125742 45 S211 M5 c4591001 interim ado randomization sensitive

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 12 15 Documents

3057

Document text

16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10051317 C4591001 1005 
10051317 12-15 20OCT2020 20158 BNT162b2 
(30 μg) 20OCT2020 BNT162b2 
(30 μg) 12NOV2020 BNT162b2 
(30 μg) 
10051328 C4591001 1005 
10051328 12-15 20OCT2020 20159 BNT162b2 
(30 μg) 20OCT2020 BNT162b2 
(30 μg) 11NOV2020 BNT162b2 
(30 μg) 
10051339 C4591001 1005 
10051339 12-15 21OCT2020 20160 Placebo 21OCT2020 Placebo 11NOV2020 Placebo 
10051410 C4591001 1005 
10051410 12-15 09DEC2020 20163 Placebo 09DEC2020 Placebo 29DEC2020 Placebo 
10051412 C4591001 1005 
10051412 12-15 14DEC2020 22270 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
10051413 C4591001 1005 
10051413 12-15 14DEC2020 22269 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
10051414 C4591001 1005 
10051414 12-15 14DEC2020 22273 Placebo 14DEC2020 Placebo 04JAN2021 Placebo 
10051415 C4591001 1005 
10051415 12-15 14DEC2020 22274 Placebo 14DEC2020 Placebo 04JAN2021 Placebo 
10051417 C4591001 1005 
10051417 12-15 16DEC2020 22785 Placebo 16DEC2020 Placebo 06JAN2021 Placebo 
10051418 C4591001 1005 
10051418 12-15 16DEC2020 22786 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10051419 C4591001 1005 
10051419 12-15 16DEC2020 22794 Placebo 16DEC2020 Placebo 04JAN2021 Placebo 
10051420 C4591001 1005 
10051420 12-15 16DEC2020 22792 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
10051421 C4591001 1005 
10051421 12-15 17DEC2020 23097 Placebo 17DEC2020 Placebo 07JAN2021 Placebo 
10051422 C4591001 1005 
10051422 12-15 17DEC2020 23098 Placebo 17DEC2020 Placebo 07JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 1
FDA-CBER-2022-5812-0231652
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10051424 C4591001 1005 
10051424 12-15 18DEC2020 23100 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
10051425 C4591001 1005 
10051425 12-15 18DEC2020 23101 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
10051427 C4591001 1005 
10051427 12-15 21DEC2020 23589 Placebo 21DEC2020 Placebo 11JAN2021 Placebo 
10051428 C4591001 1005 
10051428 12-15 21DEC2020 23596 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 13JAN2021 BNT162b2 
(30 μg) 
10051429 C4591001 1005 
10051429 12-15 21DEC2020 23597 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
10051430 C4591001 1005 
10051430 12-15 22DEC2020 23600 Placebo 22DEC2020 Placebo 12JAN2021 Placebo 
10051431 C4591001 1005 
10051431 12-15 22DEC2020 23890 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 
10051436 C4591001 1005 
10051436 12-15 22DEC2020 23897 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 
10051437 C4591001 1005 
10051437 12-15 22DEC2020 23894 Placebo 22DEC2020 Placebo 12JAN2021 Placebo 
10051438 C4591001 1005 
10051438 12-15 22DEC2020 23892 Placebo 22DEC2020 Placebo 12JAN2021 Placebo 
10051439 C4591001 1005 
10051439 12-15 22DEC2020 24039 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
10051440 C4591001 1005 
10051440 12-15 22DEC2020 24041 Placebo 22DEC2020 Placebo 11JAN2021 Placebo 
10051441 C4591001 1005 
10051441 12-15 22DEC2020 24034 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 
10051444 C4591001 1005 
10051444 12-15 22DEC2020 24043 Placebo 22DEC2020 Placebo 12JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 2
FDA-CBER-2022-5812-0231653
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10051445 C4591001 1005 
10051445 12-15 22DEC2020 24130 Placebo 22DEC2020 Placebo 12JAN2021 Placebo 
10051447 C4591001 1005 
10051447 12-15 11JAN2021 24134 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 01FEB2021 BNT162b2 
(30 μg) 
10051448 C4591001 1005 
10051448 12-15 11JAN2021 24138 Placebo 11JAN2021 Placebo 01FEB2021 Placebo 
10051449 C4591001 1005 
10051449 12-15 11JAN2021 24137 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 01FEB2021 BNT162b2 
(30 μg) 
10051450 C4591001 1005 
10051450 12-15 11JAN2021 26654 Placebo 11JAN2021 Placebo 01FEB2021 Placebo 
10051451 C4591001 1005 
10051451 12-15 12JAN2021 26655 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 03FEB2021 BNT162b2 
(30 μg) 
10061183 C4591001 1006 
10061183 12-15 30NOV2020 20339 Placebo 30NOV2020 Placebo 07JAN2021 Placebo 
10061184 C4591001 1006 
10061184 12-15 30NOV2020 20340 BNT162b2 
(30 μg) 30NOV2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
10061188 C4591001 1006 
10061188 12-15 01DEC2020 20341 Placebo 01DEC2020 Placebo 22DEC2020 Placebo 
10061189 C4591001 1006 
10061189 12-15 01DEC2020 20348 BNT162b2 
(30 μg) 01DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10061190 C4591001 1006 
10061190 12-15 02DEC2020 20638 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10061191 C4591001 1006 
10061191 12-15 02DEC2020 20640 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10061196 C4591001 1006 
10061196 12-15 02DEC2020 20644 Placebo 02DEC2020 Placebo 21DEC2020 Placebo 
10061200 C4591001 1006 
10061200 12-15 03DEC2020 20647 Placebo 03DEC2020 Placebo 24DEC2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 3
FDA-CBER-2022-5812-0231654
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10061201 C4591001 1006 
10061201 12-15 03DEC2020 20867 BNT162b2 
(30 μg) 03DEC2020 BNT162b2 
(30 μg) 24DEC2020 BNT162b2 
(30 μg) 
10061203 C4591001 1006 
10061203 12-15 03DEC2020 20871 BNT162b2 
(30 μg) 03DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10061206 C4591001 1006 
10061206 12-15 04DEC2020 20872 Placebo 04DEC2020 Placebo 23DEC2020 Placebo 
10061207 C4591001 1006 
10061207 12-15 04DEC2020 20874 Placebo 04DEC2020 Placebo 23DEC2020 Placebo 
10061209 C4591001 1006 
10061209 12-15 04DEC2020 20998 BNT162b2 
(30 μg) 04DEC2020 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 
10061212 C4591001 1006 
10061212 12-15 04DEC2020 20999 Placebo 04DEC2020 Placebo 23DEC2020 Placebo 
10061213 C4591001 1006 
10061213 12-15 04DEC2020 21000 BNT162b2 
(30 μg) 04DEC2020 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 
10061214 C4591001 1006 
10061214 12-15 04DEC2020 21001 Placebo 04DEC2020 Placebo 23DEC2020 Placebo 
10061219 C4591001 1006 
10061219 12-15 07DEC2020 21141 Placebo 07DEC2020 Placebo 24DEC2020 Placebo 
10061220 C4591001 1006 
10061220 12-15 07DEC2020 21143 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10061221 C4591001 1006 
10061221 12-15 07DEC2020 21147 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10061223 C4591001 1006 
10061223 12-15 07DEC2020 21152 Placebo 07DEC2020 Placebo 30DEC2020 Placebo 
10061224 C4591001 1006 
10061224 12-15 07DEC2020 21261 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10061226 C4591001 1006 
10061226 12-15 07DEC2020 21262 Placebo 07DEC2020 Placebo 28DEC2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 4
FDA-CBER-2022-5812-0231655
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10061227 C4591001 1006 
10061227 12-15 07DEC2020 21264 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10061228 C4591001 1006 
10061228 12-15 08DEC2020 21267 Placebo 08DEC2020 Placebo 29DEC2020 Placebo 
10061229 C4591001 1006 
10061229 12-15 08DEC2020 21442 Placebo 08DEC2020 Placebo 29DEC2020 Placebo 
10061230 C4591001 1006 
10061230 12-15 08DEC2020 21446 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 31DEC2020 BNT162b2 
(30 μg) 
10061231 C4591001 1006 
10061231 12-15 08DEC2020 21448 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10061232 C4591001 1006 
10061232 12-15 08DEC2020 21450 Placebo 08DEC2020 Placebo 29DEC2020 Placebo 
10061233 C4591001 1006 
10061233 12-15 08DEC2020 21561 Placebo 08DEC2020 Placebo 29DEC2020 Placebo 
10061234 C4591001 1006 
10061234 12-15 09DEC2020 21563 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10061235 C4591001 1006 
10061235 12-15 09DEC2020 21568 Placebo 09DEC2020 Placebo 30DEC2020 Placebo 
10061236 C4591001 1006 
10061236 12-15 09DEC2020 21571 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10061237 C4591001 1006 
10061237 12-15 09DEC2020 21696 Placebo 09DEC2020 Placebo 28DEC2020 Placebo 
10061239 C4591001 1006 
10061239 12-15 09DEC2020 21699 Placebo 09DEC2020 Placebo 30DEC2020 Placebo 
10061241 C4591001 1006 
10061241 12-15 09DEC2020 21702 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10061242 C4591001 1006 
10061242 12-15 09DEC2020 21704 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 5
FDA-CBER-2022-5812-0231656
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10061243 C4591001 1006 
10061243 12-15 10DEC2020 21864 BNT162b2 
(30 μg) 10DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10061244 C4591001 1006 
10061244 12-15 10DEC2020 21865 BNT162b2 
(30 μg) 10DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10061245 C4591001 1006 
10061245 12-15 10DEC2020 21869 Placebo 10DEC2020 Placebo 29DEC2020 Placebo 
10061247 C4591001 1006 
10061247 12-15 10DEC2020 21871 Placebo 10DEC2020 Placebo 29DEC2020 Placebo 
10061248 C4591001 1006 
10061248 12-15 11DEC2020 22046 Placebo 11DEC2020 Placebo 30DEC2020 Placebo 
10061249 C4591001 1006 
10061249 12-15 11DEC2020 22047 BNT162b2 
(30 μg) 11DEC2020 BNT162b2 
(30 μg) 31DEC2020 BNT162b2 
(30 μg) 
10061250 C4591001 1006 
10061250 12-15 11DEC2020 22050 Placebo 11DEC2020 Placebo 31DEC2020 Placebo 
10061252 C4591001 1006 
10061252 12-15 11DEC2020 22051 BNT162b2 
(30 μg) 11DEC2020 BNT162b2 
(30 μg) 31DEC2020 BNT162b2 
(30 μg) 
10061253 C4591001 1006 
10061253 12-15 11DEC2020 22173 Placebo 11DEC2020 Placebo 30DEC2020 Placebo 
10061254 C4591001 1006 
10061254 12-15 11DEC2020 22174 BNT162b2 
(30 μg) 11DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10061256 C4591001 1006 
10061256 12-15 11DEC2020 22176 BNT162b2 
(30 μg) 11DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10061257 C4591001 1006 
10061257 12-15 11DEC2020 22182 Placebo 11DEC2020 Placebo 30DEC2020 Placebo 
10061258 C4591001 1006 
10061258 12-15 14DEC2020 22296 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
10061259 C4591001 1006 
10061259 12-15 14DEC2020 22300 Placebo 14DEC2020 Placebo 05JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 6
FDA-CBER-2022-5812-0231657
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10061260 C4591001 1006 
10061260 12-15 14DEC2020 22302 Placebo 14DEC2020 Placebo 05JAN2021 Placebo 
10061261 C4591001 1006 
10061261 12-15 14DEC2020 22303 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
10061262 C4591001 1006 
10061262 12-15 14DEC2020 22426 Placebo 14DEC2020 Placebo 06JAN2021 Placebo 
10061263 C4591001 1006 
10061263 12-15 14DEC2020 22428 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
10061264 C4591001 1006 
10061264 12-15 14DEC2020 22429 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
10061265 C4591001 1006 
10061265 12-15 18DEC2020 23313 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10061266 C4591001 1006 
10061266 12-15 15DEC2020 22433 Placebo 15DEC2020 Placebo 06JAN2021 Placebo 
10061267 C4591001 1006 
10061267 12-15 15DEC2020 22558 Placebo 15DEC2020 Placebo 22JAN2021 Placebo 
10061269 C4591001 1006 
10061269 12-15 15DEC2020 22561 BNT162b2 
(30 μg) 15DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10061270 C4591001 1006 
10061270 12-15 16DEC2020 22562 Placebo 16DEC2020 Placebo 06JAN2021 Placebo 
10061271 C4591001 1006 
10061271 12-15 16DEC2020 22566 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
10061272 C4591001 1006 
10061272 12-15 16DEC2020 22821 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg)  
  
10061273 C4591001 1006 
10061273 12-15 16DEC2020 22823 Placebo 16DEC2020 Placebo 08JAN2021 Placebo 
10061274 C4591001 1006 
10061274 12-15 16DEC2020 22830 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 7
FDA-CBER-2022-5812-0231658
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10061276 C4591001 1006 
10061276 12-15 17DEC2020 22831 Placebo 17DEC2020 Placebo 06JAN2021 Placebo 
10061277 C4591001 1006 
10061277 12-15 17DEC2020 23159 Placebo 17DEC2020 Placebo 08JAN2021 Placebo 
10061278 C4591001 1006 
10061278 12-15 17DEC2020 23162 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
10061279 C4591001 1006 
10061279 12-15 17DEC2020 23166 Placebo 17DEC2020 Placebo 05JAN2021 Placebo 
10061280 C4591001 1006 
10061280 12-15 17DEC2020 23168 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 
10061282 C4591001 1006 
10061282 12-15 18DEC2020 23314 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
10061283 C4591001 1006 
10061283 12-15 18DEC2020 23315 Placebo 18DEC2020 Placebo 08JAN2021 Placebo 
10061284 C4591001 1006 
10061284 12-15 18DEC2020 23318 Placebo 18DEC2020 Placebo 08JAN2021 Placebo 
10061285 C4591001 1006 
10061285 12-15 21DEC2020 23702 Placebo 21DEC2020 Placebo 12JAN2021 Placebo 
10061286 C4591001 1006 
10061286 12-15 21DEC2020 23704 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
10061287 C4591001 1006 
10061287 12-15 21DEC2020 23706 Placebo 21DEC2020 Placebo 11JAN2021 Placebo 
10061288 C4591001 1006 
10061288 12-15 21DEC2020 23708 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
10061289 C4591001 1006 
10061289 12-15 22DEC2020 23941 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 13JAN2021 BNT162b2 
(30 μg) 
10061290 C4591001 1006 
10061290 12-15 22DEC2020 23943 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 13JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 8
FDA-CBER-2022-5812-0231659
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10061291 C4591001 1006 
10061291 12-15 22DEC2020 23946 Placebo 22DEC2020 Placebo 13JAN2021 Placebo 
10061292 C4591001 1006 
10061292 12-15 22DEC2020 23948 Placebo 22DEC2020 Placebo 12JAN2021 Placebo 
10061293 C4591001 1006 
10061293 12-15 22DEC2020 24050 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 
10061294 C4591001 1006 
10061294 12-15 22DEC2020 24054 Placebo 22DEC2020 Placebo 12JAN2021 Placebo 
10061295 C4591001 1006 
10061295 12-15 24DEC2020 24056 Placebo 24DEC2020 Placebo 12JAN2021 Placebo 
10061296 C4591001 1006 
10061296 12-15 29DEC2020 24611 Placebo 29DEC2020 Placebo 19JAN2021 Placebo 
10061297 C4591001 1006 
10061297 12-15 29DEC2020 24612 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10061298 C4591001 1006 
10061298 12-15 29DEC2020 24617 Placebo 29DEC2020 Placebo 20JAN2021 Placebo 
10061299 C4591001 1006 
10061299 12-15 31DEC2020 24618 BNT162b2 
(30 μg) 31DEC2020 BNT162b2 
(30 μg) 22JAN2021 BNT162b2 
(30 μg) 
10061300 C4591001 1006 
10061300 12-15 07JAN2021 26122 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 28JAN2021 BNT162b2 
(30 μg) 
10071409 C4591001 1007 
10071409 12-15 22OCT2020 20265 BNT162b2 
(30 μg) 22OCT2020 BNT162b2 
(30 μg)  
  
10071414 C4591001 1007 
10071414 12-15 22OCT2020 20268 Placebo 22OCT2020 Placebo 12NOV2020 Placebo 
10071415 C4591001 1007 
10071415 12-15 22OCT2020 20271 Placebo 22OCT2020 Placebo 10DEC2020 Placebo 
10071417 C4591001 1007 
10071417 12-15 22OCT2020 20272 BNT162b2 
(30 μg) 22OCT2020 BNT162b2 
(30 μg) 12NOV2020 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 9
FDA-CBER-2022-5812-0231660
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10071428 C4591001 1007 
10071428 12-15 22OCT2020 20292 Placebo 22OCT2020 Placebo 12NOV2020 Placebo 
10071429 C4591001 1007 
10071429 12-15 22OCT2020 20295 Placebo 22OCT2020 Placebo 12NOV2020 Placebo 
10071467 C4591001 1007 
10071467 12-15 30NOV2020 20296 BNT162b2 
(30 μg) 30NOV2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
10071469 C4591001 1007 
10071469 12-15 30NOV2020 20298 BNT162b2 
(30 μg) 30NOV2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
10071471 C4591001 1007 
10071471 12-15 30NOV2020 20374 BNT162b2 
(30 μg) 30NOV2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
10071472 C4591001 1007 
10071472 12-15 30NOV2020 20375 Placebo 30NOV2020 Placebo 21DEC2020 Placebo 
10071475 C4591001 1007 
10071475 12-15 30NOV2020 20378 BNT162b2 
(30 μg) 30NOV2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
10071476 C4591001 1007 
10071476 12-15 30NOV2020 20446 BNT162b2 
(30 μg) 30NOV2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
10071478 C4591001 1007 
10071478 12-15 30NOV2020 20384 Placebo 30NOV2020 Placebo 21DEC2020 Placebo 
10071480 C4591001 1007 
10071480 12-15 30NOV2020 20447 Placebo 30NOV2020 Placebo 21DEC2020 Placebo 
10071481 C4591001 1007 
10071481 12-15 01DEC2020 20449 Placebo 01DEC2020 Placebo 22DEC2020 Placebo 
10071482 C4591001 1007 
10071482 12-15 01DEC2020 20455 BNT162b2 
(30 μg) 01DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10071483 C4591001 1007 
10071483 12-15 01DEC2020 20496 Placebo 01DEC2020 Placebo 22DEC2020 Placebo 
10071484 C4591001 1007 
10071484 12-15 01DEC2020 20497 Placebo 01DEC2020 Placebo 22DEC2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 10
FDA-CBER-2022-5812-0231661
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10071485 C4591001 1007 
10071485 12-15 01DEC2020 20503 BNT162b2 
(30 μg) 01DEC2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
10071488 C4591001 1007 
10071488 12-15 01DEC2020 20504 BNT162b2 
(30 μg) 01DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10071490 C4591001 1007 
10071490 12-15 01DEC2020 20605 BNT162b2 
(30 μg) 01DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10071492 C4591001 1007 
10071492 12-15 01DEC2020 20606 Placebo 01DEC2020 Placebo 21DEC2020 Placebo 
10071494 C4591001 1007 
10071494 12-15 02DEC2020 20608 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
10071495 C4591001 1007 
10071495 12-15 02DEC2020 20610 Placebo 02DEC2020 Placebo 22DEC2020 Placebo 
10071496 C4591001 1007 
10071496 12-15 02DEC2020 20750 Placebo 02DEC2020 Placebo 22DEC2020 Placebo 
10071497 C4591001 1007 
10071497 12-15 02DEC2020 20746 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10071499 C4591001 1007 
10071499 12-15 03DEC2020 20753 Placebo 03DEC2020 Placebo 22DEC2020 Placebo 
10071500 C4591001 1007 
10071500 12-15 03DEC2020 20756 BNT162b2 
(30 μg) 03DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10071504 C4591001 1007 
10071504 12-15 07DEC2020 21085 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10071505 C4591001 1007 
10071505 12-15 07DEC2020 21087 Placebo 07DEC2020 Placebo 28DEC2020 Placebo 
10071506 C4591001 1007 
10071506 12-15 07DEC2020 21089 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10071507 C4591001 1007 
10071507 12-15 07DEC2020 21090 Placebo 07DEC2020 Placebo 28DEC2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 11
FDA-CBER-2022-5812-0231662
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10071508 C4591001 1007 
10071508 12-15 07DEC2020 21192 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10071509 C4591001 1007 
10071509 12-15 07DEC2020 21197 Placebo 07DEC2020 Placebo 30DEC2020 Placebo 
10071511 C4591001 1007 
10071511 12-15 07DEC2020 21198 Placebo 07DEC2020 Placebo 28DEC2020 Placebo 
10071512 C4591001 1007 
10071512 12-15 07DEC2020 21276 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10071514 C4591001 1007 
10071514 12-15 07DEC2020 21199 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10071515 C4591001 1007 
10071515 12-15 08DEC2020 21283 Placebo 08DEC2020 Placebo 29DEC2020 Placebo 
10071516 C4591001 1007 
10071516 12-15 08DEC2020 21282 Placebo 08DEC2020 Placebo 29DEC2020 Placebo 
10071517 C4591001 1007 
10071517 12-15 08DEC2020 21284 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10071518 C4591001 1007 
10071518 12-15 08DEC2020 21369 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10071519 C4591001 1007 
10071519 12-15 08DEC2020 21374 Placebo 08DEC2020 Placebo 29DEC2020 Placebo 
10071520 C4591001 1007 
10071520 12-15 08DEC2020 21375 Placebo 08DEC2020 Placebo 29DEC2020 Placebo 
10071521 C4591001 1007 
10071521 12-15 08DEC2020 21376 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10071522 C4591001 1007 
10071522 12-15 08DEC2020 21458 Placebo 08DEC2020 Placebo 29DEC2020 Placebo 
10071523 C4591001 1007 
10071523 12-15 08DEC2020 21453 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 12
FDA-CBER-2022-5812-0231663
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10071524 C4591001 1007 
10071524 12-15 08DEC2020 21462 Placebo 08DEC2020 Placebo 29DEC2020 Placebo 
10071525 C4591001 1007 
10071525 12-15 08DEC2020 21463 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10071526 C4591001 1007 
10071526 12-15 08DEC2020 21515 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10071527 C4591001 1007 
10071527 12-15 08DEC2020 21514 Placebo 08DEC2020 Placebo 29DEC2020 Placebo 
10071528 C4591001 1007 
10071528 12-15 09DEC2020 21521 Placebo 09DEC2020 Placebo 30DEC2020 Placebo 
10071529 C4591001 1007 
10071529 12-15 09DEC2020 21524 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10071530 C4591001 1007 
10071530 12-15 09DEC2020 21589 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10071531 C4591001 1007 
10071531 12-15 09DEC2020 21590 Placebo 09DEC2020 Placebo 29DEC2020 Placebo 
10071533 C4591001 1007 
10071533 12-15 09DEC2020 21591 Placebo 09DEC2020 Placebo 30DEC2020 Placebo 
10071535 C4591001 1007 
10071535 12-15 09DEC2020 21596 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10071536 C4591001 1007 
10071536 12-15 09DEC2020 21681 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10071537 C4591001 1007 
10071537 12-15 09DEC2020 21683 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10071539 C4591001 1007 
10071539 12-15 09DEC2020 21689 Placebo 09DEC2020 Placebo 30DEC2020 Placebo 
10071540 C4591001 1007 
10071540 12-15 09DEC2020 21685 Placebo 09DEC2020 Placebo 30DEC2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 13
FDA-CBER-2022-5812-0231664
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10071541 C4591001 1007 
10071541 12-15 09DEC2020 21767 Placebo 09DEC2020 Placebo 30DEC2020 Placebo 
10071542 C4591001 1007 
10071542 12-15 09DEC2020 21769 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10071543 C4591001 1007 
10071543 12-15 09DEC2020 21771 Placebo 09DEC2020 Placebo 30DEC2020 Placebo 
10071544 C4591001 1007 
10071544 12-15 09DEC2020 21773 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10071546 C4591001 1007 
10071546 12-15 10DEC2020 21827 BNT162b2 
(30 μg) 10DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10071547 C4591001 1007 
10071547 12-15 10DEC2020 21830 Placebo 10DEC2020 Placebo 30DEC2020 Placebo 
10071550 C4591001 1007 
10071550 12-15 10DEC2020 21832 BNT162b2 
(30 μg) 10DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10071551 C4591001 1007 
10071551 12-15 10DEC2020 21835 Placebo 10DEC2020 Placebo 29DEC2020 Placebo 
10071552 C4591001 1007 
10071552 12-15 10DEC2020 21976 Placebo 10DEC2020 Placebo 29DEC2020 Placebo 
10071554 C4591001 1007 
10071554 12-15 10DEC2020 21977 Placebo 10DEC2020 Placebo 30DEC2020 Placebo 
10071555 C4591001 1007 
10071555 12-15 10DEC2020 21979 BNT162b2 
(30 μg) 10DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10071557 C4591001 1007 
10071557 12-15 14DEC2020 21980 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
10071558 C4591001 1007 
10071558 12-15 14DEC2020 22284 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
10071559 C4591001 1007 
10071559 12-15 14DEC2020 22285 Placebo 14DEC2020 Placebo 04JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 14
FDA-CBER-2022-5812-0231665
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10071560 C4591001 1007 
10071560 12-15 14DEC2020 22286 Placebo 14DEC2020 Placebo 05JAN2021 Placebo 
10071561 C4591001 1007 
10071561 12-15 14DEC2020 22288 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
10071562 C4591001 1007 
10071562 12-15 14DEC2020 22385 Placebo 14DEC2020 Placebo 04JAN2021 Placebo 
10071563 C4591001 1007 
10071563 12-15 14DEC2020 22386 Placebo 14DEC2020 Placebo 04JAN2021 Placebo 
10071564 C4591001 1007 
10071564 12-15 14DEC2020 22387 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10071565 C4591001 1007 
10071565 12-15 14DEC2020 22388 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10071566 C4591001 1007 
10071566 12-15 14DEC2020 22402 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
10071567 C4591001 1007 
10071567 12-15 15DEC2020 22407 BNT162b2 
(30 μg) 15DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
10071568 C4591001 1007 
10071568 12-15 15DEC2020 22409 Placebo 15DEC2020 Placebo 05JAN2021 Placebo 
10071569 C4591001 1007 
10071569 12-15 15DEC2020 22411 Placebo 15DEC2020 Placebo 05JAN2021 Placebo 
10071570 C4591001 1007 
10071570 12-15 15DEC2020 22521 Placebo 15DEC2020 Placebo 05JAN2021 Placebo 
10071571 C4591001 1007 
10071571 12-15 15DEC2020 22528 BNT162b2 
(30 μg) 15DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10071572 C4591001 1007 
10071572 12-15 15DEC2020 22529 BNT162b2 
(30 μg) 15DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
10071573 C4591001 1007 
10071573 12-15 15DEC2020 22532 Placebo 15DEC2020 Placebo 04JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 15
FDA-CBER-2022-5812-0231666
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10071574 C4591001 1007 
10071574 12-15 16DEC2020 22727 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10071575 C4591001 1007 
10071575 12-15 16DEC2020 22728 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10071576 C4591001 1007 
10071576 12-15 16DEC2020 22733 Placebo 16DEC2020 Placebo 06JAN2021 Placebo 
10071577 C4591001 1007 
10071577 12-15 16DEC2020 22918 Placebo 16DEC2020 Placebo 06JAN2021 Placebo 
10071578 C4591001 1007 
10071578 12-15 16DEC2020 22736 Placebo 16DEC2020 Placebo 06JAN2021 Placebo 
10071579 C4591001 1007 
10071579 12-15 16DEC2020 22920 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10071580 C4591001 1007 
10071580 12-15 16DEC2020 22921 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10071581 C4591001 1007 
10071581 12-15 17DEC2020 22928 Placebo 17DEC2020 Placebo 07JAN2021 Placebo 
10071582 C4591001 1007 
10071582 12-15 17DEC2020 23087 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 
10071583 C4591001 1007 
10071583 12-15 17DEC2020 23146 Placebo 17DEC2020 Placebo 07JAN2021 Placebo 
10071584 C4591001 1007 
10071584 12-15 17DEC2020 23091 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 
10071585 C4591001 1007 
10071585 12-15 17DEC2020 23094 Placebo 17DEC2020 Placebo 07JAN2021 Placebo 
10071586 C4591001 1007 
10071586 12-15 17DEC2020 23096 Placebo 17DEC2020 Placebo 07JAN2021 Placebo 
10071587 C4591001 1007 
10071587 12-15 17DEC2020 23148 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 16
FDA-CBER-2022-5812-0231667
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10071588 C4591001 1007 
10071588 12-15 28DEC2020 23151 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 20JAN2021 BNT162b2 
(30 μg) 
10071589 C4591001 1007 
10071589 12-15 28DEC2020 23155 Placebo 28DEC2020 Placebo 19JAN2021 Placebo 
10071590 C4591001 1007 
10071590 12-15 28DEC2020 24372 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 20JAN2021 BNT162b2 
(30 μg) 
10071591 C4591001 1007 
10071591 12-15 28DEC2020 24378 Placebo 28DEC2020 Placebo 19JAN2021 Placebo 
10071592 C4591001 1007 
10071592 12-15 28DEC2020 24377 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10071593 C4591001 1007 
10071593 12-15 28DEC2020 24380 Placebo 28DEC2020 Placebo  
  
10071594 C4591001 1007 
10071594 12-15 28DEC2020 24453 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10071595 C4591001 1007 
10071595 12-15 28DEC2020 24454 Placebo 28DEC2020 Placebo 19JAN2021 Placebo 
10071596 C4591001 1007 
10071596 12-15 28DEC2020 24456 Placebo 28DEC2020 Placebo 20JAN2021 Placebo 
10071597 C4591001 1007 
10071597 12-15 28DEC2020 24460 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10071599 C4591001 1007 
10071599 12-15 28DEC2020 24478 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10071600 C4591001 1007 
10071600 12-15 28DEC2020 24479 Placebo 28DEC2020 Placebo 19JAN2021 Placebo 
10071601 C4591001 1007 
10071601 12-15 28DEC2020 24481 Placebo 28DEC2020 Placebo 19JAN2021 Placebo 
10071602 C4591001 1007 
10071602 12-15 28DEC2020 24483 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 17
FDA-CBER-2022-5812-0231668
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10071603 C4591001 1007 
10071603 12-15 29DEC2020 24539 Placebo 29DEC2020 Placebo 19JAN2021 Placebo 
10071604 C4591001 1007 
10071604 12-15 29DEC2020 24538 Placebo 29DEC2020 Placebo 19JAN2021 Placebo 
10071605 C4591001 1007 
10071605 12-15 29DEC2020 24544 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10071606 C4591001 1007 
10071606 12-15 29DEC2020 24545 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10071607 C4591001 1007 
10071607 12-15 29DEC2020 24683 Placebo 29DEC2020 Placebo 19JAN2021 Placebo 
10071608 C4591001 1007 
10071608 12-15 29DEC2020 24684 Placebo 29DEC2020 Placebo 19JAN2021 Placebo 
10071609 C4591001 1007 
10071609 12-15 29DEC2020 24685 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10071610 C4591001 1007 
10071610 12-15 29DEC2020 24730 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 21JAN2021 BNT162b2 
(30 μg) 
10071612 C4591001 1007 
10071612 12-15 29DEC2020 24692 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10071613 C4591001 1007 
10071613 12-15 29DEC2020 24732 Placebo 29DEC2020 Placebo 19JAN2021 Placebo 
10071614 C4591001 1007 
10071614 12-15 29DEC2020 24734 Placebo 29DEC2020 Placebo 19JAN2021 Placebo 
10071615 C4591001 1007 
10071615 12-15 29DEC2020 24740 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10071616 C4591001 1007 
10071616 12-15 29DEC2020 24777 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10071617 C4591001 1007 
10071617 12-15 29DEC2020 24781 Placebo 29DEC2020 Placebo 20JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 18
FDA-CBER-2022-5812-0231669
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10071618 C4591001 1007 
10071618 12-15 29DEC2020 24784 Placebo 29DEC2020 Placebo 19JAN2021 Placebo 
10071619 C4591001 1007 
10071619 12-15 30DEC2020 24785 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 20JAN2021 BNT162b2 
(30 μg) 
10071620 C4591001 1007 
10071620 12-15 30DEC2020 24828 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 20JAN2021 BNT162b2 
(30 μg) 
10071621 C4591001 1007 
10071621 12-15 30DEC2020 24830 Placebo 30DEC2020 Placebo 20JAN2021 Placebo 
10071622 C4591001 1007 
10071622 12-15 30DEC2020 24831 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg)  
  
10071623 C4591001 1007 
10071623 12-15 30DEC2020 24832 Placebo 30DEC2020 Placebo 21JAN2021 Placebo 
10071624 C4591001 1007 
10071624 12-15 30DEC2020 24910 Placebo 30DEC2020 Placebo 26JAN2021 Placebo 
10071625 C4591001 1007 
10071625 12-15 30DEC2020 24915 Placebo 30DEC2020 Placebo 26JAN2021 Placebo 
10071626 C4591001 1007 
10071626 12-15 30DEC2020 24917 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 20JAN2021 BNT162b2 
(30 μg) 
10071627 C4591001 1007 
10071627 12-15 30DEC2020 24919 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 20JAN2021 BNT162b2 
(30 μg) 
10071628 C4591001 1007 
10071628 12-15 30DEC2020 24997 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 20JAN2021 BNT162b2 
(30 μg) 
10071629 C4591001 1007 
10071629 12-15 30DEC2020 24994 Placebo 30DEC2020 Placebo 20JAN2021 Placebo 
10071630 C4591001 1007 
10071630 12-15 30DEC2020 24993 Placebo 30DEC2020 Placebo 20JAN2021 Placebo 
10071631 C4591001 1007 
10071631 12-15 30DEC2020 25003 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 21JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 19
FDA-CBER-2022-5812-0231670
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10071632 C4591001 1007 
10071632 12-15 30DEC2020 25062 Placebo 30DEC2020 Placebo 21JAN2021 Placebo 
10071633 C4591001 1007 
10071633 12-15 30DEC2020 25058 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 21JAN2021 BNT162b2 
(30 μg) 
10071634 C4591001 1007 
10071634 12-15 04JAN2021 25064 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 25JAN2021 BNT162b2 
(30 μg) 
10071635 C4591001 1007 
10071635 12-15 04JAN2021 25063 Placebo 04JAN2021 Placebo 25JAN2021 Placebo 
10071636 C4591001 1007 
10071636 12-15 04JAN2021 25149 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 25JAN2021 BNT162b2 
(30 μg) 
10071638 C4591001 1007 
10071638 12-15 04JAN2021 25153 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 25JAN2021 BNT162b2 
(30 μg) 
10071639 C4591001 1007 
10071639 12-15 04JAN2021 25154 Placebo 04JAN2021 Placebo 25JAN2021 Placebo 
10071640 C4591001 1007 
10071640 12-15 04JAN2021 25156 Placebo 04JAN2021 Placebo 25JAN2021 Placebo 
10071641 C4591001 1007 
10071641 12-15 04JAN2021 25202 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 26JAN2021 BNT162b2 
(30 μg) 
10071642 C4591001 1007 
10071642 12-15 04JAN2021 25205 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg)  
  
10071643 C4591001 1007 
10071643 12-15 04JAN2021 25204 Placebo 04JAN2021 Placebo 25JAN2021 Placebo 
10071644 C4591001 1007 
10071644 12-15 04JAN2021 25294 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 25JAN2021 BNT162b2 
(30 μg) 
10071645 C4591001 1007 
10071645 12-15 04JAN2021 25208 Placebo 04JAN2021 Placebo 25JAN2021 Placebo 
10071646 C4591001 1007 
10071646 12-15 04JAN2021 25299 Placebo 04JAN2021 Placebo 25JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 20
FDA-CBER-2022-5812-0231671
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10071647 C4591001 1007 
10071647 12-15 04JAN2021 25302 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 25JAN2021 BNT162b2 
(30 μg) 
10071648 C4591001 1007 
10071648 12-15 05JAN2021 25304 Placebo 05JAN2021 Placebo 26JAN2021 Placebo 
10071649 C4591001 1007 
10071649 12-15 05JAN2021 25369 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 26JAN2021 BNT162b2 
(30 μg) 
10071650 C4591001 1007 
10071650 12-15 05JAN2021 25370 Placebo 05JAN2021 Placebo 26JAN2021 Placebo 
10071651 C4591001 1007 
10071651 12-15 05JAN2021 25373 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 26JAN2021 BNT162b2 
(30 μg) 
10071652 C4591001 1007 
10071652 12-15 05JAN2021 25376 Placebo 05JAN2021 Placebo 26JAN2021 Placebo 
10071653 C4591001 1007 
10071653 12-15 05JAN2021 25437 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 26JAN2021 BNT162b2 
(30 μg) 
10071654 C4591001 1007 
10071654 12-15 05JAN2021 25443 Placebo 05JAN2021 Placebo 26JAN2021 Placebo 
10071655 C4591001 1007 
10071655 12-15 06JAN2021 25445 Placebo 06JAN2021 Placebo 27JAN2021 Placebo 
10071656 C4591001 1007 
10071656 12-15 06JAN2021 25448 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10071658 C4591001 1007 
10071658 12-15 06JAN2021 25838 Placebo 06JAN2021 Placebo 27JAN2021 Placebo 
10071659 C4591001 1007 
10071659 12-15 06JAN2021 25834 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10071660 C4591001 1007 
10071660 12-15 06JAN2021 25833 Placebo 06JAN2021 Placebo 27JAN2021 Placebo 
10071661 C4591001 1007 
10071661 12-15 07JAN2021 25840 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 28JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 21
FDA-CBER-2022-5812-0231672
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10071662 C4591001 1007 
10071662 12-15 07JAN2021 26061 Placebo 07JAN2021 Placebo 28JAN2021 Placebo 
10081751 C4591001 1008 
10081751 12-15 01DEC2020 20520 Placebo 01DEC2020 Placebo 23DEC2020 Placebo 
10081752 C4591001 1008 
10081752 12-15 01DEC2020 20525 Placebo 01DEC2020 Placebo 22DEC2020 Placebo 
10081753 C4591001 1008 
10081753 12-15 01DEC2020 20521 BNT162b2 
(30 μg) 01DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10081754 C4591001 1008 
10081754 12-15 02DEC2020 20527 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10081755 C4591001 1008 
10081755 12-15 02DEC2020 20702 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 
10081756 C4591001 1008 
10081756 12-15 02DEC2020 20704 Placebo 02DEC2020 Placebo 22DEC2020 Placebo 
10081757 C4591001 1008 
10081757 12-15 02DEC2020 20705 Placebo 02DEC2020 Placebo 22DEC2020 Placebo 
10081758 C4591001 1008 
10081758 12-15 02DEC2020 20707 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 
10081760 C4591001 1008 
10081760 12-15 07DEC2020 21257 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10081761 C4591001 1008 
10081761 12-15 07DEC2020 21256 Placebo 07DEC2020 Placebo 28DEC2020 Placebo 
10081763 C4591001 1008 
10081763 12-15 07DEC2020 21260 Placebo 07DEC2020 Placebo 30DEC2020 Placebo 
10081764 C4591001 1008 
10081764 12-15 07DEC2020 21258 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10081767 C4591001 1008 
10081767 12-15 08DEC2020 21468 Placebo 08DEC2020 Placebo 29DEC2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 22
FDA-CBER-2022-5812-0231673
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10081768 C4591001 1008 
10081768 12-15 08DEC2020 21469 Placebo 08DEC2020 Placebo 29DEC2020 Placebo 
10081769 C4591001 1008 
10081769 12-15 08DEC2020 21475 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10081770 C4591001 1008 
10081770 12-15 09DEC2020 21476 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10081771 C4591001 1008 
10081771 12-15 09DEC2020 21662 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10081773 C4591001 1008 
10081773 12-15 09DEC2020 21664 Placebo 09DEC2020 Placebo 29DEC2020 Placebo 
10081774 C4591001 1008 
10081774 12-15 09DEC2020 21668 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10081775 C4591001 1008 
10081775 12-15 09DEC2020 21667 Placebo 09DEC2020 Placebo 28DEC2020 Placebo 
10081777 C4591001 1008 
10081777 12-15 10DEC2020 21873 BNT162b2 
(30 μg) 10DEC2020 BNT162b2 
(30 μg) 31DEC2020 BNT162b2 
(30 μg) 
10081780 C4591001 1008 
10081780 12-15 10DEC2020 21875 Placebo 10DEC2020 Placebo 29DEC2020 Placebo 
10081781 C4591001 1008 
10081781 12-15 10DEC2020 21878 Placebo 10DEC2020 Placebo 31DEC2020 Placebo 
10081785 C4591001 1008 
10081785 12-15 11DEC2020 21880 BNT162b2 
(30 μg) 11DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10081788 C4591001 1008 
10081788 12-15 14DEC2020 22317 Placebo 14DEC2020 Placebo 04JAN2021 Placebo 
10081789 C4591001 1008 
10081789 12-15 14DEC2020 22321 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
10081790 C4591001 1008 
10081790 12-15 14DEC2020 22322 Placebo 14DEC2020 Placebo 04JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 23
FDA-CBER-2022-5812-0231674
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10081791 C4591001 1008 
10081791 12-15 14DEC2020 22357 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
10081792 C4591001 1008 
10081792 12-15 14DEC2020 22323 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
10081793 C4591001 1008 
10081793 12-15 14DEC2020 22359 Placebo 14DEC2020 Placebo 04JAN2021 Placebo 
10081794 C4591001 1008 
10081794 12-15 14DEC2020 22358 Placebo 14DEC2020 Placebo 04JAN2021 Placebo 
10081795 C4591001 1008 
10081795 12-15 15DEC2020 22363 BNT162b2 
(30 μg) 15DEC2020 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 
10081796 C4591001 1008 
10081796 12-15 15DEC2020 22570 Placebo 15DEC2020 Placebo 05JAN2021 Placebo 
10081797 C4591001 1008 
10081797 12-15 15DEC2020 22574 BNT162b2 
(30 μg) 15DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
10081798 C4591001 1008 
10081798 12-15 15DEC2020 22575 Placebo 15DEC2020 Placebo 05JAN2021 Placebo 
10081799 C4591001 1008 
10081799 12-15 15DEC2020 22577 BNT162b2 
(30 μg) 15DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
10081800 C4591001 1008 
10081800 12-15 16DEC2020 22775 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10081801 C4591001 1008 
10081801 12-15 17DEC2020 22776 Placebo 17DEC2020 Placebo 08JAN2021 Placebo 
10081802 C4591001 1008 
10081802 12-15 17DEC2020 22780 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 
10081803 C4591001 1008 
10081803 12-15 17DEC2020 22783 Placebo 17DEC2020 Placebo 07JAN2021 Placebo 
10081804 C4591001 1008 
10081804 12-15 17DEC2020 23122 Placebo 17DEC2020 Placebo 07JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 24
FDA-CBER-2022-5812-0231675
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10081805 C4591001 1008 
10081805 12-15 17DEC2020 23123 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 
10081806 C4591001 1008 
10081806 12-15 17DEC2020 23127 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 
10081807 C4591001 1008 
10081807 12-15 18DEC2020 23129 Placebo 18DEC2020 Placebo 08JAN2021 Placebo 
10081808 C4591001 1008 
10081808 12-15 18DEC2020 23301 Placebo 18DEC2020 Placebo 08JAN2021 Placebo 
10081809 C4591001 1008 
10081809 12-15 18DEC2020 23306 Placebo 18DEC2020 Placebo 08JAN2021 Placebo 
10081810 C4591001 1008 
10081810 12-15 18DEC2020 23307 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
10081811 C4591001 1008 
10081811 12-15 18DEC2020 23308 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
10081812 C4591001 1008 
10081812 12-15 18DEC2020 23385 Placebo 18DEC2020 Placebo 08JAN2021 Placebo 
10081813 C4591001 1008 
10081813 12-15 18DEC2020 23392 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
10081814 C4591001 1008 
10081814 12-15 18DEC2020 23394 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
10081815 C4591001 1008 
10081815 12-15 18DEC2020 23396 Placebo 18DEC2020 Placebo 08JAN2021 Placebo 
10081816 C4591001 1008 
10081816 12-15 18DEC2020 23412 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
10081817 C4591001 1008 
10081817 12-15 18DEC2020 23413 Placebo 18DEC2020 Placebo 06JAN2021 Placebo 
10081818 C4591001 1008 
10081818 12-15 18DEC2020 23415 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 25
FDA-CBER-2022-5812-0231676
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10081819 C4591001 1008 
10081819 12-15 21DEC2020 23418 Placebo 21DEC2020 Placebo 11JAN2021 Placebo 
10081820 C4591001 1008 
10081820 12-15 21DEC2020 23629 Placebo 21DEC2020 Placebo 11JAN2021 Placebo 
10081821 C4591001 1008 
10081821 12-15 21DEC2020 23634 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 
10081822 C4591001 1008 
10081822 12-15 21DEC2020 23635 Placebo 21DEC2020 Placebo 11JAN2021 Placebo 
10081823 C4591001 1008 
10081823 12-15 21DEC2020 23636 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
10081824 C4591001 1008 
10081824 12-15 21DEC2020 23654 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
10081825 C4591001 1008 
10081825 12-15 21DEC2020 23656 Placebo 21DEC2020 Placebo 11JAN2021 Placebo 
10081826 C4591001 1008 
10081826 12-15 21DEC2020 23659 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 
10081827 C4591001 1008 
10081827 12-15 21DEC2020 23821 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
10081828 C4591001 1008 
10081828 12-15 21DEC2020 23660 Placebo 21DEC2020 Placebo 22JAN2021 Placebo 
10081829 C4591001 1008 
10081829 12-15 22DEC2020 23824 Placebo 22DEC2020 Placebo 12JAN2021 Placebo 
10081830 C4591001 1008 
10081830 12-15 22DEC2020 23825 Placebo 22DEC2020 Placebo 13JAN2021 Placebo 
10081831 C4591001 1008 
10081831 12-15 22DEC2020 23827 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 
10081832 C4591001 1008 
10081832 12-15 22DEC2020 23986 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 26
FDA-CBER-2022-5812-0231677
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10081833 C4591001 1008 
10081833 12-15 22DEC2020 23988 Placebo 22DEC2020 Placebo 12JAN2021 Placebo 
10081834 C4591001 1008 
10081834 12-15 22DEC2020 23991 Placebo 22DEC2020 Placebo 13JAN2021 Placebo 
10081835 C4591001 1008 
10081835 12-15 22DEC2020 23993 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 
10081836 C4591001 1008 
10081836 12-15 22DEC2020 24088 Placebo 22DEC2020 Placebo 12JAN2021 Placebo 
10081837 C4591001 1008 
10081837 12-15 22DEC2020 24089 Placebo 22DEC2020 Placebo 12JAN2021 Placebo 
10081838 C4591001 1008 
10081838 12-15 22DEC2020 24090 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 
10081839 C4591001 1008 
10081839 12-15 22DEC2020 24091 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 
10081840 C4591001 1008 
10081840 12-15 23DEC2020 24193 Placebo 23DEC2020 Placebo 13JAN2021 Placebo 
10081841 C4591001 1008 
10081841 12-15 23DEC2020 24195 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 13JAN2021 BNT162b2 
(30 μg) 
10081842 C4591001 1008 
10081842 12-15 23DEC2020 24196 Placebo 23DEC2020 Placebo 12JAN2021 Placebo 
10081843 C4591001 1008 
10081843 12-15 23DEC2020 24198 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 13JAN2021 BNT162b2 
(30 μg) 
10081844 C4591001 1008 
10081844 12-15 23DEC2020 24201 Placebo 23DEC2020 Placebo 13JAN2021 Placebo 
10081845 C4591001 1008 
10081845 12-15 23DEC2020 24207 Placebo 23DEC2020 Placebo 11JAN2021 Placebo 
10081846 C4591001 1008 
10081846 12-15 23DEC2020 24212 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 27
FDA-CBER-2022-5812-0231678
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10081847 C4591001 1008 
10081847 12-15 23DEC2020 24206 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 13JAN2021 BNT162b2 
(30 μg) 
10081848 C4591001 1008 
10081848 12-15 23DEC2020 24216 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 14JAN2021 BNT162b2 
(30 μg) 
10081849 C4591001 1008 
10081849 12-15 23DEC2020 24219 Placebo 23DEC2020 Placebo 14JAN2021 Placebo 
10081850 C4591001 1008 
10081850 12-15 23DEC2020 24221 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 14JAN2021 BNT162b2 
(30 μg) 
10081851 C4591001 1008 
10081851 12-15 23DEC2020 24222 Placebo 23DEC2020 Placebo 15JAN2021 Placebo 
10081852 C4591001 1008 
10081852 12-15 23DEC2020 24249 Placebo 23DEC2020 Placebo 15JAN2021 Placebo 
10081853 C4591001 1008 
10081853 12-15 28DEC2020 24250 Placebo 28DEC2020 Placebo 18JAN2021 Placebo 
10081854 C4591001 1008 
10081854 12-15 28DEC2020 24253 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
10081855 C4591001 1008 
10081855 12-15 28DEC2020 24257 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
10081856 C4591001 1008 
10081856 12-15 28DEC2020 24395 Placebo 28DEC2020 Placebo 18JAN2021 Placebo 
10081857 C4591001 1008 
10081857 12-15 28DEC2020 24396 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10081858 C4591001 1008 
10081858 12-15 28DEC2020 24397 Placebo 28DEC2020 Placebo 19JAN2021 Placebo 
10081859 C4591001 1008 
10081859 12-15 28DEC2020 24402 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
10081860 C4591001 1008 
10081860 12-15 28DEC2020 24465 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 28
FDA-CBER-2022-5812-0231679
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10081861 C4591001 1008 
10081861 12-15 29DEC2020 24469 Placebo 29DEC2020 Placebo 18JAN2021 Placebo 
10081862 C4591001 1008 
10081862 12-15 29DEC2020 24471 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 20JAN2021 BNT162b2 
(30 μg) 
10081863 C4591001 1008 
10081863 12-15 29DEC2020 24472 Placebo 29DEC2020 Placebo 18JAN2021 Placebo 
10081864 C4591001 1008 
10081864 12-15 29DEC2020 24639 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
10081865 C4591001 1008 
10081865 12-15 29DEC2020 24641 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10081866 C4591001 1008 
10081866 12-15 29DEC2020 24644 Placebo 29DEC2020 Placebo 18JAN2021 Placebo 
10081867 C4591001 1008 
10081867 12-15 29DEC2020 24642 Placebo 29DEC2020 Placebo 18JAN2021 Placebo 
10081868 C4591001 1008 
10081868 12-15 29DEC2020 24765 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10081869 C4591001 1008 
10081869 12-15 29DEC2020 24766 Placebo 29DEC2020 Placebo 19JAN2021 Placebo 
10081870 C4591001 1008 
10081870 12-15 29DEC2020 24775 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
10081871 C4591001 1008 
10081871 12-15 30DEC2020 24776 Placebo 30DEC2020 Placebo  
  
10081872 C4591001 1008 
10081872 12-15 30DEC2020 24885 Placebo 30DEC2020 Placebo 22JAN2021 Placebo 
10081873 C4591001 1008 
10081873 12-15 30DEC2020 24891 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
10081874 C4591001 1008 
10081874 12-15 30DEC2020 24895 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 20JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 29
FDA-CBER-2022-5812-0231680
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10081875 C4591001 1008 
10081875 12-15 30DEC2020 24893 Placebo 30DEC2020 Placebo 20JAN2021 Placebo 
10081876 C4591001 1008 
10081876 12-15 30DEC2020 24982 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 20JAN2021 BNT162b2 
(30 μg) 
10081877 C4591001 1008 
10081877 12-15 30DEC2020 24983 Placebo 30DEC2020 Placebo 20JAN2021 Placebo 
10081878 C4591001 1008 
10081878 12-15 30DEC2020 24984 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 20JAN2021 BNT162b2 
(30 μg) 
10081879 C4591001 1008 
10081879 12-15 30DEC2020 24989 Placebo 30DEC2020 Placebo 20JAN2021 Placebo 
10081880 C4591001 1008 
10081880 12-15 30DEC2020 25011 Placebo 30DEC2020 Placebo 19JAN2021 Placebo 
10081881 C4591001 1008 
10081881 12-15 30DEC2020 25009 Placebo 30DEC2020 Placebo 19JAN2021 Placebo 
10081882 C4591001 1008 
10081882 12-15 31DEC2020 25012 BNT162b2 
(30 μg) 31DEC2020 BNT162b2 
(30 μg) 21JAN2021 BNT162b2 
(30 μg) 
10081883 C4591001 1008 
10081883 12-15 31DEC2020 25016 BNT162b2 
(30 μg) 31DEC2020 BNT162b2 
(30 μg) 21JAN2021 BNT162b2 
(30 μg) 
10081884 C4591001 1008 
10081884 12-15 31DEC2020 25114 Placebo 31DEC2020 Placebo  
  
10081885 C4591001 1008 
10081885 12-15 31DEC2020 25116 BNT162b2 
(30 μg) 31DEC2020 BNT162b2 
(30 μg) 21JAN2021 BNT162b2 
(30 μg) 
10081886 C4591001 1008 
10081886 12-15 31DEC2020 25115 BNT162b2 
(30 μg) 31DEC2020 BNT162b2 
(30 μg) 21JAN2021 BNT162b2 
(30 μg) 
10081887 C4591001 1008 
10081887 12-15 04JAN2021 25121 Placebo 04JAN2021 Placebo 25JAN2021 Placebo 
10081888 C4591001 1008 
10081888 12-15 04JAN2021 25161 Placebo 04JAN2021 Placebo 25JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 30
FDA-CBER-2022-5812-0231681
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10081889 C4591001 1008 
10081889 12-15 04JAN2021 25163 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 25JAN2021 BNT162b2 
(30 μg) 
10081890 C4591001 1008 
10081890 12-15 04JAN2021 25164 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 25JAN2021 BNT162b2 
(30 μg) 
10081891 C4591001 1008 
10081891 12-15 04JAN2021 25172 Placebo 04JAN2021 Placebo 25JAN2021 Placebo 
10081892 C4591001 1008 
10081892 12-15 04JAN2021 25245 Placebo 04JAN2021 Placebo 25JAN2021 Placebo 
10081893 C4591001 1008 
10081893 12-15 04JAN2021 25248 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 25JAN2021 BNT162b2 
(30 μg) 
10081894 C4591001 1008 
10081894 12-15 04JAN2021 25250 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10081895 C4591001 1008 
10081895 12-15 04JAN2021 25269 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 25JAN2021 BNT162b2 
(30 μg) 
10081896 C4591001 1008 
10081896 12-15 04JAN2021 25256 Placebo 04JAN2021 Placebo 25JAN2021 Placebo 
10081897 C4591001 1008 
10081897 12-15 05JAN2021 25273 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 26JAN2021 BNT162b2 
(30 μg) 
10081898 C4591001 1008 
10081898 12-15 05JAN2021 25279 Placebo 05JAN2021 Placebo 25JAN2021 Placebo 
10081899 C4591001 1008 
10081899 12-15 05JAN2021 25274 Placebo 05JAN2021 Placebo 25JAN2021 Placebo 
10081900 C4591001 1008 
10081900 12-15 05JAN2021 25509 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 26JAN2021 BNT162b2 
(30 μg) 
10081901 C4591001 1008 
10081901 12-15 05JAN2021 25516 Placebo 05JAN2021 Placebo 26JAN2021 Placebo 
10081902 C4591001 1008 
10081902 12-15 05JAN2021 25518 Placebo 05JAN2021 Placebo 26JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 31
FDA-CBER-2022-5812-0231682
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10081903 C4591001 1008 
10081903 12-15 05JAN2021 25520 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 26JAN2021 BNT162b2 
(30 μg) 
10081904 C4591001 1008 
10081904 12-15 05JAN2021 25549 Placebo 05JAN2021 Placebo 26JAN2021 Placebo 
10081905 C4591001 1008 
10081905 12-15 06JAN2021 25552 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10081906 C4591001 1008 
10081906 12-15 06JAN2021 25555 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10081907 C4591001 1008 
10081907 12-15 06JAN2021 25556 Placebo 06JAN2021 Placebo 27JAN2021 Placebo 
10081908 C4591001 1008 
10081908 12-15 06JAN2021 25689 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10081909 C4591001 1008 
10081909 12-15 06JAN2021 25690 Placebo 06JAN2021 Placebo 27JAN2021 Placebo 
10081910 C4591001 1008 
10081910 12-15 06JAN2021 25691 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10081911 C4591001 1008 
10081911 12-15 06JAN2021 25695 Placebo 06JAN2021 Placebo 28JAN2021 Placebo 
10081912 C4591001 1008 
10081912 12-15 06JAN2021 25818 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 28JAN2021 BNT162b2 
(30 μg) 
10081913 C4591001 1008 
10081913 12-15 06JAN2021 25816 Placebo 06JAN2021 Placebo 28JAN2021 Placebo 
10081914 C4591001 1008 
10081914 12-15 06JAN2021 25817 Placebo 06JAN2021 Placebo 12FEB2021 Placebo 
10081915 C4591001 1008 
10081915 12-15 07JAN2021 25820 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 28JAN2021 BNT162b2 
(30 μg) 
10081916 C4591001 1008 
10081916 12-15 07JAN2021 25929 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 28JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 32
FDA-CBER-2022-5812-0231683
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10081917 C4591001 1008 
10081917 12-15 07JAN2021 25931 Placebo 07JAN2021 Placebo 28JAN2021 Placebo 
10081918 C4591001 1008 
10081918 12-15 07JAN2021 25933 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 28JAN2021 BNT162b2 
(30 μg) 
10081919 C4591001 1008 
10081919 12-15 07JAN2021 25937 Placebo 07JAN2021 Placebo 29JAN2021 Placebo 
10081920 C4591001 1008 
10081920 12-15 07JAN2021 26085 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 28JAN2021 BNT162b2 
(30 μg) 
10081921 C4591001 1008 
10081921 12-15 07JAN2021 26087 Placebo 07JAN2021 Placebo 29JAN2021 Placebo 
10081922 C4591001 1008 
10081922 12-15 08JAN2021 26089 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10081923 C4591001 1008 
10081923 12-15 08JAN2021 26091 Placebo 08JAN2021 Placebo 29JAN2021 Placebo 
10081924 C4591001 1008 
10081924 12-15 08JAN2021 26205 Placebo 08JAN2021 Placebo 29JAN2021 Placebo 
10081925 C4591001 1008 
10081925 12-15 08JAN2021 26209 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10081926 C4591001 1008 
10081926 12-15 08JAN2021 26216 Placebo 08JAN2021 Placebo 29JAN2021 Placebo 
10081927 C4591001 1008 
10081927 12-15 08JAN2021 26211 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10081928 C4591001 1008 
10081928 12-15 08JAN2021 26362 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10081929 C4591001 1008 
10081929 12-15 08JAN2021 26366 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10081930 C4591001 1008 
10081930 12-15 11JAN2021 26368 Placebo 11JAN2021 Placebo 01FEB2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 33
FDA-CBER-2022-5812-0231684
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10081931 C4591001 1008 
10081931 12-15 11JAN2021 26369 Placebo 11JAN2021 Placebo 01FEB2021 Placebo 
10081932 C4591001 1008 
10081932 12-15 11JAN2021 26579 Placebo 11JAN2021 Placebo 01FEB2021 Placebo 
10081933 C4591001 1008 
10081933 12-15 11JAN2021 26580 Placebo 11JAN2021 Placebo 02FEB2021 Placebo 
10081934 C4591001 1008 
10081934 12-15 11JAN2021 26587 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 01FEB2021 BNT162b2 
(30 μg) 
10081935 C4591001 1008 
10081935 12-15 11JAN2021 26588 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 03FEB2021 BNT162b2 
(30 μg) 
10081936 C4591001 1008 
10081936 12-15 11JAN2021 26687 Placebo 11JAN2021 Placebo 01FEB2021 Placebo 
10081937 C4591001 1008 
10081937 12-15 11JAN2021 26689 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 01FEB2021 BNT162b2 
(30 μg) 
10081938 C4591001 1008 
10081938 12-15 11JAN2021 26690 Placebo 11JAN2021 Placebo 02FEB2021 Placebo 
10081940 C4591001 1008 
10081940 12-15 12JAN2021 26693 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 02FEB2021 BNT162b2 
(30 μg) 
10081941 C4591001 1008 
10081941 12-15 12JAN2021 26877 Placebo 12JAN2021 Placebo 02FEB2021 Placebo 
10081942 C4591001 1008 
10081942 12-15 12JAN2021 26879 Placebo 12JAN2021 Placebo 02FEB2021 Placebo 
10081943 C4591001 1008 
10081943 12-15 12JAN2021 26880 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 02FEB2021 BNT162b2 
(30 μg) 
10091204 C4591001 1009 
10091204 12-15 15OCT2020 20017 Placebo 15OCT2020 Placebo 03NOV2020 Placebo 
10091205 C4591001 1009 
10091205 12-15 15OCT2020 20018 BNT162b2 
(30 μg) 15OCT2020 BNT162b2 
(30 μg) 06NOV2020 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 34
FDA-CBER-2022-5812-0231685
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10091208 C4591001 1009 
10091208 12-15 15OCT2020 20020 Placebo 15OCT2020 Placebo 06NOV2020 Placebo 
10091209 C4591001 1009 
10091209 12-15 15OCT2020 20022 BNT162b2 
(30 μg) 15OCT2020 BNT162b2 
(30 μg) 04NOV2020 BNT162b2 
(30 μg) 
10091212 C4591001 1009 
10091212 12-15 16OCT2020 20061 Placebo 16OCT2020 Placebo 16NOV2020 Placebo 
10091213 C4591001 1009 
10091213 12-15 16OCT2020 20062 Placebo 16OCT2020 Placebo 04NOV2020 Placebo 
10091216 C4591001 1009 
10091216 12-15 16OCT2020 20067 BNT162b2 
(30 μg) 16OCT2020 BNT162b2 
(30 μg) 06NOV2020 BNT162b2 
(30 μg) 
10091218 C4591001 1009 
10091218 12-15 16OCT2020 20072 BNT162b2 
(30 μg) 16OCT2020 BNT162b2 
(30 μg) 06NOV2020 BNT162b2 
(30 μg) 
10091220 C4591001 1009 
10091220 12-15 19OCT2020 20133 Placebo 19OCT2020 Placebo 07NOV2020 Placebo 
10091221 C4591001 1009 
10091221 12-15 19OCT2020 20134 BNT162b2 
(30 μg) 19OCT2020 BNT162b2 
(30 μg) 07NOV2020 BNT162b2 
(30 μg) 
10091223 C4591001 1009 
10091223 12-15 19OCT2020 20139 BNT162b2 
(30 μg) 19OCT2020 BNT162b2 
(30 μg) 10NOV2020 BNT162b2 
(30 μg) 
10091226 C4591001 1009 
10091226 12-15 20OCT2020 20141 Placebo 20OCT2020 Placebo 09NOV2020 Placebo 
10091227 C4591001 1009 
10091227 12-15 20OCT2020 20207 BNT162b2 
(30 μg) 20OCT2020 BNT162b2 
(30 μg) 10NOV2020 BNT162b2 
(30 μg) 
10091229 C4591001 1009 
10091229 12-15 20OCT2020 20209 Placebo 20OCT2020 Placebo  
  
10091231 C4591001 1009 
10091231 12-15 20OCT2020 20210 BNT162b2 
(30 μg) 20OCT2020 BNT162b2 
(30 μg) 09NOV2020 BNT162b2 
(30 μg) 
10091233 C4591001 1009 
10091233 12-15 21OCT2020 20211 Placebo 21OCT2020 Placebo 12NOV2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 35
FDA-CBER-2022-5812-0231686
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10091234 C4591001 1009 
10091234 12-15 21OCT2020 20245 BNT162b2 
(30 μg) 21OCT2020 BNT162b2 
(30 μg) 11NOV2020 BNT162b2 
(30 μg) 
10091237 C4591001 1009 
10091237 12-15 21OCT2020 20246 Placebo 21OCT2020 Placebo 12NOV2020 Placebo 
10091238 C4591001 1009 
10091238 12-15 21OCT2020 20251 Placebo 21OCT2020 Placebo 10NOV2020 Placebo 
10091240 C4591001 1009 
10091240 12-15 21OCT2020 20252 BNT162b2 
(30 μg) 21OCT2020 BNT162b2 
(30 μg) 09NOV2020 BNT162b2 
(30 μg) 
10091246 C4591001 1009 
10091246 12-15 22OCT2020 20314 Placebo 22OCT2020 Placebo 10NOV2020 Placebo 
10091247 C4591001 1009 
10091247 12-15 22OCT2020 20316 BNT162b2 
(30 μg) 22OCT2020 BNT162b2 
(30 μg) 11NOV2020 BNT162b2 
(30 μg) 
10091249 C4591001 1009 
10091249 12-15 22OCT2020 20320 Placebo 22OCT2020 Placebo 13NOV2020 Placebo 
10091250 C4591001 1009 
10091250 12-15 22OCT2020 20323 BNT162b2 
(30 μg) 22OCT2020 BNT162b2 
(30 μg) 13NOV2020 BNT162b2 
(30 μg) 
10091265 C4591001 1009 
10091265 12-15 01DEC2020 20505 BNT162b2 
(30 μg) 01DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10091266 C4591001 1009 
10091266 12-15 01DEC2020 20506 Placebo 01DEC2020 Placebo 21DEC2020 Placebo 
10091267 C4591001 1009 
10091267 12-15 01DEC2020 20511 Placebo 01DEC2020 Placebo 22DEC2020 Placebo 
10091269 C4591001 1009 
10091269 12-15 01DEC2020 20514 BNT162b2 
(30 μg) 01DEC2020 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 
10091270 C4591001 1009 
10091270 12-15 01DEC2020 20629 BNT162b2 
(30 μg) 01DEC2020 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 
10091272 C4591001 1009 
10091272 12-15 02DEC2020 20631 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 36
FDA-CBER-2022-5812-0231687
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10091273 C4591001 1009 
10091273 12-15 02DEC2020 20633 Placebo 02DEC2020 Placebo 22DEC2020 Placebo 
10091274 C4591001 1009 
10091274 12-15 02DEC2020 20635 Placebo 02DEC2020 Placebo 28DEC2020 Placebo 
10091275 C4591001 1009 
10091275 12-15 02DEC2020 20786 Placebo 02DEC2020 Placebo 28DEC2020 Placebo 
10091277 C4591001 1009 
10091277 12-15 03DEC2020 20787 Placebo 03DEC2020 Placebo 30DEC2020 Placebo 
10091280 C4591001 1009 
10091280 12-15 03DEC2020 20789 BNT162b2 
(30 μg) 03DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10091281 C4591001 1009 
10091281 12-15 03DEC2020 20791 BNT162b2 
(30 μg) 03DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10091282 C4591001 1009 
10091282 12-15 03DEC2020 20914 Placebo 03DEC2020 Placebo 22DEC2020 Placebo 
10091283 C4591001 1009 
10091283 12-15 03DEC2020 20915 Placebo 03DEC2020 Placebo 23DEC2020 Placebo 
10091284 C4591001 1009 
10091284 12-15 03DEC2020 20919 BNT162b2 
(30 μg) 03DEC2020 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 
10091287 C4591001 1009 
10091287 12-15 04DEC2020 20922 BNT162b2 
(30 μg) 04DEC2020 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 
10091288 C4591001 1009 
10091288 12-15 04DEC2020 21011 BNT162b2 
(30 μg) 04DEC2020 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 
10091289 C4591001 1009 
10091289 12-15 04DEC2020 21012 BNT162b2 
(30 μg) 04DEC2020 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 
10091292 C4591001 1009 
10091292 12-15 04DEC2020 21014 Placebo 04DEC2020 Placebo 23DEC2020 Placebo 
10091293 C4591001 1009 
10091293 12-15 04DEC2020 21015 Placebo 04DEC2020 Placebo 23DEC2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 37
FDA-CBER-2022-5812-0231688
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10091294 C4591001 1009 
10091294 12-15 07DEC2020 21177 Placebo 07DEC2020 Placebo 28DEC2020 Placebo 
10091295 C4591001 1009 
10091295 12-15 07DEC2020 21178 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10091296 C4591001 1009 
10091296 12-15 07DEC2020 21182 Placebo 07DEC2020 Placebo 29DEC2020 Placebo 
10091297 C4591001 1009 
10091297 12-15 07DEC2020 21188 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10091298 C4591001 1009 
10091298 12-15 07DEC2020 21300 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10091300 C4591001 1009 
10091300 12-15 07DEC2020 21302 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10091301 C4591001 1009 
10091301 12-15 07DEC2020 21303 Placebo 07DEC2020 Placebo 28DEC2020 Placebo 
10091303 C4591001 1009 
10091303 12-15 08DEC2020 21304 Placebo 08DEC2020 Placebo 28DEC2020 Placebo 
10091304 C4591001 1009 
10091304 12-15 08DEC2020 21537 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10091305 C4591001 1009 
10091305 12-15 08DEC2020 21543 Placebo 08DEC2020 Placebo 29DEC2020 Placebo 
10091306 C4591001 1009 
10091306 12-15 08DEC2020 21546 Placebo 08DEC2020 Placebo 29DEC2020 Placebo 
10091307 C4591001 1009 
10091307 12-15 09DEC2020 21547 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10091308 C4591001 1009 
10091308 12-15 09DEC2020 21650 Placebo 09DEC2020 Placebo 30DEC2020 Placebo 
10091309 C4591001 1009 
10091309 12-15 09DEC2020 21652 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 38
FDA-CBER-2022-5812-0231689
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10091310 C4591001 1009 
10091310 12-15 09DEC2020 21653 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10091311 C4591001 1009 
10091311 12-15 09DEC2020 21655 Placebo 09DEC2020 Placebo 28DEC2020 Placebo 
10091312 C4591001 1009 
10091312 12-15 09DEC2020 21782 Placebo 09DEC2020 Placebo 29DEC2020 Placebo 
10091313 C4591001 1009 
10091313 12-15 09DEC2020 21778 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10091314 C4591001 1009 
10091314 12-15 09DEC2020 21783 Placebo 09DEC2020 Placebo 30DEC2020 Placebo 
10091315 C4591001 1009 
10091315 12-15 09DEC2020 21785 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10091316 C4591001 1009 
10091316 12-15 09DEC2020 21813 Placebo 09DEC2020 Placebo 28DEC2020 Placebo 
10091317 C4591001 1009 
10091317 12-15 10DEC2020 21814 Placebo 10DEC2020 Placebo 29DEC2020 Placebo 
10091318 C4591001 1009 
10091318 12-15 10DEC2020 21821 BNT162b2 
(30 μg) 10DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10091319 C4591001 1009 
10091319 12-15 10DEC2020 21823 BNT162b2 
(30 μg) 10DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10091320 C4591001 1009 
10091320 12-15 10DEC2020 21957 Placebo 10DEC2020 Placebo 30DEC2020 Placebo 
10091321 C4591001 1009 
10091321 12-15 10DEC2020 21958 BNT162b2 
(30 μg) 10DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10091322 C4591001 1009 
10091322 12-15 10DEC2020 21959 BNT162b2 
(30 μg) 10DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10091323 C4591001 1009 
10091323 12-15 10DEC2020 21964 Placebo 10DEC2020 Placebo 30DEC2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 39
FDA-CBER-2022-5812-0231690
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10091324 C4591001 1009 
10091324 12-15 11DEC2020 22066 Placebo 11DEC2020 Placebo 31DEC2020 Placebo 
10091325 C4591001 1009 
10091325 12-15 11DEC2020 22067 BNT162b2 
(30 μg) 11DEC2020 BNT162b2 
(30 μg) 31DEC2020 BNT162b2 
(30 μg) 
10091326 C4591001 1009 
10091326 12-15 11DEC2020 22072 Placebo 11DEC2020 Placebo 30DEC2020 Placebo 
10091328 C4591001 1009 
10091328 12-15 11DEC2020 22075 BNT162b2 
(30 μg) 11DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10091329 C4591001 1009 
10091329 12-15 11DEC2020 22149 Placebo 11DEC2020 Placebo 30DEC2020 Placebo 
10091330 C4591001 1009 
10091330 12-15 11DEC2020 22151 Placebo 11DEC2020 Placebo 30DEC2020 Placebo 
10091331 C4591001 1009 
10091331 12-15 11DEC2020 22157 BNT162b2 
(30 μg) 11DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10091332 C4591001 1009 
10091332 12-15 11DEC2020 22160 BNT162b2 
(30 μg) 11DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10091333 C4591001 1009 
10091333 12-15 11DEC2020 22198 BNT162b2 
(30 μg) 11DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10091334 C4591001 1009 
10091334 12-15 11DEC2020 22199 Placebo 11DEC2020 Placebo 31DEC2020 Placebo 
10091335 C4591001 1009 
10091335 12-15 11DEC2020 22200 BNT162b2 
(30 μg) 11DEC2020 BNT162b2 
(30 μg) 31DEC2020 BNT162b2 
(30 μg) 
10091336 C4591001 1009 
10091336 12-15 11DEC2020 22201 Placebo 11DEC2020 Placebo 31DEC2020 Placebo 
10091337 C4591001 1009 
10091337 12-15 14DEC2020 22329 Placebo 14DEC2020 Placebo 04JAN2021 Placebo 
10091338 C4591001 1009 
10091338 12-15 14DEC2020 22331 Placebo 14DEC2020 Placebo  
  
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 40
FDA-CBER-2022-5812-0231691
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10091339 C4591001 1009 
10091339 12-15 14DEC2020 22332 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
10091340 C4591001 1009 
10091340 12-15 14DEC2020 22339 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
10091341 C4591001 1009 
10091341 12-15 14DEC2020 22451 Placebo 14DEC2020 Placebo 04JAN2021 Placebo 
10091342 C4591001 1009 
10091342 12-15 14DEC2020 22452 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
10091343 C4591001 1009 
10091343 12-15 15DEC2020 22454 BNT162b2 
(30 μg) 15DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
10091344 C4591001 1009 
10091344 12-15 15DEC2020 22458 Placebo 15DEC2020 Placebo 04JAN2021 Placebo 
10091345 C4591001 1009 
10091345 12-15 15DEC2020 22618 BNT162b2 
(30 μg) 15DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
10091346 C4591001 1009 
10091346 12-15 15DEC2020 22621 Placebo 15DEC2020 Placebo 05JAN2021 Placebo 
10091347 C4591001 1009 
10091347 12-15 15DEC2020 22625 Placebo 15DEC2020 Placebo 06JAN2021 Placebo 
10091348 C4591001 1009 
10091348 12-15 15DEC2020 22626 BNT162b2 
(30 μg) 15DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10091349 C4591001 1009 
10091349 12-15 15DEC2020 22701 Placebo 15DEC2020 Placebo 06JAN2021 Placebo 
10091350 C4591001 1009 
10091350 12-15 16DEC2020 22702 Placebo 16DEC2020 Placebo 07JAN2021 Placebo 
10091351 C4591001 1009 
10091351 12-15 16DEC2020 22706 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10091353 C4591001 1009 
10091353 12-15 16DEC2020 22707 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 41
FDA-CBER-2022-5812-0231692
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10091354 C4591001 1009 
10091354 12-15 16DEC2020 22906 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 
10091355 C4591001 1009 
10091355 12-15 16DEC2020 22907 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
10091356 C4591001 1009 
10091356 12-15 16DEC2020 22909 Placebo 16DEC2020 Placebo 04JAN2021 Placebo 
10091357 C4591001 1009 
10091357 12-15 17DEC2020 22912 Placebo 17DEC2020 Placebo 05JAN2021 Placebo 
10091358 C4591001 1009 
10091358 12-15 17DEC2020 23001 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10091359 C4591001 1009 
10091359 12-15 17DEC2020 23002 Placebo 17DEC2020 Placebo 06JAN2021 Placebo 
10091360 C4591001 1009 
10091360 12-15 17DEC2020 23003 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10091361 C4591001 1009 
10091361 12-15 17DEC2020 23012 Placebo 17DEC2020 Placebo 05JAN2021 Placebo 
10091362 C4591001 1009 
10091362 12-15 17DEC2020 23181 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
10091363 C4591001 1009 
10091363 12-15 17DEC2020 23186 Placebo 17DEC2020 Placebo  
  
10091364 C4591001 1009 
10091364 12-15 17DEC2020 23189 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10091365 C4591001 1009 
10091365 12-15 17DEC2020 23191 Placebo 17DEC2020 Placebo 19JAN2021 Placebo 
10091366 C4591001 1009 
10091366 12-15 17DEC2020 23213 Placebo 17DEC2020 Placebo  
  
10091369 C4591001 1009 
10091369 12-15 18DEC2020 23214 Placebo 18DEC2020 Placebo 08JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 42
FDA-CBER-2022-5812-0231693
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10091370 C4591001 1009 
10091370 12-15 18DEC2020 23215 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
10091371 C4591001 1009 
10091371 12-15 18DEC2020 23216 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
10091372 C4591001 1009 
10091372 12-15 18DEC2020 23435 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
10091373 C4591001 1009 
10091373 12-15 18DEC2020 23441 Placebo 18DEC2020 Placebo 08JAN2021 Placebo 
10091374 C4591001 1009 
10091374 12-15 21DEC2020 23442 Placebo 21DEC2020 Placebo 11JAN2021 Placebo 
10091375 C4591001 1009 
10091375 12-15 21DEC2020 23444 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
10091376 C4591001 1009 
10091376 12-15 21DEC2020 23805 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
10091377 C4591001 1009 
10091377 12-15 21DEC2020 23808 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 
10091378 C4591001 1009 
10091378 12-15 21DEC2020 23812 Placebo 21DEC2020 Placebo 12JAN2021 Placebo 
10091379 C4591001 1009 
10091379 12-15 22DEC2020 23814 Placebo 22DEC2020 Placebo 14JAN2021 Placebo 
10091380 C4591001 1009 
10091380 12-15 29DEC2020 24802 Placebo 29DEC2020 Placebo 19JAN2021 Placebo 
10091381 C4591001 1009 
10091381 12-15 31DEC2020 24806 BNT162b2 
(30 μg) 31DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10091382 C4591001 1009 
10091382 12-15 04JAN2021 24808 Placebo 04JAN2021 Placebo 25JAN2021 Placebo 
10091383 C4591001 1009 
10091383 12-15 05JAN2021 24810 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 25JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 43
FDA-CBER-2022-5812-0231694
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10091384 C4591001 1009 
10091384 12-15 05JAN2021 25498 Placebo 05JAN2021 Placebo 25JAN2021 Placebo 
10091385 C4591001 1009 
10091385 12-15 05JAN2021 25502 Placebo 05JAN2021 Placebo 26JAN2021 Placebo 
10091386 C4591001 1009 
10091386 12-15 06JAN2021 25505 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 25JAN2021 BNT162b2 
(30 μg) 
10091387 C4591001 1009 
10091387 12-15 06JAN2021 25506 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 28JAN2021 BNT162b2 
(30 μg) 
10091388 C4591001 1009 
10091388 12-15 06JAN2021 25872 Placebo 06JAN2021 Placebo 28JAN2021 Placebo 
10091389 C4591001 1009 
10091389 12-15 06JAN2021 25878 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 25JAN2021 BNT162b2 
(30 μg) 
10091390 C4591001 1009 
10091390 12-15 07JAN2021 25879 Placebo 07JAN2021 Placebo 28JAN2021 Placebo 
10091391 C4591001 1009 
10091391 12-15 07JAN2021 26073 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10091392 C4591001 1009 
10091392 12-15 07JAN2021 26075 Placebo 07JAN2021 Placebo 29JAN2021 Placebo 
10091393 C4591001 1009 
10091393 12-15 07JAN2021 25880 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10091394 C4591001 1009 
10091394 12-15 07JAN2021 26076 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10091395 C4591001 1009 
10091395 12-15 07JAN2021 26079 Placebo 07JAN2021 Placebo 27JAN2021 Placebo 
10091396 C4591001 1009 
10091396 12-15 07JAN2021 26113 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 26JAN2021 BNT162b2 
(30 μg) 
10091398 C4591001 1009 
10091398 12-15 07JAN2021 26114 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 28JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 44
FDA-CBER-2022-5812-0231695
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10091399 C4591001 1009 
10091399 12-15 08JAN2021 26115 Placebo 08JAN2021 Placebo 29JAN2021 Placebo 
10091400 C4591001 1009 
10091400 12-15 08JAN2021 26119 Placebo 08JAN2021 Placebo 12FEB2021 Placebo 
10091401 C4591001 1009 
10091401 12-15 08JAN2021 26375 Placebo 08JAN2021 Placebo 29JAN2021 Placebo 
10091402 C4591001 1009 
10091402 12-15 08JAN2021 26377 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10091403 C4591001 1009 
10091403 12-15 08JAN2021 26378 Placebo 08JAN2021 Placebo 27JAN2021 Placebo 
10091404 C4591001 1009 
10091404 12-15 08JAN2021 26380 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10091405 C4591001 1009 
10091405 12-15 08JAN2021 26445 Placebo 08JAN2021 Placebo 29JAN2021 Placebo 
10091406 C4591001 1009 
10091406 12-15 08JAN2021 26447 Placebo 08JAN2021 Placebo 29JAN2021 Placebo 
10091407 C4591001 1009 
10091407 12-15 11JAN2021 26450 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 01FEB2021 BNT162b2 
(30 μg) 
10091408 C4591001 1009 
10091408 12-15 11JAN2021 26453 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 02FEB2021 BNT162b2 
(30 μg) 
10091409 C4591001 1009 
10091409 12-15 11JAN2021 26737 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 02FEB2021 BNT162b2 
(30 μg) 
10091410 C4591001 1009 
10091410 12-15 12JAN2021 26740 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 01FEB2021 BNT162b2 
(30 μg) 
10091411 C4591001 1009 
10091411 12-15 12JAN2021 26743 Placebo 12JAN2021 Placebo 01FEB2021 Placebo 
10091412 C4591001 1009 
10091412 12-15 12JAN2021 26744 Placebo 12JAN2021 Placebo 01FEB2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 45
FDA-CBER-2022-5812-0231696
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10091413 C4591001 1009 
10091413 12-15 12JAN2021 26916 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 03FEB2021 BNT162b2 
(30 μg) 
10091414 C4591001 1009 
10091414 12-15 12JAN2021 26920 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 04FEB2021 BNT162b2 
(30 μg) 
10131821 C4591001 1013 
10131821 12-15 30NOV2020 20333 BNT162b2 
(30 μg) 30NOV2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
10131822 C4591001 1013 
10131822 12-15 30NOV2020 20332 BNT162b2 
(30 μg) 30NOV2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
10131823 C4591001 1013 
10131823 12-15 01DEC2020 20335 Placebo 01DEC2020 Placebo 22DEC2020 Placebo 
10131824 C4591001 1013 
10131824 12-15 01DEC2020 20554 BNT162b2 
(30 μg) 01DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10131826 C4591001 1013 
10131826 12-15 01DEC2020 20558 Placebo 01DEC2020 Placebo 23DEC2020 Placebo 
10131828 C4591001 1013 
10131828 12-15 02DEC2020 20559 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10131830 C4591001 1013 
10131830 12-15 02DEC2020 20564 Placebo 02DEC2020 Placebo 23DEC2020 Placebo 
10131835 C4591001 1013 
10131835 12-15 02DEC2020 20676 Placebo 02DEC2020 Placebo 22DEC2020 Placebo 
10131836 C4591001 1013 
10131836 12-15 02DEC2020 20681 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10131839 C4591001 1013 
10131839 12-15 02DEC2020 20682 Placebo 02DEC2020 Placebo 23DEC2020 Placebo 
10131841 C4591001 1013 
10131841 12-15 02DEC2020 20736 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10131842 C4591001 1013 
10131842 12-15 02DEC2020 20738 Placebo 02DEC2020 Placebo 22DEC2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 46
FDA-CBER-2022-5812-0231697
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10131843 C4591001 1013 
10131843 12-15 02DEC2020 20684 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10131844 C4591001 1013 
10131844 12-15 02DEC2020 20743 Placebo 02DEC2020 Placebo 22DEC2020 Placebo 
10131845 C4591001 1013 
10131845 12-15 03DEC2020 20744 BNT162b2 
(30 μg) 03DEC2020 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 
10131846 C4591001 1013 
10131846 12-15 03DEC2020 20821 BNT162b2 
(30 μg) 03DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10131848 C4591001 1013 
10131848 12-15 03DEC2020 20825 Placebo 03DEC2020 Placebo 22DEC2020 Placebo 
10131850 C4591001 1013 
10131850 12-15 03DEC2020 20827 BNT162b2 
(30 μg) 03DEC2020 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 
10131851 C4591001 1013 
10131851 12-15 07DEC2020 20828 Placebo 07DEC2020 Placebo 28DEC2020 Placebo 
10131852 C4591001 1013 
10131852 12-15 07DEC2020 21153 Placebo 07DEC2020 Placebo 28DEC2020 Placebo 
10131855 C4591001 1013 
10131855 12-15 08DEC2020 21154 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10131856 C4591001 1013 
10131856 12-15 09DEC2020 21671 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10131858 C4591001 1013 
10131858 12-15 09DEC2020 21164 Placebo 09DEC2020 Placebo 29DEC2020 Placebo 
10131859 C4591001 1013 
10131859 12-15 09DEC2020 21155 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 31DEC2020 BNT162b2 
(30 μg) 
10131860 C4591001 1013 
10131860 12-15 09DEC2020 21673 Placebo 09DEC2020 Placebo 29DEC2020 Placebo 
10131861 C4591001 1013 
10131861 12-15 10DEC2020 21677 Placebo 10DEC2020 Placebo 04JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 47
FDA-CBER-2022-5812-0231698
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10131862 C4591001 1013 
10131862 12-15 10DEC2020 21678 BNT162b2 
(30 μg) 10DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10131863 C4591001 1013 
10131863 12-15 10DEC2020 21983 Placebo 10DEC2020 Placebo 30DEC2020 Placebo 
10131865 C4591001 1013 
10131865 12-15 14DEC2020 21987 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10131866 C4591001 1013 
10131866 12-15 14DEC2020 21990 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10131867 C4591001 1013 
10131867 12-15 17DEC2020 21992 Placebo 17DEC2020 Placebo 05JAN2021 Placebo 
10131868 C4591001 1013 
10131868 12-15 21DEC2020 23579 Placebo 21DEC2020 Placebo 12JAN2021 Placebo 
10131869 C4591001 1013 
10131869 12-15 21DEC2020 117929 Placebo 21DEC2020 Placebo 13JAN2021 Placebo 
10131870 C4591001 1013 
10131870 12-15 21DEC2020 23583 Placebo 21DEC2020 Placebo 13JAN2021 Placebo 
10131871 C4591001 1013 
10131871 12-15 21DEC2020 23585 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
10131872 C4591001 1013 
10131872 12-15 21DEC2020 23586 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
10131873 C4591001 1013 
10131873 12-15 22DEC2020 24005 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 13JAN2021 BNT162b2 
(30 μg) 
10131874 C4591001 1013 
10131874 12-15 22DEC2020 24002 Placebo 22DEC2020 Placebo 13JAN2021 Placebo 
10131875 C4591001 1013 
10131875 12-15 22DEC2020 24004 Placebo 22DEC2020 Placebo 13JAN2021 Placebo 
10131876 C4591001 1013 
10131876 12-15 22DEC2020 24008 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 48
FDA-CBER-2022-5812-0231699
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10131877 C4591001 1013 
10131877 12-15 23DEC2020 24167 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 13JAN2021 BNT162b2 
(30 μg) 
10131878 C4591001 1013 
10131878 12-15 23DEC2020 24174 Placebo 23DEC2020 Placebo 13JAN2021 Placebo 
10131879 C4591001 1013 
10131879 12-15 23DEC2020 24168 Placebo 23DEC2020 Placebo 11JAN2021 Placebo 
10131880 C4591001 1013 
10131880 12-15 23DEC2020 24173 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
10131881 C4591001 1013 
10131881 12-15 28DEC2020 24361 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 20JAN2021 BNT162b2 
(30 μg) 
10131882 C4591001 1013 
10131882 12-15 30DEC2020 24365 Placebo 30DEC2020 Placebo 19JAN2021 Placebo 
10131883 C4591001 1013 
10131883 12-15 31DEC2020 24366 Placebo 31DEC2020 Placebo 21JAN2021 Placebo 
10131884 C4591001 1013 
10131884 12-15 07JAN2021 24368 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 28JAN2021 BNT162b2 
(30 μg) 
10131885 C4591001 1013 
10131885 12-15 07JAN2021 25893 Placebo 07JAN2021 Placebo 26JAN2021 Placebo 
10131886 C4591001 1013 
10131886 12-15 07JAN2021 25894 Placebo 07JAN2021 Placebo 27JAN2021 Placebo 
10161307 C4591001 1016 
10161307 12-15 15OCT2020 20025 Placebo 15OCT2020 Placebo 04NOV2020 Placebo 
10161308 C4591001 1016 
10161308 12-15 15OCT2020 20032 Placebo 15OCT2020 Placebo 03NOV2020 Placebo 
10161309 C4591001 1016 
10161309 12-15 15OCT2020 20035 BNT162b2 
(30 μg) 15OCT2020 BNT162b2 
(30 μg) 12NOV2020 BNT162b2 
(30 μg) 
10161310 C4591001 1016 
10161310 12-15 15OCT2020 20036 BNT162b2 
(30 μg) 15OCT2020 BNT162b2 
(30 μg) 04NOV2020 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 49
FDA-CBER-2022-5812-0231700
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10161311 C4591001 1016 
10161311 12-15 15OCT2020 20052 BNT162b2 
(30 μg) 15OCT2020 BNT162b2 
(30 μg) 03NOV2020 BNT162b2 
(30 μg) 
10161314 C4591001 1016 
10161314 12-15 16OCT2020 20053 BNT162b2 
(30 μg) 16OCT2020 BNT162b2 
(30 μg) 05NOV2020 BNT162b2 
(30 μg) 
10161315 C4591001 1016 
10161315 12-15 16OCT2020 20055 Placebo 16OCT2020 Placebo 06NOV2020 Placebo 
10161316 C4591001 1016 
10161316 12-15 16OCT2020 20058 Placebo 16OCT2020 Placebo  
  
10161318 C4591001 1016 
10161318 12-15 16OCT2020 20099 Placebo 16OCT2020 Placebo 04NOV2020 Placebo 
10161319 C4591001 1016 
10161319 12-15 16OCT2020 20103 Placebo 16OCT2020 Placebo 04NOV2020 Placebo 
10161320 C4591001 1016 
10161320 12-15 21OCT2020 20176 BNT162b2 
(30 μg) 21OCT2020 BNT162b2 
(30 μg) 09NOV2020 BNT162b2 
(30 μg) 
10161322 C4591001 1016 
10161322 12-15 19OCT2020 20107 BNT162b2 
(30 μg) 19OCT2020 BNT162b2 
(30 μg) 09NOV2020 BNT162b2 
(30 μg) 
10161323 C4591001 1016 
10161323 12-15 19OCT2020 20108 BNT162b2 
(30 μg) 19OCT2020 BNT162b2 
(30 μg) 09NOV2020 BNT162b2 
(30 μg) 
10161324 C4591001 1016 
10161324 12-15 19OCT2020 20109 Placebo 19OCT2020 Placebo 09NOV2020 Placebo 
10161325 C4591001 1016 
10161325 12-15 19OCT2020 20110 BNT162b2 
(30 μg) 19OCT2020 BNT162b2 
(30 μg) 10NOV2020 BNT162b2 
(30 μg) 
10161326 C4591001 1016 
10161326 12-15 20OCT2020 20114 BNT162b2 
(30 μg) 20OCT2020 BNT162b2 
(30 μg) 10NOV2020 BNT162b2 
(30 μg) 
10161327 C4591001 1016 
10161327 12-15 20OCT2020 20120 Placebo 20OCT2020 Placebo 10NOV2020 Placebo 
10161329 C4591001 1016 
10161329 12-15 20OCT2020 20171 Placebo 20OCT2020 Placebo 10NOV2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 50
FDA-CBER-2022-5812-0231701
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10161330 C4591001 1016 
10161330 12-15 20OCT2020 20174 BNT162b2 
(30 μg) 20OCT2020 BNT162b2 
(30 μg) 11NOV2020 BNT162b2 
(30 μg) 
10161331 C4591001 1016 
10161331 12-15 20OCT2020 20172 Placebo 20OCT2020 Placebo 11NOV2020 Placebo 
10161332 C4591001 1016 
10161332 12-15 21OCT2020 20229 BNT162b2 
(30 μg) 21OCT2020 BNT162b2 
(30 μg) 09NOV2020 BNT162b2 
(30 μg) 
10161334 C4591001 1016 
10161334 12-15 21OCT2020 20231 Placebo 21OCT2020 Placebo 11NOV2020 Placebo 
10161335 C4591001 1016 
10161335 12-15 21OCT2020 20240 BNT162b2 
(30 μg) 21OCT2020 BNT162b2 
(30 μg) 11NOV2020 BNT162b2 
(30 μg) 
10161336 C4591001 1016 
10161336 12-15 21OCT2020 20258 Placebo 21OCT2020 Placebo 11NOV2020 Placebo 
10161337 C4591001 1016 
10161337 12-15 21OCT2020 20236 Placebo 21OCT2020 Placebo 10NOV2020 Placebo 
10161338 C4591001 1016 
10161338 12-15 22OCT2020 20259 BNT162b2 
(30 μg) 22OCT2020 BNT162b2 
(30 μg) 10NOV2020 BNT162b2 
(30 μg) 
10161339 C4591001 1016 
10161339 12-15 22OCT2020 20262 BNT162b2 
(30 μg) 22OCT2020 BNT162b2 
(30 μg) 10NOV2020 BNT162b2 
(30 μg) 
10161340 C4591001 1016 
10161340 12-15 22OCT2020 20263 Placebo 22OCT2020 Placebo 10NOV2020 Placebo 
10161343 C4591001 1016 
10161343 12-15 22OCT2020 20301 BNT162b2 
(30 μg) 22OCT2020 BNT162b2 
(30 μg) 13NOV2020 BNT162b2 
(30 μg) 
10161344 C4591001 1016 
10161344 12-15 22OCT2020 20306 Placebo 22OCT2020 Placebo 11NOV2020 Placebo 
10161350 C4591001 1016 
10161350 12-15 30NOV2020 20309 BNT162b2 
(30 μg) 30NOV2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
10161351 C4591001 1016 
10161351 12-15 30NOV2020 20308 Placebo 30NOV2020 Placebo 21DEC2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 51
FDA-CBER-2022-5812-0231702
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10161352 C4591001 1016 
10161352 12-15 30NOV2020 20410 Placebo 30NOV2020 Placebo 21DEC2020 Placebo 
10161353 C4591001 1016 
10161353 12-15 30NOV2020 20411 Placebo 30NOV2020 Placebo 23DEC2020 Placebo 
10161354 C4591001 1016 
10161354 12-15 02DEC2020 20412 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 
10161356 C4591001 1016 
10161356 12-15 02DEC2020 20416 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10161357 C4591001 1016 
10161357 12-15 02DEC2020 20653 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10161358 C4591001 1016 
10161358 12-15 03DEC2020 20657 Placebo 03DEC2020 Placebo 22DEC2020 Placebo 
10161361 C4591001 1016 
10161361 12-15 04DEC2020 20658 Placebo 04DEC2020 Placebo 23DEC2020 Placebo 
10161362 C4591001 1016 
10161362 12-15 04DEC2020 20659 BNT162b2 
(30 μg) 04DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10161363 C4591001 1016 
10161363 12-15 08DEC2020 21477 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10161364 C4591001 1016 
10161364 12-15 09DEC2020 21478 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 31DEC2020 BNT162b2 
(30 μg) 
10161365 C4591001 1016 
10161365 12-15 10DEC2020 21481 Placebo 10DEC2020 Placebo 29DEC2020 Placebo 
10161366 C4591001 1016 
10161366 12-15 15DEC2020 21488 Placebo 15DEC2020 Placebo 07JAN2021 Placebo 
10161367 C4591001 1016 
10161367 12-15 29DEC2020 24585 Placebo 29DEC2020 Placebo 19JAN2021 Placebo 
10161368 C4591001 1016 
10161368 12-15 30DEC2020 24589 Placebo 30DEC2020 Placebo 19JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 52
FDA-CBER-2022-5812-0231703
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10161369 C4591001 1016 
10161369 12-15 30DEC2020 24594 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10161370 C4591001 1016 
10161370 12-15 04JAN2021 24595 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 25JAN2021 BNT162b2 
(30 μg) 
10161371 C4591001 1016 
10161371 12-15 04JAN2021 25234 Placebo 04JAN2021 Placebo 26JAN2021 Placebo 
10161372 C4591001 1016 
10161372 12-15 05JAN2021 25237 Placebo 05JAN2021 Placebo 27JAN2021 Placebo 
10161373 C4591001 1016 
10161373 12-15 05JAN2021 25238 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10161374 C4591001 1016 
10161374 12-15 06JAN2021 25244 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 28JAN2021 BNT162b2 
(30 μg) 
10161375 C4591001 1016 
10161375 12-15 06JAN2021 25790 Placebo 06JAN2021 Placebo 27JAN2021 Placebo 
10161376 C4591001 1016 
10161376 12-15 07JAN2021 25795 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 26JAN2021 BNT162b2 
(30 μg) 
10161377 C4591001 1016 
10161377 12-15 07JAN2021 25793 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 26JAN2021 BNT162b2 
(30 μg) 
10161378 C4591001 1016 
10161378 12-15 07JAN2021 25796 Placebo 07JAN2021 Placebo 26JAN2021 Placebo 
10161379 C4591001 1016 
10161379 12-15 07JAN2021 26104 Placebo 07JAN2021 Placebo  
  
10161381 C4591001 1016 
10161381 12-15 08JAN2021 26105 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 28JAN2021 BNT162b2 
(30 μg) 
10161382 C4591001 1016 
10161382 12-15 08JAN2021 26106 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 28JAN2021 BNT162b2 
(30 μg) 
10161383 C4591001 1016 
10161383 12-15 08JAN2021 26107 Placebo 08JAN2021 Placebo 28JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 53
FDA-CBER-2022-5812-0231704
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10161384 C4591001 1016 
10161384 12-15 08JAN2021 26170 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10161385 C4591001 1016 
10161385 12-15 08JAN2021 26172 Placebo 08JAN2021 Placebo 29JAN2021 Placebo 
10161386 C4591001 1016 
10161386 12-15 08JAN2021 26179 Placebo 08JAN2021 Placebo 28JAN2021 Placebo 
10161387 C4591001 1016 
10161387 12-15 08JAN2021 26180 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10161388 C4591001 1016 
10161388 12-15 11JAN2021 26698 Placebo 11JAN2021 Placebo 02FEB2021 Placebo 
10391246 C4591001 1039 
10391246 12-15 01DEC2020 20459 Placebo 01DEC2020 Placebo 21DEC2020 Placebo 
10391247 C4591001 1039 
10391247 12-15 01DEC2020 20460 BNT162b2 
(30 μg) 01DEC2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
10391250 C4591001 1039 
10391250 12-15 04DEC2020 20465 BNT162b2 
(30 μg) 04DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10391251 C4591001 1039 
10391251 12-15 07DEC2020 20467 Placebo 07DEC2020 Placebo 04JAN2021 Placebo 
10391252 C4591001 1039 
10391252 12-15 07DEC2020 21109 Placebo 07DEC2020 Placebo 28DEC2020 Placebo 
10391253 C4591001 1039 
10391253 12-15 07DEC2020 21111 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10391255 C4591001 1039 
10391255 12-15 07DEC2020 21112 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10391256 C4591001 1039 
10391256 12-15 07DEC2020 21201 Placebo 07DEC2020 Placebo 29DEC2020 Placebo 
10391258 C4591001 1039 
10391258 12-15 07DEC2020 21113 Placebo 07DEC2020 Placebo 28DEC2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 54
FDA-CBER-2022-5812-0231705
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10391259 C4591001 1039 
10391259 12-15 07DEC2020 21202 Placebo 07DEC2020 Placebo 28DEC2020 Placebo 
10391260 C4591001 1039 
10391260 12-15 07DEC2020 21209 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10391262 C4591001 1039 
10391262 12-15 08DEC2020 21212 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10391263 C4591001 1039 
10391263 12-15 08DEC2020 21357 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10391264 C4591001 1039 
10391264 12-15 08DEC2020 21361 Placebo 08DEC2020 Placebo 29DEC2020 Placebo 
10391265 C4591001 1039 
10391265 12-15 08DEC2020 21364 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10391266 C4591001 1039 
10391266 12-15 08DEC2020 21368 Placebo 08DEC2020 Placebo 29DEC2020 Placebo 
10391267 C4591001 1039 
10391267 12-15 08DEC2020 21434 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10391268 C4591001 1039 
10391268 12-15 08DEC2020 21430 Placebo 08DEC2020 Placebo 28DEC2020 Placebo 
10391269 C4591001 1039 
10391269 12-15 08DEC2020 21431 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10391270 C4591001 1039 
10391270 12-15 09DEC2020 21437 Placebo 09DEC2020 Placebo 28DEC2020 Placebo 
10391271 C4591001 1039 
10391271 12-15 09DEC2020 21721 Placebo 09DEC2020 Placebo 28DEC2020 Placebo 
10391272 C4591001 1039 
10391272 12-15 09DEC2020 21723 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10391273 C4591001 1039 
10391273 12-15 09DEC2020 21717 Placebo 09DEC2020 Placebo 28DEC2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 55
FDA-CBER-2022-5812-0231706
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10391274 C4591001 1039 
10391274 12-15 16DEC2020 22739 Placebo 16DEC2020 Placebo 04JAN2021 Placebo 
10391275 C4591001 1039 
10391275 12-15 16DEC2020 21727 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
10391276 C4591001 1039 
10391276 12-15 16DEC2020 22740 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
10391277 C4591001 1039 
10391277 12-15 16DEC2020 22742 Placebo 16DEC2020 Placebo 06JAN2021 Placebo 
10391278 C4591001 1039 
10391278 12-15 16DEC2020 22747 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
10391279 C4591001 1039 
10391279 12-15 16DEC2020 22813 Placebo 16DEC2020 Placebo 06JAN2021 Placebo 
10391280 C4591001 1039 
10391280 12-15 17DEC2020 22814 Placebo 17DEC2020 Placebo 07JAN2021 Placebo 
10391281 C4591001 1039 
10391281 12-15 17DEC2020 22816 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
10391282 C4591001 1039 
10391282 12-15 18DEC2020 22818 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
10391283 C4591001 1039 
10391283 12-15 18DEC2020 23270 Placebo 18DEC2020 Placebo 07JAN2021 Placebo 
10391284 C4591001 1039 
10391284 12-15 18DEC2020 23272 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 
10391285 C4591001 1039 
10391285 12-15 18DEC2020 23275 Placebo 18DEC2020 Placebo 08JAN2021 Placebo 
10391286 C4591001 1039 
10391286 12-15 18DEC2020 23276 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
10391287 C4591001 1039 
10391287 12-15 18DEC2020 23326 Placebo 18DEC2020 Placebo 08JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 56
FDA-CBER-2022-5812-0231707
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10391289 C4591001 1039 
10391289 12-15 18DEC2020 23327 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
10391290 C4591001 1039 
10391290 12-15 18DEC2020 23328 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
10391291 C4591001 1039 
10391291 12-15 18DEC2020 23373 Placebo 18DEC2020 Placebo 08JAN2021 Placebo 
10391292 C4591001 1039 
10391292 12-15 18DEC2020 23332 Placebo 18DEC2020 Placebo 08JAN2021 Placebo 
10391293 C4591001 1039 
10391293 12-15 21DEC2020 23378 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
10391294 C4591001 1039 
10391294 12-15 21DEC2020 23381 Placebo 21DEC2020 Placebo 13JAN2021 Placebo 
10391295 C4591001 1039 
10391295 12-15 29DEC2020 23384 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10391296 C4591001 1039 
10391296 12-15 29DEC2020 24563 Placebo 29DEC2020 Placebo 19JAN2021 Placebo 
10391297 C4591001 1039 
10391297 12-15 29DEC2020 24564 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10391298 C4591001 1039 
10391298 12-15 29DEC2020 24565 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10391299 C4591001 1039 
10391299 12-15 29DEC2020 24568 Placebo 29DEC2020 Placebo 19JAN2021 Placebo 
10391300 C4591001 1039 
10391300 12-15 29DEC2020 24664 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 21JAN2021 BNT162b2 
(30 μg) 
10391301 C4591001 1039 
10391301 12-15 29DEC2020 24665 Placebo 29DEC2020 Placebo 21JAN2021 Placebo 
10391302 C4591001 1039 
10391302 12-15 29DEC2020 24666 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 57
FDA-CBER-2022-5812-0231708
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10391303 C4591001 1039 
10391303 12-15 29DEC2020 24667 Placebo 29DEC2020 Placebo 21JAN2021 Placebo 
10391304 C4591001 1039 
10391304 12-15 29DEC2020 24754 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10391305 C4591001 1039 
10391305 12-15 06JAN2021 24759 Placebo 06JAN2021 Placebo 25JAN2021 Placebo 
10391306 C4591001 1039 
10391306 12-15 06JAN2021 24762 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 25JAN2021 BNT162b2 
(30 μg) 
10391307 C4591001 1039 
10391307 12-15 06JAN2021 24764 Placebo 06JAN2021 Placebo 27JAN2021 Placebo 
10391308 C4591001 1039 
10391308 12-15 06JAN2021 25749 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10391309 C4591001 1039 
10391309 12-15 07JAN2021 25752 Placebo 07JAN2021 Placebo 27JAN2021 Placebo 
10391310 C4591001 1039 
10391310 12-15 07JAN2021 25759 Placebo 07JAN2021 Placebo 26JAN2021 Placebo 
10391311 C4591001 1039 
10391311 12-15 07JAN2021 25918 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10391312 C4591001 1039 
10391312 12-15 07JAN2021 25760 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 28JAN2021 BNT162b2 
(30 μg) 
10391313 C4591001 1039 
10391313 12-15 07JAN2021 25920 Placebo 07JAN2021 Placebo 28JAN2021 Placebo 
10391314 C4591001 1039 
10391314 12-15 07JAN2021 25921 Placebo 07JAN2021 Placebo 28JAN2021 Placebo 
10391315 C4591001 1039 
10391315 12-15 07JAN2021 25924 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10391316 C4591001 1039 
10391316 12-15 07JAN2021 26039 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 58
FDA-CBER-2022-5812-0231709
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10391317 C4591001 1039 
10391317 12-15 07JAN2021 26040 Placebo 07JAN2021 Placebo 28JAN2021 Placebo 
10391318 C4591001 1039 
10391318 12-15 07JAN2021 26041 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10391319 C4591001 1039 
10391319 12-15 08JAN2021 26042 Placebo 08JAN2021 Placebo 29JAN2021 Placebo 
10391320 C4591001 1039 
10391320 12-15 08JAN2021 26184 Placebo 08JAN2021 Placebo 29JAN2021 Placebo 
10391321 C4591001 1039 
10391321 12-15 08JAN2021 26182 Placebo 08JAN2021 Placebo 29JAN2021 Placebo 
10391322 C4591001 1039 
10391322 12-15 08JAN2021 26187 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10391323 C4591001 1039 
10391323 12-15 08JAN2021 26191 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10391324 C4591001 1039 
10391324 12-15 08JAN2021 26398 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10391325 C4591001 1039 
10391325 12-15 11JAN2021 26403 Placebo 11JAN2021 Placebo 01FEB2021 Placebo 
10391326 C4591001 1039 
10391326 12-15 11JAN2021 26405 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 01FEB2021 BNT162b2 
(30 μg) 
10391327 C4591001 1039 
10391327 12-15 11JAN2021 26408 Placebo 11JAN2021 Placebo 01FEB2021 Placebo 
10391328 C4591001 1039 
10391328 12-15 11JAN2021 26639 Placebo 11JAN2021 Placebo 02FEB2021 Placebo 
10391329 C4591001 1039 
10391329 12-15 11JAN2021 26644 Placebo 11JAN2021 Placebo 01FEB2021 Placebo 
10391330 C4591001 1039 
10391330 12-15 11JAN2021 26640 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 02FEB2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 59
FDA-CBER-2022-5812-0231710
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10391331 C4591001 1039 
10391331 12-15 12JAN2021 26648 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 01FEB2021 BNT162b2 
(30 μg) 
10391332 C4591001 1039 
10391332 12-15 12JAN2021 26769 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 02FEB2021 BNT162b2 
(30 μg) 
10391333 C4591001 1039 
10391333 12-15 12JAN2021 26770 Placebo 12JAN2021 Placebo 02FEB2021 Placebo 
10391334 C4591001 1039 
10391334 12-15 12JAN2021 26772 Placebo 12JAN2021 Placebo 02FEB2021 Placebo 
10391335 C4591001 1039 
10391335 12-15 12JAN2021 26817 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 02FEB2021 BNT162b2 
(30 μg) 
10391336 C4591001 1039 
10391336 12-15 12JAN2021 26780 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 02FEB2021 BNT162b2 
(30 μg) 
10391337 C4591001 1039 
10391337 12-15 12JAN2021 26822 Placebo 12JAN2021 Placebo 03FEB2021 Placebo 
10391338 C4591001 1039 
10391338 12-15 12JAN2021 26823 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 03FEB2021 BNT162b2 
(30 μg) 
10391339 C4591001 1039 
10391339 12-15 12JAN2021 26828 Placebo 12JAN2021 Placebo 03FEB2021 Placebo 
10441251 C4591001 1044 
10441251 12-15 30NOV2020 20354 BNT162b2 
(30 μg) 30NOV2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10441252 C4591001 1044 
10441252 12-15 30NOV2020 20360 Placebo 30NOV2020 Placebo 21DEC2020 Placebo 
10441253 C4591001 1044 
10441253 12-15 30NOV2020 20439 BNT162b2 
(30 μg) 30NOV2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
10441255 C4591001 1044 
10441255 12-15 01DEC2020 20440 BNT162b2 
(30 μg) 01DEC2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
10441256 C4591001 1044 
10441256 12-15 01DEC2020 20444 Placebo 01DEC2020 Placebo 21DEC2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 60
FDA-CBER-2022-5812-0231711
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10441257 C4591001 1044 
10441257 12-15 01DEC2020 20567 BNT162b2 
(30 μg) 01DEC2020 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 
10441259 C4591001 1044 
10441259 12-15 01DEC2020 20569 BNT162b2 
(30 μg) 01DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10441260 C4591001 1044 
10441260 12-15 01DEC2020 20576 Placebo 01DEC2020 Placebo 22DEC2020 Placebo 
10441261 C4591001 1044 
10441261 12-15 01DEC2020 20618 Placebo 01DEC2020 Placebo 22DEC2020 Placebo 
10441263 C4591001 1044 
10441263 12-15 07DEC2020 20623 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10441264 C4591001 1044 
10441264 12-15 07DEC2020 20624 Placebo 07DEC2020 Placebo 28DEC2020 Placebo 
10441265 C4591001 1044 
10441265 12-15 07DEC2020 21287 Placebo 07DEC2020 Placebo 28DEC2020 Placebo 
10441266 C4591001 1044 
10441266 12-15 08DEC2020 21289 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10441267 C4591001 1044 
10441267 12-15 08DEC2020 21290 Placebo 08DEC2020 Placebo 28DEC2020 Placebo 
10441268 C4591001 1044 
10441268 12-15 08DEC2020 21294 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10441270 C4591001 1044 
10441270 12-15 08DEC2020 21417 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 31DEC2020 BNT162b2 
(30 μg) 
10441271 C4591001 1044 
10441271 12-15 08DEC2020 21420 Placebo 08DEC2020 Placebo 28DEC2020 Placebo 
10441273 C4591001 1044 
10441273 12-15 08DEC2020 21423 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10441274 C4591001 1044 
10441274 12-15 08DEC2020 21428 Placebo 08DEC2020 Placebo 28DEC2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 61
FDA-CBER-2022-5812-0231712
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10441275 C4591001 1044 
10441275 12-15 09DEC2020 21621 Placebo 09DEC2020 Placebo 29DEC2020 Placebo 
10441276 C4591001 1044 
10441276 12-15 09DEC2020 21623 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10441277 C4591001 1044 
10441277 12-15 09DEC2020 21632 Placebo 09DEC2020 Placebo 29DEC2020 Placebo 
10441278 C4591001 1044 
10441278 12-15 09DEC2020 21631 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10441279 C4591001 1044 
10441279 12-15 09DEC2020 21789 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10441280 C4591001 1044 
10441280 12-15 09DEC2020 21792 Placebo 09DEC2020 Placebo 29DEC2020 Placebo 
10441281 C4591001 1044 
10441281 12-15 09DEC2020 21795 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10441282 C4591001 1044 
10441282 12-15 09DEC2020 21799 Placebo 09DEC2020 Placebo 30DEC2020 Placebo 
10441283 C4591001 1044 
10441283 12-15 10DEC2020 21840 BNT162b2 
(30 μg) 10DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10441284 C4591001 1044 
10441284 12-15 10DEC2020 21843 Placebo 10DEC2020 Placebo 29DEC2020 Placebo 
10441285 C4591001 1044 
10441285 12-15 10DEC2020 21845 BNT162b2 
(30 μg) 10DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10441286 C4591001 1044 
10441286 12-15 11DEC2020 21848 Placebo 11DEC2020 Placebo 30DEC2020 Placebo 
10441288 C4591001 1044 
10441288 12-15 16DEC2020 22749 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10441289 C4591001 1044 
10441289 12-15 16DEC2020 22751 Placebo 16DEC2020 Placebo 11JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 62
FDA-CBER-2022-5812-0231713
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10441290 C4591001 1044 
10441290 12-15 08JAN2021 26233 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10441291 C4591001 1044 
10441291 12-15 17DEC2020 22752 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10441292 C4591001 1044 
10441292 12-15 17DEC2020 22759 Placebo 17DEC2020 Placebo 05JAN2021 Placebo 
10441293 C4591001 1044 
10441293 12-15 17DEC2020 23195 Placebo 17DEC2020 Placebo 05JAN2021 Placebo 
10441294 C4591001 1044 
10441294 12-15 17DEC2020 23196 Placebo 17DEC2020 Placebo 05JAN2021 Placebo 
10441295 C4591001 1044 
10441295 12-15 18DEC2020 23198 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
10441296 C4591001 1044 
10441296 12-15 22DEC2020 23202 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
10441297 C4591001 1044 
10441297 12-15 23DEC2020 24157 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 13JAN2021 BNT162b2 
(30 μg) 
10441298 C4591001 1044 
10441298 12-15 23DEC2020 24160 Placebo 23DEC2020 Placebo 13JAN2021 Placebo 
10441299 C4591001 1044 
10441299 12-15 28DEC2020 24161 Placebo 28DEC2020 Placebo 19JAN2021 Placebo 
10441300 C4591001 1044 
10441300 12-15 28DEC2020 24163 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
10441301 C4591001 1044 
10441301 12-15 29DEC2020 24721 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
10441302 C4591001 1044 
10441302 12-15 29DEC2020 24723 Placebo 29DEC2020 Placebo 19JAN2021 Placebo 
10441303 C4591001 1044 
10441303 12-15 29DEC2020 24722 Placebo 29DEC2020 Placebo 19JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 63
FDA-CBER-2022-5812-0231714
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10441304 C4591001 1044 
10441304 12-15 29DEC2020 24728 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10441306 C4591001 1044 
10441306 12-15 30DEC2020 24861 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
10441307 C4591001 1044 
10441307 12-15 30DEC2020 24863 Placebo 30DEC2020 Placebo 18JAN2021 Placebo 
10441308 C4591001 1044 
10441308 12-15 30DEC2020 24869 Placebo 30DEC2020 Placebo 20JAN2021 Placebo 
10441309 C4591001 1044 
10441309 12-15 30DEC2020 24871 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
10441310 C4591001 1044 
10441310 12-15 30DEC2020 24958 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
10441311 C4591001 1044 
10441311 12-15 04JAN2021 24959 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 25JAN2021 BNT162b2 
(30 μg) 
10441312 C4591001 1044 
10441312 12-15 04JAN2021 24966 Placebo 04JAN2021 Placebo 26JAN2021 Placebo 
10441313 C4591001 1044 
10441313 12-15 04JAN2021 24968 Placebo 04JAN2021 Placebo 25JAN2021 Placebo 
10441314 C4591001 1044 
10441314 12-15 04JAN2021 25210 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 25JAN2021 BNT162b2 
(30 μg) 
10441315 C4591001 1044 
10441315 12-15 04JAN2021 25212 Placebo 04JAN2021 Placebo 25JAN2021 Placebo 
10441316 C4591001 1044 
10441316 12-15 04JAN2021 25213 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 25JAN2021 BNT162b2 
(30 μg) 
10441317 C4591001 1044 
10441317 12-15 04JAN2021 25214 Placebo 04JAN2021 Placebo 27JAN2021 Placebo 
10441318 C4591001 1044 
10441318 12-15 05JAN2021 25392 Placebo 05JAN2021 Placebo 25JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 64
FDA-CBER-2022-5812-0231715
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10441319 C4591001 1044 
10441319 12-15 05JAN2021 25394 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 25JAN2021 BNT162b2 
(30 μg) 
10441320 C4591001 1044 
10441320 12-15 05JAN2021 25395 Placebo 05JAN2021 Placebo 26JAN2021 Placebo 
10441321 C4591001 1044 
10441321 12-15 05JAN2021 25396 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 26JAN2021 BNT162b2 
(30 μg) 
10441322 C4591001 1044 
10441322 12-15 05JAN2021 25521 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10441323 C4591001 1044 
10441323 12-15 05JAN2021 25525 Placebo 05JAN2021 Placebo 28JAN2021 Placebo 
10441324 C4591001 1044 
10441324 12-15 05JAN2021 25529 Placebo 05JAN2021 Placebo 25JAN2021 Placebo 
10441325 C4591001 1044 
10441325 12-15 05JAN2021 25531 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 26JAN2021 BNT162b2 
(30 μg) 
10441326 C4591001 1044 
10441326 12-15 06JAN2021 25645 Placebo 06JAN2021 Placebo 25JAN2021 Placebo 
10441327 C4591001 1044 
10441327 12-15 06JAN2021 25647 Placebo 06JAN2021 Placebo 25JAN2021 Placebo 
10441328 C4591001 1044 
10441328 12-15 06JAN2021 25648 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 26JAN2021 BNT162b2 
(30 μg) 
10441329 C4591001 1044 
10441329 12-15 06JAN2021 25652 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10441330 C4591001 1044 
10441330 12-15 06JAN2021 25778 Placebo 06JAN2021 Placebo 27JAN2021 Placebo 
10441331 C4591001 1044 
10441331 12-15 06JAN2021 25780 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10441332 C4591001 1044 
10441332 12-15 06JAN2021 25782 Placebo 06JAN2021 Placebo 27JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 65
FDA-CBER-2022-5812-0231716
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10441333 C4591001 1044 
10441333 12-15 06JAN2021 25783 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10441334 C4591001 1044 
10441334 12-15 07JAN2021 25905 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 26JAN2021 BNT162b2 
(30 μg) 
10441335 C4591001 1044 
10441335 12-15 07JAN2021 25910 Placebo 07JAN2021 Placebo 29JAN2021 Placebo 
10441336 C4591001 1044 
10441336 12-15 07JAN2021 25913 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 28JAN2021 BNT162b2 
(30 μg) 
10441337 C4591001 1044 
10441337 12-15 08JAN2021 25916 Placebo 08JAN2021 Placebo 29JAN2021 Placebo 
10441338 C4591001 1044 
10441338 12-15 08JAN2021 26229 Placebo 08JAN2021 Placebo 29JAN2021 Placebo 
10441339 C4591001 1044 
10441339 12-15 08JAN2021 26234 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10441340 C4591001 1044 
10441340 12-15 08JAN2021 26326 Placebo 08JAN2021 Placebo 29JAN2021 Placebo 
10441341 C4591001 1044 
10441341 12-15 08JAN2021 26235 Placebo 08JAN2021 Placebo 29JAN2021 Placebo 
10441342 C4591001 1044 
10441342 12-15 09JAN2021 26334 BNT162b2 
(30 μg) 09JAN2021 BNT162b2 
(30 μg) 28JAN2021 BNT162b2 
(30 μg) 
10441343 C4591001 1044 
10441343 12-15 09JAN2021 26335 BNT162b2 
(30 μg) 09JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10441344 C4591001 1044 
10441344 12-15 09JAN2021 26336 Placebo 09JAN2021 Placebo 29JAN2021 Placebo 
10441345 C4591001 1044 
10441345 12-15 09JAN2021 26477 Placebo 09JAN2021 Placebo 28JAN2021 Placebo 
10441346 C4591001 1044 
10441346 12-15 09JAN2021 26470 BNT162b2 
(30 μg) 09JAN2021 BNT162b2 
(30 μg) 28JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 66
FDA-CBER-2022-5812-0231717
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10441347 C4591001 1044 
10441347 12-15 09JAN2021 26478 Placebo 09JAN2021 Placebo 29JAN2021 Placebo 
10441348 C4591001 1044 
10441348 12-15 09JAN2021 26494 Placebo 09JAN2021 Placebo 28JAN2021 Placebo 
10441349 C4591001 1044 
10441349 12-15 09JAN2021 26479 BNT162b2 
(30 μg) 09JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10441350 C4591001 1044 
10441350 12-15 09JAN2021 26500 BNT162b2 
(30 μg) 09JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10441351 C4591001 1044 
10441351 12-15 10JAN2021 26502 Placebo 10JAN2021 Placebo 01FEB2021 Placebo 
10441352 C4591001 1044 
10441352 12-15 10JAN2021 26504 BNT162b2 
(30 μg) 10JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10441353 C4591001 1044 
10441353 12-15 10JAN2021 26508 BNT162b2 
(30 μg) 10JAN2021 BNT162b2 
(30 μg) 01FEB2021 BNT162b2 
(30 μg) 
10441354 C4591001 1044 
10441354 12-15 10JAN2021 26509 Placebo 10JAN2021 Placebo 29JAN2021 Placebo 
10441355 C4591001 1044 
10441355 12-15 10JAN2021 26513 BNT162b2 
(30 μg) 10JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10441356 C4591001 1044 
10441356 12-15 10JAN2021 26514 Placebo 10JAN2021 Placebo 02FEB2021 Placebo 
10441357 C4591001 1044 
10441357 12-15 10JAN2021 26521 Placebo 10JAN2021 Placebo 29JAN2021 Placebo 
10441358 C4591001 1044 
10441358 12-15 10JAN2021 26522 BNT162b2 
(30 μg) 10JAN2021 BNT162b2 
(30 μg) 01FEB2021 BNT162b2 
(30 μg) 
10441359 C4591001 1044 
10441359 12-15 11JAN2021 26528 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 25FEB2021 BNT162b2 
(30 μg) 
10441360 C4591001 1044 
10441360 12-15 11JAN2021 26524 Placebo 11JAN2021 Placebo 25FEB2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 67
FDA-CBER-2022-5812-0231718
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10441361 C4591001 1044 
10441361 12-15 11JAN2021 26589 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 03FEB2021 BNT162b2 
(30 μg) 
10441362 C4591001 1044 
10441362 12-15 11JAN2021 26593 Placebo 11JAN2021 Placebo 03FEB2021 Placebo 
10441363 C4591001 1044 
10441363 12-15 11JAN2021 26595 Placebo 11JAN2021 Placebo 01FEB2021 Placebo 
10441364 C4591001 1044 
10441364 12-15 11JAN2021 26596 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 03FEB2021 BNT162b2 
(30 μg) 
10441365 C4591001 1044 
10441365 12-15 11JAN2021 26675 Placebo 11JAN2021 Placebo 02FEB2021 Placebo 
10441366 C4591001 1044 
10441366 12-15 11JAN2021 26676 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 02FEB2021 BNT162b2 
(30 μg) 
10441367 C4591001 1044 
10441367 12-15 11JAN2021 26677 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 03FEB2021 BNT162b2 
(30 μg) 
10441368 C4591001 1044 
10441368 12-15 11JAN2021 26678 Placebo 11JAN2021 Placebo 03FEB2021 Placebo 
10441369 C4591001 1044 
10441369 12-15 11JAN2021 26725 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 02FEB2021 BNT162b2 
(30 μg) 
10441370 C4591001 1044 
10441370 12-15 11JAN2021 26729 Placebo 11JAN2021 Placebo 02FEB2021 Placebo 
10441371 C4591001 1044 
10441371 12-15 11JAN2021 26730 Placebo 11JAN2021 Placebo 02FEB2021 Placebo 
10441372 C4591001 1044 
10441372 12-15 11JAN2021 26731 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 02FEB2021 BNT162b2 
(30 μg) 
10441373 C4591001 1044 
10441373 12-15 12JAN2021 26782 Placebo 12JAN2021 Placebo 04FEB2021 Placebo 
10441374 C4591001 1044 
10441374 12-15 12JAN2021 26784 Placebo 12JAN2021 Placebo 02FEB2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 68
FDA-CBER-2022-5812-0231719
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10441375 C4591001 1044 
10441375 12-15 12JAN2021 26786 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 02FEB2021 BNT162b2 
(30 μg) 
10441376 C4591001 1044 
10441376 12-15 12JAN2021 26792 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 02FEB2021 BNT162b2 
(30 μg) 
10441377 C4591001 1044 
10441377 12-15 12JAN2021 26911 BNT162b2 
(30 μg) 01FEB2021 BNT162b2 
(30 μg) 22FEB2021 BNT162b2 
(30 μg) 
10441378 C4591001 1044 
10441378 12-15 12JAN2021 26843 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 04FEB2021 BNT162b2 
(30 μg) 
10441379 C4591001 1044 
10441379 12-15 12JAN2021 26845 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 04FEB2021 BNT162b2 
(30 μg) 
10441380 C4591001 1044 
10441380 12-15 12JAN2021 26849 Placebo 12JAN2021 Placebo 03FEB2021 Placebo 
10441381 C4591001 1044 
10441381 12-15 12JAN2021 26851 Placebo 12JAN2021 Placebo 01FEB2021 Placebo 
10441382 C4591001 1044 
10441382 12-15 12JAN2021 26901 Placebo 12JAN2021 Placebo 03FEB2021 Placebo 
10441383 C4591001 1044 
10441383 12-15 12JAN2021 26902 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 03FEB2021 BNT162b2 
(30 μg) 
10441384 C4591001 1044 
10441384 12-15 12JAN2021 26912 Placebo 12JAN2021 Placebo 04FEB2021 Placebo 
10571376 C4591001 1057 
10571376 12-15 07DEC2020 21117 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
10571377 C4591001 1057 
10571377 12-15 07DEC2020 21119 Placebo 07DEC2020 Placebo 28DEC2020 Placebo 
10571378 C4591001 1057 
10571378 12-15 07DEC2020 21122 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10571379 C4591001 1057 
10571379 12-15 07DEC2020 21127 Placebo 07DEC2020 Placebo 30DEC2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 69
FDA-CBER-2022-5812-0231720
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10571380 C4591001 1057 
10571380 12-15 08DEC2020 21345 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
10571382 C4591001 1057 
10571382 12-15 08DEC2020 21352 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
10571383 C4591001 1057 
10571383 12-15 08DEC2020 21346 Placebo 08DEC2020 Placebo 30DEC2020 Placebo 
10571384 C4591001 1057 
10571384 12-15 08DEC2020 21348 Placebo 08DEC2020 Placebo 28DEC2020 Placebo 
10571385 C4591001 1057 
10571385 12-15 08DEC2020 21504 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10571386 C4591001 1057 
10571386 12-15 08DEC2020 21508 Placebo 08DEC2020 Placebo 29DEC2020 Placebo 
10571387 C4591001 1057 
10571387 12-15 09DEC2020 21509 Placebo 09DEC2020 Placebo 28DEC2020 Placebo 
10571388 C4591001 1057 
10571388 12-15 09DEC2020 21512 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10571389 C4591001 1057 
10571389 12-15 09DEC2020 21705 Placebo 09DEC2020 Placebo 04JAN2021 Placebo 
10571390 C4591001 1057 
10571390 12-15 09DEC2020 21706 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10571391 C4591001 1057 
10571391 12-15 09DEC2020 21711 Placebo 09DEC2020 Placebo 28DEC2020 Placebo 
10571392 C4591001 1057 
10571392 12-15 09DEC2020 21712 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10571393 C4591001 1057 
10571393 12-15 09DEC2020 21754 Placebo 09DEC2020 Placebo 28DEC2020 Placebo 
10571394 C4591001 1057 
10571394 12-15 09DEC2020 21756 Placebo 09DEC2020 Placebo 29DEC2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 70
FDA-CBER-2022-5812-0231721
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10571395 C4591001 1057 
10571395 12-15 09DEC2020 21757 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 14JAN2021 BNT162b2 
(30 μg) 
10571396 C4591001 1057 
10571396 12-15 10DEC2020 21761 BNT162b2 
(30 μg) 10DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10571397 C4591001 1057 
10571397 12-15 10DEC2020 21949 BNT162b2 
(30 μg) 10DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10571398 C4591001 1057 
10571398 12-15 10DEC2020 21951 Placebo 10DEC2020 Placebo 30DEC2020 Placebo 
10571399 C4591001 1057 
10571399 12-15 10DEC2020 21954 BNT162b2 
(30 μg) 10DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10571400 C4591001 1057 
10571400 12-15 11DEC2020 21956 Placebo 11DEC2020 Placebo 30DEC2020 Placebo 
10571401 C4591001 1057 
10571401 12-15 11DEC2020 22057 BNT162b2 
(30 μg) 11DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10571402 C4591001 1057 
10571402 12-15 14DEC2020 22058 Placebo 14DEC2020 Placebo 06JAN2021 Placebo 
10571403 C4591001 1057 
10571403 12-15 14DEC2020 22059 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
10571404 C4591001 1057 
10571404 12-15 16DEC2020 22062 Placebo 16DEC2020 Placebo 04JAN2021 Placebo 
10571405 C4591001 1057 
10571405 12-15 16DEC2020 22896 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
10571406 C4591001 1057 
10571406 12-15 16DEC2020 22901 Placebo 16DEC2020 Placebo 05JAN2021 Placebo 
10571407 C4591001 1057 
10571407 12-15 17DEC2020 22903 Placebo 17DEC2020 Placebo 05JAN2021 Placebo 
10571408 C4591001 1057 
10571408 12-15 17DEC2020 23052 Placebo 17DEC2020 Placebo 05JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 71
FDA-CBER-2022-5812-0231722
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10571409 C4591001 1057 
10571409 12-15 17DEC2020 22902 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
10571410 C4591001 1057 
10571410 12-15 17DEC2020 23056 Placebo 17DEC2020 Placebo 05JAN2021 Placebo 
10571411 C4591001 1057 
10571411 12-15 17DEC2020 23059 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10571412 C4591001 1057 
10571412 12-15 17DEC2020 23060 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10571413 C4591001 1057 
10571413 12-15 21DEC2020 23709 BNT162b2 
(30 μg)  
   
  
10571414 C4591001 1057 
10571414 12-15 21DEC2020 23710 Placebo 21DEC2020 Placebo 12JAN2021 Placebo 
10571415 C4591001 1057 
10571415 12-15 21DEC2020 23714 Placebo 21DEC2020 Placebo 14JAN2021 Placebo 
10571416 C4591001 1057 
10571416 12-15 21DEC2020 23716 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 13JAN2021 BNT162b2 
(30 μg) 
10571417 C4591001 1057 
10571417 12-15 21DEC2020 23793 Placebo 21DEC2020 Placebo 11JAN2021 Placebo 
10571418 C4591001 1057 
10571418 12-15 22DEC2020 23800 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
10571419 C4591001 1057 
10571419 12-15 22DEC2020 23803 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
10571420 C4591001 1057 
10571420 12-15 23DEC2020 23804 Placebo 23DEC2020 Placebo 11JAN2021 Placebo 
10571421 C4591001 1057 
10571421 12-15 23DEC2020 24261 Placebo 23DEC2020 Placebo 11JAN2021 Placebo 
10571422 C4591001 1057 
10571422 12-15 23DEC2020 24265 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 13JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 72
FDA-CBER-2022-5812-0231723
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10571423 C4591001 1057 
10571423 12-15 24DEC2020 24269 BNT162b2 
(30 μg) 24DEC2020 BNT162b2 
(30 μg) 15JAN2021 BNT162b2 
(30 μg) 
10571424 C4591001 1057 
10571424 12-15 24DEC2020 24271 Placebo 24DEC2020 Placebo 15JAN2021 Placebo 
10571425 C4591001 1057 
10571425 12-15 24DEC2020 24301 Placebo 24DEC2020 Placebo 12JAN2021 Placebo 
10571426 C4591001 1057 
10571426 12-15 24DEC2020 24305 BNT162b2 
(30 μg) 24DEC2020 BNT162b2 
(30 μg) 21JAN2021 BNT162b2 
(30 μg) 
10571427 C4591001 1057 
10571427 12-15 24DEC2020 24306 BNT162b2 
(30 μg) 24DEC2020 BNT162b2 
(30 μg) 21JAN2021 BNT162b2 
(30 μg) 
10571428 C4591001 1057 
10571428 12-15 24DEC2020 24307 Placebo 24DEC2020 Placebo 21JAN2021 Placebo 
10571429 C4591001 1057 
10571429 12-15 24DEC2020 24309 BNT162b2 
(30 μg) 24DEC2020 BNT162b2 
(30 μg) 21JAN2021 BNT162b2 
(30 μg) 
10571430 C4591001 1057 
10571430 12-15 29DEC2020 24310 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
10571431 C4591001 1057 
10571431 12-15 30DEC2020 24313 Placebo 30DEC2020 Placebo 18JAN2021 Placebo 
10571432 C4591001 1057 
10571432 12-15 30DEC2020 24314 Placebo 30DEC2020 Placebo 18JAN2021 Placebo 
10571433 C4591001 1057 
10571433 12-15 30DEC2020 25022 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 22JAN2021 BNT162b2 
(30 μg) 
10571434 C4591001 1057 
10571434 12-15 31DEC2020 25023 Placebo 31DEC2020 Placebo 21JAN2021 Placebo 
10571435 C4591001 1057 
10571435 12-15 04JAN2021 25024 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 25JAN2021 BNT162b2 
(30 μg) 
10571436 C4591001 1057 
10571436 12-15 04JAN2021 25025 Placebo 04JAN2021 Placebo 25JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 73
FDA-CBER-2022-5812-0231724
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10571437 C4591001 1057 
10571437 12-15 04JAN2021 25257 Placebo 04JAN2021 Placebo 25JAN2021 Placebo 
10571438 C4591001 1057 
10571438 12-15 04JAN2021 25260 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 25JAN2021 BNT162b2 
(30 μg) 
10571439 C4591001 1057 
10571439 12-15 06JAN2021 25263 Placebo 06JAN2021 Placebo 25JAN2021 Placebo 
10571440 C4591001 1057 
10571440 12-15 06JAN2021 25264 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10571441 C4591001 1057 
10571441 12-15 06JAN2021 25802 Placebo 06JAN2021 Placebo 27JAN2021 Placebo 
10571442 C4591001 1057 
10571442 12-15 07JAN2021 25803 Placebo 07JAN2021 Placebo 29JAN2021 Placebo 
10571443 C4591001 1057 
10571443 12-15 08JAN2021 25806 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 28JAN2021 BNT162b2 
(30 μg) 
10571444 C4591001 1057 
10571444 12-15 08JAN2021 25808 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 28JAN2021 BNT162b2 
(30 μg) 
10571445 C4591001 1057 
10571445 12-15 11JAN2021 26531 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 01FEB2021 BNT162b2 
(30 μg) 
10571446 C4591001 1057 
10571446 12-15 11JAN2021 26533 Placebo 11JAN2021 Placebo 01FEB2021 Placebo 
10571447 C4591001 1057 
10571447 12-15 11JAN2021 26537 Placebo 11JAN2021 Placebo 01FEB2021 Placebo 
10571448 C4591001 1057 
10571448 12-15 11JAN2021 26539 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 01FEB2021 BNT162b2 
(30 μg) 
10571449 C4591001 1057 
10571449 12-15 12JAN2021 26799 Placebo 12JAN2021 Placebo 02FEB2021 Placebo 
10571450 C4591001 1057 
10571450 12-15 12JAN2021 26801 Placebo 12JAN2021 Placebo 02FEB2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 74
FDA-CBER-2022-5812-0231725
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10571451 C4591001 1057 
10571451 12-15 12JAN2021 26802 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 02FEB2021 BNT162b2 
(30 μg) 
10571452 C4591001 1057 
10571452 12-15 12JAN2021 26804 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 03FEB2021 BNT162b2 
(30 μg) 
10571453 C4591001 1057 
10571453 12-15 12JAN2021 26895 Placebo 12JAN2021 Placebo 01FEB2021 Placebo 
10571454 C4591001 1057 
10571454 12-15 12JAN2021 26891 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 03FEB2021 BNT162b2 
(30 μg) 
10661394 C4591001 1066 
10661394 12-15 09DEC2020 21555 Placebo 09DEC2020 Placebo 30DEC2020 Placebo 
10661395 C4591001 1066 
10661395 12-15 01DEC2020 20590 BNT162b2 
(30 μg) 01DEC2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
10661397 C4591001 1066 
10661397 12-15 01DEC2020 20591 Placebo 01DEC2020 Placebo 22DEC2020 Placebo 
10661401 C4591001 1066 
10661401 12-15 02DEC2020 20593 Placebo 02DEC2020 Placebo 21DEC2020 Placebo 
10661402 C4591001 1066 
10661402 12-15 02DEC2020 20598 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
10661403 C4591001 1066 
10661403 12-15 03DEC2020 20829 Placebo 03DEC2020 Placebo 23DEC2020 Placebo 
10661404 C4591001 1066 
10661404 12-15 03DEC2020 20834 BNT162b2 
(30 μg) 03DEC2020 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 
10661405 C4591001 1066 
10661405 12-15 03DEC2020 20838 Placebo 03DEC2020 Placebo 22DEC2020 Placebo 
10661407 C4591001 1066 
10661407 12-15 04DEC2020 20840 BNT162b2 
(30 μg) 04DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10661408 C4591001 1066 
10661408 12-15 08DEC2020 21549 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 75
FDA-CBER-2022-5812-0231726
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10661409 C4591001 1066 
10661409 12-15 08DEC2020 21550 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10661410 C4591001 1066 
10661410 12-15 09DEC2020 21557 Placebo 09DEC2020 Placebo 29DEC2020 Placebo 
10661411 C4591001 1066 
10661411 12-15 09DEC2020 21801 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10661412 C4591001 1066 
10661412 12-15 09DEC2020 21808 Placebo 09DEC2020 Placebo 29DEC2020 Placebo 
10661414 C4591001 1066 
10661414 12-15 14DEC2020 21812 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
10661415 C4591001 1066 
10661415 12-15 14DEC2020 21809 Placebo 14DEC2020 Placebo 04JAN2021 Placebo 
10661416 C4591001 1066 
10661416 12-15 15DEC2020 22668 Placebo 15DEC2020 Placebo 05JAN2021 Placebo 
10661417 C4591001 1066 
10661417 12-15 16DEC2020 22672 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10661418 C4591001 1066 
10661418 12-15 16DEC2020 22674 Placebo 16DEC2020 Placebo 05JAN2021 Placebo 
10661419 C4591001 1066 
10661419 12-15 16DEC2020 22675 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10661420 C4591001 1066 
10661420 12-15 17DEC2020 23169 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
10661421 C4591001 1066 
10661421 12-15 22DEC2020 23175 Placebo 22DEC2020 Placebo 13JAN2021 Placebo 
10661422 C4591001 1066 
10661422 12-15 22DEC2020 23176 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 13JAN2021 BNT162b2 
(30 μg) 
10661423 C4591001 1066 
10661423 12-15 30DEC2020 23177 Placebo 30DEC2020 Placebo 26JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 76
FDA-CBER-2022-5812-0231727
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10661424 C4591001 1066 
10661424 12-15 30DEC2020 24922 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 20JAN2021 BNT162b2 
(30 μg) 
10661425 C4591001 1066 
10661425 12-15 05JAN2021 24924 Placebo 05JAN2021 Placebo 26JAN2021 Placebo 
10661426 C4591001 1066 
10661426 12-15 06JAN2021 24926 Placebo 06JAN2021 Placebo 28JAN2021 Placebo 
10661427 C4591001 1066 
10661427 12-15 06JAN2021 24930 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10661428 C4591001 1066 
10661428 12-15 06JAN2021 25737 Placebo 06JAN2021 Placebo 26JAN2021 Placebo 
10661429 C4591001 1066 
10661429 12-15 06JAN2021 25738 Placebo 06JAN2021 Placebo 27JAN2021 Placebo 
10661430 C4591001 1066 
10661430 12-15 07JAN2021 25740 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 26JAN2021 BNT162b2 
(30 μg) 
10661431 C4591001 1066 
10661431 12-15 07JAN2021 25745 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10661432 C4591001 1066 
10661432 12-15 07JAN2021 25990 Placebo 07JAN2021 Placebo 26JAN2021 Placebo 
10661433 C4591001 1066 
10661433 12-15 07JAN2021 25991 Placebo 07JAN2021 Placebo 26JAN2021 Placebo 
10661434 C4591001 1066 
10661434 12-15 12JAN2021 25995 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 02FEB2021 BNT162b2 
(30 μg) 
10661435 C4591001 1066 
10661435 12-15 12JAN2021 25998 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 02FEB2021 BNT162b2 
(30 μg) 
10771274 C4591001 1077 
10771274 12-15 03DEC2020 20843 BNT162b2 
(30 μg) 03DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
10771275 C4591001 1077 
10771275 12-15 03DEC2020 20844 Placebo 03DEC2020 Placebo 22DEC2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 77
FDA-CBER-2022-5812-0231728
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10771277 C4591001 1077 
10771277 12-15 04DEC2020 20846 Placebo 04DEC2020 Placebo 23DEC2020 Placebo 
10771278 C4591001 1077 
10771278 12-15 04DEC2020 20852 BNT162b2 
(30 μg) 04DEC2020 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 
10771279 C4591001 1077 
10771279 12-15 14DEC2020 22249 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
10771280 C4591001 1077 
10771280 12-15 14DEC2020 22250 Placebo 14DEC2020 Placebo 04JAN2021 Placebo 
10771281 C4591001 1077 
10771281 12-15 14DEC2020 22251 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
10771282 C4591001 1077 
10771282 12-15 14DEC2020 22253 Placebo 14DEC2020 Placebo 05JAN2021 Placebo 
10771283 C4591001 1077 
10771283 12-15 15DEC2020 22476 Placebo 15DEC2020 Placebo 06JAN2021 Placebo 
10771284 C4591001 1077 
10771284 12-15 15DEC2020 22478 BNT162b2 
(30 μg) 15DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10771285 C4591001 1077 
10771285 12-15 15DEC2020 22479 Placebo 15DEC2020 Placebo 07JAN2021 Placebo 
10771286 C4591001 1077 
10771286 12-15 15DEC2020 22483 BNT162b2 
(30 μg) 15DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
10771287 C4591001 1077 
10771287 12-15 15DEC2020 22545 BNT162b2 
(30 μg) 15DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10771288 C4591001 1077 
10771288 12-15 16DEC2020 22554 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10771289 C4591001 1077 
10771289 12-15 18DEC2020 22555 Placebo 18DEC2020 Placebo 08JAN2021 Placebo 
10771290 C4591001 1077 
10771290 12-15 18DEC2020 22556 Placebo 18DEC2020 Placebo 08JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 78
FDA-CBER-2022-5812-0231729
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10771291 C4591001 1077 
10771291 12-15 18DEC2020 23397 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10771292 C4591001 1077 
10771292 12-15 18DEC2020 23398 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10771293 C4591001 1077 
10771293 12-15 18DEC2020 23401 Placebo  
   
  
10771294 C4591001 1077 
10771294 12-15 28DEC2020 23404 Placebo 28DEC2020 Placebo 20JAN2021 Placebo 
10771295 C4591001 1077 
10771295 12-15 28DEC2020 24443 Placebo 28DEC2020 Placebo 20JAN2021 Placebo 
10771296 C4591001 1077 
10771296 12-15 29DEC2020 24444 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 20JAN2021 BNT162b2 
(30 μg) 
10771297 C4591001 1077 
10771297 12-15 06JAN2021 24445 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 28JAN2021 BNT162b2 
(30 μg) 
10771298 C4591001 1077 
10771298 12-15 07JAN2021 24446 Placebo 07JAN2021 Placebo 27JAN2021 Placebo 
10771299 C4591001 1077 
10771299 12-15 07JAN2021 25979 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10771300 C4591001 1077 
10771300 12-15 07JAN2021 25982 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10841541 C4591001 1084 
10841541 12-15 11DEC2020 22033 BNT162b2 
(30 μg) 11DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10841542 C4591001 1084 
10841542 12-15 11DEC2020 22034 Placebo 11DEC2020 Placebo 30DEC2020 Placebo 
10841543 C4591001 1084 
10841543 12-15 18DEC2020 22037 Placebo 18DEC2020 Placebo 08JAN2021 Placebo 
10841544 C4591001 1084 
10841544 12-15 18DEC2020 22039 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 79
FDA-CBER-2022-5812-0231730
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10841545 C4591001 1084 
10841545 12-15 18DEC2020 23459 Placebo 18DEC2020 Placebo 06JAN2021 Placebo 
10841546 C4591001 1084 
10841546 12-15 18DEC2020 23462 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10841547 C4591001 1084 
10841547 12-15 21DEC2020 23463 Placebo 21DEC2020 Placebo 13JAN2021 Placebo 
10841548 C4591001 1084 
10841548 12-15 21DEC2020 23465 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 13JAN2021 BNT162b2 
(30 μg) 
10841549 C4591001 1084 
10841549 12-15 21DEC2020 23666 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
10841550 C4591001 1084 
10841550 12-15 21DEC2020 23669 Placebo 21DEC2020 Placebo 13JAN2021 Placebo 
10841551 C4591001 1084 
10841551 12-15 21DEC2020 23670 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 13JAN2021 BNT162b2 
(30 μg) 
10841552 C4591001 1084 
10841552 12-15 21DEC2020 23671 Placebo 21DEC2020 Placebo 11JAN2021 Placebo 
10841553 C4591001 1084 
10841553 12-15 21DEC2020 23853 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
10841555 C4591001 1084 
10841555 12-15 21DEC2020 23854 Placebo 21DEC2020 Placebo 11JAN2021 Placebo 
10841556 C4591001 1084 
10841556 12-15 28DEC2020 23862 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
10841557 C4591001 1084 
10841557 12-15 28DEC2020 23860 Placebo 28DEC2020 Placebo 18JAN2021 Placebo 
10841558 C4591001 1084 
10841558 12-15 28DEC2020 24419 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
10841559 C4591001 1084 
10841559 12-15 28DEC2020 24423 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 80
FDA-CBER-2022-5812-0231731
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10841560 C4591001 1084 
10841560 12-15 28DEC2020 24418 Placebo 28DEC2020 Placebo 22JAN2021 Placebo 
10841561 C4591001 1084 
10841561 12-15 28DEC2020 24428 Placebo 28DEC2020 Placebo 18JAN2021 Placebo 
10841562 C4591001 1084 
10841562 12-15 28DEC2020 24492 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
10841563 C4591001 1084 
10841563 12-15 30DEC2020 24494 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
10841564 C4591001 1084 
10841564 12-15 30DEC2020 24497 Placebo 30DEC2020 Placebo 18JAN2021 Placebo 
10841565 C4591001 1084 
10841565 12-15 30DEC2020 24499 Placebo 30DEC2020 Placebo 20JAN2021 Placebo 
10841566 C4591001 1084 
10841566 12-15 30DEC2020 24971 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
10841567 C4591001 1084 
10841567 12-15 30DEC2020 24972 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
10841568 C4591001 1084 
10841568 12-15 30DEC2020 24977 Placebo 30DEC2020 Placebo 18JAN2021 Placebo 
10841569 C4591001 1084 
10841569 12-15 30DEC2020 24979 Placebo 30DEC2020 Placebo 22JAN2021 Placebo 
10841570 C4591001 1084 
10841570 12-15 30DEC2020 25066 Placebo 30DEC2020 Placebo 22JAN2021 Placebo 
10841571 C4591001 1084 
10841571 12-15 30DEC2020 25071 Placebo 30DEC2020 Placebo 20JAN2021 Placebo 
10841572 C4591001 1084 
10841572 12-15 04JAN2021 116601 Placebo 04JAN2021 Placebo 25JAN2021 Placebo 
10841573 C4591001 1084 
10841573 12-15 04JAN2021 25075 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 81
FDA-CBER-2022-5812-0231732
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10841574 C4591001 1084 
10841574 12-15 04JAN2021 25076 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10841575 C4591001 1084 
10841575 12-15 04JAN2021 25317 Placebo 04JAN2021 Placebo 27JAN2021 Placebo 
10841576 C4591001 1084 
10841576 12-15 06JAN2021 25320 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 25JAN2021 BNT162b2 
(30 μg) 
10841577 C4591001 1084 
10841577 12-15 06JAN2021 25326 Placebo 06JAN2021 Placebo 27JAN2021 Placebo 
10841578 C4591001 1084 
10841578 12-15 06JAN2021 25327 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10841579 C4591001 1084 
10841579 12-15 06JAN2021 25727 Placebo 06JAN2021 Placebo 27JAN2021 Placebo 
10841580 C4591001 1084 
10841580 12-15 06JAN2021 25728 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10841581 C4591001 1084 
10841581 12-15 06JAN2021 25729 Placebo 06JAN2021 Placebo 27JAN2021 Placebo 
10841582 C4591001 1084 
10841582 12-15 06JAN2021 25733 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10841583 C4591001 1084 
10841583 12-15 08JAN2021 26194 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10841584 C4591001 1084 
10841584 12-15 08JAN2021 26195 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10841586 C4591001 1084 
10841586 12-15 08JAN2021 26196 Placebo 08JAN2021 Placebo 29JAN2021 Placebo 
10841587 C4591001 1084 
10841587 12-15 08JAN2021 26202 Placebo 08JAN2021 Placebo 29JAN2021 Placebo 
10841588 C4591001 1084 
10841588 12-15 08JAN2021 26278 Placebo 08JAN2021 Placebo 27JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 82
FDA-CBER-2022-5812-0231733
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10841589 C4591001 1084 
10841589 12-15 08JAN2021 26277 Placebo 08JAN2021 Placebo 29JAN2021 Placebo 
10841590 C4591001 1084 
10841590 12-15 08JAN2021 26337 Placebo 08JAN2021 Placebo 29JAN2021 Placebo 
10841591 C4591001 1084 
10841591 12-15 08JAN2021 26286 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10841592 C4591001 1084 
10841592 12-15 08JAN2021 26281 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10841593 C4591001 1084 
10841593 12-15 08JAN2021 26341 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10841594 C4591001 1084 
10841594 12-15 08JAN2021 26343 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
10841595 C4591001 1084 
10841595 12-15 08JAN2021 26346 Placebo 08JAN2021 Placebo 27JAN2021 Placebo 
10841596 C4591001 1084 
10841596 12-15 08JAN2021 26414 Placebo 08JAN2021 Placebo 29JAN2021 Placebo 
10841597 C4591001 1084 
10841597 12-15 08JAN2021 26417 Placebo 08JAN2021 Placebo 27JAN2021 Placebo 
10911394 C4591001 1091 
10911394 12-15 02DEC2020 117070 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
10911395 C4591001 1091 
10911395 12-15 02DEC2020 20579 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
10911396 C4591001 1091 
10911396 12-15 02DEC2020 20583 Placebo 02DEC2020 Placebo 21DEC2020 Placebo 
10911399 C4591001 1091 
10911399 12-15 04DEC2020 20586 BNT162b2 
(30 μg) 04DEC2020 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 
10911400 C4591001 1091 
10911400 12-15 04DEC2020 20962 Placebo 04DEC2020 Placebo 29DEC2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 83
FDA-CBER-2022-5812-0231734
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10911402 C4591001 1091 
10911402 12-15 07DEC2020 20966 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10911403 C4591001 1091 
10911403 12-15 07DEC2020 20967 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
10911404 C4591001 1091 
10911404 12-15 07DEC2020 20969 Placebo 07DEC2020 Placebo 28DEC2020 Placebo 
10911405 C4591001 1091 
10911405 12-15 07DEC2020 21240 Placebo 07DEC2020 Placebo 28DEC2020 Placebo 
10911406 C4591001 1091 
10911406 12-15 07DEC2020 21242 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10911407 C4591001 1091 
10911407 12-15 08DEC2020 21243 Placebo 08DEC2020 Placebo 28DEC2020 Placebo 
10911408 C4591001 1091 
10911408 12-15 08DEC2020 21247 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10911409 C4591001 1091 
10911409 12-15 09DEC2020 21611 Placebo 09DEC2020 Placebo 28DEC2020 Placebo 
10911410 C4591001 1091 
10911410 12-15 09DEC2020 21612 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
10911411 C4591001 1091 
10911411 12-15 09DEC2020 21613 Placebo 09DEC2020 Placebo 28DEC2020 Placebo 
10911412 C4591001 1091 
10911412 12-15 09DEC2020 21742 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10911413 C4591001 1091 
10911413 12-15 09DEC2020 21617 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 
10911414 C4591001 1091 
10911414 12-15 09DEC2020 21741 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg)  
  
10911415 C4591001 1091 
10911415 12-15 10DEC2020 21751 Placebo 10DEC2020 Placebo 29DEC2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 84
FDA-CBER-2022-5812-0231735
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10911416 C4591001 1091 
10911416 12-15 10DEC2020 21890 BNT162b2 
(30 μg) 10DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10911417 C4591001 1091 
10911417 12-15 10DEC2020 21891 Placebo 10DEC2020 Placebo 30DEC2020 Placebo 
10911418 C4591001 1091 
10911418 12-15 10DEC2020 21752 Placebo 10DEC2020 Placebo 30DEC2020 Placebo 
10911419 C4591001 1091 
10911419 12-15 10DEC2020 21934 BNT162b2 
(30 μg) 10DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10911420 C4591001 1091 
10911420 12-15 10DEC2020 21894 BNT162b2 
(30 μg) 10DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
10911421 C4591001 1091 
10911421 12-15 10DEC2020 21896 Placebo 10DEC2020 Placebo 30DEC2020 Placebo 
10911422 C4591001 1091 
10911422 12-15 14DEC2020 21936 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10911423 C4591001 1091 
10911423 12-15 14DEC2020 21937 Placebo 14DEC2020 Placebo 06JAN2021 Placebo 
10911424 C4591001 1091 
10911424 12-15 15DEC2020 22509 Placebo 15DEC2020 Placebo 04JAN2021 Placebo 
10911425 C4591001 1091 
10911425 12-15 15DEC2020 21940 Placebo 15DEC2020 Placebo 05JAN2021 Placebo 
10911426 C4591001 1091 
10911426 12-15 16DEC2020 22510 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 
10911427 C4591001 1091 
10911427 12-15 16DEC2020 22518 Placebo 16DEC2020 Placebo 06JAN2021 Placebo 
10911428 C4591001 1091 
10911428 12-15 16DEC2020 22520 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10911429 C4591001 1091 
10911429 12-15 16DEC2020 22869 Placebo 16DEC2020 Placebo 06JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 85
FDA-CBER-2022-5812-0231736
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10911430 C4591001 1091 
10911430 12-15 16DEC2020 22874 Placebo 16DEC2020 Placebo 04JAN2021 Placebo 
10911431 C4591001 1091 
10911431 12-15 17DEC2020 22879 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 
10911432 C4591001 1091 
10911432 12-15 17DEC2020 22876 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10911433 C4591001 1091 
10911433 12-15 17DEC2020 23077 Placebo 17DEC2020 Placebo 07JAN2021 Placebo 
10911434 C4591001 1091 
10911434 12-15 17DEC2020 23076 Placebo 17DEC2020 Placebo 07JAN2021 Placebo 
10911435 C4591001 1091 
10911435 12-15 17DEC2020 23078 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 
10911436 C4591001 1091 
10911436 12-15 17DEC2020 23082 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
10911437 C4591001 1091 
10911437 12-15 17DEC2020 23134 Placebo 17DEC2020 Placebo 06JAN2021 Placebo 
10911438 C4591001 1091 
10911438 12-15 18DEC2020 23136 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
10911439 C4591001 1091 
10911439 12-15 18DEC2020 23139 Placebo 18DEC2020 Placebo 08JAN2021 Placebo 
10911440 C4591001 1091 
10911440 12-15 18DEC2020 23140 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
10911441 C4591001 1091 
10911441 12-15 18DEC2020 23253 Placebo 18DEC2020 Placebo 08JAN2021 Placebo 
10911442 C4591001 1091 
10911442 12-15 18DEC2020 23254 Placebo 18DEC2020 Placebo 08JAN2021 Placebo 
10911443 C4591001 1091 
10911443 12-15 21DEC2020 23263 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 15JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 86
FDA-CBER-2022-5812-0231737
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10911444 C4591001 1091 
10911444 12-15 21DEC2020 23259 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
10911445 C4591001 1091 
10911445 12-15 21DEC2020 23765 Placebo 21DEC2020 Placebo 11JAN2021 Placebo 
10911446 C4591001 1091 
10911446 12-15 22DEC2020 23766 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 13JAN2021 BNT162b2 
(30 μg) 
10911447 C4591001 1091 
10911447 12-15 22DEC2020 23767 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 14JAN2021 BNT162b2 
(30 μg) 
10911448 C4591001 1091 
10911448 12-15 22DEC2020 23768 Placebo 22DEC2020 Placebo 14JAN2021 Placebo 
10911449 C4591001 1091 
10911449 12-15 22DEC2020 23950 Placebo 22DEC2020 Placebo 11JAN2021 Placebo 
10911450 C4591001 1091 
10911450 12-15 22DEC2020 23951 Placebo 22DEC2020 Placebo 14JAN2021 Placebo 
10911451 C4591001 1091 
10911451 12-15 22DEC2020 23954 BNT162b2 
(30 μg)  
   
  
10911452 C4591001 1091 
10911452 12-15 22DEC2020 24105 Placebo 22DEC2020 Placebo 13JAN2021 Placebo 
10911453 C4591001 1091 
10911453 12-15 22DEC2020 23959 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 
10911454 C4591001 1091 
10911454 12-15 28DEC2020 24107 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
10911455 C4591001 1091 
10911455 12-15 29DEC2020 24109 Placebo 29DEC2020 Placebo 19JAN2021 Placebo 
10911456 C4591001 1091 
10911456 12-15 29DEC2020 24796 Placebo 29DEC2020 Placebo 18JAN2021 Placebo 
10911457 C4591001 1091 
10911457 12-15 29DEC2020 24797 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 87
FDA-CBER-2022-5812-0231738
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
10911458 C4591001 1091 
10911458 12-15 29DEC2020 24111 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10911459 C4591001 1091 
10911459 12-15 29DEC2020 24795 Placebo 29DEC2020 Placebo 19JAN2021 Placebo 
10911460 C4591001 1091 
10911460 12-15 30DEC2020 24800 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
10911461 C4591001 1091 
10911461 12-15 30DEC2020 24873 Placebo 30DEC2020 Placebo 19JAN2021 Placebo 
10911462 C4591001 1091 
10911462 12-15 04JAN2021 24875 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10911463 C4591001 1091 
10911463 12-15 04JAN2021 24877 Placebo 04JAN2021 Placebo 27JAN2021 Placebo 
10911464 C4591001 1091 
10911464 12-15 04JAN2021 24879 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10911465 C4591001 1091 
10911465 12-15 05JAN2021 25413 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
10911466 C4591001 1091 
10911466 12-15 11JAN2021 25414 Placebo 11JAN2021 Placebo 02FEB2021 Placebo 
11231422 C4591001 1123 
11231422 12-15 01DEC2020 20486 Placebo 01DEC2020 Placebo 21DEC2020 Placebo 
11231425 C4591001 1123 
11231425 12-15 02DEC2020 20487 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
11231428 C4591001 1123 
11231428 12-15 03DEC2020 20491 BNT162b2 
(30 μg) 03DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
11231431 C4591001 1123 
11231431 12-15 04DEC2020 20492 Placebo 04DEC2020 Placebo 23DEC2020 Placebo 
11231432 C4591001 1123 
11231432 12-15 04DEC2020 20939 BNT162b2 
(30 μg) 04DEC2020 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 88
FDA-CBER-2022-5812-0231739
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
11231434 C4591001 1123 
11231434 12-15 07DEC2020 20941 Placebo 07DEC2020 Placebo 28DEC2020 Placebo 
11231438 C4591001 1123 
11231438 12-15 08DEC2020 20942 Placebo 08DEC2020 Placebo 06JAN2021 Placebo 
11231439 C4591001 1123 
11231439 12-15 08DEC2020 20944 BNT162b2 
(30 μg) 08DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
11231440 C4591001 1123 
11231440 12-15 09DEC2020 21600 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 
11231441 C4591001 1123 
11231441 12-15 09DEC2020 21602 Placebo 09DEC2020 Placebo 04JAN2021 Placebo 
11231442 C4591001 1123 
11231442 12-15 09DEC2020 21604 Placebo 09DEC2020 Placebo 04JAN2021 Placebo 
11231443 C4591001 1123 
11231443 12-15 09DEC2020 21607 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
11231445 C4591001 1123 
11231445 12-15 09DEC2020 21729 Placebo 09DEC2020 Placebo 30DEC2020 Placebo 
11231446 C4591001 1123 
11231446 12-15 09DEC2020 21731 BNT162b2 
(30 μg) 09DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
11231447 C4591001 1123 
11231447 12-15 10DEC2020 21732 BNT162b2 
(30 μg) 10DEC2020 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 
11231448 C4591001 1123 
11231448 12-15 11DEC2020 21735 Placebo 11DEC2020 Placebo 30DEC2020 Placebo 
11231449 C4591001 1123 
11231449 12-15 11DEC2020 22018 BNT162b2 
(30 μg) 11DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
11231450 C4591001 1123 
11231450 12-15 11DEC2020 22023 Placebo 11DEC2020 Placebo 30DEC2020 Placebo 
11231451 C4591001 1123 
11231451 12-15 15DEC2020 22026 BNT162b2 
(30 μg) 15DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 89
FDA-CBER-2022-5812-0231740
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
11231452 C4591001 1123 
11231452 12-15 15DEC2020 22027 Placebo 15DEC2020 Placebo 04JAN2021 Placebo 
11231453 C4591001 1123 
11231453 12-15 15DEC2020 22610 BNT162b2 
(30 μg) 15DEC2020 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 
11231454 C4591001 1123 
11231454 12-15 15DEC2020 22607 Placebo 15DEC2020 Placebo 07JAN2021 Placebo 
11231455 C4591001 1123 
11231455 12-15 15DEC2020 22614 BNT162b2 
(30 μg) 15DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
11231456 C4591001 1123 
11231456 12-15 16DEC2020 22615 Placebo 16DEC2020 Placebo 04JAN2021 Placebo 
11231457 C4591001 1123 
11231457 12-15 16DEC2020 22835 Placebo 16DEC2020 Placebo 04JAN2021 Placebo 
11231458 C4591001 1123 
11231458 12-15 16DEC2020 22837 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
11231459 C4591001 1123 
11231459 12-15 16DEC2020 22841 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
11231460 C4591001 1123 
11231460 12-15 17DEC2020 22842 Placebo 17DEC2020 Placebo 08JAN2021 Placebo 
11231461 C4591001 1123 
11231461 12-15 17DEC2020 23027 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
11231462 C4591001 1123 
11231462 12-15 17DEC2020 23028 BNT162b2 
(30 μg) 17DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
11231463 C4591001 1123 
11231463 12-15 18DEC2020 23031 Placebo 18DEC2020 Placebo 07JAN2021 Placebo 
11231465 C4591001 1123 
11231465 12-15 18DEC2020 23032 Placebo 18DEC2020 Placebo 08JAN2021 Placebo 
11231466 C4591001 1123 
11231466 12-15 18DEC2020 23425 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 90
FDA-CBER-2022-5812-0231741
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
11231467 C4591001 1123 
11231467 12-15 21DEC2020 23427 Placebo 21DEC2020 Placebo 11JAN2021 Placebo 
11231468 C4591001 1123 
11231468 12-15 21DEC2020 23430 Placebo 21DEC2020 Placebo 11JAN2021 Placebo 
11231469 C4591001 1123 
11231469 12-15 21DEC2020 23432 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 
11231470 C4591001 1123 
11231470 12-15 21DEC2020 23673 Placebo 21DEC2020 Placebo 13JAN2021 Placebo 
11231472 C4591001 1123 
11231472 12-15 21DEC2020 23676 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 
11231473 C4591001 1123 
11231473 12-15 21DEC2020 23678 Placebo 21DEC2020 Placebo 12JAN2021 Placebo 
11231474 C4591001 1123 
11231474 12-15 21DEC2020 23830 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
11231475 C4591001 1123 
11231475 12-15 21DEC2020 23681 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
11231476 C4591001 1123 
11231476 12-15 21DEC2020 23831 Placebo 21DEC2020 Placebo 11JAN2021 Placebo 
11231477 C4591001 1123 
11231477 12-15 21DEC2020 23837 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
11231478 C4591001 1123 
11231478 12-15 21DEC2020 23865 Placebo 21DEC2020 Placebo 11JAN2021 Placebo 
11231479 C4591001 1123 
11231479 12-15 21DEC2020 23833 Placebo 21DEC2020 Placebo 11JAN2021 Placebo 
11231481 C4591001 1123 
11231481 12-15 21DEC2020 23869 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 
11231482 C4591001 1123 
11231482 12-15 22DEC2020 23871 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 91
FDA-CBER-2022-5812-0231742
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
11231483 C4591001 1123 
11231483 12-15 22DEC2020 23872 Placebo 22DEC2020 Placebo 11JAN2021 Placebo 
11231484 C4591001 1123 
11231484 12-15 22DEC2020 23977 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 12JAN2021 BNT162b2 
(30 μg) 
11231485 C4591001 1123 
11231485 12-15 22DEC2020 23982 Placebo 22DEC2020 Placebo 12JAN2021 Placebo 
11231486 C4591001 1123 
11231486 12-15 22DEC2020 23984 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
11231487 C4591001 1123 
11231487 12-15 22DEC2020 23980 Placebo 22DEC2020 Placebo 11JAN2021 Placebo 
11231488 C4591001 1123 
11231488 12-15 22DEC2020 24049 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 13JAN2021 BNT162b2 
(30 μg) 
11231489 C4591001 1123 
11231489 12-15 22DEC2020 24096 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
11231491 C4591001 1123 
11231491 12-15 22DEC2020 24097 Placebo 22DEC2020 Placebo 11JAN2021 Placebo 
11231492 C4591001 1123 
11231492 12-15 23DEC2020 24100 Placebo 23DEC2020 Placebo 13JAN2021 Placebo 
11231493 C4591001 1123 
11231493 12-15 23DEC2020 24103 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 15JAN2021 BNT162b2 
(30 μg) 
11231494 C4591001 1123 
11231494 12-15 23DEC2020 24237 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 14JAN2021 BNT162b2 
(30 μg) 
11231495 C4591001 1123 
11231495 12-15 23DEC2020 24238 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 13JAN2021 BNT162b2 
(30 μg) 
11231496 C4591001 1123 
11231496 12-15 23DEC2020 24240 Placebo 23DEC2020 Placebo 13JAN2021 Placebo 
11231497 C4591001 1123 
11231497 12-15 23DEC2020 24243 Placebo 23DEC2020 Placebo 20JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 92
FDA-CBER-2022-5812-0231743
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
11231499 C4591001 1123 
11231499 12-15 28DEC2020 24335 Placebo 28DEC2020 Placebo 18JAN2021 Placebo 
11231500 C4591001 1123 
11231500 12-15 28DEC2020 24336 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
11231501 C4591001 1123 
11231501 12-15 28DEC2020 24341 Placebo 28DEC2020 Placebo 18FEB2021 Placebo 
11231502 C4591001 1123 
11231502 12-15 28DEC2020 24342 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
11231503 C4591001 1123 
11231503 12-15 28DEC2020 24406 Placebo 28DEC2020 Placebo 18JAN2021 Placebo 
11231504 C4591001 1123 
11231504 12-15 28DEC2020 24412 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
11231505 C4591001 1123 
11231505 12-15 28DEC2020 24411 Placebo 28DEC2020 Placebo 18JAN2021 Placebo 
11231506 C4591001 1123 
11231506 12-15 28DEC2020 24415 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
11231507 C4591001 1123 
11231507 12-15 28DEC2020 24505 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
11231508 C4591001 1123 
11231508 12-15 28DEC2020 24508 BNT162b2 
(30 μg) 28DEC2020 BNT162b2 
(30 μg) 20JAN2021 BNT162b2 
(30 μg) 
11231509 C4591001 1123 
11231509 12-15 29DEC2020 24510 Placebo 29DEC2020 Placebo 21JAN2021 Placebo 
11231510 C4591001 1123 
11231510 12-15 29DEC2020 24512 Placebo 29DEC2020 Placebo 19JAN2021 Placebo 
11231511 C4591001 1123 
11231511 12-15 30DEC2020 24850 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
11231512 C4591001 1123 
11231512 12-15 30DEC2020 24852 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 19JAN2021 BNT162b2 
(30 μg) 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 93
FDA-CBER-2022-5812-0231744
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
11231513 C4591001 1123 
11231513 12-15 30DEC2020 24856 Placebo 30DEC2020 Placebo 20JAN2021 Placebo 
11231514 C4591001 1123 
11231514 12-15 30DEC2020 24860 Placebo 30DEC2020 Placebo 18JAN2021 Placebo 
11231515 C4591001 1123 
11231515 12-15 30DEC2020 25042 Placebo 30DEC2020 Placebo 18JAN2021 Placebo 
11231516 C4591001 1123 
11231516 12-15 30DEC2020 25047 Placebo 30DEC2020 Placebo 20JAN2021 Placebo 
11231517 C4591001 1123 
11231517 12-15 30DEC2020 25041 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
11231518 C4591001 1123 
11231518 12-15 30DEC2020 25046 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 20JAN2021 BNT162b2 
(30 μg) 
11231519 C4591001 1123 
11231519 12-15 30DEC2020 25077 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 20JAN2021 BNT162b2 
(30 μg) 
11231520 C4591001 1123 
11231520 12-15 30DEC2020 25082 Placebo 30DEC2020 Placebo 18JAN2021 Placebo 
11231521 C4591001 1123 
11231521 12-15 30DEC2020 25080 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
11231522 C4591001 1123 
11231522 12-15 05JAN2021 25083 Placebo 05JAN2021 Placebo 26JAN2021 Placebo 
11231523 C4591001 1123 
11231523 12-15 05JAN2021 25489 Placebo 05JAN2021 Placebo 26JAN2021 Placebo 
11231524 C4591001 1123 
11231524 12-15 05JAN2021 25490 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 28JAN2021 BNT162b2 
(30 μg) 
11231525 C4591001 1123 
11231525 12-15 07JAN2021 25493 BNT162b2 
(30 μg) 07JAN2021 BNT162b2 
(30 μg) 29JAN2021 BNT162b2 
(30 μg) 
11231526 C4591001 1123 
11231526 12-15 08JAN2021 25495 Placebo 08JAN2021 Placebo 29JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 94
FDA-CBER-2022-5812-0231745
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
11241236 C4591001 1124 
11241236 12-15 14DEC2020 22307 Placebo 14DEC2020 Placebo 04JAN2021 Placebo 
11241238 C4591001 1124 
11241238 12-15 14DEC2020 22311 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
11241239 C4591001 1124 
11241239 12-15 14DEC2020 22312 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
11241240 C4591001 1124 
11241240 12-15 14DEC2020 22314 Placebo 14DEC2020 Placebo 04JAN2021 Placebo 
11241241 C4591001 1124 
11241241 12-15 14DEC2020 22365 Placebo 14DEC2020 Placebo 04JAN2021 Placebo 
11241242 C4591001 1124 
11241242 12-15 14DEC2020 22368 Placebo 14DEC2020 Placebo 05JAN2021 Placebo 
11241243 C4591001 1124 
11241243 12-15 15DEC2020 22370 BNT162b2 
(30 μg) 15DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
11241244 C4591001 1124 
11241244 12-15 15DEC2020 22376 BNT162b2 
(30 μg) 15DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
11241245 C4591001 1124 
11241245 12-15 15DEC2020 22629 BNT162b2 
(30 μg) 15DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
11241246 C4591001 1124 
11241246 12-15 15DEC2020 22632 BNT162b2 
(30 μg) 15DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
11241247 C4591001 1124 
11241247 12-15 16DEC2020 22633 Placebo 16DEC2020 Placebo 05JAN2021 Placebo 
11241248 C4591001 1124 
11241248 12-15 16DEC2020 22640 Placebo 16DEC2020 Placebo 06JAN2021 Placebo 
11241249 C4591001 1124 
11241249 12-15 16DEC2020 22859 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 
11241250 C4591001 1124 
11241250 12-15 17DEC2020 22865 Placebo 17DEC2020 Placebo 07JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 95
FDA-CBER-2022-5812-0231746
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
11241251 C4591001 1124 
11241251 12-15 18DEC2020 22867 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
11241252 C4591001 1124 
11241252 12-15 18DEC2020 22866 Placebo 18DEC2020 Placebo 08JAN2021 Placebo 
11241253 C4591001 1124 
11241253 12-15 18DEC2020 23356 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
11241254 C4591001 1124 
11241254 12-15 18DEC2020 23350 BNT162b2 
(30 μg) 18DEC2020 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 
11241255 C4591001 1124 
11241255 12-15 18DEC2020 23359 Placebo 18DEC2020 Placebo 06JAN2021 Placebo 
11241256 C4591001 1124 
11241256 12-15 21DEC2020 23360 Placebo 21DEC2020 Placebo 13JAN2021 Placebo 
11241257 C4591001 1124 
11241257 12-15 22DEC2020 24118 Placebo 22DEC2020 Placebo 12JAN2021 Placebo 
11241258 C4591001 1124 
11241258 12-15 23DEC2020 24120 Placebo 23DEC2020 Placebo 14JAN2021 Placebo 
11241259 C4591001 1124 
11241259 12-15 23DEC2020 24125 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 14JAN2021 BNT162b2 
(30 μg) 
11241260 C4591001 1124 
11241260 12-15 23DEC2020 24128 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 13JAN2021 BNT162b2 
(30 μg) 
11241261 C4591001 1124 
11241261 12-15 23DEC2020 24227 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 13JAN2021 BNT162b2 
(30 μg) 
11241262 C4591001 1124 
11241262 12-15 23DEC2020 24228 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 11JAN2021 BNT162b2 
(30 μg) 
11241263 C4591001 1124 
11241263 12-15 29DEC2020 24232 Placebo 29DEC2020 Placebo 18JAN2021 Placebo 
11241264 C4591001 1124 
11241264 12-15 29DEC2020 24234 Placebo 29DEC2020 Placebo 18JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 96
FDA-CBER-2022-5812-0231747
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
11241265 C4591001 1124 
11241265 12-15 29DEC2020 24623 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
11241266 C4591001 1124 
11241266 12-15 29DEC2020 24625 BNT162b2 
(30 μg) 29DEC2020 BNT162b2 
(30 μg) 18JAN2021 BNT162b2 
(30 μg) 
11241267 C4591001 1124 
11241267 12-15 29DEC2020 24626 Placebo 29DEC2020 Placebo 18JAN2021 Placebo 
11241268 C4591001 1124 
11241268 12-15 04JAN2021 24631 Placebo 04JAN2021 Placebo 27JAN2021 Placebo 
11241269 C4591001 1124 
11241269 12-15 04JAN2021 25306 BNT162b2 
(30 μg) 04JAN2021 BNT162b2 
(30 μg) 25JAN2021 BNT162b2 
(30 μg) 
11241270 C4591001 1124 
11241270 12-15 05JAN2021 25308 Placebo 05JAN2021 Placebo 26JAN2021 Placebo 
11241271 C4591001 1124 
11241271 12-15 05JAN2021 25313 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 26JAN2021 BNT162b2 
(30 μg) 
11241272 C4591001 1124 
11241272 12-15 05JAN2021 25315 Placebo 05JAN2021 Placebo 27JAN2021 Placebo 
11241273 C4591001 1124 
11241273 12-15 06JAN2021 25847 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
11241274 C4591001 1124 
11241274 12-15 06JAN2021 25849 Placebo 06JAN2021 Placebo 27JAN2021 Placebo 
11241275 C4591001 1124 
11241275 12-15 08JAN2021 25852 BNT162b2 
(30 μg) 08JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
11251241 C4591001 1125 
11251241 12-15 07DEC2020 21093 BNT162b2 
(30 μg) 07DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
11251242 C4591001 1125 
11251242 12-15 07DEC2020 21096 Placebo 07DEC2020 Placebo 28DEC2020 Placebo 
11251244 C4591001 1125 
11251244 12-15 08DEC2020 21097 Placebo 08DEC2020 Placebo 30DEC2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 97
FDA-CBER-2022-5812-0231748
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
11251246 C4591001 1125 
11251246 12-15 10DEC2020 21100 BNT162b2 
(30 μg) 10DEC2020 BNT162b2 
(30 μg) 30DEC2020 BNT162b2 
(30 μg) 
11251248 C4591001 1125 
11251248 12-15 11DEC2020 22113 Placebo 11DEC2020 Placebo 30DEC2020 Placebo 
11251249 C4591001 1125 
11251249 12-15 11DEC2020 22116 Placebo 11DEC2020 Placebo 30DEC2020 Placebo 
11251250 C4591001 1125 
11251250 12-15 14DEC2020 22121 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
11251251 C4591001 1125 
11251251 12-15 14DEC2020 22124 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
11251252 C4591001 1125 
11251252 12-15 16DEC2020 22885 BNT162b2 
(30 μg) 16DEC2020 BNT162b2 
(30 μg) 13JAN2021 BNT162b2 
(30 μg) 
11251253 C4591001 1125 
11251253 12-15 16DEC2020 22886 Placebo 16DEC2020 Placebo 06JAN2021 Placebo 
11251254 C4591001 1125 
11251254 12-15 28DEC2020 22888 Placebo 28DEC2020 Placebo 20JAN2021 Placebo 
11251255 C4591001 1125 
11251255 12-15 06JAN2021 22892 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 27JAN2021 BNT162b2 
(30 μg) 
11261229 C4591001 1126 
11261229 12-15 30NOV2020 20421 BNT162b2 
(30 μg) 30NOV2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
11261230 C4591001 1126 
11261230 12-15 30NOV2020 20422 BNT162b2 
(30 μg) 30NOV2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
11261233 C4591001 1126 
11261233 12-15 01DEC2020 20423 Placebo 01DEC2020 Placebo 22DEC2020 Placebo 
11261235 C4591001 1126 
11261235 12-15 01DEC2020 20430 Placebo 01DEC2020 Placebo 23DEC2020 Placebo 
11261239 C4591001 1126 
11261239 12-15 02DEC2020 20686 Placebo 02DEC2020 Placebo 21DEC2020 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 98
FDA-CBER-2022-5812-0231749
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
11261240 C4591001 1126 
11261240 12-15 02DEC2020 20687 Placebo 02DEC2020 Placebo 21DEC2020 Placebo 
11261241 C4591001 1126 
11261241 12-15 02DEC2020 20690 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
11261243 C4591001 1126 
11261243 12-15 02DEC2020 20694 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 21DEC2020 BNT162b2 
(30 μg) 
11261246 C4591001 1126 
11261246 12-15 02DEC2020 20761 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 
11261249 C4591001 1126 
11261249 12-15 02DEC2020 20763 BNT162b2 
(30 μg) 02DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
11261250 C4591001 1126 
11261250 12-15 02DEC2020 20764 Placebo 02DEC2020 Placebo 22DEC2020 Placebo 
11261253 C4591001 1126 
11261253 12-15 03DEC2020 20765 Placebo 03DEC2020 Placebo 23DEC2020 Placebo 
11261254 C4591001 1126 
11261254 12-15 03DEC2020 20904 Placebo 03DEC2020 Placebo 26JAN2021 Placebo 
11261255 C4591001 1126 
11261255 12-15 03DEC2020 20907 BNT162b2 
(30 μg) 03DEC2020 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 
11261258 C4591001 1126 
11261258 12-15 03DEC2020 20910 BNT162b2 
(30 μg) 03DEC2020 BNT162b2 
(30 μg) 22DEC2020 BNT162b2 
(30 μg) 
11261262 C4591001 1126 
11261262 12-15 04DEC2020 20911 Placebo 04DEC2020 Placebo 23DEC2020 Placebo 
11261263 C4591001 1126 
11261263 12-15 04DEC2020 21033 BNT162b2 
(30 μg) 04DEC2020 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 
11261264 C4591001 1126 
11261264 12-15 04DEC2020 21038 BNT162b2 
(30 μg) 04DEC2020 BNT162b2 
(30 μg) 23DEC2020 BNT162b2 
(30 μg) 
11261265 C4591001 1126 
11261265 12-15 14DEC2020 21040 Placebo 14DEC2020 Placebo 04JAN2021 Placebo 
090177e196ac3a63\Final\Final On: 31-Mar-2021 13:00 (GMT) 
Page 99
FDA-CBER-2022-5812-0231750
16.1.7.1.1 Listing of Randomization Scheme and Actual Va ccine Received – Subjects 12 Through 25 Years of Age 
  Vaccine Received  
Subject 
Study 
IdentifieraSubject Age 
Group 
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date      Dose 1      Date      Dose 2      
  
11261266 C4591001 1126 
11261266 12-15 14DEC2020 21042 Placebo 14DEC2020 Placebo 04JAN2021 Placebo 
11261267 C4591001 1126 
11261267 12-15 14DEC2020 22342 Placebo 14DEC2020 Placebo 04JAN2021 Placebo 
11261268 C4591001 1126 
11261268 12-15 14DEC2020 22343 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
11261269 C4591001 1126 
11261269 12-15 14DEC2020 22344 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
11261270 C4591001 1126 
11261270 12-15 14DEC2020 22352 Placebo 14DEC2020 Placebo 06JAN2021 Placebo 
11261271 C4591001 1126 
11261271 12-15 14DEC2020 22440 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
11261273 C4591001 1126 
11261273 12-15 14DEC2020 22442 BNT162b2 
(30 μg) 14DEC2020 BNT162b2 
(30 μg) 06JAN2021 BNT162b2 
(30 μg) 
11261274 C4591001 1126 
11261274 12-15 15DEC2020 22446 Placebo 15DEC2020 Placebo 04JAN2021 Placebo 
11261275 C4591001 1126 
11261275 12-15 15DEC2020 22690 Placebo 15DEC2020 Placebo 06JAN2021 Placebo 
11261276 C4591001 1126 
11261276 12-15 15DEC2020 22448 Placebo 15DEC2020 Placebo 06JAN2021 Placebo 
11261277 C4591001 1126 
11261277 12-15 15DEC2020 22693 BNT162b2 
(30 μg) 15DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
11261278 C4591001 1126 
11261278 12-15 15DEC2020 22695 BNT162b2 
(30 μg) 15DEC2020 BNT162b2 
(30 μg) 05JAN2021 BNT162b2 
(30 μg) 
11261279 C4591001 1126 
11261279 12-15 16DEC2020 22700 Placebo 16DEC2
…[truncated]