• 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, April 3, 2012 - Flublok

 

Submission Type: BLA    Submission ID: 125285/0    Office: OVRR
Product:
Influenza Vaccine
Applicant:
Protein Sciences Corporation
Telecon Date/Time: 03-Apr-2012 04:25 PM        Initiated by FDA? Yes
Telephone Number: Communication conveyed via e-mail
Communication Categorie(s):
1. Advice
Author: TIMOTHY FRITZ
Telecon Summary:
Remaining advice for PSC Feb 15, 2012 questions.
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, April 03, 2012 4:25 PM
To:                         'Penny Post'
Subject:                 CBER Response to PSC February 15, 2012, Questions 3 and 4.
 
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 regarding –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 question #3 related to the –b(4)-------- study and general question #4. Comments regarding the –b(4)-------- studies have already been provided (CBER communication provided via e-mail on March 2, 2012).
 
PSC Question:
3. Does the Agency agree that the –b(4)-------- assay improvements described here will provide an acceptable level of detection of –b(4)-- to assess its presence or absence in FluBlok?
 
CBER RESPONSE:
You have agreed to improve the sensitivity of the –b(4)-------- assay by using a –b(4)----------- approach to evaluate –b(4)------------------------------------------------------------------------------ FluBlok Drug Product equivalent to 3 doses (representing 3 x 135 µg formulated rHA).
 
We have the following comment with regard to enhancing detection of –b(4)------------------------ in FluBlok. We agree that using –b(4)--------------------------------------------------------- -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
Additional comments:
 
--b(4)---- ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
--b(4)--- ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
PSC Question:
4. Does the Agency agree that the studies proposed in this document adequately assess the potential risk associated with the presence of –b(4)------ in FluBlok? If not, could the Agency please specify in detail what would be required to address this concern?
 
CBER RESPONSE:
 
On March 2, 2012 (e-mail from Timothy Fritz of CBER to Penny Post of PSC) in response to question 1, we provided advice on the methodology of the –b(4)---- studies ---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
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.