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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, January 17, 2012 - Flublok

 

Submission Type: BLA    Submission ID: 125285/0    Office: OVRR
Product:
Influenza Vaccine
Applicant:
Protein Sciences Corporation
Telecon Date/Time: 17-Jan-2012 02:31 PM        Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Advice
Author: TIMOTHY FRITZ
Telecon Summary:
--b(4)------------------ investigation of FluBlok is not complete.
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:                      Tuesday, January 17, 2012 2:31 PM
To:                         Penny Post (penny.post@proteinsciences.com)
Subject:                 CBER comments regarding PSC 09-16-2011 b(4) response
 
Importance:           High
Dear Dr. Post-
 
CBER has reviewed PSC’s September 16, 2011, response to Comment 4 of CBER’s May 27, 2011 Information RequestCBER’s comments are provided below.
 
GENERAL COMMENTS:
PSC has provided responses to CBER comments in the IR letter dated May 27, 2011 and submitted results from PSC’s and –b(4)------------------------------------ studies to address the nature of the –b(4)---------- produced from Spodoptera frugiperda-derived expresSF+ cells and present in the drug product. PSC concludes that the overall results indicate –b(4)-------------------------and therefore no further studies need to be done. We do not agree with this assessment. Our review of the information and data provided in the submission indicates that the results do not resolve the question of whether –b(4)------------------------------------------------------------- and therefore it remains unclear whether the      --b(4)--------- in the product represents a risk to vaccine recipients.
 
We recognize PSC’s efforts to understand the nature of –b(4)---------------. We also acknowledge that insect cell b(4) is a novel area of research with little information regarding its biological properties. Nevertheless, it is critical to either eliminate the –b(4)--- or resolve the nature of the –b(4)----- in the final drug product so that the risk, if any, associated with –b(4)------ can be evaluated. Possible approaches toward resolving this issue might include investigating strategies in the manufacturing processes to –b(4)---------------------- from the final drug product, and/or evaluating potential risk associated with the presence of –b(4)----------------. CBER is willing to have further scientific discussions to help understand and resolve this issue. Specific comments related to the data provided by PSC (Amendment 47, September 16, 2011) in response to CBER’s comment 4 in the IR letter dated May 27, 2011 are listed below.
 
 
SPECIFIC COMMENTS TO PSC’s RESPONSES TO CBER IR LETTER COMMENT 4:
 
--b(4)-----------
 
--b(4)----------------------------------------------------------------------------------------------------------------. 
 
--b(4)------------------------------------------------- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
COMMENTS: The results are acceptable.
 
 
b. Submit results of ongoing studies on concentrated drug product samples.
 
----b(4)--- ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- --b(4)----- -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
--b(4)----- ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
--b(4)--- -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
--b(4)---- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
 
Evaluation of SF+ cell substrate –b(4)-------
 
a. Submit the results on –b(4)----- ---------------------------------------------------------------------------------------------
 
--b(4)--- -------------------------------------------------------------- completed their investigation and submitted a final report in Appendix 2. They analyzed –b(4)------- from
 
 
1 Page determined to be not releasable: b(4)
 
 
   
--b(4)---- --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
--b(4)---- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
--b(4)--- --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
--b(4)-- -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
--b(4)--- ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
If you have any questions, please contact the Regulatory Project Manager, Dr. Timothy Fritz, at 301-796-2640.
 
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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