Document text
16.2.3.1.1 Listing of Subjects Excluded From All -Available and Evaluable Immunogenicity Populations –
Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Popula tion Reason for Exclusion
BNT162b1 65-85 10 μg C4591001 1002 10021053 Dose 1 evaluable Had major protocol deviation(s) as determined by the clinician.
Dose 2 evaluable Had major protocol deviation(s) as determined by the clinician.
BNT162b2 18-55 10 μg C4591001 1003 10031021 Dose 1 evaluable Had major protocol deviation(s) as determined by the clinician.
Dose 2 evaluable Had major protocol deviation(s) as determined by the clinician.
30 μg C4591001 1007 10071050 Dose 2 evaluable Did not have blood collection within 6 -8 days after Dose 2.
Placebo 18-55 Placebo C4591001 1003 10031017 Dose 1 evaluable Had major protocol deviation(s) as determined by the clinician.
Dose 2 evaluable Had major protocol deviation(s) as determined by the clinician.
C4591001 1003 10031070 Dose 1 evaluable Had major protocol deviation(s) as determined by the clinician.
Dose 2 evaluable Had major protocol deviation(s) as determined by the clinician.
BNT162b2 65-85 20 μg C4591001 1003 10031055 Dose 2 evaluable Did not have blood collection within 6 -8 days after Dose 2.
30 μg C4591001 1003 10031047 Dose 1 evaluable Had major protocol deviation(s) as determined by the clinician.
Dose 2 evaluable Had major protocol deviation(s) as determined by the clinician.
PFIZER CONFIDENTIAL SDTM Creation: 28AUG2020 (16:27) Source Data: adsl Table Generation: 17SEP2020 (23:36)
(Cutoff Date: 24AUG2020, Snapshot Date: 17SEP2020) Output File: ./nda3/C4591001 I A P1 Serology/adsl l001 excl eval p1
090177e194f60645\Final\Final On: 19-Sep-2020 01:53 (GMT)
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FDA-CBER-2021-5683-0019382
16.2.3.1.1.1 Listing of Subjects Excluded From All -Available and Evaluable Immunogenicity Populations – Phase 1 –
BNT162b1 (100 μg )
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Populati on Reason for Exclusion
No subject meets the reporting criteria.
PFIZER CONFIDENTIAL SDTM Creation: 17SEP2020 (22:01) Source Data: adsl Table Generation: 22SEP2020 (00:02)
(Cutoff Date: 24AUG2020, Snapshot Date: 17SEP2020) Output File: ./nda3/C4591001_IA_P1_100/adsl_l001_excl_eval_100_p1
090177e194ffc5a8\Final\Final On: 24-Sep-2020 01:40 (GMT)
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FDA-CBER-2021-5683-0019383
16.2.3.1.2 Listing of Subjects Excluded From All -Available and Evaluable Immunogenicity Populations – Phase 2
Age
Group
(Years) Subject Population Reason for Exclusion
18-55 C4591001 1003 10031101 Dose 2 Evaluable Had important protocol deviation(s) as determined by the clinician.
C4591001 1003 10031104 Dose 2 All -available Did not have at least 1 valid and determinate immunogenicity result after
Dose 2.
Dose 2 Evaluable Did not have at least 1 valid and determinate immunogenicity result after
Dose 2.
C4591001 1007 10071095 Dose 2 Evaluable Did not receive Dose 2 with in 19 -42 days after Dose 1.
C4591001 1013 10131019 Dose 2 Evaluable Did not have blood collection within 28 -42 days after Dose 2.
C4591001 1013 10131025 Dose 2 Evaluable Did not have blood collection within 28 -42 days after Dose 2.
C4591001 1079 10791004 Dose 2 All -available Did not receive Dose 2.
Dose 2 Evaluable Did not receive 2 doses of the vaccine to which they are randomly assigned.
C4591001 1082 10821004 Dose 2 Evaluable Did not have blood collection within 28 -42 days after Dose 2.
C4591001 1085 10851003 Dose 2 All -available Did not have at least 1 valid and determinate immunogenicity result after
Dose 2.
Dose 2 Evaluable Did not have at least 1 valid and determinate immunogenicity result after
Dose 2; did not have blood collection within 28 -42 days after Dose 2.
C4591001 1109 11091006 Dose 2 Evaluable Did not have blood collection within 28 -42 days after Dose 2.
C4591001 1109 11091018 Dose 2 Evaluable Did not have blood collection within 28 -42 days after Dose 2.
C4591001 1109 11091024 Dose 2 Evaluable Did not have blood collection within 28 -42 days after Dose 2.
C4591001 1109 11091030 Dose 2 All -available Did not have at least 1 valid and determin ate immunogenicity result after
Dose 2.
Dose 2 Evaluable Did not have at least 1 valid and determinate immunogenicity result after
Dose 2; did not have blood collection within 28 -42 days after Dose 2.
C4591001 1120 11201001 Dose 2 Evaluable Did not have blood collection within 28 -42 days after Dose 2.
C4591001 1129 11291005 Dose 2 All -available Did not have at least 1 valid and determinate immunogenicity result after
Dose 2.
Dose 2 Evaluable Did not have at least 1 va lid and determinate immunogenicity result after
Dose 2.
090177e1958a0c27\Final\Final On: 17-Nov-2020 05:40 (GMT)
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FDA-CBER-2021-5683-0019384
16.2.3.1.2 Listing of Subjects Excluded From All -Available and Evaluable Immunogenicity Populations – Phase 2
Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1129 11291014 Dose 2 Evaluable Did not have blood collection within 28 -42 days after Dose 2.
56-85 C4591001 1001 10011096 Dose 2 All -available Did not have at least 1 valid and determinat e immunogenicity result after
Dose 2.
Dose 2 Evaluable Did not have at least 1 valid and determinate immunogenicity result after
Dose 2.
C4591001 1082 10821001 Dose 2 Evaluable Did not have blood collection within 28 -42 days after Dose 2.
C4591001 1084 10841006 Dose 2 Evaluable Did not receive Dose 2 within 19 -42 days after Dose 1.
C4591001 1089 10891004 Dose 2 Evaluable Did not receive Dose 2 within 19 -42 days after Dose 1 .
C4591001 1109 11091032 Dose 2 Evaluable Did not have blood collection within 28 -42 days after Dose 2.
C4591001 1127 11271002 Dose 2 Evaluable Did not receive Dose 2 within 19 -42 days after Dose 1.
C4591001 1127 11271003 Dose 2 Evaluable Did not receive Dose 2 within 19 -42 days after Dose 1.
C4591001 1140 11401002 Dose 2 All -available Did not have at least 1 valid and determinate immunogenicity result after
Dose 2.
Dose 2 Evaluable Did not have at least 1 valid and determinate immunogenicity result after
Dose 2; did not have blood collection within 28 -42 days after Dose 2.
C4591001 1140 11401003 Dose 2 All -available Did not have at least 1 valid and determinate immunogenicity result after
Dose 2.
Dose 2 Eval uable Did not have at least 1 valid and determinate immunogenicity result after
Dose 2; did not have blood collection within 28 -42 days after Dose 2.
PFIZER CONFIDENTIAL SDTM Creation: 02NOV2020 (19:23) Source Data: adsl Table Generation: 12NOV2020 (02:22)
(Cutoff Date: 12OCT2020, Snapshot Date: 02NOV2020) Output File: ./nda2_unblinded/C4591001_IA_P2_Serology/adsl_l001_excl_p2_ev al
090177e1958a0c27\Final\Final On: 17-Nov-2020 05:40 (GMT)
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FDA-CBER-2021-5683-0019385
16.2.3.2.1 Listing of Subjects Excluded From Safety Population – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Reason for Exclusion
No subject meet s the reporting criteria.
PFIZER CONFIDENTIAL SDTM Creation: 28AUG2020 (16:27) Source Data: adsl Table Generation: 31AUG2020 (10:58)
(Cutoff Date: 24AUG2020, Snapshot Date: 28AUG2020) Output File: (CDISC)/C4591001 IA P1/adsl l001 excl saf p1
090177e194d78550\Final\Final On: 07-Sep-2020 03:52 (GMT)
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FDA-CBER-2021-5683-0019386
16.2.3.2.1.1 Listing of Subjects Excluded From Safety Population – Phase 1 – BNT162b1 (100 μg )
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Reason for Exclusion
No subject meets the reporting criteria.
PFIZER CONFIDENTIAL SDTM Creation: 28AUG2020 (16:27) Source Data: adsl Table Generation: 18SEP2020 (13:43)
(Cutoff Date: 24AUG2020, Snapshot Date: 28AUG2020) Output File: ./nda3/C4591001 IA P1 100/adsl l001 excl saf 100 p1
090177e194fbc506\Final\Final On: 22-Sep-2020 14:24 (GMT)
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FDA-CBER-2021-5683-0019387
16.2.3.2.2 Listing of Subjects Excluded From Safety Population – Phase 2
Age Group
(Years) Subject Reason for Exclusion
No subject meets the reporting criteria.
PFIZER CONFIDENTIAL SDTM Creation: 05SEP202 0 (14:18) Source Data: adsl Table Generation: 09SEP2020 (23:18)
(Cutoff Date: 02SEP2020, Snapshot Date: 04SEP2020) Output File: ./nda2_unblinded/C4591001_IA_P2/adsl_l001_excl_p2_saf
090177e194e7a3ab\Final\Final On: 14-Sep-2020 01:45 (GMT)
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FDA-CBER-2021-5683-0019388
16.2.3.2.4 Listing of Subjects Excluded From Safety Population – All Subject s
Age Group
(Years) Subject Reason for Exclusion
16-55 C4591001 1003 10031140 Subject did not receive study vaccine.
C4591001 1003 1 0031143 Subject did not receive study vaccine.
C4591001 1005 10051381 Subject did not receive study vaccine.
C4591001 1013 10131017 Subject did not receive study vaccine.
C4591001 1013 10131740 Subject did not receive study vaccine.
C4591001 1036 10361050 Subject did not receive study vaccine.
C4591001 1057 10571031 Subject did not receive study vaccine.
C4591001 1057 10571211 Subject did not receive study vaccine.
C4591001 1057 10571212 Subject did not receive study vaccine.
C4591001 1057 10571215 Subject did not receive study vaccine.
C4591001 1057 10571268 Subject did not receive study vaccine.
C4591001 1066 10661335 Subject did not receive study vaccine.
C4591001 1071 10711162 Subject did not receive study vaccine.
C4591001 1081 10811105 Subject did not receive study vaccine.
C4591001 1082 10821013 Subject did not receive study vaccine.
C4591001 1089 10891346 Subject did not receive study vaccine.
C4591001 1089 10891351 Subject did not receive study vaccine.
C4591001 1092 10921128 Subject did not receive study vaccine.
C4591001 1093 10931055 Subject did not receive study vaccine.
C4591001 1109 11091 349 Subject did not receive study vaccine.
C4591001 1112 11121229 Subject did not receive study vaccine.
C4591001 1116 11161015 Subject did not receive study vaccine.
C4591001 1120 11201038 Subject did not receive study vaccine.
C4591001 1120 11201252 Subject did not receive study vaccine.
C4591001 1120 11201299 Did not provide informed consent.
C4591001 1122 11221006 Subject did not receive study vaccine.
090177e1959b2158\Final\Final On: 24-Nov-2020 13:48 (GMT)
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FDA-CBER-2021-5683-0019389
16.2.3.2.4 Listing of Subjects Excluded From Safety Population – All Subject s
Age Group
(Years) Subject Reason for Exclusion
C4591001 1122 11221026 Subject did not receive study vaccine.
C4591001 1123 11231027 Subject did not receive study vaccine.
C4591001 1123 11231301 Subject did not receive study vaccine.
C4591001 1126 11261074 Subject did not receive study vaccine.
C4591001 1129 11291048 Subject did not receive study vaccine.
C4591001 1133 11331162 Subject did not receive study vaccine.
C4591001 1135 11351389 Subject did not receive study vaccine.
C4591001 1162 11621024 Subject did not receive study vaccine.
C4591001 1162 11621477 Subject did not receive study vaccine.
C4591001 1167 11671003 Subject did not receive study vaccine.
C4591001 1168 11681030 Subject did not receive study vaccine.
C4591001 1205 12051028 Subject did not receive study vaccine.
C4591001 1212 12121023 Subject did not receive study vaccine.
C4591001 1223 12231200 Subject did not receive study vaccine.
C4591001 1223 12231234 Subject did not receive study vaccine.
C4591001 1231 12311409 Subject did not receive study vaccine.
C4591001 1231 12311516 Subject did not receive study vaccine.
C4591001 1231 12311926 Subject did not receive study vaccine.
C4591001 1231 12312176 Subject did not receive study vaccine.
C4591001 1231 12312483 Subject did not receive study vaccine.
C4591001 1231 12313443 Subject did not receive study vaccine.
C4591001 1231 12313527 Subject did not receive study vaccine.
C4591001 1231 12313869 Subject did not receive study vaccine.
C4591001 1231 12314738 Subject did not receive study vaccine.
C4591001 1231 12315 308 Subject did not receive study vaccine.
C4591001 1232 12321037 Subject did not receive study vaccine.
090177e1959b2158\Final\Final On: 24-Nov-2020 13:48 (GMT)
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FDA-CBER-2021-5683-0019390
16.2.3.2.4 Listing of Subjects Excluded From Safety Population – All Subject s
Age Group
(Years) Subject Reason for Exclusion
C4591001 1235 12351167 Subject did not receive study vaccine.
C4591001 1248 12481018 Subject did not receive study vaccine.
C4591001 1248 12481025 Subject did not receive study vaccine.
C4591001 1248 12481060 Subject did not receive study vaccine.
C4591001 1248 12481218 Subject did not receive study vaccine.
C4591001 1260 12601 049 Subject did not receive study vaccine.
C4591001 1260 12601070 Subject did not receive study vaccine.
C4591001 1264 12641018 Subject did not receive study vaccine.
C4591001 4444 44441135 Subject did not receive study vaccine.
>55 C4591001 1013 10131097 Subject did not receive study vaccine.
C4591001 1019 10191033 Subject did not receive study vaccine.
C4591001 1019 10191300 Subject did not receive study vaccine.
C4591001 1022 10221015 Subject did not receive study vaccine.
C4591001 1022 10221057 Subject did not receive study vaccine.
C4591001 1022 10221150 Subject did not receive study vaccine.
C4591001 1037 10371057 Subject did not receive study vaccine.
C4591001 1037 10371117 Subject did not receive study vaccine.
C4591001 1044 10441113 Subject did not receive study vaccine.
C4591001 1054 10541071 Subject did not receive study vaccine.
C4591001 1054 10541175 Subject did not receive study vaccine.
C4591001 1056 10561078 Subject did not receive study vaccine.
C4591001 1082 10821062 Subject did not receive study vaccine.
C4591001 1084 10841366 Subject did not receive study vaccine.
C4591001 1084 10841 446 Subject did not receive study vaccine.
C4591001 1087 10871434 Subject did not receive study vaccine.
C4591001 1087 10871512 Subject did not receive study vaccine.
090177e1959b2158\Final\Final On: 24-Nov-2020 13:48 (GMT)
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FDA-CBER-2021-5683-0019391
16.2.3.2.4 Listing of Subjects Excluded From Safety Population – All Subject s
Age Group
(Years) Subject Reason for Exclusion
C4591001 1091 10911092 Subject did not receive study vaccine.
C4591001 1097 10971003 Subject did not receive study vaccine.
C4591001 1098 10981092 Subject did not receive study vaccine.
C4591001 1098 10981109 Subject did not receive study vaccine.
C4591001 1109 11091259 Subject did not receive study vaccine.
C4591001 1116 11161117 Subject did not receive study vaccine.
C4591001 1116 11161118 Subject did not receive study vaccine.
C4591001 1128 11281023 Subject did not receive study vaccine.
C4591001 1128 11281109 Subject did not receive study vaccine.
C4591001 1129 11291082 Subject did not receive study vaccine.
C4591001 1129 11291 117 Subject did not receive study vaccine.
C4591001 1133 11331197 Subject did not receive study vaccine.
C4591001 1134 11341130 Subject did not receive study vaccine.
C4591001 1157 11571028 Subject did not receive study vaccine.
C4591001 1178 11781056 Subject did not receive study vaccine.
C4591001 1185 11851006 Subject did not receive study vaccine.
C4591001 1223 12231215 Subject did not receive study vaccine.
C4591001 1223 12231 250 Subject did not receive study vaccine.
C4591001 1224 12241157 Subject did not receive study vaccine.
C4591001 1231 12312222 Subject did not receive study vaccine.
C4591001 1232 12321432 Subject did not receive study vaccine.
C4591001 1248 12481182 Subject did not receive study vaccine.
Note: Data for subjects randomized on or after 10OCT2020 are included to comprehensively show all data reported but are subje ct to change with
additi onal follow -up.
PFIZER CONFIDENTIAL SDTM Creation: 17NOV2020 (10:49) Source Data: adsl Table Generation: 17NOV2020 (21:33)
(Cutoff Date: 14NOV2020, Snapshot Date: 16NOV2020) Output File: ./nda2_unblinded/C4591001_IA_P3_2MPD2/adsl_l001_excl_p3_saf_a ll
090177e1959b2158\Final\Final On: 24-Nov-2020 13:48 (GMT)
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FDA-CBER-2021-5683-0019392
16.2.3.2.5 Listing of Subjects with Unknown Actual Dosing – ~38000 Subjects for Phase 2/3 Analysi s
Age Group
(Years) Subject Comments
16-55 C4591001 1163 11631006 Vaccinated per CRF but actual treatment not conf irmed in IRT.
>55 C4591001 1163 11631005 Vaccinated per CRF but actual treatment not confirmed in IRT.
C4591001 1163 11631008 Vaccinated per CRF but actual treatment not confirmed in IRT.
PFIZER CONFIDENTIAL SDTM Creation: 17NOV2020 (10:49) Source Data: adsl Table Generation: 17NOV2020 (16:52)
(Cutoff Date: 14NOV2020, Snapshot Date: 16NOV2020) Output File: ./nda2_unblinded/C4591001_IA_P3_2MPD2/sl_l001_spc_p3_saf
090177e1959cd674\Final\Final On: 25-Nov-2020 02:13 (GMT)
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FDA-CBER-2021-5683-0019393
16.2.3.2.6 Listing of Subjects with Unknown Actual Dosing – All Subject s
Age Group
(Years) Subject Comments
16-55 C4591001 1163 11631006 Vaccinated per CRF but actual treatment not confirmed in IRT.
>55 C459100 1 1163 11631005 Vaccinated per CRF but actual treatment not confirmed in IRT.
C4591001 1163 11631008 Vaccinated per CRF but actual treatment not confirmed in IRT.
PFIZER CONFIDENTIAL SDTM Creation: 17NOV2020 (10:49) Source Data: adsl Table Generation: 17NOV2020 (16:52)
(Cutoff Date: 14NOV2020, Snapshot Date: 16NOV2020) Output File: ./nda2_unblinded/C4591001_IA_P3_2MPD2/sl_l001_spc_p3_saf_all
090177e1959cd675\Final\Final On: 25-Nov-2020 02:13 (GMT)
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FDA-CBER-2021-5683-0019394