Moderna To Seek FDA Approval for COVID-19 Vaccine

On Monday, U.S. biotech firm Moderna said it will seek an emergency use authorization for its COVID-19 vaccine candidate after further clinical trials confirmed it is 94% effective. Moderna plans to request an “EUA” from the U.S. Food and Drug Administration and conditional approval from the European Medicines Agency after the latest positive results.

Company officials said in a press release, “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 of this pandemic and help prevent severe disease, hospitalizations and death.”

With the expected FDA approval, the first doses of Moderna’s “mRNA-1273” vaccine could become available within weeks. The company is the second drugmaker to seek an emergency use authorization from the FDA. The team of Pfizer and BioNTech sought the same authorization on Nov. 20.

Moderna announced interim results from its late-stage, 30,000-participant “COVE” study earlier this month, indicating the vaccine is 94.5% effective in preventing infection, and those results were largely confirmed Monday using a bigger sample size.

Moderna submits vaccine for approval, says trial shows 100% efficacy against ‘severe’ Covid

Via www.nbcnews.com
 

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