Source/Disclosures
Disclosures:
Goddard reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
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Key takeaways:
- Researchers found no cases of myocarditis or pericarditis in young children after more than 240,000 doses of mRNA COVID-19 vaccines.
- Findings should reassure parents, doctors, one researcher says.
A review of nearly 250,000 doses of messenger RNA COVID-19 vaccine administered to young children identified no serious side effects from the shots, according to results published in Pediatrics.
The investigation used data from the Vaccine Safety Datalink, a collaboration between the CDC and eight US health systems, according to Kristin Goddard, MPH, a project manager at Kaiser Permanente Vaccine Center, and colleagues.
“This study assessing COVID-19 vaccine safety in very young children highlights that vaccine safety monitoring for serious outcomes is ongoing for all ages,” Goddard told Healio. “We conducted this study in particular because we knew that parents and clinicians are very interested in the safety of COVID-19 vaccines given to the youngest children.”
Goddard and colleagues assessed the rates of 19 serious potential outcomes of COVID-19 vaccination — such as myocarditis, pericarditis, seizure, stroke, blood clots and brain inflammation — following the administration of 135,005 doses of the Pfizer-BioNTech vaccine to children aged 6 months to 4 years and 112,006 doses of the Moderna vaccine to children aged 6 months to 5 years.
They compared outcomes among children 1 to 21 days post-vaccination to vaccinated children 22 to 42 days after their most recent dose.
“Every week, we monitored for imbalances between the rates of outcomes among these two groups, adjusting for any differences between them,” Goddard said.
Ultimately, the researchers “found no cause for concern” during the 21 days after vaccination, the AAP noted in a summary for reporters.
Specifically, the review did not identify any cases of myocarditis or pericarditis after any dose of vaccine. One case of hemorrhagic stroke and one case of pulmonary embolism were not related to the vaccines, the researchers determined.
“This is the first analysis that looked for serious side effects from the mRNA vaccines in children aged 4 years and younger, and we identified no safety concerns,” Goddard said.
Goddard said parents and clinicians can be reassured by the study’s results because it “was large and included a diverse group of children across the country.”
“There is still a large portion of children in this age group who remain unvaccinated, and vaccine safety surveillance should continue as those kids continue to get vaccinated,” Goddard said. “If safety of these vaccines was a reason for not yet getting a child vaccinated, this study can give parents and clinicians reassurance that COVID-19 vaccines are safe even for the youngest ages.”
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