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Moderna has announced that its Covid-19 vaccine is safe and ready for use. The company has applied for emergency approval by the US Food and Drug Administration (FDA) and will be applying to Europe for clearance. Moderna says its trials show 100% efficacy against severe disease. The vaccine makes use of messenger RNA technology which has never been used to develop an FDA approved vaccine before. The vaccine requires two doses and costly cold chain infrastructure, presenting a challenge to access and distribution in less developed nations. Moderna says its entire stock will go to the US Federal government if the vaccine is approved. – Melani Nathan
Moderna seeks clearance for Covid shot after strong results
By Robert Langreth
(Bloomberg) — Moderna requested clearance for its coronavirus vaccine in the US 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 afternoon Monday that its application for an emergency use authorisation for its Covid shot had been delivered to the US Food and Drug Administration. Earlier, the company had said in a statement it would seek clearance on Monday in both the US 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. in New York. They have gained more than sevenfold since the year began. The company’s market capitalization of more than $60bn has surpassed that of Regeneron Pharmaceuticals Inc., which had $7.8bn in revenue last year and is producing a Covid-19 antibody cocktail.
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.
Advisers to the FDA will scrutinise the data at a public meeting on December 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 authorisation 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 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.”
The US reached a deal worth as much as $1.5bn 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.
Vaccine data fuels shares
If the vaccine is cleared in the US, which Bancel said could occur as soon as 24 to 72 hours after the December 17 meeting, Moderna’s entire inventory will be sent to the federal government. New lots will be shipped as soon as they pass muster, Bancel said. The company expects to be able to ship 20 million doses in the US by the end of the year.
“This will be like a typical flu vaccination, just at a scale that has never happened in the world in terms of the number of people to be vaccinated at the same time,” Bancel said Monday in an interview on Bloomberg Television.
The new analysis showed the vaccine worked consistently well in older and younger adults, as well as minorities, the company said. Moderna didn’t disclose the vaccine’s exact efficacy in those groups, and Bancel said that more detailed data is still being finalised.
Overall, there were 185 cases of Covid-19 in trial participants who got a placebo, and 11 cases in people who got the vaccine.
As mandated by the FDA, Moderna said it had also accumulated two months of safety data from its final-stage trial of more than 30,000 participants. Reported side effects included injection-site pain, fatigue, muscle or joint pain and headache. The side effects were more common and severe after the second dose of the two-dose vaccine, Moderna said.
The results bolster an interim analysis released on November 16, which showed the vaccine was 94.5% effective in preventing symptomatic Covid-19 and successful in preventing the most severe infections.
The current trial results are based on reducing symptomatic cases. But by early next year, Moderna should also know whether the vaccine can also prevent people from getting infected at all, Bancel said during the TV interview. The company also plans to begin additional trials of the vaccine in groups not included in the current study, including a trial in teenagers and another trial testing the shot in people with cancer.
On November 20, Pfizer and German partner BioNTech became the first to seek emergency US clearance for a vaccine, after their shot was 95% effective in preventing symptomatic Covid-19 in the final analysis of a nearly 44,000 participant trial. That vaccine application will be reviewed by a panel of FDA advisers on December 10, potentially paving the way for it to become available soon after that.
Both the Moderna and Pfizer vaccines rely on a technology called messenger RNA that turns the body’s cells into vaccine-making factories. Messenger RNA has never before been used to develop an approved vaccine.
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