U.S. Food and Drug Administration staff reviewed Moderna’s Covid-19 vaccine on Friday and found it safe and effective to use in children 6 months to 17. Next week, a scientific committee will vote to authorize the vaccine for children.
In briefing documents published Friday evening, FDA reviewers stated that the vaccine generated an immune response similar to that seen in adults during previous trials.
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The FDA staff stated that “all available data support the effectiveness and safety of the Moderna Covid-19 Vaccine for symptomatic Covid-19 prevention in children aged 6 months to 17 years old,”
FDA staff stated that the vaccine had similar side effects in children to adults. However, younger children experienced fevers more often.
Moderna’s and BioNTech’s messenger RNA-based Covid-19 vaccinations have been linked to myocarditis in rare cases, especially among young men.
After studies that showed it to be linked to increased risk of heart inflammation, some European countries have restricted the use of Moderna’s shot for younger age groups.
FDA stated that myocarditis was a known risk from the vaccine. However, the FDA did not believe that pediatric trials by the drugmaker were large enough to determine the frequency of rare heart inflammation in children.
For people over 5 years old, the Pfizer/BioNTech vaccine has been approved in the U.S. According to the U.S. Centers for Diseases Control and Prevention, reports of myocarditis in children aged 5-11 years old after receiving this vaccine were lower than those in young men and adolescents. This is only slightly higher than normal.
