title: The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise.
abstract: In 2009, the Department of Health and Human Services created the new Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program, which used data from national health insurance plans and immunization registries to monitor the safety of the H1N1 influenza vaccine. PRISM has now been integrated into the FDA's Mini-Sentinel pilot program. It strengthens the federal vaccine safety enterprise in two important ways. First, PRISM monitors the largest US general population cohort designated for active surveillance of vaccine safety. Second, PRISM links data from health plans with data from state and city immunization registries, which were a crucial source of exposure data in the H1N1 vaccine evaluation. The Mini-Sentinel data that support PRISM are updated quarterly, and PRISM can conduct medical record review for validation of computerized data. The FDA has structured PRISM as a program that includes specific vaccine evaluations, development of an operational framework to guide the design of vaccine safety evaluations, and development of new statistical methods. A human papillomavirus vaccine, Gardasil, and two rotavirus vaccines, RotaTeq and Rotarix, have been chosen for surveillance in the current cycle because their evaluations would benefit most from PRISM's large cohort size. The PRISM program creates important opportunities by offering a robust, responsive new surveillance program with features complementary to existing systems. Methodological and logistical lessons can be shared among PRISM and other surveillance systems, offering potential synergies. FDA and PRISM will work to maximize the program's unique strengths and contributions to a unified federal vaccine safety enterprise.
authors.affiliation: Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA. michael.nguyen@fda.hhs.gov
authors.forename: Michael
authors.initials: M
authors.lastname: Nguyen
authors.forename: Robert
authors.initials: R
authors.lastname: Ball
authors.forename: Karen
authors.initials: K
authors.lastname: Midthun
authors.forename: Tracy A
authors.initials: TA
authors.lastname: Lieu
mesh_terms: D016208:Databases, Factual / Q000706:statistics & numerical data*; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D007251:Influenza, Human / Q000517:prevention & control; D008498:Medical Record Linkage; D015233:Models, Statistical; D010865:Pilot Projects; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D016730:Program Development; D012042:Registries / Q000706:statistics & numerical data; D014481:United States; D014486:United States Food and Drug Administration; D014612:Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D054928:Validation Studies as Topic
chemical_list: D007252:Influenza Vaccines; D014612:Vaccines