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
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Wyeth Pharmaceuticals Inc.
Telecon Date/Time: 01-DEC-2009 05:20 PM Initiated by FDA? Yes
Telephone Number: 845-602 1283
Author: JULIENNE VAILLANCOURT
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
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.