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Here's What Investors Should Know About Johnson & Johnson's FDA Authorization

By Brian Orelli, PhD and Keith Speights - Mar 10, 2021 at 10:33AM

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A unanimous committee vote led to the quick authorization.

In this video from Motley Fool Live, recorded on March 1, Contributors Brian Orelli and Keith Speights discuss the FDA's emergency use authorization (EUA) for Johnson & Johnson's (JNJ 1.75%) coronavirus vaccine. The duo talk about the advisory committee meeting that reviewed the merits of the authorization, as well as the lack of information on the vaccine's use in older adults.

Brian Orelli: First up we have Johnson & Johnson, which gained emergencies authorization from the FDA on Saturday. It wasn't a big surprise after the positive briefing documents from the FDA and then the advisory committee unanimously voted 22-0 to recommend the vaccine get emergency authorization. But the devil is in the detail. Starting with the advisory committee meeting, anything interesting that the committee members brought out, I saw there was some discussion of one dose versus two doses and then maybe in two different sets of dose schedules for that double-dose. Anything else you saw?

Keith Speights: There were some interesting things, but let me first point out for our viewers Brian, that last week, I asked you, I think it was on Wednesday. I asked you to make a prediction on how the vote would go with the advisory committee. Brian Orelli said that it would be a unanimous vote in favor of authorization of J&J's vaccine, and you were exactly right. I don't know that that required nostradamus type predictions skills necessarily, Brian, but you were right.

Orelli: I did go out on an edge. [laughs] It could have been a rouge vote. [laughs]

Speights: I agree with you that it was not surprising at all. In terms of the discussion by the advisory committee, I didn't sit on pins and needles watching every minute of it on Zoom or anything. I did look at a summary of what the committee discussed after the fact. I guess one thing did jump out. You mentioned that there was discussion about should it be a one or two dose regimen. I think the answer to that is they basically said, "Hey, the one dose works great. It works well enough for us to give EUA to the vaccine." But it is possible that further tests could come out later, I think in the summer, that might show that J&J's vaccine would be better with two doses. So it's possible that when they seek full approval, there could be a two-dose regimen. Who knows? We'll just wait and see, but at least right now, it's very safe and effective with the single-dose.

The one thing that I think jumped out to me in the discussion with the committee was how little discussion there was about efficacy in older adults. Johnson & Johnson didn't have a lot of data on older adults, people aged 75 and older. In fact, the FDA even said that data had limited interpretability because of the small numbers. But there was a lot of discussion about that and that was a little surprising. I thought maybe the committee would have talked about that a little bit more. But again, I think it just came down to the efficacy was there. The EUAs for the previous two vaccines went well and those vaccines, their rollouts are going well, people are being immunized effectively by those. Again, just not a shocker whatsoever.

Orelli: Maybe the other issue with the older adults is just that a lot of the older adults have already gotten vaccinated. So by the time that we get a decent amount of Johnson & Johnson's vaccine, we'll be on to people that are younger, and so it won't necessarily be as big of a deal. My area has already started vaccinating food workers, younger food workers, and teachers. I think that we're getting to the point where whether it works in older people is not really all that relevant.

Speights: Yeah. I think even there'll even be more of the case with any other within the next few months. We probably will see Novavax (NVAX -8.57%) and AstraZeneca (AZN 2.59%) submit for their EUAs. I think you probably won't hear a lot of discussion because of that very factor you just mentioned.

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