Biotech firm Moderna said it will on Monday file requests with both U.S. and European regulators for approval of its COVID-19 vaccine, which clinical trials show is "generally well tolerated" and no serious safety concerns have been identified.
Moderna also announced plans to submit for emergency use listing of its vaccine with the World Health Organization (WHO), although it did not specify when that filing would take place.
Vaccinations could take place as early as 24 hours following approval, Moderna CEO Stephane Bancel said on CNBC's "Squawk Box" on Monday.
The announcement follows an efficacy review of the Moderna vaccine, called mRNA-1273, which showed an efficacy rate of 94.1 percent, based on an analysis of 196 cases.
Moderna's vaccine, like the one developed by Pfizer/BioNTech, uses a new technology to trigger an immune response known as synthetic messenger RNA, allowing it to be produced at scale much more quickly than traditional vaccines. Moderna estimates it will be able to make 20 million doses by the end of the year in the United States and is on track to manufacture between 500 million and 1 billion doses for global distribution in 2021.
"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,” said Stéphane Bancel, chief executive officer of Moderna, in a statement.
Moderna also said it plans to submit data from its clinical trial study to a peer-reviewed publication.
"We could be seeing both of these vaccines out and getting into people's arms before Christmas," Health Secretary Alex Azar said on "CBS This Morning" on Monday.