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Moderna plans to seek US authorization for the Covid vaccine
(Bloomberg) – Moderna Inc. plans to apply for authorization for its coronavirus vaccine in the US and Europe on Monday after new analysis showed the vaccine was highly effective in preventing Covid-19, without serious safety issues. which included 196 cases, found the vaccine to be 94.1 percent effective, in line with preliminary results published earlier this month. All 30 serious cases seen in the study occurred in participants who received a placebo, according to a company statement, indicating 100% effectiveness against severe disease for the injection. 18% Monday morning in New York for a record $ 150. They have earned more than six times since the beginning of the year. The company’s market capitalization of more than $ 58 billion has surpassed that of Regeneron Pharmaceuticals Inc., which posted revenue of $ 7.8 billion last year and is producing a cocktail of Covid-19 antibodies. The new findings put the Cambridge, Massachusetts-based biotech company on track. have one of the first Covid-19 vaccines to be phased out in the US A similar vaccine from Pfizer Inc. and BioNTech SE was unveiled to US regulators earlier this month and is scheduled to be reviewed before Moderna’s roll out. apply on Monday for an emergency use authorization of the vaccine in the United States and a conditional marketing authorization in Europe. Consultants from the U.S. Food and Drug Administration are likely to review the data at a public meeting on Dec.17, the company said, a week after a similar review of Pfizer’s vaccine is expected. US regulators declined to confirm the timing. “We respectfully refuse to comment at this time,” FDA spokesperson Abigail Capobianco said in an email. Read more: Moderna, Pfizer Shots Look Strong. Here’s how they stack up “We’ve been working tirelessly over the past few weeks” to prepare vaccine data for submission to regulators, Moderna CEO Stephane Bancel said in an interview. Once the authorities sign, the company will move swiftly to distribute the vaccines, part of a vast vaccination effort taking place as hospitals across the United States are subject to a wave of infections. “We are ready today to ship the vaccine,” Bancel said. “We have millions of doses ready, we have more and more every couple of days.” The United States reached a deal worth $ 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 UK has secured 7 million doses.If the vaccine is licensed in the US, what Bancel says could happen as soon as 24-72. hours after the December 17 meeting. , Moderna’s entire inventory will be sent to the federal government. The new batches will be shipped as soon as they pass the meeting, Bancel said. The company expects to be able to ship 20 million doses to the United States by the end of the year. The new analysis showed that the vaccine worked consistently well in older adults and young people, 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 study participants who received a placebo and 11 cases in people who received Safety Signals.As requested by the FDA, Moderna said it also accumulated two months of safety data. from his study into the final phase of over 30,000 participants. Side effects reported 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 findings support an interim analysis published Nov.16, which showed the vaccine was 94.5 percent effective in preventing the symptomatic Covid-19 and has been successful in preventing more serious infections. On November 20, Pfizer and German partner BioNTech were the first to apply for emergency clearance in the United States for a vaccine, after their shot was 95% effective in preventing symptomatic Covid-19 in the final analysis of nearly 44,000 participating trials. That vaccine application will be reviewed by a group of FDA consultants on December 10, potentially paving the way for it to become available soon thereafter, both Moderna and Pfizer vaccines are based on a technology called messenger RNA that turns the body’s cells into vaccine factories. . Messenger RNA has never been used before to develop an approved vaccine. (Updates with FDA commentary in paragraph six.) For more articles like this, visit bloomberg.com. Sign up now to stay up to date with the most trusted business news source. © 2020 Bloomberg LP
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