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Vaccines, Blood & Biologics
Submission Type: BLA Submission ID: 125408/0 Office: OVRR
Influenza Vaccine (MDCK Cells)
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 06-Mar-2012 03:30 PM Initiated by FDA? Yes
1. Information Request
Author: BRENDA BALDWIN
Comments regarding tox study #191-44
FDA Participants: Brenda Baldwin, Timothy Fritz
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Baldwin, Brenda
Sent: Tuesday, March 06, 2012 3:32 PM
To: 'Gollwitzer, Matthew'
Cc: Fritz, Timothy
Subject: 125408 Optaflu - Toxicology questions/comments
We have the following questions/comments regarding the repeat dose toxicity study performed in rabbits (Study # 191-44):
1) You have used SOP 101076-01 to determine the serology of strains A/New Caledonia (H1N1), A/ Panama (H2N3) and B/ Guangdong by (b)(4), please indicate the type of analysis performed and associated performance parameters such as sensitivity, lower limit of quantitation, and reproducibility of this assay.
2) Please provide the site(s) of blood collection for clinical chemistry, hematology and coagulation determinations.
3) The results for strain A/Panama (H2N3) by (b)(4) showed an increase in the titer levels in all treated groups including the control; however, control group animals were not supposed to have been exposed to any test article. Cross contamination with the test article or with samples taken from animals treated with the test article might be the cause of these results. Strict laboratory procedures (e.g., gloves must be changed when processing samples for each group) should be followed to prevent this kind of cross contamination. To ensure the scientific integrity of future studies, we recommend that you institute procedures to preclude the potential for cross contamination with test articles. Please comment.
In your official response to this memo, we recommend that you restate our request and follow it with your response. Use of this format helps organize the relevant information and provides a self-contained document that facilitates future reference. If you have any questions, please contact Dr. Brenda Baldwin or Dr. Timothy Fritz.