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 1
COVID-19 Vaccine (BNT162, PF -07302048; COMIRNATY)
BLA STN 125742/45
Response to CBER Information Request of 07 March Regarding Immunobridging
Data and Updated Safety Data for Adolescents 12 Through 15 Years of Age
11March 2022
090177e19995f282\Approved\Approved On: 11-Mar-2022 12:15 (GMT)
FDA-CBER-2022-5812-0235605
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 I nformation Request received from CBER on 07 March 2022.
Below, the requests are shown in bold italics followed b y Pfizer/BioNTech’s response in
plain text.
2.REQUESTS
2.1.Request 1
The submitted immunobridging data (adolescents 12 through 15 years of age vs. young
adults 16 through 25 years of age in Study C4591001) with an estimated geometric mean
titer ratio of 1.76 and a seroresponse rate difference of - 2.1% appear to be based on an
LLOQ of 20. Please confirm whether the assay LLOQ has been revis ed to 41. Please
provide updated immunobridging analysis results (i.e., geometric mean titer ratio and
seroresponse rate difference) as appropriate.
Response
The previousl y submitted immunobridging analyses werebased on an LLOQ of 20 .
Newanalyses using t he updated LLOQ of 41have been completed and are included with this
response(see Appendix 1). A track changes version of the table is also provided, which
showsthe changes to the data that resulted from using a different LLOQ (see Appendix 2 ).
The geometric mean ratio (GMR), previousl y 1.76 (95% CI : 1.47, 2.10) is now 1.77 (95%
CI: 1.50, 2.09), and the seroresponse rate difference , previousl y -2.1%(95% CI: -6.0%,
0.9%),isnow0.4%(95% CI: -4.2%, 5.5%) . Thechanges to these values are not clinicall y
significant and do not alter the conclusions of the respective analyses.
Appendix 1. Immunobridging data –Adolescents 12 through 15 years of age vs. young adults 16
through 25 years of age in Study C4591001 –Analyses based on an LLOQ of 41
Appendix 2. TRACKED CHANGES VERSION -Immunobridging data – Adolescents
12through 15 years of age vs. young adults 16 through 25 years of age in Study C4591001 –
Analyses based on an LLOQ of 41
090177e19995f282\Approved\Approved On: 11-Mar-2022 12:15 (GMT)
FDA-CBER-2022-5812-0235606
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.Request 2
Please clarify whether additional solicited adver se reaction data for adolescents
12through 15 years of age in Study C4591001 have been collected up to the September 2,
2021 data cutoff since EUA issuance. Please submit updated solicited adverse reaction
frequencies as appropriate, annotating any change s to the results.
On 08 March 2022, Captain Michael Smith clarified that the comment pertains to
reactogenicity data collected in the e -diary, as presented in Tables 5 and 6 of the draft
package insert.
Response
No additional reactogenicity data (e-diary data) have been collected for adolescents
12through 15 years of age bey ond those provided in the EUA amendment . Per protocol,
participants 12through 15 y ears of age who had been randomized to placebo and crossed
over to receive open -label BNT162b2 did not complete the e -diary. For these participants,
any reactogenicit y events were to bereported as adverse events.
090177e19995f282\Approved\Approved On: 11-Mar-2022 12:15 (GMT)
FDA-CBER-2022-5812-0235607
Document Approval Record
Document Name:
!
"
"
"#"" "$"% &
Document Title:
!
"
"
"#"" "$"% &
Signed By: Date(GMT) Signing Capacity
' %
()% #" $"&**+ ,
"# -"#
090177e19995f282\Approved\Approved On: 11-Mar-2022 12:15 (GMT)
FDA-CBER-2022-5812-0235608