Postmarketing Safety of Vaccines Approved by the U.S. Food and Drug Administration

The study explored postmarketing safety modifications in U.S. Food and Drug Administration (FDA)–approved vaccine labels.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. Annals of Internal Medicine

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