U.S. FDA authorizes Moderna's COVID-19 vaccine for emergency use

U.S. FDA authorizes Moderna's COVID-19 vaccine for emergency use Moderna Inc's coronavirus vaccine on Friday became the second to receive emergency use authorization (EUA) from the U.S. Food and Drug Administration, welcome news to a nation with a staggering COVID-19 death toll of over 307,000 lives lost. Michael Erman U.S.

(Reuters) - Moderna Inc’s coronavirus vaccine on Friday became the second to receive emergency use authorization (EUA) from the U.S. Food and Drug Administration, welcome news to a nation with a staggering COVID-19 death toll of over 307,000 lives lost.

The FDA announced the authorization the day after the agency’s panel of outside experts endorsed its use.

The decision marks the first regulatory authorization in the world for Moderna’s vaccine and validation of its messenger RNA technology, less than a year after the first COVID-19 case was identified in the United States.

The biotech company has worked with the U.S. government to prepare for the distribution of 5.9 million shots as early as this weekend.

The FDA decision is based on results from a late-stage study of 30,000 volunteers that found the vaccine was nearly 95% effective at preventing illness from COVID-19 with no serious safety concerns.

The authorization follows an EUA granted for a similar vaccine from Pfizer Inc and German partner BioNTech SE that has been put into the arms of thousands of U.S. healthcare workers this week in a massive nationwide rollout.

Moderna’s shot is expected to be used in harder-to-reach locations, such as rural hospitals. The vaccine needs to be stored and shipped frozen, but does not require the ultra-cold temperatures of the Pfizer/BioNTech shot. ...

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