In this photo illustration, a vial and a medical syringe seen displayed in front of the Food and Drug Administration (FDA) of the United States and Moderna biotechnology company's logos. (Photo Illustration by Pavlo Gonchar/SOPA Images/LightRocket vi Moderna’s COVID-19 vaccine has been given full approval from the U.S.
Food and Drug Administration, a shot that has been administered to millions of Americans throughout the course of the pandemic.The approval for those aged 18 and up came after the agency reviewed more data on the safety and effectiveness of the Moderna’s shot, marketed as "Spikevax." Full approval by the FDA means it has completed the same rigorous, time-consuming review as dozens of other long-established vaccines.In a statement, Moderna CEO Stephane Bancel called the full approval "a momentous milestone in Moderna's history" as it becomes the company's first product to achieve licensure in the U.S."The totality of real-world data and the full BLA for Spikevax in the United States reaffirms the importance of vaccination against this virus," Bancel said. "We are grateful to the U.S.
FDA for their thorough review of our application. We are humbled by the role that Spikevax is playing to help end this pandemic."The decision was bolstered by real-world evidence from the more than 204 million doses administered in the U.S.
since the FDA cleared the shot in December 2020 under an Emergency Use Authorization. The difference between EUA and full FDA approval is that they require different clinical study requirements — with full FDA approval requiring a longer monitoring period.Pfizer-BioNTech has named its COVID-19 vaccine "Comirnaty" after the FDA fully approved the drug August 23.The FDA granted full approval.