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Summary of Geometric Mean Titers, by Baseline SARS-CoV-2 Status – NT50 – Subjects 12 Through 15 and 16 Through 25 Years of Age (Immunogenicity
Subset) – Dose 2 Evaluable I mmunogenicity Population .......... ........................................................................................................................................................... 2
Summary of Geometric Mean Titers, by Baseline SARS-CoV-2 Status – NT50 – Subjects 12 Through 15 and 16 Through 25 Years of Age (Immunogenicity
Subset) – Dose 2 All-Available Immunogenicity Population ............................................................................................................................................................... 4
Summary of Geometric Mean Fold Rise From Before Vaccination to Each Subsequent Time Point, by Baseline SARS-CoV-2 Status – NT5 0 – Subjects 12
Through 15 and 16 Through 25 Years of Age (Immunogenicity Subse t) – Dose 2 Evaluable Immu nogenicity Population ............... ................................................ 6
Summary of Geometric Mean Fold Rise From Before Vaccination to Each Subsequent Time Point, by Baseline SARS-CoV-2 Status – NT5 0 – Subjects 12
Through 15 and 16 Through 25 Years of Age (Immunogenicity Subse t) – Dose 2 All-Available Immunogenicity Population ........... .............................................. 7
Summary of Geometric Mean Ratio – NT50 – Comparison of Subjects 12 Through 15 Years of Age to Subjects 16 Through 25 Years of Age (Immunogenicity
Subset) – Subjects Without Evidence of Infection up to 1 Month After Dose 2 – Dose 2 Evaluable Immunogenicity Population ..... ................................................ 8
Number (%) of Subjects Achieving a ≥4-Fold Rise From Before Vac cination to Each Subsequent Time Point, by Baseline SARS-CoV-2 Status – NT50 –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Immunoge nicity Subset) – Dose 2 Evaluable Immunogenicity Population ... ....................................... 10
Number (%) of Subjects Achieving a ≥4-Fold Rise From Before Vac cination to Each Subsequent Time Point 1 Month After Dose 2 – N T50 – Comparison of
Subjects 12 Through 15 Years of Age to Subjects 16 Through 25 Years of Age (Immunogenicity Subset) – Subjects Without Evidence of Infection up to 1
Month After Dose 2 – Dose 2 Evaluable Immunogenicity Population .............................................................................................................................................. 11
090177e19995d702\Approved\Approved On: 10-Mar-2022 23:10 (GMT)
FDA-CBER-2022-5812-0235594
Summary of Geometric Mean Titers , by Baseline SARS -CoV-2 Status – NT50 –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Immunoge nicity Subset) –
Dose 2 Evaluable Immunogenicity Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg) Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Assay Dose/
Sampling
Time
Pointa Baseline
SARS-CoV-2
Statusb ncGMTd
(95% CId) ncGMTd
(95% CId) ncGMTd
(95% CId) ncGMTd
(95% CId)
SARS-CoV-2
neutralization assay -
NT50 (titer) 1/Prevax ALL 155 1122.2
(10.3, 12.320.7, 23.8 ) 136 10.5
(9.9, 1121.1
(20.2 , 22.0 ) 29 11.2
(8.9, 14.0)22.3
(18.7, 26.7) 24 10.0
(10.0, 10.0)20.5
(20.5, 20.5)
POS 8 54.1
(19.7, 148.7)61.0
(26.4, 140.8) 5 38.6
(6.4, 23245.3
(10.2, 201 .9) 1 251.0
(NE, NE) 0 NE
(NE, NE)
NEG 146 10.3
(9.7, 10.9)21.0
(20.0, 22.1) 131 10.0
(10.0, 10.0)20.5
(20.5, 20.5) 27 10.0
(10.0, 10.0)20.5
(20.5, 20.5) 24 10.0
(10.0, 10.0)20.5
(20.5, 20.5)
2/1 Month ALL 207 1283.0
(1139.6, 1444.5)1296.4
(1160.4, 1448.4) 185 730.8
(646.7, 825733.6
(651.0, 826 .8) 36 15.1
(10.7, 21.4)27.3
(20.9, 35.6) 32 1021.5
(19.5, 23 .7
(9.3, 12.4 )
POS 10 2342.2
(1308.7, 4191.8) 8 1439.2
(727.1, 2848.7) 2 191.0
(1.2, 30873.6) 1 10.020.5
(NE, NE)
NEG 192 12391253.2
(10961118.6, 1400.51404.1 ) 177 708711.6
(630.7
(626.4, 802. 09) 33 13.1
(9.7, 17.7)24.4
(19.4, 30.8) 31 1021.5
(19.5, 23 .8
(9.3, 12.5 )
Abbreviations: COVID-19 = coronavirus disease 2019; GMT = geome tric mean titer; LLOQ = lower limit of quantitation;
NAAT = nucleic acid amplification test; N-binding = SARS-CoV-2 n ucleoprotein–binding; NE = not estimable; NEG = negative;
NT50 = 50% neutralizing titer; POS = positive; Prevax = before v accination; SARS-CoV-2 = severe acute respiratory syndrome coro navirus 2.
090177e19995d702\Approved\Approved On: 10-Mar-2022 23:10 (GMT)
FDA-CBER-2022-5812-0235595
Summary of Geometric Mean Titers , by Baseline SARS -CoV-2 Status – NT50 –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Immunoge nicity Subset) –
Dose 2 Evaluable Immunogenicity Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg) Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Assay Dose/
Sampling
Time
Pointa Baseline
SARS-CoV-2
Statusb ncGMTd
(95% CId) ncGMTd
(95% CId) ncGMTd
(95% CId) ncGMTd
(95% CId)
a. Protocol-specified timing for blood sample collection.
b. POS = positive N- binding antibody result at Visit 1, pos itive NAAT result at Visit 1, or medical history of COVID-19. N EG = negative N-binding
antibody result at Visit 1, nega tive NAAT result at Visit 1, an d no medical history of COVID- 19. ALL = irrespective of baselin e SARS-CoV-2 status, including
missing baseline status.
c. n = Number of subjects with valid and determinate assay results for the specified assay at the given dose/sampling time point.
d. GMTs and 2-sided 95% CIs were calculated by exponentiati ng the mean logarithm of the titers and the corresponding CIs ( based on the Student t
distribution). Assay results below the LLOQ were set to 0.5 × L LOQ.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:2509FEB2022 (12:16 ) Source Data: adva Table Generation: 27MAR2021 (04:5409FEB2022
(18:59 )
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2nda3 unblinded/C4591001 BLA IMM/adva s001 gm ped eval
090177e19995d702\Approved\Approved On: 10-Mar-2022 23:10 (GMT)
FDA-CBER-2022-5812-0235596
Summary of Geometric Mean Titers , by Baseline SARS -CoV-2 Status – NT50 –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Immunoge nicity Subset) –
Dose 2 All-Available Imm unogenicity Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg) Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Assay Dose/
Sampling
Time
Pointa Baseline
SARS-CoV-2
Statusb ncGMTd
(95% CId) ncGMTd
(95% CId) ncGMTd
(95% CId) ncGMTd
(95% CId)
SARS-CoV-2
neutralization assay -
NT50 (titer) 1/Prevax ALL 156 1122.2
(10.2, 12.320.7, 23.8 ) 140 10.5
(9.9, 1121 .1
(20.2, 22.0 ) 29 11.2
(8.9, 14.0)22.3
(18.7, 26.7) 25 10.0
(10.0, 10.0)20.5
(20.5, 20.5)
POS 8 54.1
(19.7, 148.7)61.0
(26.4, 140.8) 5 38.6
(6.4, 23245.3
(10.2, 201 .9) 1 251.0
(NE, NE) 0 NE
(NE, NE)
NEG 147 10.3
(9.7, 10.9)21.0
(20.0, 22.1) 135 10.0
(10.0, 10.0)20.5
(20.5, 20.5) 27 10.0
(10.0, 10.0)20.5
(20.5, 20.5) 25 10.0
(10.0, 10.0)20.5
(20.5, 20.5)
2/1 Month ALL 208 1284.4
(1141.4, 14451297.7
(1162.2 , 1449.1 ) 190 726.3
(643.9, 819729.0
(648.0, 820 .1) 36 15.1
(10.7, 21.4)27.3
(20.9, 35.6) 34 10.7
(9.3, 12.2)21.4
(19.6, 23.5)
POS 10 2342.2
(1308.7, 4191.8) 8 1439.2
(727.1, 2848.7) 2 191.0
(1.2, 30873.6) 1 10.020.5
(NE, NE)
NEG 193 1240.9
(1098.7, 1401.5)1254.8
(1120.6, 1405.1) 182 704.7
(624.1, 795.9)707.5
(628.2, 796.8) 33 13.1
(9.7, 17.7)24.4
(19.4, 30.8) 33 10.7
(9.3, 12.321.5
(19.5, 23.6 )
Abbreviations: COVID-19 = coronavirus disease 2019; GMT = geome tric mean titer; LLOQ = lower limit of quantitation;
NAAT = nucleic acid amplification test; N-binding = SARS-CoV-2 n ucleoprotein–binding; NE = not estimable; NEG = negative;
NT50 = 50% neutralizing titer; POS = positive; Prevax = before v accination; SARS-CoV-2 = severe acute respiratory syndrome coro navirus 2.
090177e19995d702\Approved\Approved On: 10-Mar-2022 23:10 (GMT)
FDA-CBER-2022-5812-0235597
Summary of Geometric Mean Titers , by Baseline SARS -CoV-2 Status – NT50 –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Immunoge nicity Subset) –
Dose 2 All-Available Imm unogenicity Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg) Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Assay Dose/
Sampling
Time
Pointa Baseline
SARS-CoV-2
Statusb ncGMTd
(95% CId) ncGMTd
(95% CId) ncGMTd
(95% CId) ncGMTd
(95% CId)
a. Protocol-specified timing for blood sample collection.
b. POS = positive N- binding antibody result at Visit 1, pos itive NAAT result at Visit 1, or medical history of COVID-19. N EG = negative N-binding
antibody result at Visit 1, nega tive NAAT result at Visit 1, an d no medical history of COVID- 19. ALL = irrespective of baselin e SARS-CoV-2 status, including
missing baseline status.
c. n = Number of subjects with valid and determinate assay results for the specified assay at the given dose/sampling time point.
d. GMTs and 2-sided 95% CIs were calculated by exponentiati ng the mean logarithm of the titers and the corresponding CIs ( based on the Student t
distribution). Assay results below the LLOQ were set to 0.5 × L LOQ.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:2509FEB2022 (12:16 ) Source Data: adva Table Generation: 27MAR2021 (04:5409FEB2022
(18:59 )
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2nda3 unblinded/C4591001 BLA IMM/adva s001 gm ped aai
090177e19995d702\Approved\Approved On: 10-Mar-2022 23:10 (GMT)
FDA-CBER-2022-5812-0235598
Summary of Geometric Mean Fold R ise From Before Vaccination to Each Subsequent Time Point, by Baseline
SARS-CoV-2 Status – NT50 – Subj ects 12 Through 15 and 16 Throug h 25 Years of Age (Immu nogenicity Subset) –
Dose 2 Evaluable Immunogenicity Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg) Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Assay Dose/
Sampling
Time PointaBaseline
SARS-CoV-2
Statusb ncGMFRd
(95% CId) ncGMFRd
(95% CId) ncGMFRd
(95% CId) ncGMFRd
(95% CId)
SARS-CoV-2 neutralization
assay - NT50 (titer) 2/1 Month ALL 154 118.3
(10160.4 , 137.9
(52.5, 69.4 ) 135 71.2
(61.3, 82.7)35.5
(30.6, 41.0) 29 1.4
(1.2
(0, 1.9, 1.6) 24 1.1
(0.9, 1. 32)
POS 8 47.6
(26.4, 8642.2
(24.8, 72 .0) 5 47.140.2
(3.1, 721.47, 437.7 ) 1 1.1
(NE, NE) 0 NE
(NE, NE)
NEG 145 125.0
(10661.9 , 146.2
(53.6, 71.5 ) 130 7235.3
(62.9, 83.230.7, 40.6 ) 27 1.4
(2
(0.9, 1.0, 2.06 ) 24 1.1
(0.9, 1. 32)
Abbreviations: COVID-19 = coronavirus disease 2019; GMFR = geom etric mean fold rise; LLOQ = lower limit of quantitation;
NAAT = nucleic acid amplification test; N-binding = SARS-CoV-2 n ucleoprotein–binding; NE = not estimable; NEG = negative;
NT50 = 50% neutralizing titer; POS = positive; SARS-CoV-2 = seve re acute respiratory syndrome coronavirus 2.
a. Protocol-specified timing for blood sample collection.
b. POS = positive N- binding antibody result at Visit 1, pos itive NAAT result at Visit 1, or medical history of COVID-19. N EG = negative N-binding
antibody result at Visit 1, nega tive NAAT result at Visit 1, an d no medical history of COVID- 19. ALL = irrespective of baselin e SARS-CoV-2 status, including
missing baseline status.
c. n = Number of subjects with valid and determinate assay results for the specified assay both prevaccination time points and at the given dose/sampling
time point.
d. GMFRs and 2-sided 95% CIs w ere calculated by exponentiat ing the mean logarithm of fold rises and the corresponding CIs (based on the Student t
distribution). Assay results below the LLOQ were set to 0.5 × L LOQ in the analysis.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:2509FEB2022 (12:16 ) Source Data: adva Table Generation: 27MAR2021 (04:5409FEB2022
(18:59 )
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2nda3_unblinded/C4591001_BLA IMM/adva_s002_gmfr_ped_eval
090177e19995d702\Approved\Approved On: 10-Mar-2022 23:10 (GMT)
FDA-CBER-2022-5812-0235599
Summary of Geometric Mean Fold R ise From Before Vaccination to Each Subsequent Time Point, by Baseline
SARS-CoV-2 Status – NT50 – Subj ects 12 Through 15 and 16 Throug h 25 Years of Age (Immu nogenicity Subset) –
Dose 2 All-Available Imm unogenicity Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg) Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Assay Dose/
Sampling
Time Pointa Baseline
SARS-CoV-2
Statusb ncGMFRd
(95% CId) ncGMFRd
(95% CId) ncGMFRd
(95% CId) ncGMFRd
(95% CId)
SARS-CoV-2 neutralization
assay - NT50 (titer) 2/1 Month ALL 155 11860.5
(10152.7, 138.069.4 ) 139 7035.0
(30.3
(60.7, 81.5, 40.4 ) 29 1.4
(1.2
(0, 1.9, 1.6) 25 1.1
(0.9, 1. 32)
POS 8 47.6
(26.4, 8642.2
(24.8, 72 .0) 5 47.140.2
(3.1, 721.47, 437.7 ) 1 1.1
(NE, NE) 0 NE
(NE, NE)
NEG 146 125.2
(107.2, 146.3)62.0
(53.7, 71.6) 134 7134.8
(30.4
(62.2, 81.9, 40.0 ) 27 1.4
(2
(0.9, 1.0, 2.06 ) 25 1.1
(0.9, 1. 32)
Abbreviations: COVID-19 = coronavirus disease 2019; GMFR = geom etric mean fold rise; LLOQ = lower limit of quantitation;
NAAT = nucleic acid amplification test; N-binding = SARS-CoV-2 n ucleoprotein–binding; NE = not estimable; NEG = negative;
NT50 = 50% neutralizing titer; POS = positive; SARS-CoV-2 = seve re acute respiratory syndrome coronavirus 2.
a. Protocol-specified timing for blood sample collection.
b. POS = positive N- binding antibody result at Visit 1, pos itive NAAT result at Visit 1, or medical history of COVID-19. N EG = negative N-binding
antibody result at Visit 1, nega tive NAAT result at Visit 1, an d no medical history of COVID- 19. ALL = irrespective of baselin e SARS-CoV-2 status, including
missing baseline status.
c. n = Number of subjects with valid and determinate assay results for the specified assay both prevaccination time points and at the given dose/sampling
time point.
d. GMFRs and 2-sided 95% CIs w ere calculated by exponentiat ing the mean logarithm of fold rises and the corresponding CIs (based on the Student t
distribution). Assay results below the LLOQ were set to 0.5 × L LOQ in the analysis.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:2509FEB2022 (12:16 ) Source Data: adva Table Generation: 27MAR2021 (06:1509FEB2022
090177e19995d702\Approved\Approved On: 10-Mar-2022 23:10 (GMT)
FDA-CBER-2022-5812-0235600
Summary of Geometric Mean Fold R ise From Before Vaccination to Each Subsequent Time Point, by Baseline
SARS-CoV-2 Status – NT50 – Subj ects 12 Through 15 and 16 Throug h 25 Years of Age (Immu nogenicity Subset) –
Dose 2 All-Available Imm unogenicity Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg) Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Assay Dose/
Sampling
Time Pointa Baseline
SARS-CoV-2
Statusb ncGMFRd
(95% CId) ncGMFRd
(95% CId) ncGMFRd
(95% CId) ncGMFRd
(95% CId)
(18:59 )
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2nda3_unblinded/C4591001_BLA IMM/adva_s002_gmfr_ped_aai
Summary of Geometric Mean Ratio – NT50 –
Comparison of Subjects 12 Throu gh 15 Years of Age to Subjects 1 6 Through 25 Years of Age (Im munogenicity Subset) –
Subjects Without Evidence of Inf ection up to 1 Month After Dose 2 – Dose 2 Evaluable Immunogenicity Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
12-15 Years 16-25 Years 12-15 Years/16-25 Years
Assay Dose/
Sampling
Time PointanbGMTc
(95% CIc) nbGMTc
(95% CIc) GMRd
(95% CId) Met Noninferiority
Objectivee
(Y/N)
SARS-CoV-2 neutralization
assay - NT50 (titer) 2/1 Month 190 1239.5
(1095.5, 1402.5)1253.6
(1117.7, 1406.1) 170 705708.1
(621.4, 800.2625.9, 801.1 ) 1.7677
(1.4750,
2.1009) Y
Abbreviations: GMR = geometric m ean ratio; GMT = geometric mean titer; LLOQ = lower limit of quantitation;
NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respira tory syndrome coronavirus 2.
Note: Subjects who had no serological or virological evidence (u p to 1 month after receipt of the last dose) of past SARS-CoV-2 infection (ie, N- binding
090177e19995d702\Approved\Approved On: 10-Mar-2022 23:10 (GMT)
FDA-CBER-2022-5812-0235601
Summary of Geometric Mean Ratio – NT50 –
Comparison of Subjects 12 Throu gh 15 Years of Age to Subjects 1 6 Through 25 Years of Age (Im munogenicity Subset) –
Subjects Without Evidence of Inf ection up to 1 Month After Dose 2 – Dose 2 Evaluable Immunogenicity Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
12-15 Years 16-25 Years 12-15 Years/16-25 Years
Assay Dose/
Sampling
Time PointanbGMTc
(95% CIc) nbGMTc
(95% CIc) GMRd
(95% CId) Met Noninferiority
Objectivee
(Y/N)
antibody [serum] negative at Visit 1 and SARS-CoV-2 not detecte d by NAAT [nasal swab] at Visits 1 and 2), and had negative NAA T (nasal swab) at any
unscheduled visit up to 1 month after Dose 2 were included in t he analysis.
a. Protocol-specified timing for blood sample collection.
b. n = Number of subjects with valid and determinate assay results for the specified assay at the given dose/sampling time point.
c. GMTs and 2-sided 95% CIs were calculated by exponentiati ng the mean logarithm of the titers and the corresponding CIs ( based on the Student t
distribution). Assay results below the LLOQ were set to 0.5 × L LOQ.
d. GMRs and 2-sided 95% CIs were calculated by exponentiati ng the mean difference of the l ogarithms of the titers (Group 1 [12-15 years] – Group 2 [16-25
years]) and the corresponding CI (based on the Student t dis tribution).
e. Noninferiority is declared if the lower bound of the 2-s ided 95% CI for the GMR is greater than 0.67.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:2509FEB2022 (12:16 ) Source Data: adva Table Generation: 27MAR2021 (04:5409FEB2022
(18:59 )
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2nda3_unblinded/C4591001_BLA IMM/adva_s001_gmr_ped_ev_eval
090177e19995d702\Approved\Approved On: 10-Mar-2022 23:10 (GMT)
FDA-CBER-2022-5812-0235602
Number (%) of Subjects Achieving a ≥4-Fold Rise From Before Vac cination to Each Subsequent Time Point,
by Baseline SARS-C oV-2 Status – NT50 – Subjects 12 Through 15 a nd 16 Through 25 Years of Age
(Immunogenicity Subset) – Dose 2 E valuable Immunogenicity Popul ation
Vaccine Group (as Randomized)
BNT162b2 (30 μg) Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Assay Dose/
Sampling
Time PointaBaseline
SARS-CoV-2
Statusb Nc nd (%)
(95% CIe) Nc nd (%)
(95% CIe) Ncnd (%)
(95% CIe)Ncnd (%)
(95% CIe)
SARS-CoV-2 neutralization
assay - NT50 (titer) 2/1 Month ALL 154 151 (98.1)
(94150 (97.4 )
(93.5 , 99.63) 135 134 (99130 (96.3)
(95.9, 100.091.6, 98.8 ) 29 1 (3.4)
(0.1, 17.8) 24 1 (40 (0.0)
(0.0, 14 .2)
(0.1, 21.1)
POS 8 8 (100.0)
(63.1, 100.0) 5 4 (80.0)
(28.4, 99.5) 1 0 (0.0)
(0.0, 97.5) 0 0 (NE)
(NE, NE)
NEG 145 142141 (97. 9)
(942)
(93.1, 99.62) 130 130 (100.0)
(97126 (96.9)
(92.3, 99 .2, 100.0 ) 27 1 (3.7)
(0.1, 19.0) 24 1 (40 (0.0)
(0.0, 14 .2)
(0.1, 21.1)
Abbreviations: LLOQ = lower limit of quantitation; NE = not est imable; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acut e respiratory syndrome
coronavirus 2.
Note: Baseline assay results below the LLOQ were set to LLOQ in the analysis.
a. Protocol-specified timing for blood sample collection.
b. POS = positive N- binding antibody result at Visit 1, pos itive NAAT result at Visit 1, or medical history of COVID-19. N EG = negative N-binding
antibody result at Visit 1, nega tive NAAT result at Visit 1, an d no medical history of COVID- 19. ALL = irrespective of baselin e SARS-CoV-2 status, including
missing baseline status
c. N = number of subjects with valid and determinate assay results for the specified assay both before vaccination and at the given dose/sampling time point.
These values are the denominator s for the percentage calculatio ns.
d. n = Number of subjects with ≥4-fold rise from before vac cination for the given assay at the given dose/sampling time po int.
e. Exact 2-sided CI based on the Clopper and Pearson method.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:2509FEB2022 (12:16 ) Source Data: adva Table Generation: 27MAR2021 (06:2909FEB2022
(18:59 )
(Cutoff Date: 13MAR2021, Snapshot Da te: 25MAR2021) Output File: . /nda2nda3_unblinded/C4591001_BLA IMM/adva_s001_4fold_ped_eval
090177e19995d702\Approved\Approved On: 10-Mar-2022 23:10 (GMT)
FDA-CBER-2022-5812-0235603
Number (%) of Subjects Achieving a ≥4-Fold Rise From Before Vac cination to Each Subsequent Time Point
1 Month After Dose 2 – NT50 – Compa rison of Subjects 12 Through 15 Years of Age to Subjects 16 Through 25
Years of Age (Immunogenicity Subset) – Subjects Without Evidenc e of Infection up to 1 M onth After Dose 2 –
Dose 2 Evaluable Immunogenicity Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
12-15 Years 16-25 Years Difference
Assay Dose/
Sampling
Time Pointa Nb nc (%)
(95% CId) Nb nc (%)
(95% CId) %e (95% CIf)
SARS-CoV-2 neutralization assay - NT50
(titer) 2/1 Month 143 140139 (97. 9)
(942)
(93.0, 99.62) 124 124 (100.0)
(97120 (96.8)
(91.9, 99 .1, 100.0 ) 2.10.4 (-6.0, 0.94.2, 5.5 )
Abbreviations: LLOQ = lower limit of quantitation; NT50 = 50% n eutralizing titer; SARS-CoV-2 = se vere acute respiratory syndro me coronavirus 2.
Note: Subjects who had no serological or virological evidence (u p to 1 month after receipt of the last dose) of past SARS-CoV-2 infection (ie, N-binding
antibody [serum] negative at Visit 1 and SARS-CoV-2 not detecte d by NAAT [nasal swab] at Visits 1 and 2), and had negative NAA T (nasal swab) at any
unscheduled visit up to 1 month after Dose 2 were included in t he analysis.
Note: Baseline assay results below the LLOQ were set to LLOQ in the analysis.
a. Protocol-specified timing for blood sample collection.
b. N = number of subjects with valid and determinate assay results for the specified assay both before vaccination and at the given dose/sampling time point.
These values are the denominator s for the percentage calculatio ns.
c. n = Number of subjects with ≥4-fold rise from before vac cination for the given assay at the given dose/sampling time po int.
d. Exact 2-sided CI based on the Clopper and Pearson method .
e. Difference in proportions, expressed as a percentage (12 -15 years – 16-25 years).
f. 2-Sided CI, based on the Mi ettinen and Nurminen method f or the difference in proportions, expressed as a percentage.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:2509FEB2022 (12:16 ) Source Data: adva Table Generation: 27MAR2021 (05:5609FEB2022
(18:59 )
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2nda3 unblinded/C4591001 BLA IMM/adva s003 4fold ped eval
090177e19995d702\Approved\Approved On: 10-Mar-2022 23:10 (GMT)
FDA-CBER-2022-5812-0235604