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Vaccines

Record of Telephone Conversation - August 6, 2009 - Prevnar 13

System Info - 120679  SMITH, MICHAEL J  21-Feb-2010 16:20:41  SMITHM

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:  06-AUG-2009 12:00 AM              Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Information Request

Author:  JULIENNE VAILLANCOURT

Telecon Summary:
To Discuss Proposed Experiments to Demonstrate -------(b)(4)----- of Serotype 5 Conjugate

FDA Participants:                   Julienne Vaillancourt, Willie Vann, Milan Blake and Daron Freedberg

Non-FDA Participants:           Jack Love, Emilio Emini and Kathrin Jansen

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:
Record of Teleconference
Date:                                       August 6, 2009
File:                                         BLA 125324
Product:                                 Prevnarv13
Sponsor:                                 Wyeth Pharmaceuticals Inc.
Subject:                                   To Discuss Proposed Experiments to Demonstrate               ----(b)(4 -------- of Serotype 5 Conjugate 
Sponsor Phone:                     sponsor provided dial in number with password
Sponsor Participants:           Jack Love, Emilio Emini, Kathrin Jansen
CBER Participant:               Willie Vann, Milan Blake, Daron Freedberg, Julienne Vaillancourt

Background:
During a face-to-face meeting on July 28, 2009, the applicant explained that serotype 5 polysaccharide contains a --(b)(4)--designated -(b)(4)-- the --(b)(4)-- of which is required for ----(b)(4)---.  While ----(b)(4)---must be ----------------(b)(4)---must be retained, and for this reason ----------------(b)(4)---, rather ----------------(b)(4)---------, is used, because ----(b)(4)----------------------------------------------------------------------.  CBER advised the applicant to propose a well-designed experiment or set of experiments to demonstrate                 ----(b)(4)----------------------------------------------------.

 The applicant sent a proposed set of experiments to CBER via e-mail on August 5, 2009, for preliminary feedback and discussion during the present teleconference.  These experiments included ----(b)(4)---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.   Wyeth has experience with this methodology. 

 

Discussion:

  1. After some discussion, CBER informed the applicant of the acceptability of the experimental plan, as proposed in the August 5, 2010 document.  CBER noted that the plans were encouraging and advised the applicant to start the experiments.
  2.       CBER requested the applicant to propose an assay to determine the ----------------------------------------------(b)(4)--- to be used to set the specification for ------------------------------------------(b)(4)---  as was demonstrated via clinical experience----(b)(4)---------------------------------------------------------------  were suggested as possible approaches.  CBER asked how long it would take to develop and implement these methods.  The applicant noted that it would take approximately six weeks for the ----(b)(4)---  and months for the ----(b)(4)------------  including validation.  The applicant noted that the ----(b)(4)--- likely would be more amenable to use in manufacturing on a continued basis than ----(b)(4)---.   Also, the applicant explained that Wyeth’s Pearl River laboratory has a panel of ----(b)(4)------------------------------------------------------------------------, and this should facilitate development of the assay.  CBER agreed that this assay might therefore be faster to develop and acknowledged that ----(b)(4)--would be more work to use routinely.  However, CBER advised the applicant to link the             ----(b)(4)-----------. 

Action:
The applicant will provide a revised set of serotype 5 ----(b)(4)---  experiments with a proposed ----(b)(4)--- assay to CBER initially via e-mail for preliminary review prior to submitting these items to the BLA.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

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Rockville, MD 20852-1448