Headline Roundup • November 30th, 2020
Moderna to Ask FDA to Approve Its Vaccine
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Wall Street Journal (News)
Moderna Inc. MRNA 16.13% said it will on Monday ask U.S. and European health regulators to authorize use of the company’s Covid-19 vaccine, after it was shown to be 94.1% effective in a full analysis of a pivotal study.
The timing keeps the vaccine on track to become possibly the second to go into use in the U.S. by year’s end—after one already under regulatory review from Pfizer Inc. and BioNTech SE —with inoculation available to the general public likely in spring or summer.
In the 30,000-person trial, 196 subjects...
Moderna announced that it would seek an emergency use authorization, or EUA, from the Food and Drug Administration on Monday after its phase three study found its coronavirus vaccine candidate to be 94% effective.
Moderna said its vaccine was 100% effective at preventing severe cases of COVID-19.
"This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course...
Politico
Moderna will file Monday for an emergency authorization of its coronavirus vaccine from the Food and Drug Administration, becoming the second company to do so.
The vaccine developer said it would simultaneously ask the European Medicines Agency for conditional approval.
The FDA filing would clear the way for the vaccine to be authorized for use in the United States within weeks. Moderna's application relies on a final analysis of its 30,000-person late-stage trial that showed the vaccine to have 94.1 percent efficacy, on par with the 94.5 percent reported in...
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