FDA Opts Out of Widely Condemned Plan for "Black Box" Warnings on COVID Shots

"On Monday, the Food and Drug Administration's (FDA) top official Marty Makary announced that the agency has opted not to put "black box" warnings on coronavirus vaccines, despite reports that FDA officials were considering such a move last week. Black box warnings are considered the most serious designation from the FDA. Such warnings are placed on opioid medication, for example, to warn users about the risks of overusing the drug, including addiction, overdose, and death."

"The news that the FDA was considering black box labels for COVID vaccines was widely condemned by medical experts as yet another attempt by the Trump administration to undermine public trust in the vaccine, which studies have consistently shown is safe and effective. Following last week's report, FDA commissioner Marty Makary told Bloomberg News on Monday that the heads of the agency had determined that there isn't a need for the black box warnings after all."

"However, the news comes as Prasad has pursued other avenues to sow distrust in the vaccine. A recently leaked FDA memo, authored by Prasad, announced that the agency would investigate whether there is a link between COVID vaccinations and deaths in the U.S. The memo sparked concerns from medical experts, who noted that many of Prasad's claims are not backed by evidence."

The Food and Drug Administration opted not to place 'black box' warnings on coronavirus vaccines. Black box warnings represent the FDA's most serious safety designation and are used to highlight risks such as addiction, overdose, or death. Reports that the agency was considering such warnings prompted widespread condemnation from medical experts and raised concerns about undermining public trust in vaccination. FDA commissioner Marty Makary said agency leaders determined the warnings were unnecessary. Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, pursued an inquiry and authored a leaked memo proposing investigation of a possible link between COVID vaccinations and deaths, which experts say lacks supporting evidence.

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