BRIEF—FDA issues EUA for Moderna's COVID-19 vaccine

In what was largely expected following a unanimous vote from an advisory panel on Thursday, the US Food and Drug Administration’s on Friday authorized the emergency use of mRNA-1273, Moderna’s vaccine against COVID-19 in individuals 18 years of age or older.

The Moderna COVID-19 Vaccine is now authorized for distribution and use under an Emergency Use Authorization (EUA).

Delivery to the US government will begin immediately, the company stated.

Moderna says it will continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021.

Around 20 million doses will be delivered to the US government by the end of December 2020. Moderna says it expects to have between 100 million and 125 million doses available globally in the first quarter of 2021, with 85-100 million of those available in the USA.

The issuance of the mRNA-1273 EUA comes just a week after the FDA granted the same status for Pfizer and BioNTech’s COVID-19 vaccine BNT162b2.

mRNA-1273’s has less onerous storage stipulations, which will be welcomed; the need to deep-freeze BNT126b2 means that the BioNTech/Pfizer option is relatively inconvenient.

FDA Commissioner Dr Stephen Hahn commented: “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.”