SURPRISE, NOT: FDA Rejects Black Box Warning for COVID Shots Despite Internal Recommendation

The black box is the FDA’s highest level of warning. COVID vaccines won’t be getting it.

Dec 16, 2025

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The FDA will not add a “black box” warning, the agency’s highest safety alert, to COVID-19 vaccines, according to Commissioner Dr. Marty Makary.

The decision comes despite an internal recommendation from an FDA safety and epidemiology center and follows reports acknowledging vaccine-related myocarditis risk, particularly in young males.

Makary argues that earlier safety findings stemmed from a now-abandoned dosing schedule and should not be extrapolated to today’s annual shots.

Critics, however, point to documented adverse outcomes, including deaths under FDA review, and question why the strongest warning remains off the table.

FDA Not Adding ‘Black Box’ Warning to COVID-19 Vaccines: Commissioner

By Zachary Stieber December 15, 2025

The Food and Drug Administration is not adding “black box” warnings to COVID-19 vaccines, even though an agency center recommended it, FDA commissioner Dr. Marty Makary said on Dec. 15

“When it comes to the ‘black box’ warning, we have no plans to put that on the COVID vaccine,” Makary said during an appearance on Bloomberg Television.

Black box warnings are the highest safety-related warnings that FDA officials can place on products. Scenarios warranting their usage include when there is an adverse reaction so serious that it is “essential that it be considered in assessing the risks and benefits of using the drug” or when there is a serious adverse reaction that can be prevented or reduced by appropriate use of the drug, according to FDA documents.

The announcement comes several weeks after FDA officials reported deaths of children following COVID-19 vaccination and concluded that at least 10 deaths were related to the vaccines, according to a November memorandum obtained by The Epoch Times. The review, which included looking at autopsies, has been broadened to other age groups.

The announcement also came several months after regulators updated language on the vaccine labels for a form of heart inflammation called myocarditis. The inflammation was discovered after the FDA first authorized COVID-19 vaccines in December 2020. The updated labels state that the highest observed risk of myocarditis was among young males aged 12 to 24 after receipt of vaccines from Pfizer-BioNTech and Moderna.

Makary said Monday that an FDA safety and epidemiology center did recommend adding a black box warning to the COVID-19 vaccines, and indicated the recommendation stemmed from the risk of myocarditis.

But, he said, Dr. Vinay Prasad, the agency’s top vaccine official, and other FDA leaders opted against accepting the recommendation because the dosage people are receiving has changed from the original two doses within weeks or months of each other.

“When you have those two doses three months apart, that’s when you see the side effects go way up, like myocarditis in young people,” Makary said on Bloomberg. “Now that it’s annual, you may not see that same prevalence. So we don’t want to extrapolate findings to today if it’s not transferable.”

COVID-19 vaccines had been cleared and recommended for virtually all Americans until Trump administration officials took a series of steps to narrow the clearance and recommendations. They are now only advised on an annual basis after consulting with a health care professional and taking into account various factors, including whether people have characteristics such as obesity that could put them at higher risk of severe problems if they contract COVID-19.

Moderna and Pfizer have said their vaccines protect people and have favorable safety profiles, a position also held by some groups such as the American Academy of Pediatrics. The academy counts Pfizer and Moderna among its partners.

Other experts and advocates have called for the removal of COVID-19 vaccines.

Dr. Robert Redfield, former director of the Centers for Disease Control and Prevention, recently told The Epoch Times that clearance for them should be withdrawn because the spike protein they deliver is immunotoxic, and that he would not be surprised if, after the FDA finished its investigation, regulators placed a black box on the shots.

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