FDA May Add Black Box Warning to COVID Shots, According to Reports
The FDA is reportedly preparing to place its most serious safety warning — a black box (boxed) warning — on COVID-19 shots, according to a CNN report cited by Reuters.
A black box warning is the strongest warning the FDA can require and is reserved for medical products associated with serious or life-threatening risks.
What Is Being Reported
According to Reuters, the move is being led by senior FDA officials and remains under internal review. While no final decision has been announced, the warning could be issued as early as the end of the year.
Key points reported by Reuters include:
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A black box warning would signal significant safety concerns
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The warning is still under review and could change
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It is not yet clear:
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Which COVID shots would be affected
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Whether the warning would apply to mRNA products only or all COVID shots
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The FDA and U.S. Department of Health and Human Services have not publicly confirmed the details
Safety Concerns Under Review
Reuters reported that an internal FDA memo suggested COVID shots may have contributed to at least 10 pediatric deaths linked to heart inflammation between 2021 and 2024. These findings have not been released publicly or peer-reviewed.
Additional concerns cited in reporting include:
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Myocarditis and other forms of heart inflammation
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Reports of serious adverse events following COVID shots
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Ongoing internal FDA investigations into vaccine-associated deaths, now reportedly expanded to include adults
What CHD Has Reported
According to The Defender, Children’s Health Defense and independent experts have long raised concerns about COVID shot safety, particularly for children and young adults.
Points highlighted by CHD include:
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Black box warnings are long overdue
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Known risks such as myocarditis were not adequately disclosed during rollout
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Post-marketing surveillance has identified serious adverse events
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Informed consent has been undermined by limited risk communication
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Emergency and later approvals occurred without long-term safety data
CHD researchers argue that a black box warning, while significant, may still fall short of fully addressing the scope of reported harms.
Why a Black Box Warning Matters
Black box warnings:
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Appear prominently on drug and biological product labels
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Are intended to alert healthcare providers and patients to serious risks
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Can influence clinical decision-making and patient consent
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Often prompt renewed scrutiny of a product’s risk-benefit profile
For COVID shots, such a warning could lead to greater transparency, particularly regarding cardiac risks and other serious adverse effects.
What Comes Next
At this time, no official FDA announcement has been made. If issued, the black box warning would represent one of the strongest acknowledgements to date by U.S. regulators that COVID shots may carry serious risks. Stay tuned!
Sources
Reuters. FDA intends to put most serious warning on COVID vaccines, CNN reports
Children’s Health Defense – The Defender. FDA Considers Black Box Warning for COVID Vaccines After Reports of Serious Adverse Effects
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