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Moderna Seeks Full U.S. Approval for Its Covid-19 Vaccine

  • The biotech initiated a Biologics License Application in June
  • Moderna vaccine expected to be second to get such an approval
Moderna Covid-19 vaccine doses at a pop up vaccination site.

Moderna Covid-19 vaccine doses at a pop up vaccination site.

Photographer: Angus Mordant/Bloomberg
Updated on

Moderna Inc. said it had completed the application process for full approval of its Covid-19 vaccine in the U.S., putting the company on course to obtain the second such clearance from federal regulators.

The company said in a statement on Wednesday that it had finished the rolling submission process for an approval from the Food and Drug Administration. Moderna first launched the process in June with the beginnings of a so-called Biologics License Application. Since then, the company has been supplying data to regulators on its shot’s safety and effectiveness as it became available in clinical testing.