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COVID-19 Vaccine (BNT162, PF -07302048)
BLA STN 125742/45
Module 1.11.3 Response to FDA Request for Information
PFIZER CONFIDENTIAL
Page 1
COVID-19 Vaccine (BNT162, PF -07302048; COMIRNATY)
BLA STN 125742/45
Response to CBER Information Request of 14 March Regarding Additional
Reactogenicity Data for Adolescents 12 Through 15 Years of Age
18March 2022
090177e199a7b0df\Approved\Approved On: 18-Mar-2022 11:04 (GMT)
FDA-CBER-2022-5812-0235613
COVID-19 Vaccine (BNT162, PF -07302048)
BLA STN 125742/45
Module 1.11.3 Response to FDA Request for Information
PFIZER CONFIDENTIAL
Page 21.INTRODUCTION
Reference is made to the sBLA to extend licensure of COMI RNATY to adolescents
12through 15 years of age submitted to FDA on 16 Dec 2021 (Sequence number 0211).
Reference is also made to the Information Request received from CBER on 07 March 2022,
the response to that request submitted by Pfizer/BioNTech on 11 March 2022 ( Sequence
number0271), and the follow -up Information Request received from CBER on 14 March
2022.
Below, the request is shown in bold italics followed by Pfizer/BioNTech’s response in plain
text.
2. RESPONSES
2.1.Request 1
The review team has a follow- up question to Pfizer’s response that was submitted in
STN125742.45.4 in response to the review team’s 3/7/22 clinical and statistical questions.
You state that no additional reactogenicity data have been recorded in the e -diary since the
EUA. However, we note that the numbers of placebo subjects who reported any headache,
chills, and diarrhea post Dose 2 are 263, 73, and 43, respectively in the SDTM (1 Month
Follow-up) datasets and the draft prescribing information, while the respective counts
appear to be 264, 74, and 44 in the SDTM (6 Month Follow- up) datasets. Please clarify the
discrepancy and provide updated reactogenicit y tables as appropriate.
Response
With reference to reactogenicity (e-diary)data from Study C4591001 for participants
12through 15 years of age, t he SDTM datasets for the 6- month follow -up include e -diary
data for one additional participant who received placebo, relative to the SDTM datasets for
the 1-month follow -up. Although the diary data for this participant were saved in the e-diary
application on the device on 07 January and 10 January 2021(during the 1 -month follow -up
period), they were not s yncedwith the server until 07 April 2021 and were included in the
data transfer of 08 April 2021. Such a delay in data sy nchronization can occur if the
participant has connection issues that cannot be resolved, in which case the data are saved on
the device an d transmitted the next time there is a successful conn ection.
The reactogenicit y tables for local reactions and systemic events b y maximum severity have
been updated and are provided in Table1and Table2, respectively . There is no change to the
results for local reactions, while data for s ystemic events have changed for headache, chills,
and diarrhea, as noted in the request. Tables for onset and duration of reactogenicity events
have not been updated, as changes to the tables would be minimal, and the label would not be
impacted.
090177e199a7b0df\Approved\Approved On: 18-Mar-2022 11:04 (GMT)
FDA-CBER-2022-5812-0235614
COVID-19 Vaccine (BNT162, PF -07302048)
BLA STN 125742/45
Module 1.11.3 Response to FDA Request for Information
PFIZER CONFIDENTIAL
Page 3Table1.Local Reactions, by Maximum Severity, Within 7 Days After Each Dose –
Subjects 12 Through 15 Years of Age (Reactogenicity Subset) – Safety
Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
12-15 Years 12-15 Years
Dose Local Reaction Nanb(%) (95%CIc)Nanb(%) (95%CIc)
1 Rednessd
Any 1127 65(5.8) (4.5,7.3)1127 12(1.1) (0.6,1.9)
Mild 1127 44(3.9) (2.9,5.2)1127 11(1.0) (0.5,1.7)
Moderate 1127 20(1.8) (1.1,2.7)1127 1(0.1) (0.0,0.5)
Severe 1127 1(0.1) (0.0,0.5)1127 0 (0.0,0.3)
Grade 4 1127 0 (0.0,0.3)1127 0 (0.0,0.3)
Swellingd
Any 1127 78(6.9) (5.5,8.6)1127 11(1.0) (0.5,1.7)
Mild 1127 55(4.9) (3.7,6.3)1127 9(0.8) (0.4,1.5)
Moderate 1127 23(2.0) (1.3,3.0)1127 2(0.2) (0.0,0.6)
Severe 1127 0 (0.0,0.3)1127 0 (0.0,0.3)
Grade 4 1127 0 (0.0,0.3)1127 0 (0.0,0.3)
Pain at the injection sitee
Any 1127971(86.2) (84.0,88.1)1127263(23.3) (20.9,25.9)
Mild 1127467(41.4) (38.5,44.4)1127227(20.1) (17.8,22.6)
Moderate 1127493(43.7) (40.8,46.7)1127 36(3.2) (2.2,4.4)
Severe 1127 11(1.0) (0.5,1.7)1127 0 (0.0,0.3)
Grade 4 1127 0 (0.0,0.3)1127 0 (0.0,0.3)
Any local reactionf1127976(86.6) (84.5,88.5)1127271(24.0) (21.6,26.7)
2 Rednessd
Any 1097 55(5.0) (3.8,6.5)1078 10(0.9) (0.4,1.7)
Mild 1097 29(2.6) (1.8,3.8)1078 8(0.7) (0.3,1.5)
Moderate 1097 26(2.4) (1.6,3.5)1078 2(0.2) (0.0,0.7)
Severe 1097 0 (0.0,0.3)1078 0 (0.0,0.3)
Grade 4 1097 0 (0.0,0.3)1078 0 (0.0,0.3)
Swellingd
Any 1097 54(4.9) (3.7,6.4)1078 6(0.6) (0.2,1.2)
Mild 1097 36(3.3) (2.3,4.5)1078 4(0.4) (0.1,0.9)
Moderate 1097 18(1.6) (1.0,2.6)1078 2(0.2) (0.0,0.7)
Severe 1097 0 (0.0,0.3)1078 0 (0.0,0.3)
Grade 4 1097 0 (0.0,0.3)1078 0 (0.0,0.3)
Pain at the injection sitee
Any 1097866(78.9) (76.4,81.3)1078193(17.9) (15.7,20.3)
Mild 1097466(42.5) (39.5,45.5)1078164(15.2) (13.1,17.5)
Moderate 1097393(35.8) (33.0,38.7)1078 29(2.7) (1.8,3.8)
Severe 1097 7(0.6) (0.3,1.3)1078 0 (0.0,0.3)
Grade 4 1097 0 (0.0,0.3)1078 0 (0.0,0.3)
Any local reactionf1097872(79.5) (77.0,81.8)1078198(18.4) (16.1,20.8)
Any dose Rednessd
Any 1131 97(8.6) (7.0,10.4)1129 18(1.6) (0.9,2.5)
Mild 1131 55(4.9) (3.7,6.3)1129 15(1.3) (0.7,2.2)
Moderate 1131 41(3.6) (2.6,4.9)1129 3(0.3) (0.1,0.8)
Severe 1131 1(0.1) (0.0,0.5)1129 0 (0.0,0.3)
090177e199a7b0df\Approved\Approved On: 18-Mar-2022 11:04 (GMT)
FDA-CBER-2022-5812-0235615
COVID-19 Vaccine (BNT162, PF -07302048)
BLA STN 125742/45
Module 1.11.3 Response to FDA Request for Information
PFIZER CONFIDENTIAL
Page 4Table1.Local Reactions, by Maximum Severity, Within 7 Days After Each Dose –
Subjects 12 Through 15 Years of Age (Reactogenicity Subset) – Safety
Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
12-15 Years 12-15 Years
Dose Local Reaction Nanb(%) (95%CIc)Nanb(%) (95%CIc)
Grade 4 1131 0 (0.0,0.3)1129 0 (0.0,0.3)
Swellingd
Any 1131 104(9.2) (7.6,11.0)1129 13(1.2) (0.6,2.0)
Mild 1131 69(6.1) (4.8,7.7)1129 10(0.9) (0.4,1.6)
Moderate 1131 35(3.1) (2.2,4.3)1129 3(0.3) (0.1,0.8)
Severe 1131 0 (0.0,0.3)1129 0 (0.0,0.3)
Grade 4 1131 0 (0.0,0.3)1129 0 (0.0,0.3)
Pain at the injection sitee
Any 11311023(90.5) (88.6,92.1)1129341(30.2) (27.5,33.0)
Mild 1131394(34.8) (32.1,37.7)1129283(25.1) (22.6,27.7)
Moderate 1131612(54.1) (51.2,57.0)1129 58(5.1) (3.9,6.6)
Severe 1131 17(1.5) (0.9,2.4)1129 0 (0.0,0.3)
Grade 4 1131 0 (0.0,0.3)1129 0 (0.0,0.3)
Any local reactionf11311028(90.9) (89.1,92.5)1129349(30.9) (28.2,33.7)
Note: Reactions were collected in the electronic diary (e -diary) from Day 1 through Day 7 after each dose.
Note: Grade 4 reactions w ere classified by the investigator or medically qualified person.
a. N = number of subjects reporting at least 1 yes or no response for the specified reaction after the specified
dose.
b. n =Number of subjects with the specified characteristic.
c. Exact 2-sided CI based on the Clopper and Pearson method.
d. Mild: >2.0 to 5.0 cm; moderate: >5.0 to 10.0 cm; severe: >10.0 cm; Grade 4: necrosis (redness and swelling
categories) or exfolia tive dermatitis (redness category only).
e. Mild: does not interfere with activity; moderate: interferes w ith activity; severe: prevents daily activity;
Grade 4: emergency room visit or hospitalization for severe pain at the injection site.
f. Any local reaction: any redness >2.0 cm, any swelling >2.0 cm, or any pain at the injection site.
PFIZER CONFIDENTIAL SDTM Creation: 05OCT2021 (18:31) Source Data: adfacevd Table Generation:
15MAR2022 (12:26)
(Data Cutoff Date: 02SEP2021, Database Snapshot Dat e: 27SEP2021) Output File:
./nda2_unblinded/C4591001_S_Peds_RR/adce_s010_lr_sev_ped_saf
090177e199a7b0df\Approved\Approved On: 18-Mar-2022 11:04 (GMT)
FDA-CBER-2022-5812-0235616
COVID-19 Vaccine (BNT162, PF -07302048)
BLA STN 125742/45
Module 1.11.3 Response to FDA Request for Information
PFIZER CONFIDENTIAL
Page 5Table2. Systemic Events, by Maximum Severity, Within 7 Days After Each Dose –
Subjects 12 Through 15 Years of Age (Reactogenicity Subset) – Safety
Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
12-15 Years 12-15 Years
Dose Systemic Event Nanb(%) (95% CIc)Nanb(%) (95% CIc)
1 Fever
≥38.0°C 1127114(10.1) (8.4,12.0)112712(1.1) (0.6,1.9)
≥38.0°C to 38.4°C 1127 74(6.6) (5.2,8.2)1127 8(0.7) (0.3,1.4)
>38.4°C to 38.9°C 1127 29(2.6) (1.7,3.7)1127 2(0.2) (0.0,0.6)
>38.9°C to 40.0°C 1127 10(0.9) (0.4,1.6)1127 2(0.2) (0.0,0.6)
>40.0°C 1127 1(0.1) (0.0,0.5)1127 0 (0.0,0.3)
Fatigued
Any 1127677(60.1) (57.1,62.9)1127457(40.6) (37.7,43.5)
Mild 1127278(24.7) (22.2,27.3)1127250(22.2) (19.8,24.7)
Moderate 1127384(34.1) (31.3,36.9)1127199(17.7) (15.5,20.0)
Severe 1127 15(1.3) (0.7,2.2)1127 8(0.7) (0.3,1.4)
Grade 4 1127 0 (0.0,0.3)1127 0 (0.0,0.3)
Headached
Any 1127623(55.3) (52.3,58.2)1127396(35.1) (32.3,38.0)
Mild 1127361(32.0) (29.3,34.8)1127256(22.7) (20.3,25.3)
Moderate 1127251(22.3) (19.9,24.8)1127131(11.6) (9.8,13.6)
Severe 1127 11(1.0) (0.5,1.7)1127 9(0.8) (0.4,1.5)
Grade 4 1127 0 (0.0,0.3)1127 0 (0.0,0.3)
Chillsd
Any 1127311(27.6) (25.0,30.3)1127109(9.7) (8.0,11.5)
Mild 1127195(17.3) (15.1,19.6)112782(7.3) (5.8,9.0)
Moderate 1127111(9.8) (8.2,11.7)112725(2.2) (1.4,3.3)
Severe 1127 5(0.4) (0.1,1.0)1127 2(0.2) (0.0,0.6)
Grade 4 1127 0 (0.0,0.3)1127 0 (0.0,0.3)
Vomitinge
Any 1127 31(2.8) (1.9,3.9)112710(0.9) (0.4,1.6)
Mild 1127 30(2.7) (1.8,3.8)1127 8(0.7) (0.3,1.4)
Moderate 1127 0 (0.0,0.3)1127 2(0.2) (0.0,0.6)
Severe 1127 1(0.1) (0.0,0.5)1127 0 (0.0,0.3)
Grade 4 1127 0 (0.0,0.3)1127 0 (0.0,0.3)
Diarrheaf
Any 1127 90(8.0) (6.5,9.7)112782(7.3) (5.8,9.0)
Mild 1127 77(6.8) (5.4,8.5)112772(6.4) (5.0,8.0)
Moderate 1127 13(1.2) (0.6,2.0)112710(0.9) (0.4,1.6)
Severe 1127 0 (0.0,0.3)1127 0 (0.0,0.3)
Grade 4 1127 0 (0.0,0.3)1127 0 (0.0,0.3)
New or worsened muscle
paind
Any 1127272(24.1) (21.7,26.7)1127148(13.1) (11.2,15.2)
Mild 1127125(11.1) (9.3,13.1)112788(7.8) (6.3,9.5)
Moderate 1127145(12.9) (11.0,15.0)112760(5.3) (4.1,6.8)
Severe 1127 2(0.2) (0.0,0.6)1127 0 (0.0,0.3)
090177e199a7b0df\Approved\Approved On: 18-Mar-2022 11:04 (GMT)
FDA-CBER-2022-5812-0235617
COVID-19 Vaccine (BNT162, PF -07302048)
BLA STN 125742/45
Module 1.11.3 Response to FDA Request for Information
PFIZER CONFIDENTIAL
Page 6Table2. Systemic Events, by Maximum Severity, Within 7 Days After Each Dose –
Subjects 12 Through 15 Years of Age (Reactogenicity Subset) – Safety
Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
12-15 Years 12-15 Years
Dose Systemic Event Nanb(%) (95% CIc)Nanb(%) (95% CIc)
Grade 4 1127 0 (0.0,0.3)1127 0 (0.0,0.3)
New or worsened joint paind
Any 1127109(9.7) (8.0,11.5)112777(6.8) (5.4,8.5)
Mild 1127 66(5.9) (4.6,7.4)112750(4.4) (3.3,5.8)
Moderate 1127 42(3.7) (2.7,5.0)112727(2.4) (1.6,3.5)
Severe 1127 1(0.1) (0.0,0.5)1127 0 (0.0,0.3)
Grade 4 1127 0 (0.0,0.3)1127 0 (0.0,0.3)
Any systemic eventg1127877(77.8) (75.3,80.2)1127636(56.4) (53.5,59.4)
Use of antipyretic or pain
medicationh1127413(36.6) (33.8,39.5)1127111(9.8) (8.2,11.7)
2 Fever
≥38.0°C 1097215(19.6) (17.3,22.1)1078 7(0.6) (0.3,1.3)
≥38.0°C to 38.4°C 1097107(9.8) (8.1,11.7)1078 5(0.5) (0.2,1.1)
>38.4°C to 38.9°C 1097 83(7.6) (6.1,9.3)1078 1(0.1) (0.0,0.5)
>38.9°C to 40.0°C 1097 25(2.3) (1.5,3.3)1078 1(0.1) (0.0,0.5)
>40.0°C 1097 0 (0.0,0.3)1078 0 (0.0,0.3)
Fatigued
Any 1097726(66.2) (63.3,69.0)1078264(24.5) (21.9,27.2)
Mild 1097232(21.1) (18.8,23.7)1078133(12.3) (10.4,14.5)
Moderate 1097468(42.7) (39.7,45.7)1078127(11.8) (9.9,13.9)
Severe 1097 26(2.4) (1.6,3.5)1078 4(0.4) (0.1,0.9)
Grade 4 1097 0 (0.0,0.3)1078 0 (0.0,0.3)
Headached
Any 1097708(64.5) (61.6,67.4)1078264(24.5) (21.9,27.2)
Mild 1097302(27.5) (24.9,30.3)1078170(15.8) (13.6,18.1)
Moderate 1097384(35.0) (32.2,37.9)107893(8.6) (7.0,10.5)
Severe 1097 22(2.0) (1.3,3.0)1078 1(0.1) (0.0,0.5)
Grade 4 1097 0 (0.0,0.3)1078 0 (0.0,0.3)
Chillsd
Any 1097455(41.5) (38.5,44.5)107874(6.9) (5.4,8.5)
Mild 1097221(20.1) (17.8,22.6)107853(4.9) (3.7,6.4)
Moderate 1097214(19.5) (17.2,22.0)107821(1.9) (1.2,3.0)
Severe 1097 20(1.8) (1.1,2.8)1078 0 (0.0,0.3)
Grade 4 1097 0 (0.0,0.3)1078 0 (0.0,0.3)
Vomitinge
Any 1097 29(2.6) (1.8,3.8)107812(1.1) (0.6,1.9)
Mild 1097 25(2.3) (1.5,3.3)107811(1.0) (0.5,1.8)
Moderate 1097 4(0.4) (0.1,0.9)1078 1(0.1) (0.0,0.5)
Severe 1097 0 (0.0,0.3)1078 0 (0.0,0.3)
Grade 4 1097 0 (0.0,0.3)1078 0 (0.0,0.3)
Diarrheaf
Any 1097 65(5.9) (4.6,7.5)107844(4.1) (3.0,5.4)
Mild 1097 59(5.4) (4.1,6.9)107839(3.6) (2.6,4.9)
090177e199a7b0df\Approved\Approved On: 18-Mar-2022 11:04 (GMT)
FDA-CBER-2022-5812-0235618
COVID-19 Vaccine (BNT162, PF -07302048)
BLA STN 125742/45
Module 1.11.3 Response to FDA Request for Information
PFIZER CONFIDENTIAL
Page 7Table2. Systemic Events, by Maximum Severity, Within 7 Days After Each Dose –
Subjects 12 Through 15 Years of Age (Reactogenicity Subset) – Safety
Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
12-15 Years 12-15 Years
Dose Systemic Event Nanb(%) (95% CIc)Nanb(%) (95% CIc)
Moderate 1097 6(0.5) (0.2,1.2)1078 5(0.5) (0.2,1.1)
Severe 1097 0 (0.0,0.3)1078 0 (0.0,0.3)
Grade 4 1097 0 (0.0,0.3)1078 0 (0.0,0.3)
New or worsened muscle
paind
Any 1097355(32.4) (29.6,35.2)107890(8.3) (6.8,10.2)
Mild 1097152(13.9) (11.9,16.0)107851(4.7) (3.5,6.2)
Moderate 1097197(18.0) (15.7,20.4)107837(3.4) (2.4,4.7)
Severe 1097 6(0.5) (0.2,1.2)1078 2(0.2) (0.0,0.7)
Grade 4 1097 0 (0.0,0.3)1078 0 (0.0,0.3)
New or worsened joint paind
Any 1097173(15.8) (13.7,18.1)107851(4.7) (3.5,6.2)
Mild 1097 91(8.3) (6.7,10.1)107830(2.8) (1.9,3.9)
Moderate 1097 78(7.1) (5.7,8.8)107821(1.9) (1.2,3.0)
Severe 1097 4(0.4) (0.1,0.9)1078 0 (0.0,0.3)
Grade 4 1097 0 (0.0,0.3)1078 0 (0.0,0.3)
Any systemic eventg1097904(82.4) (80.0,84.6)1078440(40.8) (37.9,43.8)
Use of antipyretic or pain
medicationh1097557(50.8) (47.8,53.8)107895(8.8) (7.2,10.7)
Any
doseFever
≥38.0°C 1131275(24.3) (21.8,26.9)112917(1.5) (0.9,2.4)
≥38.0°C to 38.4°C 1131141(12.5) (10.6,14.5)112911(1.0) (0.5,1.7)
>38.4°C to 38.9°C 1131100(8.8) (7.3,10.6)1129 3(0.3) (0.1,0.8)
>38.9°C to 40.0°C 1131 33(2.9) (2.0,4.1)1129 3(0.3) (0.1,0.8)
>40.0°C 1131 1(0.1) (0.0,0.5)1129 0 (0.0,0.3)
Fatigued
Any 1131876(77.5) (74.9,79.9)1129538(47.7) (44.7,50.6)
Mild 1131239(21.1) (18.8,23.6)1129266(23.6) (21.1,26.1)
Moderate 1131597(52.8) (49.8,55.7)1129260(23.0) (20.6,25.6)
Severe 1131 40(3.5) (2.5,4.8)112912(1.1) (0.6,1.8)
Grade 4 1131 0 (0.0,0.3)1129 0 (0.0,0.3)
Headached
Any 1131854(75.5) (72.9,78.0)1129506(44.8) (41.9,47.8)
Mild 1131324(28.6) (26.0,31.4)1129303(26.8) (24.3,29.5)
Moderate 1131499(44.1) (41.2,47.1)1129194(17.2) (15.0,19.5)
Severe 1131 31(2.7) (1.9,3.9)1129 9(0.8) (0.4,1.5)
Grade 4 1131 0 (0.0,0.3)1129 0 (0.0,0.3)
Chillsd
Any 1131557(49.2) (46.3,52.2)1129160(14.2) (12.2,16.3)
Mild 1131257(22.7) (20.3,25.3)1129115(10.2) (8.5,12.1)
Moderate 1131276(24.4) (21.9,27.0)112943(3.8) (2.8,5.1)
Severe 1131 24(2.1) (1.4,3.1)1129 2(0.2) (0.0,0.6)
090177e199a7b0df\Approved\Approved On: 18-Mar-2022 11:04 (GMT)
FDA-CBER-2022-5812-0235619
COVID-19 Vaccine (BNT162, PF -07302048)
BLA STN 125742/45
Module 1.11.3 Response to FDA Request for Information
PFIZER CONFIDENTIAL
Page 8Table2. Systemic Events, by Maximum Severity, Within 7 Days After Each Dose –
Subjects 12 Through 15 Years of Age (Reactogenicity Subset) – Safety
Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
12-15 Years 12-15 Years
Dose Systemic Event Nanb(%) (95% CIc)Nanb(%) (95% CIc)
Grade 4 1131 0 (0.0,0.3)1129 0 (0.0,0.3)
Vomitinge
Any 1131 59(5.2) (4.0,6.7)112921(1.9) (1.2,2.8)
Mild 1131 54(4.8) (3.6,6.2)112918(1.6) (0.9,2.5)
Moderate 1131 4(0.4) (0.1,0.9)1129 3(0.3) (0.1,0.8)
Severe 1131 1(0.1) (0.0,0.5)1129 0 (0.0,0.3)
Grade 4 1131 0 (0.0,0.3)1129 0 (0.0,0.3)
Diarrheaf
Any 1131141(12.5) (10.6,14.5)1129107(9.5) (7.8,11.3)
Mild 1131123(10.9) (9.1,12.8)112992(8.1) (6.6,9.9)
Moderate 1131 18(1.6) (0.9,2.5)112915(1.3) (0.7,2.2)
Severe 1131 0 (0.0,0.3)1129 0 (0.0,0.3)
Grade 4 1131 0 (0.0,0.3)1129 0 (0.0,0.3)
New or worsened muscle
paind
Any 1131477(42.2) (39.3,45.1)1129196(17.4) (15.2,19.7)
Mild 1131187(16.5) (14.4,18.8)1129110(9.7) (8.1,11.6)
Moderate 1131282(24.9) (22.4,27.6)112984(7.4) (6.0,9.1)
Severe 1131 8(0.7) (0.3,1.4)1129 2(0.2) (0.0,0.6)
Grade 4 1131 0 (0.0,0.3)1129 0 (0.0,0.3)
New or worsened joint paind
Any 1131229(20.2) (17.9,22.7)1129107(9.5) (7.8,11.3)
Mild 1131122(10.8) (9.0,12.7)112963(5.6) (4.3,7.1)
Moderate 1131102(9.0) (7.4,10.8)112944(3.9) (2.8,5.2)
Severe 1131 5(0.4) (0.1,1.0)1129 0 (0.0,0.3)
Grade 4 1131 0 (0.0,0.3)1129 0 (0.0,0.3)
Any systemic eventg11311026(90.7) (88.9,92.3)1129726(64.3) (61.4,67.1)
Use of antipyretic or pain
medicationh1131664(58.7) (55.8,61.6)1129176(15.6) (13.5,17.8)
090177e199a7b0df\Approved\Approved On: 18-Mar-2022 11:04 (GMT)
FDA-CBER-2022-5812-0235620
COVID-19 Vaccine (BNT162, PF -07302048)
BLA STN 125742/45
Module 1.11.3 Response to FDA Request for Information
PFIZER CONFIDENTIAL
Page 9Table2. Systemic Events, by Maximum Severity, Within 7 Days After Each Dose –
Subjects 12 Through 15 Years of Age (Reactogenicity Subset) – Safety
Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
12-15 Years 12-15 Years
Dose Systemic Event Nanb(%) (95% CIc)Nanb(%) (95% CIc)
Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e -diary) from Day 1
through Day 7 after each dose. Grade 4 events were classified by the investigator or medically qualified person.
Note: Subject C4591001 1077 10771278 (13 years of age) experienced systemic events, including a temperature of
40.4°C, on the day of Dose 2. Since these events were rec orded as adverse events and not in the e -diary, they do
not appear in this table.
a. N = number of subjects reporting at least 1 yes or no response for the specified event after the specified dose.
b. n = Number of subjects with the specified chara cteristic.
c. Exact 2-sided CI based on the Clopper and Pearson method.
d. Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily
activity; Grade 4: emergency room visit or hospitalization for seve re fatigue, severe headache, severe chills, severe
muscle pain, or severe joint pain.
e. Mild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration; Grade
4: emergency room visit or hospitalization for severe vomiting.
f. Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools
in 24 hours; Grade 4: emergency room visit or hospitalization for severe diarrhea.
g. Any systemic event: any fever ≥38.0°C, any fatigue, any vomiting, any chills, any diarrhea, any headache, any
new or worsened muscle pain, or any new or worsened joint pain.
h. Severity was not collected for use of antipyretic or pain medication.
PFIZER CONFIDENTIAL SDTM Creation: 05OCT 2021 (18:31) Source Data: adfacevd Table Generation:
15MAR2022 (12:27)
(Data Cutoff Date: 02SEP2021, Database Snapshot Date: 27SEP2021) Output File:
./nda2_unblinded/C4591001_S_Peds_RR/adce_s020_se_sev_ped_saf
090177e199a7b0df\Approved\Approved On: 18-Mar-2022 11:04 (GMT)
FDA-CBER-2022-5812-0235621
Document Approval Record
Document Name:
!
Document Title:
!
Signed By: Date(GMT) Signing Capacity
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090177e199a7b0df\Approved\Approved On: 18-Mar-2022 11:04 (GMT)
FDA-CBER-2022-5812-0235622