FDA Going to Release Report on Child Deaths From COVID Vaccines: Commissioner

Regulators are investigating reported deaths, Dr. Marty Makary said.

FDA Commissioner Dr. Marty Makary in Washington on July 29, 2025. Saul Loeb/AFP via Getty Images

The Food and Drug Administration is going to soon release a report detailing an investigation the agency is conducting into deaths among children from COVID-19 vaccines, the agency’s commissioner said on Sept. 4.

Dr. Marty Makary said that officials have been delving into reports submitted to the Vaccine Adverse Event Reporting System (VAERS), to which people, their doctors, or family members can submit reports of post-vaccination issues.

“We do know at the FDA, because we’ve been looking into the VAERS database self-reports, that there have been children that have died from the COVID vaccine,” Makary said during an appearance on CNN.

When asked how many, Makary said, “We’re going to release a report in the coming few weeks and we’re going to let people know.”

He said that the agency is carrying out “an intense investigation” that includes speaking with family members of children who died after vaccination and reviewing autopsy reports. Doctors are involved, he said.

Such a report should have been released by the government during the last administration, he added, but it was not.

Health care workers were required to report adverse events following COVID-19 vaccination to VAERS, which also accepts reports from other people.

“VAERS is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine,” the system’s website states.

Some minors died from COVID-19 vaccine side effects, according to death certificates and studies from researchers. That includes a young male in Connecticut who experienced myocarditis, or heart inflammation, after receiving a shot. The vaccines can cause myocarditis, according to the Centers for Disease Control and Prevention.

The CDC, which co-manages VAERS with the FDA, previously found evidence such as death certificates and autopsy reports that COVID-19 vaccines caused deaths in adults, according to a file obtained by The Epoch Times.

The CDC and some other authorities investigating post-vaccination deaths have maintained that if a potential viral cause is identified, they cannot definitively attribute the deaths to the vaccines.

More than 676 million doses of the COVID-19 vaccines have been administered in the United States.

The U.S. government has not released an official number of post-vaccination deaths confirmed to be from vaccination.

Dr. Peter Marks, the FDA’s top vaccine official at the time, said during a congressional hearing in February 2024 that officials had been able to confirm “only handfuls” of deaths “that we can actually associate with the vaccine.”

Marks also said that the vaccines saved many more lives than deaths caused. He did not cite any sources.

A recent paper estimated that the COVID-19 vaccines averted 2.5 million deaths worldwide, primarily among the elderly. Researchers said they did not factor in deaths caused by the vaccines.

“It would not be unrealistic for 100,000 U.S. deaths to have been caused by the vaccines,“ Dr. Harvey Risch, professor emeritus of epidemiology in Yale School of Public Health’s Department of Epidemiology and Public Health, told The Epoch Times via email after reviewing the paper. ”VAERS reports about 38,000, and that number is likely to be an appreciable undercount.”

Health Secretary Robert F. Kennedy Jr., whose department oversees the FDA, said during a hearing on Thursday that the COVID-19 vaccines saved lives, and caused deaths, but he does not know the numbers of either category due to what he described as “data chaos coming out of CDC.”