System Info - 100923 SMITH, MICHAEL J 30-Jul-2009 14:51:35 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: 24-JUL-2009 07:03 PM Initiated by FDA? Yes
Author: JULIENNE VAILLANCOURT
IR for data generated by the PPD firm on the re-assayed sera from study 004 using the Merck varicella assay
FDA Participants: JULIENNE VAILLANCOURT and Mike Smith
Non-FDA Participants: Jack Love and Carmel Devlin
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
See email below:
From: Vaillancourt, Julienne
Sent: Friday, July 24, 2009 7:03 PM
To: 'Jack Love'
Cc: 'Carmel Devlin'; Smith, Michael (CBER)
Subject: Request for Rerun Varicella Assays on study 004 sera
During a teleconference with you and Carmel on July 16, 2009, you provided an explanation to Mike Smith and me for why the Varicella response rates from the pivotal phase 3 study 6096A1-004 were so low across both arms (i.e., 7vPnC and 13vPnC). Specifically, you explained that the varicella immunogenicity data had been generated via use of an assay, which you considered to be inappropriate for this purpose, because it is really an assay which is typically used to indicate past or present infection. You used it, however, because the more appropriate assay, Merck’s licensed varicella assay, was not available to your firm at the time. You further explained that Merck has since out-licensed their varicella assay to the firm PPD and as a result, the assay finally became available to your firm for use. You have therefore re-assayed sera from study 004 using this more appropriate assay and the varicella response rates are higher and similar across both arms. We would like to see these data and information about the assay used to generate them. Please provide this information to the BLA. Thank you.
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
THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please immediately notify the sender immediately by e-mail or phone.
End of telecon