Front Burner - A patent-free vaccine for the world

Episode Date: February 1, 2022

Texas-based scientists Maria Elena Bottazzi and Peter Hotez won't make a cent off the vaccine they developed — and they don't want to. Dubbed "the world's COVID-19 vaccine," Corbevax is cheap and relatively easy to manufacture, and there's no patent on it. After multiple hurdles in the team's efforts to fund and develop the jab, Corbevax was recently approved for emergency use in India. Today, we're speaking to Bottazzi and Hotez about the story behind Corbevax, what the skeptics have to say, and why they believe their shot can be a powerful tool in the fight for vaccine equity.

In the Dragon's Den, a simple pitch can lead to a life-changing connection. Watch new episodes of Dragon's Den free on CBC Gem. Brought to you in part by National Angel Capital Organization, empowering Canada's entrepreneurs through angel investment and industry connections. This is a CBC Podcast. Hi, I'm Jamie Poisson. As we've talked about on the show before, one of the big reasons that this pandemic keeps dragging on and that new variants keep popping up is because huge parts of the world still can't access vaccines. About 50% of the world population is now fully vaccinated. In Africa, this is just 10%.

The World Health Organization says that just 11% of people in low-income countries have received at least one dose of a COVID vaccine, compared to 67% in high-income countries, 85% here in Canada. It's a problem that Tedros Adhanom Ghebreyesus, the head of the WHO, refers to as vaccine apartheid. I think I would go one step further and say not just that the world is at risk of vaccine apartheid, the world is in vaccine apartheid. For over a year now, activists have been calling on companies like Pfizer and Moderna, whose profits skyrocketed last year, to share the technology and know-how for producing their vaccines with countries around the world.

Activists are also pushing governments to agree to a deal at the World Trade Organization, which would temporarily waive intellectual property rules for COVID vaccines. Neither of those things has happened yet. But as this debate rages on, a small team of scientists in Texas has been working on their own COVID shot, which they're hoping will be a game changer for vaccine equity. It's called Corvavax, and it's been dubbed the world's COVID-19 vaccine. It's patent-free, it's cheap to produce, and the inventors won't make a cent from it.

And it was recently approved in India for emergency use. Today, I'm speaking to the two scientists developing that vaccine about the story behind Corvavax and why they think it could help fight global vaccine inequality. Maria Elena Botazzi and Peter Hotez are both medical researchers at the Texas Children's Hospital for Vaccine Development at Baylor College of Medicine. Hello, Dr. Botazzi and Dr. Hotez. Thank you so much for making the time. Oh, thanks for having us. Yes, thanks. Great to be here.

It's great to have you. So I want to start by briefly talking about what your vaccine actually is. The most common COVID vaccines in Canada, like the US, are mRNA vaccines. But your vaccine actually uses quite an old kind of vaccine technology. And Dr. Botazzi, can you just briefly explain how your vaccine works to me? You're absolutely right. So we use what is called protein-based vaccine technology. In our case, it's actually using a system of production by the yeast. So the yeast is the producer of these recombinant proteins that we make in the lab, which is ultimately what you really need to present to the immune system

compared to an RNA or adenovirus, which needs to still be translated into a protein in your body before it can activate your immune response. So we just make them in the lab, we make them, you know, a little bit vegan, because the yeast system is a vegan system. And it really can induce a very robust and also very durable immune response, very similar to how hepatitis B vaccines work, which is a system of of production. Okay. Okay. Interesting. So we have this vaccine, CorvaVax. It's based on this older technology. And I understand it's also an old project for the two of you. This is something that you started working on way before this pandemic. And Dr. Hotez, why did you originally start developing this vaccine?

Well, our product development partnership at Texas Children's, it's called the Texas Children's Center for Vaccine Development, has been focused around making the vaccines that the big pharma companies won't make because there's no financial return or significant financial return. So we've been making parasitic disease vaccines for schistosomiasis and Chagas disease, diseases of the poor, for which we've always understood that we have to make them at extremely low cost. So we build in low cost processes from the beginning, generally vegan technologies, yeast or microbial fermentation technologies that could be done for two or three dollars a dose. fermentation technologies that could be done for two or three dollars a dose. And that's how we've always done it. And about 10 years ago, we started making coronavirus vaccines because they were similarly orphaned.

And then when the COVID-19 sequence came along, we were able to pivot and make that. And that's all we know how to do is make low cost recombinant protein vaccines. And the reason that technology is particularly important using yeast fermentation is that's in place in multiple developing countries. In fact, they call themselves the Developing Country Vaccine Manufacturers Network in places like India, Bangladesh, Vietnam, Brazil. And so if you want to make a low-cost vaccine for global health using that technology means you could slide right into those kinds of manufacturers and that's been the plan. So we licensed our technology for the COVID-19 vaccine,

no patents, no strings attached. We've done this now to India. In clinical trials, the two-dose Corbravax has proven 80% effective against the Delta variant. Studies into Omicron and boosters are ongoing. In India, one manufacturer is already planning to produce 1.2 billion doses per year. Where the producer there knows biologically is making Corbivax, but we're doing it also with Indonesia, Bangladesh, Botswana, and now we're talking to three or four other countries as well. Bangladesh, Botswana, and now we're talking to three or four other countries as well. Right. And Dr. Hotez, in the intro to this conversation, we talked about what many advocates and experts, including the head of the WHO, have called vaccine apartheid. And how do you believe your vaccine can fight vaccine inequity? Well, Corby vaccine and vaccines like

it, what that means is there's no limit to the amount you could scale and scale locally. So it's the fact that we need 9 billion doses of vaccines to vaccinate a billion people on the African continent, a billion people in the smaller, low-income Asian countries, a billion people in Latin America times two or three doses. You know, you need something straightforward that you could scale. You cannot do that right now with mRNA and have no virus vector vaccines. It's still a new technology, but you can with ours. And so if you want to fill the equity gap, we think that this is the fastest way to get there. And without any compromise in terms of quality of vaccine or durability or ability to induce protective immunity. In fact, there may be advantages to our technology above some of the mRNA or adenovirus-fectored

vaccines. Dr. Batasi, I wonder if you could tell me, I understand that in the early days of the pandemic, you figured it would be quite easy to get the government to support and fund what you need to get this vaccine made. But what actually ended up happening? Well, you know, as we mentioned, we've been working on coronavirus vaccine program for 10 years. And indeed, we started with a big, you know, NIH supported project from our National Institutes of Health. So we actually already even knew that it was very likely that these type of technologies would work for COVID-19, especially after seeing how closely the viruses resembled, right, to each other, the SARS, original SARS virus with the SARS-CoV-2 virus. And in fact, we got a little bit of a bridge fund

to evaluate that cross protection between using, you know, prototypes for SARS vaccines for SARS COVID-2. But then it seems that, you know, all the interest totally dissipated. So we're a little bit also a little bit disappointed, maybe, and maybe just, you know, we don't really know why a conventional platform was not really considered around the table. And we're not the only ones who were left behind. Many others that use these conventional platforms were not selected, especially not in the US. Even our partners, the partners that Peter mentioned, the developing country vaccine manufacturers didn't also get benefit, those dollars. So there's definitely this decolonization of the process that, you know, it's missing here.

Dr. Hotez, I understand that Moderna has received close to $10 billion from the US government to develop and produce this vaccine. And why do you think that your vaccine candidate wasn't getting the traction that other candidates were? Well, I think, you know, the science policymakers were very much focused on speed and innovation. And, and the fact that we had an older technology, the fact that we're not a pharma company, I think all of that played into it, it was seen as old fashioned and, and sure, it's old-fashioned, but even though we may not be quite as fast on the front end, we're only delayed a couple of months, and you pick all that up on the distal end, on the back end, because now you could scale up and

make ours for the world, which you can't do the others or not anytime soon. So I think it was a terrible science policy failure, not so much Kovacs sharing facility, but upstream. Dr. Hotez, I know this is hypothetical, but what do you think might be different right now if you had gotten the funding and supports you were looking for at the start? Well, I think what would have happened is we could have been moving faster and vaccinating the world. And remember how this works. Delta arose out of an unvaccinated population in India. New daily cases have now topped 200,000 for a week straight. People started asking for vaccines urgently. India just did not have the supply to give them.

Omicron out of an unvaccinated population in southern Africa. In South Africa, scientists identifying a troubling new variant of the virus that is dominating infections here. variant of the virus that is dominating infections here. A variant of serious concern, which is now driving this spike in numbers. More than 30 mutations, say scientists, in the spike protein alone. It's a worrying sign. Potentially, if we had vaccinated the world earlier with our vaccine and ones like it, we could have forestalled the emergence or prevented the emergence of these variants of concern. And the only way we're going to end this pandemic is to vaccinate the world. And we think technology like ours is going to be front and center of that.

We're not going to do it otherwise. I want to talk profits now with you both. You mentioned you're not a pharma company. Companies like Moderna and Pfizer have made incredibly powerful COVID vaccines that have saved a ton of lives, but they've also made the company's billions in profits. But while I know your university stands to make a bit of money from your vaccine, you too will not make a cent from it. And Dr. Batazzi, why did you decide not to patent it or make any profit from it at all? Sure, absolutely. So first of all, our information is already out in the public domain, right? So we actually already have everything published. So companies don't even really have

to contact us to be able to replicate what we did as far as, you know, our research and development. The reason why they call us and in fact work with our institutions is because, you know, we have the, what we call the starter kits, which is the reagents that they can accelerate the production process. We have the procedures, we have, you know, all the documentation, and of course, they get our know-how and our team of scientists that can help them during the co-development. And that's mostly what the option of these producers have been. But I think the next thing, which is interesting for us is that the cost for the research and development and the work that we do in our laboratories, we don't pass it on to the producer

so that then the producer doesn't pass it on to the consumer. And ultimately, it is to support the public good, right, to be able to bring these products as cheap as possible, safe, and effective, of course, you know, keeping all the high quality requirements that we need. you know, keeping all the high quality requirements that we need. Okay. Dr. Hotez, Bill Gates and others have argued that patents help encourage innovation, so that companies will be encouraged to develop more life-saving medical inventions like this. And so how would you respond to that argument? How would you respond to that argument? Well, you know, as I'd like to say, when your house is on fire and you can make one phone call, you don't call the patent attorney.

You call the fire department and we're the fire department. And, you know, the problem of intellectual property is a complicated one. I think the model that's in place right now is clearly not working. The model says only the multinational pharma companies can do this with aggressive intellectual property restrictions. And then eventually, the crumbs will spill down to the low and middle income country. And this pandemic clearly shows that's a failed strategy. So our recommendation has been no, to say, look, the multinational companies, they're not evil. They do what they do. They've done a lot of good things in terms of providing vaccines for the Gavi Alliance and even a lot of the vaccines for the COVAX sharing facility. But to create a really robust system of vaccine equity, you need to also simultaneously support organizations

like ours and the vaccine producers in the low and middle income countries. And that's how you have to address it. But to dig in and say only the multinationals can do this with aggressive intellectual property restrictions, I think that's my album. In the Dragon's Den, a simple pitch can lead to a life-changing connection. Watch new episodes of Dragon's Den free on CBC Gem. Brought to you in part by National Angel Capital Organization, empowering Canada's entrepreneurs through angel investment and industry connections. Hi, it's Ramit Sethi here.

You may have seen my money show on Netflix. I've been talking about money for 20 years. I've talked to millions of people and I have some startling numbers to share with you. Did you know that of the people I speak to, 50% of them do not know their own household income? That's not a typo, 50%. That's because money is confusing. In my new book and podcast, Money for Couples, I help you and your partner create a financial vision together. To listen to this podcast, just search for Money for Cups. Dr. Batazzi, I understand that you also think that CarboVax could help tackle vaccine

hesitancy and how so? Well, if I were a parent and I knew that I would be able to choose from a vaccine that it has been previously used, not only in my children, but in many children around the world that most likely will give me a little bit better confidence, especially for the COVID-19 vaccines. So I think parents will be more comfortable because again, if their kids already got a protein-based vaccine, may be at more amenable. So there are many reasons, I think, but more importantly, is also the, you know, more than four decades of safety records that these protein based vaccines bring to the table, not only for the people that need to use it, but also the regulators that evaluate the quality.

also the regulators that evaluate the quality. I also want to talk about some of the drawbacks or I guess critiques here. This company in India, Biological E, says it's completed stage three clinical trials of Corvivax. And the results sound really promising. They say that Corvivax is more than 90% effective against symptomatic cases of the original variant of COVID and 80% against Delta. But there were only 3,000 people in their trials, which is relatively small. And the company hasn't released the underlying data yet to the public. And I know that has led some vaccine experts to be skeptical about Corvavax's effectiveness. And Dr. Hotez, what's your response to that? Well, a few things. I mean, first of all, you know, from our end and the Texas Children's

Center for Vaccine Development side, we've published every aspect of how to produce our vaccine. So whereas the pharma companies have not been transparent on how you exactly make mRNA and other vaccines. We've published everything in the public domain of six publications. And then with regards to the publication of their data, here's how this works. We transfer the technology, we help in the co-development, but they own the vaccine. So India's manufacturer biologically owns CorbiVax. It's their vaccine, just like BioPharma will own their vaccine in Indonesia and the same with Bangladesh and Botswana. So when a number of people say, well, why, you know, why aren't you doing this?

Why aren't you doing that? It's not us. I mean, BioVee owns the vaccine and it's there. They've worked it out with their regulators and the WHO, how they're disseminating their results. And we try not to interfere. It's this concept that's been thrown around in global health called, we used to call it Southern ownership, but now they call it decolonization. And it's to break away from this far more model. And they do say that publication is imminent, it's forthcoming, and so I think that'll happen.

Remember, when you look at the publication of the phase three trials for Moderna, it was six weeks after emergency use authorization. With J&J, it was 17 weeks. So I think BioE is still probably going to beat them. I understand there is no data at all yet for Omicron. And Dr. Bottazzi, given how prevalent it is right now, are you concerned about that, about the vaccine's potential effectiveness against Omicron? So the company, as well as our laboratories, of course, the moment that a new variant of

concern sequence comes up, we, of course, charge ourselves to evaluate not only doing new experiments or re-evaluating some of the data in context of the new variant. So that is coming also. But I think Peter can also give you a good perspective of the fact that, you know, these variants seems to be coming and going. And, you know, by the time you start evaluating these samples for the Omicron, I'm sure there's going to be something else coming out there. You know, and honestly, I think the urgency is, again, is we need fast strategies to

really close this vaccine access gap. Because if we don't do that, you know, we're going to continue seeing, you know, new variants popping up. And therefore, there's always a moving target, right? Right, right. You're saying the strategy here is to prevent the new variants, not to necessarily address them. I wonder, Dr. Hodes, if you wanted to add anything there. Yeah, it looks like Corbivax from the data we've seen on the variants is holding up pretty well, maybe better than some of the other vaccines. I mean, this is not going to be a big question moving forward because it looks like Omicron could potentially be in the rear view mirror in the next few weeks. So I'm not, even though Moderna and Pfizer are looking at producing Omicron specific variants,

I'm not certain they're ever going to be used. We're also producing an Omicron specific version of ours as well. But I think by the time all these are ready to go, Omicron may be gone and we may be on to our next variant. So on that basis, it might be that just sticking with the original lineage might be the best way to go. Okay. Okay. And just finally, a question for you both, and thank you so much for your time. I'm wondering what you hope other vaccine developers might take away from what you're doing right now with Corbivax and starting with you, Dr. Hotez. So I think the lesson is that we, you know, we have to be careful not to go running off in the mRNA basket because you never

know which technology is going to be the best for any particular pathogen. So the greater the diversity of technologies we can keep in play, new ones like mRNA or vesicular stomatitis virus, and older technologies like ours, the more shots on goal you'll have to solve the problem. Okay, and I like that hockey reference very much. And Dr. Ratafi? Yes, for me, in addition to, of course, having a diversified technology option within a producer is that we need more producers, right? And we need more producers in regions of

the world that are not doing very well in that area of vaccine development, you know, factories and know how and capacity, right? We need to really rethink how to break this paradigm that not only multinational corporations have the power of really mobilizing new technologies, of course, new medicines, and in this case, new vaccines, but bring this developing country vaccine manufacturing network, you know, and invite more to join in this effort. Okay. Thank you.

Thank you both so much for this and for all the work you're doing. This is really fascinating. I learned a lot. Thank you. Sure. And my grandfather's from Montreal. It's the, hence, AbSpan for me. Great.

Fantastic. Thank you. Bye-bye. All right. That is all for today. I'm Jamie Poisson, and thank you so much for listening. We'll talk to you tomorrow.