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Table.B Study Disposition of Phase 2/3 Randomized Participants 16 Years of Age and Older, Through Data Cutoff March 13, 2021
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=22085)
nb (%) Placebo
(Na=22080)
nb (%) Total
(Na=44165)
nb (%)
Randomized 22085 (100.0) 22080 (100.0) 44165 (100.0)
Not vaccinated 55 (0.2) 50 (0.2) 105 (0.2)
Original blinded placebo -controlled follow -up period
Vaccinated 22030 (99.8) 22030 (99.8) 44060 (99.8)
Dose 1 22030 (99.8) 22030 (99.8) 44060 ( 99.8)
Dose 2 21675 (98.1) 21650 (98.1) 43325 (98.1)
Discontinued from original blinded placebo -controlled vaccination periodc 352 (1.6) 528 (2.4) 880 (2.0)
Reason for discontinuation
Lost to follow -up 151 (0.7) 153 (0.7) 304 (0.7)
Withdrawal by subject 109 (0.5) 181 (0.8) 290 (0.7)
No longer meets eligibility criteria 26 (0.1) 120 (0.5) 146 (0.3)
Adverse event 27 (0.1) 26 (0.1) 53 (0.1)
Physician decision 5 (0.0) 8 (0.0) 13 (0.0)
Pregnancy 6 (0.0) 6 (0.0) 12 (0.0)
Protocol deviation 3 (0.0) 8 (0.0) 11 (0.0)
Death 3 (0.0) 4 (0.0) 7 (0.0)
Medication error without associated adverse event 3 (0.0) 2 (0.0) 5 (0.0)
Withdrawal by parent/guardian 1 (0.0) 0 1 (0.0)
Other 18 (0.1) 20 (0.1) 38 (0.1)
Unblinded before 1 -month post –Dose 2 visit 253 (1.1) 240 (1.1) 493 (1.1)
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Table.B Study Disposition of Phase 2/3 Randomized Participants 16 Years of Age and Older, Through Data Cutoff March 13, 2021
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=22085)
nb (%) Placebo
(Na=22080)
nb (%) Total
(Na=44165)
nb (%)
Completed 1 -month post –Dose 2 visit 21382 (96.8) 21293 (96.4) 42675 (96.6)
Withdrawn from the study 343 (1.6) 484 (2.2) 827 (1.9)
Withdrawn after Dose 1 and before Dose 2 176 (0.8) 211 (1.0) 387 (0.9)
Withdrawn after Dose 2 and before 1 -month post –Dose 2 visit 100 (0.5) 139 (0.6) 239 (0.5)
Withdrawn after 1 -month p ost–Dose 2 visit 67 (0.3) 134 (0.6) 201 (0.5)
Reason for withdrawal from the study
Lost to follow -up 174 (0.8) 191 (0.9) 365 (0.8)
Withdrawal by subject 122 (0.6) 226 (1.0) 348 (0.8)
Protocol deviation 11 (0.0) 24 (0.1) 35 (0.1)
Death 16 (0.1) 15 (0.1) 31 (0.1)
Adverse event 9 (0.0) 8 (0.0) 17 (0.0)
Physician decision 3 (0.0) 6 (0.0) 9 (0.0)
No longer meets eligibility criteria 1 (0.0) 4 (0.0) 5 (0.0)
Pregnancy 0 1 (0.0) 1 (0.0)
Medication error without associated adverse event 1 (0.0) 0 1 (0.0)
Withdrawal by parent/guardian 1 (0.0) 0 1 (0.0)
Other 5 (0.0) 9 (0.0) 14 (0.0)
Open -label follow -up period
Originally randomized to BNT162b2 20404 (92.4)
Received Dose 2/unplanned dose 87 (0.4)
Completed 1 -month post –Dose 2 visit 210 (1.0)
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Table.B Study Disposition of Phase 2/3 Randomized Participants 16 Years of Age and Older, Through Data Cutoff March 13, 2021
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=22085)
nb (%) Placebo
(Na=22080)
nb (%) Total
(Na=44165)
nb (%)
Completed 6 -month post –Dose 2 visit 6414 (29.0)
Withdrawn from the study 105 ( 0.5)
Withdrawn before 6 -month post –Dose 2 visit 103 (0.5)
Withdrawn after 6 -month post–Dose 2 visit 2 (0.0)
Reason for withdrawal from the study
Withdrawal by subject 56 (0.3)
Protocol devi ation 35 (0.2)
Lost to follow -up 4 (0.0)
Death 3 (0.0)
Physician decision 2 (0.0)
Adverse event 1 (0.0)
No longer meets eligibility criteria 1 (0.0)
Other 3 (0.0)
Originally randomized to placebo 20948 (94.9)
Completed 6 -month post –Dose 2 visit 153 (0.7)
Withdrawn from the study after unblinding and before Dose 3 497 (2.3)
Received Dose 3 (first dose of BNT162b2 [30 μg]) 19612 (88.8)
Received Dose 4 (second dose of BNT162b2 [30 μg]) 15986 (72.4)
Discontinued from open -label vaccination periodd 24 (0.1)
Reason for discontinuation from open -label vaccination period
Protocol dev iation 6 (0.0)
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Table.B Study Disposition of Phase 2/3 Randomized Participants 16 Years of Age and Older, Through Data Cutoff March 13, 2021
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=22085)
nb (%) Placebo
(Na=22080)
nb (%) Total
(Na=44165)
nb (%)
Adverse event 5 (0.0)
Withdrawal by subject 5 (0.0)
Pregnancy 4 (0.0)
Death 2 (0.0)
Lost to follow -up 2 (0.0)
Completed 1 -month post –Dose 4 visit 7209 (32.6)
Withdrawn from the study 14 (0.1)
Withdrawn after Dose 3 and before Dose 4 11 (0.0)
Withdrawn after Dose 4 and before 1 -month post –Dose 4 visit 2 (0.0)
Withdrawn after 1 -month post –Dose 4 visit 1 (0.0)
Reason for withdrawal from the study
Withdrawal by subject 7 (0.0)
Protocol deviation 3 (0.0)
Death 2 (0.0)
Adverse event 1 (0.0)
Lost to follow -up 1 (0.0)
Note: Human immunodeficiency virus (HIV) -positive subjects are included in this summary but analyzed and reported separately.
Note: Subjects randomized but did not sign informed consent or had a significant quality event due to lack of PI oversight are no t included in any analysis
population.
Note: Because of a dosing error, Subjects C4591001 1081 10811053, C4591001 1088 10881077, C4591001 1177 11771089 and C4591001 1231 12311057
received an additional dose of BNT162b2 (30 µg) at an unscheduled visi t afte r receiving 1 dose of BNT162b2 (30 µg) and 1 dose of placebo.
a. N = number of randomized subjects in the specified group, or the total sample. This value is the denominator for the percenta ge calculations.
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Table.B Study Disposition of Phase 2/3 Randomized Participants 16 Years of Age and Older, Through Data Cutoff March 13, 2021
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=22085)
nb (%) Placebo
(Na=22080)
nb (%) Total
(Na=44165)
nb (%)
b. n = Number of subjects with th e spec ified characteristic.
c. Original blinded placebo -controlled vaccination period is defined as the time period from Dose 1 to 1 month post –Dose 2.
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]).
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Table.C Disposition of Phase 2/3 Participants 16 Years of Age and Older, Through Data Cutoff March 13 2021, Safety Population
Vaccine Group (as Administered)
BNT162b2 ( 30 μg)
(Na=22026)
nb (%) Placebo
(Na=22021)
nb (%) Total
(Na=44050)
nb (%)
Randomized 44165
Not vaccinated 105
Vaccinated 22026 (100.0) 22021 (100.0) 44050 (100.0)
Completed 1 dose 22026 (100.0) 22021 (100.0) 44050 (100.0)
Complet ed 2 doses 21674 (98.4) 21645 (98.3) 43319 (98.3)
Safety population 22026 (100.0) 22021 (100.0) 44050 (100.0)
Reactogenicity subset 5033 (22.9) 5032 (22.9) 10068 (22.9)
HIV-positive 100 (0.5) 100 (0.5) 200 (0.5)
Indeterminate vaccine 3 (0.0)
Participants excluded from safety population 115 (0.3)
Reason for exclusion
Participant did not receive study vaccine 105 (0.2)
Unreliable data due to lack of PI oversight 10 (0.0)
Completed at least 6 months follow -up after Dose 2 in blinded placebo -controlled follow -up
period 1778 (8.1) 1304 (5.9) 3082 (7.0)
Completed at least 6 months follow -up after Dose 2 in blinded and open -label follow -up
period 12006 (54.5)
Completed 1 -month post –Dose 2 visit (vaccination period) 21378 (97.1) 21291 (96.7) 42669 (96.9)
Discontinued from vaccination period but continued in the study up to 1 -month post –Dose 2
visit 350 (1.6) 520 (2.4) 873 (2.0)
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Table.C Disposition of Phase 2/3 Participants 16 Years of Age and Older, Through Data Cutoff March 13 2021, Safety Population
Vaccine Group (as Administered)
BNT162b2 ( 30 μg)
(Na=22026)
nb (%) Placebo
(Na=22021)
nb (%) Total
(Na=44050)
nb (%)
Discontinued after Dose 1 and before Dose 2 233 (1.1) 359 (1.6) 595 (1.4)
Discontinued after Dose 2 and before 1 -month post –Dose 2 visit 117 (0.5) 161 (0.7) 278 (0.6)
Reason for discontinuation from vaccination period
Lost to follow -up 151 (0.7) 149 (0.7) 300 (0.7)
Withdrawal by subject 108 (0.5) 181 (0.8) 289 (0.7)
No longer meets eligibility criteria 25 (0.1) 120 (0.5) 145 (0.3)
Adverse event 27 (0.1) 26 (0.1) 53 (0.1)
Physician decision 5 (0.0) 7 (0.0) 12 (0.0)
Pregnancy 6 (0.0) 6 (0.0) 12 (0.0)
Protocol deviation 3 (0.0) 8 (0.0) 11 (0.0)
Death 3 (0.0) 4 (0.0) 7 (0.0)
Medication error without associated adverse event 2 (0.0) 0 5 (0.0)
Withdrawal by parent/guardian 1 (0.0) 0 1 (0.0)
Other 19 (0.1) 19 (0.1) 38 (0.1)
Withdrawn from study before 1 -month post –Dose 2 visit 273 (1.2) 344 (1.6) 617 (1.4)
Withdrawn after Dose 1 and before Dose 2 173 (0.8) 205 (0.9) 378 (0.9)
Withdrawn after Dose 2 and before 1 -month post–Dose 2 visit 100 (0.5) 139 (0.6) 239 (0.5)
Reason for withdrawal
Lost to follow -up 151 (0.7) 153 (0.7) 304 (0.7)
Withdrawal by subject 101 (0.5) 168 (0.8) 269 (0.6)
Adverse event 9 (0.0) 7 (0.0) 16 (0. 0)
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Table.C Disposition of Phase 2/3 Participants 16 Years of Age and Older, Through Data Cutoff March 13 2021, Safety Population
Vaccine Group (as Administered)
BNT162b2 ( 30 μg)
(Na=22026)
nb (%) Placebo
(Na=22021)
nb (%) Total
(Na=44050)
nb (%)
Physician decision 3 (0.0) 5 (0.0) 8 (0.0)
Death 3 (0.0) 4 (0.0) 7 (0.0)
Protocol deviation 0 1 (0.0) 1 (0.0)
Medication error without associated adverse event 1 (0.0) 0 1 (0.0)
No longe r meets eligibility criteria 0 1 (0.0) 1 (0.0)
Withdrawal by parent/guardian 1 (0.0) 0 1 (0.0)
Other 4 (0.0) 5 (0.0) 9 (0.0)
Note: Human immunodeficiency virus (HIV) -positive subjects are included in this summary but not incl uded in the analyses of the overall study objectives.
Note: Subjects randomized but did not sign informed consent or had a significant quality event due to lack of PI oversight are not included in any analysis
population.
Note: Because of a dosing error, Subjects C4591001 1081 10811053, C4591001 1088 10881077, C4591001 1177 11771089 and C4591001 1231 12311057
received an additional dose of BNT162b2 (30 µg) at an unscheduled visit after receiving 1 dose of BNT162b2 (30 µg) and 1 dose of placebo.
Note: "In determinate vaccine" refers to subjects whose vaccine group (as administered) could not be determined. These subjects were in cluded in the
number of subject s for "Total" column. These subjects were not included in the safety analysis but their safety data is listed separately.
a. N = number of randomized subjects in the specified group, or the total sample. This value is the denominator for the percenta ge calculations.
b. n = Number of subjects with the specified characteristic.
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Table.E Demo graphics and Other Baseline Characteristics, Phase 2/3 Participants 16 Years of Age and Older, Through Data Cutoff
March 13, 2021, Safety Population
Vaccine Group (as Administered)
Characteristic BNT162b2 (30 μg)
(Na=22026)
nb (%) Placebo
(Na=22021)
nb (%) Total
(Na=44047)
nb (%)
Sex: Female 10704 (48.6) 10923 (49.6) 21627 (49.1)
Sex: Male 11322 (51.4) 11098 (50.4) 22420 (50.9)
Age at Vaccination: Mean years (SD) 49.7 (15.99) 49.6 (16.05) 49.7 (16.02)
Age at Vaccination: Median (years) 51.0 51.0 51.0
Age at Vaccination: Min, max (years) (16, 89) (16, 91) (16, 91)
Age Group: 16 to <18 years 378 (1.7) 376 (1.7) 754 (1.7)
Age Group: 18 to 55 years 12691 (57.6) 12719 (57.8) 25410 (57.7)
Age Group: >55 years 8957 (40.7) 8926 (40.5) 17883 (40.6)
Age Group: ≥65 years 4552 (20.7) 4545 (20.6) 9097 (20.7)
Race: American Indian or Alaska Native 221 (1.0) 217 (1.0) 438 (1.0)
Race: Asian 952 (4.3) 942 (4.3) 1894 (4.3)
Race: Black or African American 2098 (9.5) 2118 (9.6) 4216 (9.6)
Race: Native Hawaiian or Other Pacific Islander 58 (0.3) 32 (0.1) 90 (0.2)
Race: White 18056 (82.0) 18064 (82.0) 36120 (82.0)
Race: Multiracial 550 (2.5) 533 (2.4) 1083 (2.5)
Race: Not reported 91 (0.4) 115 (0.5) 206 (0.5)
Ethnicity: Hispa nic or Latino 5704 (25.9) 5695 (25.9) 11399 (25.9)
Ethnicity: Not Hispanic or Latino 16211 (73.6) 16212 (73.6) 32423 (73.6)
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Table.E Demo graphics and Other Baseline Characteristics, Phase 2/3 Participants 16 Years of Age and Older, Through Data Cutoff
March 13, 2021, Safety Population
Vaccine Group (as Administered)
Characteristic BNT162b2 (30 μg)
(Na=22026)
nb (%) Placebo
(Na=22021)
nb (%) Total
(Na=44047)
nb (%)
Ethnicity: Not reported 111 (0.5) 114 (0.5) 225 (0.5)
Obesity: Yesc 7543 (34.2) 7629 (34.6) 15172 (34.4)
Obesity: No 14483 (65.8) 14392 (65.4) 28875 (65.6)
Comorbidities: Yesd 10119 (45.9) 10071 (45.7) 20190 (45.8)
Comorbidities: No 11907 (54.1) 11950 (54.3) 23857 (54.2)
Baseline evidence of prior SARS -CoV -2 infection: Negativef 21185 (96.2) 21180 (96. 2) 42365 (96.2)
Baseline evidence of prior SARS -CoV -2 infection: Positivee 689 (3.1) 716 (3.3) 1405 (3.2)
Baseline evidence of prior SARS -CoV -2 infection: Missing 152 (0.7) 125 (0.6) 277 (0.6)
Country: Argentina 2883 (13.1) 2881 (13.1) 5764 ( 13.1)
Country: Brazil 1452 (6.6) 1448 (6.6) 2900 (6.6)
Country: Germany 249 (1.1) 250 (1.1) 499 (1.1)
Country: South Africa 401 (1.8) 399 (1.8) 800 (1.8)
Country: Turkey 249 (1.1) 249 (1.1) 498 (1.1)
Country: United States of America 16792 (76.2) 16794 (76.3) 33586 (76.3)
Abbreviation: SARS -CoV -2 = severe acute respiratory syndrome coronavirus 2.
Note: HIV -positive subjects are included in this summary but not included in the analyses of the overall study objectives.
a. N = numb er 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 BMI ≥30 kg/m2.
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 ≥30 kg/m2.
e. Positive N -binding antibody result at Visit 1, positive NAAT r esult at Visit 1, or medical history of COVID -19.
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Table.E Demo graphics and Other Baseline Characteristics, Phase 2/3 Participants 16 Years of Age and Older, Through Data Cutoff
March 13, 2021, Safety Population
Vaccine Group (as Administered)
Characteristic BNT162b2 (30 μg)
(Na=22026)
nb (%) Placebo
(Na=22021)
nb (%) Total
(Na=44047)
nb (%)
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.P Safety Overview, Phase 2/3 Participants 16 Years of Age and Older, Through Da ta Cutoff March 13, 2021, Safety Population
BNT162b2 (30 μg)
n/N (%) Placebo
n/N (%)
Immediate unsolicited AE within 30 minutes after vaccination
Dose1 105/21926 (0.5) 81/21921 (0.4)
Dose2 71/21571 (0.3) 54/21549 (0.3)
Solicited injection site reaction within 7 days
Dose1 3877/4907 (79.0) 639/4897 (13.0)
Dose2 3351/4542 (73.8) 483/4517 (10.7)
Solicited systemic AE within 7 days
Dose1 2963/4907 (60.4) 2308/4897 (47.1)
Dose2 3237/4542 (71.3) 1542/4517 (34.1)
From Dose 1 through 1 month after Dose 2
Unsolicited non -serious AE 6557/21926 (29.9) 2996/21921 (13.7)
SAE 127/21926 (0.6) 116/21921 (0.5)
Dose 1 to Data Cutoff March 13 2021 /Participant Unblinding (whichever is Earlier)
SAE 268/21926 (1.2) 268/21921 (1.2)
With drawal due to AEs 45/21926 (0.2) 51/21921 (0.2)
Deaths 15/21926 (<0.1) 14/21921 (<0.1)
Note: MedDRA (v23.1) coding dictionary applied.
Note: Immediate AE refers to an AE reported in the 30 -minute observation period after vaccination.
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Table.Q Characteristics of Solicited Local and Systemic Adverse Reactions, Phase 2/3 Participants 16 Years of Age and Older,
Through Data Cutoff March 13, 2021, Safety Population
Vaccine Group (as Administered)
Event BNT162b2 (30 μg)/Dose 1
n/N BNT162b2 (30 μg)/Dose 2
n/N Placebo/Dose 1
n/N Placebo/Dose 2
n/N
Redness
Day of onset: Median (range) 2.0 (1, 7) 2.0 (1, 6) 1.0 (1, 5) 2.0 (1, 6)
Duration: Median (range) 2.0 (1, 20) 2.0 (1, 34) 1.0 (1, 10 ) 1.0 (1, 7)
Persisted beyond 7 days 8/4907 8/4542 1/4897 0
Swelling
Day of onset: Median (range) 2.0 (1, 5) 2.0 (1, 5) 1.0 (1, 5) 1.0 (1, 5)
Duration: Median (range) 1.0 (1, 12) 2.0 (1, 34) 1.0 (1, 11) 1.5 (1, 5)
Persisted beyon d 7 days 1/4907 6/4542 2/4897 0
Pain at injection site
Day of onset: Median (range) 1.0 (1, 7) 1.0 (1, 7) 1.0 (1, 7) 1.0 (1, 7)
Duration: Median (range) 2.0 (1, 22) 2.0 (1, 70) 1.0 (1, 19) 1.0 (1, 35)
Persisted beyond 7 days 32/4907 35/4542 10/4897 4/4517
Any solicited local reaction
Day of onset: Median (range) 2.0 (1, 7) 1.0 (1, 7) 1.0 (1, 7) 1.0 (1, 7)
Duration: Median (range) 2.0 (1, 22) 2.0 (1, 70) 1.0 (1, 19) 1.0 (1, 35)
Persisted beyond 7 days 41/4907 40/4542 11/4897 4/4517
Chills
Day of onset: Median (range) 2.0 (1, 7) 2.0 (1, 7) 2.0 (1, 7) 2.0 (1, 7)
Duration: Median (range) 1.0 (1, 11) 1.0 (1, 11) 1.0 (1, 31) 1.0 (1, 16)
Persisted beyond 7 days 7/4907 2/4542 6/4897 6/4517
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Table.Q Characteristics of Solicited Local and Systemic Adverse Reactions, Phase 2/3 Participants 16 Years of Age and Older,
Through Data Cutoff March 13, 2021, Safety Population
Vaccine Group (as Administered)
Event BNT162b2 (30 μg)/Dose 1
n/N BNT162b2 (30 μg)/Dose 2
n/N Placebo/Dose 1
n/N Placebo/Dose 2
n/N
Diarr hea
Day of onset: Median (range) 3.0 (1, 7) 3.0 (1, 7) 3.0 (1, 7) 3.0 (1, 7)
Duration: Median (range) 1.0 (1, 39) 1.0 (1, 31) 1.0 (1, 23) 1.0 (1, 33)
Persisted beyond 7 days 7/4907 6/4542 12/4897 5/4517
Fatigue
Day of ons et: Median (range) 2.0 (1, 7) 2.0 (1, 7) 2.0 (1, 7) 2.0 (1, 7)
Duration: Median (range) 1.0 (1, 34) 1.0 (1, 35) 1.0 (1, 23) 1.0 (1, 69)
Persisted beyond 7 days 84/4907 61/4542 93/4897 45/4517
Fever
Day of onset: Median (range) 2.0 (1 , 7) 2.0 (1, 7) 4.0 (1, 7) 4.0 (1, 7)
Duration: Median (range) 1.0 (1, 7) 1.0 (1, 8) 1.0 (1, 8) 1.0 (1, 6)
Persisted beyond 7 days 0 1/4542 1/4897 0
Joint pain
Day of onset: Median (range) 2.0 (1, 7) 2.0 (1, 7) 3.0 (1, 7) 3.0 (1, 7)
Duration: Median (range) 1.0 (1, 36) 1.0 (1, 32) 1.0 (1, 17) 1.0 (1, 16)
Persisted beyond 7 days 7/4907 13/4542 8/4897 9/4517
Muscle pain
Day of onset: Median (range) 2.0 (1, 7) 2.0 (1, 7) 3.0 (1, 7) 2.0 (1, 7)
Duration: Median ( range) 1.0 (1, 17) 1.0 (1, 23) 1.0 (1, 31) 1.0 (1, 27)
Persisted beyond 7 days 11/4907 7/4542 15/4897 12/4517
Vomiting
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Table.Q Characteristics of Solicited Local and Systemic Adverse Reactions, Phase 2/3 Participants 16 Years of Age and Older,
Through Data Cutoff March 13, 2021, Safety Population
Vaccine Group (as Administered)
Event BNT162b2 (30 μg)/Dose 1
n/N BNT162b2 (30 μg)/Dose 2
n/N Placebo/Dose 1
n/N Placebo/Dose 2
n/N
Day of onset: Median (range) 3.0 (1, 7) 2.0 (1, 7) 4.0 (1, 7) 4.0 (1, 7)
Duration: Median (range) 1.0 (1, 6) 1.0 (1, 37) 1.0 (1, 4) 1.0 (1, 6)
Persisted beyond 7 days 0 3/4542 0 0
Headache
Day of onset: Median (range) 2.0 (1, 7) 2.0 (1, 7) 2.0 (1, 7) 2.0 (1, 7)
Duration: Median (range) 1.0 (1, 25) 1.0 (1, 25) 1.0 (1, 22) 1.0 (1, 35)
Persiste d beyond 7 days 50/4907 30/4542 61/4897 32/4517
Any solicited systemic reaction
Day of onset: Median (range) 2.0 (1, 7) 2.0 (1, 7) 2.0 (1, 7) 2.0 (1, 7)
Duration: Median (range) 1.0 (1, 39) 1.0 (1, 37) 1.0 (1, 31) 1.0 (1, 69)
Persist ed beyond 7 days 138/4907 94/4542 139/4897 74/4517
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Table.R Frequency of Unsolicited AEs with Occurrence in ≥1% of Phase 2/3 Participants in Any Treatment Group From Dose 1 to 1
Month After Dose 2, 16 Years of Age and Older, Safety Population
BNT162b2 (30 μg)
(N=21926) Placebo
(N=21921)
SYSTEM ORGAN CLA SS
and Preferred Term Any n (%) Severe n (%) Any n (%) Severe n (%)
GASTROINTESTINAL DISORDERS
Diarrhoea 248(1.1) 4 (0.0) 188(0.9) 5 (0.0)
Nausea 274(1.2) 1 (0.0) 87(0.4) 2 (0.0)
GENERAL DISORDERS AND ADMINISTRATION SITE CO NDITIONS
Chills 1365(6.2) 18 (0.1) 120(0.5) 0 (0.0)
Fatigue 1463(6.7) 24 (0.1) 379(1.7) 2 (0.0)
Injection site pain 2915(13.3) 19 (0.1) 397(1.8) 0 (0.0)
Pain 628(2.9) 9 (0.0) 61(0.3) 0 (0.0)
Pyrexia 1517(6 .9) 38 (0.2) 77(0.4) 1 (0.0)
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Arthralgia 268(1.2) 4 (0.0) 102(0.5) 6 (0.0)
Myalgia 1239(5.7) 21 (0.1) 168(0.8) 3 (0.0)
NERVOUS SYSTEM DISORDERS
Headache 1339(6.1) 25 (0.1) 424(1.9) 10 (0.0)
MedDRA v23.1 coding dictionary applied.
090177e197c1681e\Final\Final On: 08-Aug-2021 04:02 (GMT)
FDA-CBER-2021-5683-0651613
Table.R.1 Frequency of Unsolicited AEs with Occurrence in ≥1% of Phase 2/3 Participants in Any Treatment Group From Dose 1 to
Data Cutoff March 13 2021 /Unblinding (whichever is E arlier),
16 Years of Age and Older, Safety Population
BNT162b2 (30 μg)
(N=21926) Placebo
(N=21921)
SYSTEM ORGAN CLASS
and Preferred Term Any n (%) Severe n (%)
n (%) Any n (%) Severe n (%)
n (%)
GASTROINTESTINAL DISORDERS
Diarrhoea 255(1.2) 4 (0.0) 189(0.9) 5 (0.0)
Nausea 277(1.3) 1 (0.0) 88(0.4) 2 (0.0)
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Chills 1368(6.2) 18 (0.1) 121(0.6) 0 (0.0)
Fatigue 1466(6.7) 24 (0.1) 379(1.7) 2 (0.0)
Injection site pain 2917(13.3) 19 (0.1) 399(1.8) 0 (0.0)
Pain 628(2.9) 9 (0.0) 62(0.3) 0 (0.0)
Pyrexia 1520(6.9) 38 (0.2) 78(0.4) 1 (0.0)
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Arthralgia 281(1.3) 5 (0.0) 122(0.6) 7 (0.0)
Myalgia 1245(5.7) 21 (0.1) 170(0.8) 3 (0.0)
NERV OUS SYSTEM DISORDERS
Headache 1348(6.1) 25 (0.1) 429(2.0) 12 (0.1)
MedDRA v23.1 coding dictionary applied.
090177e197c1681e\Final\Final On: 08-Aug-2021 04:02 (GMT)
FDA-CBER-2021-5683-0651614
Table.R.2 Frequency of Unsolicited AEs with Occurrence in ≥1% of Phase 2/3 Participants From Unblinding Date to Cutoff Date
(13MAR2021)
– Open -Label Follow -up Period – Participants Who Originally Received BNT162b2 – 16 Years of Age and Older, Safety Populat ion
Table not created
No subject meets the reporting criteria
MedDRA v23.1 coding dictionary applied.
090177e197c1681e\Final\Final On: 08-Aug-2021 04:02 (GMT)
FDA-CBER-2021-5683-0651615
Table.R.3 Frequency of Unsolicited AEs with Occurrence in ≥1% of Phase 2/3 Participants
From Dose 3 to Cutoff Date (13MAR2021) – Open -Label F ollow -up Period
– Participants Who Originally Received Placebo and Then Received BNT162b2 After Unblinding
– 16 Years of Age and Older, Safety Population
BNT162b2 (30 μg)
(N=19525)
SYSTEM ORGAN CLASS
and Preferred Term Any n (%) Severe n (%)
n (%)
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Chills 994(5.1) 15 (0.1)
Fatigue 1379(7.1) 23 (0.1)
Injection site pain 2944(15.1) 19 (0.1)
Pain 394(2.0) 5 (0.0)
Pyrexia 906(4.6) 18 (0.1)
MUSCULOSKELETA L AND CONNECTIVE TISSUE DISORDERS
Myalgia 925(4.7) 15 (0.1)
NERVOUS SYSTEM DISORDERS
Headache 1108(5.7) 18 (0.1)
Note: Dose 3 = First dose of BNT162b2 (30 μg).
MedDRA v23.1 coding dictionary applied.
090177e197c1681e\Final\Final On: 08-Aug-2021 04:02 (GMT)
FDA-CBER-2021-5683-0651616
Table.S Selected Standard MedDRA Queries From Dose 1 to Unblinding Date –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 Participants ≥16 Years of Age –
Safety Population (Data Cutoff March 13, 2021)
Vaccine Group (as Administered)
BNT162b2 (30 μg)
(Na=21926) Placebo
(Na=21921)
SMQ Overall SMQ
System Organ Class
Preferred Term nb (%) nb (%)
Subjects with any unsolicited adverse events within SMQ 224 (1.02) 217 (0.99)
Angioedema (SMQ) Any unsolicited adverse events within Angioedema (SMQ) 30 (0.14) 29 (0.13)
Eye disorders 2 (0.01) 2 (0.01)
Conjunctival oedema 0 1 (0.00)
Eye swelling 0 1 (0.00)
Eyelid oe dema 1 (0.00) 0
Swelling of eyelid 1 (0.00) 0
Gastrointestinal disorders 6 (0.03) 3 (0.01)
Gingival swelling 0 1 (0.00)
Lip oedema 1 (0.00) 0
Lip swelling 2 (0.01) 1 (0.00)
Swollen tongue 2 (0.0 1) 1 (0.00)
Tongue oedema 1 (0.00) 0
General disorders and administration site conditions 4 (0.02) 7 (0.03)
Face oedema 2 (0.01) 0
Swelling face 2 (0.01) 7 (0.03)
Respiratory, thoracic and mediastinal disorder s 1 (0.00) 3 (0.01)
090177e197c1681e\Final\Final On: 08-Aug-2021 04:02 (GMT)
FDA-CBER-2021-5683-0651617
Table.S Selected Standard MedDRA Queries From Dose 1 to Unblinding Date –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 Participants ≥16 Years of Age –
Safety Population (Data Cutoff March 13, 2021)
Vaccine Group (as Administered)
BNT162b2 (30 μg)
(Na=21926) Placebo
(Na=21921)
SMQ Overall SMQ
System Organ Class
Preferred Term nb (%) nb (%)
Pharyngeal swelling 1 (0.00) 3 (0.01)
Skin and subcutaneous tissue disorders 21 (0.10) 18 (0.08)
Angioedema 3 (0.01) 2 (0.01)
Urticaria 18 (0.08) 15 (0.07)
Urticaria papular 0 1 (0.00)
Arthritis (SMQ) Any unsolicited adverse events within Arthritis (SMQ) 35 (0.16) 48 (0.22)
Infections and infestations 1 (0.00) 0
Arthritis bacterial 1 (0.00) 0
Metabolism and nutrition disorders 5 (0.02) 3 (0.01)
Gout 5 (0.02) 3 (0.01)
Musculoskeletal and connective tissue disorders 29 (0.13) 45 (0.21)
Arthritis 6 (0.03) 6 (0.03)
Arthritis reactive 1 (0.00) 0
Osteoarthritis 15 (0.07) 23 (0.10)
Patellofemoral pain syndrom e 0 1 (0.00)
Periarthritis 4 (0.02) 1 (0.00)
Polyarthritis 0 1 (0.00)
Rheumatoid arthritis 0 2 (0.01)
090177e197c1681e\Final\Final On: 08-Aug-2021 04:02 (GMT)
FDA-CBER-2021-5683-0651618
Table.S Selected Standard MedDRA Queries From Dose 1 to Unblinding Date –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 Participants ≥16 Years of Age –
Safety Population (Data Cutoff March 13, 2021)
Vaccine Group (as Administered)
BNT162b2 (30 μg)
(Na=21926) Placebo
(Na=21921)
SMQ Overall SMQ
System Organ Class
Preferred Term nb (%) nb (%)
Spinal osteoarthritis 2 (0.01) 4 (0.02)
Spondylitis 1 (0.00) 1 (0.00)
Synovitis 0 2 (0.0 1)
Temporomandibular joint syndrome 1 (0.00) 4 (0.02)
Convulsions (SMQ) Any unsolicited adverse events within Convulsions (SMQ) 2 (0.01) 2 (0.01)
Nervous system disorders 2 (0.01) 2 (0.01)
Generalised tonic -clonic seizure 0 1 (0.00)
Seizure 2 (0.01) 1 (0.00)
Demyelination (SMQ) Any unsolicited adverse events within Demyelination (SMQ) 2 (0.01) 1 (0.00)
Nervous system disorders 2 (0.01) 1 (0.00)
Guillain -Barre syndrome 0 1 (0.00)
Optic ne uritis 2 (0.01) 0
Hypersensitivity (SMQ) Any unsolicited adverse events within Hypersensitivity (SMQ) 182 (0.83) 161 (0.73)
Ear and labyrinth disorders 0 1 (0.00)
Allergic otitis media 0 1 (0.00)
Eye disorders 5 (0.02) 5 (0.02)
Conjunctival oedema 0 1 (0.00)
Conjunctivitis allergic 3 (0.01) 2 (0.01)
090177e197c1681e\Final\Final On: 08-Aug-2021 04:02 (GMT)
FDA-CBER-2021-5683-0651619
Table.S Selected Standard MedDRA Queries From Dose 1 to Unblinding Date –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 Participants ≥16 Years of Age –
Safety Population (Data Cutoff March 13, 2021)
Vaccine Group (as Administered)
BNT162b2 (30 μg)
(Na=21926) Placebo
(Na=21921)
SMQ Overall SMQ
System Organ Class
Preferred Term nb (%) nb (%)
Eye allergy 0 1 (0.00)
Eye swelling 0 1 (0.00)
Eyelid oedema 1 (0.00) 0
Swelling of eyelid 1 (0.00) 0
Gastrointe stinal disorders 6 (0.03) 3 (0.01)
Gingival swelling 0 1 (0.00)
Lip oedema 1 (0.00) 0
Lip swelling 2 (0.01) 1 (0.00)
Swollen tongue 2 (0.01) 1 (0.00)
Tongue oedema 1 (0.00) 0
General disorders a nd administration site conditions 8 (0.04) 9 (0.04)
Application site rash 0 1 (0.00)
Face oedema 2 (0.01) 0
Injection site dermatitis 1 (0.00) 0
Injection site rash 2 (0.01) 1 (0.00)
Injection site urt icaria 1 (0.00) 0
Swelling face 2 (0.01) 7 (0.03)
Immune system disorders 10 (0.05) 13 (0.06)
090177e197c1681e\Final\Final On: 08-Aug-2021 04:02 (GMT)
FDA-CBER-2021-5683-0651620
Table.S Selected Standard MedDRA Queries From Dose 1 to Unblinding Date –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 Participants ≥16 Years of Age –
Safety Population (Data Cutoff March 13, 2021)
Vaccine Group (as Administered)
BNT162b2 (30 μg)
(Na=21926) Placebo
(Na=21921)
SMQ Overall SMQ
System Organ Class
Preferred Term nb (%) nb (%)
Anaphylactic reaction 1 (0.00) 0
Anaphylactic shock 0 1 (0.00)
Drug hypersensitivity 7 (0.03) 7 (0.03)
Hypersensitivity 2 (0.01) 5 (0.02)
Infections and infestations 5 (0.02) 1 (0.00)
Dermatitis infected 0 1 (0.00)
Pustule 3 (0.01) 0
Rash pustular 2 (0.01) 0
Injury, poisoning and procedural complications 3 (0.01) 0
Administration related reaction 2 (0.01) 0
Stoma site rash 1 (0.00) 0
Investigations 1 (0.00) 0
Blood immunoglobulin E increased 1 (0.00) 0
Respiratory, thoracic and mediastinal disorders 19 (0.09) 21 (0.10)
Allergic respiratory disease 0 1 (0.00)
Allergic sinusitis 2 (0.01) 0
Bronchospasm 3 (0.01) 3 (0.01)
Pharyngeal swelling 1 (0.00) 3 (0.01)
090177e197c1681e\Final\Final On: 08-Aug-2021 04:02 (GMT)
FDA-CBER-2021-5683-0651621
Table.S Selected Standard MedDRA Queries From Dose 1 to Unblinding Date –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 Participants ≥16 Years of Age –
Safety Population (Data Cutoff March 13, 2021)
Vaccine Group (as Administered)
BNT162b2 (30 μg)
(Na=21926) Placebo
(Na=21921)
SMQ Overall SMQ
System Organ Class
Preferred Term nb (%) nb (%)
Rhinitis allergic 13 (0.06) 14 (0.06)
Skin and s ubcutaneous tissue disorders 134 (0.61) 119 (0.54)
Angioedema 3 (0.01) 2 (0.01)
Dermatitis 5 (0.02) 4 (0.02)
Dermatitis acneiform 1 (0.00) 0
Dermatitis allergic 3 (0.01) 5 (0.02)
Dermatitis atopic 0 1 (0.00)
Dermatitis bullous 0 1 (0.00)
Dermatitis contact 14 (0.06) 21 (0.10)
Dermatitis exfoliative 1 (0.00) 0
Drug eruption 0 2 (0.01)
Eczema 7 (0.03) 3 (0.01)
Erythema nodosum 1 (0.00) 0
Fixed eruption 1 (0.00) 0
Hand dermatitis 2 (0.01) 2 (0.01)
Perioral dermatitis 0 1 (0.00)
Pruritus allergic 0 2 (0.01)
Rash 62 (0.28) 52 (0.24)
090177e197c1681e\Final\Final On: 08-Aug-2021 04:02 (GMT)
FDA-CBER-2021-5683-0651622
Table.S Selected Standard MedDRA Queries From Dose 1 to Unblinding Date –
Blinded Placebo -Controlled Follow -up Period – Phase 2/3 Participants ≥16 Years of Age –
Safety Population (Data Cutoff March 13, 2021)
Vaccine Group (as Administered)
BNT162b2 (30 μg)
(Na=21926) Placebo
(Na=21921)
SMQ Overall SMQ
System Organ Class
Preferred Term nb (%) nb (%)
Rash erythematous 2 (0.01) 3 (0.01)
Rash maculo -papular 7 (0.03) 4 (0.02)
Rash papular 1 (0.00) 0
Rash pruritic 8 (0.04) 6 (0.03)
Urticaria 18 (0.08) 15 (0.07)
Urticaria contact 0 1 (0.00)
Urticaria papular 0 1 (0.00)
Peripheral neuropa thy (SMQ) Any unsolicited adverse events within Peripheral neuropathy (SMQ) 3 (0.01) 6 (0.03)
Nervous system disorders 3 (0.01) 6 (0.03)
Guillain -Barre syndrome 0 1 (0.00)
Neuralgia 1 (0.00) 1 (0.00)
Neuritis 0 1 (0.00)
Neuropathy peripheral 1 (0.00) 3 (0.01)
Peripheral sensory neuropathy 1 (0.00) 0
a. N = number of subjects in the specified group. This value is the denominator for the percentage calculations.
b. n = Number of subjects reporting at least 1 occurrence of the specified event category. For "any event," n = the number of subjects reporting at lea st 1
occurrence o f any event.
090177e197c1681e\Final\Final On: 08-Aug-2021 04:02 (GMT)
FDA-CBER-2021-5683-0651623
Table.T SAEs considered related by Investigator – Phase 2/3 Participants 16 Years of Age and Ol der, Safety Population (Data Cutoff
March 13, 2021)
Product
(Vaccine or
Placebo) SAE Dose/Rel
Daya Demographics:
Age/Sex/Risk Factors
from Charlson Index Resolution Related per
Investigator
BNT162b2 Shoulder injury related to vaccine
administratio n 2/1 30 F; no relevant medical
history Resolved Yes
BNT162b2 Paraesthesia 2/47 53 F; no relevant medical
history Resolving Yes
BNT162b2 Ventricular arrhythmia 2/1 71 F; Any malignancy Resolved Yes
BNT162b2 Lymphadenopathy 1/13 48 F; no relevant medical
history Resolved Yes
BNT162b2 Myocardial infarction 2/71# 41 M; no relevant medical
history Resolved Yes
Placebo Psoriatic arthropathy 2/38 25 M; no relevant medical
history Not Resolved Yes
Placebo crossover to
BNT162b2 Anaphylactoid reaction 3/3# 17 F; Chronic pulmonary
disease Resolved Yes
Note: MedDRA (v23.1) coding dictionary applied.
Note: # = SAE occurring on or after unblinding.
a. Relative day (Rel Day) = date of SAE - date of last vaccination + 1.
090177e197c1681e\Final\Final On: 08-Aug-2021 04:02 (GMT)
FDA-CBER-2021-5683-0651624
Table.U Deaths, Phase 2/3 Particip ants 16 Years of Age and Older, Safety Population, (Data Cutoff March 13, 2021)
Product
- Number
of
doses
received Subject
Number Dose/Rel
Daya Primary
Cause of
Death Positive
COVID-
19 test
(Y/N) Age/Sex/
Race/Ethnicity Demographics: Risk Factors
from Charlson Index
BNT162b2
- 2 C4591001 1007
10071101∞ 2/63 Cardiac arrest N 56/F/White/Not Hispanic or
Latino Chronic pulmonary disease
BNT162b2
- 2 C4591001 1021
10211127∞ 2/88 Cardiac failure
congestive Y 54/M/Black or African
American/Not Hispanic or
Latino Chronic pulmonary diseas e, Congestive heart
failure
BNT162b2
- 2 C4591001 1036
10361140∞# 2/91 Road traffic accident N 64/M/White/Not Hispanic or
Latino
BNT162b2
- 2 C4591001 1039
10391010∞ 2/71 Arteriosclerosis N 84/M/White/Not Hispanic or
Latino Cerebrovascular disease
BNT 162b2
- 2 C4591001 1084
10841266∞ 2/121 Sepsis N 77/M/White/Hispanic or
Latino Congestive heart failure, Diabetes without
chronic complication, Peripheral vascular
disease
BNT162b2
- 2 C4591001 1088
10881139∞# 2/143 Metastases to lung N 82/M/White/Not His panic or
Latino Chronic pulmonary disease
BNT162b2
- 2 C4591001 1089
10891073∞ 2/70 Chronic obstructive
pulmonary disease N 63/F/White/Not Hispanic or
Latino Any malignancy, Chronic pulmonary disease,
Diabetes with chronic complication, Diabetes
without c hronic complication, Myocardial
infarction
BNT162b2
- 2 C4591001 1097
10971023∞ 2/98 Septic shock N 86/F/White/Not Hispanic or
Latino
BNT162b2
- 2 C4591001 1114
11141050∞ 2/42 Unevaluable event N 63/F/White/Not Hispanic or
Latino Rheumatic disease
BNT 162b2 C4591001 1120 2/73 Cardiac arrest N 58/F/White/Not Hispanic or Diabetes without chronic complication
090177e197c1681e\Final\Final On: 08-Aug-2021 04:02 (GMT)
FDA-CBER-2021-5683-0651625
Table.U Deaths, Phase 2/3 Particip ants 16 Years of Age and Older, Safety Population, (Data Cutoff March 13, 2021)
Product
- Number
of
doses
received Subject
Number Dose/Rel
Daya Primary
Cause of
Death Positive
COVID-
19 test
(Y/N) Age/Sex/
Race/Ethnicity Demographics: Risk Factors
from Charlson Index
- 2 11201050∞ Latino
BNT162b2
- 2 C4591001 1120
11201266∞ 2/113 Lung cancer
metastatic N 51/M/White/Not Hispanic or
Latino
BNT162b2
- 2 C4591001 1127
11271112∞ 2/86 Cardio -respiratory
arrest N 53/M/Multiple/Not Hispanic
or Latino Chronic pulmonary disease, Myocardial
infarction
BNT162b2
- 2 C4591001 1129
11291166∞# 2/129 Myocardial
infarction N 78/F/White/Not Hispanic or
Latino
BNT162b2
- 2 C4591001 1136
11361102∞ 2/31 Cardiac arrest N 76/M/White/Not Hispanic or
Latino
BNT162b2
- 2 C4591001 1140
11401117∞ 2/117 Cardiac arrest N 58/M/White/Not Hispanic or
Latino
BNT162b2
- 1 C4591001 1152
11521497∞ 1/36 Shigella sepsis N 72/M/White/Hispanic or
Latino Diabetes without chronic complication
BNT162b2
- 2 C4591001 1156
11561160∞† 2/74 Road traffic accident N 62/F/Black or African
American/Not Hispanic or
Latino AIDS/HIV, Chronic pulmonary disease
BNT162b2
- 1 C4591001 1162
11621327∞ 1/4 Arterio sclerosis Y 60/M/White/Not Hispanic or
Latino
BNT162b2
- 2 C4591001 1252
12521010∞ 2/110 COVID -19
pneumonia N 80/M/White/Not Hispanic or
Latino
Placebo - 2 C4591001 1019
10191146 2/87 Metastases to liver N 67/M/White/Not Hispanic or
Latino Chronic pu lmonary disease
Placebo - 2 C4591001 1027
10271191# 2/135 Respiratory failure Y 68/F/Black or African
American/Not Hispanic or Any malignancy, Chronic pulmonary disease
090177e197c1681e\Final\Final On: 08-Aug-2021 04:02 (GMT)
FDA-CBER-2021-5683-0651626
Table.U Deaths, Phase 2/3 Particip ants 16 Years of Age and Older, Safety Population, (Data Cutoff March 13, 2021)
Product
- Number
of
doses
received Subject
Number Dose/Rel
Daya Primary
Cause of
Death Positive
COVID-
19 test
(Y/N) Age/Sex/
Race/Ethnicity Demographics: Risk Factors
from Charlson Index
Latino
Placebo - 1 C4591001 1066
10661350 1/16 Myocardial
infarction N 58/M/White/Not Hispanic or
Latino Congestive heart failure, Myocardial infarction
Placebo - 2 C4591001 1081
10811194 2/37 Myocardial
infarction N 51/F/White/Not Hispanic or
Latino Chronic pulmonary disease
Placebo - 2 C4591001 1084
10841470 2/83 Multiple organ
dysfunc tion
syndrome N 65/M/White/Hispanic or
Latino Chronic pulmonary disease
Placebo - 2 C4591001 1088
10881126 2/70 Cardiac arrest Y 65/M/White/Not Hispanic or
Latino
Placebo - 2 C4591001 1089
10891088 2/125 Dementia N 82/F/White/Not Hispanic or
Latino Dem entia
Placebo - 2 C4591001 1094
10941112 2/81 Acute respiratory
failure N 57/F/White/Hispanic or Latino Chronic pulmonary disease, Diabetes without
chronic complication
Placebo - 2 C4591001 1128
11281009 2/102 Pneumonia N 66/M/White/Not Hispanic or
Latin o Diabetes without chronic complication,
Myocardial infarction
Placebo - 2 C4591001 1131
11311204*# 3/26 Cardio -respiratory
arrest N 84/M/White/Not Hispanic or
Latino Cerebrovascular disease, Peripheral vascular
disease
Placebo - 2 C4591001 1135
11351033*# 3/5 N 67/M/White/Not Hispanic or
Latino
Placebo - 1 C4591001 1152
11521085 1/8 Death N 42/F/White/Not Hispanic or
Latino Any malignancy
Placebo - 2 C4591001 1156
11561124 2/32 Overdose N 53/M/White/Not Hispanic or
Latino
090177e197c1681e\Final\Final On: 08-Aug-2021 04:02 (GMT)
FDA-CBER-2021-5683-0651627
Table.U Deaths, Phase 2/3 Particip ants 16 Years of Age and Older, Safety Population, (Data Cutoff March 13, 2021)
Product
- Number
of
doses
received Subject
Number Dose/Rel
Daya Primary
Cause of
Death Positive
COVID-
19 test
(Y/N) Age/Sex/
Race/Ethnicity Demographics: Risk Factors
from Charlson Index
Placebo - 2 C4591001 11 68
11681083 2/65 Aortic rupture N 64/M/White/Not Hispanic or
Latino
Placebo - 2 C4591001 1207
12071055# 2/76 Pneumonia bacterial N 65/M/White/Not Hispanic or
Latino Diabetes without chronic complication, Mild
liver disease
Placebo - 2 C4591001 1229
12291083† 2/76 COVID -19
pneumonia N 55/F/Black or African
American/Not Hispanic or
Latino AIDS/HIV, Chronic pulmonary disease
Placebo - 2 C4591001 1231
12313972 2/16 Haemorrhagic stroke N 61/F/White/Hispanic or Latino
Placebo - 2 C4591001 1231
12314987 2/82 Cardio -respiratory
arrest N 47/M/White/Hispanic or
Latino
Placebo - 2 C4591001 1231
12315324 2/136 Multiple organ
dysfunction
syndrome Y 58/F/White/Hispanic or Latino
Note: MedDRA (v23.1) coding dictionary applied.
Note: † = Human immunodeficiency virus (HIV)- positive subject, # = death occurring on or after unblinding, * = subjects who originally received placebo
and then received BNT162b2 after unblinding, ∞ = subjects who originally received BNT162b2.
a. Relative day (R el Day)= date of dea th - date of last vaccination + 1.
090177e197c1681e\Final\Final On: 08-Aug-2021 04:02 (GMT)
FDA-CBER-2021-5683-0651628
Table V. Clinical Trials Submitted in Support of Safety and Effectiveness of the Pfizer- BioNTech COVID -19 Vaccine
N= total number of randomized participants 16 years of age and older, as of March 13, 2021.
Study Number/ Country Study Description Number of
BNT162b2 (30
μg) subjects
(N) Number of
placebo subjects
(N) Study Status
C4591001 Phase 1 A Phase 1/2/3 Study to Evaluate the Safety, Tolerability,
Immunogenicity, and Efficacy of RNA Vaccine Candidates
Against COVID- 19 in Healthy Individuals 24 6 Ongoing
C4591001 Phase 2/3 22085 22080 Ongoing
Argentina 2887 2889
Brazil 1452 1448
Germany 250 250
South Africa 401 399
Turkey 251 249
USA 16844 16845
BNT162 -01 Phase 1/2
Germany (BNT162b2 30
µg) A multi -site, Phase I/II, 2 -part, dose escalation trial
investigating the safety and immunogenicity of four prophylactic SARS -CoV -2 RNA vaccines against COVID -
19 using different dosing regimens in healthy adults
24
0
Ongoing
090177e197c1681e\Final\Final On: 08-Aug-2021 04:02 (GMT)
FDA-CBER-2021-5683-0651629