Alex Gorsky, Johnson & Johnson Chairman & CEO, joins Yahoo Finance's Anjalee Khemlani to break down the company's FDA emegency use approval of its single-shot vaccine.

Video Transcript

- Johnson & Johnson's single-dose coronavirus vaccine received emergency use authorization. And our very own Yahoo Finance's Anjalee Khemlani chatted with Johnson & Johnson CEO Alex Gorsky. And she's here now to tell us about that conversation. Hi, Anjalee.

ANJALEE KHEMLANI: Hey, Kristin. Yeah, so of course really exciting news for the company, but a lot more in that for really the rest of the country. We know that that single-dose vaccine, normal refrigeration temperatures is something that everyone's been waiting for. Health experts have their hopes pinned on this being a lot easier to get to some of those hard-hit areas and hard-to-reach areas that other vaccines that require really specific holding temperatures to get through. So listen to what, you know, CEO Alex Gorsky had to say about the rollout, as well as the future of this new vaccine platform.

ALEX GORSKY: This started more than 13 months ago when we got the initial genetic information. Of course, we spent last year and this year doing the clinical trials, getting all of the data that was going to be necessary. And when we heard the FDA's-- the independent advisory committee on Friday give a thumbs up, a unanimous vote for our vaccine, we couldn't be more thrilled and humbled. And then, of course, just yesterday, the CDC and their advisory committee also gave us a thumbs up.

And so literally trucks are rolling as we speak. We hope to have 4 million doses-- actually, 3.9 million doses-- out over the next 24 to 48 hours here in the United States. We expect to have 20 million doses by the end of March. And we expect to have up to 100 million doses by June of this year, on a goal towards having almost a billion by the end of 2021. So we-- we're excited, we're committed, and we're doing everything we can to make sure we deliver on those things.

ANJALEE KHEMLANI: And I know that the company has really stuck to the idea of this is the time of pandemic, and you really need to roll these out at a low cost. So moving forward, you know, do you see the market growing for COVID vaccines as an annual thing?

ALEX GORSKY: Well, look, it's going to depend a lot on what happens with the underlying biology with the virus and how it continues to evolve, but I can tell you one thing-- at J&J, we're definitely invested in vaccines for the long term. We-- we're really encouraged by the data that we've been able to produce with this particular vaccine. And I mentioned to you the kind of volumes that we're talking about this year well into next year.

We're already working on other potential applications with additional variants. And we're also looking at vaccines not only for COVID-19, but also for other areas in our portfolio, potentially one day in cancer, potentially one day in Alzheimer's disease. So we think there'll be a lot of application for this. And it's important to do for patients and health care systems, but we think it'll also represent a very important business opportunity long-term, as well.

ANJALEE KHEMLANI: And I'd love to take a moment to reflect from, you know, going back to the start of it to now, the vaccine race globally has been so well covered. And I think the way that the company moved forward was a little bit unexpected. Some other companies had setbacks, and you moved ahead in the race a little bit, so to speak. Did you imagine the market to be as it is right now, with sort of more demand for the product when you're ready to roll out?

ALEX GORSKY: Well, look, having been in this industry for more than 30 years, we know that there are always challenges when you're talking about new science and new technology. And there's never a linear shot, necessarily. But we tried to be very methodical. And from the very beginning, as we considered what kind of a vaccine we ultimately wanted to produce, we said, look, how do we prioritize safety?

Hence, we used a platform that had already been used in more than 100,000 patients for things like Ebola, things like HIV in Africa and other places. So we knew we had a safe platform. We knew we had to prove effectiveness. And our early preclinical data was very encouraging. When we did our initial trials with 1,000 patients, it actually corroborated those results. And of course, when we saw the results recently out of our phase three trial, in over 40,000 patients, it really told us that we have an effective, as well as a safe platform.

Finally, we knew that it was going to be important to try to do it in one dose because the logistics, the administrative challenges of having two doses or having significant refrigeration could also get in the way of access. And last but not least, and to one of your earlier points, to do it on a not for profit basis, because we didn't want cost, we didn't want price to get into the way. We felt that that was the way to be the most comprehensive, holistic approach, not only here in the United States, but let alone around the world.

ANJALEE KHEMLANI: But on that point, you are studying the shot in two doses. What do you expect to come from that, and how do you plan to communicate if we do end up needing two doses?

ALEX GORSKY: Well, from the very beginning, we've been absolutely committed to developing a very robust data set, and then to be very transparent with it. In fact, I worked with many of our CEO colleagues in making an explicit statement committing to transparency in the data and the review process. Now, in our case, we're very pleased to see the results that we did on this trial. I mean, to see 85% effectiveness in severe disease, knowing that our trials were conducted around the world, where 15% of the patients in the trial were in South Africa, 90% of whom who developed the disease had the South African variant. Another 40% of the patients in our trial were in Latin America with another variant, the P2 variant.

So to see 85% response in severe disease, to keep 100% thus far patients out of the hospital and from dying, even with these most virulent, most difficult strains, is really important to understand in terms of the overall efficacy profile, because ultimately, what does a patient or a family look for? They don't want to go to the hospital. We have to keep our hospital systems free. Number two, they don't want to-- certainly don't want to die.

And so it's up to us to continue to educate. At the same time, we're saying, look, as things develop, there could be things that we learn. So we're also looking at a two-dose to say, is it more effective, would it have a similar effectiveness, and then how do we weigh those against all these other issues. And we'll have an extensive education and distribution program around that, as well.

ANJALEE KHEMLANI: And looking at the idea of having to respond to even more need, and if we do end up needing this on an annual basis, what are you thinking about internally about processes to develop and manufacture them? Because I know you're working with some partners, and you're a relatively large company compared to some of the other players that have had to really expand. What has been the investment so far, and what do you plan to do to keep this on a regular basis?

ALEX GORSKY: Well, look, we're doing this for the long run because we realize that this virus isn't going to go away overnight. And so with that in mind, how do we ensure that not only the scientific capabilities that we've been able to demonstrate in getting to this point with approval, but also the manufacturing processes. So we built an extensive network of internal, external partners, some of the United States, some in Europe, as well as other parts of the world. We want to make sure that we've got a resilient, durable network that allows us to get vaccines out in broad numbers.

So in addition to the 100 million that we talked about here in the United States in the first half, we have contracts for several hundred million in Europe and in the surrounding countries. We are committed to getting doses available to the developing markets around the world, as well, because we all know that we, as a globe, are not safe until everyone is safe with the vaccine. And so we're committed to this. And again, as part of our long-term strategic plan of how do we ensure that we're applying the same vaccine technology not only here, but even more robustly in other areas of our portfolio.

ANJALEE KHEMLANI: Moving forward, we know that we're dealing with the variants at the same time. And you also have the vector that you're using, the adenovirus vector. There have been some questions about whether or not a follow-up shot would reduce efficacy because of the protection that's built up. Do you see any conflict there? I'm sure that's something that you're looking at in the second dose study.

ALEX GORSKY: No, we don't thus far. And based upon the extensive experience we've had previously, again, in things like Ebola, HIV, and other areas, the confidence that we have in the safety of the platform, the durability of the platform is significant. We haven't seen the kind of immune responses that you can sometimes see in these kind of approaches. And again, it gives us great confidence going forward, as well.

So-- and on top of that, we're also seeing very robust responses at the antibody level, but also what we know as the T and the B cell. So think of that as like the second and third phase response that really leads to a longer-lasting and a more permanent kind of effect from these vaccines. So we still have to gather more data before we can draw firm conclusions, but thus far, we're very encouraged about the data that we're seeing directly related to the AdVac 26 platform.

ANJALEE KHEMLANI: So as you can hear, a lot going on. Of course, the company, being a large global company, is also focusing on delivering doses elsewhere. But definitely a lot more promising news, hopefully, to come. And experts really excited about this specific platform. Kristin.

- And Johnson & Johnson up about 3/4 of a percentage point right now. Yahoo Finance's Anjalee Khemlani, thanks so much for bringing us that interview. And for everyone at home, that full interview can be watched at YahooFinance.com.