Moderna requests full FDA approval for COVID vaccine

  • By cvbizz
  • June 2, 2021
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Drugmaker Moderna announced on Tuesday it has started the process to request full approval from the U.S. Food and Drug Administration for its mRNA coronavirus vaccine.

Moderna’s vaccine is currently authorized under an Emergency Use Authorization (EUA) for adults 18 and up. Since receiving the EUA in December, more than 124 million doses of Moderna’s vaccine have been administered across the U.S.

The company is the second drugmaker in the U.S. to apply for full FDA approval for its COVID-19 vaccine. Last month, Pfizer and BioNTech announced they had started the approval process.

Moderna said data to support its vaccine will be submitted to the FDA on a “rolling basis” over the coming weeks. Like Pfizer, Moderna requested a priority review, which asks the FDA to fast-track the application within six months instead of the usual 10 months. #WakeUpCLT #Moderna #COVID19


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