Document text
From: Smith, Michael (CBER)
Sent: Wednesday, January 19, 2022 5:30 PM
To: Mineo, Gosia
Cc: Collins, Kathleen Mary Catherine ; Naik, Ramachandra
<[email protected]>; Gottschalk, Laur a <[email protected]>; Harkins Tull,
Elisa <[email protected]>; Devlin, Carmel M <[email protected]>; Stafford, Adrienne
Kaye <[email protected]>
Subject: RE: [EXTERNAL] STN 125742/45: IR RE the datasets for adolescents 12 through 15 Years of Age
Gosia, Thank you, please submit an amendment to the supplement by Wednesday, February 2
nd with your
response. Regards, Mike
From: Mineo, Gosia
Sent: Wednesday, January 19, 2022 5:28 PM
To: Smi
th, Michael (CBER) < [email protected] >
Cc: Collins, Kathleen Mary Catherine ; Naik, Ramachandra
<Ramachand r [email protected] >; Gottschalk, Laura <[email protected] >; Harkins Tull,
Elisa < [email protected] >; Devlin, Carmel M < [email protected] >; Stafford, Adrienne
Kaye < [email protected] >
Subject: Re: [EXTERNAL] STN 125742/45: IR RE the datasets for adolescents 12 through 15 Years of Age
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Hi Mike - I confirm receipt of the below communication.
Thank you,
Gosia
On Jan 19, 2022, at 5:07 PM, Smith, Michael (CBER) < [email protected] > wrote:
Kate,
The review team has the below informati on request for STN 125742/45 IR RE the
datasets for adolescents 12 through 15 Years of Age
Michael J.
Smith -S4Digitally signed by Michael J. Smith -S4 DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=0014080934, cn=Michael J. Smith -S4 Date: 2022.01.20 11:35:26 -05'00'
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0500310
1.There are 2 subjects (10961068 and 11631062) with AE records that have
AEACN = DRUG WITHDRAWN, but they only have COMPLETED records in
DS. Please explain.
2.We have found that subject 11311279 was included in SDTM DM but not
ADSL. Please explain.
3.As previously communicated and discussed under BLA 125742 and other
BLAs/INDs reactogenicity events that begin within the prespecified assessment
period should have been reported in FACE and summarized with the subject diary data in CE. Since this was not implemented, we request that:
a.reactogenicity events that begin within the prespecified assessment period
that are currently reported in the AE dataset be included in FACE, and
then be flagged in AE so that we know that it is being included in the
FACE dataset.
b.Include all individual supporting a ssessments (daily e-diary and any
unplanned assessments) and the assessor for each finding (identified
using FAEVAL=STUDY SUBJECT or INVESTIGATOR) in the FACE domain.
c.Maintain one row per subject/vaccinat ion/symptom in the CE domain, with
CE summarizing the duration of the event and maximum severity. Maximum severity (CESEV) should be based on the highest-level severity reported by the subject (via e-diary) or investigator (in the unplanned
assessment CRF).
d.Use SUPPCE CESEV1 and CEDIFFRS to show assessment of severity
by study subject and reason investigator ’s assessment of severity differed
from study subject as needed for events reported in CE.
e.Update the analysis dataset(s) with records covering the entire event
duration (which could go beyond the pr otocol-defined a ssessment period)
with start/end dates and durations ( based on first and last days the
symptom was present as recorded in the e-diary and/or Symptom
Resolved Dates CRF) derived from both the e-diary and CRF data.
Regards,
Mike
-Please confirm receipt of this request and let us know if you have any questions.
Mike Smith, Ph.D.
Captain, USPHS
Senior Regulatory Review Officer
Food and Drug Administration
FDA-CBER-2022-5812-0500311
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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FDA-CBER-2022-5812-0500312