FDA investigating child deaths after COVID vaccination: Makary

The Food and Drug Administration is investigating reports of child deaths after COVID-19 vaccination, agency Commissioner Dr. Marty Makary said.

"We do know at the FDA, because we've been looking into the [Vaccine Adverse Event Reporting System] database self-reports, that there had been children who have died from the COVID vaccine," Makary said Thursday, MedPage Today reported.

Makary said the agency would release a report in the coming weeks on how many deaths were caused by the vaccine. He also said the FDA is talking with family members of the deceased children, reviewing autopsy reports and having physicians do the review.

"We think the public deserves to have that information," Makary said.

He also said children, particularly boys, are at increased risk of myocarditis after COVID vaccination. For males between the ages of 17 and 24 years, the incidence rate could be one in 2,600, Makary said.

The FDA commissioner also noted that when asked for data about the potential link to myocarditis, a swelling of heart tissue related to the vaccination, the Centers for Disease Control and Prevention blocked such requests and made excuses.

"It was those individuals who resigned from the CDC, that were in leadership, that gave us the hard time about getting the data," he said. "We want to get good data so people can make ... a risk-benefit analysis for their age group. We shouldn't be using dogma to say everybody should get [a COVID vaccine], and regardless of your circumstance."