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Vaccines, Blood & Biologics

Record of Telephone Conversation - December 3, 2009-1 - Prevnar 13

System Info - 120220  SMITH, MICHAEL J  17-Feb-2010 12:06:37  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:  03-DEC-2009 12:00 PM               Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):


Telecon Summary:
Outstanding CMC issues and expected CMC PMC's

FDA Participants:   Erik Henchal, Theresa Finn, Wellington Sun, Bill McCormick, Rajesh Gupta, Mike Smith, Julie Vaillancourt, Tina Roecklein, John Cipollo, Milan Blake      

Non-FDA Participants:    Kathrin Jansen, Jack Love, Carmel Devlin, Kathy Kofsky, Emilio Emini, Barry Caplan, Dave Zisa, Paul Rolfing, Rich Pelt

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

Record of Teleconference

Date/Time:                 December 3, 2009, 12 noon- 2:00 PM
STN:                           125324
Product:                     Prevnar 13
Sponsor:                     Wyeth
Purpose of Telecon:  Stability Indicating Assay and Other Outstanding CMC Issues & PMCs
CBER Participants: 
WOC-1:                      Erik Henchal, Theresa Finn, Wellington Sun, Bill McCormick, Rajesh Gupta, Mike Smith, Julie Vaillancourt
Bldg 29:                      Tina Roecklein, John Cipollo, Milan Blake   

Sponsor Participants:
Pear River:                  Kathrin Jansen, Jack Love, Carmel Devlin, Kathy Kofsky
Collegeville:                Emilio Emini, Barry Caplan, Dave Zisa
Sanford:                      Paul Rolfing, Rich Pelt

References:                1) 12/2/2009 e-mail from J. Vaillancourt to J. Love & C. Devlin w/ subject: Discussion Items for 3 December telecon at 12 noon

2) 12/3/2009 e-mail from J. Vaillancourt to J. Love & C Devlin w/Subject: Document with outstanding CMC issues and expected CMC PMCs


CBER stated that the primary purpose for requesting the teleconference was to understand why the sponsor is confident that the conjugate will remain intact throughout the duration of the proposed dating period, given the present lack of a stability indicating assay.  CBER explained that although development of a suitable assay and establishment of a specification for conjugate in final drug product will be a post marketing commitment, the Agency must assure that available data support conjugate integrity for the proposed dating period to support licensure.

CBER explained that the document with draft review comments, provided via e-mail on December 2, 2009, was to be used as background material for this discussion and that CBER did not expect the sponsor to respond to the comments one-by-one during the call.  In addition, CBER noted that the document, titled “BLA 125324 Outstanding CMC Issues and Expected CMC PMCs,” which was sent earlier in the day on December 3, 2009, listed additional items (i.e., items 3, 4 and 6a), that CBER would like to discuss with the sponsor during the call, if time permits.


1.         --(b)(4--

The sponsor noted that if CBER accepts --(b)(4-- as a reasonable release test for conjugate in FDP, then the sponsor has data (which have been submitted to the BLA) that demonstrate that the conjugate is relatively stable for the following conditions:

  • 3 lots @ 2-8°C for 24 months;
  • ---(b)(4)-----accelerated stability testing ---(b)(4------------ months.

The sponsor reviewed the data submitted to the BLA on October 8, 2009 (amendment 37) to support ---(b)(4)---- as a stability indicating assay.   The sponsor explained that the experiments conducted in follow-up to CBER’s September 1, 2009, request for such data, addressed possible conjugate --------------------(b)(4)-----------------------------

-----------------------------------------------------------------------------------------------------------------------------------------------.  The sponsor clarified that the experiments conducted were preliminary and demonstrated how ---(b)(4)--- can be used as a qualitative assay.  CBER concurred with the sponsor that efforts in further developing this assay for use as a stability indicating assay should focus on transforming it from a qualitative assay to a quantitative assay.

CBER acknowledged that the sponsor fulfilled the September 1, 2009, agreement to provide data to support --(b)(4)-- as a suitable stability indication assay.  However, CBER raised a number of questions concerning the quantitative capabilities and limitations of the assay.  CBER acknowledged that the next step would be for the sponsor to conduct additional experiments that would address the questions and concerns about the assay’s quantitative capabilities, as well as validation of the assay.  This would be done as part of the overall post marketing commitment to develop and validate --(b)(4)-- and establish a release specification using the assay.

2.         Explanation of ----(b)(4)---- Inconsistencies Regarding Lot ----(b)(4)---- 

The sponsor provided an explanation to CBER’s request for clarification concerning identified inconsistencies between ---------------(b)(4)--------------------------------------------------------for lot number ------(b)(4)------ (from page 45 of BLA Section 3.2.P.5.6), as communicated via e-mail to the sponsor on September 21, 2009, in follow-up to related discussion during the September 1, 2009, face-to-face meeting. (See attachment 1, item 8).  CBER requested that the sponsor submit the explanation in writing to the BLA.  The sponsor agreed to do so on early in the week of December 7, 2009.


3.          Additional Outstanding CMC Issues and Expected PMCs

The sponsor briefly responded to the following outstanding issues, which were itemized in the document sent via e-mail to the sponsor earlier in the day on December 3, 2009, as follows (see attachment 2):


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


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


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


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



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


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


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


4.           Expected CMC PMC’s to Date are listed in the E-mail attachment J. Vaillancourt sent to J. Love and C. Devlin on December 3, 2009.

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

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