VIDO-Intervac covid-19 vaccine development
Volker Gerdts Headshot
Volker Gerdts
President & CEO - VIDO-Intervac

COVID-19 Vaccine Development in Canada

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Takeaways

  1. In the case of COVID-19, like many emerging diseases, the virus jumped the barrier between species which has had catastrophic consequences.
  2. There is potential for the first vaccines in Canada to come out in early 2021.
  3. Although the vaccine is being developed in a short period of time, researchers are convinced of the efficacy and safety of a candidate that will be rigorously tested.

Action

Viruses like COVID-19 will continue to emerge, and Canada should be prepared for pandemics during inter-pandemic periods. Unfortunately, between viral outbreaks, other priorities stop the progress made in preparing for pandemics. Canada should learn the lesson that we cannot forget about the potential for a new emergent disease, and we should always worry about how to be better prepared.


How Would You Characterize the Canadian Research Community’s Response to COVID-19? 

I think Canada, like many other countries, really showed a lot of collaboration and enthusiasm in the beginning to collaboratively work towards this problem and solve it.  

We have a lot of really good researchers, not only vaccine researchers, but also virologists and immunologists in the country. Quickly we all came together to work towards solutions, trying to address the problem, trying to learn more about the virus, and trying to learn what kind of immune response we need, what animal model we need and so on.  

That [research] was supported by the government who very quickly announced a Rapid Response Program. The Canadian Institutes of Health Research came out with a first call for grants within weeks after the pandemic hit, and within an amazingly short review period. Within days, they had these grants reviewed and funding announced. Overall, it was a very quick and collaborative response and I think that is typical Canadian.  


What is Genomics and What Are Canada’s Strengths in That Area?  

Genomics is really the science of understanding how body function or cell functions occur. Our genetic code, if you want, is a large library, and we need to understand how each of these genes are being turned on and turned off, what the outcome of that is, and how it affects the physiology of the cell and the overall function of the organism. How the biology of it is encoded and understanding it is really what genomics is.  

Canada, I would say, has a very strong genomics profile. We have Genome Canada, which is a large research organization who, over the years, has systematically funded large genome projects in the country and really helped to build the expertise that we currently have.  

“To develop a vaccine, you need to understand how the immune system recognizes the virus and how it then launches and attacks to control this virus.”

If you want to develop a good and effective vaccine, you really need to understand what part of the immune system and what part of the immune response to the virus you need to activate. To do that, you need to understand how the immune system recognizes the virus and how it then launches and attacks to control this virus. That is all encoded in the genome and through genomics we understand how antibodies are being utilized, how key cells are being utilized, and it is really understanding how the host responds to the virus and what mechanisms are involved. 


What Research Are You Currently Working On?  

VIDO-Intervac is one of Canada’s 10 major science infrastructures. We are one of the largest infrastructures for infectious disease research and our focus is really on emerging diseases. In the context of COVID-19, we were the first lab in Canada to isolate the virus from one of the initial patients. We were then the first in Canada to establish an animal model for COVID-19, which allows us to test vaccines but also look at antivirals and other therapeutics. We are also one of the few groups in Canada that already have a vaccine candidate and proof of concept studies in animals.  

What we are doing here is really living at the interphase between human and animal health, and that is where many of these emerging diseases originate from. And as we see with COVID-19, whenever these viruses jump the species barrier and jump from one species to the next one, that is when we see this emerging disease occur. Sometimes there can be consequences that are catastrophic, as they are with the current pandemic. 

Much of our research is really focused on understanding both animal and human health, the overlap between those, the diseases that are crossed by these pathogens coming from animals or vice versa. We call them zoonotic infections. That is really where VIDO-Intervac has a niche, and that is where we really have the largest impact on Canada as a country.  

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What Are the Initial Phases in Vaccine Development? 

The normal steps in vaccine development, for human vaccines, take in the range of 10 years and sometimes even more, and you initially have what is called the lab phase where you actually make the vaccine. That is happening in the lab, and there is a lot of optimization involved and small-scale production and purifying and so on. In this case, here at VIDO-Intervac, we jumped through this in five weeks. After five weeks, we had our vaccine generated, optimized and then manufactured at a small scale in the lab and purified and ready for immunization.  

Once you have that comes a phase where we take these prototype candidates into proof of concept testing on animals. That is the first thing you have to do, and you have to show proper animal models and the vaccine are what we call immunogenic—that means inducing a response that is the right type of immune response, so that we actually protect the animals from the infections. What you need is to have an animal model, which in the case is COVID-19 is the ferret and the hamster. And then you also need to understand what type of immune response you need to provide protection.  


What Are the Next Phases of Vaccine Development?  

The next steps are critical, and that is the safety testing of the vaccine. We want to make sure that whatever we develop with humans is safe and there is no unwanted or adverse events to the vaccine or to immunization with the vaccine. That is something that the regulators around the world want to see, and it is very important that we have good rigor in those assets and those tasks to make sure that the vaccine is fully safe.  

We are predicting that that phase will take about two or three months and the critical point here is that you have to use vaccine material that is being produced the same way as your final product will be produced. This is where the crunching comes in. All of us right now are looking at how we can speed up this process. You see some of these vaccine technologies already being in human testing, and that is because they have platform technologies available that had undergone some of the safety testing, and so they could quickly get through this process.  

In our case, we have started to manufacture this clinical grade material already in March, so we are expecting now we will already have some material available so we can start our safety testing over the next few weeks.  

“Phase 1 clinical trials are simply answering the question: is the vaccine in humans as safe as it is in animals?”

After the safety testing comes the phase where the regulator now permits you to test the vaccine on humans. There are a series of clinical trials—they call them phase 1 to phase 3 clinical trials. A phase 1 clinical trial is a small trial that usually involves between 30 and 60 volunteers, or something like that, and you are looking for any adverse reactions to the vaccine. It is simply answering the question: is the vaccine in humans as safe as it is in animals? 

Then comes phase 2, which involves hundreds of volunteers, and there you are looking at understanding the immune response to the vaccine and you continue to watch for the safety profile of it.  

If those two are going well, you can continue with your phase 3 trial, and that typically involves thousands of individuals. That is really to see how well the vaccine does out there, where people are getting vaccinated, and whether they protected from an infection. 


When Will A Vaccine Be Available? 

Normally, the process like this takes 10 to 12 years, shrinking it to a year and a half is really magic. That is what all of us are trying to do right now. It really works if everything falls in place, and if you do all of these things in parallel, even if one prototype does not work out, you just throw it away and you wasted a few hundred thousand dollars but overall you are driving the process forward as quickly as possible. That is what we are seeing around the world, with potentially the first vaccines coming out early next year.  


How Much Information Do You Have On Vaccine Information Outside of Canada? 

We are part of three World Health Organization (WHO) expert groups, and one of them is an expert group on vaccines. We have a relatively open exchange of information and people presenting their data. We presented our data last week on how well our vaccine did. The data is openly shared, which is very, very unusual, and it is being discussed by these groups from around the world. That is really my experience, something that is very unprecedented compared to the normal vaccine, where everybody is trying to protect their technology.  

“The data is openly shared, which is very, very unusual, and it is being discussed by these groups from around the world.”

Nonetheless, there are some big companies and there is money involved. I mean, nobody can lose money over this—you want these vaccines to go forward. And so the issue is going to be how many vaccines are initially available and who should get them first.  This is where we are seeing global organizations like the World Health Organization and the Global Alliance for Vaccine Immunization (GAVI) taking a leadership role internationally, and countries are supporting that coordinated effort to make sure the vaccines are available for global citizens—not only in our own countries, but also globally. Canada is supporting that, and the government just announced $800 million in support for GAVI. The intent there is to be part of the effort and make sure that both Canadians as well as other people in need are getting access to the vaccine.  


Why Should Canada Develop Its Own Vaccine?  

The pandemic has really shown us the critical issue of self-sufficiency. I think it is very dangerous for a country to depend on others to produce a vaccine, hoping that they will adhere to the guidelines and share their vaccines with us.  

“We are recognizing the importance of having vaccines for Canadians available, and we would rather be in the situation where we can share with others than depending on others to share with us.”

I think with Canada, we are recognizing the importance of having vaccines for Canadians available, and we would rather be in the situation where we can share with others than depending on others to share with us.  


Is Canada Prepared to Manufacture a Vaccine?  

Canada, historically, has done phenomenally well when it comes to vaccine development and manufacturing. We have some of the largest multinational players in Canada, including Sanofi PasteurPfizer and so on, so all of the big companies are here. In addition to that, years ago we had quite a bit of infrastructure in place to manufacture those technologies that are coming out of the universities, so publicly funded research technologies.  

What we have seen over the last decade is a disappearance of those manufacturing facilities, and it really now concentrated in a few that are currently privately-owned and being used for vaccine production, including of the larger companies in Toronto.  

Where Canada has really fallen behind over the last few years is having manufacturing facilities that can take on public research technologies and produce the material to start clinical trials. We need pilot scale production and to get vaccines into development and the development process going as discussed. 

This is where we are seeing the government recognizing that it has funded a number of different facilities, including VIDO-Intervac, and we are building our own manufacturing facility here which will serve that purpose as a smaller scale research facility. But even with our own vaccine, we can produce millions of doses per month if needed.  


What Do You Say to Canadians Who Are Concerned About the Safety of a Vaccine?  

It is a good question that is a very valid concern especially when you hear that normally it takes 10 years, and now we are saying we can do it in a year and a half. Well, what kind of shortcuts are you taking? What is it you are not showing us?  

What I am trying to express is that the safety testing is really paramount in all of this, and so neither us nor the regulator are allowing anyone to take any shortcuts here. Really, what we are trying to do right now is do activities in parallel. Normally, you would wait for pre-clinical development and proof of concept before you start manufacturing. Well, in a situation like this, you would have started manufacturing already two months before to then maybe find out that you manufactured a product that is not working and then you have to throw it out.  

“In the face of the pandemic, people are willing to be a little bit riskier by going with multiple prototypes in parallel, and then just focusing on the one that shows that it is effective.”

Right now, in the face of the pandemic, people are willing to be a little bit riskier by going with multiple prototypes in parallel, and then just focusing on the one that shows that it is effective, but then you have a proper safety testing of that. So it is not that we are compromising the tests, we are just a little more willing to spend money and lose money on technologies, approaches and candidates that do not work well, all in the interest of time. That way we do not get to a certain point and then start all over. It is like a horse race. Rather than starting with one horse and finding out that horse did not make it and then starting with the next horse, we are starting with four horses in parallel and only one will make it. But that horse will be rigorously tested for safety as you would with any other vaccine candidate.  


What Lessons Must Canada Learn from This Pandemic?  

I think there are a number of things that we learned from this. Number one, to me, it just shows the impact infectious diseases can have. Living in Canada, we are very privileged here—normally we do not come in contact with a lot of infectious disease, which you know leads people to believe that we do not need vaccines anymore—that even if you do not get vaccinated, your neighbour does, and that there is herd immunity and so on. 

It also shows us the impact of a disease economically and how it can affect our lives. I also think there is a recognition that these diseases continue to emerge with a more global world, and people being today in Canada and tomorrow in Asia, the chance of spreading these diseases around is so much bigger.  

Emerging diseases will continue to happen, and this is just one example but there will be another. So really, what we need to do, is think about how we can—at all angles—better prepare for this. After SARS-1, there was a period where we talked about pandemic preparedness and how we get ready for it and so on. But then, of course, other priorities came and it kind of got forgotten. My hope is that this lesson will not let us forget so that we are always worried about how we can be better prepared. 


What Is Your Experience On The Frontline Of This Crisis?  

It makes us immensely proud to be part of the response to COVID-19, especially for me as the Director of this institute. It makes me proud to see the calibre of scientists we have, and to see how they are stepping up right now working long days, six, seven days a week. Everybody is stepping up right now and is giving it their best.  

We have students volunteering to work with them, the health authority here, and we have essentially everybody saying if there is anything we can do towards a vaccine, let me know. 

You really see how people are stepping up and it makes me proud to be part of that community and hopefully provide a solution to this problem. Most scientists, though, did not get into this profession because we wanted to be in the limelight. This is what VIDO-Intervac is here for, that is our calling and right now it is our time to show that we can deliver.