Record of Telephone Conversation - July 24, 2009 - Prevnar 13

System Info - 100923  SMITH, MICHAEL J  30-Jul-2009 14:51:35  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:  24-JUL-2009 07:03 PM     Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):
Information Request

Author:  JULIENNE VAILLANCOURT

Telecon Summary:
IR for data generated by the PPD firm on the re-assayed sera from study 004 using the Merck varicella assay

FDA Participants:   JULIENNE VAILLANCOURT and Mike Smith

Non-FDA Participants:    Jack Love and Carmel Devlin

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

See email below:

______________________________________________

From:                     Vaillancourt, Julienne 

Sent:                      Friday, July 24, 2009 7:03 PM

To:                          'Jack Love'

Cc:                          'Carmel Devlin'; Smith, Michael (CBER)

Subject:                Request for Rerun Varicella Assays on study 004 sera

Jack,

During a teleconference with you and Carmel on July 16, 2009, you provided an explanation to Mike Smith and me for why the Varicella response rates from the pivotal phase 3 study 6096A1-004 were so low across both arms (i.e., 7vPnC and 13vPnC).  Specifically, you explained that the varicella immunogenicity data had been generated via use of an assay, which you considered to be inappropriate for this purpose, because it is really an assay which is typically used to indicate past or present infection.  You used it, however, because the more appropriate assay, Merck’s licensed varicella assay, was not available to your firm at the time.  You further explained that Merck has since out-licensed their varicella assay to the firm PPD and as a result, the assay finally became available to your firm for use.  You have therefore re-assayed sera from study 004 using this more appropriate assay and the varicella response rates are higher and similar across both arms.  We would like to see these data and information about the assay used to generate them.  Please provide this information to the BLA.  Thank you.

Julie

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
E-mail:   julienne.vaillancourt@fda.hhs.gov

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End of telecon