Moderna seeks full FDA approval of its COVID-19 vaccine
CAMBRIDGE, Mass. - Moderna has started its application to obtain full approval of its COVID-19 vaccine by the U.S. Food and Drug Administration, becoming the second vaccine developer in the U.S. to do so.
The two-dose mRNA vaccine is currently being administered in the U.S. under an emergency use authorization, which was granted by the FDA in December. It gives conditional approval of necessary countermeasures, such as a vaccine, during public health emergencies, but still requires rigorous testing and at least two months of safety data before any FDA evaluation.
Experts say full approval would signify the continued safety and efficacy of the vaccine. It would also allow companies to market the vaccine directly to consumers and allow it to stay on the market as the COVID-19 pandemic ends.
Moderna announced Tuesday that it has started the Biologics License Application (BLA) for full approval and will continue to submit data to the FDA "on a rolling basis over the coming weeks," potentially paving the way for full approval in the next several months. A request for full approval requires at least six months of safety data from volunteers in the drugmaker’s Phase 3 trial.
The FDA will scrutinize the information to see if the vaccine meets stringent criteria for full licensure.
FILE - A person receives the Moderna COVID-19 vaccine at CASA de Maryland's Wheaton Welcome Center on May 21, 2021 in Wheaton, Maryland. (Photo by Chip Somodevilla/Getty Images)
More than 124 million doses of Moderna’s COVID-19 vaccine, currently authorized for those 18 and up, have already been administered in the U.S, according to data from the Centers for Disease Control and Prevention.
"We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine," Moderna CEO Stéphane Bancel said in a statement. "We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission."
Pfizer previously announced it had begun the process of seeking full FDA approval for its two-dose vaccine, developed with German partner BioNTech.
Moderna’s vaccine, which requires two doses spaced 28 days apart, has been found to be highly effective at preventing COVID-19 and severe disease in adults for up to six months after the second dose. Earlier this month, the company also shared data from its study of adolescents. The company said its two-dose vaccine was found to be 100% effective in a study of more than 3,700 12- to 17-year-olds.
Moderna said it planned to submit its teen data to the FDA and other global regulators soon.
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This story was reported from Cincinnati.