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Moderna plans to apply for authorization for its coronavirus vaccine in the US 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% 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 up to 12% before the opening of the US markets, hitting a record high of $ 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 Inc. and BioNTech SE was submitted to US regulators earlier this month and is scheduled to be reviewed prior to Moderna’s vaccine.
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. Pfizer.
“We have been working non-stop in the last few 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 US 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.”
If the vaccine is approved in the US, which Bancel said could happen as soon as 24 to 72 hours after the December 17 meeting, Moderna’s full inventory will be sent to the federal government.
The new lots will be shipped as soon as they are approved, Bancel said. The company hopes to be able to ship 20 million doses to the US before the end of the year.
The new analysis showed that the vaccine worked consistently well in older and younger adults, as well as minorities, the company said.
Moderna did not disclose the exact efficacy of the vaccine in those groups, and Bancel said more detailed data is still being finalized.
Overall, there were 185 cases of Covid-19 in trial participants who received a placebo and 11 cases in people who received the vaccine.
Safety signs
As ordered by the FDA, Moderna said it had also accumulated two months of safety data from its end-stage trial of more than 30,000 participants.
Reported side effects included injection site pain, fatigue, muscle or joint pain, and headache. Side effects were more common and severe after the second dose of the two-dose vaccine, Moderna said.
The results reinforce an interim analysis published on November 16, which showed that the vaccine was 94.5% effective in preventing symptomatic Covid-19 and successful in preventing the most serious infections.
On November 20, Pfizer and its German partner BioNTech became the first to apply for US emergency authorization for a vaccine, after its injection was 95% effective in preventing symptomatic Covid-19 in the final analysis of a trial of nearly 44,000 participants.
The vaccine’s application will be reviewed by an FDA advisory panel on December 10, which could pave the way for it to become available soon after.
Both the Moderna and Pfizer vaccines are based on a technology called messenger RNA that turns cells in the body into vaccine manufacturing factories.
Messenger RNA has never before been used to develop an approved vaccine.
Moderna, which has co-developed the mRNA candidate with the National Institutes of Health, has already reached agreements to supply 100 million doses to the United States and 80 million to the European Union, among others.
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