An advisory committee convened by the U.S. Food and Drug Administration (FDA) is scheduled to review Johnson & Johnson's (NYSE:JNJ) filing for Emergency Use Authorization for its COVID-19 vaccine this week. In this Motley Fool Live video, recorded on Feb. 17, Fool.com contributors Keith Speights and Brian Orelli discuss what the chances of success for J&J's vaccine could be.
Keith Speights: Johnson & Johnson, a healthcare giant, submitted its COVID vaccine for EU conditional approval yesterday. It filed for U.S. Emergency Use Authorization earlier this month on Feb. 4. Brian, what do you think the chances are for Johnson & Johnson to win these authorizations, and if it does, how much could emergency use authorization in the U.S. and that conditional approval in the EU impact the stock?
Brian Orelli: Johnson & Johnson has said they're not going to make any profit while the pandemic is going on so in the short term, it shouldn't affect the revenue at all. In the long term, which is how eventually the stock price should be valued, they could make some money off of it. Again, we're talking about whether the need for coronavirus vaccines lasts multiple years, or whether it's two years, whether it's 10 years, or the rest of our lives, we're taking vaccine every year to deal with new variants so I think it's really up in the air on how much it's going to affect Johnson & Johnson.
Now of course Johnson and Johnson is a very huge healthcare conglomerate. We're talking about a small portion of the company's overall revenue so I really don't think it's going to affect them that much. They're looking for 100 million doses in the U.S. in the first half of 2021, so definitely a slower rollout than Moderna. Then the FDA advisory committee meeting is scheduled for Feb. 26, and then the big date that people want to look at is the FDA docs that come two days before that so Feb. 24, which I think is next Wednesday.
Speights: Brian, are you like me, you just wait for those docs to come out so you can start speed reading through them?
Orelli: Yeah, hitting F5, F5, F5, [laughs] waiting for them to post because they don't post it a specific time, whenever the FDA feels like posting them that morning, they do.
Speights: What's your prediction, does Johnson & Johnson win Emergency Use Authorization?
Orelli: It seems like it was 70% or something in that range in the U.S. for protection so I think that's much higher than the 50% threshold that the FDA has said. I think the big question in those FDA docs we want to be looking at is how many of the patients that got placebo got a variant, and that will tell us how well it's protecting against the variant.
Then also, you'll have to look at the people who got the vaccine and see whether they got COVID-19. But the big question is whether it's protecting against the variants because the variants are coming and and that'll be a big discussion during the FDA advisory committee meeting then.
Speights: We should remember, this is a single-dose vaccine, so that's different from Moderna's vaccine or Pfizer's vaccine that have already won EUA. Do you think that will make a difference in the FDA's decision at all?
Orelli: It makes it more convenient. Maybe it lowers the threshold for people to get it. Some people are going to get the first dose of Moderna or Pfizer and then not get the second dose because they forget or they don't think it's important or whatever. So I think the fact that they're showing fairly high efficacy with just a single dose, definitely is to Johnson & Johnson's advantage.
Speights: Right. J&J is also evaluating a two-dose regimen of this vaccine. I'm not sure, I think the results for that study probably won't be available until maybe midyear or something.
Orelli: I heard toward the end of the summer.
Orelli: I think it might be a smaller study. Because it's a smaller study and they need a certain number of events, so the number of events is obviously going to be larger. You have more people are likely to get COVID-19 if you have got more people in the study. So a smaller study is going to be required to go on longer.
Speights: It's reasonable to anticipate that the efficacy for the two-dose regimen will likely be higher than the single-dose, right?
Orelli: Right. The question is just how much higher. Because it's delivered via virus, your immune system could react to the virus the second time you get it, and then therefore, the virus can't inject its DNA into your cells, and then that DNA gets expressed into the proteins that are on the coronavirus. That's where we want the immune system to react, not the viruses that's delivering the coronavirus DNA. I think that's the big question of whether how much of that is going to be in effect to see whether the booster actually helps, how much the booster actually helps.
Speights: Great. Of course like you said, Brian, this vaccine probably won't provide a big catalyst for J&J's stock certainly not in the near term. Over the long term, do you think this could be something that would be a growth driver for Johnson & Johnson?
Orelli: Everything is a slight growth thing for Johnson & Johnson but I don't know if it's a major catalyst that's going to rocket ship the company. I think that if you're buying Johnson & Johnson you're buying it for a small amount of capital growth and then the dividend to supplement the capital growth, I wouldn't expect it Johnson & Johnson is going to be super valuable, super growth story over the long term.