Document text
From: Smith, Michael (CBER)
Sent: Friday, June 25, 2021 6:09 PM
To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda
<[email protected]>; Devlin, Carmel M <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>
Subject: STN 125742.0: Clinical IR RE document titled “bnt162- 01-interim3 -report -body”
Elisa,
The clinical team has the attached IR regarding the document titled “bnt162 -01-
interim3- report -body”. Please provide a response by July 2, 2021.
Regards,
Mike
- Please confirm receipt of this e -mail and let us know if you have any
questions.
Mike Smith, Ph.D.
Captain, USPHS
Senior Regulatory Review Officer
Food and Drug Administration Center for Biologics Evaluation & Research
Office of Vaccines Research & Review
Division of Vaccines and Related Products Applications
Tel: 301- 796- 2640
[email protected]
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received this document in e
FDA-CBER-2021-5683-1024681
We have the following comment regarding the document titled “bnt162 -01-interim3 -report-
body”:
We note that possible numerical inconsistencies in Table 14.3.1 -1.3-3 page (1241/2151) titled
“Frequency of subjects with solicited local reactions by grade - BNT162b2” for the older
subjects enrolled in BNT162-01 who received 30 mcg dose of the investigational produc t.
Please clarify and provide summary tables for the cohorts (older and younger subjects) who
received 30 mcg dose of BNT162 for both solicited local and systemic adverse reactions. In the
table , please present solicited AEs (local and systemic) for the 7 days following each 30 mcg
dose of the investigational vaccine.
A suggested format for the summary table is below .
Please provide a response by 2 July 2021.
Table XX: Solicit ed Local Reactions by Grade in Subjects XX -XX years of age who received BNT162b2 30
ug (N = 12) .
BNT162b2 30 ug
Dose 1
Na=
nb (%) BNT162b2 30 ug
Dose 2
Na=
nb (%)
Redness
Any (>2.0 cm)
Mild
Moderate
Severe
Swelling
Any (>2.0 cm)
Mild
FDA-CBER-2021-5683-1024682
BNT162b2 30 ug
Dose 1
Na=
nb (%) BNT162b2 30 ug
Dose 2
Na=
nb (%)
Moderate
Severe
Pain at the injection site
Any
Mild
Moderate
Severe
Table YY: Solicited Systemic Reactions by Grade in Subjects XX -XX years of age who received BNT162b2
30 ug (N = 12) .
BNT162b2 30 ug
Dose 1
Na=
nb (%) BNT162b2 30 ug
Dose 2
Na=
nb (%)
Fever
≥38.0℃
≥38.0℃ to 38.4℃
>38.4℃ to 38.9℃
>38.9℃ to 40.0℃
>40.0℃
Fatigue
Any
FDA-CBER-2021-5683-1024683
BNT162b2 30 ug
Dose 1
Na=
nb (%) BNT162b2 30 ug
Dose 2
Na=
nb (%)
Mild
Moderate
Severe
Headache
Any
Mild
Moderate
Severe
Chills
Any
Mild
Moderate
Severe
Vomiting
Any
Mild
Moderate
Severe
Diarrhea
Any
Mild
Moderate
Severe
FDA-CBER-2021-5683-1024684
BNT162b2 30 ug
Dose 1
Na=
nb (%) BNT162b2 30 ug
Dose 2
Na=
nb (%)
New or worsened muscle pain
Any
Mild
Moderate
Severe
New or worsened joint pain
Any
Mild
Moderate
Severe
Use of antipyretic or pain medicationf
FDA-CBER-2021-5683-1024685