Moderna Inc. plans to request clearance for its coronavirus vaccine in the U.S. and Europe on Monday, after a new analysis showed the vaccine was highly effective in preventing COVID-19 with no serious safety problems.
The primary analysis, which included 196 cases, found the vaccine was 94.1% effective, in line with preliminary findings released earlier this month. None of the participants in the trial who had received the vaccine developed severe COVID-19. All 30 severe cases observed in the study occurred in participants who received placebo shots, according to a company statement.
The new results put the Cambridge, Massachusetts-based biotechnology company on track to have one of the first COVID-19 vaccines to be cleared in the U.S. A similar vaccine from Pfizer Inc. and BioNTech SE was submitted to U.S. regulators earlier this month and is scheduled to be reviewed ahead of Moderna’s shot.