摘要：In 2007 the National Vaccine Program, along with the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institutes of Health, and the Health Resources and Services Administration, sponsored a public conference titled “Vaccine Safety Evaluation: Post Marketing Surveillance.” The objective was to discuss enhanced approaches to postlicensure evaluation of vaccine safety, including active and passive surveillance systems and special studies. The conference participants reviewed the evolution of the assessment of vaccine safety, detailed current national approaches to postmarketing safety, and offered new approaches to evaluating vaccine safety. A number of the participants recommended that information systems be expanded to include reliable information on vaccination and health outcomes in large populations. We summarize the major meeting presentations and discussions. Preventing infectious diseases through immunization programs is critically dependent on ensuring the safety of vaccines and effectively communicating their benefits and risks. Vaccine-preventable diseases are rare when vaccines are effective and high coverage levels are sustained. Ironically, the decline in disease resulting from the success of vaccines often contributes to a concurrent increase in the visibility of and public concerns about vaccine-associated adverse events. Prelicensure clinical trials can demonstrate that most adverse events associated with licensed vaccines are minor and that serious adverse events are not common. However, rare, serious events are much less likely to be detected before licensure, even in relatively large clinical trials. It is important to be able to determine whether vaccines cause such events after licensure. If a serious adverse event is causally related to a vaccine, the balance between vaccine benefits and risks could shift, possibly leading to changes in recommendations for vaccination or stimulating efforts to improve vaccine safety. Robust safety studies that convincingly demonstrate that a causal relationship is unlikely should help maintain confidence in vaccine programs. In 2007, the National Vaccine Program, in conjunction with the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institutes of Health, and the Health Resources and Services Administration sponsored a public conference titled “Vaccine Safety Evaluation: Post Marketing Surveillance.” The objective of the conference was to discuss enhanced approaches to postlicensure evaluation of vaccine safety, including active and passive surveillance systems and special studies. The participants reviewed the evolution of vaccine safety assessments, detailed current national approaches to postmarketing safety, and offered new approaches to evaluating vaccine safety. Transcripts and slides from the conference are available at http://www.hhs.gov/nvpo .
