Document text
COVID-19 Vaccine (BNT162, PF -07302048)
BLA STN 125742/45
Module 1.11.3 Response to FDA Request for Information
PFIZER CONFIDENTIAL
Page 1COVID-19 Vaccine (BNT162, PF -07302048; COMIRNATY)
BLA STN 125742/45
Response to CBER IR Regarding
Cumulative Analysis of Post -Authorization Adverse Event Reports in Individuals Aged
Between 12 and 15 Year of Age Received 23 February 2022
01March2022
090177e1997c34ec\Approved\Approved On: 01-Mar-2022 16:03 (GMT)
FDA-CBER-2022-5812-0235491
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 12
through 15 years of age submitted to FDA on 16 Dec 2021 (Sequence number 0211).
On 23 February 202, Pfizer/BioNTech received the following request from the FDA
regarding BLA 125742/45, Module 5.3. from Captain Mike Smith , PhD (CBER) .
The FDA’s request is presented in bold italics followed b y Pfizer/BioNTech’s response i n
plain text.
2.FDA INFORMATION REQUEST
We are reviewing the Cumulative Analysis of Post- Authorization Adverse Event Reports in
Individuals Aged Between 12 and 15 Year of Age (BLA 125742/45, Module 5.3.6, dated
December 1, 2021; received December 16, 2021) a nd have the following information
requests.
2.1.Item 1
The cumulative analysis shows 18 adverse events reports with fatal outcomes among
individuals 12 -15 years of age. Please provide preferred terms and narratives for each of
these fatal reports and indicatehow many and which of the reports were U.S. vs foreign.
Response:
Out of the 3,320 case reports involving individuals 12- 15 years of age, there were 18 case
reports (45 events) with a fatal outcome. Narratives of the 5 case reports originated from the
United States (US) are presented in Appendix 1and those related to the 13 case reports from
foreign countries excluding US are presented in Appendix 2.
The Preferred Terms (PTs) coded in these fatal cases included: Death (9), Sudden death (4),
Pyrexia, Respiratory failure and Septic shock (2 each), Anuria, Asthenia, Blood creatinine
increased, Brain death, Brain hy poxia, Cardiac arrest, Cardiomegal y,Cardio-respiratory
arrest, Circulatory collapse, Coma, Disseminated intravascular coagulation, Dy spnoea,
Headache, Hepatic failure, Inappropriate schedule of product administration, I ntra-abdominal
haemorrhage, Malaise, Multiple organ d ysfunction sy ndrome, Pain in extremity , Pericardial
effusion, Platelet count decreased, Pulmonary haemorrhage, Pulmonary oedema, Status
epilepticus, Thoracic haemorrhage, Urinary bladder haemorrhage (1 each). A fatal clinical
outcome was reported for the PTs Death (9), Sudden death (4), Septic shock (2), Brain
hypoxia, Cardiac arrest, Cardiomegal y, Cardio-respiratory arrest, Circulatory collapse,
Disseminated intravascular coagulation, Multiple organ d ysfunction s yndrome, Pericardial
effusion, Pulmonary haemorrhage, Pulmonar y oedema, Pyrexia, Respiratory failure, and
Thoracic haemorrhage (1 each).
090177e1997c34ec\Approved\Approved On: 01-Mar-2022 16:03 (GMT)
FDA-CBER-2022-5812-0235492
COVID-19 Vaccine (BNT162, PF -07302048)
BLA STN 125742/45
Module 1.11.3 Response to FDA Request for Information
PFIZER CONFIDENTIAL
Page 32.2.Item 2
The cumulative analysis indicates that 1,215 serious reports were received for individuals
12-15 years of age. Please provide the number of serious reports that were U.S. v s. foreign.
Response:
Out of the 1,215 serious case reports, there were 259 case reports originated from the US and
956 case reports originated from foreign countries excluding US.
090177e1997c34ec\Approved\Approved On: 01-Mar-2022 16:03 (GMT)
FDA-CBER-2022-5812-0235493
COVID-19 Vaccine (BNT162, PF -07302048)
BLA STN 125742/45
Module 1.11.3 Response to FDA Request for Information
PFIZER CONFIDENTIAL
Page 43.APPENDICES
Appendix 1.Summary of Post -authorization or Post -approval AE Report: BNT162 b2
12-15 Years of Age with a fatal Outcome
(01 December 2020 through 30 September 2021)-United States
Appendix 2.Summary of Post -authorization or Post -approval AE Report: BNT162b2
12-15 Years of Age with a fatal Outcome
(01 December 2020 through 30 September 2021) -Foreign Countries (Excluding US)
090177e1997c34ec\Approved\Approved On: 01-Mar-2022 16:03 (GMT)
FDA-CBER-2022-5812-0235494
Document Approval Record
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