Moderna seeks full FDA approval of its COVID-19 vaccine

Massachusetts-based drugmaker Moderna said Tuesday it will seek full approval of its COVID-19 vaccine for use in persons 18 and older.

Nearly 125 million doses of the vaccine have been administered in the U.S. under an emergency use authorization, meaning the benefits of the shots outweigh any perceived risks amid the raging pandemic.

The company will submit data to the Food and Drug Administration on a rolling basis until regulators formally acknowledge the data packet is complete.

“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,” Moderna CEO Stéphane Bancel said. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”

It is the second company to seek full FDA approval of a COVID-19 vaccine. Pfizer, which developed a vaccine with German company BioNTech, made a similar announcement in early May.

Both vaccines use messenger-RNA technology. It delivers a snippet of genetic code, encased in bubbles of fat, that instructs the body to make imposters of the virus’ spike protein so the system knows how to fight the real thing.