Moderna to seek FDA approval for COVID-19 vaccine

HealthModerna to seek FDA approval for COVID-19 vaccine

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Moderna to seek FDA approval for COVID-19 vaccine

U.S. biotech firm Moderna said Monday it will seek an emergency use authorization from U.S. regulators 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,” CEO Stéphane Bancel said.

“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,” he said.

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