A Young Child Died During Moderna COVID Vaccine Clinical Trial — Did FDA Know?

A preschool-aged child died of cardio-respiratory arrest after getting a COVID-19 booster in a Moderna clinical trial, according to an investigation by journalist Alex Berenson.

by Suzanne Burdick, Ph.D.

A preschool-aged child died of cardio-respiratory arrest after getting a COVID-19 booster in a Moderna clinical trial. However, Moderna didn’t reveal the death to the public and only recently reported it on a European regulatory agency database, Alex Berenson reported.

The death occurred in late 2022 or early 2023, Berenson said, when children under 5 who had already received Moderna’s original mRNA-1273 COVID-19 vaccine in the trial’s main phase were offered the “1273.214” booster against an early Omicron variant.

Berenson, a former New York Times reporter who now reports on his Unreported Truths Substack, today said the U.S. Food and Drug Administration (FDA) has declined to tell him whether the U.S. agency knew that a child died during Moderna’s clinical trial.

The failure of the FDA to provide a straightforward answer about whether it knew that a young child in a Moderna clinical trial died from cardiac-respiratory arrest is “vitally important,” Berenson told The Defender.

“Of all the mistakes public health authorities made around COVID, their insistence on pressing mRNA vaccines on children was probably the worst,” Berenson said.

By the time the COVID-19 vaccines were available for kids, it was clear that children were at almost no risk of serious illness or death from COVID-19, he said. “The shots had significant side effects, so the only rationale for giving them shots — even theoretically — was to reduce transmission.”

Myocarditis — inflammation of the heart muscle — is a possible side effect of mRNA COVID-19 vaccines that can, in some instances, lead to cardiac arrest.

In its report to European regulatory authorities, Moderna said one death from cardio-respiratory arrest occurred among kids ages 6 months to 5 years who participated in its KidCOVE clinical trial of a COVID-19 vaccine for children.

Moderna did not report the child’s exact age. The company recorded the death as unrelated to its COVID-19 shot.

Doctors and parents have the right to know about the death of a child in a vaccine clinical trial — even if the company sponsoring the trial claims the death is unrelated, Berenson said.

So Berenson asked the FDA if it was aware that a child in a Moderna clinical trial died after receiving the vaccine.

“The agency has so far refused to answer,” Berenson wrote on Monday. “But based on what the FDA said to me on Friday, it seems likely the agency did know about the death — a fact it is trying to hide.”

‘FDA will not be able to stonewall much longer’

Although Moderna reported the clinical trial results containing the child’s death to European regulatory authorities, the company has yet to report the results to ClinicalTrials.gov, an official U.S. government website where drugmakers are legally required to report trial results.

According to Moderna’s report filed on Sept. 30, 2024, with the European Union’s Clinical Trials Register, the vaccine maker completed the KidCOVE trial on March 15, 2024, and finished its analysis of the results on May 17.

Berenson asked the FDA if the agency had information about pediatric deaths during the KidCOVE trial. An FDA spokesperson sent him a two-paragraph statement.

“Nowhere in its 152 words did the FDA — a federal agency that claims its job is ‘promoting and protecting human health’ — acknowledge the death,” Berenson wrote. “But the agency also did not make a simple, clean denial by saying no children had died in any trials at any time.”

Berenson sent the FDA a second round of questions. The agency did not respond, despite Berenson sending multiple follow-up emails.

Here are some of the questions left unanswered, Berenson told The Defender:

“Did Moderna inform the FDA of the death, as it was legally required to do? Neither the agency nor the company has said, but considering Moderna published the death in its report to European regulators, it seems very likely it did also tell the FDA.

“Did the FDA investigate? If so, what did it find? If not, why not? Most importantly, considering that the CDC [Centers for Disease Control and Prevention] and American health authorities continued AND STILL CONTINUE to push mRNA jabs on children (in contrast to those in other countries), why didn’t the FDA make its findings and the death public?”

Berenson called on the FDA and Moderna to immediately disclose what they know. He said:

“For the FDA, which answers to the public, transparency is even more vital. If the death of a child in the most closely scrutinized vaccine trial in history could go unreported, people will rightly wonder what else is being missed — or covered up.”

Sen. Ron Johnson (R-Wis.) told Berenson he plans later this month, after Republicans officially take control of the U.S. Senate, to subpoena the FDA to find out what it knew and when.

“The FDA will not be able to stonewall much longer,” Berenson said.

Moderna did not respond to our comment request by the deadline.