Many investors focus mainly on Moderna's (MRNA 4.54%) opportunities in the U.S. and Europe. However, the company markets its COVID-19 vaccine Spikevax in lots of other countries, notably including Canada.
Last month, Canadian regulators granted Emergency Use Authorization to Spikevax for all adults ages 18 and older. In this Motley Fool Live video recorded on Nov. 16, 2021, Motley Fool contributors Keith Speights and Brian Orelli discuss how important this Canadian booster authorization is for Moderna. (Note: This video was recorded prior to the U.S. extending authorization for Moderna's vaccine to all adults.)
Keith Speights: We were talking about Moderna with its Spikevax. The company announced on Monday of this week that Health Canada, which is the Canadian equivalent of the US Food and Drug Administration, Health Canada has granted authorization for boosters of Spikevax in all adults ages 18 and up.
How important is this news for Moderna, first of all? Secondly, do you think this just might increase the chances that Moderna wins US authorization for boosters for all adults?
Brian Orelli: It's obviously very important for Moderna, I don't actually know much about the Canadian supply, so how many doses has the country ordered versus how many have actually been given out, and then how many more might be given out for the booster, but I don't think it really matters.
What's important here is that there's a booster approved for all adults, and you can't get a second or third or fourth booster approved until you get the first booster approved. It's those annual boosters that's really what's most important for Moderna's long term valuation. Getting this first booster approved is certainly very important because they needed to get those annual boosters, which is what a lot of the sale of the future sales already priced into Moderna's valuation.
To the question of does it increase the chances of the FDA approving boosters for all. We know that the FDA doesn't really care what Health Canada does, they're going to make their own decision. But yes, it says there's an increasing number of regulators who think that the benefits of a booster are worth the risks associated with another jab.
I think that anytime you have more and more regulators doing the same thing, that makes it more likely that the FDA will eventually follow suit.
Speights: Brian, it sounds like you're saying there's at least some degree of peer pressure among governmental regulators?
Orelli: I don't know if it's peer pressure, but I think that it's just a fact that if there's a lot of people that think the same thing, then eventually the other people are going to come to the same conclusion because the science data is all the same. They're all looking at the same science data. Eventually, it's a lot more likely that the regulators are going to come to the same decision making based on the same amount of data.
I think we talked about this before, but the US and EU regulators got together and they wrote a paper in a journal, scientific journal, that looked at when they had different decisions on drugs. Most of the decisions were made based on the fact that they had made their decisions based on different sets of data.
One company might submit a clinical trial to one regulatory agency and then get more data and then submit to the other regulatory agency. The first regulatory agency might not approve the drug, and then the second regulatory agency approved the drug, then they go back and they submit that new information to the first regulatory approval agency and they approve the drug. I think that's what you're seeing here.
Speights: Yeah. In this case, I don't think there's going to be any disputing the fact that these boosters do increase protection against infection. Like we've talked about in the past, the question for the US FDA is going to be, is it more important to increase that protection against infection or is it OK that these vaccines — the two-dose regimens — are still quite effective at preventing severe cases of COVID-19.
Orelli: Right. You have to weigh that against the side effects. If there were no side effects, then obviously you go ahead and say, "Well, it's great that people aren't going have to suffer through coughing and whatever mild cases of COVID-19 they might get. You'd say, "Well, there's no side effects, you go ahead and give the people the booster." You'd say, "Everybody should get the booster." but that's not the case, there are side effects, so they have to weigh those two against each other.
