Moderna Inc. said in a statement Tuesday that it applied for full approval for its COVID-19 vaccine from the U.S. Food and Drug Administration in a move that was expected considering the company has compiled six months of safety data, Bloomberg reports.
Moderna’s confident that its vaccine is both effective enough and safe enough to meet the strict FDA requirements and will submit data to support the application for use of the vaccine in people 18 and older.
Moderna’s jab has been shown to be highly effective in preventing symptomatic Covid-19 after more than 124 million doses have been administered in the U.S. but the review process in the FDA will take several months.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research notes that the U.S. regulators would attempt speed up the review process of clearing COVID vaccines and therapies that typically takes six months.
Moderna’s vaccine is one of three jabs that received emergency authorization in the U.S. that can be revoked at any time and is valid only as long as the state of emergency itself and could become the company’s first approved product if regulators grant the company’s request.