Moderna completes submission for full FDA approval of vaccine

Moderna said Wednesday that it has completed its submission of data to the Food and Drug Administration (FDA) for full approval of its COVID-19 vaccine.

The rolling submission of data to the FDA had begun in June, but is now complete. The completed submission comes two days after the FDA announced that it had given full approval to the Pfizer vaccine.

The emergency use authorization that Pfizer had operated under and that Moderna still is covered under was only granted after a rigorous process. But full approval could help bring some hesitant people on board with getting the shots and make companies and governments more willing to mandate vaccinations.

Stéphane Bancel, Moderna’s CEO, said in a statement that the submission is an “important milestone in our battle against COVID-19 and for Moderna,” noting that it is the company’s first time submitting for a full approval, formally known as a Biologics License Application.

Moderna said earlier this month that its vaccine had maintained 93 percent effectiveness after six months, but noted that data was collected before the delta variant was dominant in the United States, which could change the equation.