Moderna completes submission for full FDA approval of vaccine

Moderna completes submission for full FDA approval of vaccine
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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. 

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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. 

The company also said then that it expects a booster shot will be needed before the winter. 

Biden administration health officials said last week that they also anticipate booster shots will be needed, and plan to begin offering for both the Pfizer and Moderna vaccines the week of Sept. 20, pending the formal green light from the FDA. 

Moderna’s filing for full approval is for people age 18 and over. The company has also applied for emergency use authorization for people aged 12 and over.