Moderna to submit emergency authorization request to FDA
Moderna announced it plans to submit a request on Monday to the U.S. Food and Drug Administration for emergency use authorization of its COVID-19 vaccine, becoming the second company after Pfizer to do so.
Moderna said in a press release that the FDA's meeting to review the safety and efficacy data for its National Institutes of Health-funded vaccine candidate, called mRNA-1273, will likely be scheduled for Dec. 17. The FDA hearing for the vaccine candidate developed by New York-based pharmaceutical company Pfizer and its German partner BioNTech is slated for Dec. 10.
Moderna also announced that the final analysis of its Phase 3 clinical trial of mRNA-1273 indicates a vaccine efficacy of 94.1%. Pending FDA authorization, Moderna said it expects to have approximately 20 million doses of mRNA-1273 available in the United States by the end of the year. The Massachusetts-based biotechnology company remains on track to manufacture 500 million to 1 billion doses globally in 2021.
"This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease," Moderna CEO Stephane Bancel said in a statement Monday. "We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death."
ABC News' Sony Salzman contributed to this report.