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.
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. 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.
FDA today be like:
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