The move would follow the agency’s blockbuster letter on Friday linking the shots to at least 10 child and adolescent deaths. Completely blocking their use in young people is another possibility.

ALEX BERENSON – DEC 1, 2025

BREAKING

The Food and Drug Administration may soon place a so-called “black box” warning on mRNA Covid vaccines to alert physicians and parents of their link to childhood deaths.

A black box warning is the strictest the agency can impose. It is generally the last step the agency takes before forcing a manufacturer to stop selling a drug or vaccine. The FDA is also considering that alternative — forcing Moderna and Pfizer, which make the Covid jabs, to stop selling them to kids and teens.

The potential move follows the FDA’s report on Friday that its reviewers had found Covid mRNA jabs killed at least 10 children and adolescents, and likely many more.

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The FDA’s finding has caused the most serious fight over the mRNA Covid jabs in the five years since they were introduced.

For the first time, Covid vaccine advocates who dominate the legacy media and public health establishment can no longer dismiss a link between the shots and the deaths of healthy children as a conspiracy theory. After reviewing 96 death reports, agency reviewers found that 10 were related to the shots. 

As Dr. Vinay Prasad, the head of the FDA division that regulates vaccines, wrote in a six-page letter to staff on Friday:

For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children. Healthy young children who faced tremendously low risk of death were coerced [to receive the Covid jabs]…

Did COVID-19 vaccine programs kill more healthy kids than [they] saved?

Studies have shown over and over that the shots do little to reduce Covid infections — much less hospitalizations or deaths — in children or teens. Thus, even a small number of jab-caused deaths might mean the answer to Prasad’s stunning question is yes.

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Now the FDA may act on its finding by strengthening its warnings on the jabs — or possibly even pulling them from the market.

“Black-box warnings,” which are legally known just as “Boxed Warnings,” are unusual. The FDA adds them to labels when it believes a drug or vaccine may cause “death or serious injury,” based on “reasonable evidence of an association.”

As a 2011 paper from two FDA scientists explained, “For most drugs, a boxed warning appears after the drug has been approved and marketed, thus providing exposure to a large number of patients sufficient to detect a serious, rare event.”

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Withdrawing the shots for kids from the market entirely is another possibility. But doing so would also be more politically complex and might take longer.

Either way, American parents have already resoundingly rejected further Covid mRNA jabs for their kids at this point.

Only about 3 percent of kids received the shots during the 2024-2025 vaccine season, according to the Centers for Disease Control. The number of jabs was likely to be even lower this year, even before the FDA’s finding on Friday.

Still, that figure translates into more than 2 million Covid jabs nationally.

If the FDA has its way, that number may soon be far lower.

THIS IS A BREAKING STORY AND MAY BE UPDATED