On Dec. 17, the Food and Drug Administration will consider Moderna's (MRNA 5.35%) request for Emergency Use Authorization for its coronavirus vaccine. The biotech company also has approached regulators in other countries. In this Motley Fool Live video recorded on Dec. 11, 2020, Healthcare and Cannabis Bureau Chief Corinne Cardina and Fool.com contributor Adria Cimino discuss the potential timeline for authorization of Moderna's investigational vaccine.
Corinne Cardina: Looking beyond the US: Canada and the UK. They green-lit the Pfizer (PFE +0.35%) BioNTech (BNTX 1.54%) vaccine before the US. They are already beginning distribution. Neither of these countries have made a decision yet on Moderna. Do you have any insight on what the timeline is for Moderna's regulatory decisions? Is the U.S.' meeting next week likely to be the first approval, good news for them, or could Health Canada or the U.K. jump in there and make an exciting decision?
Adria Cimino: Well, I would think it seems like the U.S. might be first, because as we've seen with Pfizer, this is happening so quickly, whereas there was a meeting yesterday and now they're saying, OK. We're ready to do the emergency use authorization, and vaccination could start next week. It seems like the same thing might happen for Moderna. Also, in Canada, could be soon as well because the Chief Medical Advisor at Health Canada said that they could be approved as soon as the end of the year, so that's just within a few weeks too. So that could be coming soon. As far as other countries, it's continuing with rolling reviews -- in Canada and Switzerland. It also has applied for conditional approval in Europe with the European Union. Now, all of these rolling reviews mean that has already submitted data, as the data become available, data are submitted. That speeds things up because that means regulators have already been looking at all of this. We could expect the decisions, it could be in a matter of weeks, it could be really quick, it can come really quickly. As for the timing of why is Pfizer a few steps ahead by days of Moderna, basically has to do a lot with the enrollment and enrollment schedule of the trials, as far as they needed that two-months safety data. If Pfizer for instance vaccinated its last patient on a certain date, and then Moderna with its enrollment had the last patient a few days later, well then Moderna's going to be a few days later, and there's basically nothing they can do about it. It's just part of the process.
