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Vaccines

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


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.
 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002