FDA May Slap COVID Vaccines With Black Box Warning, CNN Reports

(Source: Children’s Health Defense)

Black box warnings, also called “boxed” warnings, are the FDA’s most serious warning label, used to indicate that a drug is associated with a serious hazard, often including death or life-threatening reactions. COVID-19 vaccine critics told The Defender the warning comes too late, and that the shots should be pulled from the market.

The U.S. Food and Drug Administration (FDA) may add a “black box” warning to the COVID-19 vaccines, CNN reported today.

CNN cited unnamed FDA officials, who said that Dr. Vinay Prasad, chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, is overseeing the move to add the warnings.

The U.S. Department of Health and Human Services (HHS) declined to confirm the CNN report. “Unless the FDA announces it, any claim about what it will do is pure speculation,” HHS spokesperson Andrew Nixon said.

CNN said the officials didn’t provide specifics, including when the warnings would be issued, which side effects would be named, whether they would apply to all people who may take the drug, if they would be specific to the COVID-19 vaccines, or could refer to all mRNA technology.