Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Vaccines, Blood & Biologics

Record of Telephone Conversation - January 7, 2010-1 - Prevnar 13

System Info - 116363  SMITH, MICHAEL J  08-Jan-2010 15:56:40  SMITHM


Submission Type: Original Application   Submission ID:  125324/0    Office: OVRR  

Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Wyeth Pharmaceuticals Inc.          

Telecon Date/Time:  07-JAN-2010 04:12 PM                Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Information Request


Telecon Summary:
Email: Additional comments related to clinical PMC's

FDA Participants:   Julie Vaillancourt, Colleen Sweeney and Mike Smith

Non-FDA Participants:    Jack Love and Carmel Devlin

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:


From:                     Vaillancourt, Julienne 
Sent:                      Thursday, January 07, 2010 4:12 PM
To:                          'Love Jack'; 'Devlin Carmel'
Cc:                          Sweeney, Colleen; Smith, Michael (CBER)
Subject:                additional comments related to clinical postmarketing plans

Dear Jack and Carmel,

Dr. Marthe Bryant has the following additional requests, which concern your clinical post marketing plans:

  1. On January 12, 2009, we sent you via e-mail the set of comments, which we had verbally conveyed to you earlier that day during the teleconference to discuss your initial draft pharmacovigilance plan for Prevnar 13, which you originally submitted to your IND on December 12, 200.  Item 10, which was asked by Dr. Robert Wise from the Office of Epidemiology and Biostatistics at CBER, during the teleconference is provided below.  Please clarify whether and how you intend to address this request for identification data for lots that would be distributed to NCKP.

We understand that batch or lot identification codes will provide one method to distinguish between Prevnar and 13vPnC.  Because accuracy and completeness of lot tracking has been very challenging for vaccines and other biological products, we suggest that you consider providing valid lot distribution data for Prevnar and 13vPnC directly to the HMO(s) participating in the proposed Phase IV study. These data sets would include product lot identifiers and each final container lot's dates of initial distribution and expiration.  The files with these data could be nearly the same as the ones routinely supplied to CBER, excluding only the commercially sensitive lot size variable, or that field could display the numbers of doses shipped to the HMOs, rather than totals distributed nationwide.

The VSD has generally not been able to analyze vaccine safety by lot, due to the extent of missing and incorrect lot data. In the past, CBER has received requests for valid lot identifiers to allow the VSD HMOs to improve accuracy of data entry in vaccine exposure and adverse event records. Although CBER cannot share lot distribution data, because they are commercial confidential information, perhaps Wyeth could do so in the context of this planned study, for this same objective of improving completeness and accuracy of data. "Range checking" methods might be easily implemented.  In addition, drop-down lists could be provided with only current valid lots for these products, or programmers at the HMOs might develop other methods to take advantage of the reference data.

  1. In the protocol for study 6096A1-4005, the postmarketing IPD surveillance study to be conducted in the NCKP population, you note that the NCKP annual birth cohort is approximately 36,000 infants and the number of children under 5 years of age in the NCKP network is approximately 140,000 in any year.  Please clarify whether the “140,000 children” refers to children 1 to 4 years old or if it includes all children 0 to 4 years old. 

Thank you.


Julienne Vaillancourt, R.Ph., M.P.H.
Captain, US 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:    301-827-5414
Fax:        301-827-3532

THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW.  If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized.  If you have received this document in error, please immediately notify the sender immediately by e-mail or phone.

End of email.

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

Page Last Updated: 09/24/2013
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English