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 , 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:
- 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, Calif., 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:
A coauthor reported receiving funding from Janssen Vaccines and Prevention for a study unrelated to COVID-19 vaccines. Another coauthor reported receiving grants from Pfizer in 2019 for clinical trials for coronavirus vaccines, and from Merck, GSK, and Sanofi Pasteur for unrelated research.
A version of this article first appeared on Medscape.com.