FDA to add ‘black box’ warning to COVID vaccines, report says
The U.S. Food and Drug Administration (FDA) intends to add a “black box” warning to COVID-19 shots before the end of the year. Such labels are the strongest safety alert the agency can add to pharmaceuticals, one where serious risks to patient health and safety are noted and must be taken into consideration before a drug is prescribed.
CNN was the first to report the news, citing two sources familiar with the FDA’s plan. As the outlet noted, President Donald Trump has said repeatedly that “Operation Warpseed”—a program spearheaded by his administration in 2020 to develop, approve and distribute a vaccine against COVID—was one of his proudest accomplishments during his first term.
As CNN noted, adding such an ominous warning—which would be placed above all prescribing information and force providers to make a risk-benefit analysis for every—would undermine that accomplishment. However, the specifics of what the new labeling will say, and whether or not it’s even coming, remains to be seen.
Unconfirmed report
When asked for comment, a spokesperson for the U.S. Department of Health and Human Services (HHS) called the story “pure speculation.”
The supposed policy shift is said to be backed by Vinay Prasad, MD, chief medical and scientific officer at the FDA. In May, he and the agency’s commissioner, Martin Makary, MD penned a letter calling for stricter recommendations on COVID shots, particularly an end to seasonal boosters for anyone not deemed at high-risk of developing serious illness.
Shortly after, the Centers for Disease Control and Prevention stopped recommending that "healthy" pregnant women get the vaccine, citing a lack of evidence for efficacy.
Whether or not Prasad is actually involved with this potential labeling measure is unknown, as he is not quoted in CNN’s report. In general, there are still a lot of questions left to be answered, namely what the black box warning will say and if it will be applied to all COVID inoculations on the market.
This is a developing story. If CNN’s timeline is correct, we should know more in the next couple of weeks.
Read their full report by clicking here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.