US FDA reviewers say Moderna COVID-19 vaccine effective and safe for children

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US Food and Drug Administration staff reviewers on Friday (Jun 10) said Moderna Inc's COVID-19 vaccine appears safe and effective for use in children aged six months to 17 years old as a committee of scientists will meet next week to vote on whether to recommend the regulator authorise the vaccine in children.

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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.

Both of the messenger RNA-based COVID-19 vaccines made by Moderna and Pfizer/BioNTech have been linked to rare instances of a type of heart inflammation called myocarditis, particularly in young men.

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 the heart inflammation.

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