BOSTON (WBZ NewsRadio) – Cambridge-based Moderna has completed its submission of a Biologics License Application (BLA) to the U.S Food and Drug Administration (FDA) for full authorization.
The biotechnology company made the announcement on August 25. Chief Executive Officer of Moderna, Stéphane Bancel, said the submissions is an important milestone in the battle against Covid-19.
“This is the first BLA submission in our company’s history,” Bancel said in a statement released by the company. “We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months after dose 2.”
Moderna’s submission included clinical data from the Phase 3 study of their vaccine. That study enrolled over 30,000 participants from across the country.
Bancel thanked everyone who participated in these studies as well as the staff who have been on the front lines of the fight against the virus.
“I would also like to thank the US 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,” Bancel continued.
On December 18, 2020, the FDA granted an Emergency Use Authorization of Moderna’s vaccine. It is currently available for U.S. citizens who are 18 and older.
If approved, the Moderna vaccine would join the Pfizer vaccine as the second vaccine to receive full approval from the FDA.