Moderna is seeking full approval from the Food and Drug Administration for its coronavirus vaccine, the company announced Tuesday.
The big picture: Obtaining a Biologics License Application (BLA) from the FDA requires at least six months of data, unlike the two months of data required for emergency use authorization from the agency.
- Moderna's vaccine was found by the FDA to be safe and "highly effective" in preventing cases of COVID-19 in adults, as well as adolescents between the ages of 12 and 17. The vaccine is deemed safe and effective for pregnant women, according to a pre-print study in the American Journal of Obstetrics & Gynecology.
- Pfizer and BioNTech began the process of applying for full FDA approval of their COVID-19 vaccine for people 16 and older early last month.