
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 CBERs comments regarding PSCs 2 questions related to the b(4)------------- study. Comments regarding PSCs 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

THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please notify the sender immediately by e-mail or phone.