Once again, a recipient of Moderna's (MRNA 3.01%) mRNA-1273 coronavirus vaccine candidate is exercising its option for more doses. On Friday, the company announced that the European Commission (EC) has opted to take an extra 80 million, as per its agreement with the U.S.-based biotech.
All told, the confirmed order commitment from the EC -- the administrative arm of the 27-state European Union economic and political bloc -- is now 160 million doses.
Image source: Getty Images.
Although mRNA-1273 has not yet been fully approved for use by any major regulator, including those in Europe, it demonstrated extremely high efficacy in late-stage clinical testing. As such, it is widely expected to garner such approvals throughout the world. In the U.S., many observers and healthcare professionals expect the Food and Drug Administration (FDA) to grant mRNA-1273 emergency use approval (EUA) as soon as Friday. The FDA's advisory group has already endorsed mRNA-1273 for approval.
In its press release updating the EC's order tally, Moderna said that it expects to be able to make the first European deliveries of the vaccine early next year. The company would, of course, have to earn at least temporary approval from the EU's regulator, the European Medicines Agency (EMA), before distribution.
"As we shift our focus now to prepare for the delivery of our vaccine candidate, pending a positive opinion from the EMA and other regulators, we remain committed to working with governments and partners globally to address this pandemic," Moderna CEO Stephane Bancel said in the announcement.
While the news is encouraging, the fact that approval has still not happened for Moderna appears to be dragging its stock down (plus perhaps some profit-taking by more speculative investors). On Friday, it closed 2.6% lower, a steeper fall than that suffered by the S&P 500.
