Design of a robust infrastructure to monitor the safety of the pandemic A(H1N1) 2009 vaccination program in Taiwan

On November 1, 2009, Taiwan began a nationwide pandemic A(H1N1) 2009 vaccine (H1N1 vaccine) program to control the influenza pandemic. Timely assessment of immunization safety during this mass vaccination campaign was a public health priority. Therefore, the government developed a national postlicensure safety surveillance strategy to identify and evaluate new, unexpected, or prioritized adverse events in recipients of H1N1 vaccine in near real-time. We describe the design and methodology of this new safety assessment infrastructure, address challenges encountered, and its potential future use for routine vaccine pharmacovigilance in Taiwan. (C) 2010 Elsevier Ltd. All rights reserved.