Success of program linking data sources to monitor H1N1 vaccine safety points to potential for even broader safety surveillance

Daniel Salmon, W. Katherine Yih, Grace Lee, Robert Rosofsky, Jeffrey Brown, Kirsten Vannice, Jerome Tokars, James Roddy, Robert Ball, Bruce Gellin, Nicole Lurie, Howard Koh, Richard Platt, Tracy Lieu, Sharon Greene, Melisa Rett, Carolyn Balsbaugh, Charlene Gay, Robert Jin, Renny LiYury Vilk, Ruihua Yin, Shao Zhu, Kevin Fahey, Lauren Grosso, Barbara Lardy, Sara Pescatello, Victor Rhee, Frank Destefano, Julianne Gee, Elizabeth Skillen, Claudia Vellozzi, Eric Weintraub, Rickey Wilson, Patrick Garman, Daniel Foltz, Aurelia Ford, John Manson, Jim Van Dyke, Vik Tandon, Bill Brand, Alan Hinman, Elaine Lowery, Therese Hoyle, Ellen Wild, Joaquim Fernandes, Yihai Liu, Claire Spettell, Cheryl N.Mc Mahill Walraven, Thomas Bunz, Daniel Carmody, Therese Connor, Jason Cooper, Ha Nguyen, Mark Regine, Thomas Stambaugh, Anthony Sumner, Alex Cannon, Diane Cuff, Greg Daniel, Christy Fang, Chris Hetrick, Jenny Li, Lori Meyers, Peter Wahl, Marcus Wilson, Marc Keshishian, Amy Ball, David Nau, Jane Stacy, Yihua Xu, Yinong Young-Xu

Research output: Contribution to journalArticlepeer-review


AbstracIn 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.

Original languageEnglish (US)
Pages (from-to)2518-2527
Number of pages10
JournalHealth Affairs
Issue number11
StatePublished - Nov 2012

ASJC Scopus subject areas

  • Health Policy

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