Pharmacovigilance Plan in BLA Submission - Rotarix

STN: BL 125122

MARCH 14, 2008

MEMORANDUM

TO:	Laraine Henchal, PhD, Division of Vaccines and Related Products Applications (DVRPA), Office of Vaccines Research and Review (OVRR), Chair, BLA 125122 Committee
FROM:	Hector s. Izurieta, MD, MPH, Vaccine Safety Branch (VSB), Division of Epidemiology (DE), Office of Biostatistics and Epidemiology (OBE)
THROUGH:	Robert Ball, MD, MPH, ScM, Chief, VSB, DE, OBE Miles Braun, MD, MPH, Director, DE, OBE
DATE:	March 14, 2008
SUBJECT:	Pharmacovigilance Plan in BLA Submission, 125122 Glaxo

Reference: STN: BL 125122

Sponsor: Glaxo SmithKline, Inc.

This memorandum is to inform you that, based on all communications with the Sponsors and the amendments made to the post-marketing commitments for Glaxo's Biologics License Application (BLA) for the HRV vaccine (Rotarix®), I have no objection with the post-marketing commitments as described in Glaxo's Submission of the risk management plan dated February 29, 2008.

The PostMarketing Commitments include their agreement on an action plan to implement safety surveillance activities, including also a large U.S. post-marketing study, to address mainly the following potential safety concerns: Intussusception, lower respiratory tract infections, Kawasaki disease and convulsions. CBER will negotiate specific timelines for finalization of study protocols, study reports, and completion and submission of final study reports with the manufacturer.