FDA Opts Out of Widely Condemned Plan for “Black Box” Warnings on COVID Shots
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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.
Among the agency leaders who decided that the designation isn’t necessary is noted anti-vaxxer........





















Toi Staff
Sabine Sterk
Penny S. Tee
Gideon Levy
Waka Ikeda
Grant Arthur Gochin