Multiple U.S. media outlets have reported conflicting information about the Food and Drug Administration’s decision to place black-box warning labels on COVID-19 vaccines. The FDA has not published a formal decision or documentation confirming either account. The FDA commissioner told reporters the agency would not add the warnings.
On December 12, CNN reported that the U.S. Food and Drug Administration was planning to put a “black box” warning on COVID-19 vaccines, citing two anonymous sources.
“The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans, the latest move by President Donald Trump’s health officials to undermine a vaccine that was a standout victory of his first term. The plan shocked outside experts, who said there was no basis for the warning,” CNN reported.
Boxed warnings are the FDA’s most serious safety alerts. According to agency guidance, they are reserved for drugs or medical products associated with serious or life-threatening risks, or where restricting use can reduce those risks.
Straight Arrow News also reported the development, citing the CNN article.
“The Food and Drug Administration intends to add a “black box” warning to COVID-19 vaccines in the Trump administration’s latest attempt to question the safety and effectiveness of widely accepted vaccinations, according to a CNN report,” Straight Arrow News reported.
Three days later, Bloomberg News reported that the agency had no plans to add these warnings to COVID-19 vaccines, citing FDA commissioner Marty Makary.
“The US Food and Drug Administration has no plans to put a “black box” warning on Covid vaccines, the agency’s top official said, despite a recent report that US regulators were preparing to add a new caution to the immunizations<” Bloomberg News reported.
“Some agency officials had recommended putting a boxed warning on the shots, Makary said. But some scientists and agency leaders, including the top vaccine regulator Vinay Prasad, didn’t think it was necessary because of the changing risks,” the article also said.
Multiple other outlets — including Reuters and The Hill — cited the Bloomberg article in their reporting.
On December 17, Rheumatology Advisor, a medical trade publication, reported that the FDA was considering adding boxed warnings.
Current status
The FDA has not published a press release regarding its decision. The FDA commissioner’s public comments are the closest on-the-record indication of the agency’s position, but no formal decision has been published.
