System Info - 118611 SMITH, MICHAEL J 26-Jan-2010 18:40:15 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: 26-JAN-2010 12:00 AM Initiated by FDA? Yes
Author: MICHAEL SMITH
Clarification on lot numbers captured by NCKP for post-licensure safety study 6096A1-4002
FDA Participants: Julie Vaillancourt
Non-FDA Participants: Carmel Devlin and Jack Love
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Highlights of Ms. Carmel Devlin’s (Wyeth) email to CAPT Julie Vaillancourt on January 26, 2010, regarding lots used for the Prevnar 13 post-licensure study 6096A1-4002.
“As indicated in our last response the lot number will be captured by the Kaiser system. If there is any issue with the VAERS system then FDA can contact Pfizer and we will be able to providethat information as we keep track of all lots and where they are shipped”.
Ms. Devlin’s email was in response to CAPT Vaillancourt’s email to Ms. Devlin on January 21, 2010, the highlights of this communication (which were excerpts from an email that Dr. Marthe Bryant sent to CAPT Vaillancourt) are as follows:
“We would like Wyeth to concur with NCKP whether they is a need for NCKP to have access to lot identification data and if so whether Wyeth would be willing to provide them to NCKP. ....It is possible that the process in place is working fine for NCKP. However since the identification of vaccine lot on the VAERS form is often inaccurate, we would like to do everything possible to obtain accurate”
CAPT Vaillancourt’s email was in response to Ms. Devlin’s email to CAPT Vaillancourt on January 21, 2010, the highlights of this communication are as follows:
“When we talked yesterday you indicated that Marthe had another question on lot identification in the post marketing safety study, you said that you would forward her question to us. Just to let you know from our perspective we don't believe there is anything else we can add. Clinical is going to move ahead with the protocol based on the last version submitted on December 11th as they need to get ready to start this study after approval”.
Note: Wyeth submitted amendment 65 to CBER on December 11, 2009, this amendment contains Wyeth’s final protocol for post-licensure safety study 6096A1-4002.