FDA Issues Emergency Approval Of Moderna Coronavirus Vaccine

WASHINGTON, DC — The U.S. Food and Drug Administration issued an emergency use authorization late Friday for Moderna's coronavirus vaccine, paving the way for the vaccine to fight a pandemic that's killed nearly 312,000 Americans.

The decision came just a day after an FDA panel of advisers voted to back the vaccine's safety and efficacy.

Following the panel's decision, FDA officials said Thursday they planned to move "rapidly" toward approving the Moderna vaccine.

In a statement posted to the FDA's website Friday, chief commissioner Stephen Hahn said the emergency use authorization marks another crucial step in the battle against the coronavirus.

“Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA," Hahn said in the statement.

The emergency approval of the Moderna vaccine comes just one week after the FDA issued a similar authorization to one developed by drugmaker Pfizer and its German partner BioNTech.

Anticipating the authorization decision, Gen. Gustave Perna, who oversees Operation Warp Speed and the federal effort to distribute vaccines, said the government was preparing to ship almost 6 million doses of the Moderna vaccine to 3,285 locations in the first week after approval, according to a Washington Post report.