COVID-19 Miniseries Episode 32: The Fierce Urgency of Now - Pursuing a Safe and Efficacious Vaccine - burst 3


Trials. Now now you can adapt those trials and there are ways in which you can safely speed those up but never in my mind. Never at the cost of safety we must ensure that other physician scientists in the public trust the process in that trust is born of knowing that we're putting safety of everything else and that's where my concern revolves is that we're doing simultaneous phase one two or simultaneous space to three studies involving ten thousand. Not Twenty thousand or fifty thousand and and I have some concerns about that one of the ways in which One could shorten or at least decide whether a vaccine candidate should go forward. It's being talked about is human a challenge studies the idea behind here and we do it with some Other pathogens is we would give somebody an experimental vaccine remove them to a facility and then deliberately infect them with the virus at at this point. I personally don't think that's ethical. I think a lot has to be worked out about that primarily because we don't have a proved rescue therapy if one of those volunteers were to get in trouble so for me as as a physician as a scientist as a Mayo Clinic clinician. The safety of our patients must always come first. Just listening to you. A number of adverse effect in one hundred thousand and you need three hundred eighty five thousand Beijing are people do study it and if that's positive the billions of people we have it it would mount very soon to be of adverse effects that could be world. That's now yeah now the one in one hundred thousand. We never really discover those until face or studies. And that's understandable from a logistic feasability issue. But it's the one in ten thousand and under that I'm concerned we. We don't see when we do shortcut. Trials with small numbers of subjects behaved. This magical thing. They come up with a vaccine knowing the characteristics knowing the mutation which is going to happen at a spike in level and others is. It doesn't look like it's going to be one and done that one vaccine and it'll take care of lifelong immunity always going to be something which we have to take the flu. Shot combined with the flu shot doing the fall season and get once a year for the rest of our lives yum and the short easy answer is nobody knows yet. Net remains to be discovered but to your first question. I don't think it's going to be one and done. I think we're going to need different types of back and for this reason Right now the world's manufacturing capacity if we switched everything to just produce this vaccine if we needed to doses we. We can't do it so we're going to need different types of vaccines. We're going to need different types of vaccines because we're immunizing different. If you will categories people immuno immature children Immuno SENESCENCE ADULTS. Immuno-compromised people pregnant women That is rarely amenable to a single vaccine platform a I would put forward as an example Influenza where we have some seven different types of influenza vaccine I like that pushes companies to develop back scenes like that because I think we wanna be as a personalized in our prescription of a vaccine as we are with drugs. Choose the right vaccine for the right person at the right time. And so I think Almost assuredly we're going to need to have several different. Kobe vaccines how did the SALT? Dev LUMP The lady she'll vaccine before that Jenner read the cowpox therein so many people around and do the vaccine going in a short time with this lot of adverse effect that they did notice trial and error and they've actually become a model because vaccines that their loved the whites. You know it is interesting to look back at the Jenner and even before Jenner Jenner's noted because he was the first to publish which is a lesson for all of us academics. He wasn't the first to use it. It had been used actually probably centuries before in China India Etc but he published and your point is a good one even the advanced Second or third generation Smallpox vaccines that. We have now still suffer from the same side. Effects of being alive attenuated Vaccine Jonathan Edwards in the early colonial time of this country when he was president of Yale got smallpox vaccine in a month later died from complications of it so You know the that of course was done back in the days before they really understood the science. Now you take something like polio. Vaccine that you mentioned with salt in. It's it's very interesting. So sulk Developed an inactivated viral vaccine and. Sabin an oral vaccine and in the testing of the salk vaccine. There's the so called cutter incident. That was the name of the company making it and something went wrong in the process. This is in the nineteen fifties and the virus was not inactivated and yet was administered as an inactivated vaccine and children developed polio. As a result of that I don't think that would happen today obviously because we do lot release testing Cetera but it points to the fact that in the field of back Sinology. I've been in this field over thirty five years. I can tell you that there are always surprises. We've had influenza vaccines since the nineteen forties. We're still doing testing on next generation. Vaccines to improve them so so we will never be done. We can never really make them good enough. We have to keep improving them like all of medicine but always be for us has to be an exceptionally high bar for safety. Now you might. You might vary that bar based on Conditions for example. Let's say that SARS Kobe to was killing thirty percent like Ebola thirty percent of the people at infected. You might accept a vaccine had more side effects that were not lethal or inducing. Any permanent damage. you might. You might accept a vaccine that had lower efficacy and higher reacted in this city because the risk benefit would still be favorable. That's not the case in the current environment with this. It needs to be very very safe. I need to go back and ask you one additional point which I hear vaccine and exports talk about his mucosal immunity vaccines and what does Nichols Limited. Why's it important and you see that play a role in the of the current vaccine that dot young. That's one of those unknowns. I was referring to where I'm sure we will pay more attention to that in a second generation. Co. Bid Nineteen backseat. There were some early studies looking at entrance. Nasal Administration the vaccine. You could demonstrate the development of new Kozel immunity but insufficient sterilizing immunity to protect against disease. So you coastal immunity is important for respiratory pathogens because they are being introduced in entered through the nose and mouth but it is not more important than more systemic or immunity so so both have to be considered so a common way of remembering some of these vaccines live versus at United. Is You know if somebody's competent. Competence competent rather good sense. They can tolerate a live vaccine really good. And if you're GONNA compromise like transplant or the huguenots And the younger children you know. Give them kill rack. See that save for what you think. Are we going to approach these tire? System in The Kobe to case a amish. You're nearly there is EVAC sinologist. I'm GonNa get you into vaccines yet. You've you've articulated it very well. We basically started have four categories. You can think of of of vaccines actually either. If you think of something like tennis which is tax soy but let me leave that one offer now in terms of respiratory viruses. We have whole virus. Vaccines that you mentioned. Those can be attenuated. But live or inactivated. We have recombinant protein. Vaccines have vaccines that are delivered with replicating or non replicating viral. Vectors Nets That's actually one of the lead vaccine's right now and then we have Nucleic acid based vaccines whether M. R. A. Or DNA vaccine and then finally our our own approach at at Mayo. Which is a peptide vaccine so that you can make them cheaply store them indefinitely no cold chain and no contraindications allergic reactions so that we of course think that our platform is going to turn out to be a winner. But we'll see this really lives to Segue of the kind of side Scooby Doo vaccines which I've been studied and we have this. Recent press came out about the modern not emanate. Would you mentioned and you tell us limping about what does wreck. Scene is about so the dirt vaccine is an MRE vaccine in a lipid nanoparticle. So the idea is that you inject this. And then the M. R. A. With this Lipid Particle was taken up into cells and then the MRI which is a genetic code for the S. Protein STARTS REPRODUCING WITHIN THE CELL. So the idea is to force our own human cells to make s protein so that we developed immunity against the virus. And you're right. That is now in phase. Two clinical trials. They did a press release days ago. I think it was oddly enough and and I don't particularly like the idea of presenting science through press releases I like. Publications are peer reviewed but oddly enough Though they had studied more patients they only presented results on a fraction of the patients but in that fraction they all developed a nice high levels of and in a monkey study that was done preceding. It demonstrated that after one dose. They could protect those monkeys against severe disease. So I I would call it a promising candidate we have never licensed an MRI based vaccine before and a lot of safety work. I think to be done yet. What about Oxford University vaccine that they've been working on and it's impressed too young? That's a that's another one of these viral vectored vaccine in this case. It's a chimpanzee Adna. No virus that has been modified so that it does not go through many cycles of replication. Which of course would be a problem. But within the the virus they've inserted the genetic code for the s protein full length of the s protein. So again that virus. If you will quote unquote infects us when it's administered and then the genetic code for the s protein of SARS. Kobe to virus starts replicating making s protein. We make antibodies against that and then immunity if our bodies should see the actual live virus and and also heard about the INOVA Pharma but that is a very unique different way of inserting the vaccine which is not typical and could be problematic when you're using it for mass production and mass administration you're nailed again This is a DNA based vaccine again. That has never been licensed before. Dna vaccines contain at least the theoretical of that DNA integrating into the host genome into our own DNA. And that's that's of major concern if anything like that were to be seen. It hasn't been but were it to be saying that that would be a concern. The other issue with that on it is that you're not only having to inject the vaccine but then you're having to do something like electric peration so that the DNA can actually get into the cell. So it makes it inexpensive bulky platform that I think would be hard to use in a mass vaccination setting and likely pretty expensive and then the Mayo Peptide based vaccine which you are involved in and you did mention some of the characteristics of riot peptide vaccine could be beneficial to the steps on. What do you do? What kind of

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