Moderna Applies for Full Approval of COVID-19 Vaccine in the U.S.

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[Asia Economy Reporter Kim Hyung-min] Moderna has begun the process of obtaining full approval for its COVID-19 vaccine in the United States.

On the 1st (local time), Moderna announced in a statement that it has started the sequential data submission process to receive product approval for its COVID-19 vaccine from the U.S. Food and Drug Administration (FDA).

Stefan Bancel, CEO of Moderna, said, "We are pleased to announce the initiation of the important process for the Biologics License Application (BLA) for the COVID-19 vaccine," and added that they will work with the FDA to complete the procedure.

The FDA conducts a preliminary review after receiving the BLA, and if the data is deemed appropriate, it sets a "target date for review completion" and begins a full review.

Once product approval is granted, the Moderna COVID-19 vaccine can be sold directly on the market like other pharmaceuticals.

Moderna's COVID-19 vaccine received emergency use authorization from the FDA on December 18 of last year. Since then, a total of approximately 124 million doses have been administered in the United States as of this date.

This content was produced with the assistance of AI translation services.