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Vaccines

Record of Telephone Conversation - June 5, 2009 - Prevnar 13

System Info - 101584  SHONE, DEANNA   06-Aug-2009 16:32:35  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:  05-JUN-2009 12:00 AM               Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):
Information Request

Author:  COLLEEN SWEENEY

Telecon Summary:
RE:  E-mail regarding request for Incidence rates  for case counts of IPD serotypes

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:June 5, 2009
To:

Carmel Devlin, Associate Director

Global Regulatory Affairs,

Wyeth Pharmaceuticals Inc.

From:

CDR C. Sweeney, MS, Regulatory Coordinator

CC:

Tina Khoie, M.D., MPH Clinical Reviewer

Julienne Vaillancourt, R.Ph.,M.P.H.,Chair

LCDR Mike Smith, Ph.D. Regulatory Coordinator

Subject:Serotype IPD data

The following item pertains to the May 28, 2009, submission that contained serotype specific IPD data provided by the Center for Disease Control (CDC).

We note that you have provided case counts of IPD by serotype, year, and age group. We also note that you have denominator data for each age group and each year in the table which provides overall rates of IPD by year and age group. Incidence rates should therefore be easily calculated with these data. Please submit incidence rates by serotype, year, and age group.

 

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