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Vaccines

Minutes of Internal Meeting - July 20, 2009 - Prevnar 13

MEMORANDUM

MINUTES OF INTERNAL MEETING

Meeting Date:                        July 20, 2009
Meeting Time:                       2:30 –3:30 PM
Meeting Location:                 Woodmont Office Complex, Conference Room 300N
File:                                         BLA 125324
Product Name:                      Prevnar 13
Sponsor:                                 Wyeth Pharmaceuticals Inc.

FDA Attendees:
Norman Baylor , Marion Gruber,  Erik Henchal, Wellington Sun, Willie Vann, Milan Blake, John Cipollo, Tina. Khoie, Julienne Vaillancourt and Michael Smith

The primary CMC reviewer, Dr. John Cipollo, briefed OVRR/DVRPA management about the CMC issues to date associated with serotype 5 (see attachment).  There was a teleconference between Wyeth and CBER on June 15, 2009, to discuss CMC issues related with serotype 5 and Wyeth submitted amendment number 19 to the BLA on June 26, 2009, as a result of the telecon.  Dr. Cipollo doesn’t think amendment 19 fully answers all the questions and concerns CBER has regarding serotype 5.

Dr. Baylor instructed the BLA review team to contact the sponsor immediately and set-up a face-to-face technical meeting as soon as possible to discuss these CMC issues associated regarding  serotype 5.

Attachment:
Information from PowerPoint slide #6 from Dr. Cipollo’s briefing presentation to OVRR/DVRPA management.

Action: 
The sponsor will be invited to a face-to-face meeting in the near future with select members of CBER’s BLA review team to address these CMC issues associated with serotype 5.

Attachment: 
Information from PowerPoint slide #6 from Dr. Cipollo’s briefing presentation to OVRR/DVRPA management.

Issues:

  1. Wyeth must show that:
    1. --(b)(4)-- is efficient
    2. --(b)(4)-- is retained
    3. Develop testing methods so that these attributes can be monitored.
  1. Make the (b)(4) saccharide (b)(4) such that (b)(4) can be measured accurately or develop an assay to monitor (b)(4) to insure that its --(b)(4)-- is under control.
 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002