title: Success of program linking data sources to monitor H1N1 vaccine safety points to potential for even broader safety surveillance.
abstract: In response to the 2009 H1N1 pandemic and subsequent vaccination program, the Department of Health and Human Services and collaborators developed the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Program as a demonstration project to detect rare adverse events rapidly. The program monitored three million people who had received the H1N1 vaccine by linking data from large private health plans and from public immunization registries that had originally not been designed to share data, and on a larger scale than had been previously attempted. The program generated safety data in two weeks rather than three to six monty 10ths-the standard time frame achievable using health plan data. PRISM substantially contributed to the understanding of the safety of H1N1 vaccines. Its use in the case of H1N1 highlights the necessity of proactive planning, scalable infrastructure, and public-private partnerships in tracking adverse events after vaccination in epidemics. It also illustrates how data could be integrated to produce policy-relevant information for other medical products.
authors.affiliation: Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA. dsalmon@jhsph.edu
authors.forename: Daniel
authors.initials: D
authors.lastname: Salmon
authors.forename: W Katherine
authors.initials: WK
authors.lastname: Yih
authors.forename: Grace
authors.initials: G
authors.lastname: Lee
authors.forename: Robert
authors.initials: R
authors.lastname: Rosofsky
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Brown
authors.forename: Kirsten
authors.initials: K
authors.lastname: Vannice
authors.forename: Jerome
authors.initials: J
authors.lastname: Tokars
authors.forename: James
authors.initials: J
authors.lastname: Roddy
authors.forename: Robert
authors.initials: R
authors.lastname: Ball
authors.forename: Bruce
authors.initials: B
authors.lastname: Gellin
authors.forename: Nicole
authors.initials: N
authors.lastname: Lurie
authors.forename: Howard
authors.initials: H
authors.lastname: Koh
authors.forename: Richard
authors.initials: R
authors.lastname: Platt
authors.forename: Tracy
authors.initials: T
authors.lastname: Lieu
mesh_terms: D016208:Databases, Factual; D005260:Female; D006801:Humans; D017589:Immunization Programs; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects*; D007251:Influenza, Human / Q000453:epidemiology / Q000517:prevention & control*; D008297:Male; D032541:Mass Vaccination / Q000458:organization & administration*; D008991:Monitoring, Physiologic; D058873:Pandemics / Q000517:prevention & control*; D061214:Patient Safety; D011358:Product Surveillance, Postmarketing; D015397:Program Evaluation; D011634:Public Health; D014481:United States; D014483:United States Dept. of Health and Human Services
chemical_list: D007252:Influenza Vaccines