J&J's Heaton becomes face of COVID-19 booster debate in first months as Janssen vaccine chief

When Johnson & Johnson nabbed Penny Heaton, M.D., from the Bill & Melinda Gates Medical Research Institute to be the global therapeutic area head for vaccines at Janssen, they threw her right into the deep end.

She immediately became the face of the COVID-19 booster debate, a task she says has seen her “drinking from the proverbial fire hose” since she began in July.  

The times may be unprecedented—taking over the vaccines group in the middle of a global pandemic—but Heaton returned to the pharmaceutical world from the nonprofit with plenty of experience to back her up. She previously led vaccine R&D at Novartis, Merck and Novavax.

There’s no doubt that Heaton has earned her seat at the center of a contentious and critically important debate. Fierce Biotech caught up with Heaton ahead of Janssen’s Nov. 18 Pharmaceutical Business Review.

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The following interview has been lightly edited for clarity.

Fierce Biotech: Tell me about your new role. How did you get here, and what will you be doing at Janssen?

Penny Heaton: You probably know some of my history and pediatric infectious disease position that started off with the Centers for Disease Control and Epidemiology. Then I went into the private sector to work on vaccines, and I loved vaccine development. That led me to the Gates Foundation, where I started to work on and support our partners in vaccine development for those in low-income countries. And then that led to the start of the Gates Medical Research Institute, which is a nonprofit biotech, and there we worked on vaccines, drugs and antibodies for diseases that disproportionately affect the poor. I loved that work but really wanted to get back into vaccines full-time, and that's what led me to Janssen. The current leader is retiring. When this position opened up, it was an incredible opportunity.

FB: It's a pretty crazy time to be joining Janssen to lead vaccines R&D. You’ve been out front at some of these FDA meetings for the booster shots. How has the transition back to pharma been for you? Seems like you’ve been thrown right into it.

PH: I've been drinking from the proverbial fire hose. And yes, of course, it's been busy. But the silver lining is that it's really accelerated my onboarding. I've gotten to know the organization much more quickly and in a much deeper way. It would have taken me several months to get to this point, I think, if it had not been for the AdComm.

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So it's just been great to kind of peel back the data, as I call it, on the adenovirus COVID vaccine and on the other vaccines that we have in the pipeline, and really start to understand the clinical data, the clinical work they offer and their safety data. So it's really been a golden opportunity.

FB: J&J has been one of the leaders in getting the COVID-19 vaccines out so quickly. How has that experience transformed the overall vaccine program? What are the lessons you’ll be able to take forward from this?

PH: There have been many lessons that we already recognize that we've learned, and I think we still will learn many more over these next few months. But certainly, one thing that I think we've learned is just the capability of the AdVac technology to be able to respond really quickly and to develop highly efficacious vaccines. You know, we had the Ebola vaccine that we had been moving forward with, but now it's given us a really solid proof of concept for the platform.

The other thing that is really accelerated is our immunologic knowledge of how the Ad26 vaccine protects. What we've been able to see is that the antibodies that are induced, the titers look different than that seen with other COVID vaccines. They're durable, and we're also seeing durable efficacy. From our ENSEMBLE 1 study where we looked at the efficacy of the single dose, if you look across different variants, that efficacy is very durable, from day one to six months later.

So starting to understand that immunologic profile and how that might translate into protection against other diseases has been a huge advantage. And then, of course, there's all the operational efficiencies. We didn't know we could do it this way, but we can move nimbly even in an organization as big as Johnson & Johnson.

FB: So what other viruses or diseases could this technology be applied to?

PH: I’ve already mentioned Ebola. The other really exciting program that we have is our respiratory syncytial virus vaccine program. RSV, of course, is one of the leading causes of hospitalizations for lower respiratory tract disease in older adults.

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We just recently completed our phase 2b CYPRESS study. That RSV vaccine on the same platform as the COVID vaccine along with a fusion protein has shown 80% protection against lower respiratory tract disease in those older adults over 65. So that's exciting. Our phase 3 study's ongoing. We'll see what that shows. But it shows the promise now across three different vaccines.

FB: Did some of these advances come as a result of the COVID-19 vaccine, or were you on the cusp of this advancement before the pandemic?

PH: The work has been going on for a long time. Johan Van Hoof, my predecessor who will be retiring soon, he and his team had done a tremendous amount of work to get the platform to the point it is now. But COVID really accelerated the ability to really understand that immunology and the advantages of the platform and protection.