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.
Huang
Wan-Ting
WT
Taiwan Centers for Disease Control, 6, Linsen S. Road, Taipei City 10050, Taiwan. muagi@cdc.gov.tw
Chen
Wen-Wen
WW
Yang
Hsu-Wen
HW
Chen
Wan-Chin
WC
Chao
Yen-Nan
YN
Huang
Yu-Wen
YW
Chuang
Jen-Hsiang
JH
Kuo
Hsu-Sung
HS
D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D004196:Disease Outbreaks / Q000517:prevention & control*; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype; D007252:Influenza Vaccines / Q000009:adverse effects*; D007251:Influenza, Human / Q000453:epidemiology / Q000517:prevention & control*; D032541:Mass Vaccination / Q000458:organization & administration; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D013624:Taiwan / Q000453:epidemiology
D007252:Influenza Vaccines