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.

What You Need To Know

  • Moderna announced that it is seeking full approval for its COVID-19 vaccine from the FDA for Americans 18 and older

  • The move comes less than a month after Pfizer and BioNTech announced they were seeking the same approval for their mRNA vaccine

  • Nearly 125 million Moderna shots have been administered in the United States as of Sunday, May 30, under Emergency Use Authorization, with nearly 55 million Americans fully vaccinated by the two-dose mRNA inoculation

  • Full FDA approval could go a long way toward combatting vaccine hesitancy

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.