WASHINGTON, April 26 – A recent memo from the U.S. Food and Drug Administration (FDA) links ten deaths of children to COVID-19 vaccines, according to a report by The New York Times.The FDA resolute these deaths were likely caused by myocarditis,a rare inflammation of the heart muscle,following vaccination with Pfizer-BioNTech or Moderna vaccines.
The internal FDA document, reviewed by The New York Times, details an analysis of adverse event reports submitted to the agency’s Vaccine Adverse Event Reporting System (VAERS). While the FDA continues to maintain the vaccines are safe and effective, the memo underscores the potential, albeit rare, risk of serious side effects in children. This revelation comes as health officials continue to encourage vaccination as a primary defense against severe illness from COVID-19, notably with new variants emerging.
The cases identified in the FDA memo involve children who died within days or weeks after receiving a dose of the mRNA vaccines. The agency’s analysis found a “plausible causal association” between the vaccines and the myocarditis that led to the deaths.Nine of the ten deaths involved boys aged 16 or 17, and one involved a girl aged 14.
According to the Times report, the FDA is preparing to release more detailed information about its findings, including a risk assessment of myocarditis following COVID-19 vaccination in younger age groups. The agency has stated it is continuously monitoring vaccine safety data and will update its recommendations as needed.
Myocarditis is a known, though rare, side effect of the mRNA vaccines, particularly in young men and adolescent boys.Symptoms can include chest pain, shortness of breath, and irregular heartbeat. Most cases are mild and resolve with treatment, but severe cases can be fatal.
The FDA memo and subsequent New York Times report are likely to fuel ongoing debate about the risks and benefits of COVID-19 vaccination, especially for children. Health officials emphasize that the benefits of vaccination continue to outweigh the risks, given the potential for severe illness, hospitalization, and death from COVID-19 itself.