J&J’s New Vaccine Leader Talks Covid-19 and Pipeline Plans – Community News
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J&J’s New Vaccine Leader Talks Covid-19 and Pipeline Plans

there’s a changing of the guard at the vaccine division of Janssen, Johnson & Johnson. In June, the company announced that Penny Heaton, formerly the founder and CEO of the Bill and Melinda Gates Medical Research Institute, has joined Janssen as head of its global vaccine therapeutics division, succeeding Johan Van Hoof, who will retire at the end of 2021. retires. .

Heaton’s resume 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 heads into her first J&J Pharma Day on Wednesday — basically a two-day event for analysts — STAT caught up with Heaton to ask her about her plans for Janssen’s vaccine division. We discussed the company’s Covid-19 vaccine, made with an adenovirus 26 delivery system also used in the 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, which is now in a phase 3 clinical trial, and other things in the pipeline.

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The interview has been slightly edited for clarity and length.

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

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I think there is a great opportunity to renew interest and draw attention to vaccines. What the Covid pandemic has done is allow some of the new gears [vaccine] platforms. For example, the nucleic acid platforms, whether it’s our Ad vector platform or the RNA technologies, that acceleration is allowed.

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

And I also think that the Covid pandemic has accelerated innovation operationally. We can do some things in parallel that we didn’t expect before, instead of sequentially. I think the Covid pandemic has taught us some of those practices that we can bring into play.

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

I hope the status quo doesn’t last. I’ve wanted innovation in clinical trials for a long time. So I think now is a golden opportunity.

Do I think things will move as fast as they did during the Covid pandemic? New. The review times – be it within the companies or with regard to advisory boards, regulators – they have done a heroic job. But I do think it has changed the mindset so that we can see a different way of working. And I’m excited about the future.

You mentioned the RSV vaccine. That’s the one furthest in Janssen’s pipeline, yes? You said you hoped to apply to regulators in 2023. Any idea what part of 2023?

Phase 3 investigations are now underway. We have our primary study confirming the great efficacy we saw in the Phase 2b trial, which showed 80% efficacy against lower respiratory tract infections in older adults over 65 years of age. And so it will depend on the RSV epidemiology – how the cases unfold – 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 in the coming months, but we’ll have to wait and see.

The burden of RSV in older adults is often unrecognized as it is in children, but you know it is a significant burden; 177,000 US hospitalizations each 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 of the pandemic is mRNA vaccines. And many of your competitors — GSK, Sanofi — have followed Pfizer and Moderna into that space. Does Janssen think it shouldn’t be there either?

We already have the ability to take a gene sequence very quickly and turn it into a vaccine by using the Ad26 technology to encode the virus and express the desired protein. So we will continue to work on that.

Now this comes into my vision of the future for the vaccine program at Janssen. But especially when I look at other platforms – platforms that could 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 raises such a great cell-mediated immunity, which is important, you know, to keep the virus from spreading through the respiratory tract and to prevent serious illness. And that was something that was so elusive with other vaccine platforms. It also elicits good humorous reactions, so it’s a great foundation to build on. And so I’m thinking about which platform we can use to complement this for the future. But I think we just have a lot of potential with what we have here and now.

Will Janssen continue to work on his Ebola vaccine? Thinking of a multivalent Ebola-Marburg vaccine? Or is the Ebola Zaire vaccine the company’s contribution in this area?

We now move on to look more at special populations with the current vaccine. We have a study in which pregnant women are enrolled to monitor safety and efficacy in those at high risk, as well as children — even young infants. So that’s the work we’re focusing on now with the Ebola vaccine, as we continue to deliver it to those really high-risk countries where Ebola outbreaks are common.

That sounds like a no.

I would say we will continue to explore needs. We work very closely with the World Health Organization. But our focus now is on special populations.

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

We have developed this vaccine from the very beginning 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 found is that giving a booster two months to six months after that initial dose gives you an even higher level of protection against symptomatic and serious illness.

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

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

Let’s talk for a moment about Janssen’s work on an E. coli vaccine – which I assume is really a vaccine aimed at preventing some cases of sepsis?

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

It’s for older adults. You can clearly identify older adults who are at higher risk for E. coli sepsis. What the data shows is that if you’ve had a few UTIs and you’re an older adult, you’re at high risk for E. coli sepsis.

It is 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 a family member has suffered from it. But more likely to know about UTIs and what happens to seniors when they get them.

My own father had a urinary tract infection that led to sepsis and then organ failure. So I recognize firsthand the atypical nature of the symptoms in older adults and sometimes it is not recognized early.

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

I do look at Succession. It’s one of the few shows I have time for. However, I haven’t seen this week’s episode yet.

I don’t want to be a spoiler, but you’ll find it really interesting if you do.


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