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

System Info - 120682  SMITH, MICHAEL J  21-Feb-2010 18:00:22  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:  13-JAN-2010 12:00 AM               Initiated by FDA?  Yes
Telephone Number:    845-602-1283 

Communication Categorie(s):

Information Request

Author:  TINA KHOIE

Telecon Summary:
Request to Revise Integrated Safety Tables to Include Date from Studies 009 & 3000

FDA Participants:   Tina Khoie, Mike Smith and Julienne Vaillancourt

Non-FDA Participants:    Carmel Devlin and Jack Love

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

Record of Teleconference

Date:                                       January 13, 2010

File:                                         BLA 125324

Product:                                 Prevnar 13

Sponsor:                                 Wyeth Pharmaceuticals Inc.

Subject:                                   Request to Revise Integrated Safety Tables to Include Date from Studies 009 & 3000 

Sponsor Phone:                     845-602-1283 

Sponsor Participants:           Carmel Devlin, Jack Love

CBER Participant:               Tina Khoie, Mike Smith, Julienne Vaillancourt

Reference:
Amendment 72 to BLA 125324, submitted January 11, 2010.  This amendment contains a response to our January 4, 2010 request for integration of post infant series safety data from study 6096A1-3005 (lot consistency study).

Discussion:

Clinical Reviewer, Dr. Tina Khoie, noted that in the January 11, 2010, amendment to the BLA, which is the sponsor’s response to CBER’s January 4, 2010 request that post infant series safety data from study 3005 be included in the integrated summary of safety tables, safety data from studies 009 and 3000 were not included in these updated tables.  She informed the sponsor that she did not anticipate these data being left out of the revised tables.  She also noted some differences in rates of combined terms without mention of whether the differences were statistically significant.  She gave an example of this: in the table for the post infant series, the rate of wheezing was 14.3 in the 13vPnC group and 12.5 in the Prevnar group, but it is not noted whether the difference is statistical.  She requested that the tables be revised to include safety data from studies 009 and 3000.  The sponsor agreed to resubmit the updated tables to include safety data from studies 009 and 3000.