The Food and Drug Administration has granted full approval to the Moderna COVID-19 vaccine, the company announced today. The Moderna vaccine joins the Pfizer / BioNTech shot as the second licensed vaccine against the coronavirus in the United States.
This is Moderna’s first FDA-approved product in the US. “This is a momentous milestone in Moderna’s history,” said Stéphane Bancel, chief executive officer of Moderna, in a statement.
The Moderna vaccine has been available for over a year under an emergency use authorization (EUA), a designation that allows the FDA to sign off on products quickly during an emergency. Now that it’s fully licensed, Moderna is able to advertise its shot directly to patients. It’ll be marketed under the brand name Spikevax.
The full approval is based on clinical trial data from nearly 30,000 people, which showed the vaccine was safe and effective protection against COVID-19. There’s also a year of real-world data for this vaccine, which has been administered to tens of millions of people in the US. Along with the other COVID-19 shots available, it’s saved millions of lives through the last year of the COVID-19 pandemic.