Less than a month after winning emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its coronavirus vaccine, Moderna (NASDAQ:MRNA) has scored another major regulatory nod.
On Wednesday, the company announced that the European Commission -- the executive arm of the 27-country European Union (EU) -- granted conditional marketing authorization (CMA) for the company's mRNA-1273.
Moderna's vaccine is now authorized for use against the coronavirus in four jurisdictions. Besides the EU and the U.S., it has also been cleared in Canada and Israel.
The EU currently has a confirmed order totaling 160 million doses of Moderna's vaccine. The company said in its announcement that the first deliveries of these will occur next week.
Referring to the European Medicines Agency (EMA) and one of its key advisory bodies, Moderna CEO Stephane Bancel was quoted by the company as saying that "The EMA and the Committee for Medicinal Products for Human Use reviewers, working over the holidays, provided a thorough review and comprehensive guidance as we worked together to achieve this authorization."
"I am proud of the role Moderna has been able to play globally in helping to address this pandemic," he added.
The new authorization, while widely expected, is nevertheless a triumph for Moderna. The EU is a massive political and social block home to 446 million souls, a tally that dwarfs even the populous U.S. Meanwhile, the company has manufacturing capacity sufficient for a quick and wide rollout throughout Europe.
Investors are clearly happy about the news. In mid-afternoon trading Wednesday, Moderna was far outpacing the rise of the S&P 500, with the stock up by more than 6%.