U.S. Food and Drug Administration officials said COVID-19 vaccines killed at least 10 children, providing no evidence for the statement. Citing these deaths, the agency said it plans to make existing vaccine regulations more strict.
In an email to FDA staff, Dr. Vinay Prasad, the director of the agency’s vaccine division, said ”at least 10 children have died after and because of receiving COVID-19 vaccination.”
FDA Commissioner Dr. Marty Makary made a similar statement during an appearance on “Fox and Friends Weekend.”
Neither Prasad nor Makary provided details or data about the 10 children they said the vaccines killed or the circumstances surrounding those deaths. The Department of Health and Human Services, which oversees the FDA, 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 that relationship, doctors and public health experts have assured people that vaccination’s benefits outweigh its risks. That’s partly because COVID-19 infection carries a greater risk of myocarditis than the COVID-19 vaccines. Prasad argued otherwise in the email.
Here are three things to know about children and COVID-19 infection, vaccines and myocarditis.
More than 2,000 children in the U.S. have died from COVID-19 infections
COVID-19 infections are less risky for healthy children compared with babies and people age 65 and older. But COVID-19 can be dangerous — and sometimes deadly — for children.
Babies younger than 6 months have a higher than average risk of severe infection and are one of the age groups with the highest risk of COVID-19 hospitalization, Mayo Clinic said.
U.S. Centers for Disease Control and Prevention data shows that since the start of the pandemic, more than 2,000 children age 18 and younger in the U.S. have died from COVID-19. Nearly 700, or about 33%, were less than 1 year old.
One Pediatrics 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.
A 2023 study found that from April 1, 2020, to Aug. 31, 2022, COVID-19 was the nation’s fifth highest disease-related cause of death for people from birth to age 19.
Heart inflammation is a rare adverse effect of mRNA COVID-19 vaccines
In rare cases, people who receive mRNA COVID-19 vaccines experience heart muscle inflammation, also known as myocarditis, or inflammation of the lining surrounding the heart, called pericarditis.
Research shows boys and men ages 12 to 30 have the highest risk of experiencing COVID-19 vaccine-related myocarditis and pericarditis. Some studies show these patients are most vulnerable within 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-related myocarditis recovered after 90 days, although some had been prescribed daily medication related to myocarditis.
Kids who get vaccine-induced myocarditis have a good outlook for complete recovery, said Dr. Mark Schleiss, a University of Minnesota pediatric infectious diseases professor. “No deaths, no debilitating illnesses and no heart transplants have been observed.”
COVID-19 infection poses a higher risk of myocarditis than vaccines
A 2022 study found myocarditis’ risk was seven times higher for people with the COVID-19 virus compared with those who received an mRNA vaccine.
Doctors and public health officials repeatedly told PolitiFact during the pandemic that the risks of COVID-19 infection — including its potential to cause myocarditis — are greater than the vaccine’s risks.
The message remains unchanged now. “Without question, the risk of myocarditis is vastly greater after infection than after vaccination,” Schleiss said.
