Record of Telephone Conversation - September 17, 2009 - Prevnar 13

RECORD OF TELEPHONE CONVERSATION

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

Manufacturer:   Wyeth Pharmaceuticals Inc.          

Telecon Date/Time:  17-SEP-2009         Initiated by FDA?  Yes
Telephone Number: 845-602-1283

Communication Categorie(s): Information Request

Author:  Tina Roecklein

Telecon Summary:

-------------------(b)(4)------------------------------------------ Specifications; Future Manufacture of Working Seed

FDA Participants:
Willie Vann
Tina Roecklein

Non-FDA Participants:   
Jack Love

Telecon Body:

CBER’s review of the specifications for ------------------------------(b)(4)----------------------------------------- show that the specifications are outside of Wyeth’s clinical experience.  CBER asked Wyeth how the specifications were calculated and why they are outside of clinical experience.

Wyeth responded that the specifications were calculated by using the total manufacturing process capability and not just clinical experience.  The specifications are wide because of the minimal amount of lots manufactured.  Wyeth is re-evaluating both ----                    ----(b)(4)------------------------ in the context of what was done in the clinic.  Wyeth just submitted revised specifications for Europe and plans to revise the specifications for the U.S. post-approval.

CBER requested that the specifications be revised pre-approval.  Wyeth committed to do so.

In addition, CBER asked for clarification for their plans for manufacture of future lots of working seed.  Wyeth clarified that they have included a comparability protocol and would like to request that future changes in working seed be reported in their Annual Report and not as a supplement.  Wyeth agreed to formally submit that request to the file with references to their comparability protocol.