The Food and Drug Administration is not adding “black box” warnings to COVID-19 vaccines, even though an agency center recommended it, FDA commissioner Dr. Marty Makary said on Dec. 15
“When it comes to the ‘black box’ warning, we have no plans to put that on the COVID vaccine,” Makary said during an appearance on Bloomberg Television.
Black box warnings are the highest safety-related warnings that FDA officials can place on products. Scenarios warranting their usage include when there is an adverse reaction so serious that it is “essential that it be considered in assessing the risks and benefits of using the drug” or when there is a serious adverse reaction that can be prevented or reduced by appropriate use of the drug, according to FDA documents….