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

@article{Nguyen2012TheFA,
  title={The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise.},
  author={Michael D. Nguyen and Robert Ball and Karen Midthun and Tracy A. Lieu},
  journal={Pharmacoepidemiology and drug safety},
  year={2012},
  volume={21 Suppl 1},
  pages={
          291-7
        }
}
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… CONTINUE READING

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