Moderna applies for full FDA approval for its COVID-19 vaccine
Moderna on Tuesday said it is applying for full approval from the Food and Drug Administration (FDA) for its COVID-19 vaccine.
The vaccine is currently authorized under an emergency use authorization, which the FDA has stressed met a very rigorous standard, but applying for full approval is the next step in the process.
Why does it matter? It could also make it easier for employers, universities and other groups to mandate that people take the vaccine.
Pfizer applied for full approval, known as a biologics license application, for its vaccine last month, but the process is likely to take time.
Moderna said it had begun a “rolling submission process” of more data on its vaccine, for full approval for people 18 and older.
“We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine,” said Stéphane Bancel, Moderna’s CEO. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.