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Moderna seeks full FDA approval for its COVID-19 vaccine

The Moderna COVID-19 vaccine.Angel Navarrete/Bloomberg

(Bloomberg) -- Moderna said it has completed the application process for full approval of its COVID-19 vaccine in the US, 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 has been supplying data to regulators on its shot’s safety and effectiveness as it became available in clinical testing.

If regulators grant the approval, it would follow the full clearance earlier this week of the vaccine made by Pfizer and BioNTech.


Both the Moderna and Pfizer vaccines use messenger RNA technology to protect recipients from Covid-19. Together, the two shots have accounted for the vast majority of immunizations in the US, according to data from the Centers for Disease Control and Prevention.

Moderna shares rose 4.1 percent at 9:55 a.m. in New York trading.

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