Moderna said Monday it will request emergency clearance from the Food and Drug Administration for its coronavirus vaccine after new data confirms the vaccine is more than 94 effective in preventing Covid19 and was safe.
Moderna is the second drugmaker to seek emergency use from the FDA after Pfizer, another frontrunner in the Covid19 vaccine race, applied for the same authorization on Nov. 20. The announcement means some Americans could get the first doses of Modernas twodose vaccine within a few weeks.
The new analysis from Moderna evaluated 196 confirmed Covid infections among the latestage trials 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.
The company released Nov. 16 an early analysis of its phase three trial based on just 95 Covid19 cases that showed its vaccine was at least 94 effective. Mondays data provides a more complete picture of the vaccines effectiveness.
It also appears to prevent volunteers from getting severely sick from the virus. Of the 30 severe cases of Covid19 in the trial, none were in the group that received the vaccine, Moderna said. Additionally, there was one Covid19 related death in the study that occurred in the placebo group, according to the company.
Shares of Moderna were up more than 12 in premarket trading Monday.