The US Food and Drug Administration (FDA) on Friday authorised a Moderna coronavirus vaccine for emergency use, allowing the vaccine to be distributed in the US for use by individuals who are 18 years or older.
"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", said FDA Commissioner Stephen M. Hahn. "Through the FDA's open and transparent scientific review process, two COVID-19 vaccines have been authorised in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorisation that the American people have come to expect from the FDA".
Today, FDA issued an emergency use authorization (EUA) for the second vaccine for the prevention of #COVID19 caused by SARS-CoV-2. The emergency use authorization allows the vaccine to be distributed in the U.S for use in individuals 18 years and older. https://t.co/w4BQVg0n2G pic.twitter.com/cw5JwYqxsh
— U.S. FDA (@US_FDA) December 19, 2020
According to the FDA, the Moderna vaccine "has met the statutory criteria for issuance of an EUA", as the potential benefits outweigh the known risks.
"Today's authorisation demonstrates our steadfast commitment to the health of the American people, with the assurance that our scientific standards and the integrity of our review process have been maintained", said Peter Marks, the director of the FDA's Centre for Biologics Evaluation and Research.
US President Donald Trump took to Twitter to mark the authorisation of the Moderna vaccine in America.
Congratulations, the Moderna vaccine is now available!
— Donald J. Trump (@realDonaldTrump) December 19, 2020
Earlier in December, the FDA issued an emergency use authorisation for another coronavirus vaccine developed in partnership by the pharmaceutical giant Pfizer and German firm BioNTech.
After the authorisation, several US political figures, including Vice President Mike Pence, Speaker of the House Nancy Pelosi, and US Senate Majority Leader Mitch McConnell, publicly received shots of the Pfizer vaccine. President-elect Joe Biden announced that he would take the vaccine on Monday.
