COVID Vaccines Safe for Young Children, Study Finds

06/06/2023

TOPLINE:

COVID-19 vaccines from Moderna and Pfizer-BioNTech are safe for children under age 5 years, according to findings from a study funded by the Centers for Disease Control and Prevention.

METHODOLOGY:

Data came from the Vaccine Safety Datalink, which gathers information from eight health systems in the United States.
Analyzed data from 135,005 doses given to children age 4 and younger who received the Pfizer-BioNTech mRNA vaccine, and 112,006 doses given to children aged 5 and younger who received the Moderna version.
Assessed for 23 safety outcomes, including myocarditis, pericarditis, and seizures.

TAKEAWAY:

None of the adverse outcomes, including myocarditis or pericarditis, was detected among the children in the 21 days following receipt of either vaccine.
One case of hemorrhagic stroke and one case of pulmonary embolism occurred after vaccination but these were linked to preexisting congenital abnormalities.

IN PRACTICE:

“These results can provide reassurance to clinicians, parents, and policymakers alike.”

STUDY DETAILS:

The study was led by Kristin Goddard, MPH, a researcher at the Kaiser Permanente Vaccine Study Center in Oakland, California, and was funded by the Centers for Disease Control and Prevention.

LIMITATIONS:

The researchers reported low statistical power for early analysis, especially for rare outcomes. In addition, fewer than 25% of children in the database had received a vaccine at the time of analysis.

DISCLOSURES:

Donahue reports receiving funding from Janssen Vaccines and Prevention for a study unrelated to COVID-19 vaccines. Klein reports receiving grants from Pfizer in 2019 for clinical trials for coronavirus vaccines, and from Merck, GSK, and Sanofi Pasteur for unrelated research.

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