Record of Telephone Conversation - May 20, 2009-1 - Prevnar 13

System Info - 101581  SHONE, DEANNA   06-Aug-2009 16:21:07  SHONEDE

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application   Submission ID:  125324/0    Office: OVRR  

Product:
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Applicant:
Wyeth Pharmaceuticals Inc.          

Telecon Date/Time:  20-MAY-2009       Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Information Request

Author:  COLLEEN SWEENEY

Telecon Summary:
E-Mail: IR for IPD incidence rates

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

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Memorandum

Date:	May 20, 2009
To:	Carmel Devlin, Associate Director Global Regulatory Affairs, Wyeth Pharmaceuticals Inc.
From:	CDR C. Sweeney, MS, Regulatory Coordinator
CC:	Tina Khoie, M.D., M.P.H., Clinical Reviewer Lucia Lee, M.D., Team Leader, VCTB, DVRPA Julienne Vaillancourt, R.Ph.,M.P.H.,Chair
Subject:	CBER Clinical Comments on STN 125324

Based on preliminary review of the clinical portions of your BLA (STN 125324), Dr. Tina Khoie has the following comment:

1. We have not been able to identify recent United States serotype-specific invasive pneumococcal disease (IPD) incidence rates for children < 2 years of age in your BLA submission.  Please specify the location within the BLA that this information may have been included. If serotype-specific IPD incidence rates in the United States were not included in the BLA, please submit this information for children < 2 years of age.  If possible, please also provide these data for the following age groups: < 1 year of age, 12 to < 2 years of age, and 2-5 years of age.