Influenza A (H5N1) Virus Monovalent Vaccine
ID Biomedical Corporation of Quebec
Telecon Date/Time: 28-Sep-2012 12:24 PM Initiated by FDA? Yes
Telephone Number: 610-787-3435
1. Information Request
Author: CARMEN COLLAZO-CUSTODIO
Comments regarding the Pharmacovigilance Plan for Influenza A (H5N1) Virus Monovalent Vacine (Version 2: July 2012*) provided in the submission of July 18, 2012.
FDA Participants: CARMEN COLLAZO-CUSTODIO
Non-FDA Participants: Michael Schwartz
The following was communicated to GSK via e-mail correspondence:
From: Collazo, Carmen
Sent: Friday, September 28, 2012 12:24 PM
To: Michael Schwartz
Cc: Collazo, Carmen; Wally, Jeremy; Prutzman, Kirk C
Subject: STN 125419-IR request PVP
Dear Dr. Schwartz,
We have the following comments regarding your U.S. Pharmacovigilance Plan (PVP) for Influenza A (H5N1) Virus Monovalent Vaccine (Version 2: July 2012) provided in your July 18, 2012, submission:
1. Sections 188.8.131.52.9 (NARCOLEPSY) and 2.3.2 (IMPORTANT POTENTIAL RISKS) of the PVP do not mention the narcolepsy cases after vaccination with Arepanrix. Please revise these sections accordingly to include these cases.
2. In Section 3.1.1, you stated, “Prior to an officially-declared H5N1 influenza pandemic, routine pharmacovigilance will be performed for Q-Pan H5N1 vaccine.” Please clarify what you mean by routine pharmacovigilance in the context of a vaccine that is going to be in the Strategic National Stockpile, and will not be marketed.
Please submit your responses in an amendment to the BLA submission.
If you have any questions about this communication, please contact Carmen M. Collazo. Thank you!
Carmen M. Collazo-Custodio, Ph.D.
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
1451 Rockville Pike Rm. 2236
Rockville, MD 20852
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