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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, February 20, 2013 - 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: 20-Feb-2013 10:24 AM        Initiated by FDA? Yes

Telephone Number: 610-787-3435

Communication Categorie(s):
1. Advice

Author: CARMEN COLLAZO-CUSTODIO

Telecon Summary:
Comments regarding leachables studies

FDA Participants: Carmen Collazo-Custodio, Jeremy Wally, Kirk Prutzman

Non-FDA Participants: Michael Schwartz, Jillian Horvath

Telecon Body:
The following was provided to GSK via e-mail correspondence:

 

______________________________________________
From:                     Collazo, Carmen 
Sent:                      Wednesday, February 20, 2013 10:24 AM
To:                          Michael Schwartz; Jillian Horvath
Cc:                          Collazo, Carmen; Wally, Jeremy; Prutzman, Kirk C
Subject:                STN 125419 - recommendation on leachables studies
Importance:        High

Dear Dr. Schwartz,

We have the following comments regarding leachables studies:
1. You propose to store the H5N1 –b(4)------------------------- for –b(4)---------------------------------------------------- While you provided stability data for –b(4)--, the data from extractables studies for these –b(4)---------------- are limited (up to a maximum of 6 months).  These data are insufficient to draw any conclusions about the leachables profile of these –b(4)---- for –b(4) storage for the proposed shelf life of –b(4)-----. 

We recommend that the leachables studies be carried out in presence of the –b(4) for the length of the proposed shelf life and that you provide these data to us as they become available.  Such studies can be part of the ongoing long term stability studies for the H5N1 –b(4) in the –b(4)------------------.  As an additional control, we recommend that you also include newly filled –b(4)------------------- with H5N1 antigen –b(4) and/or monovalent seasonal influenza virus vaccine.

2. The H5N1 formulated drug product will be stored in final container glass vials for 3 years. While the data provided support the stability of the H5N1 formulated drug product up to 36 months, the E/L studies for the H5N1 formulated drug product stored in these glass vials have been performed up to a maximum of 12 months.  We noted that        --b(4)------------------------------------------------------- were detected in these studies. These data are insufficient to draw any conclusions about the leachables profile of these final container glass vials for the proposed shelf life of 36 months. 

We recommend that leachables studies be carried out in these glass vials in the presence of the H5N1 drug product for the length of the proposed shelf life as part of the ongoing long term stability studies for the H5N1 final container lots.  As controls, we recommend that you also include newly filled container vials with H5N1 antigen DP and/or monovalent seasonal influenza virus vaccine.

Please consider submitting protocols for the above studies to BB-IND 13413 for our review and concurrence. 

Regards,

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