Moderna is seeking full approval from the US Food and Drug Administration for its mRNA-based SARS-CoV-2 vaccine, CNBC reports.
The company received emergency use authorization from the regulatory agency for its vaccine in December, which allowed people over the age of 18 in the US to receive the shot. As CNBC notes, approval requires additional data and would enable Moderna to market the vaccine directly to consumers.
"We are pleased to announce this important step in the US regulatory process for a Biologics License Application of our COVID-19 vaccine," Stéphane Bancel, CEO of Moderna, says in a statement. "We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission."
CNBC notes that the FDA approval process may take months.
Moderna is the second SARS-CoV-2 vaccine maker to announce its intention to seek FDA approval. In May, Pfizer and BioNTech said they would be seeking approval for their vaccine.