FDA Launches New Consolidated Adverse Event Monitoring System
The U.S. Food and Drug Administration (FDA) has announced the launch of a new Adverse Event Monitoring System (AEMS) that consolidates adverse event reporting systems for different types of products licensed by the FDA, including the Vaccine Adverse Event Reporting System (VAERS) that was created under the 1986 National Childhood Vaccine Injury Act (NCVIA). The […]
FDA Authorizes COVID Bivalent Shots for Children as Young as Five Years Old
On Oct. 12, 2022, the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) of the COVID bivalent booster versions of messenger RNA (mRNA) Comirnaty and Spikevax biologics developed by Pfizer/BioNTech and Moderna/NIAID for children as young as five or six years old, respectively. The FDA’s decision on Aug. 31 to grant […]