Moderna seeks full FDA approval for COVID-19 vaccine

Moderna has started a rolling admission process with the FDA for full approval of its COVID-19 vaccine for use in people aged 18 and older, the company announced Tuesday. …

Moderna has started a rolling admission process with the FDA for full approval of its COVID-19 vaccine for use in people aged 18 and older, the company announced Tuesday.

“We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine,” Stéphane Bancel, CEO of Moderna, said in a statement. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”

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Moderna will continue to submit data over the coming weeks with a request for a priority review, according to a company statement. Once the process is complete, FDA will alert Moderna when the application is formally accepted for review.

The BLA is the next step following emergency use authorization (EUA). The FDA granted Moderna’s COVID-19 vaccine (mRNA-1273) emergency approval for individuals aged 18 and older in December. 

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Last week, Moderna announced its COVID-19 vaccine was 100% effective in adolescents aged 12 to 17 in a clinical trial. Bancel said the company intends to submit the findings to regulators around the world in early June.

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