How Serious Are Moderna's FDA Delays?

The U.S. Food and Drug Administration (FDA) will take longer than expected to complete its review of Moderna's (MRNA -0.58%) Emergency Use Authorization (EUA) for its COVID-19 vaccine in adolescents ages 12 to 17. Moderna is pushing back its filing for EUA in younger children while this review moves forward. In this Motley Fool Live video recorded on Nov. 3, 2021, Motley Fool contributors Keith Speights and Brian Orelli discuss how serious these FDA delays are for Moderna.

Keith Speights:: Moderna announced on Sunday that the FDA is going to take longer to complete its review of the Emergency Use Authorization filing for its COVID-19 vaccine in adolescents ages 12-17. The company also said that it's going to hold off on filing for EUA in younger kids ages 6-11 while the FDA completes this review in the adolescent age group.

Brian, how serious of a setback do you think this is for Moderna?

Brian Orelli: I was a little worried. I first saw the headline that it was going to say, "Brian Orelli's kids didn't fill out their e-diaries to report their side effects." But apparently, this is a clinical trial that my kids were in. Apparently, it wasn't my kid's fault that the decision is being delayed.

Speights: Don't blame it on the Orellis!

Orelli: [laughs] The FDA says it may take until January to make this decision. The agency wants to evaluate recent international analysis of risk of myocarditis, which is inflammation of the heart muscle after vaccinations with mRNA drugs. As the infection rate goes down, the risk of not getting vaccinated also goes down.

You're less likely to get sick getting in the hospital from COVID-19, but the risks of side effects stays the same. At some point, the risks of side effects basically are justified by whatever you're saving if the COVID-19 infection rates go down low enough. That's the reason why we stopped giving smallpox vaccinations in the US long before it was truly wiped out in all of the world because it was just your chance of getting it here in the US was so low that it wasn't important for everybody else to get it.

How serious this is for Moderna? I don't really think that the side effect issue is really that big of a deal. If they're pretty uncommon and when they do happen, they're fairly mild. Out of decent infection rate that you're going to get, the benefit of the vaccine is going to outweigh the issues with the side effects.

I think that, in general, Moderna's OK. I think that the issue is that investors should be a little more worried about the infection rates going down low enough. Because if the infection rates go down low enough, you're not going to sell those vaccines because people aren't going to take them because the infection rates are down low enough. At the point where we get to the point where the side effects are too severe to justify taking the vaccine, you're also not going to be selling much vaccine because the infection rates are so low that nobody's really worried about COVID-19 anymore.

Speights: We're looking at, you're saying it could be January before the FDA makes a decision. That's not far away. We're talking about probably a couple of months or so, two or three months. The bigger story here, at least over the short term is Moderna really isn't going to sell any more doses of its vaccine even if it gets this EUA, not in the short term, right?

Orelli: Right, yeah. Looking at 2022 sales or 2023 sales, those are what's important for Moderna's valuation right now. The 2021 sales are already priced into the valuation, as well [laughs] as some quite a few sales in 2022 and 2023. That's what investors should be focused on. Therefore, that's the reason why I say you should be focused on the infection rates because if the infection rate goes down low enough then those sales aren't going to materialize.