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Vaccines

Record of Telephone Conversation - August 31, 2009 - Prevnar 13

(System Info - 113308 SHONE DEANNA 12/09/2009 12:34:53 SHONEDE)

RECORD OF TELEPHONE CONVERSATION

Submission Type: BLA    Submission ID: 125324/0    Office: OVRR

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

Applicant:
Wyeth Pharmaceuticals Inc.

Telecon Date/Time: 31-Aug-2009 10:36 AM        Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):
1. Other -

Author: COLLEEN SWEENEY

Telecon Summary:
PeRC PREA Subcommittee recommendation for a partial waiver/deferral/plan/assesment on July 22, 2009.

FDA Participants: Colleen Sweeney, George Greeley, Ginneh Stowe

Non-FDA Participants: No

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:
From: Greeley, George
Sent: Monday, August 31, 2009 10:36 AM
To: Sweeney, Colleen
Cc: Stowe, Ginneh D.
Subject: BLA 125324 Prevnar 13
Importance: High

Hi Colleen,

The Prevnar 13: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM(197) Protein) partial waiver/deferral/plan/assessment was reviewed by the PeRC PREA Subcommittee on July 22, 2009.

The Division recommended a partial waiver for the Active immunization of infants and toddlers for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F indication because the product is not feasible and offers no meaningful therapeutic benefit from birth to 5 weeks. The Division recommended a deferral from 6-16 years because the product is ready for approval in adults and an assessment from 6 weeks to 5 years.

The PeRC agrees with the Division to grant a partial waiver/deferral/plan and the assessment for this product.

In addition, the PeRC has requested that the pediatric page be modified to uncheck the box for "not feasible" for the partial waiver under this indication.

The Division recommended a partial waiver for the Active immunization of infants and toddlers for the prevention of otitis media caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F indication because the product is not feasible and offers no meaningful therapeutic benefit from birth to 5 weeks and 6 years to 16 years of age. The Division presented an assessment for ages 6 weeks to 5 year.

The PeRC agrees with the Division to grant a partial waiver and assessment for this product.

Thank you.

George Greeley
Regulatory Health Project Manager
Pediatric and Maternal Health Staff
Office of New Drugs
FDA/CDER
10903 New Hampshire Ave.
Bldg #22, Room 6467
Silver Spring, MD 20993-0002
301.796.4025

 

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