Food and Drug Administration (FDA) Commissioner Dr. Marty Makary said his agency is "doing a proper investigation" into child vaccination deaths linked to the COVID-19 vaccine, promising a level of transparency he said the Biden administration failed to provide.
Further, Makary said some of the officials who left the Centers for Disease Control and Prevention were instrumental in blocking his request on data that linked myocarditis — inflammation of the heart muscle, usually caused by a viral infection but sometimes triggered by autoimmune reactions — to the COVID vaccines.
Makary made the comments in an interview with CNN on Thursday, hours after Health Secretary Robert F. Kennedy Jr. testified before a Senate hearing.
Makary said some children "have died from the COVID vaccine" and promised that his agency's report will give those numbers. Makary, citing a study published in the New England Journal of Medicine, said that males particularly are at "higher risk" for myocarditis. "It can be as high as 1 in 2,600 young males between the ages of 17 and 24," he said.
"We do know at the FDA — because we've been looking into the [Vaccine Adverse Event Reporting System] database of self-reports — that there have been children who have died from the COVID vaccine," Makary told CNN.
The VAERS database is designed as an early warning system to detect possible safety issues with vaccines once they're in widespread use. Anyone — patients, parents, doctors — can file a report if they notice a health problem after vaccination; however, entries are not proof of causation.
Makary said that's where the FDA's review comes in, doing interviews with "the primary sources, the family members who lost a child" as well as an examination of autopsy reports.
"We think the public deserves to have that information," Makary said. "It was not released in the last administration, and it should have been."
It's that data that Makary asserted was withheld by CDC officials early on in the Trump administration.
"When we have asked for the CDC to give us data since we came into office, early on in the first few months, we got blocked, we were given different excuses and told to wait, and 'we can't do it.' It was those individuals who resigned from CDC, that were leadership, that gave us the hard time about getting the data," Makary said.
Dr. Debra Houry, who served as CDC chief medical officer; Dr. Daniel Jernigan, who directed the National Center for Emerging and Zoonotic Infectious Diseases; and Dr. Demetre Daskalakis, who directed the National Center for Immunization and Respiratory Diseases were among the officials who resigned from the CDC in protest of the administration's announcement that Susan Monarez would be removed as CDC director.
"We wanna get good data so people can … make a risk-to-benefit analysis for their age group. That is the ultimate question; we shouldn't be using dogma to say, 'everybody should get it.'"
Mark Swanson ✉
Mark Swanson, a Newsmax writer and editor, has nearly three decades of experience covering news, culture and politics.