Eggheads

We've talked before about how government policy has prevented the egg industry from using vaccines to fight Highly Pathogenic Avian Influenza. But if there was a policy shift tomorrow, and producers were given the green light to immunize their birds, what would that effort even look like? Where would the vaccines comes from? How would we know they're safe and effective? How much would they cost? And who would be expected to foot that bill?

Joel Harris is the co-founder of Genvax. An economist by trade, he has nearly 20 years of experience working in the field of animal vaccine development. His company, Genvax, uses an RNA platform that allows them to quickly develop vaccines, and respond rapidly to emerging diseases. Today, Joel walks us through the complex logistics and economics of vaccine development, as well as his own companies efforts to develop a tool to fight HPAI.

This is a fascinating issue that sits at the intersection of business, politics and science. Joel does a great job of breaking it all down for us, and shedding light on the inner workings of a niche but vital industry. 

Are you an egg industry pro? Reach out to be a guest on the show! Connect with us on LinkedIn and Instagram. And please rate Eggheads on Spotify and Apple Podcasts.

If you're interested in sponsoring a future episode of Eggheads, you can contact us by filling out this form.



Creators and Guests

GS
Host
Greg Schonefeld
CEO at Ag Installers, Inc.
AR
Editor
Alex Rose
Audio Engineer at Lower Street Media
NT
Producer
Nathan Tower
Podcast Producer at Lower Street Media

What is Eggheads?

Eggheads is the go-to podcast for egg industry professionals who are interested in leadership and innovation in the egg world. Host Greg Schonefeld explores the evolving world of modern egg farming, from the latest in cage-free innovations and organic certifications to navigating the economics of large-scale production. Whether you're an egg producer, supplier, or involved in poultry genetics, this show provides the insights and expert discussions you need to thrive in the industry. Crack open the science, strategies, and stories behind the egg industry’s biggest challenges and opportunities.

Joel:
By protecting our livestock and food supply, we are protecting the people that work in this industry that we've deemed essential, right? And then we're preventing the next human pandemic.

Greg:
Hey, there. I'm Greg Schonefeld and this is Eggheads. In this day and age, keeping your animals healthy doesn't just mean keeping them warm and well fed. It means taking steps to protect them from viruses that can very quickly decimate a herd or flock. Our guest today is working hard to do just that, and funny enough, he isn't even a scientist.

Joel:
Yeah. I'm just an economist that just knows enough about virology to be dangerous.

Greg:
That's Joel Harris, the co-founder and CEO of Genvax, a company that specializes in animal vaccine production. And that position seems like a perfect fit for Joel because animal agriculture and biotech are essentially in his DNA.

Joel:
My family has a long history of swine production. My grandfather raised Duroc boars out of Mount Pleasant, Iowa. Both my parents are veterinarians but also PhDs, so my mother has a PhD with epidemiology from Iowa State University and then my father has a immunology PhD. And they both actually worked and started a vaccine company in the '80s called Noble Labs.

Greg:
Like so many kids, Joel never imagined himself following in his parents' footsteps.

Joel:
I tried like hell to get away from it as much as I could. I went to the University of Iowa for economics. And then around 2006, my father was at Iowa State University and I was about to graduate and he came to me with some research he was doing on a novel way to build vaccines.

Greg:
So Joel decided to join his dad at his new company, Harris Vaccines.

Joel:
We were taking a novel, what we called an RNA platform where we could build customized vaccines and basically respond rapidly to new and emerging diseases.

Greg:
And they did so with great success. In 2013, they were the first company to get USDA approval for a vaccine to protect against porcine epidemic diarrhea, a disease that killed 8 million pigs within months. Then in 2015, there was the outbreak of high-path avian influenza.

Joel:
Within nine months of that outbreak, we had a candidate vaccine, conditional approval from USDA, and an order for 50 million doses that we produced. And it was around that time that we then exited the business and sold to Merck Animal Health.

Greg:
And now Joel is trying to build on that previous effort.

Joel:
About four years ago, we founded Genvax Technologies, which is another vaccine platform that we're trying to address things like high-path avian influenza again.

Greg:
We've talked a lot about HPAI on the show and if you work in the egg industry, then you know how devastating the disease can be for producers. Even strict biosecurity procedures are often not enough to keep your birds safe. The disease just needs one foothold on your farm to destroy an entire flock, creating a nightmare for producers and their employees. But what if we had a vaccine that could prevent all this? What would that look like? Could we protect chickens from AI the same way we protect ourselves from measles or polio?

Joel:
Yeah. So we've been using vaccines for decades in livestock production. They're a very effective tool for eliminating disease and increasing productivity. In more recent years, some of the mission and the belief we have at Genvax is that by protecting animals from these infectious diseases that are potentially zoonotic, meaning they can transfer from animals to people and vice versa, by vaccinating the animals, you're also protecting the people that work with these animals.
You should really only do it when you need to, right? So there is a judicious application of vaccines, so I think that's part of the confusion too. As consumers, people aren't very aware of herd health management or flock health management and it's just something that I think we've got to work on educating the public.

Greg:
That mission, was it inspired partly by the COVID experience or just by your history doing this kind of thing?

Joel:
Yeah. I mean, I think COVID shined a light on it a little bit, but I mean we at Harris Vaccines were working on in 2009 the pandemic H1N1, so that was the swine flu scare of 2009. So I mean it kind of always been in the back of my mind. COVID definitely made me think about that more. And then as we think about 70% of all infectious diseases are zoonotic that can pass between humans and animals, so the more frequent we see these outbreaks and the more frequent we see new diseases emerge in different species like in dairy cattle or some of the mammals that are conducting AI, again, I just think it's something to keep in mind, not just protecting the flock, but also the people that work there and then our food supply chain.

Greg:
Yeah. We've certainly seen that with AI, right, with some human cases already. And I understand you are working to develop a vaccine for HPAI. Can you talk some about that?

Joel:
Yeah. Our technology allows us to look at a multitude of diseases. We founded the company to focus primarily on swine influenza, but also African swine fever, which has this existential threat on the US livestock economy. So we're already working in influenza and I think another thing for people to remember is that we've been dealing with flu for over a hundred years.
We know so much about influenza, how to make good vaccines, how to improve biosecurity treatments. I mean everything, right? So it's not a huge leap for us to start working on that in poultry and in cattle and other species. So as this outbreak has continued and the impacts on it, both emotionally and economically, we felt like it was pertinent that we dedicate resources and investment into developing a tool.
Shortly after the initial outbreaks, we had some vaccine candidates designs. And then when it spilled over into cattle, into dairy herds, within a couple of weeks, we had a dairy vaccine designed. So really the last year, we've been doing both laboratory and animal work to refine those products and then we're going through the process with USDA to register them.

Greg:
When you say you already had a vaccine designed and you just whip it up in a couple of weeks, is it something that is functional by that time?

Joel:
Yeah. Like I said, I mean we know so much about influenza and we know what parts of the influenza virus can stimulate an immune response and protect the animal. And our technology allows us to synthetically create those antigens and insert it into our vaccine, so within a couple of weeks, we can develop candidate vaccines to test. If the virus mutates or the strain changes or there's a new variant like, you saw, the H7 that came into Mississippi, we can update the vaccine in a matter of weeks.
We're relying on what's called synthetic biology or these RNA platforms, so we're not reliant on having to grow the virus or isolate the virus. It's not necessarily mRNA as you would think of with the COVID vaccines. It's a derivative of that. It's different and it just makes it a lot faster and a lot more efficient to develop candidate vaccines.

Greg:
You have the ability to create something that can work very rapidly, but I understand policy can ultimately stand in the way of it being implemented. I would imagine there's investment. There's time to developing this. And ultimately it may never see the market even if it's a perfect solution. How does that work?

Joel:
There's a couple of different components to that. If we just talk about high-path avian influenza, regardless of the technical hurdles and the regulatory process and oversight and the safety and efficacy and potency that they require you to do, there is an overarching federal policy that we are not to vaccinate for high-path avian influenza. I mean, that full stop is what can prevent this.
Generally though, although animal health has a faster approval process than FDA human vaccine development, it's just as or even potentially more capital intensive. So there's not a lot of investment in new technologies, especially for livestock production where livestock vaccines are typically considered commodity priced, so it's low-cost, high-margin, right? I mean, you've got sometimes tens of thousands of animals or hundreds of thousands of animals you need to vaccinate efficiently, so it's not a very attractive industry for venture capital.
And where we've been successful is finding stakeholders all along the supply chain. Johnsonville, the brat company, is an investor of ours. United Animal Health, which is traditionally a nutrition animal science product company, is an investor of ours. The Iowa Corn Growers Association. So you've got the feed companies, the processing companies, the nutrition companies all know that these can be problems and they know that tools are needed, so that's where we've found kind of unique investors and stakeholders to support this.
But you're absolutely right. I mean, I've been a part of other companies that have really great technology. It works and they fall into this. They call it this valley of death where you don't have enough funding, you don't have enough time, you don't have enough support to get a product approved and commercialized. And we're really building a platform that we can react to what challenges come to us and that's the investment, is we don't know what's going to happen. I mean, if you looked five years ago before we founded the company, everyone was so worried African swine fever was going to be the issue that came into the US and now you hear about it, but it's not talked about nearly as much as high-path.

Greg:
On the human side of things, I mean, there's always the talk of the big pharmaceuticals, but I think even within the animal-specific space, there's some pretty big names. How are you able to compete in that environment?

Joel:
Yeah. We are a startup. I mean, we founded the company a little over four years ago. We have 11 people right now. So where we're able to find kind of our niche is going after some of these unmet needs that don't have maybe a defined market today. In the large animal pharmaceutical space, there's been a lot of emphasis on companion animal. Not to say that they're not working on high-path. I mean, you see those press releases as well, but if you look at their earnings, a lot of their growth has been on not just companion animal biologics, but also the therapeutics, the pain management tools, and there's just a lot more margin for those companion animal applications.
So where Genvax can succeed is looking at these fringe problems that are endemic, say, in the swine population like influenza, rotavirus, porcine circovirus, and coming up with better tools that are available today and having customized tools for the producer or the veterinarian. That's kind of how we can compete. We can be faster. We can be more agile. We can rely on those deeper relationships with producers. That's how we were kind of successful with Harrisvaccines in developing new vaccines that we were able to get to market faster than the incumbents. About 30% or 40% of all innovation is happening outside of these large organizations, so that's kind of the place that a Genvax fits in.

Greg:
Innovation is great, but again, we come back to the issue of policy standing in the way of actually implementing these solutions. During our recent Scramble episode, our panel talked a lot about how the biggest barrier to widespread vaccination is the impact on exports in the broiler market.
Without getting too deep in the weeds here, the HPAI vaccines are not internationally recognized and the broiler industry is worried that vaccination will limit their ability to sell their birds abroad. That vaccination ban also applies to eggs, despite the fact that it operates as a separate market.

Joel:
I mean, we're focused on making candidate vaccines and developing the technology. At the end of the day, it is going to have to be a policy change or action to utilize those. What's interesting is when I hear these conversations, it's like, "If only we could have a vaccine." Well, we have vaccines. We produced one a decade ago and made 50 million doses specifically. There was another 150 million doses produced by three other companies 10 years ago that sat in a freezer and was eventually thrown away.
So again, it's not just me. It's not just our company that's working on it. There's academics. There's small startups. There's large companies that have these tools available. Mexico and France have a policy or a strategy that is interesting and seems to be gaining some momentum. So frankly, I think it's a matter of time before it happens in the United States, but again, it's not my call or position to make. You see exports and trade being the main linchpin here, so I would hope that with these negotiations that are going on presently, maybe that does bring some relief to egg producers, that we're able to start to utilize all of these vaccines and tools that we already have developed.

Greg:
So if the policy changes and basically everyone can say, "Hey, go. We're going to put a vaccine program for HPAI in place," can that happen quickly or what does the process look like From there?

Joel:
You would still want to have products that are USDA approved, either fully licensed or conditionally approved, which just means they're temporarily approved in emergency situations. Those products could be, depending on the manufacturer, ramped up depending on what those products are necessarily, so they all might have a different manufacturing process. They'll all have different safety and potency testing. What I mean by that is that you've established that you're manufacturing the exact same product every time or every batch.
It's not just like, "Okay, we're ready to go," and everyone can use whatever they can grab. I mean, there's going to be products that are registered and vetted and validated and approved that would be available. So a lot of companies, including ours, we're in the process, right? I mean, we're submitting data. We're submitting our production outline, how we're going to make the vaccines. We're making the steps to get these approvals in place, so that we are ready in case the policy changes. So a lot of the work will already be done. I think then the challenge will be deployment.

Greg:
Does Genvax do the manufacturing or does that get outsourced?

Joel:
We do everything out of our facility in Ames, Iowa, out of the Iowa State University Research Park. We have about a 10,000 square foot vaccine manufacturing site. It used to be owned by a company developing cancer therapeutics, so it was an FDA-approved facility at one point, so we're reactivating and retrofitting that for our purposes. So we're doing everything ourselves and on site and that allows us to control our costs, control the quality, and everything like that.
So if the USDA were to grant us our product and facility approval, if the US policy change that allowed either producers to buy AI vaccine or the government was going to buy it and supply it to egg layers, our turnaround time is that we could have product out the door in four to six weeks from start to finish. And that includes all the safety and release testing that we would need to do. To scale up to hundreds of thousands to millions of doses, that'd probably take a few more months, but it can be done very quickly. But that's different for every manufacturer, right? It just depends on the product and the technology.

Greg:
What are the different factors that come into play when it comes to being competitive in the vaccine market?

Joel:
I think there's a lot of different features that you need to shoot for and some of this is even outlined in what the USDA is looking for for these grant applications. How quickly can you produce the vaccine is one, the immune response that you get. The application, so is it a single dose? Can you put it in the water and different administration routes? The duration of immunity, so how long are you protected? And at the end of the day, it is going to be price.
Part of the reason that mRNA vaccines like what was used at Moderna and Pfizer haven't broken into livestock vaccines is that it requires a large amount of RNA to get an effective dose, so you're kind of falling into this 30 to $50 in cost per dose. And that's just not economically viable, right? I mean, traditional poultry vaccines are measured in the pennies as the price, right? So you need these other types of vaccines or these other approaches that allow you to get into that price range. Otherwise, there's not a return on investment. Even if you are protecting the elimination of the flock, economics just come into play at that point.

Greg:
Who's the ultimate buyer then? Who ultimately buys the vaccine and decides which one to go with?

Joel:
Our target customers are producers and veterinarians, so the approach we are taking with these custom vaccines is that they're available under prescription by the herd or flock veterinarian that's overseeing the barns. If there's a stockpile or some sort of subsidy that goes in place, the ultimate buyer is going to be the US government. Or if you look outside of the United States, it's going to be the larger poultry producers in different countries or their ministries of agriculture that allow these types of technologies to be imported. Because it's high-path, again, there's so much more oversight and policy around it that it makes it a little bit more complicated than maybe the other products that we're working on in swine that could be readily available to vets and producers.

Greg:
What are some factors that impact the cost? Does your technology have cost advantages versus other vaccine technologies?

Joel:
We believe so. I mean, the thing you got to remember is for 30, 40 years, there's been a significant investment and scale up of traditional vaccines. And traditional vaccines are either viruses that can be grown and then killed or attenuated in some way that basically weakens them, so that when administered, they give you protection and not cause disease. If you imagine these giant vats and huge infrastructure and lots of people, processes in place, those have been kind of commoditized. It's kind of been a race to the bottom in terms of every large animal pharmaceutical company has a version of vaccine A and they're basically competing on price.
When you have these new and emerging diseases or these unmet problems, that's an opportunity for Genvax to bring in a new technology that's maybe targeting a smaller market. I'll give you an example of how price and market opportunity plays a role here. There's a disease that started to pop up in turkeys called metapneumonia virus. I think I'm saying that right. I'm sorry, veterinarians, if I'm not. So we looked at it. The Turkey Federation and turkey producers were clamoring for a vaccine, some sort of tool. It was just devastating.
We looked at it. It was similar to some other things we had worked on, but it doesn't have a huge market potential. And as a small startup, you got to focus on some of the low-hanging fruit that you can do or if there's a big carrot at the end of this, a huge stockpile order from the government or orders from outside the United States because, let's face it, high-path is all over the world and other countries are dealing with this too, then that's going to take priority over a domestic need.
So the result of that is finally USDA allowed for the import metapneumonia vaccines that are made outside the US for US turkey producers. That's what I mean when cost and market opportunity do play a role in this because every dollar I raise from investors, I've got to utilize as efficiently that I can to get a product to market to generate revenue, whether that's from producers, veterinarians, or governments.

Greg:
As you look ahead, do you see some big challenges and possibly some opportunities out there, just generally speaking, for the future of poultry vaccination?

Joel:
Some of the things I'm excited about, I've always worried that this type of technology, even with these economies of scale, that we still couldn't get to price parity for traditional poultry vaccines, which was kind of the impetus for focusing on swine and cattle initially. The opportunity with high-path and some of the work we've done in the last year, I do feel like we have a line of sight that we can get this technology to be either as effective or more effective than traditional products and have that cost parity.
There's so much advancements on how we can manufacture this. I think the next hurdle is going to be like, how do you deliver this en masse or how do you extend the duration of immunity by vaccinating day-old chicks through their life cycle? So there's still a lot of things that we got to figure out, but I am more optimistic. I would say that my hope is that these types of newer vaccine technologies, not just ours but others that are starting to emerge, completely replace traditional vaccines that frankly have so many more limitations and even I would say manufacturing issues and delays than what we're working on.

Greg:
Interesting. You mentioned earlier just capital being a constraint in general. Do you see that ever improving for this market?

Joel:
No, frankly. I mean, sadly, no especially right now. Even if you look at some of the larger IPOs or acquisitions in animal health the last decade, it hasn't really topped half a billion in market cap. So we haven't had a billion dollar or unicorn animal health biotech startup.
And then I think you're even seeing in agriculture technology in general some of the Silicon Valley venture capital model for investing in Ag-Tech just doesn't play out, right? I mean, we have longer production cycles. There's a smaller population of farmers in general. They're inundated with new tools that are looking for a problem. So I think because of that, you get a misalignment of investor expectations and the reality of agriculture. I'm trying to work with groups that do bring more capital into these innovations because they're desperately needed, but it's going to take different financing vehicles and creative ways to support these technologies than what's used for the next app or software as a service play.

Greg:
What would be your pitch to venture capitalists of why they should enter this space or is it more of an emotional appeal and less so a financial appeal?

Joel:
Well, yeah. I mean, I think fundamentally some things have got to change in the market with consumers, right? And honestly, I think you're seeing that. People get pissed off about egg prices and we should invest in new technologies that prevent the next egg shortage or the next outbreak. I mean, we're not even talking about the next outbreak anymore, right? This is just continuing and you're just going to get one after the other or it's going to change or it's whack-a-mole, right? I think if there was more talk of the One Health solution mindset that, again, by protecting our livestock and food supply, we are protecting the people that work in this industry that we've deemed essential, and then we're preventing the next human pandemic that could come about as well. And I don't think that's an emotional thing. I think you can see the economic impact of that, but it's indirect, right?
There's a couple of people I used to work with at Merck that you think about vaccine sales is a lot like insurance salesmen, right? I mean, you're basically selling something to prevent an outcome or to recoup on a disastrous outcome. I mean, that's what we're talking about. You invest all this money to prevent something you hope doesn't happen, so it's hard to see the value over time when nothing happens. And maybe I have the luxury of having sold a vaccine company before and having some success in this previously or just that experience that I'm able to benefit off that a little bit and maybe work on more worthwhile and these more scary boogeyman infectious diseases that haven't come to the US yet, but again, we need people to work on stuff like that.

Greg:
After talking to Joel, it's clear that so much time and effort goes into developing these vaccines and then clearing all the necessary regulatory hurdles to actually get them into animals. And then even if you can get the approval and scale up production, all it takes is a shift in political or economic wins and you end up with millions of doses expiring in a fridge.
I'm glad there are companies out there like Genvax who are going forward anyway and using their cutting-edge technology to create new tools to help us fight diseases like AI that are threatening the health of our livestock and food supply.
Thanks so much to Joel Harris for joining us on the program to give us an inside look at the realities of animal vaccine development, but I couldn't let Joel go without holding his feet to the fire with my toughest question yet. I've got one more question for you, Joel. How do you prefer your eggs?

Joel:
Oh, man. I'm a big scramble guy. What's funny is that I'm really bad at making eggs. My wife is so much better at it to the point that my six-year-old dreads it when I'm making them. I don't know why. I smoke a lot of meat. I bake my own bread, but for whatever reason, I cannot do an egg right.

Greg:
Make sure you follow Eggheads on Spotify or Apple Podcasts and connect with us on Instagram and LinkedIn too. If you want to be a guest or have topic ideas, please send us a message. And if you're interested in sponsoring the show, we'll link to a form in the show notes where you can reach out. Until next time, I'm Greg Schonefeld and we'll talk to you soon.