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Vaccines, Blood & Biologics

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 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.

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