Record of Telephone Conversation - December 1, 2009 - Prevnar 13

System Info - 120670  SMITH, MICHAEL J  21-Feb-2010 10:32:14  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:  01-DEC-2009 05:20 PM               Initiated by FDA?  Yes

Telephone Number:  845-602 1283   

Communication Categorie(s):
Information Request

Author:  JULIENNE VAILLANCOURT

Telecon Summary:
Line listings and tables of available post dose 4 and six month follow-up safety data from Prevnar 13 study 6096A1-3005

FDA Participants:   Julienne Vaillancourt

Non-FDA Participants:    Jack Love, Dan Scott

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

Background: During the November 18, 2009 VRBPAC meeting, the US safety database was noted to be relatively small.  In response, the sponsor noted that post dose 4 and 6-month follow-up safety data from the US lot consistency study, 3005, which were not available at the time of the original BLA submission, were now available. 

Discussion: The sponsor was requested to provide line listings and tables of available post dose 4 and six month follow-up safety data from Prevnar 13 study 6096A1-3005.  The sponsor noted that a 58 page report, which contains tables similar to what has been submitted for other studies to the BLA, was available and offered to submit this report along with datasets in lieu of line listings.  The sponsor explained that this report would be part of the final CSR, which will be available in early 2010.  The data have been audited and cleaned.  The sponsor also offered to provide just line listings, if CBER would only want to see them; however, they would have to be created from the datasets. 

After an internal inquiry was made at CBER about the preference of how the requested data should be submitted, the sponsor was notified and informed that the available 58 page report in lieu of line listings would be acceptable.  CBER requested that these data be requested ASAP.