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Vaccines, Blood & Biologics

Memo on Amendment for BLA STN 125324/0.50

DATE:            17 February 2010


FROM:            Milan S. Blake, Ph.D., HFM-425

Director, Division of Bacterial, Parasitic and Allergenic Products, OVRR


SUBJECT:      STN 125324/0.50


TO:                  Julienne Vaillancourt, R.Ph., M.P.H.,

                        Chairperson, STN 125324


THROUGH:   Norman W. Baylor, Ph.D., Director, OVRR




Amendment 50 of this BLA was submitted on 12 November 2009.  The subject of this amendment is Pfizer Inc’s (formerly Wyeth Pharmaceuticals Inc.) response to four recommendations made to the firm during a BiMo inspection.  I have reviewed each of the four responses to our recommendations and each appear to be a reasonable solution to a potential risk.   The long term plan for securing the raw data from both the ELISA and OPA clinical assays is to make a ----------------------------------------------------(b)(4)-----------------------------------------------------------------------------------------------------------------------------------------------------------------. The sponsor has also made changes to their preventative maintence schedules to include documentation and rationale for the change.  In addition, a plan to ----------------------------------------------------(b)(4)-----------------------------.  Finally, the sponsor has revised their SOP to state that the Laboratory Deviation Report (LDR) tracking database should be updated on a real time basis, and for any event no later than (b)(4) business days after closing an investigation.




A Bioresearch Monitoring (BIMO) inspection in support of Biological License Application 125324/0 was conducted between 29 June 2009 and 2 July 2009 at Wyeth Research and Clinical Testing and Assay Development Laboratory (Building #(b)(4)) which is a Division of Wyeth Pharmaceuticals, Inc.  Both are located on the same campus in Pearl River, NY.   The findings of this inspection revealed that both the IgG and OPA’s immunogenicity assays were validated to support the endpoints in the clinical evaluation of the 13-valent pneumococcal conjugate (13vPnC) vaccine. However, our inspection revealed that the security of the raw data from both the ELISA and OPA assays was not maintained.  As the raw data was transferred from the clinical testing laboratories to clinical data management, at least 16 individuals had the potential to access the raw data and modify the results without audit trails or notification.  The data were not compared between the two data sets to ensure exactness.  Recommendations for improvement in the firm’s laboratory operations were also discussed and included: documenting procedure changes as part of change control; performing periodic challenges to the -(b)(4) freezer monitoring system; and, entering closure dates of the OPA deviation reports in a timelier manner.



I have reviewed amendment 50 which includes the responses to our recommendations during the BIMO inspection and find them to be a reasonable solution to a potential risk.   No further action is necessary.

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