
Record of Telephone Conversation, September 25, 2012 - Q-Pan

 

 
Submission Type: BLA Submission ID: 125419/0 Office: OVRR

Product: Influenza A (H5N1) Virus Monovalent Vaccine

Applicant: ID Biomedical Corporation of Quebec

Telecon Date/Time: 25-Sep-2012 09:22 AM Initiated by FDA? Yes

Telephone Number: Email

Communication Categorie(s):
 1. Information Request
 2. Advice

 Author: Jeremy Wally

Telecon Summary: IR/Comments Regarding SRID, VRBPAC and Proper Name

FDA Participants: Jeremy Wally

Non-FDA Participants: Michael Scwartz

Trans-BLA Group: No

 Related STNs: None

Related PMCs: None

Telecon Body:
 The following was emailed to the sponsor:

From: Wally, Jeremy 
Sent: Tuesday, September 25, 2012 9:22 AM
To: 'michael.p.schwartz@gsk.com'
Subject: STN 125419 Information Request and Recommendations

Dear Dr. Schwartz,

We have the following comments and questions regarding information provided on the SRID assay in Section 3.2.R of the original BLA submission for STN 125419:
1.For VR010 Radial Immunodiffusion for Low HA-concentration Influenza Vaccine- 9000018734-VO8, the SOP states, -------------------------------------------------------------------------------------------------------------(b)(4)---------------------------------------------------." Please clarify the following in your SOP: 

- Please clarify what is meant by “at least three tests” and describe any instances when more than 3 tests are performed.
- Please provide the specifications for potency value and standard deviation (SD) for any cases when more than 3 tests are used to calculate results.
- Please describe how the out of specification results are handled and additional testing performed if the calculated potency value from the initial 3 tests is out of specification.
- Please specify the potency specifications (along with SD) for ---(b)(4)--- final container vaccine based on the number of tests performed.

2. For HA Content Summarized SOP 9000018772, the SOP states, ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- No specification is described regarding the standard deviation for the calculated results. Please include these specifications in the SOP and submit the revised SOP.

We have the following additional comments:
3. We note that in the amendment of September 14, 2012, containing responses to our Information Request of July 30, 2012, you state on page 1 that “Responses to the remainder of the questions will be submitted as they become available.” Please advise us on when you will be submitting a response to Question 4.
4. We refer to your e-mail of August 7, 2012, in which you asked CBER about presenting supportive data from studies Q-Pan H1N1-035 and FLU Q-QIV-006 during the VRBPAC meeting scheduled for November 14, 2012. We agree that you can provide summaries of these studies during your VRBPAC presentation if you acknowledge that these data are still under review by the FDA or will be submitted for review to the FDA, as appropriate.
5.We refer to the March 1, 2012, communication in which CBER stated our agreement with the proposed proper name provided in the BLA. After further consideration, we ask that you please revise the proper name as follows: "Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted".

Please respond in an amendment to the BLA and feel free to contact me if you have any questions.

Thanks, 
 Jeremy

Jeremy L. Wally, Ph.D., M.A., ASQ CQPA
 LCDR, U.S. Public Health Service
 Senior Regulatory Review Officer
 Food and Drug Administration
 Center for Biologics Evaluation and Research
 Office of Vaccines Research and Review
 Division of Vaccines and Related Product Applications
 1451 Rockville Pike
 Rockville, MD 20892-1448 
 Tel: 301-796-2640
 Fax: 301-827-3532
 jeremy.wally@fda.hhs.gov

U.S. Public Health Service Rapid Deployment Force PHS-2 ("Second to None") Planning Section, Documentation Branch Staff

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