COVID-19 vaccines developed by Moderna and Pfizer-BioNTech are safe for children under the age of 5, according to a new study.

The study, funded by the Centers for Disease Control and Prevention (CDC) and published in the American Academy of Pediatrics journal, utilized data from the Vaccine Safety Datalink, a system that collects information from eight healthcare systems across the United States.

The researchers analyzed data from 135,005 doses of the Pfizer-BioNTech mRNA vaccine administered to children aged 4 and younger, as well as 112,006 doses of the Moderna vaccine administered to children aged 5 and younger. They examined 23 safety outcomes, including conditions like myocarditis, pericarditis, and seizures.

The study's findings revealed that none of the adverse outcomes, including myocarditis or pericarditis, were observed in the 21 days following the administration of either vaccine to children. However, there were two cases of adverse events — a hemorrhagic stroke and a pulmonary embolism — but these were determined to be linked to preexisting congenital abnormalities.

The researchers acknowledged certain limitations of the study, including low statistical power for early analysis, particularly for rare outcomes, and the fact that fewer than 25% of children in the database had received a vaccine at the time of analysis.

The findings reportedly provide reassurance to healthcare professionals, parents, and policymakers regarding the safety of COVID-19 vaccines for children under the age of 5, according to Medscape.

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It is worth noting that the researchers had previously assessed the safety of monovalent messenger RNA COVID-19 vaccines among individuals aged 5 years and older using rapid cycle analysis (RCA), which identified an increased risk of myocarditis and pericarditis, particularly in younger males after the second dose of the primary series. However, there was limited information available about the safety of COVID-19 vaccines in children under the age of 5 before the new study.

Based on the interim analysis of over 245,000 COVID-19 mRNA vaccine doses administered to children aged 5 years and younger for nine months, no safety concerns were detected during the 21 days following vaccination. More importantly, no cases of myocarditis or pericarditis were reported after vaccination. These safety findings align with the results observed in other vaccine safety monitoring systems.