Speaker Abstract: S-31
The Vaccine Adverse Event Reporting System - A Tool for Safety and Surveillance
Jane Woo, M.D., M.P.H., Center for Biologics Evaluation & Research/FDA
Vaccines are the foundation of public health disease prevention programs. They are highly effective and extremely safe. Before widespread childhood immunization programs were implemented, most children experienced one or more serious infectious diseases and many suffered severe sequelae; because the diseases were feared, vaccines that prevented these diseases were widely accepted. With these diseases now controlled by vaccination and thus rarely observed, there is a greater focus on safety of vaccination itself. Because of the large target population for vaccines, some serious medical events will inevitably occur coincidentally after immunization. Ascertaining the likelihood of a causal connection of such an event with a vaccine is often impossible. Each year, the FDA's Vaccine Adverse Event Reporting System (VAERS) receives 15,000 reports of possible adverse events after vaccination. Most of the events are minor and transient. Medical officers review reports of serious events in order to look for new or unusual patterns that could suggest a plausible link of an event to a vaccine. Although VAERS has all the limitations of passive surveillance systems, its data have been used to provide important information about new vaccines and rare but serious adverse events. Surveillance with VAERS allows the FDA to reassure the public that vaccines are safe and to identify topics which need further research.
2004 FDA Science Forum | FDA Chapter, Sigma Xi | CFSAN | FDA
Last updated on 2004-MAY-28 by frf