Document text
16.2.2.1 Listing of Important Protocol Deviations – Subjects 12 Through 25 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Age Group/Subject
(Number of
Deviations if >1)
Concomitant
medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. 14 16-25 Years/C4591001
1007 10071082 (2)
16-25 Years/C4591001
1007 10071556
12-15 Years/C4591001
1007 10071593
16-25 Years/C4591001
1080 10801019
16-25 Years/C4591001
1080 10801055
16-25 Years/C4591001
1085 10851244
16-25 Years/C4591001
1091 10911122
16-25 Years/C4591001
1094 10941169
16-25 Years/C4591001
1121 11211067
16-25 Years/C4591001
1128 11281177
16-25 Years/C4591001
1167 11671132
16-25 Years/C4591001
1169 11691014
16-25 Years/C4591001
1231 12312528
16-25 Years/C4591001
1269 12691047
Subject received systemic corticosteroids (>=20mg/day of prednisone or equivalent) for >=14
days is prohibited from 28 days prior to enrollment to specified visits/cohorts per protocol. 2 12-15 Years/C4591001
1126 11261254
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16.2.2.1 Listing of Important Protocol Deviations – Subjects 12 Through 25 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Age Group/Subject
(Number of
Deviations if >1)
16-25 Years/C4591001
1247 12471244
Inclusion/exclusion 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) 3 16-25 Years/C4591001
1120 11201038
16-25 Years/C4591001
1161 11611023
16-25 Years/C4591001
1231 12311088
Participant met exclusion criterion #01 (participant having other medical or psychiatric
condition) 3 16-25 Years/C4591001
1006 10061246
12-15 Years/C4591001
1006 10061272
12-15 Years/C4591001
1009 10091320
Participant met exclusion criterion #05 (previous clinical or microbiological diagnosis of
COVID -19) 1 16-25 Years/C4591001
1231 12311191
Participant met exclusion criterion #11 (women who are pregnant or breastfeeding) 4 16-25 Years/C4591001
1133 11331207
16-25 Years/C4591001
1156 11561015
16-25 Years/C4591001
1161 11611016
16-25 Years/C4591001
1254 12541142
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 membe rs) 3 16-25 Years/C4591001
1112 11121058
16-25 Years/C4591001
1161 11611008
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16.2.2.1 Listing of Important Protocol Deviations – Subjects 12 Through 25 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Age Group/Subject
(Number of
Deviations if >1)
16-25 Years/C4591001
1161 11611018
Investigational product Blind compromised 1 16-25 Years/C4591001
1096 10961195
Dosing/administration error, subject did not receive correct dose of vaccine 16 16-25 Years/C4591001
1068 10681002
16-25 Years/C4591001
1068 10681010
16-25 Years/C4591001
1068 10681018
16-25 Years/C4591001
1068 10681037
16-25 Years/C4591001
1068 10681047
16-25 Years/C4591001
1141 11411065
16-25 Years/C4591001
1141 11411139
16-25 Years/C4591001
1231 12313467
16-25 Years/C4591001
1231 12313498
16-25 Years/C4591001
1231 12313505
16-25 Years/C4591001
1231 12313515
16-25 Years/C4591001
1231 12313519
16-25 Years/C4591001
1231 12313533
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16.2.2.1 Listing of Important Protocol Deviations – Subjects 12 Through 25 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Age Group/Subject
(Number of
Deviations if >1)
16-25 Years/C4591001
1231 12313542
16-25 Years/C4591001
1231 12313546
16-25 Years/C4591001
1231 12313553
IP administered that was deemed not suitable for use by Almac 4 16-25 Years/C4591001
1024 10241091
16-25 Years/C4591001
1044 10441034
16-25 Years/C4591001
1096 10961027
16-25 Years/C4591001
1096 10961245
Other IP deviation 3 16-25 Years/C4591001
1096 10961195
16-25 Years/C4591001
1126 11261053
16-25 Years/C4591001
1161 11611015
Subject was vaccinated despite being ineligible 1 16-25 Years/C4591001
1092 10921158
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. 2 16-25 Years/C4591001
1028 10281294
16-25 Years/C4591001
1247 12471244
Other Efficacy data considered potentially unreliable due to lack of PI oversight identified as
significant quality event 8 16-25 Years/C4591001
1161 11611007
16-25 Years/C4591001
1161 11611008
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16.2.2.1 Listing of Important Protocol Deviations – Subjects 12 Through 25 Years of Ag e
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Age Group/Subject
(Number of
Deviations if >1)
16-25 Years/C4591001
1161 11611009
16-25 Years/ C4591001
1161 11611010
16-25 Years/C4591001
1161 11611023
16-25 Years/C4591001
1161 11611024
16-25 Years/C4591001
1161 11611026
16-25 Years/C4591001
1161 11611028
Safety and efficacy data considered potentially unreliable due to lack of PI oversight identified
as significant quality event. 5 16-25 Years/C4591001
1161 11611006
16-25 Years/C4591001
1161 11611015
16-25 Years/C4591001
1161 11611016
16-25 Years/C4591001
1161 11611018
16-25 Years/C4591001
1161 11611019
Procedures/tests Subject had a vaccination diary activated, but was not part of the reactogenicity subset 2 16-25 Years/C4591001
1219 12 191004
16-25 Years/C4591001
1235 12351153
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: addv Table Generation: 27MAR2021 (01:37)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_BLA/addv_l001_pd_ped
090177e196ac9157\Final\Final On: 31-Mar-2021 13:05 (GMT)
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16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
Dosing/administration error, subj ect did not receive correct dose of vaccine 1 C4591001 1231
12313428
Concomitant
medications Receipt of any other nonstudy coronavirus vaccine at any time p rior to or during the study. 259 C4591001 1003
10031166
C4591001 1006
10061078 (2)
C4591001 1006
10061109 (2)
C4591001 1007
10071082 (2)
C4591001 1007
10071110
C4591001 1007
10071186
C4591001 1007
10071212
C4591001 1007
10071218
C4591001 1007
10071225
C4591001 1007
10071243
C4591001 1007
10071250
C4591001 1007
10071266
C4591001 1007
10071269
C4591001 1007
10071276
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16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1007
10071286
C4591001 1007
10071295
C4591001 1007
10071339
C4591001 1007
10071380
C4591001 1007
10071387
C4591001 1007
10071402
C4591001 1007
10071556
C4591001 1009
10091133
C4591001 1009
10091185
C4591001 1012
10121083
C4591001 1012
10121110
C4591001 1015
10151116
C4591001 1016
10161087
C4591001 1016
10161280
C4591001 1018
10181009
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16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1018
10181027
C4591001 1018
10181039
C4591001 1018
10181058
C4591001 1018
10181105
C4591001 1018
10181111
C4591001 1018
10181113
C4591001 1018
10181127
C4591001 1018
10181141
C4591001 1018
10181164
C4591001 1018
10181170
C4591001 1018
10181191
C4591001 1018
10181204
C4591001 1018
10181214
C4591001 1018
10181223
C4591001 1018
10181302
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16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1018
10181306
C4591001 1018
10181319
C4591001 1019
10191063
C4591001 1028
10281162 (2)
C4591001 1037
10371219
C4591001 1039
10391124
C4591001 1039
10391153
C4591001 1042
10421028
C4591001 1042
10421262
C4591001 1044
10441056
C4591001 1048
10481027
C4591001 1048
10481070
C4591001 1048
10481085
C4591001 1052
10521121
C4591001 1054
10541110
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16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1054
10541161
C4591001 1055
10551145
C4591001 1055
10551152
C4591001 1056
10561009 (2)
C4591001 1056
10561197 (2)
C4591001 1056
10561477 (2)
C4591001 1057
10571050
C4591001 1057
10571198
C4591001 1057
10571201
C4591001 1057
10571222
C4591001 1057
10571236 (2)
C4591001 1066
10661121
C4591001 1071
10711234
C4591001 1072
10721012
C4591001 1072
10721029
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16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1072
10721058
C4591001 1072
10721077
C4591001 1072
10721084
C4591001 1079
10791177 (2)
C4591001 1080
10801019
C4591001 1080
10801055
C4591001 1081
10811094
C4591001 1081
10811114
C4591001 1081
10811186
C4591001 1083
10831154
C4591001 1083
10831162
C4591001 1083
10831242
C4591001 1083
10831252
C4591001 1083
10831284
C4591001 1084
10841017
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16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1084
10841061
C4591001 1084
10841137
C4591001 1084
10841156
C4591001 1084
10841241
C4591001 1084
10841358
C4591001 1084
10841439 (2)
C4591001 1084
10841456
C4591001 1084
10841480
C4591001 1085
10851064
C4591001 1085
10851069
C4591001 1085
10851136
C4591001 1085
10851137
C4591001 1085
10851237
C4591001 1085
10851244
C4591001 1085
10851286 (2)
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16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1085
10851287
C4591001 1087
10871066
C4591001 1089
10891103 (2)
C4591001 1091
10911091
C4591001 1091
10911122
C4591001 1091
10911215
C4591001 1093
10931216
C4591001 1094
10941167
C4591001 1094
10941169
C4591001 1095
10951031
C4591001 1096
10961026
C4591001 1096
10961109
C4591001 1096
10961216
C4591001 1096
10961256
C4591001 1096
10961318
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16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1098
10981224
C4591001 1107
11071013
C4591001 1109
11091275
C4591001 1109
11091352
C4591001 1110
11101053
C4591001 1110
11101177
C4591001 1110
11101234
C4591001 1110
11101244
C4591001 1111
11111051
C4591001 1112
11121062
C4591001 1112
11121083
C4591001 1112
11121135
C4591001 1112
11121243
C4591001 1114
11141015
C4591001 1114
11141054
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16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1116
11161008
C4591001 1116
11161012 (2)
C4591001 1120
11201096
C4591001 1121
11211029 (2)
C4591001 1121
11211057 (2)
C4591001 1121
11211059
C4591001 1121
11211067
C4591001 1121
11211087
C4591001 1122
11221003
C4591001 1122
11221038
C4591001 1123
11231104
C4591001 1123
11231145
C4591001 1123
11231249
C4591001 1124
11241025
C4591001 1124
11241052
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16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1124
11241103
C4591001 1124
11241120 (2)
C4591001 1125
11251043
C4591001 1126
11261045
C4591001 1126
11261080
C4591001 1126
11261135
C4591001 1126
11261151
C4591001 1128
11281026
C4591001 1128
11281083
C4591001 1128
11281112
C4591001 1128
11281132
C4591001 1128
11281177
C4591001 1128
11281227
C4591001 1128
11281265
C4591001 1129
11291064
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16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1129
11291072
C4591001 1130
11301028
C4591001 1130
11301094 (2)
C4591001 1133
11331130
C4591001 1133
11331406
C4591001 1133
11331438 (2)
C4591001 1133
11331555
C4591001 1135
11351241 (2)
C4591001 1135
11351555
C4591001 1139
11391042
C4591001 1140
11401176
C4591001 1142
11421112
C4591001 1147
11471001
C4591001 1147
11471007 (3)
C4591001 1147
11471047
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16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1149
11491025 (2)
C4591001 1149
11491040
C4591001 1149
11491307
C4591001 1152
11521137
C4591001 1152
11521192 (2)
C4591001 1152
11521347 (2)
C4591001 1167
11671071 (2)
C4591001 1167
11671132
C4591001 1169
11691014
C4591001 1169
11691023
C4591001 1169
11691034
C4591001 1169
11691057
C4591001 1169
11691069
C4591001 1170
11701026
C4591001 1170
11701045
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16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1170
11701081
C4591001 1170
11701110
C4591001 1170
11701171
C4591001 1170
11701209
C4591001 1170
11701231 (2)
C4591001 1170
11701296
C4591001 1170
11701413
C4591001 1171
11711071
C4591001 1171
11711181
C4591001 1171
11711183
C4591001 1171
11711186
C4591001 1171
11711247
C4591001 1171
11711250
C4591001 1171
11711261
C4591001 1177
11771076
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16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1177
11771157
C4591001 1177
11771369
C4591001 1178
11781065
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
12262132
C4591001 1226
12262138
C4591001 1231
12311081
C4591001 1231
12311145
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16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1231
12311230
C4591001 1231
12311237
C4591001 1231
12311647
C4591001 1231
12311975 (2)
C4591001 1231
12312528
C4591001 1231
12312856
C4591001 1231
12313059
C4591001 1231
12314046
C4591001 1231
12314324
C4591001 1231
12314974
C4591001 1231
12315286
C4591001 1231
12315386
C4591001 1231
12315578
C4591001 1232
12321054
C4591001 1232
12321202
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16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1241
12411211
C4591001 1241
12411449
C4591001 1241
12411465 (2)
C4591001 1241
12411569 (2)
C4591001 1241
12412120
C4591001 1254
12541007
C4591001 1254
12541167
C4591001 1264
12641159
C4591001 1265
12651153 (2)
C4591001 1269
12691014
C4591001 1269
12691026
C4591001 1269
12691047
C4591001 1269
12691088
C4591001 1270
12701003
C4591001 1270
12701008
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16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1270
12701069
C4591001 1270
12701118
C4591001 1270
12701137
C4591001 4444
44441327
C4591001 4444
44442088
Receipt of blood/plasma products or immunoglobulin s within 60 days before enrollment through
conclusion of the stud y.8 C4591001 1091
10911241
C4591001 1096
10961012
C4591001 1096
10961305
C4591001 1107
11071065
C4591001 1170
11701482
C4591001 1218
12181027
C4591001 1231
12313697
C4591001 1231
12313895
Subject received chronic systemic treatment with known immunosu ppressant medication, or
radiotherap y, within 60 da ys before enrollment throu gh conclusion of the stud y.6 C4591001 1028
10281059
C4591001 1046
10461261
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16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1128
11281241
C4591001 1140
11401020 (2)
C4591001 1226
12262078
C4591001 1254
12541144
Subject received systemic cortico steroids (>=20mg/day of predni sone or equivalent) for >=14 days is
prohibited from 28 da ys prior to enrollment to specified visits/cohorts per protocol.7 C4591001 1003
10031101
C4591001 1007
10071276
C4591001 1028
10281026
C4591001 1220
12201029
C4591001 1221
12211002 (2)
C4591001 1247
12471244
C4591001 1261
12611054
Inclusion/exclusion Participant failed to meet inclusion criterion #01 (Male or female participants bet ween the ages of 18
and 55 years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
(dependent upon stud y phase).1 C4591001 1142
11421084
Participant failed to meet inclusi on criterion #02 (Participant s who are willing and able to comply
with all scheduled visits, vaccin ation plan, laboratory tests, lifestyle considerations, and other study
procedures). 1 C4591001 1229
12291135†
Participant failed to meet inclusi on criterion #03 (Healthy par ticipants who are determined by
medical history, physical examination and clinical judgement of the investigator to be eligible for
inclusion in the stud y)9 C4591001 1044
10441152†
090177e196ac9177\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 24
FDA-CBER-2022-5812-0231579
16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1096
10961036
C4591001 1117
11171036
C4591001 1117
11171186
C4591001 1120
11201038
C4591001 1161
11611023
C4591001 1203
12031048
C4591001 1231
12311088
C4591001 1231
12313140
Participant met exclusion criteri on #01 (participant having oth er medical or psychiatric condition) 4 C4591001 1006
10061246
C4591001 1096
10961036
C4591001 1117
11171036
C4591001 1117
11171186
Participant met exclusion criteri on #02 (participant having known infection with H IV, HCV or HBV) 6 C4591001 1098
10981155
C4591001 1098
10981168†
C4591001 1098
10981169†
090177e196ac9177\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 25
FDA-CBER-2022-5812-0231580
16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1170
11701457†
C4591001 1224
12241158†
C4591001 1226
12262255†
Participant met exclusion criteri on #05 (previous clinical or m icrobiological diagnosis of COVID-19) 4 C4591001 1054
10541033
C4591001 1231
12311191
C4591001 1231
12313211
C4591001 1235
12351167
Participant met exclusion criteri on #11 (women who are pregnant or breastfeeding) 23 C4591001 1003
10031186
C4591001 1015
10151071
C4591001 1047
10471301
C4591001 1133
11331207
C4591001 1136
11361082
C4591001 1152
11521450
C4591001 1156
11561015
C4591001 1161
11611016
090177e196ac9177\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 26
FDA-CBER-2022-5812-0231581
16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
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
C4591001 1231
12312378
C4591001 1231
12313998
C4591001 1241
12411679
C4591001 1241
12412369
C4591001 1241
12412411
C4591001 1254
12541142
C4591001 1254
12541145
090177e196ac9177\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 27
FDA-CBER-2022-5812-0231582
16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
Participant met exclusion criterion #13 (particip ant receiving treatment with immunosuppressive
therap y as specified in protocol)1 C4591001 1038
10381061
Participant met exclusion criteri on #16 (Participation in other studies involving study intervention
within 28 da ys prior to stud y entry and/or durin g stud y participation) 3 C4591001 1006
10061099
C4591001 1081
10811114
C4591001 1081
10811186
Participant met exclusion criteri on #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
famil y members)6 C4591001 1112
11121058
C4591001 1161
11611002
C4591001 1161
11611008
C4591001 1161
11611011
C4591001 1161
11611014
C4591001 1161
11611018
Investigational product Blind compromised 2 C4591001 1096
10961195
C4591001 1096
10961197
Dosing/administration error, subj ect did not receive correct dose of vaccine 96 C4591001 1068
10681002
C4591001 1068
10681003
C4591001 1068
10681006
090177e196ac9177\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 28
FDA-CBER-2022-5812-0231583
16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1068
10681010
C4591001 1068
10681011
C4591001 1068
10681012
C4591001 1068
10681013
C4591001 1068
10681016
C4591001 1068
10681017
C4591001 1068
10681018
C4591001 1068
10681021
C4591001 1068
10681024
C4591001 1068
10681025
C4591001 1068
10681026
C4591001 1068
10681027
C4591001 1068
10681028
C4591001 1068
10681031
C4591001 1068
10681034
090177e196ac9177\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 29
FDA-CBER-2022-5812-0231584
16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1068
10681035
C4591001 1068
10681036
C4591001 1068
10681037
C4591001 1068
10681038
C4591001 1068
10681042
C4591001 1068
10681046
C4591001 1068
10681047
C4591001 1068
10681052
C4591001 1068
10681053
C4591001 1068
10681058
C4591001 1068
10681060
C4591001 1068
10681061
C4591001 1068
10681064
C4591001 1068
10681066
C4591001 1068
10681071
090177e196ac9177\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 30
FDA-CBER-2022-5812-0231585
16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1068
10681072
C4591001 1068
10681073
C4591001 1068
10681074
C4591001 1068
10681076
C4591001 1068
10681077
C4591001 1068
10681080
C4591001 1068
10681081
C4591001 1068
10681083
C4591001 1091
10911005
C4591001 1091
10911008
C4591001 1091
10911014
C4591001 1091
10911015
C4591001 1136
11361027
C4591001 1136
11361039
C4591001 1136
11361083
090177e196ac9177\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 31
FDA-CBER-2022-5812-0231586
16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1136
11361084
C4591001 1136
11361109
C4591001 1141
11411011
C4591001 1141
11411014
C4591001 1141
11411023
C4591001 1141
11411065
C4591001 1141
11411068
C4591001 1141
11411080
C4591001 1141
11411093
C4591001 1141
11411139
C4591001 1169
11691033
C4591001 1231
12313429
C4591001 1231
12313449
C4591001 1231
12313456
C4591001 1231
12313459
090177e196ac9177\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 32
FDA-CBER-2022-5812-0231587
16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1231
12313467
C4591001 1231
12313469 (2)
C4591001 1231
12313479
C4591001 1231
12313483
C4591001 1231
12313486
C4591001 1231
12313487
C4591001 1231
12313492
C4591001 1231
12313497
C4591001 1231
12313498
C4591001 1231
12313501
C4591001 1231
12313505
C4591001 1231
12313506
C4591001 1231
12313508
C4591001 1231
12313509
C4591001 1231
12313512
090177e196ac9177\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 33
FDA-CBER-2022-5812-0231588
16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1231
12313514
C4591001 1231
12313515
C4591001 1231
12313517
C4591001 1231
12313518
C4591001 1231
12313519
C4591001 1231
12313528
C4591001 1231
12313533
C4591001 1231
12313534
C4591001 1231
12313537
C4591001 1231
12313541
C4591001 1231
12313542
C4591001 1231
12313546
C4591001 1231
12313551
C4591001 1231
12313553
C4591001 1231
12313554
090177e196ac9177\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 34
FDA-CBER-2022-5812-0231589
16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1231
12313556
C4591001 1231
12313564
C4591001 1231
12313567
IP administered that was deemed not suita ble for use by Almac 68 C4591001 1024
10241002
C4591001 1024
10241004
C4591001 1024
10241006
C4591001 1024
10241014
C4591001 1024
10241023
C4591001 1024
10241032
C4591001 1024
10241033
C4591001 1024
10241039
C4591001 1024
10241040
C4591001 1024
10241042
C4591001 1024
10241044
C4591001 1024
10241046
090177e196ac9177\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 35
FDA-CBER-2022-5812-0231590
16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1024
10241054
C4591001 1024
10241055
C4591001 1024
10241061
C4591001 1024
10241066
C4591001 1024
10241067
C4591001 1024
10241071
C4591001 1024
10241072
C4591001 1024
10241074
C4591001 1024
10241078
C4591001 1024
10241084
C4591001 1024
10241085
C4591001 1024
10241091
C4591001 1024
10241094
C4591001 1024
10241100
C4591001 1024
10241102
090177e196ac9177\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 36
FDA-CBER-2022-5812-0231591
16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1024
10241104
C4591001 1024
10241108
C4591001 1044
10441001
C4591001 1044
10441015
C4591001 1044
10441028
C4591001 1044
10441029
C4591001 1044
10441031
C4591001 1044
10441034
C4591001 1044
10441037
C4591001 1044
10441045
C4591001 1044
10441048
C4591001 1044
10441050
C4591001 1044
10441052
C4591001 1044
10441054
C4591001 1044
10441060
090177e196ac9177\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 37
FDA-CBER-2022-5812-0231592
16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1044
10441063
C4591001 1044
10441068
C4591001 1044
10441071
C4591001 1044
10441076
C4591001 1044
10441079
C4591001 1044
10441088
C4591001 1044
10441089
C4591001 1096
10961011
C4591001 1096
10961027
C4591001 1096
10961059
C4591001 1096
10961209
C4591001 1096
10961245
C4591001 1096
10961246
C4591001 1163
11631117
C4591001 1163
11631121
090177e196ac9177\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 38
FDA-CBER-2022-5812-0231593
16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1163
11631124
C4591001 1163
11631127
C4591001 1163
11631136
C4591001 1163
11631142
C4591001 1163
11631145
C4591001 1232
12321354
C4591001 1232
12321373
C4591001 1232
12321382
C4591001 1232
12321385
C4591001 1232
12321394
C4591001 1232
12321395
Incorrect IP assigned to subject due to IRT not being utilized 1 C4591001 1163
11631006 (2)
Incorrect vaccine allocation/assigned to subject 6 C4591001 1012
10121103
C4591001 1079
10791130
C4591001 1088
10881077 (2)
090177e196ac9177\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 39
FDA-CBER-2022-5812-0231594
16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1090
10901334
C4591001 1116
11161226
C4591001 1169
11691049
Other IP deviation 10 C4591001 1096
10961195
C4591001 1096
10961197
C4591001 1101
11011024
C4591001 1126
11261053
C4591001 1161
11611015
C4591001 1163
11631039
C4591001 1163
11631064
C4591001 1163
11631096
C4591001 1213
12131012
C4591001 1221
12211079
Subject was vaccinated de spite being ineligible 4 C4591001 1092
10921158
C4591001 1112
11121270†
090177e196ac9177\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 40
FDA-CBER-2022-5812-0231595
16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1170
11701334†
C4591001 1265
12651164†
Subject was vaccinated despite meeting temporary delay criterio n #4 (receiving short-term (<14
days) systemic corticosteroids, I P administration should be del ayed untill systemic corticosteroid use
has been discontinued for at least 28 da ys.4 C4591001 1028
10281241
C4591001 1028
10281294
C4591001 1231
12311499
C4591001 1247
12471244
Laboratory Nasal swab can't be analyzed due to incorrect shipping procedure 1 C4591001 1083
10831154
Other Efficacy data considered potentially unreliable due to lack of PI oversight identified as significant
qualit y even t 19 C4591001 1161
11611001
C4591001 1161
11611004
C4591001 1161
11611007
C4591001 1161
11611008
C4591001 1161
11611009
C4591001 1161
11611010
C4591001 1161
11611014
C4591001 1161
11611017
090177e196ac9177\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 41
FDA-CBER-2022-5812-0231596
16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1161
11611020
C4591001 1161
11611023
C4591001 1161
11611024
C4591001 1161
11611026
C4591001 1161
11611027
C4591001 1161
11611028
C4591001 1161
11611032
C4591001 1161
11611033
C4591001 1161
11611034
C4591001 1161
11611040
C4591001 1161
11611041
Safety and efficacy data consider ed potentially unreliable due to lack of PI oversight identified as
significant qualit y event.8 C4591001 1161
11611002
C4591001 1161
11611005
C4591001 1161
11611006
C4591001 1161
11611011
090177e196ac9177\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 42
FDA-CBER-2022-5812-0231597
16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
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 ac tivated, but was not part of the reactogenicity subset 18 C4591001 1098
10981168† (2)
C4591001 1098
10981169†
C4591001 1112
11121174
C4591001 1133
11331537
C4591001 1219
12191001
C4591001 1219
12191002
C4591001 1219
12191003
C4591001 1219
12191004
C4591001 1219
12191013
C4591001 1219
12191014
090177e196ac9177\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 43
FDA-CBER-2022-5812-0231598
16.2.2.2 Listing of Important Protocol Deviations – Phase 2/3 S ubjects 16-55 Years of Age
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
SubjectsSubject
(Number of
Deviations if >1)
C4591001 1219
12191016
C4591001 1219
12191017
C4591001 1219
12191042
C4591001 1219
12191044
C4591001 1219
12191048
C4591001 1235
12351152
C4591001 1235
12351153
C4591001 1235
12351155
Note: † = Human immunodeficiency virus (HIV)-positive subject.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: addv Table Generation: 30MAR2021 (13:45)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 _unblinded/C4591001 _EUA _1655/addv _l001_1655
090177e196ac9177\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 44
FDA-CBER-2022-5812-0231599