COVID Vaccines Safe for Young Children, Study Finds
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:
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Data came from the Vaccine Safety Datalink, which gathers information from eight health systems in the United States.
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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.
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Assessed for 23 safety outcomes, including myocarditis, pericarditis, and seizures.
TAKEAWAY:
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None of the adverse outcomes, including myocarditis or pericarditis, was detected among the children in the 21 days following receipt of either vaccine.
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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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