Vaccines, Blood & Biologics
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3/17/2008 Telecon 2 - Rotarix
|DATE:||March 17, 2008|
|FROM:||Laraine S. Henchal, Microbiologist Reviewer, DVRPA, CBER, Review Committee Chair, STN 125265/0|
|SUBJECT:||Second telecon to discuss the the potency release specifications for STN #125265/0, Rotarix®, Rotavirus Vaccine, Live, Oral from GlaxoSmithKline Biologicals|
This meeting was held to discuss GSK's March 7, 2008 response to the previous meeting held on February 29, 2008. The lot release potency specification now proposed by GSK is to release final product at a titer of ---------------------------------------------------------. End-of expiry titer is then stated as --------------------------- Requested dating period is -- months.
We don't consider the response to be satisfactory. It appears from what was submitted that the variability of the potency assay is actually around --- and not ---, which had been cited previously. The maximum titer at release should still not exceed the maximum titer that was studied in the clinical trials, therefore ----- should be the maximum for Iot release (thereby assuring with 95% confidence that the material's potency does not exceed --- given the --- variability). The lower end-of-expiry is harder to deal with due to the lack of data points. Does GSK have additional data on lots for stability? Yes, they do, but thought that they were only able to include stability for the actual lots used for the Phase 3 clinical studies. CBER replied that GSK can use any number of lots prepared with the same manufacturing process that will be licensed. GSK replied that they will have much more additional information to provide us on the stability in that case. CBER emphasized that the stability needs to be evaluated appropriately with statistical analysis of the regression line, slope and the standard error of the slope line. This will give us a better handle on the loss of potency over time. But it may be that the end expiry titer will be in the ----------- range.
GSK agreed to reconsider their specifications and will submit an additional data on the stability and a re-analysis of the data.