FDA Investigating Reports of Child Deaths After COVID Vaccination, Makary Says

 The FDA is carrying out an "intensive investigation" into whether COVID-19 vaccines have caused deaths in children, according to Commissioner Marty Makary, MD, MPH.

"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 in an interview with CNNopens in a new tab or window.

When asked how many deaths were caused by the vaccine, Makary said the FDA would release a report in the coming weeks. The FDA is talking with family members, reviewing autopsy reports, and having physicians do the review, he explained. "We think the public deserves to have that information."

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

The CDC has posted safety dataopens in a new tab or window on the COVID vaccine and myocarditis. Noting that "the evidence suggests that, although rare, these events are linked to certain types of COVID-19 vaccinations," the CDC added that "surveys of patients diagnosed with myocarditis who developed symptoms at least three months prior to answering the survey showed most patients (80%) were considered by their cardiologist or other healthcare provider to have either fully or probably fully recovered."

Makary said in the interview that when asked for data about the potential myocarditis link, the CDC 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 added.

"We want to get good data so people can make ... a risk-benefit analysis for their age group," he said. "We shouldn't be using dogma to say everybody should get [a COVID vaccine], and regardless of your circumstance."

Makary's remarks come in the wake of the FDA's tightened restrictionsopens in a new tab or window on who should get COVID vaccines, restrictions that could force most vaccinations for children off-label.

The agency approvedopens in a new tab or window updated 2025-2026 COVID vaccines late last month for all adults 65 and older, but only for kids and younger adults with an underlying condition. Previous years' vaccines had been approved for everyone 6 months and up.

The American Academy of Pediatrics (AAP) broke with federal COVID vaccine recommendations, issuing its own recommendationsopens in a new tab or window in August. In a statement, AAP President Susan J. Kressly, MD, called the new proposal to limit the availability of COVID vaccines in children and young adults "deeply troubling."

The "unprecedented action from HHS not only prevents this option for many families, but adds further confusion and stress for parents trying to make the best choices for their children," she said.

In the CNN interview, Makary shot back that the AAP "is the same group that insisted that schools stay shut down" during the COVID-19 pandemic.

https://www.medpagetoday.com/infectiousdisease/covid19vaccine/117340