The Biden administration withheld data from the public about the risk of myocarditis from the Covid vaccine, Food and Drug Administration Commissioner Marty Macari said Thursday. This bold accusation contradicts years of public statements from federal health officials.
“We've done more to study myocarditis and also to go back and look at the mortality of people and children from the Covid vaccine,” Macari told NBC News. “The internal data presented 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 announcement comes less than a week after Vinay Prasad, the FDA's top vaccine regulator, informed agency employees in a memo An internal review has found that at least 10 children have died “after and because of receiving” a Covid vaccine. Prasad suggested (without evidence to support his claim) that infant mortality was related to myocarditis.
Myocarditis, inflammation of the heart muscle, is a known but small risk associated with the Pfizer and Moderna mRNA Covid vaccines. This information has been openly discussed by federal agencies since 2021.
The FDA has not made its new findings public or published them in a peer-reviewed journal. On Wednesday, a dozen former F.D.A. made a sharp denunciation new statements.
The first signs of a possible vaccine-related myocarditis appeared in March 2021, when reports from the US and Israel mentioned rare cases following Covid vaccination. Symptoms of the disease include shortness of breath, chest pain and a fluttering or pounding heartbeat.
In May 2021—around the same time that the Pfizer Covid vaccine was authorized for teenagers—the Centers for Disease Control and Prevention's vaccine safety panel said as much. looked through messages about heart inflammation in young people.
A month later, in June, the CDC's vaccine advisory group met publicly to discuss possible side effects. During this meeting, health officials said there was a “probable link” between myocarditis and vaccines, but experts concluded that the benefits of vaccination outweighed the risks.
Then, on June 25, 2021, the FDA added a warning about the rare risk of myocarditis to patient and provider advisories for the Pfizer and Moderna Covid shots.
A senior federal health official who served in the Biden administration called Macari's statement “absurd” and said the comment would cause “irreparable damage” to the public's trust in the FDA.
“There was no pressure from the White House,” the official said. “Nobody told us not to report side effects. Nobody told us to approve products.”
Since Covid shots were first approved in late 2020, the federal government has held more than a dozen public meetings to review data on Covid vaccines and published several papers on the risk of myocarditis, the official said.
Dr. Ofer Levy, who was a member of the FDA advisory panel at the height of the myocarditis debate, said the federal government posted data and information documents online that were available to any American.
“I certainly have not seen any classified information or cover-up in my experience 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 did not have access to more information than any other American.”
“It was a pretty good process, not perfect, but a pretty good process that is respected around the world,” he said.
Makary said Thursday that the agency's new findings on child deaths were the result of an investigation that “met with families and reviewed autopsy results.”
“These were children who died immediately after receiving the Covid vaccine,” he said. “They developed myocarditis or other serious complications from the vaccination.”
“When a healthy child immediately receives a Covid vaccine and then develops a series of complications that lead to a cascade of complications leading to the death of the child,” he said, “that is causation until proven otherwise.”
Makariy did not specify key details such as the children’s ages, medical histories and whether they had been diagnosed with Covid. He did not specify when the data would be made public.
“Our scientists are working on this, so they are putting everything together,” he said.
The new FDA statements are inconsistent with existing data on vaccine-associated myocarditis.
The highest risk was observed in adolescent and young adult men, especially in the days after receiving the second dose of the primary series of mRNA vaccines.
CDC report published in 2021 The rates found were 40.6 cases per million of second doses of mRNA Covid vaccine given to men aged 12 to 29 years, and 2.4 cases per million of second doses given to men aged 30 years and over.
Most cases turned out to be easy and decide within a few days. Covid infection is also associated with myocarditis and is often more severe than cases seen after vaccination.
To date, there have been no confirmed deaths from myocarditis associated with Covid vaccines.
