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Vaccines, Blood & Biologics

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Vaccines

Meeting Summary - January 22, 2010 - Prevnar 13

Summary of Face-to-Face Meeting

Date/Time:     January 22, 2010, 10:00 AM – 12:00 Noon

Location:        5516 Nicholson Lane, Conference Room 2407

File:                 BLA 125324

Product:         Prevnar 13

Sponsor:         Wyeth Pharmaceuticals Inc.

Purpose of Meeting:

  • To discuss CBER’s scientific rationale for each of the assay validation PMCs.
  • To clarify each assay validation-related PMC.
  • To assure mutual understanding and concurrence of each assay validation-related PMC.

CBER Participants: Phil Krause, Erik Henchal, Rajesh Gupta, William McCormick, Karen Campbell, John Cipollo, Willie Vann, Milan Blake, Tina Roecklein, Mike Smith and Julienne Vaillancourt

Sponsor Participants: Kathrin Jansen, Bart Corsaro, Margaret Savage, Marsha Richmond and Jack Love

I.          Assay Validation-Related CMC PMCs

Each assay validation-related PMC, as stated in CBER’s January 7, 2010, was discussed. It was agreed that the assay validation-related CMC PMCs would be revised.  Wyeth will send a draft set of revised CMC PMCs via e-mail for CBER review and concurrence prior to submitting this as an official amendment to the BLA. 

It was agreed that items 9.1 and 9.2 will be submitted by August 2010 and items 9.3 through 9.8 by February 2011. 

Each assay validation-related CMC PMC will be revised based on agreements during the meeting.  The previous draft wording for each of these PMCs is provided below along with agreed on content for the revision of each.  

  1. Assay Validation CMC PMCs
    1. ---------------------------------------(b)(4)-----------------

Original PMC wording:

 

4 Pages determined not to be releasable: (b)(4)

 

 

-------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)--------------------------------------------------------------------------------------.

 

  1. Stability Indicating Assay for Drug Product

The sponsor noted that they would like to come and meet with CBER sometime after approval of Prevnar 13 to discuss development plans for a stability indicating assay in greater detail.  In particular, the sponsor would like to obtain CBER’s advice or ideas on acceptable options.  CBER agreed that this should be the focus of a separate meeting after February 2010.

  II. Miscellaneous

  1. CBER noted that the unknown effect of succinate (which is contained in Prevnar 13, but was not contained in Prevnar) on -----(b)(4)----------- is a concern and requested any available information on this.   In particular, CBER would like to know what succinate is doing to ---(b)(4)----- for the 7 serotypes in Prevnar 7.
  2. CBER asked the sponsor to specify the relative difference between the QL for      -----------(b)(4)---- in Prevnar 13 final drug product and the -----(b)(4)------ for a –(b)(4)--.  The sponsor will follow-up with CBER with this information, which is in 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

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448