|Moderna 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’d 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.
Both the Moderna vaccine and Pfizer’s are based on mRNA technology designed to transform the body’s own cells into vaccine making factories.
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 and BioNTech was submitted to U.S. regulators earlier this month, and is scheduled to be reviewed ahead of Moderna’s shot.
Moderna said it plans to apply on Monday for an emergency-use authorization for the vaccine in the U.S. and for conditional marketing authorization in Europe. Advisers to the U.S. Food and Drug Administration will likely scrutinize the data at a public meeting on Dec. 17, the company said, one week after a similar review of Pfizer’s vaccine is expected to take place.