MR. IGNATIUS: Welcome to Washington Post Live. I’m David Ignatius, a columnist for the Post.

This morning on our series, The Path Forward, our guest is Alex Gorsky, the chief executive of Johnson & Johnson, one of the biggest pharmaceutical companies in the world and a company that this week was the third to receive emergency use authorization from the FDA to sell its vaccine in the U.S. We want to, in this period, shed some light on some of the complicated questions and also learn from Mr. Gorsky just exactly how he sees this rollout moving forward.

Thank you so much, Alex, for joining us today.

MR. GORSKY: Well, David, it's a real pleasure to be here, and thank you for having us.

MR. IGNATIUS: So, let's begin with the amazing announcement yesterday that you're going to partner with Merck, one of your biggest competitors, to produce your J&J vaccine in sufficient volumes. Tell us how that agreement came to be. President Biden described it as the type of collaboration between companies that we saw in World War II. It certainly is unusual. Tell us how it happened.

MR. GORSKY: Well, David, you're right. These are unusual times, to say the least, and we felt that given everything that's occurred with the virus, the unexpected twists and turns, the surges that we've seen, the rising observation of variants and mutations, that it's absolutely necessary for us not only as a country, not only as a health care system, but as Johnson & Johnson to be doing everything we can to accelerate and to increase the capacity of vials of our vaccine that can be available.

Look, I'm incredibly proud of the progress that our team has made. If I think back 13 months ago when we started on this journey, literally with an email, with the genomics sequencing information of the COVID-19 virus, and to see where we are today, having received FDA approval, the nod from the CDC, and now already having distributed almost 4 million vaccines, we know that we should be doing everything possible and expanding partnerships.

We've got a vast network now, but we couldn't be more proud than to be in this partnership with Merck, a company that has got a long and very steeped experience in vaccines in addition to other biopharmaceuticals, and by working with them and the United States government, we've been able to form this venture that is going to enable us, again, to move some of those vaccines forward and to work throughout the remainder of 2021 of expanding our production and building additional capacities.

So, we're really pleased to be able to do that, and I think it's also a great example for the larger pharmaceutical industry in the way that we're seeing companies partner, that we're seeing public-private partnerships coming together, all as part of a broader effort to do everything we can to make a real difference with this virus.

MR. IGNATIUS: In practical terms, administration officials were telling The Post last night that they had worried that without this partnership with Merck that Johnson & Johnson might fall short of its target production. Is there any truth to that? Were you worried that you were not going to meet your plans without this additional production capacity?

MR. GORSKY: Well, David, look, I think it's important to put this into perspective in that when we started with this, as I mentioned, about 13 months ago, some of the manufacturing facilities that we're now utilizing were literally parking lots, and the complexity of bringing up this kind of scale, this kind of scope within that period of time, I don't think it's ever been done before in the history of our industry.

As with any startup like that, look, there are twists and turns. There are ups and downs. It's never a straight linear shot. I think our team has made remarkable progress. We've been incredibly committed to making sure that we are maintaining a very high integrity as it relates to the technology transfer, the quality that's required.

Look, we feel very good about the fact that we were able to ship, right at the announcement of approval, almost 4 million doses, and we have a commitment to do 20 million by the end of March. We have previously announced 100 million by June, but in discussions with the government and trying to say, "Hey, what else could we be doing? How else could we accelerate? Are there ways that we could partner even more broadly to not only reinforce that confidence, but to perhaps accelerate it even further?" and that's when in conversations that we were able to sit down together and bring this partnership to fruition, again, which I think is going to do nothing but, again, give us greater confidence, hopefully greater opportunity for acceleration, and ultimately more shots in arms for Americans and longer term for people around the world.

MR. IGNATIUS: I take it, just to be clear, that there was some legitimate concern that absent this partnership that you wouldn't be able to certainly accelerate production, might not be able to meet the targets that had been set. Am I right in that?

MR. GORSKY: Well, the way that I would classify it is we're confident, but this is helping to reinforce that in a significant way.

Look, we've recently announced, for example, in Europe a partnership with Sanofi as well. We've got more than 10 different companies involved in a broad network here in the United States but also in Europe and in other parts of the world, and as I think the prudent thing to do is for anyone in this situation, particularly given the implications, are to make sure we're taking every step possible, again, to reinforce, to buttress, to support, to accelerate our opportunity for vaccines.

MR. IGNATIUS: You said something interesting last night to CNBC talking about the Merck production partnership. You said, "We think it's going to add considerably to our capabilities, both near and long term." You're committed, I think, to delivering 100 million doses by the end of June. Do you think that you can actually exceed that target with this new capability?

MR. GORSKY: Well, that's our goal, and again, this involves biology. This involves chemistry. This involves very sophisticated engineering, not only in the production of the drug substance, but also in the fill and finish. Our engineers and our scientists are working, again, hand-in-hand with the Merck supply-chain team as we speak to make this possible, and look, we're very confident, based upon the early work that we've done, that by working in the coming months that we're going to be able to accelerate.

The exact details of that, look, we're still working out, but the early signs and the early data transfer and technology transfer has been encouraging, and we're committed to doing everything possible to making that acceleration possible.

MR. IGNATIUS: Again, when we say acceleration, we mean that you might be above the targeted goal of 100 million doses by June. Am I right?

MR. GORSKY: That's our goal. That's our goal.

MR. IGNATIUS: Okay. So, President Biden said a couple of other really interesting things yesterday, and I want to get your perspective as an industry leader on them. He said that he'd like to get every teacher in America vaccinated by the end of March and every adult by the end of May. Are those realistic targets, do you think, given what you know about supply and demand?

MR. GORSKY: Well, David, I'm really encouraged by not only the steps that we're taking at Johnson & Johnson and things even as we've just been discussing around our partnership, but also the steps by companies like Moderna and Pfizer. I know all three of these companies have literally been working around the clock to do everything we possibly can to expand the number of vaccine doses that are going to be delivered, especially over the next two- or three-month period, and I think the reason for optimism is that if we can achieve this distribution of several hundred million additional doses during this time frame, we are going to be at a point where there will be enough doses available for every American that can realistically be vaccinated.

I think once we remove the supply issue, then what we're going to see is the ability to actually distribute and administer go up significantly, and what I mean by that is, look, the CDC has issued guidelines, especially when we were supply constrained, about going to the elderly first, going to first responders, and developing a very robust and well understood hierarchy in terms of vaccinations. But as we get more supply and as we're no longer supply constrained, I think we'll be able to ease some of those guidelines up, and then, of course, we can start the actual administration at scale, so whether it's through drive-throughs in stadiums, getting more and more pharmacies involved. And once we start doing that, the number of vaccinations is going to go up significantly.

So, I'm getting a lot more confidence. I think that the states, local-level governments, local communities are particularly important in communities of color, and Black, African American, Hispanic communities, to be reaching there to make sure we have equitable distribution. But I think that those efforts are picking up significant momentum as we speak, and again, as they get access to more vaccines, we're going to be able to accelerate that throughput to a very significant degree in the coming months.

MR. IGNATIUS: That's encouraging.

I want to ask you about one puzzle that I know parents who are watching our show today are thinking about, and that is, where do we stand on getting vaccines for children? Are you in the stage now of trials for children's vaccines? Are there issues that complicate that? Just give us a brief perspective on where that stands.

MR. GORSKY: David, the initial indication for these vaccines has been 18 and older, but all the companies now, including ourselves, are working on its utilization, its testing in some clinical trials for younger children. Our first step would be in the age of 12 to 18, and then we would look at testing it earlier than 12 and actually also women of childbearing age and pregnancy. We're working with the FDA as we speak, and we hope to have results--we'll hope to have results of those trials by later this year.

I'm not sure of the exact timelines of the other companies, but I think in certain cases, some of those trials are already underway.

MR. IGNATIUS: Just thinking about the basic timetable realities of testing and production, is it possible that vaccines would be available for children under 18 by September, when parents want them to go back to school, or are we really thinking--should we be thinking more about the end of the year?

MR. GORSKY: I think it's likely to occur right in that timeline. The good news is that the FDA is already working with companies to establish the clear regulatory guidelines so that the appropriate data can be collected, and again, I know that all the companies are working.

Look, in our case, we're particularly hopeful because our vector platform that we were using for this, the AdVac 26, was used extensively among broad age groups, young and old, in Africa, when we were developing this for other conditions such as Ebola and HIV. So, it gives us reasons to be optimistic regarding the safety profile in that patient population, but we still have to do the clinical work.

But I would be hopeful that in that time frame, near the end of the--or the third quarter and into the fourth quarter that hopefully we can get that information to demonstrate safety and efficacy in adolescents and children.

MR. IGNATIUS: Let's talk about efficacy, which is one of the puzzles for the public. Your new one-dose vaccine has been estimated to be roughly 70 percent effective overall, but it works--my numbers say 85 percent of the time against severe disease, and it's 100 percent effective in preventing hospitalization and death.

I think the question that people are wondering about, are those numbers sufficient at a time when the two alternative vaccines are promising 95 percent efficacy? Are people going to begin to vaccine shop, and what are you going to do about that basic issue as people look at the three and make comparisons?

MR. GORSKY: And, David, it's a great question, and it's an important one to spend some time on because, look, I think all of us over the past 12 months have almost tried to become experts on statistics, on clinical trials, and it can be an apples-to-orange and apples-to-apples and apples-to-tires comparison sometime, depending on exactly how you look at the data.

I would bring up a few points that are really important for patients to understand and that I think are quite consistent with comments from people like Dr. Fauci and others who are really experts in this field and have reviewed the data in considerable detail, and that is that the clinical trials for our vaccine really were done in a period from about September of 2020 to January of 2021. As you remember, the incidence rate of COVID-19, certainly here in the United States, but even more broadly around the world, had experienced a bit of a flattening trend last summer. But then as we, unfortunately, entered that fall season, we saw it begin to increase dramatically.

What's really important when looking at our results is our trials reflected a very significant incidence rate increase through this period.

Number two, our trial was conducted on a global basis versus the other vaccines, and so what I mean by that is about 45 percent of the patients in our trial were here in the United States. Approximately 40 percent were in Latin America, the significant percentage in Brazil, and approximately 15 percent in South Africa. Of course, Northern Brazil and South Africa are also the places where we're seeing the rise of these variants and these mutations that have occurred as the rate of transmission increased through the latter part of 2020 and early 2021.

So, we believe what we've seen is evolution, unfortunately, of the disease. We've seen in certain cases these variants perhaps be more easily transmittable, perhaps more serious in the nature of the disease, and perhaps even resistant to either monoclonal antibodies or some of the other vaccines.

And even in these patient populations--and again, in our South African patients where the disease was observed, 90 percent of them had the South African variant. We saw 85 percent effectiveness in severe disease, and we saw it work 100 percent of the time thus far in keeping patients out of a hospital, in keeping them from dying. And we think that's a very significant statistic for the population, for citizens to think about, to understand, because, ultimately, I think all of us for ourselves, for our families, for our friends want to make sure that we don't get seriously ill, we don't have to go to the hospital, that the hospitals are not filled with high numbers of patients that clog up our system and that challenge it in even greater ways, and we certainly don't want them to die. So, as a result, I think they can have a lot of confidence.

Look, it's important that, as the government said, people should feel confident to get the first vaccine that they can. All these vaccines are very effective and very efficient. We're going to find more over time on how some of the other vaccines work against these variants or not.

But what's most important right now is to stop the transmission, is to stop some of these additional variants and mutations from developing, and that starts by getting vaccinated with a high degree of confidence and trust in all of them based upon the safety and efficacy that we've seen thus far.

MR. IGNATIUS: So, should I understand from what you just said that the testing that you did in these hotspots in Latin America and South Africa that it's possible and even likely that your J&J vaccine is more effective against the variants that we've seen in those places than the other two, the Modern and the Pfizer vaccines, that we've read so much about? Is that possible?

MR. GORSKY: Well, you'll never know for certain until we do head-to-head clinical trials directly between these various vaccines, but as of now, I believe we're the only vaccine to have an extensive database of actual real-world clinical evidence against these variants. And I believe that's underway with some of the other vaccines, but we were very pleased to see these kind of outcomes.

We were optimistic based upon some of the early data, the preclinical data, that we shared and that Moderna and Pfizer also have, but seeing it actually in these trials, again, gives us a lot of confidence, so that even in these more virulent, even in these more pernicious strains that we're seeing very good protection.

MR. IGNATIUS: That's helpful, Alex.

Let me ask another sort of technical question. Are you thinking of adding a second shot to your one-dose vaccine to deal with additional variants or other complications? Are you thinking about a booster that someone who has taken the J&J vaccine this year might take a year hence to catch them up, as it were, against new strains?

MR. GORSKY: David, we're attempting to take a very thoughtful, long-term strategic approach because we believe we will be fighting COVID-19 for some time, and from the beginning, our scientists really set their sights on saying how could we optimally discover and develop a vaccine that was safe, that was effective, that was convenient, ideally one dose that would require minimal refrigeration, and that also could be scaled up significantly in terms of manufacturing in the number of doses that could actually be produced.

As I'm sure you can appreciate and your listeners will be able to appreciate, there are tradeoffs in pulling that together, and the approach, the construct that they were able to develop, really met all those criteria, and so that became the candidate that we selected and we took into our Phase 1/2a and then Phase 3 testing that we've been discussing the results on. So, again, we think that based upon the clinical data that we generated thus far, again, that we've been able to achieve the majority of those criteria.

Now, at the same time, we realized that we have to prepare for the future. So, we simultaneously started a trial looking at a second dose, and so in this case, it would be our single dose followed up by another dose of Johnson & Johnson product vaccine to say would that be even more effective, could it perhaps have an even more durable, a longer sustainability and protection, and we're in the midst of that trial as we speak. I believe it's around 30,000 patients. We'll have more data, more information at the back end of this year to find that out.

Nonetheless, we still have tremendous confidence in the single dose, what we're saying, "Hey, what could happen if we have another dose at a later point in time?" and again, we'll have more information on that later this year.

We're also simultaneously--

MR. IGNATIUS: Do you have--

MR. GORSKY: What?

MR. IGNATIUS: I just was going to ask, Alex, if you have any early indications about whether that second dose might produce longer duration or other benefits.

MR. GORSKY: Now, at this point in time, we remain very encouraged by the data that we're seeing from the single dose, and that we've got data points now that go out, David, to 56 and, I believe, over 80 days that are showing a very nice persistent curve, no diminution of effect, and of course, we're going to continue to monitor that as we go forward. And our previous studies with other vaccines would not indicate that you would see a substantive improvement, but nonetheless, we want to try that specifically with the COVID-19 vaccine to answer that question going forward.

Look, simultaneously, we're working on other formulations of our vaccines for variants and future mutations, should they develop. So, I think we could be in a world where similar to a flu shot, you could require either additional boosters of the same vaccines over time or vaccines that have been created for new variants that have been identified that could potentially be challenging to the initial vaccine so that we can have those for application in the future.

MR. IGNATIUS: Let's talk about one of the really tricky problems here, and that's what we'll call vaccine hesitancy or vaccine resistance. There are people who don't want to take vaccines. Numbers in the military seem to be as high as 30 percent. The larger population is probably similar. Also, the U.S. Conference of Catholic Bishops has been issuing some warnings about taking vaccines that may have cell lines that they think are inappropriate. Could you just address the basic question of encouraging people to take these so that as large a percentage of the population as possible is vaccinated?

MR. GORSKY: Yes. Look, I think it's so important for our country, for our health care system, for all of our citizens to get as many people vaccinated as soon as possible, and hence, it's also incumbent upon us to be as transparent with our data and to do everything we can to educate people about the importance of being vaccinated because, unfortunately, we know that every time this virus is transmitted, which is going to happen more frequently if people aren't vaccinated, you run the risk or there's the potential for it to slightly mutate and change its form that over time can lead to variations that could be resistant to either a monoclonal antibody. It could be more transmittable. It could lead to more hospitalization or death or be resistant to vaccines. So, the sooner we get more people vaccinated, the less of a probability or an opportunity we have that from happening.

But I also realize that there is some skepticism. We can certainly understand that. We tried to address that very early on, where I worked with some of my fellow CEOs who are developing vaccines, to make a statement about the importance of being very transparent with our data, about the regulatory process that we were following. I think even the fact that in this case, not only had these vaccines undergone a review by the FDA, but they've also gone through a review by an independent advisory committee that made a recommendation to the FDA after reviewing all of the data. And then yet there was another review by the CDC to take a look at that approval data, to ultimately make a recommendation on where and when and how these vaccines could be used.

Also, I think if you look now at the data that we're gathering real world. So, in our case, prior to us being approved, we had almost 200,000 patients of experience in other areas. So, again, that gave us a high degree of confidence in the safety of the vaccines.

Now we've seen this has been used in tens of millions of people in the United States, let alone more than hundreds of millions of people around the world, and we're seeing results in terms of safety and adverse events being very consistent with what we saw in the earlier clinical trials.

So, it's certainly my hope that as we share that data, as we do even more to educate and encourage, as we make it easier and more accessible by getting to communities so that barriers are broken down for people to get access and hopefully, frankly, people say, "Hey, I've seen my neighbor. I've seen others take it"--and even some of the surveys, while I realize there's a certain percentage, perhaps 10 percent of the population, that would be resistant to vaccines ever, there's maybe 10 or 20 percent that say, "I'm going to wait and see." And, hopefully, as they're waiting and they're seeing now the good results that are taking place and knowing that, look, all of us want to get our lives back to normal, all of us want to see our family and friends and get back to school and get back to work and be able to maybe take that vacation or do other activities that we enjoyed before, vaccines are going to be such an important part of that.

So, again, I'm hopeful that through all those things that we just talked about that we're going to see the acceptance and the willingness to get a vaccine go up so that we can achieve a level of herd immunity that will clearly be in the best interest for our country and the world.

MR. IGNATIUS: Well, we'll all be looking at those numbers on hesitancy, and hopefully, as you say, as the record of safety and efficacy improves, more people will want to take them.

Let me ask you a final question, and that is what it's been like dealing with Uncle Sam as your business partner. You've been receiving substantial money, as has Merck, as have many of the companies. I wonder if your industry is ever going to be the same after this extraordinary marriage of government efforts and private-sector efforts. Do you think your pharmaceutical industry will go back to the way it was, or are we really on a new trajectory now?

MR. GORSKY: Well, David, I hope we don't go back to doing business as usual. I think having spent more than 30 years of my life in this industry, I have never seen the level of partnership and collaboration that I've observed over the last 13 months, and that starts with there in our discovery efforts. For example, with us, we worked with physicians and scientists out at Beth Deaconess Israel [sic] up in Boston where we really gathered some great data and great information in our platform.

You're seeing that with the other companies as well, the way that the FDA and BARDA has worked in a very collaborative way to try to accelerate and look at the way that we did clinical trials. Look, there's a lot of good rationale why we've done clinical trials the way that we have for decades, but given this extraordinary point in time and the challenge that the world is facing and, frankly, the rising tide of deaths and morbidity and mortality, just to take an ordinary path was not acceptable. And yet doing that in a way where we weren't compromising safety, we weren't compromising quality meant that the regulators were sharing information. We were sharing data between companies real time so that we weren't relying only on our own datasets but other datasets. So that gave us much greater certainty in a shorter period of time.

The partnering that we're seeing on the manufacturing side. You know, when I reached out to my colleagues, Paula Annunziato, Ken Frazier at Merck, they could not have been more open and more willing to get involved in any way that they could, and they've reached out. I think the government has clearly gotten involved in a significant way.

Look, I believe that the way we're demonstrating not only that companies can partner, but that we can have public-private partnerships that maintain that kind of reliance on innovation and entrepreneurialism so that we have that real sense of urgency to get this through, but also harness resources, bring critical mass together, help to set certain priorities to allow us to do things that we couldn't do on our own is a really promising approach.

On top of that, whether it's the way that we're incorporating technology, data sciences, into some of our clinical trial techniques, the way we use it to have meetings like this, being able to collaborate and communicate virtually versus real time, I think all of these are going to be capabilities and lessons that will be applied forward that hopefully makes us more effective, more efficient, better, more resilient, and ultimately is going to get treatments to patients faster in the future.

MR. IGNATIUS: Well, that's a great note to close on. I want to thank Alex Gorsky, the chief executive of Johnson & Johnson, for helping untangle some of these issues and making clear the significant developments as, in his words, we accelerate production and distribution of vaccines. Alex, thank you for joining us today.

MR. GORSKY: Well, David, thank you very much for the thoughtful questions, and look, I'd encourage everyone to please get vaccinated as soon as you can. Stay vigilant. We can get through this, and I know we'll all be stronger on the other side. Thank you very much.

MR. IGNATIUS: So, we'll be back at 2:00 today for "Race in America," a special on the rise in Asian-American violence. The national reporter from the Post, Michelle Ye Hee Lee, will be speaking with actors and producers about this problem and the growing fears in the Asian-American community, calls for action, and other related issues. Please join us.

Thanks for watching Washington Post Live. We'll be back with you.

[End recorded session.]