A new study shows that the COVID-19 vaccine developed by Moderna and Pfizer-BioNTech is safe for children under 5 years old.
The study was funded by the Centers for Disease Control and Prevention (CDC) and published in Journal of the American Academy of Pediatricsusing data from the Vaccine Safety Datalink, which collects information from eight U.S. health care systems.
The researchers analyzed data on 135,005 doses of the Pfizer-BioNTech mRNA vaccine given to children ages 4 and younger and 112,006 doses of the Moderna vaccine given to children ages 5 and younger. They examined 23 safety outcomes, including conditions such as myocarditis, pericarditis and seizures.
The findings showed that no adverse outcomes, including myocarditis or pericarditis, were observed within 21 days of administering the two vaccines to children. However, there were two adverse events — hemorrhagic stroke and pulmonary embolism — but these events were determined to be related to preexisting congenital anomalies.
The researchers acknowledged certain limitations of the study, including the low statistical power of the earlier analysis, especially for the rare outcomes, and the fact that fewer than 25% of the children in the database were vaccinated at the time of the analysis.
The findings reportedly reassure healthcare professionals, parents, and policymakers about the safety of COVID-19 vaccines for children under 5 years of age. medical scene.
Of note, researchers previously assessed the safety of a monovalent messenger RNA COVID-19 vaccine in people aged 5 years and older using rapid cycle analysis (RCA), which identified an increased risk of myocarditis and pericarditis, especially in younger adults. The second dose of the main series after vaccination in men. However, prior to the new study, there was limited information on the safety of the COVID-19 vaccine in children younger than 5 years old.
No safety concerns were found up to 21 days after vaccination, according to an interim analysis of more than 245,000 doses of the COVID-19 mRNA vaccine given to children 5 years and younger for 9 months. More importantly, no cases of myocarditis or pericarditis were reported after vaccination. These safety findings are consistent with those observed in other vaccine safety surveillance systems.
Published by Medicaldaily.com