What would an ideal post licensure vaccine safety system be?
This meeting addressed the evolution of the assessment of vaccine safety, the current approaches to post-marketing safety evaluation, and opportunities for making advances and developing innovative approaches. Presenters represented FDA, CDC, HRSA, NIH, NVPO, the vaccine industry, the international public health community and their regulatory agencies, the clinical community, academic medicine, HMOs and group health organizations, parental groups, vaccine advocacy groups. The objective of the workshop was to enhance approaches to the evaluation of vaccine safety once a vaccine has been licensed and is in use through a discussion of methodologies, opportunities and limitations. The meeting included discussion of current methods, study designs, including meta-analyses, case-control, prospective and cohort studies; new approaches and novel designs; techniques used by international regulatory agencies and other countries; hypotheses that each study design in use can and cannot address; and
