System Info - 105141 SHONE, DEANNA 17-Sep-2009 13:47:16 SHONEDE
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125259/0 Office: OVRR
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
Telecon Date/Time: 05-OCT-2007 06:22 PM Initiated by FDA? Yes
Author: HELEN GEMIGNANI
GSK email RE: postmarketing AE's
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Sharon.W.Shapowal@gsk.com [mailto:Sharon.W.Shapowal@gsk.com]
Sent: Friday, October 05, 2007 6:22 PM
To: Sullivan, Helen M
My team has asked for clarification regarding the FAX of October 2, 2007. I'm attaching a clarifying note back to your team. Please let us know if our interpretation and/or proposal is acceptable.
Thanks and regards,
Director, Adult Vaccines
"EMF <fda.hhs.gov>" made the following annotations.------------------------------------------------------------------------------
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Regarding post-marketing experience for Cervarix, we have the following comments:
1. We request that you provide all adverse events reported internationally post-licensure of Cervarix (e.g., in Australia and European countries) through October 1, 2007 to CBER as soon as possible. We request that you submit this information in Periodic Safety Update Report (PSUR) or similar format. Please respond.
GSK response: Through October 1, 2007, GSK received 4 spontaneous, postmarketing, adverse event reports for Cervarix. We propose submission of the international event forms (CIOMS I), for each report, rather than a PSUR, as the data lock point for the first PSUR will not have been reached.
2. We request that you provide information regarding vaccine lot distribution (i.e., number of doses of Cervarix administered) through Oct. 1, 2007 by country of distribution. Please submit this information to CBER as soon as possible.
GSK response: Agree. In progress.
3. We request that you provide all follow-up information, including (but not limited to) serious adverse events or deaths reported post-marketing of Cervarix internationally. All serious adverse event and death reports after administration of Cervarix received through November 1, 2007 should be provided to CBER in an expedited manner. Please respond.
GSK response: All follow-up information received for the 4 post-marketing events through October 1, 2007 (follow-up information that may be received through November 1, 2007) will be submitted. All post-marketing serious adverse events and/or reports of death from October 1, 2007 through the November 1, 2007 data lock point will be submitted to CBER in a timeframe consistent with the expedited reporting process. Because some of these events may not qualify for expedited reporting (by definition), GSK may not be able to submit all events per U.S. regulatory and international reporting timelines, but will plan to do so as soon after the November 1st data lock point as possible.
4. At the December 12, 2007 VRBPAC meeting, we recommend that you present any available data on post-marketing adverse event experience after administration of Cervarix (i.e., postmarketing safety data from any country where Cervarix is licensed). Please respond.
GSK response: GSK will give consideration to presentation of such data. Very little information is available to date to be able to comment, substantively. At this time, however, we would propose that the data lock point of November 1, 2007 be implemented as the cutoff for the PMS data.