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Table.A Follow -up Duration After Dose 2 – Participants 12 Through 15 Years of Age –
Safety Population (Data Cutoff September 2, 2021)
Vaccine Group (as Administered)
BNT162b2 (30 μg)
(Na=1131)
nb (%) Placebo
(Na=1129)
nb (%) Total
(Na=2260)
nb (%)
Length of Blinded Placebo -controlled Follow -up
<4 Months 345 (30.5) 356 (31.5) 701 (31.0)
≥4-<5 Months 528 (46.7) 532 (47.1) 1060 (46.9)
≥5-<6 Months 106 (9.4) 97 (8.6) 203 (9.0)
≥6 Months 152 (13.4) 144 (12.8) 296 (13.1)
Total Follow -up Period from Dose 2 to Cutoff Date September 2, 2021
<4 Months 8 (0.7)
≥4-<5 Months 7 (0.6)
≥5-<6 Months 3 (0.3)
≥6 Months 1113 (98.4)
a. N = number of participants in the specified group, or the total sample. This value is the denominator for the percentage calc ulations.
b. n = Number of participants with the specified characteristic.
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Table.B Study Disposition of Phase 2/3 Randomized Participants 12 Through 15 Years of Age (Data Cutoff September 2, 2021)
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=1134)
nb (%) Placebo
(Na=1130)
nb (%) Total
(Na=2264)
nb (%)
Randomized 1134 (100.0) 1130 (100.0) 2264 (100.0)
Not vaccinated 3 (0.3) 1 (0.1) 4 (0.2)
Original blinded placebo -controlled follow -up period
Vaccinated 1131 (99.7) 1129 (99.9) 2260 (99.8)
Dose 1 1131 (99.7) 1129 (99.9) 2260 (99.8)
Dose 2 1124 (99.1) 1117 (98.8) 2241 (99.0)
Discontinued from original blinded placebo -controlled vaccination periodc 3 (0.3) 14 (1.2) 17 (0.8)
Reason for discontinuation
No longer meets eligibility criteria 0 7 (0.6) 7 (0.3)
Protocol deviation 0 2 (0.2) 2 (0.1)
Adverse event 1 (0.1) 0 1 (0.0)
Physician decision 1 (0.1) 0 1 (0.0)
Withdrawal by subject 0 1 (0.1) 1 (0.0)
Withdrawal by parent/guardian 0 1 (0.1) 1 (0.0)
Other 1 (0.1) 3 (0.3) 4 (0.2)
Unblinded before 1 -month post –Dose 2 visit 12 (1.1) 21 (1.9) 33 (1.5)
Completed 1 -month post –Dose 2 visit 1113 (98.1) 1096 (97.0) 2209 (97.6)
Withdrawn from the study 5 (0.4) 14 (1.2) 19 (0.8)
Withdrawn after Dose 1 and before Dose 2 0 0 0
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Table.B Study Disposition of Phase 2/3 Randomized Participants 12 Through 15 Years of Age (Data Cutoff September 2, 2021)
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=1134)
nb (%) Placebo
(Na=1130)
nb (%) Total
(Na=2264)
nb (%)
Withdrawn after Dose 2 and before 1 -month post –Dose 2 visit 0 3 (0.3) 3 (0.1)
Withdrawn after 1 -month post –Dose 2 visit 5 (0.4) 11 (1.0) 16 (0.7)
Reason for withdrawal from the study
Withdrawal by subject 1 (0.1) 7 (0.6) 8 (0.4)
Withdrawal by parent/guardian 1 (0.1) 5 (0.4) 6 (0.3)
Lost to follow -up 3 (0.3) 2 (0.2) 5 (0.2)
Open -label follow -up period
Originally randomized to BNT162b2 1107 (97.6)
Received Dose 2/unplanned dose 4 (0.4)
Completed 1 -month post –Dose 2 visit 15 (1.3)
Completed 6 -month post –Dose 2 visit 1065 (93.9)
Withdrawn from the study 45 (4.0)
Withdrawn before 6 -month post –Dose 2 visit 25 (2.2)
Withdrawn after 6 -month post –Dose 2 visit 20 (1.8)
Reason for withdrawal from the study
Withdrawal by subject 7 (0.6)
Withdrawal by parent/guardian 7 (0.6)
Lost to follow -up 6 (0.5)
Protocol deviation 1 (0.1)
No longer meets eligibility criteria 1 (0.1)
Other 23 (2.0)
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Table.B Study Disposition of Phase 2/3 Randomized Participants 12 Through 15 Years of Age (Data Cutoff September 2, 2021)
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=1134)
nb (%) Placebo
(Na=1130)
nb (%) Total
(Na=2264)
nb (%)
Originally randomized to placebo 1108 (98.1)
Withdrawn from the study after unblinding and before Dose 3 47 (4.2)
Received Dose 3 (first dose of BNT162b2 [30 μg]) 1010 (89.4)
Received Dose 4 (second dose of BNT162b2 [30 μg]) 992 (87.8)
Discontinued from open -label vaccination periodd 5 (0.4)
Reason for discontinuation from open -label vaccination period
Protocol deviation 4 (0.4)
Withdrawal by subject 1 (0.1)
Completed 1 -month post –Dose 4 visit 933 (82.6)
Withdrawn from the study 6 (0.5)
Withdrawn after Dose 3 and before Dose 4 5 (0.4)
Withdrawn after Dose 4 and before 1 -month post –Dose 4 visit 0
Withdrawn after 1 -month post –Dose 4 visit 1 (0.1)
Reason for withdrawal from the study
Withdrawal by subject 3 (0.3)
Lost to follow -up 2 (0.2)
Protocol deviation 1 (0.1)
a. N = number of randomized participants in the specified group, or the total sample. This value is the denominator for the perc entage calculations.
b. n = Number of participants with the specified characteristic.
c. Original blinded placebo -controlled vaccination period is defined as the time period from Dose 1 to 1- month post –Dose 2 visit.
d. Open -label vaccination period is defined as the time period from Dose 3 (first dose of BNT162b2 [30 µg]) to 1- month post –Dose 4 (second dose of
BNT162b2 [30 µg]) visit.
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Table .C Study Disposition, Participants 12 Through 15 Years of Age , Open -label Unblinded Follow -Up Time Period
Pfizer Response: Disposition data for open-label unblinded follow-up time period is included in Table B.
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Table.D Disposition of Participants 12 Through 15 Years of Age – Safety Population (Data Cutoff September 2, 2021)
Vaccine Group (as Administered)
BNT162b2 (30 μg)
(Na=1131)
nb (%) Placebo
(Na=1129)
nb (%) Total
(Na=2260)
nb (%)
Randomized 2264
Not vaccinated 4
Vaccinated 1131 (100.0) 1129 (100.0) 2260 (100.0)
Completed 1 dose 1131 (100.0) 1129 (100.0) 2260 (100.0)
Completed 2 doses 1124 (99.4) 1117 (98.9) 2241 (99.2)
Safety population 1131 (100.0) 1129 (100.0) 2260 (100.0)
Participants excluded from safety population 4
Reason for exclusion
Participant did not receive study vaccine 4
Completed at least 6 months follow -up after Dose 2 in blinded placebo -controlled follow -up period 152 (13.4) 144 (12.8) 296 (13.1)
Completed at least 6 months follow -up after Dose 2 in blinded and open -label follow -up period 1113 (98.4)
Completed 1 -month post –Dose 2 visit (vaccination period) 1113 (98.4) 1096 (97.1) 2209 (97.7)
Discontinued from vaccination period but continued in the study up to 1 -month post –Dose 2 visit 3 (0.3) 14 (1.2) 17 (0.8)
Discontinued after Dose 1 and before Dose 2 3 (0.3) 10 (0.9) 13 (0.6)
Discontinued after Dose 2 and before 1 -month post –Dose 2 visit 0 4 (0.4) 4 (0.2)
Reason for discontinuation from vaccination period
No longer meets eligibility criteria 0 7 (0.6) 7 (0.3)
Protocol deviation 0 2 (0.2) 2 (0.1)
Adverse event 1 (0.1) 0 1 (0.0)
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Table.D Disposition of Participants 12 Through 15 Years of Age – Safety Population (Data Cutoff September 2, 2021)
Vaccine Group (as Administered)
BNT162b2 (30 μg)
(Na=1131)
nb (%) Placebo
(Na=1129)
nb (%) Total
(Na=2260)
nb (%)
Physician decision 1 (0.1) 0 1 (0.0)
Withdrawal by subject 0 1 (0.1) 1 (0.0)
Withdrawal by parent/guardian 0 1 (0.1) 1 (0.0)
Other 1 (0.1) 3 (0.3) 4 (0.2)
Withdrawn from study before 1 -month post –Dose 2 visit 0 3 (0.3) 3 (0.1)
Withdrawn after Dose 1 and before Dose 2 0 0 0
Withdrawn after Dose 2 and before 1 -month post –Dose 2 visit 0 3 (0.3) 3 (0.1)
Reason for withdrawal
Withdrawal by parent/guardian 0 2 (0.2) 2 (0.1)
Withdrawal by subject 0 1 (0.1) 1 (0.0)
a. N = number of participants in the specified group, or the total sample. This value is the denominator for the percentage calc ulations.
b. n = Number of participants with the specified characteristic.
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Table.E Disposition of Participants 12 Through 15 Years of Age – Efficacy Population (Data Cutoff September 2, 2021)
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
na (%) Placebo
na (%) Total
na (%)
Randomizedb 1134 (100.0) 1130 (100.0) 2264 (100.0)
Dose 1 all -available efficacy population 1131 (99.7) 1129 (99.9) 2260 (99.8)
Subjects without evidence of infection before Dose 1 1083 (95.5) 1078 (95.4) 2161 (95.5)
Subjects excluded from Dose 1 all -available efficacy population 3 (0.3) 1 (0.1) 4 (0.2)
Reason for exclusionc
Did not receive at least 1 vaccination 3 (0.3) 1 (0.1) 4 (0.2)
Dose 2 all -available efficacy population 1123 (99.0) 1117 (98.8) 2240 (98.9)
Subjects without evidence of infection prior to 7 days after Dose 2 1061 (93.6) 1037 (91.8) 2098 (92.7)
Subjects excluded from Dose 2 all -available efficacy population 11 (1.0) 13 (1.2) 24 (1.1)
Reason for exclusionc
Did not receive 2 vaccinations 10 (0.9) 13 (1.2) 23 (1.0)
Unblinded prior to 7 days after Dose 2 1 (0.1) 0 1 (0.0)
Evaluable efficacy (7 days) population 1119 (98.7) 1109 (98.1) 2228 (98.4)
Subjects without evidence of infection prior to 7 days after Dose 2 1057 (93.2) 1030 (91.2) 2087 (92.2)
Subjects excluded from evaluable efficacy (7 days) population 15 (1.3) 21 (1.9) 36 (1.6)
Reason for exclusionc
Randomized but did not meet all eligibility criteria 1 (0.1) 1 (0.1) 2 (0.1)
Did not receive all vaccinations as randomized or did not receive Dose 2
within the predefined window (19- 42 days after Dose 1) 14 (1.2) 19 (1.7) 33 (1.5)
Unblinded prior to 7 days after Dose 2 1 (0.1) 0 1 (0.0)
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Table.E Disposition of Participants 12 Through 15 Years of Age – Efficacy Population (Data Cutoff September 2, 2021)
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
na (%) Placebo
na (%) Total
na (%)
Had other important prot ocol deviations on or prior to 7 days after Dose 2 0 3 (0.3) 3 (0.1)
a. n = Number of subjects with the specified characteristic.
b. These values are the denominators for the percentage calculations.
c. Subjects may have been excluded for more than 1 reason.
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Table.F Demographics and Other Baseline Characteristics – Participants 12 Through 15 Years of Age –
Safety Population (Data Cutoff September 2, 2021)
Vaccine Group (as Administered)
Characteristic BNT162b2 (30 μg)
(Na=1131)
nb (%) Placebo
(Na=1129)
nb (%) Total
(Na=2260)
nb (%)
Sex: Female 564 (49.9) 544 (48.2) 1108 (49.0)
Sex: Male 567 (50.1) 585 (51.8) 1152 (51.0)
Age at Vaccination: Mean years (SD) 13.6 (1.11) 13.6 (1.11) 13.6 (1.11)
Age at Vaccination: Median (years) 14.0 14.0 14.0
Age at Vaccination: Min, max (years) (12, 15) (12, 15) (12, 15)
Race: American Indian or Alaska Native 4 (0.4) 3 (0.3) 7 (0.3)
Race: Asian 72 (6.4) 71 (6.3) 143 (6.3)
Race: Black or African American 52 (4.6) 57 (5.0) 109 (4.8)
Race: Native Hawaiian or Other Pacific Islander 3 (0.3) 0 3 (0.1)
Race: White 970 (85.8) 962 (85.2) 1932 (85.5)
Race: Multiracial 24 (2.1) 29 (2.6) 53 (2.3)
Race: Not reported 6 (0.5) 7 (0.6) 13 (0.6)
Ethnicity: Hispanic or Latino 132 (11.7) 130 (11.5) 262 (11.6)
Ethnicity: Not Hispanic or Latino 997 (88.2) 996 (88.2) 1993 (88.2)
Ethnicity: Not reported 2 (0.2) 3 (0.3) 5 (0.2)
Obesity: Yesc 143 (12.6) 128 (11.3) 271 (12.0)
Obesity: No 988 (87.4) 1001 (88.7) 1989 (88.0)
Comorbidities: Yesd 249 (22.0) 242 (21.4) 491 (21.7)
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Table.F Demographics and Other Baseline Characteristics – Participants 12 Through 15 Years of Age –
Safety Population (Data Cutoff September 2, 2021)
Vaccine Group (as Administered)
Characteristic BNT162b2 (30 μg)
(Na=1131)
nb (%) Placebo
(Na=1129)
nb (%) Total
(Na=2260)
nb (%)
Comorbidities: No 882 (78.0) 887 (78.6) 1769 (78.3)
Baseline evidence of prior SARS -CoV -2 infection: Negativee 1083 (95.8) 1078 (95.5) 2161 (95.6)
Baseline evidence of prior SARS -CoV -2 infection: Positivef 46 (4.1) 50 (4.4) 96 (4.2)
Baseline evidence of prior SARS -CoV -2 infection: Missing 2 (0.2) 1 (0.1) 3 (0.1)
Country: United States of America 1131 (100.0) 1129 (100.0) 2260 (100.0)
Abbreviation: SARS -CoV -2 = severe acute respiratory syndrome coronavirus 2.
a. N = number of subjects in the specified group, or the total sample. This value is the denominator for the percentage calculat ions.
b. n = Number of subjects with the specified characteristic.
c. Subjects who had a BMI at or above the 95th percentile from the CDC growth chart.
d. Number of subjects who have 1 or more comorbidities that increase the risk of severe COVID -19 disease: defined as subjects who had at least one of
the Charlson comorbidity index category or BMI ≥95th percentile.
e. Positive N -binding antibody result at Visit 1, positive NAAT result at Visit 1, or medical history of COVID -19.
f. Negative N -binding antibody result and negative NAAT result at Visit 1 and no medical history of COVID -19.
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Table.G Demographics and Other Baseline Characteristics – Participants 12 Through 15 Years of Age With or Without
Evidence of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy Population (Data Cutoff September 2, 2021)
Vaccine Group (as Randomized)
Characteristic BNT162b2 (30 μg)
(Na=1119)
nb (%) Placebo
(Na=1109)
nb (%) Total
(Na=2228)
nb (%)
Sex: Female 560 (50.0) 536 (48.3) 1096 (49.2)
Sex: Male 559 (50.0) 573 (51.7) 1132 (50.8)
Age at Vaccination: Mean years (SD) 13.6 (1.11) 13.6 (1.11) 13.6 (1.11)
Age at Vaccination: Median (years) 14.0 14.0 14.0
Age at Vaccination: Min, max (years) (12, 15) (12, 15) (12, 15)
Race: American Indian or Alaska Native 4 (0.4) 2 (0.2) 6 (0.3)
Race: Asian 71 (6.3) 71 (6.4) 142 (6.4)
Race: Black or African American 50 (4.5) 57 (5.1) 107 (4.8)
Race: Native Hawaiian or Other Pacific Islander 3 (0.3) 0 3 (0.1)
Race: White 961 (85.9) 943 (85.0) 1904 (85.5)
Race: Multiracial 24 (2.1) 29 (2.6) 53 (2.4)
Race: Not reported 6 (0.5) 7 (0.6) 13 (0.6)
Ethnicity: Hispanic or Latino 131 (11.7) 127 (11.5) 258 (11.6)
Ethnicity: Not Hispanic or Latino 986 (88.1) 979 (88.3) 1965 (88.2)
Ethnicity: Not reported 2 (0.2) 3 (0.3) 5 (0.2)
Obesity: Yesc 141 (12.6) 125 (11.3) 266 (11.9)
Obesity: No 978 (87.4) 984 (88.7) 1962 (88.1)
Comorbidities: Yesd 244 (21.8) 236 (21.3) 480 (21.5)
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Table.G Demographics and Other Baseline Characteristics – Participants 12 Through 15 Years of Age With or Without
Evidence of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy Population (Data Cutoff September 2, 2021)
Vaccine Group (as Randomized)
Characteristic BNT162b2 (30 μg)
(Na=1119)
nb (%) Placebo
(Na=1109)
nb (%) Total
(Na=2228)
nb (%)
Comorbidities: No 875 (78.2) 873 (78.7) 1748 (78.5)
Baseline evidence of prior SARS -CoV -2 infection: Negativee 1071 (95.7) 1059 (95.5) 2130 (95.6)
Baseline evidence of prior SARS -CoV -2 infection: Positivef 46 (4.1) 49 (4.4) 95 (4.3)
Baseline evidence of prior SARS -CoV -2 infection: Missing 2 (0.2) 1 (0.1) 3 (0.1)
Country: United States of America 1119 (100.0) 1109 (100.0) 2228 (100.0)
Abbreviation: SARS -CoV -2 = severe acute respiratory syndrome coronavirus 2.
a. N = number of subjects in the specified group, or the total sample. This value is the denominator for the percentage calculat ions.
b. n = Number of subjects with the specified characteristic.
c. Subjects who had a BMI at or above the 95th percentile from the CDC growth chart.
d. Number of subjects who have 1 or more comorbidities that increase the risk of severe COVID -19 disease: defined as subjects who had at least one of
the Charlson comorbidity index category or BMI ≥95th percentile .
e. Negative N -binding antibody result and negative NAAT result at Visit 1 and no medical history of COVID -19.
f. Positive N -binding antibody result at Visit 1, positive NAAT result at Visit 1, or medical history of COVID -19.
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Table.H Vaccine Efficacy – Blinded Placebo -Controlled Follow -up Period – Participants 12 Through 15 Years of Age
Without Evidence of Prior SARS -CoV -2 Infection – Evaluable Efficacy Population (Data Cutoff March, 2021)
Endpoint BNT162b2
(Na=1005)
Cases
n1b
Surveillance Timec
(n2d) Placebo
(Na=978)
Cases
n1b
Surveillance Timec
(n2d) Vaccine Efficacy
%
(95% CI)e
First COVID -19 occurrence from 7 days after Dose 2 in subjects without evidence of
prior SARS -CoV -2 infection 0
0.154
(1001) 16
0.147
(972) 100.0
(75.3, 100.0)
Abbreviations: N -binding = SARS -CoV -2 nucleoprotein –binding; NAAT = nucleic acid amplification test;
SARS -CoV -2 = severe acute respiratory syndrome coronavirus 2; VE = vaccine efficacy.
Note: Subjects who had no serological or virological evidence (prior to 7 days 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 detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any
unscheduled visit prior to 7 days after Dose 2 were included in the analysis.
a. N = number of subjects in the specified group.
b. n1 = Number of subjects meeting the endpoint definition.
c. Total surve illance time in 1000 person -years for the given endpoint across all subjects within each group at risk for the endpoint. Time period for
COVID -19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
d. n2 = Number of subjects at risk for the endpoint.
e. Confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
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Table.I Updated Vaccine Efficacy – Blinded Placebo -Controlled Follow -up Period – Participants 12 Through 15 Years of Age
Without Evidence of Prior SARS -CoV -2 Infection – Evaluable Efficacy Population (Data Cutoff September 2, 2021)
Endpoint BNT162b2
(Na=1057)
Cases
n1b
Surveillance Timec
(n2d) Placebo
(Na=1030)
Cases
n1b
Surveillance Timec
(n2d) Vaccine Efficacy
%
(95% CI)e
First COVID -19 occurrence from 7 days after Dose 2 in subjects without evidence of
prior SARS -CoV -2 infection 0
0.343
(1043) 28
0.322
(1019) 100.0
(86.8, 100.0)
Abbreviations: N -binding = SARS -CoV -2 nucleoprotein –binding; NAAT = nucleic acid amplification test;
SARS -CoV -2 = severe acute respiratory syndrome coronavirus 2; VE = vaccine efficacy.
Note: Subjects who had no serological or virological evidence (prior to 7 days 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 detected by NAAT [nasal swab] at Visits 1 and 2), and had negative N AAT (nasal swab) at any
unscheduled visit prior to 7 days after Dose 2 were included in the analysis.
a. N = number of subjects in the specified group.
b. n1 = Number of subjects meeting the endpoint definition.
c. Total surveillance time in 1 000 person -years for the given endpoint across all subjects within each group at risk for the endpoint. Time period for
COVID -19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
d. n2 = Number of subjects at risk for the endpoint.
e. Confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
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Table.J Updated Vaccine Efficacy – Blinded Placebo -Controlled Follow -up Period – Participants 12 Through 15 Years of Age
With or Without Evidence of Prior SARS -CoV -2 Infection – Evaluable Efficacy Population (Data Cutoff September 2, 2021)
Endpoint BNT162b2
(Na=1119)
Cases
n1b
Surveillance Timec
(n2d) Placebo
(Na=1109)
Cases
n1b
Surveillance Timec
(n2d) Vaccine Efficacy %
(95% CI)e
First COVID -19 occurrence from 7 days after Dose 2 0
0.362
(1098) 30
0.345
(1088) 100.0
(87.5, 100.0)
Abbreviations: SARS -CoV -2 = severe acute respiratory syndrome coronavirus 2; VE = vaccine efficacy.
a. N = number of subjects in the specified group.
b. n1 = Number of subjects meeting the endpoint definition.
c. Total surveillance time in 100 0 person -years for the given endpoint across all subjects within each group at risk for the endpoint. Time period for
COVID -19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
d. n2 = Number of subjects at risk for the endpoint.
e. Confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
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Figure A. Cumulative Incidence Curve s for the First COVID -19 Occurrence After Dose 1, Participants 12 Through 15 Years of Age,
Dose 1 All -Available Efficacy Population
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Table.K Updated Vaccine Efficacy – Blinded Placebo -Controlled Follow -up Period – Participan ts 12 Through 15 Years of Age – Dose
1 All -Available Efficacy Population (Data Cutoff September 2, 2021)
Efficacy Endpoint Subgroup BNT162b2
(Na=1131)
Cases
n1b
Surveillance Timec
(n2d) Placebo
(Na=1129)
Cases
n1b
Surveillance Timec
(n2d) Vaccine Efficacy %
(95% CI)e
First COVID -19 occurrence after Dose 1 3
0.450
(1109) 48
0.434
(1114) 94.0
(81.3, 98.8)
After Dose 1 to before Dose 2 3
0.065
(1109) 12
0.065
(1114) 75.1
(7.6, 95.5)
Dose 2 to 7 days after Dose 2 0
0.021
(1103) 5
0.021
(1100) 100.0
(-8.7, 100.0)
≥7 Days after Dose 2 0
0.364
(1102) 31
0.348
(1095) 100.0
(87.9, 100.0)
≥7 days after Dose 2 to <2 Months after Dose 2 0
0.146
(1102) 17
0.143
(1095) 100.0
(76.3, 100.0)
≥2 Months after Dose 2 to <4 Months after Dose 2 0
0.156
(1065) 10
0.149
(1029) 100.0
(57.3, 100.0)
≥4 Months after Dose 2 to <6 Months after Dose 2 0
0.053
(770) 4
0.049
(732) 100.0
(-40.7, 100.0)
≥6 Months after Dose 2 0 0 NE
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Table.K Updated Vaccine Efficacy – Blinded Placebo -Controlled Follow -up Period – Participan ts 12 Through 15 Years of Age – Dose
1 All -Available Efficacy Population (Data Cutoff September 2, 2021)
Efficacy Endpoint Subgroup BNT162b2
(Na=1131)
Cases
n1b
Surveillance Timec
(n2d) Placebo
(Na=1129)
Cases
n1b
Surveillance Timec
(n2d) Vaccine Efficacy %
(95% CI)e
0.009
(149) 0.007
(133)
Abbreviation: VE = vaccine efficacy.
a. N = number of subjects in the specified group.
b. n1 = Number of subjects meeting the endpoint definition.
c. Total surveillance time in 1000 person -years for the given endpoint across all subjects within each group at risk for the endpoint. Time period for
COVID -19 case accrual is from Dose 1 to the end of the surveillance period for the overall row and from start to the end of the range stated for each time
interval.
d. n2 = Number of subjects at risk for the endpoint.
e. Confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
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Table.L Subgroup Analyses of The Updated Vaccine Efficacy – Blinded Placebo -Controlled Follow -up Period –
Participants 12 Through 15 Years of Age With or Without Evidence of Prior SARS- CoV-2 Infection –
Evaluable Efficacy Population (Data Cutoff September 2, 2021 )
Vaccine Group (as Randomized)
Efficacy Endpoint
Subgroup BNT162b2 (30 μg)
(Na=1119)
Cases n1b
Surveillance Timec
(n2d) Placebo
(Na=1109)
Cases n1b
Surveillance Timec
(n2d) Vaccine Efficacy (%)
(95% CIe)
First COVID -19 occurrence from 7 days after Dose 2
Overall 0
0.362
(1098) 30
0.345
(1088) 100.0
(87.5, 100.0)
Age group: 12 to 13 years 0
0.180
(521) 13
0.168
(503) 100.0
(69.3, 100.0)
Age group: 14 to 15 years 0
0.183
(577) 17
0.178
(585) 100.0
(76.5, 100.0)
At risk: Yesf 0
0.082
(241) 11
0.073
(228) 100.0
(64.6, 100.0)
At risk: No 0
0.280
(857) 19
0.273
(860) 100.0
(79.2, 100.0)
Obese: Yesg 0
0.048
(140) 7
0.039
(122) 100.0
(43.1, 100.0)
Obese: No 0 23 100.0
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Table.L Subgroup Analyses of The Updated Vaccine Efficacy – Blinded Placebo -Controlled Follow -up Period –
Participants 12 Through 15 Years of Age With or Without Evidence of Prior SARS- CoV-2 Infection –
Evaluable Efficacy Population (Data Cutoff September 2, 2021 )
Vaccine Group (as Randomized)
Efficacy Endpoint
Subgroup BNT162b2 (30 μg)
(Na=1119)
Cases n1b
Surveillance Timec
(n2d) Placebo
(Na=1109)
Cases n1b
Surveillance Timec
(n2d) Vaccine Efficacy (%)
(95% CIe)
0.314
(958) 0.306
(966) (83.1, 100.0)
Sex: Female 0
0.179
(548) 12
0.169
(527) 100.0
(66.1, 100.0)
Sex: Male 0
0.183
(550) 18
0.177
(561) 100.0
(78.0, 100.0)
Ethnicity: Hispanic or Latino 0
0.045
(127) 7
0.040
(125) 100.0
(37.8, 100.0)
Ethnicity: Not Hispanic or Latino 0
0.317
(969) 23
0.304
(960) 100.0
(83.3, 100.0)
Race: Black or African American 0
0.019
(47) 2
0.021
(56) 100.0
(-492.9, 100.0)
Race: White 0
0.309
(945) 28
0.291
(926) 100.0
(86.8, 100.0)
Baseline SARS -CoV -2 Status:Negativei 0 30 100.0
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Table.L Subgroup Analyses of The Updated Vaccine Efficacy – Blinded Placebo -Controlled Follow -up Period –
Participants 12 Through 15 Years of Age With or Without Evidence of Prior SARS- CoV-2 Infection –
Evaluable Efficacy Population (Data Cutoff September 2, 2021 )
Vaccine Group (as Randomized)
Efficacy Endpoint
Subgroup BNT162b2 (30 μg)
(Na=1119)
Cases n1b
Surveillance Timec
(n2d) Placebo
(Na=1109)
Cases n1b
Surveillance Timec
(n2d) Vaccine Efficacy (%)
(95% CIe)
0.347
(1051) 0.328
(1038) (87.6, 100.0)
Country: United States 0
0.362
(1098) 30
0.345
(1088) 100.0
(87.5, 100.0)
Abbreviations: N -binding = SARS -CoV -2 nucleoprotein –binding; NAAT = nucleic acid amplification test;
SARS -CoV -2 = severe acute respiratory syndrome coronavirus 2; VE = vaccine efficacy.
a. N = number of subjects in the specified group.
b. n1 = Number of subjects meeting the endpoint definition.
c. Total surveillance time in 1000 person -years for the given endpoint across all subjects within each group at risk for the endpoint. Time period for
COVID -19 case accrual is from 7 days after Dose 2 t o the end of the surveillance period.
d. n2 = Number of subjects at risk for the endpoint.
e. Confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
f. Includes subjects who had at le ast one of the Charlson Comorbidity Index (CMI) category or obesity (BMI ≥95th percentile).
g. Subjects who had a BMI at or above the 95th percentile from the CDC growth chart.
h. Positive N -binding antibody result at Visit 1, positive NAAT result at Visit 1, or medical history of COVID -19.
i. Negative N -binding antibody result and negative NAAT result at Visit 1 and no medical history of COVID -19.
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Table.M Demographic Characteristics – Participants 12 Through 15 Years of Age With Protocol -Defined COVID -19 Without
Evidence of Infection Prior to 7 Days After Dose 2 (Data Cutoff September 2, 2021)
Vaccine Group (as Randomized)
Characteristic BNT162b2 (30 μg)
(Na=0)
nb (%) Placebo
(Na=28)
nb (%) Total
(Na=28)
nb (%)
Age at Vaccination: Mean years (SD) - (-) 13.8 (1.08) 13.8 (1.08)
Age at Vaccination: Median (years) - 14.0 14.0
Age Group: 12 -13 years 0 12 (42.9) 12 (42.9)
Age Group: 14 -15 years 0 16 (57.1) 16 (57.1)
Race: Black or African American 0 2 (7.1) 2 (7.1)
Race: White 0 26 (92.9) 26 (92.9)
Sex: Female 0 12 (42.9) 12 (42.9)
Sex: Male 0 16 (57.1) 16 (57.1)
Ethnicity: Hispanic or Latino 0 7 (25.0) 7 (25.0)
Ethnicity: Not Hispanic or Latino 0 21 (75.0) 21 (75.0)
Comorbidities: Yesc 0 9 (32.1) 9 (32.1)
Comorbidities: No 0 19 (67.9) 19 (67.9)
Obesity: Yesd 0 6 (21.4) 6 (21.4)
Obesity: No 0 22 (78.6) 22 (78.6)
Country: United States 0 28 (100.0) 28 (100.0)
a. N = number of subjects in the specified group, or the total sample. This value is the denominator for the percentage calculat ions.
b. n = Number of subjects with the specified characteristic.
c. Number of subjects who have 1 or more comorb idities that increase the risk of severe COVID -19 disease: defined as subjects who had at least one of
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Table.M Demographic Characteristics – Participants 12 Through 15 Years of Age With Protocol -Defined COVID -19 Without
Evidence of Infection Prior to 7 Days After Dose 2 (Data Cutoff September 2, 2021)
Vaccine Group (as Randomized)
Characteristic BNT162b2 (30 μg)
(Na=0)
nb (%) Placebo
(Na=28)
nb (%) Total
(Na=28)
nb (%)
the Charlson comorbidity index category or BMI ≥95th percentile.
d. Subjects who had a BMI at or above the 95th percentile from the CDC growth chart .
Table.N Updated Vaccine Efficacy Against Severe COVID -19, Participants Without Evidence of Prior SARS- CoV-2 Infection,
Evaluable Efficacy Population
Pfizer Response: No Severe COVID- 19 cases occurred in participants 12 through 15 years of age.
Table.O Updated Vaccine Efficacy Against First Occurrence of Severe COVID -19 After Dose 1, Dose 1 All-Available Efficacy
Population
Pfizer Response: No Severe COVID- 19 cases occurred in participants 12 through 15 years of age.
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Table .P Safety Overview – Participants 12 Through 15 Years of Age – Safety Population (Data Cutoff September 2, 2021)
BNT162b2 (30 μg)
n/N (%) Placebo
n/N (%)
Immediate unsolicited AE within 30 minutes after vaccination
Dose1 0/1131 (0.0) 4/1129 (0.4)
Dose2 2/1124 (0.2) 3/1117 (0.3)
From Dose 1 through 1 month after Dose 2
Any unsolicited AE 74/1131 (6.5) 77/1129 (6.8)
Unsolicited non -serious AE 72/1131 (6.4) 76/1129 (6.7)
SAE 4/1131 (0.4) 1/1129 (<0.1)
Withdrawal due to unsolicited AE 1/1131 (<0.1) 0/1129 (0.0)
Death 0/1131 (0.0) 0/1129 (0.0)
Dose 1 to Data Cutoff (September 2, 2021) or participant unblinding (whichever is earlier)
Any unsolicited AE 95/1131 (8.4) 113/1129 (10.0)
Unsolicited non -serious AE 89/1131 (7.9) 111/1129 (9.8)
SAE 10/1131 (0.9) 2/1129 (0.2)
Withdrawal due to unsolicited AE 1/1131 (<0.1) 0/1129 (0.0)
Death 0/1131 (0.0) 0/1129 (0.0)
Note: MedDRA (v24.0) coding dictionary applied.
Note: Immediate AE refers to an AE reported in the 30 -minute observation period after vaccination.
Table.Q Unsolicited Adverse Events, Blinded Placebo -controlled Follow -up Period, Participants 12 Through 15 Years of Age and 16-
25 Years of Age, Safety Population
Pfizer Response: Table Q data is reported in Table P.
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Table.R Frequency of Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose – Participants 12 Through 15
Years of Age – Reactogenicity Subset of the Safety Population
Pfizer Response: Please refer to EUA 12 -15 508 document. No new e-diary data is reported.
Table.S Freque ncy of Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose – Participants 12 Through
15 Years of Age – Reactogenicity Subset of the Safety Population
Pfizer Response: Please refer to EUA 12 -15 508 document. No new e-diary da ta is reported.
Table.T Frequency of Unsolicited Adverse Events Occurring in ≥1% of Participants in Any Treatment Group From Dose 1 to 1
Month After Dose 2, Safety Population
Pfizer Response: No unsolicited adverse events are reported occurring in ≥1% of participants 12 through 15 years of age from dose 1 to 1
month after dose 2 .
Table.U Frequency of Unsolicited Adverse Events Occurring in ≥1% of Participants in Any Treatment Group From Dose 1 to Data
Cutoff or Date of Unblinding (Whichever is Earlier), Safety Population
Pfizer Response: No unsolicited adverse events are reported occurring in ≥1% of participants 12 through 15 years of age from dose 1 to data cutoff or date of unblinding.
Table.V Frequency of Unsolicited Adverse Events Occurring in ≥1% of Participants in Any Treatment Group From Date of
Unblinding to Data Cutoff Date, Safety Population
Pfizer Response: No unsolicited adverse events are reported occurring in ≥1% of participants 12 through 15 years of age from date of
unblinding to data cutoff date.
Table. W Frequency of Unsolicited AEs with Occurrence in ≥1% From Dose 1 to 6 Months After Dose 2, Participants Who Originally
Received BNT162b2 With at Least 6 Months of Follow- up Time, Safety Population
Pfizer Response: No unsolicited adverse events are reported occurring in ≥1% of participants 12 through 15 years of age and who originally
received BNT162b2 with at least 6 months of follow- up time
.
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Table.X Frequency of Unsolicited AEs with Occurrence in ≥1% of Participants From Dose 3 to Cutoff Date (September 2, 2021) –
Open -Label Follow- up Period –
Participants Who Originally Received Placebo and Then Received BNT162b2 After Unblinding – Participants 12 Through 15 Years
of Age – Safety Population
BNT162b2 (30 μg)
(N=1010)
SYSTEM ORGAN CLASS
and Preferred Term Any n (%) Severe n (%)
GASTROINTESTINAL DISORDERS
Nausea 12(1.2) 0 (0.0)
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Chills 45(4.5) 0 (0.0)
Fatigue 104(10.3) 2 (0.2)
Injection site pain 157(15.5) 0 (0.0)
Pain 35(3.5) 0 (0.0)
Pyrexia 64(6.3) 3 (0.3)
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Myalgia 38(3.8) 1 (0.1)
NERVOUS SYSTEM DISORDERS
Headache 71(7.0) 0 (0.0)
Note: Dose 3 = First dose of BNT162b2 (30 μg).
MedDRA v24.0 coding dictionary applied.
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Table.Y Selected Standard MedDRA Queries From Dose 1 to Unblinding Date – Blinded Placebo -Controlled Follow -up Period –
Participants 12 Through 15 Years of Age – Safety Population (Data Cutoff September 2, 2021)
Vaccine Group (as Administered)
BNT162b2 (30 μg)
(Na=1131) Placebo
(Na=1129)
SMQ Overall SMQ
System Organ Class
Preferred Term nb (%) nb (%)
Subjects with any unsolicited adverse events within SMQ 8 (0.71) 12 (1.06)
Angioedema (SMQ) Any unsolicited adverse events within Angioedema (SMQ) 3 (0.27) 5 (0.44)
Gastrointestinal disorders 1 (0.09) 0
Lip swelling 1 (0.09) 0
Mouth swelling 1 (0.09) 0
Skin and subcutaneous tissue disorders 2 (0.18) 5 (0.44)
Urticaria 2 (0.18) 5 (0.44)
Hypersensitivity (SMQ) Any unsolicited adverse events within Hypersensitivity (SMQ) 8 (0.71) 12 (1.06)
Gastrointestinal disorders 1 (0.09) 0
Lip swelling 1 (0.09) 0
Mouth swelling 1 (0.09) 0
Skin and subcutaneous tissue disorders 7 (0.62) 12 (1.06)
Dermatitis contact 2 (0.18) 1 (0.09)
Eczema 0 1 (0.09)
Rash 3 (0.27) 5 (0.44)
Rash maculo -papular 0 1 (0.09)
Urticaria 2 (0.18) 5 (0.44)
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Table.Y Selected Standard MedDRA Queries From Dose 1 to Unblinding Date – Blinded Placebo -Controlled Follow -up Period –
Participants 12 Through 15 Years of Age – Safety Population (Data Cutoff September 2, 2021)
Vaccine Group (as Administered)
BNT162b2 (30 μg)
(Na=1131) Placebo
(Na=1129)
SMQ Overall SMQ
System Organ Class
Preferred Term nb (%) nb (%)
a. N = number of participants in the specified group. This value is the denominator for the percentage calculations.
b. n = Number of participants reporting at least 1 occurrence of the specified event category. For "any event," n = the number of p articipants reporting at
least 1 occurrence of any event.
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Table.Z SAEs considered related by Investigator – Phase 2/3 – Participants 12 Through 15 Years of Age – Safety Population (Data
Cutoff September 2, 2021)
Product
(Vaccine or
Placebo) SAE Dose/Rel Daya Demographics:
Age/Sex/Risk Factors
from Charlson Index Resolution Related per
Investigator
Placebo crossover to BNT162b2 Appendicitis 4*/4# 12 F; no relevant medical history Resolved Yes
Note: MedDRA (v24.0) coding dictionary applied.
Note: # = SAE occurring on or after unblinding.
Note: * indicates Dose 3 = first dose of BNT162b2 (30 μg), Dose 4 = second dose of BNT162b2 (30 μg).
a. Relative day (Rel Day) = date of SAE - date of last vaccination + 1.
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