Moderna to file application with FDA for COVID-19 vaccine

November 30, 2020

A possible coronavirus vaccine developed by the Massachusetts-based biotech firm Moderna will reportedly be subitted to the Food and Drug Administration for approval today.

Moderna reported it will ask the FDA for emergency use authorization after completing its Phase 3 trial. The company has reported their vaccine is 94% effective against the deadly coronavirus.

“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,” said Stéphane Bancel, Chief Executive Officer of Moderna.

Moderna's first vaccine development announcement came one week after drugmaker Pfizer and its German partner BioNTech reported their potential COVID-19 vaccine to be more than 90% effective in mid November.

The one benefit that Moderna announced with it's vaccine is that it does not require "ultra-cold storage" but rather a simple refridgeration model to keep it viable, making it an easier option to transport and distribute worldwide.

COVID-19 vaccines are being carefully evaluated in clinical trials and will be authorized or approved only if they make it substantially less likely you’ll get COVID-19, said a statement from the CDC. "Based on what we know about vaccines for other diseases, experts believe that getting a COVID-19 vaccine may help keep you from getting seriously ill even if you do get COVID-19."

"The known and potential benefits of a COVID-19 vaccine must outweigh the known and potential risks of the vaccine for use under what is known as an Emergency Use Authorization (EUA)" says the CDC.

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