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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, March 7, 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: 07-Mar-2012 01:00 PM        Initiated by FDA? Yes
Telephone Number: ----(b)(4)--------
Communication Categorie(s):
1. Advice
 
Author: TIMOTHY FRITZ
 
Telecon Summary:
SRID testing, samples for CBER testing
 
FDA Participants:                  
Rajesh Gupta
William McCormick
Manju Joshi
Alexander Neverov
Karen Campbell
Catherine Poole
Timothy Nelle
Brenda Baldwin
Timothy Fritz
 
Non-FDA Participants:
Matthew Gollwitzer
Umang Shah
Mark Roache
Jessica Mercer
Jowita Mikolajczyk
Bernard Knapp
Glenn Barbrey
Markus Schweitzer
 
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Telecon Body:
 
CBER held a telecon with Novartis to discuss SRID testing and samples for CBER testing. Below is a list of the issues covered followed by summaries of the discussion.
 
1.     Novartis status on SRID Tests
 
Discussion:
Novartis stated that it had received the CBER reagents for SRID suitability testing but that samples shipped from Marburg to Holly Springs for testing became contaminated while at Holly Springs. An investigation was done and a deviation report regarding the contamination had been completed and closed. Because of the contamination, retesting had to be performed which has caused a delay in sending the SRID suitability report to CBER. Novartis stated that the final report would be ready for submission on or about March 31, 2012.
 
2.     Timing for qualification of egg based reagents and standards for cell based vaccine
 
Discussion:
CBER indicated that, due to time constraints, an interim assessment (in scientific report form) of the SRID assay suitability should be submitted prior to the March 31 submission to allow CBER an opportunity to identify potential problems. Novartis replied that such a report could be provided to CBER near the middle of March, 2012. CBER stated that this interim report should be submitted as an amendment to the Optaflu BLA.
 
3.     CBER comments on Novartis protocol for SRID validation
 
Discussion:
Novartis requested comments regarding the draft protocol. CBER noted that it had not thoroughly reviewed the document, but that it does not provide formal approvals of such documents.  CBER also indicated that it is the responsibility of Novartis to ensure that parameters to be validated are those which pertain to reportable results.
 
4.     OPTAFLU samples for CBER testing 
 
Discussion:
CBER stated that samples for testing should come from formulated bulks, not final containers. Novartis indicated that material from formulated trivalent bulks would not be available until June/July 2012, but that it could provide CBER with monovalent bulks from 2011 process (cleaning) validation studies. These bulks have an expiration dating in the February to April, 2012 time frame. CBER indicated that it could begin its testing on monovalent bulks, but that the samples must be representative of the manufacturing process and that a statement to that effect would need to accompany the samples. CBER recommended that 5 lots of each of 3 strains be submitted for testing. Novartis noted that CBER had requested 3 lots of each of 3 strains in its January 30, 2012, information request, but that it would try to provide the additional lots if available.
 
5.     Draft Lot Release Protocol
 
Discussion:
CBER indicated that Novartis’ draft lot release protocol was unacceptable. CBER suggested that Novartis use its Agriflu Lot Release Protocol as a template but that, since Optaflu is a cell-based vaccine, additional information such as testing on production control cells and viral harvests for mycoplasma and adventitious agents would also need to be provided. Novartis stated that -----(b)(4)---- testing was only performed on filled container, not on formulated trivalent bulks. For the purpose of expedited release of influenza vaccines, CBER suggested that Novartis consider performing ---(b)(4)-- testing on trivalent bulk prior to filling so that CBER could release the trivalent bulk following CBER testing. However, CBER indicated that Novartis could submit an alternative proposal for --(b)(4)--- testing for review. Novartis asked how much material is needed during routine manufacturing for CBER testing. CBER replied that it normally requests 5 to 6 vials (20 mL each vial).
 
CBER recommended that Novartis begin to submit information previously requested by CBER to avoid delay in the review of the BLA.