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:

  • 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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