Vaccines, Blood & Biologics
Resources for You
3/10/2008 Telecon - Rotarix
|DATE:||March 10, 2008, 11:00 AM|
|FROM:||Laraine S. Henchal, Microbiologist Reveiwer, DVRPA, CBER, Review Committee Chair, STN 125265/0|
|SUBJECT:||Telecon in regard to inclusion/exclusion of Neisseria meningitidis assay data from review for BLA for Rotarix®|
I received a call from Milan Blake and Chris Lynch in regard to the necessity for inclusion of Chris's review of the Neisseria meningitidis assay data in the BLA. Since the co-administration of other vaccines study 060 is considered by CBER to be the pivotal co-administration study, and no Neisseria vaccine was administered in that study, we all agreed that it was not necessary to include the assay review in the file.