Moderna asks US, Europe for emergency approval of vaccine

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Moderna, which also plans to seek European approval, reported that its vaccine's efficacy was consistent across age, race, ethnicity and gender demographics as well as having 100% success in preventing severe cases of the disease that has killed almost 1.5 million people worldwide.

The company, which is using mRNA technology that involves injecting genetic instructions to human cells for creating proteins to fight the virus, said that the primary analysis on 196 cases, revealed that 185 cases of Covid-19 were observed in the placebo group as against only 11 cases in the vaccine group, "resulting in a point estimate of vaccine efficacy of 94.1%". None of the participants in the trial who'd received the vaccine developed severe Covid-19. The shares extended their gains to as much as 12 per cent before U.S. markets opened, hitting a record of $142.85.

The US biotech, whose share price has soared by more than half since it first unveiled promising vaccine trial data two weeks ago, said it would be submitting its findings to the US drugs regulator in the "coming weeks" alongside United Kingdom and European regulators.

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Approval for the company's Pfizer Inc. -partnered Covid-19 vaccine is already reflected in the stock's 268% rally this year, so that now there's limited room for additional gains despite the two companies' first-mover advantage, BofA analyst Tazeen Ahmad wrote in a note to clients, downgrading BioNTech to neutral from buy. Advisers to the US Food and Drug Administration will likely scrutinize the data at a public meeting on December 17, the company said, one week after a similar review of Pfizer's vaccine is expected to take place. "We now have the data to prove it", Moderna Chief Medical Officer Tal Zaks said.

"We are ready today to ship the vaccine", Bancel said.

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