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Vaccines

Record of Telephone Conversation - June 15, 2009 - Prevnar 13

System Info - 113101  SMITH, MICHAEL J  08-Dec-2009 13:06:09  SMITHM

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application   Submission ID:  125324/0    Office: OVRR  

Product:
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Applicant:                                                                       
Wyeth Pharmaceuticals Inc.          

Telecon Date/Time:  15-JUN-2009 02:00 PM                Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Advice

Author:  MICHAEL SMITH

Telecon Summary:
RE: CMC serotype 5 issues

FDA Participants:   John Cipollo, Willie Vann, Milan Blake, Mustafa Akkoyunlu, Tina Khoie Julienne Vaillancourt and Mike Smith

Non-FDA Participants:    Emilio Emini, Dave Zisa, Paul Rohlfing, Krishna Prasad, Bo Arve, Steve Doares, Kathy Kofsky, Rich Pelt, Nikki Burkehalter, Jack Love and Carmel Devlin

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:
Reference: June 12, 2009, email to Wyeth entitled “RE: Talking points for June 15 teleconference to discuss the (b)(4) of serotype 5”, containing John Ciplollo’s talking points for the June 15, 2009, teleconference concerning serotype 5 issues.

Background:
On June 8, 2009, an internal meeting was held to discuss CMC issues regarding serotype 5 with OVRR/DVPRA management and as a result of this meeting Dr. Baylor suggested a teleconference between the CBER BLA review team and representatives from Wyeth to discuss these issues. The teleconference was arranged to occur on June 15, 2009. On June 12, 2009, CBER provided to the sponsor a set of talking points, which were prepared by John Cipollo and Willie Vann (see EDR), for use during the meeting.

Discussion:
Discussion focused on CBER’s June 12, 2009, set of talking points, and resulted in a series of agreements by the sponsor to submit information to the BLA, as follows:

  • The sponsor explained that the -----------(b)(4)-------------- for serotype 5 has demonstrated some ---(b)(4)---, since development of their (b)(4) valent vaccine, which also contained this serotype. After continued and more indepth investigation, the sponsor determined that the cause of the ----(b)(4)---- was related to the ----------------------(b)(4)--------------------------- as the (b)(4) for              ---(b)(4)--- polysaccharide for the other 12 serotypes is stable. Wyeth agreed to submit data on the (b)(4) for serotype 5 dating back to the (b)(4) valent vaccine and a historical summary of the issue to date.
  • The sponsor agreed to provide updated stability data for activated serotype 5 under storage (i.e., (b)(4)).
  • Efficiency of the conjugation process as -------------(b)(4)------------- was discussed. Wyeth agreed to submit post-conjugation -------(b)(4)----------- for serotype 5.
  • The process of -----------------(b)(4)------------- groups post conjugation for serotype 5 was discussed. Wyeth explained that because serotype 5 polysaccharide has a ------------------(b)(4)--------------------------- is used as a                                          ------------(b)(4)------------------------- is used as the ---(b)(4)----- for the other 12 polysaccharides in Prevnar 13 and for all 7 serotypes in Prevnar. CBER questioned the sponsor’s method for measuring ----------(b)(4)--------------- process. The sponsor indicated that there is no such direct measure. The sponsor further explained, however, that ---------(b)(4)------------ is used to ensure completion of the process. CBER requested information to support -------(b)(4)---------------- process. The sponsor agreed to provide such information.
  • CBER questioned whether the sponsor had a method for measuring ---------(b)(4)-------------------------------------- in final drug product. The sponsor indicated that they do not have such a method. CBER questioned the possibility of assaying available sera from clinical trials to measure antibody against theoretical (b)(4)/CRM197 impurities in subjects who received 13vPnC. Wyeth agreed to consider developing an assay to analyze sera for antibodies to (b)(4)/CRM197 conjugate in final product.
  • CBER asked the sponsor to describe the molecular structure of the (b)(4) and (b)(4)-CRM197 impurities in final product and methods for determining such structures. The sponsor agreed to provide information in this regard.
  • CBER asked the sponsor to describe the methods for measuring amount of  -------------(b)(4)-----------------------------------------------. The sponsor noted that it might be possible to measure -------(b)(4)------------------ and agreed to provide information in this regard.

Action:
Wyeth will submit an amendment to the BLA with a response to CBER’s requests for information concerning the serotype 5 (b)(4) issue and the --(b)(4)-- process following ---(b)(4)---.

End of telecon.

 

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