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Record of Telephone Conversation - May 11, 2009 - Prevnar 13
System Info - 101580 SHONE, DEANNA 06-Aug-2009 16:18:34 SHONEDE
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125324/0 Office: OVRR
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Wyeth Pharmaceuticals Inc.
Telecon Date/Time: 11-MAY-2009 01:00 PM Initiated by FDA? Yes
Author: COLLEEN SWEENEY
RE: Telecon with Wyeth regarding serotype 6B (b)(4)
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
DEPARTMENT OF HEALTH & HUMAN SERVICES
DATE: May 11, 2009
TIME: 1:00 – 1:30 PM EASTERN
Sponsor: Wyeth Pharmaceuticals, Inc.
Product: 13VPnC: Pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19a, 19F, and 23F conjugated to cross-reacting material (CRM 197).
Subject: Clarification of serotype 6B ------(b)4)------------- specification.
Tina Khoie, M.D., M.P.H.
Julienne Vaillancourt, R.Ph., M.P.H.
Mike Smith, Ph.D.
John Cipollo, Ph.D.
Colleen Sweeney, M.S.
Jack Love, Ph.D.
Emilio Emini, Ph.D.
On May 11, 2009, CBER contacted Wyeth regarding conflicting information for the specification, ------(b)(4)--------------- of --(b)(4)-- saccharide, for serotype 6B bulk conjugate. The following items were discussed:
Your BLA submission indicates two different specifications for serotype 6B (b)(4)specifications. In section 3.2.S.2, page 8, you list the specification for ---(b)(4)--- However, in section 2.3.S, page 36, you list the specification as (b)(4). Please clarify the (b)(4) for specification for --(b)(4)-- 6B conjugates for 13vPnC commercial manufacture.
In the Prevnar license we had submitted an application to change the specification from (b)(4) to (b)(4); however, CBER requested that the upper limit of the range not exceed(b)(4). So we agreed on the upper limit of(b)(4)and that is why we propose a specification range of (b)(4)
for serotype 6B (b)(4) for the 13vPnC. This is summarized in the BLA submission.
Both CBER and Wyeth referred to the pages indicated by Wyeth regarding this reference summary and CBER concluded that the information provided was not explicitly clear. Wyeth agreed to submit a more detailed summary for methods of validation for -----(b)(4)------ for 6B –(b)(4)-- polysaccharides.
Please confirm that no out of specification clinical lot 6B for (b)(4) were used in the final product lots for clinical use.
Wyeth clarified that no serotype 6B bulk conjugate lots, which exceeded the (b)(4) specification, would be used in the further manufacture of final product.
Wyeth agreed to provide this in writing.
Wyeth will submit an amendment to the BLA with the following information:
- A detailed explanation of the identified discrepancies in the BLA concerning (b)(4) for serotype 6B.
- Written confirmation that no 6B polysaccharide batches with out of specification (b)(4) values would be used in further manufacture of product.