The US FDA is reportedly considering adding a "black box" warning, the highest level of warning, for COVID-19 vaccines

According to a report by CNN, the U.S. Food and Drug Administration (FDA) is preparing to add a "black box" warning to COVID-19 vaccines. Sources reveal that FDA vaccine director Vinay Prasad is leading the efforts to adjust vaccine safety information. The "black box" is the highest level of warning for prescription drugs, primarily used to indicate adverse reactions that may lead to death or serious injury, typically displayed prominently in a black box on drug packaging.

An FDA spokesperson stated that any related claims are "pure speculation" until the agency makes an official announcement.

U.S. Secretary of Health and Human Services Xavier Becerra has recently challenged several existing vaccine guidelines and frequently questioned the safety of COVID-19 vaccines