US Food and Drug Administration officials have said, without evidence, that COVID-19 vaccines have killed children. Here’s what you should know

This article originally appeared on PolitiFact.

US Food and Drug Administration officials said COVID-19 vaccines have killed at least 10 children, and provided no evidence for that statement. Citing these deaths, the agency said it plans to make current vaccine regulations more stringent.

In an email to FDA staff, Dr. Vinay Prasad, director of the agency’s vaccine division, said that “at least 10 children have died after receiving the coronavirus vaccination.”

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FDA Commissioner Dr. Marty McCary made a similar statement during an appearance on “Fox and Friends Weekend.”

Neither Prasad nor Makari provided details or data about the 10 children who said the vaccines killed them or the circumstances surrounding those deaths. The Department of Health and Human Services, which oversees the Food and Drug Administration, did not respond to our request for more information.

In his six-page email, Prasad mentioned myocarditis, a rare side effect of mRNA COVID-19 vaccines. Since researchers first documented this relationship, doctors and public health experts have assured people that the benefits of vaccination outweigh its risks. This is partly because COVID-19 infection carries a greater risk of myocarditis than COVID-19 vaccines. Prasad argued otherwise in the email.

Here are three things to know about children, COVID-19 infection, vaccines, and myocarditis.

More than 2,000 children have died in the United States due to COVID-19 infection

COVID-19 infection is less serious for healthy children than it is for children and people 65 and older. But COVID-19 can be dangerous — and sometimes deadly — for children.

The Mayo Clinic said babies younger than 6 months have a higher-than-average risk of severe infection and are one of the age groups most at risk of hospitalization due to COVID-19.

Data from the U.S. Centers for Disease Control and Prevention shows that since the beginning of the pandemic, more than 2,000 children 18 or younger in the United States have died from COVID-19. Nearly 700, or about 33%, were younger than 1 year old.

One pediatric study found that 68% of children ages 1 to 17 who died from COVID-19 from 2020 to 2022 had one or more other medical conditions, including nervous system disorders, congenital disorders, obesity, neurodevelopmental disorders, and respiratory disorders including asthma.

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A 2023 study found that from April 1, 2020, to August 31, 2022, COVID-19 was the nation’s fifth-highest cause of disease-related death for people from birth to age 19.

Carditis is a rare adverse effect of mRNA COVID-19 vaccines

In rare cases, people receiving mRNA COVID-19 vaccines have developed inflammation of the heart muscle, also known as myocarditis, or inflammation of the lining surrounding the heart, called pericarditis.

Research shows that boys and men ages 12 to 30 are at greatest risk of developing myocarditis and pericarditis associated with the COVID-19 vaccine. Some studies show these patients are most at risk during the first 14 days of the second vaccine dose, while the CDC says the risk window is seven days.

A 2022 Lancet study found that 81% of patients who developed vaccine-associated myocarditis recovered after 90 days, even though some were prescribed daily medications related to the myocarditis.

Children who develop vaccine-induced myocarditis have a good prognosis for a full recovery, said Dr. Mark Schleiss, a professor of pediatric infectious diseases at the University of Minnesota. “No deaths, debilitating illnesses, or heart transplants were observed.”

COVID-19 infection poses a greater risk of myocarditis than vaccines

A 2022 study found that the risk of myocarditis was seven times higher in people with COVID-19 than in those who received an mRNA vaccine.

Doctors and public health officials have repeatedly told PolitiFact during the pandemic that the risks of contracting COVID-19 — including its ability to cause myocarditis — are greater than the risks of the vaccine.

The message remains unchanged now. “There is no doubt that the risk of developing myocarditis is much greater after developing it after vaccination,” Schleiss said.