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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Meeting Summary - July 28, 2009 - Prevnar 13

MINUTES OF SPONSOR MEETING (FACE-TO-FACE)

Meeting Date:                        July 28, 2009
Meeting Time:                       12:00 –2:00 PM
Meeting Location:                 Woodmont Office Complex, Conference Room 1
File:                                         BLA 125324
Product Name:                      Prevnar 13
Sponsor:                                 Wyeth Pharmaceuticals Inc.

FDA Attendees:
Willie Vann, Milan Blake, John Cipollo, Rajesh Gupta, Daron Freedberg, Julienne Vaillancourt and Michael Smith

Sponsor Attendees:
Emilio Emini, Paul Rohlfing, Bo Arve, Steve Doares, Krishna Prasad, Dave Zisa, Kathrin Jansen and Jack Love

Reference:      Amendment 22 to BLA 125324 (submitted 6/26/2009)

Background:
This face-to-face meeting with the sponsor occurred as a result of an internal CBER meeting in which Dr. Norman Baylor was briefed by Drs. John Cipollo, Willie Vann, Milan Blake and Rajesh Gupta about progress concerning two previously identified CMC review issues, which specifically pertain to serotype 5.  These issues are:

  1. During the June 15, 2009 teleconference it became evident that the efficiency of the --(b)(4)--- process for serotype 5 conjugate is not measured and a non-typical --(b)(4)--- (i.e., -------------(b)(4)-----------------------------------------) is used.  The sponsor was requested to provide information to support complete --(b)(4)---  for this serotype.  On June 26, 2009, the sponsor submitted response to this information request (see item 4, section 1.11.1).  Based on review of this response, CBER determined that the issue has not been adequately addressed.
  2. -------------(b)(4)-------------------------------------------------------------------------------- ---------------------------------------------------------------------------------------------------------------------------------------. 

 

2 pages determined not to be releasable : (b)(4)

 

 

With regard to the ------(b)(4)----)  issue:

  • The sponsor will propose an operable definition for complete ---(b)(4)---  and a set of experiments to demonstrate complete ---(b)(4)-----.

With regard to the serotype 5 –(b)(4)- issue:

  • The sponsor will develop a plan for characterizing serotype 5 polysaccharide -----(b)(4)------- products (including -------------(b)(4)--------------------------------------------------.
  • CBER will review available data demonstrating process consistency for the activation and conjugation of serotype 5 and decide whether such data are adequate for the interim pending implementation of an agreed upon characterization plan.

Note: Amendment 40 was submitted to CBER in response to questions raised during the July 28, 2009, face-to-face meeting.

 

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