Why Did Johnson & Johnson Cut the Size of Its Coronavirus Vaccine Trial? – The Motley Fool

Johnson & Johnson (NYSE:JNJ) is trailing the leaders in the coronavirus vaccine race, but the healthcare giant is approaching the finish line, thanks to cutting the size of its phase 3 clinical trial. In this video from Motley Fool Live, recorded on Dec. 21, Corinne Cardina, bureau chief of healthcare and cannabis, and Fool.com contributor Brian Orelli discuss the implications of the smaller clinical trial. They also talk about whether it makes sense to invest in Johnson & Johnson specifically for its vaccine candidate.

Corrine Cardina: So Johnson & Johnson announced that they have completed enrollment for their trial, for their one-dose vaccine candidate. They actually ended up lowering the target number of participants in the study. What drove that decision and does it have any implications, Brian?

Brian Orelli: Yes. They were planning for 60,000 patients and then they lowered it to 45,000 patients. This is an event-driven clinical trial. Most clinical trials are time-driven. If you think of something like psoriasis, rheumatoid arthritis, you treat for a certain amount of time and then at the end of that time, you see whether the symptoms improved. Events-driven trials are measuring a certain event. So in the case of a vaccine, that's infections. Cancer trials are also usually run as event-driven clinical trials, and then you're looking at survival or progression of the disease. You run the trial, you count the number of events, and the trial is blinded so you don't know whether those are occurring in the placebo group or in the treatment group. Then after you get to a certain number of events, then you unblind it, and look and see do these people get treatment or do they get vaccines.

If the infection rate is higher, which it is, than when they first started the clinical trial. Then trials can be smaller because the number of events will happen sooner. If it is a very rare event, then you need more patients than if it is a more likely event. Then also, if the efficacy is higher, then the trials can be smaller. If you were looking at 200 events, and it was going to be 90 and 110, you don't know whether that's necessarily a difference, but because other vaccines were so good, they may have also decided that they're more likely to get a bigger separation, it's going to be the 190 and 10 out of 200. The breakdown is pretty obvious if the vaccines work.

Cardina: Definitely. So when should we look for data from Johnson & Johnson's phase 3 trial? Do you have any estimates for timeline on regulatory submission?

Orelli: Yeah. The interim data Johnson & Johnson have said, they expect the data by the end of January. But again, it's event-driven, so it's going to depend on when people actually get infected and whether they're going to get infected in the placebo group or the vaccine group. If that happens, then they're planning on submitting, the emergency use the authorization to the FDA in February, and they'll do other countries in parallel. I think they probably need some more additional safety data. That's why they can't quite do it at the end of January. Then it will take a few weeks for the FDA to review it. They didn't say when in February they would be ready, so it could be as early as they could get approved or authorized as early as late February, and maybe as late as the second half of March.

Cardina: Definitely. One thing investors should know is that Johnson & Johnson has pledged not to profit on this vaccine during the pandemic. How does that factor into any sort of investment decision into Johnson & Johnson?

Orelli: It goes back to that same immunity question. We just don't know how long the vaccine is going to last. If it's a one and done, there's enough herd immunity that the virus goes away, then obviously they're not going to benefit at all. If it requires that we get a booster every year, four years, five years, to 10 years, then it will obviously benefit a little bit. Johnson & Johnson is huge, well diversified. I wouldn't invest for the coronavirus, but it doesn't mean you shouldn't invest in Johnson & Johnson if you're looking for a solid diversified healthcare investment with a solid dividend that just keeps going up.

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Why Did Johnson & Johnson Cut the Size of Its Coronavirus Vaccine Trial? - The Motley Fool