November 30, 2020 – Moderna announced today that it will request emergency clearance from the Food and Drug Administration (FDA) for its coronavirus vaccine, following new data that showed the vaccine is more than 94% effective in preventing COVID-19 and was safe.
Moderna will be the second drugmaker to seek emergency use from the FDA after Pfizer and BioNTech, applied for the same authorization on Nov. 20.
The announcement means some Americans could get the first doses of Moderna’s two-dose vaccine within a few weeks.
The new analysis from Moderna evaluated 196 confirmed COVID infections among the late-stage trial’s 30,000 participants. The company said 185 cases of Covid were observed in the placebo group versus 11 cases observed in the group that received its vaccine.
That resulted in an estimated vaccine efficacy of 94.1%, the company said.
Moderna’s vaccine also appears to prevent volunteers from getting severely sick from the virus. Of the 30 severe cases of Covid-19 in the trial, none were in the group that received the vaccine, Moderna said.