"Moderna... today announced the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for SPIKEVAX (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 18 years of age and older," the company said in a press release.
Moderna CEO Stephane Bancel in the same release said the full licensure of Spikevax is a momentous milestone because it is the company's first product to achieve licensure in the US.
The FDA, according to the release, based its decision on the totality of scientific evidence shared by the company in its submission package, including follow-up data from the Phase 3 COVE study that showed high efficacy and favorable safety around six months after the second dose.
SPIKEVAX, the company added, has received approval by regulators in more than 70 countries, including Canada, Japan, the European Union, the United Kingdom and Israel.
The company said it shipped 807 million doses of its COVID-19 vaccine worldwide in 2021, with about 25 percent of those doses shipped to low- and middle-income countries.