Document text
From: Smith, Michael (CBER)
Sent: Friday, August 13, 2021 3:40 PM
To: Aghajani Memar, Neda <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>; Harkins Tull, Elisa <[email protected]>; Devlin, Carmel M
<[email protected]>
Subject: RE: [EXTERNAL] RE: STN 125742.0: Three questions f rom the clinical team
Neda,
The clinical team has the below response to your clarification question.
No, that doesn’t address our question #3. Please provide a breakdown of the
subjects by age cohorts (young adults and older adults) who have ≥6 months of
follow -up from Dose 2 to the earlier of discontinuation or the cutoff date,
separately for the Safety and Evaluable Efficacy Populations.
Regards,
Mike
- Please confirm receipt of this e -mail and let us know if you have any
questions.
From: Aghajani Memar, Neda <[email protected] >
Sent: Friday, August 13, 2021 2:22 PM
To: Smith, Michael (CBER) < [email protected] >
Cc: Naik, Ram achandra < [email protected] >; Gottschalk, Laura
<[email protected] >; Harkins Tull, Elisa < [email protected] >; Devlin, Carmel M
<[email protected] >
Subject: RE: [EXTERNAL] RE: STN 125742.0: Three questions from the clinical team
CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you
recognize the sender and know the content is safe.
Dear Mike,
Thank you, I really appreciate it.
Kind regards,
Neda
FDA-CBER-2021-5683-1024781
From: Smith, Michael (CBER) < [email protected] >
Sent: Friday, August 13, 2021 2:18 PM
To: Aghajani Memar, Neda < [email protected] >
Cc: Naik, Ramachandra < [email protected] >; Gottschalk, Laura
<[email protected] >; Harkins Tull, Elisa < [email protected] >; Devlin, Carmel M
<[email protected] >
Subject: RE: [EXTERNAL] RE: STN 125742.0: Three questions from the clinical team
Neda,
I confirm receipt of your e -mail and I will get back to you with a response after the
clinical team discusses the clarification question.
Regards,
Mike
From: Aghajani Memar, Neda < [email protected] om>
Sent: Friday, August 13, 2021 2:03 PM
To: Smith, Michael (CBER) < [email protected] >
Cc: Naik, Ramachandra < [email protected] >; Go ttschalk, Laura
<[email protected] >; Harkins Tull, Elisa < [email protected] >; Devlin, Carmel M
<[email protected] >
Subject: [EXTERNAL] RE: STN 125742.0: Three questions from the clinical team
CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you
recognize the sender and know the content is safe.
Dear Mike,
We are working on the responses to CBER’s clinical information request and have the below clarification
question regarding question 3.
Clarification question on #3 :
Table 9 (shown below) of the 6 -month interim CSR presented summary of follow -up time after Dose 2
for the safety population with age cohort data presented in Tables 14.26 and 14.27. The yellow -
highlighted row represents subjects who have ≥6 months of follow -up from Dose 2 to the earlier of
discon tinuation or the cutoff date combining the blinded placebo- controlled follow -up period and open
label follow -up period. By definition, subjects in this cohort received 2 doses of BNT162b2 and the
follow up time after last dose (Dose 2) is ≥6 months. The bl ue highlighted row shows subjects who have
≥6 months of follow -up from Dose 2 to the earlier of unblinding, discontinuation or the cutoff date
(blinded follow -up period only). Similarly, such subjects received 2 doses and had ≥6 months follow -up
after the last dose.
FDA-CBER-2021-5683-1024782
Please advise if Table 9 and Tables 14.26 and 14.27 in the interim CSR addressed the request.
Follow -up Time After Dose 2 – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg)
(Na=22026)
nb (%) Placebo
(Na=22021)
nb (%) Total
(Na=44047)
nb (%)
Subjects (%) with length of follow -up of:
Origina l blinded pla cebo -controlled follow -up period
<2 Months 1251 (5.7) 1331 (6.0) 2582 (5.9)
≥2 Months to <4 months 7744 (35.2) 8070 (36.6) 15814 (35.9)
≥4 Months to <6 months 11253 (51.1) 11316 (51.4) 22569 (51.2)
≥6 Months 1778 (8.1) 1304 (5.9) 3082 (7.0)
Total exposure from Dose 2 to cutoff date
<2 Months 390 (1.8)
≥2 Months to <4 months 679 (3.1)
≥4 Months to <6 months 8951 (40.6)
≥6 Months 12006 (54.5)
Note: Human immunodeficiency virus (HIV) -positive subjects are included in this summary but analyzed and
reported separately.
a. N = number of subjects in the specified group, or the total sample. This value is the denominator for the
percentage calculations.
b. n = Number of subjects with the specified characteristic.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2 021 (23:24) Source Data: adsl Table Generation:
27MAR2021 (01:37)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output
File: ./nda 2_unblinded/C4591001_BLA/adsl_fu_d2_p3_saf
Kind regards,
Neda
FDA-CBER-2021-5683-1024783