Johnson & Johnson Chief Scientific Officer Paul Stoffels joins Yahoo Finance’s Zack Guzman and Anjalee Khemlani to discuss the latest on a possible coronavirus vaccine, as Johnson & Johnson begins trials of its one-shot vaccine.
ZACK GUZMAN: The latest here coming from Johnson & Johnson announcing that their experimental vaccine would be moving forward with phase three trials, that announcement coming today. It's a little bit later than some of those other companies out there working on it, but there are some benefits to note here, including, not to be overlooked, the fact that it may be just a single dose vaccine compared to some of the other candidates out there that might be requiring two doses, two trips to get a vaccine, as well as the case to be made that this vaccine wouldn't require some of those other stringent storage mechanisms that we've been discussing, including some pretty tough things to roll out, including freezing these things. And here to chat all about that with us is the Chief Scientific Officer at Johnson & Johnson.
Paul Stoffels joins us along with Yahoo Finance's Anjalee Khemlani. And Paul, I mean, it's big news. A lot of people are excited about this, but talk to me about why you guys might be taking a little bit more time to get this right, because you're still going to be waiting until about the end of the year to get these phase three trial results. But taking a different tactic here, so explain what you're seeing in your progress and how it stacks up to the other companies out there.
PAUL STOFFELS: Well, the vaccine is a platform that's developed over the last 10 years. We didn't start last year or yesterday, and so we learned over many years that we could do a single dose vaccine. But in order to do that, at the beginning of the research process, we took some more time to optimize the vaccine vector combined with a COVID spike, as that is the way we induce antibodies, and so that took us three months to working through 12 different versions of the vaccines, testing in animal models and learning which piece of the pie was the best one to bring forward to the vaccine into humans and generate the maximum protection.
Then from that, we did challenge studies in animals. And there again, we showed that the one we chose gave full protection for disease and nearly full protection for transmission in a single dose. And that then was taken into humans. We started that mid-July, because we took some time to optimize the vaccine then upscale it. Mid-July, we started the phase one. Those data are now available in agreement with the FDA. We reviewed the data, and it's ready to go into phase three.
And so with a single dose, we now can start reading endpoints 15 days after vaccination, because that's, at the moment, there should be enough protection to be protective for humans. And that's studying in 60,000 people combined with a false readout will give us probably still efficacy data around the year end or early next year. And so that's why catching up a bit with a single dose but also with the number of people which we study in clinical trials.
ANJALEE KHEMLANI: Doctor, this is Anjalee, thanks so much for joining again. I want to talk to you about the technology that's being used. Obviously, we are hearing the benefits, Zack covered it, with the proven track of it in the Ebola virus vaccine. But when you're talking about, you know, some of the concerns that have emerged from the AstraZeneca trial, because it's a similar technology, there have been some concerns about what the results of the Johnson & Johnson vaccine will be. Can you explain if there is a difference, or if you're also concerned about the future?
PAUL STOFFELS: Well, it's an adenovirus, which we made into a vector, but this is a different, totally different one than AstraZeneca. AstraZeneca used the chimpanzee adenovirus. We used the human adenovirus, and that is the difference. It's a different strain, different type of virus. But at the same time, we worked on this for 10 years, and we did a clinical experiment since six, seven years. We've vaccinated now more than 100,000 people with that vector, and we have not seen serious adverse events, the like of what AstraZeneca has seen. So we trust on the very extensive safety database we have generated already. Now going forward, you never know what you don't know. So we now need to study it in a large population to make sure it's safe and effective, and we'll report it as it becomes available.
ZACK GUZMAN: And that's kind of the thing, too. I mean, we're talking about the AstraZeneca trial, you know, the reason why it was halted here in the US, still a lot of more questions around that spinal cord injury, the patient that, you know, was impacted in that trial. But when we talk about how it differs, just to back up and maybe explain it for people who don't have an understanding of what exactly is going on when we think about using that protein here to kind of create the immune response in humans after that's, you know, injected or given in this vaccine. When we think about the timeline here, talk to me about that, because that is something we just heard from the head of the FDA here today and kind of making these guidelines and thresholds a bit more stringent in making sure that these things are safe.
What's your take on the timeline here and when you might expect this to roll out, because I know you're working closely with the US government to make sure that it can happen. But we hear the president still talking about potentially getting there by Election Day. It doesn't seem plausible based on the timeline you're raising.
PAUL STOFFELS: No, it's not possible. We, first of all, we are several weeks, if not a month or two later than everybody else to start a phase three study. So that's why, and we won't have the data by end of October. Maybe by the end of the year as we recruit a large cohort as well as we will recruit fast. So but that is not the pressure or that's not what is driving us. It's the basic science we have done over many years. We have an approved Ebola vaccine based on the same vector, so we did fundamental work to show safety and efficacy in a large number of people in that, and so that's the basis on which we work.
And also, we will use our own values also to put the vaccine into people, because if you go from 60,000 people to 100 million to a billion, you want to be sure that it's safe and effective and that you know what the guidance is you have to give to people when they get vaccinated and where to look for. The vaccines will always give local reactogenicity and a little bit of fever like you get with the flu vaccine. Typically, it disappears between 24 and 48 hours, so it will not be without side effects, but we definitely want to study the serious adverse events, which could happen and that we learn about what they are and how to prevent them.
ANJALEE KHEMLANI: Dr. Stoffels, one quick last question. The climate that you're developing this vaccine, especially politically, is very different from what you, you know, pursued for the Ebola vaccine. And with, you know, being very transparent about the clinical trial protocols, that's also a very different move for the company. So looking at all of that put together, are any of these extra steps, you know, an additional burden and adding extra time to the process, and is that something that will impact, you know, essentially how you go about even filing for an EUA when the time comes?
PAUL STOFFELS: Well, it's such an exceptional time. Nobody ever had expected that a virus like this would put the world to a stop, and so everyone is interested, so there is a lot of debate. And so we need to involve the larger community into what we do here, and that's why we'll publish the phase one data in the next two days on an online platform. We've published this morning with a press release on the phase three protocol. As we go forward, we'll be very transparent on everything we do and the outcome. As we can report that according to FDA and others, we can and will report it to the general public, but also explain much better and educate people what we do. So hopefully that transparency helps to later on accepting that people will take the vaccine, because that's going to be very important.
ZACK GUZMAN: Yes, we've heard from other medical experts out there. You can't be too careful with all these things, and it shouldn't be overlooked. It's a much larger trial than these other vaccine candidates are putting together as well. But Paul Stoffels, Johnson & Johnson Chief Scientific Officer, appreciate you taking the time to chat along with Yahoo Finance's Anjalee Khemlani.