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31 Jul, 2020 06:24

No vaccine will give 100% protection against COVID-19 – vaccine developer

As the effect of the coronavirus pandemic continues to create shocking figures, vaccine trials offer a glimmer of hope. What are the odds of beating the virus before it causes even more devastation? We talked about this with microbiologist Dr Michael Piontek, whose lab – ARTES Biotechnology – is working on a COVID-19 vaccine.

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Sophie Shevardnadze: Dr. Michael Piontek, microbiologist, head of ARTES Biotechnology working on a COVID-19 vaccine. I've got so many questions for Dr. Piontek. Hi, welcome to our show. 

Michael Piontek: Thank you very much for inviting me and a pleasure to talk to you. 

SS: Alright, so your lab is using yeast cells to grow antigens that activate immune response to coronavirus in our bodies, if I understand it correctly. What are the advantages of this technology as opposed to others? 

MP: Well, first of all this technology is in the market for decades already to produce vaccines. So I'm sure you may know about a Hepatitis B vaccine, Human Papilloma vaccine. These are just two examples of vaccines in the market produced in yeast cells as virus-like particles, it's virus-like particles are kind of virus dummies, empty virus shells, used as an active ingredient for vaccines. And we have adapted this platform to produce new vaccines and the most recent candidate is candidate against COVID-19. 

SS: Well, it usually takes up to 10 years to develop an effective and safe vaccine. But now it’s being told that we're actually going to have a viable coronavirus vaccine by the end of the year with the majority of people getting a shot next year.  

MP: Yes.  

SS: How realistic is it? 

MP: It's really ambitious. And I think technically speaking, people are in the position to develop a candidate on a short term. So we started in April, we are pretty much advanced right now, we have the cell line producing the vaccine candidate. We have the process know-how, so that's not the time-limiting step. What took 5-10 years in the past is more the regulatory aspect of getting a product approved for the market, getting it through the preclinical trials, getting it through clinical trials, having long-term proof of vaccination effect of the protection against the disease. And that is what people are right now talking about to cut down to get the approval in a much faster way so that the vaccine is available in the market. The question then remaining is, is it active? 

SS: So, I mean, that goes to say that there's a pressing necessity a vaccine can be made much faster? 

MP: Principally, technically speaking, yes, people can do the production of a vaccine candidate with modern genetic tools in a reasonably short time. And we've seen this with the mRNA vaccine candidates, which can be produced really fast, we have the know-how to do this virus-like particles in our yeast cells in a couple of weeks, in a few months, but then it's about the testing, producing, manufacturing and testing it in human. 

SS: Okay, so from what I understand the human clinical trials are the most time-consuming phase of a vaccine testing. 

MP: Yes. 

SS: You give it to portions of people and then you observe at different stages if they develop any side effects and if the vaccine works and so this may take years. 

MP: Absolutely right. 

SS: Does speeding up this by far probably the most crucial phase mean compromising the safety of the vaccine? 

MP: I don't think it's compromising on the safety. Safety is first of all, of course, clear must, it has to be safe before you can administer it to humans, even to human volunteers in clinical trials so that what comes first is a preclinical test, assessing the safety and maybe the initial immune response in animals. What comes next is the first trial in human when you just go for detecting if you develop the right immune answer, if you develop antibodies against the virus, in this case COVID-19. What remains open and then will remain open for quite some time is if you develop a long-lasting immune response which protects you not only for a few weeks but maybe for years against this disease. So this will still take time before we can be rest assured that COVID-19 vaccine protects us for many, many years. 

SS: But what about the harm that it can do as opposed to protecting? Because what we're talking right now to you is a period of time it will make you immune to COVID-19. What I'm asking is that, could it be that a vaccine that is tested promptly on humans could be dangerous for humans? Because we dug up this case where in the 1950s some poorly made vaccines infected some 40,000 people with polio and killed 200? 

MP: Yeah, we have to be very clear about what kind of vaccine we are talking about. If you talk about a vaccine, which is an inactivated virus, which could theoretically be also contaminated with still alive and infectious viruses, then you're right, it could be dangerous if safety is not assessed sufficiently. If we talk about mRNA vaccines, probably no harm to humans, but we have to know that those kind of vaccines are so far not in the market for any kind of human vaccine. So the COVID-19 mRNA vaccine will be the first of its kind in the market, if it comes to maturity. Other vaccines like our virus-like particles, again, we use an approach which is so to say the backbone is the same as it is applied for a Hepatitis B vaccine. So we know about the safety of the production organism. We know about the safety of the approach, we do not use anything which is infectious at all. So the risk is really minimal. You do, of course, again, assess it in preclinical trials and, first of all, then in a small group of volunteers in the phase one trial, which you do for every kind of pharmaceutical new product. 

SS: So here's another thing. When a vaccine has survived human clinical trials, it's believed to be safe for use, but seeing how different people have different immune responses to сoronavirus itself (some losing half of their lung function, others not even noticing they were sick), do you think people will have a different reaction to the COVID-vaccine as well? 

MP: They will as people have in general for each and every vaccine. You will always have non-responders who do not develop protective immune response. Then you may have to develop a second-generation vaccine to overcome those immune non-responders so that they get protected as well. For sure, you will have this for COVID-19. Again, you have the same for the flu vaccine, for virtually every kind of vaccine. There is no hundred per cent guarantee. 

SS: Yeah, but do you think it could be deadly for some people, this vaccine? 

MP: No, definitely not. The worst it can do that people do not get protected, that they do not develop the immune response. Those hopefully only few percentage of people, of course, will still be at risk to get infected with COVID-19 and develop symptoms, which then have to be treated and hopefully we have other medicines to treat them in a good way. But the vaccine itself for sure will not be deadly or harmful to you. 

SS: Alright, well, that's a reassuring thing to hear. It's clear that nobody knows how much exactly a shot against COVID-19 will cost. But a tentative price I’ve come across most often is $10. What are your suggestions? 

MP: Well, we know that, again, I refer back to the example of Hepatitis B vaccine, where we have most of our know-how experience because, again, this vaccine is manufactured since the mid-90s, you can produce it at a cost of less than 1dollar, one euro. So that can be really affordable and you can do this in large amounts. I have to admit that on the production costs, manufacturing costs, for example from mRNA-based vaccine, I'm not familiar with this technology, what it's about the manufacturing costs, what could be the calculated cost for this one, it shouldn't be too much in my expectation, but, again, it's a new product that may have other risk factors associated to production, we have to take care about it. But for our approach, I think we can guarantee it will be affordable. We do license this product for emerging market countries like Vietnam, Thailand, Indonesia, India, where there's enormous price pressure on this product. 

SS: Yeah, because I’m thinking that a vaccine only makes sense if everybody can have it, right? Does it mean that a vaccine against COVID-19 maybe should be free like we have free vaccines against polio or measles? Can the world afford it? 

MP: I think it is a general task of all governments to come to a solution to provide it to their population, at least at affordable costs, or even for free. That's depending on the different individual health systems in each country. But you're right, it's definitely something we talk about which is not a luxury problem where only a few travellers may want to get vaccinated and protected. If we want to overcome the global restrictions, travel restrictions, economy restrictions, then we have to have a global vaccine. 

SS: Then a different question comes into play - if the world could do it free or close to a free vaccine, will it go for it? Because I'm thinking governments in Europe are now investing in all these biotech securing promises of making the final product accessible, but once you have the final product, who’s to force you to give it out for next to nothing? 

MP: Well, we have to look on the industry producing it, manufacturing it and they at least have to get some return because of the development costs and even manufacturing costs. So, of course, the company cannot afford to give it out for free. But, of course, government, supranational organisations like the WHO can put an enormous pressure to give it out at an affordable cost, and they can subsidize it so that it is either free delivered to the population or at least at affordable costs. If I look at the situation of flu vaccination here, we have every season a new flu spread, a new virus type, you need a new vaccine. And looking at the German situation, this is, of course, you have to pay for it, but it's at affordable costs. The same situation definitely will be that's what we recognise also in our discussions with representatives of different nations, even other industry partners, there's a lot of awareness that it has to be affordable. Even the vaccine industry is committed to produce it and sell it at affordable costs. 

SS: Mr. Piontek, there is a question of quantity, right? Because getting an effective vaccine doesn't in itself put an end to a pandemic what does is  a herd immunity. But that means that at least 5 billion people need to get a shot. I mean, can we as humans produce as many as 5 billion doses? 

MP: Certainly, yes, because many, many countries do have their own vaccine manufacturing capabilities. Luckily, we are in a situation where a lot of vaccines are out on the market. As I've given the example, you have annually, a new flu vaccine, you have Hepatitis B vaccine, papilloma vaccine, malaria vaccine, whatever. And you have in many, many different places all over the world, suitable manufacturing sites with an enormous capacity. And, of course, it has to be a combined effort to have this available to produce COVID-19 vaccines and I'm sure there will be many different at the end of the day and even the mRNA technology may be able to deliver on a short-term an enormous amount of doses. 

SS: But I'm thinking even if we do have several different kinds of vaccine in different parts of the world, the supplies will still be limited at a certain point. Will there be a danger of richer countries hoarding vaccines at the expense of countries with worse logistics and less money? You know, when I remember the situation with masks during this pandemic, it makes me think of the worst because this is like a very simple thing to do a mask, it's not technologically as complex as making a vaccine. And when I think of the mask shortages and how people were trying to overtake the mask supplies for themselves and instead of giving it out to everyone, I'm thinking what's gonna happen with a vaccine when it arrives... 

MP: Of course, I think that's a very valid comment and question and we all have to take care of our responsibility also. If we look ahead, if you want to go back to some kind of normal, we need to kind of, as you said, global herd immunity or vaccination or whatsoever. So it doesn't help Russia or Germany to have our country protected, because it still will avoid that people come travelling to our places and the global economy will get affected. We have to take care about also underdeveloped countries to make technologies affordable. So we are in discussion with countries in Latin America, for example, in Southeast Asia to bring our process to their manufacturing sites so that the local government and the local vaccine manufacturer can take care about their country, about their region to deliver the vaccine to this corner of the world. I'm sure, of course, I mean, it's natural that European, U.S., Russian vaccine manufacturer has a responsibility to take in the first-order care about their own population and that's what people, of course, expect. But again, it's a global pandemic. So if we leave the rest of the world unprotected, we still will not have a free flow of people, travellers, economy, wares, and so on. 

SS: But then you may remember, in 2009 when the swine flu outbreak happened an Australian company was among the first to make a vaccine and the government made it available only to Australians, United States citizens and Canada did the same thing. Does that mean that despite the fact that the world leaders are saying about this being a global interest vaccine, nationalism will still sort of prevail? 

MP: No, I don't think that in this situation we have now, it's different to what we had in 2009. We had small outbreaks, which were shuddered in different regions and it was not spread so globally. We now have a situation where, of course, people, governments, every politician is speaking for his country to give his population the image, they take care about them. But again, at the end of the day, it's a global challenge. And also the industry will take care about getting back to normal. There's an interest from everybody concerned in these race for a vaccine to give it to everybody. It's a different situation than we had with other diseases and other outbreaks  

SS: Ok, I agree and at this point, and I think unprecedented, there are 150 groups around the world trying to make a vaccine. And I keep hearing, this team stole his data from another team, that team stole from that team, our scientists will surely develop the vaccine faster than scientists there etc. So tell me as someone who's actually developing a vaccine, why can't all these 150 groups make their vaccine projects accessible to each other and work together? I mean, what are the pitfalls to that? 

MP: It's not a pitfall. I think it's good that these different groups work on different solutions. It's not all the same and nobody knows what will be the one solution to the problem. The best chance we have is that we have these many groups working on their individual competencies, technologies and combining their strengths, and the variety of approaches will help us to get the solution in a shorter time and again at affordable costs and for a larger number of population. At the moment, there's a lot of focus on mRNA vaccines, they are fast, it's the most progressed vaccine approach. But still nobody knows if at the end of the day it will bring the solution to all the problems. So we can be lucky that we have these 150 groups and within these groups there's a lot of exchange. I've never experienced this amount of open exchange between researchers as we do have these days.  

SS: Then from what you're saying, does a thing called “vaccine race” even exist outside of a political discourse? I mean, politicians talk about that a lot. But from someone in the process, are you guys in an actual race to get there first with your colleagues? 

MP: No, it's not about being the first. We need a fast solution. That is why everybody is rushing and hurrying up to offer a solution as soon as possible. As we discussed, there will be billions of people to be vaccinated. So we need several approaches and we need several manufacturing sites worldwide. So I'm sure this time also number 5, number 10 in the so-called race will be very successful and well-recognised and we can be glad that we will have a number of solutions offered at the end of the day. It's not a race about being the first and the rest have lost the market. That's not about it. 

SS: It may be still too early to judge but there are concerns that going through a coronavirus episode may not give a long-lasting immunity. What about the vaccine? I mean, can we say now for how long it can possibly grant protection? 

MP: No, we can’t and that's the one open question. There are now  results coming up one by one, that there will be certain vaccine approaches resulting in the induction of the so-called T-cell answer which is inducing a memory response so that your body remembers that it has seen this virus and develops during the next infection the antibodies faster without being again vaccinated. So these are the first indications but it's not a proof. The proof will be once the products, onсe the vaccines are on the market and then over a period of years we will see if people are really protected for a long time. That's what we cannot predict right now. We can do some probability studies making some educated guess on it but we cannot be sure. 

SS: You know, there's a Swiss immunologist, Beda Stadler, who has a published a piece, where he says that it's actually very likely that immunity against COVID does exist and previous reactions to the virus were more fueled by panic than by real evidence. Could it be that the world is majorly overreacting to the threat posed by the virus? 

MP: There are discussions out that, for example, also, children do not react so strong to COVID infection because they are basically infected every day, every week by another kind of virus, another flu virus and maybe another coronavirus, maybe just something else. So, they have a very active immune system, which may have to protect them against the COVID-19 virus infection. And so yes, it can be that there’s general immunogenicity against COVID-19 vaccine in some parts of the world also that we have differences in different countries. And that may be a reason that kind of background immunity is sometimes stronger in certain populations protecting also against COVID-19. 

SS: Stadler also writes that like the cold virus, this one may not survive the summer but even if that's true, there will be a new winter and with it supposedly a new form of COVID, like with a seasonal flu, what do you think? 

MP: Honestly, we will have to wait and see what's happening in the next fall. If we are lucky, the COVID-19 outbreak will disappear like a flu outbreak. I remember two years ago in Germany, we had a pretty severe flu outbreak with more deaths than we have up to now due to COVID. And the next year, we had a new flu virus, which was less aggressive. And we have Coronavirus all the time. It's not something which is popping up newly. It's an old virus. It's just that this year we have a very aggressive one. And again, maybe if we are lucky that this one disappears and we have again a less aggressive Coronavirus in the next winter. It may as well be that it sustains and we will have to deal with it for a long time. And that's, again, why we have to develop now a vaccine against this type of virus. We had SARS outbreak a couple of years ago. And we may have done better developing at that time already a very efficient SARS vaccine, which could now have helped us be better prepared for COVID-19. 

SS: Dr. Piontek, good luck with the vaccine for the sake of all of us, I really hope it's going to be out there sooner rather than later. Take care of yourself, be safe. And thank you for all your work, and for everything that you're doing for us. 

MP: My pleasure. Thank you for your interest, for your good wishes. And yeah, all the best to all of you and let's get fingers crossed altogether for the sake of the vaccine.  

SS: Thank you so much.  

MP: Thank you, goodbye.