Modern Inc.’s coronavirus vaccine on Friday became the second to receive emergency use (EUA) approval from the US Food and Drug Administration, welcome news to a nation with an astonishing COVID-19 death toll of over 307,000 lives lost.
The FDA announced the approval the day after the agency’s panel of external experts approved its use.
The decision marks the first worldwide approval 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 biotechnology company has been working with the US government to prepare for the distribution of 5.9 million shots already this weekend.
The FDA decision is based on results from a late study of 30,000 volunteers who found that the vaccine was almost 95% effective in preventing COVID-19 disease without any serious safety concerns.
The authorization follows an EUA granted for a similar vaccine from Pfizer Inc and German partner BioNTech SE, which has been placed in the arms of thousands of US healthcare professionals this week in a massive nationwide launch.
“With the availability of two vaccines now to prevent COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing a large number of hospital stays and deaths in the United States every day,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.
Modern shots are expected to be used in hard-to-reach places, such as rural hospitals. The vaccine must be stored and transported frozen, but does not require the extremely cold temperatures in the Pfizer / BioNTech shot.
After thawing, the Moderna vaccine can be kept at typical refrigerator temperatures. It is administered in two shots at 28-day intervals.
Moderna has an agreement with the US government to provide 20 million doses this year and a total of 200 million doses by the end of June 2021.