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The U.S. Food and Drug Administration authorized Moderna’s (MRNA) COVID-19 vaccine for emergency use Friday evening, after an independent advisory panel voted overwhelmingly to recommend the EUA.
The EUA marks an important moment in the company’s history, as the vaccine is its first product to emerge from clinical trials. It also marks the second vaccine using a new platform, messenger RNA or mRNA, to deliver protection.
“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 Moderna CEO Stéphane Bancel in a statement late Friday.
Moderna was the first company to begin clinical trials, beginning 63 days after the virus was sequenced from China.
“On January 7, before China had reported even one death from the novel coronavirus or confirmed human-to-human transmission, NIH scientists and innovators at Moderna agreed to begin work on the vaccine that received FDA authorization today,” said Heath and Human Services Secretary Alex Azar.
The authorization makes Moderna’s the second vaccine to be available in the U.S., following that of Pfizer’s (PFE) and BioNTech’s (BNTX).
“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 Stephen Hahn in a statement.
The 20-0 vote in favor of authorization Thursday evening paved the way for what was widely expected to be a sprint to the finish line for Moderna.
Experts including National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci say the platform holds promise for the future of vaccines, as well as treatments.
Originally, Moderna had been working on mRNA for cancer treatments. It has also announced efforts to begin working on a flu vaccine.
The company began as a small biotech at the start of the year, but became the first to be approved for clinical trials in March. It’s valuation has spiked, from trading at $17 per share in January, to a high of nearly $170 per share this month — pushing its market cap to $56 billion.
In a statement following the conclusion of Thursday’s meeting, the FDA said in a statement that the agency “will rapidly work toward finalization and issuance of an emergency use authorization.”
Similar to last week’s process, when Pfizer (PFE) and BioNTech (BNTX) clinched the first authorization in the U.S., the FDA also notified Operation Warp Speed officials to ready the first shipments.