Moderna (NASDAQ: MRNA), an American pharmaceutical, announced it has applied for full approval from the Food and Drug Administration for its Covid-19 vaccine. It is the second U.S. drugmaker to explore a biologics license, which will allow it to advertise the shots directly to consumers. Modena shares remained unfazed during premarket trading.
The company’s vaccine is currently certified under Emergency Use Authorization (EUA), the next step was to apply for full approval. Nevertheless, the approval procedure is expected to take months.
Moderna revealed it had commenced a “rolling submission process” of additional data of its vaccine, for the full approval of people 18 years of age or 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,” Moderna CEO Stephane Bancel said in a press release. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”
Furthermore, last month Moderna said its vaccine had proven to be highly effective in kids aged 12-17 and commented it would apply for authorization in “early June.” Meanwhile, competitor Pfizer, has already been authorized for that age range.
The pharmaceutical’s vaccine has proven to be 90% effective against Covid as well as 95% effective against severe disease for up to six months following the second dose.