125742 S1 M5 5351 c4591001 interim mth6 randomization sensitive
Document text
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
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/
BNT162b1
(10 μg) 27MAY2020/
BNT162b1
(10 μg)
10011007 C4591001 1001
100110 07^ 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 100 1
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 C459 1001 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 19JAN2021/
BNT162b2
(30 μg) 09FEB2021 /
BNT162b2
(30 μg)
10011015 C4591001 1001
10011015^ 18-55 11MAY2020 1219 BNT162b1
(30 μg) 11MAY2020/
BNT162b1
(30 μg) 01JUN2020/
BNT162b1
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 1
FDA-CBER-2021-5683-0035553
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10011017 C4591001 1001
10011017^ 18-55 13MAY2020 1228 BNT162b1
(30 μg) 13MAY2020/
BNT162b1
(30 μg) 03JUN 2020/
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 μ g) 03JUN2020/
BNT162b1
(30 μg)
10011021 C4591001 1001
10011021^ 18-55 20MAY2020 1356 Placebo 20MAY2020/
Placebo 17AUG2020/
Placebo 06JAN2021/
BNT162b2
(30 μg) 25JAN2021/
BNT162b2
(30 μg)
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 18MAY2020/
BNT162b1
(100 μg) 13AUG2020/
BNT162b1
(10 μg)
10011028 C4591001 1001
10011028^ 18-55 20MAY2020 1359 20MAY2020/
BNT162b1
(100 μg) 17AUG2020/
BNT162b1
(10 μg)
10011030 C4591001 1001
10011030^ 18-55 20MAY2020 1357 20MAY2020/
BNT162b1
(100 μg) 17AUG2020/
BNT162b1
(10 μg)
10011032 C4591001 1001
10011032^ 18-55 20MAY2020 1360 20MAY2020/
BNT162b1
(100 μg) 13AU G2020/
BNT162b1
(10 μg)
10011034 C4591001 1001
10011034^ 18-55 20MAY2020 1358 20MAY2020/
BNT162b1
(100 μg) 17AUG2020/
BNT162b1
(10 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 2
FDA-CBER-2021-5683-0035554
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10011066 C4591001 1001
10011066^ 18-55 29JUN2020 1489 Placebo 29JUN2020/
Placebo 20JUL2020/
Placebo
1001 1067 C4591001 1001
10011067^ 18-55 01JUL2020 1499 BNT162b1
(20 μg) 01JUL2020/
BNT162b1
(20 μg) 22JUL2020/
BNT162b1
(20 μg)
10011068 C4591001 1001
10011068^ 18-55 29JUN2020 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 05JAN2021/
BNT162b2
(30 μg) 25JAN2021/
BNT162b2
(30 μg)
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 01JUL2020 1498 BNT162b1
(20 μg) 01JUL2020/
BNT16 2b1
(20 μg) 21JUL2020/
BNT162b1
(20 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) 04MAY202 0/
BNT162b1
(10 μg) 26MAY2020/
BNT162b1
(10 μg)
10021005 C4591001 1002
10021005^ 18-55 04MAY2020 1083 Placebo 04MAY2020/
Placebo 26MAY2020/
Placebo 28DEC2020/
BNT162b2
(30 μg) 19JAN2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 3
FDA-CBER-2021-5683-0035555
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10021006 C4591001 1002
10021006^ 18-55 11MAY20 20 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)
10021008 C4591001 1002
10021008^ 18-55 06MAY2020 1088 Placebo 06MAY2020/
Placebo 26MAY2020/
Placebo
10021009 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 BNT 162b1
(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)
10021014 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)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 4
FDA-CBER-2021-5683-0035556
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10021018 C4591001 1002
10021018^ 18-55 11MAY2020 1217 Placebo 11MAY2020/
Placebo 02JUN2020/
Placebo 28DEC2020/
BNT162b2
(30 μg) 19JAN2021/
BNT162b2
(30 μg)
10021020 C4591001 1002
10021020^ 18-55 13MAY2020 1222 BNT162b1
(30 μg) 13MAY2020/
BNT162b1
(30 μg) 02JUN2020/
BNT162b1
(30 μg)
10021021 C4591001 1002
10021021^ 18-55 13MAY2020 1223 Placebo 13MAY2020/
Placebo 02JUN2020/
Placebo 12JAN2021/
BNT162b2
(30 μg) 03FEB2021/
BNT162b2
(30 μg)
10021022 C4591001 1002
10021022^ 18-55 13MAY2020 1227 Placebo 13MAY2020/
Placebo 02JUN2020/
Placebo 28DEC2020/
BNT162b2
(30 μg) 19JAN2021/
BNT162b2
(30 μg)
10021023 C4591001 1002
10021023^ 18-55 18MAY2020 1352 18MAY2020/
BNT162b1
(100 μg) 17AUG2020/
BNT162b1
(10 μg)
10021024 C4591001 1002
10021024^ 18-55 18MAY2020 1353 18MAY2020/
BNT162b1
(100 μg) 31AUG2020/
BNT162b1
(10 μg)
10021027 C4591001 1002
10021027^ 18-55 18MAY2020 1351 18MAY2020/
BNT162b1
(100 μg) 17AUG2020/
BNT162b1
(10 μg)
10021034 C4591001 1002
10021034^ 18-55 21MAY2020 1363 21MAY2020/
BNT162b1
(100 μg) 17AUG2020/
BNT1 62b1
(10 μg)
10021035 C4591001 1002
10021035^ 18-55 21MAY2020 1361 21MAY2020/
BNT162b1
(100 μg) 18AUG2020/
BNT162b1
(10 μg)
10021036 C4591001 1002
10021036^ 18-55 21MAY2020 1364 21MAY2020/
BNT162b1
(100 μg) 18AUG2020/
BNT162b1
(10 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 5
FDA-CBER-2021-5683-0035557
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10021038 C4591001 1002
10021038^ 18-55 21MAY2020 1365 21MAY2020/
BNT162b1
(100 μg) 17AUG2020/
BNT162b1
(10 μg)
10021041 C4591001 1002
10021041^ 18-55 21MAY2020 1362 Placebo 21MAY2020/
Placebo 17AUG2020/
Placebo 05JAN2021/
BNT162b2
(30 μg) 03FEB2021/
BNT162b2
(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) 21JUL202 0/
BNT162b1
(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 12JAN2021/
BNT162b2
(30 μg) 03FEB 2021/
BNT162b2
(30 μg)
10021084 C4591001 1002
10021084^ 18-55 29JUN2020 1488 BNT162b1
(20 μg) 29JUN2020/
BNT162b1
(20 μg) 21JUL2020/
BNT162b1
(20 μg)
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 BNT1 62b1
(20 μg) 01JUL2020/
BNT162b1
(20 μg) 21JUL2020/
BNT162b1
(20 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 6
FDA-CBER-2021-5683-0035558
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10031016 C4591001 1003
10031016^ 18-55 09JUN2020 2164 Placebo 09JUN2020/
Placebo 30JUN2020/
Placebo 07JAN2021/
BNT162b2
(30 μg) 26JAN2021/
BNT162b2
(30 μg)
10031017 C4591001 1003
10031017^ 18-55 11JUN2020 2172 Placebo 11JUN2020/
Placebo 02JUL2020/
Placebo 31DEC2020/
BNT162b2
(30 μg) 22JAN2021/
BNT162b2
(30 μg)
10031018 C4591001 1003
10031018^ 18-55 09JUN2020 2163 BNT162b2
(10 μg) 09JUN2020/
BNT162b2
(10 μg) 30JUN2020/
BNT162b2
(10 μ g)
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/
BNT162 b2
(10 μg)
10031021 C4591001 1003
10031021^ 18-55 09JUN2020 2165 BNT162b2
(10 μg) 09JUN2020/
BNT162b2
(10 μg) 30JUN2020/
BNT162b2
(10 μ g)
10031022 C4591001 1003
10031022^ 18-55 11JUN2020 2171 BNT162b2
(10 μg) 11JUN2020/
BNT162b2
(10 μg) 02JUL2020 /
BNT162b2
(10 μg)
10031024 C4591001 1003
10031024^ 18-55 11JUN2020 2173 BNT162b2
(10 μg) 11JUN2020/
BNT162b2
(10 μg) 02JUL2020/
BNT162b2
(10 μg)
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)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 7
FDA-CBER-2021-5683-0035559
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10031028 C4591001 1003
10031028^ 18-55 15JUN2020 2566 BNT162b2
(20 μg) 15JUN2020/
BNT162b2
(20 μg) 06JUL2020/
BNT162b2
(20 μg)
10031029 C4591001 1003
10031029^ 18-55 15JUN2020 2568 Placebo 15JUN2020/
Placebo 06JUL2020/
Placebo 31DEC2020/
BNT162b2
(30 μg) 22JAN2021/
BNT162b2
(30 μg)
10031030 C4591001 1003
10031030^ 18-55 17JUN2020 2575 BNT16 2b2
(20 μg) 17JUN2020/
BNT162b2
(20 μg) 08JUL2020/
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
10031034^ 18-55 17JUN2020 2571 Placebo 17JUN2020/
Placebo 08JUL2020/
Placebo 04JAN2021/
BNT162b2
(30 μg) 25JAN 2021/
BNT162b2
(30 μg)
10031038 C4591001 1003
10031038^ 18-55 17JUN2020 2574 BNT162b2
(20 μg) 17JUN2020/
BNT162b2
(20 μg) 08JUL2020/
BNT162b2
(20 μg)
10031050 C4591001 1003
10031050^ 18-55 22JUN2020 2297 Placebo 22JUN2020/
Placebo 13JUL2020/
Placebo 22DEC2020/
BNT162b2
(30 μg) 12JAN2021/
BNT162b2
(30 μg)
10031057 C4591001 1003
10031057^ 18-55 24JUN2020 2301 BNT162b2
(30 μg) 24JUN2020/
BNT162b2
(30 μg) 15JUL2020/
BNT162b 2
(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/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 8
FDA-CBER-2021-5683-0035560
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
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 μ g)
10031070 C4591001 1003
10031070^ 18-55 24JUN2020 2304 Placebo 24JUN2020/
Placebo 15JUL2020/
Placebo 08JAN2021/
BNT162b2
(30 μg) 29JAN2021/
BNT162b2
(30 μg)
10031072 C4591001 1003
10031072^ 18-55 24JUN2020 2302 BNT162b2
(30 μ g) 24JUN2020/
BNT162b2
(30 μg) 16JUL2020/
BNT162b2
(30 μg)
10071014 C4591001 1007
10071014^ 18-55 11JUN2020 2175 BNT162b2
(10 μg) 11JUN2020/
BNT162b2
(10 μg) 01JUL2020/
BNT162b2
(10 μg)
10071015 C4591001 1007
10071015^ 18-55 08JUN2020 2161 BNT162 b2
(10 μg) 08JUN2020/
BNT162b2
(10 μg) 29JUN2020/
BNT162b2
(10 μg)
10071016 C4591001 1007
10071016^ 18-55 10JUN2020 2166 BNT162b2
(10 μg) 10JUN2020/
BNT162b2
(10 μg) 01JUL2020/
BNT162b2
(10 μg)
10071017 C4591001 1007
10071017^ 18-55 15JUN2020 2569 BNT162b2
(20 μg) 15JUN2020/
BNT162b2
(20 μg) 06JUL2020/
BNT162b2
(20 μg)
10071019 C4591001 1007
10071019^ 18-55 08JUN2020 2162 BNT162b2
(10 μg) 08JUN2020/
BNT162b2
(10 μg) 29JUN2020/
BNT162b2
(10 μg)
10071020 C4591001 1007
10071020^ 18-55 10JUN 2020 2167 Placebo 10JUN2020/
Placebo 01JUL2020/
Placebo 13JAN2021/
BNT162b2
(30 μg) 03FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 9
FDA-CBER-2021-5683-0035561
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10071021 C4591001 1007
10071021^ 18-55 10JUN2020 2168 BNT162b2
(10 μg) 10JUN2020/
BNT162b2
(10 μg) 01JUL2020 /
BNT162b2
(10 μg)
10071022 C4591001 1007
10071022^ 18-55 10JUN2020 2169 BNT162b2
(10 μg) 10JUN2020/
BNT162b2
(10 μg) 01JUL2020/
BNT162b2
(10 μg)
10071023 C4591001 1007
10071023^ 18-55 17JUN2020 2577 BNT162b2
(20 μg) 17JUN2020/
BNT162b2
(20 μg) 08JUL2020/
BNT162b2
(20 μg)
10071025 C4591001 1007
10071025^ 18-55 17JUN2020 2580 Placebo 17JUN2020/
Placebo 08JUL2020/
Placebo 11JAN2021/
BNT162b2
(30 μg) 01FEB2021/
BNT162b2
(30 μg)
10071026 C4591001 1007
10071026^ 18-55 15JUN2020 2570 BNT162b2
(20 μg) 15JUN2020/
BNT162b2
(20 μg) 06JUL2020/
BNT162b2
(20 μg)
10071027 C4591001 1007
10071027^ 18-55 17JUN2020 2576 BNT162b2
(20 μg) 17JUN2020/
BNT162b2
(20 μg) 08JUL2020/
BNT162b2
(20 μg)
10071029 C4591001 1007
10071029^ 18-55 17JUN2020 2578 BNT162b2
(20 μg) 17JUN2020/
BNT162b2
(20 μg) 08JUL2020/
BNT162b2
(20 μg)
10071040 C4591001 1007
10071040^ 18-55 17JUN2020 2579 BNT162b2
(20 μg) 17JUN2020/
BNT162b2
(20 μg) 08JUL2020/
BNT162b2
(20 μg)
10071046 C4591001 1007
10071046^ 18-55 22JUN2020 2299 BNT162b2
(30 μg) 22JUN2020/
BNT1 62b2
(30 μg) 15JUL2020/
BNT162b2
(30 μg)
10071050 C4591001 1007
10071050^ 18-55 22JUN2020 2300 BNT162b2
(30 μg) 22JUN2020/
BNT162b2
(30 μg) 13JUL2020/
BNT162b2
(30 μ g)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 10
FDA-CBER-2021-5683-0035562
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10071058 C4591001 1007
10071058^ 18-55 24JUN2020 2309 BNT162b2
(30 μg) 24JUN20 20/
BNT162b2
(30 μg) 15JUL2020/
BNT162b2
(30 μg)
10071063 C4591001 1007
10071063^ 18-55 24JUN2020 2306 BNT162b2
(30 μg) 24JUN2020/
BNT162b2
(30 μg) 15JUL2020/
BNT162b2
(30 μg)
10071064 C4591001 1007
10071064^ 18-55 24JUN2020 2307 BNT162b2
(30 μg) 24JUN2020/
BNT162b2
(30 μg) 15JUL2020/
BNT162b2
(30 μg)
10071065 C4591001 1007
10071065^ 18-55 24JUN2020 2308 Placebo 24JUN2020/
Placebo 15JUL2020/
Placebo 06JAN2021/
BNT162b2
(30 μg) 27JAN2021/
BNT162b2
(30 μg)
10071066 C4591001 1007
10071066^ 18-55 24JUN2020 2310 BNT162b2
(30 μg) 24JUN2020/
BNT162b2
(30 μg) 15JUL2020/
BNT162b2
(30 μg)
10011037 C4591001 1001
10011037^ 65-85 11JUN2020 1631 BNT162b1
(10 μg) 11JUN2020/
BNT162b1
(10 μg) 30JUN2020/
BNT162b1
(10 μg)
10011039 C4591001 1001
100110 39^ 65-85 09JUN2020 1624 BNT162b1
(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 100 1
10011041^ 65-85 11JUN2020 1632 BNT162b1
(10 μg) 11JUN2020/
BNT162b1
(10 μg) 02JUL2020/
BNT162b1
(10 μ g)
10011042 C4591001 1001
10011042^ 65-85 11JUN2020 1634 Placebo 11JUN2020/
Placebo 30JUN2020/
Placebo
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 11
FDA-CBER-2021-5683-0035563
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
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) 02JUL2020/
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/
BNT162b1
(30 μg)
10011049 C4591001 1001
10011049^ 65-85 15JUN2020 2030 BNT162b1
(20 μg) 15JUN2020/
BNT162b1
(20 μg) 06JUL2020/
BNT162b1
(20 μg)
10011050 C459100 1 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)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 12
FDA-CBER-2021-5683-0035564
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10011057 C4591001 1001
1001 1057^ 65-85 17JUN2020 2038 Placebo 17JUN2020/
Placebo 08JUL2020/
Placebo 12JAN2021/
BNT162b2
(30 μg) 03FEB2021/
BNT162b2
(30 μg)
10011058 C4591001 1001
10011058^ 65-85 18JUN2020 1768 BNT162b1
(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)
10011064 C4591001 1001
10011064^ 65-85 18JUN2020 1770 Placebo 18JUN2020/
Placebo 07JUL2020/
Placebo 15JAN2021/
BNT162b2
(30 μg) 04FEB2021/
BNT162b2
(30 μg)
10021042 C4591001 1002
10021042^ 65-85 09JUN2020 1623 Placebo 09JUN2020/
Placebo 30JUN2020/
Placebo 28DEC2020/
BNT162b2
(30 μg) 19JAN2021/
BNT162b2
(30 μg)
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 11JUN 2020 1629 BNT162b1
(10 μg) 11JUN2020/
BNT162b1
(10 μg) 30JUN2020/
BNT162b1
(10 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 13
FDA-CBER-2021-5683-0035565
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10021047 C4591001 1002
10021047^ 65-85 11JUN2020 1626 Placebo 11JUN2020/
Placebo 30JUN2020/
Placebo 28DEC2020/
BNT162b2
(30 μg) 19JAN2021/
BNT162b2
(30 μg)
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 05JAN2021/
BNT162b2
(30 μg) 26JAN20 21/
BNT162b2
(30 μg)
10021052 C4591001 1002
10021052^ 65-85 11JUN2020 1628 BNT162b1
(10 μg) 11JUN2020/
BNT162b1
(10 μg) 30JUN2020/
BNT162b1
(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)
10021059 C4591001 1002
10021059 ^ 65-85 15JUN2020 1757 BNT162b1
(30 μg) 15JUN2020/
BNT162b1
(30 μg) 07JUL2020/
BNT162b1
(30 μg)
10021060 C4591001 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/
BNT1 62b1
(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)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 14
FDA-CBER-2021-5683-0035566
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10021064 C4591001 1002
10021064^ 65-85 17JUN2020 2034 BNT162b1
(20 μg) 17JUN20 20/
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 05JAN2021/
BNT162b2
(30 μg) 26JAN2021/
BNT162b2
(30 μg)
10021073 C4591001 1002
100210 73^ 65-85 17JUN2020 2033 Placebo 17JUN2020/
Placebo 08JUL2020/
Placebo 12JAN2021/
BNT162b2
(30 μg) 03FEB2021/
BNT162b2
(30 μg)
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) 08JUL2020/
BNT162b1
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 15
FDA-CBER-2021-5683-0035567
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10031031 C4591001 1003
10031031^ 65-85 15JUN2020 3109 BNT162b2
(20 μg) 15JUN2020/
BNT162b2
(20 μg) 06JUL2020/
BNT162b2
(20 μg)
10031035 C4591001 1003
10031035^ 65-85 15JUN2020 3108 BNT162b2
(20 μg) 15JUN2020/
BNT162b2
(20 μg) 06JUL2020/
BNT162b2
(20 μg)
10031036 C4591001 1003
10031036^ 65-85 15JUN2020 3110 Placebo 15JUN2020/
Placebo 06JUL2020/
Placebo 04JAN2021/
BNT162b2
(30 μg) 25JAN2021/
BNT162b2
(30 μg)
10031037 C4591001 1003
10031037^ 65-85 16JUN2020 2840 BNT162b2
(30 μg) 16JUN202 0/
BNT162b2
(30 μg) 07JUL2020/
BNT162b2
(30 μg)
10031043 C4591001 1003
10031043^ 65-85 16JUN2020 2838 Place bo 16JUN2020/
Placebo 07JUL2020/
Placebo 08JAN2021/
BNT162b2
(30 μg) 29JAN2021/
BNT162b2
(30 μg)
10031046 C4591001 1003
10031046^ 65-85 18JUN20 20 2847 Placebo 18JUN2020/
Placebo 09JUL2020/
Placebo 04JAN2021/
BNT162b2
(30 μg) 26JAN2021/
BNT162b2
(30 μg)
10031047 C4591001 1003
10031047^ 65-85 16JUN2020 2839 BNT162b2
(30 μg) 16JUN2020/
BNT162b2
(30 μg) 07JUL2020/
BNT162b2
(30 μg)
10031051 C459 1001 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)
10031 054 C4591001 1003
10031054^ 65-85 17JUN2020 3115 BNT162b2
(20 μg) 17JUN2020/
BNT162b2
(20 μg) 08JUL2020/
BNT162b2
(20 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 16
FDA-CBER-2021-5683-0035568
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10031055 C4591001 1003
10031055^ 65-85 17JUN2020 3112 BNT162b2
(20 μg) 17JUN2020/
BNT162b2
(20 μg) 06JUL2020/
BNT162b2
(20 μg)
10031056 C4591001 1003
10031056^ 65-85 18JUN2020 2844 Placebo 18JUN2020/
Placebo 09JUL2020/
Placebo 04JAN2021/
BNT162b2
(30 μg) 25JAN2021/
BNT162b2
(30 μg)
10031058 C4591001 1003
10031058^ 65-85 18JUN2020 2846 BNT162b2
(30 μg) 18JUN2020/
BNT162b2
(30 μ g) 09JUL2020/
BNT162b2
(30 μg)
10031063 C4591001 1003
10031063^ 65-85 17JUN2020 3113 BNT162b2
(20 μg) 17JUN2020/
BNT162b2
(20 μg) 08JUL2020/
BNT162b2
(20 μg)
10031067 C4591001 1003
10031067^ 65-85 17JUN2020 3114 Placebo 17JUN2020/
Placebo 08JUL20 20/
Placebo 30DEC2020/
BNT162b2
(30 μg) 19JAN2021/
BNT162b2
(30 μg)
10031069 C4591001 1003
10031069^ 65-85 18JUN2020 2845 BNT162b2
(30 μg) 18JUN2020/
BNT162b2
(30 μg) 09JUL2020/
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 01JUL202 0 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)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 17
FDA-CBER-2021-5683-0035569
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
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 13JAN2021/
BNT162b2
(30 μg) 03FEB2021/
BNT162b2
(30 μg)
100310 87 C4591001 1003
10031087^ 65-85 01JUL2020 2713 BNT162b2
(10 μg) 01JUL2020/
BNT162b2
(10 μg) 22JUL2020/
BNT162b2
(10 μg)
10071031 C4591001 1007
10071031^ 65-85 17JUN2020 3117 BNT162b2
(20 μg) 17JUN2020/
BNT162b2
(20 μg) 08JUL2020/
BNT162b2
(20 μg)
10071032 C4591001 1007
10071032^ 65-85 15JUN2020 3106 BNT162b2
(20 μg) 15JUN2020/
BNT162b2
(20 μg) 06JUL2020/
BNT162b2
(20 μg)
10071034 C4591001 1007
10071034^ 65-85 15JUN2020 2836 BNT162b2
(30 μg) 15JUN2020/
BNT162b2
(30 μg) 06JUL2020/
BNT162b2
(30 μg)
10071035 C4591001 1007
10071035^ 65-85 15JUN2020 3107 BNT162b2
(20 μg) 15JUN2020/
BNT162b2
(20 μg) 06JUL2020/
BNT162b2
(20 μg)
10071037 C4591001 1007
10071037^ 65-85 15JUN2020 2837 BNT162b2
(30 μg) 15JUN2020/
BNT162b2
(30 μg) 06JUL2020/
BNT1 62b2
(30 μg)
10071038 C4591001 1007
10071038^ 65-85 17JUN2020 3120 BNT162b2
(20 μg) 17JUN2020/
BNT162b2
(20 μg) 08JUL2020/
BNT162b2
(20 μg)
10071039 C4591001 1007
10071039^ 65-85 17JUN2020 3118 BNT162b2
(20 μg) 17JUN2020/
BNT162b2
(20 μg) 08JUL20 20/
BNT162b2
(20 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 18
FDA-CBER-2021-5683-0035570
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10071042 C4591001 1007
10071042^ 65-85 17JUN2020 3119 Placebo 17JUN2020/
Placebo 08JUL2020/
Placebo
10071043 C4591001 1007
10071043^ 65-85 18JUN2020 2843 BNT162b2
(30 μg) 18JUN2020/
BNT162b2
(30 μg) 09JUL2020/
BNT162b2
(30 μg )
10071044 C4591001 1007
10071044^ 65-85 18JUN2020 2841 BNT162b2
(30 μg) 18JUN2020/
BNT162b2
(30 μg) 09JUL2020/
BNT162b2
(30 μg)
10071045 C4591001 1007
10071045^ 65-85 18JUN2020 2842 BNT162b2
(30 μg) 18JUN2020/
BNT162b2
(30 μg) 09JUL2020/
BNT162b 2
(30 μg)
10071049 C4591001 1007
10071049^ 65-85 18JUN2020 2849 BNT162b2
(30 μg) 18JUN2020/
BNT162b2
(30 μg) 09JUL2020/
BNT162b2
(30 μg)
10071051 C4591001 1007
10071051^ 65-85 29JUN2020 2701 BNT162b2
(10 μg) 29JUN2020/
BNT162b2
(10 μg) 20JUL2020/
BNT162b2
(10 μg)
10071052 C4591001 1007
10071052^ 65-85 17JUN2020 3116 BNT162b2
(20 μg) 17JUN2020/
BNT162b2
(20 μg) 08JUL2020/
BNT162b2
(20 μg)
10071053 C4591001 1007
10071053^ 65-85 18JUN2020 2850 BNT162b2
(30 μg) 18JUN2020/
BNT162b2
(30 μg) 09JUL2020/
BNT162b2
(30 μg)
10071056 C4591001 1007
10071056^ 65-85 29JUN2020 2704 Placebo 29JUN2020/
Placebo 20JUL2020/
Placebo 11JAN2021/
BNT162b2
(30 μg) 01FEB2021/
BNT162b2
(30 μg)
10071057 C4591001 1007
10071057^ 65-85 30JUN2020 2706 BNT162b2
(10 μ g) 30JUN2020/
BNT162b2
(10 μg) 22JUL2020/
BNT162b2
(10 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 19
FDA-CBER-2021-5683-0035571
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10071071 C4591001 1007
10071071^ 65-85 29JUN2020 2705 BNT162b2
(10 μg) 29JUN2020/
BNT162b2
(10 μg) 20JUL2020/
BNT162b2
(10 μg)
10071073 C4591001 1007
10071073^ 65-85 30JUN2020 2707 BNT162 b2
(10 μg) 30JUN2020/
BNT162b2
(10 μg) 22JUL2020/
BNT162b2
(10 μg)
10071074 C4591001 1007
10071074^ 65-85 30JUN2020 2708 BNT162b2
(10 μg) 30JUN2020/
BNT162b2
(10 μg) 20JUL2020/
BNT162b2
(10 μg)
10071075 C4591001 1007
10071075^ 65-85 30JUN2020 2710 Placebo 30JUN2020/
Placebo 22JUL2020/
Placebo 14JAN2021/
BNT162b2
(30 μg) 04FEB2021/
BNT162b2
(30 μg)
10071077 C4591001 1007
10071077^ 65-85 30JUN2020 2709 BNT162b2
(10 μg) 30JUN2020/
BNT162b2
(10 μg) 22JUL2020/
BNT162b2
(10 μg)
10011085 C4591001 1 001
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 18AUG2020/
Placebo 20JAN2021/
BNT162b2
(30 μg) 08FEB2021/
BNT1 62b2
(30 μg)
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)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 20
FDA-CBER-2021-5683-0035572
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
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 20JAN2021/
BNT162b2
(30 μg) 09FEB2021/
BNT162b2
(30 μg)
10011095 C4591001 1001
10011095 16-55 29JUL2020 40178 BNT162b2
(30 μg ) 29JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10011101 C4591001 1001
10011101 16-55 30JUL2020 40180 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 09FEB2021/
BNT162b2
(30 μg) 02MAR2021/
BNT162b2
(30 μg)
10011102 C4591001 1001
10011102 16-55 30JUL2020 40541 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 03FEB2021/
BNT162b2
(30 μg) 25FEB2021/
BNT162b2
(30 μg)
10031088 C4591001 1003
10031088 16-55 27JUL2020 40003 Placebo 27JUL2020/
Placebo 17AUG2020/
Placebo 11JAN2021/
BNT162b2
(30 μg) 01FEB20 21/
BNT162b2
(30 μg)
10031090 C4591001 1003
10031090 16-55 27JUL2020 40006 BNT162b2
(30 μg) 27JUL2020/
BNT162b2
(30 μg) 17AUG2020/
BNT162b2
(30 μg)
10031094 C4591001 1003
10031094 16-55 28JUL2020 40009 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 18AUG2020/
Placebo 17DEC2020/
BNT162b2
(30 μg) 05JAN2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 21
FDA-CBER-2021-5683-0035573
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10031100 C4591001 1003
10031100 16-55 28JUL2020 40037 Placebo 28JUL2020/
Placebo 18AUG2020/
Placebo 01FEB2021/
BNT162b2
(30 μg) 22FEB2021/
BNT162b2
(30 μg)
10031101 C4591001 1003
10031101 16-55 28JUL2020 40043 Placebo 28JUL2020/
Placebo 18AUG2020/
Placebo 28JAN2021/
BNT162b2
(30 μg) 18FEB2021/
BNT162b2
(30 μg)
10031104 C4591001 1003
10031104 16-55 29JUL2020 40145 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10031111 C4591001 1003
10031111 16-55 30JUL2020 40149 Placebo 30JUL 2020/
Placebo 20AUG2020/
Placebo 02FEB2021/
BNT162b2
(30 μg) 22FEB2021/
BNT162b2
(30 μg)
10031115 C4591001 1003
10031115 16-55 30JUL2020 40151 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
10071080 C4591001 1007
10071080 16-55 28JUL2020 40012 Placebo 28JUL2020/
Placebo 19AUG2020/
Placebo 05JAN2021/
BNT162b2
(30 μg) 26JAN2021/
BNT162b2
(30 μg)
10071082 C4591001 1007
10071082 16-55 28JUL2020 40035 Placebo 28JUL20 20/
Placebo 19AUG2020/
Placebo
10071083 C4591001 1007
10071083 16-55 28JUL2020 40026 Placebo 28JUL2020/
Placebo 17AUG2020/
Placebo 05JAN2021/
BNT162b2
(30 μg) 26JAN2021/
BNT162b2
(30 μg)
10071087 C4591001 1007
10071087 16-55 29JUL2020 40111 Placebo 29JUL2020/
Placebo 19AUG2020/
Placebo 05JAN2021/
BNT162b2
(30 μg) 26JAN2021/
BNT162b2
(30 μg)
10071089 C4591001 1007
10071089 16-55 29JUL2020 40113 Placebo 29JUL2020/
Placebo 17AUG2020/
Placebo 05JAN2021/
BNT162b2
(30 μg) 26JAN2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 22
FDA-CBER-2021-5683-0035574
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10071 092 C4591001 1007
10071092 16-55 29JUL2020 40117 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 17AUG2020/
BNT162b2
(30 μg)
10071093 C4591001 1007
10071093 16-55 29JUL2020 40120 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 17AUG2020/
BNT162b2
(30 μg)
10071095 C4591001 1007
10071095 16-55 30JUL2020 40422 Placebo 30JUL2020/
Placebo 17AUG2020/
Placebo 13JAN2021/
BNT162b2
(30 μg) 11FEB2021/
BNT162b2
(30 μg)
10071096 C4591001 1007
10071096 16-55 30JUL2020 40425 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 04FEB2021/
BNT162b2
(30 μg) 25FEB2021/
BNT162b2
(30 μg)
10071097 C4591001 1007
10071097 16-55 30JUL2020 40427 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
10071100 C4591001 1007
10071100 16-55 30JUL2020 40430 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
10071102 C4591001 1007
10071102 16-55 30JUL2020 40639 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 11FEB2021/
BNT162b2
(30 μg) 03MAR2021/
BNT162b2
(30 μg)
10131 002 C4591001 1013
1013100 2 16-55 28JUL2020 40033 BNT162b2
(30 μg) 28JUL2020/
BNT162b2
(30 μg) 17AUG2020/
BNT162b2
(30 μg)
10131003 C4591001 1013
10131003 16-55 28JUL2020 40056 BNT162b2
(30 μg) 28JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10131005 C4591001 1013
10131005 16-55 28JUL2020 40063 Placebo 28JUL2020/
Placebo 19AUG2020/
Placebo 29JAN2021/
BNT162b2
(30 μg) 19FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 23
FDA-CBER-2021-5683-0035575
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10131006 C4591001 1013
10131006 16-55 28JUL2020 40057 Placebo 28JUL2020/
Placebo 19AUG2020/
Placebo 21JAN2021/
BNT162b2
(30 μg) 17FEB2021/
BNT162b2
(30 μg)
10131007 C4591001 1013
10131007 16-55 28JUL2020 40044 BNT162b2
(30 μg) 28JUL2020/
BNT162b2
(30 μg) 17AUG2020/
BNT162b2
(30 μg)
10131008 C4591001 1013
10131008 16-55 28JUL2020 40060 BNT162b2
(30 μg) 28JUL2020/
BNT162 b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
10131009 C4591001 1013
10131009 16-55 28JUL2020 40050 Placebo 28JUL2020/
Placebo 17AUG2020/
Placebo 25JAN2021/
BNT162b2
(30 μg) 16FEB 2021/
BNT162b2
(30 μg)
10131010 C4591001 1013
10131010 16-55 29JUL2020 40087 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10131011 C4591001 1013
10131011 16-55 29JUL2020 40085 Placebo 29JUL2020/
Placebo 17AUG2020/
Placebo 25JAN2021/
BNT162b2
(30 μg) 16FEB2021/
BNT162b2
(30 μg)
10131012 C4591001 1013
10131012 16-55 29JUL2020 40129 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10131013 C4591001 1013
10131013 16-55 29JUL2020 40123 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
10131014 C4591 001 1013
10131014 16-55 29JUL2020 40092 Placebo 29JUL2020/
Placebo 21AUG2020/
Placebo 11FEB2021/
BNT162b2
(30 μg) 04MAR2021/
BNT162b2
(30 μg)
10131015 C4591001 1013
10131015 16-55 29JUL2020 40124 Placebo 29JUL2020/
Placebo 20AUG2020/
Placebo 25JAN2021/
BNT162b2
(30 μg) 15FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 24
FDA-CBER-2021-5683-0035576
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10131016 C4591001 1013
10131016 16-55 29JUL2020 40094 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
10131018 C4591001 1013
10131018 16-55 30JUL2020 40402 BNT162b2
(30 μg) 30JUL2020 /
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10131019 C4591001 1013
10131019 16-55 30JUL2020 40398 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 01FEB2021/
BNT162b2
(30 μg) 22FEB2021/
BNT162b2
(30 μg)
10131020 C4591001 1013
10131020 16-55 30JUL2020 40404 Placebo 30JUL2020/
Placebo 19AUG2020/
Placebo 22JAN2021/
BNT162b2
(30 μg) 11FEB2021/
BNT162b2
(30 μg)
10131021 C4591001 1013
10131021 16-55 30JUL2020 40407 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 25AUG2020/
BNT162b2
(30 μg)
10131022 C4591 001 1013
10131022 16-55 30JUL2020 40417 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10131023 C4591001 1013
10131023 16-55 30JUL2020 40413 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
101310 24 C4591001 1013
10131024 16-55 30JUL2020 40416 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 01FEB2021/
BNT162b2
(30 μg) 22FEB2021/
BNT162b2
(30 μg)
10131025 C4591001 1013
10131025 16-55 30JUL2020 40419 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 09FEB 2021/
BNT162b2
(30 μg) 02MAR2021/
BNT162b2
(30 μg)
10131026 C4591001 1013
10131026 16-55 30JUL2020 40493 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 25
FDA-CBER-2021-5683-0035577
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10131030 C4591001 1013
10131030 16-55 30JUL2020 40497 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
10131031 C4591001 1013
10131031 16-55 30JUL2020 40500 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 28DEC2020/
BNT162b2
(30 μg) 21JAN2021/
BNT162b2
(30 μg)
10131032 C4591001 1013
10131032 16-55 30JUL2020 40504 Placebo 30JUL2020/
Placebo 19AUG2020/
Placebo 30DEC2020/
BNT162b2
(30 μg) 20JAN2021/
BNT162b2
(30 μg)
10161003 C4591001 1016
10161003 16-55 29JUL2020 40137 Placebo 29JUL2020/
Placebo 19AUG2020/
Placebo 03FEB2021/
BNT162b2
(30 μg) 22FEB2021/
BNT162b2
(30 μg)
10161004 C4591001 1016
10161004 16-55 29JUL2020 40139 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10161005 C4591001 1016
10161005 16-55 29JUL2020 40142 Placebo 29JUL2020/
Placebo 17AUG2020/
Placebo 14JAN 2021/
BNT162b2
(30 μg) 05FEB2021/
BNT162b2
(30 μg)
10161006 C4591001 1016
10161006 16-55 29JUL2020 40144 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
10161009 C4591001 1016
10161009 16-55 30JUL2020 40433 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
10161010 C4591001 1016
10161010 16-55 30JUL2020 40434 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10161014 C4591001 1016
10161014 16-55 30JUL2020 40440 Placebo 30JUL2020/
Placebo 19AUG2020/
Placebo
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 26
FDA-CBER-2021-5683-0035578
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10181001 C4591001 1018
10181001 16-55 29JUL2020 40193 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
10181003 C4591001 1018
10181003 16-55 29JUL2020 40194 Placebo 29JUL2020/
Placebo 19AUG2020/
Placebo 23JAN2021/
BNT162b2
(30 μg)
10181007 C4591001 1018
10181007 16-55 29JUL2020 40199 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10421001 C4591001 1042
10421001 16-55 29JUL2020 40290 Placebo 29JUL2020/
Placebo 19AUG2020/
Placebo 25JAN2021/
BNT162b2
(30 μg) 23FEB2021/
BNT162b2
(30 μg)
10421003 C4591001 1042
10421003 16-55 29JUL2020 40293 Placebo 29JUL2020/
Placebo 17AUG2020/
Placebo 23FEB2021/
BNT162b2
(30 μg)
10421004 C4591001 1042
10421004 16-55 29JUL2 020 40295 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
10421008 C4591001 1042
10421008 16-55 30JUL2020 40296 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
10731006 C4591001 1073
10731006 16-55 30JUL2020 40529 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
10731008 C4591001 1073
10731008 16-55 30JUL2020 40530 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 12JAN2021/
BNT162b2
(30 μg) 02FEB2021/
BNT162b2
(30 μg)
10731009 C4591001 1073
10731009 16-55 30JUL2020 40535 Placebo 30JUL2020/
Placebo 24AUG2020/
Placebo 20JAN2021/
BNT162b2
(30 μg) 10FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 27
FDA-CBER-2021-5683-0035579
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10731012 C4591001 1073
10731012 16-55 30JUL2020 40537 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
10731013 C4591001 1073
10731013 16-55 30JUL2020 40722 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 21JAN2021/
BNT162b2
(30 μg) 11FEB2021/
BNT162b2
(30 μg)
10791002 C4591001 1079
10791002 16-55 29JUL2020 40279 Placebo 29JUL20 20/
Placebo 19AUG2020/
Placebo 12FEB2021/
BNT162b2
(30 μg) 05MAR2021/
BNT162b2
(30 μg)
10791003 C4591001 1079
10791003 16-55 29JUL2020 40282 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 17AUG2020/
BNT162b2
(30 μg)
10791004 C4591001 1079
10791004 16-55 29JUL2020 40283 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg)
10791007 C4591001 1079
10791007 16-55 29JUL2020 40285 Placebo 29JUL2020/
Placebo 17AUG2020/
Placebo 04JAN2021/
BNT162b2
(30 μg) 26JAN2021/
BNT162b2
(30 μg)
10791008 C4591001 1079
107910 08 16-55 29JUL2020 40301 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
10791010 C4591001 1079
10791010 16-55 30JUL2020 40303 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 20JAN2021/
BNT162b2
(30 μg) 10FEB2021/
BNT162b2
(30 μ g)
10791013 C4591001 1079
10791013 16-55 30JUL2020 40306 Placebo 30JUL2020/
Placebo 19AUG2020/
Placebo 20JAN2021/
BNT162b2
(30 μg) 10FEB2021/
BNT162b2
(30 μ g)
10821003 C4591001 1082
10821003 16-55 30JUL2020 40519 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 28
FDA-CBER-2021-5683-0035580
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10821004 C4591001 1082
10821004 16-55 30JUL2020 40521 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
10831001 C4591001 1083
10831001 16-55 29JUL2020 40326 Placebo 29JUL2020/
Placebo 21AUG2 020/
Placebo 18JAN2021/
BNT162b2
(30 μg) 26FEB2021/
BNT162b2
(30 μg)
10831002 C4591001 1083
10831002 16-55 29JUL2020 40331 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
10831004 C4591001 1083
10831004 16-55 29JUL2020 40333 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
10831005 C4591001 1083
10831005 16-55 29JUL2020 40336 Placebo 29JUL2020/
Placebo 21AUG2020/
Placebo 12FEB2021/
BNT162b2
(30 μg) 03MAR2021/
BNT162b2
(30 μg)
10831006 C4591001 108 3
10831006 16-55 29JUL2020 40362 Placebo 29JUL2020/
Placebo 21AUG2020/
Placebo 12FEB2021/
BNT162b2
(30 μg) 04MAR2021/
BNT162b2
(30 μ g)
10841001 C4591001 1084
10841001 16-55 30JUL2020 40590 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
10841003 C4591001 1084
10841003 16-55 30JUL2020 40591 Placebo 30JUL2020/
Placebo 21AUG2020/
Placebo 27JAN2021/
BNT162b2
(30 μg) 25FEB2021/
BNT162b2
(30 μg)
10851003 C4591001 1085
10851003 16-55 30JUL2020 40554 Placebo 30JUL2020/
Placebo 21AUG2 020/
Placebo
10851004 C4591001 1085
10851004 16-55 30JUL2020 40555 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 26JAN2021/
BNT162b2
(30 μg) 23FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 29
FDA-CBER-2021-5683-0035581
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10891011 C4591001 1089
10891011 16-55 30JUL2020 40567 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10891013 C4591001 1089
10891013 16-55 30JUL2020 40569 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 25FEB2021/
BNT162b2
(30 μg)
10891015 C4591001 1089
10891015 16-55 30JUL2020 40572 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 18DEC2020/
BNT162b2
(30 μg) 06JAN2021/
BNT162b2
(30 μg)
10951001 C4591001 1095
10951001 16-55 30JUL2020 40449 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
10951002 C4591001 1095
10951002 16-55 30JUL2020 40445 Placebo 30JUL2020/
Placebo 21AUG2020/
Placebo 12MAR2021/
BNT162b2
(30 μg)
10951005 C4591001 1095
10951005 16-55 30JUL2020 40452 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
10951006 C4591001 1095
10951006 16-55 30JUL2020 40455 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 21JAN2021/
BNT162b2
(30 μg) 12FEB2021/
BNT162b2
(30 μg)
10951007 C4591001 1095
10951007 16-55 30JUL2020 40697 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 19JAN2021/
BNT162b2
(30 μg) 09FEB 2021/
BNT162b2
(30 μg)
11071003 C4591001 1107
11071003 16-55 29JUL2020 40317 Placebo 29JUL2020/
Placebo 18AUG2020/
Placebo 17DEC2020/
BNT162b2
(30 μg) 06JAN2021/
BNT162b2
(30 μg)
11071006 C4591001 1107
11071006 16-55 30JUL2020 40319 BNT162b2
(30 μg) 30JU L2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 30
FDA-CBER-2021-5683-0035582
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
11071 010 C4591001 1107
11071010 16-55 30JUL2020 40320 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 18FEB2021/
BNT162b2
(30 μg)
11091001 C4591001 1109
11091001 16-55 29JUL2020 40243 Placebo 29JUL2 020/
Placebo 17AUG2020/
Placebo 29JAN2021/
BNT162b2
(30 μg) 19FEB2021/
BNT162b2
(30 μg)
11091002 C4591001 1109
11091002 16-55 29JUL2020 40249 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 17AUG2020/
BNT162b2
(30 μg)
11091003 C4591001 1109
11091003 16-55 29JUL2020 40244 Placebo 29JUL2020/
Placebo 18AUG2020/
Placebo 18FEB2021/
BNT162b2
(30 μg) 11MAR2021/
BNT162b2
(30 μg)
11091004 C4591001 1109
11091004 16-55 29JUL2020 40266 Placebo 29JUL2020/
Placebo 17AUG2020/
Placebo
11091006 C4591001 1109
110910 06 16-55 29JUL2020 40251 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 26AUG2020/
BNT162b2
(30 μg)
11091007 C4591001 1109
11091007 16-55 29JUL2020 40267 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
11091010 C4591001 110 9
11091010 16-55 29JUL2020 40271 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 17AUG2020/
BNT162b2
(30 μg)
11091011 C4591001 1109
11091011 16-55 29JUL2020 40270 Placebo 29JUL2020/
Placebo 17AUG2020/
Placebo 19FEB2021/
BNT162b2
(30 μg) 10MAR2021/
BNT162 b2
(30 μg)
11091013 C4591001 1109
11091013 16-55 29JUL2020 40339 Placebo 29JUL2020/
Placebo 17AUG2020/
Placebo 23JAN2021/
BNT162b2
(30 μg) 13FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 31
FDA-CBER-2021-5683-0035583
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
11091014 C4591001 1109
11091014 16-55 29JUL2020 40343 BNT162b2
(30 μg) 29JUL2020/
BNT16 2b2
(30 μg) 26AUG2020/
BNT162b2
(30 μg)
11091015 C4591001 1109
11091015 16-55 29JUL2020 40346 Placebo 29JUL2020/
Placebo 18AUG2020/
Placebo 24FEB2021/
BNT162b2
(30 μg)
11091016 C4591001 1109
11091016 16-55 30JUL2020 40382 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 22FEB2021/
BNT162b2
(30 μg)
11091017 C4591001 1109
11091017 16-55 30JUL2020 40348 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
11091018 C4591001 1109
11091018 16-55 30JUL2020 40373 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 02FEB2021/
BNT162b2
(30 μg) 23FEB2021/
BNT162b2
(30 μg)
11091019 C4591001 1109
11091019 16-55 30JUL2020 40377 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
11091020 C4591001 1109
11091020 16-55 30JUL2020 40384 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
11091021 C4591001 1109
11091021 16-55 30JUL2020 40387 Placebo 30JUL2020/
Placebo 21AUG2020/
Placebo 12FEB2021/
BNT162b2
(30 μg) 05MAR 2021/
BNT162b2
(30 μg)
1109102 2 C4591001 1109
11091022 16-55 30JUL2020 40388 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 16FEB2021/
BNT162b2
(30 μg) 09MAR2021/
BNT162b2
(30 μg)
11091023 C4591001 1109
11091023 16-55 30JUL2020 40394 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 21AUG20 20/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 32
FDA-CBER-2021-5683-0035584
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
11091024 C4591001 1109
11091024 16-55 30JUL2020 40396 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
11091027 C4591001 1109
11091027 16-55 30JUL2020 40505 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
11091028 C4591001 1109
11091028 16-55 30JUL2020 40506 Placebo 30JUL2020/
Placebo 21AUG2020/
Placebo 12FEB2021/
BNT162b2
(30 μg) 05MAR2021/
BNT162b2
(30 μg)
11091030 C4591001 1109
11091030 16-55 30JUL2020 40507 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo
11091033 C4591001 1109
11091033 16-55 30JUL2020 40515 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
11111001 C4591001 1111
11111 001 16-55 30JUL2020 40473 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
11121004 C4591001 1112
11121004 16-55 29JUL2020 40208 Placebo 29JUL2020/
Placebo 19AUG2020/
Placebo 21JAN2021/
BNT162b2
(30 μg) 10FEB2021/
BNT162b2
(30 μg)
11121006 C4591001 1112
11121006 16-55 29JUL2020 40214 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
11121008 C4591001 1112
11121008 16-55 29JUL2020 40215 Placebo 29JUL2020/
Placebo 19AUG2020/
Placebo
11121009 C4591001 1112
11121009 16-55 30JUL2020 40216 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
11121011 C4591001 1112
11121011 16-55 30JUL2020 40482 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 04FEB2021/
BNT162b2
(30 μg) 25FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 33
FDA-CBER-2021-5683-0035585
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
11121012 C4591001 1112
11121012 16-55 30JUL2020 40485 Placebo 30JUL2020/
Placebo 21AUG2020/
Placebo 18DEC2020/
BNT162b2
(30 μg) 07JAN2021/
BNT162b2
(30 μg)
11121013 C4591001 1112
11121013 16-55 30JUL2020 40486 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
1112 1015 C4591001 1112
11121015 16-55 30JUL2020 40674 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
11121016 C4591001 1112
1112101 6 16-55 30JUL2020 40487 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
11201001 C4591001 1120
11201001 16-55 29JUL2020 40349 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
11231001 C4591001 1123
11231001 16-55 29JUL2020 40221 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
11231002 C4591001 1123
11231002 16-55 30JUL2020 40223 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo
11231003 C4591001 1123
11231003 16-55 30JUL2020 40225 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
1127100 4 C4591001 1127
11271004 16-55 29JUL2020 40230 Placebo 29JUL2020/
Placebo 17AUG2020/
Placebo 27JAN2021/
BNT162b2
(30 μg) 17FEB2021/
BNT162b2
(30 μg)
11271011 C4591001 1127
11271011 16-55 30JUL2020 40234 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG20 20/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 34
FDA-CBER-2021-5683-0035586
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
11271014 C4591001 1127
11271014 16-55 30JUL2020 40613 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
11271015 C4591001 1127
11271015 16-55 30JUL2020 40235 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
11271016 C4591001 1127
11271016 16-55 30JUL2020 40238 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 06FEB2021/
BNT162b2
(30 μg) 27FEB2021/
BNT162b2
(30 μg)
11271017 C4591001 1127
11271017 16-55 30JUL2020 40619 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 06FEB2021/
BNT162b2
(30 μg) 27FEB2021/
BNT162b2
(30 μg)
1129 1001 C4591001 1129
11291001 16-55 29JUL2020 40183 Placebo 29JUL2020/
Placebo 19AUG2020/
Placebo 23DEC2020/
BNT162b2
(30 μg) 11JAN2021/
BNT162b2
(30 μg)
1129100 5 C4591001 1129
11291005 16-55 29JUL2020 40184 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
11291006 C4591001 1129
11291006 16-55 29JUL2020 40188 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 17AUG2020/
BNT162b2
(30 μg)
11291010 C4591001 1129
11291010 16-55 30JUL2020 40192 Placebo 30JUL2020/
Placebo 19AUG2020/
Placebo 25JAN2021/
BNT162b2
(30 μg) 16FEB2021/
BNT162b2
(30 μg)
11291014 C4591001 1129
11291014 16-55 30JUL2020 40626 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
11331001 C4591001 1133
11331001 16-55 30JUL2020 40463 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 35
FDA-CBER-2021-5683-0035587
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
11331003 C4591001 1133
11331003 16-55 30JUL2020 40466 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
11331004 C4591001 1133
1133100 4 16-55 30JUL2020 40465 Placebo 30JUL2020/
Placebo 21AUG2020/
Placebo 27JAN2021/
BNT162b2
(30 μg) 17FEB2021/
BNT162b2
(30 μg)
11331011 C4591001 1133
11331011 16-55 30JUL2020 40467 Placebo 30JUL2020/
Placebo 21AUG2020/
Placebo 22JAN2021/
BNT162b2
(30 μg) 17FEB2021/
BNT162b2
(30 μg)
11331014 C4591001 1133
11331014 16-55 30JUL2020 40650 Placebo 30JUL2020/
Placebo 21AUG2020/
Placebo 17FEB2021/
BNT162b2
(30 μg) 10MAR2021/
BNT162b2
(30 μg)
11331016 C4591001 1133
11331016 16-55 30JUL2020 40651 Placebo 30JUL2020/
Placebo 24AUG2020/
Placebo
11391001 C4591001 1139
11391001 16-55 29JUL2020 40075 Placebo 29JUL2020/
Placebo 20AUG2020/
Placebo 12FEB2021/
BNT162b2
(30 μg) 05MAR2021/
BNT162b2
(30 μg)
11391007 C4591001 1139
11391007 16-55 29JUL2020 40076 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
11391010 C4591001 1139
11391010 16-55 29JUL2020 40078 Placebo 29JUL2020/
Placebo 20AUG2020/
Placebo 08FEB2021/
BNT162 b2
(30 μg) 11MAR2021/
BNT162b2
(30 μg)
11391015 C45910 01 1139
11391015 16-55 30JUL2020 40084 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
11401001 C4591001 1140
11401001 16-55 29JUL2020 40099 Placebo 29JUL2020/
Placebo 19AUG2020/
Placebo 10FEB2021/
BNT162b2
(30 μg) 01MAR2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 36
FDA-CBER-2021-5683-0035588
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
11401006 C4591001 1140
11401006 16-55 30JUL2020 40103 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
11421001 C4591001 1142
11421001 16-55 29JUL2020 40157 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 17AUG2020/
BNT162b2
(30 μg)
11421002 C4591001 1142
11421002 16-55 29JUL2020 40160 Placebo 29JUL2020/
Placebo 19AUG2020/
Placebo 30DEC2020/
BNT162b2
(30 μg) 19JAN2021/
BNT162b2
(30 μg)
11421004 C4591001 1142
11421004 16-55 29JUL2020 40167 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 17AUG2020/
BNT162b2
(30 μg)
11421007 C4591001 1142
11421007 16-55 29JUL2020 40168 Placebo 29JUL2020/
Placebo 17AUG2020/
Placebo 30DEC2020/
BNT162b2
(30 μg) 20JAN 2021/
BNT 162b2
(30 μg)
11421008 C4591001 1142
11421008 16-55 29JUL2020 40254 Placebo 29JUL2020/
Placebo 17AUG2020/
Placebo 08FEB2021/
BNT162b2
(30 μg) 02MAR2021/
BNT162b2
(30 μg)
11421010 C4591001 1142
11421010 16-55 30JUL2020 40259 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 18DEC2020/
BNT162b2
(30 μg) 07JAN2021/
BNT162b2
(30 μg)
11421011 C4591001 1142
11421011 16-55 30JUL2020 40261 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
11421014 C4591001 1142
11421014 16-55 30JUL2020 40264 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
11421015 C4591001 1142
11421015 16-55 30JUL2020 40607 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 37
FDA-CBER-2021-5683-0035589
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
11421016 C4591001 1142
11421016 16-55 30JUL 2020 40610 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 05FEB2021/
BNT162b2
(30 μg) 26FEB2021/
BNT162b2
(30 μg)
11471001 C4591001 1147
11471001 16-55 30JUL2020 40577 Placebo 30JUL2020/
Placebo 21AUG2020/
Placebo
10011081 C4591001 1001
10011081 >55 28JUL2020 220015 Placebo 28JUL2020/
Placebo 18AUG2020/
Placebo
10011084 C4591001 1001
10011084 >55 28JUL2020 220026 BNT162b2
(30 μg) 28JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
10011090 C4591001 1001
10011090 >55 29JUL2020 220087 BNT16 2b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
10011093 C4591001 1001
10011093 >55 29JUL2020 220088 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μ g)
10011094 C4591001 1001
10011094 >55 29JUL2020 220090 Placebo 29JUL2020/
Placebo 20AUG2020/
Placebo 15JAN2021/
BNT162b2
(30 μg) 04FEB2021/
BNT162b2
(30 μg)
10011096 C4591001 1001
10011096 >55 29JUL2020 220095 Placebo 29JUL2020/
Placebo 20AUG2020/
Placebo 15JAN2021/
BNT162b2
(30 μg) 03FEB2021/
BNT162b2
(30 μ g)
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 14JAN2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 38
FDA-CBER-2021-5683-0035590
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10011100 C4591001 1001
10011100 >55 30JUL2020 220395 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 20JAN2021/
BNT162 b2
(30 μg) 08FEB2021/
BNT162b2
(30 μg)
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/
BNT1 62b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
10031089 C4591001 1003
10031089 >55 27JUL2020 220001 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 14JAN2021/
BNT162b2
(30 μg) 02FEB2021/
BNT162b2
(30 μg)
10031093 C4591001 1003
10031093 >55 28JUL2020 220011 Placebo 28JUL2020/
Placebo 18AUG2020/
Placebo 14JAN2021/
BNT162b2
(30 μg) 02FEB2021/
BNT162b2
(30 μg)
10031095 C4591001 1003
10031095 >55 28JUL2020 220019 BNT162b2
(30 μg) 28JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
10031098 C4591001 1003
10031098 >55 28JUL2020 220023 Placebo 28JUL2020/
Placebo 18AUG2020/
Placebo 25JAN2021/
BNT162b2
(30 μg )
10031099 C4591001 1003
10031099 >55 28JUL2020 220037 Placebo 28JUL2020/
Placebo 18AUG2020/
Placebo 20JAN2021/
BNT162b2
(30 μg) 10FEB2021/
BNT16 2b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 39
FDA-CBER-2021-5683-0035591
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
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 21JAN2021/
BNT162b2
(30 μg) 11FEB2021/
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 28JAN2021/
BNT162b2
(30 μg) 18FEB2021/
BNT162b2
(30 μg)
10031107 C4591001 1003
10031107 >55 29JUL2020 220132 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10031108 C4591001 1003
10031108 >55 29JUL2020 2202 19 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg ) 19AUG2020/
BNT162b2
(30 μg)
10031109 C4591001 1003
10031109 >55 30JUL2020 220223 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 21JAN2021/
BNT162b2
(30 μg) 11FEB2021/
BNT162b2
(30 μg)
10031110 C4591001 1 003
10031110 >55 30JUL2020 220225 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 19JAN2021/
BNT162b2
(30 μg) 09FEB2021/
BNT162b2
(30 μg)
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
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 40
FDA-CBER-2021-5683-0035592
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10031114 C4591001 1003
10031114 >55 30JUL2020 220531 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
10031117 C4591001 1003
10031117 >55 30JUL2020 220534 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 30DEC2020/
BNT162b2
(30 μg) 20JAN2021/
BNT162b2
(30 μg)
10071079 C4591001 1007
10071079 >55 28JUL2020 220021 BNT162b2
(30 μg) 28JUL2020/
BNT162b2
(30 μg) 17AUG2020/
BNT162b2
(30 μg)
10071081 C4591001 1007
10071081 >55 28JUL2020 220025 Placebo 28JUL2020/
Placebo 19AUG2020/
Placebo 23FEB2021/
BNT162b2
(30 μg)
10071084 C4591001 1007
10071084 >55 28JUL2020 220030 BNT162b2
(30 μg) 28JUL2020/
BNT162b2
(30 μg) 19AUG2 020/
BNT162b2
(30 μg)
10071085 C4591001 1007
10071085 >55 28JUL2020 220035 Placebo 28JUL2020/
Placebo 20AUG2020/
Placebo 05JAN2021/
BNT162b2
(30 μg) 26JAN2021/
BNT162b2
(30 μg)
10071086 C4591001 1007
10071086 >55 28JUL2020 220041 BNT162b2
(30 μg) 28JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10071088 C4591001 1007
10071088 >55 29JUL2020 220077 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10071090 C4591001 1007
10071090 >55 29JUL2020 220078 Placebo 29JUL2 020/
Placebo 17AUG2020/
Placebo 03FEB2021/
BNT162b2
(30 μg) 24FEB2021/
BNT162b2
(30 μg)
10071091 C4591001 1007
10071091 >55 29JUL2020 220081 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 17AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 41
FDA-CBER-2021-5683-0035593
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10071094 C4591001 1007
10071094 >55 29JUL2020 220083 Placebo 29JUL2020/
Placebo 19AUG2020/
Placebo 06JAN2021/
BNT162b2
(30 μg) 27JAN2021/
BNT162b2
(30 μg)
10071098 C4591001 1007
10071098 >55 30JUL2020 220493 Placebo 30JUL2 020/
Placebo 20AUG2020/
Placebo 26JAN2021/
BNT162b2
(30 μg) 17FEB2021 /
BNT162b2
(30 μg)
10071099 C4591001 1007
10071099 >55 30JUL2020 220499 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
10071101 C4591001 1007
10071101 >55 30JUL2020 220496 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG20 20/
BNT162b2
(30 μg)
10131001 C4591001 1013
10131001 >55 28JUL2020 220038 Placebo 28JUL2020/
Placebo 17AUG2020/
Placebo 19JAN2021/
BNT162b2
(30 μg) 10FEB2021/
BNT162b2
(30 μg)
10131004 C4591001 1013
10131004 >55 28JUL2020 220049 Placebo 28JUL2020/
Placebo 19AUG2020/
Placebo 14JAN2021/
BNT162b2
(30 μg) 03FEB2021/
BNT162b2
(30 μg)
10131028 C4591001 1013
10131028 >55 30JUL2020 220409 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
10131029 C4591001 1013
10131029 >55 30JUL20 20 220414 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
10161001 C4591001 1016
10161001 >55 29JUL2020 220097 Placebo 29JUL2020/
Placebo 18AUG2020/
Placebo 22JAN2021/
BNT162b2
(30 μg) 10FEB2021/
BNT162b2
(30 μg)
10161002 C4591001 1016
10161002 >55 29JUL2020 220098 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 42
FDA-CBER-2021-5683-0035594
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10161007 C4591001 1016
10161007 >55 29JUL2020 220101 Placebo 29JUL2020/
Placebo 18AUG2020/
Placebo 17DEC2020/
BNT162b2
(30 μg) 07JAN2021/
BNT162b2
(30 μg)
10161011 C4591001 1016
10161011 >55 30JUL2020 220105 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
10161012 C4591001 1016
10161012 >55 30JUL2020 220433 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 21AUG202 0/
BNT162b2
(30 μg)
10161013 C4591001 1016
10161013 >55 30JUL2020 220436 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 17DEC2020/
BNT162b2
(30 μg) 06JAN2021/
BNT162b2
(30 μg)
10161015 C4591001 1016
10161015 >55 30JUL2020 220438 BNT162b2
(30 μg) 30JUL 2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
10161016 C4591001 1016
10161016 >55 30JUL2020 220442 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 17DEC2020/
BNT162b2
(30 μg) 07JAN2021/
BNT162b2
(30 μg)
10181002 C4591001 1018
10181002 >55 29JUL202 0 220183 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10181004 C4591001 1018
10181004 >55 29JUL2020 220186 Placebo 29JUL2020/
Placebo 19AUG2020/
Placebo 07JAN2021/
BNT162b2
(30 μg) 28JAN2021/
BNT162b2
(30 μg)
10181005 C459 1001 1018
10181005 >55 29JUL2020 220188 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10181006 C4591001 1018
10181006 >55 29JUL2020 220192 Placebo 29JUL2020/
Placebo 19AUG2020/
Placebo 16JAN2021/
BNT162b2
(30 μg) 05FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 43
FDA-CBER-2021-5683-0035595
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10421002 C4591001 1042
10421002 >55 29JUL2020 220340 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 17AUG2020/
BNT162b2
(30 μg)
10421009 C4591001 1042
10421009 >55 30JUL2020 220341 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 19AUG2020 /
BNT162b2
(30 μg)
10731001 C4591001 1073
10731001 >55 29JUL2020 220302 Placebo 29JUL2020/
Placebo 19AUG2020/
Placebo 28JAN2021/
BNT162b2
(30 μg) 18FEB2021/
BNT162b2
(30 μg)
10731002 C4591001 1073
10731002 >55 29JUL2020 220303 BNT162b2
(30 μg) 29JUL2 020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10731 003 C4591001 1073
10731003 >55 29JUL2020 220306 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10731004 C4591001 1073
10731004 >55 29JUL2020 220311 Placebo 29JUL2020 /
Placebo 19AUG2020/
Placebo 12JAN2021/
BNT162b2
(30 μg) 02FEB2021/
BNT162b2
(30 μg)
10731005 C4591001 1073
10731005 >55 29JUL2020 220319 Placebo 29JUL2020/
Placebo 19AUG2020/
Placebo 21JAN2021/
BNT162b2
(30 μg) 11FEB2021/
BNT162b2
(30 μg)
10731007 C4591 001 1073
10731007 >55 30JUL2020 220320 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
10731010 C4591001 1073
10731010 >55 30JUL2020 220323 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10731011 C4591001 1073
10731011 >55 30JUL2020 220324 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 27JAN2021/
BNT162b2
(30 μg) 17FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 44
FDA-CBER-2021-5683-0035596
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10731014 C4591001 1073
10731014 >55 30JUL2020 220771 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 27JAN2021 /
BNT162b2
(30 μg) 17FEB2021/
BNT162b2
(30 μg )
10791001 C4591001 1079
10791001 >55 29JUL2020 220231 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
10791005 C4591001 1079
10791005 >55 29JUL2020 220232 BNT162b2
(30 μg) 29JUL20 20/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
10791006 C4591001 1079
10791006 >55 29JUL2020 220234 Placebo 29JUL2020/
Placebo 17AUG2020/
Placebo 22DEC2020/
BNT162b2
(30 μg) 12JAN2021/
BNT162b2
(30 μg)
10791009 C4591001 1079
10791009 >55 30JUL2020 220240 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 19JAN2021/
BNT162b2
(30 μg) 10FEB2021/
BNT162b2
(30 μg)
10791011 C4591001 1079
10791011 >55 30JUL2020 220637 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 03FEB2021/
BNT162b2
(30 μg) 24FEB2021/
BNT162b2
(30 μg)
10791014 C4591001 1079
10791014 >55 30JUL2020 220646 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 08JAN2021/
BNT162b2
(30 μg) 29JAN2021/
BNT162b2
(30 μg)
10821001 C4591001 1082
10821001 >55 30JUL2020 220376 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
10821002 C4591001 1082
10821002 >55 30JUL2020 220379 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
10831003 C4591001 1083
10831003 >55 29JUL2020 220349 Placebo 29JUL2020/
Placebo 21AU G2020/
Placebo 12FEB2021/
BNT162b2
(30 μg) 06MAR2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 45
FDA-CBER-2021-5683-0035597
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10841002 C4591001 1084
10841002 >55 30JUL2020 220615 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 29DEC2020/
BNT162b2
(30 μg) 19JAN2021/
BNT162b2
(30 μg)
10841006 C4591001 1084
10841 006 >55 30JUL2020 220618 Placebo 30JUL2020/
Placebo 17AUG2020/
Placebo 20JAN2021/
BNT162b2
(30 μg) 10FEB2021/
BNT162b2
(30 μg)
10851001 C4591001 1085
10851001 >55 30JUL2020 220505 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
10851002 C4591001 1085
10851002 >55 30JUL2020 220506 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 22JAN2021/
BNT162b2
(30 μg) 12FEB2021/
BNT162b2
(30 μg)
10851005 C4591001 1085
10851005 >55 30JUL2020 220514 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
10851006 C4591001 1085
10851006 >55 30JUL2020 220516 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 12FEB2021/
BNT162b2
(30 μg) 03MAR2021/
BNT162b2
(30 μg)
10851007 C4591001 1085
10851007 >55 30JUL2020 40556 BNT162b2
(30 μ g) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
10851008 C4591001 1085
10851008 >55 30JUL2020 40564 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
10891001 C4591001 1089
10891001 >55 29JUL2020 220201 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10891002 C4591001 1089
10891002 >55 29JUL2020 220202 Placebo 29JUL2020/
Placebo 19AUG2020/
Placebo 11JAN2021/
BNT162b2
(30 μg) 01FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 46
FDA-CBER-2021-5683-0035598
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10891003 C4591001 1089
10891003 >55 29JUL2020 220203 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
10891004 C4591001 1089
10891004 >55 29JUL2020 220204 Placebo 29JUL2020/
Placebo 14SEP2020/
Placebo 20JAN2021/
BNT162b2
(30 μg) 10FEB2021/
BNT162b2
(30 μg)
10891005 C4591001 1089
10891005 >55 29JUL2020 220265 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
10891006 C4591001 1089
10891006 >55 29JUL2020 220267 Placebo 29JUL2020/
Placebo 17AUG2020/
Placebo 06JAN2021/
BNT162b2
(30 μg ) 25JAN2021/
BNT162b2
(30 μg)
10891007 C4591001 1089
10891007 >55 29JUL2020 220268 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 17AUG2020/
BNT162b2
(30 μg)
10891008 C4591001 1089
10891008 >55 29JUL2020 220272 Placebo 29JUL2020/
Placebo 18AUG2020/
Placebo 29JAN2021/
BNT162b2
(30 μg) 19FEB2021/
BNT162b2
(30 μg)
10891009 C4591001 1089
10891009 >55 30JUL2020 220566 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 19JAN2021/
BNT162b2
(30 μg) 09FEB2021/
BNT162b2
(30 μg)
10891012 C4591001 1089
10891012 >55 30JUL2020 220571 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10891014 C4591001 1089
1089101 4 >55 30JUL2020 220572 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 05FEB2021/
BNT162b2
(30 μg) 24FEB2021/
BNT162b2
(30 μg)
1089101 6 C4591001 1089
10891016 >55 30JUL2020 220574 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 47
FDA-CBER-2021-5683-0035599
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10951003 C4591001 1095
10951003 >55 30JUL2020 220591 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
10951004 C4591001 1095
10951004 >55 30JUL2020 220589 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 05JAN2021/
BNT162b2
(30 μg) 26JAN2021/
BNT162b2
(30 μg)
11071001 C4591001 1107
11071001 >55 29JUL2020 220281 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
11071004 C4591001 1107
11071004 >55 30JUL2020 220285 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 16DEC2020/
BNT162b2
(30 μg) 05JAN2021/
BNT162b2
(30 μg)
11071005 C4591001 1107
11071005 >55 30JUL2020 220287 Placebo 30JUL2020 /
Placebo 20AUG2020/
Placebo 17DEC2020/
BNT162b2
(30 μg) 07JAN2021/
BNT162b2
(30 μg)
11071 007 C4591001 1107
11071007 >55 30JUL2020 220579 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
11071008 C4591001 1107
11071008 >55 30JUL2020 220587 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 18JAN2021/
BNT162b2
(30 μg) 08FEB2021/
BNT162b2
(30 μg)
11071009 C4591001 1107
11071009 >55 30JUL2020 220581 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 19JAN2021/
BNT162b2
(30 μg) 09FEB2021/
BNT162b2
(30 μg)
11091005 C4591001 1109
11091005 >55 29JUL2020 220253 Placebo 29JUL2020/
Placebo 17AUG2020/
Placebo 13FEB2021/
BNT162b2
(30 μg) 06MAR2021/
BNT162b2
(30 μg)
11091008 C4591001 1109
11091008 >55 29JUL2020 220256 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 48
FDA-CBER-2021-5683-0035600
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
11091009 C4591001 1109
11091009 >55 29JUL2020 220261 Placebo 29JUL2020/
Placebo 21AUG2020/
Placebo 29DEC2020/
BNT162b2
(30 μg) 18JAN2021/
BNT162b2
(30 μg)
11091012 C4591001 1109
11091012 >55 29JUL2020 220264 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
11091025 C4591001 1109
11091025 >55 30JUL2020 220518 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 22FEB2021/
BNT162b2
(30 μg)
11091026 C4591001 1109
11091026 >55 30JUL2020 220523 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
11091029 C4591001 1109
11091029 >55 30JUL2020 220517 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 22AUG2020/
BNT162b2
(30 μg)
11091031 C4591001 1109
11091031 >55 30JUL 2020 220520 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 29JAN2021/
BNT162b2
(30 μg) 19FEB2021/
BNT162b2
(30 μg)
11091032 C4591001 1109
11091032 >55 30JUL2020 220687 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 10FEB2021/
BNT162b2
(30 μg) 03MAR2021/
BNT 162b2
(30 μg)
11111002 C4591001 1111
11111002 >55 30JUL2020 220448 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
11111003 C4591001 1111
11111003 >55 30JUL2020 220449 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 05JAN2021/
BNT162b2
(30 μg) 26JAN20 21/
BNT162b2
(30 μg)
11111004 C4591001 1111
11111004 >55 30JUL2020 220450 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 49
FDA-CBER-2021-5683-0035601
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
11111005 C4591001 1111
11111005 >55 30JUL2020 220452 Placebo 30JUL2020/
Placebo 21AUG2020/
Placebo 29JAN2021/
BNT162b2
(30 μg) 19FEB2021/
BNT162b2
(30 μg)
11121001 C4591001 1112
11121001 >55 29JUL2020 220110 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
11121002 C4591001 1112
11121002 >55 29JUL2020 220111 Placebo 29JUL2020/
Placebo 19AUG2020/
Placebo 12JAN2021/
BNT162b2
(30 μg) 02FEB2021/
BNT162b2
(30 μg)
11121003 C4591001 1112
11121003 >55 29JUL2020 220120 Placebo 29JUL2020/
Placebo 19AUG2020/
Placebo 11FEB2021/
BNT162b2
(30 μg) 03MAR2021/
BNT162b2
(30 μg)
11121005 C4591001 1112
11121005 >55 29JUL2020 220115 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
11121007 C4591001 1112
11121007 >55 29JUL2020 220296 Placebo 29JUL2020/
Placebo 19AUG2020/
Placebo 17DEC2020/
BNT162b 2
(30 μg) 07JAN2021/
BNT162b2
(30 μg)
11121010 C4591001 1112
11121010 >55 30JUL2020 220297 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
11201002 C4591001 1120
11201002 >55 29JUL2020 220363 Placebo 29JUL2020/
Placebo 19AUG2 020/
Placebo
11201003 C4591001 1120
11201003 >55 29JUL2020 220361 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
11201006 C4591001 1120
11201006 >55 29JUL2020 220362 Placebo 29JUL2020/
Placebo 21AUG2020/
Placebo 19FEB202 1/
BNT162b2
(30 μg) 10MAR2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 50
FDA-CBER-2021-5683-0035602
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
11201007 C4591001 1120
11201007 >55 29JUL2020 220366 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
11271001 C4591001 1127
11271001 >55 29JUL2020 220147 BNT162b2
(30 μg) 29JUL2 020/
BNT162b2
(30 μg) 17AUG2020/
BNT162b2
(30 μg)
11271002 C4591001 1127
11271002 >55 29JUL2020 220152 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 16AUG2020/
BNT162b2
(30 μg)
11271003 C4591001 1127
11271003 >55 29JUL2020 220155 Placebo 29JUL2020 /
Placebo 16AUG2020/
Placebo 29JAN2021/
BNT162b2
(30 μg) 17FEB2021/
BNT162b2
(30 μg)
11271005 C4591001 1127
11271005 >55 29JUL2020 220207 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 17AUG2020/
BNT162b2
(30 μg)
11271006 C4591001 1127
11271006 >55 29JUL2020 220156 Placebo 29JUL2020/
Placebo 17AUG2020/
Placebo 01FEB2021/
BNT162b2
(30 μg) 22FEB2021/
BNT162b2
(30 μg)
11271007 C4591001 1127
11271007 >55 29JUL2020 220206 BNT162b2
(30 μ g) 29JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
11271008 C4591001 1127
11271008 >55 29JUL2020 220214 Placebo 29JUL2020/
Placebo 18AUG2020/
Placebo 06FEB2021/
BNT162b2
(30 μg) 27FEB2021/
BNT162b2
(30 μg)
11271009 C4591001 1127
11271009 >55 30JUL2020 220460 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo
1127 1010 C4591001 1127
11271010 >55 30JUL2020 220216 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 28JAN2021/
BNT162b2
(30 μg) 24FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 51
FDA-CBER-2021-5683-0035603
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
11271012 C4591001 1127
11271012 >55 30JUL2020 220461 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2 020/
BNT162b2
(30 μg)
11291002 C4591001 1129
11291002 >55 29JUL2020 220159 Placebo 29JUL2020/
Placebo 19AUG2020/
Placebo 23DEC2020/
BNT162b2
(30 μg ) 13JAN2021/
BNT162b2
(30 μg)
11291003 C4591001 1129
11291003 >55 29JUL2020 220164 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
11291004 C4591001 1129
11291004 >55 29JUL2020 220165 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
11291007 C4591001 1129
11291007 >55 29JUL2020 220166 Placebo 29JUL2 020/
Placebo 17AUG2020/
Placebo 04JAN2021/
BNT162b2
(30 μg) 22JAN2021/
BNT162b2
(30 μg)
11291008 C4591001 1129
11291008 >55 29JUL2020 220325 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 17AUG2020/
BNT162b2
(30 μg)
11291009 C4591001 1129
11291009 >55 30JUL2020 220332 Placebo 30JUL2020/
Placebo 19AUG2020/
Placebo 24DEC2020/
BNT162b2
(30 μg) 14JAN2021/
BNT162b2
(30 μg)
11291011 C4591001 1129
11291011 >55 30JUL2020 220334 Placebo 30JUL2020/
Placebo 19AUG2020/
Placebo 05JAN2021/
BNT162b2
(30 μg) 25JAN2021 /
BNT162b2
(30 μg)
11291012 C4591001 1129
11291012 >55 30JUL2020 220336 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
11291013 C4591001 1129
11291013 >55 30JUL2020 220481 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG20 20/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 52
FDA-CBER-2021-5683-0035604
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
11291015 C4591001 1129
11291015 >55 30JUL2020 220484 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 23FEB2021/
BNT162b2
(30 μg)
11291016 C4591001 1129
11291016 >55 30JUL2020 220489 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 06JAN2021/
BNT162b2
(30 μg) 26JAN2021/
BNT162b2
(30 μg)
11331002 C4591001 1133
11331002 >55 30JUL2020 220397 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
11331005 C4591001 1133
11331005 >55 30JUL2020 220400 Placebo 30JUL202 0/
Placebo 21AUG2020/
Placebo 04JAN2021/
BNT162b2
(30 μg) 25JAN2021/
BNT162b2
(30 μg)
11331007 C4591001 1133
11331007 >55 30JUL2020 220403 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
11331008 C4591001 1133
11331008 >55 30JUL2020 220554 Placebo 30JUL2020/
Placebo 21AUG2020/
Placebo 04JAN2021/
BNT162b2
(30 μg) 25JAN2021/
BNT162b2
(30 μg)
11331009 C4591001 1133
11331009 >55 30JUL2020 220401 Placebo 30JUL2020/
Placebo 21AUG2020/
Placebo 15JAN2021/
BNT162b2
(30 μg) 05FEB2021/
BNT162b2
(30 μg)
11331010 C4591001 1133
11331010 >55 30JUL2020 220553 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
11331012 C4591001 1133
11331012 >55 30JUL2020 220561 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 21AUG2020 /
BNT162b2
(30 μg)
11331013 C4591001 1133
11331013 >55 30JUL2020 220563 Placebo 30JUL2020/
Placebo 21AUG2020/
Placebo 04JAN2021/
BNT162b2
(30 μg) 25JAN2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 53
FDA-CBER-2021-5683-0035605
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
11391002 C4591001 1139
11391002 >55 29JUL2020 220061 BNT162b2
(30 μg) 29JUL2 020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
11391003 C4591001 1139
11391003 >55 29JUL2020 220062 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
11391004 C4591001 1139
11391004 >55 29JUL2020 220068 Placebo 29JUL2020 /
Placebo 20AUG2020/
Placebo 21JAN2021/
BNT162b2
(30 μg) 11FEB2021/
BNT162b2
(30 μg)
11391005 C4591001 1139
11391005 >55 29JUL2020 220071 Placebo 29JUL2020/
Placebo 20AUG2020/
Placebo 21JAN2021/
BNT162b2
(30 μg) 11FEB2021/
BNT162b2
(30 μg)
11391006 C4591 001 1139
11391006 >55 29JUL2020 220175 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
11391008 C4591001 1139
11391008 >55 29JUL2020 220177 Placebo 29JUL2020/
Placebo 20AUG2020/
Placebo 29JAN2021/
BNT162b2
(30 μg) 19FEB2021/
BNT162b2
(30 μg)
11391009 C4591001 1139
11391009 >55 29JUL2020 220178 Placebo 29JUL2020/
Placebo 20AUG2020/
Placebo 21JAN2021/
BNT162b2
(30 μg) 11FEB2021/
BNT162b2
(30 μg)
11391011 C4591001 1139
11391011 >55 30JUL2020 220180 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
11391012 C4591001 1139
11391012 >55 30JUL2020 220421 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
11391013 C4591001 1139
11391013 >55 30JUL2020 220423 Placebo 30JUL2020/
Place bo 19AUG2020/
Placebo 22JAN2021/
BNT162b2
(30 μg) 11FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 54
FDA-CBER-2021-5683-0035606
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
11391014 C4591001 1139
11391014 >55 30JUL2020 220425 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
11401002 C4591001 1140
11401002 >55 29JUL2020 220241 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 17AUG2020/
BNT162b2
(30 μg)
11401003 C4591001 1140
11401003 >55 29JUL2020 220245 Placebo 29JUL2020/
Placebo 17AUG2020/
Placebo
11401004 C4591001 1140
11401004 >55 29JUL2020 220246 BNT162b2
(30 μ g) 29JUL2020/
BNT162b2
(30 μg) 17AUG2020/
BNT162b2
(30 μg)
11401005 C4591001 1140
11401005 >55 30JUL2020 220251 Placebo 30JUL2020/
Placebo 18AUG2020/
Placebo 29DEC2020/
BNT162b2
(30 μg) 20JAN2021/
BNT162b2
(30 μg)
11401007 C4591001 1140
11401007 >55 30JUL2020 220541 Placebo 30JUL2020/
Placebo 19AUG2020/
Placebo 17DEC2020/
BNT162b2
(30 μg) 06JAN2021/
BNT162b2
(30 μg)
11401008 C4591001 1140
11401008 >55 30JUL2020 220542 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
11411 001 C4591001 1141
11411001 >55 30JUL2020 220469 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
11421003 C4591001 1142
11421003 >55 29JUL2020 220134 BNT162b2
(30 μg) 29JUL2020/
BNT162b2
(30 μg) 17AUG2020/
BNT162b2
(30 μg)
11421005 C4591001 1142
11421005 >55 29JUL2020 220135 Placebo 29JUL2020/
Placebo 17AUG2020/
Placebo 04JAN2021/
BNT162b2
(30 μg) 25JAN2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 55
FDA-CBER-2021-5683-0035607
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
11421006 C4591001 1142
11421006 >55 29JUL2020 220136 Placebo 29JUL2020/
Placebo 17AUG2020/
Placebo 04JAN2021/
BNT162b2
(30 μg) 25JAN2021/
BNT162b2
(30 μg)
11421012 C4591001 1142
11421012 >55 30JUL2020 220138 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
11421013 C4591001 1142
11421013 >55 30JUL2020 220601 BNT162b2
(30 μg ) 30JUL2020/
BNT162b2
(30 μg) 18AUG2020/
BNT162b2
(30 μg)
10011083 C4591001 1001
10011083 16-55 31JUL2020 40545 BNT162b2
(30 μg) 31JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10011105 C4591001 1001
10011105 16-55 31JUL2020 40547 Placebo 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 14JAN2021/
BNT162b2
(30 μg) 04FEB2021/
BNT162b2
(30 μg)
10011113 C4591001 1001
10011113 16-55 03AUG2020 41039 BNT162b2
(30 μg) 03AUG2020/
BNT162b2
(30 μg) 24AUG2020/
BNT162b2
(30 μg)
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 05FEB2021/
BNT162b2
(30 μg) 24FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 56
FDA-CBER-2021-5683-0035608
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10011129 C4591001 1001
10011129 16-55 05AUG2020 42967 BNT162b2
(30 μg) 05AUG2020/
BNT162b2
(30 μg) 24AUG2020/
BNT162b2
(30 μg)
10011130 C4591001 1001
100111 30 16-55 05AUG2020 42969 Placebo 05AUG2020/
Placebo 26AUG2020/
Placebo 08FEB2021/
BNT162b2
(30 μg) 01MAR2021/
BNT162b2
(30 μg)
1001113 1 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 09FEB2021/
BNT162b2
(30 μg) 01M AR2021/
BNT162b2
(30 μg)
10011135 C4591001 1001
10011135 16-55 05AUG2020 43218 Placebo 05AUG2020/
Placebo 24AUG2020/
Placebo 14JAN2021/
BNT162b2
(30 μg) 19FEB2021/
BNT162b2
(30 μg)
10011136 C4591001 1001
10011136 16-55 06AUG2020 43219 BNT162b2
(30 μg) 06AUG2020/
BNT162b2
(30 μg) 27AUG2020/
BNT162b2
(30 μg)
10011138 C4591001 1001
10011138 16-55 06AUG2020 43225 Placebo 06AUG2020/
Placebo 27AUG2020/
Placebo 22JAN2021/
BNT162b2
(30 μg) 11FEB2021/
BNT162b2
(30 μg)
10011143 C4591001 1001
10011143 16-55 06AUG2020 43877 BNT162b2
(30 μg) 06AUG2020/
BNT162b2
(30 μg) 27AUG2020/
BNT162b2
(30 μg)
10011145 C45910 01 1001
10011145 16-55 07AUG2020 43878 Placebo 07AUG2020/
Placebo 28AUG2020/
Placebo 06JAN2021/
BNT162b2
(30 μg) 25JAN2021/
BNT162b2
(30 μg)
1001114 6 C4591001 1001
10011146 16-55 07AUG2020 43882 Placebo 07AUG2020/
Placebo 28AUG2020/
Placebo 08FEB2021/
BNT162b2
(30 μg) 01MAR2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 57
FDA-CBER-2021-5683-0035609
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10011149 C4591001 1001
10011149 16-55 07AUG2020 43887 BNT162b2
(30 μg) 07AUG2020/
BNT162b2
(30 μg) 28AUG20 20/
BNT162b2
(30 μg)
10031116 C4591001 1003
10031116 16-55 30JUL2020 40153 Placebo 30JUL2020/
Placebo 21AUG2020/
Placebo 22DEC2020/
BNT162b2
(30 μg) 11JAN2021/
BNT162b2
(30 μg)
10031122 C4591001 1003
10031122 16-55 31JUL2020 40819 Placebo 31JUL2020/
Placebo 21AUG2020/
Placebo 01FEB2021/
BNT162b2
(30 μg) 22FEB2021/
BNT162b2
(30 μ g)
10031124 C4591001 1003
10031124 16-55 31JUL2020 40820 Placebo 31JUL2020/
Placebo 21AUG2020/
Placebo 12JAN2021/
BNT162b2
(30 μg) 02FEB2021/
BNT162b2
(30 μg)
10031125 C45910 01 1003
10031125 16-55 31JUL2020 40823 BNT162b2
(30 μg) 31JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
10031137 C4591001 1003
10031137 16-55 04AUG2020 40828 BNT162b2
(30 μg) 04AUG2020/
BNT162b2
(30 μg) 25AUG2020/
BNT162b2
(30 μg)
1003113 8 C4591001 1003
10031138 16-55 04AUG2020 42130 BNT162b2
(30 μg) 04AUG2020/
BNT162b2
(30 μg) 25AUG2020/
BNT162b2
(30 μg)
10031141 C4591001 1003
10031141 16-55 04AUG2020 42133 Placebo 04AUG2020/
Placebo 25AUG2020/
Placebo 22DEC2020/
BNT162b2
(30 μg) 12JAN2021/
BNT162b2
(30 μg)
10031144 C4591001 1003
10031144 16-55 04AUG2020 42522 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)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 58
FDA-CBER-2021-5683-0035610
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10031147 C4591001 1003
10031147 16-55 05AUG2020 42526 Placebo 05AUG2020/
Placebo 26AUG2020/
Placebo 11JAN2021/
BNT162b2
(30 μg) 01FEB2021/
BNT162b2
(30 μg)
10031151 C4591001 1003
10031151 16-55 05AUG2020 42529 Placebo 05AUG2020/
Placebo 26AUG2020/
Placebo 04JAN2021/
BNT162b2
(30 μg) 27JAN2021/
BNT162b2
(30 μg)
10031155 C4591001 1003
10031155 16-55 06AUG2020 43470 Placebo 06AUG2020/
Placebo 27AUG2020/
Placebo 28JAN2021/
BNT162b2
(30 μg) 18FEB2021/
BNT162b2
(30 μg)
1003115 6 C4591001 1003
10031156 16-55 06AUG2020 43474 Placebo 06AUG2020/
Placebo 27AUG2020/
Placebo 29JAN2021/
BNT162b2
(30 μg) 19FEB2021/
BNT162b2
(30 μg)
10031158 C4591001 1003
10031158 16-55 06AUG2020 43479 BNT162b2
(30 μg) 06AUG2020/
BNT162b2
(30 μg) 28AUG20 20/
BNT162b2
(30 μg)
10031160 C4591001 1003
10031160 16-55 06AUG2020 43480 BNT162b2
(30 μg) 06AUG2020/
BNT162b2
(30 μg) 27AUG2020/
BNT162b2
(30 μg)
10031161 C4591001 1003
10031161 16-55 07AUG2020 44214 Placebo 07AUG2020/
Placebo 28AUG2020/
Placeb o 17DEC2020/
BNT162b2
(30 μg) 08JAN2021/
BNT162b2
(30 μg)
10031162 C4591001 1003
10031162 16-55 07AUG2020 44217 BNT162b2
(30 μg) 07AUG2020/
BNT162b2
(30 μg) 28AUG2020/
BNT162b2
(30 μg)
10031166 C4591001 1003
10031166 16-55 07AUG2020 44221 BNT162b2
(30 μg) 07AUG2020/
BNT162b2
(30 μg) 28AUG2020/
BNT162b2
(30 μg)
10031170 C4591001 1003
10031170 16-55 10AUG2020 44224 Placebo 10AUG2020/
Placebo 31AUG2020/
Placebo 29DEC2020/
BNT162b2
(30 μg) 13JAN2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 59
FDA-CBER-2021-5683-0035611
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10031171 C4591001 1003
10031171 16-55 10AUG2020 45113 BNT162b2
(30 μg) 10AUG2020/
BNT162b2
(30 μg) 31AUG2020/
BNT162b2
(30 μg)
10031174 C4591001 1003
10031174 16-55 10AUG2020 45115 Placebo 10AUG2020/
Placebo 31AUG2020/
Placebo 17DEC2020/
BNT162b2
(30 μg) 08JAN2021/
BNT162b2
(30 μg)
10031175 C4591001 1003
10031175 16-55 10AUG2020 45118 Placebo 10AUG2020/
Placebo 31AUG2020/
Placebo 14JAN2021/
BNT162b2
(30 μg) 02FEB2021/
BNT162b2
(30 μg)
10031177 C4591001 1003
10031177 16-55 10AUG2020 45122 BNT162b2
(30 μg) 10AUG2020/
BNT162b2
(30 μg) 31AUG2020/
BNT162b2
(30 μg)
10031179 C4591001 1003
10031179 16-55 11AUG2020 46111 Placebo 11AUG2020/
Placebo 01SEP2020/
Placebo 01FEB2021/
BNT162b2
(30 μg) 22FEB2021/
BNT162b2
(30 μg)
10031180 C4591001 1003
10031180 16-55 11AUG2020 46116 BNT162b2
(30 μg) 11AUG2020/
BNT162b2
(30 μg) 01SEP2020/
BNT162b2
(30 μg)
10031183 C4591001 1003
10031183 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 17DEC2020/
BNT162b2
(30 μg) 06JAN2021/
BNT162b2
(30 μg)
10031186 C4591001 1003
10031186 16-55 12AUG2020 47001 Placebo 12AUG2020/
Placebo 03SEP2020/
Placebo 19JAN2021/
BNT162b2
(30 μg) 09FEB2021/
BNT162b2
(30 μg)
10031187 C4591001 1003
10031187 16-55 12AUG2020 47003 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 01SEP2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 60
FDA-CBER-2021-5683-0035612
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10031190 C4591001 1003
10031190 16-55 12AUG2020 47004 Placebo 12AUG2020/
Placebo 01SEP2020/
Placebo 22DEC2020/
BNT162b2
(30 μg) 12JAN2021/
BNT162b2
(30 μg)
10031191 C4591001 1003
10031191 16-55 12AUG2020 47008 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
10031194 C4591001 1003
10031194 16-55 13AUG2020 48774 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
10031196 C4591001 1003
10031196 16-55 13AUG2020 48776 Placebo 13AUG2020/
Placebo 03SEP2020/
Placebo 17DEC2020/
BNT162b2
(30 μg) 06JAN2021/
BNT162b2
(30 μg)
10031197 C4591001 1003
10031197 16-55 13AUG2020 48777 Placebo 13AUG2020/
Placebo 03SEP2020/
Placebo 17DEC2020/
BNT162b2
(30 μg) 06JAN2021/
BNT162b2
(30 μg)
10031198 C4591001 1003
10031198 16-55 13AUG2020 48779 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
10031199 C4591001 1003
10031199 16-55 13AUG2020 49242 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
10031201 C4591001 1003
1003120 1 16-55 13AUG2020 49250 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
10031203 C459100 1 1003
10031203 16-55 14AUG2020 49251 Placebo 14AUG2020/
Placebo 04SEP2020/
Placebo 17DEC2020/
BNT162b2
(30 μg) 06JAN2021/
BNT162b2
(30 μg)
10031204 C4591001 1003
10031204 16-55 14AUG2020 49252 Placebo 14AUG2020/
Placebo 04SEP2020/
Placebo 14JAN2021/
BNT1 62b2
(30 μg) 04FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 61
FDA-CBER-2021-5683-0035613
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10031205 C4591001 1003
10031205 16-55 14AUG2020 49868 Placebo 14AUG2020/
Placebo 04SEP2020/
Placebo 29JAN2021/
BNT162b2
(30 μg) 19FEB2021/
BNT162b2
(30 μg)
10031206 C4591001 1003
10031206 16-55 14AUG2020 49870 Placebo 14AUG2020/
Placebo 04SEP2020/
Placebo 12JAN2021/
BNT162b2
(30 μg) 03FEB2021/
BNT162b2
(30 μg)
10031207 C4591001 1003
10031207 16-55 14AUG2020 49872 BNT162b2
(30 μg) 14AUG2020/
BNT162b2
(30 μg) 04SEP2020/
BNT162b2
(30 μg)
10051002 C4591001 1005
10051002 16-55 07AUG2020 44385 BNT162b2
(30 μg) 07AUG2020/
BNT162b2
(30 μg) 26AUG2020/
BNT162b2
(30 μ g)
10051003 C4591001 1005
10051003 16-55 07AUG2020 44387 Placebo 07AUG2020/
Placebo 30AUG2020/
Placebo 22FEB2021/
BNT162b2
(30 μg)
10051004 C4591001 1005
10051004 16-55 10AUG2020 44389 BNT162b2
(30 μg) 10AUG2020/
BNT162b2
(30 μg) 31AUG2020/
BNT162b2
(30 μg)
10051007 C4591001 1005
10051007 16-55 10AUG2020 44392 Placebo 10AUG2020/
Placebo 31AUG2020/
Placebo 14JAN2021/
BNT162b2
(30 μg) 04FEB2021/
BNT162b2
(30 μg)
10051008 C4591001 1005
10051008 16-55 10AUG2020 45368 BNT162b2
(30 μg) 10AUG2020/
BNT162b2
(30 μg) 01SEP2020/
BNT162b2
(30 μg)
10051015 C4591001 1005
10051015 16-55 10AUG2020 45372 Placebo 10AUG2020/
Placebo 31AUG2020/
Placebo 22FEB202 1/
BNT162b2
(30 μg)
10051016 C4591001 1005
10051016 16-55 11AUG2020 45373 BNT162b2
(30 μg) 11AUG2020/
BNT162b2
(30 μg) 31AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 62
FDA-CBER-2021-5683-0035614
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10051017 C4591001 1005
10051017 16-55 11AUG2020 45374 Placebo 11AUG2020/
Placebo 01SEP2020/
Placebo 19JAN2021/
BNT162b2
(30 μg) 09FEB 2021/
BNT162b2
(30 μg)
10051024 C4591001 1005
10051024 16-55 11AUG2020 46639 BNT162b2
(30 μg) 11AUG2020/
BNT162b2
(30 μg) 31AUG2020/
BNT162b2
(30 μg)
10051026 C4591001 1005
10051026 16-55 11AUG2020 46641 Placebo 11AUG2 020/
Placebo 02SEP2020/
Placebo
10051027 C4591001 1005
10051027 16-55 11AUG2020 46642 Placebo 11AUG2020/
Placebo 31AUG2020/
Placebo 27JAN2021/
BNT162b2
(30 μg) 19FEB2021/
BNT162b2
(30 μg)
10051028 C4591001 1005
10051028 16-55 12AUG2020 47011 Placebo 12AUG2020/
Placebo 01SEP2020/
Placebo 23FEB2021/
BNT162b2
(30 μg)
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 17FEB2021/
BNT162b2
(30 μg) 10MAR2021/
BNT162b2
(30 μg)
10051031 C4591001 1005
10051031 16-55 12AUG2020 47019 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
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 μ g)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 63
FDA-CBER-2021-5683-0035615
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10051041 C4591 001 1005
10051041 16-55 12AUG2020 47921 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 04SEP2020/
BNT162b2
(30 μg)
10051048 C4591001 1005
10051048 16-55 13AUG2020 47924 Placebo 13AUG2020/
Placebo 02SEP2020/
Placebo 18FEB2021/
BNT162b2
(30 μg) 12MAR2021/
BNT162b2
(30 μg)
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 08FEB 2021/
BNT162b2
(30 μg) 01MAR2021/
BNT162b2
(30 μg)
10051054 C4591001 1005
10051054 16-55 13AUG2020 48727 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 04SEP2020/
BNT162b2
(30 μg)
10051055 C4591001 1005
10051055 16-55 13AUG2020 48728 Placebo 13AUG2020/
Placebo 01SEP2020/
Placebo 26JAN2021/
BNT162b2
(30 μg) 17FEB2021/
BNT162b2
(30 μg)
10051057 C4591001 1005
10051057 16-55 13AUG2020 48729 Placebo 13AUG2020/
Placebo 02SEP2020/
Placebo 02FEB202 1/
BNT162b2
(30 μg) 23FEB2021/
BNT162b2
(30 μg)
10051059 C4591 001 1005
10051059 16-55 13AUG2020 48733 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
10051066 C4591001 1005
10051066 16-55 13AUG2020 49457 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
100510 67 C4591001 1005
10051067 16-55 13AUG2020 49463 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 01SEP2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
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FDA-CBER-2021-5683-0035616
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10051070 C4591001 1005
10051070 16-55 14AUG2020 49464 Placebo 14AUG2020/
Placebo 02SEP2020/
Placebo 24FEB2021/
BNT162b2
(30 μg)
10051071 C4591001 1005
10051071 16-55 14AUG2020 49468 Placebo 14AUG2020/
Placebo 04SEP2020/
Placebo 20JAN2021/
BNT162b2
(30 μg) 10FEB2021/
BNT162b2
(30 μg)
10051073 C4591001 1005
10051073 16-55 14AUG2020 49998 Placebo 14AUG2020/
Placebo 04SEP2020/
Placeb o 24FEB2021/
BNT162b2
(30 μg)
10051075 C4591001 1005
10051075 16-55 14AUG2020 50002 Placebo 14AUG2020/
Placebo 04SEP2020/
Placebo 19JAN2021/
BNT162b2
(30 μg) 09FEB2021/
BNT162b2
(30 μg)
10061005 C4591001 1006
10061005 16-55 10AUG2020 45485 Placebo 10AU G2020/
Placebo 31AUG2020/
Placebo 28DEC2020/
BNT162b2
(30 μg) 20JAN2021/
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 27JAN2021/
BNT162b2
(30 μg) 19FEB2021/
BNT162b2
(30 μg)
10061009 C4591001 1006
10061009 16-55 10AUG2020 45495 BNT162b2
(30 μg) 10AUG2020/
BNT162b2
(30 μg) 02SEP2020/
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 11AUG2020/
Placebo 31AUG2020/
Placebo 03FEB2021/
BNT162b2
(30 μg) 26FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 65
FDA-CBER-2021-5683-0035617
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10061013 C4591001 1006
10061013 16-55 11AUG2020 46294 Placebo 11AUG2020/
Placebo 31AUG2020/
Placebo 16FEB2021/
BNT162b2
(30 μg) 08MAR2021/
BNT162b2
(30 μg)
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)
10061018 C4591001 1006
10061018 16-55 11AUG2020 46868 Placebo 11AUG2020/
Placebo 31AUG2020/
Placebo 12FEB2021/
BNT162b2
(30 μg) 04MAR2021/
BNT162b2
(30 μg)
10061019 C4591001 1006
10061019 16-55 12AUG2020 46869 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
10061021 C4591001 1006
10061021 16-55 12AUG2020 46874 Placebo 12AUG2020/
Placebo 01SEP2020/
Placebo 15JAN2021/
BNT162b2
(30 μg) 04FEB2021/
BNT162b2
(30 μg)
10061022 C4591001 1006
10061022 16-55 12AUG2020 47813 Placebo 12AUG2020/
Placebo 31AUG2020/
Placebo 15JAN2021/
BNT162b2
(30 μg) 03FEB2021/
BNT162b2
(30 μg)
10061023 C4591001 1006
10061023 16-55 12AUG2020 47819 Placebo 12AUG2020/
Placebo 31AUG2020/
Placebo 15JAN2021/
BNT162b2
(30 μg) 04FEB2021/
BNT162b2
(30 μg)
10061024 C4591001 1006
10061024 16-55 12AUG2020 47820 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 31AUG2020/
BNT162b2
(30 μg)
10061 028 C4591001 1006
10061028 16-55 13AUG2020 47823 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 66
FDA-CBER-2021-5683-0035618
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10061031 C4591001 1006
10061031 16-55 13AUG2020 49714 Placebo 13AUG2020/
Placebo 04SEP2020/
Placebo 27JAN2021/
BNT162b2
(30 μg) 15FEB2021/
BNT162b2
(30 μg)
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)
10061036 C4591001 1006
10061036 16-55 14AUG2020 49719 Placebo 14AUG2020/
Placebo 04SEP2020/
Placebo 01FEB2021/
BNT162b2
(30 μg) 22FEB2021/
BNT162b2
(30 μg)
10061037 C4591001 1006
10061037 16-55 14AUG2020 50868 Placebo 14AUG2020/
Placebo 04SEP2020/
Placebo 01FEB2021/
BNT162b2
(30 μg) 22FEB2021/
BNT162b2
(30 μg)
10071106 C4591001 1007
10071106 16-55 03AUG2020 40640 BNT162b2
(30 μg) 03AUG2020/
BNT162b2
(30 μg) 24AUG2020 /
BNT162b2
(30 μg)
10071107 C4591001 1007
10071107 16-55 03AUG2020 40643 BNT162b2
(30 μg) 03AUG2020/
BNT162b2
(30 μg) 26AUG2020/
BNT162b2
(30 μg)
10071108 C4591001 1007
10071108 16-55 03AUG2020 40648 Placebo 03AUG2020/
Placebo 27AUG2020/
Placebo 24FEB2021/
BNT162b2
(30 μg)
10071109 C4591001 1007
10071109 16-55 03AUG2020 41642 Placebo 03AUG2020/
Placebo 24AUG2020/
Placebo 15FEB2021/
BNT162b2
(30 μg) 08MAR2021/
BNT162b2
(30 μg)
10071110 C4591001 1007
10071110 16-55 03AUG2020 41636 BNT162b2
(30 μg) 03AUG2020/
BNT162b2
(30 μg) 24AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 67
FDA-CBER-2021-5683-0035619
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10071111 C4591001 1007
10071111 16-55 03AUG2020 41643 BNT162b2
(30 μg) 03AUG2020/
BNT162b2
(30 μg) 24AUG2020/
BNT162b2
(30 μg)
10071112 C4591001 1007
10071112 16-55 03AUG 2020 41644 Placebo 03AUG2020/
Placebo 24AUG2020/
Placebo 18FEB2021/
BNT162b2
(30 μg) 11MAR2021/
BNT162b2
(30 μg)
10071117 C4591001 1007
10071117 16-55 03AUG2020 41898 Placebo 03AUG2020/
Placebo 24AUG2020/
Placebo 15FEB2021/
BNT162b2
(30 μg) 08MAR2021/
BNT 162b2
(30 μg)
10071118 C4591001 1007
10071118 16-55 03AUG2020 41901 BNT162b2
(30 μg) 03AUG2020/
BNT162b2
(30 μg) 24AUG2020/
BNT162b2
(30 μg)
10071119 C4591001 1007
10071119 16-55 05AUG2020 41902 Placebo 05AUG2020/
Placebo 26AUG2020/
Placebo 04JAN2021 /
BNT162b2
(30 μg) 25JAN2021/
BNT162b2
(30 μg)
10071123 C4591001 1007
10071123 16-55 05AUG2020 41903 BNT162b2
(30 μg) 05AUG2020/
BNT162b2
(30 μg) 26AUG2020/
BNT162b2
(30 μg)
10071125 C4591001 1007
10071125 16-55 05AUG2020 42920 Placebo 05AUG2020/
Placebo 24AUG2020/
Placebo 08MAR2021/
BNT162b2
(30 μg)
10071129 C4591001 1007
10071129 16-55 05AUG2020 42924 Placebo 05AUG2020/
Placebo 26AUG2020/
Placebo 17FEB2021/
BNT162b2
(30 μg) 10MAR2021/
BNT162b2
(30 μg)
10071130 C4591001 1007
10071130 16-55 05AUG2 020 42921 BNT162b2
(30 μg) 05AUG2020/
BNT162b2
(30 μg) 26AUG2020/
BNT162b2
(30 μg)
10071131 C4591001 1007
10071131 16-55 05AUG2020 42926 BNT162b2
(30 μg) 05AUG2020/
BNT162b2
(30 μg) 27AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 68
FDA-CBER-2021-5683-0035620
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10071132 C4591001 1007
10071132 16-55 05AUG2020 43159 Placebo 05AUG2020/
Placebo 27AUG2020/
Placebo 06JAN2021/
BNT162b2
(30 μg) 27JAN2021/
BNT162b2
(30 μg)
10071133 C4591001 1007
10071133 16-55 05AUG2020 43163 Placebo 05AUG2020/
Placebo 31AUG2020/
Placebo 12JAN2021/
BNT162b2
(30 μg) 01FEB20 21/
BNT162b2
(30 μg)
10071137 C4591001 1007
10071137 16-55 06AUG2020 43164 BNT162b2
(30 μg) 06AUG2020/
BNT162b2
(30 μg) 27AUG2020/
BNT162b2
(30 μg)
10071138 C4591001 1007
10071138 16-55 06AUG2020 43165 BNT162b2
(30 μg) 06AUG2020/
BNT162b2
(30 μg) 27AUG2020/
BNT162b2
(30 μg)
10071143 C4591001 1007
10071143 16-55 06AUG2020 43834 Placebo 06AUG2020/
Placebo 27AUG2020/
Placebo 18FEB2021/
BNT162b2
(30 μg) 11MAR2021/
BNT162b2
(30 μg)
10071145 C4591001 1007
10071145 16-55 06AUG2020 43832 Placebo 06AUG20 20/
Placebo 27AUG2020/
Placebo 07JAN2021/
BNT162b2
(30 μg) 28JAN2021/
BNT162b2
(30 μg)
10071146 C4591001 1007
10071146 16-55 06AUG2020 43838 BNT162b2
(30 μg) 06AUG2020/
BNT162b2
(30 μg) 27AUG2020/
BNT162b2
(30 μg)
10071148 C4591001 1007
10071148 16-55 06AUG2020 43839 BNT162b2
(30 μg) 06AUG2020/
BNT162b2
(30 μg) 27AUG2020/
BNT162b2
(30 μg)
10071150 C4591001 1007
10071150 16-55 10AUG2020 45188 Placebo 10AUG2020/
Placebo 31AUG2020/
Placebo 22FEB2021/
BNT162b2
(30 μg)
10071151 C4591001 1007
100711 51 16-55 10AUG2020 45186 BNT162b2
(30 μg) 10AUG2020/
BNT162b2
(30 μg) 31AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 69
FDA-CBER-2021-5683-0035621
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10071152 C4591001 1007
10071152 16-55 10AUG2020 45191 BNT162b2
(30 μg) 10AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
10071153 C4591001 100 7
10071153 16-55 10AUG2020 45270 BNT162b2
(30 μg) 10AUG2020/
BNT162b2
(30 μg) 31AUG2020/
BNT162b2
(30 μg)
10071154 C4591001 1007
10071154 16-55 10AUG2020 45272 Placebo 10AUG2020/
Placebo 31AUG2020/
Placebo 14JAN2021/
BNT162b2
(30 μg) 02FEB2021/
BNT162 b2
(30 μg)
10071155 C4591001 1007
10071155 16-55 10AUG2020 45189 Placebo 10AUG2020/
Placebo 31AUG2020/
Placebo 22FEB2021/
BNT162b2
(30 μg)
10071157 C4591001 1007
10071157 16-55 10AUG2020 45273 BNT162b2
(30 μg) 10AUG2020/
BNT162b2
(30 μg) 31AUG2020/
BNT 162b2
(30 μg)
10071158 C4591001 1007
10071158 16-55 10AUG2020 45280 Placebo 10AUG2020/
Placebo 31AUG2020/
Placebo 18FEB2021/
BNT162b2
(30 μg) 11MAR2021/
BNT162b2
(30 μg)
10071159 C4591001 1007
10071159 16-55 10AUG2020 45643 BNT162b2
(30 μg) 10AUG2020 /
BNT162b2
(30 μg) 31AUG2020/
BNT162b2
(30 μg)
10071162 C4591001 1007
10071162 16-55 10AUG2020 45644 Placebo 10AUG2020/
Placebo 31AUG2020/
Placebo 22FEB2021/
BNT162b2
(30 μg)
10071171 C4591001 1007
10071171 16-55 12AUG2020 45645 Placebo 12AUG2020/
Placebo 02SEP2020/
Placebo 12JAN2021/
BNT162b2
(30 μg) 03FEB2021/
BNT162b2
(30 μg)
10071172 C4591001 1007
10071172 16-55 12AUG2020 45647 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 70
FDA-CBER-2021-5683-0035622
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10071175 C4591001 1007
10071175 16-55 12AUG2020 47633 Placebo 12AUG2020/
Placebo 03SEP2020/
Placebo 14JAN2021/
BNT162b2
(30 μg) 04FEB2021/
BNT162b2
(30 μg)
10071178 C4591001 1007
10071178 16-55 12AUG2020 47644 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
1007117 9 C4591001 1007
10071179 16-55 12AUG2020 47634 Placebo 12AUG2020/
Placebo 03SEP2020/
Placebo
10071181 C4591001 1007
10071181 16-55 12AUG2020 47640 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
10071184 C4591001 1007
10071184 16-55 13AUG2020 48452 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
10071185 C4591001 1007
10071185 16-55 13AUG2020 48455 Placebo 13AUG2020/
Placebo 03SEP2020/
Placebo 05JAN2021/
BNT162b2
(30 μg) 26JAN2021/
BNT162b2
(30 μg)
10071186 C4591001 1007
10071186 16-55 13AUG2020 48459 Placebo 13AUG2020/
Placebo 03SEP2020/
Placebo
10071193 C4591001 1007
10071193 16-55 13AUG2020 49097 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
10071194 C4591001 1007
10071194 16-55 13AUG2020 49099 Placebo 13AUG2020/
Placebo 03SEP2020/
Placebo 11JAN2021/
BNT162b2
(30 μg) 02FEB2021/
BNT162b2
(30 μg)
10071195 C4591001 1007
10071195 16-55 13AUG2020 49098 Placebo 13AUG2020/
Placebo 03SEP2020/
Placebo 25FEB2021/
BNT162b2
(30 μg)
10071196 C4591001 1007
10071196 16-55 13AUG2020 49103 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 71
FDA-CBER-2021-5683-0035623
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10071197 C4591001 1007
10071197 16-55 13AUG2020 49338 Placebo 13AUG2020/
Placebo 02SEP2020/
Placebo 05JA N2021/
BNT162b2
(30 μg) 27JAN2021/
BNT162b2
(30 μg)
10081006 C4591001 1008
10081006 16-55 10AUG2020 45761 BNT162b2
(30 μg) 10AUG2020/
BNT162b2
(30 μg) 31AUG2020/
BNT162b2
(30 μg)
10081007 C4591001 1008
10081007 16-55 10AUG2020 45762 Placebo 10AUG2020 /
Placebo 31AUG2020/
Placebo 13JAN2021/
BNT162b2
(30 μg) 02FEB2021/
BNT162b2
(30 μg)
10081011 C4591001 1008
10081011 16-55 11AUG2020 45768 Placebo 11AUG2020/
Placebo 01SEP2020/
Placebo 25JAN2021/
BNT162b2
(30 μg)
10081013 C4591001 1008
10081013 16-55 11AUG2020 45771 BNT162b2
(30 μg) 11AUG2020/
BNT162b2
(30 μg) 01SEP2020/
BNT162b2
(30 μg)
10081015 C4591001 1008
10081015 16-55 11AUG2020 46721 Placebo 11AUG2020/
Placebo 02SEP2020/
Placebo 14JAN2021/
BNT162b2
(30 μg) 04FEB2021/
BNT162b2
(30 μg)
100810 18 C4591001 1008
10081018 16-55 12AUG2020 46722 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
10081019 C4591001 1008
10081019 16-55 12AUG2020 46728 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
10081022 C4591001 1008
10081022 16-55 12AUG2020 46730 Placebo 12AUG2020/
Placebo 02SEP2020/
Placebo 13JAN2021/
BNT162b2
(30 μg) 03FEB2021/
BNT162b2
(30 μg)
10081024 C4591001 1008
10081024 16-55 12AUG2020 48101 Placebo 12AUG2020/
Placebo 02SEP2020/
Place bo 13JAN2021/
BNT162b2
(30 μg) 03FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 72
FDA-CBER-2021-5683-0035624
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10081025 C4591001 1008
10081025 16-55 13AUG2020 48109 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
10081028 C4591001 1008
10081028 16-55 13AUG2020 48110 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 04SEP2020/
BNT162b2
(30 μg)
10081029 C4591001 1008
10081029 16-55 13AUG2020 48112 Placebo 13AUG2020/
Placebo 03SEP2020/
Placebo 16DEC2020/
BNT162b2
(30 μg) 05JAN2021/
BNT162b2
(30 μg)
10081030 C4591001 1008
10081030 16-55 13AUG2020 49435 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 04SEP2020/
BNT162b2
(30 μg)
10081031 C4591001 1008
10081031 16-55 13AUG2020 49441 Placebo 13AUG2020/
Placebo 03SEP2020/
Placebo 19JAN2021/
BNT162b2
(30 μg) 09FEB2021/
BNT162b2
(30 μg)
10081033 C4591001 1008
10081033 16-55 14AUG2020 49443 BNT162b2
(30 μg) 14AUG2020/
BNT162b2
(30 μg) 04SEP2020/
BNT162b2
(30 μg)
10081036 C4591001 1008
10081036 16-55 14AUG2020 49444 Placebo 14AUG2020/
Placebo 03SEP2020/
Placebo 15JAN2021/
BNT162b2
(30 μg) 05FEB2021/
BNT162b2
(30 μg)
10081037 C4591001 1008
10081037 16-55 14AUG2020 50633 BNT162b2
(30 μg) 14AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
10081040 C4591001 1008
10081040 16-55 14AUG2020 50634 Placebo 14AUG2020/
Placebo 04SEP202 0/
Placebo 16DEC2020/
BNT162b2
(30 μg) 06JAN2021/
BNT162b2
(30 μg)
10091002 C4591001 1009
10091002 16-55 07AUG2020 44552 BNT162b2
(30 μg) 07AUG2020/
BNT162b2
(30 μ g) 27AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 73
FDA-CBER-2021-5683-0035625
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10091005 C4591001 1009
10091005 16-55 10AUG2020 44556 Placebo 10AUG2020/
Placebo 02SEP2020/
Placebo 22JAN2021/
BNT162b2
(30 μg) 10FEB2021/
BNT162b2
(30 μg)
10091006 C4591001 1009
10091006 16-55 10AUG2020 44558 BNT162b2
(30 μg) 10AUG2020/
BNT162b2
(30 μg) 31AUG2020/
BNT162b2
(30 μg)
10091012 C4591001 1009
10091012 16-55 10AUG2020 44559 Placebo 10AUG2020/
Placebo 31AUG2020/
Placebo 15JAN2021/
BNT162b2
(30 μg) 05FEB2021/
BNT162b2
(30 μg)
10091021 C4591001 100 9
10091021 16-55 11AUG2020 46841 Placebo 11AUG2020/
Placebo 02SEP2020/
Placebo 11FEB2021/
BNT162b2
(30 μg) 03MAR2021/
BNT162b2
(30 μg)
10091023 C4591001 1009
10091023 16-55 11AUG2020 46842 BNT162b2
(30 μg) 11AUG2020/
BNT162b2
(30 μg) 01SEP2020/
BNT162b2
(30 μg)
10091028 C4591001 1009
10091028 16-55 12AUG2020 46847 BNT162b2
(30 μg) 12AUG2020/
BNT162b 2
(30 μg) 31AUG2020/
BNT162b2
(30 μg)
10091031 C4591001 1009
10091031 16-55 12AUG2020 46850 Placebo 12AUG2020/
Placebo 01SEP2020/
Placebo 23FEB2021/
BNT162b2
(30 μg)
10091032 C4591001 1009
10091032 16-55 12AUG2020 48235 Placebo 12AUG2020/
Placebo 02SEP2020/
Placebo 10FEB2021/
BNT162b2
(30 μg) 01MAR2021/
BNT162b2
(30 μg)
10091042 C4591001 1009
10091042 16-55 14AUG2020 48238 BNT162b2
(30 μg) 14AUG2020/
BNT162b2
(30 μg) 04SEP2020/
BNT162b2
(30 μg)
10091045 C4591001 1009
10091045 16-55 14AUG2020 48240 Placebo 14AUG2020/
Placebo 03SEP2020/
Placebo 31DEC2020/
BNT162b2
(30 μg) 22JAN2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 74
FDA-CBER-2021-5683-0035626
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10091049 C4591001 100 9
10091049 16-55 14AUG2020 50934 Placebo 14AUG2020/
Placebo 02SEP2020/
Placebo 28JAN2021/
BNT162b2
(30 μg) 19FEB2021/
BNT162b2
(30 μg)
10091050 C4591001 1009
10091050 16-55 14AUG2020 50936 Placebo 14AUG2020/
Placebo 02SEP2020/
Placebo 28JAN2021/
BNT162b2
(30 μg) 19FEB2021/
BNT162b2
(30 μg)
10111001 C4591001 1011
10111001 16-55 11AUG2020 46499 Placebo 11AUG2020/
Placebo 01SEP2020 /
Placebo 04FEB2021/
BNT162b2
(30 μg) 01MAR2021/
BNT162b2
(30 μg)
10111004 C4591001 1011
10111004 16-55 12AUG2020 46500 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
10111005 C4591001 1011
10111005 16-55 12AUG2020 46501 BNT 162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
10111006 C4591001 1011
10111006 16-55 12AUG2020 47094 Placebo 12AUG2020/
Placebo 03SEP2020/
Placebo 29DEC2020/
BNT162b2
(30 μg) 19JAN2021/
BNT162b2
(30 μg)
10111008 C4591001 1011
10111008 16-55 12AUG2020 47095 Placebo 12AUG2020/
Placebo 01SEP2020/
Placebo 18DEC202 0/
BNT162b2
(30 μg) 08JAN2021/
BNT162b2
(30 μg)
10111009 C4591001 1011
10111009 16-55 12AUG2020 47103 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
10111013 C4591001 1011
10111013 16-55 12AUG2020 47104 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
10111016 C4591001 1011
10111016 16-55 13AUG2020 48308 Placebo 13AUG2020/
Placebo 03SEP2020/
Placebo 04FEB2021/
BNT1 62b2
(30 μg) 25FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 75
FDA-CBER-2021-5683-0035627
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10111017 C4591001 1011
10111017 16-55 13AUG2020 48313 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
10111021 C4591001 1011
10111021 16-55 13AUG2020 48314 Placebo 13AUG2020/
Placebo 03SEP2020/
Placebo 08FEB2021/
BNT162b2
(30 μg) 01MAR2021/
BNT162b2
(30 μg)
10111024 C4591001 1011
10111024 16-55 13AUG2020 48315 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
10111031 C4591001 1011
10111031 16-55 13AUG2020 49649 Placebo 13AUG2020/
Placebo 03SEP2020/
Placebo 11FEB2021/
BNT162b2
(30 μg) 04MAR2021/
BNT162b2
(30 μg)
10111032 C4591001 1011
10111032 16-55 13AUG2020 49651 Placebo 13AUG2020/
Placebo 03SEP2020/
Placebo 12FEB2021/
BNT162b2
(30 μg) 05MAR2021/
BNT162b2
(30 μg)
10111034 C4591001 1011
10111034 16-55 14AUG2020 49652 BNT162b2
(30 μg) 14AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
10111035 C4591001 1011
10111035 16-55 14AUG2020 49653 BNT162b2
(30 μg) 14AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT16 2b2
(30 μg)
10111038 C4591001 1011
10111038 16-55 14AUG2020 50273 BNT162b2
(30 μg) 14AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
10111039 C4591001 1011
10111039 16-55 14AUG2020 50274 BNT162b2
(30 μg) 14AUG2020/
BNT162b2
(30 μg) 01SEP202 0/
BNT162b2
(30 μg)
10121001 C4591001 1012
10121001 16-55 03AUG2020 41719 BNT162b2
(30 μg) 03AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 76
FDA-CBER-2021-5683-0035628
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10121003 C4591001 1012
10121003 16-55 03AUG2020 41723 Placebo 03AUG2020/
Placebo 24AUG2020/
Placebo 04FEB2021/
BNT162b2
(30 μ g) 25FEB2021/
BNT162b2
(30 μg)
10121005 C4591001 1012
10121005 16-55 03AUG2020 41725 BNT162b2
(30 μg) 03AUG2020/
BNT162b2
(30 μg) 25AUG2020/
BNT162b2
(30 μg)
10121006 C4591001 1012
10121006 16-55 03AUG2020 41728 Placebo 03AUG2020/
Placebo 28AUG2020/
Placebo 11FEB2021/
BNT162b2
(30 μg) 05MAR2021/
BNT162b2
(30 μg)
10121013 C4591001 1012
10121013 16-55 05AUG2020 43014 Placebo 05AUG2020/
Placebo 26AUG2020/
Placebo 20JAN2021/
BNT162b2
(30 μg) 10FEB2021/
BNT162b2
(30 μg)
10121014 C4591001 1012
10121014 16-55 05AUG2020 43017 Placebo 05AUG2020/
Placebo 26AUG2020/
Placebo 30JAN2021/
BNT162b2
(30 μg) 18FEB2021/
BNT162b2
(30 μg)
10121016 C4591001 1012
10121016 16-55 06AUG2020 43018 BNT162b2
(30 μg) 06AUG2020/
BNT162b2
(30 μg) 28AUG2020/
BNT162b2
(30 μg)
10121020 C4591001 1012
10121020 16-55 07AUG2020 44658 BNT162b2
(30 μg) 07AUG2020/
BNT162b2
(30 μg) 27AUG2020/
BNT162b2
(30 μg)
10121021 C4591001 1012
10121021 16-55 07AUG2020 43021 BNT162b2
(30 μg) 07AUG2020/
BNT162b2
(30 μg) 28AUG2020/
BNT162b2
(30 μg )
10121022 C4591001 1012
10121022 16-55 10AUG2020 44659 BNT162b2
(30 μg) 10AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
10121024 C4591001 1012
10121024 16-55 10AUG2020 44664 Placebo 10AUG2020/
Placebo 02SEP2020/
Placebo 16FEB2021/
BNT162 b2
(30 μg) 09MAR2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 77
FDA-CBER-2021-5683-0035629
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10121025 C4591001 1012
10121025 16-55 10AUG2020 44666 Placebo 10AUG2020/
Placebo 31AUG2020/
Placebo 30JAN2021/
BNT162b2
(30 μg) 09MAR2021/
BNT162b2
(30 μg)
10121027 C4591001 1012
10121027 16-55 11AUG2020 46506 BNT16 2b2
(30 μg) 11AUG2020/
BNT162b2
(30 μg) 31AUG2020/
BNT162b2
(30 μg)
10121030 C4591001 1012
10121030 16-55 12AUG2020 46509 Placebo 12AUG2020/
Placebo 31AUG2020/
Placebo 23DEC2020/
BNT162b2
(30 μg) 13JAN2021/
BNT162b2
(30 μg)
10121032 C4591001 1012
10121032 16-55 12AUG2020 46512 Placebo 12AUG2020/
Placebo 31AUG2020/
Placebo 03FEB2021/
BNT162b2
(30 μg) 24FEB2021/
BNT162b2
(30 μg)
10121036 C4591001 1012
10121036 16-55 14AUG2020 46516 BNT162b2
(30 μg) 14AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg )
10121037 C4591001 1012
10121037 16-55 14AUG2020 51058 BNT162b2
(30 μg) 14AUG2020/
BNT162b2
(30 μg) 04SEP2020/
BNT162b2
(30 μg)
10131033 C4591001 1013
10131033 16-55 31JUL2020 40835 Placebo 31JUL2020/
Placebo 19AUG2020/
Placebo 26JAN2021/
BNT162 b2
(30 μg) 17FEB2021/
BNT162b2
(30 μg)
10131034 C4591001 1013
10131034 16-55 31JUL2020 40829 Placebo 31JUL2020/
Placebo 18AUG2020/
Placebo 25JAN2021/
BNT162b2
(30 μg) 15FEB2021/
BNT162b2
(30 μg)
10131035 C4591001 1013
10131035 16-55 31JUL2020 40833 BNT16 2b2
(30 μg) 31JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10131036 C4591001 1013
10131036 16-55 31JUL2020 40836 BNT162b2
(30 μg) 31JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 78
FDA-CBER-2021-5683-0035630
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10131038 C4591001 1013
10131038 16-55 31JUL2020 40842 Placebo 31JUL2020/
Placebo 19AUG2020/
Placebo 25JAN2021/
BNT162b2
(30 μg) 15FEB2021/
BNT162b2
(30 μg)
10131039 C4591001 101 3
10131039 16-55 31JUL2020 40848 BNT162b2
(30 μg) 31JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10131040 C4591001 1013
10131040 16-55 31JUL2020 40849 Placebo 31JUL2020/
Placebo 18AUG2020/
Placebo 20JAN2021/
BNT162b2
(30 μg) 11FEB2021/
BNT162b2
(30 μg)
10131042 C4591001 1013
10131042 16-55 31JUL2020 40851 BNT162b2
(30 μg) 31JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b 2
(30 μg)
10131044 C4591001 1013
10131044 16-55 31JUL2020 40937 BNT162b2
(30 μg) 31JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10131045 C4591001 1013
10131045 16-55 31JUL2020 40940 Placebo 31JUL2020/
Placebo 19AUG2020/
Placebo 20JAN2021 /
BNT162b2
(30 μg) 09FEB2021/
BNT162b2
(30 μg)
10131046 C4591001 1013
10131046 16-55 31JUL2020 40943 BNT162b2
(30 μg) 31JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10131047 C4591001 1013
10131047 16-55 31JUL2020 40942 Placebo 31JUL2020/
Placebo 20AUG2020/
Placebo 12FEB2021/
BNT162b2
(30 μg) 03MAR 2021/
BNT162b2
(30 μg)
10131048 C4591001 1013
10131048 16-55 31JUL2020 41000 BNT162b2
(30 μg) 31JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
10131049 C4591001 1013
10131049 16-55 31JUL 2020 41006 Placebo 31JUL2020/
Placebo 20AUG2020/
Placebo 22JAN2021/
BNT162b2
(30 μg) 11FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 79
FDA-CBER-2021-5683-0035631
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10131050 C4591001 1013
10131050 16-55 31JUL2020 41003 Placebo 31JUL2020/
Placebo 20AUG2020/
Placebo 22DEC2020/
BNT162b2
(30 μg) 12JAN2021/
BNT 162b2
(30 μg)
10131051 C4591001 1013
10131051 16-55 03AUG2020 41007 BNT162b2
(30 μg) 03AUG2020/
BNT162b2
(30 μg) 25AUG2020/
BNT162b2
(30 μg)
10131052 C4591001 1013
10131052 16-55 03AUG2020 41462 BNT162b2
(30 μg) 03AUG2020/
BNT162b2
(30 μg) 26AUG2020/
BNT162b2
(30 μg)
10131054 C4591001 1013
10131054 16-55 03AUG2020 41456 Placebo 03AUG2020/
Placebo 24AUG2020/
Placebo
10131055 C4591001 1013
10131055 16-55 03AUG2020 41455 BNT162b2
(30 μg) 03AUG2020/
BNT162b2
(30 μg) 24AUG2020/
BNT162b2
(30 μg)
10131056 C4591001 1013
10131056 16-55 03AUG2020 41463 Placebo 03AUG2020/
Placebo 26AUG2020/
Placebo 03FEB2021/
BNT162b2
(30 μg) 24FEB2021/
BNT162b2
(30 μg)
10131057 C4591001 1013
10131057 16-55 03AUG2020 41537 BNT162b2
(30 μg) 03AUG2020/
BNT162b2
(30 μg) 24AUG2020 /
BNT162b2
(30 μg)
10131058 C4591001 1013
10131058 16-55 03AUG2020 41542 Placebo 03AUG2020/
Placebo 24AUG2020/
Placebo 02MAR2021/
BNT162b2
(30 μg)
10131059 C4591001 1013
10131059 16-55 03AUG2020 41544 BNT162b2
(30 μg) 03AUG2020/
BNT162 b2
(30 μg) 25AUG2020/
BNT162b2
(30 μg)
10131060 C4591001 1013
10131060 16-55 03AUG2020 41547 Placebo 03AUG2020/
Placebo 24AUG2020/
Placebo 22FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 80
FDA-CBER-2021-5683-0035632
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10131062 C4591001 1013
10131062 16-55 04AUG2020 42203 BNT162b2
(30 μg) 04AUG2020/
BNT162b2
(30 μg) 24AUG2020/
BNT162b2
(30 μg)
10131063 C4591001 1013
10131063 16-55 04AUG2020 42114 BNT162b2
(30 μg) 04AUG2020/
BNT162b2
(30 μg) 26AUG2020/
BNT162b2
(30 μg)
10131064 C4591001 1013
10131064 16-55 04AUG2020 42205 Placebo 04AUG2020/
Placebo 24AUG2020/
Placebo
10131066 C4591001 1013
10131066 16-55 04AUG2020 42115 Placebo 04AUG2020/
Placebo 27AUG2020/
Placebo 15DEC2020/
BNT162b2
(30 μg) 05JAN2021/
BNT162b2
(30 μg)
10131067 C4591001 1013
10131067 16-55 04AUG2020 42119 BNT162b2
(30 μg) 04AUG2020/
BNT162b2
(30 μg) 26AUG2020/
BNT162b2
(30 μg)
10131068 C4591001 1013
10131068 16-55 04AUG2020 42116 Placebo 04AUG2020/
Placebo 26AUG2020/
Placebo 01FEB2021/
BNT162b2
(30 μg) 24FEB2021/
BNT162b2
(30 μg)
10131071 C45910 01 1013
10131071 16-55 04AUG2020 42206 Placebo 04AUG2020/
Placebo 25AUG2020/
Placebo 20JAN2021/
BNT162b2
(30 μg) 11FEB2021/
BNT162b2
(30 μg)
10131072 C4591001 1013
10131072 16-55 04AUG2020 42207 BNT162b2
(30 μg) 04AUG2020/
BNT162b2
(30 μg) 24AUG2020/
BNT162b2
(30 μg)
10131074 C4591001 1013
10131074 16-55 04AUG2020 42309 Placebo 04AUG2020/
Placebo 26AUG2020/
Placebo 25JAN2021/
BNT162b2
(30 μg) 15FEB2021/
BNT162b2
(30 μg)
10131076 C4591001 1013
10131076 16-55 04AUG2020 42305 Placebo 04AUG2020/
Placebo 25AUG2020/
Placebo
10131077 C4591001 1013
10131077 16-55 04AUG2020 42311 BNT162b2
(30 μg) 04AUG2020/
BNT162b2
(30 μg) 26AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 81
FDA-CBER-2021-5683-0035633
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10131078 C4591001 1013
10131078 16-55 04AUG2020 42314 BNT162b2
(30 μg) 04AUG2020/
BNT162b2
(30 μg) 25AUG2020/
BNT162b2
(30 μg)
10131079 C4591001 1013
10131079 16-55 04AUG2020 42473 Placebo 04AUG2020/
Placebo 25AUG2020/
Placebo 15JAN2021/
BNT162b2
(30 μg) 03FEB2021/
BNT162b2
(30 μg)
10131081 C4591001 1013
10131081 16-55 05AUG2020 42476 Placebo 05AUG2020/
Placebo 25AUG 2020/
Placebo 16FEB2021/
BNT162b2
(30 μg) 11MAR2021/
BNT162b2
(30 μg)
10131082 C4591001 1013
10131082 16-55 05AUG2020 42478 BNT162b2
(30 μg) 05AUG2020/
BNT162b2
(30 μg) 27AUG2020 /
BNT162b2
(30 μg)
10131083 C4591001 1013
10131083 16-55 05AUG2020 42484 BNT162b2
(30 μg) 05AUG2020/
BNT162b2
(30 μg) 26AUG2020/
BNT162b2
(30 μg)
10131084 C4591001 1013
10131084 16-55 05AUG2020 42812 BNT162b2
(30 μg) 05AUG2020/
BNT162b2
(30 μg) 26AUG2020/
BNT162b2
(30 μg)
10131087 C4591001 1013
10131087 16-55 06AUG20 20 42813 Placebo 06AUG2020/
Placebo 26AUG2020/
Placebo 18FEB2021/
BNT162b2
(30 μg)
10131089 C4591001 1013
10131089 16-55 06AUG2020 42820 Placebo 06AUG2020/
Placebo 27AUG2020/
Placebo 02FEB2021/
BNT162b2
(30 μg) 25FEB2021/
BNT162b2
(30 μg)
10131090 C459 1001 1013
10131090 16-55 06AUG2020 42815 BNT162b2
(30 μg) 06AUG2020/
BNT162b2
(30 μg) 27AUG2020/
BNT162b2
(30 μg)
10131093 C4591001 1013
10131093 16-55 06AUG2020 43639 Placebo 06AUG2020/
Placebo 27AUG2020/
Placebo 27JAN2021/
BNT162b2
(30 μg) 17FEB2021 /
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 82
FDA-CBER-2021-5683-0035634
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10131094 C4591001 1013
10131094 16-55 06AUG2020 43637 BNT162b2
(30 μg) 06AUG2020/
BNT162b2
(30 μg) 26AUG2020 /
BNT162b2
(30 μg)
10131098 C4591001 1013
10131098 16-55 06AUG2020 43645 BNT162b2
(30 μg) 06AUG2020/
BNT162b2
(30 μg) 26AUG 2020/
BNT162b2
(30 μg)
10131102 C4591001 1013
10131102 16-55 06AUG2020 43647 Placebo 06AUG2020/
Placebo 27AUG2020/
Placebo 22DEC2020/
BNT162b2
(30 μg) 12JAN2021/
BNT162b2
(30 μg)
10131103 C4591001 1013
10131103 16-55 06AUG2020 44014 BNT162b2
(30 μg) 06AUG2020/
BNT162b2
(30 μg) 27AUG2020/
BNT162b2
(30 μg)
10131105 C4591001 1013
10131105 16-55 10AUG2020 44017 Placebo 10AUG2020/
Placebo 31AUG2020/
Placebo 01FEB2021/
BNT162b2
(30 μg) 22FEB2021/
BNT162b2
(30 μg)
10131106 C4591001 1013
10131106 16-55 10AUG2020 44018 Placebo 10AUG2020/
Placebo 31AUG2020/
Placebo 18JAN2021/
BNT162b2
(30 μg) 08FEB2021/
BNT162b2
(30 μg)
10131107 C4591001 1013
10131107 16-55 10AUG2020 45343 BNT162b2
(30 μg) 10AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
10131 108 C4591001 1013
10131108 16-55 10AUG2020 44019 BNT162b2
(30 μg) 10AUG2020/
BNT162b2
(30 μg) 31AUG2020/
BNT162b2
(30 μg)
10131109 C4591001 1013
10131109 16-55 10AUG2020 45349 BNT162b2
(30 μg) 10AUG2020/
BNT162b2
(30 μg) 31AUG2020/
BNT162b2
(30 μg)
10131111 C4591001 1013
10131111 16-55 10AUG2020 45348 Placebo 10AUG2020/
Placebo 01SEP2020/
Placebo 28JAN2021/
BNT162b2
(30 μg) 18FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 83
FDA-CBER-2021-5683-0035635
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10131113 C4591001 1013
10131113 16-55 10AUG2020 45351 Placebo 10AUG2020/
Placebo 01SEP2020/
Placebo 23FEB2021/
BNT162b2
(30 μg)
10131115 C4591001 1013
10131115 16-55 10AUG2020 45534 BNT162b2
(30 μg) 10AUG2020/
BNT162b2
(30 μg) 31AUG2020/
BNT162b2
(30 μg)
10131116 C4591001 1013
10131116 16-55 10AUG2020 45533 Placebo 10AUG2020/
Placebo 02SEP202 0/
Placebo
10131117 C4591001 1013
10131117 16-55 10AUG2020 45542 BNT162b2
(30 μg) 10AUG2020/
BNT162b2
(30 μg) 31AUG2020/
BNT162b2
(30 μg)
10131118 C4591001 1013
10131118 16-55 10AUG2020 45541 Placebo 10AUG2020/
Placebo 31AUG2020/
Placebo 28JAN202 1/
BNT162b2
(30 μg) 03MAR2021/
BNT162b2
(30 μg)
10131119 C4591001 1013
10131119 16-55 10AUG2020 45606 Placebo 10AUG2020/
Placebo 01SEP2020/
Placebo 21JAN2021/
BNT162b2
(30 μg) 10FEB2021/
BNT162b2
(30 μg)
10131120 C4591001 1013
10131120 16-55 10AUG2020 45607 BNT162b2
(30 μg) 10AUG2020/
BNT162b2
(30 μg) 31AUG2020/
BNT162b2
(30 μg)
10131121 C4591001 1013
10131121 16-55 10AUG2020 45611 BNT162b2
(30 μg) 10AUG2020/
BNT162b2
(30 μg) 31AUG2020/
BNT162b2
(30 μg)
10131122 C4591001 1013
10131122 16-55 10AU G2020 45614 Placebo 10AUG2020/
Placebo 31AUG2020/
Placebo 22FEB2021/
BNT162b2
(30 μg)
10131124 C4591001 1013
10131124 16-55 11AUG2020 46088 BNT162b2
(30 μg) 11AUG2020/
BNT162b2
(30 μg) 01SEP2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 84
FDA-CBER-2021-5683-0035636
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10131125 C4591001 1013
10131125 16-55 11AUG2020 46085 BNT162b2
(30 μg) 11AUG2020/
BNT162b2
(30 μg) 01SEP2020/
BNT162b2
(30 μg)
10131126 C4591001 1013
10131126 16-55 11AUG2020 46090 Placebo 11AUG2020/
Placebo 01SEP2020/
Placebo 25JAN2021/
BNT162b2
(30 μg) 15FEB2021/
BNT162b2
(30 μg)
10131127 C4591001 1013
10131127 16-55 11AUG2020 46092 Placebo 11AUG2020/
Placebo 02SEP2020/
Placebo 21DEC2020/
BNT162b2
(30 μg) 11JAN2021/
BNT162b2
(30 μg)
10131128 C4591001 1013
10131128 16-55 11AUG2020 46146 Placebo 11AUG202 0/
Placebo 02SEP2020/
Placebo 18JAN2021/
BNT162b2
(30 μg) 10FEB2021/
BNT162b2
(30 μg)
10131131 C4591001 1013
10131131 16-55 11AUG2020 46148 BNT162b2
(30 μg) 11AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
10131132 C4591001 1013
10131132 16-55 11AUG2020 46147 Placebo 11AUG2 020/
Placebo 03SEP2020/
Placebo 25JAN2021/
BNT162b2
(30 μg) 15FEB2021/
BNT162b2
(30 μg)
10131135 C4591001 1013
10131135 16-55 11AUG2020 46154 BNT162b2
(30 μg) 11AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
10131136 C4591001 1013
10131136 16-55 11AUG2020 46459 BNT162b2
(30 μg) 11AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
10131137 C4591001 1013
10131137 16-55 11AUG2020 46460 Placebo 11AUG2020/
Placebo 01SEP2020/
Placebo
10131138 C4591001 1013
10131138 16-55 11AUG2020 46461 BNT162b2
(30 μg) 11AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 85
FDA-CBER-2021-5683-0035637
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10131139 C4591001 1013
10131139 16-55 11AUG2020 46465 Placebo 11AUG2020/
Placebo 01SEP2020/
Placebo 01MAR2021/
BNT162b2
(30 μg)
10131143 C4591001 1013
10131143 16-55 12AUG2020 47033 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
10131145 C4591001 1013
10131145 16-55 12AUG2020 47035 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 03SEP 2020/
BNT162b2
(30 μg)
10131146 C4591001 1013
10131146 16-55 12AUG2020 47129 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
10131147 C4591001 1013
10131147 16-55 12AUG2020 47130 Placebo 12AUG2020/
Placebo 03SEP2020/
Placebo 29JAN2021/
BNT162b2
(30 μg) 18FEB2021/
BNT162b2
(30 μg)
10131148 C4591001 1013
10131148 16-55 12AUG2020 47036 Placebo 12AUG2020/
Placebo 02SEP2020/
Placebo 21JAN2021/
BNT162b2
(30 μg) 11FEB2021/
BNT162b2
(30 μg)
10131149 C4591001 1013
10131149 16-55 12AUG2020 47039 Placebo 12AUG2020/
Placebo 03SEP2020/
Placebo 18JAN2021/
BNT162b2
(30 μg) 08FEB2021/
BNT162b2
(30 μg)
10131155 C4591001 1013
10131155 16-55 12AUG2020 47134 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
10131156 C4591001 1013
10131156 16-55 12AUG2020 47132 Placebo 12AUG2020/
Placebo 03SEP2020/
Placeb o 22FEB2021/
BNT162b2
(30 μg)
10131158 C4591001 1013
10131158 16-55 12AUG2020 47347 Placebo 12AUG2020/
Placebo 03SEP2020/
Placebo 21JAN2021/
BNT162b2
(30 μg) 11FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 86
FDA-CBER-2021-5683-0035638
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10131159 C4591001 1013
10131159 16-55 12AUG2020 47349 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
10131163 C4591001 1013
10131163 16-55 13AUG2020 47355 Placebo 13AUG2020/
Placebo 03SEP2020/
Placebo 23FEB2021/
BNT162b2
(30 μg)
10131165 C4591001 1013
10131165 16-55 13AUG2020 48413 BNT16 2b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
10131166 C4591001 1013
10131166 16-55 13AUG2020 48419 Placebo 13AUG2020/
Placebo 03SEP2020/
Placebo 16FEB2021/
BNT162b2
(30 μg) 09MAR2021/
BNT162b2
(30 μg)
10131167 C4591001 1013
10131167 16-55 13AUG2020 48415 Placebo 13AUG2020/
Placebo 03SEP2020/
Placebo 16FEB2021/
BNT162b2
(30 μg) 09MAR2021/
BNT162b2
(30 μg)
10131169 C4591001 1013
10131169 16-55 13AUG2020 48420 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg )
10131171 C4591001 1013
10131171 16-55 13AUG2020 48549 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
10131172 C4591001 1013
10131172 16-55 13AUG2020 48552 Placebo 13AUG2020/
Placebo 03SEP2020/
Placebo 29JAN2021/
BNT162 b2
(30 μg) 18FEB2021/
BNT162b2
(30 μg)
10131173 C4591001 1013
10131173 16-55 13AUG2020 48555 Placebo 13AUG2020/
Placebo 01SEP2020/
Placebo 21JAN2021/
BNT162b2
(30 μg) 09FEB2021/
BNT162b2
(30 μg)
10131174 C4591001 1013
10131174 16-55 13AUG2020 48556 BNT16 2b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 87
FDA-CBER-2021-5683-0035639
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10131177 C4591001 1013
10131177 16-55 13AUG2020 48718 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 01SEP2020/
BNT162b2
(30 μg)
10131179 C4591001 1013
10131179 16-55 13AUG2020 48716 Placebo 13AUG2020/
Placebo 02SEP2020/
Placebo 04FEB2021/
BNT162b2
(30 μg) 24FEB2021/
BNT162b2
(30 μg)
10131180 C4591001 1013
10131180 16-55 13AUG2020 48722 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
10131182 C4591001 1013
10131182 16-55 13AUG2020 48717 Placebo 13AUG2020/
Placebo 03SEP2020/
Placebo 25FEB2021/
BNT162b2
(30 μg)
10131185 C4591001 1013
10131185 16-55 13AUG2020 49013 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
10151001 C4591001 1015
10151001 16-55 10AUG2020 45329 BNT162b2
(30 μg) 10AUG2020/
BNT162b2
(30 μg) 31AUG2020/
BNT162b2
(30 μg)
10151005 C4591001 1015
10151005 16-55 12AUG2020 45331 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
10151006 C4591001 1015
10151006 16-55 12AUG2020 45333 Placebo 12AUG2020/
Placebo 03SEP2020/
Placebo 28JAN2021/
BNT162b2
(30 μg) 16FEB2021/
BNT162b2
(30 μg)
10151009 C4591001 1015
10151009 16-55 13AUG2020 45339 Placebo 13AUG2020/
Placebo 03SEP2020/
Placebo 17DEC2020/
BNT162b2
(30 μg) 07JAN2021/
BNT162b2
(30 μg)
10151010 C4591001 1015
10151010 16-55 13AUG2020 48846 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 88
FDA-CBER-2021-5683-0035640
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10151011 C4591001 1015
10151011 16-55 13AUG2020 48847 Placebo 13AUG20 20/
Placebo 03SEP2020/
Placebo 28JAN2021/
BNT162b2
(30 μg) 18FEB2021/
BNT162b2
(30 μg)
10151013 C4591001 1015
10151013 16-55 13AUG2020 48853 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
10151 014 C4591001 1015
10151014 16-55 13AUG2020 48856 Placebo 13AUG2020/
Placebo 02SEP2020/
Placebo 26JAN2021/
BNT162b2
(30 μg) 18FEB2021/
BNT162b2
(30 μg)
10151015 C4591001 1015
10151015 16-55 14AUG2020 49890 BNT162b2
(30 μg) 14AUG2020/
BNT162b2
(30 μg) 04SEP2020/
BNT162b2
(30 μg)
10151017 C4591001 1015
10151017 16-55 14AUG2020 49892 Placebo 14AUG2020/
Placebo 04SEP2020/
Placebo
10151018 C4591001 1015
10151018 16-55 14AUG2020 49895 Placebo 14AUG2020/
Placebo 04SEP2020/
Placebo 16DEC2020/
BNT162b2
(30 μg) 06JAN2021/
BNT162b2
(30 μg )
10151021 C4591001 1015
10151021 16-55 14AUG2020 50793 Placebo 14AUG2020/
Placebo 02SEP2020/
Placebo 21DEC2020/
BNT162b2
(30 μg) 11JAN2021/
BNT162b2
(30 μg)
10151023 C4591001 1015
10151023 16-55 14AUG2020 50790 BNT162b2
(30 μg) 14AUG2020/
BNT162b2
(30 μ g) 03SEP2020/
BNT162b2
(30 μg)
10151026 C4591001 1015
10151026 16-55 15AUG2020 50800 Placebo 15AUG2020/
Placebo 03SEP2020/
Placebo 05JAN2021/
BNT162b2
(30 μg) 25JAN 2021/
BNT162b2
(30 μg)
10151027 C4591001 1015
10151027 16-55 15AUG2020 51187 BNT162b2
(30 μg) 15AUG2020/
BNT162b2
(30 μg) 04SEP2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 89
FDA-CBER-2021-5683-0035641
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10161017 C4591001 1016
10161017 16-55 31JUL2020 40441 Placebo 31JUL2020/
Placebo 20AUG2020/
Placebo 03FEB2021/
BNT162b2
(30 μg) 24FEB2021/
BNT162b2
(30 μg)
10161018 C4591001 1016
1016101 8 16-55 31JUL2020 40901 Placebo 31JUL2020/
Placebo 20AUG2020/
Placebo 18DEC2020/
BNT162b2
(30 μg) 07JAN2021/
BNT162b2
(30 μg)
10161019 C4591001 1016
10161019 16-55 31JUL2020 40909 BNT162b2
(30 μg) 31JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
10161020 C4591001 1016
10161020 16-55 31JUL2020 40908 BNT162b2
(30 μg) 31JUL2020/
BNT162b2
(30 μg) 19AUG2020/
BNT162b2
(30 μg)
10161021 C4591001 1016
10161021 16-55 31JUL2020 40912 Placebo 31JUL2020/
Placebo 20AUG2020/
Placebo 18DEC2020/
BNT162b2
(30 μg) 07JAN2021/
BNT162b2
(30 μg)
10161028 C4591001 1016
10161028 16-55 03AUG2020 41590 BNT162b2
(30 μg) 03AUG2020/
BNT162b2
(30 μg) 08SEP2020/
BNT162b2
(30 μg)
10161029 C4591001 1016
10161029 16-55 03AUG2020 41592 BNT162b2
(30 μg) 03AUG2020/
BNT162 b2
(30 μg) 26AUG2020/
BNT162b2
(30 μg)
10161030 C4591001 1016
10161030 16-55 03AUG2020 41587 Placebo 03AUG2020/
Placebo 25AUG2020/
Placebo 15DEC2020/
BNT162b2
(30 μg) 06JAN2021/
BNT162b2
(30 μg)
10161031 C4591001 1016
10161031 16-55 03AUG2020 41594 Placebo 03AUG2020/
Placebo 24AUG2020/
Placebo 20JAN2021/
BNT162b2
(30 μg) 12FEB2021/
BNT162b2
(30 μg)
10161038 C4591001 1016
10161038 16-55 04AUG2020 42174 BNT162b2
(30 μg) 04AUG2020/
BNT162b2
(30 μg) 25AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 90
FDA-CBER-2021-5683-0035642
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10161043 C4591001 1016
10161043 16-55 04AUG2020 42176 Placebo 04AUG2020/
Placebo 25AUG2020/
Placebo 03FEB2021/
BNT162b2
(30 μg) 22FEB2021/
BNT162b2
(30 μg)
10161045 C4591001 1016
10161045 16-55 04AUG2020 42182 BNT162b2
(30 μg) 04AUG2020/
BNT162b2
(30 μg) 27AUG2020/
BNT162b2
(30 μg)
10161046 C4591001 1016
10161046 16-55 04AUG2020 42184 Placebo 04AUG2020/
Placebo 28AUG2020/
Placebo 23DEC2020/
BNT162b2
(30 μg) 13JAN2021/
BNT162b2
(30 μg)
10161047 C4591001 1016
10161047 16-55 04AUG2020 42612 BNT162b2
(30 μg) 04AUG2020/
BNT162 b2
(30 μg)
10161048 C4591001 1016
10161048 16-55 04AUG2020 42614 Placebo 04AUG2020/
Placebo 24AUG2020/
Placebo 06JAN2021/
BNT162b2
(30 μg) 26JAN2021/
BNT162b2
(30 μg)
10161049 C4591001 1016
10161049 16-55 04AUG2020 42615 BNT162b2
(30 μg) 04AUG2020/
BNT162b2
(30 μg) 24AUG2020/
BNT162b2
(30 μg)
10161051 C4591001 1016
10161051 16-55 05AUG2020 42616 Placebo 05AUG2020/
Placebo 26AUG2020/
Placebo 28DEC2020/
BNT162b2
(30 μg) 20JAN2021/
BNT162b2
(30 μg)
10161054 C4591001 1016
10161054 16-55 05AUG2020 42823 BNT162b2
(30 μg) 05AUG2020/
BNT162b2
(30 μg) 25AUG2020/
BNT162b2
(30 μg)
10161057 C4591001 1016
10161057 16-55 05AUG2020 42824 Placebo 05AUG2020/
Placebo 27AUG2020/
Placebo 28DEC2020/
BNT162b2
(30 μg) 18JAN2021/
BNT162b2
(30 μg)
10161058 C45910 01 1016
10161058 16-55 05AUG2020 42828 Placebo 05AU G2020/
Placebo 25AUG2020/
Placebo
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 91
FDA-CBER-2021-5683-0035643
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10161060 C4591001 1016
10161060 16-55 06AUG2020 43553 Placebo 06AUG2020/
Placebo 27AUG2020/
Placebo 17DEC2020/
BNT162b2
(30 μg) 06JAN2021/
BNT162b2
(30 μg)
10161064 C4591001 1016
10161064 16-55 06AUG2020 43554 BNT162b2
(30 μg) 06AUG2020/
BNT162b2
(30 μg) 25AUG2020/
BNT162b2
(30 μg)
10161065 C4591001 1016
10161065 16-55 06AUG2020 43561 Placebo 06AUG2020/
Placebo 27AUG2020/
Placebo 29JAN2021/
BNT162b2
(30 μg) 19FEB 2021/
BNT162b2
(30 μg)
10161069 C4591001 1016
10161069 16-55 06AUG2020 43562 BNT162b2
(30 μg) 06AUG2020/
BNT162b2
(30 μg) 26AUG2020/
BNT162b2
(30 μg)
10161071 C4591001 1016
10161071 16-55 06AUG2020 44022 BNT162b2
(30 μg) 06AUG2020/
BNT162b2
(30 μg) 28AUG2020/
BNT162b2
(30 μg)
10161073 C4591001 1016
10161073 16-55 06AUG2020 44023 BNT162b2
(30 μg) 06AUG2020/
BNT162b2
(30 μg) 28AUG2020/
BNT162b2
(30 μg)
10161076 C4591001 1016
10161076 16-55 06AUG2020 44025 Placebo 06AUG2020/
Placebo 28AUG2020/
Placebo 02FEB2021/
BNT162b2
(30 μg) 24FEB2021/
BNT162b2
(30 μg)
10161077 C4591001 1016
10161077 16-55 07AUG2020 44028 Placebo 07AUG2020/
Placebo 28AUG2020/
Placebo 17DEC2020/
BNT162b2
(30 μg) 08JAN2021/
BNT162b2
(30 μg)
10161078 C4591001 1016
10161078 16-55 07AUG2020 44280 BNT162b2
(30 μg) 07AUG2020/
BNT162b2
(30 μg) 28AUG2020/
BNT162b2
(30 μg)
10161080 C4591001 1016
10161080 16-55 07AUG2020 44282 BNT162b2
(30 μg) 07AUG2020/
BNT162b2
(30 μg) 27AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
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16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10161081 C4591001 1016
10161081 16-55 07AUG2020 44281 Placebo 07AUG2020/
Placebo 28AUG2020/
Placebo 15JAN2021/
BNT162b2
(30 μg) 05FEB2021/
BNT162b2
(30 μg)
10161082 C4591001 1016
10161082 16-55 07AUG2020 44283 Placebo 07AUG2020/
Placebo 28AUG2020/
Placebo 17DEC2020/
BNT162b2
(30 μ g) 05JAN2021/
BNT162b2
(30 μg)
10161084 C4591001 1016
10161084 16-55 07AUG2020 44491 BNT162b2
(30 μg) 07AUG2020/
BNT162b2
(30 μg) 26AUG2020/
BNT162b2
(30 μg)
10161085 C4591001 1016
10161085 16-55 10AUG2020 44492 Placebo 10AUG2020/
Placebo 31AUG2020/
Placebo 28DEC2020/
BNT162b2
(30 μg) 18JAN2021/
BNT162b2
(30 μg)
10161087 C4591001 1016
10161087 16-55 10AUG2020 44493 BNT162b2
(30 μg) 10AUG2020/
BNT162b2
(30 μg)
10161091 C4591001 1016
10161091 16-55 10AUG2020 44495 Placebo 10AUG2020/
Placebo 31AU G2020/
Placebo
10161092 C4591001 1016
10161092 16-55 10AUG2020 45455 Placebo 10AUG2020/
Placebo 01SEP2020/
Placebo 18DEC2020/
BNT162b2
(30 μg) 08JAN2021/
BNT162b2
(30 μg)
10161093 C4591001 1016
10161093 16-55 11AUG2020 45457 BNT162b2
(30 μg) 11AUG202 0/
BNT162b2
(30 μg) 01SEP2020/
BNT162b2
(30 μg)
10161094 C4591001 1016
10161094 16-55 11AUG2020 45460 BNT162b2
(30 μg) 11AUG2020/
BNT162b2
(30 μg) 31AUG2020/
BNT162b2
(30 μg)
10161095 C4591001 1016
10161095 16-55 11AUG2020 45458 Placebo 11AUG2020 /
Placebo 01SEP2020/
Placebo 01FEB2021/
BNT162b2
(30 μg) 22FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
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16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10161097 C4591001 1016
10161097 16-55 11AUG2020 46229 Placebo 11AUG2020/
Placebo 02SEP2020/
Placebo 18DEC2020/
BNT162b2
(30 μg) 07JAN2021/
BNT162b2
(30 μg)
10161101 C459 1001 1016
10161101 16-55 11AUG2020 46230 BNT162b2
(30 μg) 11AUG2020/
BNT162b2
(30 μg) 31AUG2020/
BNT162b2
(30 μg)
10161102 C4591001 1016
10161102 16-55 12AUG2020 46234 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 02SEP2020/
BNT162b2
(30 μg)
10161 103 C4591001 1016
10161103 16-55 12AUG2020 46237 Placebo 12AUG2020/
Placebo 02SEP2020/
Placebo 23DEC2020/
BNT162b2
(30 μg) 13JAN2021/
BNT162b2
(30 μg)
10161105 C4591001 1016
10161105 16-55 12AUG2020 47441 Placebo 12AUG2020/
Placebo 01SEP2020/
Placebo 21JA N2021/
BNT162b2
(30 μg) 10FEB2021/
BNT162b2
(30 μg)
10161106 C4591001 1016
10161106 16-55 12AUG2020 47442 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μ g) 03SEP2020/
BNT162b2
(30 μg)
10161107 C4591001 1016
10161107 16-55 12AUG2020 47444 BNT162b2
(30 μg) 12AUG2020/
BNT162b2
(30 μg) 01SEP2020/
BNT162b2
(30 μg)
10161109 C4591001 1016
10161109 16-55 12AUG2020 47448 Placebo 12AUG2020/
Placebo 03SEP2020/
Placebo 01FEB2021/
BNT162b2
(30 μg) 23FEB2021/
BNT162b2
(30 μg)
10161114 C4591001 1016
10161114 16-55 13AUG2020 48605 BNT162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
10161117 C4591001 1016
10161117 16-55 13AUG2020 48606 Placebo 13AUG2020/
Placebo 02SEP2020/
Placebo
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
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16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10161118 C4591001 1016
10161118 16-55 13AUG2020 48607 BNT 162b2
(30 μg) 13AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
10161119 C4591001 1016
10161119 16-55 14AUG2020 48615 Placebo 14AUG 2020/
Placebo 02SEP2020/
Placebo 19JAN2021/
BNT162b2
(30 μg) 08FEB2021/
BNT162b2
(30 μg)
10161120 C4591001 1016
10161120 16-55 14AUG2020 50034 Placebo 14AUG2020/
Placebo 04SEP2020/
Placebo 23DEC2020/
BNT162b2
(30 μg) 11JAN2021/
BNT162b2
(30 μg)
10161122 C4591001 1016
10161122 16-55 14AUG2020 50036 BNT162b2
(30 μg) 14AUG2020/
BNT162b2
(30 μg) 03SEP2020/
BNT162b2
(30 μg)
10161123 C4591001 1016
10161123 16-55 14AUG2020 50038 Placebo 14AUG2020/
Placebo 03SEP2020/
Placebo 19JAN2021/
BNT162b2
(30 μg) 09FEB2021/
BNT162b2
(30 μg)
10161125 C4591001 1016
10161125 16-55 14AUG2020 50042 BNT162b2
(30 μg) 14AUG2020/
BNT162b2
(30 μg) 04SEP2020/
BNT162b2
(30 μg)
10181009 C4591001 1018
10181009 16-55 30JUL2020 40200 Placebo 30JUL2020/
Placebo 22AUG2020/
Placebo
10181010 C4591001 1018
10181010 16-55 30JUL2020 40781 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 18JAN2021 /
BNT162b2
(30 μg) 08FEB2021/
BNT162b2
(30 μg)
10181011 C4591001 1018
10181011 16-55 30JUL2020 40783 BNT162b2
(30 μg) 30JUL2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
10181012 C4591001 1018
10181012 16-55 30JUL2020 40790 BNT162b2
(30 μg) 30JUL 2020/
BNT162b2
(30 μg) 20AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
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16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10181013 C4591001 1018
10181013 16-55 30JUL202 0 40792 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 16JAN2021/
BNT162b2
(30 μg) 04FEB2021/
BNT162b2
(30 μg)
10181014 C4591001 1018
10181014 16-55 30JUL 2020 40799 Placebo 30JUL2020/
Placebo 20AUG2020/
Placebo 11JAN2021/
BNT162b2
(30 μg) 02FEB2021/
BNT162b2
(30 μg)
10181015 C4591001 1018
10181015 16-55 31JUL2020 40800 BNT162b2
(30 μg) 31JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
10181016 C4591001 1018
10181016 16-55 31JUL2020 41014 Placebo 31JUL2020/
Placebo 21AUG2020/
Placebo 09JAN2021/
BNT162b2
(30 μg) 29JAN2021/
BNT162b2
(30 μg)
10181017 C4591001 1018
10181017 16-55 31JUL2020 40804 Placebo 31JUL2020/
Placebo 22AUG2020/
Placebo 18JAN2021 /
BNT162b2
(30 μg) 11MAR2021/
BNT162b2
(30 μg)
10181018 C4591001 1018
10181018 16-55 31JUL2020 40802 BNT162b2
(30 μg) 31JUL2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
10181019 C4591001 1018
10181019 16-55 31JUL2020 41010 BNT162b2
(30 μg) 31JUL 2020/
BNT162b2
(30 μg) 21AUG2020/
BNT162b2
(30 μg)
10181020 C4591001 1018
10181020 16-55 31JUL2020 41015 Placebo 31JUL2020/
Placebo 21AUG2020/
Placebo 18JAN2021/
BNT162b2
(30 μg) 08FEB2021/
BNT162b2
(30 μg)
10181021 C4591001 1018
10181021 16-55 31JUL 2020 41013 BNT162b2
(30 μg) 31JUL2020/
BNT162b2
(30 μ g) 21AUG2020/
BNT162b2
(30 μg)
10181022 C4591001 1018
10181022 16-55 31JUL2020 41117 Placebo 31JUL2020/
Placebo 21AUG2020/
Placebo 15JAN2021/
BNT162b2
(30 μg) 04FEB2021/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
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16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vacci ne Group Date/
Dose 1 Date/
Dose 2 Date/
Dose 3 Date/
Dose 4
10181024 C4591001 1018
10181024 16-55 03AUG2020 41121 BNT162b2
(30 μg) 03AUG2020/
BNT162b2
(30 μg) 22AUG2020/
BNT162b2
(30 μg)
10181025 C4591001 1018
10181025 16-55 03AUG2020 41125 BNT162b2
(30 μg) 03AUG2020/
BNT162b2
(30 μg)
10181026 C4591001 1018
10181 026 16-55 03AUG2020 41694 BNT162b2
(30 μg) 03AUG2020/
BNT162b2
(30 μg) 24AUG2020/
BNT162b2
(30 μg)
10181027 C4591001 1018
10181027 16-55 03AUG2020 41127 Placebo 03AUG2020/
Placebo 24AUG2020/
Placebo
10181028 C4591001 1018
10181028 16-55 03AUG2020 41765 BNT162b2
(30 μg) 03AUG2020/
BNT162b2
(30 μg) 23SEP2020/
BNT162b2
(30 μg)
10181029 C4591001 1018
10181029 16-55 03AUG2020 41701 BNT162b2
(30 μg) 03AUG2020/
BNT162b2
(30 μg) 24AUG2020/
BNT162b2
(30 μg)
10181030 C4591001 1018
10181030 16-55 03AUG2020 41695 Placebo 03AUG2020/
Placebo 22AUG2020/
Placebo 19JAN2021/
BNT162b2
(30 μg) 09FEB2021/
BNT162b2
(30 μg)
10181031 C4591001 1018
10181031 16-55 03AUG2020 41766 Placebo 03AUG2020/
Placebo 24AUG2020/
Placebo 19JAN2021/
BNT162b2
(30 μg) 09FEB2021/
BNT162b2
(30 μg)
10181032 C4591001 1018
10181032 16-55 03AUG2020 41702 Placebo 03AUG2020/
Placebo 24AUG2020/
Placebo
10181033 C4591001 1018
10181033 16-55 03AUG2020 41768 Placebo 03AUG2020/
Placebo 24AUG2020/
Placebo 12FEB2021/
BNT162b2
(30 μg) 05MA R2021/
BNT162b2
(30 μg)
10181034 C4591001 1018
10181034 16-55 03AUG2020 41776 BNT162b2
(30 μg) 03AUG2020/
BNT162b2
(30 μg) 24AUG2020/
BNT162b2
(30 μg)
090177e196af7307\Final\Final On: 01-Apr-2021 13:56 (GMT)
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16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e
Vaccine Received
…[truncated]