Monkey Neurovirulence Safety Testing of GSK Rotarix Vaccine

Date:	March 4, 2008
From:	Philip Snoy DVM Director, Division of Veterinary Services/CBER
Subject:	Monkey Neurovirulence Safety Testing of GSK Rotarix Vaccine DATS Log Number 434317, BLA Amendment Applicant: Glaxosmithkline Biologicals/1617 Product: Rotavirus Vaccine, Live, Oral, Monovalent Application Number: 125265

I have reviewed the neurovirulence data from two lots of rotavirus vaccine presented in Section 4.2.3.7.7 of the original BLA application submission dated June 2 2007. -----------------------, lot ---------------- and lot ---------------- were each tested in ---------------------------- monkeys ------------------------. All test subjects were inoculated with 0.5 ml of vaccine into the left and right side of the thalamus and then observed for 21 days for neurologic signs. The monkeys were then humanely killed and their brains and spinal cords examined histologically for inflammatory lesions. No excessive neurologic signs were seen clinically, and most of the inflammatory lesions seen in the brain were associated with the inoculation tracks near the thalamus. There was no evidence of viral spread to any areas of the spinal cord.

My evaluation is that there is no indication of neurovirulence in either of the two working seed lots of rotavirus vaccine tested.