Moderna Inc plans to apply for authorization 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, without serious safety concerns.
The primary analysis, which included 196 cases, found the vaccine to be 94.1 percent effective, in line with preliminary findings published earlier this month. None of the trial participants who had received the vaccine developed severe Covid-19. The 30 serious cases seen in the study occurred in participants who received placebo injections, according to a company statement. The shares extended their gains as much as 12 percent before the US markets opened, hitting a record $ 142.85. They have multiplied by more than six since the year began.
The new results put the Cambridge, Massachusetts-based biotech company on track to have one of the first Covid-19 vaccines approved in the US A similar vaccine from Pfizer and BioNTech was shipped to US regulators. Earlier this month and is scheduled to be reviewed prior to the Moderna injection.
Moderna said it plans to apply for an emergency use authorization for the vaccine in the United States and a conditional marketing authorization in Europe on Monday. Advisers to the U.S. Food and Drug Administration will likely examine the data at a public meeting on Dec. 17, the company said, a week after a similar review of the vaccine is expected to take place. from Pfizer.
“We have been working non-stop in recent weeks” to get the vaccine data ready to send to regulators, Stephane Bancel, Moderna’s chief executive, said in an interview.
Once approved by authorities, the company will move quickly to distribute the vaccines, part of a vast vaccination effort that will unfold as U.S. hospitals are hit by 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 two days.”
Dear reader,
Business Standard has always strived to provide up-to-date information and commentary on developments that interest you and that have broader political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering has only strengthened our determination and commitment to these ideals. Even during these difficult times arising from Covid-19, we remain committed to keeping you informed and up-to-date with credible news, authoritative opinions, and incisive commentary on relevant current affairs.
However, we have a request.
As we fight the economic impact of the pandemic, we need your support even more so that we can continue to bring you more quality content. Our subscription model has received an encouraging response from many of you, who have subscribed to our content online. Increased subscription to our online content can only help us achieve the goals of bringing you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practice the journalism to which we are committed.
Support quality journalism and subscribe to Business Standard.
Digital editor
.
