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Vaccines, Blood & Biologics

Post-Marketing Commitment, Revised Protocol Template and Revised Specifications - Prevnar 13


Date:     March 23, 2010

To:        Administrative file STN 125324 Amendment 0.88

From:    John F. Cipollo Ph. D. CBER/OVRR/DBPAP/LBP

Through: Willie Vann, Ph.D. CBER/OVRR/DBPAP/LBP

Subject: Post – Marketing Commitment (PMC), Revised Protocol Template and Revised Specifications

Action Recommended


Amendment STN 125324/0.88 received 02.18.2010 submitted to the file fully satisfies CBER’s concerns regarding agreement on Lot Release Specifications and rectification of those present in the BLA and those submitted to DPQ as Lot Release Protocol. This Amendment also provides a clear path to the Post Marketing Commitment regarding re-evaluation of --------(b)(4)-------------------------------------------------------------------------------




During discussions between members of DPQ and DBPAP on 02.17.2010 it became clear that some specifications present in the BLA current to 02.17.2010 did not match those present in the Lot Release Protocols submitted to DPQ.  The BLA current to 02.17.2010 did not reflect the most recently agreed upon Specifications and differed from those submitted to DPQ for Lot Release. Some of these specifications, namely ---------(b)(4)--------------------------------------------------------- for a number of serotype conjugates were the subject of a Post Marketing Commitment.  It was imparitive that agreed upon specifications be consistent in both the BLA and Lot Release Protocol submitted to DPQ for lot testing and to make for a clear path to the Post Marketing Commitment regarding the above specifications.


To rectify the situation a conference call occurred on 02.17.2010 between members of CBER and Wyeth. Wyeth agreed to submit an amendment to the file documenting a change in specifications that reflects the current and agreed upon specifications and Lot Release Protocol submitted to DPQ. Wyeth submitted to the file Amendment STN 125324/0.88 received 02.18.2010, which made the required clarifications and contained the a commitment to submit one or more CBE-0 supplements on or before the end of March 2010 for any revised specification all of which will be tighter than ones currently agreed upon.

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