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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, October 10, 2012 - Q-Pan


Submission Type: BLA    Submission ID: 125419/0    Office: OVRR

Product:
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

Applicant:
ID Biomedical Corporation of Quebec

Telecon Date/Time: 10-Oct-2012 12:51 PM        Initiated by FDA? Yes

Telephone Number: 610-787-3435

Communication Categorie(s):
1. Information Request

Author: CARMEN COLLAZO-CUSTODIO

Telecon Summary:
Comments regarding the Pharmacovigilance Plan

FDA Participants: Jeremy Wally, Kirk Prutzman, Carmen Collazo

Non-FDA Participants: Michael Schwartz

Telecon Body:
The following was communicated to GSK via e-mail correspondence.
______________________________________________
From:                     Collazo, Carmen 
Sent:                      Wednesday, October 10, 2012 12:51 PM
To:                          Michael Schwartz
Cc:                          Wally, Jeremy; Prutzman, Kirk C; Collazo, Carmen
Subject:                IR request PVP
Importance:        High

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. In section 3.1.3.1.2. PREGNANCY REGISTRY, you stated, "GSK Biologicals proposes to obtain data regarding vaccine use during pregnancy from existing pregnancy registries.  Please clarify what you mean by existing registries.
  2. In section 3.1.2.2.2. FREQUENCY OF SUBMISSION, you stated: "When it has been agreed by the CHMP that the simplified PSUR is no longer necessary, a full PSUR prepared in the format endorsed by the International Conference on Harmonization (ICH) and covering the entire pandemic period, will be submitted."  Please revise the statement to say, "When it has been agreed by the CHMP and the FDA that the simplified PSUR is no longer necessary, a full PSUR prepared in the format endorsed by the International Conference on Harmonization (ICH) and covering the entire pandemic period, will be submitted."

3.   You indicated that in the event that a pandemic is officially declared, you will work with the CHMP in an urgent manner to develop tailored pharmacovigilance activities based on CHMP guidelines.  We ask that you please communicate with the US FDA promptly regarding the modified pharmacovigilance activities (i.e., at the same time as you discuss with the CHMP and European countries for the PV activities during a pandemic).
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
Office location:
1451 Rockville Pike  Rm. 2236
Rockville, MD 20852

Tel. 301-796-2640
Fax: 301-827-3532
E-mail address: carmen.collazo@fda.hhs.gov

Mailing address:
Center for Biologics Evaluation and Research
Document Control Center HFM-481
1401 Rockville Pike
Rockville, MD 20852-1448