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)----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.

 

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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.