
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.
