Vaccine
Volume 28, Issue 44 pp. 7137-7240 (18 October 2010)

Regular Articles
Design of a robust infrastructure to monitor the safety of the pandemic A(H1N1) 2009 vaccination program in Taiwan
Original Research Article
Pages 7161-7166
Wan-Ting Huang, Wen-Wen Chen, Hsu-Wen Yang, Wan-Chin Chen, Yen-Nan Chao, Yu-Wen Huang, Jen-Hsiang Chuang, Hsu-Sung Kuo

Abstract
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.