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  

Product:
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Applicant:                                                                       
Wyeth Pharmaceuticals Inc.          

Telecon Date/Time:  11-MAY-2009 01:00 PM              Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Information Request

Author:  COLLEEN SWEENEY

Telecon Summary:
RE: Telecon with Wyeth regarding serotype 6B (b)(4)

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:
DEPARTMENT OF HEALTH & HUMAN SERVICES
FDA/CBER/OVRR/DVRPA
Teleconference Memorandum

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.

CBER Participants
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.

Wyeth Participants
Jack Love, Ph.D.
Emilio Emini, Ph.D.
Carmel Devlin
Paul Rohfling
Rick Pelt

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:

CBER
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.

Wyeth
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.

CBER
Please confirm that no out of specification clinical lot 6B for (b)(4) were used in the final product lots for clinical use.

Wyeth
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.

Action:
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.