(The Epoch Times)—Food and Drug Administration experts concluded that COVID-19 vaccination probably or possibly resulted in the deaths of 10 children, before revising that number to seven, according to recently released documents.

FDA experts said the deaths of two boys, aged 13 and 7, from heart inflammation, were probably due to a COVID-19 vaccination, according to the files.

The 13-year-old was found dead three days after a COVID-19 vaccination. The death was reported after an autopsy in a study by medical examiners in 2022.

“There was temporal association of death following vaccination, and autopsy findings showed myocarditis of uncertain etiology as the cause of death,” FDA reviewers said in one of the files, a safety memorandum, made public by Sen. Ron Johnson (R-Wis.).

The 7-year-old, with no prior medical history, developed a fever and other problems 12 days after vaccination and died of cardiac arrest two days later.

“This case was assessed as probably associated with COVID-19 vaccination due to the 12-day symptom onset fitting into the known risk window,” the reviewers said.

The experts also concluded that the deaths of a 13-year-old male, two 13-year-old females, a 15-year-old male, and two 16-year-old males were possibly caused by COVID-19 vaccination, according to the memo.

All of the deaths deemed probable or possible came following vaccination with the Pfizer-BioNTech messenger ribonucleic acid (mRNA) vaccine.

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Neither Pfizer nor BioNTech responded to The Epoch Times’ requests for comment by time of publication.

The assessment of deaths reported to the Vaccine Adverse Event Reporting System (VAERS) uncovered dangers “not currently described in the prescribing information for mRNA COVID-19 vaccines,” the FDA’s Center for Biologics Evaluation and Research said in the memo, dated Dec. 5, 2025. Prescribing information is given to doctors who administer vaccines.

From 10 to 7

Dr. Vinay Prasad, head of the center at that time, said in a Nov. 28, 2025, memorandum, previously made public, that the investigation concluded that at least 10 deaths of children that were reported to the VAERS were related to COVID-19 vaccination.

“This is a profound revelation. For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children,” he said.

Prasad also said the number of actual related deaths was actually higher, since VAERS is a passive reporting system.

FDA experts had assessed 10 deaths as probably or possibly related to COVID-19 vaccination, according to emails released by Johnson. The emails, first reported by the Daily Caller, show that FDA employee Meghna Alimchandani wrote to Prasad twice in November outlining the number of 10.

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On Dec. 5, 2025, however, as her team moved to finalize the report, Alimchandani said it downgraded several of the deaths. One of the deaths that had been deemed probable, for instance, was shifted to unlikely because an unidentified pediatric cardiologist said it appeared to have been caused by genetic heart disease. Another was changed from possible to assessable because COVID-19 and parvovirus “presented alternative etiologies,” she said.

“This was a MONUMENTAL effort from all of us, to try to do a diligent thorough review while being bombarded with media articles on the subject,” Alimchandani wrote. Any responses from Prasad have not been released.

Alimchandani is not listed in the Department of Health and Human Services employee directory. Prasad and other FDA employees copied on the email did not respond to The Epoch Times’ requests for comment by publication time.

No Labeling Changes

The FDA has on multiple occasions directed COVID-19 vaccine manufacturers to add warnings to their labels, including for myocarditis, or heart inflammation.

The Center for Biologics Evaluation and Research, after finalizing the report, recommended possibly changing the vaccine labels. They planned a Dec. 11, 2025, meeting to discuss the recommendation.

Dr. Marty Makary, now the FDA’s former commissioner, said 10 days later that the FDA would not add a safety-related warning called a black box to COVID-19 vaccines.

Johnson, chairman of the Senate’s Permanent Subcommittee on Investigations, said in a June 16 letter to Health Secretary Robert F. Kennedy Jr. and the FDA’s acting commissioner that it was not clear whether the meeting took place. He wanted to know whether the recommendation was accepted, and, if it was not, why it was not.

The FDA and its parent agency, the Department of Health and Human Services, did not return requests for comment from The Epoch Times by time of publication.

Johnson previously released records showing the FDA identified safety signals for the messenger ribonucleic acid (mRNA) COVID-19 vaccines shortly after they were rolled out, but did not alert the public.

“It is shocking that Senator Johnson has had to work so hard to try to obtain truthful information from the FDA about the coverup of mRNA COVID shot safety signals in 2021, and the failure to make label changes to the product in 2025 after 10 COVID shot-associated pediatric deaths were identified,” Barbara Loe Fisher, president and co-founder of the National Vaccine Information Center, said in an email to The Epoch Times.

“Hopefully, Senator Johnson will find out why the health and safety of the public continues to be put in jeopardy by both the pharmaceutical industry and by federal health agency officials failing to effectively regulate that industry.”