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1009 
10091346/ 
Place bo 15 Male 172.72 79.55 26.6 Multiracial    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1009 
10091347/ 
Placebo 13 Female 160.02 51.45 20.1 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1009 
10091348/ 
BNT162b2 (30 μg) 14 Female 162.56 59.18 22.3 White    Non-Hispanic/non-
Latino 15DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 57
FDA-CBER-2022-5812-0224361
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1009 
10091349/ 
Placebo 15 Female 160.02 56.73 22.1 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1009 
10091350/ 
Placebo 14 Female 160.02 71.27 27.8 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1009 
10091351/ 
BNT162b2 (30 μg) 12 Female 154.94 40.82 17 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1009 
10091353/ 
BNT162b2 (30 μg) 12 Female 149.86 46.36 20.6 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1009 
10091354/ 
BNT162b2 (30 μg) 14 Female 167.64 54.45 19.3 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1009 
10091355/ 
BNT162b2 (30 μg) 12 Male 151.13 40.36 17.6 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1009 
10091356/ 
Placebo 13 Female 165.61 41.64 15.1 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1009 
10091357/ 
Placebo 15 Male 187.96 101.36 28.6 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1009 
10091358/ 
BNT162b2 (30 μg) 14 Female 158.75 44.55 17.6 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1009 
10091359/ 
Placebo 13 Male 156.97 54.64 22.1 White    Non-Hispanic/non-
Latino 17DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 58
FDA-CBER-2022-5812-0224362
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1009 
10091360/ 
BNT162b2 (30 μg) 15 Female 156.21 67 27.4 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1009 
10091361/ 
Placebo 13 Female 165.1 62.91 23 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1009 
10091362/ 
BNT162b2 (30 μg) 12 Male 172.72 53.27 17.8 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1009 
10091363/ 
Placebo 14 Male 185.42 62.36 18.1 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1009 
10091364/ 
BNT162b2 (30 μg) 12 Female 162.56 83.09 31.4 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1009 
10091365/ 
Placebo 12 Male 167.64 60.18 21.4 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1009 
10091366/ 
Placebo 14 Female 170.82 72.18 24.7 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1009 
10091369/ 
Placebo 12 Female 167.64 52 18.5 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1009 
10091370/ 
BNT162b2 (30 μg) 13 Female 168.91 48.27 16.9 White    Hispanic/Latino  18DEC2020 
C4591001 1009 
10091371/ 
BNT162b2 (30 μg) 13 Male 167.64 61.45 21.8 White    Non-Hispanic/non-
Latino 18DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 59
FDA-CBER-2022-5812-0224363
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1009 
10091372/ 
BNT162b2 (30 μg) 13 Male 167.64 64.73 23 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1009 
10091373/ 
Placebo 14 Female 154.94 52.82 22 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1009 
10091374/ 
Placebo 15 Male 153.67 60.55 25.6 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1009 
10091375/ 
BNT162b2 (30 μg) 13 Female 166.37 60.36 21.8 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1009 
10091376/ 
BNT162b2 (30 μg) 12 Male 168.91 90.45 31.6 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1009 
10091377/ 
BNT162b2 (30 μg) 12 Male 160.02 47.82 18.6 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1009 
10091378/ 
Placebo 14 Female 162.56 49.55 18.7 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1009 
10091379/ 
Placebo 13 Female 157.48 42.64 17.2 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1009 
10091380/ 
Placebo 14 Male 172.72 60.09 20.1 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1009 
10091381/ 
BNT162b2 (30 μg) 12 Female 151.13 39.36 17.2 White    Non-Hispanic/non-
Latino 31DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 60
FDA-CBER-2022-5812-0224364
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1009 
10091382/ 
Placebo 14 Female 160.02 71 27.7 White    Hispanic/Latino  04JAN2021 
C4591001 1009 
10091383/ 
BNT162b2 (30 μg) 15 Male 163.83 53.73 20 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1009 
10091384/ 
Placebo 15 Female 167.64 51.73 18.4 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1009 
10091385/ 
Placebo 14 Male 158.24 70.27 28 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1009 
10091386/ 
BNT162b2 (30 μg) 14 Male 166.37 51.55 18.6 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1009 
10091387/ 
BNT162b2 (30 μg) 12 Male 173.99 57.64 19 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1009 
10091388/ 
Placebo 13 Male 149.86 43 19.1 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1009 
10091389/ 
BNT162b2 (30 μg) 15 Male 165.1 58.73 21.5 White    Hispanic/Latino  06JAN2021 
C4591001 1009 
10091390/ 
Placebo 14 Female 162.56 56.55 21.4 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1009 
10091391/ 
BNT162b2 (30 μg) 14 Male 170.18 52 17.9 White    Non-Hispanic/non-
Latino 07JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 61
FDA-CBER-2022-5812-0224365
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1009 
10091392/ 
Placebo 12 Female 156.21 50.82 20.8 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1009 
10091393/ 
BNT162b2 (30 μg) 14 Male 171.45 59.45 20.2 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1009 
10091394/ 
BNT162b2 (30 μg) 15 Male 170.18 58.45 20.1 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1009 
10091395/ 
Placebo 13 Male 161.29 46.27 17.7 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1009 
10091396/ 
BNT162b2 (30 μg) 15 Male 167.64 55.73 19.8 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1009 
10091398/ 
BNT162b2 (30 μg) 15 Female 160.02 48.45 18.9 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1009 
10091399/ 
Placebo 12 Female 152.4 38.86 16.7 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1009 
10091400/ 
Placebo 12 Male 154.31 41.64 17.4 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1009 
10091401/ 
Placebo 12 Male 151.13 40.18 17.6 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1009 
10091402/ 
BNT162b2 (30 μg) 14 Female 157.48 42.36 17 White    Hispanic/Latino  08JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 62
FDA-CBER-2022-5812-0224366
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1009 
10091403/ 
Placebo 15 Female 179.07 102.55 31.9 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1009 
10091404/ 
BNT162b2 (30 μg) 12 Female 149.86 40.32 17.9 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1009 
10091405/ 
Placebo 15 Female 160.02 50 19.5 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1009 
10091406/ 
Placebo 15 Male 173.99 53.18 17.5 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1009 
10091407/ 
BNT162b2 (30 μg) 13 Female 167.64 50.64 18 Asian  Other Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1009 
10091408/ 
BNT162b2 (30 μg) 13 Female 166.37 42.45 15.3 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1009 
10091409/ 
BNT162b2 (30 μg) 14 Female 172.72 50 16.7 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1009 
10091410/ 
BNT162b2 (30 μg) 12 Female 161.29 45.36 17.4 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1009 
10091411/ 
Placebo 15 Male 171.45 50.82 17.3 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1009 
10091412/ 
Placebo 15 Male 165.1 52.27 19.1 White    Non-Hispanic/non-
Latino 12JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 63
FDA-CBER-2022-5812-0224367
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1009 
10091413/ 
BNT162b2 (30 μg) 13 Female 156.21 50.91 20.8 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1009 
10091414/ 
BNT162b2 (30 μg) 14 Female 176.53 61.91 19.8 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1013 
10131821/ 
BNT162b2 (30 μg) 14 Male 164.7 74.8 27.6 Black or African American    Non-Hispanic/non-
Latino 30NOV2020 
C4591001 1013 
10131822/ 
BNT162b2 (30 μg) 15 Female 160 54.8 21.4 Black or African American    Non-Hispanic/non-
Latino 30NOV2020 
C4591001 1013 
10131823/ 
Placebo 15 Female 160 118.2 46.2 Black or African American    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1013 
10131824/ 
BNT162b2 (30 μg) 14 Female 157.5 54.5 22 Black or African American    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1013 
10131826/ 
Placebo 14 Male 167.6 56.2 20 White    Hispanic/Latino  01DEC2020 
C4591001 1013 
10131828/ 
BNT162b2 (30 μg) 14 Male 162.5 47 17.8 White    Hispanic/Latino  02DEC2020 
C4591001 1013 
10131830/ 
Placebo 14 Female 172.1 57.2 19.3 White    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1013 
10131835/ 
Placebo 14 Female 161.5 50.7 19.4 Black or African American    Non-Hispanic/non-
Latino 02DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 64
FDA-CBER-2022-5812-0224368
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1013 
10131836/ 
BNT162b2 (30 μg) 12 Female 154 77.7 32.8 Black or African American    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1013 
10131839/ 
Placebo 14 Female 167.6 53.35 19 White    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1013 
10131841/ 
BNT162b2 (30 μg) 13 Female 163 64.4 24.2 Black or African American    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1013 
10131842/ 
Placebo 15 Female 157.5 51.9 20.9 Black or African American    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1013 
10131843/ 
BNT162b2 (30 μg) 14 Male 179.1 72 22.4 Black or African American    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1013 
10131844/ 
Placebo 13 Male 164 69.15 25.7 Black or African American    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1013 
10131845/ 
BNT162b2 (30 μg) 12 Female 157.4 55.3 22.3 White    Non-Hispanic/non-
Latino 03DEC2020 
C4591001 1013 
10131846/ 
BNT162b2 (30 μg) 15 Male 178.4 76.9 24.2 White    Non-Hispanic/non-
Latino 03DEC2020 
C4591001 1013 
10131848/ 
Placebo 12 Male 175.2 55 17.9 White    Non-Hispanic/non-
Latino 03DEC2020 
C4591001 1013 
10131850/ 
BNT162b2 (30 μg) 15 Female 170.1 75.8 26.2 White    Non-Hispanic/non-
Latino 03DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 65
FDA-CBER-2022-5812-0224369
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1013 
10131851/ 
Placebo 15 Female 164 58.6 21.8 Multiracial    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1013 
10131852/ 
Placebo 14 Female 162.5 52.6 19.9 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1013 
10131855/ 
BNT162b2 (30 μg) 14 Male 162 52.05 19.8 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1013 
10131856/ 
BNT162b2 (30 μg) 15 Male 180.5 71.05 21.8 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1013 
10131858/ 
Placebo 13 Female 154.3 40.8 17.1 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1013 
10131859/ 
BNT162b2 (30 μg) 15 Male 171.1 50.5 17.3 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1013 
10131860/ 
Placebo 13 Male 171.5 72.6 24.7 White    Hispanic/Latino  09DEC2020 
C4591001 1013 
10131861/ 
Placebo 12 Male 153.4 39.6 16.8 Black or African American    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1013 
10131862/ 
BNT162b2 (30 μg) 13 Female 162.5 68 25.8 White    Hispanic/Latino  10DEC2020 
C4591001 1013 
10131863/ 
Placebo 14 Female 164.8 48.5 17.9 White    Non-Hispanic/non-
Latino 10DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 66
FDA-CBER-2022-5812-0224370
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1013 
10131865/ 
BNT162b2 (30 μg) 13 Male 175.6 93.2 30.2 White    Hispanic/Latino  14DEC2020 
C4591001 1013 
10131866/ 
BNT162b2 (30 μg) 15 Male 175.3 86.2 28.1 White    Hispanic/Latino  14DEC2020 
C4591001 1013 
10131867/ 
Placebo 12 Male 152.4 40.8 17.6 Black or African American    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1013 
10131868/ 
Placebo 13 Female 166 53.9 19.6 Multiracial  Other Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1013 
10131869/ 
Placebo 14 Male 162 45.8 17.5 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1013 
10131870/ 
Placebo 15 Male 171 64.3 22 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1013 
10131871/ 
BNT162b2 (30 μg) 13 Male 161.6 47.6 18.2 Multiracial    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1013 
10131872/ 
BNT162b2 (30 μg) 12 Male 154.9 38.2 15.9 Multiracial    Hispanic/Latino  21DEC2020 
C4591001 1013 
10131873/ 
BNT162b2 (30 μg) 13 Female 154 71 29.9 Asian  Other Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1013 
10131874/ 
Placebo 12 Male 165 72 26.4 Asian  Other Non-Hispanic/non-
Latino 22DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 67
FDA-CBER-2022-5812-0224371
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1013 
10131875/ 
Placebo 14 Male 160 49.8 19.5 Multiracial  Other Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1013 
10131876/ 
BNT162b2 (30 μg) 15 Female 155 44.6 18.6 Asian  Other Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1013 
10131877/ 
BNT162b2 (30 μg) 13 Male 162 65.15 24.8 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1013 
10131878/ 
Placebo 12 Male 149.9 46 20.5 White    Hispanic/Latino  23DEC2020 
C4591001 1013 
10131879/ 
Placebo 15 Male 178.3 54.7 17.2 White    Hispanic/Latino  23DEC2020 
C4591001 1013 
10131880/ 
BNT162b2 (30 μg) 14 Male 164.2 75.2 27.9 White    Hispanic/Latino  23DEC2020 
C4591001 1013 
10131881/ 
BNT162b2 (30 μg) 14 Male 170.4 53.8 18.5 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1013 
10131882/ 
Placebo 15 Male 184 73.7 21.8 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1013 
10131883/ 
Placebo 14 Female 157.7 40.5 16.3 White    Non-Hispanic/non-
Latino 31DEC2020 
C4591001 1013 
10131884/ 
BNT162b2 (30 μg) 14 Female 160 50 19.5 Asian  Other Non-Hispanic/non-
Latino 07JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 68
FDA-CBER-2022-5812-0224372
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1013 
10131885/ 
Placebo 14 Female 160 43.9 17.1 White    Hispanic/Latino  07JAN2021 
C4591001 1013 
10131886/ 
Placebo 12 Male 158.3 49.6 19.8 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1016 
10161307/ 
Placebo 13 Female 160.02 128.64 50.1 Black or African American    Non-Hispanic/non-
Latino 15OCT2020 
C4591001 1016 
10161308/ 
Placebo 13 Male 175.26 51.91 16.9 White    Non-Hispanic/non-
Latino 15OCT2020 
C4591001 1016 
10161309/ 
BNT162b2 (30 μg) 14 Male 179.07 60.91 19 White    Non-Hispanic/non-
Latino 15OCT2020 
C4591001 1016 
10161310/ 
BNT162b2 (30 μg) 13 Male 165.1 60.82 22.3 White    Non-Hispanic/non-
Latino 15OCT2020 
C4591001 1016 
10161311/ 
BNT162b2 (30 μg) 15 Male 168.91 87.73 30.7 White    Hispanic/Latino  15OCT2020 
C4591001 1016 
10161314/ 
BNT162b2 (30 μg) 13 Female 152.4 52.18 22.4 White    Non-Hispanic/non-
Latino 16OCT2020 
C4591001 1016 
10161315/ 
Placebo 14 Female 158.75 57.05 22.6 White    Non-Hispanic/non-
Latino 16OCT2020 
C4591001 1016 
10161316/ 
Placebo 15 Male 175.77 70 22.6 White    Non-Hispanic/non-
Latino 16OCT2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 69
FDA-CBER-2022-5812-0224373
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1016 
10161318/ 
Placebo 14 Male 161.29 71 27.2 White    Non-Hispanic/non-
Latino 16OCT2020 
C4591001 1016 
10161319/ 
Placebo 12 Female 159.51 111.18 43.6 White    Hispanic/Latino  16OCT2020 
C4591001 1016 
10161320/ 
BNT162b2 (30 μg) 14 Male 168.91 68.18 23.8 White    Non-Hispanic/non-
Latino 19OCT2020 
C4591001 1016 
10161322/ 
BNT162b2 (30 μg) 14 Female 160.02 65.45 25.5 White    Hispanic/Latino  19OCT2020 
C4591001 1016 
10161323/ 
BNT162b2 (30 μg) 13 Female 165.1 67.82 24.8 Black or African American    Non-Hispanic/non-
Latino 19OCT2020 
C4591001 1016 
10161324/ 
Placebo 15 Female 165.1 64.55 23.6 Black or African American    Non-Hispanic/non-
Latino 19OCT2020 
C4591001 1016 
10161325/ 
BNT162b2 (30 μg) 14 Female 170.18 79.55 27.4 White    Non-Hispanic/non-
Latino 19OCT2020 
C4591001 1016 
10161326/ 
BNT162b2 (30 μg) 14 Male 175.26 68.45 22.2 White    Non-Hispanic/non-
Latino 20OCT2020 
C4591001 1016 
10161327/ 
Placebo 12 Male 170.18 52.73 18.2 White    Non-Hispanic/non-
Latino 20OCT2020 
C4591001 1016 
10161329/ 
Placebo 14 Male 176.53 108.18 34.6 White    Non-Hispanic/non-
Latino 20OCT2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 70
FDA-CBER-2022-5812-0224374
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1016 
10161330/ 
BNT162b2 (30 μg) 13 Female 155.45 45.95 19 White    Non-Hispanic/non-
Latino 20OCT2020 
C4591001 1016 
10161331/ 
Placebo 12 Female 161.29 65.27 25 White    Non-Hispanic/non-
Latino 20OCT2020 
C4591001 1016 
10161332/ 
BNT162b2 (30 μg) 14 Male 162.56 68.64 25.9 Black or African American    Non-Hispanic/non-
Latino 21OCT2020 
C4591001 1016 
10161334/ 
Placebo 14 Female 177.8 78.73 24.8 White    Non-Hispanic/non-
Latino 21OCT2020 
C4591001 1016 
10161335/ 
BNT162b2 (30 μg) 13 Female 170.18 101.73 35 White    Non-Hispanic/non-
Latino 21OCT2020 
C4591001 1016 
10161336/ 
Placebo 15 Female 161.29 56 21.5 White    Non-Hispanic/non-
Latino 21OCT2020 
C4591001 1016 
10161337/ 
Placebo 15 Female 162.56 53.91 20.4 White    Non-Hispanic/non-
Latino 21OCT2020 
C4591001 1016 
10161338/ 
BNT162b2 (30 μg) 12 Male 162.56 45 17 Black or African American    Non-Hispanic/non-
Latino 22OCT2020 
C4591001 1016 
10161339/ 
BNT162b2 (30 μg) 13 Male 160.02 49.09 19.1 White    Non-Hispanic/non-
Latino 22OCT2020 
C4591001 1016 
10161340/ 
Placebo 12 Male 163.83 84.64 31.5 White    Non-Hispanic/non-
Latino 22OCT2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 71
FDA-CBER-2022-5812-0224375
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1016 
10161343/ 
BNT162b2 (30 μg) 14 Male 173.99 79.55 26.2 White    Non-Hispanic/non-
Latino 22OCT2020 
C4591001 1016 
10161344/ 
Placebo 15 Female 152.4 51.36 22.1 White    Non-Hispanic/non-
Latino 22OCT2020 
C4591001 1016 
10161350/ 
BNT162b2 (30 μg) 14 Male 170.18 53.18 18.3 White    Non-Hispanic/non-
Latino 30NOV2020 
C4591001 1016 
10161351/ 
Placebo 14 Female 162.05 55.82 21.2 White    Non-Hispanic/non-
Latino 30NOV2020 
C4591001 1016 
10161352/ 
Placebo 15 Female 155.7 44.82 18.4 White    Non-Hispanic/non-
Latino 30NOV2020 
C4591001 1016 
10161353/ 
Placebo 13 Female 147.32 33.45 15.4 White    Non-Hispanic/non-
Latino 30NOV2020 
C4591001 1016 
10161354/ 
BNT162b2 (30 μg) 14 Female 171.45 56.36 19.1 White    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1016 
10161356/ 
BNT162b2 (30 μg) 13 Male 163.83 55.82 20.8 White    Hispanic/Latino  02DEC2020 
C4591001 1016 
10161357/ 
BNT162b2 (30 μg) 12 Male 172.72 62.27 20.8 White    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1016 
10161358/ 
Placebo 13 Male 172.72 56.27 18.8 White    Non-Hispanic/non-
Latino 03DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 72
FDA-CBER-2022-5812-0224376
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1016 
10161361/ 
Placebo 13 Male 167.64 48.91 17.4 White    Non-Hispanic/non-
Latino 04DEC2020 
C4591001 1016 
10161362/ 
BNT162b2 (30 μg) 12 Male 148.59 30.91 14 Black or African American    Non-Hispanic/non-
Latino 04DEC2020 
C4591001 1016 
10161363/ 
BNT162b2 (30 μg) 15 Female 162.56 59.64 22.5 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1016 
10161364/ 
BNT162b2 (30 μg) 15 Female 158.75 46.36 18.4 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1016 
10161365/ 
Placebo 13 Female 163.83 76.55 28.5 Multiracial    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1016 
10161366/ 
Placebo 12 Male 162.56 65.82 24.9 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1016 
10161367/ 
Placebo 12 Female 165.1 87.36 32 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1016 
10161368/ 
Placebo 12 Female 148.08 35 15.9 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1016 
10161369/ 
BNT162b2 (30 μg) 12 Female 140.97 37.55 18.9 White    Hispanic/Latino  30DEC2020 
C4591001 1016 
10161370/ 
BNT162b2 (30 μg) 15 Male 173.99 63.18 20.8 Multiracial    Non-Hispanic/non-
Latino 04JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 73
FDA-CBER-2022-5812-0224377
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1016 
10161371/ 
Placebo 12 Female 167.64 55.45 19.7 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1016 
10161372/ 
Placebo 14 Female 162.56 75.64 28.6 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1016 
10161373/ 
BNT162b2 (30 μg) 14 Female 160.02 75.09 29.3 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1016 
10161374/ 
BNT162b2 (30 μg) 13 Female 160.02 49.45 19.3 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1016 
10161375/ 
Placebo 14 Female 165.1 46.73 17.1 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1016 
10161376/ 
BNT162b2 (30 μg) 15 Female 168.91 70.36 24.6 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1016 
10161377/ 
BNT162b2 (30 μg) 13 Female 163.83 55.36 20.6 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1016 
10161378/ 
Placebo 12 Male 153.16 37.27 15.9 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1016 
10161379/ 
Placebo 13 Male 176.53 77.73 24.9 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1016 
10161381/ 
BNT162b2 (30 μg) 15 Male 184.91 70.09 20.5 White    Non-Hispanic/non-
Latino 08JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 74
FDA-CBER-2022-5812-0224378
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1016 
10161382/ 
BNT162b2 (30 μg) 12 Male 172.72 62.18 20.8 Asian  Other Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1016 
10161383/ 
Placebo 12 Male 175.26 71 23.1 Asian  Other Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1016 
10161384/ 
BNT162b2 (30 μg) 13 Female 172.72 57 19.1 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1016 
10161385/ 
Placebo 14 Male 177.29 53.64 17 Black or African American    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1016 
10161386/ 
Placebo 13 Female 152.4 36.82 15.8 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1016 
10161387/ 
BNT162b2 (30 μg) 14 Female 170.18 89.55 30.9 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1016 
10161388/ 
Placebo 15 Female 166.37 80.82 29.1 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1039 
10391246/ 
Placebo 15 Male 183.5 71.8 21.3 White    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1039 
10391247/ 
BNT162b2 (30 μg) 12 Male 149 33.6 15.1 White    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1039 
10391250/ 
BNT162b2 (30 μg) 14 Female 167.5 60.6 21.6 White    Non-Hispanic/non-
Latino 04DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 75
FDA-CBER-2022-5812-0224379
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1039 
10391251/ 
Placebo 15 Female 165.6 53.5 19.5 Asian    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1039 
10391252/ 
Placebo 15 Male 180.1 87.2 26.9 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1039 
10391253/ 
BNT162b2 (30 μg) 12 Female 159.5 68.6 27 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1039 
10391255/ 
BNT162b2 (30 μg) 12 Male 174.1 73.6 24.3 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1039 
10391256/ 
Placebo 12 Male 167.5 51.6 18.4 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1039 
10391258/ 
Placebo 13 Female 167.5 75.8 27 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1039 
10391259/ 
Placebo 13 Male 168 77.5 27.5 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1039 
10391260/ 
BNT162b2 (30 μg) 14 Male 169.5 64.1 22.3 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1039 
10391262/ 
BNT162b2 (30 μg) 14 Female 158 51.3 20.5 White    Hispanic/Latino  08DEC2020 
C4591001 1039 
10391263/ 
BNT162b2 (30 μg) 13 Male 177.4 69.8 22.2 White    Non-Hispanic/non-
Latino 08DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 76
FDA-CBER-2022-5812-0224380
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1039 
10391264/ 
Placebo 12 Female 158.5 43.8 17.4 Asian    Hispanic/Latino  08DEC2020 
C4591001 1039 
10391265/ 
BNT162b2 (30 μg) 12 Male 152.7 40.4 17.3 Asian    Hispanic/Latino  08DEC2020 
C4591001 1039 
10391266/ 
Placebo 12 Male 158 39.1 15.7 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1039 
10391267/ 
BNT162b2 (30 μg) 15 Female 164.3 53.1 19.7 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1039 
10391268/ 
Placebo 13 Female 160 47.1 18.4 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1039 
10391269/ 
BNT162b2 (30 μg) 12 Male 162.1 45 17.1 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1039 
10391270/ 
Placebo 13 Female 166.6 58.1 20.9 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1039 
10391271/ 
Placebo 14 Female 169 63.6 22.3 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1039 
10391272/ 
BNT162b2 (30 μg) 12 Male 165.5 43.7 16 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1039 
10391273/ 
Placebo 12 Female 165.5 45.2 16.5 White    Non-Hispanic/non-
Latino 09DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 77
FDA-CBER-2022-5812-0224381
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1039 
10391274/ 
Placebo 13 Male 165.5 48.5 17.7 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1039 
10391275/ 
BNT162b2 (30 μg) 12 Male 160 40.4 15.8 White    Hispanic/Latino  16DEC2020 
C4591001 1039 
10391276/ 
BNT162b2 (30 μg) 13 Male 174 82 27.1 Asian  Other Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1039 
10391277/ 
Placebo 14 Female 165.3 45.8 16.8 Black or African American    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1039 
10391278/ 
BNT162b2 (30 μg) 12 Male 152.3 39.4 17 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1039 
10391279/ 
Placebo 14 Female 151 43.2 18.9 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1039 
10391280/ 
Placebo 13 Female 156.9 68.9 28 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1039 
10391281/ 
BNT162b2 (30 μg) 15 Female 171.5 87.6 29.8 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1039 
10391282/ 
BNT162b2 (30 μg) 13 Male 165 48.1 17.7 White    Hispanic/Latino  18DEC2020 
C4591001 1039 
10391283/ 
Placebo 15 Male 170.5 51.9 17.9 White    Non-Hispanic/non-
Latino 18DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 78
FDA-CBER-2022-5812-0224382
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1039 
10391284/ 
BNT162b2 (30 μg) 13 Male 169 59.7 20.9 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1039 
10391285/ 
Placebo 13 Female 156.1 40.8 16.7 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1039 
10391286/ 
BNT162b2 (30 μg) 13 Female 152.2 40.6 17.5 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1039 
10391287/ 
Placebo 14 Female 161.5 54.2 20.8 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1039 
10391289/ 
BNT162b2 (30 μg) 15 Male 177.5 64.3 20.4 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1039 
10391290/ 
BNT162b2 (30 μg) 12 Female 155.5 41.8 17.3 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1039 
10391291/ 
Placebo 15 Female 167.5 63.8 22.7 White    Hispanic/Latino  18DEC2020 
C4591001 1039 
10391292/ 
Placebo 13 Female 169 64.1 22.4 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1039 
10391293/ 
BNT162b2 (30 μg) 14 Male 168 63.3 22.4 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1039 
10391294/ 
Placebo 13 Male 167.5 46.6 16.6 Asian  Other Non-Hispanic/non-
Latino 21DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 79
FDA-CBER-2022-5812-0224383
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1039 
10391295/ 
BNT162b2 (30 μg) 13 Female 159.5 78.1 30.7 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1039 
10391296/ 
Placebo 13 Male 158.4 47.2 18.8 White    Not reported  29DEC2020 
C4591001 1039 
10391297/ 
BNT162b2 (30 μg) 13 Male 168.6 49.1 17.3 White    Hispanic/Latino  29DEC2020 
C4591001 1039 
10391298/ 
BNT162b2 (30 μg) 14 Male 186.2 75.2 21.7 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1039 
10391299/ 
Placebo 15 Male 176.4 63.3 20.3 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1039 
10391300/ 
BNT162b2 (30 μg) 12 Male 153.4 44.2 18.8 White    Hispanic/Latino  29DEC2020 
C4591001 1039 
10391301/ 
Placebo 14 Male 154.5 45 18.9 White    Hispanic/Latino  29DEC2020 
C4591001 1039 
10391302/ 
BNT162b2 (30 μg) 14 Male 170.6 47.3 16.3 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1039 
10391303/ 
Placebo 13 Male 162 64.4 24.5 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1039 
10391304/ 
BNT162b2 (30 μg) 13 Male 167 41.1 14.7 White    Non-Hispanic/non-
Latino 29DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 80
FDA-CBER-2022-5812-0224384
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1039 
10391305/ 
Placebo 13 Male 169.5 55.7 19.4 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1039 
10391306/ 
BNT162b2 (30 μg) 12 Male 155.5 51.6 21.3 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1039 
10391307/ 
Placebo 15 Female 169.7 61.2 21.3 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1039 
10391308/ 
BNT162b2 (30 μg) 13 Female 155.1 42 17.5 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1039 
10391309/ 
Placebo 14 Male 172.2 52.7 17.8 Asian  Other Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1039 
10391310/ 
Placebo 13 Male 158 73.1 29.3 White    Hispanic/Latino  07JAN2021 
C4591001 1039 
10391311/ 
BNT162b2 (30 μg) 15 Male 167 65.7 23.6 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1039 
10391312/ 
BNT162b2 (30 μg) 13 Male 171 59.3 20.3 White    Hispanic/Latino  07JAN2021 
C4591001 1039 
10391313/ 
Placebo 14 Male 175 53.1 17.3 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1039 
10391314/ 
Placebo 14 Female 167.4 65.9 23.5 Asian  Other Non-Hispanic/non-
Latino 07JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 81
FDA-CBER-2022-5812-0224385
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1039 
10391315/ 
BNT162b2 (30 μg) 14 Male 172.5 49.3 16.6 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1039 
10391316/ 
BNT162b2 (30 μg) 12 Female 156 48.5 19.9 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1039 
10391317/ 
Placebo 12 Male 168.6 66.2 23.3 Asian  Other Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1039 
10391318/ 
BNT162b2 (30 μg) 15 Female 163 66.8 25.1 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1039 
10391319/ 
Placebo 12 Male 156.1 55.5 22.8 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1039 
10391320/ 
Placebo 12 Female 167.1 49.1 17.6 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1039 
10391321/ 
Placebo 12 Female 166 43.5 15.8 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1039 
10391322/ 
BNT162b2 (30 μg) 15 Female 164 47.7 17.7 White    Hispanic/Latino  08JAN2021 
C4591001 1039 
10391323/ 
BNT162b2 (30 μg) 13 Female 164 63 23.4 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1039 
10391324/ 
BNT162b2 (30 μg) 12 Female 155.4 58.1 24.1 White    Non-Hispanic/non-
Latino 08JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 82
FDA-CBER-2022-5812-0224386
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1039 
10391325/ 
Placebo 13 Female 155.8 42.1 17.3 Asian  Other Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1039 
10391326/ 
BNT162b2 (30 μg) 15 Male 177.7 65.5 20.7 Asian  Other Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1039 
10391327/ 
Placebo 15 Male 169 59.4 20.8 White    Hispanic/Latino  11JAN2021 
C4591001 1039 
10391328/ 
Placebo 14 Female 164 67.5 25.1 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1039 
10391329/ 
Placebo 13 Male 168.1 76.2 27 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1039 
10391330/ 
BNT162b2 (30 μg) 15 Male 182 67 20.2 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1039 
10391331/ 
BNT162b2 (30 μg) 13 Male 160 42.5 16.6 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1039 
10391332/ 
BNT162b2 (30 μg) 13 Female 156 38.7 15.9 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1039 
10391333/ 
Placebo 15 Male 171.6 72 24.5 White    Hispanic/Latino  12JAN2021 
C4591001 1039 
10391334/ 
Placebo 12 Male 149.1 38.9 17.5 White    Hispanic/Latino  12JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 83
FDA-CBER-2022-5812-0224387
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1039 
10391335/ 
BNT162b2 (30 μg) 15 Male 175 54.3 17.7 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1039 
10391336/ 
BNT162b2 (30 μg) 14 Male 177.4 62.2 19.8 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1039 
10391337/ 
Placebo 15 Male 182.4 84.7 25.5 White    Hispanic/Latino  12JAN2021 
C4591001 1039 
10391338/ 
BNT162b2 (30 μg) 15 Female 150 48.9 21.7 White    Hispanic/Latino  12JAN2021 
C4591001 1039 
10391339/ 
Placebo 12 Female 149.5 40.7 18.2 White    Hispanic/Latino  12JAN2021 
C4591001 1044 
10441251/ 
BNT162b2 (30 μg) 14 Female 160 59.1 23.1 White    Non-Hispanic/non-
Latino 30NOV2020 
C4591001 1044 
10441252/ 
Placebo 13 Male 167.6 45.9 16.3 White    Non-Hispanic/non-
Latino 30NOV2020 
C4591001 1044 
10441253/ 
BNT162b2 (30 μg) 13 Male 163.8 46.8 17.4 White    Hispanic/Latino  30NOV2020 
C4591001 1044 
10441255/ 
BNT162b2 (30 μg) 12 Male 156.2 67.2 27.5 White    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1044 
10441256/ 
Placebo 14 Male 167.6 60.1 21.4 White    Non-Hispanic/non-
Latino 01DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 84
FDA-CBER-2022-5812-0224388
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1044 
10441257/ 
BNT162b2 (30 μg) 14 Female 159.4 55 21.6 White    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1044 
10441259/ 
BNT162b2 (30 μg) 12 Female 150.5 43.4 19.2 Asian    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1044 
10441260/ 
Placebo 15 Male 172.7 72.9 24.4 White    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1044 
10441261/ 
Placebo 14 Female 160 67.2 26.2 White    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1044 
10441263/ 
BNT162b2 (30 μg) 13 Male 165.1 53 19.4 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1044 
10441264/ 
Placebo 14 Female 167.6 98.3 35 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1044 
10441265/ 
Placebo 14 Male 157.5 37 14.9 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1044 
10441266/ 
BNT162b2 (30 μg) 14 Female 165.1 74.2 27.2 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1044 
10441267/ 
Placebo 14 Male 170.2 58.6 20.2 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1044 
10441268/ 
BNT162b2 (30 μg) 15 Male 180.3 129.2 39.7 White    Non-Hispanic/non-
Latino 08DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 85
FDA-CBER-2022-5812-0224389
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1044 
10441270/ 
BNT162b2 (30 μg) 13 Female 148.6 38.6 17.5 Not reported    Hispanic/Latino  08DEC2020 
C4591001 1044 
10441271/ 
Placebo 15 Female 183.5 51.7 15.4 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1044 
10441273/ 
BNT162b2 (30 μg) 12 Female 149.9 46.5 20.7 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1044 
10441274/ 
Placebo 15 Male 170.2 66.3 22.9 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1044 
10441275/ 
Placebo 12 Female 168.9 53.4 18.7 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1044 
10441276/ 
BNT162b2 (30 μg) 14 Male 177.8 56.2 17.8 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1044 
10441277/ 
Placebo 15 Female 172.7 49.7 16.7 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1044 
10441278/ 
BNT162b2 (30 μg) 13 Female 168.9 87.1 30.5 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1044 
10441279/ 
BNT162b2 (30 μg) 15 Female 160 55.5 21.7 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1044 
10441280/ 
Placebo 15 Male 175.3 70.5 22.9 White    Non-Hispanic/non-
Latino 09DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 86
FDA-CBER-2022-5812-0224390
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1044 
10441281/ 
BNT162b2 (30 μg) 15 Male 171.5 54.4 18.5 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1044 
10441282/ 
Placebo 15 Male 180.3 66.5 20.5 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1044 
10441283/ 
BNT162b2 (30 μg) 14 Male 171.5 48.1 16.4 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1044 
10441284/ 
Placebo 15 Male 179.1 68.7 21.4 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1044 
10441285/ 
BNT162b2 (30 μg) 15 Female 157.5 58 23.4 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1044 
10441286/ 
Placebo 15 Female 163.8 62.1 23.1 White    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1044 
10441288/ 
BNT162b2 (30 μg) 12 Female 165.7 29 10.6 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1044 
10441289/ 
Placebo 13 Female 157.5 37.8 15.2 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1044 
10441290/ 
BNT162b2 (30 μg) 12 Female 152.4 42.5 18.3 Asian  Other Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1044 
10441291/ 
BNT162b2 (30 μg) 13 Male 160 46.6 18.2 White    Non-Hispanic/non-
Latino 17DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 87
FDA-CBER-2022-5812-0224391
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1044 
10441292/ 
Placebo 15 Male 172.7 51.9 17.4 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1044 
10441293/ 
Placebo 12 Male 162.6 58.8 22.2 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1044 
10441294/ 
Placebo 14 Male 181.6 63.3 19.2 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1044 
10441295/ 
BNT162b2 (30 μg) 12 Male 154.9 45.7 19 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1044 
10441296/ 
BNT162b2 (30 μg) 13 Male 161.3 56.8 21.8 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1044 
10441297/ 
BNT162b2 (30 μg) 14 Female 168.9 50.7 17.8 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1044 
10441298/ 
Placebo 14 Female 161.3 39.6 15.2 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1044 
10441299/ 
Placebo 15 Male 188 74.8 21.2 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1044 
10441300/ 
BNT162b2 (30 μg) 15 Male 180.3 95.5 29.4 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1044 
10441301/ 
BNT162b2 (30 μg) 15 Female 165.1 49.9 18.3 White    Non-Hispanic/non-
Latino 29DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 88
FDA-CBER-2022-5812-0224392
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1044 
10441302/ 
Placebo 14 Female 170.8 58.2 20 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1044 
10441303/ 
Placebo 15 Male 188 60.3 17.1 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1044 
10441304/ 
BNT162b2 (30 μg) 15 Female 167.6 57.5 20.5 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1044 
10441306/ 
BNT162b2 (30 μg) 12 Male 158.1 57.3 22.9 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1044 
10441307/ 
Placebo 14 Male 168.9 62 21.7 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1044 
10441308/ 
Placebo 12 Male 165.1 44.9 16.5 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1044 
10441309/ 
BNT162b2 (30 μg) 12 Male 167.6 74.2 26.4 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1044 
10441310/ 
BNT162b2 (30 μg) 13 Male 162.6 51.9 19.6 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1044 
10441311/ 
BNT162b2 (30 μg) 12 Female 157.5 46.7 18.8 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1044 
10441312/ 
Placebo 14 Male 167.6 48.4 17.2 White    Non-Hispanic/non-
Latino 04JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 89
FDA-CBER-2022-5812-0224393
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1044 
10441313/ 
Placebo 14 Female 166.4 48.5 17.5 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1044 
10441314/ 
BNT162b2 (30 μg) 14 Female 165.1 56.3 20.7 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1044 
10441315/ 
Placebo 14 Female 172.7 56 18.8 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1044 
10441316/ 
BNT162b2 (30 μg) 15 Male 177.8 67.4 21.3 White    Hispanic/Latino  04JAN2021 
C4591001 1044 
10441317/ 
Placebo 13 Female 167.6 51.5 18.3 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1044 
10441318/ 
Placebo 14 Female 172.7 52.3 17.5 Black or African American    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1044 
10441319/ 
BNT162b2 (30 μg) 12 Male 172.7 53.3 17.9 Black or African American    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1044 
10441320/ 
Placebo 15 Male 177.8 65.8 20.8 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1044 
10441321/ 
BNT162b2 (30 μg) 14 Male 160 78.3 30.6 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1044 
10441322/ 
BNT162b2 (30 μg) 14 Male 160 83.6 32.7 Asian  Other Non-Hispanic/non-
Latino 05JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 90
FDA-CBER-2022-5812-0224394
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1044 
10441323/ 
Placebo 15 Male 182.9 65.2 19.5 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1044 
10441324/ 
Placebo 15 Female 168.9 59.6 20.9 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1044 
10441325/ 
BNT162b2 (30 μg) 12 Male 165.1 55.4 20.3 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1044 
10441326/ 
Placebo 13 Female 157.5 40.8 16.4 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1044 
10441327/ 
Placebo 15 Female 170.2 62.1 21.4 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1044 
10441328/ 
BNT162b2 (30 μg) 15 Female 160 60.1 23.5 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1044 
10441329/ 
BNT162b2 (30 μg) 12 Female 163.8 55.1 20.5 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1044 
10441330/ 
Placebo 14 Female 159.8 44.9 17.6 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1044 
10441331/ 
BNT162b2 (30 μg) 12 Male 162.6 43.1 16.3 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1044 
10441332/ 
Placebo 15 Male 173.4 58.6 19.5 White    Non-Hispanic/non-
Latino 06JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 91
FDA-CBER-2022-5812-0224395
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1044 
10441333/ 
BNT162b2 (30 μg) 13 Male 160 38.1 14.9 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1044 
10441334/ 
BNT162b2 (30 μg) 12 Female 157.5 45 18.1 White    Hispanic/Latino  07JAN2021 
C4591001 1044 
10441335/ 
Placebo 15 Female 161.9 60.1 22.9 White    Hispanic/Latino  07JAN2021 
C4591001 1044 
10441336/ 
BNT162b2 (30 μg) 12 Female 157.5 41.3 16.6 Asian  Other Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1044 
10441337/ 
Placebo 13 Male 152.4 36.8 15.8 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1044 
10441338/ 
Placebo 13 Female 170.2 44.7 15.4 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1044 
10441339/ 
BNT162b2 (30 μg) 15 Female 171.5 55.1 18.7 Asian  Other Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1044 
10441340/ 
Placebo 13 Male 157.5 57.9 23.3 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1044 
10441341/ 
Placebo 14 Male 165.1 49.4 18.1 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1044 
10441342/ 
BNT162b2 (30 μg) 13 Male 170.2 42.5 14.7 White    Non-Hispanic/non-
Latino 09JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 92
FDA-CBER-2022-5812-0224396
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1044 
10441343/ 
BNT162b2 (30 μg) 14 Male 162.6 39.9 15.1 Asian  Other Non-Hispanic/non-
Latino 09JAN2021 
C4591001 1044 
10441344/ 
Placebo 15 Male 165.1 69.8 25.6 Asian  Other Non-Hispanic/non-
Latino 09JAN2021 
C4591001 1044 
10441345/ 
Placebo 12 Female 157.5 38.3 15.4 White    Non-Hispanic/non-
Latino 09JAN2021 
C4591001 1044 
10441346/ 
BNT162b2 (30 μg) 12 Male 160 53.5 20.9 White    Non-Hispanic/non-
Latino 09JAN2021 
C4591001 1044 
10441347/ 
Placebo 14 Female 157.5 59.1 23.8 White    Non-Hispanic/non-
Latino 09JAN2021 
C4591001 1044 
10441348/ 
Placebo 13 Male 157.5 36.1 14.6 White    Non-Hispanic/non-
Latino 09JAN2021 
C4591001 1044 
10441349/ 
BNT162b2 (30 μg) 13 Male 170.2 72.2 24.9 White    Non-Hispanic/non-
Latino 09JAN2021 
C4591001 1044 
10441350/ 
BNT162b2 (30 μg) 15 Female 157.5 54.7 22.1 Asian  Other Non-Hispanic/non-
Latino 09JAN2021 
C4591001 1044 
10441351/ 
Placebo 15 Male 180.3 81.3 25 White    Non-Hispanic/non-
Latino 10JAN2021 
C4591001 1044 
10441352/ 
BNT162b2 (30 μg) 15 Female 162.6 54 20.4 White    Hispanic/Latino  10JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 93
FDA-CBER-2022-5812-0224397
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1044 
10441353/ 
BNT162b2 (30 μg) 13 Female 165.1 58.9 21.6 White    Non-Hispanic/non-
Latino 10JAN2021 
C4591001 1044 
10441354/ 
Placebo 13 Female 160 42.9 16.8 White    Non-Hispanic/non-
Latino 10JAN2021 
C4591001 1044 
10441355/ 
BNT162b2 (30 μg) 14 Female 163.8 55.4 20.6 Asian  Other Non-Hispanic/non-
Latino 10JAN2021 
C4591001 1044 
10441356/ 
Placebo 12 Male 163.8 42.4 15.8 White    Non-Hispanic/non-
Latino 10JAN2021 
C4591001 1044 
10441357/ 
Placebo 13 Male 148.6 39.2 17.8 White    Hispanic/Latino  10JAN2021 
C4591001 1044 
10441358/ 
BNT162b2 (30 μg) 14 Male 174 45.4 15 Asian  Other Non-Hispanic/non-
Latino 10JAN2021 
C4591001 1044 
10441359/ 
BNT162b2 (30 μg) 15 Female 166.4 61.1 22.1 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1044 
10441360/ 
Placebo 13 Male 177.8 55.9 17.7 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1044 
10441361/ 
BNT162b2 (30 μg) 15 Male 183.5 60.2 17.9 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1044 
10441362/ 
Placebo 14 Male 182.9 54.2 16.2 White    Non-Hispanic/non-
Latino 11JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 94
FDA-CBER-2022-5812-0224398
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1044 
10441363/ 
Placebo 13 Female 174 59.2 19.6 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1044 
10441364/ 
BNT162b2 (30 μg) 15 Female 156.2 61.5 25.2 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1044 
10441365/ 
Placebo 15 Female 163.2 54.8 20.6 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1044 
10441366/ 
BNT162b2 (30 μg) 15 Male 176.5 57.8 18.6 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1044 
10441367/ 
BNT162b2 (30 μg) 12 Male 154.9 92 38.3 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1044 
10441368/ 
Placebo 15 Female 162.6 56.2 21.3 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1044 
10441369/ 
BNT162b2 (30 μg) 12 Male 154.9 80.6 33.6 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1044 
10441370/ 
Placebo 15 Male 175.3 54.2 17.6 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1044 
10441371/ 
Placebo 15 Female 160 55 21.5 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1044 
10441372/ 
BNT162b2 (30 μg) 13 Male 167.6 65.1 23.2 White    Non-Hispanic/non-
Latino 11JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 95
FDA-CBER-2022-5812-0224399
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1044 
10441373/ 
Placebo 14 Female 156.2 43.9 18 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1044 
10441374/ 
Placebo 15 Male 174 53.4 17.6 White    Hispanic/Latino  12JAN2021 
C4591001 1044 
10441375/ 
BNT162b2 (30 μg) 13 Female 154.9 44.2 18.4 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1044 
10441376/ 
BNT162b2 (30 μg) 15 Male 162.6 47.4 17.9 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1044 
10441377/ 
BNT162b2 (30 μg) 12 Female 165.1 49.9 18.3 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1044 
10441378/ 
BNT162b2 (30 μg) 12 Female 152.4 40.5 17.4 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1044 
10441379/ 
BNT162b2 (30 μg) 15 Male 168.9 54.5 19.1 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1044 
10441380/ 
Placebo 13 Male 165.1 44.2 16.2 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1044 
10441381/ 
Placebo 12 Male 167.6 42.9 15.3 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1044 
10441382/ 
Placebo 13 Female 160 51.6 20.2 White    Non-Hispanic/non-
Latino 12JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 96
FDA-CBER-2022-5812-0224400
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1044 
10441383/ 
BNT162b2 (30 μg) 14 Male 175.3 61.3 19.9 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1044 
10441384/ 
Placebo 13 Male 174 96.8 32 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1057 
10571376/ 
BNT162b2 (30 μg) 13 Male 167.2 55.2 19.7 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1057 
10571377/ 
Placebo 13 Female 159.2 49.8 19.6 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1057 
10571378/ 
BNT162b2 (30 μg) 12 Female 161.3 85.8 33 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1057 
10571379/ 
Placebo 14 Female 163.5 63.5 23.8 Asian  Other Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1057 
10571380/ 
BNT162b2 (30 μg) 13 Female 157.1 43 17.4 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1057 
10571382/ 
BNT162b2 (30 μg) 13 Female 151.7 52.6 22.9 Black or African American    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1057 
10571383/ 
Placebo 14 Female 160.5 59.5 23.1 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1057 
10571384/ 
Placebo 15 Male 155.2 44 18.3 White    Non-Hispanic/non-
Latino 08DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 97
FDA-CBER-2022-5812-0224401
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1057 
10571385/ 
BNT162b2 (30 μg) 15 Female 174.5 61.5 20.2 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1057 
10571386/ 
Placebo 14 Male 171.5 115.8 39.4 Black or African American    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1057 
10571387/ 
Placebo 14 Female 158.2 59.9 23.9 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1057 
10571388/ 
BNT162b2 (30 μg) 14 Male 166 45 16.3 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1057 
10571389/ 
Placebo 12 Female 165.5 48.5 17.7 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1057 
10571390/ 
BNT162b2 (30 μg) 15 Male 173 79.5 26.6 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1057 
10571391/ 
Placebo 15 Male 178.3 66 20.8 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1057 
10571392/ 
BNT162b2 (30 μg) 15 Female 165.8 55.9 20.3 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1057 
10571393/ 
Placebo 15 Female 161.5 42 16.1 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1057 
10571394/ 
Placebo 15 Female 155.6 64.5 26.6 White    Non-Hispanic/non-
Latino 09DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 98
FDA-CBER-2022-5812-0224402
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1057 
10571395/ 
BNT162b2 (30 μg) 13 Female 163 71.2 26.8 Black or African American    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1057 
10571396/ 
BNT162b2 (30 μg) 13 Male 161 44 17 Black or African American    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1057 
10571397/ 
BNT162b2 (30 μg) 14 Female 161.5 63.2 24.2 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1057 
10571398/ 
Placebo 14 Male 180 64 19.8 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1057 
10571399/ 
BNT162b2 (30 μg) 12 Male 160 66.5 26 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1057 
10571400/ 
Placebo 13 Male 168 59.5 21.1 Black or African American    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1057 
10571401/ 
BNT162b2 (30 μg) 13 Female 172.7 70.9 23.8 White    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1057 
10571402/ 
Placebo 15 Female 169 86 30.1 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1057 
10571403/ 
BNT162b2 (30 μg) 12 Male 154.5 41.3 17.3 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1057 
10571404/ 
Placebo 13 Female 155.3 64 26.5 White    Non-Hispanic/non-
Latino 16DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 99
FDA-CBER-2022-5812-0224403
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1057 
10571405/ 
BNT162b2 (30 μg) 15 Male 175.8 63.1 20.4 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1057 
10571406/ 
Placebo 13 Male 166.8 55.2 19.8 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1057 
10571407/ 
Placebo 15 Male 171.9 53.3 18 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1057 
10571408/ 
Placebo 14 Male 176.7 58.2 18.6 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1057 
10571409/ 
BNT162b2 (30 μg) 12 Male 146.8 33.3 15.5 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1057 
10571410/ 
Placebo 12 Male 147.8 34.2 15.7 Asian  Other Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1057 
10571411/ 
BNT162b2 (30 μg) 15 Female 155.8 47 19.4 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1057 
10571412/ 
BNT162b2 (30 μg) 13 Male 165.4 54.8 20 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1057 
10571413/ 
BNT162b2 (30 μg) 13 Male 160.3 49.4 19.2 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1057 
10571414/ 
Placebo 15 Female 163.2 47.9 18 Multiracial    Hispanic/Latino  21DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 100
FDA-CBER-2022-5812-0224404
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1057 
10571415/ 
Placebo 14 Female 163 42.5 16 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1057 
10571416/ 
BNT162b2 (30 μg) 14 Male 161 55.3 21.3 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1057 
10571417/ 
Placebo 14 Female 158 70.1 28.1 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1057 
10571418/ 
BNT162b2 (30 μg) 14 Female 161.5 114.8 44 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1057 
10571419/ 
BNT162b2 (30 μg) 14 Male 173.8 67 22.2 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1057 
10571420/ 
Placebo 14 Male 171.2 56.5 19.3 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1057 
10571421/ 
Placebo 15 Male 166.7 111.5 40.1 Black or African American    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1057 
10571422/ 
BNT162b2 (30 μg) 14 Male 175 119 38.9 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1057 
10571423/ 
BNT162b2 (30 μg) 15 Male 175.2 78.3 25.5 Black or African American    Hispanic/Latino  24DEC2020 
C4591001 1057 
10571424/ 
Placebo 12 Male 172.6 80 26.9 Black or African American    Hispanic/Latino  24DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 101
FDA-CBER-2022-5812-0224405
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1057 
10571425/ 
Placebo 13 Female 157.8 41 16.5 White    Non-Hispanic/non-
Latino 24DEC2020 
C4591001 1057 
10571426/ 
BNT162b2 (30 μg) 12 Female 148 36.6 16.7 White    Hispanic/Latino  24DEC2020 
C4591001 1057 
10571427/ 
BNT162b2 (30 μg) 12 Female 148.5 31.6 14.3 White    Hispanic/Latino  24DEC2020 
C4591001 1057 
10571428/ 
Placebo 14 Male 154.5 37.8 15.8 White    Hispanic/Latino  24DEC2020 
C4591001 1057 
10571429/ 
BNT162b2 (30 μg) 15 Female 162.9 56.2 21.2 White    Hispanic/Latino  24DEC2020 
C4591001 1057 
10571430/ 
BNT162b2 (30 μg) 12 Female 172.6 104.3 35 Black or African American    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1057 
10571431/ 
Placebo 13 Male 161 49.3 19 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1057 
10571432/ 
Placebo 12 Female 155.1 33.1 13.8 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1057 
10571433/ 
BNT162b2 (30 μg) 12 Female 166 67.5 24.5 Black or African American    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1057 
10571434/ 
Placebo 13 Male 159 92.5 36.6 Multiracial    Non-Hispanic/non-
Latino 31DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 102
FDA-CBER-2022-5812-0224406
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1057 
10571435/ 
BNT162b2 (30 μg) 12 Male 156.2 69.3 28.4 Black or African American    Hispanic/Latino  04JAN2021 
C4591001 1057 
10571436/ 
Placebo 14 Female 165 60 22 Black or African American    Hispanic/Latino  04JAN2021 
C4591001 1057 
10571437/ 
Placebo 15 Male 173.5 64.5 21.4 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1057 
10571438/ 
BNT162b2 (30 μg) 13 Female 172.3 71.6 24.1 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1057 
10571439/ 
Placebo 14 Female 163.4 48.1 18 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1057 
10571440/ 
BNT162b2 (30 μg) 12 Male 166.5 47.7 17.2 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1057 
10571441/ 
Placebo 13 Male 162.2 51.7 19.7 Asian  Other Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1057 
10571442/ 
Placebo 13 Male 168 62.3 22.1 Black or African American    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1057 
10571443/ 
BNT162b2 (30 μg) 12 Female 169.6 68 23.6 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1057 
10571444/ 
BNT162b2 (30 μg) 14 Female 168.6 58.2 20.5 White    Non-Hispanic/non-
Latino 08JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 103
FDA-CBER-2022-5812-0224407
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1057 
10571445/ 
BNT162b2 (30 μg) 15 Male 183.5 88.2 26.2 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1057 
10571446/ 
Placebo 13 Female 168.4 55.1 19.4 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1057 
10571447/ 
Placebo 15 Male 189.5 115.3 32.1 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1057 
10571448/ 
BNT162b2 (30 μg) 13 Female 167 67 24 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1057 
10571449/ 
Placebo 12 Male 169.5 37 12.9 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1057 
10571450/ 
Placebo 13 Male 176 62.7 20.2 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1057 
10571451/ 
BNT162b2 (30 μg) 12 Female 177.4 55.1 17.5 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1057 
10571452/ 
BNT162b2 (30 μg) 12 Female 168.5 63.5 22.4 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1057 
10571453/ 
Placebo 13 Male 169.5 57.6 20 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1057 
10571454/ 
BNT162b2 (30 μg) 13 Female 160 46.4 18.1 White    Non-Hispanic/non-
Latino 12JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 104
FDA-CBER-2022-5812-0224408
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1066 
10661394/ 
Placebo 14 Male 168.91 58.27 20.4 White    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1066 
10661395/ 
BNT162b2 (30 μg) 12 Male 161.29 101.09 38.8 White    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1066 
10661397/ 
Placebo 14 Male 180.34 60.64 18.6 White    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1066 
10661401/ 
Placebo 14 Male 172.72 57.86 19.4 White    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1066 
10661402/ 
BNT162b2 (30 μg) 14 Female 162.56 54.36 20.5 White    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1066 
10661403/ 
Placebo 14 Male 158.75 53.27 21.1 White    Non-Hispanic/non-
Latino 03DEC2020 
C4591001 1066 
10661404/ 
BNT162b2 (30 μg) 12 Female 160.02 58.5 22.8 White    Non-Hispanic/non-
Latino 03DEC2020 
C4591001 1066 
10661405/ 
Placebo 13 Male 157.48 40.09 16.1 White    Non-Hispanic/non-
Latino 03DEC2020 
C4591001 1066 
10661407/ 
BNT162b2 (30 μg) 15 Female 177.8 62.27 19.7 White    Non-Hispanic/non-
Latino 04DEC2020 
C4591001 1066 
10661408/ 
BNT162b2 (30 μg) 15 Female 175.9 65.32 21.1 White    Non-Hispanic/non-
Latino 08DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 105
FDA-CBER-2022-5812-0224409
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1066 
10661409/ 
BNT162b2 (30 μg) 12 Male 148.59 33.73 15.2 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1066 
10661410/ 
Placebo 13 Female 162.56 60.09 22.7 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1066 
10661411/ 
BNT162b2 (30 μg) 15 Male 168.91 65.64 23 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1066 
10661412/ 
Placebo 14 Female 154.94 56.41 23.4 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1066 
10661414/ 
BNT162b2 (30 μg) 15 Male 160.02 76.45 29.8 White    Hispanic/Latino  14DEC2020 
C4591001 1066 
10661415/ 
Placebo 14 Female 165.1 93.45 34.2 White    Hispanic/Latino  14DEC2020 
C4591001 1066 
10661416/ 
Placebo 12 Male 151.13 37.09 16.2 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1066 
10661417/ 
BNT162b2 (30 μg) 12 Male 149.86 43.18 19.2 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1066 
10661418/ 
Placebo 14 Male 187.96 77.73 22 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1066 
10661419/ 
BNT162b2 (30 μg) 14 Female 157.48 42.27 17 Multiracial    Non-Hispanic/non-
Latino 16DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 106
FDA-CBER-2022-5812-0224410
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1066 
10661420/ 
BNT162b2 (30 μg) 15 Female 172.72 61.45 20.6 White    Hispanic/Latino  17DEC2020 
C4591001 1066 
10661421/ 
Placebo 14 Male 160.02 53.27 20.8 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1066 
10661422/ 
BNT162b2 (30 μg) 12 Male 160.02 53.05 20.7 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1066 
10661423/ 
Placebo 14 Male 179.71 87.55 27 White    Hispanic/Latino  30DEC2020 
C4591001 1066 
10661424/ 
BNT162b2 (30 μg) 14 Male 166.37 52.73 19 Native Hawaiian or other 
Pacific Islander   Hispanic/Latino  30DEC2020 
C4591001 1066 
10661425/ 
Placebo 14 Female 163.2 53.18 19.9 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1066 
10661426/ 
Placebo 15 Male 173.99 54 17.8 Multiracial    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1066 
10661427/ 
BNT162b2 (30 μg) 15 Male 180.34 64.36 19.7 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1066 
10661428/ 
Placebo 15 Female 165.1 59.14 21.6 Black or African American    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1066 
10661429/ 
Placebo 12 Male 154.94 52.73 21.9 White    Non-Hispanic/non-
Latino 06JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 107
FDA-CBER-2022-5812-0224411
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1066 
10661430/ 
BNT162b2 (30 μg) 13 Male 173.99 91.73 30.2 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1066 
10661431/ 
BNT162b2 (30 μg) 15 Female 175.26 74.73 24.3 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1066 
10661432/ 
Placebo 14 Female 161.93 58.27 22.2 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1066 
10661433/ 
Placebo 12 Female 152.4 56.59 24.3 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1066 
10661434/ 
BNT162b2 (30 μg) 15 Male 165.1 53.18 19.5 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1066 
10661435/ 
BNT162b2 (30 μg) 13 Female 157.48 42.64 17.2 White    Non-Hispanic/non-
Latino 12JAN2021 
C4591001 1077 
10771274/ 
BNT162b2 (30 μg) 14 Female 163.83 63.64 23.7 White    Non-Hispanic/non-
Latino 03DEC2020 
C4591001 1077 
10771275/ 
Placebo 13 Male 160.02 41.45 16.2 White    Non-Hispanic/non-
Latino 03DEC2020 
C4591001 1077 
10771277/ 
Placebo 13 Male 158.75 39.64 15.7 White    Non-Hispanic/non-
Latino 04DEC2020 
C4591001 1077 
10771278/ 
BNT162b2 (30 μg) 13 Male 165.1 47.09 17.2 White    Non-Hispanic/non-
Latino 04DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 108
FDA-CBER-2022-5812-0224412
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1077 
10771279/ 
BNT162b2 (30 μg) 13 Male 163.07 48.73 18.3 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1077 
10771280/ 
Placebo 14 Female 163.83 50.36 18.7 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1077 
10771281/ 
BNT162b2 (30 μg) 14 Male 168 70.8 25.1 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1077 
10771282/ 
Placebo 14 Male 180.34 67.09 20.6 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1077 
10771283/ 
Placebo 13 Male 167 62.7 22.5 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1077 
10771284/ 
BNT162b2 (30 μg) 15 Male 187 78.7 22.5 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1077 
10771285/ 
Placebo 14 Female 160.02 57.55 22.4 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1077 
10771286/ 
BNT162b2 (30 μg) 14 Female 170 62.8 21.7 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1077 
10771287/ 
BNT162b2 (30 μg) 15 Male 172.72 60.45 20.2 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1077 
10771288/ 
BNT162b2 (30 μg) 15 Male 180.34 72.73 22.3 Black or African American    Non-Hispanic/non-
Latino 16DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 109
FDA-CBER-2022-5812-0224413
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1077 
10771289/ 
Placebo 14 Female 175.26 54.09 17.6 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1077 
10771290/ 
Placebo 14 Female 170.18 58.91 20.3 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1077 
10771291/ 
BNT162b2 (30 μg) 15 Male 167.64 55.36 19.7 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1077 
10771292/ 
BNT162b2 (30 μg) 14 Male 167.64 48.55 17.2 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1077 
10771293/ 
Placebo 12 Male 152.4 44.09 18.9 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1077 
10771294/ 
Placebo 14 Male 167 48.9 17.5 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1077 
10771295/ 
Placebo 15 Male 172.5 70 23.5 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1077 
10771296/ 
BNT162b2 (30 μg) 13 Male 161 42.2 16.3 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1077 
10771297/ 
BNT162b2 (30 μg) 12 Female 148 57.7 26.3 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1077 
10771298/ 
Placebo 14 Male 166.37 50.36 18.2 White    Non-Hispanic/non-
Latino 07JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 110
FDA-CBER-2022-5812-0224414
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1077 
10771299/ 
BNT162b2 (30 μg) 13 Male 150.5 34.4 15.2 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1077 
10771300/ 
BNT162b2 (30 μg) 15 Female 158 62.4 25 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1084 
10841541/ 
BNT162b2 (30 μg) 14 Male 174 84.7 28 White    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1084 
10841542/ 
Placebo 15 Female 149 54.3 24.5 Asian    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1084 
10841543/ 
Placebo 12 Male 160 45 17.6 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1084 
10841544/ 
BNT162b2 (30 μg) 15 Male 175.3 59.4 19.3 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1084 
10841545/ 
Placebo 12 Female 158 51.5 20.6 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1084 
10841546/ 
BNT162b2 (30 μg) 14 Female 158 41.2 16.5 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1084 
10841547/ 
Placebo 15 Male 171 92.3 31.6 White    Hispanic/Latino  21DEC2020 
C4591001 1084 
10841548/ 
BNT162b2 (30 μg) 13 Female 159.5 53.9 21.2 White    Non-Hispanic/non-
Latino 21DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 111
FDA-CBER-2022-5812-0224415
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1084 
10841549/ 
BNT162b2 (30 μg) 14 Male 171 78 26.7 White    Hispanic/Latino  21DEC2020 
C4591001 1084 
10841550/ 
Placebo 15 Male 167 54.1 19.4 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1084 
10841551/ 
BNT162b2 (30 μg) 13 Male 158 48.4 19.4 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1084 
10841552/ 
Placebo 13 Male 164.5 48.1 17.8 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1084 
10841553/ 
BNT162b2 (30 μg) 15 Male 166.7 60.5 21.8 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1084 
10841555/ 
Placebo 13 Male 176.9 67.8 21.7 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1084 
10841556/ 
BNT162b2 (30 μg) 15 Female 167.5 75.5 26.9 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1084 
10841557/ 
Placebo 13 Female 160 88.8 34.7 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1084 
10841558/ 
BNT162b2 (30 μg) 15 Female 164 124.1 46.1 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1084 
10841559/ 
BNT162b2 (30 μg) 13 Male 159 98.2 38.8 White    Non-Hispanic/non-
Latino 28DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 112
FDA-CBER-2022-5812-0224416
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1084 
10841560/ 
Placebo 15 Male 177.9 58.6 18.5 White    Hispanic/Latino  28DEC2020 
C4591001 1084 
10841561/ 
Placebo 15 Female 168 69.9 24.8 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1084 
10841562/ 
BNT162b2 (30 μg) 12 Male 170 65.2 22.6 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1084 
10841563/ 
BNT162b2 (30 μg) 13 Female 152 42.5 18.4 White    Hispanic/Latino  30DEC2020 
C4591001 1084 
10841564/ 
Placebo 12 Male 153 53.1 22.7 White    Hispanic/Latino  30DEC2020 
C4591001 1084 
10841565/ 
Placebo 14 Female 157 52 21.1 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1084 
10841566/ 
BNT162b2 (30 μg) 15 Male 175 69.5 22.7 Asian  Other Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1084 
10841567/ 
BNT162b2 (30 μg) 14 Female 168.5 54.3 19.1 Asian  Other Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1084 
10841568/ 
Placebo 15 Male 181.5 78.6 23.9 White    Hispanic/Latino  30DEC2020 
C4591001 1084 
10841569/ 
Placebo 14 Female 161 48.8 18.8 White    Hispanic/Latino  30DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 113
FDA-CBER-2022-5812-0224417
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1084 
10841570/ 
Placebo 13 Male 172.6 44.9 15.1 White    Hispanic/Latino  30DEC2020 
C4591001 1084 
10841571/ 
Placebo 15 Female 164.2 58.3 21.6 Asian  Other Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1084 
10841572/ 
Placebo 13 Female 161.6 56.1 21.5 White    Hispanic/Latino  04JAN2021 
C4591001 1084 
10841573/ 
BNT162b2 (30 μg) 12 Female 150.6 58 25.6 White    Hispanic/Latino  04JAN2021 
C4591001 1084 
10841574/ 
BNT162b2 (30 μg) 12 Male 160.4 73.6 28.6 White    Hispanic/Latino  04JAN2021 
C4591001 1084 
10841575/ 
Placebo 15 Male 168.5 46 16.2 Asian  Other Hispanic/Latino  04JAN2021 
C4591001 1084 
10841576/ 
BNT162b2 (30 μg) 15 Male 173 62.5 20.9 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1084 
10841577/ 
Placebo 15 Female 159 60 23.7 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1084 
10841578/ 
BNT162b2 (30 μg) 13 Male 150 42.1 18.7 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1084 
10841579/ 
Placebo 13 Female 161 59.2 22.8 White    Non-Hispanic/non-
Latino 06JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 114
FDA-CBER-2022-5812-0224418
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1084 
10841580/ 
BNT162b2 (30 μg) 12 Female 160 53.5 20.9 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1084 
10841581/ 
Placebo 14 Male 175 63.4 20.7 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1084 
10841582/ 
BNT162b2 (30 μg) 12 Male 154 42 17.7 Asian  Other Hispanic/Latino  06JAN2021 
C4591001 1084 
10841583/ 
BNT162b2 (30 μg) 15 Female 162.5 77.7 29.4 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1084 
10841584/ 
BNT162b2 (30 μg) 14 Female 158.9 71.2 28.2 White    Hispanic/Latino  08JAN2021 
C4591001 1084 
10841586/ 
Placebo 15 Male 182 112.3 33.9 White    Hispanic/Latino  08JAN2021 
C4591001 1084 
10841587/ 
Placebo 12 Male 147.6 31.6 14.5 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1084 
10841588/ 
Placebo 14 Female 153.9 80.6 34 White    Hispanic/Latino  08JAN2021 
C4591001 1084 
10841589/ 
Placebo 15 Male 169.5 95.6 33.3 White    Hispanic/Latino  08JAN2021 
C4591001 1084 
10841590/ 
Placebo 15 Male 172 58.8 19.9 White    Non-Hispanic/non-
Latino 08JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 115
FDA-CBER-2022-5812-0224419
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1084 
10841591/ 
BNT162b2 (30 μg) 12 Female 161 46.7 18 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1084 
10841592/ 
BNT162b2 (30 μg) 14 Female 161 42.2 16.3 Asian  Other Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1084 
10841593/ 
BNT162b2 (30 μg) 12 Male 158.3 45.6 18.2 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1084 
10841594/ 
BNT162b2 (30 μg) 12 Male 169.1 52.8 18.5 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1084 
10841595/ 
Placebo 13 Female 152 56.4 24.4 White    Hispanic/Latino  08JAN2021 
C4591001 1084 
10841596/ 
Placebo 14 Female 159.1 50.5 20 White    Hispanic/Latino  08JAN2021 
C4591001 1084 
10841597/ 
Placebo 15 Male 170.6 79.95 27.5 White    Hispanic/Latino  08JAN2021 
C4591001 1091 
10911394/ 
BNT162b2 (30 μg) 15 Female 174 69.5 23 White    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1091 
10911395/ 
BNT162b2 (30 μg) 14 Male 171.5 51.5 17.5 White    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1091 
10911396/ 
Placebo 15 Female 154.9 50.6 21.1 White    Non-Hispanic/non-
Latino 02DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 116
FDA-CBER-2022-5812-0224420
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1091 
10911399/ 
BNT162b2 (30 μg) 14 Male 182.6 60.5 18.1 White    Non-Hispanic/non-
Latino 04DEC2020 
C4591001 1091 
10911400/ 
Placebo 14 Female 152.6 61.1 26.2 White    Non-Hispanic/non-
Latino 04DEC2020 
C4591001 1091 
10911402/ 
BNT162b2 (30 μg) 12 Female 153.7 48.1 20.4 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1091 
10911403/ 
BNT162b2 (30 μg) 15 Male 166.4 48.2 17.4 Black or African American    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1091 
10911404/ 
Placebo 13 Female 175.3 86.9 28.3 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1091 
10911405/ 
Placebo 12 Male 157.5 56.7 22.9 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1091 
10911406/ 
BNT162b2 (30 μg) 14 Male 157.5 46.1 18.6 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1091 
10911407/ 
Placebo 12 Male 160.5 45.4 17.6 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1091 
10911408/ 
BNT162b2 (30 μg) 15 Male 174 69.2 22.9 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1091 
10911409/ 
Placebo 14 Female 154.2 43.9 18.5 Asian    Non-Hispanic/non-
Latino 09DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 117
FDA-CBER-2022-5812-0224421
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1091 
10911410/ 
BNT162b2 (30 μg) 12 Female 150.9 39.4 17.3 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1091 
10911411/ 
Placebo 15 Male 173.2 54.2 18.1 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1091 
10911412/ 
BNT162b2 (30 μg) 15 Female 162.6 79 29.9 Multiracial    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1091 
10911413/ 
BNT162b2 (30 μg) 12 Male 160.7 57.1 22.1 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1091 
10911414/ 
BNT162b2 (30 μg) 14 Male 162.3 71.9 27.3 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1091 
10911415/ 
Placebo 15 Female 158.8 52.4 20.8 Asian  Other Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1091 
10911416/ 
BNT162b2 (30 μg) 15 Male 176.5 60.1 19.3 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1091 
10911417/ 
Placebo 13 Female 172.7 59.5 19.9 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1091 
10911418/ 
Placebo 14 Male 160.7 48.6 18.8 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1091 
10911419/ 
BNT162b2 (30 μg) 13 Female 161.3 39.9 15.3 White    Non-Hispanic/non-
Latino 10DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 118
FDA-CBER-2022-5812-0224422
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1091 
10911420/ 
BNT162b2 (30 μg) 12 Female 130.2 41.7 24.6 White    Hispanic/Latino  10DEC2020 
C4591001 1091 
10911421/ 
Placebo 15 Male 167 52.2 18.7 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1091 
10911422/ 
BNT162b2 (30 μg) 15 Female 168.9 55.2 19.3 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1091 
10911423/ 
Placebo 14 Female 158.8 48.5 19.2 Black or African American    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1091 
10911424/ 
Placebo 14 Male 179.1 62.5 19.5 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1091 
10911425/ 
Placebo 12 Female 157.5 53.6 21.6 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1091 
10911426/ 
BNT162b2 (30 μg) 13 Female 167.6 50.6 18 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1091 
10911427/ 
Placebo 12 Male 149.6 36.6 16.4 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1091 
10911428/ 
BNT162b2 (30 μg) 13 Female 152.7 43 18.4 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1091 
10911429/ 
Placebo 15 Male 177.8 74 23.4 White    Non-Hispanic/non-
Latino 16DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 119
FDA-CBER-2022-5812-0224423
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1091 
10911430/ 
Placebo 13 Female 156.2 44 18 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1091 
10911431/ 
BNT162b2 (30 μg) 13 Male 165.1 71.3 26.2 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1091 
10911432/ 
BNT162b2 (30 μg) 12 Female 144.8 32.4 15.5 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1091 
10911433/ 
Placebo 14 Male 173.2 57.2 19.1 White    Hispanic/Latino  17DEC2020 
C4591001 1091 
10911434/ 
Placebo 14 Male 160 44.9 17.5 Black or African American    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1091 
10911435/ 
BNT162b2 (30 μg) 12 Male 163.8 46.1 17.2 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1091 
10911436/ 
BNT162b2 (30 μg) 14 Male 175.3 53.8 17.5 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1091 
10911437/ 
Placebo 13 Male 174 47.5 15.7 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1091 
10911438/ 
BNT162b2 (30 μg) 12 Male 160 51.2 20 Asian  Other Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1091 
10911439/ 
Placebo 14 Male 161.3 50 19.2 White    Non-Hispanic/non-
Latino 18DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 120
FDA-CBER-2022-5812-0224424
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1091 
10911440/ 
BNT162b2 (30 μg) 13 Female 160 40.6 15.9 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1091 
10911441/ 
Placebo 13 Female 158.1 36.6 14.6 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1091 
10911442/ 
Placebo 15 Female 175.3 71.6 23.3 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1091 
10911443/ 
BNT162b2 (30 μg) 12 Male 154.9 51.1 21.3 Asian  Other Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1091 
10911444/ 
BNT162b2 (30 μg) 15 Male 180.3 68 20.9 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1091 
10911445/ 
Placebo 13 Male 182.9 62 18.5 Asian  Other Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1091 
10911446/ 
BNT162b2 (30 μg) 12 Male 161.3 66.8 25.7 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1091 
10911447/ 
BNT162b2 (30 μg) 15 Male 158.8 48.1 19.1 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1091 
10911448/ 
Placebo 13 Male 156.2 39 16 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1091 
10911449/ 
Placebo 13 Male 172.7 56.8 19 White    Non-Hispanic/non-
Latino 22DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 121
FDA-CBER-2022-5812-0224425
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1091 
10911450/ 
Placebo 13 Male 160 51.9 20.3 Multiracial  Other Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1091 
10911451/ 
BNT162b2 (30 μg) 15 Male 179.1 95.3 29.7 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1091 
10911452/ 
Placebo 14 Female 174 76.7 25.3 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1091 
10911453/ 
BNT162b2 (30 μg) 15 Female 153.7 54.6 23.1 Asian  Other Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1091 
10911454/ 
BNT162b2 (30 μg) 14 Male 181.6 62.6 19 Multiracial  Other Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1091 
10911455/ 
Placebo 12 Female 159.3 52.1 20.5 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1091 
10911456/ 
Placebo 13 Female 160 69.5 27.1 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1091 
10911457/ 
BNT162b2 (30 μg) 13 Female 158.8 61 24.2 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1091 
10911458/ 
BNT162b2 (30 μg) 14 Male 165.1 50.2 18.4 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1091 
10911459/ 
Placebo 14 Male 165.1 50.9 18.7 White    Non-Hispanic/non-
Latino 29DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 122
FDA-CBER-2022-5812-0224426
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1091 
10911460/ 
BNT162b2 (30 μg) 13 Female 164.3 54 20 Black or African American    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1091 
10911461/ 
Placebo 14 Female 149.9 54 24 Asian  Other Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1091 
10911462/ 
BNT162b2 (30 μg) 15 Male 179.1 95.3 29.7 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1091 
10911463/ 
Placebo 15 Male 182.9 64.7 19.3 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1091 
10911464/ 
BNT162b2 (30 μg) 13 Female 167.6 48 17.1 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1091 
10911465/ 
BNT162b2 (30 μg) 15 Female 164.6 45.9 16.9 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1091 
10911466/ 
Placebo 13 Male 168.9 62.9 22 White    Non-Hispanic/non-
Latino 11JAN2021 
C4591001 1123 
11231422/ 
Placebo 15 Male 187 80.3 23 White    Non-Hispanic/non-
Latino 01DEC2020 
C4591001 1123 
11231425/ 
BNT162b2 (30 μg) 14 Female 167 88.4 31.7 White    Non-Hispanic/non-
Latino 02DEC2020 
C4591001 1123 
11231428/ 
BNT162b2 (30 μg) 12 Male 154 40.5 17.1 White    Non-Hispanic/non-
Latino 03DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 123
FDA-CBER-2022-5812-0224427
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1123 
11231431/ 
Placebo 13 Male 165 51 18.7 White    Non-Hispanic/non-
Latino 04DEC2020 
C4591001 1123 
11231432/ 
BNT162b2 (30 μg) 14 Male 170 63.3 21.9 White    Non-Hispanic/non-
Latino 04DEC2020 
C4591001 1123 
11231434/ 
Placebo 12 Female 160 55.2 21.6 White    Hispanic/Latino  07DEC2020 
C4591001 1123 
11231438/ 
Placebo 14 Female 162.5 59.1 22.4 American Indian or Alaska 
Native    Hispanic/Latino  08DEC2020 
C4591001 1123 
11231439/ 
BNT162b2 (30 μg) 12 Female 166 101 36.7 American Indian or Alaska 
Native    Hispanic/Latino  08DEC2020 
C4591001 1123 
11231440/ 
BNT162b2 (30 μg) 13 Male 171.5 79.5 27 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1123 
11231441/ 
Placebo 14 Male 170 77.4 26.8 Black or African American    Hispanic/Latino  09DEC2020 
C4591001 1123 
11231442/ 
Placebo 12 Male 164 86.5 32.2 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1123 
11231443/ 
BNT162b2 (30 μg) 14 Female 163 61.1 23 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1123 
11231445/ 
Placebo 12 Female 147 36.7 17 White    Non-Hispanic/non-
Latino 09DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 124
FDA-CBER-2022-5812-0224428
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1123 
11231446/ 
BNT162b2 (30 μg) 14 Male 174.5 56 18.4 White    Non-Hispanic/non-
Latino 09DEC2020 
C4591001 1123 
11231447/ 
BNT162b2 (30 μg) 13 Male 149 43.6 19.6 White    Non-Hispanic/non-
Latino 10DEC2020 
C4591001 1123 
11231448/ 
Placebo 13 Male 170 117 40.5 Black or African American    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1123 
11231449/ 
BNT162b2 (30 μg) 15 Female 135.2 64 35 White    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1123 
11231450/ 
Placebo 15 Male 179 68.5 21.4 Black or African American    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1123 
11231451/ 
BNT162b2 (30 μg) 12 Male 164.1 68.9 25.6 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1123 
11231452/ 
Placebo 15 Female 164 58.5 21.8 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1123 
11231453/ 
BNT162b2 (30 μg) 12 Male 167 69.2 24.8 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1123 
11231454/ 
Placebo 15 Female 171 50.8 17.4 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1123 
11231455/ 
BNT162b2 (30 μg) 13 Female 166.5 61.7 22.3 White    Non-Hispanic/non-
Latino 15DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 125
FDA-CBER-2022-5812-0224429
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1123 
11231456/ 
Placebo 13 Female 158.1 58.1 23.2 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1123 
11231457/ 
Placebo 15 Female 158.5 38.6 15.4 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1123 
11231458/ 
BNT162b2 (30 μg) 12 Female 161 62.9 24.3 White    Hispanic/Latino  16DEC2020 
C4591001 1123 
11231459/ 
BNT162b2 (30 μg) 15 Female 165 75.4 27.7 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1123 
11231460/ 
Placebo 15 Female 164 58 21.6 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1123 
11231461/ 
BNT162b2 (30 μg) 15 Male 201 80.9 20 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1123 
11231462/ 
BNT162b2 (30 μg) 12 Male 157.5 51 20.6 White    Non-Hispanic/non-
Latino 17DEC2020 
C4591001 1123 
11231463/ 
Placebo 14 Female 171 47.9 16.4 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1123 
11231465/ 
Placebo 14 Female 165.5 51.1 18.7 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1123 
11231466/ 
BNT162b2 (30 μg) 13 Female 155 34.9 14.5 White    Non-Hispanic/non-
Latino 18DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 126
FDA-CBER-2022-5812-0224430
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1123 
11231467/ 
Placebo 13 Male 159.2 51.2 20.2 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1123 
11231468/ 
Placebo 15 Female 167.5 74.7 26.6 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1123 
11231469/ 
BNT162b2 (30 μg) 14 Female 164 64.6 24 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1123 
11231470/ 
Placebo 13 Female 159 60.6 24 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1123 
11231472/ 
BNT162b2 (30 μg) 15 Female 165 47.4 17.4 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1123 
11231473/ 
Placebo 15 Female 163 54 20.3 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1123 
11231474/ 
BNT162b2 (30 μg) 12 Female 162.5 61.1 23.1 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1123 
11231475/ 
BNT162b2 (30 μg) 14 Male 174 72.5 23.9 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1123 
11231476/ 
Placebo 13 Female 164.5 44.5 16.4 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1123 
11231477/ 
BNT162b2 (30 μg) 12 Female 148.5 39.9 18.1 White    Non-Hispanic/non-
Latino 21DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 127
FDA-CBER-2022-5812-0224431
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1123 
11231478/ 
Placebo 13 Female 156.5 54.4 22.2 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1123 
11231479/ 
Placebo 14 Female 170.5 62.2 21.4 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1123 
11231481/ 
BNT162b2 (30 μg) 15 Female 172.5 49.7 16.7 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1123 
11231482/ 
BNT162b2 (30 μg) 13 Male 162.5 51.6 19.5 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1123 
11231483/ 
Placebo 12 Female 167 53.6 19.2 Multiracial    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1123 
11231484/ 
BNT162b2 (30 μg) 14 Female 158 38.8 15.5 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1123 
11231485/ 
Placebo 13 Female 165 47 17.3 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1123 
11231486/ 
BNT162b2 (30 μg) 14 Female 163.2 53.5 20.1 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1123 
11231487/ 
Placebo 14 Male 170 72.7 25.2 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1123 
11231488/ 
BNT162b2 (30 μg) 12 Female 159 44.7 17.7 White    Non-Hispanic/non-
Latino 22DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 128
FDA-CBER-2022-5812-0224432
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1123 
11231489/ 
BNT162b2 (30 μg) 13 Male 160 43.8 17.1 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1123 
11231491/ 
Placebo 14 Male 174.1 49.9 16.5 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1123 
11231492/ 
Placebo 15 Male 188 99 28 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1123 
11231493/ 
BNT162b2 (30 μg) 14 Male 184 107.5 31.8 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1123 
11231494/ 
BNT162b2 (30 μg) 13 Female 164.5 51.1 18.9 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1123 
11231495/ 
BNT162b2 (30 μg) 15 Male 192.3 84.7 22.9 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1123 
11231496/ 
Placebo 13 Female 166.2 46.6 16.9 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1123 
11231497/ 
Placebo 13 Male 180 76.1 23.5 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1123 
11231499/ 
Placebo 12 Male 165.5 59.2 21.6 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1123 
11231500/ 
BNT162b2 (30 μg) 14 Male 177.6 65.6 20.8 White    Non-Hispanic/non-
Latino 28DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 129
FDA-CBER-2022-5812-0224433
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1123 
11231501/ 
Placebo 12 Female 167 67.1 24.1 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1123 
11231502/ 
BNT162b2 (30 μg) 14 Female 176 59.9 19.3 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1123 
11231503/ 
Placebo 13 Female 155 38.2 15.9 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1123 
11231504/ 
BNT162b2 (30 μg) 15 Male 178 62.7 19.8 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1123 
11231505/ 
Placebo 12 Female 164.5 49.9 18.4 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1123 
11231506/ 
BNT162b2 (30 μg) 12 Female 160 55.9 21.8 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1123 
11231507/ 
BNT162b2 (30 μg) 14 Female 162.5 50.7 19.2 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1123 
11231508/ 
BNT162b2 (30 μg) 13 Female 165 51.5 18.9 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1123 
11231509/ 
Placebo 12 Female 161.5 51.4 19.7 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1123 
11231510/ 
Placebo 13 Female 165 52 19.1 White    Non-Hispanic/non-
Latino 29DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 130
FDA-CBER-2022-5812-0224434
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1123 
11231511/ 
BNT162b2 (30 μg) 13 Male 170 57.1 19.8 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1123 
11231512/ 
BNT162b2 (30 μg) 13 Female 163.5 52.9 19.8 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1123 
11231513/ 
Placebo 12 Male 156 43.7 18 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1123 
11231514/ 
Placebo 15 Male 180 60.4 18.6 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1123 
11231515/ 
Placebo 14 Male 171.5 56.4 19.2 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1123 
11231516/ 
Placebo 13 Male 177 78.7 25.1 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1123 
11231517/ 
BNT162b2 (30 μg) 15 Male 177 56.5 18 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1123 
11231518/ 
BNT162b2 (30 μg) 15 Male 185 107.1 31.3 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1123 
11231519/ 
BNT162b2 (30 μg) 12 Female 154.9 84.1 35.1 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1123 
11231520/ 
Placebo 12 Male 160 38.3 15 White    Non-Hispanic/non-
Latino 30DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 131
FDA-CBER-2022-5812-0224435
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1123 
11231521/ 
BNT162b2 (30 μg) 12 Female 147.3 37.7 17.4 White    Non-Hispanic/non-
Latino 30DEC2020 
C4591001 1123 
11231522/ 
Placebo 15 Male 162.5 40.4 15.3 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1123 
11231523/ 
Placebo 12 Male 155 33.3 13.9 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1123 
11231524/ 
BNT162b2 (30 μg) 14 Male 178 59 18.6 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1123 
11231525/ 
BNT162b2 (30 μg) 14 Female 170 68 23.5 White    Non-Hispanic/non-
Latino 07JAN2021 
C4591001 1123 
11231526/ 
Placebo 14 Female 165 78.2 28.7 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1124 
11241236/ 
Placebo 13 Female 160.02 63.18 24.6 Asian    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1124 
11241238/ 
BNT162b2 (30 μg) 13 Male 165.1 52.27 19.1 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1124 
11241239/ 
BNT162b2 (30 μg) 12 Male 165.1 36.36 13.3 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1124 
11241240/ 
Placebo 15 Female 167.64 61.36 21.8 White    Non-Hispanic/non-
Latino 14DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 132
FDA-CBER-2022-5812-0224436
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1124 
11241241/ 
Placebo 13 Male 152.4 50 21.5 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1124 
11241242/ 
Placebo 14 Male 177.8 97.73 30.8 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1124 
11241243/ 
BNT162b2 (30 μg) 13 Male 165.1 94.09 34.4 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1124 
11241244/ 
BNT162b2 (30 μg) 12 Female 152.4 42 18 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1124 
11241245/ 
BNT162b2 (30 μg) 14 Female 162.56 54.55 20.6 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1124 
11241246/ 
BNT162b2 (30 μg) 12 Female 152.4 43.64 18.7 White    Non-Hispanic/non-
Latino 15DEC2020 
C4591001 1124 
11241247/ 
Placebo 13 Male 162.56 75 28.3 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1124 
11241248/ 
Placebo 13 Female 152.4 50 21.5 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1124 
11241249/ 
BNT162b2 (30 μg) 14 Male 162.56 43.64 16.5 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1124 
11241250/ 
Placebo 12 Female 157.48 43.18 17.4 White    Non-Hispanic/non-
Latino 17DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 133
FDA-CBER-2022-5812-0224437
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1124 
11241251/ 
BNT162b2 (30 μg) 15 Female 154.94 52.73 21.9 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1124 
11241252/ 
Placebo 13 Male 147.32 38.64 17.8 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1124 
11241253/ 
BNT162b2 (30 μg) 12 Female 160.02 40 15.6 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1124 
11241254/ 
BNT162b2 (30 μg) 14 Male 172.72 50 16.7 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1124 
11241255/ 
Placebo 13 Female 152.4 49.55 21.3 White    Non-Hispanic/non-
Latino 18DEC2020 
C4591001 1124 
11241256/ 
Placebo 12 Male 154.94 44.09 18.3 White    Non-Hispanic/non-
Latino 21DEC2020 
C4591001 1124 
11241257/ 
Placebo 13 Female 149.86 37.27 16.6 White    Non-Hispanic/non-
Latino 22DEC2020 
C4591001 1124 
11241258/ 
Placebo 14 Female 162.56 73 27.6 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1124 
11241259/ 
BNT162b2 (30 μg) 13 Female 165.1 72.09 26.4 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1124 
11241260/ 
BNT162b2 (30 μg) 13 Male 162.56 75.09 28.4 White    Non-Hispanic/non-
Latino 23DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 134
FDA-CBER-2022-5812-0224438
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1124 
11241261/ 
BNT162b2 (30 μg) 13 Male 149.86 40.91 18.2 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1124 
11241262/ 
BNT162b2 (30 μg) 15 Female 175.26 61 19.8 White    Non-Hispanic/non-
Latino 23DEC2020 
C4591001 1124 
11241263/ 
Placebo 13 Female 162.56 57.27 21.6 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1124 
11241264/ 
Placebo 14 Male 154.94 42.82 17.8 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1124 
11241265/ 
BNT162b2 (30 μg) 14 Female 165.1 56.82 20.8 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1124 
11241266/ 
BNT162b2 (30 μg) 12 Male 147.32 39.09 18 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1124 
11241267/ 
Placebo 12 Male 149.86 39.09 17.4 White    Non-Hispanic/non-
Latino 29DEC2020 
C4591001 1124 
11241268/ 
Placebo 14 Female 157.48 63.64 25.6 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1124 
11241269/ 
BNT162b2 (30 μg) 15 Male 177.8 54.45 17.2 White    Non-Hispanic/non-
Latino 04JAN2021 
C4591001 1124 
11241270/ 
Placebo 15 Female 154.94 54.55 22.7 White    Non-Hispanic/non-
Latino 05JAN2021 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 135
FDA-CBER-2022-5812-0224439
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1124 
11241271/ 
BNT162b2 (30 μg) 12 Male 167.64 57.36 20.4 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1124 
11241272/ 
Placebo 12 Male 142.24 37.27 18.4 White    Non-Hispanic/non-
Latino 05JAN2021 
C4591001 1124 
11241273/ 
BNT162b2 (30 μg) 12 Female 149.86 48.36 21.5 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1124 
11241274/ 
Placebo 15 Male 167.64 47.55 16.9 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1124 
11241275/ 
BNT162b2 (30 μg) 13 Male 161.29 41.18 15.8 White    Non-Hispanic/non-
Latino 08JAN2021 
C4591001 1125 
11251241/ 
BNT162b2 (30 μg) 15 Female 165.1 69.09 25.3 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1125 
11251242/ 
Placebo 15 Female 168.9 57.1 20 White    Non-Hispanic/non-
Latino 07DEC2020 
C4591001 1125 
11251244/ 
Placebo 13 Female 152.4 41.36 17.8 White    Non-Hispanic/non-
Latino 08DEC2020 
C4591001 1125 
11251246/ 
BNT162b2 (30 μg) 13 Female 170.18 91.36 31.5 White    Hispanic/Latino  10DEC2020 
C4591001 1125 
11251248/ 
Placebo 15 Male 180.34 75 23 White    Non-Hispanic/non-
Latino 11DEC2020 
090177e1988b7710\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 136
FDA-CBER-2022-5812-0224440
16.2.4 Listing of Demographic Characteristics – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Age 
(Years) Sex Height
(cm)Weight
(kg) Body 
Mass 
Index 
(BMI) 
(kg/m2) Race Racial 
Designation Ethnicity Informed Consent 
Date 
(Screening) 
  
C4591001 1125 
11251249/ 
Placebo 14 Female 170.18 64.55 22.2 White    Non-Hispanic/non-
Latino 11DEC2020 
C4591001 1125 
11251250/ 
BNT162b2 (30 μg) 12 Male 153.67 60 25.4 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1125 
11251251/ 
BNT162b2 (30 μg) 13 Female 167.6 64.8 23.1 White    Non-Hispanic/non-
Latino 14DEC2020 
C4591001 1125 
11251252/ 
BNT162b2 (30 μg) 13 Male 170.18 72.73 25.1 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1125 
11251253/ 
Placebo 12 Male 162.56 47.73 18 White    Non-Hispanic/non-
Latino 16DEC2020 
C4591001 1125 
11251254/ 
Placebo 13 Male 172.72 56.36 18.9 White    Non-Hispanic/non-
Latino 28DEC2020 
C4591001 1125 
11251255/ 
BNT162b2 (30 μg) 12 Male 156.21 55.45 22.7 White    Non-Hispanic/non-
Latino 06JAN2021 
C4591001 1126 
11261229/ 
BNT162b2 (30 μg) 14 Male 172.7 55.5 18.6 White    Non-Hispanic/non-
Latino 30NOV2020 
C4591001 1126 
11261230/ 
BNT162b2 (30 μg) 13 Male 175.3 68.4 22.3 White    Non-Hispanic/non-
Latino 30NOV2020 
C4591001 1126 
1126123
…[truncated]