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Vaccines

Record of Telephone Conversation - May 8, 2009 - Prevnar 13

System Info - 101578  SHONE, DEANNA   06-Aug-2009 16:15:13  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:  08-MAY-2009 12:00 AM             Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Information Request

Author:  COLLEEN SWEENEY

Telecon Summary:
RE: E-mail regarding pertussiss ELISAs comment

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 8, 2009
To:                  Carmel Devlin, Associate Director
                      Global Regulatory Affairs,
                      Wyeth Pharmaceuticals Inc.
From:             CDR C. Sweeney, MS, Regulatory Coordinator
CC:                Drusilla Burns, Ph.D., Product Reviewer
                     Julienne Vaillancourt, R.Ph.,M.P.H.,Chair
Subject:         CBER comment on pertussis enzyme-linked immunosorbent assays (ELISAs) to BLA (STN                             125324)

Based on review of  the pertussis ELISAs, submitted to your BLA (STN 125324),

Dr. Drusilla Burns has the following comment:

We note that on April 9, 2008, you submitted information to IND ---(b)(4)-- documenting adequate purity of the PT, FHA, and PRN coating antigens used in the pertussis ELISAs conducted for study 6096A1-004.  However, in reviewing the information provided in the October 24, 2008, submission to your BLA (STN 125324), we note that on Page 5, section 5.3.1.4-Pert EIA IgG, you indicate the following specifications for the pertussis ELISA coating antigens: “Antigens were accepted if their purity met the following pre-determined purity limits:-(b)(4)-- PRN--(b)(4)- PT, -(b)(4)- FHA, and -(b)(4)-- FIM.”  Please note that these specifications are not adequate to insure specificity of the assay if used for future studies.  If you intend to use these pertussis assays for future studies,  specifications should be amended appropriately.  Please acknowledge.

 

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

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Building 71 Room 3103

Silver Spring, MD 20993-0002