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Asked for an update on her work, Dr. Maria Elena Bottazzi quickly rattles off numbers and names of nations. India is the source of most of the numbers. That’s where her Corbevax COVID-19 vaccine is rolling out for children aged 12 to 14. Vaccinations began March 17, so children in India are now getting their second dose. Progress is being made also in Indonesia and Botswana.
Bottazzi — associate dean at the National School of Tropical Medicine at the Baylor College of Medicine and co-director at Texas Children’s Hospital Center for Vaccine Development — collaborated with Dr. Peter Hotez to lead the team that developed Corbevax. Having spent their careers studying neglected tropical diseases, the two knew too well that a domestic vaccine in the United States was just one small part of combating the virus, as variants have continued to emerge abroad.
As their protein-based vaccine begins to circulate, Bottazzi and Hotez continue to take calls in hopes of getting the vaccine to Central and South America, while also considering its potential uses in the US, where the vaccinated are beginning to consider the value of a fourth dose of the prevalent mRNA vaccines.
Bottazzi discussed the applications of both vaccines, at home and abroad.
Q: We’re seeing millions of vaccine Corbevax doses finding their way to children 12 to 14 in India each day. It appears a similar rollout is targeted for Indonesia next, correct?
A: Yes, we’ve been talking to them. They’re already in clinical development. The way they’re working is they mature the manufacturing parallel to advancing the clinical development. The traditional way of doing things, there’d be a Phase 1, then a Phase 2, but until you see a hint of efficacy you don’t invest a hundred into manufacturing and scaling. They’re maturing scaling and production while still in the clinical stages. … They’re doing production parallel to evaluation —instead of waiting for the evaluation to invest in production.
Q: You spent some time studying business, so I imagine this is a particularly interesting process for you.
A: Yes, it is. And, honestly, it is risky. Vaccine development is a risk business. It requires a lot of funding to be able to do these things in parallel. But it’s the urgency right now. There are ways to reduce time frames by not doing things sequentially. You can get a little leeway. That’s what we’ve been trying to do, to help build that capacity to mature the process while doing the evaluations so you don’t have to start from scratch once you know a product works. Maybe in the future it won’t be as long a process. Instead of 10 or 15 years, a process can come down to a five-year time frame. And the good news for us is, because we’re enticing people with this recombinant protein technology, we hope they want to replicate the model, which could lead them to adopt our other neglected disease vaccines. They’ll have the knowhow because we’ve piloted it a little with COVID.
Q: What does that entail?
A: We have to keep what we call a “warm base” in manufacturing factories. The training has to be constant. You can’t say, “We’ll do this work and then go home until the next one shows up. You have to keep constantly trained and intellectually stimulated. In a non-crisis mode, you still have to keep the training and building capacity, potentially with our other neglected disease vaccines. That keeps their skills strong, it keeps them learning.
I just had a call with the regulatory industry in Indonesia about training to get ahead of understanding the technology. They need to be constantly trained, so we’re setting up a training program where we show them how we work in the lab; how we do document control; how we qualify assets; how we process the documentation. When they receive documentation, they need people trained in biochemistry and in analytics. The people who receive the regulatory dossiers have to be scientists, right? They have to be able to read the science. So we’re trying to do that, too. That’s part of the work.
Q: Dr. Hotez said there has been great progress in Botswana. Could you elaborate?
A: Botswana is a very interesting model. The way we work with Botswana is three-way. We are working with a group, a US-based (biotech) company called ImmunityBio with (South-African-American transplant surgeon and billionaire businessman) Patrick Soon-Shiong. We just gave our technology to (Soon-Shiong) because he has a lot of money and interest in building brick-and-mortar infrastructure in Africa. He’s building a factory in Botswana where our technology will be used as a pilot for them to learn how to develop protein-based vaccines.
We at Baylor College of Medicine and Texas Children’s are training the workforce that will go into that plant, and ImmunityBio will flow through our technology. That will take time—three years, five years. But they’re also working with a giant industrial producer to brand our technology as a Botswana Corbevax. They’re calling it Pula Corbevax. So they receive bulk or vials and relabel it because it’s now authorized. Botswana is a small country, but they acquired 100 million doses. What they want to do is help the other African countries. There’s regulatory framework in Africa, so if one agency reviewed and granted approval, as happened in Botswana, it allows approval in other countries to use Pula Corbevax. So Botswana can ship it to other countries. It’s an innovative model where Botswana serves as a conduit that opens the door for access to other countries in Africa.
Q: Quite a few people are asking me about a vaccine for children under 5 years old. Any thoughts?
A: I know that Texas Children’s, because it’s a pediatric hospital, is very interested in that information. We want to protect pregnant mothers; we want to protect infants and children in the early years of life. There have been some clinical studies that Texas Children’s is doing, especially with Pfizer and Moderna, for children below the age of 5. But I understand the cautiousness. There’s push and pull because it’s a new technology, and there have been a few red flags from adults. So the studies have to be very well designed and really look closely at the safety of the technology. It’s a little bit of an unfortunate situation the US is in, because we put all our eggs in the mRNA basket. Therefore the US population doesn’t have another option. Maybe, eventually, Novavax will be authorized in the US We may see advance with protein-based vaccines. We have hopes for finding a partner to help us bring our protein-based vaccine here. But it doesn’t look promising in the short term. Maybe long term that will change, but it’s unfortunate.
I have a feeling many of us will come to a point where we don’t want to get more boosters. But we need the data to show the results if you continue boosting with the RNA. With protein-based vaccines, you had more historical evidence that boosting a protein vaccine could be more durable. People will wonder how often they need to boost themselves. Instead of every six months, maybe once a year or every two-to-three years. We’re in a little bit of a Catch-22. We have some good vaccines. But you also have to wonder what we can afford. Once they come out from the subsidies from the government, we’re going to get hit on the insurance side. Who knows what happens? Some will be immediately detracted if they have to pay for it. But right now we don’t offer an alternative.
Q: I believe Dr. Hotez suggested Corbevax would have value as a booster. That it’s being used as a booster for adults in India.
A: That is another study. Besides getting their age 5-11 approval, they’re also doing studies on those under 5 and also getting booster data. Now there’s a limitation: You can only do a booster study with the vaccine in India because they don’t have mRNA in India. That’s another reason we want to have a partner here. We can study whether the protein-based vaccine could be a good booster for mRNA, or other things. Could it be mixed with the flu vaccine? Mixing it with another vaccine could ease deployment. Can you, for example, add it alongside human papillomavirus? …In the US, we are the ones who don’t have as many options. The moment you can show the protein-based vaccine is a good booster for the adenovirus vaccines or the inactivated virus vaccines, you can vaccinate many countries around the world. But we don’t have any evidence of mRNA boosted with protein-based virus at the clinical level.
Q: Do you think through experience we’re better prepared to handle something like this years from now?
A: Well, I would say yes and no. Yes, because right now our memory is fresh. There are papers and reports highlighting lessons learned and what we should be doing. Ultimately, I don’t think you can ever be 100 percent prepared. Every emergency has its own issues. There are different scenarios — if it looks like this, you address it this way. You’d need to be a crystal ball reader for that. But yes, because we have all this information. But no because we humans are good at forgetting.
We have to change the business paradigm. At the end of the day, you can do great things with the science and find great collaborators, but you need money to sustain it. That’s the reality. Money linked with policies. We need to change and make more flexible very stale and static policies. It takes such a long time to change them, so when we have emergencies, we’re not quick enough. The worst is what we’re doing now, which is changing policies in the middle of a pandemic. We need something structured, but with the flexibility to modify and adapt. Scientists are good at that. They love stressful and adaptive environments. Those who work in government structures and policy-makers are stuck in their ways. We need more flexibility there.
[email protected] | Twitter: @andrewdansby
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