System Info - 106066 SMITH, MICHAEL J 28-Sep-2009 14:44:15 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: 22-SEP-2009 06:53 AM Initiated by FDA? No
Author: MICHAEL SMITH
Email: Carmel Devlin emailed Julie Vaillancourt reagrding update on Otitis Media in response to Julie's email on 9/21/2009 to Jack Love.
FDA Participants: Julie Vaillancourt
Non-FDA Participants: Carmel Devlin and Jack Love
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Devlin Carmel [mailto:DEVLINC@wyeth.com]
Sent: Tuesday, September 22, 2009 6:53 AM
To: Vaillancourt, Julienne
Cc: Love Jack
Subject: Re: update on Otitis Media
Thank you for the information. We had anticipated that you might pose this to the advisory committee after we received your comments on the first draft of the label. Speaking of which, when do you anticipate providing comments on our second draft? We should get to consensus on as many lines as possible prior to the VRBPAC meeting, so that afterwards there is not much left to do.
Regarding the AOM post-marketing study, are you aware that we have an ongoing, fully-enrolled NP carriage study in Israel with Ron Dagan? There are 1600 subjects enrolled to compare carriage between 7v and 13v. This may satisfy your request for wider surveillance. We would appreciate having a follow-up telephone conversation about the path forward, perhaps late next week.
>>> "Vaillancourt, Julienne" <Julienne.Vaillancourt@fda.hhs.gov> 9/21/2009 5:54 PM >>>
Please note that we had an internal meeting last Friday, September 18, 2009, to discuss your proposal that Prevnar 13 be indicated for prevention of otitis media, caused by the serotypes in the vaccine, in addition to invasive disease. We would like you to be aware that we plan to ask the VRBPAC to comment on the proposed indication for prevention of otitis media, so that you have the opportunity to adequately address this in your briefing package and in your presentation for the meeting, before the deadline for these items.
In addition, we briefly discussed your synopsis for proposed post marketing study 6096A1-4010, which would evaluate the effectiveness of Prevnar 13 in reducing AOM and NP colonizationcaused by serotypes inthe vaccine in approximately 360 young children. In general, we view this study to be inadequate as a stand alone postmarketing study for evaluating vaccine effectiveness in preventing OM. We acknowledge your plans to serotype S. pneumoniae isolates identified in samples of middle ear fluid obtained via tympanocentesis. In addition, we acknowledge your plans to evaluate nasal pharyngeal colonization in this study. We recommend that you consider expanding this study to include other geographic locations across the US. We understand the difficulty in obtaining middle ear fluid via tympanocentesis in children presenting with AOM or a history of recurrent AOM, because the procedure is not routinely done in the US. Therefore, we would consider a study design in which tympanocentesis would be performed in a subset of subjects only, perhaps evenlimited to the currently proposed clinical site. However, we would expect nasopharyngeal and oropharyngeal samples to be obtained from all subjects across all sites. We think that it would be useful to further discuss with you how this study might be expanded to optimally serve a post marketing source of data on effectiveness of Prevnar 13 in preventing OM. We look forward to hearing back from you in this regard.
Julienne Vaillancourt, R.Ph., M.P.H.
Captain, US Public Health Service
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
US Food and Drug Administration
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