The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise.

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.

Evaluating the safety of new vaccines: summary of a workshop.

Public concerns about the safety of vaccines arise on a regular basis. In November 2000, a workshop titled "Evaluation of New Vaccines: How Much Safety Data?" was convened by US Public Health Service agencies, including the Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration, to discuss appropriate methods for evaluating the safety of new vaccines. Workshop presentations addressed the current standards and approaches for new vaccine evaluation and postlicensure surveillance, as well as public views about vaccine safety and alternative approaches that could be considered. The advantages and disadvantages of conducting large controlled trials before licensure or widespread use of a new vaccine were discussed. We summarize these presentations and discussions.

Getting the science right and doing the right science in vaccine safety.

Because of the potential for conflicts of interest, Salmon et al. propose in this issue the creation of an independent vaccine safety board to assume responsibility for assessing the safety of licensed vaccines.We believe that the current system at the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) facilitates needed interactions between those involved in risk assessment and risk management, provides substantial safeguards against conflicts of interest, and results in sound decisions. The CDC, given its role in promoting immunization, may be perceived to have a greater potential conflict and plans to review its vaccine safety activities. Both agencies recognize the importance of transparency in considering vaccine safety and welcome the opportunity to work with the public and the medical community to improve the quality of scientific information and decisionmaking.