125742 S1 M5 5351 c4591001 fa interim randomization sensitive

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 16 Plus Documents

4412

Document text

16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10011081  C4591001 1001 
10011081  56-85 28JUL2020  220015  Placebo  28JUL2020  Placebo  18AUG2020  Placebo  
10011084  C4591001 1001 
10011084  56-85 28JUL2020  220026  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10011085  C4591001 1001 
10011085  18-55 28JUL2020  40018  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10011086  C4591001 1001 
10011086  18-55 28JUL2020  40021  Placebo  28JUL2020  Placebo  18AUG2020  Placebo  
10011087  C4591001 1001 
10011087  18-55 28JUL2020  40032  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10011088  C4591001 1001 
10011088  18-55 28JUL2020  40047  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10011089  C4591001 1001 
10011089  18-55 28JUL2020  40070  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10011090  C4591001 1001 
10011090  56-85 29JUL2020  220087  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10011091  C4591001 1001 
10011091  18-55 29JUL2020  40171  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10011092  C4591001 1001 
10011092  18-55 29JUL2020  40172  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 1
FDA-CBER-2021-5683-0024778
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10011093  C4591001 1001 
10011093  56-85 29JUL2020  220088  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10011094  C4591001 1001 
10011094  56-85 29JUL2020  220090  Placebo  29JUL2020  Placebo  20AUG2020  Placebo  
10011095  C4591001 1001 
10011095  18-55 29JUL2020  40178  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10011096  C4591001 1001 
10011096  56-85 29JUL2020  220095  Placebo  29JUL2020  Placebo  20AUG2020  Placebo  
10011097  C4591001 1001 
10011097  56-85 30JUL2020  220387  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
10011098  C4591001 1001 
10011098  56-85 30JUL2020  220393  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10011099  C4591001 1001 
10011099  56-85 30JUL2020  220389  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10011100  C4591001 1001 
10011100  56-85 30JUL2020  220395  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
10011101  C4591001 1001 
10011101  18-55 30JUL2020  40180  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10011102  C4591001 1001 
10011102  18-55 30JUL2020  40541  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 2
FDA-CBER-2021-5683-0024779
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10011103  C4591001 1001 
10011103  56-85 30JUL2020  220625  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
10011104  C4591001 1001 
10011104  56-85 30JUL2020  220626  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
10031088  C4591001 1003 
10031088  18-55 27JUL2020  40003  Placebo  27JUL2020  Placebo  17AUG2020  Placebo  
10031089  C4591001 1003 
10031089  56-85 27JUL2020  220001  BNT162b2  
(30 μg)  27JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
10031090  C4591001 1003 
10031090  18-55 27JUL2020  40006  BNT162b2  
(30 μg)  27JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
10031091  C4591001 1003 
10031091  56-85 27JUL2020  220002  BNT162b2  
(30 μg)  27JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
10031092  C4591001 1003 
10031092  56-85 28JUL2020  220005  Placebo  28JUL2020  Placebo  18AUG2020  Placebo  
10031093  C4591001 1003 
10031093  56-85 28JUL2020  220011  Placebo  28JUL2020  Placebo  18AUG2020  Placebo  
10031094  C4591001 1003 
10031094  18-55 28JUL2020  40009  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10031095  C4591001 1003 
10031095  56-85 28JUL2020  220019  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 3
FDA-CBER-2021-5683-0024780
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10031096  C4591001 1003 
10031096  18-55 28JUL2020  40013  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10031097  C4591001 1003 
10031097  18-55 28JUL2020  40017  Placebo  28JUL2020  Placebo  18AUG2020  Placebo  
10031098  C4591001 1003 
10031098  56-85 28JUL2020  220023  Placebo  28JUL2020  Placebo  18AUG2020  Placebo  
10031099  C4591001 1003 
10031099  56-85 28JUL2020  220037  Placebo  28JUL2020  Placebo  18AUG2020  Placebo  
10031100  C4591001 1003 
10031100  18-55 28JUL2020  40037  Placebo  28JUL2020  Placebo  18AUG2020  Placebo  
10031101  C4591001 1003 
10031101  18-55 28JUL2020  40043  Placebo  28JUL2020  Placebo  18AUG2020  Placebo  
10031102  C4591001 1003 
10031102  56-85 28JUL2020  220039  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10031103  C4591001 1003 
10031103  56-85 29JUL2020  220124  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
10031104  C4591001 1003 
10031104  18-55 29JUL2020  40145  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10031105  C4591001 1003 
10031105  56-85 29JUL2020  220125  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 4
FDA-CBER-2021-5683-0024781
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10031106  C4591001 1003 
10031106  56-85 29JUL2020  220127  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
10031107  C4591001 1003 
10031107  56-85 29JUL2020  220132  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10031108  C4591001 1003 
10031108  56-85 29JUL2020  220219  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10031109  C4591001 1003 
10031109  56-85 30JUL2020  220223  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10031110  C4591001 1003 
10031110  56-85 30JUL2020  220225  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10031111  C4591001 1003 
10031111  18-55 30JUL2020  40149  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10031112  C4591001 1003 
10031112  56-85 30JUL2020  220226  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10031113  C4591001 1003 
10031113  56-85 30JUL2020  220530  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10031114  C4591001 1003 
10031114  56-85 30JUL2020  220531  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10031115  C4591001 1003 
10031115  18-55 30JUL2020  40151  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 5
FDA-CBER-2021-5683-0024782
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10031117  C4591001 1003 
10031117  56-85 30JUL2020  220534  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10071079  C4591001 1007 
10071079  56-85 28JUL2020  220021  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
10071080  C4591001 1007 
10071080  18-55 28JUL2020  40012  Placebo  28JUL2020  Placebo  19AUG2020  Placebo  
10071081  C4591001 1007 
10071081  56-85 28JUL2020  220025  Placebo  28JUL2020  Placebo  19AUG2020  Placebo  
10071082  C4591001 1007 
10071082  18-55 28JUL2020  40035  Placebo  28JUL2020  Placebo  19AUG2020  Placebo  
10071083  C4591001 1007 
10071083  18-55 28JUL2020  40026  Placebo  28JUL2020  Placebo  17AUG2020  Placebo  
10071084  C4591001 1007 
10071084  56-85 28JUL2020  220030  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10071085  C4591001 1007 
10071085  56-85 28JUL2020  220035  Placebo  28JUL2020  Placebo  20AUG2020  Placebo  
10071086  C4591001 1007 
10071086  56-85 28JUL2020  220041  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10071087  C4591001 1007 
10071087  18-55 29JUL2020  40111  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 6
FDA-CBER-2021-5683-0024783
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10071088  C4591001 1007 
10071088  56-85 29JUL2020  220077  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10071089  C4591001 1007 
10071089  18-55 29JUL2020  40113  Placebo  29JUL2020  Placebo  17AUG2020  Placebo  
10071090  C4591001 1007 
10071090  56-85 29JUL2020  220078  Placebo  29JUL2020  Placebo  17AUG2020  Placebo  
10071091  C4591001 1007 
10071091  56-85 29JUL2020  220081  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
10071092  C4591001 1007 
10071092  18-55 29JUL2020  40117  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
10071093  C4591001 1007 
10071093  18-55 29JUL2020  40120  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT1 62b2  
(30 μg)  
10071094  C4591001 1007 
10071094  56-85 29JUL2020  220083  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
10071095  C4591001 1007 
10071095  18-55 30JUL2020  40422  Placebo  30JUL2020  Placebo  17AUG2020  Placebo  
10071096  C4591001 1007 
10071096  18-55 30JUL2020  40425  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10071097  C4591001 1007 
10071097  18-55 30JUL2020  40427  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 7
FDA-CBER-2021-5683-0024784
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10071098  C4591001 1007 
10071098  56-85 30JUL2020  220493  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10071099  C4591001 1007 
10071099  56-85 30JUL2020  220499  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10071100  C4591001 1007 
10071100  18-55 30JUL2020  40430  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10071101  C4591001 1007 
10071101  56-85 30JUL2020  220496  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10071102  C4591001 1007 
10071102  18-55 30JUL2020  40639  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10131001  C4591001 1013 
10131001  56-85 28JUL2020  220038  Placebo  28JUL2020  Placebo  17AUG2020  Placebo  
10131002  C4591001 1013 
10131002  18-55 28JUL2020  40033  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
10131003  C4591001 1013 
10131003  18-55 28JUL2020  40056  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10131004  C4591001 1013 
10131004  56-85 28JUL2020  220049  Placebo  28JUL2020  Placebo  19AUG2020  Placebo  
10131005  C4591001 1013 
10131005  18-55 28JUL2020  40063  Placebo  28JUL2020  Placebo  19AUG2020  Placebo  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 8
FDA-CBER-2021-5683-0024785
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10131006  C4591001 1013 
10131006  18-55 28JUL2020  40057  Placebo  28JUL2020  Placebo  19AUG2020  Placebo  
10131007  C4591001 1013 
10131007  18-55 28JUL2020  40044  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
10131008  C4591001 1013 
10131008  18-55 28JUL2020  40060  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10131009  C4591001 1013 
10131009  18-55 28JUL2020  40050  Placebo  28JUL2020  Placebo  17AUG2020  Placebo  
10131010  C4591001 1013 
10131010  18-55 29JUL2020  40087  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10131011  C4591001 1013 
10131011  18-55 29JUL2020  40085  Placebo  29JUL2020  Placebo  17AUG2020  Placebo  
10131012  C4591001 1013 
10131012  18-55 29JUL2020  40129  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10131013  C4591001 1013 
10131013  18-55 29JUL2020  40123  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10131014  C4591001 1013 
10131014  18-55 29JUL2020  40092  Placebo  29JUL2020  Placebo  21AUG2020  Placebo  
10131015  C4591001 1013 
10131015  18-55 29JUL2020  40124  Placebo  29JUL2020  Placebo  20AUG2020  Placebo  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 9
FDA-CBER-2021-5683-0024786
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10131016  C4591001 1013 
10131016  18-55 29JUL2020  40094  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
10131018  C4591001 1013 
10131018  18-55 30JUL2020  40402  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10131019  C4591001 1013 
10131019  18-55 30JUL2020  40398  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
10131020  C4591001 1013 
10131020  18-55 30JUL2020  40404  Placebo  30JUL2020  Placebo  19AUG2020  Placebo  
10131021  C4591001 1013 
10131021  18-55 30JUL2020  40407  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  25AUG2020  BNT162b2  
(30 μg)  
10131022  C4591001 1013 
10131022  18-55 30JUL2020  40417  BNT162b2  
(30 μ g) 30JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10131023  C4591001 1013 
10131023  18-55 30JUL2020  40413  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10131024  C4591001 1013 
10131024  18-55 30JUL2020  40416  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
10131025  C4591001 1013 
10131025  18-55 30JUL2020  40419  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
10131026  C4591001 1013 
10131026  18-55 30JUL2020  40493  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 10
FDA-CBER-2021-5683-0024787
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10131028  C4591001 1013 
10131028  56-85 30JUL2020  220409  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10131029  C4591001 1013 
10131029  56-85 30JUL2020  220414  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10131030  C4591001 1013 
10131030  18-55 30JUL2020  40497  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10131031  C4591001 1013 
10131031  18-55 30JUL2020  40500  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
10131032  C4591001 1013 
10131032  18-55 30JUL2020  40504  Placebo  30JUL2020  Placebo  19AUG2020  Placebo  
10161001  C4591001 1016 
10161001  56-85 29JUL2020  220097  Placebo  29JUL2020  Placebo  18AUG2020  Placebo  
10161002  C4591001 1016 
10161002  56-85 29JUL2020  220098  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10161003  C4591001 1016 
10161003  18-55 29JUL2020  40137  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
10161004  C4591001 1016 
10161004  18-55 29JUL2020  40139  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10161005  C4591001 1016 
10161005  18-55 29JUL2020  40142  Placebo  29JUL2020  Placebo  17AUG2020  Placebo  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 11
FDA-CBER-2021-5683-0024788
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10161006  C4591001 1016 
10161006  18-55 29JUL2020  40144  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10161007  C4591001 1016 
10161007  56-85 29JUL2020  220101  Placebo  29JUL2020  Placebo  18AUG2020  Placebo  
10161009  C4591001 1016 
10161009  18-55 30JUL2020  40433  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10161010  C4591001 1016 
10161010  18-55 30JUL2020  40434  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10161011  C4591001 1016 
10161011  56-85 30JUL2020  220105  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10161012  C4591001 1016 
10161012  56-85 30JUL2020  220433  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
10161013  C4591001 1016 
10161013  56-85 30JUL2020  220436  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
10161014  C4591001 1016 
10161014  18-55 30JUL2020  40440  Placebo  30JUL2020  Placebo  19AUG2020  Placebo  
10161015  C4591001 1016 
10161015  56-85 30JUL2020  220438  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10161016  C4591001 1016 
10161016  56-85 30JUL2020  220442  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 12
FDA-CBER-2021-5683-0024789
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10181001  C4591001 1018 
10181001  18-55 29JUL2020  40193  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10181002  C4591001 1018 
10181002  56-85 29JUL2020  220183  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10181003  C4591001 1018 
10181003  18-55 29JUL2020  40194  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
10181004  C4591001 1018 
10181004  56-85 29JUL2020  220186  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
10181005  C4591001 1018 
10181005  56-85 29JUL2020  220188  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10181006  C4591001 1018 
10181006  56-85 29JUL2020  220192  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
10181007  C4591001 1018 
10181007  18-55 29JUL2020  40199  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10421001  C4591001 1042 
10421001  18-55 29JUL2020  40290  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
10421002  C4591001 1042 
10421002  56-85 29JUL2020  220340  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
10421003  C4591001 1042 
10421003  18-55 29JUL2020  40293  Placebo  29JUL2020  Placebo  17AUG2020  Placebo  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 13
FDA-CBER-2021-5683-0024790
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10421004  C4591001 1042 
10421004  18-55 29JUL2020  40295  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
10421008  C4591001 1042 
10421008  18-55 30JUL2020  40296  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
10421009  C4591001 1042 
10421009  56-85 30JUL2020  220341  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10731001  C4591001 1073 
10731001  56-85 29JUL2020  220302  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
10731002  C4591001 1073 
10731002  56-85 29JUL2020  220303  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10731003  C4591001 1073 
10731003  56-85 29JUL2020  220306  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10731004  C4591001 1073 
10731004  56-85 29JUL2020  220311  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
10731005  C4591001 1073 
10731005  56-85 29JUL2020  220319  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
10731006  C4591001 1073 
10731006  18-55 30JUL2020  40529  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10731007  C4591001 1073 
10731007  56-85 30JUL2020  220320  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 14
FDA-CBER-2021-5683-0024791
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10731008  C4591001 1073 
10731008  18-55 30JUL2020  40530  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10731009  C4591001 1073 
10731009  18-55 30JUL2020  40535  Placebo  30JUL2020  Placebo  24AUG2020  Placebo  
10731010  C4591001 1073 
10731010  56-85 30JUL2020  220323  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10731011  C4591001 1073 
10731011  56-85 30JUL2020  220324  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10731012  C4591001 1073 
10731012  18-55 30JUL2020  40537  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10731013  C4591001 1073 
10731013  18-55 30JUL2020  40722  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10731014  C4591001 1073 
10731014  56-85 30JUL2020  220771  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10791001  C4591001 1079 
10791001  56-85 29JUL2020  220231  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
10791002  C4591001 1079 
10791002  18-55 29JUL2020  40279  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
10791003  C4591001 1079 
10791003  18-55 29JUL2020  40282  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 15
FDA-CBER-2021-5683-0024792
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10791004  C4591001 1079 
10791004  18-55 29JUL2020  40283  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)   
  
10791005  C4591001 1079 
10791005  56-85 29JUL2020  220232  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10791006  C4591001 1079 
10791006  56-85 29JUL2020  220234  Placebo  29JUL2020  Placebo  17AUG2020  Placebo  
10791007  C4591001 1079 
10791007  18-55 29JUL2020  40285  Placebo  29JUL2020  Placebo  17AUG2020  Placebo  
10791008  C4591001 1079 
10791008  18-55 29JUL2020  40301  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10791009  C4591001 1079 
10791009  56-85 30JUL2020  220240  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
10791010  C4591001 1079 
10791010  18-55 30JUL2020  40303  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10791011  C4591001 1079 
10791011  56-85 30JUL2020  220637  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
10791013  C4591001 1079 
10791013  18-55 30JUL2020  40306  Placebo  30JUL2020  Placebo  19AUG2020  Placebo  
10791014  C4591001 1079 
10791014  56-85 30JUL2020  220646  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 16
FDA-CBER-2021-5683-0024793
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10821001  C4591001 1082 
10821001  56-85 30JUL2020  220376  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10821002  C4591001 1082 
10821002  56-85 30JUL2020  220379  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10821003  C4591001 1082 
10821003  18-55 30JUL2020  40519  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10821004  C4591001 1082 
10821004  18-55 30JUL2020  40521  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10831001  C4591001 1083 
10831001  18-55 29JUL2020  40326  Placebo  29JUL2020  Placebo  21AUG2020  Placebo  
10831002  C4591001 1083 
10831002  18-55 29JUL2020  40331  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
10831003  C4591001 1083 
10831003  56-85 29JUL2020  220349  Placebo  29JUL2020  Placebo  21AUG2020  Placebo  
10831004  C4591001 1083 
10831004  18-55 29JUL2020  40333  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
10831005  C4591001 1083 
10831005  18-55 29JUL2020  40336  Placebo  29JUL2020  Placebo  21AUG2020  Placebo  
10831006  C4591001 1083 
10831006  18-55 29JUL2020  40362  Placebo  29JUL2020  Placebo  21AUG2020  Placebo  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 17
FDA-CBER-2021-5683-0024794
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10841001  C4591001 1084 
10841001  18-55 30JUL2020  40590  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10841002  C4591001 1084 
10841002  56-85 30JUL2020  220615  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
10841003  C4591001 1084 
10841003  18-55 30JUL2020  40591  Placebo  30JUL2020  Placebo  21AUG2020  Placebo  
10841006  C4591001 1084 
10841006  56-85 30JUL2020  220618  Placebo  30JUL2020  Placebo  17AUG2020  Placebo  
10851001  C4591001 1085 
10851001  56-85 30JUL2020  220505  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10851002  C4591001 1085 
10851002  56-85 30JUL2020  220506  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10851003  C4591001 1085 
10851003  18-55 30JUL2020  40554  Placebo  30JUL2020  Placebo  21AUG2020  Placebo  
10851004  C4591001 1085 
10851004  18-55 30JUL2020  40555  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10851005  C4591001 1085 
10851005  56-85 30JUL2020  220514  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10851006  C4591001 1085 
10851006  56-85 30JUL2020  220516  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 18
FDA-CBER-2021-5683-0024795
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10851007  C4591001 1085 
10851007  56-85 30JUL2020  40556  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10851008  C4591001 1085 
10851008  56-85 30JUL2020  40564  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10891001  C4591001 1089 
10891001  56-85 29JUL2020  220201  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10891002  C4591001 1089 
10891002  56-85 29JUL2020  220202  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
10891003  C4591001 1089 
108910 03 56-85 29JUL2020  220203  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10891004  C4591001 1089 
10891004  56-85 29JUL2020  220204  Placebo  29JUL2020  Placebo   
  
10891005  C4591001 1089 
10891005  56-85 29JUL2020  220265  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10891006  C4591001 1089 
10891006  56-85 29JUL2020  220267  Placebo  29JUL2020  Placebo  17AUG2020  Placebo  
10891007  C4591001 1089 
10891007  56-85 29JUL2020  220268  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
10891008  C4591001 1089 
10891008  56-85 29JUL2020  220272  Placebo  29JUL2020  Placebo  18AUG2020  Placebo  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 19
FDA-CBER-2021-5683-0024796
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10891009  C4591001 1089 
10891009  56-85 30JUL2020  220566  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
10891011  C4591001 1089 
10891011  18-55 30JUL2020  40567  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10891012  C4591001 1089 
10891012  56-85 30JUL2020  220571  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10891013  C4591001 1089 
10891013  18-55 30JUL2020  40569  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
10891014  C4591001 1089 
10891014  56-85 30JUL2020  220572  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
10891015  C4591001 1089 
10891015  18-55 30JUL2020  40572  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
10891016  C4591001 1089 
10891016  56-85 30JUL2020  220574  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10951001  C4591001 1095 
10951001  18-55 30JUL2020  40449  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10951002  C4591001 1095 
10951002  18-55 30JUL2020  40445  Placebo  30JUL2020  Placebo  21AUG2020  Placebo  
10951003  C4591001 1095 
10951003  56-85 30JUL2020  220591  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 20
FDA-CBER-2021-5683-0024797
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10951004  C4591001 1095 
10951004  56-85 30JUL2020  220589  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10951005  C4591001 1095 
10951005  18-55 30JUL2020  40452  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10951006  C4591001 1095 
10951006  18-55 30JUL2020  40455  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10951007  C4591001 1095 
10951007  18-55 30JUL2020  40697  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
11071001  C4591001 1107 
11071001  56-85 29JUL2020  220281  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
11071003  C4591001 1107 
11071003  18-55 29JUL2020  40317  Placebo  29JUL2020  Placebo  18AUG2020  Placebo  
11071004  C4591001 1107 
11071004  56-85 30JUL2020  220285  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
11071005  C4591001 1107 
11071005  56-85 30JUL2020  220287  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
11071006  C4591001 1107 
11071006  18-55 30JUL2020  40319  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
11071007  C4591001 1107 
11071007  56-85 30JUL2020  220579  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 21
FDA-CBER-2021-5683-0024798
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
11071008  C4591001 1107 
11071008  56-85 30JUL2020  220587  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
11071009  C4591001 1107 
11071009  56-85 30JUL2020  220581  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
11071010  C4591001 1107 
11071010  18-55 30JUL2020  40320  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
11091001  C4591001 1109 
11091001  18-55 29JUL2020  40243  Placebo  29JUL2020  Placebo  17AUG2020  Placebo  
11091002  C4591001 1109 
11091002  18-55 29JUL2020  40249  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
11091003  C4591001 1109 
11091003  18-55 29JUL2020  40244  Placebo  29JUL2020  Placebo  18AUG2020  Placebo  
11091004  C4591001 1109 
11091004  18-55 29JUL2020  40266  Placebo  29JUL2020  Placebo  17AUG2020  Placebo  
11091005  C4591001 1109 
11091005  56-85 29JUL2020  220253  Placebo  29JUL2020  Placebo  17AUG2020  Placebo  
11091006  C4591001 1109 
11091006  18-55 29JUL2020  40251  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  26AUG2020  BNT162b2  
(30 μg)  
11091007  C4591001 1109 
11091007  18-55 29JUL2020  40267  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 22
FDA-CBER-2021-5683-0024799
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
11091008  C4591001 1109 
11091008  56-85 29JUL2020  220256  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
11091009  C4591001 1109 
11091009  56-85 29JUL2020  220261  Placebo  29JUL2020  Placebo  21AUG2020  Placebo  
11091010  C4591001 1109 
11091010  18-55 29JUL2020  40271  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
11091011  C4591001 1109 
11091011  18-55 29JUL2020  40270  Placebo  29JUL2020  Placebo  17AUG2020  Placebo  
11091012  C4591001 1109 
11091012  56-85 29JUL2020  220264  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
11091013  C4591001 1109 
11091013  18-55 29JUL2020  40339  Placebo  29JUL2020  Placebo  17AUG2020  Placebo  
11091014  C4591001 1109 
11091014  18-55 29JUL2020  40343  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  26AUG2020  BNT162b2  
(30 μg)  
11091015  C4591001 1109 
11091015  18-55 29JUL2020  40346  Placebo  29JUL2020  Placebo  18AUG2020  Placebo  
11091016  C4591001 1109 
11091016  18-55 30JUL2020  40382  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
11091017  C4591001 1109 
11091017  18-55 30JUL2020  40348  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 23
FDA-CBER-2021-5683-0024800
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
11091018  C4591001 1109 
11091018  18-55 30JUL2020  40373  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
11091019  C4591001 1109 
11091019  18-55 30JUL2020  40377  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
11091020  C4591001 1109 
11091020  18-55 30JUL2020  40384  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
11091021  C4591001 1109 
11091021  18-55 30JUL2020  40387  Placebo  30JUL2020  Placebo  21AUG2020  Placebo  
11091022  C4591001 1109 
11091022  18-55 30JUL2020  40388  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
11091023  C4591001 1109 
11091023  18-55 30JUL2020  40394  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
11091024  C4591001 1109 
11091024  18-55 30JUL2020  40396  BNT162b2  
(30 μg ) 30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
11091025  C4591001 1109 
11091025  56-85 30JUL2020  220518  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
11091026  C4591001 1109 
11091026  56-85 30JUL2020  220523  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μ g) 18AUG2020  BNT162b2  
(30 μg)  
11091027  C4591001 1109 
11091027  18-55 30JUL2020  40505  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 24
FDA-CBER-2021-5683-0024801
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
11091028  C4591001 1109 
11091028  18-55 30JUL2020  40506  Placebo  30JUL2020  Placebo  21AUG2020  Placebo  
11091029  C4591001 1109 
11091029  56-85 30JUL2020  220517  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  22AUG2020  BNT162b2  
(30 μg)  
11091030  C4591001 1109 
11091030  18-55 30JUL2020  40507  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
11091031  C4591001 1109 
11091031  56-85 30JUL2020  220520  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
11091032  C4591001 1109 
11091032  56-85 30JUL2020  220687  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
11091033  C4591001 1109 
11091033  18-55 30JUL2020  40515  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
11111001  C4591001 1111 
11111001  18-55 30JUL2020  40473  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
11111002  C4591001 1111 
11111002  56-85 30JUL2020  220448  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
11111003  C4591001 1111 
11111003  56-85 30JUL2020  220449  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
11111004  C4591001 1111 
11111004  56-85 30JUL2020  220450  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 25
FDA-CBER-2021-5683-0024802
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
11111005  C4591001 1111 
11111005  56-85 30JUL2020  220452  Placebo  30JUL2020  Placebo  21AUG2020  Placebo  
11121001  C4591001 1112 
11121001  56-85 29JUL2020  220110  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
11121002  C4591001 1112 
11121002  56-85 29JUL2020  220111  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
11121003  C4591001 1112 
11121003  56-85 29JUL2020  220120  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
11121004  C4591001 1112 
11121004  18-55 29JUL2020  40208  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
11121005  C4591001 1112 
11121005  56-85 29JUL2020  220115  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
11121006  C4591001 1112 
11121006  18-55 29JUL2020  40214  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
11121007  C4591001 1112 
11121007  56-85 29JUL2020  220296  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
11121008  C4591001 1112 
11121008  18-55 29JUL2020  40215  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
11121009  C4591001 1112 
11121009  18-55 30JUL2020  40216  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 26
FDA-CBER-2021-5683-0024803
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
11121010  C4591001 1112 
11121010  56-85 30JUL2020  220297  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
11121011  C4591001 1112 
11121011  18-55 30JUL2020  40482  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
11121012  C4591001 1112 
11121012  18-55 30JUL2020  40485  Placebo  30JUL2020  Placebo  21AUG2020  Placebo  
11121013  C4591001 1112 
11121013  18-55 30JUL2020  40486  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
11121015  C4591001 1112 
11121015  18-55 30JUL2020  40674  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
11121016  C4591001 1112 
11121016  18-55 30JUL2020  40487  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
11201001  C4591001 1120 
11201001  18-55 29JUL2020  40349  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
11201002  C4591001 1120 
11201002  56-85 29JUL2020  220363  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
11201003  C4591001 1120 
11201003  56-85 29JUL2020  220361  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
11201006  C4591001 1120 
11201006  56-85 29JUL2020  220362  Placebo  29JUL2020  Placebo  21AUG2020  Placebo  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 27
FDA-CBER-2021-5683-0024804
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
11201007  C4591001 1120 
11201007  56-85 29JUL2020  220366  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
11231001  C4591001 1123 
11231001  18-55 29JUL2020  40221  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
11231002  C4591001 1123 
11231002  18-55 30JUL2020  40223  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
11231003  C4591001 1123 
11231003  18-55 30JUL2020  40225  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
11271001  C4591001 1127 
11271001  56-85 29JUL2020  220147  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
11271002  C4591001 1127 
11271002  56-85 29JUL2020  220152  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  16AUG2020  BNT162b2  
(30 μg)  
11271003  C4591001 1127 
11271003  56-85 29JUL2020  220155  Placebo  29JUL2020  Placebo  16AUG2020  Placebo  
11271004  C4591001 1127 
11271004  18-55 29JUL2020  40230  Placebo  29JUL2020  Placebo  17AUG2020  Placebo  
11271005  C4591001 1127 
11271005  56-85 29JUL2020  220207  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
11271006  C4591001 1127 
11271006  56-85 29JUL2020  220156  Placebo  29JUL2020  Placebo  17AUG2020  Placebo  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 28
FDA-CBER-2021-5683-0024805
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
11271007  C4591001 1127 
11271007  56-85 29JUL2020  220206  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
11271008  C4591001 1127 
11271008  56-85 29JUL2020  220214  Placebo  29JUL2020  Placebo  18AUG2020  Placebo  
11271009  C4591001 1127 
11271009  56-85 30JUL2020  220460  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
11271010  C4591001 1127 
11271010  56-85 30JUL2020  220216  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
11271011  C4591001 1127 
11271011  18-55 30JUL2020  40234  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
11271012  C4591001 1127 
11271012  56-85 30JUL2020  220461  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
11271014  C4591001 1127 
11271014  18-55 30JUL2020  40613  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
11271015  C4591001 1127 
11271015  18-55 30JUL2020  40235  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
11271016  C4591001 1127 
11271016  18-55 30JUL2020  40238  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
11271017  C4591001 1127 
11271017  18-55 30JUL2020  40619  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 29
FDA-CBER-2021-5683-0024806
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
11291001  C4591001 1129 
11291001  18-55 29JUL2020  40183  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
11291002  C4591001 1129 
11291002  56-85 29JUL2020  220159  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
11291003  C4591001 1129 
11291003  56-85 29JUL2020  220164  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
11291004  C4591001 1129 
11291004  56-85 29JUL2020  220165  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
11291005  C4591001 1129 
11291005  18-55 29JUL2020  40184  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
11291006  C4591001 1129 
11291006  18-55 29JUL2020  40188  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
11291007  C4591001 1129 
11291007  56-85 29JUL2020  220166  Placebo  29JUL2020  Placebo  17AUG2020  Placebo  
11291008  C4591001 1129 
11291008  56-85 29JUL2020  220325  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
11291009  C4591001 1129 
11291009  56-85 30JUL2020  220332  Placebo  30JUL2020  Placebo  19AUG2020  Placebo  
11291010  C4591001 1129 
11291010  18-55 30JUL2020  40192  Placebo  30JUL2020  Placebo  19AUG2020  Placebo  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 30
FDA-CBER-2021-5683-0024807
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
11291011  C4591001 1129 
11291011  56-85 30JUL2020  220334  Placebo  30JUL2020  Placebo  19AUG2020  Placebo  
11291012  C4591001 1129 
11291012  56-85 30JUL2020  220336  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
11291013  C4591001 1129 
11291013  56-85 30JUL2020  220481  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
11291014  C4591001 1129 
11291014  18-55 30JUL2020  40626  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
11291015  C4591001 1129 
11291015  56-85 30JUL2020  220484  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
11291016  C4591001 1129 
11291016  56-85 30JUL2020  220489  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
11331001  C4591001 1133 
11331001  18-55 30JUL2020  40463  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
11331002  C4591001 1133 
11331002  56-85 30JUL2020  220397  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
11331003  C4591001 1133 
11331003  18-55 30JUL2020  40466  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
11331004  C4591001 1133 
11331004  18-55 30JUL2020  40465  Placebo  30JUL2020  Placebo  21AUG2020  Placebo  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 31
FDA-CBER-2021-5683-0024808
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
11331005  C4591001 1133 
11331005  56-85 30JUL2020  220400  Placebo  30JUL2020  Placebo  21AUG2020  Placebo  
11331007  C4591001 1133 
11331007  56-85 30JUL2020  220403  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
11331008  C4591001 1133 
11331008  56-85 30JUL2020  220554  Placebo  30JUL2020  Placebo  21AUG2020  Placebo  
11331009  C4591001 1133 
11331009  56-85 30JUL2020  220401  Placebo  30JUL2020  Placebo  21AUG2020  Placebo  
11331010  C4591001 1133 
11331010  56-85 30JUL2020  220553  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
11331011  C4591001 1133 
11331011  18-55 30JUL2020  40467  Placebo  30JUL2020  Placebo  21AUG2020  Placebo  
11331012  C4591001 1133 
11331012  56-85 30JUL2020  220561  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
11331013  C4591001 1133 
11331013  56-85 30JUL2020  220563  Placebo  30JUL2020  Placebo  21AUG2020  Placebo  
11331014  C4591001 1133 
11331014  18-55 30JUL2020  40650  Placebo  30JUL2020  Placebo  21AUG2020  Placebo  
11331016  C4591001 1133 
11331016  18-55 30JUL2020  40651  Placebo  30JUL2020  Placebo  24AUG2020  Placebo  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 32
FDA-CBER-2021-5683-0024809
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
11391001  C4591001 1139 
11391001  18-55 29JUL2020  40075  Placebo  29JUL2020  Placebo  20AUG2020  Placebo  
11391002  C4591001 1139 
11391002  56-85 29JUL2020  220061  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
11391003  C4591001 1139 
11391003  56-85 29JUL2020  220062  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
11391004  C4591001 1139 
11391004  56-85 29JUL2020  220068  Placebo  29JUL2020  Placebo  20AUG2020  Placebo  
11391005  C4591001 1139 
11391005  56-85 29JUL2020  220071  Placebo  29JUL2020  Placebo  20AUG2020  Placebo  
11391006  C4591001 1139 
11391006  56-85 29JUL2020  220175  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
11391007  C4591001 1139 
11391007  18-55 29JUL2020  40076  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
11391008  C4591001 1139 
11391008  56-85 29JUL2020  220177  Placebo  29JUL2020  Placebo  20AUG2020  Placebo  
11391009  C4591001 1139 
11391009  56-85 29JUL2020  220178  Placebo  29JUL2020  Placebo  20AUG2020  Placebo  
11391010  C4591001 1139 
11391010  18-55 29JUL2020  40078  Placebo  29JUL2020  Placebo  20AUG2020  Placebo  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 33
FDA-CBER-2021-5683-0024810
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
11391011  C4591001 1139 
11391011  56-85 30JUL2020  220180  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
11391012  C4591001 1139 
11391012  56-85 30JUL2020  220421  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
11391013  C4591001 1139 
11391013  56-85 30JUL2020  220423  Placebo  30JUL2020  Placebo  19AUG2020  Placebo  
11391014  C4591001 1139 
11391014  56-85 30JUL2020  220425  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
11391015  C4591001 1139 
11391015  18-55 30JUL2020  40084  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
11401001  C4591001 1140 
11401001  18-55 29JUL2020  40099  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
11401002  C4591001 1140 
11401002  56-85 29JUL2020  220241  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
11401003  C4591001 1140 
11401003  56-85 29JUL2020  220245  Placebo  29JUL2020  Placebo  17AUG2020  Placebo  
11401004  C4591001 1140 
11401004  56-85 29JUL2020  220246  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
11401005  C4591001 1140 
11401005  56-85 30JUL2020  220251  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 34
FDA-CBER-2021-5683-0024811
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
11401006  C4591001 1140 
11401006  18-55 30JUL2020  40103  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
11401007  C4591001 1140 
11401007  56-85 30JUL2020  220541  Placebo  30JUL2020  Placebo  19AUG2020  Placebo  
11401008  C4591001 1140 
11401008  56-85 30JUL2020  220542  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
11411001  C4591001 1141 
11411001  56-85 30JUL2020  220469  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
11421001  C4591001 1142 
11421001  18-55 29JUL2020  40157  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
11421002  C4591001 1142 
11421002  18-55 29JUL2020  40160  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
11421003  C4591001 1142 
11421003  56-85 29JUL2020  220134  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
11421004  C4591001 1142 
11421004  18-55 29JUL2020  40167  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
11421005  C4591001 1142 
11421005  56-85 29JUL2020  220135  Placebo  29JUL2020  Placebo  17AUG2020  Placebo  
11421006  C4591001 1142 
11421006  56-85 29JUL2020  220136  Placebo  29JUL2020  Placebo  17AUG2020  Placebo  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 35
FDA-CBER-2021-5683-0024812
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
11421007  C4591001 1142 
11421007  18-55 29JUL2020  40168  Placebo  29JUL2020  Placebo  17AUG2020  Placebo  
11421008  C4591001 1142 
11421008  18-55 29JUL2020  40254  Placebo  29JUL2020  Placebo  17AUG2020  Placebo  
11421010  C4591001 1142 
11421010  18-55 30JUL2020  40259  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
11421011  C4591001 1142 
11421011  18-55 30JUL2020  40261  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
11421012  C4591001 1142 
11421012  56-85 30JUL2020  220138  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
11421013  C4591001 1142 
11421013  56-85 30JUL2020  220601  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
11421014  C4591001 1142 
11421014  18-55 30JUL2020  40264  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
11421015  C4591001 1142 
11421015  18-55 30JUL2020  40607  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
11421016  C4591001 1142 
11421016  18-55 30JUL2020  40610  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
11471001  C4591001 1147 
11471001  18-55 30JUL2020  40577  Placebo  30JUL2020  Placebo  21AUG2020  Placebo  
  
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 36
FDA-CBER-2021-5683-0024813
16.1.7.2 Listing of Randomization Scheme and Actual Vaccine Received – Phase 2 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
a.     Subject Study Identifier = the subject study identifier is the current study 4 -digit site number followed by unique 4 -digit subject identifier.  
PFIZER CONFIDENTIAL SDTM Creation: 05SEP2020 (14:18) Source Data: adsl Table Generation: 10SEP2020 (21:41)  
(Cutoff Date: 02SEP2020, Snapshot Date: 04SEP2020) Output File: ./nda2_unblinded/C4591001_IA_P2/adsl_l003_p2   
 
 
090177e194e7a460\Final\Final On: 14-Sep-2020 01:45 (GMT) 
Page 37
FDA-CBER-2021-5683-0024814
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10011004  C4591001 
1001 
10011004  18-55 04MAY2020  1084  BNT162b1  
(10 μg)  04MAY2020  BNT162b1  
(10 μg)  26MAY2020  BNT162b1  
(10 μg)  
10011005  C4591001 
1001 
10011005  18-55 06MAY2020  1093  Placebo  06MAY2020  Placebo  26MAY2020  Placebo  
10011006  C4591001 
1001 
10011006  18-55 06MAY2020  1090  BNT162b1  
(10 μg)  06MAY2020  BNT162 b1 
(10 μg)  27MAY2020  BNT162b1  
(10 μg)  
10011007  C4591001 
1001 
10011007  18-55 06MAY2020  1092  BNT162b1  
(10 μg)  06MAY2020  BNT162b1  
(10 μg)  28MAY2020  BNT162b1  
(10 μg)  
10011008  C4591001 
1001 
10011008  18-55 06MAY2020  1094  BNT162b1  
(10 μg)  06MAY2020  BNT162b1  
(10 μg) 27MAY2020  BNT162b1  
(10 μg)  
10011009  C4591001 
1001 
10011009  18-55 06MAY2020  1095  BNT162b1  
(10 μg)  06MAY2020  BNT162b1  
(10 μg)  27MAY2020  BNT162b1  
(10 μg)  
10011011  C4591001 
1001 
10011011  18-55 11MAY2020  1220  BNT162b1  
(30 μg)  11MAY2020  BNT162b1  
(30 μg)  01JUN2020  BNT162b1  
(30 μg)  
10011012  C4591001 
1001 
10011012  18-55 13MAY2020  1230  BNT162b1  
(30 μg)  13MAY2020  BNT162b1  
(30 μg)  03JUN2020  BNT162b1  
(30 μg)  
10011013  C4591001 
1001 
10011013  18-55 18MAY2020  1355  Placebo  18MAY2020  Placebo  17AUG2020  Placebo  
100110 15 C4591001 
1001 
10011015  18-55 11MAY2020  1219  BNT162b1  
(30 μg)  11MAY2020  BNT162b1  
(30 μg)  01JUN2020  BNT162b1  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 38
FDA-CBER-2021-5683-0024815
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10011017  C4591001 
1001 
10011017  18-55 13MAY2020  1228  BNT162b1  
(30 μg)  13MAY2020  BNT162b1  
(30 μg)  03JUN2020  BNT162b1  
(30 μg)  
10011019  C4591001 
1001 
10011019  18-55 13MAY2020  1229  BNT162b1  
(30 μg)  13MAY2020  BNT162b1  
(30 μg)  03JUN2020  BNT162b1  
(30 μg)  
10011020  C4591001 
1001 
10011020  18-55 13MAY2020  1226  BNT162b1  
(30 μg)  13MAY2020  BNT162b1  
(30 μg)  03JUN2020  BNT162b1  
(30 μg)  
10011021  C4591001 
1001 
10011021  18-55 20MAY2020  1356  Placebo  20MAY2020  Placebo  17AUG2020  Placebo  
10011024  C4591001 
1001 
10011024  18-55 13MAY2020  1225  BNT162b1  
(30 μg)  13MAY2020  BNT162b1  
(30 μg)  03JUN2020  BNT162b1  
(30 μg)  
10011026  C4591001 
1001 
10011026  18-55 18MAY2020  1354 BNT162b1  
(100 μg)  18MAY2020  BNT162b1  
(100 μg)  13AUG2020  BNT162b1  
(10 μg)  
10011028  C4591001 
1001 
10011028  18-55 20MAY2020  1359  BNT162b1  
(100 μg)  20MAY2020  BNT162b1  
(100 μg)  17AUG2020  BNT162b1  
(10 μg)  
10011030  C4591001 
1001 
10011030  18-55 20MAY2020  1357  BNT162b1  
(100 μg)  20MAY2020  BNT162b1  
(100 μg)  17AUG2020  BNT162b1  
(10 μg)  
10011032  C4591001 
1001 
10011032  18-55 20MAY2020  1360  BNT162b1  
(100 μg)  20MAY2020  BNT162b1  
(100 μg)  13AUG2020  BNT162b1  
(10 μg)  
10011034  C4591001 
1001 
10011034  18-55 20MAY2020  1358  BNT162b1  
(100 μg)  20MAY2020  BNT162b1  
(100 μg)  17AUG2020  BNT162b1  
(10 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 39
FDA-CBER-2021-5683-0024816
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10011037  C4591001 
1001 
10011037  65-85 11JUN2020  1631  BNT162b1  
(10 μg)  11JUN2020  BNT162b1  
(10 μg)  30JUN2020  BNT162b1  
(10 μg)  
10011039  C4591001 
1001 
10011039  65-85 09JUN2020  1624  BNT162 b1 
(10 μg)  09JUN2020  BNT162b1  
(10 μg)  29JUN2020  BNT162b1  
(10 μg)  
10011040  C4591001 
1001 
10011040  65-85 11JUN2020  1635  BNT162b1  
(10 μg)  11JUN2020  BNT162b1  
(10 μg)  02JUL2020  BNT162b1  
(10 μg)  
10011041  C4591001 
1001 
10011041  65-85 11JUN2020  1632  BNT162b1  
(10 μg) 11JUN2020  BNT162b1  
(10 μg)  02JUL2020  BNT162b1  
(10 μg)  
10011042  C4591001 
1001 
10011042  65-85 11JUN2020  1634  Placebo  11JUN2020  Placebo  30JUN2020  Placebo  
10011043  C4591001 
1001 
10011043  65-85 15JUN2020  2029  BNT162b1  
(20 μg)  15JUN2020  BNT162b1  
(20 μg)  08JUL2020  BNT162b1  
(20 μg)  
10011044  C4591001 
1001 
10011044  65-85 09JUN2020  1625  BNT162b1  
(10 μg)  09JUN2020  BNT162b1  
(10 μg)  29JUN2020  BNT162b1  
(10 μg)  
10011045  C4591001 
1001 
10011045  65-85 11JUN2020  1633  BNT162b1  
(10 μg)  11JUN2020  BNT162b1  
(10 μg)  02JUL20 20 BNT162b1  
(10 μg)  
10011046  C4591001 
1001 
10011046  65-85 18JUN2020  1767  BNT162b1  
(30 μg)  18JUN2020  BNT162b1  
(30 μg)  09JUL2020  BNT162b1  
(30 μg)  
10011048  C4591001 
1001 
10011048  65-85 16JUN2020  1759  BNT162b1  
(30 μg)  16JUN2020  BNT162b1  
(30 μg)  08JUL2020  BNT 162b1  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 40
FDA-CBER-2021-5683-0024817
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10011049  C4591001 
1001 
10011049  65-85 15JUN2020  2030  BNT162b1  
(20 μg)  15JUN2020  BNT162b1  
(20 μg)  06JUL2020  BNT162b1  
(20 μg)  
10011050  C4591001 
1001 
10011050  65-85 17JUN2020  2031  BNT162b1  
(20 μg)  17JUN2020  BNT162b1  
(20 μg)  07JUL2020  BNT162b1  
(20 μg)  
10011052  C4591001 
1001 
10011052  65-85 17JUN2020  2037  BNT162b1  
(20 μg)  17JUN2020  BNT162b1  
(20 μg)  08JUL2020  BNT162b1  
(20 μg)  
10011053  C4591001 
1001 
10011053  65-85 16JUN2020  1760  Placebo  16JUN2020  Placebo  09JUL2020  Placebo  
10011055  C4591001 
1001 
10011055  65-85 17JUN2020  2039  BNT162b1  
(20 μg)  17JUN2020  BNT162b1  
(20 μg)  08JUL2020  BNT162b1  
(20 μg)  
10011057  C4591001 
1001 
10011057  65-85 17JUN2020  2038  Placebo  17JUN2020  Placebo  08JUL2020  Placebo  
10011058  C4591001 
1001 
10011058  65-85 18JUN2020  1768  BNT1 62b1  
(30 μg)  18JUN2020  BNT162b1  
(30 μg)  09JUL2020  BNT162b1  
(30 μg)  
10011059  C4591001 
1001 
10011059  65-85 17JUN2020  2040  BNT162b1  
(20 μg)  17JUN2020  BNT162b1  
(20 μg)  08JUL2020  BNT162b1  
(20 μg)  
10011061  C4591001 
1001 
10011061  65-85 18JUN2020  1765  BNT162b1  
(30 μg)  18JUN2020  BNT162b1  
(30 μg)  09JUL2020  BNT162b1  
(30 μg)  
10011063  C4591001 
1001 
10011063  65-85 18JUN2020  1769  BNT162b1  
(30 μg)  18JUN2020  BNT162b1  
(30 μg)  07JUL2020  BNT162b1  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 41
FDA-CBER-2021-5683-0024818
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10011064  C4591001 
1001 
10011064  65-85 18JUN2020  1770  Placebo  18JUN202 0 Placebo  07JUL2020  Placebo  
10011066  C4591001 
1001 
10011066  18-55 29JUN2020  1489  Placebo  29JUN2020  Placebo  20JUL2020  Placebo  
10011067  C4591001 
1001 
10011067  18-55 01JUL2020  1499  BNT162b1  
(20 μg)  01JUL2020  BNT162b1  
(20 μg)  22JUL2020  BNT162b1  
(20 μg)  
1001 1068  C4591001 
1001 
10011068  18-55 29JU N2020  1490  BNT162b1  
(20 μg)  29JUN2020  BNT162b1  
(20 μg)  20JUL2020  BNT162b1  
(20 μg)  
10011069  C4591001 
1001 
10011069  18-55 01JUL2020  1496  Placebo  01JUL2020  Placebo  22JUL2020  Placebo  
10011070  C4591001 
1001 
10011070  18-55 01JUL2020  1500  BNT162b1  
(20 μg)  01JUL2020  BNT162b1  
(20 μg)  22JUL2020  BNT162b1  
(20 μg)  
10011071  C4591001 
1001 
10011071  18-55 01JUL2020  1497  BNT162b1  
(20 μg)  01JUL2020  BNT162b1  
(20 μg)  22JUL2020  BNT162b1  
(20 μg)  
10011076  C4591001 
1001 
10011076  18-55 01JUL 2020  1498  BNT162b1  
(20 μg)  01JUL2020  BNT162b1  
(20 μg)  21JUL2020  BNT162b1  
(20 μg)  
10011081  C4591001 
1001 
10011081  >55 28JUL2020  220015  Placebo  28JUL2020  Placebo  18AUG2020  Placebo  
10011082  C4591001 
1001 
10011082  >55 03AUG2020  221589  BNT162b2  
(30 μg)  03AUG2 020 BNT162b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 42
FDA-CBER-2021-5683-0024819
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10011083  C4591001 
1001 
10011083  16-55 31JUL2020  40545  BNT162b2  
(30 μg)  31JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10011084  C4591001 
1001 
10011084  >55 28JUL2020  220026  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10011085  C4591001 
1001 
10011085  16-55 28JUL2020  40018  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10011086  C4591001 
1001 
10011086  16-55 28JUL2020  40021  Placebo  28JUL2020  Placebo  18AUG2 020 Placebo  
10011087  C4591001 
1001 
10011087  16-55 28JUL2020  40032  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10011088  C4591001 
1001 
10011088  16-55 28JUL2020  40047  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10011089  C4591001 
1001 
10011089  16-55 28JUL2020  40070  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10011090  C4591001 
1001 
10011090  >55 29JUL2020  220087  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μ g) 
10011091  C4591001 
1001 
10011091  16-55 29JUL2020  40171  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10011092  C4591001 
1001 
10011092  16-55 29JUL2020  40172  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 43
FDA-CBER-2021-5683-0024820
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10011093  C4591001 
1001 
1001 1093  >55 29JUL2020  220088  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10011094  C4591001 
1001 
10011094  >55 29JUL2020  220090  Placebo  29JUL2020  Placebo  20AUG2020  Placebo  
10011095  C4591001 
1001 
10011095  16-55 29JUL2020  40178  BNT162 b2 
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10011096  C4591001 
1001 
10011096  >55 29JUL2020  220095  Placebo  29JUL2020  Placebo  20AUG2020  Placebo  
10011097  C4591001 
1001 
10011097  >55 30JUL2020  220387  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg) 21AUG2020  BNT162b2  
(30 μg)  
10011098  C4591001 
1001 
10011098  >55 30JUL2020  220393  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10011099  C4591001 
1001 
10011099  >55 30JUL2020  220389  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10011100  C4591001 
1001 
10011100  >55 30JUL2020  220395  Placebo  30JUL2020  Placebo  18AUG2020  Placebo  
10011101  C4591001 
1001 
10011101  16-55 30JUL2020  40180  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10011102  C4591001 
1001 
10011102  16-55 30JUL2020  40541  Place bo 30JUL2020  Placebo  20AUG2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 44
FDA-CBER-2021-5683-0024821
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10011103  C4591001 
1001 
10011103  >55 30JUL2020  220625  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
10011104  C4591001 
1001 
10011104  >55 30JUL2020  220626  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
10011105  C4591001 
1001 
10011105  16-55 31JUL2020  40547  Place bo 31JUL2020  Placebo  21AUG2020  Placebo  
10011106  C4591001 
1001 
10011106  16-55 31JUL2020  40552  BNT162b2  
(30 μg)  31JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10011107  C4591001 
1001 
10011107  16-55 31JUL2020  41035  Placebo  31JUL2020  Placebo  21AUG2020  Placebo  
10011108  C4591001 
1001 
10011108  >55 31JUL2020  220631  Placebo  31JUL2020  Placebo  19AUG2020  Placebo  
10011109  C4591001 
1001 
10011109  >55 31JUL2020  221105  BNT162b2  
(30 μg)  31JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10011110  C4591001 
1001 
10011110  >55 31JUL2020  220633  Placebo  31JUL2020  Placebo  21AUG2020  Placebo  
10011111  C4591001 
1001 
10011111  >55 31JUL2020  221108  Placebo  31JUL2020  Placebo  24AUG2020  Placebo  
10011112  C4591001 
1001 
10011112  >55 03AUG2020  221112  BNT162b2  
(30 μg)  03AUG2020  BNT1 62b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 45
FDA-CBER-2021-5683-0024822
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10011113  C4591001 
1001 
10011113  16-55 03AUG2020  41039  BNT162b2  
(30 μg)  03AUG2020  BNT162b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  
10011114  C4591001 
1001 
10011114  >55 03AUG2020  221113  Placebo  03AUG2020  Placebo  24AUG2020  Placebo  
10011115  C4591001 
1001 
10011115  >55 03AUG2020  221593  Placebo  03AUG2020  Placebo  25AUG2020  Placebo  
10011116  C4591001 
1001 
10011116  >55 03AUG2020  221595  Placebo  03AUG2020  Placebo  25AUG2020  Placebo  
10011117  C4591001 
1001 
10011117  >55 03AUG2020  22159 6 BNT162b2  
(30 μg)  03AUG2020  BNT162b2  
(30 μg)  26AUG2020  BNT162b2  
(30 μg)  
10011118  C4591001 
1001 
10011118  >55 03AUG2020  221792  BNT162b2  
(30 μg)  03AUG2020  BNT162b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  
10011119  C4591001 
1001 
10011119  >55 03AUG2020  221793  Placeb o 03AUG2020  Placebo  24AUG2020  Placebo  
10011120  C4591001 
1001 
10011120  >55 04AUG2020  221798  Placebo  04AUG2020  Placebo  25AUG2020  Placebo  
10011121  C4591001 
1001 
10011121  >55 04AUG2020  221799  BNT162b2  
(30 μg)  04AUG2020  BNT162b2  
(30 μg)  25AUG2020  BNT162b2  
(30 μg) 
10011122  C4591001 
1001 
10011122  >55 04AUG2020  222235  BNT162b2  
(30 μg)  04AUG2020  BNT162b2  
(30 μg)  25AUG2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 46
FDA-CBER-2021-5683-0024823
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10011123  C4591001 
1001 
10011123  >55 04AUG2020  222239  BNT162b2  
(30 μg)  04AUG2020  BNT162b2  
(30 μg)  25AUG2020  BNT162 b2 
(30 μg)  
10011124  C4591001 
1001 
10011124  >55 04AUG2020  222244  Placebo  04AUG2020  Placebo  26AUG2020  Placebo  
10011125  C4591001 
1001 
10011125  16-55 04AUG2020  41040  BNT162b2  
(30 μg)  04AUG2020  BNT162b2  
(30 μg)   
  
10011126  C4591001 
1001 
10011126  16-55 04AUG2020  41042  Placebo  04AUG2020  Placebo  24AUG2020  Placebo  
10011127  C4591001 
1001 
10011127  >55 04AUG2020  222243  Placebo  04AUG2020  Placebo  25AUG2020  Placebo  
10011129  C4591001 
1001 
10011129  16-55 05AUG2020  42967  BNT162b2  
(30 μg)  05AUG2020  BNT162b2  
(30 μg)  24AUG2020  BNT162b 2 
(30 μg)  
10011130  C4591001 
1001 
10011130  16-55 05AUG2020  42969  Placebo  05AUG2020  Placebo  26AUG2020  Placebo  
10011131  C4591001 
1001 
10011131  16-55 05AUG2020  42976  BNT162b2  
(30 μg)  05AUG2020  BNT162b2  
(30 μg)  26AUG2020  BNT162b2  
(30 μg)  
10011132  C4591001 
1001 
10011132  16-55 05AUG2020  42973  Placebo  05AUG2020  Placebo  26AUG2020  Placebo  
10011133  C4591001 
1001 
10011133  >55 05AUG2020  222907  BNT162b2  
(30 μg)  05AUG2020  BNT162b2  
(30 μg)  27AUG2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 47
FDA-CBER-2021-5683-0024824
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10011134  C4591001 
1001 
10011134  >55 05AUG2020  222906  Placebo  05AUG2020  Placebo  26AUG2020  Placebo  
10011135  C4591001 
1001 
10011135  16-55 05AUG2020  43218  Placebo  05AUG2020  Placebo  24AUG2020  Placebo  
10011136  C4591001 
1001 
10011136  16-55 06AUG2020  43219  BNT162b2  
(30 μg)  06AUG2020  BNT162b2  
(30 μg)  27AUG2020  BNT 162b2  
(30 μg)  
10011137  C4591001 
1001 
10011137  >55 06AUG2020  43221  BNT162b2  
(30 μg)  06AUG2020  BNT162b2  
(30 μg)  27AUG2020  BNT162b2  
(30 μg)  
10011138  C4591001 
1001 
10011138  16-55 06AUG2020  43225  Placebo  06AUG2020  Placebo  27AUG2020  Placebo  
10011139  C4591001 
1001 
10011139  >55 06AUG2020  222908  BNT162b2  
(30 μg)  06AUG2020  BNT162b2  
(30 μg)  27AUG2020  BNT162b2  
(30 μg)  
10011141  C4591001 
1001 
10011141  >55 06AUG2020  222916  Placebo  06AUG2020  Placebo  27AUG2020  Placebo  
10011142  C4591001 
1001 
10011142  >55 06AUG2020  22364 9 Placebo  06AUG2020  Placebo  25AUG2020  Placebo  
10011143  C4591001 
1001 
10011143  16-55 06AUG2020  43877  BNT162b2  
(30 μg)  06AUG2020  BNT162b2  
(30 μg)  27AUG2020  BNT162b2  
(30 μg)  
10011144  C4591001 
1001 
10011144  >55 07AUG2020  223653  Placebo  07AUG2020  Placebo  28AU G2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 48
FDA-CBER-2021-5683-0024825
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10011145  C4591001 
1001 
10011145  16-55 07AUG2020  43878  Placebo  07AUG2020  Placebo  28AUG2020  Placebo  
10011146  C4591001 
1001 
10011146  16-55 07AUG2020  43882  Placebo  07AUG2020  Placebo  28AUG2020  Placebo  
10011147  C4591001 
1001 
10011147  >55 07AUG20 20 223655  BNT162b2  
(30 μg)  07AUG2020  BNT162b2  
(30 μg)  28AUG2020  BNT162b2  
(30 μg)  
10011148  C4591001 
1001 
10011148  >55 07AUG2020  223656  BNT162b2  
(30 μg)  07AUG2020  BNT162b2  
(30 μg)  28AUG2020  BNT162b2  
(30 μg)  
10011149  C4591001 
1001 
10011149  16-55 07AUG2020  43887  BNT16 2b2 
(30 μg)  07AUG2020  BNT162b2  
(30 μg)  28AUG2020  BNT162b2  
(30 μg)  
10021003  C4591001 
1002 
10021003  18-55 04MAY2020  1081  BNT162b1  
(10 μg)  04MAY2020  BNT162b1  
(10 μg)  26MAY2020  BNT162b1  
(10 μg)  
10021004  C4591001 
1002 
10021004  18-55 04MAY2020  1082  BNT162b1  
(10 μg)  04MAY2020  BNT162b1  
(10 μg)  26MAY2020  BNT162b1  
(10 μg)  
10021005  C4591001 
1002 
10021005  18-55 04MAY2020  1083  Placebo  04MAY2020  Placebo  26MAY2020  Placebo  
10021006  C4591001 
1002 
10021006  18-55 11MAY2020  1218  BNT162b1  
(30 μg)  11MAY2020  BNT162b1  
(30 μg)  02JUN2020  BNT162b1  
(30 μg)  
10021007  C4591001 
1002 
10021007  18-55 06MAY2020  1089  BNT162b1  
(10 μg)  06MAY2020  BNT162b1  
(10 μg)  26MAY2020  BNT162b1  
(10 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 49
FDA-CBER-2021-5683-0024826
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10021008  C4591001 
1002 
10021008  18-55 06MAY2020  1088  Placebo  06MAY2020  Placebo  26MAY2020  Placebo  
10021 009 C4591001 
1002 
10021009  18-55 06MAY2020  1091  BNT162b1  
(10 μg)  06MAY2020  BNT162b1  
(10 μg)  26MAY2020  BNT162b1  
(10 μg)  
10021011  C4591001 
1002 
10021011  18-55 06MAY2020  1086  BNT162b1  
(10 μg)  06MAY2020  BNT162b1  
(10 μg)  26MAY2020  BNT162b1  
(10 μg)  
10021012  C4591001 
1002 
10021012  18-55 05MAY2020  1085  BNT162b1  
(10 μg)  05MAY2020  BNT162b1  
(10 μg)  26MAY2020  BNT162b1  
(10 μg)  
10021013  C4591001 
1002 
10021013  18-55 06MAY2020  1087  BNT162b1  
(10 μg)  06MAY2020  BNT162b1  
(10 μg)  26MAY2020  BNT162b1  
(10 μg)  
100210 14 C4591001  
1002 
10021014  18-55 13MAY2020  1224  BNT162b1  
(30 μg)  13MAY2020  BNT162b1  
(30 μg)  02JUN2020  BNT162b1  
(30 μg)  
10021015  C4591001 
1002 
10021015  18-55 11MAY2020  1216  BNT162b1  
(30 μg)  11MAY2020  BNT162b1  
(30 μg)  02JUN2020  BNT162b1  
(30 μg)  
10021017  C4591001 
1002 
10021017  18-55 13MAY2020  1221  BNT162b1  
(30 μg)  13MAY2020  BNT162b1  
(30 μg)  02JUN2020  BNT162b1  
(30 μg)  
10021018  C4591001 
1002 
10021018  18-55 11MAY2020  1217  Placebo  11MAY2020  Placebo  02JUN2020  Placebo  
10021020  C4591001 
1002 
10021020  18-55 13MAY2020  1222  BNT 162b1  
(30 μg)  13MAY2020  BNT162b1  
(30 μg)  02JUN2020  BNT162b1  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 50
FDA-CBER-2021-5683-0024827
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10021021  C4591001 
1002 
10021021  18-55 13MAY2020  1223  Placebo  13MAY2020  Placebo  02JUN2020  Placebo  
10021022  C4591001 
1002 
10021022  18-55 13MAY2020  1227  Placebo  13MAY2020  Placebo  02JUN2020  Placebo  
10021023  C4591001 
1002 
10021023  18-55 18MAY2020  1352  BNT162b1  
(100 μg)  18MAY2020  BNT162b1  
(100 μg)  17AUG2020  BNT162b1  
(10 μg)  
10021024  C4591001 
1002 
10021024  18-55 18MAY2020  1353  BNT162b1  
(100 μg)  18MAY2020  BNT162b1  
(100 μg)  31AUG2020  BNT162b1  
(10 μg)  
10021027  C4591001 
1002 
10021027  18-55 18MAY2020  1351  BNT162b1  
(100 μg)  18MAY2020  BNT162b1  
(100 μg)  17AUG2020  BNT162b1  
(10 μg)  
10021034  C4591001 
1002 
10021034  18-55 21MAY2020  1363  BNT162b1  
(100 μg)  21MAY2020  BNT162b1  
(100 μg)  17AUG2020  BNT162b1  
(10 μg) 
10021035  C4591001 
1002 
10021035  18-55 21MAY2020  1361  BNT162b1  
(100 μg)  21MAY2020  BNT162b1  
(100 μg)  18AUG2020  BNT162b1  
(10 μg)  
10021036  C4591001 
1002 
10021036  18-55 21MAY2020  1364  BNT162b1  
(100 μg)  21MAY2020  BNT162b1  
(100 μg)  18AUG2020  BNT162b1  
(10 μg ) 
10021038  C4591001 
1002 
10021038  18-55 21MAY2020  1365  BNT162b1  
(100 μg)  21MAY2020  BNT162b1  
(100 μg)  17AUG2020  BNT162b1  
(10 μg)  
10021041  C4591001 
1002 
10021041  18-55 21MAY2020  1362  Placebo  21MAY2020  Placebo  17AUG2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 51
FDA-CBER-2021-5683-0024828
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10021042  C4591001 
1002 
10021 042 65-85 09JUN2020  1623  Placebo  09JUN2020  Placebo  30JUN2020  Placebo  
10021043  C4591001 
1002 
10021043  65-85 09JUN2020  1621  BNT162b1  
(10 μg)  09JUN2020  BNT162b1  
(10 μg)  30JUN2020  BNT162b1  
(10 μg)  
10021044  C4591001 
1002 
10021044  65-85 09JUN2020  1622  BNT162b1  
(10 μg)  09JUN2020  BNT162b1  
(10 μg)  30JUN2020  BNT162b1  
(10 μg)  
10021045  C4591001 
1002 
10021045  65-85 11JUN2020  1629  BNT162b1  
(10 μg)  11JUN2020  BNT162b1  
(10 μg)  30JUN2020  BNT162b1  
(10 μg)  
10021047  C4591001 
1002 
10021047  65-85 11JUN2020  1626  Placebo  11JUN2 020 Placebo  30JUN2020  Placebo  
10021049  C4591001 
1002 
10021049  65-85 11JUN2020  1630  BNT162b1  
(10 μg)  11JUN2020  BNT162b1  
(10 μg)  30JUN2020  BNT162b1  
(10 μg)  
10021050  C4591001 
1002 
10021050  65-85 15JUN2020  2026  Placebo  15JUN2020  Placebo  07JUL2020  Placebo  
10021052  C4591001 
1002 
10021052  65-85 11JUN2020  1628  BNT162b1  
(10 μg)  11JUN2020  BNT162b1  
(10 μg)  30JUN2020  BNT162 b1 
(10 μg)  
10021053  C4591001 
1002 
10021053  65-85 11JUN2020  1627  BNT162b1  
(10 μg)  11JUN2020  BNT162b1  
(10 μg)  30JUN2020  BNT162b1  
(10 μg)  
10021054  C4591001 
1002 
10021054  65-85 15JUN2020  2028  BNT162b1  
(20 μg)  15JUN2020  BNT162b1  
(20 μg)  07JUL2020  BNT162b1  
(20 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 52
FDA-CBER-2021-5683-0024829
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10021059  C4591001 
1002 
10021059  65-85 15JUN2020  1757  BNT162b1  
(30 μg)  15JUN2020  BNT162b1  
(30 μg)  07JUL2020  BNT162b1  
(30 μg)  
10021060  C4591 001 
1002 
10021060  65-85 15JUN2020  2027  BNT162b1  
(20 μg)  15JUN2020  BNT162b1  
(20 μg)  07JUL2020  BNT162b1  
(20 μg)  
10021062  C4591001 
1002 
10021062  65-85 15JUN2020  1756  BNT162b1  
(30 μg)  15JUN2020  BNT162b1  
(30 μg)  07JUL2020  BNT162b1  
(30 μg)  
10021063  C4591001 
1002 
10021063  65-85 15JUN2020  1758  BNT162b1  
(30 μg)  15JUN2020  BNT162b1  
(30 μg)  07JUL2020  BNT162b1  
(30 μg)  
10021064  C4591001 
1002 
10021064  65-85 17JUN2020  2034  BNT162b1  
(20 μg)  17JUN2020  BNT162b1  
(20 μg)  08JUL2020  BNT162b1  
(20 μg)  
10021067  C4591001 
1002 
10021067  65-85 17JUN2020  2032  BNT162b1  
(20 μg)  17JUN2020  BNT162b1  
(20 μg)  08JUL2020  BNT162b1  
(20 μg)  
10021068  C4591001 
1002 
10021068  65-85 17JUN2020  2035  BNT162b1  
(20 μg)  17JUN2020  BNT162b1  
(20 μg)  08JUL2020  BNT162b1  
(20 μg)  
10021069  C4591001 
1002 
10021069  65-85 18JUN2020  1764  BNT162b1  
(30 μg)  18JUN2020  BNT162b1  
(30 μg)  08JUL2020  BNT162b1  
(30 μg)  
10021071  C4591001 
1002 
10021071  65-85 17JUN2020  2036  BNT162b1  
(20 μg)  17JUN2020  BNT162b1  
(20 μg)  08JUL2020  BNT162b1  
(20 μg)  
10021072  C4591001 
1002 
10021072  65-85 18JUN2020  1761  Placebo  18JUN2020  Placebo  08JUL2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 53
FDA-CBER-2021-5683-0024830
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10021073  C4591001 
1002 
10021073  65-85 17JUN2020  2033  Placebo  17JUN2020  Placebo  08JUL2020  Placebo  
10021074  C4591001 
1002 
10021074  65-85 18JUN2020  1762  BNT162b1  
(30 μg)  18JUN2020  BNT162b1  
(30 μg)  08JUL2020  BNT162b1  
(30 μg)  
10021075  C4591001 
1002 
10021075  65-85 18JUN2020  1766  BNT162b1  
(30 μg)  18JUN2020  BNT162b1  
(30 μg)  08JUL2020  BNT162b1  
(30 μg)  
10021077  C4591001 
1002 
10021077  65-85 18JUN2020  1763  BNT162b1  
(30 μg)  18JUN2020  BNT162b1  
(30 μg)  08JUL20 20 BNT162b1  
(30 μg)  
10021079  C4591001 
1002 
10021079  18-55 29JUN2020  1487  BNT162b1  
(20 μg)  29JUN2020  BNT162b1  
(20 μg)  21JUL2020  BNT162b1  
(20 μg)  
10021080  C4591001 
1002 
10021080  18-55 01JUL2020  1491  BNT162b1  
(20 μg)  01JUL2020  BNT162b1  
(20 μg)  21JUL2020  BNT 162b1  
(20 μg)  
10021081  C4591001 
1002 
10021081  18-55 01JUL2020  1492  BNT162b1  
(20 μg)  01JUL2020  BNT162b1  
(20 μg)  21JUL2020  BNT162b1  
(20 μg)  
10021082  C4591001 
1002 
10021082  18-55 01JUL2020  1494  BNT162b1  
(20 μg)  01JUL2020  BNT162b1  
(20 μg)  21JUL2020  BNT162b1  
(20 μg)  
10021083  C4591001 
1002 
10021083  18-55 01JUL2020  1495  Placebo  01JUL2020  Placebo  21JUL2020  Placebo  
10021084  C4591001 
1002 
10021084  18-55 29JUN2020  1488  BNT162b1  
(20 μg)  29JUN2020  BNT162b1  
(20 μg)  21JUL2020  BNT162b1  
(20 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 54
FDA-CBER-2021-5683-0024831
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10021085  C4591001 
1002 
10021085  18-55 29JUN2020  1486  BNT162b1  
(20 μg)  29JUN2020  BNT162b1  
(20 μg)  21JUL2020  BNT162b1  
(20 μg)  
10021087  C4591001 
1002 
10021087  18-55 01JUL2020  1493  BNT162b1  
(20 μg)  01JUL2020  BNT162b1  
(20 μg)  21JUL2020  BNT162b1  
(20 μg)  
10031016  C4591001 
1003 
1003101 6 18-55 09JUN2020  2164  Placebo  09JUN2020  Placebo  30JUN2020  Placebo  
10031017  C4591001 
1003 
10031017  18-55 11JUN2020  2172  Placebo  11JUN2020  Placebo  02JUL2020  Placebo  
10031018  C4591001 
1003 
10031018  18-55 09JUN2020  2163  BNT162b2  
(10 μg)  09JUN2020  BNT162b2  
(10 μg)  30JUN2020  BNT162b2  
(10 μg)  
10031019  C4591001 
1003 
10031019  18-55 11JUN2020  2170  BNT162b2  
(10 μg)  11JUN2020  BNT162b2  
(10 μg)  02JUL2020  BNT162b2  
(10 μg)  
10031020  C4591001 
1003 
10031020  18-55 11JUN2020  2174  BNT162b2  
(10 μg)  11JUN2020  BNT162b2  
(10 μg)  02JUL2020  BNT162b2  
(10 μg)  
10031021  C4591001 
1003 
10031021  18-55 09JUN2020  2165  BNT162b2  
(10 μg)  09JUN2020  BNT162b2  
(10 μg)  30JUN2020  BNT162b2  
(10 μg)  
10031022  C4591001 
1003 
10031022  18-55 11JUN2020  2171  BNT162b2  
(10 μg)  11JUN2020  BNT162b2  
(10 μg)  02JUL 2020  BNT162b2  
(10 μg)  
10031024  C4591001 
1003 
10031024  18-55 11JUN2020  2173  BNT162b2  
(10 μg)  11JUN2020  BNT162b2  
(10 μg)  02JUL2020  BNT162b2  
(10 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 55
FDA-CBER-2021-5683-0024832
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10031026  C4591001 
1003 
10031026  18-55 17JUN2020  2573  BNT162b2  
(20 μg)  17JUN2020  BNT162b2  
(20 μg)  08JUL2020  BNT162b2  
(20 μg)  
10031027  C4591001 
1003 
10031027  18-55 15JUN2020  2567  BNT162b2  
(20 μg)  15JUN2020  BNT162b2  
(20 μg)  06JUL2020  BNT162b2  
(20 μg)  
10031028  C4591001 
1003 
10031028  18-55 15JUN2020  2566  BNT162b2  
(20 μg)  15JUN2020  BNT162b2  
(20 μg)  06JUL2020  BNT162b 2 
(20 μg)  
10031029  C4591001 
1003 
10031029  18-55 15JUN2020  2568  Placebo  15JUN2020  Placebo  06JUL2020  Placebo  
10031030  C4591001 
1003 
10031030  18-55 17JUN2020  2575  BNT162b2  
(20 μg)  17JUN2020  BNT162b2  
(20 μg)  08JUL2020  BNT162b2  
(20 μg)  
10031031  C4591001 
1003  
10031031  65-85 15JUN2020  3109  BNT162b2  
(20 μg)  15JUN2020  BNT162b2  
(20 μg)  06JUL2020  BNT162b2  
(20 μg)  
10031032  C4591001 
1003 
10031032  18-55 17JUN2020  2572  BNT162b2  
(20 μg)  17JUN2020  BNT162b2  
(20 μg)  08JUL2020  BNT162b2  
(20 μg)  
10031034  C4591001 
1003 
10031 034 18-55 17JUN2020  2571  Placebo  17JUN2020  Placebo  08JUL2020  Placebo  
10031035  C4591001 
1003 
10031035  65-85 15JUN2020  3108  BNT162b2  
(20 μg)  15JUN2020  BNT162b2  
(20 μg)  06JUL2 020 BNT162b2  
(20 μg)  
10031036  C4591001 
1003 
10031036  65-85 15JUN2020  3110  Placebo  15JUN2020  Placebo  06JUL2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 56
FDA-CBER-2021-5683-0024833
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10031037  C4591001 
1003 
10031037  65-85 16JUN2020  2840  BNT162b2  
(30 μg)  16JUN2020  BNT162b2  
(30 μg)  07JUL2020  BNT162b2  
(30 μg)  
10031038  C4591001 
1003 
10031038  18-55 17JUN2020  2574  BNT162b2  
(20 μg)  17JUN2020  BNT162b2  
(20 μ g) 08JUL2020  BNT162b2  
(20 μg)  
10031043  C4591001 
1003 
10031043  65-85 16JUN2020  2838  Placebo  16JUN2020  Placebo  07JUL2020  Placebo  
10031046  C4591001 
1003 
10031046  65-85 18JUN2020  2847  Placebo  18JUN2020  Placebo  09JUL2020  Placebo  
10031047  C4591001 
1003 
100310 47 65-85 16JUN2020  2839  BNT162b2  
(30 μg)  16JUN2020  BNT162b2  
(30 μg)  07JUL2020  BNT162b2  
(30 μg)  
10031050  C4591001 
1003 
10031050  18-55 22JUN2020  2297  Placebo  22JUN2020  Placebo  13JUL2020  Placebo  
10031051  C4591001 
1003 
10031051  65-85 18JUN2020  2848  BNT162b2  
(30 μg)  18JUN2020  BNT162b2  
(30 μg)  09JUL2020  BNT162b2  
(30 μg)  
10031053  C4591001 
1003 
10031053  65-85 17JUN2020  3111  BNT162b2  
(20 μg)  17JUN2020  BNT162b2  
(20 μg)  08JUL2020  BNT162b2  
(20 μg)  
10031054  C4591001 
1003 
10031054  65-85 17JUN2020  3115  BNT162b2  
(20 μg ) 17JUN2020  BNT162b2  
(20 μg)  08JUL2020  BNT162b2  
(20 μg)  
10031055  C4591001 
1003 
10031055  65-85 17JUN2020  3112  BNT162b2  
(20 μg)  17JUN2020  BNT162b2  
(20 μg)  06JUL2020  BNT162b2  
(20 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 57
FDA-CBER-2021-5683-0024834
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10031056  C4591001 
1003 
10031056  65-85 18JUN2020  2844  Placebo  18JUN2020  Placebo  09JUL2020  Placebo  
10031057  C4591001 
1003 
10031057  18-55 24JUN2020  2301  BNT162b2  
(30 μg)  24JUN2020  BNT162b2  
(30 μg)  15JUL2020  BNT162b2  
(30 μg)  
10031058  C4591001 
1003 
10031058  65-85 18JUN2020  2846  BNT162b2  
(30 μg)  18JUN2020  BNT162b2  
(30 μg)  09JUL2020  BNT162b2  
(30 μg)  
10031059  C4591001 
1003 
10031059  18-55 24JUN2020  2305  BNT162b2  
(30 μg)  24JUN2020  BNT162b2  
(30 μg)  15JUL2020  BNT162b2  
(30 μg)  
10031061  C4591001 
1003 
10031061  18-55 22JUN2020  2298  BNT162b2  
(30 μg)  22JUN2020  BNT162b2  
(30 μg)  13JUL2020  BNT162 b2 
(30 μg)  
10031063  C4591001 
1003 
10031063  65-85 17JUN2020  3113  BNT162b2  
(20 μg)  17JUN2020  BNT162b2  
(20 μg)  08JUL2020  BNT162b2  
(20 μg)  
10031065  C4591001 
1003 
10031065  18-55 24JUN2020  2303  BNT162b2  
(30 μg)  24JUN2020  BNT162b2  
(30 μg)  15JUL2020  BNT162b2  
(30 μg) 
10031066  C4591001 
1003 
10031066  18-55 22JUN2020  2296  BNT162b2  
(30 μg)  22JUN2020  BNT162b2  
(30 μg)  13JUL2020  BNT162b2  
(30 μg)  
10031067  C4591001 
1003 
10031067  65-85 17JUN2020  3114  Placebo  17JUN2020  Placebo  08JUL2020  Placebo  
10031069  C4591001 
1003 
1003 1069  65-85 18JUN2020  2845  BNT162b2  
(30 μg)  18JUN2020  BNT162b2  
(30 μg)  09JUL2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 58
FDA-CBER-2021-5683-0024835
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10031070  C4591001 
1003 
10031070  18-55 24JUN2020  2304  Placebo  24JUN2020  Placebo  15JUL2020  Placebo  
10031072  C4591001 
1003 
10031072  18-55 24JUN2020  2302  BNT162b 2 
(30 μg)  24JUN2020  BNT162b2  
(30 μg)  16JUL2020  BNT162b2  
(30 μg)  
10031076  C4591001 
1003 
10031076  65-85 29JUN2020  2702  BNT162b2  
(10 μg)  29JUN2020  BNT162b2  
(10 μg)  20JUL2020  BNT162b2  
(10 μg)  
10031077  C4591001 
1003 
10031077  65-85 01JUL2020  2711  BNT162b2  
(10 μg) 01JUL2020  BNT162b2  
(10 μg)  22JUL2020  BNT162b2  
(10 μg)  
10031078  C4591001 
1003 
10031078  65-85 01JUL2020  2712  BNT162b2  
(10 μg)  01JUL2020  BNT162b2  
(10 μg)  22JUL2020  BNT162b2  
(10 μg)  
10031079  C4591001 
1003 
10031079  65-85 01JUL2020  2715  BNT162b2  
(10 μg)  01JUL2020  BNT162b2  
(10 μg)  22JUL2020  BNT162b2  
(10 μg)  
10031080  C4591001 
1003 
10031080  65-85 29JUN2020  2703  BNT162b2  
(10 μg)  29JUN2020  BNT162b2  
(10 μg)  20JUL2020  BNT162b2  
(10 μg)  
10031083  C4591001 
1003 
10031083  65-85 01JUL2020  2714  Placebo  01JUL2020  Placebo  22JUL2020  Placebo  
10031087  C4591001 
1003 
10031087  65-85 01JUL2020  2713  BNT162b2  
(10 μg)  01JUL2020  BNT162b2  
(10 μg)  22JUL2020  BNT162b2  
(10 μg)  
10031088  C4591001 
1003 
10031088  16-55 27JUL2020  40003  Placebo  27JUL2020  Placebo  17AUG2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 59
FDA-CBER-2021-5683-0024836
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10031089  C4591001 
1003 
10031089  >55 27JUL2020  220001  BNT162b2  
(30 μg)  27JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
10031090  C4591001 
1003 
10031090  16-55 27JUL2020  40006  BNT162b2  
(30 μg)  27JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
10031091  C4591001  
1003 
10031091  >55 27JUL2020  220002  BNT162b2  
(30 μg)  27JUL2020  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  
10031092  C4591001 
1003 
10031092  >55 28JUL2020  220005  Placebo  28JUL2020  Placebo  18AUG2020  Placebo  
10031093  C4591001 
1003 
10031093  >55 28JUL2020  2200 11 Placebo  28JUL2020  Placebo  18AUG2020  Placebo  
10031094  C4591001 
1003 
10031094  16-55 28JUL2020  40009  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10031095  C4591001 
1003 
10031095  >55 28JUL2020  220019  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10031096  C4591001 
1003 
10031096  16-55 28JUL2020  40013  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10031097  C4591001 
1003 
10031097  16-55 28JUL2020  40017  Placebo  28JUL2020  Placebo  18AUG20 20 Placebo  
10031098  C4591001 
1003 
10031098  >55 28JUL2020  220023  Placebo  28JUL2020  Placebo  18AUG2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 60
FDA-CBER-2021-5683-0024837
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10031099  C4591001 
1003 
10031099  >55 28JUL2020  220037  Placebo  28JUL2020  Placebo  18AUG2020  Placebo  
10031100  C4591001 
1003 
10031100  16-55 28JUL2020  40037  Placebo  28JUL2020  Placebo  18AUG2020  Placebo  
10031101  C4591001 
1003 
10031101  16-55 28JUL2020  40043  Placebo  28JUL2020  Placebo  18AUG2020  Placebo  
10031102  C4591001 
1003 
10031102  >55 28JUL2020  220039  BNT162b2  
(30 μg)  28JUL2020  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  
10031103  C4591001 
1003 
10031103  >55 29JUL2020  220124  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
10031104  C4591001 
1003 
10031104  16-55 29JUL2020  40145  BNT162b2  
(30 μg)  29JUL2020  BNT16 2b2 
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10031105  C4591001 
1003 
10031105  >55 29JUL2020  220125  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10031106  C4591001 
1003 
10031106  >55 29JUL2020  220127  Placebo  29JUL2020  Placebo  19AUG2020  Placebo  
10031107  C4591001 
1003 
10031107  >55 29JUL2020  220132  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
10031108  C4591001 
1003 
10031108  >55 29JUL2020  220219  BNT162b2  
(30 μg)  29JUL2020  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 61
FDA-CBER-2021-5683-0024838
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10031109  C4591001 
1003 
10031109  >55 30JUL2020  220223  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10031110  C4591001 
1003 
10031110  >55 30JUL2020  220225  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10031111  C4591001 
1003 
10031111  16-55 30JUL2020  40149  Place bo 30JUL2020  Placebo  20AUG2020  Placebo  
10031112  C4591001 
1003 
10031112  >55 30JUL2020  220226  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10031113  C4591001 
1003 
10031113  >55 30JUL2020  220530  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10031114  C4591001 
1003 
10031114  >55 30JUL2020  220531  BNT162b2  
(30 μg)  30JUL2020  BNT162 b2 
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10031115  C4591001 
1003 
10031115  16-55 30JUL2020  40151  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
10031116  C4591001 
1003 
10031116  16-55 30JUL2020  40153  Placebo  30JUL2020  Placebo  21AUG 2020  Placebo  
10031117  C4591001 
1003 
10031117  >55 30JUL2020  220534  Placebo  30JUL2020  Placebo  20AUG2020  Placebo  
10031118  C4591001 
1003 
10031118  >55 30JUL2020  220540  BNT162b2  
(30 μg)  30JUL2020  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 62
FDA-CBER-2021-5683-0024839
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10031119  C4591001 
1003 
10031119  >55 31JUL2020  220818  Placebo  31JUL2020  Placebo  21AUG2020  Placebo  
10031120  C4591001 
1003 
10031120  >55 31JUL2020  220820  BNT162b2  
(30 μg)  31JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
10031121  C4591001 
1003 
10031121  >55 31JUL2020  220821  Place bo 31JUL2020  Placebo  21AUG2020  Placebo  
10031122  C4591001 
1003 
10031122  16-55 31JUL2020  40819  Placebo  31JUL2020  Placebo  21AUG2020  Placebo  
10031123  C4591001 
1003 
10031123  >55 31JUL2020  220826  BNT162b2  
(30 μg)  31JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
10031124  C4591001 
1003 
10031124  16-55 31JUL2020  40820  Placebo  31JUL2020  Placebo  21AUG2020  Placebo  
10031125  C4591001 
1003 
10031125  16-55 31JUL2020  40823  BNT162b2  
(30 μg)  31JUL2020  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  
10031126  C4591001 
1003 
10031126  >55 31JUL2020  220902  Placebo  31JUL2020  Placebo  21AUG2020  Placebo  
10031127  C4591001 
1003 
10031127  >55 03AUG2020  220906  Placebo  03AUG2020  Placebo  24AUG2020  Placebo  
10031128  C4591001 
1003 
10031128  >55 03AUG2020  220909  BNT162b2  
(30 μg)  03AUG2020  BNT 162b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 63
FDA-CBER-2021-5683-0024840
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10031129  C4591001 
1003 
10031129  >55 03AUG2020  220910  BNT162b2  
(30 μg)  03AUG2020  BNT162b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  
10031130  C4591001 
1003 
10031130  >55 03AUG2020  221506  Placebo  03AUG2020  Placebo  24AUG2020  Placebo  
10031131  C4591001 
1003 
10031131  >55 03AUG2020  221507  BNT162b2  
(30 μg)  03AUG2020  BNT162b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  
10031132  C4591001 
1003 
10031132  >55 03AUG2020  221511  Placebo  03AUG2020  Placebo  24AUG2020  Placebo  
10031133  C4591001 
1003 
10031133  >55 03AUG2020  221512  BNT162b2  
(30 μg)  03AUG2020  BNT162b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  
10031134  C4591001 
1003 
10031134  >55 03AUG2020  221671  Placebo  03AUG2020  Placebo  24AUG2020  Placebo  
10031135  C4591001 
1003 
10031135  >55 03AUG2020  221672  BNT1 62b2  
(30 μg)  03AUG2020  BNT162b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  
10031136  C4591001 
1003 
10031136  >55 03AUG2020  221673  BNT162b2  
(30 μg)  03AUG2020  BNT162b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  
10031137  C4591001 
1003 
10031137  16-55 04AUG2020  40828  BNT162b2  
(30 μg)  04AUG2020  BNT162b2  
(30 μg)  25AUG2020  BNT162b2  
(30 μg)  
10031138  C4591001 
1003 
10031138  16-55 04AUG2020  42130  BNT162b2  
(30 μg)  04AUG2020  BNT162b2  
(30 μg)  25AUG2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 64
FDA-CBER-2021-5683-0024841
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10031139  C4591001 
1003 
10031139  >55 04AUG2020  221679  Placebo  04AUG2 020 Placebo  26AUG2020  Placebo  
10031140  C4591001 
1003 
10031140  16-55 04AUG2020  42131  Placebo   
   
  
10031141  C4591001 
1003 
10031141  16-55 04AUG2020  42133  Placebo  04AUG2020  Placebo  25AUG2020  Placebo  
10031142  C4591001 
1003 
10031142  >55 04AUG2020  222355  Placebo 04AUG2020  Placebo  25AUG2020  Placebo  
10031143  C4591001 
1003 
10031143  16-55 04AUG2020  42136  BNT162b2  
(30 μg)   
   
  
10031144  C4591001 
1003 
10031144  16-55 04AUG2020  42522  BNT162b2  
(30 μg)  04AUG2020  BNT162b2  
(30 μg)  25AUG2020  BNT162b2  
(30 μg)  
10031145  C4591001 
1003 
10031145  >55 04AUG2020  222356  BNT162b2  
(30 μg)  04AUG2020  BNT162b2  
(30 μg)  25AUG2020  BNT162b2  
(30 μg)  
10031146  C4591001 
1003 
10031146  16-55 05AUG2020  42524  BNT162b2  
(30 μg)  05AUG2020  BNT162b2  
(30 μg)  25AUG2020  BNT162b2  
(30 μg)  
10031147  C4591001 
1003 
10031147  16-55 05AUG2020  42526  Placebo  05AUG2020  Placebo  26AUG2020  Placebo  
10031148  C4591001 
1003 
10031148  >55 05AUG2020  222358  BNT162b2  
(30 μg)  05AUG2020  BNT162b2  
(30 μg)  26AUG2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 65
FDA-CBER-2021-5683-0024842
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10031149  C4591001 
1003 
10031149  >55 05AUG2020  222359  Placebo  05AUG2020  Placebo  26AUG2020  Placebo  
10031150  C4591001 
1003 
10031150  >55 05AUG2020  222874  Placebo  05AUG2020  Placebo  26AUG2020  Placebo  
10031151  C4591001 
1003 
10031151  16-55 05AUG2020  42529  Placebo  05AUG2020  Placebo  26AUG2020  Placebo  
10031152  C4591001 
1003 
10031152  >55 05AUG2020  222875  BNT162b2  
(30 μg)  05AUG2020  BNT162b2  
(30 μg)  26AUG20 20 BNT162b2  
(30 μg)  
10031153  C4591001 
1003 
10031153  >55 06AUG2020  222877  BNT162b2  
(30 μg)  06AUG2020  BNT162b2  
(30 μg)  25AUG2020  BNT162b2  
(30 μg)  
10031154  C4591001 
1003 
10031154  >55 06AUG2020  222880  Placebo  06AUG2020  Placebo  27AUG2020  Placebo  
10031155  C4591001 
1003 
10031155  16-55 06AUG2020  43470  Placebo  06AUG2020  Placebo  27AUG2020  Placebo  
10031156  C4591001 
1003 
10031156  16-55 06AUG2020  43474  Placebo  06AUG2020  Placebo  27AUG2020  Placebo  
10031157  C4591001 
1003 
10031157  >55 06AUG2020  223388  Placebo  06AUG2020  Placebo  27AUG2020  Placebo  
10031158  C4591001 
1003 
10031158  16-55 06AUG2020  43479  BNT162b2  
(30 μg)  06AUG2020  BNT162b2  
(30 μg)  28AUG2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 66
FDA-CBER-2021-5683-0024843
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10031159  C4591001 
1003 
10031159  >55 06AUG2020  223389  BNT162b2  
(30 μg)  06AUG2020  BNT162b2  
(30 μg)  27AUG2020  BNT162b2  
(30 μg)  
10031160  C4591001 
1003 
10031160  16-55 06AUG2020  43480  BNT16 2b2 
(30 μg)  06AUG2020  BNT162b2  
(30 μg)  27AUG2020  BNT162b2  
(30 μg)  
10031161  C4591001 
1003 
10031161  16-55 07AUG2020  44214  Placebo  07AUG2020  Placebo  28AUG2020  Placebo  
10031162  C4591001 
1003 
10031162  16-55 07AUG2020  44217  BNT162b2  
(30 μg)  07AUG2020  BNT162b2  
(30 μg)  28AUG2020  BNT162b2  
(30 μg)  
10031163  C4591001 
1003 
10031163  >55 07AUG2020  223393  Placebo  07AUG2020  Placebo  28AUG2020  Placebo  
10031164  C4591001 
1003 
10031164  >55 07AUG2020  223396  BNT162b2  
(30 μg)  07AUG2020  BNT162b2  
(30 μg)  28AUG2020  BNT162b2  
(30 μg ) 
10031165  C4591001 
1003 
10031165  >55 07AUG2020  223880  Placebo  07AUG2020  Placebo  28AUG2020  Placebo  
10031166  C4591001 
1003 
10031166  16-55 07AUG2020  44221  BNT162b2  
(30 μg)  07AUG2020  BNT162b2  
(30 μg)  28AUG2020  BNT162b2  
(30 μg)  
10031167  C4591001 
1003 
100311 67 >55 07AUG2020  223886  Placebo  07AUG2020  Placebo  28AUG2020  Placebo  
10031168  C4591001 
1003 
10031168  >55 07AUG2020  223887  BNT162b2  
(30 μg)  07AUG2020  BNT162b2  
(30 μg)  28AUG2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 67
FDA-CBER-2021-5683-0024844
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10031169  C4591001 
1003 
10031169  >55 07AUG2020  223888  BNT162b2  
(30 μg)  07AUG2020  BNT162b2  
(30 μg)  28AUG2020  BNT162b2  
(30 μg)  
10031170  C4591001 
1003 
10031170  16-55 10AUG2020  44224  Placebo  10AUG2020  Placebo  31AUG2020  Placebo  
10031171  C4591001 
1003 
10031171  16-55 10AUG2020  45113  BNT162b2  
(30 μg)  10AUG2020  BNT162b2  
(30 μg) 31AUG2020  BNT162b2  
(30 μg)  
10031172  C4591001 
1003 
10031172  >55 10AUG2020  224657  BNT162b2  
(30 μg)  10AUG2020  BNT162b2  
(30 μg)  31AUG2020  BNT162b2  
(30 μg)  
10031173  C4591001 
1003 
10031173  >55 10AUG2020  224660  Placebo  10AUG2020  Placebo  31AUG2020  Placebo  
10031174  C4591001 
1003 
10031174  16-55 10AUG2020  45115  Placebo  10AUG2020  Placebo  31AUG2020  Placebo  
10031175  C4591001 
1003 
10031175  16-55 10AUG2020  45118  Placebo  10AUG2020  Placebo  31AUG2020  Placebo  
10031176  C4591001 
1003 
10031176  >55 10AUG2020  224663  BNT162 b2 
(30 μg)  10AUG2020  BNT162b2  
(30 μg)  31AUG2020  BNT162b2  
(30 μg)  
10031177  C4591001 
1003 
10031177  16-55 10AUG2020  45122  BNT162b2  
(30 μg)  10AUG2020  BNT162b2  
(30 μg)  31AUG2020  BNT162b2  
(30 μg)  
10031 178 C4591001 
1003 
10031178  >55 11AUG2020  224668  Placebo  11AUG2020  Placebo  01SEP2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 68
FDA-CBER-2021-5683-0024845
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10031179  C4591001 
1003 
10031179  16-55 11AUG2020  46111  Placebo  11AUG2020  Placebo  01SEP2020  Placebo  
10031180  C4591001 
1003 
10031180  16-55 11AUG2020  46116  BNT162b2  
(30 μg)  11AUG2020  BNT162b2  
(30 μg)  01SEP2020  BNT162b2  
(30 μg ) 
10031181  C4591001 
1003 
10031181  >55 11AUG2020  225593  Placebo  11AUG2020  Placebo  01SEP2020  Placebo  
10031182  C4591001 
1003 
10031182  >55 11AUG2020  225594  BNT162b2  
(30 μg)  11AUG2020  BNT162b2  
(30 μg)  01SEP2020  BNT162b2  
(30 μg)  
10031183  C4591001 
1003 
1003118 3 16-55 11AUG2020  46117  BNT162b2  
(30 μg)  11AUG2020  BNT162b2  
(30 μg)  01SEP2020  BNT162b2  
(30 μg)  
10031184  C4591001 
1003 
10031184  16-55 11AUG2020  46119  Placebo  11AUG2020  Placebo  01SEP2020  Placebo  
10031185  C4591001 
1003 
10031185  >55 11AUG2020  225595  Placebo  11AUG2020  Placebo  01SEP2020  Placebo  
10031186  C4591001 
1003 
10031186  16-55 12AUG2020  47001  Placebo  12AUG2020  Placebo  03SEP2020  Placebo  
10031187  C4591001 
1003 
10031187  16-55 12AUG2020  47003  BNT162b2  
(30 μg)  12AUG2020  BNT162b2  
(30 μg)  01SEP2020  BNT162b2  
(30 μg) 
10031188  C4591001 
1003 
10031188  >55 12AUG2020  225597  BNT162b2  
(30 μg)  12AUG2020  BNT162b2  
(30 μg)  02SEP2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 69
FDA-CBER-2021-5683-0024846
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10031189  C4591001 
1003 
10031189  >55 12AUG2020  226409  BNT162b2  
(30 μg)  12AUG2020  BNT162b2  
(30 μg)  31AUG2020  BNT162b2  
(30 μg)  
10031190  C4591001 
1003 
10031190  16-55 12AUG2020  47004  Placebo  12AUG2020  Placebo  01SEP2020  Placebo  
10031191  C4591001 
1003 
10031191  16-55 12AUG2020  47008  BNT162b2  
(30 μg)  12AUG2020  BNT162b2  
(30 μg)  02SEP2020  BNT162b2  
(30 μg)  
10031192  C4591001 
1003 
10031192  >55 12AUG2020  226412  Placebo  12AUG2020  Placebo  01SEP2020  Placebo  
10031193  C4591001 
1003 
10031193  >55 13AUG2020  226413  Placebo  13AUG2020  Placebo  03SEP2020  Placebo  
10031194  C4591001 
1003 
10031194  16-55 13AUG2020  48774  BNT162b2  
(30 μg)  13AUG2020  BNT162b2  
(30 μg)  03SEP2020  BNT162b2  
(30 μg)  
10031195  C4591001 
1003 
10031195  >55 13AUG2020  226417  BNT162b2  
(30 μg)  13AUG2020  BNT162b2  
(30 μg)  03SEP2020  BNT162b2  
(30 μg)  
10031196  C4591001 
1003 
10031196  16-55 13AUG2020  48776  Placebo  13AUG2020  Placebo  03SEP2020  Placeb o 
10031197  C4591001 
1003 
10031197  16-55 13AUG2020  48777  Placebo  13AUG2020  Placebo  03SEP2020  Placebo  
10031198  C4591001 
1003 
10031198  16-55 13AUG2020  48779  BNT162b2  
(30 μg)  13AUG2020  BNT162b2  
(30 μg)  03SEP2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 70
FDA-CBER-2021-5683-0024847
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10031199  C4591001 
1003 
10031 199 16-55 13AUG2020  49242  BNT162b2  
(30 μg)  13AUG2020  BNT162b2  
(30 μg)  03SEP2020  BNT162b2  
(30 μg)  
10031200  C4591001 
1003 
10031200  >55 13AUG2020  228161  Placebo  13AUG2020  Placebo  03SEP2020  Placebo  
10031201  C4591001 
1003 
10031201  16-55 13AUG2020  49250  BNT162 b2 
(30 μg)  13AUG2020  BNT162b2  
(30 μg)  03SEP2020  BNT162b2  
(30 μg)  
10031202  C4591001 
1003 
10031202  >55 14AUG2020  228167  Placebo  14AUG2020  Placebo  04SEP2020  Placebo  
10031203  C4591001 
1003 
10031203  16-55 14AUG2020  49251  Placebo  14AUG2020  Placebo  04SEP2020  Placebo  
10031204  C4591001 
1003 
10031204  16-55 14AUG2020  49252  Placebo  14AUG2020  Placebo  04SEP2020  Placebo  
10031205  C4591001 
1003 
10031205  16-55 14AUG2020  49868  Placebo  14AUG2020  Placebo  04SEP2020  Placebo  
10031206  C4591001 
1003 
10031206  16-55 14AUG2020  49870 Placebo  14AUG2020  Placebo  04SEP2020  Placebo  
10031207  C4591001 
1003 
10031207  16-55 14AUG2020  49872  BNT162b2  
(30 μg)  14AUG2020  BNT162b2  
(30 μg)  04SEP2020  BNT162b2  
(30 μg)  
10031208  C4591001 
1003 
10031208  >55 14AUG2020  228168  BNT162b2  
(30 μg)  14AUG2020  BNT162b2  
(30 μg)  04SEP2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 71
FDA-CBER-2021-5683-0024848
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10031209  C4591001 
1003 
10031209  >55 14AUG2020  228172  BNT162 b2 
(30 μg)  14AUG2020  BNT162b2  
(30 μg)  04SEP2020  BNT162b2  
(30 μg)  
100510 02 C4591001 
1005 
10051002  16-55 07AUG2020  44385  BNT162b2  
(30 μg)  07AUG2020  BNT162b2  
(30 μg)  26AUG2020  BNT162b2  
(30 μg)  
10051003  C4591001 
1005 
10051003  16-55 07AUG2020  44387  Placebo  07AUG2020  Placebo  30AUG2020  Placebo  
10051004  C4591001 
1005 
10051004  16-55 10AUG2020  44389  BNT162b2  
(30 μg)  10AUG2020  BNT162b2  
(30 μg)  31AUG2020  BNT162b2  
(30 μg)  
10051005  C4591001 
1005 
10051005  >55 10AUG2020  224844  BNT162b2  
(30 μg)  10AUG2020  BNT162b2  
(30 μg ) 31AUG2020  BNT162b2  
(30 μg)  
10051006  C4591001 
1005 
10051006  >55 10AUG2020  224842  Placebo  10AUG2020  Placebo  31AUG2020  Placebo  
10051007  C4591001 
1005 
10051007  16-55 10AUG2020  44392  Placebo  10AUG2020  Placebo  31AUG2020  Placebo  
10051008  C4591001 
1005 
100510 08 16-55 10AUG2020  45368  BNT162b2  
(30 μg)  10AUG2020  BNT162b2  
(30 μg)  01SEP2020  BNT162b2  
(30 μg)  
10051009  C4591001 
1005 
10051009  >55 10AUG2020  224845  Placebo  10AUG2020  Placebo  31AUG2020  Placebo  
10051010  C4591001 
1005 
10051010  >55 10AUG2020  224848  BNT162b2  
(30 μg)  10AUG2020  BNT162b2  
(30 μg)  01SEP2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 72
FDA-CBER-2021-5683-0024849
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051011  C4591001 
1005 
10051011  >55 10AUG2020  225142  Placebo  10AUG2020  Placebo  31AUG2020  Placebo  
10051012  C4591001 
1005 
10051012  >55 10AUG2020  225140  Placebo  10AUG2020  Placebo  31AUG2020  Place bo 
10051013  C4591001 
1005 
10051013  >55 10AUG2020  225143  BNT162b2  
(30 μg)  10AUG2020  BNT162b2  
(30 μg)  31AUG2020  BNT162b2  
(30 μg)  
10051014  C4591001 
1005 
10051014  >55 10AUG2020  225146  BNT162b2  
(30 μg)  10AUG2020  BNT162b2  
(30 μg)  31AUG2020  BNT162b2  
(30 μg)  
10051015  C4591001 
1005 
10051015  16-55 10AUG2020  45372  Placebo  10AUG2020  Placebo  31AUG2020  Placebo  
10051016  C4591001 
1005 
10051016  16-55 11AUG2020  45373  BNT162b2  
(30 μg)  11AUG2020  BNT162b2  
(30 μg)  31AUG2020  BNT162b2  
(30 μg)  
10051017  C4591001 
1005 
10051017  16-55 11AUG2020  45374  Placebo  11AUG2020  Placebo  01SEP2020  Placebo  
10051018  C4591001 
1005 
10051018  >55 11AUG2020  225607  BNT162b2  
(30 μg)  11AUG2020  BNT162b2  
(30 μg)  31AUG2020  BNT162b2  
(30 μg)  
10051019  C4591001 
1005 
10051019  >55 11AUG2020  225608  Placebo  11AU G2020  Placebo  01SEP2020  Placebo  
10051020  C4591001 
1005 
10051020  >55 11AUG2020  225610  Placebo  11AUG2020  Placebo  01SEP2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 73
FDA-CBER-2021-5683-0024850
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051021  C4591001 
1005 
10051021  >55 11AUG2020  225614  BNT162b2  
(30 μ g) 11AUG2020  BNT162b2  
(30 μg)  31AUG2020  BNT162b2  
(30 μg)  
10051022  C4591001 
1005 
10051022  >55 11AUG2020  225774  Placebo  11AUG2020  Placebo  31AUG2020  Placebo  
10051023  C4591001 
1005 
10051023  >55 11AUG2020  225777  BNT162b2  
(30 μg)  11AUG2020  BNT162b2  
(30 μg)  31AUG2020  BNT162b2  
(30 μg)  
10051024  C4591001 
1005 
10051024  16-55 11AUG2020  46639  BNT162b2  
(30 μg)  11AUG2020  BNT162b2  
(30 μg)  31AUG2020  BNT162b2  
(30 μg)  
10051025  C4591001 
1005 
10051025  >55 11AUG2020  225779  BNT162b2  
(30 μg)  11AUG2020  BNT162b2  
(30 μg)  01SEP2020  BNT162b2  
(30 μg)  
10051026  C4591001 
1005 
10051026  16-55 11AUG2020  46641  Placebo  11AUG2020  Placebo  02SEP2020  Placebo  
10051027  C4591001 
1005 
10051027  16-55 11AUG2020  46642  Placebo  11AUG2020  Placebo  31AUG2020  Placebo  
10051028  C4591001 
1005 
10051028  16-55 12AUG2020  47011  Placebo  12AUG2020  Placebo  01SEP2020  Placeb o 
10051029  C4591001 
1005 
10051029  16-55 12AUG2020  46647  BNT162b2  
(30 μg)  12AUG2020  BNT162b2  
(30 μg)  01SEP2020  BNT162b2  
(30 μg)  
10051030  C4591001 
1005 
10051030  16-55 12AUG2020  47015  Placebo  12AUG2020  Placebo  01SEP2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 74
FDA-CBER-2021-5683-0024851
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051031  C4591001 
1005 
10051031  16-55 12AUG2020  47019  BNT162b2  
(30 μg)  12AUG2020  BNT1 62b2  
(30 μg)  02SEP2020  BNT162b2  
(30 μg)  
10051032  C4591001 
1005 
10051032  >55 12AUG2020  225781  Placebo  12AUG2020  Placebo  04SEP2020  Placebo  
10051033  C4591001 
1005 
10051033  >55 12AUG2020  226579  Placebo  12AUG2020  Placebo  31AUG2020  Placebo  
10051034  C4591001 
1005 
10051034  >55 12AUG2020  226582  Placebo  12AUG2020  Placebo  02SEP2020  Placebo  
10051035  C4591001 
1005 
10051035  16-55 12AUG2020  47020  BNT162b2  
(30 μg)  12AUG2020  BNT162b2  
(30 μg)  02SEP2020  BNT162b2  
(30 μg)  
10051036  C4591001 
1005 
10051036  16-55 12AUG2020  47597 BNT162b2  
(30 μg)  12AUG2020  BNT162b2  
(30 μg)  04SEP2020  BNT162b2  
(30 μg)  
10051037  C4591001 
1005 
10051037  >55 12AUG2020  226586  BNT162b2  
(30 μg)  12AUG2020  BNT162b2  
(30 μg)  31AUG2020  BNT162b2  
(30 μg)  
10051038  C4591001 
1005 
10051038  >55 12AUG2020  226587  BNT 162b2  
(30 μg)  12AUG2020  BNT162b2  
(30 μg)  01SEP2020  BNT162b2  
(30 μg)  
10051039  C4591001 
1005 
10051039  >55 12AUG2020  227059  BNT162b2  
(30 μg)  12AUG2020  BNT162b2  
(30 μg)  02SEP2020  BNT162b2  
(30 μg)  
10051040  C4591001 
1005 
10051040  >55 12AUG2020  227061  BNT162b2  
(30 μg)  12AUG2 020 BNT162b2  
(30 μg)  31AUG2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 75
FDA-CBER-2021-5683-0024852
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051041  C4591001 
1005 
10051041  16-55 12AUG2020  47921  BNT162b2  
(30 μg)  12AUG2020  BNT162b2  
(30 μg)  04SEP2020  BNT162b2  
(30 μg)  
10051042  C4591001 
1005 
10051042  >55 12AUG2020  227062  Placebo  12AUG2 020 Placebo  02SEP2020  Placebo  
10051043  C4591001 
1005 
10051043  >55 12AUG2020  227067  Placebo  12AUG2020  Placebo  31AUG2020  Placebo  
10051044  C4591001 
1005 
10051044  >55 13AUG2020  227506  Placebo  13AUG2020  Placebo  04SEP2020  Placebo  
10051045  C4591001 
1005 
100510 45 >55 13AUG2020  227504  BNT162b2  
(30 μg)  13AUG2020  BNT162b2  
(30 μg)  02SEP2020  BNT162b2  
(30 μg)  
10051046  C4591001 
1005 
10051046  >55 13AUG2020  227510  Placebo  13AUG2020  Placebo  02SEP2020  Placebo  
10051047  C4591001 
1005 
10051047  >55 13AUG2020  227512  BNT162b2  
(30 μg)  13AUG2020  BNT162 b2 
(30 μg)  01SEP2020  BNT162b2  
(30 μg)  
10051048  C4591001 
1005 
10051048  16-55 13AUG2020  47924  Placebo  13AUG2020  Placebo  02SEP2020  Placebo  
10051049  C4591001 
1005 
10051049  >55 13AUG2020  227670  Placebo  13AUG2020  Placebo  01SEP2020  Placebo  
10051050  C4591001 
1005 
10051050  >55 13AUG2020  227669  BNT162b2  
(30 μg)  13AUG2020  BNT162b2  
(30 μg)  02SEP2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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FDA-CBER-2021-5683-0024853
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051051  C4591001 
1005 
10051051  16-55 13AUG2020  47932  BNT162b2  
(30 μg)  13AUG2020  BNT162b2  
(30 μg)  01SEP2020  BNT162b2  
(30 μg)  
10051052  C4591001 
1005 
10051052  16-55 13AUG2020  47929  Placebo  13AUG2020  Placebo  02SEP2020  Placebo  
10051053  C4591001 
1005 
10051053  >55 13AUG2020  227677  BNT162b2  
(30 μg)  13AUG2020  BNT162b2  
(30 μg)  02SEP2020  BNT162b2  
(30 μg)  
10051054  C4591001 
1005 
10051054  16-55 13AUG2020  48727  BNT 162b2  
(30 μg)  13AUG2020  BNT162b2  
(30 μg)  04SEP2020  BNT162b2  
(30 μg)  
10051055  C4591001 
1005 
10051055  16-55 13AUG2020  48728  Placebo  13AUG2020  Placebo  01SEP2020  Placebo  
10051056  C4591001 
1005 
10051056  >55 13AUG2020  227678  Placebo  13AUG2020  Placebo  01SEP2020  Placebo  
10051057  C4591001 
1005 
10051057  16-55 13AUG2020  48729  Placebo  13AUG2020  Placebo  02SEP2020  Placebo  
10051058  C4591001 
1005 
10051058  >55 13AUG2020  228066  Placebo  13AUG2020  Placebo  01SEP2020  Placebo  
10051059  C4591001 
1005 
10051059  16-55 13AUG2020  48733  BNT162b2  
(30 μg)  13AUG2020  BNT162b2  
(30 μg)  02SEP2020  BNT162b2  
(30 μg)  
10051060  C4591001 
1005 
10051060  >55 13AUG2020  228067  BNT162b2  
(30 μg)  13AUG2020  BNT162b2  
(30 μg)  02SEP2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 77
FDA-CBER-2021-5683-0024854
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051061  C4591001 
1005 
10051061  >55 13AUG2020  228076  Placeb o 13AUG2020  Placebo  08SEP2020  Placebo  
10051062  C4591001 
1005 
10051062  >55 13AUG2020  228068  BNT162b2  
(30 μg)  13AUG2020  BNT162b2  
(30 μg)  02SEP2020  BNT162b2  
(30 μg)  
10051063  C4591001 
1005 
10051063  >55 13AUG2020  228248  BNT162b2  
(30 μg)  13AUG2020  BNT162b2  
(30 μg) 01SEP2020  BNT162b2  
(30 μg)  
10051064  C4591001 
1005 
10051064  >55 13AUG2020  228247  Placebo  13AUG2020  Placebo  01SEP2020  Placebo  
10051065  C4591001 
1005 
10051065  >55 13AUG2020  228249  Placebo  13AUG2020  Placebo  02SEP2020  Placebo  
10051066  C4591001 
1005 
1005 1066  16-55 13AUG2020  49457  BNT162b2  
(30 μg)  13AUG2020  BNT162b2  
(30 μg)  02SEP2020  BNT162b2  
(30 μg)  
10051067  C4591001 
1005 
10051067  16-55 13AUG2020  49463  BNT162b2  
(30 μg)  13AUG2020  BNT162b2  
(30 μg)  01SEP2020  BNT162b2  
(30 μg)  
10051068  C4591001 
1005 
10051068  >55 14AUG2020  228255  BNT162b2  
(30 μg)  14AUG2020  BNT162b2  
(30 μg)  04SEP2020  BNT162b2  
(30 μg)  
10051069  C4591001 
1005 
10051069  >55 14AUG2020  228557  Placebo  14AUG2020  Placebo  02SEP2020  Placebo  
10051070  C4591001 
1005 
10051070  16-55 14AUG2020  49464  Placebo  14AUG2020  Placebo  02SEP2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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FDA-CBER-2021-5683-0024855
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051071  C4591001 
1005 
10051071  16-55 14AUG2020  49468  Placebo  14AUG2020  Placebo  04SEP2020  Placebo  
10051072  C4591001 
1005 
10051072  >55 14AUG2020  228558  Placebo  14AUG2020  Placebo  03SEP2020  Placebo  
10051073  C4591001 
1005 
10051073  16-55 14AUG2020  49998  Placebo  14AUG2020  Placebo  04SEP2020  Placebo  
10051074  C4591001 
1005 
10051074  >55 14AUG2020  228564  BNT162b2  
(30 μg)  14AUG2020  BNT162b2  
(30 μg)  02SEP2020  BNT162b2  
(30 μg)  
10051075  C4591001 
1005 
10051075  16-55 14AUG2020  50002  Placebo  14AUG2020  Placebo  04SEP2020  Placebo  
10051076  C4591001 
1005 
10051076  16-55 17AUG2020  50006  BNT162b2  
(30 μg)  17AUG2020  BNT1 62b2  
(30 μg)  09SEP2020  BNT162b2  
(30 μg)  
10051077  C4591001 
1005 
10051077  16-55 17AUG2020  50008  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  09SEP2020  BNT162b2  
(30 μg)  
10051078  C4591001 
1005 
10051078  >55 19AUG2020  228567  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  09SEP2020  BNT162b2  
(30 μg)  
10051079  C4591 001 
1005 
10051079  16-55 19AUG2020  55901  Placebo  19AUG2020  Placebo  09SEP2020  Placebo  
10051080  C4591001 
1005 
10051080  >55 19AUG2020  233154  Placebo  19AUG2020  Placebo  09SEP2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 79
FDA-CBER-2021-5683-0024856
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051081  C4591001 
1005 
10051081  16-55 19AUG2020  55904  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  10SEP2020  BNT162b2  
(30 μg)  
10051082  C4591001 
1005 
10051082  16-55 19AUG2020  55905  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  09SEP2020  BNT162b2  
(30 μg)  
10051083  C4591001 
1005 
1005 1083  >55 19AUG2020  233159  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  09SEP2020  BNT162b2  
(30 μg)  
10051084  C4591001 
1005 
10051084  16-55 19AUG2020  55912  Placebo  19AUG2020  Placebo  09SEP2020  Placebo  
10051085  C4591001 
1005 
10051085  16-55 19AUG2020  57222  Place bo 19AUG2020  Placebo  09SEP2020  Placebo  
10051086  C4591001 
1005 
10051086  >55 20AUG2020  233161  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  08SEP2020  BNT162b2  
(30 μg)  
10051087  C4591001 
1005 
10051087  16-55 20AUG2020  57224  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  09SEP2020  BNT162b2  
(30 μg)  
10051088  C4591001 
1005 
10051088  >55 20AUG2020  234438  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  10SEP2020  BNT162b2  
(30 μg)  
10051089  C4591001 
1005 
10051089  >55 20AUG2020  233164  Placebo  20AUG2020  Placebo  09SEP2020  Placebo  
10051090  C4591001 
1005 
10051090  >55 20AUG2020  234443  Placebo  20AUG2020  Placebo  09SEP2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 80
FDA-CBER-2021-5683-0024857
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051091  C4591001 
1005 
10051091  >55 20AUG2020  234444  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  08SEP2020  BNT162b2  
(30 μg)  
10051092  C4591001 
1005 
10051092  >55 20AUG2020  234448  Placebo  20AUG2020  Placebo  09SEP2020  Placebo  
10051093  C4591001 
1005 
10051093  16-55 20AUG2020  57225  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  10SEP2020  BNT162b2  
(30 μg)  
10051094  C4591001 
1005 
10051094  16-55 20AUG2020  57229  Placebo  20AUG2020  Placebo  10SEP2020  Placebo  
10051095  C4591001 
1005 
10051095  >55 20AUG2020  234745  Placebo  20AUG2020  Placebo  09SEP2020  Placebo  
10051096  C4591001 
1005 
10051096  >55 20AUG2020  234746  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  08SEP2020  BNT162b2  
(30 μg ) 
10051097  C4591001 
1005 
10051097  >55 20AUG2020  234747  Placebo  20AUG2020  Placebo  10SEP2020  Placebo  
10051098  C4591001 
1005 
10051098  >55 20AUG2020  234748  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  09SEP2020  BNT162b2  
(30 μg)  
10051100  C4591001 
1005 
1005110 0 16-55 20AUG2020  59217  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  09SEP2020  BNT162b2  
(30 μg)  
10051101  C4591001 
1005 
10051101  16-55 20AUG2020  59214  Placebo  20AUG2020  Placebo  08SEP2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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FDA-CBER-2021-5683-0024858
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051102  C4591001 
1005 
10051102  >55 20AUG2020  235415  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  10SEP2020  BNT162b2  
(30 μg)  
10051103  C4591001 
1005 
10051103  >55 20AUG2020  235416  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  09SEP2020  BNT162b2  
(30 μg)  
10051104  C4591001 
1005 
10051104  >55 20AUG2020  59219  BNT162b2  
(30 μg ) 20AUG2020  BNT162b2  
(30 μg)  10SEP2020  BNT162b2  
(30 μg)  
10051105  C4591001 
1005 
10051105  16-55 21AUG2020  59220  Placebo  21AUG2020  Placebo  10SEP2020  Placebo  
10051106  C4591001 
1005 
10051106  16-55 21AUG2020  60019  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  11SEP2020  BNT162b2  
(30 μg)  
10051107  C4591001 
1005 
10051107  16-55 21AUG2020  60025  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  10SEP2020  BNT162b2  
(30 μg)  
10051108  C4591001 
1005 
10051108  16-55 21AUG2020  60024  Placebo  21AUG2020  Placebo  11SEP2020  Placebo  
10051 109 C4591001 
1005 
10051109  >55 21AUG2020  235417  Placebo  21AUG2020  Placebo  10SEP2020  Placebo  
10051111  C4591001 
1005 
10051111  >55 21AUG2020  235419  Placebo  21AUG2020  Placebo  10SEP2020  Placebo  
10051114  C4591001 
1005 
10051114  >55 21AUG2020  236052  BNT162b2  
(30 μg) 21AUG2020  BNT162b2  
(30 μg)  11SEP2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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FDA-CBER-2021-5683-0024859
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051115  C4591001 
1005 
10051115  16-55 21AUG2020  60026  Placebo  21AUG2020  Placebo  09SEP2020  Placebo  
10051116  C4591001 
1005 
10051116  >55 21AUG2020  236053  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  10SEP2020  BNT162b2  
(30 μg)  
10051117  C4591001 
1005 
10051117  16-55 21AUG2020  60516  Placebo  21AUG2020  Placebo  11SEP2020  Placebo  
10051118  C4591001 
1005 
10051118  16-55 21AUG2020  60510  Placebo  21AUG2020  Placebo  10SEP2020  Placebo  
10051119  C4591001 
1005 
1005111 9 16-55 24AUG2020  60517  BNT162b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  14SEP2020  BNT162b2  
(30 μg)  
10051120  C4591001 
1005 
10051120  >55 24AUG2020  236055  Placebo  24AUG2020  Placebo  14SEP2020  Placebo  
10051121  C4591001 
1005 
10051121  >55 24AUG2020  236056  Placebo  24AUG2020  Placebo  14SEP2020  Placebo  
10051122  C4591001 
1005 
10051122  >55 24AUG2020  237835  Placebo  24AUG2020  Placebo  14SEP2020  Placebo  
10051123  C4591001 
1005 
10051123  16-55 24AUG2020  60518  BNT162b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  14SEP2020  BNT162b2  
(30 μ g) 
10051124  C4591001 
1005 
10051124  >55 24AUG2020  237838  BNT162b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  16SEP2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051125  C4591001 
1005 
10051125  16-55 24AUG2020  63763  BNT162b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  16SEP2020  BNT162b2  
(30 μg)  
10051126  C4591001 
1005 
10051126  >55 24AUG 2020  237839  Placebo  24AUG2020  Placebo  14SEP2020  Placebo  
10051127  C4591001 
1005 
10051127  >55 24AUG2020  237840  BNT162b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  16SEP2020  BNT162b2  
(30 μg)  
10051128  C4591001 
1005 
10051128  >55 24AUG2020  238531  Placebo  24AUG2020  Placebo  16SEP2020  Placebo  
10051129  C4591001 
1005 
10051129  16-55 24AUG2020  63766  BNT162b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  15SEP2020  BNT162b2  
(30 μg)  
10051130  C4591001 
1005 
10051130  >55 24AUG2020  238538  BNT162b2  
(30 μg) 24AUG2020  BNT162b2  
(30 μg)  16SEP2020  BNT162b2  
(30 μg)  
10051131  C4591001 
1005 
10051131  >55 24AUG2020  238540  Placebo  24AUG2020  Placebo  16SEP2020  Placebo  
10051132  C4591001 
1005 
10051132  >55 24AUG2020  238539  BNT162b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  15SEP2020  BNT162b2  
(30 μg)  
10051134  C4591001 
1005 
10051134  16-55 24AUG2020  63769  Placebo  24AUG2020  Placebo  15SEP2020  Placebo  
10051135  C4591001 
1005 
10051135  16-55 24AUG2020  63772  Placebo  24AUG2020  Placebo  16SEP2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051136  C4591001 
1005 
10051136  >55 25AUG2020  239285  BNT162b2  
(30 μg)  25AUG2020  BNT162b2  
(30 μg)  15SEP2020  BNT162b2  
(30 μg)  
10051137  C4591001 
1005 
10051137  >55 16SEP2020  251644  BNT162b2  
(30 μg)  16SEP2020  BNT162b2  
(30 μg)  05OCT2020  BNT162b2  
(30 μg)  
10051138  C4591001 
1005 
10051138  >55 25AUG2020  239286  BNT162b2  
(30 μg)  25AUG2020  BNT162b2  
(30 μg)  16SEP2020  BNT162b2  
(30 μg)  
10051139  C4591001 
1005 
10051139  >55 25AUG2020  239288  Placebo  25AUG2020  Placebo  17SEP2020  Placebo  
10051141  C4591001 
1005 
10051141  >55 25AUG2020  239291  Placebo  25AUG2020  Placebo  15SEP2020  Placebo  
10051142  C4591001 
1005 
10051142  16-55 25AUG2020  65566  Placebo  25AUG2020  Placebo  14SEP2020  Placebo  
10051143  C4591001 
1005 
10051143  >55 25AUG2020  239969  BNT162b2  
(30 μg)  25AUG2020  BNT162b2  
(30 μg)  16SEP2020  BNT162b2  
(30 μg)  
10051 144 C4591001 
1005 
10051144  16-55 25AUG2020  65570  Placebo  25AUG2020  Placebo  15SEP2020  Placebo  
10051145  C4591001 
1005 
10051145  16-55 25AUG2020  65572  BNT162b2  
(30 μg)  25AUG2020  BNT162b2  
(30 μg)  14SEP2020  BNT162b2  
(30 μg)  
10051146  C4591001 
1005 
10051146  16-55 25AUG2020  65571  BNT162b2  
(30 μg)  25AUG2020  BNT162b2  
(30 μg)  14SEP2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 85
FDA-CBER-2021-5683-0024862
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051147  C4591001 
1005 
10051147  16-55 25AUG2020  66642  Placebo  25AUG2020  Placebo  17SEP2020  Placebo  
10051148  C4591001 
1005 
10051148  16-55 25AUG2020  66646  BNT162b2  
(30 μg) 25AUG2020  BNT162b2  
(30 μg)  16SEP2020  BNT162b2  
(30 μg)  
10051149  C4591001 
1005 
10051149  >55 26AUG2020  239971  Placebo  26AUG2020  Placebo  17SEP2020  Placebo  
10051150  C4591001 
1005 
10051150  16-55 26AUG2020  66647  Placebo  26AUG2020  Placebo  14SEP2020  Placebo  
10051151  C4591001 
1005 
10051151  16-55 26AUG2020  66652  BNT162b2  
(30 μg)  26AUG2020  BNT162b2  
(30 μg)  14SEP2020  BNT162b2  
(30 μg)  
10051152  C4591001 
1005 
10051152  >55 26AUG2020  239973  BNT162b2  
(30 μg)  26AUG2020  BNT162b2  
(30 μg)  18SEP2020  BNT162b2  
(30 μg)  
10051 153 C4591001 
1005 
10051153  16-55 26AUG2020  67421  Placebo  26AUG2020  Placebo  17SEP2020  Placebo  
10051154  C4591001 
1005 
10051154  >55 26AUG2020  239980  Placebo  26AUG2020  Placebo  16SEP2020  Placebo  
10051155  C4591001 
1005 
10051155  >55 26AUG2020  241136  Placebo  26AUG2020  Placebo  16SEP2020  Placebo  
10051156  C4591001 
1005 
10051156  >55 26AUG2020  241138  BNT162b2  
(30 μ g) 26AUG2020  BNT162b2  
(30 μg)  16SEP2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 86
FDA-CBER-2021-5683-0024863
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051157  C4591001 
1005 
10051157  >55 26AUG2020  241142  Placebo  26AUG2020  Placebo  16SEP2020  Placebo  
10051158  C4591001 
1005 
10051158  >55 26AUG2020  241143  BNT162b2  
(30 μg)  26AUG2020  BNT162 b2 
(30 μg)  16SEP2020  BNT162b2  
(30 μg)  
10051159  C4591001 
1005 
10051159  >55 26AUG2020  241649  Placebo  26AUG2020  Placebo  16SEP2020  Placebo  
10051160  C4591001 
1005 
10051160  >55 26AUG2020  241653  BNT162b2  
(30 μg)  26AUG2020  BNT162b2  
(30 μg)  16SEP2020  BNT162b2  
(30 μg) 
10051161  C4591001 
1005 
10051161  16-55 26AUG2020  67422  BNT162b2  
(30 μg)  26AUG2020  BNT162b2  
(30 μg)  17SEP2020  BNT162b2  
(30 μg)  
10051162  C4591001 
1005 
10051162  >55 26AUG2020  241656  BNT162b2  
(30 μg)  26AUG2020  BNT162b2  
(30 μg)  16SEP2020  BNT162b2  
(30 μg)  
10051163  C4591001 
1005 
10051163  >55 26AUG2020  241657  Placebo  26AUG2020  Placebo  16SEP2020  Placebo  
10051164  C4591001 
1005 
10051164  16-55 26AUG2020  67425  Placebo  26AUG2020  Placebo  30SEP2020  Placebo  
10051165  C4591001 
1005 
10051165  16-55 26AUG2020  67427  BNT1 62b2  
(30 μg)  26AUG2020  BNT162b2  
(30 μg)  17SEP2020  BNT162b2  
(30 μg)  
10051166  C4591001 
1005 
10051166  16-55 26AUG2020  68664  Placebo  26AUG2020  Placebo  15SEP2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 87
FDA-CBER-2021-5683-0024864
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051167  C4591001 
1005 
10051167  16-55 26AUG2020  68665  BNT162b2  
(30 μg)  26AUG2020  BNT162b2  
(30 μg)  16SEP2020  BNT162b2  
(30 μg)  
10051168  C4591001 
1005 
10051168  16-55 27AUG2020  68666  BNT162b2  
(30 μg)  27AUG2020  BNT162b2  
(30 μg)  17SEP2020  BNT162b2  
(30 μg)  
10051169  C4591001 
1005 
10051169  16-55 27AUG2020  68668  Placebo  27AUG2020  Placebo  17SEP2020  Placebo  
10051170  C4591001 
1005 
10051170  16-55 27AUG2020  69678  Placebo  27AUG2020  Placebo  17SEP2020  Placebo  
10051171  C4591001 
1005 
10051171  16-55 27AUG2020  69684  BNT162b2  
(30 μg)  27AUG2020  BNT162b2  
(30 μg)  15SEP2020  BNT162b2  
(30 μg)  
10051172  C4591001 
1005 
10051172  >55 27AUG2020  242861  Placebo  27AUG2020  Placebo  28SEP2020  Placebo  
10051173  C4591001 
1005 
10051173  >55 27AUG2020  242864  BNT162b2  
(30 μg)  27AUG2020  BNT162b2  
(30 μg)  17SEP2020  BNT162b2  
(30 μg)  
10051174  C4591001 
1005 
10051174  >55 27AUG2020  242867  BNT16 2b2 
(30 μg)  27AUG2020  BNT162b2  
(30 μg)  17SEP2020  BNT162b2  
(30 μg)  
10051175  C4591001 
1005 
10051175  16-55 27AUG2020  69686  Placebo  27AUG2020  Placebo  17SEP2020  Placebo  
10051176  C4591001 
1005 
10051176  >55 27AUG2020  242868  Placebo  27AUG2020  Placebo  15SEP2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 88
FDA-CBER-2021-5683-0024865
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051177  C4591001 
1005 
10051177  >55 27AUG2020  243461  BNT162b2  
(30 μg)  27AUG2020  BNT162b2  
(30 μg)  16SEP2020  BNT162b2  
(30 μg)  
10051178  C4591001 
1005 
10051178  16-55 28AUG2020  69688  BNT162b2  
(30 μg)  28AUG2020  BNT162b2  
(30 μg)  18SEP2020  BNT162b2  
(30 μg ) 
10051179  C4591001 
1005 
10051179  16-55 28AUG2020  71693  Placebo  28AUG2020  Placebo  17SEP2020  Placebo  
10051180  C4591001 
1005 
10051180  >55 28AUG2020  243463  Placebo  28AUG2020  Placebo  17SEP2020  Placebo  
10051181  C4591001 
1005 
10051181  16-55 28AUG2020  71695  BNT162b2  
(30 μg)  28AUG2020  BNT162b2  
(30 μg)  18SEP2020  BNT162b2  
(30 μg)  
10051182  C4591001 
1005 
10051182  16-55 28AUG2020  71703  Placebo  28AUG2020  Placebo  18SEP2020  Placebo  
10051183  C4591001 
1005 
10051183  16-55 31AUG2020  71704  BNT162b2  
(30 μg)  31AUG2020  BNT162 b2 
(30 μg)  23SEP2020  BNT162b2  
(30 μg)  
10051184  C4591001 
1005 
10051184  >55 31AUG2020  243468  Placebo  31AUG2020  Placebo  21SEP2020  Placebo  
10051185  C4591001 
1005 
10051185  >55 31AUG2020  243471  BNT162b2  
(30 μg)  31AUG2020  BNT162b2  
(30 μg)  21SEP2020  BNT162b2  
(30 μg) 
10051186  C4591001 
1005 
10051186  >55 31AUG2020  247473  Placebo  31AUG2020  Placebo  21SEP2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 89
FDA-CBER-2021-5683-0024866
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051187  C4591001 
1005 
10051187  16-55 31AUG2020  76003  Placebo  31AUG2020  Placebo  21SEP2020  Placebo  
10051188  C4591001 
1005 
10051188  16-55 01SEP2020  76004  BNT162b2  
(30 μg)  01SEP2020  BNT162b2  
(30 μg)  24SEP2020  BNT162b2  
(30 μg)  
10051189  C4591001 
1005 
10051189  16-55 01SEP2020  76005  Placebo  01SEP2020  Placebo  22SEP2020  Placebo  
10051191  C4591001 
1005 
10051191  >55 02SEP2020  247475  BNT162b2  
(30 μg)  02SEP2020  BNT1 62b2  
(30 μg)  21SEP2020  BNT162b2  
(30 μg)  
10051192  C4591001 
1005 
10051192  16-55 02SEP2020  76009  BNT162b2  
(30 μg)  02SEP2020  BNT162b2  
(30 μg)  23SEP2020  BNT162b2  
(30 μg)  
10051193  C4591001 
1005 
10051193  >55 02SEP2020  247476  Placebo  02SEP2020  Placebo  21SEP2020  Placebo  
10051194  C4591001 
1005 
10051194  >55 02SEP2020  247479  BNT162b2  
(30 μg)  02SEP2020  BNT162b2  
(30 μg)  23SEP2020  BNT162b2  
(30 μg)  
10051195  C4591001 
1005 
10051195  >55 02SEP2020  250337  BNT162b2  
(30 μg)  02SEP2020  BNT162b2  
(30 μg)  24SEP2020  BNT162b2  
(30 μg ) 
10051196  C4591001 
1005 
10051196  >55 02SEP2020  250340  Placebo  02SEP2020  Placebo  25SEP2020  Placebo  
10051197  C4591001 
1005 
10051197  >55 03SEP2020  250342  Placebo  03SEP2020  Placebo  25SEP2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 90
FDA-CBER-2021-5683-0024867
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051198  C4591001 
1005 
10051198  16-55 03SEP2020  79548  Placebo  03SEP2020  Placebo  25SEP2020  Placebo  
10051199  C4591001 
1005 
10051199  16-55 03SEP2020  79545  BNT162b2  
(30 μg)  03SEP2020  BNT162b2  
(30 μg)  24SEP2020  BNT162b2  
(30 μg)  
10051200  C4591001 
1005 
10051200  16-55 03SEP2020  79549  Placebo  03SEP2020  Placebo  23SEP202 0 Placebo  
10051201  C4591001 
1005 
10051201  >55 03SEP2020  250347  BNT162b2  
(30 μg)  03SEP2020  BNT16 2b2 
(30 μg)  22SEP2020  BNT162b2  
(30 μg)  
10051202  C4591001 
1005 
10051202  >55 03SEP2020  251010  BNT162b2  
(30 μg)  03SEP2020  BNT162b2  
(30 μg)  24SEP2020  BNT162b2  
(30 μg) 
10051203  C4591001 
1005 
10051203  16-55 03SEP2020  79551  BNT162b2  
(30 μg)  03SEP2020  BNT162b2  
(30 μg)  22SEP2020  BNT162b2  
(30 μg)  
10051204  C4591001 
1005 
10051204  >55 03SEP2020  251011  BNT162b2  
(30 μg)  03SEP2020  BNT162b2  
(30 μg)  22SEP2020  BNT162b2  
(30 μg)  
10051205  C4591001 
1005 
10051205  >55 03SEP2020  251225  BNT162b2  
(30 μg)  03SEP2020  BNT162b2  
(30 μg)  24SEP2020  BNT162b2  
(30 μg)  
10051206  C4591001 
1005 
10051206  >55 03SEP2020  251015  Placebo  03SEP2020  Placebo  24SEP2020  Placebo  
10051207  C4591001 
1005 
10051207  >55 03SEP2020  251018  Placebo  03SEP2020  Placebo  23SEP2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 91
FDA-CBER-2021-5683-0024868
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051208  C4591001 
1005 
10051208  >55 03SEP2020  251229  BNT162b2  
(30 μg)  03SEP2020  BNT162b2  
(30 μg)  25SEP2020  BNT162b2  
(30 μg)  
10051209  C4591001 
1005 
10051209  >55 03SEP2020  251227  Placebo  03SEP 2020  Placebo  23SEP2020  Placebo  
10051210  C4591001 
1005 
10051210  16-55 03SEP2020  79914  Placebo  03SEP2020  Placebo  22SEP2020  Placebo  
10051211  C4591001 
1005 
10051211  >55 03SEP2020  251230  Placebo  03SEP2020  Placebo  25SEP2020  Placebo  
10051212  C4591001 
1005 
1005 1212  16-55 03SEP2020  79915  BNT162b2  
(30 μg)  03SEP2020  BNT162b2  
(30 μg)  24SEP2020  BNT162b2  
(30 μg ) 
10051213  C4591001 
1005 
10051213  >55 03SEP2020  251634  Placebo  03SEP2020  Placebo  24SEP2020  Placebo  
10051214  C4591001 
1005 
10051214  >55 03SEP2020  251636  BNT162b2  
(30 μg)  03SEP2020  BNT162 b2 
(30 μg)   
  
10051215  C4591001 
1005 
10051215  16-55 10SEP2020  80877  Placebo  10SEP2020  Placebo  01OCT2020  Placebo  
10051216  C4591001 
1005 
10051216  16-55 03SEP2020  79923  Placebo  03SEP2020  Placebo  24SEP2020  Placebo  
10051217  C4591001 
1005 
10051217  16-55 03SEP 2020  79916  BNT162b2  
(30 μg)  03SEP2020  BNT162b2  
(30 μg)  24SEP2020  BNT1 62b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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FDA-CBER-2021-5683-0024869
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051218  C4591001 
1005 
10051218  >55 03SEP2020  251641  Placebo  03SEP2020  Placebo  25SEP2020  Placebo  
10051219  C4591001 
1005 
10051219  16-55 03SEP2020  80873  BNT162b2  
(30 μg)  03SE P2020  BNT162b2  
(30 μg)  24SEP2020  BNT162b2  
(30 μg)  
10051220  C4591001 
1005 
10051220  16-55 12OCT2020  80882  Placebo  12OCT2020  Placebo  02NOV2020  Placebo  
10051221  C4591001 
1005 
10051221  16-55 12OCT2020  106314  Placebo  12OCT2020  Placebo  03NOV2020  Placebo  
100512 22 C4591001 
1005 
10051222  16-55 12OCT2020  80878  BNT162b2  
(30 μg)  12OC T2020  BNT162b2  
(30 μg)  02NOV2020  BNT162b2  
(30 μg)  
10051223  C4591001 
1005 
10051223  16-55 12OCT2020  106316  BNT162b2  
(30 μg)  12OCT2020  BNT162b2  
(30 μg)  04NOV2020  BNT162b2  
(30 μg)  
10051224  C4591001 
1005 
10051224  16-55 12OCT2020  106315  Placebo  12OCT2020  Place bo 04NOV2020  Placebo  
10051225  C4591001 
1005 
10051225  16-55 12OCT2020  106322  BNT162b2  
(30 μg)  12OCT2020  BNT162b2  
(30 μg)  02NOV2020  BNT162b2  
(30 μg)  
10051226  C4591001 
1005 
10051226  16-55 12OCT2020  106409  Placebo  12OCT2020  Placebo  04NOV2020  Placebo  
1005122 7 C4591001 
1005 
100512 27 >55 12OCT2020  268569  Placebo  12OCT2020  Placebo  03NOV2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 93
FDA-CBER-2021-5683-0024870
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051228  C4591001 
1005 
10051228  16-55 12OCT2020  106414  BNT162b2  
(30 μg)  12OCT2020  BNT162b2  
(30 μ g) 02NOV2020  BNT162b2  
(30 μg)  
10051229  C4591001 
1005 
10051229  >55 12OCT2020  268571  BNT162b2  
(30 μg)  12OCT2020  BNT162b2  
(30 μg)  02NOV2020  BNT162b2  
(30 μg)  
10051230  C4591001 
1005 
10051230  >55 12OCT2020  268573  BNT162b2  
(30 μg)  12OCT2020  BNT162b2  
(30 μg)  02NOV2020  BNT162b2  
(30 μg)  
10051231  C4591001 
1005 
10051231  >55 12OCT202 0 268575  Placebo  12OCT2020  Placebo  02NOV2020  Placebo  
10051232  C4591001 
1005 
10051232  16-55 12OCT2020  106416  Placebo  12OCT2020  Placebo  02NOV2020  Placebo  
10051233  C4591001 
1005 
10051233  16-55 12OCT2020  106418  BNT162b2  
(30 μg)  12OCT2020  BNT162b2  
(30 μg)  02NOV2020  BNT162b2  
(30 μg)  
10051234  C4591001 
1005 
10051234  >55 12OCT2020  268686  Placebo  12OCT2020  Placebo  02NOV2020  Placebo  
10051235  C4591001 
1005 
10051235  16-55 12OCT2020  106685  Placebo  12OCT2020  Placebo  02NOV2020  Placebo  
10051236  C4591001 
1005 
10051236  16-55 13OCT2020  106687  BNT162b2  
(30 μg)  13OCT2020  BNT162b2  
(30 μg)  03NOV2020  BNT162b2  
(30 μg)  
10051237  C4591001 
1005 
10051237  16-55 13OCT2020  106691  BNT162b2  
(30 μg)  13OCT2020  BNT162b2  
(30 μg)  02NOV2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051238  C4591001 
1005 
10051238  16-55 13OCT2020  106696  Placebo  13OCT2020  Placebo  03NOV2020  Placebo  
10051239  C4591001 
1005 
10051239  >55 13OCT2020  268687  BNT162b2  
(30 μg)  13OCT2020  BNT162b2  
(30 μg)  03NOV2020  BNT162b2  
(30 μg ) 
10051240  C4591001 
1005 
10051240  16-55 13OCT2020  107157  Placebo  13OCT2020  Placebo  03NOV2020  Placebo  
10051241  C4591001 
1005 
10051241  16-55 13OCT2020  107153  BNT162b2  
(30 μg)  13OCT2020  BNT162b2  
(30 μg)  03NOV2020  BNT162b2  
(30 μg)  
10051242  C4591001 
1005 
10051242  16-55 13OCT2020  107159  Placebo  13OCT2020  Placebo  03NOV2020  Placebo 
10051243  C4591001 
1005 
10051243  16-55 13OCT2020  107160  BNT162b2  
(30 μg)  13OCT2020  BNT162b2  
(30 μg)  04NOV2020  BNT162b2  
(30 μg)  
10051244  C4591001 
1005 
10051244  16-55 13OCT2020  107246  BNT162b2  
(30 μg)  13OCT2020  BNT162b2  
(30 μg)  02NOV2020  BNT162b2  
(30 μg ) 
10051245  C4591001 
1005 
10051245  16-55 13OCT2020  107245  Placebo  13OCT2020  Placebo  03NOV2020  Placebo  
10051246  C4591001 
1005 
10051246  16-55 13OCT2020  107241  BNT162b2  
(30 μg)  13OCT2020  BNT162b2  
(30 μg)  02NOV2020  BNT162b2  
(30 μg)  
10051247  C4591001 
1005 
10051247  >55 13OCT2020  268695  BNT162b2  
(30 μg)  13OCT2020  BNT162b2  
(30 μg)  05NOV2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051248  C4591001 
1005 
10051248  16-55 14OCT2020  107248  Placebo  14OCT2020  Placebo  03NOV20 20 Placebo  
10051249  C4591001 
1005 
10051249  >55 14OCT2020  268696  Placebo 14OCT2020  Placebo  04NOV2020  Placebo  
10051250  C4591001 
1005 
10051250  >55 14OCT2020  269130  Placebo  14OCT2020  Placebo  04NOV2020  Placebo  
10051251  C4591001 
1005 
10051251  16-55 14OCT2020  107406  Placebo  14OCT2020  Placebo  05NOV2020  Placebo  
10051252  C4591001  
1005 
10051252  >55 14OCT2020  269131  Placebo  14OCT2020  Placebo  04NOV2020  Placebo  
10051253  C4591001 
1005 
10051253  >55 14OCT2020  269133  BNT162b2  
(30 μg)  14OCT2020  BNT162b2  
(30 μg)  05NOV2020  BNT162b2  
(30 μg)  
10051254  C4591001 
1005 
10051254  16-55 14OCT2020  107409  Placebo  14OCT2020  Placebo  05NOV2020  Placebo  
10051255  C4591001 
1005 
10051255  >55 14OCT2020  269347  Placebo  14OCT2020  Placebo  03NOV 2020  Placebo  
10051256  C4591001 
1005 
10051256  >55 14OCT2020  269138  BNT162b2  
(30 μg)  14OCT2020  BNT162b2  
(30 μg)  04NOV2020  BNT162b2  
(30 μg)  
10051257  C4591001 
1005 
10051257  16-55 14OCT2020  107410  BNT162b2  
(30 μg)  14OCT2020  BNT162b2  
(30 μg)  05NOV2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051258  C4591001 
1005 
10051258  >55 14OCT2020  269350  BNT162b2  
(30 μg)  14OCT2020  BNT162b2  
(30 μg)  04NOV2020  BNT162b2  
(30 μg)  
10051259  C4591001 
1005 
10051259  16-55 14OCT2020  107414  BNT162b2  
(30 μg)  14OCT2020  BNT162b2  
(30 μg)  04NOV2020  BNT162b2  
(30 μg) 
10051260  C4591001 
1005 
10051260  16-55 14OCT2020  107790  BNT162b2  
(30 μg)  14OCT2020  BNT162b2  
(30 μg)  04NOV2020  BNT162b2  
(30 μg)  
10051261  C4591001 
1005 
10051261  >55 14OCT2020  269351  BNT162b2  
(30 μg)  14OCT2020  BNT162b2  
(30 μg)  02NOV2020  BNT162b2  
(30 μg)  
10051262  C4591001 
1005 
10051262  >55 15OCT2020  269354  Placebo  15OCT2020  Placebo  05NOV2020  Placebo  
10051263  C4591001 
1005 
10051263  >55 15OCT2020  269599  BNT162b2  
(30 μg)  15OCT2020  BNT162b2  
(30 μg)  05NOV2020  BNT162b2  
(30 μg)  
10051264  C4591001 
1005 
10051264  16-55 15OCT2020  107793  Placebo  15OCT2020  Placebo  04NOV2020  Placebo  
10051265  C4591001 
1005 
10051265  >55 15OCT2020  269603  BNT162b2  
(30 μg)  15OCT2020  BNT162b2  
(30 μg)  05NOV2020  BNT162b2  
(30 μg)  
10051266  C4591001 
1005 
10051266  >55 15OCT2020  269607  Placebo  15OCT2020  Placebo  05NOV2020  Placebo  
10051267  C4591001 
1005 
10051267  16-55 15OCT2020  107796  BNT162b2  
(30 μg)  15OCT2020  BNT162b2  
(30 μg)  03NOV2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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FDA-CBER-2021-5683-0024874
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051268  C4591001 
1005 
10051268  16-55 15OCT2020  107797  Placebo  15OCT2020  Placebo  05NOV2020  Placebo  
10051269  C4591001 
1005 
10051269  >55 15OCT2020  269608  Placebo  15OCT2020  Placebo  03NOV2020  Placebo  
10051270  C4591001 
1005 
10051270  16-55 15OCT2020  108269  Placebo  15OCT2020  Placebo  03NOV2020  Placebo  
10051271  C4591001 
1005 
10051271  >55 15OCT2020  26988 2 BNT162b2  
(30 μg)  15OCT2020  BNT162b2  
(30 μg)  05NOV2020  BNT162b2  
(30 μg)  
10051272  C4591001 
1005 
10051272  >55 15OCT2020  269873  BNT162b2  
(30 μg)  15OCT2020  BNT162b2  
(30 μg)  03NOV2020  BNT162b2  
(30 μg)  
10051273  C4591001 
1005 
10051273  16-55 15OCT2020  108272  Placebo 15OCT2020  Placebo  03NOV2020  Placebo  
10051274  C4591001 
1005 
10051274  16-55 15OCT2020  108277  BNT162b2  
(30 μg)  15OCT2020  BNT162b2  
(30 μg)  03NOV2020  BNT162b2  
(30 μg)  
10051275  C4591001 
1005 
10051275  >55 15OCT2020  269883  Placebo  15OCT2020  Placebo  04NOV2020  Placebo  
10051276  C4591001 
1005 
10051276  16-55 15OCT2020  108425  Placebo  15OCT2020  Placebo  04NOV2020  Placebo  
10051277  C4591001 
1005 
10051277  16-55 15OCT2020  108278  BNT162b2  
(30 μg)  15OCT2020  BNT162b2  
(30 μg)  06NOV2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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FDA-CBER-2021-5683-0024875
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051278  C4591001 
1005 
10051278  >55 15OCT2020  269884  Placebo  15OCT2020  Placebo  04NOV2020  Placebo  
10051280  C4591001 
1005 
10051280  16-55 16OCT2020  108428  BNT162b2  
(30 μg)  16OCT2020  BNT162b2  
(30 μg)  05NOV2020  BNT162b2  
(30 μg)  
10051281  C4591001 
1005 
10051281  16-55 16OCT2020  108429  Placebo  16OCT2020  Placebo  06NOV2020  Placebo  
10051282  C4591001 
1005 
10051282  >55 16OCT2020  270029  BNT162b2  
(30 μg)  16OCT2020  BNT162b2  
(30 μg)  06NOV2020  BNT162b2  
(30 μg)  
10051283  C4591001 
1005 
10051283  16-55 16OCT2020  108430  BNT162b2  
(30 μg)  16OCT2020  BNT162b2  
(30 μg)  06NOV2020  BNT162b2  
(30 μg)  
10051284  C4591001 
1005 
10051284  >55 16OCT2020  270030  Placebo  16OCT2020  Placebo  06NOV2020  Placebo  
10051285  C4591001 
1005 
10051285  16-55 16OCT2020  109004  BNT162b2  
(30 μg)  16OCT2020  BNT162b2  
(30 μg)  05NOV2020  BNT 162b2  
(30 μg)  
10051286  C4591001 
1005 
10051286  >55 16OCT2020  270032  BNT162b2  
(30 μg)  16OCT2020  BNT162b2  
(30 μg)  06NOV2020  BNT162b2  
(30 μg)  
10051287  C459 1001 
1005 
10051287  >55 16OCT2020  270035  Placebo  16OCT2020  Placebo  04NOV2020  Placebo  
10051288  C4591001 
1005 
10051288  16-55 16OCT2020  109006  Placebo  16OCT2020  Placebo  06NOV2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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FDA-CBER-2021-5683-0024876
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051289  C4591001 
1005 
10051289  16-55 16OCT2020  109010  Placebo  16OCT2020  Placebo  04NOV2020  Placebo  
10051290  C4591001 
1005 
10051290  16-55 16OCT2020  109012  BNT162b2  
(30 μg)  16OCT2020  BNT162b2  
(30 μg)  04NOV2020  BNT162b2  
(30 μg)  
10051291  C4591001 
1005 
10051291  16-55 19OCT2020  109823  BNT162b2  
(30 μg)  19OCT2020  BNT162b2  
(30 μg)  09NOV2020  BNT162b2  
(30 μg)  
10051292  C4591001 
1005 
10051292  16-55 19OCT2020  109825  BNT162b2  
(30 μg)  19OC T2020  BNT162b2  
(30 μg)  09NOV2020  BNT162b2  
(30 μg)  
10051293  C4591001 
1005 
10051293  >55 19OCT2020  270739  BNT162b2  
(30 μg)  19OCT2020  BNT162b2  
(30 μg)   
  
10051294  C4591001 
1005 
10051294  16-55 19OCT2020  109827  Placebo  19OCT2020  Placebo  10NOV2020  Placebo  
1005 1295  C4591001 
1005 
10051295  16-55 19OCT2020  109828  Placebo  19OCT2020  Placebo  09NOV2020  Placebo  
10051296  C4591001 
1005 
10051296  >55 19OCT2020  270741  Placebo  19OCT2020  Placebo  09NOV2020  Placebo  
10051298  C4591001 
1005 
10051298  >55 19OCT2020  270744  BNT162b2  
(30 μg)  19OCT2020  BNT162b2  
(30 μg)  09NOV2020  BNT162b2  
(30 μg)  
10051299  C4591001 
1005 
10051299  >55 19OCT2020  270747  Placebo  19OCT2020  Placebo  09NOV2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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FDA-CBER-2021-5683-0024877
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051300  C4591001 
1005 
10051300  >55 19OCT2020  270917  BNT162b2  
(30 μg)  19OCT2020  BNT162b2  
(30 μg ) 09NOV2020  BNT162b2  
(30 μg)  
10051301  C4591001 
1005 
10051301  16-55 19OCT2020  110106  BNT162b2  
(30 μg)  19OCT2020  BNT162b2  
(30 μg)  09NOV2020  BNT162b2  
(30 μg)  
10051302  C4591001 
1005 
10051302  16-55 19OCT2020  110107  BNT162b2  
(30 μg)  19OCT2020  BNT162b2  
(30 μg)  09NOV2020  BNT162b2  
(30 μg)  
10051303  C4591001 
1005 
10051303  >55 19OCT2020  270920  Placebo  19OCT2020  Placebo  09NOV2020  Placebo  
10051304  C4591001 
1005 
10051304  >55 19OCT2020  270926  BNT162b2  
(30 μg)  19OCT2020  BNT162b2  
(30 μg)  09NOV2020  BNT162b2  
(30 μg)  
10051 306 C4591001 
1005 
10051306  >55 19OCT2020  270928  Placebo  19OCT2020  Placebo  09NOV2020  Placebo  
10051307  C4591001 
1005 
10051307  >55 19OCT2020  271014  Placebo  19OCT2020  Placebo  10NOV2020  Placebo  
10051308  C4591001 
1005 
10051308  16-55 19OCT2020  110110  Placebo  19OCT2020  Placebo   
  
10051309  C4591001 
1005 
10051309  >55 19OCT2020  271017  Placebo  19OCT2020  Placebo  09NOV2020  Placebo  
10051310  C4591001 
1005 
10051310  16-55 19OCT2020  110114  Placebo  19OCT2020  Placebo  09NOV2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051311  C4591001 
1005 
10051311  16-55 19OCT2020  110432  Placebo  19OCT2020  Placebo  09NOV2020  Placebo  
10051312  C4591001 
1005 
10051312  >55 19OCT2020  271021  BNT162b2  
(30 μg)  19OCT2020  BNT162b2  
(30 μg)  13NOV2020  BNT162b2  
(30 μg)  
10051313  C4591001 
1005 
10051313  >55 19OCT2020  271023  BNT162b2  
(30 μg)  19OCT2020  BNT162b2  
(30 μg)  09NOV2020  BNT162b2  
(30 μg)  
10051314  C4591001 
1005 
10051314  16-55 19OCT2020  110435  BNT162b2  
(30 μg)  19OCT2020  BNT162b2  
(30 μg)  09NOV2020  BNT162b2  
(30 μg)  
10051315  C4591001 
1005 
10051315  16-55 20OCT2020  110436  BNT162b2  
(30 μg)  20OCT2020  BNT162b2  
(30 μg)  09NOV2020  BNT162b2  
(30 μg)  
10051316  C4591001 
1005 
10051316  16-55 20OCT2020  110440  Placebo  20OCT2020  Placebo  11NOV2020  Placebo  
10051318  C4591001 
1005 
10051318  16-55 20OCT2020  110705  BNT162b2  
(30 μg)  20OCT2020  BNT162b2  
(30 μg)  11NOV2020  BNT162b2  
(30 μg)  
10051319  C4591001 
1005 
10051319  >55 20OCT2020  271237  BNT162b2  
(30 μg)  20OCT2020  BNT162b2  
(30 μg)  12NOV2020  BNT162b2  
(30 μg)  
10051320  C4591001 
1005 
10051320  >55 20OCT2020  271232  BNT162b2  
(30 μg)  20OCT2020  BNT162b2  
(30 μg)  10NOV2020  BNT162b2  
(30 μg)  
10051321  C4591001 
1005 
10051321  >55 20OCT2020  271234  Placebo  20OCT2020  Placebo  11NOV2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051322  C4591001 
1005 
10051322  16-55 20OCT2020  110707  BNT162b2  
(30 μg)  20OCT2020  BNT162b2  
(30 μg)  10NOV2020  BNT162b2  
(30 μg)  
10051323  C4591001 
1005 
10051323  16-55 20OCT2020  110712  Placebo  20OCT2020  Placebo  09NOV2020  Placebo  
10051324  C4591001 
1005 
10051324  >55 20OCT2020  271238  Placebo  20OCT2020  Placebo  10NOV2020  Placebo  
10051325  C4591001 
1005 
10051325  >55 20OCT2020  271333  Placebo  20OCT2020  Placebo  09NOV2020  Placebo  
10051326  C4591001 
1005 
10051326  16-55 20OCT2020  110716  Placebo  20OCT2020  Placebo  10NOV2020  Placebo  
10051327  C4591001 
1005 
10051327  >55 20OCT2020  271334  BNT162b2  
(30 μg)  20OCT2020  BNT162b2  
(30 μg)  10NOV2020  BNT162b2  
(30 μg)  
10051329  C4591001 
1005 
10051329  >55 20OCT2020  271335  BNT162b2  
(30 μg)  20OCT2020  BNT162b2  
(30 μg)  11NOV2020  BNT162b2  
(30 μg)  
10051330  C4591001 
1005 
10051330  >55 20OCT2020  271336  Placeb o 20OCT2020  Placebo  10NOV2020  Placebo  
10051331  C4591001 
1005 
10051331  16-55 20OCT2020  110911  BNT162b2  
(30 μg)  20OCT2020  BNT162b2  
(30 μg)  10NOV2020  BNT162b2  
(30 μg)  
10051332  C4591001 
1005 
10051332  16-55 20OCT2020  110913  BNT162b2  
(30 μg)  20OCT2020  BNT162b2  
(30 μg)  10NOV2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051333  C4591001 
1005 
10051333  >55 20OCT2020  271501  Placebo  20OCT2020  Placebo  11NOV2020  Placebo  
10051334  C4591001 
1005 
10051334  >55 20OCT2020  271502  BNT162b2  
(30 μg)  20OCT2020  BNT162b2  
(30 μg)  10NOV2020  BNT162b2  
(30 μ g) 
10051335  C4591001 
1005 
10051335  16-55 21OCT2020  110915  Placebo  21OCT2020  Placebo  11NOV2020  Placebo  
10051336  C4591001 
1005 
10051336  >55 21OCT2020  271503  BNT162b2  
(30 μg)  21OCT2020  BNT162b2  
(30 μg)  11NOV2020  BNT162b2  
(30 μg)  
10051337  C4591001 
1005 
1005 1337  >55 21OCT2020  271504  Placebo  21OCT2020  Placebo  10NOV2020  Placebo  
10051338  C4591001 
1005 
10051338  >55 21OCT2020  271758  Placebo  21OCT2020  Placebo   
  
10051340  C4591001 
1005 
10051340  16-55 21OCT2020  110919  Placebo  21OCT2020  Placebo  11NOV2020  Placebo  
10051341  C4591001 
1005 
10051341  16-55 21OCT2020  111573  Placebo  21OCT2020  Placebo   
  
10051342  C4591001 
1005 
10051342  >55 21OCT2020  271760  Placebo  21OCT2020  Placebo  10NOV2020  Placebo  
10051343  C4591001 
1005 
10051343  16-55 21OCT2020  111578  BNT162b2  
(30 μg)  21OCT2020  BNT162b2  
(30 μg)  11NOV2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051344  C4591001 
1005 
10051344  >55 21OCT2020  271763  BNT162b2  
(30 μg)  21OCT2020  BNT162b2  
(30 μg)  09NOV2020  BNT162b2  
(30 μg)  
10051345  C4591001 
1005 
10051345  16-55 21OCT2020  111579  Placebo 21OCT2020  Placebo  12NOV2020  Placebo  
10051346  C4591001 
1005 
10051346  16-55 21OCT2020  111580  BNT162b2  
(30 μg)  21OCT2020  BNT162b2  
(30 μg)  13NOV2020  BNT162b2  
(30 μg)  
10051347  C4591001 
1005 
10051347  >55 22OCT2020  272165  Placebo  22OCT2020  Placebo  12NOV2020  Placebo  
10051348  C4591001 
1005 
10051348  >55 22OCT2020  271766  BNT162b2  
(30 μg)  22OCT2020  BNT162b2  
(30 μg)  12NOV2020  BNT162b2  
(30 μg)  
10051349  C4591001 
1005 
10051349  16-55 22OCT2020  112037  Placebo  22OCT2020  Placebo  11NOV2020  Placebo  
10051350  C4591001 
1005 
10051350  16-55 22OCT2020  112038  BNT162b2  
(30 μg)  22OCT2020  BNT162b2  
(30 μg)  11NOV2020  BNT162b2  
(30 μg)  
10051351  C4591001 
1005 
10051351  >55 22OCT2020  272166  BNT162b2  
(30 μg)  22OCT2020  BNT162b2  
(30 μg)  10NOV2020  BNT162b2  
(30 μg)  
10051353  C4591001 
1005 
10051353  >55 22OCT2020  272172  Placebo  22OCT2020  Placebo  10NOV2020  Placebo  
10051354  C4591001 
1005 
10051354  16-55 22OCT2020  112040  Placebo  22OCT2020  Placebo  12NOV2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051355  C4591001 
1005 
10051355  >55 22OCT2020  272175  BNT162b2  
(30 μg)  22OCT2020  BNT 162b2  
(30 μg)  11NOV2020  BNT162b2  
(30 μg)  
10051356  C4591001 
1005 
10051356  16-55 22OCT2020  112042  BNT162b2  
(30 μg)  22OCT2020  BNT162b2  
(30 μg)  12NOV2020  BNT162b2  
(30 μg)  
10051357  C4591001 
1005 
10051357  16-55 22OCT2020  112290  BNT162b2  
(30 μg)  22OCT2020  BNT16 2b2 
(30 μg)  12NOV2020  BNT162b2  
(30 μg)  
10051358  C4591001 
1005 
10051358  16-55 22OCT2020  112295  Placebo  22OCT2020  Placebo  13NOV2020  Placebo  
10051360  C4591001 
1005 
10051360  >55 22OCT2020  272454  Placebo  22OCT2020  Placebo  12NOV2020  Placebo  
10051361  C4591001 
1005 
10051361  16-55 22OCT2020  112297  BNT162b2  
(30 μg)  22OCT2020  BNT162b2  
(30 μg)  11NOV2020  BNT162b2  
(30 μg)  
10051362  C4591001 
1005 
10051362  16-55 23OCT2020  112300  Placebo  23OCT2020  Placebo  13NOV2020  Placebo  
10051363  C4591001 
1005 
10051363  16-55 23OCT2020  112711  Placebo  23OCT2020  Placebo  13NOV2020  Placebo  
10051364  C4591001 
1005 
10051364  16-55 23OCT2020  112714  Placebo  23OCT2020  Placebo  13NOV2020  Placebo  
10051365  C4591001 
1005 
10051365  16-55 23OCT2020  112715  BNT162b2  
(30 μg)  23OCT2020  BNT162b2  
(30 μg)  11NO V2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051366  C4591001 
1005 
10051366  16-55 23OCT2020  112717  BNT162b2  
(30 μg)  23OCT2020  BNT162b2  
(30 μg)  13NOV2020  BNT162b2  
(30 μg)  
10051367  C4591001 
1005 
10051367  >55 23OCT2020  272457  Placebo  23OCT2020  Placebo  12NOV2020  Placebo  
1005136 8 C4591001 
1005 
10051368  16-55 23OCT2020  112976  Placebo  23OCT2020  Placebo  13NOV2020  Placebo  
10051369  C4591001 
1005 
10051369  16-55 26OCT2020  112979  BNT162b2  
(30 μg)  26OCT2020  BNT162b2  
(30 μg)   
  
10051370  C4591001 
1005 
10051370  16-55 26OCT2020  112984  Place bo 26OCT2020  Placebo   
  
10051371  C4591001 
1005 
10051371  16-55 26OCT2020  112983  BNT162b2  
(30 μg)  26OCT2020  BNT162b2  
(30 μg)   
  
10051372  C4591001 
1005 
10051372  >55 26OCT2020  272464  BNT162b2  
(30 μg)  26OCT2020  BNT162b2  
(30 μg)   
  
10051373  C4591001 
1005 
1005 1373  >55 26OCT2020  272463  BNT162b2  
(30 μg)  26OCT2020  BNT162b2  
(30 μg)   
  
10051374  C4591001 
1005 
10051374  >55 26OCT2020  273042  BNT162b2  
(30 μg)  26OCT2020  BNT162b2  
(30 μg)   
  
10051375  C4591001 
1005 
10051375  >55 26OCT2020  273043  Placebo  26OCT2020  Placebo   
  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051377  C4591001 
1005 
10051377  16-55 27OCT2020  113982  Placebo  27OCT2020  Placebo   
  
10051378  C4591001 
1005 
10051378  16-55 27OCT2020  113984  BNT162b2  
(30 μg)  27OCT2020  BNT162b2  
(30 μg)   
  
10051379  C4591001 
1005 
10051379  >55 27OCT2020  273047  Placebo  27OCT 2020  Placebo   
  
10051380  C4591001 
1005 
10051380  16-55 27OCT2020  113991  Placebo  27OCT2020  Placebo   
  
10051381  C4591001 
1005 
10051381  16-55 28OCT2020  113992  BNT162b2  
(30 μg)   
   
  
10051382  C4591001 
1005 
10051382  >55 28OCT2020  273051  BNT162b2  
(30 μg)  28OCT 2020  BNT162b2  
(30 μg)   
  
10051385  C4591001 
1005 
10051385  16-55 28OCT2020  114463  BNT162b2  
(30 μg)  28OCT2020  BNT162b2  
(30 μg)   
  
10051386  C4591001 
1005 
10051386  16-55 28OCT2020  114465  Placebo  28OCT2020  Placebo   
  
10051387  C4591001 
1005 
10051387  >55 29OCT2 020 273643  BNT162b2  
(30 μg)  29OCT2020  BNT162b2  
(30 μg)   
  
10051389  C4591001 
1005 
10051389  >55 29OCT2020  273645  BNT162b2  
(30 μg)  29OCT2020  BNT162b2  
(30 μg)   
  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051390  C4591001 
1005 
10051390  16-55 30OCT2020  273647  Placebo  30OCT2020  Placebo   
  
10051391  C4591001 
1005 
10051391  >55 30OCT2020  273646  Placebo  30OCT2020  Placebo   
  
10051392  C4591001 
1005 
10051392  >55 30OCT2020  273857  Placebo  30OCT2020  Placebo   
  
10051393  C4591001 
1005 
10051393  16-55 30OCT2020  114466  BNT162b2  
(30 μg)  30OCT2020  BNT162b2  
(30 μg)   
  
10051394  C4591001 
1005 
10051394  16-55 02NOV2020  114472  Placebo  02NOV2020  Placebo   
  
10051395  C4591001 
1005 
10051395  >55 02NOV2020  273860  BNT162b2  
(30 μg)  02NOV2020  BNT162b2  
(30 μg)   
  
10051396  C4591001 
1005 
10051396  16-55 02NOV2020  115315  BNT162b2  
(30 μg) 02NOV2020  BNT162b2  
(30 μg)   
  
10051397  C4591001 
1005 
10051397  16-55 02NOV2020  115317  Placebo  02NOV2020  Placebo   
  
10051398  C4591001 
1005 
10051398  16-55 03NOV2020  115318  Placebo  03NOV2020  Placebo   
  
10051399  C4591001 
1005 
10051399  >55 03NOV2020  27386 6 Placebo  03NOV2020  Placebo   
  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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FDA-CBER-2021-5683-0024886
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10051400  C4591001 
1005 
10051400  16-55 03NOV2020  115320  BNT162b2  
(30 μg)  03NOV2020  BNT162b2  
(30 μg)   
  
10051402  C4591001 
1005 
10051402  >55 03NOV2020  273868  BNT162b2  
(30 μg)  03NOV2020  BNT162b2  
(30 μg)   
  
10051403  C4591001 
1005 
10051403  >55 04NOV2020  274026  BNT162b2  
(30 μg)  04NOV2020  BNT162b2  
(30 μg)   
  
10051405  C4591001 
1005 
10051405  >55 06NOV2020  274029  Placebo  06NOV2020  Placebo   
  
10051406  C4591001 
1005 
10051406  >55 09NOV2020  274031  BNT162b2  
(30 μg)  09NOV2020  BNT162b2  
(30 μg)  
  
10051407  C4591001 
1005 
10051407  16-55 11NOV2020  116093  Placebo  11NOV2020  Placebo   
  
10051408  C4591001 
1005 
10051408  16-55 11NOV2020  116096  BNT162b2  
(30 μg)  11NOV2020  BNT162b2  
(30 μg)   
  
10061001  C4591001 
1006 
10061001  >55 06AUG2020  223782  Placeb o 06AUG2020  Placebo  25AUG2020  Placebo  
10061002  C4591001 
1006 
10061002  >55 06AUG2020  223783  Placebo  06AUG2020  Placebo  25AUG2020  Placebo  
10061003  C4591001 
1006 
10061003  >55 10AUG2020  223787  BNT162b2  
(30 μg)  10AUG2020  BNT162b2  
(30 μg)  01SEP2020  BNT162b2  
(30 μg) 
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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FDA-CBER-2021-5683-0024887
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10061004  C4591001 
1006 
10061004  >55 10AUG2020  223789  BNT162b2  
(30 μg)  10AUG2020  BNT162b2  
(30 μg)  01SEP2020  BNT162b2  
(30 μg)  
10061005  C4591001 
1006 
10061005  16-55 10AUG2020  45485  Placebo  10AUG2020  Placebo  31AUG2020  Placebo  
10061006  C4591001 
1006 
10061006  >55 10AUG2020  225005  BNT162b2  
(30 μg)  10AUG2020  BNT162b2  
(30 μg)  31AUG2020  BNT162b2  
(30 μg)  
10061007  C4591001 
1006 
10061007  16-55 10AUG2020  45487  BNT162b2  
(30 μg)  10AUG2020  BNT162b2  
(30 μg)  31AUG2020  BNT162b2  
(30 μg)  
10061008  C4591001 
1006 
10061008  16-55 10AUG2020  45490  Placebo  10AUG2020  Placebo  31AUG2020  Placebo  
10061009  C4591001 
1006 
10061009  16-55 10AUG2020  45495  BNT162b2  
(30 μg)  10AUG2020  BNT162b2  
(30 μg)  02SEP2020  BNT162b2  
(30 μg)  
10061010  C4591001 
1006 
10061010  >55 10AUG2020  225006  BNT162b2  
(30 μg)  10AUG2020  BNT162b2  
(30 μg)  31AUG2020  BNT162b2  
(30 μg)  
10061011  C4591001 
1006 
10061011  16-55 11AUG2020  46289  BNT162b2  
(30 μg)  11AUG2020  BNT162b2  
(30 μg)  31AUG2020  BNT162b2  
(30 μg)  
10061012  C4591001 
1006 
10061012  16-55 11AUG2020  46292  Placebo  11AUG 2020  Placebo  31AUG2020  Placebo  
10061013  C4591001 
1006 
10061013  16-55 11AUG2020  46294  Placebo  11AUG2020  Placebo  31AUG2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10061014  C4591001 
1006 
10061014  16-55 11AUG2020  46296  BNT162b2  
(30 μg)  11AUG2020  BNT162b2  
(30 μg)  31AUG2020  BNT162b2  
(30 μg)  
10061015  C4591001 
1006 
10061015  16-55 11AUG2020  46865  BNT162b2  
(30 μg)  11AUG2020  BNT162b2  
(30 μg)  01SEP2020  BNT162b2  
(30 μg)  
10061016  C4591001 
1006 
10061016  >55 11AUG2020  225010  Placebo  11AUG2020  Placebo  31AUG2020  Placebo  
10061017  C4591001 
1006 
10061017  >55 11AUG2020  225013  Placebo  11AUG2020  Placebo  01SEP2020  Placebo  
10061018  C4591001 
1006 
10061018  16-55 11AUG2020  46868  Placebo  11AUG2020  Placebo  31AUG2020  Placebo  
10061019  C4591001 
1006 
10061019  16-55 12AUG2020  46869  BNT162b2  
(30 μg)  12AUG2020  BNT162b2  
(30 μg)  03SEP2020  BNT162b2  
(30 μg)  
10061020  C4591001 
1006 
10061020  >55 12AUG2020  226866  Placebo  12AUG2020  Placebo   
  
10061021  C4591001 
1006 
10061021  16-55 12AUG2020  46874  Placebo  12AUG2020  Placebo  01SEP2020  Placebo  
10061022  C4591001 
1006 
10061022  16-55 12AUG2020  47813  Placebo  12AUG2020  Placebo  31AUG2020  Placebo  
10061023  C4591001 
1006 
10061023  16-55 12AUG2020  47819  Placebo  12AUG2020  Placebo  31AUG2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10061024  C4591001 
1006 
10061024  16-55 12AUG2020  47820  BNT162b2  
(30 μg)  12AUG2020  BNT162b2  
(30 μg ) 31AUG2020  BNT162b2  
(30 μg)  
10061025  C4591001 
1006 
10061025  >55 12AUG2020  226870  Placebo  12AUG2020  Placebo  01SEP2020  Placebo  
10061027  C4591001 
1006 
10061027  >55 13AUG2020  226873  BNT162b2  
(30 μg)  13AUG2020  BNT162b2  
(30 μg)  04SEP2020  BNT162b2  
(30 μg)  
10061028  C4591001 
1006 
10061028  16-55 13AUG2020  47823  BNT162b2  
(30 μg)  13AUG2020  BNT162b2  
(30 μg)  03SEP2020  BNT162b2  
(30 μg)  
10061029  C4591001 
1006 
10061029  >55 13AUG2020  226875  BNT162b2  
(30 μg)  13AUG2020  BNT162b2  
(30 μg)  03SEP2020  BNT162b2  
(30 μg)  
10061030  C4591001 
1006 
10061030  >55 13AUG2020  228500  Placebo  13AUG2020  Placebo  03SEP2020  Placebo  
10061031  C4591001 
1006 
10061031  16-55 13AUG2020  49714  Placebo  13AUG2020  Placebo  04SEP2020  Placebo  
10061032  C4591001 
1006 
10061032  16-55 13AUG2020  49718  BNT162b2  
(30 μg) 13AUG2020  BNT162b2  
(30 μg)  04SEP2020  BNT162b2  
(30 μg)  
10061033  C4591001 
1006 
10061033  16-55 13AUG2020  49712  BNT162b2  
(30 μg)  13AUG2020  BNT162b2  
(30 μg)  04SEP2020  BNT162b2  
(30 μg)  
10061034  C4591001 
1006 
10061034  >55 14AUG2020  228501  BNT162b2  
(30 μg)  14AUG2020  BNT162b2  
(30 μg)  02SEP2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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FDA-CBER-2021-5683-0024890
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10061035  C4591001 
1006 
10061035  >55 14AUG2020  228503  BNT162b2  
(30 μg)  14AUG2020  BNT162b2  
(30 μg)  04SEP2020  BNT162b2  
(30 μg)  
10061036  C4591001 
1006 
10061036  16-55 14AUG2020  49719  Placebo  14AUG2020  Place bo 04SEP2020  Placebo  
10061037  C4591001 
1006 
10061037  16-55 14AUG2020  50868  Placebo  14AUG2020  Placebo  04SEP2020  Placebo  
10061039  C4591001 
1006 
10061039  >55 14AUG2020  228507  Placebo  14AUG2020  Placebo  04SEP2020  Placebo  
10061040  C4591001 
1006 
10061040  16-55 14AUG2020  50870  Placebo  14AUG2020  Placebo  04SEP2020  Placebo  
10061041  C4591001 
1006 
10061041  16-55 14AUG2020  50871  BNT162b2  
(30 μg)  14AUG2020  BNT162b2  
(30 μg)  04SEP2020  BNT162b2  
(30 μg)  
10061043  C4591001 
1006 
10061043  16-55 17AUG2020  50872  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  10SEP2020  BNT162b2  
(30 μg)  
10061044  C4591001 
1006 
10061044  >55 17AUG2020  230657  BNT16 2b2 
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  09SEP2020  BNT162b2  
(30 μg)  
10061045  C4591001 
1006 
10061045  >55 17AUG2020  230658  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  09SEP2020  BNT162b2  
(30 μg)  
10061046  C4591001 
1006 
10061046  >55 17AUG2020  230661  Placebo  17AUG2020  Placebo  08SEP2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10061047  C4591001 
1006 
10061047  >55 17AUG2020  230664  Placebo  17AUG2020  Placebo  08SEP2020  Placebo  
10061049  C4591001 
1006 
10061049  >55 17AUG2020  231223  Placebo  17AUG2020  Placebo  09SEP2020  Placebo  
10061050  C4591001 
1006 
10061050  16-55 17AUG2020  53731  BNT162b2  
(30 μg)  17AUG2020  BNT162b2  
(30 μg)  09SEP2020  BNT162b2  
(30 μg)  
10061051  C4591001 
1006 
10061051  >55 18AUG2020  231226  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  09SEP2020  BNT162b2  
(30 μg)  
10061052  C4591001 
1006 
10061052  16-55 18AUG2020  53735  Place bo 18AUG2020  Placebo  08SEP2020  Placebo  
10061053  C4591001 
1006 
10061053  16-55 18AUG2020  53737  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  09SEP2020  BNT162b2  
(30 μg)  
10061054  C4591001 
1006 
10061054  16-55 18AUG2020  53738  Placebo  18AUG2020  Placebo  08SEP2020  Placebo  
10061055  C4591001 
1006 
10061055  16-55 18AUG2020  54787  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  10SEP2020  BNT162b2  
(30 μg)  
10061056  C4591001 
1006 
10061056  16-55 18AUG2020  54791  Placebo  18AUG2020  Placebo  08SEP2020  Placebo  
10061057  C4591001 
1006  
10061057  16-55 18AUG2020  54788  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  10SEP2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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FDA-CBER-2021-5683-0024892
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10061059  C4591001 
1006 
10061059  >55 18AUG2020  231229  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  08SEP2020  BNT162b2  
(30 μg)  
10061060  C4591001 
1006 
1006 1060  >55 18AUG2020  231232  Placebo  18AUG2020  Placebo  08SEP2020  Placebo  
10061061  C4591001 
1006 
10061061  16-55 18AUG2020  54792  Placebo  18AUG2020  Placebo  09SEP2020  Placebo  
10061062  C4591001 
1006 
10061062  16-55 18AUG2020  55590  BNT162b2  
(30 μg)  18AUG2020  BNT16 2b2 
(30 μg)  09SEP2020  BNT162b2  
(30 μg)  
10061063  C4591001 
1006 
10061063  >55 18AUG2020  232793  BNT162b2  
(30 μg)  18AUG2020  BNT162b2  
(30 μg)  10SEP2020  BNT162b2  
(30 μg)  
10061064  C4591001 
1006 
10061064  >55 04SEP2020  248821  Placebo  04SEP2020  Placebo  25SEP2020  Placebo  
10061065  C4591001 
1006 
10061065  >55 19AUG2020  232798  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  09SEP2020  BNT162b2  
(30 μg)  
10061066  C4591001 
1006 
10061066  16-55 19AUG2020  55592  Placebo  19AUG2020  Placebo  14SEP2020  Placebo  
10061067  C4591001 
1006 
10061067  16-55 19AUG2020  55593  Placebo  19AUG2020  Placebo  08SEP2020  Placebo  
10061068  C4591001 
1006 
10061068  16-55 19AUG2020  55595  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  09SEP2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
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16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10061069  C4591001 
1006 
10061069  >55 19AUG2020  232800  Placebo  19AUG2020  Placebo  09SEP2020  Placebo  
10061070  C4591001 
1006 
10061070  16-55 19AUG2020  57392  Placebo  19AUG2020  Placebo  02OCT2020  Placebo  
10061071  C4591001 
1006 
10061071  16-55 19AUG2020  57393  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  15SEP2020  BNT162b 2 
(30 μg)  
10061073  C4591001 
1006 
10061073  16-55 19AUG2020  57394  Placebo  19AUG2020  Placebo  10SEP2020  Placebo  
10061074  C4591001 
1006 
10061074  16-55 19AUG2020  57395  BNT162b2  
(30 μg)  19AUG2020  BNT162b2  
(30 μg)  10SEP2020  BNT162b2  
(30 μg)  
10061075  C4591001 
1006 
10061075  16-55 20AUG2020  58337  Placebo  20AUG2020  Placebo  09SEP2020  Placebo  
10061076  C4591001 
1006 
10061076  >55 20AUG2020  232801  Placebo  20AUG2020  Placebo  11SEP2020  Placebo  
10061077  C4591001 
1006 
10061077  >55 20AUG2020  235148  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  10SEP2020  BNT162b2  
(30 μg)  
10061078  C4591001 
1006 
10061078  16-55 20AUG2020  58342  Placebo  20AUG2020  Placebo  10SEP2020  Placebo  
10061079  C4591001 
1006 
10061079  16-55 20AUG2020  58343  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  16SEP2020  BNT 162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 117
FDA-CBER-2021-5683-0024894
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10061080  C4591001 
1006 
10061080  >55 20AUG2020  235149  Placebo  20AUG2020  Placebo  08SEP2020  Placebo  
10061081  C4591001 
1006 
10061081  16-55 20AUG2020  58344  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  11SEP2020  BNT162b2  
(30 μg)  
10061082  C4591001  
1006 
10061082  >55 20AUG2020  235152  Placebo  20AUG2020  Placebo  09SEP2020  Placebo  
10061083  C4591001 
1006 
10061083  >55 20AUG2020  235154  BNT162b2  
(30 μg)  20AUG2020  BNT162b2  
(30 μg)  10SEP2020  BNT162b2  
(30 μg)  
10061084  C4591001 
1006 
10061084  16-55 20AUG2020  59827 Placebo  20AUG2020  Placebo  10SEP2020  Placebo  
10061086  C4591001 
1006 
10061086  >55 21AUG2020  236118  Placebo  21AUG2020  Placebo  09SEP2020  Placebo  
10061088  C4591001 
1006 
10061088  16-55 21AUG2020  59828  Placebo  21AUG2020  Placebo  11SEP2020  Placebo  
10061089  C4591001 
1006 
10061089  16-55 21AUG2020  59831  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  10SEP2020  BNT162b2  
(30 μg)  
10061090  C4591001 
1006 
10061090  16-55 21AUG2020  59835  BNT162b2  
(30 μg)  21AUG2020  BNT162b2  
(30 μg)  11SEP2020  BNT162b2  
(30 μg)  
10061091  C4591001 
1006 
10061091  16-55 21AUG2020  61613  Placebo 21AUG2020  Placebo  11SEP2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 118
FDA-CBER-2021-5683-0024895
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10061092  C4591001 
1006 
10061092  16-55 21AUG2020  61614  Placebo  21AUG2020  Placebo  11SEP2020  Placebo  
10061093  C4591001 
1006 
10061093  16-55 24AUG2020  61616  BNT162b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  18SEP2020  BNT162b2  
(30 μg)  
10061094  C4591001 
1006 
10061094  16-55 24AUG2020  61617  BNT162b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  18SEP2020  BNT162b2  
(30 μg)  
10061095  C4591001 
1006 
10061095  16-55 24AUG2020  63883  Placebo  24AUG2020  Placebo  15SEP2020  Placebo  
10061096  C4591001 
1006 
10061096  16-55 24AUG2020  63885  BNT162b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  29SEP2020  BNT162b2  
(30 μg)  
10061097  C4591001 
1006 
10061097  >55 24AUG2020  236120  BNT162b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  15SEP2020  BNT162b2  
(30 μ g) 
10061098  C4591001 
1006 
10061098  >55 24AUG2020  236124  BNT162b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  15SEP2020  BNT162b2  
(30 μg)  
10061099  C4591001 
1006 
10061099  16-55 24AUG2020  63886  Placebo  24AUG2020  Placebo  15SEP2020  Placebo  
10061100  C4591001 
1006 
10061100  16-55 24AUG2020  63892  BNT1 62b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  14SEP2020  BNT162b2  
(30 μg)  
10061101  C4591001 
1006 
10061101  >55 24AUG2020  236127  Placebo  24AUG2020  Placebo  14SEP2020  Placebo  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 119
FDA-CBER-2021-5683-0024896
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10061102  C4591001 
1006 
10061102  16-55 24AUG2020  64939  Placebo  24AUG2020  Placebo  14SEP2020  Placebo  
10061103  C4591001 
1006 
10061103  16-55 24AUG2020  64940  BNT162b2  
(30 μg)  24AUG2020  BNT162b2  
(30 μg)  14SEP2020  BNT162b2  
(30 μg)  
10061104  C4591001 
1006 
10061104  16-55 25AUG2020  64944  BNT162b2  
(30 μg)  25AUG2020  BNT162b2  
(30 μg)  15SEP2020  BNT162b2  
(30 μg) 
10061105  C4591001 
1006 
10061105  >55 25AUG2020  239598  Placebo  25AUG2020  Placebo  16SEP2020  Placebo  
10061106  C4591001 
1006 
10061106  16-55 25AUG2020  64947  Placebo  25AUG2020  Placebo  14SEP2020  Placebo  
10061107  C4591001 
1006 
10061107  16-55 25AUG2020  66439  BNT162b2  
(30 μg)  25AUG2020  BNT162b2  
(30 μg)  15SEP2020  BNT162b2  
(30 μg)  
10061108  C4591001 
1006 
10061108  16-55 25AUG2020  66442  BNT162b2  
(30 μg)  25AUG2020  BNT162b2  
(30 μg)  18SEP2020  BNT162b2  
(30 μg)  
10061109  C4591001 
1006 
10061109  16-55 25AUG2020  66446  Placebo 25AUG2020  Placebo  14SEP2020  Placebo  
10061110  C4591001 
1006 
10061110  16-55 25AUG2020  66447  Placebo  25AUG2020  Placebo  17SEP2020  Placebo  
10061112  C4591001 
1006 
10061112  16-55 26AUG2020  67556  BNT162b2  
(30 μg)  26AUG2020  BNT162b2  
(30 μg)  16SEP2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 120
FDA-CBER-2021-5683-0024897
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10061113  C4591001 
1006 
10061113  16-55 26AUG2020  67557  BNT162b2  
(30 μg)  26AUG2020  BNT162b2  
(30 μg)  21SEP2020  BNT162b2  
(30 μg)  
10061114  C4591001 
1006 
10061114  16-55 26AUG2020  67561  Placebo  26AUG2020  Placebo  16SEP2020  Placebo  
10061115  C4591001 
1006 
10061115  >55 26AUG2020  239600  BNT162b2  
(30 μg)  26AUG2020  BNT162b2  
(30 μg)  16SEP2020  BNT162b2  
(30 μg)  
10061116  C4591001 
1006 
10061116  16-55 26AUG2020  67562  Placebo  26AUG2020  Placebo  16SEP2020  Placebo  
10061117  C4591001 
1006 
10061117  16-55 26AUG2020  69344  BNT162b2  
(30 μg)  26AUG2020  BNT162b2  
(30 μg)  14SEP2020  BNT162b2  
(30 μg)  
10061118  C4591001 
1006 
10061118  16-55 27AUG2020  69346  Placebo  27AUG2020  Placebo  18SEP2020  Placebo  
10061119  C4591001 
1006 
10061119  >55 27AUG2020  239604  BNT162b2  
(30 μg)  27AUG2020  BNT1 62b2  
(30 μg)  16SEP2020  BNT162b2  
(30 μg)  
10061120  C4591001 
1006 
10061120  >55 27AUG2020  239608  Placebo  27AUG2020  Placebo  16SEP2020  Placebo  
10061121  C4591001 
1006 
10061121  >55 27AUG2020  243930  Placebo  27AUG2020  Placebo  16SEP2020  Placebo  
10061122  C4591001 
1006 
10061122  16-55 27AUG2020  69348  BNT162b2  
(30 μg)  27AUG2020  BNT162b2  
(30 μg)  18SEP2020  BNT162b2  
(30 μg)  
090177e1959b1f96\Final\Final On: 24-Nov-2020 13:50 (GMT) 
Page 121
FDA-CBER-2021-5683-0024898
16.1.7.4 Listing of Randomization Scheme and Actual Vaccine Received – All Subject s 
  Vaccine Received  
Subject  
Study  
Identifiera Subject  Age 
Group  
(Years)  Randomization 
Date  Randomization  
Number  Randomization  
Vaccine Group  Date       Dose  1      Date       Dose  2      
  
10061123  C4591001 
1006 
10061123  >55 27AUG2020  243932  BNT162b2  
(30 μg)  27AUG2020  BNT162b2  
(30 μg)  17SEP2020  BNT162b2  
(30 μ g) 
10061124  C4591001 
1006 
10061124  16-55 28AUG2020  69350  Placebo  28AUG2020  Placebo  21SEP2020  Placebo  
10061125  C4591001 
1006 
10061125  >55 28AUG2020  243936  Placebo  28AUG2020  Placebo  18SEP2020  Placebo  
10061128  C4591001 
1006 
10061128  16-55 28AUG2020  73077  BNT162b2  
(30 μg)  28AUG2020  BNT162b2  
(30 μg)  18SEP2020  BNT162b2  
(30 μg)  
10061129  C4591001 
1006 
10061129  16-55 28AUG2020  73076  BNT162b2  
(30 μg)  28AUG2020  BNT162b2  
(30 μg)  16SEP2020  BNT162b2  
(30 μg)  
10061130  C4591001 
1006 
10061130  16-55 28AUG2020  73081  Placebo  28AUG2020  Placebo  18SEP20 20 Placebo  
10061131  C4591001 
1006 
10061131  16-55
…[truncated]