125742 S1 M5 5351 c4591001 interim mth6 excluded patients

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16.2.3.2 Listing of Subjects Excluded From Immunogenicity Popul ations – Phase 1, 2 Doses, 21 Days Apart – 
BNT162b2 (30 μg)/Placebo 
Age 
Group 
(Years) Vaccine Group  
(as 
Randomized) Subject Population Reason for Exclusion 
  
18-55 BNT162b2 (30 
μg) C4591001 1007 
10071050Dose 2 evaluable Did not have blood collection within 6-8 days after Dose 2. 
  Placebo C4591001 1003 
10031070Dose 1 evaluable Not eligible for the study at ra ndomization; had important prot ocol deviation(s) as 
determined b y the clinician.
      Dose 2 evaluable Not eligible for the study at ra ndomization; had important prot ocol deviation(s) as 
determined b y the clinician.
65-85 BNT162b2 (30 
μg) C4591001 1003 
10031047Dose 1 evaluable Not eligible for the study at ra ndomization; had important prot ocol deviation(s) as 
determined b y the clinician.
      Dose 2 evaluable Not eligible for the study at ra ndomization; had important prot ocol deviation(s) as 
determined by the clinician. 
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: adsl Table Generation: 28MAR2021 (15:28)  
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File:  ./nda2 unblinded/C4591001 BLA/adsl l001 excl eval p1 
 
090177e196af71fc\Final\Final On: 01-Apr-2021 13:33 (GMT) 
Page 1
FDA-CBER-2021-5683-0220380
16.2.3.3 Listing of Subjects Excluded From Safety Population – All Subjects ≥16 Years of Ag e 
Age Group (Years)  Subject  Reason for Exclusion  
  
16-55 C4591001 1003 10031140  Subject did not receive study vaccine.  
  C4591001 1003 10031143  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 1122 11221006  Subject did not receive study vaccine.  
  C4591001 1122 11221026  Subject did not receive study vaccine.  
  C4591001 1123 11231 027 Subject did not receive study vaccine.  
090177e196af71fd\Final\Final On: 01-Apr-2021 13:33 (GMT) 
Page 2
FDA-CBER-2021-5683-0220381
16.2.3.3 Listing of Subjects Excluded From Safety Population – All Subjects ≥16 Years of Ag e 
Age Group (Years)  Subject  Reason for Exclusion  
  
  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 1149 11491108  Subject did not receive study vaccine.  
  C4591001 1161 11611002  Unreliable data due to lack of PI oversight.  
  C4591001 1161 11611005  Unreliable data due to lack of PI oversight.  
  C4591001 1161 11611006  Unreliable data due to lack of PI oversight.  
  C4591001 1161 11611011  Unreliable data due to lack of PI oversight.  
  C4591001 1161 11611015  Unreliable data due to lack of PI oversight.  
  C4591001 1161 11611016  Unreliable data due to lack of PI oversight . 
  C4591001 1161 11611018  Unreliable data due to lack of PI oversight.  
  C4591001 1161 11611019  Unreliable data due to lack of PI oversight.  
  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 1224 12241 170 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.  
090177e196af71fd\Final\Final On: 01-Apr-2021 13:33 (GMT) 
Page 3
FDA-CBER-2021-5683-0220382
16.2.3.3 Listing of Subjects Excluded From Safety Population – All Subjects ≥16 Years of Ag e 
Age Group (Years)  Subject  Reason for Exclusion  
  
  C4591001 1231 12312483  Subject did not receive study vaccine.  
  C4591001 1231 12313443  Subject did not receive study vaccine.  
  C4591001 1231 12313 527 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 12315308  Subject did not receive study vaccine.  
  C4591001 1232 12321037  Subject did not receive study vaccine.  
  C4591001 1235 12351167  Subject did not receive study vaccine.  
  C4591001 1248 12481018  Subject did not receive study vaccine.  
  C4591001 1248 12481 025 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 1251 12511204  Subject did not receive study vaccine.  
  C4591001 1260 12601049  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 44441 135 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.  
090177e196af71fd\Final\Final On: 01-Apr-2021 13:33 (GMT) 
Page 4
FDA-CBER-2021-5683-0220383
16.2.3.3 Listing of Subjects Excluded From Safety Population – All Subjects ≥16 Years of Ag e 
Age Group (Years)  Subject  Reason for Exclusion  
  
  C4591001 1054 10541175  Subject did not receive study vaccine.  
  C4591001 1056 10561078  Subject did not receive study vaccine.  
  C4591001 1080 10801222  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 10841446  Subject did not receive study vaccine.  
  C4591001 1087 10871 434 Subject did not receive study vaccine.  
  C4591001 1087 10871512  Subject did not receive study vaccine.  
  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 11161 117 Subject did not receive study vaccine.  
  C4591001 1116 11161118  Subject did not receive study vaccine.  
  C4591001 1120 11201436  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 11291117  Subject did not receive study vaccine.  
  C4591001 1133 11331 197 Subject did not receive study vaccine.  
  C4591001 1134 11341130  Subject did not receive study vaccine.  
  C4591001 1149 11491100  Subject did not receive study vaccine.  
  C4591001 1157 11571028  Subject did not receive study vaccine.  
  C4591001 1161 11611012  Unreliable data due to lack of PI oversight.  
  C4591001 1161 11611013  Unreliable data due to lack of PI oversight.  
  C4591001 1178 11781056  Subject did not receive study vaccine.  
090177e196af71fd\Final\Final On: 01-Apr-2021 13:33 (GMT) 
Page 5
FDA-CBER-2021-5683-0220384
16.2.3.3 Listing of Subjects Excluded From Safety Population – All Subjects ≥16 Years of Ag e 
Age Group (Years)  Subject  Reason for Exclusion  
  
  C4591001 1185 11851006  Subject did not receive study vaccine.  
  C4591001 1223 12231215  Subject did not receive study vaccine.  
  C4591001 1223 12231250  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.  
  
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: adsl Table Generation: 27MAR2021 (01:45)  
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unblinded/C4591001 BLA/adsl l001 excl p3 saf all   
 
090177e196af71fd\Final\Final On: 01-Apr-2021 13:33 (GMT) 
Page 6
FDA-CBER-2021-5683-0220385