“Is this year really possible?” A COVID-19 vaccine explained

Jordan: If I had to guess what you’d say if I asked you how long a COBIT 19 vaccine would take, I bet I could do that.

News Clip: But best estimates, even though we’ve ramped this up, are probably 12 to even 18 months away from having that available. The first vaccine could be ready in 18 months. A vaccine could still be at least a year away. And like I said, that could be a year to a year and a half. I’m not changing any of the dates.

Jordan: So where does that 12 to 18 month timeframe come from? To be honest, I couldn’t really tell you, but I’ve heard about it since March. And it does sound good to think that a year and a half is the long end of this. But this of course is one of the challenges that we all face in the course of learning about this virus. The guts of how we research and test and develop and manufacture vaccines is probably not something a lot of us spent time thinking about, until now. All of a sudden though, any piece of good news is desperately welcome. So we start to hear about every single potential saviour.

News Clip: Tonight, the new findings from the NIH on the antiviral drug, Remdesivir, showing promise and speeding up recovery. Worldwide there are now roughly 100 vaccine candidates under review. Researchers at Pfizer believe this genetic code vaccine could be available as soon as September.

Jordan: How likely, though, are any of those trials to result in an actual vaccine? And even if one of them does, will it really be available later this year or early next year? Do we even know how to make the vaccine that we might find on a large enough scale? And have we come to grips with the fact that not every disease has a vaccine. How well do we really understand this process? How well do we understand the hope that we’re clinging to? Today we’ll try to help you understand it a little better. Right after a very quick update from Claire Brassard.

Claire: Well, the federal government says it’ll be very careful when it comes to easing border restrictions with the US. That deal, which means no non-essential travel between the two countries, is set to expire next week. But Prime Minister Justin Trudeau did not say whether or not the border would reopen at that time. Deputy Prime Minister Christia Freeland said talks were ongoing. The federal government has also announced financial aid for seniors, a onetime tax-free top-up payment. Those who receive old age security will get $300 and those who receive the guaranteed income supplement will receive $200. As the number of new cases of COVID-19 in Ontario remains steady, the province’s chief medical officer of health, Dr. David Williams says that by the weekend, health officials may consider advising the province to move to the first stage of its reopening plan, and that includes opening select workplaces, allowing for more people at certain events like funerals, and having hospitals resume some non-urgent surgeries. And lastly, a summer tradition in Ontario, the Canadian National Exhibition has been canceled for the first time since the second World War. It was set to take place August 21st to September 7th. The president of the CNE association says they did not take this decision lightly and it was made in consultation and with the support of public health experts. As of Tuesday evening, 71,157 cases of COVID-19 in Canada with 5,283 deaths.

Jordan: I’m Jordan Heath Rawlings, and this is The Big Story. Robert Vanexan has worked on various vaccines and in the vaccination industry for almost 40 years now, so I’m hoping that he can kind of walk us through this. Hi, Robert.

Robert: Hi. How are you?

Jordan: I’m doing really well, except I never know how to feel these days when I see news reports about a new potential vaccine for COVID-19 and breakthrough and success, and then it’s still 18 months away. Do you know what I mean?

Robert: Yeah, I do.

Jordan: Why don’t you sort of start by telling me what the media and the public get wrong when we discuss a potential vaccine for this virus.

Robert: Well, what I hear on the media is it’s almost like it’s a slam dunk for starters, and that it’s not going to take very long at all 12 months, 18 months. I feel that’s really very overly optimistic. My view is that it could take much longer. The probability of success is a lot lower, and, you know, for some diseases we’ve never been able to come up with a vaccine, like AIDS for example.

Jordan: Right. Can you sort of walk me through the typical process for finding a vaccine for something? I won’t say something like this, cause I realized this is kind of unprecedented in its global scope, but, but when you normally discover something and you’re searching for a vaccine, what happens?

Robert: Well, the normal process takes 15 years. The range is between 10 and 30 years. And it starts with an awful lot of academic research of understanding the disease and the disease organism before manufacturers even start looking at a potential vaccine. But once they do, then there’s what we call the preclinical phase where we do a lot of animal testing and develop what was called a vaccine platform, and a scale up occurs and production of enough vaccine for clinical trials, and then after the clinical trials, there’s three phases– one, two, and three– submit to the regulators for a license, which usually takes a year, and then you have to manufacture it. And some vaccines, like Salk polio vaccine, for example, it takes 18 months to make. From scratch. It’s not like pharmaceuticals. You’re not cranking out pills.

Jordan: Can you tell me how the search for a COVID-19 vaccine can cut down that really depressing timeline? Like everybody’s working on this one thing around the world. What do you do to shorten that?

Robert: Okay. There’s a number of things that we can do. First of all. We do everything in parallel, instead of doing one thing first and step two second and step three first, we start all of the steps at the same time where wherever we can. So we’re going to do without a lot of academic research and knowledge of the organism. We’re going to use some new technologies that we haven’t used for vaccines before. So these newer technologies hopefully will make us able to manufacture a vaccine much quicker.

Jordan: What are those technologies?

Robert: These are some of the DNA and RNA vaccines that are being looked at. There’s never been a vaccine currently licensed using these technologies, but there’s a lot of vaccines in the pipeline. So the thought is it might work for this. So while these cut down the timeframe, on the other hand, they reduce the probability of success.

Jordan: Where are we then in that process? I mean, I read different reports every few days.

Robert: Well, the good news is there’s about 95 vaccines that are candidates for clinical trials. Not all of them have started yet, and of those, the top sort of 20 that I’ve looked at the top 20 contenders, some of those are finishing up animal studies, and some of them have actually already started in phase one clinical studies. So the positive thing is that there’s so many companies developing candidates, that while the probability of success of any one of those is low, the fact that there’s a lot of them means that we may get lucky and one of those will come through, or two.

Jordan: When you say you look at 95 or however many that are being done around the world, and then you look at the top 20 contenders, what makes a potential vaccine a contender as opposed to one of the other ones on the list? What are you looking for?

Robert: Well, what I’m looking for, because I know how difficult the process is, I’m looking for basically platforms that we have some experience with. So, we’ve had some success with this platform in making another vaccine. And I look at, you know, how fast that platform will be able to be scaled up to make a manufacturer  vaccine. Because  normally it takes five years just to build a manufacturing plant for many of the traditional vaccines. So we need something that’s a lot faster. So I look at that, I look if they’ve got any animal data so far, and, you know, if it shows to be immunogenic in animals, then that’s a good sign. And then finally, I look at the company and I say, look, do they have any manufacturing experience? Do they have facilities they could use to make this stuff? Are they familiar with the regulator and getting a vaccine to license? Do they have any licensed vaccines? Those are all the things I think that increase the probability of success.

Jordan: When we talk about companies working together or working with governments or research bodies on this vaccine, how unusual is that? How cutthroat a competition is it usually to try to develop one of these?

Robert: Well, it’s usually very cutthroat, and it’s been, I mean, this is one of the reasons for the Gates foundation, trying to bring companies together and provide a global approach to development of vaccines. And it’s had some limited success so far, but in this case, it’s unprecedented the amount of collaboration and work going on. I mean, one of the announcements that Sanofi pasture and GlaxoSmithKline are collaborating together on a vaccine is a unheard of. And the same with some of the other big manufacturers.

Jordan: When we hear that something is starting trials and you know, that’s something we see a lot, what, what does that really mean? Like what’s going on there? And what is the actual success rate from that point? Like how many vaccines make it to trial then go nowhere?

Robert: So, trials are done in three phases. Phase one is you immunize a small number of people, and what you’re really looking for is, is it safe? And does it produce an immune response? The next one, phase two, you use more people and you’re still looking for safety. You’re looking for immune response, but you’re trying to figure out what dose I should use. And then the third phase is called safety and efficacy. And here we want to prove that it works, prove that it’s effective, and we need lots of people, thousands of people in that trial, and they usually take a very long time. So those are the three phases. And, like right now, the leading candidates are barely into phase one and it takes a while to get results from these trials.

Jordan: I’m going to ask a question that I’m sure is on a lot of people’s minds, what happens if we just don’t find one? Like that’s happened before, right?

Robert: Yeah. In fact, there’s a fairly high probability we won’t find one. This is a very tricky virus. There’s a lot of challenges in developing a vaccine for this one. And so, if we look at what happened with AIDS, for example, and I’ve been through the whole story, I remember. 1984 we discovered the virus. And when we first  discovered it, we didn’t even know how it worked, or we thought it was not sexually transmitted. We thought it could only be transmitted through blood. And boy, were we wrong. And we’re seeing the same thing today with the Coronavirus, that our initial thoughts often are not correct. But we’ve been now, you know, from ’84 to 2020, a long time. And as far as we’ve got in terms of a vaccine, we’ve had two vaccines that went into phase three clinical trials. One didn’t work at all, and the other one was only 30% effective. So that can happen. I think we’ll be more lucky with Coronavirus. I don’t think it’s quite as complicated as AIDS. But it’s still a challenge.

Jordan: How, and when, will we know if one of these vaccines is doing really well and is something to get more excited about than the general optimism of a new trial?

Robert: Well, each stage gives you optimism. I mean, in phase one, if it’s immunogenic, if it’s creating antibodies, that’s a good sign. And it’s really not until phase three, the larger studies, that you start to see, Oh, it seems to be effective. It actually prevents disease. It’s not just making antibodies. It’s actually preventing the disease. That’s the key to the whole thing. Now we’re hurrying that along by trying to run some of these studies in parallel. I think there’s an indication that as long as they’re safe, they may go to some phase three studies right after phase one or a very small phase two. So there’s a possibility of speeding the process up a little bit.

Jordan: When will you feel good though? As somebody who’s crushed some of my optimism about this, when will you see something and you’ll be like, ah, we’re onto it?

Robert: Well, again, it’ll be the results of a phase three, but that’s not the end of it because then you still have to manufacture enough doses. You know, this is a pandemic, so it’s all over the world. There’s 7.7 billion people in the world. Even if we just did senior citizens. That would be almost a billion doses that you would need, assuming that one dose works. If you need two doses, it’s 2 billion. To manufacture 2 billion doses is going to take a couple of years.

Jordan: So what needs to be happening right now then so that, you know, when hopefully something does start performing well in phase three, like we’re ready to go and we can actually deliver that?

Robert: Well, normally vaccine manufacturers don’t spend, you know, hundreds of millions of dollars building a factory until after they’re sure the phase three trial’s gonna work. In this case, we need to start building those factories now on the hope that the vaccine works. And that’s the big difference. That’s one of the ways that we speed it up. It’s by taking a lot of risks.

Jordan: But you mentioned that, you know, different vaccines are made on different platforms. So is there, I mean, again, sounds kind of dumb, but is there a chance we just build the wrong factory?

Robert: Well there is that chance, the factories tend to be very specific to the platform that you’re using. But they can, given, you know, a certain amount of time, manufacturing facilities can be repurposed. It takes a while. Let’s say it takes a couple of years to repurpose an existing factory. But if you start that now, then by the time you get through your phase three and you get a license, you’re going to have some capacity. The newer technologies like the DNA and the RNA technologies, these are much faster production cycles and they take much smaller manufacturing facilities to do them in. And so, those are a much more hopeful to get to the end of being actually seeing a vaccine quicker than some of the older technologies.

Jordan: So assuming we do find one, and we’ve built manufacturing plants. I mean, as you mentioned, 1 or 2 billion just for senior citizens is an impressive amount. But how quickly can we do that worldwide? Like, have we ever done anything on this scale?

Robert: Not really this fast. I mean, our response, for example, to the polio epidemics in the fifties was pretty fast when Jonas Salk discovered the polio vaccine, and actually he collaborated with Connaught laboratories here in Toronto who produced all of the live virus to make the vaccine, here in Canada. He started a clinical trial that involved 1.8 million people. It’s the largest clinical trial ever done in history. And the trial itself was really consisted of immunizing the whole population, and then monitoring them to make sure it was safe and effective. But it was an unprecedented  response. And I would see something like that potentially happening here, where the phase three trial is part of the immunization of the at risk people. So those are some ways you can see it moving a bit faster.

Jordan: But even if we speed it up, like we’re still talking months, if not years after the actual vaccine is found before everybody in the world gets a shot?

Robert: Yes, absolutely. I mean, to get enough for everybody is a huge challenge. But I think we need to break the problem down a little more. While we’re developing a vaccine, we need to be doing a lot of research to understand who are the people who get the most serious cases? And how do we identify them? Because those are the people we want to immunize first and foremost. And if we can start identifying those groups that are smaller, than we can start directing vaccine to those who need it most.

Jordan: So we kind of talked off the top about, you know, how optimistic or not you are about the 12 to 18 months that gets thrown around. But is there any way– I can see all sorts of problems coming up that you’ve just kind of outlined that would delay it– is there any way we stumble onto something that cuts that timeline down? You know, is there a chance– and I’m being wildly optimistic here because people want me to ask this question– that, you know, we realize like, Oh, actually this thing that’s in phase one is really good and we can just rush it and off we go. You know, when politicians say, Maybe by the fall, like is there a world in which that’s even possible?

Robert: Well, yes. And in fact, that’s what we’re doing. We are operating largely on luck rather than knowledge, which is not the way we normally make vaccines. But we’re trying– if you look at the list of candidates, we’re trying all kinds of technologies and there’s all kinds of people working on it. So the optimism comes from the fact that we have taken a shotgun approach where I have a whole bunch of different technologies being used, surely one of these will come through, and fairly fast. So that’s where the optimism comes from. But it is like taking a shot in the dark. So, we’re doing the right things. And some of the technologies, like I said, the DNA and the messenger RNA technologies, these, if they’re successful, would be very fast to get the production going and getting the vaccine out of the house. The only reason I’m more skeptical of those is because we’ve never licensed a vaccine like that before. And experience seems to count for a lot in this business. So yeah, I’m skeptical, but I’m also heartened by the fact that there’s a global approach, there’s a lot of cooperation, and there are a lot of candidates, which means, you know, just by probability, one of these is going to come through.

Jordan: And on the other side of that question, is there a point where you’ll be looking at how the phases have gone and how the trials have gone and you’ll see something and say to yourself, you know what, we’re in this for years, or we’re maybe never getting it?

Robert: Yeah, I would think within the next two years or so, we’ll start to get a feel whether we need to know more about how this virus works to come up with something. Like everything else, there’s a lot of places it can go wrong, but on the other hand, as I said, we have a lot of different technologies that we’re trying, and I think we’ll start to narrow it down. The other thing that’s important is that every failure points the direction to a successful candidate. So we learned from our mistakes.

Jordan: Is there anything else that we should know about the vaccine process that, you know, frustrates you when you’re watching the news or when you’re hearing, you know, your neighbours talk about it?

Robert: Well, I think it’s about managing expectations. It’s probably not good for any of us to have unrealistic expectations regarding having a vaccine really quickly, because we need to plan what we’re going to do over the next 12 to 18 months or two years or three years, and so do the public health professionals who are planning, you know, how we’re going to get through this situation. And so, of all the scenarios they’re planning for, one of them has to be, maybe we’re planning that there’s no vaccine. Now, the positive note here, going back to AIDS, is that very quickly after AIDS, we developed drugs to treat AIDS. And they were so successful that we hardly needed a vaccine after that. And so this is another area that I’m saying there should be a lot of focus on, is drugs that we either have and could direct towards this disease, or new drugs to be developed that could  be used to treat the serious cases. And that sort of reduces the urgency of coming up with a vaccine as the only line of defence. So we should not forget the treatment and the use of drugs to try and deal with this situation.

Jordan: Robert, thanks so much for helping explain this a little bit to a lay person.

Robert: Well, I hope it’s helped and I hope it hasn’t made you too pessimistic, sort of softened that expectation that it’s going to be available instantly.

Jordan: Well, I just, I want to understand, and you know, if that’s reality, I want reality, so thank you.

Robert: Alrighty. Thank you.

Jordan: Robert Vanexan with a dose of reality for us all. That was The Big Story. If you would like more, you can head to thebigstorypodcast.ca. You can also find us on Twitter at @thebigstoryFPN. You can write to us or send a video to us or send a voice memo to us at thebigstorypodcastatrci.rogers.com we read every email. And of course, every podcast player, we’re in it, Apple, Google, Stitcher, Spotify. Pick one. Pick your favourite. Find us, rate us, review us. We love to hear from you. Thanks for listening. I’m Jordan Heath Rawlings. We’ll talk tomorrow.

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