Document text
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
Dosing/admini stration error, subject did not receive correct dose of vaccine 1 C4591001 1231
12313428
Concomitant
medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. 462 C4591001 1001
10011005^ (2)
C4591001 1001
10011041^
C4591001 1001
10011042^
C4591001 1001
10011044^
C4591001 1001
10011053^ (2)
C4591001 1001
10011081 (2)
C4591001 1001
10011099
C4591001 1003
10031166
C4591001 1005
10051019
C4591001 1006
10061078 (2)
C4591001 1006
10061109 (2)
C4591001 1006
10061147
C4591001 1007
10071082 (2)
C4591001 1007
10071110
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 1
FDA-CBER-2021-5683-0221015
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1007
10071114
C4591001 1007
10071173 (2)
C4591001 1007
10071186
C4591001 1007
10071188
C4591001 1007
10071212
C4591001 1007
10071218
C4591001 1007
10071225
C4591001 1007
10071237
C4591001 1007
10071243
C4591001 1007
10071250
C4591001 1007
10071266
C4591001 1007
10071269
C4591001 1007
10071276
C4591001 1007
10071286
C4591001 1007
10071291 (2)
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 2
FDA-CBER-2021-5683-0221016
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1007
10071295
C4591001 1007
10071335
C4591001 1007
10071339
C4591001 1007
10071380
C4591001 1007
10071387
C4591001 1007
10071402
C4591001 1007
10071556
C4591001 1009
10091035
C4591001 1009
10091064
C4591001 1009
10091107 (2)
C4591001 1009
10091133
C4591001 1009
10091185
C4591001 1012
10121040 (2)
C4591001 1012
10121083
C4591001 1012
10121110
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 3
FDA-CBER-2021-5683-0221017
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1013
10131604
C4591001 1015
10151116
C4591001 1016
10161087
C4591001 1016
10161194
C4591001 1016
10161280
C4591001 1018
10181009
C4591001 1018
10181027
C4591001 1018
10181039
C4591001 1018
10181058
C4591001 1018
10181105
C4591001 1018
10181111
C4591001 1018
10181112
C4591001 1018
10181113
C4591001 1018
10181127
C4591001 1018
10181141
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 4
FDA-CBER-2021-5683-0221018
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1018
10181164
C4591001 1018
10181170
C4591001 1018
10181191
C4591001 1018
10181204
C4591001 1018
10181214
C4591001 1018
10181223
C4591001 1018
10181302
C4591001 1018
10181306
C4591001 1018
10181319
C4591001 1019
10191021
C4591001 1019
10191063
C4591001 1019
10191223
C4591001 1021
10211177
C4591001 1021
10211233
C4591001 1028
10281160
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 5
FDA-CBER-2021-5683-0221019
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1028
10281162 (2)
C4591001 1030
10301094
C4591001 1037
10371219
C4591001 1039
10391124
C4591001 1039
10391142
C4591001 1039
10391153
C4591001 1042
10421028
C4591001 1042
10421097
C4591001 1042
10421119
C4591001 1042
10421134
C4591001 1042
10421139
C4591001 1042
10421156
C4591001 1042
10421187
C4591001 1042
10421262
C4591001 1044
10441056
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 6
FDA-CBER-2021-5683-0221020
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1046
10461079 (2)
C4591001 1046
10461251 (2)
C4591001 1047
10471280
C4591001 1047
10471281
C4591001 1048
10481027
C4591001 1048
10481070
C4591001 1048
10481085
C4591001 1052
10521037
C4591001 1052
10521121
C4591001 1052
10521127
C4591001 1052
10521151
C4591001 1054
10541059
C4591001 1054
10541062
C4591001 1054
10541110
C4591001 1054
10541161
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 7
FDA-CBER-2021-5683-0221021
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1055
10551093
C4591001 1055
10551145
C4591001 1055
10551152
C4591001 1056
10561009 (2)
C4591001 1056
10561197 (2)
C4591001 1056
10561477 (2)
C4591001 1057
10571040 (2)
C4591001 1057
10571050
C4591001 1057
10571094
C4591001 1057
10571114
C4591001 1057
10571198
C4591001 1057
10571201
C4591001 1057
10571222
C4591001 1057
10571236 (2)
C4591001 1066
10661032 (2)
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 8
FDA-CBER-2021-5683-0221022
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1066
10661121
C4591001 1068
10681107
C4591001 1071
10711234
C4591001 1072
10721003
C4591001 1072
10721012
C4591001 1072
10721029
C4591001 1072
10721044
C4591001 1072
10721058
C4591001 1072
10721062
C4591001 1072
10721068
C4591001 1072
10721077
C4591001 1072
10721084
C4591001 1079
10791020
C4591001 1079
10791177 (2)
C4591001 1080
10801019
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 9
FDA-CBER-2021-5683-0221023
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1080
10801055
C4591001 1081
10811094
C4591001 1081
10811114
C4591001 1081
10811186
C4591001 1083
10831154
C4591001 1083
10831162
C4591001 1083
10831220
C4591001 1083
10831230
C4591001 1083
10831239
C4591001 1083
10831242
C4591001 1083
10831248
C4591001 1083
10831252
C4591001 1083
10831284
C4591001 1084
10841017
C4591001 1084
10841061
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 10
FDA-CBER-2021-5683-0221024
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1084
10841077
C4591001 1084
10841078
C4591001 1084
10841137
C4591001 1084
10841156
C4591001 1084
10841158
C4591001 1084
10841198
C4591001 1084
10841241
C4591001 1084
10841245
C4591001 1084
10841264
C4591001 1084
10841358
C4591001 1084
10841439 (2)
C4591001 1084
10841456
C4591001 1084
10841470
C4591001 1084
10841476
C4591001 1084
10841480
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 11
FDA-CBER-2021-5683-0221025
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1084
10841505 (2)
C4591001 1085
10851064
C4591001 1085
10851069
C4591001 1085
10851080
C4591001 1085
10851136
C4591001 1085
10851137
C4591001 1085
10851161
C4591001 1085
10851218
C4591001 1085
10851223
C4591001 1085
10851237
C4591001 1085
10851244
C4591001 1085
10851286 (2)
C4591001 1085
10851287
C4591001 1085
10851322
C4591001 1085
10851340
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 12
FDA-CBER-2021-5683-0221026
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1087
10871066
C4591001 1087
10871269
C4591001 1087
10871270
C4591001 1089
10891103 (2)
C4591001 1090
10901404
C4591001 1091
10911091
C4591001 1091
10911122
C4591001 1091
10911215
C4591001 1091
10911228
C4591001 1093
10931216
C4591001 1094
10941027
C4591001 1094
10941054
C4591001 1094
10941167
C4591001 1094
10941169
C4591001 1095
10951031
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 13
FDA-CBER-2021-5683-0221027
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1095
10951077
C4591001 1095
10951139
C4591001 1096
10961026
C4591001 1096
10961109
C4591001 1096
10961216
C4591001 1096
10961234
C4591001 1096
10961256
C4591001 1096
10961292
C4591001 1096
10961318
C4591001 1096
10961371
C4591001 1098
10981008
C4591001 1098
10981178
C4591001 1098
10981201
C4591001 1098
10981203
C4591001 1098
10981212
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 14
FDA-CBER-2021-5683-0221028
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1098
10981224
C4591001 1098
10981227
C4591001 1098
10981237 (2)
C4591001 1107
11071013
C4591001 1107
11071024 (2)
C4591001 1109
11091275
C4591001 1109
11091352
C4591001 1110
11101053
C4591001 1110
11101060
C4591001 1110
11101177
C4591001 1110
11101188
C4591001 1110
11101207
C4591001 1110
11101210 (2)
C4591001 1110
11101234
C4591001 1110
11101244
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 15
FDA-CBER-2021-5683-0221029
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1111
11111051
C4591001 1111
11111063
C4591001 1111
11111065
C4591001 1111
11111100
C4591001 1111
11111206
C4591001 1112
11121062
C4591001 1112
11121083
C4591001 1112
11121135
C4591001 1112
11121243
C4591001 1114
11141015
C4591001 1114
11141054
C4591001 1114
11141102
C4591001 1114
11141120
C4591001 1116
11161008
C4591001 1116
11161012 (2)
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 16
FDA-CBER-2021-5683-0221030
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1116
11161094
C4591001 1116
11161253
C4591001 1117
11171114
C4591001 1118
11181124
C4591001 1120
11201002
C4591001 1120
11201096
C4591001 1120
11201109 (2)
C4591001 1120
11201164
C4591001 1120
11201212 (2)
C4591001 1120
11201242 (2)
C4591001 1120
11201287
C4591001 1120
11201317
C4591001 1121
11211007 (3)
C4591001 1121
11211029 (2)
C4591001 1121
11211042 (2)
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 17
FDA-CBER-2021-5683-0221031
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1121
11211057 (2)
C4591001 1121
11211059
C4591001 1121
11211067
C4591001 1121
11211071 (2)
C4591001 1121
11211079
C4591001 1121
11211087
C4591001 1121
11211104
C4591001 1122
11221002
C4591001 1122
11221003
C4591001 1122
11221038
C4591001 1122
11221050
C4591001 1123
11231104
C4591001 1123
11231145
C4591001 1123
11231193
C4591001 1123
11231214
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 18
FDA-CBER-2021-5683-0221032
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1123
11231244
C4591001 1123
11231249
C4591001 1123
11231273
C4591001 1124
11241015
C4591001 1124
11241025
C4591001 1124
11241052
C4591001 1124
11241103
C4591001 1124
11241120 (2)
C4591001 1124
11241140
C4591001 1125
11251043
C4591001 1126
11261045
C4591001 1126
11261080
C4591001 1126
11261135
C4591001 1126
11261147
C4591001 1126
11261151
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 19
FDA-CBER-2021-5683-0221033
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1127
11271009
C4591001 1127
11271041 (2)
C4591001 1127
11271051
C4591001 1127
11271089
C4591001 1127
11271098
C4591001 1128
11281010
C4591001 1128
11281026
C4591001 1128
11281036
C4591001 1128
11281079
C4591001 1128
11281083
C4591001 1128
11281112
C4591001 1128
11281132
C4591001 1128
11281177
C4591001 1128
11281185
C4591001 1128
11281227
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 20
FDA-CBER-2021-5683-0221034
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1128
11281265
C4591001 1128
11281335
C4591001 1129
11291037
C4591001 1129
11291064
C4591001 1129
11291072
C4591001 1129
11291174
C4591001 1129
11291199
C4591001 1130
11301028
C4591001 1130
11301094 (2)
C4591001 1133
11331089
C4591001 1133
11331104
C4591001 1133
11331130
C4591001 1133
11331304 (2)
C4591001 1133
11331314
C4591001 1133
11331406
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 21
FDA-CBER-2021-5683-0221035
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1133
11331424
C4591001 1133
11331425
C4591001 1133
11331438 (2)
C4591001 1133
11331555
C4591001 1134
11341069
C4591001 1134
11341073
C4591001 1134
11341206
C4591001 1135
11351092
C4591001 1135
11351241 (2)
C4591001 1135
11351426 (2)
C4591001 1135
11351555
C4591001 1139
11391042
C4591001 1140
11401172
C4591001 1140
11401176
C4591001 1140
11401191
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 22
FDA-CBER-2021-5683-0221036
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1142
11421112
C4591001 1145
11451014
C4591001 1145
11451023
C4591001 1145
11451040
C4591001 1147
11471001
C4591001 1147
11471007 (3)
C4591001 1147
11471023
C4591001 1147
11471036
C4591001 1147
11471047
C4591001 1147
11471117
C4591001 1149
11491025 (2)
C4591001 1149
11491040
C4591001 1149
11491307
C4591001 1152
11521099
C4591001 1152
11521134 (2)
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 23
FDA-CBER-2021-5683-0221037
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1152
11521137
C4591001 1152
11521192 (2)
C4591001 1152
11521347 (2)
C4591001 1152
11521425
C4591001 1156
11561024 (2)
C4591001 1156
11561038
C4591001 1157
11571069
C4591001 1157
11571161
C4591001 1163
11631005
C4591001 1163
11631041
C4591001 1166
11661013
C4591001 1166
11661105
C4591001 1167
11671071 (2)
C4591001 1167
11671132
C4591001 1169
11691014
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 24
FDA-CBER-2021-5683-0221038
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1169
11691023
C4591001 1169
11691034
C4591001 1169
11691045
C4591001 1169
11691057
C4591001 1169
11691069
C4591001 1170
11701026
C4591001 1170
11701045
C4591001 1170
11701081
C4591001 1170
11701110
C4591001 1170
11701113
C4591001 1170
11701171
C4591001 1170
11701173
C4591001 1170
11701209
C4591001 1170
11701224
C4591001 1170
11701231 (2)
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 25
FDA-CBER-2021-5683-0221039
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1170
11701296
C4591001 1170
11701413
C4591001 1171
11711071
C4591001 1171
11711132
C4591001 1171
11711181
C4591001 1171
11711183
C4591001 1171
11711186
C4591001 1171
11711247
C4591001 1171
11711250
C4591001 1171
11711261
C4591001 1177
11771076
C4591001 1177
11771157
C4591001 1177
11771189
C4591001 1177
11771369
C4591001 1177
11771476
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 26
FDA-CBER-2021-5683-0221040
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1178
11781060
C4591001 1178
11781065
C4591001 1178
11781068
C4591001 1203
12031013
C4591001 1204
12041094
C4591001 1204
12041176†
C4591001 1204
12041280
C4591001 1207
12071045
C4591001 1208
12081012
C4591001 1226
12261080
C4591001 1226
12261085
C4591001 1226
12261455
C4591001 1226
12261467 (2)
C4591001 1226
12262132
C4591001 1226
12262138
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 27
FDA-CBER-2021-5683-0221041
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1231
12311081
C4591001 1231
12311132 (2)
C4591001 1231
12311145
C4591001 1231
12311230
C4591001 1231
12311237
C4591001 1231
12311379
C4591001 1231
12311647
C4591001 1231
12311855
C4591001 1231
12311975 (2)
C4591001 1231
12312528
C4591001 1231
12312856
C4591001 1231
12313059
C4591001 1231
12313346
C4591001 1231
12313391
C4591001 1231
12314046
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 28
FDA-CBER-2021-5683-0221042
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1231
12314324
C4591001 1231
12314974
C4591001 1231
12315141
C4591001 1231
12315286
C4591001 1231
12315386
C4591001 1231
12315578
C4591001 1231
12315582 (2)
C4591001 1232
12321054
C4591001 1232
12321110
C4591001 1232
12321202
C4591001 1241
12411211
C4591001 1241
12411449
C4591001 1241
12411465 (2)
C4591001 1241
12411569 (2)
C4591001 1241
12412120
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 29
FDA-CBER-2021-5683-0221043
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1248
12481041
C4591001 1251
12511072 (2)
C4591001 1251
12511264
C4591001 1254
12541007
C4591001 1254
12541013
C4591001 1254
12541167
C4591001 1258
12581076
C4591001 1264
12641159
C4591001 1265
12651015 (2)
C4591001 1265
12651050
C4591001 1265
12651087
C4591001 1265
12651153 (2)
C4591001 1269
12691014
C4591001 1269
12691026
C4591001 1269
12691047
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 30
FDA-CBER-2021-5683-0221044
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1269
12691066
C4591001 1269
12691088
C4591001 1270
12701003
C4591001 1270
12701008
C4591001 1270
12701057
C4591001 1270
12701069
C4591001 1270
12701118
C4591001 1270
12701137
C4591001 4444
44441327
C4591001 4444
44441389
C4591001 4444
44442088
C4591001 4444
44442130
C4591001 4444
44442247
Receipt of blood/plasma products or immunoglobulins within 60 days before enrollment through
conclusion of the study. 17 C4591001 1007
10071192
C4591001 1042
10421023
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 31
FDA-CBER-2021-5683-0221045
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1055
10551102
C4591001 1084
10841470
C4591001 1091
10911241
C4591001 1096
10961012
C4591001 1096
10961305
C4591001 1107
11071037
C4591001 1107
11071065
C4591001 1107
11071121
C4591001 1125
11251154
C4591001 1131
11311222
C4591001 1167
11671228
C4591001 1170
11701482
C4591001 1218
12181027
C4591001 1231
12313697
C4591001 1231
12313895
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 32
FDA-CBER-2021-5683-0221046
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
Subject received chronic systemic treatment with known immunosuppressant medication, or
radiotherapy, within 60 days before enrollment through conclusion of the study. 20 C4591001 1027
10271054 (2)
C4591001 1028
10281059
C4591001 1037
10371146
C4591001 1046
10461261
C4591001 1055
10551182
C4591001 1072
10721037
C4591001 1084
10841077
C4591001 1084
10841403
C4591001 1128
11281138 (3)
C4591001 1128
11281241
C4591001 1128
11281250
C4591001 1129
11291037
C4591001 1140
11401020 (2)
C4591001 1177
11771204 (2)
C4591001 1178
11781282
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 33
FDA-CBER-2021-5683-0221047
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1223
12231159 (3)
C4591001 1226
12262078
C4591001 1231
12314401
C4591001 1235
12351205
C4591001 1254
12541144
Subject received systemic corticosteroids (>=20mg/day of prednisone or equivalent) for >=14 days
is prohibited from 28 days prior to enrollm ent to specified visits/cohorts per protocol. 13 C4591001 1003
10031101
C4591001 1007
10071276
C4591001 1007
10071315
C4591001 1028
10281026
C4591001 1039
10391019
C4591001 1055
10551196
C4591001 1084
10841077
C4591001 1130
11301039
C4591001 1177
11771131
C4591001 1220
12201029
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 34
FDA-CBER-2021-5683-0221048
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1221
12211002 (2)
C4591001 1247
12471244
C4591001 1261
12611054
Inclusion/exclusion Participant failed to meet inclusion criterion #01 (Male or female participants between the ages of
18 and 55 years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years, inclusive, at
randomization (dependent upon study phase). 2 C4591001 1097
10971023
C4591001 1142
11421084
Participant failed to meet inclusion criterion #02 (Participants who are willing and able to comply
with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study
procedures). 3 C4591001 1178
11781282
C4591001 1178
11781315
C4591001 1229
12291135†
Participant failed to meet inclusion criterion #03 (Healthy participants who are determined by
medical history, physical examination and clinical judgement of the investigator to be eligible for
inclusion in the study) 14 C4591001 1044
10441152†
C4591001 1081
10811093
C4591001 1094
10941191†
C4591001 1095
10951107
C4591001 1096
10961036
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 35
FDA-CBER-2021-5683-0221049
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1117
11171036
C4591001 1117
11171186
C4591001 1120
11201038
C4591001 1122
11221034†
C4591001 1161
11611023
C4591001 1203
12031048
C4591001 1231
12311088
C4591001 1231
12313140
C4591001 1231
12315608
Participant failed to meet inclusion criterion #04 (Participants who, in the judgment of the
investigator, are at risk for acquiring COVID -19) 1 C4591001 1129
11291117
Participant met exclusion criterion #01 (participant having other medical or psychiatric condition) 4 C4591001 1006
10061246
C459 1001 1096
10961036
C4591001 1117
11171036
C4591001 1117
11171186
Participant met exclusion criterion #02 (participant having known infection with HIV, HCV or
HBV) 8 C4591001 1098
10981155
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 36
FDA-CBER-2021-5683-0221050
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1098
10981162
C4591001 1098
10981168†
C4591001 1098
10981169†
C4591001 1170
11701457†
C4591001 1224
12241158†
C4591001 1226
12262255†
C4591001 1251
12511050
Participant met exclusion criterion #05 (previous clinical or microbiological diagnosis of COVID -
19) 6 C4591001 1054
10541033
C4591001 1231
12311191
C4591001 1231
12311549
C4591001 1231
12313211
C4591001 1235
12351167
C4591001 1248
12481132
Participant met exclusion criterion #08 (Immunocompromised individual with known or suspected
immunodeficiency, as determined by history and/or laboratory/physical examination) 1 C4591001 1022
10221167
Participant met exclusion criterion #11 (women who are pregnant or breastfeeding) 23 C4591001 1003
10031186
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 37
FDA-CBER-2021-5683-0221051
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1015
10151071
C4591001 1047
10471301
C4591001 1133
11331207
C4591001 1136
11361082
C4591001 1152
11521450
C4591001 1156
11561015
C4591001 1161
11611016
C4591001 1162
11621128
C4591001 1166
11661078
C4591001 1170
11701365 (2)
C4591001 1178
11781061
C4591001 1185
11851055
C4591001 1204
12041280
C4591001 1220
12201020
C4591001 1226
12261313
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 38
FDA-CBER-2021-5683-0221052
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1231
12312378
C4591001 1231
12313998
C4591001 1241
12411679
C4591001 1241
12412369
C4591001 1241
12412411
C4591001 1254
12541142
C4591001 1254
12541145
Participant met exclusion criterion #13 (participant receiving treatment with immunosuppressive
therapy as specified in protocol) 6 C4591001 1022
10221092
C4591001 1038
10381061
C4591001 1047
10471122
C4591001 1047
10471228
C4591001 1097
10971107
C4591001 1101
11011077
Participant met exclusion criterion #16 (Participation in other studies involving study intervention
within 28 days prior to study entry and/or during study participation) 7 C4591001 1006
10061099
C4591001 1016
10161194
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 39
FDA-CBER-2021-5683-0221053
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1073
10731023
C4591001 1081
10811114
C4591001 1081
10811186
C4591001 1133
11331085
C4591001 1134
11341067
Participant met exclusion criterion #19 ( Phase 1 only: any screening hematology and/or blood
chemistry laboratory value that meets the definition of a >=grade 1 abnormality) 5 C4591001 1002
10021053^
C4591001 1003
10031017^
C4591001 1003
10031021^
C4591001 1003
10031047^
C4591001 1003
10031070^
Participant met exclusion criterion #22 (investigator site staff or Pfizer employees directly involved
in the conduct of the study, site staff otherwise supervised by the investigator, and their respective
family members) 6 C4591001 1112
11121058
C4591001 1161
11611002
C4591001 1161
11611008
C4591001 1161
11611011
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 40
FDA-CBER-2021-5683-0221054
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1161
11611014
C4591001 1161
11611018
Investigational product Blind compromised 5 C4591001 1068
10681001
C4591001 1096
10961195
C4591001 1096
10961197
C4591001 1096
10961212
C4591001 1131
11311044
Dosing/administration error, subject did not receive correct dose of vaccine 160 C4591001 1003
10031120
C4591001 1068
10681001
C4591001 1068
10681002
C4591001 1068
10681003
C4591001 1068
10681004
C4591001 1068
10681005
C4591001 1068
10681006
C4591001 1068
10681007
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 41
FDA-CBER-2021-5683-0221055
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1068
10681008
C4591001 1068
10681009
C4591001 1068
10681010
C4591001 1068
10681011
C4591001 1068
10681012
C4591001 1068
10681013
C4591001 1068
10681014
C4591001 1068
10681015
C4591001 1068
10681016
C4591001 1068
10681017
C4591001 1068
10681018
C4591001 1068
10681019
C4591001 1068
10681020
C4591001 1068
10681021
C4591001 1068
10681022
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 42
FDA-CBER-2021-5683-0221056
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1068
10681023
C4591001 1068
10681024
C4591001 1068
10681025
C4591001 1068
10681026
C4591001 1068
10681027
C4591001 1068
10681028
C4591001 1068
10681029
C4591001 1068
10681030
C4591001 1068
10681031
C4591001 1068
10681032
C4591001 1068
10681033
C4591001 1068
10681034
C4591001 1068
10681035
C4591001 1068
10681036
C4591001 1068
10681037
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 43
FDA-CBER-2021-5683-0221057
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1068
10681038
C4591001 1068
10681039
C4591001 1068
10681040
C4591001 1068
10681041
C4591001 1068
10681042
C4591001 1068
10681043
C4591001 1068
10681044
C4591001 1068
10681045
C4591001 1068
10681046
C4591001 1068
10681047
C4591001 1068
10681050
C4591001 1068
10681051
C4591001 1068
10681052
C4591001 1068
10681053
C4591001 1068
10681054
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 44
FDA-CBER-2021-5683-0221058
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1068
10681055
C4591001 1068
10681056
C4591001 1068
10681057
C4591001 1068
10681058
C4591001 1068
10681059
C4591001 1068
10681060
C4591001 1068
10681061
C4591001 1068
10681062
C4591001 1068
10681063
C4591001 1068
10681064
C4591001 1068
10681065
C4591001 1068
10681066
C4591001 1068
10681068
C4591001 1068
10681069
C4591001 1068
10681071
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 45
FDA-CBER-2021-5683-0221059
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1068
10681072
C4591001 1068
10681073
C4591001 1068
10681074
C4591001 1068
10681075
C4591001 1068
10681076
C4591001 1068
10681077
C4591001 1068
10681078
C4591001 1068
10681079
C4591001 1068
10681080
C4591001 1068
10681081
C4591001 1068
10681082
C4591001 1068
10681083
C4591001 1068
10681084
C4591001 1091
10911001
C4591001 1091
10911004
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 46
FDA-CBER-2021-5683-0221060
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1091
10911005
C4591001 1091
10911008
C4591001 1091
10911010
C4591001 1091
10911012
C4591001 1091
10911014
C4591001 1091
10911015
C4591001 1129
11291091
C4591001 1136
11361027
C4591001 1136
11361039
C4591001 1136
11361057
C4591001 1136
11361059
C4591001 1136
11361079
C4591001 1136
11361083
C4591001 1136
11361084
C4591001 1136
11361105
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 47
FDA-CBER-2021-5683-0221061
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1136
11361109
C4591001 1141
11411011
C4591001 1141
11411014
C4591001 1141
11411023
C4591001 1141
11411065
C4591001 1141
11411066
C4591001 1141
11411068
C4591001 1141
11411080
C4591001 1141
11411093
C4591001 1141
11411139
C4591001 1169
11691033
C4591001 1231
12313429
C4591001 1231
12313446
C4591001 1231
12313449
C4591001 1231
12313456
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 48
FDA-CBER-2021-5683-0221062
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1231
12313459
C4591001 1231
12313461
C4591001 1231
12313467
C4591001 1231
12313468 (2)
C4591001 1231
12313469 (2)
C4591001 1231
12313478
C4591001 1231
12313479
C4591001 1231
12313480
C4591001 1231
12313483
C4591001 1231
12313486
C4591001 1231
12313487
C4591001 1231
12313492
C4591001 1231
12313496
C4591001 1231
12313497
C4591001 1231
12313498
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 49
FDA-CBER-2021-5683-0221063
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1231
12313501
C4591001 1231
12313503
C4591001 1231
12313505
C4591001 1231
12313506
C4591001 1231
12313508
C4591001 1231
12313509
C4591001 1231
12313511
C4591001 1231
12313512
C4591001 1231
12313514
C4591001 1231
12313515
C4591001 1231
12313517
C4591001 1231
12313518
C4591001 1231
12313519
C4591001 1231
12313524
C4591001 1231
12313528
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 50
FDA-CBER-2021-5683-0221064
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1231
12313530
C4591001 1231
12313533
C4591001 1231
12313534
C4591001 1231
12313536
C4591001 1231
12313537
C4591001 1231
12313538
C4591001 1231
12313541
C4591001 1231
12313542
C4591001 1231
12313546
C4591001 1231
12313549
C4591001 1231
12313551
C4591001 1231
12313553
C4591001 1231
12313554
C4591001 1231
12313556
C4591001 1231
12313562
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 51
FDA-CBER-2021-5683-0221065
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1231
12313564
C4591001 1231
12313567
IP administered that was deemed not suitable for use by Almac 121 C4591001 1024
10241002
C4591001 1024
10241003
C4591001 1024
10241004
C4591001 1024
10241006
C4591001 1024
10241014
C4591001 1024
10241023
C4591001 1024
10241031
C4591001 1024
10241032
C4591001 1024
10241033
C4591001 1024
10241037
C4591001 1024
10241039
C4591001 1024
10241040
C4591001 1024
10241041
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 52
FDA-CBER-2021-5683-0221066
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1024
10241042
C4591001 1024
10241044
C4591001 1024
10241046
C4591001 1024
10241049
C4591001 1024
10241054
C4591001 1024
10241055
C4591001 1024
10241057
C4591001 1024
10241059
C4591001 1024
10241061
C4591001 1024
10241065
C4591001 1024
10241066
C4591001 1024
10241067
C4591001 1024
10241068
C4591001 1024
10241071
C4591001 1024
10241072
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 53
FDA-CBER-2021-5683-0221067
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1024
10241074
C4591001 1024
10241077
C4591001 1024
10241078
C4591001 1024
10241081
C4591001 1024
10241083
C4591001 1024
10241084
C4591001 1024
10241085
C4591001 1024
10241087
C4591001 1024
10241091
C4591001 1024
10241094
C4591001 1024
10241096
C4591001 1024
10241097
C4591001 1024
10241100
C4591001 1024
10241102
C4591001 1024
10241104
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 54
FDA-CBER-2021-5683-0221068
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1024
10241108
C4591001 1044
10441001
C4591001 1044
10441002
C4591001 1044
10441004
C4591001 1044
10441007
C4591001 1044
10441010
C4591001 1044
10441015
C4591001 1044
10441016
C4591001 1044
10441018
C4591001 1044
10441028
C4591001 1044
10441029
C4591001 1044
10441031
C4591001 1044
10441032
C4591001 1044
10441034
C4591001 1044
10441036
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 55
FDA-CBER-2021-5683-0221069
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1044
10441037
C4591001 1044
10441041
C4591001 1044
10441045
C4591001 1044
10441047
C4591001 1044
10441048
C4591001 1044
10441049
C4591001 1044
10441050
C4591001 1044
10441052
C4591001 1044
10441054
C4591001 1044
10441055
C4591001 1044
10441060
C4591001 1044
10441062
C4591001 1044
10441063
C4591001 1044
10441067
C4591001 1044
10441068
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 56
FDA-CBER-2021-5683-0221070
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1044
10441071
C4591001 1044
10441073
C4591001 1044
10441075
C4591001 1044
10441076
C4591001 1044
10441079
C4591001 1044
10441080
C4591001 1044
10441083
C4591001 1044
10441085
C4591001 1044
10441088
C4591001 1044
10441089
C4591001 1044
10441090
C4591001 1044
10441092
C4591001 1044
10441093
C4591001 1044
10441094
C4591001 1096
10961011
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 57
FDA-CBER-2021-5683-0221071
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1096
10961027
C4591001 1096
10961059
C4591001 1096
10961068
C4591001 1096
10961149
C4591001 1096
10961209
C4591001 1096
10961245
C4591001 1096
10961246
C4591001 1096
10961247
C4591001 1096
10961324
C4591001 1129
11291091
C4591001 1163
11631117
C4591001 1163
11631121
C4591001 1163
11631124
C4591001 1163
11631126
C4591001 1163
11631127
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 58
FDA-CBER-2021-5683-0221072
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1163
11631131
C4591001 1163
11631132
C4591001 1163
11631133
C4591001 1163
11631136
C4591001 1163
11631142
C4591001 1163
11631144
C4591001 1163
11631145
C4591001 1163
11631149
C4591001 1232
12321354
C4591001 1232
12321373
C4591001 1232
12321382
C4591001 1232
12321383
C4591001 1232
12321385
C4591001 1232
12321389†
C4591001 1232
12321390
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 59
FDA-CBER-2021-5683-0221073
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1232
12321394
C4591001 1232
12321395
C4591001 1232
12321398
Incorrect IP assigned to subject due to IRT not being utilized 4 C4591001 1121
11211071
C4591001 1163
11631005 (2)
C4591001 1163
11631006 (2)
C4591001 1163
11631008
Incorrect vaccine allocation/assigned to subject 11 C4591001 1012
10121103
C4591001 1054
10541024
C4591001 1079
10791130
C4591001 1081
10811053
C4591001 1088
10881077 (2)
C4591001 1090
10901334
C4591001 1116
11161226
C4591001 1169
11691049
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 60
FDA-CBER-2021-5683-0221074
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1177
11771089
C4591001 1231
12311057
C4591001 1265
12651026
Other IP deviation 23 C4591001 1037
10371356
C4591001 1081
10811204
C4591001 1096
10961195
C4591001 1096
10961197
C4591001 1101
11011024
C4591001 1126
11261053
C4591001 1129
11291115
C4591001 1129
11291166
C4591001 1161
11611015
C4591001 1163
11631003 (2)
C4591001 1163
11631007
C4591001 1163
11631008 (3)
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 61
FDA-CBER-2021-5683-0221075
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1163
11631010
C4591001 1163
11631011
C4591001 1163
11631013
C4591001 1163
11631030
C4591001 1163
11631039
C4591001 1163
11631062
C4591001 1163
11631064
C4591001 1163
11631092
C4591001 1163
11631096
C4591001 1213
12131012
C4591001 1221
12211079
Subject was vaccinated despite being ineligible 4 C4591001 1092
10921158
C4591001 1112
11121270†
C4591001 1170
11701334†
C4591001 1265
12651164†
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 62
FDA-CBER-2021-5683-0221076
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
Subject was vaccinated despite meeting temporary delay criterion #4 (receiving short -term (<14
days) systemic corticosteroids, IP administration should be delayed untill systemic corticosteroid
use has been discontinued for at least 28 days. 6 C4591001 100 7
10071105
C4591001 1028
10281241
C4591001 1028
10281294
C4591001 1097
10971060
C4591001 1231
12311499
C4591001 1247
12471244
Laboratory Nasal swab can't be analyzed due to incorrect shipping procedure 4 C4591001 1068
10681043
C4591001 1068
10681068
C4591001 1083
10831154
C4591001 1128
11281313
Other Efficacy data considered potentially unreliable due to lack of PI oversight identified as significant
quality event 33 C4591001 1161
11611001
C4591001 1161
11611003
C4591001 1161
11611004
C4591001 1161
11611007
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 63
FDA-CBER-2021-5683-0221077
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1161
11611008
C4591001 1161
11611009
C4591001 1161
11611010
C4591001 1161
11611014
C4591001 1161
11611017
C4591001 1161
11611020
C4591001 1161
11611021
C4591001 1161
11611022
C4591001 1161
11611023
C4591001 1161
11611024
C4591001 1161
11611025
C4591001 1161
11611026
C4591001 1161
11611027
C4591001 1161
11611028
C4591001 1161
11611029
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 64
FDA-CBER-2021-5683-0221078
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1161
11611030
C4591001 1161
11611031
C4591001 1161
11611032
C4591001 1161
11611033
C4591001 1161
11611034
C4591001 1161
11611035
C4591001 1161
11611036
C4591001 1161
11611037
C4591001 1161
11611038
C4591001 1161
11611040
C4591001 1161
11611041
C4591001 1161
11611042
C4591001 1161
11611043
C4591001 1161
11611044
Safety and efficacy data considered potentially unreliable due to lack of PI oversight identified as
significant quality event. 10 C4591001 1161
11611002
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 65
FDA-CBER-2021-5683-0221079
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1161
11611005
C4591001 1161
11611006
C4591001 1161
11611011
C4591001 1161
11611012
C4591001 1161
11611013
C4591001 1161
11611015
C4591001 1161
11611016
C4591001 1161
11611018
C4591001 1161
11611019
Procedures/tests Procedure/Test not done 1 C4591001 1146
11461010
Subject had a vaccination diary activated, but was not part of the reactogenicity subset 31 C4591001 1098
10981168† (2)
C4591001 1098
10981169†
C4591001 1110
11101279†
C4591001 1112
11121174
C4591001 1133
11331537
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 66
FDA-CBER-2021-5683-0221080
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1219
12191001
C4591001 1219
12191002
C4591001 1219
12191003
C4591001 1219
12191004
C4591001 1219
12191005
C4591001 1219
12191007
C4591001 1219
12191008
C4591001 1219
12191009
C4591001 1219
12191010
C4591001 1219
12191011
C4591001 1219
12191012
C4591001 1219
12191013
C4591001 1219
12191014
C4591001 1219
12191015
C4591001 1219
12191016
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 67
FDA-CBER-2021-5683-0221081
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject
(Number of
Deviations if >1)
C4591001 1219
12191017
C4591001 1219
12191018
C4591001 1219
12191042
C4591001 1219
12191043
C4591001 1219
12191044
C4591001 1219
12191045
C4591001 1219
12191048
C4591001 1235
12351150
C4591001 1235
12351152
C4591001 1235
12351153
C4591001 1235
12351155
Note: † = Human immunodeficiency virus (HIV) -positive subject, ^ = Phase 1 subjects.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: addv Table Generation: 27MAR2021 (01:38)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_BLA/addv_l001_all
090177e196af71f9\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 68
FDA-CBER-2021-5683-0221082