125742 45 S211 M5 c4591001 interim ado mth6 randomization

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 12 15 Documents

218

Document text

16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10051317 C4591001 1005 
10051317 20OCT2020 20158 BNT162b2 
(30 μg) 20OCT2020/
BNT162b2 
(30 μg)12NOV2020/
BNT162b2 
(30 μg)    
10051328 C4591001 1005 
10051328 20OCT2020 20159 BNT162b2 
(30 μg) 20OCT2020/
BNT162b2 
(30 μg)11NOV2020/
BNT162b2 
(30 μg)    
10051339 C4591001 1005 
10051339 21OCT2020 20160 Placebo 21OCT2020/
Placebo 11NOV2020/
Placebo 17MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10051410 C4591001 1005 
10051410 09DEC2020 20163 Placebo 09DEC2020/
Placebo 29DEC2020/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10051412 C4591001 1005 
10051412 14DEC2020 22270 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)05JAN2021/
BNT162b2 
(30 μg)    
10051413 C4591001 1005 
10051413 14DEC2020 22269 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)04JAN2021/
BNT162b2 
(30 μg)    
10051414 C4591001 1005 
10051414 14DEC2020 22273 Placebo 14DEC2020/
Placebo 04JAN2021/
Placebo 25MAY2021/
BNT162b2 
(30 μg)25JUN2021/
BNT162b2 
(30 μg)
10051415 C4591001 1005 
10051415 14DEC2020 22274 Placebo 14DEC2020/
Placebo 04JAN2021/
Placebo 20MAY2021/
BNT162b2 
(30 μg)10JUN2021/
BNT162b2 
(30 μg)
10051417 C4591001 1005 
10051417 16DEC2020 22785 Placebo 16DEC2020/
Placebo 06JAN2021/
Placebo 20JUL2021/
BNT162b2 
(30 μg)13AUG2021/
BNT162b2 
(30 μg)
10051418 C4591001 1005 
10051418 16DEC2020 22786 BNT162b2 
(30 μg) 16DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 1
FDA-CBER-2022-5812-0228206
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10051419 C4591001 1005 
10051419 16DEC2020 22794 Placebo 16DEC2020/
Placebo 04JAN2021/
Placebo 24FEB2021/
BNT162b2 
(30 μg)17MAR2021/
BNT162b2 
(30 μg)
10051420 C4591001 1005 
10051420 16DEC2020 22792 BNT162b2 
(30 μg) 16DEC2020/
BNT162b2 
(30 μg)04JAN2021/
BNT162b2 
(30 μg)    
10051421 C4591001 1005 
10051421 17DEC2020 23097 Placebo 17DEC2020/
Placebo 07JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10051422 C4591001 1005 
10051422 17DEC2020 23098 Placebo 17DEC2020/
Placebo 07JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10051424 C4591001 1005 
10051424 18DEC2020 23100 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)08JAN2021/
BNT162b2 
(30 μg)    
10051425 C4591001 1005 
10051425 18DEC2020 23101 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)08JAN2021/
BNT162b2 
(30 μg)    
10051427 C4591001 1005 
10051427 21DEC2020 23589 Placebo 21DEC2020/
Placebo 11JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10051428 C4591001 1005 
10051428 21DEC2020 23596 BNT162b2 
(30 μg) 21DEC2020/
BNT162b2 
(30 μg)13JAN2021/
BNT162b2 
(30 μg)    
10051429 C4591001 1005 
10051429 21DEC2020 23597 BNT162b2 
(30 μg) 21DEC2020/
BNT162b2 
(30 μg)11JAN2021/
BNT162b2 
(30 μg)    
10051430 C4591001 1005 
10051430 22DEC2020 23600 Placebo 22DEC2020/
Placebo 12JAN2021/
Placebo 22APR2021/
BNT162b2 
(30 μg)13MAY2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 2
FDA-CBER-2022-5812-0228207
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10051431 C4591001 1005 
10051431 22DEC2020 23890 BNT162b2 
(30 μg) 22DEC2020/
BNT162b2 
(30 μg)12JAN2021/
BNT162b2 
(30 μg)    
10051436 C4591001 1005 
10051436 22DEC2020 23897 BNT162b2 
(30 μg) 22DEC2020/
BNT162b2 
(30 μg)12JAN2021/
BNT162b2 
(30 μg)    
10051437 C4591001 1005 
10051437 22DEC2020 23894 Placebo 22DEC2020/
Placebo 12JAN2021/
Placebo 27MAY2021/
BNT162b2 
(30 μg)17JUN2021/
BNT162b2 
(30 μg)
10051438 C4591001 1005 
10051438 22DEC2020 23892 Placebo 22DEC2020/
Placebo 12JAN2021/
Placebo 27MAY2021/
BNT162b2 
(30 μg)17JUN2021/
BNT162b2 
(30 μg)
10051439 C4591001 1005 
10051439 22DEC2020 24039 BNT162b2 
(30 μg) 22DEC2020/
BNT162b2 
(30 μg)11JAN2021/
BNT162b2 
(30 μg)    
10051440 C4591001 1005 
10051440 22DEC2020 24041 Placebo 22DEC2020/
Placebo 11JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10051441 C4591001 1005 
10051441 22DEC2020 24034 BNT162b2 
(30 μg) 22DEC2020/
BNT162b2 
(30 μg)12JAN2021/
BNT162b2 
(30 μg)    
10051444 C4591001 1005 
10051444 22DEC2020 24043 Placebo 22DEC2020/
Placebo 12JAN2021/
Placebo 20MAY2021/
BNT162b2 
(30 μg)10JUN2021/
BNT162b2 
(30 μg)
10051445 C4591001 1005 
10051445 22DEC2020 24130 Placebo 22DEC2020/
Placebo 12JAN2021/
Placebo 26MAY2021/
BNT162b2 
(30 μg)16JUN2021/
BNT162b2 
(30 μg)
10051447 C4591001 1005 
10051447 11JAN2021 24134 BNT162b2 
(30 μg) 11JAN2021/
BNT162b2 
(30 μg)01FEB2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 3
FDA-CBER-2022-5812-0228208
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10051448 C4591001 1005 
10051448 11JAN2021 24138 Placebo 11JAN2021/
Placebo 01FEB2021/
Placebo 26MAY2021/
BNT162b2 
(30 μg)16JUN2021/
BNT162b2 
(30 μg)
10051449 C4591001 1005 
10051449 11JAN2021 24137 BNT162b2 
(30 μg) 11JAN2021/
BNT162b2 
(30 μg)01FEB2021/
BNT162b2 
(30 μg)    
10051450 C4591001 1005 
10051450 11JAN2021 26654 Placebo 11JAN2021/
Placebo 01FEB2021/
Placebo 24MAY2021/
BNT162b2 
(30 μg)14JUN2021/
BNT162b2 
(30 μg)
10051451 C4591001 1005 
10051451 12JAN2021 26655 BNT162b2 
(30 μg) 12JAN2021/
BNT162b2 
(30 μg)03FEB2021/
BNT162b2 
(30 μg)    
10061183 C4591001 1006 
10061183 30NOV2020 20339 Placebo 30NOV2020/
Placebo 07JAN2021/
Placebo 20MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10061184 C4591001 1006 
10061184 30NOV2020 20340 BNT162b2 
(30 μg) 30NOV2020/
BNT162b2 
(30 μg)21DEC2020/
BNT162b2 
(30 μg)    
10061188 C4591001 1006 
10061188 01DEC2020 20341 Placebo 01DEC2020/
Placebo 22DEC2020/
Placebo 18MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10061189 C4591001 1006 
10061189 01DEC2020 20348 BNT162b2 
(30 μg) 01DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10061190 C4591001 1006 
10061190 02DEC2020 20638 BNT162b2 
(30 μg) 02DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10061191 C4591001 1006 
10061191 02DEC2020 20640 BNT162b2 
(30 μg) 02DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 4
FDA-CBER-2022-5812-0228209
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10061196 C4591001 1006 
10061196 02DEC2020 20644 Placebo 02DEC2020/
Placebo 21DEC2020/
Placebo 19MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10061200 C4591001 1006 
10061200 03DEC2020 20647 Placebo 03DEC2020/
Placebo 24DEC2020/
Placebo 16MAR2021/
BNT162b2 
(30 μg)07APR2021/
BNT162b2 
(30 μg)
10061201 C4591001 1006 
10061201 03DEC2020 20867 BNT162b2 
(30 μg) 03DEC2020/
BNT162b2 
(30 μg)24DEC2020/
BNT162b2 
(30 μg)    
10061203 C4591001 1006 
10061203 03DEC2020 20871 BNT162b2 
(30 μg) 03DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10061206 C4591001 1006 
10061206 04DEC2020 20872 Placebo 04DEC2020/
Placebo23DEC2020/
Placebo    
10061207 C4591001 1006 
10061207 04DEC2020 20874 Placebo 04DEC2020/
Placebo23DEC2020/
Placebo    
10061209 C4591001 1006 
10061209 04DEC2020 20998 BNT162b2 
(30 μg) 04DEC2020/
BNT162b2 
(30 μg)23DEC2020/
BNT162b2 
(30 μg)    
10061212 C4591001 1006 
10061212 04DEC2020 20999 Placebo 04DEC2020/
Placebo 23DEC2020/
Placebo 18MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10061213 C4591001 1006 
10061213 04DEC2020 21000 BNT162b2 
(30 μg) 04DEC2020/
BNT162b2 
(30 μg)23DEC2020/
BNT162b2 
(30 μg)    
10061214 C4591001 1006 
10061214 04DEC2020 21001 Placebo 04DEC2020/
Placebo 23DEC2020/
Placebo 18MAY2021/
BNT162b2 
(30 μg)21JUN2021/
BNT162b2 
(30 μg)
10061219 C4591001 1006 
10061219 07DEC2020 21141 Placebo 07DEC2020/
Placebo 24DEC2020/
Placebo 15JUN2021/
BNT162b2 
(30 μg)30JUL2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 5
FDA-CBER-2022-5812-0228210
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10061220 C4591001 1006 
10061220 07DEC2020 21143 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10061221 C4591001 1006 
10061221 07DEC2020 21147 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10061223 C4591001 1006 
10061223 07DEC2020 21152 Placebo 07DEC2020/
Placebo 30DEC2020/
Placebo 17MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10061224 C4591001 1006 
10061224 07DEC2020 21261 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10061226 C4591001 1006 
10061226 07DEC2020 21262 Placebo 07DEC2020/
Placebo 28DEC2020/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10061227 C4591001 1006 
10061227 07DEC2020 21264 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10061228 C4591001 1006 
10061228 08DEC2020 21267 Placebo 08DEC2020/
Placebo 29DEC2020/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10061229 C4591001 1006 
10061229 08DEC2020 21442 Placebo 08DEC2020/
Placebo 29DEC2020/
Placebo 18FEB2021/
BNT162b2 
(30 μg)11MAR2021/
BNT162b2 
(30 μg)
10061230 C4591001 1006 
10061230 08DEC2020 21446 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)31DEC2020/
BNT162b2 
(30 μg)    
10061231 C4591001 1006 
10061231 08DEC2020 21448 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 6
FDA-CBER-2022-5812-0228211
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10061232 C4591001 1006 
10061232 08DEC2020 21450 Placebo 08DEC2020/
Placebo 29DEC2020/
Placebo 18MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10061233 C4591001 1006 
10061233 08DEC2020 21561 Placebo 08DEC2020/
Placebo 29DEC2020/
Placebo 18MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10061234 C4591001 1006 
10061234 09DEC2020 21563 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10061235 C4591001 1006 
10061235 09DEC2020 21568 Placebo 09DEC2020/
Placebo 30DEC2020/
Placebo 19MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10061236 C4591001 1006 
10061236 09DEC2020 21571 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10061237 C4591001 1006 
10061237 09DEC2020 21696 Placebo 09DEC2020/
Placebo 28DEC2020/
Placebo 14MAY2021/
BNT162b2 
(30 μg)02JUN2021/
BNT162b2 
(30 μg)
10061239 C4591001 1006 
10061239 09DEC2020 21699 Placebo 09DEC2020/
Placebo 30DEC2020/
Placebo 17MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10061241 C4591001 1006 
10061241 09DEC2020 21702 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10061242 C4591001 1006 
10061242 09DEC2020 21704 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10061243 C4591001 1006 
10061243 10DEC2020 21864 BNT162b2 
(30 μg) 10DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 7
FDA-CBER-2022-5812-0228212
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10061244 C4591001 1006 
10061244 10DEC2020 21865 BNT162b2 
(30 μg) 10DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10061245 C4591001 1006 
10061245 10DEC2020 21869 Placebo 10DEC2020/
Placebo 29DEC2020/
Placebo 18MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10061247 C4591001 1006 
10061247 10DEC2020 21871 Placebo 10DEC2020/
Placebo 29DEC2020/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10061248 C4591001 1006 
10061248 11DEC2020 22046 Placebo 11DEC2020/
Placebo 30DEC2020/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10061249 C4591001 1006 
10061249 11DEC2020 22047 BNT162b2 
(30 μg) 11DEC2020/
BNT162b2 
(30 μg)31DEC2020/
BNT162b2 
(30 μg)    
10061250 C4591001 1006 
10061250 11DEC2020 22050 Placebo 11DEC2020/
Placebo 31DEC2020/
Placebo 20MAY2021/
BNT162b2 
(30 μg)28JUN2021/
BNT162b2 
(30 μg)
10061252 C4591001 1006 
10061252 11DEC2020 22051 BNT162b2 
(30 μg) 11DEC2020/
BNT162b2 
(30 μg)31DEC2020/
BNT162b2 
(30 μg)    
10061253 C4591001 1006 
10061253 11DEC2020 22173 Placebo 11DEC2020/
Placebo 30DEC2020/
Placebo 17MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10061254 C4591001 1006 
10061254 11DEC2020 22174 BNT162b2 
(30 μg) 11DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10061256 C4591001 1006 
10061256 11DEC2020 22176 BNT162b2 
(30 μg) 11DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 8
FDA-CBER-2022-5812-0228213
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10061257 C4591001 1006 
10061257 11DEC2020 22182 Placebo 11DEC2020/
Placebo 30DEC2020/
Placebo 19FEB2021/
BNT162b2 
(30 μg)12MAR2021/
BNT162b2 
(30 μg)
10061258 C4591001 1006 
10061258 14DEC2020 22296 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)05JAN2021/
BNT162b2 
(30 μg)    
10061259 C4591001 1006 
10061259 14DEC2020 22300 Placebo 14DEC2020/
Placebo 05JAN2021/
Placebo 19MAR2021/
BNT162b2 
(30 μg)13APR2021/
BNT162b2 
(30 μg)
10061260 C4591001 1006 
10061260 14DEC2020 22302 Placebo 14DEC2020/
Placebo 05JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10061261 C4591001 1006 
10061261 14DEC2020 22303 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)05JAN2021/
BNT162b2 
(30 μg)    
10061262 C4591001 1006 
10061262 14DEC2020 22426 Placebo 14DEC2020/
Placebo 06JAN2021/
Placebo 25MAY2021/
BNT162b2 
(30 μg)07JUL2021/
BNT162b2 
(30 μg)
10061263 C4591001 1006 
10061263 14DEC2020 22428 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)04JAN2021/
BNT162b2 
(30 μg)    
10061264 C4591001 1006 
10061264 14DEC2020 22429 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)04JAN2021/
BNT162b2 
(30 μg)    
10061265 C4591001 1006 
10061265 18DEC2020 23313 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10061266 C4591001 1006 
10061266 15DEC2020 22433 Placebo 15DEC2020/
Placebo 06JAN2021/
Placebo 24FEB2021/
BNT162b2 
(30 μg)17MAR2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 9
FDA-CBER-2022-5812-0228214
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10061267 C4591001 1006 
10061267 15DEC2020 22558 Placebo 15DEC2020/
Placebo 22JAN2021/
Placebo 21JUL2021/
BNT162b2 
(30 μg)13AUG2021/
BNT162b2 
(30 μg)
10061269 C4591001 1006 
10061269 15DEC2020 22561 BNT162b2 
(30 μg) 15DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10061270 C4591001 1006 
10061270 16DEC2020 22562 Placebo 16DEC2020/
Placebo 06JAN2021/
Placebo 18FEB2021/
BNT162b2 
(30 μg)11MAR2021/
BNT162b2 
(30 μg)
10061271 C4591001 1006 
10061271 16DEC2020 22566 BNT162b2 
(30 μg) 16DEC2020/
BNT162b2 
(30 μg)05JAN2021/
BNT162b2 
(30 μg)    
10061272 C4591001 1006 
10061272 16DEC2020 22821 BNT162b2 
(30 μg) 16DEC2020/
BNT162b2 
(30 μg)      
10061273 C4591001 1006 
10061273 16DEC2020 22823 Placebo 16DEC2020/
Placebo 08JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)10JUN2021/
BNT162b2 
(30 μg)
10061274 C4591001 1006 
10061274 16DEC2020 22830 BNT162b2 
(30 μg) 16DEC2020/
BNT162b2 
(30 μg)08JAN2021/
BNT162b2 
(30 μg)    
10061276 C4591001 1006 
10061276 17DEC2020 22831 Placebo 17DEC2020/
Placebo 06JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)22JUN2021/
BNT162b2 
(30 μg)
10061277 C4591001 1006 
10061277 17DEC2020 23159 Placebo 17DEC2020/
Placebo 08JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10061278 C4591001 1006 
10061278 17DEC2020 23162 BNT162b2 
(30 μg) 17DEC2020/
BNT162b2 
(30 μg)05JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 10
FDA-CBER-2022-5812-0228215
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10061279 C4591001 1006 
10061279 17DEC2020 23166 Placebo 17DEC2020/
Placebo 05JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10061280 C4591001 1006 
10061280 17DEC2020 23168 BNT162b2 
(30 μg) 17DEC2020/
BNT162b2 
(30 μg)07JAN2021/
BNT162b2 
(30 μg)    
10061282 C4591001 1006 
10061282 18DEC2020 23314 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)08JAN2021/
BNT162b2 
(30 μg)    
10061283 C4591001 1006 
10061283 18DEC2020 23315 Placebo 18DEC2020/
Placebo 08JAN2021/
Placebo 20MAY2021/
BNT162b2 
(30 μg)10JUN2021/
BNT162b2 
(30 μg)
10061284 C4591001 1006 
10061284 18DEC2020 23318 Placebo 18DEC2020/
Placebo 08JAN2021/
Placebo 25MAY2021/
BNT162b2 
(30 μg)15JUN2021/
BNT162b2 
(30 μg)
10061285 C4591001 1006 
10061285 21DEC2020 23702 Placebo 21DEC2020/
Placebo 12JAN2021/
Placebo 03JUN2021/
BNT162b2 
(30 μg)22JUN2021/
BNT162b2 
(30 μg)
10061286 C4591001 1006 
10061286 21DEC2020 23704 BNT162b2 
(30 μg) 21DEC2020/
BNT162b2 
(30 μg)11JAN2021/
BNT162b2 
(30 μg)    
10061287 C4591001 1006 
10061287 21DEC2020 23706 Placebo 21DEC2020/
Placebo11JAN2021/
Placebo    
10061288 C4591001 1006 
10061288 21DEC2020 23708 BNT162b2 
(30 μg) 21DEC2020/
BNT162b2 
(30 μg)11JAN2021/
BNT162b2 
(30 μg)    
10061289 C4591001 1006 
10061289 22DEC2020 23941 BNT162b2 
(30 μg) 22DEC2020/
BNT162b2 
(30 μg)13JAN2021/
BNT162b2 
(30 μg)    
10061290 C4591001 1006 
10061290 22DEC2020 23943 BNT162b2 
(30 μg) 22DEC2020/
BNT162b2 
(30 μg)13JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 11
FDA-CBER-2022-5812-0228216
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10061291 C4591001 1006 
10061291 22DEC2020 23946 Placebo 22DEC2020/
Placebo 13JAN2021/
Placebo 24MAY2021/
BNT162b2 
(30 μg)14JUN2021/
BNT162b2 
(30 μg)
10061292 C4591001 1006 
10061292 22DEC2020 23948 Placebo 22DEC2020/
Placebo 12JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)02JUN2021/
BNT162b2 
(30 μg)
10061293 C4591001 1006 
10061293 22DEC2020 24050 BNT162b2 
(30 μg) 22DEC2020/
BNT162b2 
(30 μg)12JAN2021/
BNT162b2 
(30 μg)    
10061294 C4591001 1006 
10061294 22DEC2020 24054 Placebo 22DEC2020/
Placebo 12JAN2021/
Placebo 20MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10061295 C4591001 1006 
10061295 24DEC2020 24056 Placebo 24DEC2020/
Placebo 12JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)02JUN2021/
BNT162b2 
(30 μg)
10061296 C4591001 1006 
10061296 29DEC2020 24611 Placebo 29DEC2020/
Placebo19JAN2021/
Placebo    
10061297 C4591001 1006 
10061297 29DEC2020 24612 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)19JAN2021/
BNT162b2 
(30 μg)    
10061298 C4591001 1006 
10061298 29DEC2020 24617 Placebo 29DEC2020/
Placebo 20JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10061299 C4591001 1006 
10061299 31DEC2020 24618 BNT162b2 
(30 μg) 31DEC2020/
BNT162b2 
(30 μg)22JAN2021/
BNT162b2 
(30 μg)    
10061300 C4591001 1006 
10061300 07JAN2021 26122 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)28JAN2021/
BNT162b2 
(30 μg)    
10071409 C4591001 1007 
10071409 22OCT2020 20265 BNT162b2 
(30 μg) 22OCT2020/
BNT162b2 
(30 μg)      
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 12
FDA-CBER-2022-5812-0228217
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10071414 C4591001 1007 
10071414 22OCT2020 20268 Placebo 22OCT2020/
Placebo 12NOV2020/
Placebo 19MAY2021/
BNT162b2 
(30 μg)14JUN2021/
BNT162b2 
(30 μg)
10071415 C4591001 1007 
10071415 22OCT2020 20271 Placebo 22OCT2020/
Placebo10DEC2020/
Placebo    
10071417 C4591001 1007 
10071417 22OCT2020 20272 BNT162b2 
(30 μg) 22OCT2020/
BNT162b2 
(30 μg)12NOV2020/
BNT162b2 
(30 μg)    
10071428 C4591001 1007 
10071428 22OCT2020 20292 Placebo 22OCT2020/
Placebo12NOV2020/
Placebo    
10071429 C4591001 1007 
10071429 22OCT2020 20295 Placebo 22OCT2020/
Placebo12NOV2020/
Placebo    
10071467 C4591001 1007 
10071467 30NOV2020 20296 BNT162b2 
(30 μg) 30NOV2020/
BNT162b2 
(30 μg)21DEC2020/
BNT162b2 
(30 μg)    
10071469 C4591001 1007 
10071469 30NOV2020 20298 BNT162b2 
(30 μg) 30NOV2020/
BNT162b2 
(30 μg)21DEC2020/
BNT162b2 
(30 μg)    
10071471 C4591001 1007 
10071471 30NOV2020 20374 BNT162b2 
(30 μg) 30NOV2020/
BNT162b2 
(30 μg)21DEC2020/
BNT162b2 
(30 μg)    
10071472 C4591001 1007 
10071472 30NOV2020 20375 Placebo 30NOV2020/
Placebo 21DEC2020/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10071475 C4591001 1007 
10071475 30NOV2020 20378 BNT162b2 
(30 μg) 30NOV2020/
BNT162b2 
(30 μg)21DEC2020/
BNT162b2 
(30 μg)    
10071476 C4591001 1007 
10071476 30NOV2020 20446 BNT162b2 
(30 μg) 30NOV2020/
BNT162b2 
(30 μg)21DEC2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 13
FDA-CBER-2022-5812-0228218
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10071478 C4591001 1007 
10071478 30NOV2020 20384 Placebo 30NOV2020/
Placebo 21DEC2020/
Placebo 20MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10071480 C4591001 1007 
10071480 30NOV2020 20447 Placebo 30NOV2020/
Placebo 21DEC2020/
Placebo 17MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10071481 C4591001 1007 
10071481 01DEC2020 20449 Placebo 01DEC2020/
Placebo 22DEC2020/
Placebo 07JUN2021/
BNT162b2 
(30 μg)28JUN2021/
BNT162b2 
(30 μg)
10071482 C4591001 1007 
10071482 01DEC2020 20455 BNT162b2 
(30 μg) 01DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10071483 C4591001 1007 
10071483 01DEC2020 20496 Placebo 01DEC2020/
Placebo 22DEC2020/
Placebo 30MAR2021/
BNT162b2 
(30 μg)20APR2021/
BNT162b2 
(30 μg)
10071484 C4591001 1007 
10071484 01DEC2020 20497 Placebo 01DEC2020/
Placebo 22DEC2020/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10071485 C4591001 1007 
10071485 01DEC2020 20503 BNT162b2 
(30 μg) 01DEC2020/
BNT162b2 
(30 μg)21DEC2020/
BNT162b2 
(30 μg)    
10071488 C4591001 1007 
10071488 01DEC2020 20504 BNT162b2 
(30 μg) 01DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10071490 C4591001 1007 
10071490 01DEC2020 20605 BNT162b2 
(30 μg) 01DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10071492 C4591001 1007 
10071492 01DEC2020 20606 Placebo 01DEC2020/
Placebo21DEC2020/
Placebo    
10071494 C4591001 1007 
10071494 02DEC2020 20608 BNT162b2 
(30 μg) 02DEC2020/
BNT162b2 
(30 μg)21DEC2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 14
FDA-CBER-2022-5812-0228219
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10071495 C4591001 1007 
10071495 02DEC2020 20610 Placebo 02DEC2020/
Placebo 22DEC2020/
Placebo 25MAY2021/
BNT162b2 
(30 μg)14JUN2021/
BNT162b2 
(30 μg)
10071496 C4591001 1007 
10071496 02DEC2020 20750 Placebo 02DEC2020/
Placebo 22DEC2020/
Placebo 24MAY2021/
BNT162b2 
(30 μg)14JUN2021/
BNT162b2 
(30 μg)
10071497 C4591001 1007 
10071497 02DEC2020 20746 BNT162b2 
(30 μg) 02DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10071499 C4591001 1007 
10071499 03DEC2020 20753 Placebo 03DEC2020/
Placebo22DEC2020/
Placebo    
10071500 C4591001 1007 
10071500 03DEC2020 20756 BNT162b2 
(30 μg) 03DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10071504 C4591001 1007 
10071504 07DEC2020 21085 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10071505 C4591001 1007 
10071505 07DEC2020 21087 Placebo 07DEC2020/
Placebo 28DEC2020/
Placebo 02JUN2021/
BNT162b2 
(30 μg)23JUN2021/
BNT162b2 
(30 μg)
10071506 C4591001 1007 
10071506 07DEC2020 21089 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10071507 C4591001 1007 
10071507 07DEC2020 21090 Placebo 07DEC2020/
Placebo 28DEC2020/
Placebo 19MAY2021/
BNT162b2 
(30 μg)10JUN2021/
BNT162b2 
(30 μg)
10071508 C4591001 1007 
10071508 07DEC2020 21192 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10071509 C4591001 1007 
10071509 07DEC2020 21197 Placebo 07DEC2020/
Placebo 30DEC2020/
Placebo 20MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 15
FDA-CBER-2022-5812-0228220
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10071511 C4591001 1007 
10071511 07DEC2020 21198 Placebo 07DEC2020/
Placebo 28DEC2020/
Placebo 18MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10071512 C4591001 1007 
10071512 07DEC2020 21276 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10071514 C4591001 1007 
10071514 07DEC2020 21199 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10071515 C4591001 1007 
10071515 08DEC2020 21283 Placebo 08DEC2020/
Placebo29DEC2020/
Placebo    
10071516 C4591001 1007 
10071516 08DEC2020 21282 Placebo 08DEC2020/
Placebo 29DEC2020/
Placebo 18MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10071517 C4591001 1007 
10071517 08DEC2020 21284 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10071518 C4591001 1007 
10071518 08DEC2020 21369 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10071519 C4591001 1007 
10071519 08DEC2020 21374 Placebo 08DEC2020/
Placebo 29DEC2020/
Placebo 31MAR2021/
BNT162b2 
(30 μg)21APR2021/
BNT162b2 
(30 μg)
10071520 C4591001 1007 
10071520 08DEC2020 21375 Placebo 08DEC2020/
Placebo 29DEC2020/
Placebo 09JUN2021/
BNT162b2 
(30 μg)01JUL2021/
BNT162b2 
(30 μg)
10071521 C4591001 1007 
10071521 08DEC2020 21376 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10071522 C4591001 1007 
10071522 08DEC2020 21458 Placebo 08DEC2020/
Placebo 29DEC2020/
Placebo 26MAY2021/
BNT162b2 
(30 μg)16JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 16
FDA-CBER-2022-5812-0228221
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10071523 C4591001 1007 
10071523 08DEC2020 21453 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10071524 C4591001 1007 
10071524 08DEC2020 21462 Placebo 08DEC2020/
Placebo 29DEC2020/
Placebo 25FEB2021/
BNT162b2 
(30 μg)18MAR2021/
BNT162b2 
(30 μg)
10071525 C4591001 1007 
10071525 08DEC2020 21463 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10071526 C4591001 1007 
10071526 08DEC2020 21515 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10071527 C4591001 1007 
10071527 08DEC2020 21514 Placebo 08DEC2020/
Placebo 29DEC2020/
Placebo 03JUN2021/
BNT162b2 
(30 μg)22JUN2021/
BNT162b2 
(30 μg)
10071528 C4591001 1007 
10071528 09DEC2020 21521 Placebo 09DEC2020/
Place bo30DEC2020/
Placebo    
10071529 C4591001 1007 
10071529 09DEC2020 21524 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10071530 C4591001 1007 
10071530 09DEC2020 21589 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10071531 C4591001 1007 
10071531 09DEC2020 21590 Placebo 09DEC2020/
Placebo 29DEC2020/
Placebo 25MAY2021/
BNT162b2 
(30 μg)22JUN2021/
BNT162b2 
(30 μg)
10071533 C4591001 1007 
10071533 09DEC2020 21591 Placebo 09DEC2020/
Placebo 30DEC2020/
Placebo 26MAY2021/
BNT162b2 
(30 μg)16JUN2021/
BNT162b2 
(30 μg)
10071535 C4591001 1007 
10071535 09DEC2020 21596 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 17
FDA-CBER-2022-5812-0228222
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10071536 C4591001 1007 
10071536 09DEC2020 21681 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10071537 C4591001 1007 
10071537 09DEC2020 21683 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10071539 C4591001 1007 
10071539 09DEC2020 21689 Placebo 09DEC2020/
Placebo 30DEC2020/
Placebo 02JUN2021/
BNT162b2 
(30 μg)23JUN2021/
BNT162b2 
(30 μg)
10071540 C4591001 1007 
10071540 09DEC2020 21685 Placebo 09DEC2020/
Placebo 30DEC2020/
Placebo 02JUN2021/
BNT162b2 
(30 μg)23JUN2021/
BNT162b2 
(30 μg)
10071541 C4591001 1007 
10071541 09DEC2020 21767 Placebo 09DEC2020/
Placebo 30DEC2020/
Placebo 09FEB2021/
BNT162b2 
(30 μg)02MAR2021/
BNT162b2 
(30 μg)
10071542 C4591001 1007 
10071542 09DEC2020 21769 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10071543 C4591001 1007 
10071543 09DEC2020 21771 Placebo 09DEC2020/
Placebo30DEC2020/
Placebo    
10071544 C4591001 1007 
10071544 09DEC2020 21773 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10071546 C4591001 1007 
10071546 10DEC2020 21827 BNT162b2 
(30 μg) 10DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10071547 C4591001 1007 
10071547 10DEC2020 21830 Placebo 10DEC2020/
Placebo 30DEC2020/
Placebo 20MAY2021/
BNT162b2 
(30 μg)10JUN2021/
BNT162b2 
(30 μg)
10071550 C4591001 1007 
10071550 10DEC2020 21832 BNT162b2 
(30 μg) 10DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 18
FDA-CBER-2022-5812-0228223
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10071551 C4591001 1007 
10071551 10DEC2020 21835 Placebo 10DEC2020/
Placebo 29DEC2020/
Placebo 24MAY2021/
BNT162b2 
(30 μg)14JUN2021/
BNT162b2 
(30 μg)
10071552 C4591001 1007 
10071552 10DEC2020 21976 Placebo 10DEC2020/
Placebo 29DEC2020/
Placebo 26MAY2021/
BNT162b2 
(30 μg)16JUN2021/
BNT162b2 
(30 μg)
10071554 C4591001 1007 
10071554 10DEC2020 21977 Placebo 10DEC2020/
Placebo30DEC2020/
Placebo    
10071555 C4591001 1007 
10071555 10DEC2020 21979 BNT162b2 
(30 μg) 10DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10071557 C4591001 1007 
10071557 14DEC2020 21980 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)04JAN2021/
BNT162b2 
(30 μg)    
10071558 C4591001 1007 
10071558 14DEC2020 22284 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)04JAN2021/
BNT162b2 
(30 μg)    
10071559 C4591001 1007 
10071559 14DEC2020 22285 Placebo 14DEC2020/
Placebo 04JAN2021/
Placebo 27MAY2021/
BNT162b2 
(30 μg)17JUN2021/
BNT162b2 
(30 μg)
10071560 C4591001 1007 
10071560 14DEC2020 22286 Placebo 14DEC2020/
Placebo 05JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10071561 C4591001 1007 
10071561 14DEC2020 22288 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)04JAN2021/
BNT162b2 
(30 μg)    
10071562 C4591001 1007 
10071562 14DEC2020 22385 Placebo 14DEC2020/
Placebo 04JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10071563 C4591001 1007 
10071563 14DEC2020 22386 Placebo 14DEC2020/
Placebo 04JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 19
FDA-CBER-2022-5812-0228224
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10071564 C4591001 1007 
10071564 14DEC2020 22387 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10071565 C4591001 1007 
10071565 14DEC2020 22388 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10071566 C4591001 1007 
10071566 14DEC2020 22402 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)04JAN2021/
BNT162b2 
(30 μg)    
10071567 C4591001 1007 
10071567 15DEC2020 22407 BNT162b2 
(30 μg) 15DEC2020/
BNT162b2 
(30 μg)05JAN2021/
BNT162b2 
(30 μg)    
10071568 C4591001 1007 
10071568 15DEC2020 22409 Placebo 15DEC2020/
Placebo 05JAN2021/
Placebo 01JUN2021/
BNT162b2 
(30 μg)22JUN2021/
BNT162b2 
(30 μg)
10071569 C4591001 1007 
10071569 15DEC2020 22411 Placebo 15DEC2020/
Placebo 05JAN2021/
Placebo 03JUN2021/
BNT162b2 
(30 μg)23JUN2021/
BNT162b2 
(30 μg)
10071570 C4591001 1007 
10071570 15DEC2020 22521 Placebo 15DEC2020/
Placebo 05JAN2021/
Placebo 03JUN2021/
BNT162b2 
(30 μg)23JUN2021/
BNT162b2 
(30 μg)
10071571 C4591001 1007 
10071571 15DEC2020 22528 BNT162b2 
(30 μg) 15DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10071572 C4591001 1007 
10071572 15DEC2020 22529 BNT162b2 
(30 μg) 15DEC2020/
BNT162b2 
(30 μg)05JAN2021/
BNT162b2 
(30 μg)    
10071573 C4591001 1007 
10071573 15DEC2020 22532 Placebo 15DEC2020/
Placebo04JAN2021/
Placebo    
10071574 C4591001 1007 
10071574 16DEC2020 22727 BNT162b2 
(30 μg) 16DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 20
FDA-CBER-2022-5812-0228225
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10071575 C4591001 1007 
10071575 16DEC2020 22728 BNT162b2 
(30 μg) 16DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10071576 C4591001 1007 
10071576 16DEC2020 22733 Placebo 16DEC2020/
Placebo 06JAN2021/
Placebo 12MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10071577 C4591001 1007 
10071577 16DEC2020 22918 Placebo 16DEC2020/
Placebo 06JAN2021/
Placebo 19APR2021/
BNT162b2 
(30 μg)11MAY2021/
BNT162b2 
(30 μg)
10071578 C4591001 1007 
10071578 16DEC2020 22736 Placebo 16DEC2020/
Placebo 06JAN2021/
Placebo 24MAY2021/
BNT162b2 
(30 μg)14JUN2021/
BNT162b2 
(30 μg)
10071579 C4591001 1007 
10071579 16DEC2020 22920 BNT162b2 
(30 μg) 16DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10071580 C4591001 1007 
10071580 16DEC2020 22921 BNT162b2 
(30 μg) 16DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10071581 C4591001 1007 
10071581 17DEC2020 22928 Placebo 17DEC2020/
Placebo 07JAN2021/
Placebo 24MAY2021/
BNT162b2 
(30 μg)14JUN2021/
BNT162b2 
(30 μg)
10071582 C4591001 1007 
10071582 17DEC2020 23087 BNT162b2 
(30 μg) 17DEC2020/
BNT162b2 
(30 μg)07JAN2021/
BNT162b2 
(30 μg)    
10071583 C4591001 1007 
10071583 17DEC2020 23146 Placebo 17DEC2020/
Placebo 07JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10071584 C4591001 1007 
10071584 17DEC2020 23091 BNT162b2 
(30 μg) 17DEC2020/
BNT162b2 
(30 μg)07JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 21
FDA-CBER-2022-5812-0228226
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10071585 C4591001 1007 
10071585 17DEC2020 23094 Placebo 17DEC2020/
Placebo 07JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10071586 C4591001 1007 
10071586 17DEC2020 23096 Placebo 17DEC2020/
Placebo 07JAN2021/
Placebo 01JUN2021/
BNT162b2 
(30 μg)22JUN2021/
BNT162b2 
(30 μg)
10071587 C4591001 1007 
10071587 17DEC2020 23148 BNT162b2 
(30 μg) 17DEC2020/
BNT162b2 
(30 μg)07JAN2021/
BNT162b2 
(30 μg)    
10071588 C4591001 1007 
10071588 28DEC2020 23151 BNT162b2 
(30 μg) 28DEC2020/
BNT162b2 
(30 μg)20JAN2021/
BNT162b2 
(30 μg)    
10071589 C4591001 1007 
10071589 28DEC2020 23155 Placebo 28DEC2020/
Placebo 19JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10071590 C4591001 1007 
10071590 28DEC2020 24372 BNT162b2 
(30 μg) 28DEC2020/
BNT162b2 
(30 μg)20JAN2021/
BNT162b2 
(30 μg)    
10071591 C4591001 1007 
10071591 28DEC2020 24378 Placebo 28DEC2020/
Placebo 19JAN2021/
Placebo 02JUN2021/
BNT162b2 
(30 μg)23JUN2021/
BNT162b2 
(30 μg)
10071592 C4591001 1007 
10071592 28DEC2020 24377 BNT162b2 
(30 μg) 28DEC2020/
BNT162b2 
(30 μg)19JAN2021/
BNT162b2 
(30 μg)    
10071593 C4591001 1007 
10071593 28DEC2020 24380 Placebo 28DEC2020/
Placebo      
10071594 C4591001 1007 
10071594 28DEC2020 24453 BNT162b2 
(30 μg) 28DEC2020/
BNT162b2 
(30 μg)19JAN2021/
BNT162b2 
(30 μg)    
10071595 C4591001 1007 
10071595 28DEC2020 24454 Placebo 28DEC2020/
Placebo 19JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)10JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 22
FDA-CBER-2022-5812-0228227
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10071596 C4591001 1007 
10071596 28DEC2020 24456 Placebo 28DEC2020/
Placebo 20JAN2021/
Placebo 24MAY2021/
BNT162b2 
(30 μg)14JUN2021/
BNT162b2 
(30 μg)
10071597 C4591001 1007 
10071597 28DEC2020 24460 BNT162b2 
(30 μg) 28DEC2020/
BNT162b2 
(30 μg)19JAN2021/
BNT162b2 
(30 μg)    
10071599 C4591001 1007 
10071599 28DEC2020 24478 BNT162b2 
(30 μg) 28DEC2020/
BNT162b2 
(30 μg)19JAN2021/
BNT162b2 
(30 μg)    
10071600 C4591001 1007 
10071600 28DEC2020 24479 Placebo 28DEC2020/
Placebo 19JAN2021/
Placebo 01JUN2021/
BNT162b2 
(30 μg)14JUL2021/
BNT162b2 
(30 μg)
10071601 C4591001 1007 
10071601 28DEC2020 24481 Placebo 28DEC2020/
Placebo19JAN2021/
Placebo    
10071602 C4591001 1007 
10071602 28DEC2020 24483 BNT162b2 
(30 μg) 28DEC2020/
BNT162b2 
(30 μg)19JAN2021/
BNT162b2 
(30 μg)    
10071603 C4591001 1007 
10071603 29DEC2020 24539 Placebo 29DEC2020/
Placebo19JAN2021/
Placebo    
10071604 C4591001 1007 
10071604 29DEC2020 24538 Placebo 29DEC2020/
Placebo19JAN2021/
Placebo    
10071605 C4591001 1007 
10071605 29DEC2020 24544 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)19JAN2021/
BNT162b2 
(30 μg)    
10071606 C4591001 1007 
10071606 29DEC2020 24545 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)19JAN2021/
BNT162b2 
(30 μg)    
10071607 C4591001 1007 
10071607 29DEC2020 24683 Placebo 29DEC2020/
Placebo 19JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)10JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 23
FDA-CBER-2022-5812-0228228
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10071608 C4591001 1007 
10071608 29DEC2020 24684 Placebo 29DEC2020/
Placebo 19JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)10JUN2021/
BNT162b2 
(30 μg)
10071609 C4591001 1007 
10071609 29DEC2020 24685 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)19JAN2021/
BNT162b2 
(30 μg)    
10071610 C4591001 1007 
10071610 29DEC2020 24730 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)21JAN2021/
BNT162b2 
(30 μg)    
10071612 C4591001 1007 
10071612 29DEC2020 24692 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)19JAN2021/
BNT162b2 
(30 μg)    
10071613 C4591001 1007 
10071613 29DEC2020 24732 Placebo 29DEC2020/
Placebo 19JAN2021/
Placebo 25MAY2021/
BNT162b2 
(30 μg)15JUN2021/
BNT162b2 
(30 μg)
10071614 C4591001 1007 
10071614 29DEC2020 24734 Placebo 29DEC2020/
Placebo 19JAN2021/
Placebo 20MAY2021/
BNT162b2 
(30 μg)28JUN2021/
BNT162b2 
(30 μg)
10071615 C4591001 1007 
10071615 29DEC2020 24740 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)19JAN2021/
BNT162b2 
(30 μg)    
10071616 C4591001 1007 
10071616 29DEC2020 24777 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)19JAN2021/
BNT162b2 
(30 μg)    
10071617 C4591001 1007 
10071617 29DEC2020 24781 Placebo 29DEC2020/
Placebo 20JAN2021/
Placebo 19APR2021/
BNT162b2 
(30 μg)10MAY2021/
BNT162b2 
(30 μg)
10071618 C4591001 1007 
10071618 29DEC2020 24784 Placebo 29DEC2020/
Placebo19JAN2021/
Placebo    
10071619 C4591001 1007 
10071619 30DEC2020 24785 BNT162b2 
(30 μg) 30DEC2020/
BNT162b2 
(30 μg)20JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 24
FDA-CBER-2022-5812-0228229
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10071620 C4591001 1007 
10071620 30DEC2020 24828 BNT162b2 
(30 μg) 30DEC2020/
BNT162b2 
(30 μg)20JAN2021/
BNT162b2 
(30 μg)    
10071621 C4591001 1007 
10071621 30DEC2020 24830 Placebo 30DEC2020/
Placebo20JAN2021/
Placebo    
10071622 C4591001 1007 
10071622 30DEC2020 24831 BNT162b2 
(30 μg) 30DEC2020/
BNT162b2 
(30 μg)      
10071623 C4591001 1007 
10071623 30DEC2020 24832 Placebo 30DEC2020/
Placebo 21JAN2021/
Placebo 01JUN2021/
BNT162b2 
(30 μg)22JUN2021/
BNT162b2 
(30 μg)
10071624 C4591001 1007 
10071624 30DEC2020 24910 Placebo 30DEC2020/
Placebo 26JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10071625 C4591001 1007 
10071625 30DEC2020 24915 Placebo 30DEC2020/
Placebo 26JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10071626 C4591001 1007 
10071626 30DEC2020 24917 BNT162b2 
(30 μg) 30DEC2020/
BNT162b2 
(30 μg)20JAN2021/
BNT162b2 
(30 μg)    
10071627 C4591001 1007 
10071627 30DEC2020 24919 BNT162b2 
(30 μg) 30DEC2020/
BNT162b2 
(30 μg)20JAN2021/
BNT162b2 
(30 μg)    
10071628 C4591001 1007 
10071628 30DEC2020 24997 BNT162b2 
(30 μg) 30DEC2020/
BNT162b2 
(30 μg)20JAN2021/
BNT162b2 
(30 μg)    
10071629 C4591001 1007 
10071629 30DEC2020 24994 Placebo 30DEC2020/
Placebo 20JAN2021/
Placebo 01JUN2021/
BNT162b2 
(30 μg)22JUN2021/
BNT162b2 
(30 μg)
10071630 C4591001 1007 
10071630 30DEC2020 24993 Placebo 30DEC2020/
Placebo 20JAN2021/
Placebo 01JUN2021/
BNT162b2 
(30 μg)22JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 25
FDA-CBER-2022-5812-0228230
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10071631 C4591001 1007 
10071631 30DEC2020 25003 BNT162b2 
(30 μg) 30DEC2020/
BNT162b2 
(30 μg)21JAN2021/
BNT162b2 
(30 μg)    
10071632 C4591001 1007 
10071632 30DEC2020 25062 Placebo 30DEC2020/
Placebo 21JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10071633 C4591001 1007 
10071633 30DEC2020 25058 BNT162b2 
(30 μg) 30DEC2020/
BNT162b2 
(30 μg)21JAN2021/
BNT162b2 
(30 μg)    
10071634 C4591001 1007 
10071634 04JAN2021 25064 BNT162b2 
(30 μg) 04JAN2021/
BNT162b2 
(30 μg)25JAN2021/
BNT162b2 
(30 μg)    
10071635 C4591001 1007 
10071635 04JAN2021 25063 Placebo 04JAN2021/
Placebo25JAN2021/
Placebo    
10071636 C4591001 1007 
10071636 04JAN2021 25149 BNT162b2 
(30 μg) 04JAN2021/
BNT162b2 
(30 μg)25JAN2021/
BNT162b2 
(30 μg)    
10071638 C4591001 1007 
10071638 04JAN2021 25153 BNT162b2 
(30 μg) 04JAN2021/
BNT162b2 
(30 μg)25JAN2021/
BNT162b2 
(30 μg)    
10071639 C4591001 1007 
10071639 04JAN2021 25154 Placebo 04JAN2021/
Placebo25JAN2021/
Placebo    
10071640 C4591001 1007 
10071640 04JAN2021 25156 Placebo 04JAN2021/
Placebo 25JAN2021/
Placebo 03JUN2021/
BNT162b2 
(30 μg)22JUN2021/
BNT162b2 
(30 μg)
10071641 C4591001 1007 
10071641 04JAN2021 25202 BNT162b2 
(30 μg) 04JAN2021/
BNT162b2 
(30 μg)26JAN2021/
BNT162b2 
(30 μg)    
10071642 C4591001 1007 
10071642 04JAN2021 25205 BNT162b2 
(30 μg) 04JAN2021/
BNT162b2 
(30 μg)      
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 26
FDA-CBER-2022-5812-0228231
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10071643 C4591001 1007 
10071643 04JAN2021 25204 Placebo 04JAN2021/
Placebo 25JAN2021/
Placebo 27MAY2021/
BNT162b2 
(30 μg)24JUN2021/
BNT162b2 
(30 μg)
10071644 C4591001 1007 
10071644 04JAN2021 25294 BNT162b2 
(30 μg) 04JAN2021/
BNT162b2 
(30 μg)25JAN2021/
BNT162b2 
(30 μg)    
10071645 C4591001 1007 
10071645 04JAN2021 25208 Placebo 04JAN2021/
Placebo 25JAN2021/
Placebo 26MAY2021/
BNT162b2 
(30 μg)16JUN2021/
BNT162b2 
(30 μg)
10071646 C4591001 1007 
10071646 04JAN2021 25299 Placebo 04JAN2021/
Placebo 25JAN2021/
Placebo 03JUN2021/
BNT162b2 
(30 μg)22JUN2021/
BNT162b2 
(30 μg)
10071647 C4591001 1007 
10071647 04JAN2021 25302 BNT162b2 
(30 μg) 04JAN2021/
BNT162b2 
(30 μg)25JAN2021/
BNT162b2 
(30 μg)    
10071648 C4591001 1007 
10071648 05JAN2021 25304 Placebo 05JAN2021/
Placebo 26JAN2021/
Placebo 20APR2021/
BNT162b2 
(30 μg)11MAY2021/
BNT162b2 
(30 μg)
10071649 C4591001 1007 
10071649 05JAN2021 25369 BNT162b2 
(30 μg) 05JAN2021/
BNT162b2 
(30 μg)26JAN2021/
BNT162b2 
(30 μg)    
10071650 C4591001 1007 
10071650 05JAN2021 25370 Placebo 05JAN2021/
Placebo 26JAN2021/
Placebo 25MAY2021/
BNT162b2 
(30 μg)15JUN2021/
BNT162b2 
(30 μg)
10071651 C4591001 1007 
10071651 05JAN2021 25373 BNT162b2 
(30 μg) 05JAN2021/
BNT162b2 
(30 μg)26JAN2021/
BNT162b2 
(30 μg)    
10071652 C4591001 1007 
10071652 05JAN2021 25376 Placebo 05JAN2021/
Placebo 26JAN2021/
Placebo 25MAY2021/
BNT162b2 
(30 μg)21JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 27
FDA-CBER-2022-5812-0228232
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10071653 C4591001 1007 
10071653 05JAN2021 25437 BNT162b2 
(30 μg) 05JAN2021/
BNT162b2 
(30 μg)26JAN2021/
BNT162b2 
(30 μg)    
10071654 C4591001 1007 
10071654 05JAN2021 25443 Placebo 05JAN2021/
Placebo26JAN2021/
Placebo    
10071655 C4591001 1007 
10071655 06JAN2021 25445 Placebo 06JAN2021/
Placebo 27JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10071656 C4591001 1007 
10071656 06JAN2021 25448 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10071658 C4591001 1007 
10071658 06JAN2021 25838 Placebo 06JAN2021/
Placebo 27JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10071659 C4591001 1007 
10071659 06JAN2021 25834 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10071660 C4591001 1007 
10071660 06JAN2021 25833 Placebo 06JAN2021/
Placebo 27JAN2021/
Placebo 02JUN2021/
BNT162b2 
(30 μg)24JUN2021/
BNT162b2 
(30 μg)
10071661 C4591001 1007 
10071661 07JAN2021 25840 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)28JAN2021/
BNT162b2 
(30 μg)    
10071662 C4591001 1007 
10071662 07JAN2021 26061 Placebo 07JAN2021/
Placebo28JAN2021/
Placebo    
10081751 C4591001 1008 
10081751 01DEC2020 20520 Placebo 01DEC2020/
Placebo 23DEC2020/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10081752 C4591001 1008 
10081752 01DEC2020 20525 Placebo 01DEC2020/
Placebo 22DEC2020/
Placebo 13MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 28
FDA-CBER-2022-5812-0228233
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10081753 C4591001 1008 
10081753 01DEC2020 20521 BNT162b2 
(30 μg) 01DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10081754 C4591001 1008 
10081754 02DEC2020 20527 BNT162b2 
(30 μg) 02DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10081755 C4591001 1008 
10081755 02DEC2020 20702 BNT162b2 
(30 μg) 02DEC2020/
BNT162b2 
(30 μg)23DEC2020/
BNT162b2 
(30 μg)    
10081756 C4591001 1008 
10081756 02DEC2020 20704 Placebo 02DEC2020/
Placebo 22DEC2020/
Placebo 22APR2021/
BNT162b2 
(30 μg)12MAY2021/
BNT162b2 
(30 μg)
10081757 C4591001 1008 
10081757 02DEC2020 20705 Placebo 02DEC2020/
Placebo 22DEC2020/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10081758 C4591001 1008 
10081758 02DEC2020 20707 BNT162b2 
(30 μg) 02DEC2020/
BNT162b2 
(30 μg)23DEC2020/
BNT162b2 
(30 μg)    
10081760 C4591001 1008 
10081760 07DEC2020 21257 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10081761 C4591001 1008 
10081761 07DEC2020 21256 Placebo 07DEC2020/
Placebo 28DEC2020/
Placebo 05APR2021/
BNT162b2 
(30 μg)27APR2021/
BNT162b2 
(30 μg)
10081763 C4591001 1008 
10081763 07DEC2020 21260 Placebo 07DEC2020/
Placebo 30DEC2020/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10081764 C4591001 1008 
10081764 07DEC2020 21258 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 29
FDA-CBER-2022-5812-0228234
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10081767 C4591001 1008 
10081767 08DEC2020 21468 Placebo 08DEC2020/
Placebo 29DEC2020/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10081768 C4591001 1008 
10081768 08DEC2020 21469 Placebo 08DEC2020/
Placebo29DEC2020/
Placebo    
10081769 C4591001 1008 
10081769 08DEC2020 21475 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10081770 C4591001 1008 
10081770 09DEC2020 21476 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10081771 C4591001 1008 
10081771 09DEC2020 21662 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10081773 C4591001 1008 
10081773 09DEC2020 21664 Placebo 09DEC2020/
Placebo 29DEC2020/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10081774 C4591001 1008 
10081774 09DEC2020 21668 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10081775 C4591001 1008 
10081775 09DEC2020 21667 Placebo 09DEC2020/
Placebo 28DEC2020/
Placebo 21MAY2021/
BNT162b2 
(30 μg)18JUN2021/
BNT162b2 
(30 μg)
10081777 C4591001 1008 
10081777 10DEC2020 21873 BNT162b2 
(30 μg) 10DEC2020/
BNT162b2 
(30 μg)31DEC2020/
BNT162b2 
(30 μg)    
10081780 C4591001 1008 
10081780 10DEC2020 21875 Placebo 10DEC2020/
Placebo 29DEC2020/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10081781 C4591001 1008 
10081781 10DEC2020 21878 Placebo 10DEC2020/
Placebo 31DEC2020/
Placebo 20MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 30
FDA-CBER-2022-5812-0228235
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10081785 C4591001 1008 
10081785 11DEC2020 21880 BNT162b2 
(30 μg) 11DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10081788 C4591001 1008 
10081788 14DEC2020 22317 Placebo 14DEC2020/
Placebo 04JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10081789 C4591001 1008 
10081789 14DEC2020 22321 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)04JAN2021/
BNT162b2 
(30 μg)    
10081790 C4591001 1008 
10081790 14DEC2020 22322 Placebo 14DEC2020/
Placebo 04JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10081791 C4591001 1008 
10081791 14DEC2020 22357 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)04JAN2021/
BNT162b2 
(30 μg)    
10081792 C4591001 1008 
10081792 14DEC2020 22323 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)04JAN2021/
BNT162b2 
(30 μg)    
10081793 C4591001 1008 
10081793 14DEC2020 22359 Placebo 14DEC2020/
Placebo 04JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10081794 C4591001 1008 
10081794 14DEC2020 22358 Placebo 14DEC2020/
Placebo 04JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10081795 C4591001 1008 
10081795 15DEC2020 22363 BNT162b2 
(30 μg) 15DEC2020/
BNT162b2 
(30 μg)07JAN2021/
BNT162b2 
(30 μg)    
10081796 C4591001 1008 
10081796 15DEC2020 22570 Placebo 15DEC2020/
Placebo 05JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 31
FDA-CBER-2022-5812-0228236
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10081797 C4591001 1008 
10081797 15DEC2020 22574 BNT162b2 
(30 μg) 15DEC2020/
BNT162b2 
(30 μg)05JAN2021/
BNT162b2 
(30 μg)    
10081798 C4591001 1008 
10081798 15DEC2020 22575 Placebo 15DEC2020/
Placebo 05JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10081799 C4591001 1008 
10081799 15DEC2020 22577 BNT162b2 
(30 μg) 15DEC2020/
BNT162b2 
(30 μg)05JAN2021/
BNT162b2 
(30 μg)    
10081800 C4591001 1008 
10081800 16DEC2020 22775 BNT162b2 
(30 μg) 16DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10081801 C4591001 1008 
10081801 17DEC2020 22776 Placebo 17DEC2020/
Placebo 08JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10081802 C4591001 1008 
10081802 17DEC2020 22780 BNT162b2 
(30 μg) 17DEC2020/
BNT162b2 
(30 μg)07JAN2021/
BNT162b2 
(30 μg)    
10081803 C4591001 1008 
10081803 17DEC2020 22783 Placebo 17DEC2020/
Placebo 07JAN2021/
Placebo 19MAR2021/
BNT162b2 
(30 μg)09APR2021/
BNT162b2 
(30 μg)
10081804 C4591001 1008 
10081804 17DEC2020 23122 Placebo 17DEC2020/
Placebo 07JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10081805 C4591001 1008 
10081805 17DEC2020 23123 BNT162b2 
(30 μg) 17DEC2020/
BNT162b2 
(30 μg)07JAN2021/
BNT162b2 
(30 μg)    
10081806 C4591001 1008 
10081806 17DEC2020 23127 BNT162b2 
(30 μg) 17DEC2020/
BNT162b2 
(30 μg)07JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 32
FDA-CBER-2022-5812-0228237
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10081807 C4591001 1008 
10081807 18DEC2020 23129 Placebo 18DEC2020/
Placebo 08JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10081808 C4591001 1008 
10081808 18DEC2020 23301 Placebo 18DEC2020/
Placebo 08JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10081809 C4591001 1008 
10081809 18DEC2020 23306 Placebo 18DEC2020/
Placebo 08JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10081810 C4591001 1008 
10081810 18DEC2020 23307 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)08JAN2021/
BNT162b2 
(30 μg)    
10081811 C4591001 1008 
10081811 18DEC2020 23308 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)08JAN2021/
BNT162b2 
(30 μg)    
10081812 C4591001 1008 
10081812 18DEC2020 23385 Placebo 18DEC2020/
Placebo 08JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10081813 C4591001 1008 
10081813 18DEC2020 23392 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)08JAN2021/
BNT162b2 
(30 μg)    
10081814 C4591001 1008 
10081814 18DEC2020 23394 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)08JAN2021/
BNT162b2 
(30 μg)    
10081815 C4591001 1008 
10081815 18DEC2020 23396 Placebo 18DEC2020/
Placebo 08JAN2021/
Placebo 20MAY2021/
BNT162b2 
(30 μg)10JUN2021/
BNT162b2 
(30 μg)
10081816 C4591001 1008 
10081816 18DEC2020 23412 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)08JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 33
FDA-CBER-2022-5812-0228238
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10081817 C4591001 1008 
10081817 18DEC2020 23413 Placebo 18DEC2020/
Placebo 06JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10081818 C4591001 1008 
10081818 18DEC2020 23415 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)08JAN2021/
BNT162b2 
(30 μg)    
10081819 C4591001 1008 
10081819 21DEC2020 23418 Placebo 21DEC2020/
Placebo 11JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10081820 C4591001 1008 
10081820 21DEC2020 23629 Placebo 21DEC2020/
Placebo 11JAN2021/
Placebo 25MAY2021/
BNT162b2 
(30 μg)15JUN2021/
BNT162b2 
(30 μg)
10081821 C4591001 1008 
10081821 21DEC2020 23634 BNT162b2 
(30 μg) 21DEC2020/
BNT162b2 
(30 μg)12JAN2021/
BNT162b2 
(30 μg)    
10081822 C4591001 1008 
10081822 21DEC2020 23635 Placebo 21DEC2020/
Placebo 11JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10081823 C4591001 1008 
10081823 21DEC2020 23636 BNT162b2 
(30 μg) 21DEC2020/
BNT162b2 
(30 μg)11JAN2021/
BNT162b2 
(30 μg)    
10081824 C4591001 1008 
10081824 21DEC2020 23654 BNT162b2 
(30 μg) 21DEC2020/
BNT162b2 
(30 μg)11JAN2021/
BNT162b2 
(30 μg)    
10081825 C4591001 1008 
10081825 21DEC2020 23656 Placebo 21DEC2020/
Placebo 11JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10081826 C4591001 1008 
10081826 21DEC2020 23659 BNT162b2 
(30 μg) 21DEC2020/
BNT162b2 
(30 μg)12JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 34
FDA-CBER-2022-5812-0228239
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10081827 C4591001 1008 
10081827 21DEC2020 23821 BNT162b2 
(30 μg) 21DEC2020/
BNT162b2 
(30 μg)11JAN2021/
BNT162b2 
(30 μg)    
10081828 C4591001 1008 
10081828 21DEC2020 23660 Placebo 21DEC2020/
Placebo 22JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10081829 C4591001 1008 
10081829 22DEC2020 23824 Placebo 22DEC2020/
Placebo12JAN2021/
Placebo    
10081830 C4591001 1008 
10081830 22DEC2020 23825 Placebo 22DEC2020/
Placebo 13JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10081831 C4591001 1008 
10081831 22DEC2020 23827 BNT162b2 
(30 μg) 22DEC2020/
BNT162b2 
(30 μg)12JAN2021/
BNT162b2 
(30 μg)    
10081832 C4591001 1008 
10081832 22DEC2020 23986 BNT162b2 
(30 μg) 22DEC2020/
BNT162b2 
(30 μg)12JAN2021/
BNT162b2 
(30 μg)    
10081833 C4591001 1008 
10081833 22DEC2020 23988 Placebo 22DEC2020/
Placebo 12JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10081834 C4591001 1008 
10081834 22DEC2020 23991 Placebo 22DEC2020/
Placebo13JAN2021/
Placebo    
10081835 C4591001 1008 
10081835 22DEC2020 23993 BNT162b2 
(30 μg) 22DEC2020/
BNT162b2 
(30 μg)12JAN2021/
BNT162b2 
(30 μg)    
10081836 C4591001 1008 
10081836 22DEC2020 24088 Placebo 22DEC2020/
Placebo 12JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10081837 C4591001 1008 
10081837 22DEC2020 24089 Placebo 22DEC2020/
Placebo 12JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 35
FDA-CBER-2022-5812-0228240
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10081838 C4591001 1008 
10081838 22DEC2020 24090 BNT162b2 
(30 μg) 22DEC2020/
BNT162b2 
(30 μg)12JAN2021/
BNT162b2 
(30 μg)    
10081839 C4591001 1008 
10081839 22DEC2020 24091 BNT162b2 
(30 μg) 22DEC2020/
BNT162b2 
(30 μg)12JAN2021/
BNT162b2 
(30 μg)    
10081840 C4591001 1008 
10081840 23DEC2020 24193 Placebo 23DEC2020/
Placebo 13JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10081841 C4591001 1008 
10081841 23DEC2020 24195 BNT162b2 
(30 μg) 23DEC2020/
BNT162b2 
(30 μg)13JAN2021/
BNT162b2 
(30 μg)    
10081842 C4591001 1008 
10081842 23DEC2020 24196 Placebo 23DEC2020/
Placebo 12JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10081843 C4591001 1008 
10081843 23DEC2020 24198 BNT162b2 
(30 μg) 23DEC2020/
BNT162b2 
(30 μg)13JAN2021/
BNT162b2 
(30 μg)    
10081844 C4591001 1008 
10081844 23DEC2020 24201 Placebo 23DEC2020/
Placebo 13JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10081845 C4591001 1008 
10081845 23DEC2020 24207 Placebo 23DEC2020/
Placebo 11JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10081846 C4591001 1008 
10081846 23DEC2020 24212 BNT162b2 
(30 μg) 23DEC2020/
BNT162b2 
(30 μg)11JAN2021/
BNT162b2 
(30 μg)    
10081847 C4591001 1008 
10081847 23DEC2020 24206 BNT162b2 
(30 μg) 23DEC2020/
BNT162b2 
(30 μg)13JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 36
FDA-CBER-2022-5812-0228241
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10081848 C4591001 1008 
10081848 23DEC2020 24216 BNT162b2 
(30 μg) 23DEC2020/
BNT162b2 
(30 μg)14JAN2021/
BNT162b2 
(30 μg)    
10081849 C4591001 1008 
10081849 23DEC2020 24219 Placebo 23DEC2020/
Placebo 14JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10081850 C4591001 1008 
10081850 23DEC2020 24221 BNT162b2 
(30 μg) 23DEC2020/
BNT162b2 
(30 μg)14JAN2021/
BNT162b2 
(30 μg)    
10081851 C4591001 1008 
10081851 23DEC2020 24222 Placebo 23DEC2020/
Placebo 15JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10081852 C4591001 1008 
10081852 23DEC2020 24249 Placebo 23DEC2020/
Placebo 15JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10081853 C4591001 1008 
10081853 28DEC2020 24250 Placebo 28DEC2020/
Placebo 18JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10081854 C4591001 1008 
10081854 28DEC2020 24253 BNT162b2 
(30 μg) 28DEC2020/
BNT162b2 
(30 μg)18JAN2021/
BNT162b2 
(30 μg)    
10081855 C4591001 1008 
10081855 28DEC2020 24257 BNT162b2 
(30 μg) 28DEC2020/
BNT162b2 
(30 μg)18JAN2021/
BNT162b2 
(30 μg)    
10081856 C4591001 1008 
10081856 28DEC2020 24395 Placebo 28DEC2020/
Placebo 18JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10081857 C4591001 1008 
10081857 28DEC2020 24396 BNT162b2 
(30 μg) 28DEC2020/
BNT162b2 
(30 μg)19JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 37
FDA-CBER-2022-5812-0228242
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10081858 C4591001 1008 
10081858 28DEC2020 24397 Placebo 28DEC2020/
Placebo 19JAN2021/
Placebo 17FEB2021/
BNT162b2 
(30 μg)08MAR2021/
BNT162b2 
(30 μg)
10081859 C4591001 1008 
10081859 28DEC2020 24402 BNT162b2 
(30 μg) 28DEC2020/
BNT162b2 
(30 μg)18JAN2021/
BNT162b2 
(30 μg)    
10081860 C4591001 1008 
10081860 28DEC2020 24465 BNT162b2 
(30 μg) 28DEC2020/
BNT162b2 
(30 μg)18JAN2021/
BNT162b2 
(30 μg)    
10081861 C4591001 1008 
10081861 29DEC2020 24469 Placebo 29DEC2020/
Placebo 18JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)02JUN2021/
BNT162b2 
(30 μg)
10081862 C4591001 1008 
10081862 29DEC2020 24471 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)20JAN2021/
BNT162b2 
(30 μg)    
10081863 C4591001 1008 
10081863 29DEC2020 24472 Placebo 29DEC2020/
Placebo 18JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10081864 C4591001 1008 
10081864 29DEC2020 24639 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)18JAN2021/
BNT162b2 
(30 μg)    
10081865 C4591001 1008 
10081865 29DEC2020 24641 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)19JAN2021/
BNT162b2 
(30 μg)    
10081866 C4591001 1008 
10081866 29DEC2020 24644 Placebo 29DEC2020/
Placebo 18JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10081867 C4591001 1008 
10081867 29DEC2020 24642 Placebo 29DEC2020/
Placebo 18JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 38
FDA-CBER-2022-5812-0228243
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10081868 C4591001 1008 
10081868 29DEC2020 24765 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)19JAN2021/
BNT162b2 
(30 μg)    
10081869 C4591001 1008 
10081869 29DEC2020 24766 Placebo 29DEC2020/
Placebo 19JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)02JUN2021/
BNT162b2 
(30 μg)
10081870 C4591001 1008 
10081870 29DEC2020 24775 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)18JAN2021/
BNT162b2 
(30 μg)    
10081871 C4591001 1008 
10081871 30DEC2020 24776 Placebo 30DEC2020/
Placebo   13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10081872 C4591001 1008 
10081872 30DEC2020 24885 Placebo 30DEC2020/
Placebo 22JAN2021/
Placebo 09APR2021/
BNT162b2 
(30 μg)28APR2021/
BNT162b2 
(30 μg)
10081873 C4591001 1008 
10081873 30DEC2020 24891 BNT162b2 
(30 μg) 30DEC2020/
BNT162b2 
(30 μg)18JAN2021/
BNT162b2 
(30 μg)    
10081874 C4591001 1008 
10081874 30DEC2020 24895 BNT162b2 
(30 μg) 30DEC2020/
BNT162b2 
(30 μg)20JAN2021/
BNT162b2 
(30 μg)    
10081875 C4591001 1008 
10081875 30DEC2020 24893 Placebo 30DEC2020/
Placebo 20JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10081876 C4591001 1008 
10081876 30DEC2020 24982 BNT162b2 
(30 μg) 30DEC2020/
BNT162b2 
(30 μg)20JAN2021/
BNT162b2 
(30 μg)    
10081877 C4591001 1008 
10081877 30DEC2020 24983 Placebo 30DEC2020/
Placebo 20JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 39
FDA-CBER-2022-5812-0228244
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10081878 C4591001 1008 
10081878 30DEC2020 24984 BNT162b2 
(30 μg) 30DEC2020/
BNT162b2 
(30 μg)20JAN2021/
BNT162b2 
(30 μg)    
10081879 C4591001 1008 
10081879 30DEC2020 24989 Placebo 30DEC2020/
Placebo20JAN2021/
Placebo    
10081880 C4591001 1008 
10081880 30DEC2020 25011 Placebo 30DEC2020/
Placebo 19JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10081881 C4591001 1008 
10081881 30DEC2020 25009 Placebo 30DEC2020/
Placebo 19JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10081882 C4591001 1008 
10081882 31DEC2020 25012 BNT162b2 
(30 μg) 31DEC2020/
BNT162b2 
(30 μg)21JAN2021/
BNT162b2 
(30 μg)    
10081883 C4591001 1008 
10081883 31DEC2020 25016 BNT162b2 
(30 μg) 31DEC2020/
BNT162b2 
(30 μg)21JAN2021/
BNT162b2 
(30 μg)    
10081884 C4591001 1008 
10081884 31DEC2020 25114 Placebo 31DEC2020/
Placebo   13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10081885 C4591001 1008 
10081885 31DEC2020 25116 BNT162b2 
(30 μg) 31DEC2020/
BNT162b2 
(30 μg)21JAN2021/
BNT162b2 
(30 μg)    
10081886 C4591001 1008 
10081886 31DEC2020 25115 BNT162b2 
(30 μg) 31DEC2020/
BNT162b2 
(30 μg)21JAN2021/
BNT162b2 
(30 μg)    
10081887 C4591001 1008 
10081887 04JAN2021 25121 Placebo 04JAN2021/
Placebo 25JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10081888 C4591001 1008 
10081888 04JAN2021 25161 Placebo 04JAN2021/
Placebo 25JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 40
FDA-CBER-2022-5812-0228245
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10081889 C4591001 1008 
10081889 04JAN2021 25163 BNT162b2 
(30 μg) 04JAN2021/
BNT162b2 
(30 μg)25JAN2021/
BNT162b2 
(30 μg)    
10081890 C4591001 1008 
10081890 04JAN2021 25164 BNT162b2 
(30 μg) 04JAN2021/
BNT162b2 
(30 μg)25JAN2021/
BNT162b2 
(30 μg)    
10081891 C4591001 1008 
10081891 04JAN2021 25172 Placebo 04JAN2021/
Placebo 25JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10081892 C4591001 1008 
10081892 04JAN2021 25245 Placebo 04JAN2021/
Placebo 25JAN2021/
Placebo 25MAY2021/
BNT162b2 
(30 μg)15JUN2021/
BNT162b2 
(30 μg)
10081893 C4591001 1008 
10081893 04JAN2021 25248 BNT162b2 
(30 μg) 04JAN2021/
BNT162b2 
(30 μg)25JAN2021/
BNT162b2 
(30 μg)    
10081894 C4591001 1008 
10081894 04JAN2021 25250 BNT162b2 
(30 μg) 04JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10081895 C4591001 1008 
10081895 04JAN2021 25269 BNT162b2 
(30 μg) 04JAN2021/
BNT162b2 
(30 μg)25JAN2021/
BNT162b2 
(30 μg)    
10081896 C4591001 1008 
10081896 04JAN2021 25256 Placebo 04JAN2021/
Placebo 25JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10081897 C4591001 1008 
10081897 05JAN2021 25273 BNT162b2 
(30 μg) 05JAN2021/
BNT162b2 
(30 μg)26JAN2021/
BNT162b2 
(30 μg)    
10081898 C4591001 1008 
10081898 05JAN2021 25279 Placebo 05JAN2021/
Placebo 25JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)02JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 41
FDA-CBER-2022-5812-0228246
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10081899 C4591001 1008 
10081899 05JAN2021 25274 Placebo 05JAN2021/
Placebo 25JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)02JUN2021/
BNT162b2 
(30 μg)
10081900 C4591001 1008 
10081900 05JAN2021 25509 BNT162b2 
(30 μg) 05JAN2021/
BNT162b2 
(30 μg)26JAN2021/
BNT162b2 
(30 μg)    
10081901 C4591001 1008 
10081901 05JAN2021 25516 Placebo 05JAN2021/
Placebo 26JAN2021/
Placebo 15FEB2021/
BNT162b2 
(30 μg)08MAR2021/
BNT162b2 
(30 μg)
10081902 C4591001 1008 
10081902 05JAN2021 25518 Placebo 05JAN2021/
Placebo 26JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10081903 C4591001 1008 
10081903 05JAN2021 25520 BNT162b2 
(30 μg) 05JAN2021/
BNT162b2 
(30 μg)26JAN2021/
BNT162b2 
(30 μg)    
10081904 C4591001 1008 
10081904 05JAN2021 25549 Placebo 05JAN2021/
Placebo 26JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10081905 C4591001 1008 
10081905 06JAN2021 25552 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10081906 C4591001 1008 
10081906 06JAN2021 25555 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10081907 C4591001 1008 
10081907 06JAN2021 25556 Placebo 06JAN2021/
Placebo 27JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10081908 C4591001 1008 
10081908 06JAN2021 25689 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 42
FDA-CBER-2022-5812-0228247
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10081909 C4591001 1008 
10081909 06JAN2021 25690 Placebo 06JAN2021/
Placebo 27JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10081910 C4591001 1008 
10081910 06JAN2021 25691 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10081911 C4591001 1008 
10081911 06JAN2021 25695 Placebo 06JAN2021/
Placebo 28JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10081912 C4591001 1008 
10081912 06JAN2021 25818 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)28JAN2021/
BNT162b2 
(30 μg)    
10081913 C4591001 1008 
10081913 06JAN2021 25816 Placebo 06JAN2021/
Placebo 28JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10081914 C4591001 1008 
10081914 06JAN2021 25817 Placebo 06JAN2021/
Placebo 12FEB2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)02JUN2021/
BNT162b2 
(30 μg)
10081915 C4591001 1008 
10081915 07JAN2021 25820 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)28JAN2021/
BNT162b2 
(30 μg)    
10081916 C4591001 1008 
10081916 07JAN2021 25929 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)28JAN2021/
BNT162b2 
(30 μg)    
10081917 C4591001 1008 
10081917 07JAN2021 25931 Placebo 07JAN2021/
Placebo 28JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)10JUN2021/
BNT162b2 
(30 μg)
10081918 C4591001 1008 
10081918 07JAN2021 25933 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)28JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 43
FDA-CBER-2022-5812-0228248
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10081919 C4591001 1008 
10081919 07JAN2021 25937 Placebo 07JAN2021/
Placebo 29JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)10JUN2021/
BNT162b2 
(30 μg)
10081920 C4591001 1008 
10081920 07JAN2021 26085 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)28JAN2021/
BNT162b2 
(30 μg)    
10081921 C4591001 1008 
10081921 07JAN2021 26087 Placebo 07JAN2021/
Placebo 29JAN2021/
Placebo 26APR2021/
BNT162b2 
(30 μg)17MAY2021/
BNT162b2 
(30 μg)
10081922 C4591001 1008 
10081922 08JAN2021 26089 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10081923 C4591001 1008 
10081923 08JAN2021 26091 Placebo 08JAN2021/
Placebo 29JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10081924 C4591001 1008 
10081924 08JAN2021 26205 Placebo 08JAN2021/
Placebo 29JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10081925 C4591001 1008 
10081925 08JAN2021 26209 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10081926 C4591001 1008 
10081926 08JAN2021 26216 Placebo 08JAN2021/
Placebo 29JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10081927 C4591001 1008 
10081927 08JAN2021 26211 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10081928 C4591001 1008 
10081928 08JAN2021 26362 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 44
FDA-CBER-2022-5812-0228249
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10081929 C4591001 1008 
10081929 08JAN2021 26366 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10081930 C4591001 1008 
10081930 11JAN2021 26368 Placebo 11JAN2021/
Placebo 01FEB2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10081931 C4591001 1008 
10081931 11JAN2021 26369 Placebo 11JAN2021/
Placebo 01FEB2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10081932 C4591001 1008 
10081932 11JAN2021 26579 Placebo 11JAN2021/
Placebo 01FEB2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10081933 C4591001 1008 
10081933 11JAN2021 26580 Placebo 11JAN2021/
Placebo 02FEB2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10081934 C4591001 1008 
10081934 11JAN2021 26587 BNT162b2 
(30 μg) 11JAN2021/
BNT162b2 
(30 μg)01FEB2021/
BNT162b2 
(30 μg)    
10081935 C4591001 1008 
10081935 11JAN2021 26588 BNT162b2 
(30 μg) 11JAN2021/
BNT162b2 
(30 μg)03FEB2021/
BNT162b2 
(30 μg)    
10081936 C4591001 1008 
10081936 11JAN2021 26687 Placebo 11JAN2021/
Placebo 01FEB2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)02JUN2021/
BNT162b2 
(30 μg)
10081937 C4591001 1008 
10081937 11JAN2021 26689 BNT162b2 
(30 μg) 11JAN2021/
BNT162b2 
(30 μg)01FEB2021/
BNT162b2 
(30 μg)    
10081938 C4591001 1008 
10081938 11JAN2021 26690 Placebo 11JAN2021/
Placebo 02FEB2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 45
FDA-CBER-2022-5812-0228250
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10081940 C4591001 1008 
10081940 12JAN2021 26693 BNT162b2 
(30 μg) 12JAN2021/
BNT162b2 
(30 μg)02FEB2021/
BNT162b2 
(30 μg)    
10081941 C4591001 1008 
10081941 12JAN2021 26877 Placebo 12JAN2021/
Placebo 02FEB2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10081942 C4591001 1008 
10081942 12JAN2021 26879 Placebo 12JAN2021/
Placebo 02FEB2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10081943 C4591001 1008 
10081943 12JAN2021 26880 BNT162b2 
(30 μg) 12JAN2021/
BNT162b2 
(30 μg)02FEB2021/
BNT162b2 
(30 μg)    
10091204 C4591001 1009 
10091204 15OCT2020 20017 Placebo 15OCT2020/
Placebo 03NOV2020/
Placebo 02AUG2021/
BNT162b2 
(30 μg)23AUG2021/
BNT162b2 
(30 μg)
10091205 C4591001 1009 
10091205 15OCT2020 20018 BNT162b2 
(30 μg) 15OCT2020/
BNT162b2 
(30 μg)06NOV2020/
BNT162b2 
(30 μg)    
10091208 C4591001 1009 
10091208 15OCT2020 20020 Placebo 15OCT2020/
Placebo 06NOV2020/
Placebo 05MAR2021/
BNT162b2 
(30 μg)25MAR2021/
BNT162b2 
(30 μg)
10091209 C4591001 1009 
10091209 15OCT2020 20022 BNT162b2 
(30 μg) 15OCT2020/
BNT162b2 
(30 μg)04NOV2020/
BNT162b2 
(30 μg)    
10091212 C4591001 1009 
10091212 16OCT2020 20061 Placebo 16OCT2020/
Placebo 16NOV2020/
Placebo 21MAY2021/
BNT162b2 
(30 μg)10JUN2021/
BNT162b2 
(30 μg)
10091213 C4591001 1009 
10091213 16OCT2020 20062 Placebo 16OCT2020/
Placebo 04NOV2020/
Placebo 22FEB2021/
BNT162b2 
(30 μg)16MAR2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 46
FDA-CBER-2022-5812-0228251
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10091216 C4591001 1009 
10091216 16OCT2020 20067 BNT162b2 
(30 μg) 16OCT2020/
BNT162b2 
(30 μg)06NOV2020/
BNT162b2 
(30 μg)    
10091218 C4591001 1009 
10091218 16OCT2020 20072 BNT162b2 
(30 μg) 16OCT2020/
BNT162b2 
(30 μg)06NOV2020/
BNT162b2 
(30 μg)    
10091220 C4591001 1009 
10091220 19OCT2020 20133 Placebo 19OCT2020/
Placebo07NOV2020/
Placebo    
10091221 C4591001 1009 
10091221 19OCT2020 20134 BNT162b2 
(30 μg) 19OCT2020/
BNT162b2 
(30 μg)07NOV2020/
BNT162b2 
(30 μg)    
10091223 C4591001 1009 
10091223 19OCT2020 20139 BNT162b2 
(30 μg) 19OCT2020/
BNT162b2 
(30 μg)10NOV2020/
BNT162b2 
(30 μg)    
10091226 C4591001 1009 
10091226 20OCT2020 20141 Placebo 20OCT2020/
Placebo 09NOV2020/
Placebo 20MAY2021/
BNT162b2 
(30 μg)11JUN2021/
BNT162b2 
(30 μg)
10091227 C4591001 1009 
10091227 20OCT2020 20207 BNT162b2 
(30 μg) 20OCT2020/
BNT162b2 
(30 μg)10NOV2020/
BNT162b2 
(30 μg)    
10091229 C4591001 1009 
10091229 20OCT2020 20209 Placebo 20OCT2020/
Placebo   21MAY2021/
BNT162b2 
(30 μg)11JUN2021/
BNT162b2 
(30 μg)
10091231 C4591001 1009 
10091231 20OCT2020 20210 BNT162b2 
(30 μg) 20OCT2020/
BNT162b2 
(30 μg)09NOV2020/
BNT162b2 
(30 μg)    
10091233 C4591001 1009 
10091233 21OCT2020 20211 Placebo 21OCT2020/
Placebo 12NOV2020/
Placebo 02JUN2021/
BNT162b2 
(30 μg)23JUN2021/
BNT162b2 
(30 μg)
10091234 C4591001 1009 
10091234 21OCT2020 20245 BNT162b2 
(30 μg) 21OCT2020/
BNT162b2 
(30 μg)11NOV2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 47
FDA-CBER-2022-5812-0228252
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10091237 C4591001 1009 
10091237 21OCT2020 20246 Placebo 21OCT2020/
Placebo12NOV2020/
Placebo    
10091238 C4591001 1009 
10091238 21OCT2020 20251 Placebo 21OCT2020/
Placebo 10NOV2020/
Placebo 26APR2021/
BNT162b2 
(30 μg)17MAY2021/
BNT162b2 
(30 μg)
10091240 C4591001 1009 
10091240 21OCT2020 20252 BNT162b2 
(30 μg) 21OCT2020/
BNT162b2 
(30 μg)09NOV2020/
BNT162b2 
(30 μg)    
10091246 C4591001 1009 
10091246 22OCT2020 20314 Placebo 22OCT2020/
Placebo 10NOV2020/
Placebo 18MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10091247 C4591001 1009 
10091247 22OCT2020 20316 BNT162b2 
(30 μg) 22OCT2020/
BNT162b2 
(30 μg)11NOV2020/
BNT162b2 
(30 μg)    
10091249 C4591001 1009 
10091249 22OCT2020 20320 Placebo 22OCT2020/
Placebo 13NOV2020/
Placebo 18MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10091250 C4591001 1009 
10091250 22OCT2020 20323 BNT162b2 
(30 μg) 22OCT2020/
BNT162b2 
(30 μg)13NOV2020/
BNT162b2 
(30 μg)    
10091265 C4591001 1009 
10091265 01DEC2020 20505 BNT162b2 
(30 μg) 01DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10091266 C4591001 1009 
10091266 01DEC2020 20506 Placebo 01DEC2020/
Placebo 21DEC2020/
Placebo 04MAR2021/
BNT162b2 
(30 μg)23MAR2021/
BNT162b2 
(30 μg)
10091267 C4591001 1009 
10091267 01DEC2020 20511 Placebo 01DEC2020/
Placebo 22DEC2020/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10091269 C4591001 1009 
10091269 01DEC2020 20514 BNT162b2 
(30 μg) 01DEC2020/
BNT162b2 
(30 μg)23DEC2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 48
FDA-CBER-2022-5812-0228253
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10091270 C4591001 1009 
10091270 01DEC2020 20629 BNT162b2 
(30 μg) 01DEC2020/
BNT162b2 
(30 μg)23DEC2020/
BNT162b2 
(30 μg)    
10091272 C4591001 1009 
10091272 02DEC2020 20631 BNT162b2 
(30 μg) 02DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10091273 C4591001 1009 
10091273 02DEC2020 20633 Placebo 02DEC2020/
Placebo 22DEC2020/
Placebo 21MAY2021/
BNT162b2 
(30 μg)11JUN2021/
BNT162b2 
(30 μg)
10091274 C4591001 1009 
10091274 02DEC2020 20635 Placebo 02DEC2020/
Placebo 28DEC2020/
Placebo 02JUL2021/
BNT162b2 
(30 μg)21JUL2021/
BNT162b2 
(30 μg)
10091275 C4591001 1009 
10091275 02DEC2020 20786 Placebo 02DEC2020/
Placebo 28DEC2020/
Placebo 02JUL2021/
BNT162b2 
(30 μg)21JUL2021/
BNT162b2 
(30 μg)
10091277 C4591001 1009 
10091277 03DEC2020 20787 Placebo 03DEC2020/
Placebo 30DEC2020/
Placebo 09JUN2021/
BNT162b2 
(30 μg)28JUN2021/
BNT162b2 
(30 μg)
10091280 C4591001 1009 
10091280 03DEC2020 20789 BNT162b2 
(30 μg) 03DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10091281 C4591001 1009 
10091281 03DEC2020 20791 BNT162b2 
(30 μg) 03DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10091282 C4591001 1009 
10091282 03DEC2020 20914 Placebo 03DEC2020/
Placebo 22DEC2020/
Placebo 21JUN2021/
BNT162b2 
(30 μg)12JUL2021/
BNT162b2 
(30 μg)
10091283 C4591001 1009 
10091283 03DEC2020 20915 Placebo 03DEC2020/
Placebo 23DEC2020/
Placebo 23JUN2021/
BNT162b2 
(30 μg)15JUL2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 49
FDA-CBER-2022-5812-0228254
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10091284 C4591001 1009 
10091284 03DEC2020 20919 BNT162b2 
(30 μg) 03DEC2020/
BNT162b2 
(30 μg)23DEC2020/
BNT162b2 
(30 μg)    
10091287 C4591001 1009 
10091287 04DEC2020 20922 BNT162b2 
(30 μg) 04DEC2020/
BNT162b2 
(30 μg)23DEC2020/
BNT162b2 
(30 μg)    
10091288 C4591001 1009 
10091288 04DEC2020 21011 BNT162b2 
(30 μg) 04DEC2020/
BNT162b2 
(30 μg)23DEC2020/
BNT162b2 
(30 μg)    
10091289 C4591001 1009 
10091289 04DEC2020 21012 BNT162b2 
(30 μg) 04DEC2020/
BNT162b2 
(30 μg)23DEC2020/
BNT162b2 
(30 μg)    
10091292 C4591001 1009 
10091292 04DEC2020 21014 Placebo 04DEC2020/
Placebo 23DEC2020/
Placebo 02APR2021/
BNT162b2 
(30 μg)23APR2021/
BNT162b2 
(30 μg)
10091293 C4591001 1009 
10091293 04DEC2020 21015 Placebo 04DEC2020/
Placebo 23DEC2020/
Placebo 19MAY2021/
BNT162b2 
(30 μg)10JUN2021/
BNT162b2 
(30 μg)
10091294 C4591001 1009 
10091294 07DEC2020 21177 Placebo 07DEC2020/
Placebo 28DEC2020/
Placebo 06APR2021/
BNT162b2 
(30 μg)28APR2021/
BNT162b2 
(30 μg)
10091295 C4591001 1009 
10091295 07DEC2020 21178 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10091296 C4591001 1009 
10091296 07DEC2020 21182 Placebo 07DEC2020/
Placebo 29DEC2020/
Placebo 24JUN2021/
BNT162b2 
(30 μg)16JUL2021/
BNT162b2 
(30 μg)
10091297 C4591001 1009 
10091297 07DEC2020 21188 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 50
FDA-CBER-2022-5812-0228255
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10091298 C4591001 1009 
10091298 07DEC2020 21300 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10091300 C4591001 1009 
10091300 07DEC2020 21302 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10091301 C4591001 1009 
10091301 07DEC2020 21303 Placebo 07DEC2020/
Placebo 28DEC2020/
Placebo 01JUN2021/
BNT162b2 
(30 μg)21JUN2021/
BNT162b2 
(30 μg)
10091303 C4591001 1009 
10091303 08DEC2020 21304 Placebo 08DEC2020/
Placebo 28DEC2020/
Placebo 21JUN2021/
BNT162b2 
(30 μg)12JUL2021/
BNT162b2 
(30 μg)
10091304 C4591001 1009 
10091304 08DEC2020 21537 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10091305 C4591001 1009 
10091305 08DEC2020 21543 Placebo 08DEC2020/
Placebo 29DEC2020/
Placebo 19MAR2021/
BNT162b2 
(30 μg)09APR2021/
BNT162b2 
(30 μg)
10091306 C4591001 1009 
10091306 08DEC2020 21546 Placebo 08DEC2020/
Placebo 29DEC2020/
Placebo 14MAY2021/
BNT162b2 
(30 μg)02JUN2021/
BNT162b2 
(30 μg)
10091307 C4591001 1009 
10091307 09DEC2020 21547 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10091308 C4591001 1009 
10091308 09DEC2020 21650 Placebo 09DEC2020/
Placebo30DEC2020/
Placebo    
10091309 C4591001 1009 
10091309 09DEC2020 21652 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10091310 C4591001 1009 
10091310 09DEC2020 21653 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 51
FDA-CBER-2022-5812-0228256
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10091311 C4591001 1009 
10091311 09DEC2020 21655 Placebo 09DEC2020/
Placebo 28DEC2020/
Placebo 17MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10091312 C4591001 1009 
10091312 09DEC2020 21782 Placebo 09DEC2020/
Placebo 29DEC2020/
Placebo 01JUN2021/
BNT162b2 
(30 μg)25JUN2021/
BNT162b2 
(30 μg)
10091313 C4591001 1009 
10091313 09DEC2020 21778 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10091314 C4591001 1009 
10091314 09DEC2020 21783 Placebo 09DEC2020/
Placebo 30DEC2020/
Placebo 06JUL2021/
BNT162b2 
(30 μg)02AUG2021/
BNT162b2 
(30 μg)
10091315 C4591001 1009 
10091315 09DEC2020 21785 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10091316 C4591001 1009 
10091316 09DEC2020 21813 Placebo 09DEC2020/
Placebo 28DEC2020/
Placebo 17MAR2021/
BNT162b2 
(30 μg)08APR2021/
BNT162b2 
(30 μg)
10091317 C4591001 1009 
10091317 10DEC2020 21814 Placebo 10DEC2020/
Placebo 29DEC2020/
Placebo 25JUN2021/
BNT162b2 
(30 μg)15JUL2021/
BNT162b2 
(30 μg)
10091318 C4591001 1009 
10091318 10DEC2020 21821 BNT162b2 
(30 μg) 10DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10091319 C4591001 1009 
10091319 10DEC2020 21823 BNT162b2 
(30 μg) 10DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10091320 C4591001 1009 
10091320 10DEC2020 21957 Placebo 10DEC2020/
Placebo 30DEC2020/
Placebo 01JUN2021/
BNT162b2 
(30 μg)28JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 52
FDA-CBER-2022-5812-0228257
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10091321 C4591001 1009 
10091321 10DEC2020 21958 BNT162b2 
(30 μg) 10DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10091322 C4591001 1009 
10091322 10DEC2020 21959 BNT162b2 
(30 μg) 10DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10091323 C4591001 1009 
10091323 10DEC2020 21964 Placebo 10DEC2020/
Placebo 30DEC2020/
Placebo 06JUL2021/
BNT162b2 
(30 μg)26JUL2021/
BNT162b2 
(30 μg)
10091324 C4591001 1009 
10091324 11DEC2020 22066 Placebo 11DEC2020/
Placebo 31DEC2020/
Placebo 29JUL2021/
BNT162b2 
(30 μg)18AUG2021/
BNT162b2 
(30 μg)
10091325 C4591001 1009 
10091325 11DEC2020 22067 BNT162b2 
(30 μg) 11DEC2020/
BNT162b2 
(30 μg)31DEC2020/
BNT162b2 
(30 μg)    
10091326 C4591001 1009 
10091326 11DEC2020 22072 Placebo 11DEC2020/
Placebo 30DEC2020/
Placebo 27MAY2021/
BNT162b2 
(30 μg)25JUN2021/
BNT162b2 
(30 μg)
10091328 C4591001 1009 
10091328 11DEC2020 22075 BNT162b2 
(30 μg) 11DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10091329 C4591001 1009 
10091329 11DEC2020 22149 Placebo 11DEC2020/
Placebo 30DEC2020/
Placebo 28MAY2021/
BNT162b2 
(30 μg)17JUN2021/
BNT162b2 
(30 μg)
10091330 C4591001 1009 
10091330 11DEC2020 22151 Placebo 11DEC2020/
Placebo 30DEC2020/
Placebo 07JUL2021/
BNT162b2 
(30 μg)28JUL2021/
BNT162b2 
(30 μg)
10091331 C4591001 1009 
10091331 11DEC2020 22157 BNT162b2 
(30 μg) 11DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 53
FDA-CBER-2022-5812-0228258
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10091332 C4591001 1009 
10091332 11DEC2020 22160 BNT162b2 
(30 μg) 11DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10091333 C4591001 1009 
10091333 11DEC2020 22198 BNT162b2 
(30 μg) 11DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10091334 C4591001 1009 
10091334 11DEC2020 22199 Placebo 11DEC2020/
Placebo 31DEC2020/
Placebo 19MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10091335 C4591001 1009 
10091335 11DEC2020 22200 BNT162b2 
(30 μg) 11DEC2020/
BNT162b2 
(30 μg)31DEC2020/
BNT162b2 
(30 μg)    
10091336 C4591001 1009 
10091336 11DEC2020 22201 Placebo 11DEC2020/
Placebo 31DEC2020/
Placebo 16JUL2021/
BNT162b2 
(30 μg)05AUG2021/
BNT162b2 
(30 μg)
10091337 C4591001 1009 
10091337 14DEC2020 22329 Placebo 14DEC2020/
Placebo 04JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10091338 C4591001 1009 
10091338 14DEC2020 22331 Placebo 14DEC2020/
Placebo   20JUL2021/
BNT162b2 
(30 μg)10AUG2021/
BNT162b2 
(30 μg)
10091339 C4591001 1009 
10091339 14DEC2020 22332 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)18JAN2021/
BNT162b2 
(30 μg)    
10091340 C4591001 1009 
10091340 14DEC2020 22339 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)04JAN2021/
BNT162b2 
(30 μg)    
10091341 C4591001 1009 
10091341 14DEC2020 22451 Placebo 14DEC2020/
Placebo 04JAN2021/
Placebo 02JUL2021/
BNT162b2 
(30 μg)21JUL2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 54
FDA-CBER-2022-5812-0228259
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10091342 C4591001 1009 
10091342 14DEC2020 22452 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)04JAN2021/
BNT162b2 
(30 μg)    
10091343 C4591001 1009 
10091343 15DEC2020 22454 BNT162b2 
(30 μg) 15DEC2020/
BNT162b2 
(30 μg)05JAN2021/
BNT162b2 
(30 μg)    
10091344 C4591001 1009 
10091344 15DEC2020 22458 Placebo 15DEC2020/
Placebo 04JAN2021/
Placebo 01MAR2021/
BNT162b2 
(30 μg)23MAR2021/
BNT162b2 
(30 μg)
10091345 C4591001 1009 
10091345 15DEC2020 22618 BNT162b2 
(30 μg) 15DEC2020/
BNT162b2 
(30 μg)05JAN2021/
BNT162b2 
(30 μg)    
10091346 C4591001 1009 
10091346 15DEC2020 22621 Placebo 15DEC2020/
Placebo 05JAN2021/
Placebo 18MAR2021/
BNT162b2 
(30 μg)06APR2021/
BNT162b2 
(30 μg)
10091347 C4591001 1009 
10091347 15DEC2020 22625 Placebo 15DEC2020/
Placebo 06JAN2021/
Placebo 09JUL2021/
BNT162b2 
(30 μg)05AUG2021/
BNT162b2 
(30 μg)
10091348 C4591001 1009 
10091348 15DEC2020 22626 BNT162b2 
(30 μg) 15DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10091349 C4591001 1009 
10091349 15DEC2020 22701 Placebo 15DEC2020/
Placebo 06JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10091350 C4591001 1009 
10091350 16DEC2020 22702 Placebo 16DEC2020/
Placebo 07JAN2021/
Placebo 14JUL2021/
BNT162b2 
(30 μg)04AUG2021/
BNT162b2 
(30 μg)
10091351 C4591001 1009 
10091351 16DEC2020 22706 BNT162b2 
(30 μg) 16DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 55
FDA-CBER-2022-5812-0228260
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10091353 C4591001 1009 
10091353 16DEC2020 22707 BNT162b2 
(30 μg) 16DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10091354 C4591001 1009 
10091354 16DEC2020 22906 BNT162b2 
(30 μg) 16DEC2020/
BNT162b2 
(30 μg)07JAN2021/
BNT162b2 
(30 μg)    
10091355 C4591001 1009 
10091355 16DEC2020 22907 BNT162b2 
(30 μg) 16DEC2020/
BNT162b2 
(30 μg)08JAN2021/
BNT162b2 
(30 μg)    
10091356 C4591001 1009 
10091356 16DEC2020 22909 Placebo 16DEC2020/
Placebo 04JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10091357 C4591001 1009 
10091357 17DEC2020 22912 Placebo 17DEC2020/
Placebo 05JAN2021/
Placebo 16MAR2021/
BNT162b2 
(30 μg)05APR2021/
BNT162b2 
(30 μg)
10091358 C4591001 1009 
10091358 17DEC2020 23001 BNT162b2 
(30 μg) 17DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10091359 C4591001 1009 
10091359 17DEC2020 23002 Placebo 17DEC2020/
Placebo 06JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10091360 C4591001 1009 
10091360 17DEC2020 23003 BNT162b2 
(30 μg) 17DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10091361 C4591001 1009 
10091361 17DEC2020 23012 Placebo 17DEC2020/
Placebo 05JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10091362 C4591001 1009 
10091362 17DEC2020 23181 BNT162b2 
(30 μg) 17DEC2020/
BNT162b2 
(30 μg)11JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 56
FDA-CBER-2022-5812-0228261
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10091363 C4591001 1009 
10091363 17DEC2020 23186 Placebo 17DEC2020/
Placebo   30JUL2021/
BNT162b2 
(30 μg)27AUG2021/
BNT162b2 
(30 μg)
10091364 C4591001 1009 
10091364 17DEC2020 23189 BNT162b2 
(30 μg) 17DEC2020/
BNT162b2 
(30 μg)19JAN2021/
BNT162b2 
(30 μg)    
10091365 C4591001 1009 
10091365 17DEC2020 23191 Placebo 17DEC2020/
Placebo 19JAN2021/
Placebo 20JUL2021/
BNT162b2 
(30 μg)19AUG2021/
BNT162b2 
(30 μg)
10091366 C4591001 1009 
10091366 17DEC2020 23213 Placebo 17DEC2020/
Placebo   10AUG2021/
BNT162b2 
(30 μg)30AUG2021/
BNT162b2 
(30 μg)
10091369 C4591001 1009 
10091369 18DEC2020 23214 Placebo 18DEC2020/
Placebo 08JAN2021/
Placebo 21MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10091370 C4591001 1009 
10091370 18DEC2020 23215 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)08JAN2021/
BNT162b2 
(30 μg)    
10091371 C4591001 1009 
10091371 18DEC2020 23216 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)08JAN2021/
BNT162b2 
(30 μg)    
10091372 C4591001 1009 
10091372 18DEC2020 23435 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)08JAN2021/
BNT162b2 
(30 μg)    
10091373 C4591001 1009 
10091373 18DEC2020 23441 Placebo 18DEC2020/
Placebo 08JAN2021/
Placebo 16JUL2021/
BNT162b2 
(30 μg)06AUG2021/
BNT162b2 
(30 μg)
10091374 C4591001 1009 
10091374 21DEC2020 23442 Placebo 21DEC2020/
Placebo 11JAN2021/
Placebo 24MAY2021/
BNT162b2 
(30 μg)14JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 57
FDA-CBER-2022-5812-0228262
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10091375 C4591001 1009 
10091375 21DEC2020 23444 BNT162b2 
(30 μg) 21DEC2020/
BNT162b2 
(30 μg)11JAN2021/
BNT162b2 
(30 μg)    
10091376 C4591001 1009 
10091376 21DEC2020 23805 BNT162b2 
(30 μg) 21DEC2020/
BNT162b2 
(30 μg)11JAN2021/
BNT162b2 
(30 μg)    
10091377 C4591001 1009 
10091377 21DEC2020 23808 BNT162b2 
(30 μg) 21DEC2020/
BNT162b2 
(30 μg)12JAN2021/
BNT162b2 
(30 μg)    
10091378 C4591001 1009 
10091378 21DEC2020 23812 Placebo 21DEC2020/
Placebo 12JAN2021/
Placebo 26JUL2021/
BNT162b2 
(30 μg)18AUG2021/
BNT162b2 
(30 μg)
10091379 C4591001 1009 
10091379 22DEC2020 23814 Placebo 22DEC2020/
Placebo 14JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10091380 C4591001 1009 
10091380 29DEC2020 24802 Placebo 29DEC2020/
Placebo 19JAN2021/
Placebo 23JUN2021/
BNT162b2 
(30 μg)12JUL2021/
BNT162b2 
(30 μg)
10091381 C4591001 1009 
10091381 31DEC2020 24806 BNT162b2 
(30 μg) 31DEC2020/
BNT162b2 
(30 μg)19JAN2021/
BNT162b2 
(30 μg)    
10091382 C4591001 1009 
10091382 04JAN2021 24808 Placebo 04JAN2021/
Placebo 25JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)02JUN2021/
BNT162b2 
(30 μg)
10091383 C4591001 1009 
10091383 05JAN2021 24810 BNT162b2 
(30 μg) 05JAN2021/
BNT162b2 
(30 μg)25JAN2021/
BNT162b2 
(30 μg)    
10091384 C4591001 1009 
10091384 05JAN2021 25498 Placebo 05JAN2021/
Placebo 25JAN2021/
Placebo 23FEB2021/
BNT162b2 
(30 μg)16MAR2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 58
FDA-CBER-2022-5812-0228263
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10091385 C4591001 1009 
10091385 05JAN2021 25502 Placebo 05JAN2021/
Placebo 26JAN2021/
Placebo 24MAY2021/
BNT162b2 
(30 μg)15JUN2021/
BNT162b2 
(30 μg)
10091386 C4591001 1009 
10091386 06JAN2021 25505 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)25JAN2021/
BNT162b2 
(30 μg)    
10091387 C4591001 1009 
10091387 06JAN2021 25506 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)28JAN2021/
BNT162b2 
(30 μg)    
10091388 C4591001 1009 
10091388 06JAN2021 25872 Placebo 06JAN2021/
Placebo 28JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10091389 C4591001 1009 
10091389 06JAN2021 25878 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)25JAN2021/
BNT162b2 
(30 μg)    
10091390 C4591001 1009 
10091390 07JAN2021 25879 Placebo 07JAN2021/
Placebo 28JAN2021/
Placebo 02AUG2021/
BNT162b2 
(30 μg)23AUG2021/
BNT162b2 
(30 μg)
10091391 C4591001 1009 
10091391 07JAN2021 26073 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10091392 C4591001 1009 
10091392 07JAN2021 26075 Placebo 07JAN2021/
Placebo 29JAN2021/
Placebo 01JUL2021/
BNT162b2 
(30 μg)22JUL2021/
BNT162b2 
(30 μg)
10091393 C4591001 1009 
10091393 07JAN2021 25880 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10091394 C4591001 1009 
10091394 07JAN2021 26076 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 59
FDA-CBER-2022-5812-0228264
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10091395 C4591001 1009 
10091395 07JAN2021 26079 Placebo 07JAN2021/
Placebo 27JAN2021/
Placebo 26MAY2021/
BNT162b2 
(30 μg)14JUN2021/
BNT162b2 
(30 μg)
10091396 C4591001 1009 
10091396 07JAN2021 26113 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)26JAN2021/
BNT162b2 
(30 μg)    
10091398 C4591001 1009 
10091398 07JAN2021 26114 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)28JAN2021/
BNT162b2 
(30 μg)    
10091399 C4591001 1009 
10091399 08JAN2021 26115 Placebo 08JAN2021/
Placebo 29JAN2021/
Placebo 30JUL2021/
BNT162b2 
(30 μg)20AUG2021/
BNT162b2 
(30 μg)
10091400 C4591001 1009 
10091400 08JAN2021 26119 Placebo 08JAN2021/
Placebo 12FEB2021/
Placebo 30AUG2021/
BNT162b2 
(30 μg)  
10091401 C4591001 1009 
10091401 08JAN2021 26375 Placebo 08JAN2021/
Placebo 29JAN2021/
Placebo 02AUG2021/
BNT162b2 
(30 μg)23AUG2021/
BNT162b2 
(30 μg)
10091402 C4591001 1009 
10091402 08JAN2021 26377 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10091403 C4591001 1009 
10091403 08JAN2021 26378 Placebo 08JAN2021/
Placebo 27JAN2021/
Placebo 24FEB2021/
BNT162b2 
(30 μg)19MAR2021/
BNT162b2 
(30 μg)
10091404 C4591001 1009 
10091404 08JAN2021 26380 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10091405 C4591001 1009 
10091405 08JAN2021 26445 Placebo 08JAN2021/
Placebo 29JAN2021/
Placebo 28JUL2021/
BNT162b2 
(30 μg)19AUG2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 60
FDA-CBER-2022-5812-0228265
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10091406 C4591001 1009 
10091406 08JAN2021 26447 Placebo 08JAN2021/
Placebo 29JAN2021/
Placebo 27JUL2021/
BNT162b2 
(30 μg)19AUG2021/
BNT162b2 
(30 μg)
10091407 C4591001 1009 
10091407 11JAN2021 26450 BNT162b2 
(30 μg) 11JAN2021/
BNT162b2 
(30 μg)01FEB2021/
BNT162b2 
(30 μg)    
10091408 C4591001 1009 
10091408 11JAN2021 26453 BNT162b2 
(30 μg) 11JAN2021/
BNT162b2 
(30 μg)02FEB2021/
BNT162b2 
(30 μg)    
10091409 C4591001 1009 
10091409 11JAN2021 26737 BNT162b2 
(30 μg) 11JAN2021/
BNT162b2 
(30 μg)02FEB2021/
BNT162b2 
(30 μg)    
10091410 C4591001 1009 
10091410 12JAN2021 26740 BNT162b2 
(30 μg) 12JAN2021/
BNT162b2 
(30 μg)01FEB2021/
BNT162b2 
(30 μg)    
10091411 C4591001 1009 
10091411 12JAN2021 26743 Placebo 12JAN2021/
Placebo 01FEB2021/
Placebo 20MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10091412 C4591001 1009 
10091412 12JAN2021 26744 Placebo 12JAN2021/
Placebo 01FEB2021/
Placebo 30JUL2021/
BNT162b2 
(30 μg)20AUG2021/
BNT162b2 
(30 μg)
10091413 C4591001 1009 
10091413 12JAN2021 26916 BNT162b2 
(30 μg) 12JAN2021/
BNT162b2 
(30 μg)03FEB2021/
BNT162b2 
(30 μg)    
10091414 C4591001 1009 
10091414 12JAN2021 26920 BNT162b2 
(30 μg) 12JAN2021/
BNT162b2 
(30 μg)04FEB2021/
BNT162b2 
(30 μg)    
10131821 C4591001 1013 
10131821 30NOV2020 20333 BNT162b2 
(30 μg) 30NOV2020/
BNT162b2 
(30 μg)21DEC2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 61
FDA-CBER-2022-5812-0228266
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10131822 C4591001 1013 
10131822 30NOV2020 20332 BNT162b2 
(30 μg) 30NOV2020/
BNT162b2 
(30 μg)21DEC2020/
BNT162b2 
(30 μg)    
10131823 C4591001 1013 
10131823 01DEC2020 20335 Placebo 01DEC2020/
Placebo 22DEC2020/
Placebo 23JUN2021/
BNT162b2 
(30 μg)13JUL2021/
BNT162b2 
(30 μg)
10131824 C4591001 1013 
10131824 01DEC2020 20554 BNT162b2 
(30 μg) 01DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10131826 C4591001 1013 
10131826 01DEC2020 20558 Placebo 01DEC2020/
Placebo 23DEC2020/
Placebo 02JUN2021/
BNT162b2 
(30 μg)21JUN2021/
BNT162b2 
(30 μg)
10131828 C4591001 1013 
10131828 02DEC2020 20559 BNT162b2 
(30 μg) 02DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10131830 C4591001 1013 
10131830 02DEC2020 20564 Placebo 02DEC2020/
Placebo23DEC2020/
Placebo    
10131835 C4591001 1013 
10131835 02DEC2020 20676 Placebo 02DEC2020/
Placebo 22DEC2020/
Placebo 26MAY2021/
BNT162b2 
(30 μg)15JUN2021/
BNT162b2 
(30 μg)
10131836 C4591001 1013 
10131836 02DEC2020 20681 BNT162b2 
(30 μg) 02DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10131839 C4591001 1013 
10131839 02DEC2020 20682 Placebo 02DEC2020/
Placebo23DEC2020/
Placebo    
10131841 C4591001 1013 
10131841 02DEC2020 20736 BNT162b2 
(30 μg) 02DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10131842 C4591001 1013 
10131842 02DEC2020 20738 Placebo 02DEC2020/
Placebo 22DEC2020/
Placebo 17JUN2021/
BNT162b2 
(30 μg)20JUL2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 62
FDA-CBER-2022-5812-0228267
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10131843 C4591001 1013 
10131843 02DEC2020 20684 BNT162b2 
(30 μg) 02DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10131844 C4591001 1013 
10131844 02DEC2020 20743 Placebo 02DEC2020/
Placebo 22DEC2020/
Placebo 24JUN2021/
BNT162b2 
(30 μg)15JUL2021/
BNT162b2 
(30 μg)
10131845 C4591001 1013 
10131845 03DEC2020 20744 BNT162b2 
(30 μg) 03DEC2020/
BNT162b2 
(30 μg)23DEC2020/
BNT162b2 
(30 μg)    
10131846 C4591001 1013 
10131846 03DEC2020 20821 BNT162b2 
(30 μg) 03DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10131848 C4591001 1013 
10131848 03DEC2020 20825 Placebo 03DEC2020/
Placebo22DEC2020/
Placebo    
10131850 C4591001 1013 
10131850 03DEC2020 20827 BNT162b2 
(30 μg) 03DEC2020/
BNT162b2 
(30 μg)23DEC2020/
BNT162b2 
(30 μg)    
10131851 C4591001 1013 
10131851 07DEC2020 20828 Placebo 07DEC2020/
Placebo 28DEC2020/
Placebo 21JUN2021/
BNT162b2 
(30 μg)26JUL2021/
BNT162b2 
(30 μg)
10131852 C4591001 1013 
10131852 07DEC2020 21153 Placebo 07DEC2020/
Placebo 28DEC2020/
Placebo 01JUN2021/
BNT162b2 
(30 μg)22JUN2021/
BNT162b2 
(30 μg)
10131855 C4591001 1013 
10131855 08DEC2020 21154 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10131856 C4591001 1013 
10131856 09DEC2020 21671 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10131858 C4591001 1013 
10131858 09DEC2020 21164 Placebo 09DEC2020/
Placebo 29DEC2020/
Placebo 18MAY2021/
BNT162b2 
(30 μg)15JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 63
FDA-CBER-2022-5812-0228268
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10131859 C4591001 1013 
10131859 09DEC2020 21155 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)31DEC2020/
BNT162b2 
(30 μg)    
10131860 C4591001 1013 
10131860 09DEC2020 21673 Placebo 09DEC2020/
Placebo 29DEC2020/
Placebo 26MAY2021/
BNT162b2 
(30 μg)15JUN2021/
BNT162b2 
(30 μg)
10131861 C4591001 1013 
10131861 10DEC2020 21677 Placebo 10DEC2020/
Placebo04JAN2021/
Placebo    
10131862 C4591001 1013 
10131862 10DEC2020 21678 BNT162b2 
(30 μg) 10DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10131863 C4591001 1013 
10131863 10DEC2020 21983 Placebo 10DEC2020/
Placebo 30DEC2020/
Placebo 24MAY2021/
BNT162b2 
(30 μg)14JUN2021/
BNT162b2 
(30 μg)
10131865 C4591001 1013 
10131865 14DEC2020 21987 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10131866 C4591001 1013 
10131866 14DEC2020 21990 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10131867 C4591001 1013 
10131867 17DEC2020 21992 Placebo 17DEC2020/
Placebo 05JAN2021/
Placebo 01JUN2021/
BNT162b2 
(30 μg)30JUN2021/
BNT162b2 
(30 μg)
10131868 C4591001 1013 
10131868 21DEC2020 23579 Placebo 21DEC2020/
Placebo12JAN2021/
Placebo    
10131869 C4591001 1013 
10131869 21DEC2020 117929 Placebo 21DEC2020/
Placebo13JAN2021/
Placebo    
10131870 C4591001 1013 
10131870 21DEC2020 23583 Placebo 21DEC2020/
Placebo13JAN2021/
Placebo    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 64
FDA-CBER-2022-5812-0228269
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10131871 C4591001 1013 
10131871 21DEC2020 23585 BNT162b2 
(30 μg) 21DEC2020/
BNT162b2 
(30 μg)11JAN2021/
BNT162b2 
(30 μg)    
10131872 C4591001 1013 
10131872 21DEC2020 23586 BNT162b2 
(30 μg) 21DEC2020/
BNT162b2 
(30 μg)11JAN2021/
BNT162b2 
(30 μg)    
10131873 C4591001 1013 
10131873 22DEC2020 24005 BNT162b2 
(30 μg) 22DEC2020/
BNT162b2 
(30 μg)13JAN2021/
BNT162b2 
(30 μg)    
10131874 C4591001 1013 
10131874 22DEC2020 24002 Placebo 22DEC2020/
Placebo 13JAN2021/
Placebo 20JUL2021/
BNT162b2 
(30 μg)11AUG2021/
BNT162b2 
(30 μg)
10131875 C4591001 1013 
10131875 22DEC2020 24004 Placebo 22DEC2020/
Placebo 13JAN2021/
Placebo 24MAY2021/
BNT162b2 
(30 μg)14JUN2021/
BNT162b2 
(30 μg)
10131876 C4591001 1013 
10131876 22DEC2020 24008 BNT162b2 
(30 μg) 22DEC2020/
BNT162b2 
(30 μg)12JAN2021/
BNT162b2 
(30 μg)    
10131877 C4591001 1013 
10131877 23DEC2020 24167 BNT162b2 
(30 μg) 23DEC2020/
BNT162b2 
(30 μg)13JAN2021/
BNT162b2 
(30 μg)    
10131878 C4591001 1013 
10131878 23DEC2020 24174 Placebo 23DEC2020/
Placebo13JAN2021/
Placebo    
10131879 C4591001 1013 
10131879 23DEC2020 24168 Placebo 23DEC2020/
Placebo 11JAN2021/
Placebo 28APR2021/
BNT162b2 
(30 μg)19MAY2021/
BNT162b2 
(30 μg)
10131880 C4591001 1013 
10131880 23DEC2020 24173 BNT162b2 
(30 μg) 23DEC2020/
BNT162b2 
(30 μg)11JAN2021/
BNT162b2 
(30 μg)    
10131881 C4591001 1013 
10131881 28DEC2020 24361 BNT162b2 
(30 μg) 28DEC2020/
BNT162b2 
(30 μg)20JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
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FDA-CBER-2022-5812-0228270
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10131882 C4591001 1013 
10131882 30DEC2020 24365 Placebo 30DEC2020/
Placebo 19JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10131883 C4591001 1013 
10131883 31DEC2020 24366 Placebo 31DEC2020/
Placebo 21JAN2021/
Placebo 20MAY2021/
BNT162b2 
(30 μg)10JUN2021/
BNT162b2 
(30 μg)
10131884 C4591001 1013 
10131884 07JAN2021 24368 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)28JAN2021/
BNT162b2 
(30 μg)    
10131885 C4591001 1013 
10131885 07JAN2021 25893 Placebo 07JAN2021/
Placebo 26JAN2021/
Placebo 27MAY2021/
BNT162b2 
(30 μg)15JUN2021/
BNT162b2 
(30 μg)
10131886 C4591001 1013 
10131886 07JAN2021 25894 Placebo 07JAN2021/
Placebo 27JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)10JUN2021/
BNT162b2 
(30 μg)
10161307 C4591001 1016 
10161307 15OCT2020 20025 Placebo 15OCT2020/
Placebo 04NOV2020/
Placebo 19MAY2021/
BNT162b2 
(30 μg)10JUN2021/
BNT162b2 
(30 μg)
10161308 C4591001 1016 
10161308 15OCT2020 20032 Placebo 15OCT2020/
Placebo 03NOV2020/
Placebo 26MAY2021/
BNT162b2 
(30 μg)14JUN2021/
BNT162b2 
(30 μg)
10161309 C4591001 1016 
10161309 15OCT2020 20035 BNT162b2 
(30 μg) 15OCT2020/
BNT162b2 
(30 μg)12NOV2020/
BNT162b2 
(30 μg)    
10161310 C4591001 1016 
10161310 15OCT2020 20036 BNT162b2 
(30 μg) 15OCT2020/
BNT162b2 
(30 μg)04NOV2020/
BNT162b2 
(30 μg)    
10161311 C4591001 1016 
10161311 15OCT2020 20052 BNT162b2 
(30 μg) 15OCT2020/
BNT162b2 
(30 μg)03NOV2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 66
FDA-CBER-2022-5812-0228271
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10161314 C4591001 1016 
10161314 16OCT2020 20053 BNT162b2 
(30 μg) 16OCT2020/
BNT162b2 
(30 μg)05NOV2020/
BNT162b2 
(30 μg)    
10161315 C4591001 1016 
10161315 16OCT2020 20055 Placebo 16OCT2020/
Placebo 06NOV2020/
Placebo 20MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10161316 C4591001 1016 
10161316 16OCT2020 20058 Placebo 16OCT2020/
Placebo   25FEB2021/
BNT162b2 
(30 μg)16MAR2021/
BNT162b2 
(30 μg)
10161318 C4591001 1016 
10161318 16OCT2020 20099 Placebo 16OCT2020/
Placebo 04NOV2020/
Placebo 10JUN2021/
BNT162b2 
(30 μg)29JUN2021/
BNT162b2 
(30 μg)
10161319 C4591001 1016 
10161319 16OCT2020 20103 Placebo 16OCT2020/
Placebo 04NOV2020/
Placebo 25MAY2021/
BNT162b2 
(30 μg)14JUN2021/
BNT162b2 
(30 μg)
10161320 C4591001 1016 
10161320 21OCT2020 20176 BNT162b2 
(30 μg) 21OCT2020/
BNT162b2 
(30 μg)09NOV2020/
BNT162b2 
(30 μg)    
10161322 C4591001 1016 
10161322 19OCT2020 20107 BNT162b2 
(30 μg) 19OCT2020/
BNT162b2 
(30 μg)09NOV2020/
BNT162b2 
(30 μg)    
10161323 C4591001 1016 
10161323 19OCT2020 20108 BNT162b2 
(30 μg) 19OCT2020/
BNT162b2 
(30 μg)09NOV2020/
BNT162b2 
(30 μg)    
10161324 C4591001 1016 
10161324 19OCT2020 20109 Placebo 19OCT2020/
Placebo 09NOV2020/
Placebo 27MAY2021/
BNT162b2 
(30 μg)17JUN2021/
BNT162b2 
(30 μg)
10161325 C4591001 1016 
10161325 19OCT2020 20110 BNT162b2 
(30 μg) 19OCT2020/
BNT162b2 
(30 μg)10NOV2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 67
FDA-CBER-2022-5812-0228272
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10161326 C4591001 1016 
10161326 20OCT2020 20114 BNT162b2 
(30 μg) 20OCT2020/
BNT162b2 
(30 μg)10NOV2020/
BNT162b2 
(30 μg)    
10161327 C4591001 1016 
10161327 20OCT2020 20120 Placebo 20OCT2020/
Placebo 10NOV2020/
Placebo 01JUN2021/
BNT162b2 
(30 μg)22JUN2021/
BNT162b2 
(30 μg)
10161329 C4591001 1016 
10161329 20OCT2020 20171 Placebo 20OCT2020/
Placebo 10NOV2020/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10161330 C4591001 1016 
10161330 20OCT2020 20174 BNT162b2 
(30 μg) 20OCT2020/
BNT162b2 
(30 μg)11NOV2020/
BNT162b2 
(30 μg)    
10161331 C4591001 1016 
10161331 20OCT2020 20172 Placebo 20OCT2020/
Placebo 11NOV2020/
Placebo 26MAY2021/
BNT162b2 
(30 μg)14JUN2021/
BNT162b2 
(30 μg)
10161332 C4591001 1016 
10161332 21OCT2020 20229 BNT162b2 
(30 μg) 21OCT2020/
BNT162b2 
(30 μg)09NOV2020/
BNT162b2 
(30 μg)    
10161334 C4591001 1016 
10161334 21OCT2020 20231 Placebo 21OCT2020/
Placebo 11NOV2020/
Placebo 27MAY2021/
BNT162b2 
(30 μg)15JUN2021/
BNT162b2 
(30 μg)
10161335 C4591001 1016 
10161335 21OCT2020 20240 BNT162b2 
(30 μg) 21OCT2020/
BNT162b2 
(30 μg)11NOV2020/
BNT162b2 
(30 μg)    
10161336 C4591001 1016 
10161336 21OCT2020 20258 Placebo 21OCT2020/
Placebo 11NOV2020/
Placebo 06JUL2021/
BNT162b2 
(30 μg)26JUL2021/
BNT162b2 
(30 μg)
10161337 C4591001 1016 
10161337 21OCT2020 20236 Placebo 21OCT2020/
Placebo 10NOV2020/
Placebo 19APR2021/
BNT162b2 
(30 μg)10MAY2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 68
FDA-CBER-2022-5812-0228273
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10161338 C4591001 1016 
10161338 22OCT2020 20259 BNT162b2 
(30 μg) 22OCT2020/
BNT162b2 
(30 μg)10NOV2020/
BNT162b2 
(30 μg)    
10161339 C4591001 1016 
10161339 22OCT2020 20262 BNT162b2 
(30 μg) 22OCT2020/
BNT162b2 
(30 μg)10NOV2020/
BNT162b2 
(30 μg)    
10161340 C4591001 1016 
10161340 22OCT2020 20263 Placebo 22OCT2020/
Placebo 10NOV2020/
Placebo 26MAY2021/
BNT162b2 
(30 μg)15JUN2021/
BNT162b2 
(30 μg)
10161343 C4591001 1016 
10161343 22OCT2020 20301 BNT162b2 
(30 μg) 22OCT2020/
BNT162b2 
(30 μg)13NOV2020/
BNT162b2 
(30 μg)    
10161344 C4591001 1016 
10161344 22OCT2020 20306 Placebo 22OCT2020/
Placebo 11NOV2020/
Placebo 19MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10161350 C4591001 1016 
10161350 30NOV2020 20309 BNT162b2 
(30 μg) 30NOV2020/
BNT162b2 
(30 μg)21DEC2020/
BNT162b2 
(30 μg)    
10161351 C4591001 1016 
10161351 30NOV2020 20308 Placebo 30NOV2020/
Placebo 21DEC2020/
Placebo 14JUN2021/
BNT162b2 
(30 μg)12JUL2021/
BNT162b2 
(30 μg)
10161352 C4591001 1016 
10161352 30NOV2020 20410 Placebo 30NOV2020/
Placebo 21DEC2020/
Placebo 01JUN2021/
BNT162b2 
(30 μg)21JUN2021/
BNT162b2 
(30 μg)
10161353 C4591001 1016 
10161353 30NOV2020 20411 Placebo 30NOV2020/
Placebo 23DEC2020/
Placebo 24MAY2021/
BNT162b2 
(30 μg)14JUN2021/
BNT162b2 
(30 μg)
10161354 C4591001 1016 
10161354 02DEC2020 20412 BNT162b2 
(30 μg) 02DEC2020/
BNT162b2 
(30 μg)23DEC2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 69
FDA-CBER-2022-5812-0228274
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10161356 C4591001 1016 
10161356 02DEC2020 20416 BNT162b2 
(30 μg) 02DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10161357 C4591001 1016 
10161357 02DEC2020 20653 BNT162b2 
(30 μg) 02DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10161358 C4591001 1016 
10161358 03DEC2020 20657 Placebo 03DEC2020/
Placebo22DEC2020/
Placebo    
10161361 C4591001 1016 
10161361 04DEC2020 20658 Placebo 04DEC2020/
Placebo 23DEC2020/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10161362 C4591001 1016 
10161362 04DEC2020 20659 BNT162b2 
(30 μg) 04DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10161363 C4591001 1016 
10161363 08DEC2020 21477 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10161364 C4591001 1016 
10161364 09DEC2020 21478 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)31DEC2020/
BNT162b2 
(30 μg)    
10161365 C4591001 1016 
10161365 10DEC2020 21481 Placebo 10DEC2020/
Placebo 29DEC2020/
Placebo 17MAY2021/
BNT162b2 
(30 μg)10JUN2021/
BNT162b2 
(30 μg)
10161366 C4591001 1016 
10161366 15DEC2020 21488 Placebo 15DEC2020/
Placebo 07JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)07JUL2021/
BNT162b2 
(30 μg)
10161367 C4591001 1016 
10161367 29DEC2020 24585 Placebo 29DEC2020/
Placebo 19JAN2021/
Placebo 24MAY2021/
BNT162b2 
(30 μg)14JUN2021/
BNT162b2 
(30 μg)
10161368 C4591001 1016 
10161368 30DEC2020 24589 Placebo 30DEC2020/
Placebo 19JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 70
FDA-CBER-2022-5812-0228275
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10161369 C4591001 1016 
10161369 30DEC2020 24594 BNT162b2 
(30 μg) 30DEC2020/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10161370 C4591001 1016 
10161370 04JAN2021 24595 BNT162b2 
(30 μg) 04JAN2021/
BNT162b2 
(30 μg)25JAN2021/
BNT162b2 
(30 μg)    
10161371 C4591001 1016 
10161371 04JAN2021 25234 Placebo 04JAN2021/
Placebo 26JAN2021/
Placebo 25MAY2021/
BNT162b2 
(30 μg)14JUN2021/
BNT162b2 
(30 μg)
10161372 C4591001 1016 
10161372 05JAN2021 25237 Placebo 05JAN2021/
Placebo 27JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10161373 C4591001 1016 
10161373 05JAN2021 25238 BNT162b2 
(30 μg) 05JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10161374 C4591001 1016 
10161374 06JAN2021 25244 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)28JAN2021/
BNT162b2 
(30 μg)    
10161375 C4591001 1016 
10161375 06JAN2021 25790 Placebo 06JAN2021/
Placebo 27JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10161376 C4591001 1016 
10161376 07JAN2021 25795 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)26JAN2021/
BNT162b2 
(30 μg)    
10161377 C4591001 1016 
10161377 07JAN2021 25793 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)26JAN2021/
BNT162b2 
(30 μg)    
10161378 C4591001 1016 
10161378 07JAN2021 25796 Placebo 07JAN2021/
Placebo 26JAN2021/
Placebo 04AUG2021/
BNT162b2 
(30 μg)25AUG2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 71
FDA-CBER-2022-5812-0228276
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10161379 C4591001 1016 
10161379 07JAN2021 26104 Placebo 07JAN2021/
Placebo   01JUN2021/
BNT162b2 
(30 μg)28JUN2021/
BNT162b2 
(30 μg)
10161381 C4591001 1016 
10161381 08JAN2021 26105 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)28JAN2021/
BNT162b2 
(30 μg)    
10161382 C4591001 1016 
10161382 08JAN2021 26106 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)28JAN2021/
BNT162b2 
(30 μg)    
10161383 C4591001 1016 
10161383 08JAN2021 26107 Placebo 08JAN2021/
Placebo 28JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)01JUN2021/
BNT162b2 
(30 μg)
10161384 C4591001 1016 
10161384 08JAN2021 26170 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10161385 C4591001 1016 
10161385 08JAN2021 26172 Placebo 08JAN2021/
Placebo29JAN2021/
Placebo    
10161386 C4591001 1016 
10161386 08JAN2021 26179 Placebo 08JAN2021/
Placebo 28JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)01JUN2021/
BNT162b2 
(30 μg)
10161387 C4591001 1016 
10161387 08JAN2021 26180 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10161388 C4591001 1016 
10161388 11JAN2021 26698 Placebo 11JAN2021/
Placebo 02FEB2021/
Placebo 05MAY2021/
BNT162b2 
(30 μg)24MAY2021/
BNT162b2 
(30 μg)
10391246 C4591001 1039 
10391246 01DEC2020 20459 Placebo 01DEC2020/
Placebo 21DEC2020/
Placebo 26FEB2021/
BNT162b2 
(30 μg)18MAR2021/
BNT162b2 
(30 μg)
10391247 C4591001 1039 
10391247 01DEC2020 20460 BNT162b2 
(30 μg) 01DEC2020/
BNT162b2 
(30 μg)21DEC2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 72
FDA-CBER-2022-5812-0228277
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10391250 C4591001 1039 
10391250 04DEC2020 20465 BNT162b2 
(30 μg) 04DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10391251 C4591001 1039 
10391251 07DEC2020 20467 Placebo 07DEC2020/
Placebo 04JAN2021/
Placebo 02FEB2021/
BNT162b2 
(30 μg)25FEB2021/
BNT162b2 
(30 μg)
10391252 C4591001 1039 
10391252 07DEC2020 21109 Placebo 07DEC2020/
Placebo 28DEC2020/
Placebo 25MAR2021/
BNT162b2 
(30 μg)15APR2021/
BNT162b2 
(30 μg)
10391253 C4591001 1039 
10391253 07DEC2020 21111 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10391255 C4591001 1039 
10391255 07DEC2020 21112 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10391256 C4591001 1039 
10391256 07DEC2020 21201 Placebo 07DEC2020/
Placebo 29DEC2020/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10391258 C4591001 1039 
10391258 07DEC2020 21113 Placebo 07DEC2020/
Placebo 28DEC2020/
Placebo 13MAY2021/
BNT162b2 
(30 μg)01JUN2021/
BNT162b2 
(30 μg)
10391259 C4591001 1039 
10391259 07DEC2020 21202 Placebo 07DEC2020/
Placebo 28DEC2020/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10391260 C4591001 1039 
10391260 07DEC2020 21209 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10391262 C4591001 1039 
10391262 08DEC2020 21212 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 73
FDA-CBER-2022-5812-0228278
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10391263 C4591001 1039 
10391263 08DEC2020 21357 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10391264 C4591001 1039 
10391264 08DEC2020 21361 Placebo 08DEC2020/
Placebo 29DEC2020/
Placebo 24MAY2021/
BNT162b2 
(30 μg)  
10391265 C4591001 1039 
10391265 08DEC2020 21364 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10391266 C4591001 1039 
10391266 08DEC2020 21368 Placebo 08DEC2020/
Placebo 29DEC2020/
Placebo 14MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10391267 C4591001 1039 
10391267 08DEC2020 21434 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10391268 C4591001 1039 
10391268 08DEC2020 21430 Placebo 08DEC2020/
Placebo 28DEC2020/
Placebo 13MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10391269 C4591001 1039 
10391269 08DEC2020 21431 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10391270 C4591001 1039 
10391270 09DEC2020 21437 Placebo 09DEC2020/
Placebo 28DEC2020/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10391271 C4591001 1039 
10391271 09DEC2020 21721 Placebo 09DEC2020/
Placebo 28DEC2020/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10391272 C4591001 1039 
10391272 09DEC2020 21723 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 74
FDA-CBER-2022-5812-0228279
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10391273 C4591001 1039 
10391273 09DEC2020 21717 Placebo 09DEC2020/
Placebo 28DEC2020/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10391274 C4591001 1039 
10391274 16DEC2020 22739 Placebo 16DEC2020/
Placebo 04JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10391275 C4591001 1039 
10391275 16DEC2020 21727 BNT162b2 
(30 μg) 16DEC2020/
BNT162b2 
(30 μg)04JAN2021/
BNT162b2 
(30 μg)    
10391276 C4591001 1039 
10391276 16DEC2020 22740 BNT162b2 
(30 μg) 16DEC2020/
BNT162b2 
(30 μg)05JAN2021/
BNT162b2 
(30 μg)    
10391277 C4591001 1039 
10391277 16DEC2020 22742 Placebo 16DEC2020/
Placebo 06JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10391278 C4591001 1039 
10391278 16DEC2020 22747 BNT162b2 
(30 μg) 16DEC2020/
BNT162b2 
(30 μg)05JAN2021/
BNT162b2 
(30 μg)    
10391279 C4591001 1039 
10391279 16DEC2020 22813 Placebo 16DEC2020/
Placebo 06JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10391280 C4591001 1039 
10391280 17DEC2020 22814 Placebo 17DEC2020/
Placebo 07JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10391281 C4591001 1039 
10391281 17DEC2020 22816 BNT162b2 
(30 μg) 17DEC2020/
BNT162b2 
(30 μg)05JAN2021/
BNT162b2 
(30 μg)    
10391282 C4591001 1039 
10391282 18DEC2020 22818 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)08JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 75
FDA-CBER-2022-5812-0228280
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10391283 C4591001 1039 
10391283 18DEC2020 23270 Placebo 18DEC2020/
Placebo 07JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10391284 C4591001 1039 
10391284 18DEC2020 23272 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)07JAN2021/
BNT162b2 
(30 μg)    
10391285 C4591001 1039 
10391285 18DEC2020 23275 Placebo 18DEC2020/
Placebo 08JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10391286 C4591001 1039 
10391286 18DEC2020 23276 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)08JAN2021/
BNT162b2 
(30 μg)    
10391287 C4591001 1039 
10391287 18DEC2020 23326 Placebo 18DEC2020/
Placebo 08JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10391289 C4591001 1039 
10391289 18DEC2020 23327 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)08JAN2021/
BNT162b2 
(30 μg)    
10391290 C4591001 1039 
10391290 18DEC2020 23328 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)08JAN2021/
BNT162b2 
(30 μg)    
10391291 C4591001 1039 
10391291 18DEC2020 23373 Placebo 18DEC2020/
Placebo 08JAN2021/
Placebo 26MAR2021/
BNT162b2 
(30 μg)16APR2021/
BNT162b2 
(30 μg)
10391292 C4591001 1039 
10391292 18DEC2020 23332 Placebo 18DEC2020/
Placebo 08JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10391293 C4591001 1039 
10391293 21DEC2020 23378 BNT162b2 
(30 μg) 21DEC2020/
BNT162b2 
(30 μg)11JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 76
FDA-CBER-2022-5812-0228281
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10391294 C4591001 1039 
10391294 21DEC2020 23381 Placebo 21DEC2020/
Placebo 13JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10391295 C4591001 1039 
10391295 29DEC2020 23384 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)19JAN2021/
BNT162b2 
(30 μg)    
10391296 C4591001 1039 
10391296 29DEC2020 24563 Placebo 29DEC2020/
Placebo 19JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10391297 C4591001 1039 
10391297 29DEC2020 24564 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)19JAN2021/
BNT162b2 
(30 μg)    
10391298 C4591001 1039 
10391298 29DEC2020 24565 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)19JAN2021/
BNT162b2 
(30 μg)    
10391299 C4591001 1039 
10391299 29DEC2020 24568 Placebo 29DEC2020/
Placebo 19JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10391300 C4591001 1039 
10391300 29DEC2020 24664 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)21JAN2021/
BNT162b2 
(30 μg)    
10391301 C4591001 1039 
10391301 29DEC2020 24665 Placebo 29DEC2020/
Placebo 21JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10391302 C4591001 1039 
10391302 29DEC2020 24666 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)18JAN2021/
BNT162b2 
(30 μg)    
10391303 C4591001 1039 
10391303 29DEC2020 24667 Placebo 29DEC2020/
Placebo 21JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 77
FDA-CBER-2022-5812-0228282
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10391304 C4591001 1039 
10391304 29DEC2020 24754 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)19JAN2021/
BNT162b2 
(30 μg)    
10391305 C4591001 1039 
10391305 06JAN2021 24759 Placebo 06JAN2021/
Placebo 25JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10391306 C4591001 1039 
10391306 06JAN2021 24762 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)25JAN2021/
BNT162b2 
(30 μg)    
10391307 C4591001 1039 
10391307 06JAN2021 24764 Placebo 06JAN2021/
Placebo 27JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10391308 C4591001 1039 
10391308 06JAN2021 25749 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10391309 C4591001 1039 
10391309 07JAN2021 25752 Placebo 07JAN2021/
Placebo 27JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10391310 C4591001 1039 
10391310 07JAN2021 25759 Placebo 07JAN2021/
Placebo 26JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10391311 C4591001 1039 
10391311 07JAN2021 25918 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10391312 C4591001 1039 
10391312 07JAN2021 25760 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)28JAN2021/
BNT162b2 
(30 μg)    
10391313 C4591001 1039 
10391313 07JAN2021 25920 Placebo 07JAN2021/
Placebo 28JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 78
FDA-CBER-2022-5812-0228283
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10391314 C4591001 1039 
10391314 07JAN2021 25921 Placebo 07JAN2021/
Placebo 28JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10391315 C4591001 1039 
10391315 07JAN2021 25924 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10391316 C4591001 1039 
10391316 07JAN2021 26039 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10391317 C4591001 1039 
10391317 07JAN2021 26040 Placebo 07JAN2021/
Placebo 28JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10391318 C4591001 1039 
10391318 07JAN2021 26041 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10391319 C4591001 1039 
10391319 08JAN2021 26042 Placebo 08JAN2021/
Placebo 29JAN2021/
Placebo 20MAY2021/
BNT162b2 
(30 μg)11JUN2021/
BNT162b2 
(30 μg)
10391320 C4591001 1039 
10391320 08JAN2021 26184 Placebo 08JAN2021/
Placebo29JAN2021/
Placebo    
10391321 C4591001 1039 
10391321 08JAN2021 26182 Placebo 08JAN2021/
Placebo 29JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10391322 C4591001 1039 
10391322 08JAN2021 26187 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10391323 C4591001 1039 
10391323 08JAN2021 26191 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10391324 C4591001 1039 
10391324 08JAN2021 26398 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 79
FDA-CBER-2022-5812-0228284
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10391325 C4591001 1039 
10391325 11JAN2021 26403 Placebo 11JAN2021/
Placebo 01FEB2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10391326 C4591001 1039 
10391326 11JAN2021 26405 BNT162b2 
(30 μg) 11JAN2021/
BNT162b2 
(30 μg)01FEB2021/
BNT162b2 
(30 μg)    
10391327 C4591001 1039 
10391327 11JAN2021 26408 Placebo 11JAN2021/
Placebo01FEB2021/
Placebo    
10391328 C4591001 1039 
10391328 11JAN2021 26639 Placebo 11JAN2021/
Placebo 02FEB2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10391329 C4591001 1039 
10391329 11JAN2021 26644 Placebo 11JAN2021/
Placebo 01FEB2021/
Placebo 20MAY2021/
BNT162b2 
(30 μg)10JUN2021/
BNT162b2 
(30 μg)
10391330 C4591001 1039 
10391330 11JAN2021 26640 BNT162b2 
(30 μg) 11JAN2021/
BNT162b2 
(30 μg)02FEB2021/
BNT162b2 
(30 μg)    
10391331 C4591001 1039 
10391331 12JAN2021 26648 BNT162b2 
(30 μg) 12JAN2021/
BNT162b2 
(30 μg)01FEB2021/
BNT162b2 
(30 μg)    
10391332 C4591001 1039 
10391332 12JAN2021 26769 BNT162b2 
(30 μg) 12JAN2021/
BNT162b2 
(30 μg)02FEB2021/
BNT162b2 
(30 μg)    
10391333 C4591001 1039 
10391333 12JAN2021 26770 Placebo 12JAN2021/
Placebo 02FEB2021/
Placebo 21MAY2021/
BNT162b2 
(30 μg)11JUN2021/
BNT162b2 
(30 μg)
10391334 C4591001 1039 
10391334 12JAN2021 26772 Placebo 12JAN2021/
Placebo 02FEB2021/
Placebo 21MAY2021/
BNT162b2 
(30 μg)11JUN2021/
BNT162b2 
(30 μg)
10391335 C4591001 1039 
10391335 12JAN2021 26817 BNT162b2 
(30 μg) 12JAN2021/
BNT162b2 
(30 μg)02FEB2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 80
FDA-CBER-2022-5812-0228285
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10391336 C4591001 1039 
10391336 12JAN2021 26780 BNT162b2 
(30 μg) 12JAN2021/
BNT162b2 
(30 μg)02FEB2021/
BNT162b2 
(30 μg)    
10391337 C4591001 1039 
10391337 12JAN2021 26822 Placebo 12JAN2021/
Placebo 03FEB2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10391338 C4591001 1039 
10391338 12JAN2021 26823 BNT162b2 
(30 μg) 12JAN2021/
BNT162b2 
(30 μg)03FEB2021/
BNT162b2 
(30 μg)    
10391339 C4591001 1039 
10391339 12JAN2021 26828 Placebo 12JAN2021/
Placebo 03FEB2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10441251 C4591001 1044 
10441251 30NOV2020 20354 BNT162b2 
(30 μg) 30NOV2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10441252 C4591001 1044 
10441252 30NOV2020 20360 Placebo 30NOV2020/
Placebo 21DEC2020/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10441253 C4591001 1044 
10441253 30NOV2020 20439 BNT162b2 
(30 μg) 30NOV2020/
BNT162b2 
(30 μg)21DEC2020/
BNT162b2 
(30 μg)    
10441255 C4591001 1044 
10441255 01DEC2020 20440 BNT162b2 
(30 μg) 01DEC2020/
BNT162b2 
(30 μg)21DEC2020/
BNT162b2 
(30 μg)    
10441256 C4591001 1044 
10441256 01DEC2020 20444 Placebo 01DEC2020/
Placebo 21DEC2020/
Placebo 17MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10441257 C4591001 1044 
10441257 01DEC2020 20567 BNT162b2 
(30 μg) 01DEC2020/
BNT162b2 
(30 μg)23DEC2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 81
FDA-CBER-2022-5812-0228286
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10441259 C4591001 1044 
10441259 01DEC2020 20569 BNT162b2 
(30 μg) 01DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10441260 C4591001 1044 
10441260 01DEC2020 20576 Placebo 01DEC2020/
Placebo 22DEC2020/
Placebo 14MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10441261 C4591001 1044 
10441261 01DEC2020 20618 Placebo 01DEC2020/
Placebo 22DEC2020/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10441263 C4591001 1044 
10441263 07DEC2020 20623 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10441264 C4591001 1044 
10441264 07DEC2020 20624 Placebo 07DEC2020/
Placebo 28DEC2020/
Placebo 26JUL2021/
BNT162b2 
(30 μg)23AUG2021/
BNT162b2 
(30 μg)
10441265 C4591001 1044 
10441265 07DEC2020 21287 Placebo 07DEC2020/
Placebo 28DEC2020/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10441266 C4591001 1044 
10441266 08DEC2020 21289 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10441267 C4591001 1044 
10441267 08DEC2020 21290 Placebo 08DEC2020/
Placebo 28DEC2020/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10441268 C4591001 1044 
10441268 08DEC2020 21294 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10441270 C4591001 1044 
10441270 08DEC2020 21417 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)31DEC2020/
BNT162b2 
(30 μg)    
10441271 C4591001 1044 
10441271 08DEC2020 21420 Placebo 08DEC2020/
Placebo28DEC2020/
Placebo    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 82
FDA-CBER-2022-5812-0228287
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10441273 C4591001 1044 
10441273 08DEC2020 21423 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10441274 C4591001 1044 
10441274 08DEC2020 21428 Placebo 08DEC2020/
Placebo 28DEC2020/
Placebo 17FEB2021/
BNT162b2 
(30 μg)12MAR2021/
BNT162b2 
(30 μg)
10441275 C4591001 1044 
10441275 09DEC2020 21621 Placebo 09DEC2020/
Placebo 29DEC2020/
Placebo 17MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10441276 C4591001 1044 
10441276 09DEC2020 21623 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10441277 C4591001 1044 
10441277 09DEC2020 21632 Placebo 09DEC2020/
Placebo 29DEC2020/
Placebo 17MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10441278 C4591001 1044 
10441278 09DEC2020 21631 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10441279 C4591001 1044 
10441279 09DEC2020 21789 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10441280 C4591001 1044 
10441280 09DEC2020 21792 Placebo 09DEC2020/
Placebo 29DEC2020/
Placebo 28JAN2021/
BNT162b2 
(30 μg)17FEB2021/
BNT162b2 
(30 μg)
10441281 C4591001 1044 
10441281 09DEC2020 21795 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10441282 C4591001 1044 
10441282 09DEC2020 21799 Placebo 09DEC2020/
Placebo 30DEC2020/
Placebo 03MAR2021/
BNT162b2 
(30 μg)24MAR2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 83
FDA-CBER-2022-5812-0228288
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10441283 C4591001 1044 
10441283 10DEC2020 21840 BNT162b2 
(30 μg) 10DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10441284 C4591001 1044 
10441284 10DEC2020 21843 Placebo 10DEC2020/
Placebo 29DEC2020/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10441285 C4591001 1044 
10441285 10DEC2020 21845 BNT162b2 
(30 μg) 10DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10441286 C4591001 1044 
10441286 11DEC2020 21848 Placebo 11DEC2020/
Placebo 30DEC2020/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10441288 C4591001 1044 
10441288 16DEC2020 22749 BNT162b2 
(30 μg) 16DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10441289 C4591001 1044 
10441289 16DEC2020 22751 Placebo 16DEC2020/
Placebo11JAN2021/
Placebo    
10441290 C4591001 1044 
10441290 08JAN2021 26233 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10441291 C4591001 1044 
10441291 17DEC2020 22752 BNT162b2 
(30 μg) 17DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10441292 C4591001 1044 
10441292 17DEC2020 22759 Placebo 17DEC2020/
Placebo 05JAN2021/
Placebo 10MAR2021/
BNT162b2 
(30 μg)01APR2021/
BNT162b2 
(30 μg)
10441293 C4591001 1044 
10441293 17DEC2020 23195 Placebo 17DEC2020/
Placebo 05JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)  
10441294 C4591001 1044 
10441294 17DEC2020 23196 Placebo 17DEC2020/
Placebo 05JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)  
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 84
FDA-CBER-2022-5812-0228289
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10441295 C4591001 1044 
10441295 18DEC2020 23198 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)08JAN2021/
BNT162b2 
(30 μg)    
10441296 C4591001 1044 
10441296 22DEC2020 23202 BNT162b2 
(30 μg) 22DEC2020/
BNT162b2 
(30 μg)11JAN2021/
BNT162b2 
(30 μg)    
10441297 C4591001 1044 
10441297 23DEC2020 24157 BNT162b2 
(30 μg) 23DEC2020/
BNT162b2 
(30 μg)13JAN2021/
BNT162b2 
(30 μg)    
10441298 C4591001 1044 
10441298 23DEC2020 24160 Placebo 23DEC2020/
Placebo 13JAN2021/
Placebo 28MAY2021/
BNT162b2 
(30 μg)18JUN2021/
BNT162b2 
(30 μg)
10441299 C4591001 1044 
10441299 28DEC2020 24161 Placebo 28DEC2020/
Placebo 19JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10441300 C4591001 1044 
10441300 28DEC2020 24163 BNT162b2 
(30 μg) 28DEC2020/
BNT162b2 
(30 μg)18JAN2021/
BNT162b2 
(30 μg)    
10441301 C4591001 1044 
10441301 29DEC2020 24721 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)18JAN2021/
BNT162b2 
(30 μg)    
10441302 C4591001 1044 
10441302 29DEC2020 24723 Placebo 29DEC2020/
Placebo 19JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10441303 C4591001 1044 
10441303 29DEC2020 24722 Placebo 29DEC2020/
Placebo 19JAN2021/
Placebo 20APR2021/
BNT162b2 
(30 μg)13MAY2021/
BNT162b2 
(30 μg)
10441304 C4591001 1044 
10441304 29DEC2020 24728 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)19JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 85
FDA-CBER-2022-5812-0228290
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10441306 C4591001 1044 
10441306 30DEC2020 24861 BNT162b2 
(30 μg) 30DEC2020/
BNT162b2 
(30 μg)18JAN2021/
BNT162b2 
(30 μg)    
10441307 C4591001 1044 
10441307 30DEC2020 24863 Placebo 30DEC2020/
Placebo 18JAN2021/
Placebo 17AUG2021/
BNT162b2 
(30 μg)  
10441308 C4591001 1044 
10441308 30DEC2020 24869 Placebo 30DEC2020/
Placebo 20JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10441309 C4591001 1044 
10441309 30DEC2020 24871 BNT162b2 
(30 μg) 30DEC2020/
BNT162b2 
(30 μg)18JAN2021/
BNT162b2 
(30 μg)    
10441310 C4591001 1044 
10441310 30DEC2020 24958 BNT162b2 
(30 μg) 30DEC2020/
BNT162b2 
(30 μg)18JAN2021/
BNT162b2 
(30 μg)    
10441311 C4591001 1044 
10441311 04JAN2021 24959 BNT162b2 
(30 μg) 04JAN2021/
BNT162b2 
(30 μg)25JAN2021/
BNT162b2 
(30 μg)    
10441312 C4591001 1044 
10441312 04JAN2021 24966 Placebo 04JAN2021/
Placebo 26JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)02JUN2021/
BNT162b2 
(30 μg)
10441313 C4591001 1044 
10441313 04JAN2021 24968 Placebo 04JAN2021/
Placebo 25JAN2021/
Placebo 26JUL2021/
BNT162b2 
(30 μg)17AUG2021/
BNT162b2 
(30 μg)
10441314 C4591001 1044 
10441314 04JAN2021 25210 BNT162b2 
(30 μg) 04JAN2021/
BNT162b2 
(30 μg)25JAN2021/
BNT162b2 
(30 μg)    
10441315 C4591001 1044 
10441315 04JAN2021 25212 Placebo 04JAN2021/
Placebo 25JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 86
FDA-CBER-2022-5812-0228291
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10441316 C4591001 1044 
10441316 04JAN2021 25213 BNT162b2 
(30 μg) 04JAN2021/
BNT162b2 
(30 μg)25JAN2021/
BNT162b2 
(30 μg)    
10441317 C4591001 1044 
10441317 04JAN2021 25214 Placebo 04JAN2021/
Placebo 27JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10441318 C4591001 1044 
10441318 05JAN2021 25392 Placebo 05JAN2021/
Placebo 25JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10441319 C4591001 1044 
10441319 05JAN2021 25394 BNT162b2 
(30 μg) 05JAN2021/
BNT162b2 
(30 μg)25JAN2021/
BNT162b2 
(30 μg)    
10441320 C4591001 1044 
10441320 05JAN2021 25395 Placebo 05JAN2021/
Placebo 26JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10441321 C4591001 1044 
10441321 05JAN2021 25396 BNT162b2 
(30 μg) 05JAN2021/
BNT162b2 
(30 μg)26JAN2021/
BNT162b2 
(30 μg)    
10441322 C4591001 1044 
10441322 05JAN2021 25521 BNT162b2 
(30 μg) 05JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10441323 C4591001 1044 
10441323 05JAN2021 25525 Placebo 05JAN2021/
Placebo 28JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10441324 C4591001 1044 
10441324 05JAN2021 25529 Placebo 05JAN2021/
Placebo 25JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10441325 C4591001 1044 
10441325 05JAN2021 25531 BNT162b2 
(30 μg) 05JAN2021/
BNT162b2 
(30 μg)26JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 87
FDA-CBER-2022-5812-0228292
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10441326 C4591001 1044 
10441326 06JAN2021 25645 Placebo 06JAN2021/
Placebo 25JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10441327 C4591001 1044 
10441327 06JAN2021 25647 Placebo 06JAN2021/
Placebo 25JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10441328 C4591001 1044 
10441328 06JAN2021 25648 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)26JAN2021/
BNT162b2 
(30 μg)    
10441329 C4591001 1044 
10441329 06JAN2021 25652 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10441330 C4591001 1044 
10441330 06JAN2021 25778 Placebo 06JAN2021/
Placebo 27JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10441331 C4591001 1044 
10441331 06JAN2021 25780 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10441332 C4591001 1044 
10441332 06JAN2021 25782 Placebo 06JAN2021/
Placebo 27JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10441333 C4591001 1044 
10441333 06JAN2021 25783 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10441334 C4591001 1044 
10441334 07JAN2021 25905 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)26JAN2021/
BNT162b2 
(30 μg)    
10441335 C4591001 1044 
10441335 07JAN2021 25910 Placebo 07JAN2021/
Placebo 29JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 88
FDA-CBER-2022-5812-0228293
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10441336 C4591001 1044 
10441336 07JAN2021 25913 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)28JAN2021/
BNT162b2 
(30 μg)    
10441337 C4591001 1044 
10441337 08JAN2021 25916 Placebo 08JAN2021/
Placebo 29JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10441338 C4591001 1044 
10441338 08JAN2021 26229 Placebo 08JAN2021/
Placebo29JAN2021/
Placebo    
10441339 C4591001 1044 
10441339 08JAN2021 26234 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10441340 C4591001 1044 
10441340 08JAN2021 26326 Placebo 08JAN2021/
Placebo 29JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)01JUN2021/
BNT162b2 
(30 μg)
10441341 C4591001 1044 
10441341 08JAN2021 26235 Placebo 08JAN2021/
Placebo 29JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)01JUN2021/
BNT162b2 
(30 μg)
10441342 C4591001 1044 
10441342 09JAN2021 26334 BNT162b2 
(30 μg) 09JAN2021/
BNT162b2 
(30 μg)28JAN2021/
BNT162b2 
(30 μg)    
10441343 C4591001 1044 
10441343 09JAN2021 26335 BNT162b2 
(30 μg) 09JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10441344 C4591001 1044 
10441344 09JAN2021 26336 Placebo 09JAN2021/
Placebo 29JAN2021/
Placebo 19FEB2021/
BNT162b2 
(30 μg)16MAR2021/
BNT162b2 
(30 μg)
10441345 C4591001 1044 
10441345 09JAN2021 26477 Placebo 09JAN2021/
Placebo 28JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10441346 C4591001 1044 
10441346 09JAN2021 26470 BNT162b2 
(30 μg) 09JAN2021/
BNT162b2 
(30 μg)28JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 89
FDA-CBER-2022-5812-0228294
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10441347 C4591001 1044 
10441347 09JAN2021 26478 Placebo 09JAN2021/
Placebo29JAN2021/
Placebo    
10441348 C4591001 1044 
10441348 09JAN2021 26494 Placebo 09JAN2021/
Placebo 28JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10441349 C4591001 1044 
10441349 09JAN2021 26479 BNT162b2 
(30 μg) 09JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10441350 C4591001 1044 
10441350 09JAN2021 26500 BNT162b2 
(30 μg) 09JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10441351 C4591001 1044 
10441351 10JAN2021 26502 Placebo 10JAN2021/
Placebo 01FEB2021/
Placebo 03AUG2021/
BNT162b2 
(30 μg)23AUG2021/
BNT162b2 
(30 μg)
10441352 C4591001 1044 
10441352 10JAN2021 26504 BNT162b2 
(30 μg) 10JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10441353 C4591001 1044 
10441353 10JAN2021 26508 BNT162b2 
(30 μg) 10JAN2021/
BNT162b2 
(30 μg)01FEB2021/
BNT162b2 
(30 μg)    
10441354 C4591001 1044 
10441354 10JAN2021 26509 Placebo 10JAN2021/
Placebo 29JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10441355 C4591001 1044 
10441355 10JAN2021 26513 BNT162b2 
(30 μg) 10JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10441356 C4591001 1044 
10441356 10JAN2021 26514 Placebo 10JAN2021/
Placebo02FEB2021/
Placebo    
10441357 C4591001 1044 
10441357 10JAN2021 26521 Placebo 10JAN2021/
Placebo 29JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 90
FDA-CBER-2022-5812-0228295
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10441358 C4591001 1044 
10441358 10JAN2021 26522 BNT162b2 
(30 μg) 10JAN2021/
BNT162b2 
(30 μg)01FEB2021/
BNT162b2 
(30 μg)    
10441359 C4591001 1044 
10441359 11JAN2021 26528 BNT162b2 
(30 μg) 11JAN2021/
BNT162b2 
(30 μg)25FEB2021/
BNT162b2 
(30 μg)    
10441360 C4591001 1044 
10441360 11JAN2021 26524 Placebo 11JAN2021/
Placebo 25FEB2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10441361 C4591001 1044 
10441361 11JAN2021 26589 BNT162b2 
(30 μg) 11JAN2021/
BNT162b2 
(30 μg)03FEB2021/
BNT162b2 
(30 μg)    
10441362 C4591001 1044 
10441362 11JAN2021 26593 Placebo 11JAN2021/
Placebo 03FEB2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10441363 C4591001 1044 
10441363 11JAN2021 26595 Placebo 11JAN2021/
Placebo 01FEB2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10441364 C4591001 1044 
10441364 11JAN2021 26596 BNT162b2 
(30 μg) 11JAN2021/
BNT162b2 
(30 μg)03FEB2021/
BNT162b2 
(30 μg)    
10441365 C4591001 1044 
10441365 11JAN2021 26675 Placebo 11JAN2021/
Placebo 02FEB2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)02JUN2021/
BNT162b2 
(30 μg)
10441366 C4591001 1044 
10441366 11JAN2021 26676 BNT162b2 
(30 μg) 11JAN2021/
BNT162b2 
(30 μg)02FEB2021/
BNT162b2 
(30 μg)    
10441367 C4591001 1044 
10441367 11JAN2021 26677 BNT162b2 
(30 μg) 11JAN2021/
BNT162b2 
(30 μg)03FEB2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 91
FDA-CBER-2022-5812-0228296
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10441368 C4591001 1044 
10441368 11JAN2021 26678 Placebo 11JAN2021/
Placebo 03FEB2021/
Placebo 09MAR2021/
BNT162b2 
(30 μg)30MAR2021/
BNT162b2 
(30 μg)
10441369 C4591001 1044 
10441369 11JAN2021 26725 BNT162b2 
(30 μg) 11JAN2021/
BNT162b2 
(30 μg)02FEB2021/
BNT162b2 
(30 μg)    
10441370 C4591001 1044 
10441370 11JAN2021 26729 Placebo 11JAN2021/
Placebo 02FEB2021/
Placebo 01JUN2021/
BNT162b2 
(30 μg)21JUN2021/
BNT162b2 
(30 μg)
10441371 C4591001 1044 
10441371 11JAN2021 26730 Placebo 11JAN2021/
Placebo02FEB2021/
Placebo    
10441372 C4591001 1044 
10441372 11JAN2021 26731 BNT162b2 
(30 μg) 11JAN2021/
BNT162b2 
(30 μg)02FEB2021/
BNT162b2 
(30 μg)    
10441373 C4591001 1044 
10441373 12JAN2021 26782 Placebo 12JAN2021/
Placebo 04FEB2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10441374 C4591001 1044 
10441374 12JAN2021 26784 Placebo 12JAN2021/
Placebo 02FEB2021/
Placebo 20AUG2021/
BNT162b2 
(30 μg)  
10441375 C4591001 1044 
10441375 12JAN2021 26786 BNT162b2 
(30 μg) 12JAN2021/
BNT162b2 
(30 μg)02FEB2021/
BNT162b2 
(30 μg)    
10441376 C4591001 1044 
10441376 12JAN2021 26792 BNT162b2 
(30 μg) 12JAN2021/
BNT162b2 
(30 μg)02FEB2021/
BNT162b2 
(30 μg)    
10441377 C4591001 1044 
10441377 12JAN2021 26911 BNT162b2 
(30 μg) 01FEB2021/
BNT162b2 
(30 μg)22FEB2021/
BNT162b2 
(30 μg)    
10441378 C4591001 1044 
10441378 12JAN2021 26843 BNT162b2 
(30 μg) 12JAN2021/
BNT162b2 
(30 μg)04FEB2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 92
FDA-CBER-2022-5812-0228297
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10441379 C4591001 1044 
10441379 12JAN2021 26845 BNT162b2 
(30 μg) 12JAN2021/
BNT162b2 
(30 μg)04FEB2021/
BNT162b2 
(30 μg)    
10441380 C4591001 1044 
10441380 12JAN2021 26849 Placebo 12JAN2021/
Placebo 03FEB2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10441381 C4591001 1044 
10441381 12JAN2021 26851 Placebo 12JAN2021/
Placebo 01FEB2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)11JUN2021/
BNT162b2 
(30 μg)
10441382 C4591001 1044 
10441382 12JAN2021 26901 Placebo 12JAN2021/
Placebo 03FEB2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)02JUN2021/
BNT162b2 
(30 μg)
10441383 C4591001 1044 
10441383 12JAN2021 26902 BNT162b2 
(30 μg) 12JAN2021/
BNT162b2 
(30 μg)03FEB2021/
BNT162b2 
(30 μg)    
10441384 C4591001 1044 
10441384 12JAN2021 26912 Placebo 12JAN2021/
Placebo 04FEB2021/
Placebo 20MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10571376 C4591001 1057 
10571376 07DEC2020 21117 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)04JAN2021/
BNT162b2 
(30 μg)    
10571377 C4591001 1057 
10571377 07DEC2020 21119 Placebo 07DEC2020/
Placebo28DEC2020/
Placebo    
10571378 C4591001 1057 
10571378 07DEC2020 21122 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10571379 C4591001 1057 
10571379 07DEC2020 21127 Placebo 07DEC2020/
Placebo 30DEC2020/
Placebo 13MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10571380 C4591001 1057 
10571380 08DEC2020 21345 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)04JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 93
FDA-CBER-2022-5812-0228298
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10571382 C4591001 1057 
10571382 08DEC2020 21352 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)05JAN2021/
BNT162b2 
(30 μg)    
10571383 C4591001 1057 
10571383 08DEC2020 21346 Placebo 08DEC2020/
Placebo 30DEC2020/
Placebo 17MAY2021/
BNT162b2 
(30 μg)11JUN2021/
BNT162b2 
(30 μg)
10571384 C4591001 1057 
10571384 08DEC2020 21348 Placebo 08DEC2020/
Placebo 28DEC2020/
Placebo 29JUN2021/
BNT162b2 
(30 μg)20JUL2021/
BNT162b2 
(30 μg)
10571385 C4591001 1057 
10571385 08DEC2020 21504 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10571386 C4591001 1057 
10571386 08DEC2020 21508 Placebo 08DEC2020/
Placebo29DEC2020/
Placebo    
10571387 C4591001 1057 
10571387 09DEC2020 21509 Placebo 09DEC2020/
Placebo 28DEC2020/
Placebo 02JUN2021/
BNT162b2 
(30 μg)23JUN2021/
BNT162b2 
(30 μg)
10571388 C4591001 1057 
10571388 09DEC2020 21512 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10571389 C4591001 1057 
10571389 09DEC2020 21705 Placebo 09DEC2020/
Placebo04JAN2021/
Placebo    
10571390 C4591001 1057 
10571390 09DEC2020 21706 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10571391 C4591001 1057 
10571391 09DEC2020 21711 Placebo 09DEC2020/
Placebo 28DEC2020/
Placebo 24FEB2021/
BNT162b2 
(30 μg)17MAR2021/
BNT162b2 
(30 μg)
10571392 C4591001 1057 
10571392 09DEC2020 21712 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 94
FDA-CBER-2022-5812-0228299
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10571393 C4591001 1057 
10571393 09DEC2020 21754 Placebo 09DEC2020/
Placebo 28DEC2020/
Placebo 27MAY2021/
BNT162b2 
(30 μg)15JUN2021/
BNT162b2 
(30 μg)
10571394 C4591001 1057 
10571394 09DEC2020 21756 Placebo 09DEC2020/
Placebo 29DEC2020/
Placebo 17MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10571395 C4591001 1057 
10571395 09DEC2020 21757 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)14JAN2021/
BNT162b2 
(30 μg)    
10571396 C4591001 1057 
10571396 10DEC2020 21761 BNT162b2 
(30 μg) 10DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10571397 C4591001 1057 
10571397 10DEC2020 21949 BNT162b2 
(30 μg) 10DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10571398 C4591001 1057 
10571398 10DEC2020 21951 Placebo 10DEC2020/
Placebo 30DEC2020/
Placebo 17MAY2021/
BNT162b2 
(30 μg)03JUN2021/
BNT162b2 
(30 μg)
10571399 C4591001 1057 
10571399 10DEC2020 21954 BNT162b2 
(30 μg) 10DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10571400 C4591001 1057 
10571400 11DEC2020 21956 Placebo 11DEC2020/
Placebo 30DEC2020/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10571401 C4591001 1057 
10571401 11DEC2020 22057 BNT162b2 
(30 μg) 11DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10571402 C4591001 1057 
10571402 14DEC2020 22058 Placebo 14DEC2020/
Placebo 06JAN2021/
Placebo 03MAR2021/
BNT162b2 
(30 μg)24MAR2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 95
FDA-CBER-2022-5812-0228300
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10571403 C4591001 1057 
10571403 14DEC2020 22059 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)04JAN2021/
BNT162b2 
(30 μg)    
10571404 C4591001 1057 
10571404 16DEC2020 22062 Placebo 16DEC2020/
Placebo 04JAN2021/
Placebo 28JUN2021/
BNT162b2 
(30 μg)21JUL2021/
BNT162b2 
(30 μg)
10571405 C4591001 1057 
10571405 16DEC2020 22896 BNT162b2 
(30 μg) 16DEC2020/
BNT162b2 
(30 μg)05JAN2021/
BNT162b2 
(30 μg)    
10571406 C4591001 1057 
10571406 16DEC2020 22901 Placebo 16DEC2020/
Placebo 05JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10571407 C4591001 1057 
10571407 17DEC2020 22903 Placebo 17DEC2020/
Placebo 05JAN2021/
Placebo 12MAR2021/
BNT162b2 
(30 μg)02APR2021/
BNT162b2 
(30 μg)
10571408 C4591001 1057 
10571408 17DEC2020 23052 Placebo 17DEC2020/
Placebo 05JAN2021/
Placebo 25MAY2021/
BNT162b2 
(30 μg)16JUN2021/
BNT162b2 
(30 μg)
10571409 C4591001 1057 
10571409 17DEC2020 22902 BNT162b2 
(30 μg) 17DEC2020/
BNT162b2 
(30 μg)05JAN2021/
BNT162b2 
(30 μg)    
10571410 C4591001 1057 
10571410 17DEC2020 23056 Placebo 17DEC2020/
Placebo 05JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10571411 C4591001 1057 
10571411 17DEC2020 23059 BNT162b2 
(30 μg) 17DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10571412 C4591001 1057 
10571412 17DEC2020 23060 BNT162b2 
(30 μg) 17DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10571413 C4591001 1057 
10571413 21DEC2020 23709 BNT162b2 
(30 μg)        
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 96
FDA-CBER-2022-5812-0228301
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10571414 C4591001 1057 
10571414 21DEC2020 23710 Placebo 21DEC2020/
Placebo12JAN2021/
Placebo    
10571415 C4591001 1057 
10571415 21DEC2020 23714 Placebo 21DEC2020/
Placebo 14JAN2021/
Placebo 03JUN2021/
BNT162b2 
(30 μg)09JUL2021/
BNT162b2 
(30 μg)
10571416 C4591001 1057 
10571416 21DEC2020 23716 BNT162b2 
(30 μg) 21DEC2020/
BNT162b2 
(30 μg)13JAN2021/
BNT162b2 
(30 μg)    
10571417 C4591001 1057 
10571417 21DEC2020 23793 Placebo 21DEC2020/
Placebo 11JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)14JUN2021/
BNT162b2 
(30 μg)
10571418 C4591001 1057 
10571418 22DEC2020 23800 BNT162b2 
(30 μg) 22DEC2020/
BNT162b2 
(30 μg)11JAN2021/
BNT162b2 
(30 μg)    
10571419 C4591001 1057 
10571419 22DEC2020 23803 BNT162b2 
(30 μg) 22DEC2020/
BNT162b2 
(30 μg)11JAN2021/
BNT162b2 
(30 μg)    
10571420 C4591001 1057 
10571420 23DEC2020 23804 Placebo 23DEC2020/
Placebo11JAN2021/
Placebo    
10571421 C4591001 1057 
10571421 23DEC2020 24261 Placebo 23DEC2020/
Placebo11JAN2021/
Placebo    
10571422 C4591001 1057 
10571422 23DEC2020 24265 BNT162b2 
(30 μg) 23DEC2020/
BNT162b2 
(30 μg)13JAN2021/
BNT162b2 
(30 μg)    
10571423 C4591001 1057 
10571423 24DEC2020 24269 BNT162b2 
(30 μg) 24DEC2020/
BNT162b2 
(30 μg)15JAN2021/
BNT162b2 
(30 μg)    
10571424 C4591001 1057 
10571424 24DEC2020 24271 Placebo 24DEC2020/
Placebo 15JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 97
FDA-CBER-2022-5812-0228302
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10571425 C4591001 1057 
10571425 24DEC2020 24301 Placebo 24DEC2020/
Placebo12JAN2021/
Placebo    
10571426 C4591001 1057 
10571426 24DEC2020 24305 BNT162b2 
(30 μg) 24DEC2020/
BNT162b2 
(30 μg)21JAN2021/
BNT162b2 
(30 μg)    
10571427 C4591001 1057 
10571427 24DEC2020 24306 BNT162b2 
(30 μg) 24DEC2020/
BNT162b2 
(30 μg)21JAN2021/
BNT162b2 
(30 μg)    
10571428 C4591001 1057 
10571428 24DEC2020 24307 Placebo 24DEC2020/
Placebo21JAN2021/
Placebo    
10571429 C4591001 1057 
10571429 24DEC2020 24309 BNT162b2 
(30 μg) 24DEC2020/
BNT162b2 
(30 μg)21JAN2021/
BNT162b2 
(30 μg)    
10571430 C4591001 1057 
10571430 29DEC2020 24310 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)18JAN2021/
BNT162b2 
(30 μg)    
10571431 C4591001 1057 
10571431 30DEC2020 24313 Placebo 30DEC2020/
Placebo 18JAN2021/
Placebo 27MAY2021/
BNT162b2 
(30 μg)21JUN2021/
BNT162b2 
(30 μg)
10571432 C4591001 1057 
10571432 30DEC2020 24314 Placebo 30DEC2020/
Placebo 18JAN2021/
Placebo 13MAY2021/
BNT162b2 
(30 μg)01JUN2021/
BNT162b2 
(30 μg)
10571433 C4591001 1057 
10571433 30DEC2020 25022 BNT162b2 
(30 μg) 30DEC2020/
BNT162b2 
(30 μg)22JAN2021/
BNT162b2 
(30 μg)    
10571434 C4591001 1057 
10571434 31DEC2020 25023 Placebo 31DEC2020/
Placebo 21JAN2021/
Placebo 10JUN2021/
BNT162b2 
(30 μg)29JUN2021/
BNT162b2 
(30 μg)
10571435 C4591001 1057 
10571435 04JAN2021 25024 BNT162b2 
(30 μg) 04JAN2021/
BNT162b2 
(30 μg)25JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 98
FDA-CBER-2022-5812-0228303
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10571436 C4591001 1057 
10571436 04JAN2021 25025 Placebo 04JAN2021/
Placebo 25JAN2021/
Placebo 22JUL2021/
BNT162b2 
(30 μg)17AUG2021/
BNT162b2 
(30 μg)
10571437 C4591001 1057 
10571437 04JAN2021 25257 Placebo 04JAN2021/
Placebo 25JAN2021/
Placebo 20JUL2021/
BNT162b2 
(30 μg)10AUG2021/
BNT162b2 
(30 μg)
10571438 C4591001 1057 
10571438 04JAN2021 25260 BNT162b2 
(30 μg) 04JAN2021/
BNT162b2 
(30 μg)25JAN2021/
BNT162b2 
(30 μg)    
10571439 C4591001 1057 
10571439 06JAN2021 25263 Placebo 06JAN2021/
Placebo 25JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10571440 C4591001 1057 
10571440 06JAN2021 25264 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10571441 C4591001 1057 
10571441 06JAN2021 25802 Placebo 06JAN2021/
Placebo 27JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10571442 C4591001 1057 
10571442 07JAN2021 25803 Placebo 07JAN2021/
Placebo 29JAN2021/
Placebo 28MAY2021/
BNT162b2 
(30 μg)22JUL2021/
BNT162b2 
(30 μg)
10571443 C4591001 1057 
10571443 08JAN2021 25806 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)28JAN2021/
BNT162b2 
(30 μg)    
10571444 C4591001 1057 
10571444 08JAN2021 25808 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)28JAN2021/
BNT162b2 
(30 μg)    
10571445 C4591001 1057 
10571445 11JAN2021 26531 BNT162b2 
(30 μg) 11JAN2021/
BNT162b2 
(30 μg)01FEB2021/
BNT162b2 
(30 μg)    
10571446 C4591001 1057 
10571446 11JAN2021 26533 Placebo 11JAN2021/
Placebo01FEB2021/
Placebo    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 99
FDA-CBER-2022-5812-0228304
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10571447 C4591001 1057 
10571447 11JAN2021 26537 Placebo 11JAN2021/
Placebo 01FEB2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10571448 C4591001 1057 
10571448 11JAN2021 26539 BNT162b2 
(30 μg) 11JAN2021/
BNT162b2 
(30 μg)01FEB2021/
BNT162b2 
(30 μg)    
10571449 C4591001 1057 
10571449 12JAN2021 26799 Placebo 12JAN2021/
Placebo 02FEB2021/
Placebo 20MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10571450 C4591001 1057 
10571450 12JAN2021 26801 Placebo 12JAN2021/
Placebo02FEB2021/
Placebo    
10571451 C4591001 1057 
10571451 12JAN2021 26802 BNT162b2 
(30 μg) 12JAN2021/
BNT162b2 
(30 μg)02FEB2021/
BNT162b2 
(30 μg)    
10571452 C4591001 1057 
10571452 12JAN2021 26804 BNT162b2 
(30 μg) 12JAN2021/
BNT162b2 
(30 μg)03FEB2021/
BNT162b2 
(30 μg)    
10571453 C4591001 1057 
10571453 12JAN2021 26895 Placebo 12JAN2021/
Placebo 01FEB2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10571454 C4591001 1057 
10571454 12JAN2021 26891 BNT162b2 
(30 μg) 12JAN2021/
BNT162b2 
(30 μg)03FEB2021/
BNT162b2 
(30 μg)    
10661394 C4591001 1066 
10661394 09DEC2020 21555 Placebo 09DEC2020/
Placebo 30DEC2020/
Placebo 18MAY2021/
BNT162b2 
(30 μg)15JUN2021/
BNT162b2 
(30 μg)
10661395 C4591001 1066 
10661395 01DEC2020 20590 BNT162b2 
(30 μg) 01DEC2020/
BNT162b2 
(30 μg)21DEC2020/
BNT162b2 
(30 μg)    
10661397 C4591001 1066 
10661397 01DEC2020 20591 Placebo 01DEC2020/
Placebo 22DEC2020/
Placebo 19MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 100
FDA-CBER-2022-5812-0228305
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10661401 C4591001 1066 
10661401 02DEC2020 20593 Placebo 02DEC2020/
Placebo 21DEC2020/
Placebo 19MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10661402 C4591001 1066 
10661402 02DEC2020 20598 BNT162b2 
(30 μg) 02DEC2020/
BNT162b2 
(30 μg)21DEC2020/
BNT162b2 
(30 μg)    
10661403 C4591001 1066 
10661403 03DEC2020 20829 Placebo 03DEC2020/
Placebo 23DEC2020/
Placebo 18MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10661404 C4591001 1066 
10661404 03DEC2020 20834 BNT162b2 
(30 μg) 03DEC2020/
BNT162b2 
(30 μg)23DEC2020/
BNT162b2 
(30 μg)    
10661405 C4591001 1066 
10661405 03DEC2020 20838 Placebo 03DEC2020/
Placebo 22DEC2020/
Placebo 18MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10661407 C4591001 1066 
10661407 04DEC2020 20840 BNT162b2 
(30 μg) 04DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10661408 C4591001 1066 
10661408 08DEC2020 21549 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10661409 C4591001 1066 
10661409 08DEC2020 21550 BNT162b2 
(30 μg) 08DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10661410 C4591001 1066 
10661410 09DEC2020 21557 Placebo 09DEC2020/
Placebo 29DEC2020/
Placebo 18MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10661411 C4591001 1066 
10661411 09DEC2020 21801 BNT162b2 
(30 μg) 09DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 101
FDA-CBER-2022-5812-0228306
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10661412 C4591001 1066 
10661412 09DEC2020 21808 Placebo 09DEC2020/
Placebo 29DEC2020/
Placebo 18MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10661414 C4591001 1066 
10661414 14DEC2020 21812 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)04JAN2021/
BNT162b2 
(30 μg)    
10661415 C4591001 1066 
10661415 14DEC2020 21809 Placebo 14DEC2020/
Placebo 04JAN2021/
Placebo 05JUL2021/
BNT162b2 
(30 μg)26JUL2021/
BNT162b2 
(30 μg)
10661416 C4591001 1066 
10661416 15DEC2020 22668 Placebo 15DEC2020/
Placebo 05JAN2021/
Placebo 25MAY2021/
BNT162b2 
(30 μg)16JUN2021/
BNT162b2 
(30 μg)
10661417 C4591001 1066 
10661417 16DEC2020 22672 BNT162b2 
(30 μg) 16DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10661418 C4591001 1066 
10661418 16DEC2020 22674 Placebo 16DEC2020/
Placebo 05JAN2021/
Placebo 20MAY2021/
BNT162b2 
(30 μg)17JUN2021/
BNT162b2 
(30 μg)
10661419 C4591001 1066 
10661419 16DEC2020 22675 BNT162b2 
(30 μg) 16DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10661420 C4591001 1066 
10661420 17DEC2020 23169 BNT162b2 
(30 μg) 17DEC2020/
BNT162b2 
(30 μg)05JAN2021/
BNT162b2 
(30 μg)    
10661421 C4591001 1066 
10661421 22DEC2020 23175 Placebo 22DEC2020/
Placebo 13JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)17JUN2021/
BNT162b2 
(30 μg)
10661422 C4591001 1066 
10661422 22DEC2020 23176 BNT162b2 
(30 μg) 22DEC2020/
BNT162b2 
(30 μg)13JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 102
FDA-CBER-2022-5812-0228307
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10661423 C4591001 1066 
10661423 30DEC2020 23177 Placebo 30DEC2020/
Placebo 26JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)14JUN2021/
BNT162b2 
(30 μg)
10661424 C4591001 1066 
10661424 30DEC2020 24922 BNT162b2 
(30 μg) 30DEC2020/
BNT162b2 
(30 μg)20JAN2021/
BNT162b2 
(30 μg)    
10661425 C4591001 1066 
10661425 05JAN2021 24924 Placebo 05JAN2021/
Placebo 26JAN2021/
Placebo 20MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10661426 C4591001 1066 
10661426 06JAN2021 24926 Placebo 06JAN2021/
Placebo 28JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10661427 C4591001 1066 
10661427 06JAN2021 24930 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10661428 C4591001 1066 
10661428 06JAN2021 25737 Placebo 06JAN2021/
Placebo 26JAN2021/
Placebo 15MAR2021/
BNT162b2 
(30 μg)05APR2021/
BNT162b2 
(30 μg)
10661429 C4591001 1066 
10661429 06JAN2021 25738 Placebo 06JAN2021/
Placebo 27JAN2021/
Placebo 26JUL2021/
BNT162b2 
(30 μg)16AUG2021/
BNT162b2 
(30 μg)
10661430 C4591001 1066 
10661430 07JAN2021 25740 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)26JAN2021/
BNT162b2 
(30 μg)    
10661431 C4591001 1066 
10661431 07JAN2021 25745 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10661432 C4591001 1066 
10661432 07JAN2021 25990 Placebo 07JAN2021/
Placebo 26JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 103
FDA-CBER-2022-5812-0228308
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10661433 C4591001 1066 
10661433 07JAN2021 25991 Placebo 07JAN2021/
Placebo 26JAN2021/
Placebo 19MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10661434 C4591001 1066 
10661434 12JAN2021 25995 BNT162b2 
(30 μg) 12JAN2021/
BNT162b2 
(30 μg)02FEB2021/
BNT162b2 
(30 μg)    
10661435 C4591001 1066 
10661435 12JAN2021 25998 BNT162b2 
(30 μg) 12JAN2021/
BNT162b2 
(30 μg)02FEB2021/
BNT162b2 
(30 μg)    
10771274 C4591001 1077 
10771274 03DEC2020 20843 BNT162b2 
(30 μg) 03DEC2020/
BNT162b2 
(30 μg)22DEC2020/
BNT162b2 
(30 μg)    
10771275 C4591001 1077 
10771275 03DEC2020 20844 Placebo 03DEC2020/
Placebo 22DEC2020/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10771277 C4591001 1077 
10771277 04DEC2020 20846 Placebo 04DEC2020/
Placebo 23DEC2020/
Placebo 24MAY2021/
BNT162b2 
(30 μg)16JUN2021/
BNT162b2 
(30 μg)
10771278 C4591001 1077 
10771278 04DEC2020 20852 BNT162b2 
(30 μg) 04DEC2020/
BNT162b2 
(30 μg)23DEC2020/
BNT162b2 
(30 μg)    
10771279 C4591001 1077 
10771279 14DEC2020 22249 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)04JAN2021/
BNT162b2 
(30 μg)    
10771280 C4591001 1077 
10771280 14DEC2020 22250 Placebo 14DEC2020/
Placebo 04JAN2021/
Placebo 28MAY2021/
BNT162b2 
(30 μg)18JUN2021/
BNT162b2 
(30 μg)
10771281 C4591001 1077 
10771281 14DEC2020 22251 BNT162b2 
(30 μg) 14DEC2020/
BNT162b2 
(30 μg)04JAN2021/
BNT162b2 
(30 μg)    
10771282 C4591001 1077 
10771282 14DEC2020 22253 Placebo 14DEC2020/
Placebo05JAN2021/
Placebo    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 104
FDA-CBER-2022-5812-0228309
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10771283 C4591001 1077 
10771283 15DEC2020 22476 Placebo 15DEC2020/
Placebo 06JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)08JUN2021/
BNT162b2 
(30 μg)
10771284 C4591001 1077 
10771284 15DEC2020 22478 BNT162b2 
(30 μg) 15DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10771285 C4591001 1077 
10771285 15DEC2020 22479 Placebo 15DEC2020/
Placebo 07JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10771286 C4591001 1077 
10771286 15DEC2020 22483 BNT162b2 
(30 μg) 15DEC2020/
BNT162b2 
(30 μg)04JAN2021/
BNT162b2 
(30 μg)    
10771287 C4591001 1077 
10771287 15DEC2020 22545 BNT162b2 
(30 μg) 15DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10771288 C4591001 1077 
10771288 16DEC2020 22554 BNT162b2 
(30 μg) 16DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10771289 C4591001 1077 
10771289 18DEC2020 22555 Placebo 18DEC2020/
Placebo08JAN2021/
Placebo    
10771290 C4591001 1077 
10771290 18DEC2020 22556 Placebo 18DEC2020/
Placebo08JAN2021/
Placebo    
10771291 C4591001 1077 
10771291 18DEC2020 23397 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10771292 C4591001 1077 
10771292 18DEC2020 23398 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10771293 C4591001 1077 
10771293 18DEC2020 23401 Placebo         
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 105
FDA-CBER-2022-5812-0228310
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10771294 C4591001 1077 
10771294 28DEC2020 23404 Placebo 28DEC2020/
Placebo 20JAN2021/
Placebo 24MAY2021/
BNT162b2 
(30 μg)18JUN2021/
BNT162b2 
(30 μg)
10771295 C4591001 1077 
10771295 28DEC2020 24443 Placebo 28DEC2020/
Placebo 20JAN2021/
Placebo 25FEB2021/
BNT162b2 
(30 μg)17MAR2021/
BNT162b2 
(30 μg)
10771296 C4591001 1077 
10771296 29DEC2020 24444 BNT162b2 
(30 μg) 29DEC2020/
BNT162b2 
(30 μg)20JAN2021/
BNT162b2 
(30 μg)    
10771297 C4591001 1077 
10771297 06JAN2021 24445 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)28JAN2021/
BNT162b2 
(30 μg)    
10771298 C4591001 1077 
10771298 07JAN2021 24446 Placebo 07JAN2021/
Placebo 27JAN2021/
Placebo 14MAY2021/
BNT162b2 
(30 μg)04JUN2021/
BNT162b2 
(30 μg)
10771299 C4591001 1077 
10771299 07JAN2021 25979 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10771300 C4591001 1077 
10771300 07JAN2021 25982 BNT162b2 
(30 μg) 07JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10841541 C4591001 1084 
10841541 11DEC2020 22033 BNT162b2 
(30 μg) 11DEC2020/
BNT162b2 
(30 μg)30DEC2020/
BNT162b2 
(30 μg)    
10841542 C4591001 1084 
10841542 11DEC2020 22034 Placebo 11DEC2020/
Placebo30DEC2020/
Placebo    
10841543 C4591001 1084 
10841543 18DEC2020 22037 Placebo 18DEC2020/
Placebo 08JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10841544 C4591001 1084 
10841544 18DEC2020 22039 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 106
FDA-CBER-2022-5812-0228311
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10841545 C4591001 1084 
10841545 18DEC2020 23459 Placebo 18DEC2020/
Placebo 06JAN2021/
Placebo 18MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10841546 C4591001 1084 
10841546 18DEC2020 23462 BNT162b2 
(30 μg) 18DEC2020/
BNT162b2 
(30 μg)06JAN2021/
BNT162b2 
(30 μg)    
10841547 C4591001 1084 
10841547 21DEC2020 23463 Placebo 21DEC2020/
Placebo 13JAN2021/
Placebo 21MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10841548 C4591001 1084 
10841548 21DEC2020 23465 BNT162b2 
(30 μg) 21DEC2020/
BNT162b2 
(30 μg)13JAN2021/
BNT162b2 
(30 μg)    
10841549 C4591001 1084 
10841549 21DEC2020 23666 BNT162b2 
(30 μg) 21DEC2020/
BNT162b2 
(30 μg)11JAN2021/
BNT162b2 
(30 μg)    
10841550 C4591001 1084 
10841550 21DEC2020 23669 Placebo 21DEC2020/
Placebo 13JAN2021/
Placebo 02AUG2021/
BNT162b2 
(30 μg)25AUG2021/
BNT162b2 
(30 μg)
10841551 C4591001 1084 
10841551 21DEC2020 23670 BNT162b2 
(30 μg) 21DEC2020/
BNT162b2 
(30 μg)13JAN2021/
BNT162b2 
(30 μg)    
10841552 C4591001 1084 
10841552 21DEC2020 23671 Placebo 21DEC2020/
Placebo 11JAN2021/
Placebo 24MAY2021/
BNT162b2 
(30 μg)11JUN2021/
BNT162b2 
(30 μg)
10841553 C4591001 1084 
10841553 21DEC2020 23853 BNT162b2 
(30 μg) 21DEC2020/
BNT162b2 
(30 μg)11JAN2021/
BNT162b2 
(30 μg)    
10841555 C4591001 1084 
10841555 21DEC2020 23854 Placebo 21DEC2020/
Placebo 11JAN2021/
Placebo 30JUL2021/
BNT162b2 
(30 μg)20AUG2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 107
FDA-CBER-2022-5812-0228312
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10841556 C4591001 1084 
10841556 28DEC2020 23862 BNT162b2 
(30 μg) 28DEC2020/
BNT162b2 
(30 μg)18JAN2021/
BNT162b2 
(30 μg)    
10841557 C4591001 1084 
10841557 28DEC2020 23860 Placebo 28DEC2020/
Placebo18JAN2021/
Placebo    
10841558 C4591001 1084 
10841558 28DEC2020 24419 BNT162b2 
(30 μg) 28DEC2020/
BNT162b2 
(30 μg)18JAN2021/
BNT162b2 
(30 μg)    
10841559 C4591001 1084 
10841559 28DEC2020 24423 BNT162b2 
(30 μg) 28DEC2020/
BNT162b2 
(30 μg)18JAN2021/
BNT162b2 
(30 μg)    
10841560 C4591001 1084 
10841560 28DEC2020 24418 Placebo 28DEC2020/
Placebo 22JAN2021/
Placebo 28MAY2021/
BNT162b2 
(30 μg)21JUN2021/
BNT162b2 
(30 μg)
10841561 C4591001 1084 
10841561 28DEC2020 24428 Placebo 28DEC2020/
Placebo 18JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10841562 C4591001 1084 
10841562 28DEC2020 24492 BNT162b2 
(30 μg) 28DEC2020/
BNT162b2 
(30 μg)18JAN2021/
BNT162b2 
(30 μg)    
10841563 C4591001 1084 
10841563 30DEC2020 24494 BNT162b2 
(30 μg) 30DEC2020/
BNT162b2 
(30 μg)18JAN2021/
BNT162b2 
(30 μg)    
10841564 C4591001 1084 
10841564 30DEC2020 24497 Placebo 30DEC2020/
Placebo 18JAN2021/
Placebo 21MAY2021/
BNT162b2 
(30 μg)11JUN2021/
BNT162b2 
(30 μg)
10841565 C4591001 1084 
10841565 30DEC2020 24499 Placebo 30DEC2020/
Placebo 20JAN2021/
Placebo 21MAY2021/
BNT162b2 
(30 μg)11JUN2021/
BNT162b2 
(30 μg)
10841566 C4591001 1084 
10841566 30DEC2020 24971 BNT162b2 
(30 μg) 30DEC2020/
BNT162b2 
(30 μg)18JAN2021/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 108
FDA-CBER-2022-5812-0228313
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10841567 C4591001 1084 
10841567 30DEC2020 24972 BNT162b2 
(30 μg) 30DEC2020/
BNT162b2 
(30 μg)18JAN2021/
BNT162b2 
(30 μg)    
10841568 C4591001 1084 
10841568 30DEC2020 24977 Placebo 30DEC2020/
Placebo18JAN2021/
Placebo    
10841569 C4591001 1084 
10841569 30DEC2020 24979 Placebo 30DEC2020/
Placebo 22JAN2021/
Placebo 21MAY2021/
BNT162b2 
(30 μg)11JUN2021/
BNT162b2 
(30 μg)
10841570 C4591001 1084 
10841570 30DEC2020 25066 Placebo 30DEC2020/
Placebo 22JAN2021/
Placebo 21MAY2021/
BNT162b2 
(30 μg)11JUN2021/
BNT162b2 
(30 μg)
10841571 C4591001 1084 
10841571 30DEC2020 25071 Placebo 30DEC2020/
Placebo 20JAN2021/
Placebo 21MAY2021/
BNT162b2 
(30 μg)04AUG2021/
BNT162b2 
(30 μg)
10841572 C4591001 1084 
10841572 04JAN2021 116601 Placebo 04JAN2021/
Placebo 25JAN2021/
Placebo 28MAY2021/
BNT162b2 
(30 μg)18JUN2021/
BNT162b2 
(30 μg)
10841573 C4591001 1084 
10841573 04JAN2021 25075 BNT162b2 
(30 μg) 04JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10841574 C4591001 1084 
10841574 04JAN2021 25076 BNT162b2 
(30 μg) 04JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10841575 C4591001 1084 
10841575 04JAN2021 25317 Placebo 04JAN2021/
Placebo 27JAN2021/
Placebo 16APR2021/
BNT162b2 
(30 μg)07MAY2021/
BNT162b2 
(30 μg)
10841576 C4591001 1084 
10841576 06JAN2021 25320 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)25JAN2021/
BNT162b2 
(30 μg)    
10841577 C4591001 1084 
10841577 06JAN2021 25326 Placebo 06JAN2021/
Placebo 27JAN2021/
Placebo 20MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 109
FDA-CBER-2022-5812-0228314
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10841578 C4591001 1084 
10841578 06JAN2021 25327 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10841579 C4591001 1084 
10841579 06JAN2021 25727 Placebo 06JAN2021/
Placebo27JAN2021/
Placebo    
10841580 C4591001 1084 
10841580 06JAN2021 25728 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10841581 C4591001 1084 
10841581 06JAN2021 25729 Placebo 06JAN2021/
Placebo 27JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10841582 C4591001 1084 
10841582 06JAN2021 25733 BNT162b2 
(30 μg) 06JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10841583 C4591001 1084 
10841583 08JAN2021 26194 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10841584 C4591001 1084 
10841584 08JAN2021 26195 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10841586 C4591001 1084 
10841586 08JAN2021 26196 Placebo 08JAN2021/
Placebo 29JAN2021/
Placebo 20MAY2021/
BNT162b2 
(30 μg)11JUN2021/
BNT162b2 
(30 μg)
10841587 C4591001 1084 
10841587 08JAN2021 26202 Placebo 08JAN2021/
Placebo 29JAN2021/
Placebo 20MAY2021/
BNT162b2 
(30 μg)09JUN2021/
BNT162b2 
(30 μg)
10841588 C4591001 1084 
10841588 08JAN2021 26278 Placebo 08JAN2021/
Placebo 27JAN2021/
Placebo 21MAY2021/
BNT162b2 
(30 μg)11JUN2021/
BNT162b2 
(30 μg)
10841589 C4591001 1084 
10841589 08JAN2021 26277 Placebo 08JAN2021/
Placebo29JAN2021/
Placebo    
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Page 110
FDA-CBER-2022-5812-0228315
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10841590 C4591001 1084 
10841590 08JAN2021 26337 Placebo 08JAN2021/
Placebo 29JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10841591 C4591001 1084 
10841591 08JAN2021 26286 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10841592 C4591001 1084 
10841592 08JAN2021 26281 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)27JAN2021/
BNT162b2 
(30 μg)    
10841593 C4591001 1084 
10841593 08JAN2021 26341 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10841594 C4591001 1084 
10841594 08JAN2021 26343 BNT162b2 
(30 μg) 08JAN2021/
BNT162b2 
(30 μg)29JAN2021/
BNT162b2 
(30 μg)    
10841595 C4591001 1084 
10841595 08JAN2021 26346 Placebo 08JAN2021/
Placebo 27JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10841596 C4591001 1084 
10841596 08JAN2021 26414 Placebo 08JAN2021/
Placebo 29JAN2021/
Placebo 17MAY2021/
BNT162b2 
(30 μg)07JUN2021/
BNT162b2 
(30 μg)
10841597 C4591001 1084 
10841597 08JAN2021 26417 Placebo 08JAN2021/
Placebo 27JAN2021/
Placebo 07MAY2021/
BNT162b2 
(30 μg)28MAY2021/
BNT162b2 
(30 μg)
10911394 C4591001 1091 
10911394 02DEC2020 117070 BNT162b2 
(30 μg) 02DEC2020/
BNT162b2 
(30 μg)21DEC2020/
BNT162b2 
(30 μg)    
10911395 C4591001 1091 
10911395 02DEC2020 20579 BNT162b2 
(30 μg) 02DEC2020/
BNT162b2 
(30 μg)21DEC2020/
BNT162b2 
(30 μg)    
090177e1988b7714\Final\Final On: 09-Nov-2021 04:12 (GMT) 
Page 111
FDA-CBER-2022-5812-0228316
16.1.7 Listing of Randomization Sch eme and Actual Vaccine Received – All Subjects 12 Through 15 Years of Age 
  Vaccine Received 
Subjecta USUBJID Randomization
Date Randomization
Number Randomized
Vaccine GroupDate/ 
Dose 1 Date/ 
Dose 2 Date/ 
Dose 3 Date/ 
Dose 4 
  
10911396 C4591001 1091 
10911396 02DEC2020 20583 Placebo 02DEC2020/
Placebo 21DEC2020/
Placebo 12MAY2021/
BNT162b2 
(30 μg)01JUN2021/
BNT162b2 
(30 μg)
10911399 C4591001 1091 
10911399 04DEC2020 20586 BNT162b2 
(30 μg) 04DEC2020/
BNT162b2 
(30 μg)07JAN2021/
BNT162b2 
(30 μg)    
10911400 C4591001 1091 
10911400 04DEC2020 20962 Placebo 04DEC2020/
Placebo 29DEC2020/
Placebo 01JUN2021/
BNT162b2 
(30 μg)06JUL2021/
BNT162b2 
(30 μg)
10911402 C4591001 1091 
10911402 07DEC2020 20966 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10911403 C4591001 1091 
10911403 07DEC2020 20967 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)29DEC2020/
BNT162b2 
(30 μg)    
10911404 C4591001 1091 
10911404 07DEC2020 20969 Placebo 07DEC2020/
Placebo28DEC2020/
Placebo    
10911405 C4591001 1091 
10911405 07DEC2020 21240 Placebo 07DEC2020/
Placebo 28DEC2020/
Placebo 27MAY2021/
BNT162b2 
(30 μg)16JUN2021/
BNT162b2 
(30 μg)
10911406 C4591001 1091 
10911406 07DEC2020 21242 BNT162b2 
(30 μg) 07DEC2020/
BNT162b2 
(30 μg)28DEC2020/
BNT162b2 
(30 μg)    
10911407 C4591001 1091 
10911407 08DE
…[truncated]