System Info - 106052 SMITH, MICHAEL J 28-Sep-2009 14:16:31 SMITHM
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125324/0 Office: OVRR
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Wyeth Pharmaceuticals Inc.
Telecon Date/Time: 16-SEP-2009 05:16 PM Initiated by FDA? Yes
Author: MICHAEL SMITH
CBER's response to Safety Study comments contained in 9-16-2009 email (7:59 AM) from Jack Love
FDA Participants: Julienne Vaillancourt and Marthe Bryant
Non-FDA Participants: Love Jack, Carmel Devlin and Edwards Elizabeth
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Vaillancourt, Julienne
Sent: Wednesday, September 16, 2009 5:16 PM
To: 'Love Jack'
Cc: 'Devlin Carmel'; 'Edwards Elizabeth'; Bryant, Marthe
Subject: RE: Safety Study comments
Dr. Bryant has responded to your request for clarification on two items in her September 11, 2009, set of comments concerning the phase 4 safety study, as follows:
In response to your first question, concerning her comment 1(d):
“Grouped events” refers to ALL medically attended events and NOT just the pre-specified events. In one tabulation, the data should be presented by group of related ICD 9 codes. The choice of grouping would be the sponsor's.
In response to your second question, concerning her comment 1(d), first bullet:
The understanding of the sponsor is correct.
Please let me know if you have any other questions.
From: Love Jack [mailto:LOVEJ@wyeth.com]
Sent: Wednesday, September 16, 2009 7:59 AM
To: Vaillancourt, Julienne
Cc: Devlin Carmel; Edwards Elizabeth
Subject: Safety Study comments
Wyeth met internally yesterday to review CBER's comments on the safety study. They plan to meet with Kaiser tomorrow to find out if they are in agreement and can implement these requests. The Wyeth team has two questions shown below that they were not completely certain as to what was being requested and are asking for clarification from CBER. The Wyeth interpretation is shown next to the CBER comment. Is there anyway you can talk this over with Marthe and get back to me today, so that the meeting with Kaiser tomorrow can address these requests appropriately?
Item 1(d), CBER notes: "Please submit two types of tabulations: one with grouped events/ICD-9 codes..." The wyeth team understands these "grouped events" to refer to the pre-specified events previously identified by CBER.
Item 1(d), 1st bullet CBER notes: "For other doses, tabulations need not include events that occurred in the pre-vaccination control window." Wyeth interprets this to mean that the pre-vaccine window will be required for the FIRST dose only; the pre-vaccine window will NOT be utilized in all subsequent doses.
End of email