Moderna vaccine 100% effective in severe cases; to seek US, EU approval

Moderna said it plans to apply on Monday for an emergency-use authorisation for the vaccine in the US and for conditional marketing authorisation in Europe.
Moderna Inc plans to request clearance for its coronavirus vaccine in the United States 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 per cent 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. The shares extended their gains to as much as 12 per cent before US markets opened, hitting a record of $142.85. They have risen more than sixfold since the year began.

 

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 US. A similar vaccine from Pfizer and BioNTech was submitted to US 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 authorisation for the vaccine in the US and for conditional marketing authorisation in Europe. Advisers to the US Food and Drug Administration will likely scrutinize the data at a public meeting on December 17, the company said, one week after a similar review of Pfizer’s vaccine is expected to take place.

 

“We have been working nonstop in the last few weeks” to get the vaccine data ready to submit to regulators, Stephane Bancel, Moderna’s chief executive officer, said in an interview.

 

Once authorities sign off, the company will move quickly to distribute the shots, part of a vast vaccination effort that will unfold as hospitals in the US strain under a surge in infections.

 

“We are ready today to ship the vaccine,” Bancel said. “We have millions of doses ready, we have more and more every couple days.”



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