FDA issues emergency use authorization for Moderna vaccine

The FDA has granted emergency use authorization for Moderna’s coronavirus vaccine, giving the world a second shot at beating back the pandemic and clearing the way for doses to be shipped to states immediately.
“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 hospitalizations and deaths in the United States each day,” said FDA Commissioner Dr. Stephen Hahn in a statement.

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

Massachusetts superstar Moderna, based in Cambridge, created an mRNA vaccine that is 94.1% effective and will join Pfizer as the second company to get the green light from the Food and Drug Administration to distribute a coronavirus vaccine.
“I am proud of what the Moderna team has achieved in collaboration with our partners. We were able to create and manufacture the Moderna COVID-19 vaccine in 11 months from sequence to authorization, while advancing clinical development with a Phase 1, Phase 2 and pivotal Phase 3 study of 30,000 participants,” said Moderna CEO Stéphane Bancel.
“It has been a 10-year scientific, entrepreneurial and medical journey and I am thankful to all those who have helped us get here today. We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease,” said Bancel.
The vaccine was found to be safe and effective by the FDA and is cleared for use in adults 18 years and older.
Moderna said it plans to submit a Biologics License Application for full U.S. licensure in 2021. There has never been a licensed mRNA vaccine in the United States.
Vice President Mike Pence said Friday morning that once the FDA had cleared the way for the Moderna vaccine, 5.9 million doses would soon go out to states.
“Today’s authorization 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 Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
The Vaccines and Related Biological Products Advisory Committee met Thursday and overwhelmingly voted to recommend emergency use of the vaccine, with 20 yes votes and one abstention.
Immediately following the meeting, the FDA said in a statement that it would rapidly work toward finalizing the necessary steps for emergency use while also informing Operation Warp Speed and the Centers for Disease Control and Preventionin preparation for timely distribution.
An emergency use authorization is not the same as an FDA approval, but still allows for the vaccine doses to be administered.
Moderna has an agreement with the U.S. government to supply 200 million vaccine doses, 20 million of which will be delivered by the end of the month.

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