Moderna Announces EUA Request to FDA for COVID-19 Vaccine Candidate

On November 30, 2020, Moderna announced that it has submitted an emergency use authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine candidate mRNA-1273. Additionally, Moderna announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the safety and efficacy data package for mRNA-1273 will likely be scheduled for Thursday, December 17.

The company shared that the primary efficacy analysis of the Phase 3 COVE study of mRNA-1273 based on 196 cases confirms the high efficacy observed at the first interim analysis. The point estimate performed indicates a vaccine efficacy of 94.1 percent. Efficacy was consistent across age, race, ethnicity, and gender demographics.

Moderna anticipates that the shipping of mRNA-1273 to designated distribution points throughout the U.S. will occur shortly after an EUA is granted.

Read Moderna's press release. You can find out more on Moderna's COVID-19 vaccine candidate from the Wall Street Journal, New York Times, and Bloomberg.

Posted 12/1/2020