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8/25, 3:51 PM (Source: TeleTrader)
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Moderna completes submission for full vaccine approval

Moderna Inc. announced on Wednesday that it has completed the rolling submission process for full approval to the United States Food and Drug Administration (FDA) for Americans 18 years of age and older.

The Biologics License Application (BLA) submission is the first in the history of the company, CEO Stephane Bancel pointed out. "In final analysis of Phase 3 COVE study data, the Moderna COVID-19 vaccine showed 93% efficacy, with the efficacy remaining durable through six months after administration of the second dose," the company specified. Moderna has delivered more than 300 million doses to the US government so far under an Emergency Use Authorization (EUA) granted by the FDA in December 2020.

The company's shares jumped as much as 4.47% after the announcement.

Baha Breaking the News (BBN) / MS