• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Section Contents Menu

Vaccines

Record of Telephone Conversation, July 9, 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: 09-Jul-2012 04:52 PM        Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Advice
 
Author: BRENDA BALDWIN
Telecon Summary:
Seed virus submission information
FDA Participants: Brenda Baldwin
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
E-mail Body:
From: Baldwin, Brenda [mailto:Brenda.Baldwin@fda.hhs.gov]
Sent: Monday, July 09, 2012 4:52 PM
To: Gollwitzer, Matthew
Subject: 125408
Sensitivity: Confidential
 
Hi Matt,
 
Regarding the questions you raised in your July 6, 2012 e-mail, I have a response to 2 of the questions thus far and a need for clarification from 1 of your questions:
 
The package insert will not be further revised until after you submit your revised package insert. You do not need to apply for a permit for sending virus to CBER, but should include the attached permit in the package. The package should be sent to:   Dr. Vladimir Lugovtsev
                        Laboratory of Respiratory Viruses
                        CBER/FDA
                        8800 Rockville Pike,
                        Bldg. 29A, Room 2B17
                        HFM-463
                        Bethesda, MD 20892, USA
Please clarify if you are sending the trivalent bulk from the 2011/2012 formulation or the 2012/2013 formulation, or if you are sending monovalent strains for the 2012/2013 formulation.
 
Regards,
Brenda

From: Gollwitzer, Matthew [mailto:matthew.gollwitzer@novartis.com]
Sent: Thursday, July 12, 2012 1:04 PM
To: Baldwin, Brenda
Subject: RE: 125408
Sensitivity: Confidential
Hi Brenda,
 
Thank you for sending the permit and information below.  Also to answer your question, we will be sending trivalent and monovalent strains for the 2012/2013 formulation.
 
Kind Regards,
 
Matt

 
From: Baldwin, Brenda [mailto:Brenda.Baldwin@fda.hhs.gov]
Sent: Thursday, July 12, 2012 1:58 PM
To: Gollwitzer, Matthew
Subject: RE: 125408
Sensitivity: Confidential
 
Hi Matt,
 
I understand that the monovalents will be sent in soon.  Do you have an estimated date when the trivalent bulk will be sent to CBER?
 
Regards,
Brenda
 

From: Gollwitzer, Matthew [mailto:matthew.gollwitzer@novartis.com]
Sent: Friday, July 13, 2012 7:22 AM
To: Baldwin, Brenda
Subject: RE: 125408
Sensitivity: Confidential
Hi Brenda,
 
Just following up on yesterday’s email, it looks like one lot of trivalent bulk will be ready late August followed by the other two lots in early September.  I’m not sure if the manufacture can be expedited, but let me know if you foresee any issues with the timeline.
 
Kind Regards,
 
Matt

From: Gollwitzer, Matthew [mailto:matthew.gollwitzer@novartis.com]
Sent: Wednesday, July 18, 2012 3:21 PM
To: Baldwin, Brenda; Fritz, Timothy
Subject: 125408 - USDA permit for Seed Virus Shipment?
Sensitivity: Confidential
Hello,
 
A couple weeks back you sent me a CDC permit for the shipment of the seed virus.  Would you happen to have a USDA permit as well?  We tried to ship the seed virus and the courier refused to ship because we didn’t have a USDA permit.    I have applied for USDA permits in the past (for delivery of FLUAD to US) and it took 6-8 weeks to obtain it.   Please let me know when you get a chance.  If you have one, we will try to reship next Monday.
 
Kind Regards,
 
Matt
 

From: Fritz, Timothy
Sent: Thursday, July 19, 2012 10:55 AM
To: 'Gollwitzer, Matthew'
Cc: Baldwin, Brenda
Subject: RE: 125408 - USDA permit for Seed Virus Shipment?
Sensitivity: Confidential
Hi Matt-
 
It is not clear to us that a USDA permit is required (since the seeds are grown in MDCK cells) and we do not have the appropriate permit available.  Our best recommendation would be to try to use a different courier.  Please keep us informed of the outcome.
 
Thanks,
Tim