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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, May 14, 2012 - MenHibrix

Submission Type: BLA    Submission ID: 125363/0    Office: OVRR

Product:
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine

Applicant:
GlaxoSmithKline Biologicals

Telecon Date/Time: 14-May-2012 01:00 PM        Initiated by FDA? Yes

Telephone Number: -----b(4)--------------

Communication Categorie(s):
1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary:
Meeting to discuss remaining issues with the LRP and CR Items

FDA Participants: KIRK PRUTZMAN, JOSEPH TEMENAK, DAVID STATEN, TINA ROECKLEIN, WILLIE VANN, RAJESH GUPTA, KAREN CAMPBELL, CATHERINE POOLE

Non-FDA Participants: NORRIS PYLE, JODY GOULD, NANCY CAUWENBERGHS, CATHERINE POTY, CATHERINE VIGANO-WOLFF
Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

CBER and GSK met to discuss the remaining issues regarding the LRP (from the 3-20-2012 IR and GSK’s 5-11-2012 revised LRP) and CMC issues from GSK’s response to CBER’s 5-2-2012 IR.

  1. Regarding Item 2b from the 5-2-2012 IR (reporting of Free TT Content by –b(4)- as a limit of varying results).
    CBER asked for a better explanation of the variability.  GSK explained that the results are a percentage of the –b(4)----- content and the calculation needs to address the protein content of each bulk as the protein content can vary between bulks.  CBER wanted to discuss this internally and get back to GSK.
  2. Regarding the LRP submitted via email from GSK on 5-11-2012 and remaining LRP issues from the 3-20-2012 IR.
    LRP Item 17a from 3/20/2012 IR:  CBER asked GSK to clarify if the specification should be “not more than” or “not less than.”  GSK indicated that the language should be “not more than” and would update it in a revised LRP.
    LRP Item 19d from 3/20/2012 IR:  CBER asked GSK to explain how their PSC content was calculated from the –b(4)- results.  GSK agreed to submit an explanation.
    LRP Item 19e and 19f from 3/20/2012 IR:  CBER indicated that GSK has not responded to these request.  GSK agreed to submit responses. 
    LRP Item 20 from 3/20/2012 IR:  CBER indicated that conjugated material needs to be separated from activated material.
    LRP General Discussion:  CBER requested a table outlining the history as to where the most current information was submitted to the BLA for the test methods and acceptance criteria documented in the LRP.  CBER outlined that it is typical to have all eCTD modules updated with agreements/changes made during the review cycle prior to approval and this would be preferable for MenHibrix.  GSK indicated that they intend to bring the BLA eCTD modules up to date shortly after BLA approval, with a detailed history of where changes were introduced in the review process, similar to what GSK performed for Hiberix.  CBER stated that they would discuss this further internally. 
    CBER asked if the header in the LRP for the specific intermediate or item being tested could be placed at the top of each page instead of just on the first page of each section.  GSK stated they would look into this request and get back to CBER with the answer.
  3. Regarding the demonstration labels that were sent to CBER on May 10, 2012.
    There was some confusion as CBER stated that the vaccine labels had two lot numbers.  CBER asked for re-confirmation that the auxiliary label (that incorporates lot number and expiry dating for combo box) can’t be moved so that it is not used as a tamper-evident seal.  CBER also asked as to how vaccine vials are received by –b(4)---- from Belgium.
    GSK indicated that the pdf of the demonstration labels sent on May 10, 2012 do have just one lot number for the vaccine vial label, vaccine carton label, and the auxiliary label (Lot                             --b(4)---------).  The expiration dating on the auxiliary label is the shortest dating between the diluent and the vaccine.
    GSK re-confirmed that the auxiliary, outer carton sticker-label could not be moved.  GSK indicated that they are moving towards ----b(4)----------------------------------------------------------------------------------------------------------------------------------------- ------------------------------------------------------

    GSK discussed that the vaccine vials that come from –b(4)------- are received in –b(4)------- as unlabeled vials.  –b(4)--------- performs all labelling and packaging for the vaccine. 
  4. Regarding the Approval timeline.
    CBER indicated that the timelines for approval were getting tight and that GSK still had not responded to all of CBER’s requests.  As such, CBER was considering classifying Amendment 31 (submitted 5/9/2012) as a major amendment.  GSK understood and committed to submitting the revised LRP and associated history table on May 16, 2012.