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Vaccines, Blood & Biologics

Record of Telephone Conversation, February 8, 2013 - Q-Pan

Submission Type: BLA

Submission ID: 125419/0

Office: OVRR

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

ID Biomedical Corporation of Quebec

Telecon Date/Time: 08-Feb-2013 04:21 PM Initiated by FDA? Yes

Telephone Number: 610-787-3435

Communication Categorie(s):
1. Advice


Telecon Summary:
Extractables and Leachables studies for the ---(b)(4)--- are limited and the data are insufficient to draw any conclusions about the appropriateness of these (b)(4) for ----(b)(4)------ storage.

FDA Participants: Carmen Collazo, Jeremy Wally, Prutzman, Kirk C

Non-FDA Participants: Michael Schwartz, Jillian Horvath

Telecon Body:
The following draft comments were provided to GSK via e-mail correspondence:

From: Collazo, Carmen
Sent: Friday, February 08, 2013 4:21 PM
To: Collazo, Carmen; 'Michael Schwartz'; Jillian Horvath
Cc: Wally, Jeremy; Prutzman, Kirk C
Subject: RE: STN 125419/0 Q-PAN - Confirmed conference call scheduled for Monday, February 11th at 2 PM
Importance: High

Dear Mike,

Please see draft comments below. Please use these comments in preparation for our discussion scheduled for February 11th at 2 PM. Thank you!


Extractables and Leachables (E/L):

The primary container system for storage of the H5N1 antigen ----(b)(4)------------) is --------(b)(4)---------------------- (approved for use in FluLaval seasonal influenza vaccines), the --------(b)(4)----------------------------------.

The final report containing the extractables and leachables data summarized in the submission for the ----(b)(4)------------------was provided in Amendment 26, February, 1, 2013.

Regarding study ---------(b)(4)------------------ Extractables Analysis, ----(b)(4)------- was identified as the major extractable, and low amounts of --------------------------------------------------------------(b)(4)-------------------------------- were identified, within -----(b)(4)-----------------------------------------. These extractable levels increased in water from ------(b)(4)-------- when stored at ------(b)(4)------.

The final report for a Controlled Extractables Study to compare the ------------------(b)(4)------------------------------ was also provided.

In this study, ---(b)(4)------ was detected in every sample extract and was the most abundant compound in each (b)(4) extract. Its concentration was higher (3-5 fold) in the ----(b)(4)- extracts from ---(b)(4)------ compared to ---(b)(4)--. Also the degradation product of -------------------------------------------(b)(4)------------------------------------------------------------------- extract from the ---(b)(4)------- when compared to ---(b)(4)----. In the ----(b)(4)------- analysis for the water solutions, ------------------(b)(4)--------------------------------- were detected in the ---------(b)(4)--.

Data on leachables were not provided for ---(b)(4)-----.

Reviewer’s comments:
You propose to store the H5N1 ---(b)(4)-------- for at least -(b)(4)- in these storage (b)(4). Since the E/L studies for this ---(b)(4)---- are limited (only -----(b)(4)------------ and ----------(b)(4)------------------------), these data are insufficient to draw any conclusions about the appropriateness of these ---(b)(4)----- for ---(b)(4)--- for the proposed shelf life.

We have the following comment:
We recommend that the leachables studies be carried out in presence of the ---(b)(4)---------- for the length of the indicated shelf life. Such studies can be part of the long term stability studies for the H5N1 (b)(4) in the --------(b)(4)----------. These leachable studies using ----(b)(4)----- should be compared with (b)(4) stored in the ---(b)(4)------- under similar conditions and storage times. As an additional control, it is advisable to use newly filled ------(b)(4)----------- with H5N1 antigen (b)(4) and/or monovalent seasonal influenza vaccine.

Carmen M. Collazo-Custodio, Ph.D.
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
WOC2 RM2236 HFM-481
1451 Rockville Pike
Rockville, MD 20852

Tel. 301-796-2640
Fax: 301-827-3532
E-mail address:

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