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Here's What the FDA Liked About Johnson & Johnson's COVID Vaccine

By Keith Speights and Brian Orelli, PhD - Mar 3, 2021 at 6:14AM

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There weren't any yellow flags.

Johnson & Johnson's (JNJ 2.04%) COVID-19 vaccine is now the third to win emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA). What did the FDA like about J&J's vaccine? In this Motley Fool Live video recorded on Feb. 24, 2021, contributors Keith Speights and Brian Orelli talk about the key factors in the FDA's decision. (Note: This conversation was recorded after the FDA released a briefing document for use by the advisory committee for its review but before the committee's vote and the FDA's EUA decision.)

Keith Speights: Brian, I guess the big here and now item for us to talk about on the COVID-19 front is that an FDA Advisory Committee will review Johnson & Johnson's emergency use authorization submission for their COVID-19 vaccine this week. The FDA just released, I mean it is hot off the press, released a briefing document for the committee this morning. I don't know if you've had time to take a look at it, Brian. But have you looked at the document yet?

Brian Orelli: I went over some of the 60 something pages. I read the highlights.

Speights: I didn't expect either one of us to have read it in detail yet because it did come out just this morning. Brian, what are your main takeaways from this FDA briefing document?

Orelli: The FDA said, it had a favorable safety profile. They said, no specific safety concern is identified to preclude the issuance of an emergency use authorization. Sixty-six percent efficacy which is higher than the threshold needed for emergency use authorization which is 50 percent. No COVID-19 cases requiring medical intervention after 28 days after the vaccination, and the people got the vaccine [inaudible] maybe 18 or so in the group, they got their placebo. They did an analysis of the South African variant and saw that it had 81.7 percent protection for severe or critical COVID-19 and 64 percent for moderate COVID-19.

Speights: I didn't personally see -- and again, I just skimmed through the document looking for the highlights-- I didn't see anything particularly surprising. Did you?

Orelli: No. There was over 75. It looked like they weren't quite sure whether it was protecting against people that were over 75, and so that might be a concern although probably most of those people are going to be vaccinated by the time Johnson & Johnson's vaccine is out in full force so maybe that's not necessarily that big of an issue.

Speights: I said, we would try to do a prediction. Let's do a prediction, Brian. What is your prediction for the FDA Advisory Committee vote this week?

Orelli: Unanimous that it gets emergency use authorization. I'll even pick the number because I would be surprised if anybody is going to vote against the data. It's not great but it's definitely good enough.

Speights: Yeah.

Orelli: It's beyond good enough.

Speights: I think you're probably right. I think it will likely be unanimous. If there are any discerning votes, it's going to be probably one, and maybe on philosophical grounds. I think if you looked at the previous votes, Pfizer and Moderna have both won EUA for their vaccines and it wasn't unanimous because I think one person maybe just thought there was a better way than going the EUA route.

Orelli: The Pfizer one had a couple of people and I talked to them afterward, it was because they were worried about the age. So there was a big debate on the Pfizer Advisory Committee meeting about whether to set the age at 16 or 18 and the FDA wanted 16. Then there were a couple of people who said, they didn't think there was enough data on the 16- and 17-year-olds, decided at 16, so that's why they voted against it.

Speights: You think it'll be unanimous from the committee. What about the FDA's decision which will probably come by this weekend?

Orelli: I think it'd probably have the approval. What most interesting to me is not whether it gets approved or not because it's definitely going to get authorized. The question is what time frame do we have. The other two committee meetings were on Thursdays, and so then that gives the FDA on Friday to authorize it, so they are going to work through the weekend, and then it will get an authorization on Saturday. We'll be all writing articles on Saturday or are they going to wait until Monday? [laughs]

Speights: Really, do you think the FDA has probably already made up its mind on this?

Orelli: Yeah, I think the FDA has probably made up its mind 90 percent of the time. For 90 percent of drugs, it's probably made up its mind by the time that it writes the FDA briefing documents for the committee meeting. Those briefing documents tend to be your best indicator of whether something is going to get approved or not. If those briefing documents are negative and the FDA Advisory Committee meeting is positive, it's still more likely that a drug is going to get rejected than if the FDA Advisory Committee is. If the FDA documents are positive and the committee is a little bit more negative, that's actually more likely to get a positive recommendation, so I think that those FDA briefing documents are really important to investors.

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