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There’s a changing of the guard at Janssen, Johnson & Johnson’s vaccines division. In June, the company announced that Penny Heaton, formerly the founding CEO of the Bill and Melinda Gates Medical Research Institute, was joining Janssen as the global therapeutic area head for vaccines, taking over from Johan Van Hoof, who retires at the end of 2021.

Heaton’s CV shows her chops. She also previously worked for Merck, Novartis, and Novavax, and earlier in her career at the Centers for Disease Control and Prevention.

As she faces her first J&J Pharma Day on Wednesday — actually a two-day event for analysts — STAT caught up to Heaton to ask her about her plans for Janssen’s vaccines division. We discussed the company’s Covid-19 vaccine, made with an adenovirus 26 delivery system that is also used in its Ebola vaccine, which has been licensed in Europe. We also talked about Janssen’s promising vaccine to protect adults against respiratory syncytial virus or RSV, now in a Phase 3 clinical trial, and other things in its pipeline.

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The interview has been lightly edited for clarity and length.

The Covid-19 pandemic has created a moment for vaccines that could be both transformational and also a little bit dangerous, given what’s going on in terms of the entrenchment of hesitancy around Covid vaccines and whether that transfers to other immunizations. How do you see things?

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I think there’s an amazing opportunity to renew interest and refocus attention on vaccines. What the Covid pandemic has done is it’s allowed acceleration of some of the new [vaccine] platforms. The nucleic acid platforms, for example, whether it be our Ad-vector platform or the RNA technologies, it’s allowed that acceleration.

With our adenovirus technology, we had our Ebola vaccine and we’re bringing on the RSV vaccine but it’s certainly allowed us to accelerate our understanding of that technology, the immune profile that it provides. Now we have data on what are immune responses with respect to the antibody production and the cell-mediated immunity, the durability and the response. Those are all things that we know much more quickly than we would have without the Covid pandemic.

And I also think operationally the Covid pandemic has really accelerated innovation. We can do some things in parallel that we hadn’t anticipated before rather than sequentially. I think the Covid pandemic has taught us some of those practices that we can put in into play.

Do you think the compression of vaccine development timelines will make its way into the development of non-emergency vaccines or will the status quo continue there?

My hope is the status quo doesn’t continue. I have wanted innovation in clinical trials for a long time. So I think it’s a golden opportunity right now.

Do I think things will be as fast as in the Covid pandemic? No. The review times — whether it be within the companies or whether it be with respect to advisory boards, regulatory agencies — they have been doing heroic work. But I do think that it has shifted the mindset, so we can see a different way of operating. And I’m excited about the future.

You mentioned the RSV vaccine. That’s the one that’s furthest along in Janssen’s pipeline, yes? You said you hoped to file with regulators in 2023. Any idea which part of 2023?

The Phase 3 studies are going right now. We have our primary study confirming the wonderful efficacy that we saw in the Phase 2b study, that 80% efficacy against lower respiratory tract infection in older adults over 65. And so it will depend on the RSV epidemiology — how cases occur — that will actually ultimately determine the filing date.

I wish I had a crystal ball and could tell you exactly what’s going to happen with RSV epidemiology over the next several months but we’ll have to wait and see.

The burden of RSV in older adults is often not recognized like it is in children, but you know it’s a significant burden; 177,000 hospitalizations in the U.S. every year in older adults from respiratory syncytial virus and then about 14,000 deaths.

As you said, the pandemic has accelerated work on new vaccine platforms. The big story out of the pandemic has been mRNA vaccines. And a lot of your competitors — GSK, Sanofi — have followed Pfizer and Moderna into that space. Does Janssen not feel it needs to be there too?

We already have the capability to very quickly take a gene sequence and turn it into a vaccine by using the Ad26 technology to code for the virus and express the protein of interest. So we’re continuing to move forward with that.

Now this gets into my vision of the future for the vaccine program at Janssen. But certainly looking at other platforms — platforms that might complement the Ad26 platform — I’m excited that we have such a great foundation to build on with Ad26.

When you look at the platform, it induces such great cell-mediated immunity, which is important, you know, to prevent virus spread down the respiratory tract and to prevent severe disease. And that’s been something that’s been so elusive with other vaccine platforms. It also induces good humoral responses, so it’s an amazing foundation to build on. And so for the future I’m thinking about what platform could we bring in to complement this. But I think we just have a lot of potential with what we have right here and now.

Is Janssen going to do any more work on its Ebola vaccine? Are you thinking about a multivalent Ebola-Marburg vaccine? Or is the Ebola Zaire vaccine the company’s contribution to this area?

We’re continuing right now to look more at special populations with the current vaccine. We have a study that’s ongoing enrolling pregnant women to follow the safety and efficacy in those high-risk individuals, as well as children — even young infants. So that’s the work we’re focused on right now with the Ebola vaccine, as we continue to provide it for those really high-risk countries where Ebola outbreaks often occur.

 

That sounds like a no.

I would say that we will be continuing to explore the needs. We’re working really closely with the World Health Organization. But our focus right now is on special populations.

J&J tested both a one-dose and a two-dose Covid vaccine, but has focused so far on the one-dose version. Is it the company’s preference not to sell a two-dose vaccine?

We have from the very beginning been developing this vaccine as a global vaccine, starting with that single dose for efficient pandemic control. We quickly followed that up with the two-dose trial. And what that study showed is that when you give a booster two months to six months after that initial dose you get an even higher level of protection against symptomatic and severe disease.

We support this flexible schedule. I think the world is in a different place now, especially the U.S. and Europe with the pandemic. And booster doses are now authorized by FDA, recommended by ACIP and other bodies, and we certainly support that also.

In other areas where they still don’t have a large percentage of the population vaccinated and they’re trying to increase the overall protection of the population, they may choose to continue with a single dose. So whatever the choices of those regulatory agencies and those advisory committees are, we have the data to support the use of the flexible regimen, whether it be the two dose — the one plus the booster — or the single dose.

Let’s talk a bit about Janssen’s work on an E. coli vaccine — which I take it is really a vaccine aimed at preventing some cases of sepsis?

There are 10 million cases of E. coli sepsis a year [globally] and a million deaths. So we’re really excited about this vaccine that can meet such a huge amount of unmet medical needs for which there’s not a lot of awareness, it seems. We had a very promising Phase 2 study, so we’ve started our Phase 3 program and we’re enrolling now.

It’s for older adults. You can clearly identify older adults who are at higher risk of E. coli sepsis. What the data show is that if you’ve had a couple of urinary tract infections and you’re an older adult, you’re at high risk of E. coli sepsis.

It’s the most common cause of community-acquired sepsis. We see it as a broader vaccine for older adults.

Many people may not know much about sepsis, unless they’ve had a relative suffer from it. But more probably know about UTIs and what happens to seniors when they get them.

My own father had a UTI that led to sepsis and actually then to some organ failure. So I recognize firsthand the atypical nature of the symptoms in older adults and sometimes it’s not recognized early.

Do you watch the HBO show Succession? You probably don’t have time…

I do watch Succession, actually. It’s one of the few shows I have time for. I haven’t seen this week’s episode yet, though.

I don’t want to be a spoiler, but you’re going to find it really, really interesting when you do.

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