Drugmaker Moderna announced Wednesday that it has completed the submission process to the Food and Drug Administration (FDA) for full approval of its COVID-19 vaccine in Americans 18 and older.

What You Need To Know

  • Moderna announced Wednesday that it has completed the submission process to the Food and Drug Administration (FDA) for full approval of its COVID-19 vaccine in Americans 18 and older

  • The move comes after the FDA gave full approval to the Pfizer-BioNTech vaccine for Americans 16 and older, the first vaccine to receive such designation

  • This is the first BLA submission in the Massachusetts-based company's history, CEO Stéphane Bancel wrote in a statement

  • More than 64 million Americans have been fully vaccinated with the two-dose Moderna vaccine as of Tuesday, according to data from the Centers for Disease Control and Prevention (CDC)

The Massachusetts-based company began submitting for a Biologics License Application (BLA) in June. This is the first BLA submission in the company’s history, CEO Stéphane Bancel wrote in a statement.

"We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months after dose 2," Bancel wrote. "I want to thank the people who participated in our clinical studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus."

The move follows FDA approval of the Pfizer-BioNTech COVID-19 vaccine for Americans 16 and older on Monday, the first coronavirus vaccination to receive such a designation.

"I would again like to thank our partners at NIH, NIAID and BARDA who have helped us advance the clinical development of our mRNA COVID-19 vaccine," Bancel continued. "I would also like to thank the U.S. FDA for their hard work and guidance through the BLA submission process and the entire Moderna team for their relentlessness in pursuing our mission of delivering on the promise of mRNA science."

Moderna's vaccine is currently authorized for Americans 18 and older, but the company filed for emergency use authorization (EUA) for Americans 12-17 with the FDA in June.

Dr. Anthony Fauci, the nation's top infectious disease expert, when asked when full approval for the Moderna and Johnson & Johnson vaccines could come, said that it can be difficult to predict but added, “I would imagine ... that it likely would be a matter of a month or so, but not a lot more than that."

Fauci told PBS Newshour on Monday that people should not interpret "any difference in safety or efficacy" because Pfizer came first, saying that it's a matter of timing.

"Pfizer presented their data in a very timely way to the FDA," Dr. Fauci explained. "Moderna is a bit behind in the presentation of their data to the FDA. That doesn't mean the data is any less effective or less safe. It's just that's the timing of when they present it."

"The timing was a little bit different," Fauci continued. "People need to understand it's a timing issue, not an efficacy or a safety issue."

More than 64 million Americans have been fully vaccinated with the two-dose Moderna vaccine as of Tuesday, according to data from the Centers for Disease Control and Prevention (CDC).