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Vaccines, Blood & Biologics

Minutes of Internal Meeting - June 8, 2009 - Prevnar 13

MEMORANDUM

MINUTES OF INTERNAL MEETING

 

Meeting Date:                        June 8, 2009

Meeting Time:                       1:00 –2:00 PM

Meeting Location:                 Woodmont Office Complex, Conference Room 2

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, Colleen Sweeney, Julienne Vaillancourt and Michael Smith

 

The primary CMC reviewer, Dr. John Cipollo, briefed OVRR/DVRPA management about the CMC issues that he has identified associated with serotype 5 as of May 19, 2009 (see attachment).

 

Dr. Baylor instructed the BLA review team to contact the sponsor and set-up a teleconference with Wyeth to discuss these CMC issues associated with serotype.

 

Action: 

CBER will arrange a teleconference with the sponsor to discuss these CMC issues associated with serotype 5, to take place as soon as possible.

 

Attachment

 

Background Information on serotype 5 issues prepared and provided by Dr. John Cipollo on May 19, 2009, for June 8, 2009 Internal Meeting.

 

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

 

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

 

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

           

CBER is concerned with the removal of(b)(4) testing and is further concerned based on submitted data on several grounds:

 

1.  The activation and subsequent conjugation chemistries are not under control.

2.  The --(b)(4)--, and products thereof, are contaminants leading to a purity issue.

3.  The --(b)(4)-- is incorporated into the conjugate in unknown amounts and the affects on vaccine safety are unknown.

4.  Not having the --(b)(4)-- assay under control makes immunogenicity uncertain.

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

Page Last Updated: 04/12/2010
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