Moderna is applying for an Emergency Use Authorization from the US Food and Drug Administration for its SARS-CoV-2 vaccine, the New York Times reports.
Earlier this month, Moderna reported that its candidate SARS-CoV-2 vaccine, which is an mRNA-based vaccine, had an efficacy of nearly 95 percent in initial clinical testing. The company has now reported additional data that found 11 individuals who received two vaccine doses developed COVID-19, while 185 people in the placebo group did, indicating a vaccine efficacy of 94.1 percent. It further says that none of the individuals given the vaccine developed severe COVID-19.
"I would still like to see all of the actual data, but what we've seen so far is absolutely remarkable," Paul Offit from Children's Hospital of Philadelphia tells ScienceInsider.
In its press release, Moderna adds that it is filing for an EUA from the FDA and conditional approval from the European Medicines Agency.
About 10 days ago, Pfizer and BioNTech announced they would be seeking an EUA for their coronavirus vaccine, and the Huffington Post says Pfizer and BioNTech are to present their data to an FDA panel on December 10 and Moderna on December 17.