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Vaccines, Blood & Biologics

Record of Telephone Conversation, October 5, 2012 - Flucelvax

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

Product:
Influenza Vaccine (MDCK Cells)

Applicant:
Novartis Vaccines and Diagnostics, Inc.

Telecon Date/Time: 05-Oct-2012 10:00 AM

Initiated by FDA? Yes

Telephone Number: -----(b)(4)----------

Communication Categorie(s):
1. Advice

Author: TIMOTHY FRITZ

Telecon Summary:
B strain SRID testing

FDA Participants: Rajesh Gupta, Karen Campbell, William McCormick, Brenda Baldwin, Timothy Nelle

Non-FDA Participants: Matthew Gollwitzer, Umang Shah, Manish Vyas, Mark Roache, Daniele Hastings, Brent Harpham, Jessica Mercer, Harold Alterson, Karsten Kattmann, Klaus Diehl, Stefan Knapp, Manfred Brunen

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

  • Novartis stated that only the 3 trivalent bulk lots of Flucelvax submitted to CBER to date would be released. No additional lots were planned for release this season. Novartis said that approximately -(b)(4)- doses of Flucelvax would be produced from these 3 lots.
  • CBER said that the 3 trivalent lots submitted by Novartis had passed SRID testing using the cell–based, B/Wisconsin reagents and that we would share the testing results with Novartis as we do with other sponsors. Because these were the only lots planned for release, CBER said that Novartis could test the lots using either the cell-based, B/Wisconsin reagents or the egg-based, B strain reagents. In the unlikely event that additional lots were planned for release, CBER recommended that they be tested using the B/Wisconsin reagents. Novartis said that, based on the discussion, it would likely not test the 3 lots using the B/Wisconsin reagents and would consult with CBER regarding SRID testing for subsequent influenza seasons.
  • CBER said that it was finalizing the Flucelvax Lot Release Protocol and would provide it to Novartis as soon as possible.

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