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Vaccines

Record of Telephone Conversation - June 12, 2009 - Prevnar 13

System Info - 96689  SMITH, MICHAEL J  15-Jun-2009 09:37:39  SMITHM

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:  12-JUN-2009 12:00 AM               Initiated by FDA?  Yes
Telephone Number:    email

Communication Categorie(s):
Information Request

Author:  MICHAEL SMITH

Telecon Summary:
email; Talking points for serotype 5 telecon on 15JUNE09

FDA Participants:   Mike Smith, Julienne Vaillancourt, Colleen Sweeney

Non-FDA Participants:    Jack Love; Carmel Devlin

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

_____________________________________________

From:                     Smith, Michael (CBER) 

Sent:                      Friday, June 12, 2009 12:54 PM

To:                          Jack Love; 'Carmel Devlin'

Cc:                          Vaillancourt, Julienne; Sweeney, Colleen

Subject:               RE: Talking points for June 15 teleconference to discuss the DO of serotype 5

Jack and Carmel,

    The talking points that Dr. John Cipollo generated regarding the ------(b)(4)---------------- for serotype 5 are included in this email (see below) to help facilitate the discussion at the June 15th teleconference.

    The –(b)(4)-- type-5 polysaccharide appears to --------(b)(4)--------------------------------------- -------------------.  This causes some concern as to manufacturing consistency and safety of the drug product.

    We would like to discuss the following issues and how you plan to address them.  These issues are related to the consistency of manufacturing of Type 5 product, the stability of the drug substance, and the safety of the drug product.  Your response should not be limited to these issues alone but should address the global issue of the of Type 5 chemistry on manufacturing consistency and safety of the drug product.

1. -------------------------------------(b)(4)--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

2. -----------------------------------------------(b)(4)----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

3. -----------------------------------------------(b)(4)-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

4. -----------------------------------------------(b)(4)--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

5. -----------------------------------------------(b)(4)--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

6. -----------------------------------------------(b)(4)---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

-------------------------------------------------(b)(4)------------------------------------------------------------------------------------------------

7. -------------------------------------(b)(4)-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

8. . -----------------------------------------------(b)(4)--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

9. . -----------------------------------------------(b)(4)-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

We look forward to discussing these talking points with you at the 2:00 PM teleconference on Monday, June 15, 2009.

Regards,
Mike

Mike Smith, Ph.D.
Lieutenant Commander (LCDR), U.S. Public Health Service
Regulatory Reviewer
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
US Food and Drug Administration

Phone:    301-827-9047
Fax:        301-827-3532
E-mail:   michael.smith2@fda.hhs.gov

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End of email

 

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