S02 E07

Approving a Covid-19 Vaccine in Canada

Mark Lievonen

Retired President

Sanofi Pasteur Canada

In the seventh episode of our second season, Peter Brenders, CEO of the New Brunswick Health Research Foundation, talks with Mark Lievonen, retired President of Sanofi Pasteur Canada, about manufacturing and distributing a Covid-19 vaccine in Canada.

LIONA WINDSOR-VISSER (LWV):

 

Thank you for downloading the NPC podcast from the National Pharmaceutical Congress for December 2 2020. This program is all about discussing and considering the purpose, process and people of the pharma industry during the Age of Covid. Today we're continuing the healthcare conversation by answering questions sent by listeners like you. 

 

If you care to ask a question, just call our comment line anytime at 647-875-9011. 

 

This program is presented in cooperation with Impres, Impres best in class commercial solutions offer top line and bottom line growth with maximum sales force, flexibility, speed and efficiency. Learn more about their next generation commercial model at www.impres.com. 

 

On today's podcast, our guest is Mark Lievonen, co-chair of Canada's Covid-19 Vaccine Taskforce. Your host for today's podcast, coming to you today from our studio in historic Fredericton, is Peter Brenders, CEO of the New Brunswick Health Research Foundation. 

 

Before we begin, here is Mitch Shannon of Chronicle Companies. 

 

MITCH SHANNON (MS):

 

Thanks Liona. Hard to believe it's December already, isn't it? 

 

With regulatory approvals expected this month for Covid vaccine candidates from Pfizer, Moderna and AstraZeneca and many other research programs underway. There's no hotter topic in the world right now than vaccine research. But beyond R&D, you'll find a ton of questions about practical matters, including manufacturing, distribution, social policy and economics. It's safe to say that few people in the world know more about these things than Mark Lievonen, longtime CEO of Sanofi Pasteur in Toronto. 

 

Here's Mark answering the questions everyone is asking in conversation with Peter.

 

PETER BRENDERS (PB):

 

Welcome to the NPC podcast. I'm Peter Brenders, your host. In our continuing look at the purpose, process and people in pharma, this episode explores the world of vaccines in Canada. 

 

Joining me today is Canada's foremost expert on domestic vaccine commercialization, Mark Lievonen, retired president of Sanofi Pasteur Canada. 

 

We are especially fortunate to have Mark here today as he's very busy as the co-chair of Canada's Covid-19 Vaccine Task Force and Chair of the Joint Biomanufacturing Subcommittee. 

 

Welcome, Mark. Thanks for joining us.

 

MARK LIEVONEN (ML):

 

Hello, Peter. Great to be with you. My pleasure.

 

PB:

 

So Covid vaccine availability is the hot topic today. Even hotter is Canada's place in line. But before we get to that, let's start with some background. 

 

We've heard much on the exciting research and clinical testing of vaccines. But what does it really take to actually manufacture a vaccine? Is it hard? 

 

ML:

 

Vaccines are very complicated, but it's fascinating as we go to new technologies and new ways of manufacturing them, that's changing as well. So traditionally, it would take, for an existing vaccine, anywhere from 18 to 24 months to prepare the product to get ready for market. What we're seeing now is really changing that paradigm.

 

PB:

 

So we have one of the best legacies in the world regarding vaccines. I mean, you've been the president of Canada's largest company for vaccine production. But the PM said we don't have manufacturing capability anymore. What happened? 

 

ML:
 

We still do have manufacturing capability. It's a matter of how you look at it. So the history of Connaught Laboratories, which is now part of Sanofi Pasteur, is rich and continues to exist. There is a major facility at Dufferin and Steeles on 50 acres of land, with about 1500 employees producing vaccines for the world. And it's basically a billion dollar enterprise. GSK also has a facility in Laval in Quebec, where they make flu vaccine. So we actually have pretty strong vaccine capabilities. Now they're part of global organizations, companies that are not owned in Canada without head offices here, but they are a fundamental part of the global manufacturing of vaccines.

 

PB:

 

So is it fair to say then, like vaccine companies are like every other manufacturing company in the world, they consolidate and find efficiencies for what they're going to produce where they're going to produce it? And if that's true, why wouldn't Canada be a sort of a more obvious choice for it to be a bigger global center for vaccines for other companies too. 

 

ML:

 

So to some extent, actually, vaccine companies are setting up new manufacturing plants. So there was a time when the site in Toronto was one of four major vaccine plants in the Sanofi Pasteur world now there's a number of them there could be eight or 10 around the world, so they continue to thrive and grow. 

 

The thing is this plant in Toronto, for example, makes tetanus, diphtheria, pertussis, polio vaccines for the world. It's at full capacity. It's exporting 90% plus of what it manufactures. So it truly is a great Canadian success story. And out of that company and out of GSKs operation in Laval, people have entered the vaccine industry in other ways. So when you come across people who are involved with vaccine companies, biotech companies, small companies, medium sized enterprises, a lot of them have earned their way through the Connaught lab/Sanofi Pasteur world. And that continues to be the case. 

 

Now one of the points of differentiation that seems to be coming up quite a bit these days, and the link between that and Covid-19 vaccines, and a lot of effort has gone into procuring COVID-19 vaccines, we can talk about that as a separate question. But there is not necessarily a direct linkage between what manufacturing activities are going on in Canada right now. And the procurement of COVID-19 vaccines.

 

PB:

 

Alright, so let's talk about that then. So the link is trying to be made between "actually, we have to make it here before we can get it." And if that's not really the case, what is going on? What is the story? 

 

ML:

 

So I think the Vaccine Taskforce recognized early on, as we reviewed the leading vaccine candidates, that the first ones would not be made in Canada. So at this point, you may be well aware that there are seven vaccine candidates that the Taskforce has advise the Government of Canada to procure, the Government of Canada has done that. And so far, so good. The top three vaccine candidates that have emerged are all ones that we recommended the government procure, and that they've gone ahead and done it. 

 

Now these vaccines are made in the US in Europe, they're going to come from different places. And that's where we will secure them. The sole Canadian candidate at this point is from Medicago, a virus like particle is grown in plants. And Medicago has been at this for some time commercializing a flu vaccine. They've just announced their phase I data, which was quite strong, and they are one of the seven candidates. 

 

People think about, should we do technology transfer? Should we license it in? What about filling and packaging in Canada, which actually may be a very viable strategy. If you look at worldwide vaccine production across all vaccines, and COVID-19 vaccines, the candidates, the constraint is really filling and finishing, there's bulk manufacturing capacity that's easier to bring on more than fill and finish. So it may very well be that some of these products the bulk is imported into Canada, and Canada can fill and finish it. 

 

The point is, even at the fastest that could happen, it would not happen faster than importing these vaccines. So clearly the quickest timeline to a Covid-19 vaccine in Canada. Q1, Q2, as has been discussed quite a bit, is really quite soon. And anything like establishing production facilities in Canada, or licensing in and filling and packaging, that's going to take years. It's very viable, but it's not the short term answer. The best way to get vaccines in the short run is to import the vaccines that we are procuring. 

 

PB:

 

You're listening to the NPC podcast, our guest today, Mark Lievonen, retired president of Sanofi Pasteur Canada. 

 

Okay, so that's the best answer for the situation we find ourselves in today. And so I guess a question I could ask you two ways if we knew 5, 10 years ago, what we know today, what would we done differently? Or I guess the other way of saying it is, thinking about our future when the next pandemic might hit, if things accelerate, what should we be doing different to be in a better situation? Could we be more prepared? 

 

ML:

 

So the Vaccine Taskforce has considered that as well. You mentioned the role of the Joint Biomanufacturing Subcommittee, and that's a subcommittee that exists between the Vaccine Taskforce and the Therapeutics Taskforce, which is looking at treatments for Covid-19. And we have considered that question, and we've made a number of recommendations in that regard that the government is acting upon. 

 

The first is in terms of procurement of short term supplies: vials, syringes, swabs, all those sorts of things. Which of course, you can imagine, the worldwide demand is shooting up astronomically. So we've made recommendations in that area. We have looked at the short term manufacturing capability of various Canadian entities and while there are a number of them, they are in the small to medium size range and so strategic investments are being made to shore them up and to see if they have a role to play. 

 

It would be great if they could do it immediately with Covid-19, but we do have an eye on future pandemics. I think most people involved with this would say there will be more pandemics to come. We do have to prepare for it, as you said. And so we're looking at that, we're looking at regional spokes that might fit into an overall hub. I think that generally speaking, there's a recognition we need to do more in the Biomanufacturing area to prepare for a future pandemic and there's active advice and consideration being given to how Canada should do that. 

 

PB:

 

So what about the fact that these vaccines are made in another country and not our own? What's the impact of tha? 

 

ML:

 

So there is an impact. So as I said, there'll be the first ones we get. But if a vaccine is made in another country, for example, the US, when it's approved, it's very easy to ship it out because it's within that border. I mean, that's just part of the rules and regulations. 

 

For Canada, we can't import the vaccine from another country until it's licensed. Those are the rules and regulations. So there's going to be a delay to some extent just because of that, and that's one of the things that gets in the way. So these international candidates will be our first vaccines, but we'll have some delays over those countries that are making it and using it within their own border. And that's the case for everybody.

 

PB:

 

So those rules are our own rules. And so presumably, if the government was really interested, could they not come up with some interim rule to allow for earlier importation? 

 

ML:

 

So I think it would be very challenging. So when you think about it, and we buy these products, they're not licensed. So now you're buying a product that you will purchase if it's licensed. And there's a down payment for that to cover the risk, and so on. 

 

So if it's not licensed in Canada, I don't think companies would be willing to ship it to Canada, because if you ship it to Canada, once it's here, it's gone. And so if it's not licensed, it just gets thrown out. And this is a scarce commodity. So the fact that it has to go through import, export, cross borders, trade agreements, all of those things, I think makes that very challenging.

 

PB:

 

So do you sense then that this sort of thought of that we need to do more, might be sort of almost a change in philosophy? As I think back for years, if not decades, vaccines were commodities that should be tendered and we should get the lowest possible price and get it from anywhere. We just don't really care about Canadian production. How has the sort of philosophy to sort of our own, I guess, national security for vaccine production changed? Is our world getting better? 

 

ML:

 

Well, I think it is changing. I think this is a moment in time when the pandemic hits us. It's real, and there's an opportunity to react to it. So things like the tendering process and how we prepared in the past, what kind of considerations should be given to various aspects in that, I think that's changing. You're quite right. I think a number of years ago, tenders were lowest price, who could supply it, didn't matter the borders, there was not much given to security of supply. The only exception to that would have been for pandemic flu vaccine, where it was felt that that was a national security issue. And so there should be a desire, there was a desire for assets in Canada, I think that's probably changing now. 

 

A tender process that recognizes things like value added in Canada, Canadian excellence, manufacturing here, security of supply, those might be valued differently now and to be incorporated differently going forward. 

 

There are also and there has been constraints around trade agreements and so on, and global competitive issues where one had to be careful, you know, to not subsidize local industry. But I think this whole security of supply safety for the country against pandemic diseases, is becoming more and more real apparent, and will probably be valued more highly going forward.

 

PB:

 

You're listening to the NPC podcast on COVID vaccines in Canada.

 

So that's encouraging. So you're closer than most to what's been going on during this pandemic related to certainly the vaccines and the development and the plans. So when you reflect on all this, what lessons have you learned? 

 

ML:

 

So I think it is a moment. And so we do need to react to that. I think over the years, as we've cut budgets and things, you know, dollars have been diverted away from public health and other aspects related to that, I think it is a matter of recognizing these pandemics will come about in the future, we should prepare for them. These are valuable investments to make in public health, public health agencies, things like diagnostic testing, contact tracing, and so on. I think enabling the groups and departments that work in those areas is extremely important. 

 

You can look at, unfortunately, the nursing home situation where it's a tragedy, that's what has happened there. We've also as a group, as a society, as a country, reduced the expenses in those areas. So these things cost money. People need to agree that these are worth investing in. And if we do, we'll be prepared and if not, we will suffer the consequences again, going forward. 

 

It's all about anticipating being prepared and having the resources in place to deal with it when it comes along. 

 

PB:

 

So being prepared not just as a country, but how much of a willingness do you see in terms of a new approach does the government have to working with industry? I got a sense in the past, it's always been a little bit more adversarial, or in the sense where the government's weren't so keen to be partners with industry. How has that changed? 

 

ML:

 

Well, I'll tell you, it's changed quite dramatically during this situation. I mean, I'm very pleased with how the Vaccine Taskforce has operated and our interaction with government, they've been very responsive. Our Vaccine Taskforce reports to the Minister of Health and the Minister of Industry, Science and Economic Development. 

 

And people are very responsive. We've been working very closely with the procurement agency, Procurement Canada. And it's one thing to provide the advice, it's another thing to watch it be implemented and it's been remarkable. 

 

The collaboration and cooperation between academia, industry, government, policy groups like ours has been unbelievable. You know, back in May, when this was just starting, I gave a talk on vaccine development. And I could give the same talk today in a way but I'd emphasize different things. It typically takes 10 to 15 years to develop a vaccine, the fastest ever was four to five years. And that was for Ebola and Mumps. 

 

People were talking about 12 to 18 months for Covid-19 vaccine and I got to tell you in May, I was thinking I'm not so sure that's feasible. And then the fourth category is never. There are some diseases for which we've never had a vaccine: HIV, hepatitis C, tuberculosis, we have a vaccine, but it's not very good. So there's some targets, we'll never have one, or we've never had one yet. So the thing about 12 to 18 months, and to then fast forward several months later, and to see how everybody has collaborated and moved together. It's unbelievable. 

 

So then the question becomes, how do you go from 10 to 15 years to 12 to 18 months without taking shortcuts? And I would certainly make the point when these vaccines are approved, if they're approved, there will be no scientific shortcuts taken. Health Canada will do the review, science will rule the day, I'm very comfortable and confident that will happen. 

 

But if you look at the RNA vaccines, which is the first platform, they had a scale up and development of a vaccine within weeks, it used to take two to three years to develop a candidate vaccine, and then animal models and then get into the clinical trial testing, you know, clinical trial testing, phase I safety could take a year, phase II could take a couple years, phase III, three or four years, these whole timeframes have been compressed. 

 

Now one of the reasons, you can move quickly from phase I to phase II to phase III, unfortunately, is there's quite a bit of disease out there. For a vaccine to be proven effective, there needs to be disease to prove that it works. So while we may lament the fact that the US has done a- not a very good job of managing Covid-19, they've created a great environment for phase III clinical trials. 

 

And so that comes along and then the companies have been manufacturing at risk, which is another thing that has not traditionally been the case. And the regulatory agencies have put in place the capability to review them as they go along. So you will have heard perhaps about emergency use authorization in the US. We have interim orders in Canada, which means that companies can submit the data as they're proceeding. 

 

So all of this has compressed what could be 10 to 15 years, four to five: the shortest ever, into something like 12 to 18 months. Quite remarkable. 

 

PB:

 

Let me pick up on something you said maybe you can explain a little bit more clearly, for our listeners, you said manufacturers have been manufacturing at risk. What does that mean? 

 

ML:

 

So normally, when you're manufacturing a vaccine for clinical trials, you would pilot lots for the clinical trials. When you get to phase III, you have to have a manufacturing process in place that will be the the process that you use going forward. But you're not going to make a whole bunch of vaccine till the product is approved. You'll make enough for the clinical trials, you might make a decision about you scale up bulk or not. 

 

But what companies are doing now they're scaling up at risk. They're producing millions, hundreds of millions of doses of vaccine without knowing if they'll be licensed. And you know, when we get to this point and the question people say "when we get that vaccine?" We don't know yet, we don't know when there'll be licensed, we have a pretty good idea of the path forward and we can make some predictions. But nothing's been licensed yet. 

 

With the Vaccine Taskforce and our advice to Canada, we did recommend seven vaccines, a portfolio of vaccines across three or four different platforms, the RNA vaccines, viral vector vaccines, and the traditional protein subunit vaccines. So we are kind of hedging our bets quite a bit. We're hedging our bets. We don't know how many of these will be licensed or not. But that will really come into play in terms of think about the companies. They're spending all this money producing vaccines that they may have to throw out.

 

PB:

 

Huge investment. So Mark over the years I found you to be the calm statesman with wise counsel. Today's been no different on that one. Thank you for that. 

 

Any last words of wisdom you can offer our industry? 

 

ML:

 

So it's clearly an important time, these are important issues, there's been an opportunity for the industry to get involved. I think the spirit of collaboration, and working together with academia and government is tremendous and the way to go. Our industry, I always used to think I keep in mind that the government was our major customer. So that really is important and driving that relationship that affected how I did it, and how our company did it. 

 

I think recognizing that we do have these issues to address we should make investments. And this is a time to make them and they are being made. And I hope that we can keep the spirit of collaboration and cooperation going, going forward. 

 

You know, I used to remember at Sanofi Pasteur, there was nothing like a crisis to get us going forward. It throw somebody a crisis, everybody would work together, and it was collegial and work extra hours. And that's what we're seeing here. So you know, let's not waste this crisis, and learn from it and go forward in that regard. 

 

One other comment. I think it's important to try to look at and say everybody's trying to do their best. It's very easy to criticize governments, industry when things go wrong when things change. But I think a whole lot of people are working very, very hard on this. They're well intended, they're doing their best. There are going to be bumps along the way, but let's support that and try to be part of the effort to be successful in this area and not throw stones at it. 

 

PB:

 

A great message to wrap up our podcast today is that we all have positive intentions, and we're working hard together trying to come up with a solution. 

 

You've been listening to Canada's foremost vaccine expert, Mark Lievonen on the NPC Podcast. Thank you for listening. 

 

MS:

 

Thanks to Mark and Peter. 

 

I'm struck by Mark's comment about compressing the R&D cycle on a new vaccine from 10 to 15 years down to 12 to 18 months. Whatever it is that this experience will have taught us, it seems a decent bet that things will never go back to the pre-Covid thinking. 

 

If you're new to this podcast series, you can download past episodes of the NPC Podcast from Google Podcasts, Apple iTunes, Stitcher, and many other sites. Or subscribe at www.pharmacongress.info and get set up for the coming year. 

 

Speaking of 2021, circle your calendar for February 10, 2021. That's the day of the Winter Webinar of the National Pharmaceutical Congress, speakers and topics will be posted soon to our website at pharmacongres.info. 

 

Keep sending your questions and comments by email to health@chronicle.org. Or you can call our comment line. Leave your name a callback number and the question you'd like to ask for our guest number is 647-875-9011. 

 

The NPC Podcast was presented in cooperation with Impres, Canada's next generation commercial partner. Learn more at www.impres.com. 

 

In Toronto, I'm Mitch Shannon of Chronicle Companies. Jeremy Visser is your producer. The announcer was Liona Windsor-Visser. 

 

We'll see you again December 9th, when Mike Cloutier of Accelera joins us. Have a great week and stay safe.

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