Record of Telephone Conversation, September 17, 2012 - Flucelvax
Submission Type: BLA Submission ID: 125408/0 Office: OVRR
Influenza Virus Vaccine
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 17-Sep-2012 04:00 PM Initiated by FDA? Yes
Author: TIMOTHY NELLE
Reagents for testing of 2012-2013 vaccine
FDA Participants: Rajesh Gupta
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
CBER stated that they agree with the use of homologous H3N2 egg-based reagents; however, CBER does not recommend the use of heterologous reagents for B strain. This is based on CBER’s experience with discrepant results when heterologous reagents were used during the H1N1 pandemic.
While heterologous reagents for the H1N1 strain were re-calibrated by CBER, Novartis refused to test this year’s vaccine with the homologous B strain reagents, available from NIBSC. This caused a concern, particularly when Novartis has been using the homologous B strain reagents for releasing vaccine in Europe.
Novartis argued that they did not know if they could use reagents from NIBSC.
To move forward with this issue, CBER decided to test all lots with the homologous reagents B strain reagents for lot release at CBER.