FDAnews Drug Daily Bulletin


April 28, 2006

The FDA is withdrawing revisions to its Vaccine Adverse Event Reporting System form, a recent Federal Register notice says.

The agency had originally implemented changes to the form, known as VAERS-2, in November 2001 in an effort to facilitate electronic reporting by deleting fields that the FDA considered redundant or unnecessary. The notice provided no explanation for this withdrawal other than to say that the agency "is no longer pursuing changes to the form."

The Vaccine Adverse Event Reporting System is a cooperative program for vaccine safety of the FDA and the Centers for Disease Control and Prevention. VAERS is a postmarketing safety surveillance program collecting information about adverse events (side effects) that occur after the administration of U.S. licensed vaccines.

The notice is available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/01n-0464-nwl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/01n-0464-nwl0001.pdf).