Moderna to apply for FDA emergency use authorization for COVID-19 vaccine candidate

Following analysis of additional primary efficacy data for its mRNA-1273 COVID-19 vaccine candidate, Moderna Inc. today said it will apply for emergency use authorization from the Food and Drug Administration; a review of its safety and efficacy package is scheduled for Dec. 17. Moderna said that its candidate showed 94.1% efficacy against COVID-19, with a 100% efficacy against severe cases. In the event of approval, it is expected that 20 million mRNA-1273 doses will be available in the U.S. by the end of 2020, with a total of 500 million to 1 billion doses available globally in 2021.