Document text
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – Phase 1, 2 Doses, 21 Days Apar t
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date Dose 1 Date Dose 2
10011004 C4591001 1001
10011004 18-55 04MAY2020 1084 BNT162b1
(10 μg) 04MAY2020 BNT162b1
(10 μg) 26MAY2020 BNT162b1
(10 μg)
10011005 C4591001 1001
10011005 18-55 06MAY2020 1093 Placebo 06MAY2020 Placebo 26MAY2020 Placebo
10011006 C4591001 1001
10011006 18-55 06MAY2020 1090 BNT162b1
(10 μg) 06MAY2020 BNT162b1
(10 μg) 27MAY2020 BNT162b1
(10 μg)
10011007 C4591001 1001
10011007 18-55 06MAY2020 1092 BNT162b1
(10 μg) 06MAY2020 BNT162b1
(10 μg) 28MAY2020 BNT162b1
(10 μg)
10011008 C4591001 1001
10011008 18-55 06MAY2020 1094 BNT162b1
(10 μg) 06MAY2020 BNT162b1
(10 μg) 27MAY2020 BNT162b1
(10 μg)
10011009 C4591001 1001
10011009 18-55 06MAY2020 1095 BNT162b1
(10 μg) 06MAY2020 BNT162b1
(10 μg) 27MAY2020 BNT162b1
(10 μg)
10011011 C4591001 1001
10011011 18-55 11MAY2020 1220 BNT162b1
(30 μg) 11MAY2020 BNT162b1
(30 μg) 01JUN2020 BNT162b1
(30 μg)
10011012 C4591001 1001
10011012 18-55 13MAY2020 1230 BNT162b1
(30 μg) 13MAY2020 BNT162b1
(30 μg) 03JUN2020 BNT162b1
(30 μg)
10011015 C4591001 1001
10011015 18-55 11MAY2020 1219 BNT162b1
(30 μg) 11MAY2020 BNT162b1
(30 μg) 01JUN2020 BNT162b1
(30 μg)
100110 17 C4591001 1001
10011017 18-55 13MAY2020 1228 BNT162b1
(30 μg) 13MAY2020 BNT162b1
(30 μg) 03JUN2020 BNT162b1
(30 μg)
10011019 C4591001 1001
10011019 18-55 13MAY2020 1229 BNT162b1
(30 μg) 13MAY2020 BNT162b1
(30 μg) 03JUN2020 BNT162b1
(30 μg)
10011020 C4591001 1001
10011020 18-55 13MAY2020 1226 BNT162b1
(30 μg) 13MAY2020 BNT162b1
(30 μg) 03JUN2020 BNT162b1
(30 μg)
10011024 C4591001 1001
10011024 18-55 13MAY2020 1225 BNT162b1
(30 μg) 13MAY2020 BNT162b1
(30 μg) 03JUN2020 BNT162b1
(30 μg)
10011037 C4591001 1001
10011037 65-85 11JUN2020 1631 BNT162b1
(10 μg) 11JUN2020 BNT162b1
(10 μg) 30JUN2020 BNT162b1
(10 μg)
090177e194d7854d\Final\Final On: 07-Sep-2020 03:51 (GMT)
Page 1
FDA-CBER-2021-5683-0024763
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – Phase 1, 2 Doses, 21 Days Apar t
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date Dose 1 Date Dose 2
10011039 C4591001 1001
10011039 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 1001
10011041 65-85 11JUN2020 1632 BNT162b1
(10 μg) 11JUN2020 BNT162b1
(10 μg) 02JUL2020 BNT162b1
(10 μg)
10011042 C4591001 1001
10011042 65-85 11JUN2020 1634 Placebo 11JUN2020 Placebo 30JUN2020 Placebo
10011043 C4591001 1001
10011043 65-85 15JUN2020 2029 BNT162b1
(20 μg) 15JUN2020 BNT162b1
(20 μg) 08JUL2020 BNT162b1
(20 μg)
10011044 C4591001 1001
10011044 65-85 09JUN2020 1625 BNT162b1
(10 μg) 09JUN2020 BNT162b1
(10 μg) 29JUN2020 BNT162b1
(10 μg)
10011045 C4591001 1001
10011045 65-85 11JUN2020 1633 BNT162b1
(10 μg) 11JUN2020 BNT162b1
(10 μg) 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 C4591001 1001
10011050 65-85 17JUN2020 2031 BNT162b1
(20 μg) 17JUN2020 BNT162b1
(20 μg) 07JUL2020 BNT162b1
(20 μg)
100110 52 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)
090177e194d7854d\Final\Final On: 07-Sep-2020 03:51 (GMT)
Page 2
FDA-CBER-2021-5683-0024764
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – Phase 1, 2 Doses, 21 Days Apar t
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date Dose 1 Date Dose 2
10011057 C4591001 1001
10011057 65-85 17JUN2020 2038 Placebo 17JUN2020 Placebo 08JUL2020 Placebo
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
10011066 C4591001 1001
10011066 18-55 29JUN2020 1489 Placebo 29JUN2020 Placebo 20JUL2020 Placebo
10011067 C4591001 1001
10011067 18-55 01JUL2020 1499 BNT162b1
(20 μg) 01JUL2020 BNT162b1
(20 μg) 22JUL2020 BNT162b1
(20 μg)
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
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 BNT162b1
(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)
090177e194d7854d\Final\Final On: 07-Sep-2020 03:51 (GMT)
Page 3
FDA-CBER-2021-5683-0024765
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – Phase 1, 2 Doses, 21 Days Apar t
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date Dose 1 Date Dose 2
10021004 C4591001 1002
10021004 18-55 04MAY2020 1082 BNT162b1
(10 μg) 04MAY2020 BNT162b1
(10 μg) 26MAY2020 BNT162b1
(10 μg)
10021005 C4591001 1002
10021005 18-55 04MAY2020 1083 Placebo 04MAY2020 Placebo 26MAY2020 Placebo
10021006 C4591001 1002
10021006 18-55 11MAY2020 1218 BNT162b1
(30 μg) 11MAY2020 BNT162b1
(30 μg) 02JUN2020 BNT162b1
(30 μg)
10021007 C4591001 1002
10021007 18-55 06MAY2020 1089 BNT162b1
(10 μg) 06MAY2020 BNT162b1
(10 μg) 26MAY2020 BNT162b1
(10 μg)
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 BNT162 b1
(10 μg)
10021011 C4591001 1002
10021011 18-55 06MAY2020 1086 BNT162b1
(10 μg) 06MAY2020 BNT162b1
(10 μg) 26MAY2020 BNT162b1
(10 μg)
10021012 C4591001 1002
10021012 18-55 05MAY2020 1085 BNT162b1
(10 μg) 05MAY2020 BNT162b1
(10 μg) 26MAY2020 BNT162b1
(10 μg)
10021013 C4591001 1002
10021013 18-55 06MAY2020 1087 BNT162b1
(10 μg) 06MAY2020 BNT162b1
(10 μg) 26MAY2020 BNT162b1
(10 μg)
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)
10021018 C4591001 1002
10021018 18-55 11MAY2020 1217 Placebo 11MAY2020 Placebo 02JUN2020 Placebo
10021020 C4591001 1002
10021020 18-55 13MAY2020 1222 BNT162b1
(30 μg) 13MAY2020 BNT162b1
(30 μg) 02JUN2020 BNT162b1
(30 μg)
090177e194d7854d\Final\Final On: 07-Sep-2020 03:51 (GMT)
Page 4
FDA-CBER-2021-5683-0024766
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – Phase 1, 2 Doses, 21 Days Apar t
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date Dose 1 Date Dose 2
10021021 C4591001 1002
10021021 18-55 13MAY2020 1223 Placebo 13MAY2020 Placebo 02JUN2020 Placebo
10021022 C4591001 1002
10021022 18-55 13MAY2020 1227 Placebo 13MAY2020 Placebo 02JUN2020 Placebo
10021042 C4591001 1002
10021042 65-85 09JUN2020 1623 Placebo 09JUN2020 Placebo 30JUN2020 Placebo
10021043 C4591001 1002
10021043 65-85 09JUN2020 1621 BNT162b1
(10 μg) 09JUN2020 BNT162b1
(10 μg) 30JUN2020 BNT162b1
(10 μg)
10021044 C4591001 1002
10021044 65-85 09JUN2020 1622 BNT162b1
(10 μg) 09JUN2020 BNT162b1
(10 μg) 30JUN2020 BNT162b1
(10 μg)
10021045 C4591001 1002
10021045 65-85 11JUN2020 1629 BNT162b1
(10 μg) 11JUN2020 BNT162b1
(10 μg) 30JUN2020 BNT162b1
(10 μg)
10021047 C4591001 1002
10021047 65-85 11JUN2020 1626 Placebo 11JUN2020 Placebo 30JUN2020 Placebo
10021049 C4591001 1002
10021049 65-85 11JUN2020 1630 BNT162b1
(10 μg) 11JUN2020 BNT162b1
(10 μg) 30JUN2020 BNT162b1
(10 μg)
10021050 C4591001 1002
10021050 65-85 15JUN2020 2026 Placebo 15JUN2020 Placebo 07JUL2020 Placebo
10021052 C4591001 1002
10021052 65-85 11JUN2020 1628 BNT162b1
(10 μg) 11JUN2020 BNT162b1
(10 μg) 30JUN2020 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)
090177e194d7854d\Final\Final On: 07-Sep-2020 03:51 (GMT)
Page 5
FDA-CBER-2021-5683-0024767
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – Phase 1, 2 Doses, 21 Days Apar t
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date Dose 1 Date Dose 2
10021062 C4591001 1002
10021062 65-85 15JUN2020 1756 BNT162b1
(30 μg) 15JUN2020 BNT162b1
(30 μg) 07JUL2020 BNT162b1
(30 μg)
10021063 C4591001 1002
10021063 65-85 15JUN2020 1758 BNT162b1
(30 μg) 15JUN2020 BNT162b1
(30 μg) 07JUL2020 BNT162b1
(30 μg)
10021064 C4591001 1002
10021064 65-85 17JUN2020 2034 BNT162b1
(20 μg) 17JUN2020 BNT162b1
(20 μg) 08JUL2 020 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
10021073 C4591001 1002
10021073 65-85 17JUN2020 2033 Placebo 17JUN2020 Placebo 08JUL2020 Placebo
10021074 C4591001 1002
10021074 65-85 18JUN2020 1762 BNT162b1
(30 μg) 18JUN2020 BNT162b1
(30 μg) 08JUL2020 BNT162b1
(30 μg)
10021075 C4591001 1002
10021075 65-85 18JUN2020 1766 BNT162b1
(30 μg) 18JUN2020 BNT162b1
(30 μg) 08JUL2020 BNT162b1
(30 μg)
10021077 C4591001 1002
10021077 65-85 18JUN2020 1763 BNT162b1
(30 μg) 18JUN2020 BNT162b1
(30 μg) 08JUL2020 BNT162b1
(30 μg)
10021079 C4591001 1002
10021079 18-55 29JUN2020 1487 BNT162b1
(20 μg) 29JUN2020 BNT162b1
(20 μg) 21JUL2020 BNT162b1
(20 μg)
10021080 C4591001 1002
10021080 18-55 01JUL2020 1491 BNT162b1
(20 μg) 01JUL2020 BNT162b1
(20 μg) 21JUL2020 BNT162b1
(20 μg)
090177e194d7854d\Final\Final On: 07-Sep-2020 03:51 (GMT)
Page 6
FDA-CBER-2021-5683-0024768
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – Phase 1, 2 Doses, 21 Days Apar t
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date Dose 1 Date Dose 2
10021081 C4591001 1002
10021081 18-55 01JUL2020 1492 BNT162b1
(20 μg) 01JUL2020 BNT162b1
(20 μg) 21JUL2020 BNT162b1
(20 μg)
10021082 C4591001 1002
10021082 18-55 01JUL2020 1494 BNT162b1
(20 μg) 01JUL2020 BNT162b1
(20 μg) 21JUL2020 BNT162b1
(20 μg)
10021083 C4591001 1002
10021083 18-55 01JUL2020 1495 Placebo 01JUL2020 Placebo 21JUL2020 Placebo
10021084 C4591001 1002
10021084 18-55 29JUN2020 1488 BNT162b1
(20 μg) 29JUN2020 BNT162b1
(20 μg) 21JUL2020 BNT162b1
(20 μg)
10021085 C4591001 1002
10021085 18-55 29JUN2020 1486 BNT162b1
(20 μg) 29JUN2020 BNT162b1
(20 μg) 21JUL2020 BNT162b1
(20 μg)
10021087 C4591001 1002
10021087 18-55 01JUL2020 1493 BNT162b1
(20 μg) 01JUL2020 BNT162b1
(20 μg) 21JUL2020 BNT162b1
(20 μg)
10031016 C4591001 1003
10031016 18-55 09JUN2020 2164 Placebo 09JUN2020 Placebo 30JUN2020 Placebo
10031017 C4591001 1003
10031017 18-55 11JUN2020 2172 Placebo 11JUN2020 Placebo 02JUL2020 Placebo
10031018 C4591001 1003
10031018 18-55 09JUN2020 2163 BNT162b2
(10 μg) 09JUN2020 BNT162b2
(10 μg) 30JUN2020 BNT162b2
(10 μg)
10031019 C4591001 1003
10031019 18-55 11JU N2020 2170 BNT162b2
(10 μg) 11JUN2020 BNT162b2
(10 μg) 02JUL2020 BNT162b2
(10 μg)
10031020 C4591001 1003
10031020 18-55 11JUN2020 2174 BNT162b2
(10 μg) 11JUN2020 BNT162b2
(10 μg) 02JUL2020 BNT162b2
(10 μg)
10031021 C4591001 1003
10031021 18-55 09JUN2020 2165 BNT162b2
(10 μg) 09JUN2020 BNT162b2
(10 μg) 30JUN2020 BNT162b2
(10 μg)
10031022 C4591001 1003
10031022 18-55 11JUN2020 2171 BNT162b2
(10 μg) 11JUN2020 BNT162b2
(10 μg) 02JUL2020 BNT162b2
(10 μg)
10031024 C4591001 1003
10031024 18-55 11JUN2020 2173 BNT162b2
(10 μg) 11JUN2020 BNT162b2
(10 μg) 02JUL2020 BNT162b2
(10 μg)
090177e194d7854d\Final\Final On: 07-Sep-2020 03:51 (GMT)
Page 7
FDA-CBER-2021-5683-0024769
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – Phase 1, 2 Doses, 21 Days Apar t
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date Dose 1 Date Dose 2
10031026 C4591001 1003
10031026 18-55 17JUN2020 2573 BNT162b2
(20 μg) 17JUN2020 BNT162b2
(20 μg) 08JUL2020 BNT162b2
(20 μg)
10031027 C4591001 1003
10031027 18-55 15JUN2020 2567 BNT162b2
(20 μg) 15JUN2020 BNT162b2
(20 μg) 06JUL2020 BNT162b2
(20 μg)
10031028 C4591001 1003
10031028 18-55 15JUN2020 2566 BNT162b2
(20 μg) 15JUN2020 BNT162b2
(20 μg) 06JUL2020 BNT162b2
(20 μg)
10031029 C4591001 1003
10031029 18-55 15JUN2020 2568 Placebo 15JUN2020 Placebo 06JUL2020 Placebo
10031030 C4591001 1003
10031030 18-55 17JUN2020 2575 BNT162b2
(20 μg) 17JUN2020 BNT162b2
(20 μg) 08JUL2020 BNT162b2
(20 μg)
10031031 C4591001 1003
10031031 65-85 15JUN2020 3109 BNT162b2
(20 μg) 15JUN2020 BNT162b2
(20 μg) 06JUL2020 BNT162b2
(20 μg)
10031032 C4591001 1003
10031032 18-55 17JUN2020 2572 BNT162b2
(20 μg) 17JUN2020 BNT162b2
(20 μg) 08JUL2020 BNT162b2
(20 μg)
10031034 C4591001 1003
10031034 18-55 17JUN2020 2571 Placebo 17JUN2020 Placebo 08JUL2020 Placebo
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
10031037 C4591001 1003
10031037 65-85 16JUN2020 2840 BNT162b2
(30 μg) 16JUN2020 BNT162b2
(30 μg) 07JUL2020 BNT162b2
(30 μg)
10031038 C4591001 1003
10031038 18-55 17JUN2020 2574 BNT162b2
(20 μg) 17JUN2020 BNT162b2
(20 μg) 08JUL2020 BNT162b2
(20 μg)
10031043 C4591001 1003
10031043 65-85 16JUN2020 2838 Placebo 16JUN2020 Placebo 07JUL2020 Placebo
10031046 C4591001 1003
10031046 65-85 18JUN2020 2847 Placebo 18JUN2020 Placebo 09JUL2020 Placebo
090177e194d7854d\Final\Final On: 07-Sep-2020 03:51 (GMT)
Page 8
FDA-CBER-2021-5683-0024770
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – Phase 1, 2 Doses, 21 Days Apar t
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date Dose 1 Date Dose 2
10031047 C4591001 1003
10031047 65-85 16JUN2020 2839 BNT162b2
(30 μg) 16JUN2020 BNT162b2
(30 μg) 07JUL2020 BNT162b2
(30 μg)
10031050 C4591001 1003
10031050 18-55 22JUN2020 2297 Placebo 22JUN2020 Placebo 13JUL2020 Placebo
10031051 C4591001 1003
10031051 65-85 18JUN2020 2848 BNT162b2
(30 μg) 18JUN2020 BNT162b2
(30 μg) 09JUL2020 BNT162b2
(30 μg)
10031053 C4591001 1003
10031053 65-85 17JUN2020 3111 BNT162b2
(20 μg) 17JUN2020 BNT162b2
(20 μg) 08JUL2020 BNT162b2
(20 μg )
10031054 C4591001 1003
10031054 65-85 17JUN2020 3115 BNT162b2
(20 μg) 17JUN2020 BNT162b2
(20 μg) 08JUL2020 BNT162b2
(20 μg)
10031055 C4591001 1003
10031055 65-85 17JUN2020 3112 BNT162b2
(20 μg) 17JUN2020 BNT162b2
(20 μg) 06JUL2020 BNT162b2
(20 μg)
10031056 C4591001 1003
10031056 65-85 18JUN2020 2844 Placebo 18JUN2020 Placebo 09JUL2020 Placebo
10031057 C4591001 1003
10031057 18-55 24JUN2020 2301 BNT162b2
(30 μg) 24JUN2020 BNT162b2
(30 μg) 15JUL2020 BNT162b2
(30 μg)
10031058 C4591001 1003
10031058 65-85 18JUN2020 2846 BNT162b2
(30 μg) 18JUN2020 BNT162b2
(30 μg) 09JUL2020 BNT162b2
(30 μg)
10031059 C4591001 1003
10031059 18-55 24JUN2020 2305 BNT162b2
(30 μg) 24JUN2020 BNT162b2
(30 μg) 15JUL2020 BNT162b2
(30 μg)
10031061 C4591001 1003
10031061 18-55 22JUN2020 2298 BNT162b2
(30 μg) 22JUN2020 BNT162b2
(30 μg) 13JUL2020 BNT162b2
(30 μg)
10031063 C4591001 1003
10031063 65-85 17JUN2020 3113 BNT162b2
(20 μg) 17JUN2020 BNT162b2
(20 μg) 08JUL2020 BNT162b2
(20 μg)
10031065 C4591001 1003
10031065 18-55 24JUN2020 2303 BNT162b2
(30 μg) 24JUN2020 BNT162b2
(30 μg) 15JUL2020 BNT162b2
(30 μg)
10031066 C4591001 1003
10031066 18-55 22JUN2020 2296 BNT162b2
(30 μg) 22JUN2020 BNT162b2
(30 μg) 13JUL2020 BNT162b2
(30 μg)
090177e194d7854d\Final\Final On: 07-Sep-2020 03:51 (GMT)
Page 9
FDA-CBER-2021-5683-0024771
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – Phase 1, 2 Doses, 21 Days Apar t
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date Dose 1 Date Dose 2
10031067 C4591001 1003
10031067 65-85 17JUN2020 3114 Placebo 17JUN2020 Placebo 08JUL2020 Placebo
10031069 C4591001 1003
10031069 65-85 18JUN2020 2845 BNT162b2
(30 μg) 18JUN2020 BNT162b2
(30 μg) 09JUL2020 BNT162b2
(30 μg)
10031070 C4591001 1003
10031070 18-55 24JUN2020 2304 Placebo 24JUN2020 Placebo 15JUL2020 Placebo
10031072 C4591001 1003
10031072 18-55 24JUN2020 2302 BNT162b2
(30 μg) 24JUN2020 BNT162b2
(30 μg) 16JUL2020 BNT162b2
(30 μg)
10031076 C4591001 1003
10031076 65-85 29JUN2020 2702 BNT162b2
(10 μg) 29JUN2020 BNT162b2
(10 μg) 20JUL2020 BNT162b2
(10 μg)
10031077 C4591001 1003
10031077 65-85 01JUL2020 2711 BNT162b2
(10 μg) 01JUL2020 BNT162b2
(10 μg) 22JUL2020 BNT162b2
(10 μg)
10031078 C4591001 1003
10031078 65-85 01JUL2020 2712 BNT162b2
(10 μg) 01JUL2020 BNT162b2
(10 μg) 22JUL2020 BNT162b2
(10 μg)
10031079 C4591001 1003
10031079 65-85 01JUL2020 2715 BNT162b2
(10 μg) 01JUL2020 BNT162b2
(10 μg) 22JUL2020 BNT162b2
(10 μg)
100310 80 C4591001 1003
10031080 65-85 29JUN2020 2703 BNT162b2
(10 μg) 29JUN2020 BNT162b2
(10 μg) 20JUL2020 BNT162b2
(10 μg)
10031083 C4591001 1003
10031083 65-85 01JUL2020 2714 Placebo 01JUL2020 Placebo 22JUL2020 Placebo
10031087 C4591001 1003
10031087 65-85 01JUL2020 2713 BNT162b2
(10 μg) 01JUL2020 BNT162b2
(10 μg) 22JUL2020 BNT162b2
(10 μg)
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 BNT162b2
(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)
090177e194d7854d\Final\Final On: 07-Sep-2020 03:51 (GMT)
Page 10
FDA-CBER-2021-5683-0024772
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – Phase 1, 2 Doses, 21 Days Apar t
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date Dose 1 Date Dose 2
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 10JUN2020 2167 Placebo 10JUN2020 Placebo 01JUL2020 Placebo
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
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)
10071031 C45910 01 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)
090177e194d7854d\Final\Final On: 07-Sep-2020 03:51 (GMT)
Page 11
FDA-CBER-2021-5683-0024773
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – Phase 1, 2 Doses, 21 Days Apar t
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date Dose 1 Date Dose 2
10071037 C4591001 1007
10071037 65-85 15JUN2020 2837 BNT162b2
(30 μg) 15JUN2020 BNT162b2
(30 μg) 06JUL2020 BNT162b2
(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) 08JUL2020 BNT162b2
(20 μg)
10071040 C4591001 1007
10071040 18-55 17JUN2020 2579 BNT162b2
(20 μg) 17JUN2020 BNT162b2
(20 μg) 08JUL2020 BNT162b2
(20 μg)
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 BNT162b2
(30 μg)
10071046 C4591001 1007
10071046 18-55 22JUN2020 2299 BNT162b2
(30 μg) 22JUN2020 BNT162b2
(30 μg) 15JUL2020 BNT162b2
(30 μg)
10071049 C4591001 1007
10071049 65-85 18JUN2020 2849 BNT162b2
(30 μg) 18JUN2020 BNT162b2
(30 μg) 09JUL2020 BNT162b2
(30 μg)
10071050 C4591001 1007
10071050 18-55 22JUN2020 2300 BNT162b2
(30 μg) 22JUN2020 BNT162b2
(30 μg) 13JUL2020 BNT162b2
(30 μg)
10071051 C4591001 1007
10071051 65-85 29JUN2020 2701 BNT162b2
(10 μg) 29JUN2020 BNT162b2
(10 μg) 20JUL2020 BNT162b2
(10 μg)
100710 52 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)
090177e194d7854d\Final\Final On: 07-Sep-2020 03:51 (GMT)
Page 12
FDA-CBER-2021-5683-0024774
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – Phase 1, 2 Doses, 21 Days Apar t
Vaccine Received
Subject
Study
Identifiera Subject Age
Group
(Years) Randomization
Date Randomization
Number Randomization
Vaccine Group Date Dose 1 Date Dose 2
10071056 C4591001 1007
10071056 65-85 29JUN2020 2704 Placebo 29JUN2020 Placebo 20JUL2020 Placebo
10071057 C4591001 1007
10071057 65-85 30JUN2020 2706 BNT162b2
(10 μg) 30JUN2020 BNT162b2
(10 μg) 22JUL2020 BNT162b2
(10 μg)
10071058 C4591001 1007
10071058 18-55 24JUN2020 2309 BNT162b2
(30 μg) 24JUN2020 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
10071066 C4591001 1007
10071066 18-55 24JUN2020 2310 BNT162b2
(30 μg) 24JUN2020 BNT162b2
(30 μg) 15JUL2020 BNT162b2
(30 μg)
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 BNT162b2
(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
10071077 C4591001 1007
10071077 65-85 30JUN2020 2709 BNT162b2
(10 μg) 30JUN2020 BNT162b2
(10 μg) 22JUL2020 BNT162b2
(10 μg)
a. Subject Study Identifier = the subject number is the current study 4 -digit site number followed by unique 4 -digit subject identifier.
PFIZER CONFIDENTIAL SDTM Creation: 28AUG2020 (16:27) Source Data: adsl Table Generation: 02SEP2020 (17:24)
(Cutoff Date: 24AUG2020, Snapshot Date: 28AUG2020) Output File: (CDISC)/C4591001_IA_P1/adsl_l003_p1
090177e194d7854d\Final\Final On: 07-Sep-2020 03:51 (GMT)
Page 13
FDA-CBER-2021-5683-0024775
16.1.7.1.1 Listing of Randomization Scheme and Actual Vaccine Received – Phase 1 – BNT162b1 (100 μg )
Vaccine Received
Study
Subject
Identifiera Subject Age Group
(Years) Randomization Date Randomization
Number Randomization
Vaccine Group Date Dose 1
10011013 C4591001 1001 10011013 18-55 18MAY2020 1355 Placebo 18MAY2020 Placebo
10011021 C4591001 1001 10011021 18-55 20MAY2020 1356 Placebo 20MAY2020 Placebo
10011026 C4591001 1001 10011026 18-55 18MAY2020 1354 BNT162b1
(100 μg) 18MAY2020 BNT162b1
(100 μg)
10011028 C4591001 1001 10011028 18-55 20MAY2020 1359 BNT162b1
(100 μg) 20MAY2020 BNT162b1
(100 μg)
10011030 C4591001 1001 10011030 18-55 20MAY2020 1357 BNT162b1
(100 μg) 20MAY2020 BNT162b1
(100 μg)
10011032 C4591001 1001 10011032 18-55 20MAY2020 1360 BNT162b1
(100 μg) 20MAY2020 BNT162b1
(100 μg)
10011034 C4591001 1001 10011034 18-55 20MAY2020 1358 BNT162b1
(100 μg) 20MAY2020 BNT162b1
(100 μg)
10021023 C4591001 1002 10021023 18-55 18MAY2020 1352 BNT162b1
(100 μg) 18MAY2020 BNT162b1
(100 μg)
10021024 C4591001 1002 10021024 18-55 18MAY2020 1353 BNT162b1
(100 μg) 18MAY2020 BNT162b1
(100 μg)
10021027 C4591001 1002 10021027 18-55 18MAY2020 1351 BNT162b1
(100 μg) 18MAY2020 BNT162b1
(100 μg)
10021034 C4591001 1002 10021034 18-55 21MAY2020 1363 BNT162b1
(100 μg) 21MAY2020 BNT162b1
(100 μg)
090177e194fbc507\Final\Final On: 22-Sep-2020 14:24 (GMT)
Page 14
FDA-CBER-2021-5683-0024776
16.1.7.1.1 Listing of Randomization Scheme and Actual Vaccine Received – Phase 1 – BNT162b1 (100 μg )
Vaccine Received
Study
Subject
Identifiera Subject Age Group
(Years) Randomization Date Randomization
Number Randomization
Vaccine Group Date Dose 1
10021035 C4591001 1002 10021035 18-55 21MAY2020 1361 BNT162b1
(100 μg) 21MAY2020 BNT162b1
(100 μg)
10021036 C4591001 1002 10021036 18-55 21MAY2020 1364 BNT162b1
(100 μg) 21MAY2020 BNT162b1
(100 μg)
10021038 C4591001 1002 10021038 18-55 21MAY2020 1365 BNT162b1
(100 μg) 21MAY2020 BNT162b1
(100 μg)
10021041 C4591001 1002 10021041 18-55 21MAY2020 1362 Placebo 21MAY2020 Placebo
a. Subject Study Identifier = the subject number is the current study 4 -digit site number followed by unique 4 -digit subject identifier.
PFIZER CONFIDENTIAL SDTM Creation: 28AUG2020 (16:27) Source Data: adsl Table Generation: 19SEP2020 (10:20)
(Cutoff Date: 24AUG2020, Snapshot Date: 28AUG2020) Output File: ./nda3/C4591001 IA P1 100/adsl l003 100 p1
090177e194fbc507\Final\Final On: 22-Sep-2020 14:24 (GMT)
Page 15
FDA-CBER-2021-5683-0024777