System Info - 116363 SMITH, MICHAEL J 08-Jan-2010 15:56:40 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: 07-JAN-2010 04:12 PM Initiated by FDA? Yes
Author: JULIENNE VAILLANCOURT
Email: Additional comments related to clinical PMC's
FDA Participants: Julie Vaillancourt, Colleen Sweeney and Mike Smith
Non-FDA Participants: Jack Love and Carmel Devlin
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Vaillancourt, Julienne
Sent: Thursday, January 07, 2010 4:12 PM
To: 'Love Jack'; 'Devlin Carmel'
Cc: Sweeney, Colleen; Smith, Michael (CBER)
Subject: additional comments related to clinical postmarketing plans
Dear Jack and Carmel,
Dr. Marthe Bryant has the following additional requests, which concern your clinical post marketing plans:
- On January 12, 2009, we sent you via e-mail the set of comments, which we had verbally conveyed to you earlier that day during the teleconference to discuss your initial draft pharmacovigilance plan for Prevnar 13, which you originally submitted to your IND on December 12, 200. Item 10, which was asked by Dr. Robert Wise from the Office of Epidemiology and Biostatistics at CBER, during the teleconference is provided below. Please clarify whether and how you intend to address this request for identification data for lots that would be distributed to NCKP.
We understand that batch or lot identification codes will provide one method to distinguish between Prevnar and 13vPnC. Because accuracy and completeness of lot tracking has been very challenging for vaccines and other biological products, we suggest that you consider providing valid lot distribution data for Prevnar and 13vPnC directly to the HMO(s) participating in the proposed Phase IV study. These data sets would include product lot identifiers and each final container lot's dates of initial distribution and expiration. The files with these data could be nearly the same as the ones routinely supplied to CBER, excluding only the commercially sensitive lot size variable, or that field could display the numbers of doses shipped to the HMOs, rather than totals distributed nationwide.
The VSD has generally not been able to analyze vaccine safety by lot, due to the extent of missing and incorrect lot data. In the past, CBER has received requests for valid lot identifiers to allow the VSD HMOs to improve accuracy of data entry in vaccine exposure and adverse event records. Although CBER cannot share lot distribution data, because they are commercial confidential information, perhaps Wyeth could do so in the context of this planned study, for this same objective of improving completeness and accuracy of data. "Range checking" methods might be easily implemented. In addition, drop-down lists could be provided with only current valid lots for these products, or programmers at the HMOs might develop other methods to take advantage of the reference data.
- In the protocol for study 6096A1-4005, the postmarketing IPD surveillance study to be conducted in the NCKP population, you note that the NCKP annual birth cohort is approximately 36,000 infants and the number of children under 5 years of age in the NCKP network is approximately 140,000 in any year. Please clarify whether the “140,000 children” refers to children 1 to 4 years old or if it includes all children 0 to 4 years old.
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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