Annals of Internal Medicine
15 September 2020 Volume 173, Issue 6
Postmarketing Safety of Vaccines Approved by the U.S. Food and Drug Administration – A Cohort Study
Noam Tau, MD, Dafna Yahav, MD, and Daniel Shepshelovich, MD
Vaccinations are an important public health strategy that has reduced morbidity and mortality from many infectious diseases. Postmarketing surveillance helps to detect vaccine-related adverse events or long-term complications. This cohort study describes the prevalence and types of safety issues reported for vaccines approved by the U.S. Food and Drug Administration between 1996 and 2015.
Over a 20-year period, vaccines were found to be remarkably safe. A large proportion of safety issues were identified through existing postmarketing surveillance programs and were of limited clinical significance. These findings confirm the robustness of the vaccine approval system and postmarketing surveillance.