U.S. Food and Drug Administration staff reviewers on Friday said Moderna Inc’s COVID-19 vaccine appears safe and effective for use in people aged 6 months to 17 years old as a committee of scientists will meet next week to vote on whether to recommend the regulator authorize the vaccine in children.
The FDA’s reviewers said in briefing documents published on Friday evening that the vaccine had generated a similar immune response in the children than that observed in adults in previous trials.
“Available data support the effectiveness of the Moderna COVID-19 Vaccine in preventing symptomatic COVID-19 in pediatric age groups from 6 months through 17 years of age,” the FDA staff said.
The FDA staff also said the vaccine generally had a similar side effect profile in children as seen in adults, although younger children had fevers more frequently.
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Some countries in Europe have limited the use of Moderna’s shots for younger age groups after some studies showed that it was tied to a higher risk of myocarditis – a type of heart inflammation.
The FDA said myocarditits is a known risk associated with the vaccine, but that the drugmaker’s pediatric trials were not large enough to quantify the frequency of the rare heart inflammation in pediatric age groups.
(Reporting by Michael Erman in New Jersey; editing by Grant McCool)