OAN Staff Cory Hawkins
2:37 PM – Friday, December 12, 2025
According to new report, the U.S. Food and Drug Administration (FDA) intends to add a “black box” warning, the agency’s most severe safety alert, to mRNA COVID-19 vaccines, potentially by the end of the year.
The FDA is an agency within the Department of Health and Human Services (HHS), run by Secretary Robert F. Kennedy. The FDA Commissioner reports to the HHS Secretary.
Meanwhile, if the incoming reports prove true, the upcoming “black box” warning would highlight risks like serious possible side effects, such as myocarditis or sudden unexpected deaths, to be weighed against benefits. However, the plan is not yet finalized and could change — as the FDA has not officially announced the change.
An FDA memo from late November this year stated that after an analysis of 96 VAERS-reported pediatric deaths (2021–2024), at least 10 children died due to the mRNA COVID-19 vaccines, primarily via myocarditis. The memo, by Dr. Vinay Prasad, FDA’s chief medical officer, an internal review of those 96 reports concluded “no fewer than 10” were related to vaccination.
Nonetheless, many heath experts have since argued that there is no basis for the warning.
A black box warning, or boxed warning, typically appears at the top of a medication’s prescription information insert within a black border. It is the most consequential type of warning, designed to inform prescribers of risks, such as life-threatening reactions, that must be carefully considered against the vaccines’ benefits.
Opioids frequently have boxed warnings cautioning abuse, addiction, overdose and death. For example, the acne medication Accutane warns of birth defects when used while pregnant, while ACAM2000, a smallpox vaccine, has a boxed warning about potential heart inflammation and encephalitis.
Two anonymous sources familiar with the matter informed CNN of the FDA’s internal deliberations on adding a “black box” warning to COVID-19 vaccines. The effort is reportedly being led by Dr. Vinay Prasad, the FDA’s chief medical and scientific officer, though the plans remain preliminary and unconfirmed.
It is unclear whether the plans for the warnings would be applied solely to mRNA COVID-19 vaccines, or to all COVID-related vaccines, or whether they would apply to a specific age group. All information is expected to be released by the end of the year, the anonymous sources claimed.
Three vaccines are approved by the FDA for use in the U.S. Two out of the three, Pfizer and Moderna’s variants, use mRNA technology — which has been the key focus of the FDA’s boxed warning.
“Unless the FDA announces it, any claim about what it will do is pure speculation,” U.S. Department of Health and Human Services (HHS) spokesperson Andrew Nixon said Thursday.
President Donald Trump has frequently criticized the volume of childhood vaccines. In September this year, Trump suggested spacing out or separating shots like MMR (Measles, Mumps, and Rubella).
“Vaccines are very interesting,” the President stated. “They can be great, but when you put the wrong stuff in them, you know… And, you know, children get these massive vaccines like you’d give to a horse…”
“And I’ve said for a long time, I mean, this is no secret – spread them out over five years. Get five shots, small ones. Did you ever see what they give? I mean, for a little baby to be injected with that much fluid, even beyond the actual ingredients, they have sometimes 80 different vaccines in them. It’s crazy.”
“You know that’s a common sense thing too… It’s like you’re shooting up a horse. You have a little body, a little baby, and you’re pumping this big thing. It’s a horrible thing. So I’ve always felt that,” he continued.
Dr. Aaron Kesselheim, director of Harvard University’s Program on Regulation, Therapeutics and Law, noted that black box warnings are typically issued after a formal investigation — either by the manufacturer or the FDA — and often involve convening an advisory committee for public review.
He expressed concern that none of these standard steps appear to have been followed in this case.
“I guess my concern is that in this case, there’s not a process,” Kesselheim said in an interview. “There isn’t that same opportunity for discussion and good-faith review of the data on which this decision is being made.”
“My concern is that this will be seen as yet another in the long line of decisions that this FDA is making based on its own political goals, rather than after a dutiful and thoughtful and public review of the science.”
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