125742 S10 M1 appendix 1
Document text
BioNTech SE / Tables - Final 1.0 BNT162b2
BNT162 -01 Created on 30JUN2021 Page 1 of 16
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Table of content
14.3 Safety ................................ ................................ ................................ ................................ ................................ ................................ ................................ ....2
14.3.1 Primary endpoints ................................ ................................ ................................ ................................ ................................ ................................ .......... 2
14.3.1 -1 Local reactions ................................ ................................ ................................ ................................ ................................ ................................ ........ 3
Table 14.3.1 -1.2.1 -3: Frequency of subjects with solicited local reactions (assessed by subject) by wors t grade - BNT162b2 ................................ ..4
14.3.1 -2 Systemic reactions ................................ ................................ ................................ ................................ ................................ ................................ ..8
Table 14.3.1 -2.2.1 -3: Frequency of subjects with solicited systemic reactions (assessed by subject) by worst grade - BNT162b2 ........................... 9
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BioNTech SE / Tables - Final 1.0 BNT162b2
BNT162 -01 Created on 30JUN2021 Page 2 of 16
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. 14.3 Safety
14.3.1 Primary endpoints
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BioNTech SE / Tables - Final 1.0 BNT162b2
BNT162 -01 Created on 30JUN2021 Page 3 of 16
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut-off: 23OCT2020. 14.3.1 -1 Local reactions
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FDA-CBER-2021-5683-0950060
BioNTech SE / Tables - Final 1.0 BNT162b2
BNT162 -01 Created on 30JUN2021 Page 4 of 16
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Table 14.3.1 -1.2.1 -3: Frequency of subjects with solicited local reactions (assessed by subject) by worst grade - BNT162b2
Safety set
Time interval 30 µg Younger
(N=12) 30 µg Older
(N=12)
Prime up to Day 7
after prime nn 12 12
Any Any n (%) 10 (83) 9 (75)
Mild n (%) 7 (58) 8 (67)
Moderate n (%) 3 (25) 1 (8)
Pain Any n (%) 8 (67) 7 (58)
Mild n (%) 7 (58) 7 (58)
Moderate n (%) 1 (8) 0 (0)
Tenderness Any n (%) 10 (83) 8 (67)
Mild n (%) 7 (58) 7 (58)
Moderate n (%) 3 (25) 1 (8)
Erythema/Redness Any n (%) 0 (0) 0 (0)
Mild n (%) 0 (0) 0 (0)
Induration/Swelling Any n (%) 2 (17) 0 (0)
Mild n (%) 2 (17) 0 (0)
The combined interval is the union of the intervals 'Prime up to Day 7 after prime' and 'Boost up to Day 7 after boost'. The denominator for the percentage calculation
is nn.
N = number of subjects in the analysis set; n = number of subjects with the respe ctive local reaction; nn = number of subjects with any information on local reactions
available; N/A = not available; - = not estimable.
Program: Tsaf_locR_2.sas (Page 1 of 4)
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BioNTech SE / Tables - Final 1.0 BNT162b2
BNT162 -01 Created on 30JUN2021 Page 5 of 16
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Table 14.3.1 -1.2.1 -3: Frequency of subjects with solicited local reactions (assessed by subject) by worst grade - BNT162b2
Safety set
Time interval 30 µg Younger
(N=12) 30 µg Older
(N=12)
Boost up to Day 7
after boost nn 12 12
Any Any n (%) 11 (92) 10 (83)
Mild n (%) 11 (92) 5 (42)
Moderate n (%) 0 (0) 4 (33)
Severe n (%) 0 (0) 1 (8)
Pain Any n (%) 9 (75) 8 (67)
Mild n (%) 9 (75) 4 (33)
Moderate n (%) 0 (0) 3 (25)
Severe n (%) 0 (0) 1 (8)
Tenderness Any n (%) 11 (92) 8 (67)
Mild n (%) 11 (92) 5 (42)
Moderate n (%) 0 (0) 3 (25)
Erythema/Redness Any n (%) 1 (8) 2 (17)
Mild n (%) 1 (8) 2 (17)
The combined interval is the union of the intervals 'Prime up to Day 7 after prime' and 'Boost up to Day 7 after boost'. The denominator for the percentage calculation
is nn.
N = number of subjects in the analysis set; n = number of subjects with the respe ctive local reaction; nn = number of subjects with any information on local reactions
available; N/A = not available; - = not estimable.
Program: Tsaf_locR_2.sas (Page 2 of 4)
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BioNTech SE / Tables - Final 1.0 BNT162b2
BNT162 -01 Created on 30JUN2021 Page 6 of 16
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Table 14.3.1 -1.2.1 -3: Frequency of subjects with solicited local reactions (assessed by subject) by worst grade - BNT162b2
Safety set
Time interval 30 µg Younger
(N=12) 30 µg Older
(N=12)
Boost up to Day 7
after boost Erythema/Redness Moderate n (%) 0 (0) 0 (0)
Induration/Swelling Any n (%) 2 (17) 1 (8)
Mild n (%) 2 (17) 1 (8)
Combined interval nn 12 12
Any Any n (%) 11 (92) 11 (92)
Mild n (%) 8 (67) 5 (42)
Moderate n (%) 3 (25) 5 (42)
Severe n (%) 0 (0) 1 (8)
Pain Any n (%) 10 (83) 11 (92)
Mild n (%) 9 (75) 7 (58)
Moderate n (%) 1 (8) 3 (25)
Severe n (%) 0 (0) 1 (8)
Tenderness Any n (%) 11 (92) 9 (75)
Mild n (%) 8 (67) 5 (42)
The combined interval is the union of the intervals 'Prime up to Day 7 after prime' and 'Boost up to Day 7 after boost'. The denominator for the percentage calculation
is nn.
N = number of subjects in the analysis set; n = number of subjects with the respe ctive local reaction; nn = number of subjects with any information on local reactions
available; N/A = not available; - = not estimable.
Program: Tsaf_locR_2.sas (Page 3 of 4)
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BioNTech SE / Tables - Final 1.0 BNT162b2
BNT162 -01 Created on 30JUN2021 Page 7 of 16
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Table 14.3.1 -1.2.1 -3: Frequency of subjects with solicited local reactions (assessed by subject) by worst grade - BNT162b2
Safety set
Time interval 30 µg Younger
(N=12) 30 µg Older
(N=12)
Combined interval Tenderness Moderate n (%) 3 (25) 4 (33)
Erythema/Redness Any n (%) 1 (8) 2 (17)
Mild n (%) 1 (8) 2 (17)
Moderate n (%) 0 (0) 0 (0)
Induration/Swelling Any n (%) 3 (25) 1 (8)
Mild n (%) 3 (25) 1 (8)
The combined interval is the union of the intervals 'Prime up to Day 7 after prime' and 'Boost up to Day 7 after boost'. The denominator for the percentage calculation
is nn.
N = number of subjects in the analysis set; n = number of subjects with the respe ctive local reaction; nn = number of subjects with any information on local reactions
available; N/A = not available; - = not estimable.
Program: Tsaf_locR_2.sas (Page 4 of 4)
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BioNTech SE / Tables - Final 1.0 BNT162b2
BNT162 -01 Created on 30JUN2021 Page 8 of 16
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. 14.3.1 -2 Systemic reactions
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FDA-CBER-2021-5683-0950065
BioNTech SE / Tables - Final 1.0 BNT162b2
BNT162 -01 Created on 30JUN2021 Page 9 of 16
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Table 14.3.1 -2.2.1 -3: Frequency of subjects with solicited systemic reactions (assessed by subject) by wors t grade - BNT162b2
Safety set
Time interval 30 µg Younger
(N=12) 30 µg Older
(N=12)
Prime up to Day 7
after prime nn 12 12
Any Any n (%) 9 (75) 9 (75)
Mild n (%) 7 (58) 8 (67)
Moderate n (%) 2 (17) 1 (8)
Severe n (%) 0 (0) 0 (0)
Nausea Any n (%) 2 (17) 1 (8)
Mild n (%) 2 (17) 1 (8)
Diarrhea Any n (%) 2 (17) 1 (8)
Mild n (%) 2 (17) 1 (8)
Headache Any n (%) 5 (42) 5 (42)
Mild n (%) 5 (42) 4 (33)
Moderate n (%) 0 (0) 1 (8)
Severe n (%) 0 (0) 0 (0)
Fatigue Any n (%) 5 (42) 7 (58)
The combined interval is the union of the intervals 'Prime up to Day 7 after prime' and 'Boost up to Day 7 after boost'. The denominator for the percentage calculation
is nn.
N = number of subjects in the analysis set; n = number of subjects with the respective systemic reaction; nn = number of subjects with any information on systemic reactions
available; N/A = not available; - = not estimable.
Program: Tsaf_sysR_2.sas (Page 1 of 8)
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FDA-CBER-2021-5683-0950066
BioNTech SE / Tables - Final 1.0 BNT162b2
BNT162 -01 Created on 30JUN2021 Page 10 of 16
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Table 14.3.1 -2.2.1 -3: Frequency of subjects with solicited systemic reactions (assessed by subject) by worst grade - BNT162b2
Safety set
Time interval 30 µg Younger
(N=12) 30 µg Older
(N=12)
Prime up to Day 7
after prime Fatigue Mild n (%) 3 (25) 7 (58)
Moderate n (%) 2 (17) 0 (0)
Severe n (%) 0 (0) 0 (0)
Myalgia Any n (%) 2 (17) 2 (17)
Mild n (%) 1 (8) 2 (17)
Moderate n (%) 1 (8) 0 (0)
Arthralgia Any n (%) 0 (0) 0 (0)
Mild n (%) 0 (0) 0 (0)
Moderate n (%) 0 (0) 0 (0)
Chills Any n (%) 1 (8) 1 (8)
Mild n (%) 1 (8) 1 (8)
Loss of Appetite Any n (%) 0 (0) 0 (0)
Mild n (%) 0 (0) 0 (0)
Malaise Any n (%) 4 (33) 2 (17)
The combined interval is the union of the intervals 'Prime up to Day 7 after prime' and 'Boost up to Day 7 after boost'. The denominator for the percentage calculation
is nn.
N = number of subjects in the analysis set; n = number of subjects with the respe ctive systemic reaction; nn = number of subjects with any information on systemic reactions
available; N/A = not available; - = not estimable.
Program: Tsaf_sysR_2.sas (Page 2 of 8)
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FDA-CBER-2021-5683-0950067
BioNTech SE / Tables - Final 1.0 BNT162b2
BNT162 -01 Created on 30JUN2021 Page 11 of 16
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Table 14.3.1 -2.2.1 -3: Frequency of subjects with solicited systemic reactions (assessed by subject) by worst grade - BNT162b2
Safety set
Time interval 30 µg Younger
(N=12) 30 µg Older
(N=12)
Prime up to Day 7
after prime Malaise Mild n (%) 3 (25) 2 (17)
Moderate n (%) 1 (8) 0 (0)
Boost up to Day 7
after boost nn 12 12
Any Any n (%) 10 (83) 11 (92)
Mild n (%) 4 (33) 4 (33)
Moderate n (%) 3 (25) 5 (42)
Severe n (%) 3 (25) 2 (17)
Nausea Any n (%) 1 (8) 2 (17)
Mild n (%) 0 (0) 2 (17)
Severe n (%) 1 (8) 0 (0)
Diarrhea Any n (%) 0 (0) 1 (8)
Mild n (%) 0 (0) 1 (8)
Headache Any n (%) 5 (42) 8 (67)
Mild n (%) 3 (25) 4 (33)
The combined interval is the union of the intervals 'Prime up to Day 7 after prime' and 'Boost up to Day 7 after boost'. The denominator for the percentage calculation
is nn.
N = number of subjects in the analysis set; n = number of subjects with the respe ctive systemic reaction; nn = number of subjects with any information on systemic reactions
available; N/A = not available; - = not estimable.
Program: Tsaf_sysR_2.sas (Page 3 of 8)
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FDA-CBER-2021-5683-0950068
BioNTech SE / Tables - Final 1.0 BNT162b2
BNT162 -01 Created on 30JUN2021 Page 12 of 16
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Table 14.3.1 -2.2.1 -3: Frequency of subjects with solicited systemic reactions (assessed by subject) by worst grade - BNT162b2
Safety set
Time interval 30 µg Younger
(N=12) 30 µg Older
(N=12)
Boost up to Day 7
after boost Headache Moderate n (%) 2 (17) 3 (25)
Severe n (%) 0 (0) 1 (8)
Fatigue Any n (%) 8 (67) 7 (58)
Mild n (%) 4 (33) 4 (33)
Moderate n (%) 2 (17) 3 (25)
Severe n (%) 2 (17) 0 (0)
Myalgia Any n (%) 6 (50) 4 (33)
Mild n (%) 3 (25) 3 (25)
Moderate n (%) 1 (8) 1 (8)
Severe n (%) 2 (17) 0 (0)
Arthralgia Any n (%) 6 (50) 3 (25)
Mild n (%) 2 (17) 3 (25)
Moderate n (%) 1 (8) 0 (0)
Severe n (%) 3 (25) 0 (0)
The combined interval is the union of the intervals 'Prime up to Day 7 after prime' and 'Boost up to Day 7 after boost'. The denominator for the percentage calculation
is nn.
N = number of subjects in the analysis set; n = number of subjects with the respe ctive systemic reaction; nn = number of subjects with any information on systemic reactions
available; N/A = not available; - = not estimable.
Program: Tsaf_sysR_2.sas (Page 4 of 8)
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FDA-CBER-2021-5683-0950069
BioNTech SE / Tables - Final 1.0 BNT162b2
BNT162 -01 Created on 30JUN2021 Page 13 of 16
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Table 14.3.1 -2.2.1 -3: Frequency of subjects with solicited systemic reactions (assessed by subject) by worst grade - BNT162b2
Safety set
Time interval 30 µg Younger
(N=12) 30 µg Older
(N=12)
Boost up to Day 7
after boost Chills Any n (%) 6 (50) 4 (33)
Mild n (%) 4 (33) 1 (8)
Moderate n (%) 1 (8) 2 (17)
Severe n (%) 1 (8) 1 (8)
Loss of Appetite Any n (%) 2 (17) 3 (25)
Mild n (%) 1 (8) 2 (17)
Moderate n (%) 1 (8) 1 (8)
Malaise Any n (%) 6 (50) 5 (42)
Mild n (%) 1 (8) 2 (17)
Moderate n (%) 4 (33) 3 (25)
Severe n (%) 1 (8) 0 (0)
Fever Any n (%) 0 (0) 3 (25)
Mild n (%) 0 (0) 3 (25)
Combined interval nn 12 12
The combined interval is the union of the intervals 'Prime up to Day 7 after prime' and 'Boost up to Day 7 after boost'. The denominator for the percentage calculation
is nn.
N = number of subjects in the analysis set; n = number of subjects with the respe ctive systemic reaction; nn = number of subjects with any information on systemic reactions
available; N/A = not available; - = not estimable.
Program: Tsaf_sysR_2.sas (Page 5 of 8)
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FDA-CBER-2021-5683-0950070
BioNTech SE / Tables - Final 1.0 BNT162b2
BNT162 -01 Created on 30JUN2021 Page 14 of 16
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Table 14.3.1 -2.2.1 -3: Frequency of subjects with solicited systemic reactions (assessed by subject) by worst grade - BNT162b2
Safety set
Time interval 30 µg Younger
(N=12) 30 µg Older
(N=12)
Combined interval Any Any n (%) 12 (100) 11 (92)
Mild n (%) 5 (42) 4 (33)
Moderate n (%) 4 (33) 5 (42)
Severe n (%) 3 (25) 2 (17)
Nausea Any n (%) 2 (17) 3 (25)
Mild n (%) 1 (8) 3 (25)
Severe n (%) 1 (8) 0 (0)
Diarrhea Any n (%) 2 (17) 2 (17)
Mild n (%) 2 (17) 2 (17)
Headache Any n (%) 7 (58) 8 (67)
Mild n (%) 5 (42) 4 (33)
Moderate n (%) 2 (17) 3 (25)
Severe n (%) 0 (0) 1 (8)
Fatigue Any n (%) 9 (75) 9 (75)
The combined interval is the union of the intervals 'Prime up to Day 7 after prime' and 'Boost up to Day 7 after boost'. The denominator for the percentage calculation
is nn.
N = number of subjects in the analysis set; n = number of subjects with the respe ctive systemic reaction; nn = number of subjects with any information on systemic reactions
available; N/A = not available; - = not estimable.
Program: Tsaf_sysR_2.sas (Page 6 of 8)
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FDA-CBER-2021-5683-0950071
BioNTech SE / Tables - Final 1.0 BNT162b2
BNT162 -01 Created on 30JUN2021 Page 15 of 16
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Table 14.3.1 -2.2.1 -3: Frequency of subjects with solicited systemic reactions (assessed by subject) by worst grade - BNT162b2
Safety set
Time interval 30 µg Younger
(N=12) 30 µg Older
(N=12)
Combined interval Fatigue Mild n (%) 4 (33) 6 (50)
Moderate n (%) 3 (25) 3 (25)
Severe n (%) 2 (17) 0 (0)
Myalgia Any n (%) 7 (58) 5 (42)
Mild n (%) 3 (25) 4 (33)
Moderate n (%) 2 (17) 1 (8)
Severe n (%) 2 (17) 0 (0)
Arthralgia Any n (%) 6 (50) 3 (25)
Mild n (%) 2 (17) 3 (25)
Moderate n (%) 1 (8) 0 (0)
Severe n (%) 3 (25) 0 (0)
Chills Any n (%) 6 (50) 4 (33)
Mild n (%) 4 (33) 1 (8)
Moderate n (%) 1 (8) 2 (17)
The combined interval is the union of the intervals 'Prime up to Day 7 after prime' and 'Boost up to Day 7 after boost'. The denominator for the percentage calculation
is nn.
N = number of subjects in the analysis set; n = number of subjects with the respe ctive systemic reaction; nn = number of subjects with any information on systemic reactions
available; N/A = not available; - = not estimable.
Program: Tsaf_sysR_2.sas (Page 7 of 8)
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FDA-CBER-2021-5683-0950072
BioNTech SE / Tables - Final 1.0 BNT162b2
BNT162 -01 Created on 30JUN2021 Page 16 of 16
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Table 14.3.1 -2.2.1 -3: Frequency of subjects with solicited systemic reactions (assessed by subject) by worst grade - BNT162b2
Safety set
Time interval 30 µg Younger
(N=12) 30 µg Older
(N=12)
Combined interval Chills Severe n (%) 1 (8) 1 (8)
Loss of Appetite Any n (%) 2 (17) 3 (25)
Mild n (%) 1 (8) 2 (17)
Moderate n (%) 1 (8) 1 (8)
Malaise Any n (%) 7 (58) 7 (58)
Mild n (%) 1 (8) 4 (33)
Moderate n (%) 5 (42) 3 (25)
Severe n (%) 1 (8) 0 (0)
Fever Any n (%) 0 (0) 3 (25)
Mild n (%) 0 (0) 3 (25)
The combined interval is the union of the intervals 'Prime up to Day 7 after prime' and 'Boost up to Day 7 after boost'. The denominator for the percentage calculation
is nn.
N = number of subjects in the analysis set; n = number of subjects with the respe ctive systemic reaction; nn = number of subjects with any information on systemic reactions
available; N/A = not available; - = not estimable.
Program: Tsaf_sysR_2.sas (Page 8 of 8)
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FDA-CBER-2021-5683-0950073
Document Approval Record
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