Moderna has completed a submission filing for full FDA approval of its COVID-19 vaccine in individuals 18 and up, the company announced Wednesday. The biotech firm began submitting data for regulatory review in June.
Pending FDA review, the vaccine could become the second COVID-19 shot following Pfizer/BioNTech to win full approval, the next step beyond emergency authorization. Licensure involves rigorous review of additional data on safety, efficacy and quality, not to mention site inspections and independent FDA analyses.
"This BLA submission for our COVID-19 vaccine, which we began in June, is an important milestone in our battle against COVID-19 and for Moderna, as this is the first BLA submission in our company’s history," Stéphane Bancel, CEO of Moderna, said in a statement posted Wednesday. "We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months after dose 2."
The company also requested a priority review designation. Moderna’s application for licensure included late-stage trial data from the COVE study, involving over 30,000 participants in the U.S. According to the company statement, most frequent side effects post-vaccination included " pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site."
The Moderna vaccine is available under emergency use authorization for individuals 18 years and older, and the company also requested to expand authorization to adolescents ages 12-17.