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16.2.6 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apart – BNT162b2 (30 µg)/Placebo
Assay
Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer) S1-Binding
IgG Level
(U/mL)
18-55 BNT162b2 (30 μg) C4591001 1003 10031057 1/Prevax 24JUN2020 1 10.00 BLQ
1/Da y 21 15JUL2020 22 127.84 530.363
2/1 Month 14AUG2020 31 135.45 2786.473
2/6 Months 13JAN2021 183 28.02 463.85
C4591001 1003 10031059 1/Prevax 24JUN2020 1 10.00 BLQ
1/Da y 21 15JUL2020 22 82.25 1848.867
2/1 Month 12AUG2020 29 257.68 5829.146
2/6 Months 08JAN2021 178 33.20 771.147
C4591001 1003 10031061 1/Prevax 22JUN2020 1 10.00 BLQ
1/Da y 21 13JUL2020 22 72.74 427.932
2/1 Month 10AUG2020 29 175.85 5660.364
2/6 Months 08JAN2021 180 75.30 1046.509
C4591001 1003 10031065 1/Prevax 24JUN2020 1 10.00 BLQ
1/Da y 21 15JUL2020 22 10.00 925.76
2/1 Month 19AUG2020 36 962.68 13393.623
2/6 Months 08JAN2021 178 114.16 1724.284
C4591001 1003 10031066 1/Prevax 22JUN2020 1 10.00 BLQ
1/Da y 21 13JUL2020 22 78.30 399.817
2/1 Month 13AUG2020 32 122.66 9897.22
2/6 Months 04JAN2021 176 44.01 538.771
C4591001 1003 10031072 1/Prevax 24JUN2020 1 10.00 BLQ
1/Da y 21 16JUL2020 23 10.00 553.482
2/1 Month 19AUG2020 35 92.04 5257.297
2/6 Months 07JAN2021 176 69.39 934.959
C4591001 1007 10071046 1/Prevax 22JUN2020 1 10.00 BLQ
1/Da y 21 15JUL2020 24 10.00 475.638
2/1 Month 10AUG2020 27 75.78 7642.997
2/6 Months 04JAN2021 174 10.00 395.017
090177e196af7200\Final\Final On: 01-Apr-2021 13:33 (GMT)
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FDA-CBER-2021-5683-0220373
16.2.6 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apart – BNT162b2 (30 µg)/Placebo
Assay
Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer) S1-Binding
IgG Level
(U/mL)
C4591001 1007 10071050 1/Prevax 22JUN2020 1 10.00 BLQ
1/Da y 21 13JUL2020 22 88.61 1295.29
2/1 Month 10AUG2020 29 191.17 8857.72
2/6 Months 04JAN2021 176 36.53 710.176
C4591001 1007 10071058 1/Prevax 24JUN2020 1 10.00 BLQ
1/Da y 21 15JUL2020 22 70.08 646.145
2/1 Month 12AUG2020 29 642.09 6451.389
C4591001 1007 10071063 1/Prevax 24JUN2020 1 10.00 BLQ
1/Da y 21 15JUL2020 22 10.00 573.795
2/1 Month 19AUG2020 36 128.62 4024.352
2/6 Months 07JAN2021 177 24.77 481.076
C4591001 1007 10071064 1/Prevax 24JUN2020 1 10.00 BLQ
1/Da y 21 15JUL2020 22 10.00 135.052
2/1 Month 12AUG2020 29 204.04 5119.635
2/6 Months 06JAN2021 176 60.46 1028.15
C4591001 1007 10071066 1/Prevax 24JUN2020 1 10.00 BLQ
1/Da y 21 15JUL2020 22 10.00 403.233
2/1 Month 12AUG2020 29 71.74 4858.413
2/6 Months 06JAN2021 176 653.46 10552.95
Placebo C4591001 1003 10031050 1/Prevax 22JUN2020 1 10.00 BLQ
1/Da y 21 13JUL2020 22 10.00 BLQ
2/1 Month 13AUG2020 32 10.00 BLQ
C4591001 1003 10031070 1/Prevax 24JUN2020 1 10.00 BLQ
1/Da y 21 15JUL2020 22 10.00 BLQ
2/1 Month 12AUG2020 29 10.00 BLQ
C4591001 1007 10071065 1/Prevax 24JUN2020 1 10.00 BLQ
1/Da y 21 15JUL2020 22 10.00 BLQ
2/1 Month 12AUG2020 29 10.00 BLQ
090177e196af7200\Final\Final On: 01-Apr-2021 13:33 (GMT)
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FDA-CBER-2021-5683-0220374
16.2.6 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apart – BNT162b2 (30 µg)/Placebo
Assay
Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer) S1-Binding
IgG Level
(U/mL)
65-85 BNT162b2 (30 μg) C4591001 1003 10031037 1/Prevax 16JUN2020 1 10.00 BLQ
1/Da y 21 07JUL2020 22 31.46 2141.783
2/1 Month 07AUG2020 32 403.35 22091.375
2/6 Months 08JAN2021 186 30.70 556.288
C4591001 1003 10031047 1/Prevax 16JUN2020 1 10.00 BLQ
1/Da y 21 07JUL2020 22 10.00 1751.532
2/1 Month 07AUG2020 32 89.05 9349.196
2/6 Months 04JAN2021 182 23.08 1328.069
C4591001 1003 10031051 1/Prevax 18JUN2020 1 10.00 BLQ
1/Da y 21 09JUL2020 22 10.00 687.383
2/1 Month 12AUG2020 35 390.56 5523.432
2/6 Months 29DEC2020 174 36.83 687.657
C4591001 1003 10031058 1/Prevax 18JUN2020 1 10.00 BLQ
1/Da y 21 09JUL2020 22 10.00 34.257
2/1 Month 06AUG2020 29 10.00 2330.549
2/6 Months 31DEC2020 176 27.80 594.548
C4591001 1003 10031069 1/Prevax 18JUN2020 1 10.00 BLQ
1/Da y 21 09JUL2020 22 10.00 115.815
2/1 Month 10AUG2020 33 48.51 1525.019
2/6 Months 31DEC2020 176 21.11 269.535
C4591001 1007 10071034 1/Prevax 15JUN2020 1 10.00 BLQ
1/Da y 21 06JUL2020 22 36.29 151.88
2/1 Month 03AUG2020 29 207.03 2728.832
2/6 Months 28DEC2020 176 10.00 205.531
C4591001 1007 10071037 1/Prevax 15JUN2020 1 10.00 BLQ
1/Da y 21 06JUL2020 22 10.00 362.55
2/1 Month 05AUG2020 31 293.34 5440.505
2/6 Months 04JAN2021 183 57.76 990.531
090177e196af7200\Final\Final On: 01-Apr-2021 13:33 (GMT)
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FDA-CBER-2021-5683-0220375
16.2.6 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apart – BNT162b2 (30 µg)/Placebo
Assay
Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer) S1-Binding
IgG Level
(U/mL)
C4591001 1007 10071043 1/Prevax 18JUN2020 1 10.00 BLQ
1/Da y 21 09JUL2020 22 24.18 339.124
2/1 Month 06AUG2020 29 433.37 7277.572
2/6 Months 04JAN2021 180 33.81 527.782
C4591001 1007 10071044 1/Prevax 18JUN2020 1 10.00 BLQ
1/Da y 21 09JUL2020 22 52.38 1307.168
2/1 Month 06AUG2020 29 1457.45 16973.01
2/6 Months 04JAN2021 180 55.92 1524.031
C4591001 1007 10071045 1/Prevax 18JUN2020 1 10.00 BLQ
1/Da y 21 09JUL2020 22 10.00 497.692
2/1 Month 06AUG2020 29 123.99 5663.073
2/6 Months 04JAN2021 180 39.94 1243.902
C4591001 1007 10071049 1/Prevax 18JUN2020 1 10.00 BLQ
1/Da y 21 09JUL2020 22 20.93 198.941
2/1 Month 06AUG2020 29 33.98 2318.744
2/6 Months 04JAN2021 180 10.00 259.008
C4591001 1007 10071053 1/Prevax 18JUN2020 1 10.00 BLQ
1/Da y 21 09JUL2020 22 10.00 733.863
2/1 Month 06AUG2020 29 78.63 3235.365
2/6 Months 04JAN2021 180 42.58 521.125
Placebo C4591001 1003 10031043 1/Prevax 16JUN2020 1 10.00 BLQ
1/Da y 21 07JUL2020 22 10.00 BLQ
C4591001 1003 10031046 1/Prevax 18JUN2020 1 10.00 BLQ
1/Da y 21 09JUL2020 22 10.00 BLQ
2/1 Month 10AUG2020 33 10.00 BLQ
C4591001 1003 10031056 1/Prevax 18JUN2020 1 10.00 2.015
1/Da y 21 09JUL2020 22 10.00 2.451
2/1 Month 06AUG2020 29 10.00 3.258
090177e196af7200\Final\Final On: 01-Apr-2021 13:33 (GMT)
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FDA-CBER-2021-5683-0220376
16.2.6 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apart – BNT162b2 (30 µg)/Placebo
Assay
Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer) S1-Binding
IgG Level
(U/mL)
Abbreviations: BLQ = below the limit of quantitation; IgG = imm unoglobulin G; NT50 = 50% neutr alizing titer; S1 = spike protei n S1 subunit.
Note: Blood samples from the Day 7 and Day 14 pos t–Dose 2 visits are not included since these samples were not re tested with the 6-month post–Dose 2
samples.
a. Relative day (Rel Day) = da te of blood draw - date of la st vaccination + 1.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:25) Source Dat a: adva Table Generation: 27MAR2021 (05:00)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unblinded/C4591001 BLA/adva l001 p1
090177e196af7200\Final\Final On: 01-Apr-2021 13:33 (GMT)
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