(WAND) - Moderna announced it has finalized its submission process for full approval of its COVID-19 vaccine.
The company's Biologics License Application has been submitted to the U.S. Food and Drug Administration. The full approval would be for people at age 18 and older.
The company, which seeks to follow Pfizer in having a COVID-19 vaccine fully approved by federal regulators, requested Priority Review designation.
Moderna said its vaccine showed a durable efficacy of 93 percent through six months after two doses.
"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," said Moderna Chief Executive Officer Stéphane Bancel. "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. 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.”
The Moderna vaccine currently has Emergency Use Authorization approval from the FDA for use with adults at age 18 and older. Moderna has released over 300 million vaccine doses to the U.S. government since EUA approval came on Dec. 18, 2020.
