
Record of Telephone Conversation, September 17, 2012 - Flucelvax


 

Submission Type: BLA    Submission ID: 125408/0    Office: OVRR

Product:

Influenza Virus Vaccine

Applicant:

Novartis Vaccines and Diagnostics, Inc.

Telecon Date/Time: 17-Sep-2012 04:00 PM        Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):

1. Advice

 

Author: TIMOTHY NELLE

Telecon Summary:

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

 

Telecon Body:

 

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.