Delay hits Moderna's hopes of adding adolescent approval for Spikevax
The US Food and Drug Administration (FDA) has told Moderna (Nasdaq: MRNA) that it will need more time to complete its assessment of the Emergency Use Authorization (EUA) request for the use of the company’s COVID-19 vaccine at the 100µg dose level in adolescents aged 12 to 17 years.
On Friday evening, the FDA informed Moderna that the agency requires additional time to evaluate recent international analyses of the risk of myocarditis after vaccination.
The agency told the company that this review may not be completed before January 2022.
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