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

Vaccine. 2010 Oct 18;28(44):7161-6. doi: 10.1016/j.vaccine.2010.08.069. Epub 2010 Sep 15.

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adverse Drug Reaction Reporting Systems / organization & administration*
  • Disease Outbreaks / prevention & control*
  • Humans
  • Influenza A Virus, H1N1 Subtype
  • Influenza Vaccines / adverse effects*
  • Influenza, Human / epidemiology
  • Influenza, Human / prevention & control*
  • Mass Vaccination / organization & administration
  • Product Surveillance, Postmarketing / methods*
  • Taiwan / epidemiology

Substances

  • Influenza Vaccines