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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, March 02, 2012 - Flublok

 

Submission Type: BLA    Submission ID: 125285/0    Office: OVRR
Product:
Influenza Vaccine
Applicant:
Protein Sciences Corporation
Telecon Date/Time: 02-Mar-2012 01:08 PM        Initiated by FDA? Yes
Telephone Number: Communication conveyed via e-mail.
Communication Categorie(s):
1. Advice
Author: TIMOTHY FRITZ
Telecon Summary:
Partial advice re PSC's Feb 16 –b(4)- investigation plan.
FDA Participants: Timothy Fritz
Non-FDA Participants: Penny Post
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Telecon Body: From: Fritz, Timothy
Sent:                      Friday, March 02, 2012 1:08 PM
To:                         'Penny Post'
Subject:                 CBER comments for PSC proposed b(4) investigation
 
Importance:           High
Dear Dr. Post-
 
On February 15, 2012, PSC submitted their "b(4) Investigational Plan" in response to CBER's advice dated January 17, 2012 expressing concerns -----b(4)----------------------------------------------- in FluBlok. In addition to the b(4) Investigational Plan, PSC included 3 questions regarding their plan and 1 general question.
 
Below are CBER’s comments regarding PSC’s 2 questions related to the –b(4)------------- study. Comments regarding PSC’s remaining 2 questions will be addressed in a separate communication.
 
PSC Question:
1. Does the Agency find the protocol design of the proposed –b(4)----------- studies suitable for assessing the possible –b(4)--------------------------------------------------------- found in SF+ cells? In particular, --b(4)----------------------------------------------------------------------------------------------------, the controls, and the test articles (including –b(4)----------------) to be used appropriate?
 
CBER RESPONSE:
--b(4)-- ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
--b(4)--- -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
--b(4)--- -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
--b(4)--- -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
PSC Question:
2. Does the Agency agree that negative results from the proposed –b(4)---------- studies will be sufficient to exclude the presence in our cell line of –b(4)--------------------------- that would be a potential risk to vaccine recipients? If not, what additional studies does CBER consider necessary?
 
CBER RESPONSE:
A negative result from the proposed –b(4)--------- studies will be acceptable to demonstrate the –b(4)-----------------------------------------. However, additional studies will be needed to demonstrate the –b(4)--- --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- during –b(4)------------ study (as indicated in Attachment 1, page 4 of 9, item 7.2.1.5). The analysis will –b(4)--- -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
Please contact the Regulatory Project Manager, Dr. Timothy Fritz, at 301-796-2640 if you have additional questions.
 
Thank you,
Timothy A. Fritz, Ph.D.
Microbiologist
FDA/CBER/OVRR/DVRPA/CMC2
WOC2 HFM-478
1451 Rockville Pike
Rockville, MD 20852
Phone: 301-796-2640
Fax: 301-827-1597
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