The Biden administration withheld data from the public on the risks of myocarditis from the Covid vaccine, Food and Drug Administration Commissioner Marty Makary claimed Thursday — a bold accusation that clashes with years of public statements from federal health officials.
“We have done more to study myocarditis and to go back and look at deaths of people, of children from the Covid vaccine,” Makary told NBC News in an interview. “Internal data submitted on myocarditis, we found that the Biden administration was sitting on data on myocarditis in young people, and it was not made public.”
Makary’s claim comes less than a week after Vinay Prasad, the FDA’s top vaccine regulator, told agency staff in a memo that an internal review found that at least 10 children died “after and because of receiving” the Covid shot. Prasad suggested — without evidence to support his claim — that the child deaths were tied to myocarditis.
Myocarditis, an inflammation of the heart muscle, is a known — but small — risk of the mRNA Covid vaccines from Pfizer and Moderna, information that federal agencies have discussed openly since 2021.
The FDA has not released its new findings publicly, nor has the agency published them in a peer-reviewed journal. On Wednesday, a dozen former FDA leaders issued a scathing denunciation of the new assertions.
The first signs of a possible myocarditis link to the shots emerged in March 2021, when reports from both the U.S. and Israel cited rare cases following Covid vaccination. Symptoms of the condition include shortness of breath, chest pain and a fluttering or pounding heart.
In May 2021 — around the same time Pfizer’s Covid shot was authorized for young teens — the Centers for Disease Control and Prevention’s vaccine safety group said it was reviewing reports of heart inflammation in young people.
A month later, in June, the CDC’s vaccine advisory group met publicly to discuss the possible side effect. During that meeting, health officials said there was a “likely association” between myocarditis and the vaccines but panel experts concluded the benefits of vaccination outweighed the risks.
Then on June 25, 2021, the FDA added a warning about a rare risk of myocarditis to the patient and provider fact sheets for Pfizer’s and Moderna’s Covid shots.
A senior federal health official who worked in the Biden administration called Makary’s claim “absurd” and said the comment would do “irrevocable harm” to public trust in the FDA.
“There was no pressure coming from the White House,” the official said. “No one told us not to report adverse events. No one told us to approve products.”
Since the Covid shots were first approved in late 2020, the official said, the federal government has held more than a dozen public meetings to review data on Covid vaccines and published several papers on the myocarditis risk.
Dr. Ofer Levy, who was a member of the FDA’s advisory group at the height of discussion around myocarditis, said the federal government posted data and briefing documents online that were available to any American.
“I certainly didn’t see any secret information or cover-up in my experience working with the FDA,” said Levy, also director of the Precision Vaccines Program at Boston Children’s Hospital. “We were broadcast live in real time, with public commentary, and I didn’t have access to any more information than any other American.”
“It was a pretty good process, not perfect, but a pretty good process that’s respected around the world,” he said.
Makary said Thursday that the agency’s new findings about child deaths stem from an investigation, “reaching out to the families, reviewing the autopsies.”
“These were kids who died immediately after getting the Covid shot,” he said. “They went into myocarditis, or other serious vaccine complications.”
“When a healthy kid immediately gets a Covid shot and then develops a string of complications that results in a cascade resulting in the child’s demise,” he said, “that’s causal until proven otherwise.”
Makary didn’t elaborate on key details, such as the children’s ages, medical histories or whether they’d been diagnosed with Covid. He didn’t indicate when the data would be made public.
“Our scientists are working on this, so they’re putting it together,” he said.
The FDA’s new claims don’t align with the available evidence on vaccine-associated myocarditis.
The highest risk has been seen in teen and young adult males, particularly within several days after receiving the second dose of the primary series of the mRNA vaccines.
A CDC report published in 2021 found rates were 40.6 cases per million second doses of mRNA Covid vaccines administered to males ages 12 to 29 and 2.4 cases per million second doses administered to males ages 30 and older.
Most cases have been found to be mild and resolve within a few days. Covid infection is also associated with myocarditis and is often more severe than cases seen after vaccination.
To date, no known deaths from myocarditis have been confirmed to be linked with the Covid vaccines.
