Armed with impressive trial data, Moderna requests EUA

Nov. 30, 2020

Moderna has announced plans to submit a request to the U.S. FDA for an Emergency Use Authorization (EUA) of its COVID-19 vaccine candidate, mRNA-1273.

The drugmaker will also apply for a conditional marketing authorization with the European Medicines Agency (EMA).

Following the Pfizer-BioNTech submission last week, Moderna is now the second drugmaker to request an EUA for its COVID-19 vaccine candidate.

Moderna announced the results of its 30,000-person phase 3 COVE study today: Only 11 people who received two doses of the vaccine developed COVID-19 symptoms after being infected with coronavirus, versus 185 symptomatic cases in a placebo group. That is an efficacy of 94.1%, the company says — far above what many scientists were expecting just a few weeks ago.

Perhaps most impressive is that Moderna’s vaccine candidate had 100% efficacy against severe disease. There were zero severe COVID-19 cases among those vaccinated, but 30 in the placebo group.

The drugmaker expects 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.

Read the press release