Moderna seeks vaccine EUA for adolescents in US

Thursday, 10. June 2021 14:15

Moderna Inc. announced on Thursday it filed for United States Food and Drug Administration's emergency use authorization (EUA) for its coronavirus vaccine in adolescents.

The company specified that it based its request on its Phase 2/3 TeenCOVE study that included almost 2,500 adolescents aged 12 to less than 18 and that showed that the vaccine efficacy was 100% in that age group after two doses.

"The Moderna COVID-19 vaccine was generally well tolerated with a safety and tolerability profile generally consistent with the Phase 3 COVE study in adults. No significant safety concerns have been identified to date. The majority of adverse events were mild or moderate in severity," the company noted.

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