Moderna Applies For Full FDA Approval For Its COVID-19 Vaccine

By Bill Galluccio

June 1, 2021

Moderna has started the process of applying for full FDA approval for its COVID-19 vaccine for people over the age of 18. The drug company will continue to submit trial data to the FDA on a rolling basis over the next several weeks as it waits for the agency to conduct a priority review. The review is expected to take about six months.

"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 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."

Moderna said that after two doses, its vaccine is 90% effective at protecting against COVID-19 and more than 95% effective against severe disease for up to six months.

As of June 1, over 124 million doses of Moderna's vaccine have been administered in the United States.

Getting full approval for its vaccine will allow Moderna to continue to market the shot once the pandemic has come to an end. Currently, all three vaccines in the U.S. are being distributed under an emergency use authorization.

Moderna is the second company to apply for a biologics license for its coronavirus vaccine. Pfizer requested full approval for its vaccine last month for people over the age of 16.

Both companies are testing their vaccines in adolescents and children as young as six months.

Photo: Getty Images

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