Moderna’s coronavirus vaccine has become the second to receive emergency use authorisation (EUA) from the US Food and Drug Administration, which is welcome news to a nation with a staggering COVID-19 death toll of more than 307,000 lives lost.
The FDA announced the authorisation a day after the agency’s panel of outside experts endorsed its use.
The decision on Friday (local time) marks the first regulatory authorisation in the world for Moderna’s vaccine and validation of its messenger RNA technology.
It came less than a year after the first COVID-19 case was identified in the United States.
The biotech company has worked with the US 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 per cent effective at preventing illness from COVID-19 with no serious safety concerns.
The authorisation follows an EUA granted for a similar vaccine from Pfizer and German partner BioNTech SE that has been put into the arms of thousands of US healthcare workers this week in a massive nationwide rollout.
“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalisations and deaths in the United States each day,” FDA Commissioner Stephen Hahn said.
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.
Moderna has deals with the US government to provide 20 million doses this year and a total of 200 million doses by the end of June 2021.
The biotech company is preparing for the distribution of 5.9 million shots as early as this weekend.