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Vaccines, Blood & Biologics

Request for post-marketing safety data for Cervarix, October 2, 2007

To: Ms. Sharon Shapowal
File: STN 125259/0 CERVARIX
RE: Request for post-marketing safety data for Cervarix
Date: October 2, 2007
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.
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.
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.
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., post-marketing safety data from any country where Cervarix is licensed). Please respond.
In your reply to this memo, we recommend that you restate each item and follow it with your explanation or clarification. Use of this format helps organize the relevant information and provides a self-contained document that facilitates future reference.

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