Earlier this week, a Canadian company called Medicago struck two deals to supply its plant-based technology to other companies in hopes of developing a Covid-19 vaccine. The agreements with GlaxoSmithKline (GSK) and Dynavax (DVAX) drew attention to a company that, although partly owned by Philip Morris International, has had a relatively low profile, despite its novel approach. The privately held entity uses a virus-like particle, or VLP, grown in a close relative of the tobacco plant to produce one of the three spike proteins found in Covid-19. The plan is to marry its VLP to an adjuvant, with the goal of providing vaccine doses to the greatest number of people. We spoke with Medicago chief executive Bruce Clark about its approach, as well as the challenges in finding a vaccine to combat Covid-19 and satisfying global demand. This is an edited version of our conversation…
So this is a big step. What brought you to this point?
We’ve been in the pandemic business for a number of years, going back to the Blue Angel program (begun by the U.S. Defense Advanced Research Projects Agency) in 2012 in response to H1N1. We produced millions of doses each month… And we’re building on our platform used for a seasonal flu vaccine, which is under review by Health Canada. We hope for approval later this year.
But as far as vaccine technology, they have a traditional egg-based manufacturing platform and we have recombinant platform. Our strategy is that we just need the sequence for the virus spike proteins. We don’t have to grow live viruses in eggs. We get the genetic sequence and insert that into the host bacteria. We use that as a vector and the plant is our bio-reactor – the big tanks that can incubate the cells spitting out the proteins we’re interested in. We don’t need a special environment.
With Glaxo, they’re not developing a vaccine for Covid, but have an approved adjuvant. We partnered with them to gain access to their adjuvant. The idea is it boosts effectiveness of our vaccine for a better immunological response and reduces the dose needed to maximize production.
There are several efforts under way to develop a vaccine, as you certainly know, but we keep hearing it may be possible by the fall or winter to have a vaccine. And there is also this political overlay in the U.S. with an election coming up. Doing what you do, how realistic is this?
This is one of the biggest questions being debated by people behind closed doors. A lot is in the hands of regulators. We don’t have the latitude to short circuit safety measures — which means you need to bring the data. You heard Dr. Fauci saying data are everything. It will be based on data from a safety and efficacy point of view and that’s when regulators will say it’s safe enough to go to this segment of the population… But I don’t think [a vaccine] will [be given] to everybody all at once.
I think the regulators are going to be cautious. Which segment — based on age — gets it first? But we don’t know enough to go there until we get more data. I don’t think it’s going to be a one-size-fits-all solution necessarily. It’s going to be up to regulators after they have enough on the safety side to trust the efficacy data.
Should we expect to settle for a vaccine that’s much less than 50% effective? You know, that’s threshold the FDA mentioned.
That’s a piece we don’t know… But when you put something into humans, the old adage of ‘do no harm’ is there, particularly in the case of a pandemic. All of the companies have had discussions with regulators, but nobody has put final data on the table yet to say it’s good enough to say go ahead… or it’s better than 50%… What if the best is 45%? Will they let that go? It really will depend on how the pandemic is raging.
Let’s take it in extremes: 100% efficacy is very unlikely, just based on what we’ve seen with the flu, while only 10% is dubious. There’s a huge range in between there and FDA has stuck a stake in the ground and said they want 50%. That’s fine. But even if you don’t have 100%, but you can reduce deaths and hospitalizations, you can still have a huge impact on public health and a huge dollar impact. That’s not trivial. A 50% reduction is substantial.
But whatever we get in the first round of a vaccine, it will be highly unlikely it will be a magic bullet. We’ll get something maybe by the end of this year, or early next year is feasible for something to come out, but it will not be the ‘be all, end all.’ It will take a number of years to understand this disease. We may need a vaccine and a therapeutic. We don’t know which end will win in this case. The farther we go the more we don’t know about this disease… All the different approaches are teaching us what we need to know about this virus and defeat it. Will all get to the finish line? No, but we need to try them.
Speaking of which, where is your company when it comes to Operation Warp Speed?
We’re in discussion with folks at Operation Warp Speed. One goal is to support novel technologies and have a range of options… We already have domestic manufacturing capability in the U.S. — in Raleigh, North Carolina — so they can consider us as a rapid response… Under Blue Angel, we could make 10 million doses a month or 100 million or so a year… Assuming similar dosage and product yield with H1n1, we can produce the same kind of volume now. And we’re building another facility in Quebec with 1 billion doses a year capacity. We’re looking at 2024 (for completion).
That’s a lot of doses, but it’s a big world. How are we going to enough vaccine around the globe? Is it even doable?
I don’t have a crystal ball and as this situation develops, it’s going to put pressure on every model of public health we’ve relied on, because we’ve never had anything of this nature before. It puts demands on entire world modeling that will force new solutions. It’s definitely going to require public-private partnership. I think that will be inevitable. Will it be established agencies like the WHO? None of the manufacturers have enough capacity yet to cover the entire world. Even ours at a 100 million doses a year works for the U.S., possibly, and Canada, for sure. But no one company has the kind of capacity for 7 or 8 billion doses. We’ll have to find ways to allocate product to different regions…
One thing coming to the fore are supply chain logistics. Some vaccines have to be stored at room temperature or refrigerated. There will be limits on how things are distributed. So the nature of the product will also somehow determine how a product gets used and accessed. If you have a supply chain nightmare getting vaccine to patients, it can be a whole other game. A typical supply chain focuses on a region or country, much less on a global basis. So will there be a level of global cooperation? I don’t know. You see a lot of nationalism – discussions about domestic manufacturing capabilities. Everyone wants the ability to have the capacity to cover their own population. But how is that shared on a global basis? There aren’t many models that have demonstrated that ability, historically.
You’re a Canadian company with a U.S. plant. You have some Canadian government funding and you’re building another plant in Canada. How do you think you’ll handle ‘vaccine nationalism,’ if it comes up?
We’re in discussion with all the players. We’ve been approached directly by multiple countries and we look at things like tech transfer to regions to set up manufacturing. We haven’t had discusions with who gets dibs on products first… We’d rely on cross-border transfer in some fashion. It is a concern to us, because we’ve seen strange things happen to borders in this pandemic.
With everything said, is the glass half full or half empty?
Clark: I’ll pick half full. We’re realizing how something that happens half way around the world can suddenly have an effect in my backyard. Nothing has been as pervasive as this virus or spread as rapidly. The motivation this time is to get it right. If this pandemic is not enough motivation to get this global public health infrastructure working, then I don’t know what is.