Moderna seeks clearance for COVID-19 vaccine after strong test results
Moderna Inc. requested clearance for its coronavirus vaccine in the U.S. after a new analysis showed the vaccine was highly effective in preventing COVID-19, with no serious safety problems.
A Moderna spokesman said in a text message late Monday afternoon that its application for an emergency use authorization for its COVID-19 shot had been delivered to the U.S. Food and Drug Administration. Earlier, the company had said in a statement it would seek clearance Monday in both the U.S. and Europe.
The primary analysis, which included 196 cases, found the vaccine was 94.1% effective, in line with preliminary findings released earlier this month. All 30 severe cases observed in the study occurred in participants who received a placebo, according to a company statement, indicating 100% efficacy against severe disease for the shot.
Moderna shares rose
20% to close at $152.74 at 4 p.m. EST in New York. They have gained more than sevenfold since the year began. The company’s market capitalization of more than $60 billion has surpassed that of Regeneron Pharmaceuticals Inc., which had $7.8 billion in revenue last year and is producing a COVID-19 antibody cocktail.
The new results put the
Cambridge, Massachusettsbased 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.
Advisers to the FDA will scrutinize the data at a public meeting Dec. 17, the agency said in a statement, one week after a similar review of Pfizer’s vaccine is expected to take place. Moderna also plans to apply for conditional marketing authorization in Europe.
“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 U.S. 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.”
The U.S. reached a deal worth as much as $1.5 billion for 100 million doses of the Moderna shot in August. The European Union, Canada and Japan also have large purchase agreements, and the U.K. has secured 7 million doses.