Moderna announced Tuesday that it is seeking full approval for its COVID-19 vaccine from the U.S. Food and Drug Administration (FDA) for Americans 18 years of age and older — the second drugmaker to initiate this process.
The mRNA vaccine produced by the Massachusetts-based biotechnology company is currently available to Americans via Emergency Use Authorization, but applying for a Biologics License Application will allow the company to market the inoculation directly to consumers.
“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,” Stéphane Bancel, Chief Executive Officer of Moderna said 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.”
The FDA approval process is likely to take months. The company has asked for priority review.
The move by Moderna comes less than a month after Pfizer and BioNTech announced they would seek the same approval from the FDA for Americans age 16 and older for their mRNA COVID-19 vaccine.
Nearly 125 million Moderna shots have been administered in the United States as of Sunday, May 30, with nearly 55 million Americans fully vaccinated by the two-dose mRNA inoculation, according to data from the Centers for Disease Control and Prevention.
Full FDA approval could go a long way toward combatting vaccine hesitancy. According to data from the Kaiser Family Foundation's COVID-19 Vaccine Monitor, 32% of unvaccinated adults said they would be more likely to get the shots if they received such approval.