Washington: US pharmaceutical giant Moderna said on Tuesday it will start the process of applying for full US Federal Drug Administration (FDA) approval of its COVID-19 vaccine.
The vaccine is currently being administered to citizens under an Emergency Use Authorization (EUA) that it had obtained from the FDA in December last year.
“We are pleased to announce this important step in the US regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine,” Moderna Chief Executive Officer Stephane Bancel said.
The company will continue cooperating with the FDA and submit data from the Phase 3 study, Bancel added.
The EUA license granted to Moderna’s mRNA vaccine requires two months of data while the full approval requires at least six months. The approval process by the FDA may take several additional months.
US Centers for Disease Control and Prevention data noted that more than 124 million doses of the Moderna COVID-19 Vaccine have been administered in the country, the statement added. (Sputnik)