Moderna began submitting data for the biologics license application, or BLA, in June. As part of the completed submission, the company has requested priority review from the FDA.
“This BLA submission for our COVID-19 vaccine … 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,” Stephane Bancel, CEO of Moderna, said in a statement.
In a final analysis of late-stage clinical trial data, the Moderna vaccine showed 93% efficacy, the company announced. The efficacy remained high through 6 months after the second dose.
People who took part in the trial reported typical symptoms observed after COVID-19 vaccine shots, such as pain and swelling at the injection site, fatigue, headache, muscle pain, joint pain, chills, nausea, fever, and tenderness.
Moderna’s COVID-19 vaccine is currently available under FDA emergency use authorization for ages 18 and older. The company has also filed for emergency use authorization for ages 12 and older.
The news comes after the FDA fully approved Pfizer’s COVID-19 vaccine on Monday for ages 16 and older. If Moderna receives full approval, its vaccine would be the second COVID-19 shot available under full FDA approval.
Under priority review, the approval process can still take months, according to CNN. The FDA reviews thousands of documents on safety and efficacy, does its own analyses, and inspects facilities.
To approve the Pfizer vaccine, the agency pulled in extra resources to complete the process as soon as possible, Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, told CNN on Monday.
“It’s actually 97 days since Pfizer completed the role of its BLA and the clock started, which means that we completed this in about 40% of the normal clock time for a submission of this magnitude,” he said.