This Podcast Will Kill You - COVID-19 Chapter 13: Vaccines, Take 2

Episode Date: December 22, 2020

We’re back with another episode in our Anatomy of a Pandemic series on COVID-19. This time, our subject matter is the one everyone has been waiting for: vaccines. In this episode, with the help of two amazing guests, we attempt to answer all of your burning questions about the new vaccines for the virus that causes COVID-19. We walk you through the ins and outs of the technology behind these vaccines, the safety and regulation steps required for their approval, and some of the logistical challenges involved in their distribution. For this info-packed episode, we were so fortunate to be joined by Dr. Maria Sundaram (interview recorded Dec 14, 2020), postdoctoral fellow at the University of Toronto Center for Vaccine Preventable Diseases and fellow at ICES and Dr. Orin Levine (interview recorded Nov 24, 2020), Director of Vaccine Delivery at the Bill and Melinda Gates Foundation. As always, we wrap up the episode by discussing the top five things we learned from our experts. If at the end of this interview, your curiosity about vaccines is not quite satisfied, check out the COVID-19 Vaccine Tracker website, which is an incredible resource for pretty much anything you could ever want to know about these vaccines.To help you get a better idea of the topics covered in this episode, we’ve listed the questions below: Can you break down what the three potentially successful COVID-19 vaccines are and how each of them work? What are in these vaccines? What are the ingredients and what do they do? There has been some misunderstanding that these vaccines have the potential to give you COVID-19. Can you explain why that isn’t possible? Why are people being advised to wear a mask even after getting vaccinated? What does the timeline look like for these vaccines until we can go to the doctor or pharmacy and get one? Is it a valid concern that this vaccine was developed so rapidly? And could you walk us through some of the steps being taken to ensure safety and efficacy of a vaccine? Can you talk about what emergency use authorization means and whether we’ve seen this before and under what circumstances? Why should people be no more scared of this vaccine than the usual vaccines, like MMR and seasonal influenza? How likely is it that additional side effects we haven’t yet seen or long-term side effects will emerge later on? What do we know about the risk of vaccine-induced antibody-dependent enhancement with this vaccine? What do we know so far about the efficacy of these vaccines? Can you walk us through efficacy vs effectiveness in terms of vaccines? What do we know so far about how long immunity is expected to last from the various vaccines that are close to completion? What are some of the issues with clinical trials in vaccine development in terms of getting a representative subsection of the population and what does this mean for who may be able to get a vaccine once one is ready? Why do you still need to get vaccinated even if you’ve already had COVID-19? For our listeners who may know someone who is hesitant to receive the vaccine, what advice or reassurance can you give them that choosing to get one of these vaccines is a better option than taking your chances with COVID-19? What are the biggest hurdles to vaccine distribution here in the US? What are the biggest hurdles in terms of global distribution of the vaccine? And what is being done to address some of these challenges in vaccine access? We’ve heard about some countries pre-purchasing large stocks of vaccines, how may that affect the global availability especially in lower income countries? How might the availability of several different successful COVID-19 vaccines affect how different countries build their vaccine supply or distribution chain?  Could you talk about how skepticism surrounding vaccines plays into not only vaccine development but administration, and what can be done to rebuild trust in those communities? How do you think this pandemic will change the way that we view either emerging infectious diseases or vaccines in the future? See omnystudio.com/listener for privacy information.

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Listen to the sixth bureau on the Iheart radio app, Apple Podcasts, or wherever you get your podcasts. I'm Amanda Knox, and in the new podcast, doubt the case of Lucy Letby, we unpack the story of an unimaginable tragedy that gripped the UK in 2023. But what if we didn't get the whole story? Evidence has been made to fit.

The moment you look at the whole picture, the case collapsed. What if the truth was disguised by a story we chose to believe? Oh, my God, I think she might be innocent. Listen to Doubt, the case of Lucy Lettby, on the Iheart Radio app, Apple Podcasts, or wherever you get your podcasts. Hi, everyone. My name is Ashley Pleasant. I work as a paralegal in Tyler, Texas, but I live about an hour away in Wood County with my mom and stepdad.

Tyler is a college town, but the surrounding area, including my county, is very rural. I think people have had a false sense of security that COVID wouldn't come here, but in reality, our little bit. population density could only delay its arrival. My family and I have been taking all the precautions we can since the nationwide lockdowns began happening in March and April. We only leave the house to go to work in the store. We wear multi-layer cloth masks every time we leave the house. We wash our hands, use hand sanitizer frequently, and we stop seeing anyone in person socially, but at the beginning of October, COVID still found us. It started off like a mild cold. My mom started experiencing mild fatigue and a cough. We were slightly worried, but trying not to read too much into it. I mean,

we were being careful after all. Within three days, though, I started having the same symptoms, my stepdad the day after me, and my 87-year-old grandmother the day after him. We were still trying to not worry too much. I mean, colds are common and still happen even during a pandemic. That all changed, though, the night my mom decided to grill hamburgers. I realized we had a serious problem when I couldn't smell the charcoal grill or cooking burgers. After that, we couldn't keep telling ourselves it was just a cold. Over the course of the next week, all four of us were tested, and all four of our tests came back positive for COVID. The second week of symptoms felt more severe, with more extreme fatigue and coughing, as well as headaches, body aches, and a loss of appetite.

None of us really ran fever, with the exception of my grandmother, for just one morning. She was struggling with dementia and wasn't eating or drinking enough. My mom and I had to get her to drink fluids every hour to keep her hydrated and keep her fever down, and we had to make sure she was eating so she didn't get too weak. We meddled through well enough for a few weeks, feeling pretty crummy but managing. Around the end of October, we felt like we'd made it through the worst of things and were starting a slow recovery process. My grandmother had even gotten a most of a clean bill of health from her doctor and was getting up and walking around more. We really thought we were in the clear.

Then at 4 o'clock in the morning, on October 24th, I heard my grandmother call out for my mom while I was on my way to bring her a drink of water. When I got to her, she was having difficulty breathing. She was still aware and talking, but she couldn't take air in properly. I ran to get my mom, called an ambulance, and within 15 minutes, she was gone. My mom's stepdad and I are still experiencing mild symptoms from COVID two and a half months later. I personally still have shortness of breath, fatigue, trouble concentrating, and a reduced affidavit. tight. We're all still struggling with the fact my grandmother isn't here this year for the holidays. This is something no family should have to go through, but this pandemic only ends if we all do our part.

So please, everyone, wear your masks, wash your hands, stay safe, and save a life. Thank you. My name is Rianan. I live in Central Florida. I work as a paralegal for a small family law firm, and I am a volunteer participant in the phase three trial of the COVID-19. vaccine produced by Pfizer. Before my first visit, I had a pre-screening eligibility phone call with someone from the study. She mentioned that it was $150 per visit, and I was like, ooh, well, I guess it's worth it to be able to participate. Then she mentioned that they would add the money to a debit card starting at my first visit.

It took a minute to register that they would pay me. In late August, I went to my first appointment. They took a blood sample, gave me a pregnancy test and a COVID test, had me complete and sign an informed consent form, I gave them my complete medical history, and finally they injected me with the vaccine or placebo. They sent me home with the thermometer, a copy of the informed consent form, an emergency information card in case I have to go to the ER during the study, and a swab test kit that I can administer myself and mail in if I develop symptoms and can't get tested right away. Three weeks later at my second visit, they gave me another pregnancy test,

COVID nasal swab, and a second injection, which was the same as the first. They administer either vaccine vaccine or placebo placebo. About a month after that, I returned for my third visit, during which they drew blood to check antibody levels. My fourth visit will be in March of 2021, and then I'll return for at least a fifth and a sixth visit over the next 20 months. This is an observer blind study, so they will not tell me whether I receive the vaccine or placebo until it's over.

They also don't share with me the results of my blood tests. Once a week, I'm asked to complete an illness diary through an app on my phone, I simply answer yes or no to the question of whether I have developed any symptoms of COVID-19. So far, I've been able to answer no every week. After my first injection, I felt nothing. No pain at the injection site, no indication of any side effects at all. After the second injection, though, my arm was sore for days. It was itchy, and there was a raised bruise at the injection site. I was cautiously optimistic that I had received the vaccine. Actually, I was pretty thrilled. I work from home most of the time, but I had worked in the office one Thursday in

late October, and by the following Monday, two of my four coworkers had symptoms and tested positive. By the next week, a third coworker was also positive and symptomatic. Knowing that I had been exposed, I got tested and was negative. At that point, I was pretty sure that the vaccine had made me, well, immune is the right word, but invincible is how I felt. So in November, I asked my primary care physician for an order for an antibody test. It came back negative. I was so disappointed. I don't know what will happen when the vaccine is approved and available. The study doctor said that I would not be at a disadvantage for having participated in the trial. He sent a letter a couple weeks ago saying that they were, quote, exploring potential ways to change the study to create a process that would

allow interested participants in the placebo group who meet the eligibility criteria for early access in their country to cross over to the vaccine group in the study." At my first visit, the doctor in charge of the research facility asked me why I decided to take part in the study. I was speechless for a moment thinking, you see, there's this podcast. Aaron and Aaron got me all excited about vaccines and medical research even before the pandemic, and I was really excited for this opportunity to not only take part in an important study, but to see for myself how informed consent forms look these days, because, you know, they haven't always been like this. But before I found words, he said that most people tell them they're just so tired of all this

and want to help things get back to normal as fast as possible. I nodded and said that, yes, I just wanted to help. Our conversation was over pretty quickly, so I never got to tell them the rest, that I don't believe things are ever going to get back to normal because some things have changed forever, that this could be my one chance as a paralegal to help save lives through medical science. that I feel like it's my duty to do what others can't do, and that I'm incredibly grateful to live in 2020 when so many medical professionals have worked tirelessly

so that there is already a vaccine. Thank you so much, Ashley and Riannan, for sharing your stories with us. We really appreciate it. And thank you to everyone else who is sent in their first-hand accounts of how COVID-19 has impacted their lives. I think it's so important that we tell these stories and hear these stories to know that we're not in the same.

alone and to remind ourselves of the far-reaching effects of this pandemic. Yeah, absolutely. Hi, I'm Erin Welsh. And I'm Aaron Alman Updike. And this is This Podcast Will Kill You. Yeah. In this episode of our Anatomy of a Pandemic series on COVID-19, we're revisiting the topic on everyone's minds.

Vaccines! Yes. How do these COVID-19 vaccines work? How do we know that they're safe to take? And when will they become widely available? Great questions, Aaron. Great questions. And these questions are just the tiniest sampling of what we covered in this super-duper info-packed episode. Really truly, I don't think we've ever packed more information into one episode. Oh my gosh. And we are so excited to share with you all of the vaccine

info you could ever hope for. But first, we have some very important business to take care of. It's quarantini time. It is quarantini time. What are we drinking this week? Well, of course, quarantini 13. Naturally. And in the quarantini 13 is bourbon, ginger ale, rosemary simple syrup, lime juice, and muddled blackberries. Delicious.

It really, really is. And also, we want to give a shout out to Abby and Jessie, who are the daughters of one of our guests for this episode. Dr. Orrin Levine, and who sent along a placebo-reda version of this recipe, which they called the Sweet Lady Levine. I love it so much. Amazing. Thank you both so much for the suggestion. It made our lives easier coming up with this quarantini, and it's delicious.

Yeah, really. I was like, oh my gosh, a recipe? Just here? Just gifted? This is amazing. We will post the full recipe for the Quarantini 13th. along with the non-alcoholic placebo rita on our website, this podcast will kill you.com,

as well as on all of our social media channels. So make sure you follow us there. Okay. What else? We are, of course, still soliciting firsthand accounts for this COVID-19 series. So if you haven't yet and you'd like to submit your first-hand account, you can go to our website, this podcast will kill you.com.

Click on the COVID-19 tab, and that'll send you to a Google form that you can fill out. And thank you again so much to everyone who has submitted their first-hand account so far. Absolutely. And we are also in the process of getting transcripts done for all of our episodes. And we are so excited about this. Yeah, really. And we will announce on our social media when the transcripts are ready for current or past episodes.

So make sure that you follow us on there. And we'll also be posting links to the transcripts on our website under the transcripts tab. So you can also check back. in there periodically if you are curious. Yeah. Other than that, we have kind of usual business things really quick. We have a Goodreads list. Check that out. A bookshop affiliate account. Really phenomenal and amazing TPWKY merch. You can find links to all of these on our website. This Podcast Will Kill You.com. Okay. Aaron. I think it's finally time to get to the meat of this episode. I think so too.

I mean, this is what everyone has been waiting for. Really, truly, myself included. Oh, my gosh. At the time of recording this, which is December 15th, 2020, according to the New York Times coronavirus vaccine tracker, there are currently 41 vaccines in phase one trials, 16 in phase two, 16 also in phase three, five vaccines approved for early or limited use, and two approved for full use. That is huge. Amazing. Truly phenomenal. Absolutely, like, remarkable. I can't stop smiling thinking about it. It's amazing. It just feels like such a relief. And it's really hard to take

in, like, good news. And so it sort of feels like. It's true. The news that there are multiple vaccines that have been shown to be effective against this virus that causes COVID-19 is some of the best news that we've had in a very long time. And it really does finally feel like the light at the end of that very, very long pandemic tunnel we're living in is finally visible. Yes, it really does feel that way. But there are many questions that remain. There has been a lot of concern about the safety of these vaccines and possible side effects in addition to questions of access and vaccine distribution. And to help us address these concerns, we were fortunate enough to talk to two amazing scientists. Two! Two! Two! How cool. Dr. Maria Sundaram, postdoctoral fellow at the University

of Toronto Center for Vaccine Preventable Diseases, and fellow at ICES, a non-profit health research organization, and also Dr. Oran Levine, Director of Vaccine Delivery at the Bill and Melinda Gates Foundation. Both are phenomenal interviews. We can't wait for you to hear them. We're going to start with Dr. Sundrum, who answered our many, many, many questions about the vaccines themselves. Questions like, what are the ingredients and how do they actually work? We recorded this interview on December 14th, 2020. So we'll let her introduce herself right after this break. Dinner shows up every night, whether you're prepared for it or not. And with Blue Apron, you won't need to panic order takeout again. Blue Apron meals are designed to. by chefs and arrive with pre-portioned ingredients so there's no meal planning and no extra grocery trip. There, assemble and bake meals take about five minutes of hands-on prep. Just spread the pre-chopped ingredients on a sheet pan, put it in the oven, and that's it. And if there's truly no time to cook, dish by Blue Apron meals are fully prepared. Just heat them in the oven or microwave, and dinner is

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their first order of O'Keefs. Just visit O'Keef's company.com slash this podcast and code this podcast at checkout. I'm Clayton Neckerd, and in 2022, I was the lead of ABC's The Bachelor. Unfortunately, it didn't go according to plan. He became the first Bachelor to ever have his final Rose rejected.

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Agree to date me, but I'm also suing you. Please search for it. This is unlike anything I've ever seen before. I'm Stephanie Young. This is Love Trapped. This season, an epic battle of He Said She Said, and the search for accountability in a sea of lies. Listen to Love Trapped on the IHeart Radio app, Apple Podcasts, or wherever you get your podcasts. So my name is Maria Sundrum.

I'm an infectious disease epidemiologist. and I'm a postdoctoral fellow at the University of Toronto Center for Vaccine Preventable Diseases. And I'm also a fellow at ICES, which is a not-for-profit research institute in Toronto. Excellent. Thank you. We're very excited to have you here. Over the last month or so, there have been some very optimistic and exciting headlines with the emergence of what appears to be at least three potentially successful vaccines for SARS-CoV-2. could you kind of break down what those vaccines are and how maybe each of them work? Yes, definitely. So I think the three vaccines that we're talking about are this Pfizer-Biontech vaccine,

the Moderna vaccine, and then this vaccine that's being developed by Oxford and AstraZeneca. And it's worth noting there's a couple other vaccines that have been approved for use in other countries. But I can just talk about these three. I think they've been at the top of our national conversation at least. So the Pfizer, Beyond Tech, and the Moderna vaccines are both MRNA vaccines, and the Oxford Astrosetica vaccine is a non-replicating viral factor vaccine. Your listeners may know that when we're talking about kind of a traditional vaccine and normal vaccine like your seasonal flu shot,

what we're doing is we're showing our immune systems a dead virus, a killed virus that can't infect us, but it's the whole thing. So our immune systems are seeing this complete virus that is dead and saying, okay, this is really helpful. Now I know what this looks like. I'm going to be prepared for next time when I see this one that looks like this, but it's alive. So we're starting at an earlier point in the process with the mRNA vaccines. And what we're actually doing there is we're giving ourselves like the IKEA instructions to make one part of the virus. And in this case, it's the spike protein, which is this protein on the outside of the coronavirus.

So our cells are able to produce this protein only, not the whole virus, but just this protein. And then they say, okay, we're going to protect specifically against this protein, which is the protein that we really need to protect against. And then we're prepared when we see the whole virus. So that's really helpful because it allows us to understand how to protect against this virus without the risk of actually getting ill. And the non-replicating viral vector that's in the Oxford Astrosanica vaccine works kind of in a similar way. But instead of us making that protein, we're asking a different virus to make that protein. In this case, it's an adenovirus. So this is another rest tray virus that in this case, it's usually among chimpanzees.

It doesn't really cause us any physical discomfort or anything. We probably don't even notice that it's there. but we've given that this adenovirus, the information to also make this spike protein. So it's on its little membrane, it's showing all of its sort of normal adenovirus stuff, and then it's also got the spike protein. So our immune system is like, oh, okay, there's that thing that I need to protect against. Now I know. So that's kind of how those vaccines work.

Awesome. So let's start at the very beginning. And this might be sort of a more general question. But, you know, what are in these vaccines? Like, what are the ingredients and what do they do? What do each of them do? Yeah. So I did talk a little bit about this already, kind of like how the MRNA vaccines work and then how this adenovirus vector vaccine works. The other things that are in these vaccines, so for example, the Pfizer vaccine has lipids, salts, and sugar. And this is pretty similar to what's in the Moderna vaccine as well. So the lipids are these tiny little fat globules. And they're there because we want to be able to protect this MRNA before it can be

absorbed into ourselves. And I said before that MRNA is kind of like IKEA instructions. And it very much is, but it's not in the like book that you get. For my Kia, it's like it's like it was written on ticker tape or like a super long CBS receipt. So it's kind of like, you know, flapping in the wind a little bit. It's bopping around. And it can. can be really fragile. And so we want to make sure that when we're giving it to people, that it really like stays intact enough so that when it gets to ourselves, it really has something meaningful to say and ourselves can read it instead of being confused. So they've charged these little fat globs and the charge allows the MRNA to stick inside them. So it's really,

it's almost like a little sphere that surrounds the mRNA and protects it. The salts or the buffer that's in the Pfizer-Biantec and the Moderna vaccines, respectively, allow all of the stuff that's in the vaccine, including the antigen and everything else, to be the same pH and the same salinity as our bodies. And that's really helpful so that we can only react to the antigen. And then there's sugar in both vaccines as well. And this can help, for example,

if the vaccine has to be stored at very cold temperatures, it can help with the vaccine antigen not being damaged. in that process. And then the Bourdainterra vaccine also has something called sodium acetate. And this can be something that kind of holds all of this other stuff together and kind of stabilizing everything that's in the vaccine. Because there's, there's like polar items and then there's non-polar items, which would be the lipids, it can sort of wind up, you know how salad dressing separates? And you've got like the oil and the vinegar and you have to like shake it up in order to like have it be like palatable. So we like obviously don't want our vaccines to be like salad dressing that has separated. So so some of

these things sodium acetate for example can help kind of stabilize that and the buffer can help with that as well. And both of those vaccines are preservative free. Gotcha. So there has been some misunderstanding. I think that we've heard a lot that these vaccines have the potential to give somebody COVID-19. And I think you kind of touched on this already, but could you kind of explain more specifically why that isn't possible in this case? Yes, I can. So I understand why this is a concern, and there are, way in the beginning, we are making vaccines, we used attenuated versions of viruses, and that means kind of, you know, it was alive, but it was, you know, kind of limping along, not as effective as a sort of natural infection against some of these different pathogens.

And that's still the case for some of the immunizations that we receive today. For example, there's a live attenuated version of the flu vaccine that you can get in a nasal spray. So this is an example of a virus that really can't cause illness, but is still sort of limping along enough for our immune system to really take notice. These vaccines that I've just mentioned, they don't contain a whole virus, much less one that's alive. As I mentioned, they only contain one part of the virus, which is the spike protein. And so there's really, there's no virus in any of these vaccines that I've mentioned.

And so it's really just not possible. It's just not there. So that being said, you know, there is this advisory that people who receive the vaccine are still told you should still wear a mask. So can you explain why people should wear a mask even after getting vaccinated? Yes, this is a great question. Why should you wear a mask even after you've been vaccinated? So one really important thing to remember is that after you get the first shot, you're going to have to wait three weeks and you're going to have to go back for another shot. And then you're going to have to wait a little bit after that to build the maximum amount of antibodies that we would consider for you to be fully vaccinated. And this is actually the case for a lot of vaccines.

For example, when you get your flu shot, you're not considered to be truly vaccinated until two weeks later, because that's when your body has made sort of the maximum amount of antibody that's going to really protect you throughout the flu season. So first of all, you're not sort of immune, like superhero style. like right after you get the first shot, unfortunately. It's going to take a while at least five weeks. And you have to go back for the second shot, which is also like going to be challenging, I know, for some people. The other thing is that part of this is about humoral versus mucosal immunity. So when we get these shots, we're going to have these antibodies in our blood.

And you and I know, that's not where COVID-19 goes first. It doesn't sort of like get injected directly into our skin. it comes into our body through our respiratory pathways. And so there are these mucosal surfaces in our nose and our nasopharynx, kind of the back of our nose and throat area, that also have kind of their own sort of unique mucosal defense mechanisms. And there can be cells waiting at that mucosal surface for different pathogens. It's not clear yet exactly what kind of immunity we might be developing from the vaccine at those mucosal surfaces. And so if that's not as robust as the immunity that's in our blood, we could wind up sort of hosting COVID-19 in our nasal mucosa and then inadvertently, you know, sort of like wiping our nose and then like sort of exposing someone else to

that. It's possible that it could happen. Even though we wouldn't experience sort of physical discomfort from any sort of colonization, it's still possible. that we could spread that on to someone else. And it's always possible for us to sort of touch a surface and then touch something else that someone else may touch and then touch their face. So it's not as though we're completely cutting off all modes of transmission. We're reducing them quite a lot.

But it's still maybe possible to transmit that virus, even if you don't feel unwell. So that's why it's a really good reason to continue wearing a mask and continue taking those other precautions as well, including washing your hands. That makes so much sense. So kind of looking big picture, what does the timeline look like for these vaccines until like we could just go to our doctor or the pharmacy and actually get one? What kind of steps

are still remaining in the process? So I will start by saying, I wish I could give you a date. I wish I could give myself a date and be like, oh, on this day, that's when I'm going to go and get vaccinated. I don't have that date yet because so much of this process is moving so fast and there are so many different moving components. And all of those moving components are happening sort of simultaneously. So a couple of things that I'm keeping in mind, you know, certainly it's going to be longer for you and for me than it would be for health care workers, older adults and essential workers. Those people have the greatest risk and they need to be prioritized. We need to protect them. The additional steps include sort of the manufacturing, the delivery,

rollout campaigns and, you know, establishment of systems that help people remember to come back for their second dose. Again, that can be really challenging. So those are all of the steps for vaccines that have obtained this emergency use authorization for vaccines that aren't quite there yet. That's another step. So it's really hard to say exactly what all of that means. I'm hopeful for the fall. But I have to be honest and tell you, I'm not. Haunted is exactly sure what date. Mm-hmm. Yeah.

That's fair. So even before this pandemic, there was a great deal of vaccine hesitancy. And now many people are expressing concerns about receiving a vaccine that was developed so rapidly. And, you know, is that actually a valid concern? And maybe by way of answering that, could you walk us through some of the steps being taken to ensure safety and efficacy of a vaccine and these vaccines in particular? Yeah, this is a great question. So I completely understand that when you're not part of these steps and when you're not sort of living and breathing them every day, this can be incredibly confusing. It's happened so fast. And so many other things have been happening this year

that it's just really, really hard to sort of put all of this in context. And even people like myself who are infectious disease epidemiologists by training and by trade, we often struggle to keep up with the incredible amount of information that's being sort of circulated every day. So I'll walk you through some of the steps that have been taken to ensure the safety and the effectiveness of these vaccines. So this is why we do phase one in phase two and phase three studies, different phases of clinical trials. So in phase one studies and preclinical studies, what we're trying to do is identify, is this something that could help people? But more specifically, is this something that could potentially be harmful to people. And we're continuing to ask that question about

safety in each subsequent phase of clinical trials. And in each subsequent phase, we're asking more and more people, hey, are you feeling okay? How was that for you? Are you feeling discomfort? Even, you know, do you have like a mild headache? We want to know about that as well. And that doesn't stop after the emergency use authorization or even after full approval from FDA. So the U.S., for example, and this is true in other countries too, but specifically in the U.S., there are several different mechanisms for the reporting and sort of identification of different safety outcomes for vaccines. One of those is called the Vaccine Safety Data Link, and another one is called Vairs, or the Vaccine Adverse Event Reporting System.

So these are super fast mechanisms where we're constantly looking to see, hey, is there anyone who received this vaccine that maybe a week later they had like a headache, or they had some fatigue or they had some other sort of safety outcome. We want to know about that. Even though this vaccine has been approved by FDA, we're going to continue to ask these questions and continue to make sure that there isn't, for example, some really super rare one in a million type of event that could make us reassess the risk-benefit ratio of this vaccine.

And so along these same lines, can you talk about what emergency use authorization means? and whether we've seen this before and if we have under what circumstances? Yes, I will say we have seen emergency use authorization before, and maybe one of the best examples is during the 2009 swine flu pandemic. During that time, we had an EUA to use Tamiflu, which is a flu antiviral, for children less than a year old. At the time, it was already approved for children over a year old, but we knew during that swine flu pandemic that very young children were having

really severe outcomes. And we were really concerned specifically for that age group. And so we said, okay, you know, the available safety data indicates that this is probably a good risk benefit ratio for children under one year old. And then, you know, that kind of became part of our pandemic response. So it's certainly not the first time that we've used this mechanism. And I think it's really important that we do use it when we really need it, such as during a global pandemic. EUAs can only be given based on phase three results or interim results from phase three studies. And those interim results are sort of decided upon by this independent data safety and monitoring board. And then there's this expectation that those applications for EUAs that companies have to make formally to FDA.

When they apply for the EUA, they include all of the safety information from their phase one and their phase two studies. and then ideally their phase three study with a median of two months of follow-up. So that means that not only are they assessing safety outcomes, but they're making sure that they're identifying safety outcomes on the kind of time frame that we really think is relevant as well. So they're not just looking for the day after and then like two days after they forget about it. No, they really are looking for quite a long time after people do receive this shot. Yeah, that makes sense.

So I feel like you've explained a lot about how, you know, we've tried to make sure that this is a very safe vaccine. But for people who are maybe still a bit nervous or a bit scared, could you explain why someone maybe doesn't need to be any more afraid of this vaccine than any of our usual vaccines like MMR or even the seasonal influenza vaccine? So I do think it's understandable why people might be more hesitant or cautious about this vaccine development process because the MRI. RNA and the viral vector vaccines are relatively new to us. And the development process has been really quick. So it is definitely understandable. I think the main thing to remember is that all of these vaccines have gone through the same evaluation process as all of the other vaccines that we've had. So we took the same amount of steps and asked the same amount of questions that we would have if this vaccine development process had taken 10 to 15 years. We just did it in a much shorter

timeframe. And that was possible because we all decided, sort of, as a society, that these vaccines would be incredibly important to all of us. So there was a great amount of monetary support, of political will, and then also tens of thousands of people agreed to be participants in these studies as well. And that, you know, we wouldn't have had a vaccine so quickly if people were slower to say, oh, okay, I'm going to, I'm going to participate in this study. So they, they've all gone through the same evaluation process, and they all continue. to be assessed with the same safety reporting mechanisms. So, you know, we're not just skipping steps just because, you know, this one time it's convenient for us. No, we're still adhering to all

of those rules. We're not cutting any corners there. And again, I kind of mentioned this a little bit earlier, but the vaccines also cannot, these MRNA vaccines and the viral factor vaccines that can't give you COVID-19 because they don't contain the virus. Yeah. I also keep thinking about how this is just such a high-stakes situation for the companies producing these vaccines. Like if there's a misstep, if they, you know, if something happens, like there's a lot on the line. And not only that, but just like public faith or acceptance or, you know, whatever of vaccines, that's also hugely on the line at this point. And so it really does seem like there's so much to risk. So why would there be steps skipped or? something like that. Like there's just so much on the line. Oh, yes, absolutely. And, you know,

they have to still get the go ahead from FDA. So if they were to skip steps and then apply for this EUA, if they skip the steps, FDA has to say, you know what, sorry, we can't award you this emergency use authorization. We can't do it. And that really, just like you said, it represents a huge loss of investment for those companies. There's really no reason for them to skip steps. And there's a lot of reasons for them to not skip those steps. Right. Exactly. Yeah. So much of this concern also that I've seen around seems to be centered around potential side effects of the vaccines. And, you know, we expect to see things or it's not unusual to see things like mild side effects, you know, like you mentioned, a slight headache or maybe some fatigue. And this happens for many vaccines,

including potentially the vaccines for SARS-CoV-2. And these side effects are not really something to worry about because they do seem to be short and mild. But how likely is it that additional side effects, severe or not, that we haven't yet seen or even long-term side effects may emerge later on months from now as more people take the vaccine? So some of these outcomes, as you mentioned, kind of like headache, fatigue, what my mom calls just feeling junky, feeling cruddy, you know, maybe like feeling tired,

or maybe even having like a low-grade fever for a day. Those kind of, they're unpleasant, but they kind of mean your immune system is working. And so that's a really good sign for us. And, you know, it's a possibility, however small, that rare side effects that maybe more serious could happen. And that's why we continue to monitor vaccines for safety well after they're approved. We still are doing safety assessments for flu vaccines, for example. So we take that so seriously.

And especially, you know, you mentioned with COVID-19 vaccines, there's so much on the line with keeping people safe and then, you know, proving to people that we've made sure that these vaccines are safe and okay for them to get. We really take that so, so seriously. Yeah, definitely. So speaking of kind of long-term side effects, there's been some discussion lately of a fear of, antibody dependent enhancement, which is something that we've only touched very briefly on

on this podcast, I think, in our Dengue episode. So what do we know? Maybe if you could explain for people who don't remember kind of what antibody dependent enhancement is and what do we know about the risk of vaccine-induced ADE with this COVID vaccine or maybe, I don't know, with vaccines in general? Yeah, this is a great question. So antibody dependent enhancement of disease is kind of this phenomenon where, for example, a vaccine might not work in the way that you intended it to work. And for dengue, we know that, for example, if you get infected with dengue serotype 1, you may recover. And ideally, you know, it won't be like that bad of an infection, and it's going to be uncomfortable, but maybe not terrible. But then your risk of more severe

disease, including, like dengue hemorrhagic fever, is really increased if you then get infected with a different serotype, like two through four. And that's because your body has created these antibodies, but those antibodies don't neutralize the virus. And so unfortunately, one of two things can happen. One of those things is that those antibodies then promote the uptake of the virus into, for example, macrophages, other cells in your immune system. And instead of destroying the virus, the virus then infects the macrophage and then

produces more copies of itself. So that's one sort of way in which that can sort of make the disease more severe. And the other way that's kind of generally seen is that we're reacting to this infection in a much more severe way than we might have during the first time around. And so our bodies are forming these immune complexes that are kind of viruses plus a bunch of antibodies glommed on. And they're promoting these kind of really severe inflammatory chains. that kind of really cause a lot of discomfort and maybe some really bad side effects.

So that's kind of like the two main avenues where this could happen and where we've seen it potentially happen for stuff like Denke. I will say for SARS-CoV-2, the studies that have been done in animals, the results are really variable about which, if any of these things could be happening. But what does seem to be consistent is that neutralizing antibodies, so antibodies that can sort of take out the virus, those do protect animals from subsequent challenge. So subsequent exposure to that virus on purpose. And we do see neutralizing antibodies for these vaccines, the Pfizer and Moderna vaccines that have been reported. So that's a really good sign that this is not

sort of a major concern for these vaccines. And I will say as well, this hasn't been sort of a focus of the primary sort of efficacy or safety outcomes of the vaccine. but it's certainly the case that people in both the Pfizer and the Moderna clinical trials will have been seropositive at baseline. So that means some people, whether they know it or not, will have had a Sarascombe 2 infection before they get vaccinated. And we see very favorable safety profiles for both of these vaccines. And so we really do sort of that's an additional sort of, you know, notch that can help us feel comfortable about this. But we're obviously going to sort of of still be assessing that particular question.

Okay. That is good news, though. We haven't seen anything yet. That's pretty promising. So speaking of efficacy, what do we know so far about the efficacy of these vaccines? Can you walk us through also what efficacy versus effectiveness means in terms of vaccines and how that translates into protection under real world conditions? Yeah.

So efficacy versus effectiveness, this is something that is totally inside baseball, I think, to infectious disease epidemiologists and other epidemiologists. They're very similar, actually. So efficacy really refers to how something works, either a drug or a vaccine or something else, in a clinical trial setting under ideal conditions, where we're asking people to keep a diary and, like, set a reminder, 7 p.m., think about if you have a headache. And, you know, if you do, like, write that down. So we're like really like very closely following everyone that that are in these clinical trials.

Now in the real world, you can, I'm sure you can imagine a lot of differences. For example, I don't check a timer at 7 p.m. every night to see if I have a headache. So there is like, you know, the real world is a little bit messier. And, you know, things might sort of float away from us. We might forget, for example, that we're feeling just a little chunky today if something really good is on TV or something. So there's a little bit of a difference in terms of like how well we know it works in the ideal scenario where like we're absolutely like assessing every possible thing we can assess and we're making sure everyone's coming back for their second dose at the right time. In the real world, you know, maybe it doesn't happen exactly that way. And so we want to make sure that it's also as effective and as safe in the real world setting.

And so that's what effectiveness is. So when we say the Pfizer and Moderna vaccines are about 95% of the, effective. That means we're saying, okay, you know, we gave people these shots. We tried to get them in at the time that they were supposed to for their second shot. But, you know, they weren't living in a lab. They were also kind of at home, like living their own normal lives. So when we say that they're about 95% effective, that kind of relates to this understanding that this is, we think that this is more mirroring like a real world scenario than like a, you know, a very regimented clinical trial. Of course, they're still in a clinical trial.

So we do, after vaccines become available for use by, like for example, you and me, we do something called a phase four study. And that's kind of to assess, like, in truly real world conditions where people are not participants in a clinical trial, how well is this vaccine working? So we're going to continue to update that number. What do we know, at least so far, about how long immunity is expected to last from the various vaccines that we have? I will say that the existing evidence sort of suggests that immunity is what we call durable up until a certain point.

So we have this kind of durable immune response that seems to last for at least a few months. And of course, we don't know exactly how long it lasts because we would need a crystal ball into the future to know that for sure. The existing evidence, based on the follow-up that we've been able to have so far, suggests that it does last for at least a few months, and that is really great news. So what are some of the issues with clinical trials and vaccine development in terms of getting, you know, like a representative subsection of the population? And what does this mean for who may be able to get a vaccine once, you know, once they're ready or once they're all available, particularly in terms of like age group or immune status? So yeah, so I already mentioned a little bit how, you know,

trials are like not quite like real life. And this, you've touched on something that I think is so important. The people who are willing to participate in clinical trials are often a little bit different than the people who are just in our population in general. So they represent a subsection of the general, for example, the general US population, but maybe not every single person. For example, frequently clinical trials for vaccines don't include pregnant women. And they don't include people with underlying immunosuppressive conditions like people that have MS or Mycenae Gravis. And that's because we want to know, is this vaccine going to work in people that it absolutely definitely should work in? People whose immune systems are functioning in the way that we kind

of expect. And unfortunately, this can exclude people who are at really high risk sometimes. And so this is a really challenging sort of push and pull with vaccine development. And, you know, the other really important component here, I think a lot of the global clinical trials have really tried to address this, but it's still very challenging, is that there's probably not enough outreach to folks who are not white in clinical trials. And so that makes it hard to understand exactly, is this vaccine going to be, for example, better in this community, or is it going to be exactly the same? Or is it going to underperform? You know, so we need to make sure that we're getting a really representative sample. And then sometimes age two. I mentioned earlier

the EUA for Tamiflu was sort of then applied to children under one year of age. A lot of things are not tested for children unless the disease is specifically, like, mostly in children, because we have this different sort of, you know, risk-benefit calculus for children. We really want to keep them safe from any possible thing that they could experience that's unpleasant. So what this all means is that we have a vaccine, for example, the Pfizer-Biontac vaccine, that we feel. really confident about for adults. And there's some inclusion in their clinical trials of children a little bit younger. And we need to follow that data a little bit more before we can expand

those recommendations to children who are, like, for example, younger than 16. And we'll probably have to do separate studies about the safety and effectiveness of these vaccines, for example, in pregnant women or people with underlying immunosuppressive conditions. Interesting. I've seen a misconception kind of floating around that if you've already had COVID-19, you don't have to get vaccinated with this like immunity passport kind of idea. Can you explain, please, why that is not the case? Yes. So I will say for many folks who do have an actual COVID-19 infection, it does appear that they're neutralizing anybody does last, again, at least a few months. So that's a good sort of first step, but I will say again, it's not clear the difference between humoral antibody and mucosal antibody.

That's kind of this thing that I was talking about earlier, where those cells in your nasoferings or your nasal mucose are kind of, you know, lying in wait for that virus at that sort of respiratory epithelial interface. It's also not clear, for example, if you actually truly have a COVID-19 infection, how long you may shed that virus. So that's another really important difference between COVID-19 infection and receiving a vaccine against COVID-19. There are reports of people shedding virus for quite a long time. You know, even if you are recovered sort of physically and you are feeling great and you have antibodies, you could still be exposing other people. And that's certainly not something that you want to do. And then finally, it's not really clear from the available data exactly how long you're neutralizing antibody is going to last.

And so it's really tough to say, oh, you know, I was, I had a COVID-19 infection in March, so I'm good. I'm a Superman. I can do whatever. It's really hard to know. Based on the epidemiological data, what's your antibody level? How much of that antibody is neutralizing antibody? Are you going to be able to protect other people as well from transmission?

All of that is unclear. So I think maybe the last and possibly the most obvious thing to mention here is that it's better get vaccinated, it's not as uncomfortable as getting the actual illness. And that's why we have vaccines. They're much safer. Absolutely. So for our listeners who may know someone who is hesitant to receive this vaccine, what advice or reassurance can you give them that choosing to get one of these vaccines is a better option than taking your chances with COVID-19? I think it's important to consider your kind of risk-benefit measurement. And I'll tell you guys what I'm thinking about when I think about my risk benefit measurement.

So my risk, as cases rise in the U.S. and in Canada where I am, my personal risk for infection is increasing every day. And it's not, the risk doesn't just represent like a respiratory illness of like a common cold. It's a respiratory illness that could be quite severe for me and could give me really unpleasant long-term effects. And it's also about the risk of me spreading it to others that I really love and care. about. And on the flip side, the benefit from this potential vaccine is that I could be protected against an illness that could cause very severe and or long-term illness, but it would also give me peace of mind. And it wouldn't just benefit me. It would likely also benefit my community. So for me, that's more than enough to say, you know, this is a really good thing that I'm doing

for myself and also for all of the people that I care about around me. If you're embarking on a conversation with someone, you maybe don't see eye to eye with in terms of your risk benefit, or maybe they just have questions and they're not totally sure. I think it's really important to start from a place of common ground and kind of lead with empathy. I know that can be challenging sometimes, especially if you don't see eye to eye, but if you can see kind of common ground in terms of like, you know, you care about the people around you or you don't want to be out of work for two or three weeks or potentially longer, you know, or thinking about like, what is important to them? I think that's, that is really important. And then as much as you can,

sort of just being patient and empathetic with the reasons that they might be concerned or the way that they're thinking about risk benefit, I think is also really important. It can be challenging sometimes. And so I also recommend that you take breaks. If you get really frustrated, be like, you know what, I'm so sorry. I have to go right now. I got to go to the bathroom. Or like, I'm just sitting down at dinner or, oh, someone just called me. Can I call you back? I think it's really helpful and important to take breaks and then maybe revisit it when you're feeling like you have more emotional equipment to have that conversation. I've been thinking about this a lot and how great it is that we have like a vaccine that can be delivered to people in the U.S. now.

And I was really thinking about my mom who was born before the polio vaccine existed. So she was six when the polio vaccine became a thing. And at the time, there was just huge amounts of celebration. There were literal ticker tape parades for this vaccine because it was just this terrifying childhood illness that could just be so challenging and so terrible for so many people. And it was a huge relief to know that we would be able to protect children against that. And I have been thinking about like, man, it's kind of a shame that we can't have a ticker tape parade for these vaccines because they represent an incredible amount of of effort and sacrifice and hard work on so many people, including the trial participants who've

given their time and their energy for us to know that these vaccines are safe and effective. And I really hope, you know, as silly as it might seem, I hope that everyone gets a chance to set aside some time and truly celebrate the fact that this work has been done and it continues to happen and that people are working so, so hard to help us bring an end to this pandemic. It is truly amazing and just a feat. Specifically, the contributions of the people who have been study participants, I think is so amazing. And when I think about it, it really kind of gets me choked up because it is literally these people are heroes for us. They have helped save so many lives.

And we're very lucky, I think, to live in a world where people are going to work this hard to keep us safe. Thank you so, so very much, Dr. Sundaram. That was such a great interview. It was so fun, too. I learned so much. So much good information there. And I feel like, yeah, I feel just a lot more knowledgeable about the COVID-19 vaccines. It's been so hard to keep up with all of this news.

So it was great to have it in a digestible, here you go way. Exactly. I agree. It's been even as someone who's like into this kind of thing. Right. It's really hard to keep up. So. But Erin, we're not done yet. No, we're not. We're never done. Just kidding. Never. We also wanted to learn more about the logistical challenges that we know are huge in trying to get this vaccine distributed, both in the U.S. and across the globe.

And luckily, we were able to chat with someone whose actual job title has vaccine delivery in the name. Dr. Orrin Levine. This interview was recorded on November 24, 2020. So we'll let him introduce himself right after this break. Anyone who works long hours knows the routine. Wash, sanitize, repeat. By the end of the day, your hands feel like they've been through something. That's why O'Keefe's working hands hand cream is such a relief. It's a concentrated hand cream that is specifically designed to relieve extremely dry, cracked hands

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He became the first bachelor to ever have his final rose rejected. The internet turned on him. If I could press a button and rewind it all I would. But what happened to Clayton after the show made even bigger headlines. It began as a one-night stand and ended in a courtroom, with Clayton at the center of a very strange paternity scandal. The media is here. This case has gone viral. The dating contract. Agree to date me, but I'm also suing you.

Please search warrant. This is unlike anything I've ever seen before. I'm Stephanie Young. This is Love Trapped. This season, an epic battle of He Said She Said, and the search for accountability in a sea of lies. Listen to Love Trapped on the IHeart Radio app, Apple Podcasts, or wherever you get your podcasts. In 2023, a story gripped the UK,

evoking horror and disbelief. The nurse who should have been in charge of caring for tiny babies is now the most prolific child killer in modern British history. Everyone thought they knew how it had. ended. A verdict, a villain, a nurse named Lucy Lettby. Lucy Lettby has been found guilty. But what if we didn't get the whole story? The moment you look at the whole picture, the case collapses.

I'm Amanda Knox, and in the new podcast, Doubt the case of Lucy Lettby, we follow the evidence and hear from the people that lived it, to ask what really happened when the world decided who Lucy Lettby was. No voicing of any skepticism or doubt. It'll cause so much harm at every single level of the British establishment of this is wrong. Listen to Doubt, the case of Lucy Letby, on the IHeartRadio app, Apple Podcasts, or wherever you get your podcasts. Hi, I'm Orrin Levine. I'm the director of the Global Delivery Programs at the Bill and Melinda Gates Foundation. In this role at the foundation, I lead a series of teams that help to both introduce and scale new life-saving vaccines and improve primary health.

health care systems around the world. One of the roles that I play externally for the foundation is that I sit on the board of Gabby, the Vaccine Alliance, which is one of the central players in global immunizations. And more recently, in COVAX, the international collaborative effort to vaccinate everybody around the world. Awesome. Great. So our first question has to do with some of the biggest hurdles to vaccine distribution here in the U.S. and just just like big picture, what are the kind of things that we might see at a national level that might make vaccine deployment a little bit more challenging? So preparing for the rollout of vaccines in the U.S. or anywhere is going to be an effort of

unprecedented scale. The number of people that we want to try and vaccinate, the speed with which we want to vaccinate them, and the fact that we need to vaccinate them with not one but two doses of vaccines make the rollout of COVID-19 vaccines kind of a scale and complexity that's really going to challenge every system around the world. And the challenges can be bucketed, if you will, into both supply challenges, right? So there's a volume of materials, logistics that need to be sorted out to make sure that the right vaccines end up in the right place with the right supplies and the right people to deliver them at the right time and demand issues. And we're seeing the emergence of demand issues

around the world in the U.S. and elsewhere. Ironically, COVID vaccines had an anti-vaccine movement even before they had vaccines. And that complicates things in terms of the acceptance and demand for the vaccine. So I think that's a very important. one of the things I worry about in the USNS where is we can't take for granted vaccine demand. We're really going to have to engage with people and listen to them and then answer their questions so that they can feel the confidence they need to accept the vaccine and get the immunity and protection that comes from those and help us all to get back to an increased comfort of interacting with each other. Are there any hurdles that might be different

in terms of global distribution of the vaccine compared to the hurdles and distribution in the U.S.? There are some challenges, obviously, for different places that differ. I tend to focus on what brings us together and what's more common, but there are some unique characteristics. One is access to the supply. As you may know, there's a global effort called covacs, which is trying to bring together high-income countries and low-income countries to jointly fund a portfolio of vaccines that could then help to kind of vaccinate the world evenly, that is operating in an environment where there's been a lot of bilateral deals, individual countries kind of locking out vaccine supply for themselves. So one of the things

that is different is a kind of power dynamic and who's, you know, laying claim to different doses at different points in time. There's a financing element to that as well. Wealthier countries are typically able to pay more, and that sometimes puts them at the front of the line in those negotiations. It's a big reason why COVAX was created, because it's, I think, a shared value of many of us that in the middle of a pandemic vaccine allocation should be equitable, not just driven by the lottery of whether you happen to live in a country that's wealthier than another one. Yeah, absolutely. We've heard a lot about different countries pre-purchasing, as you mentioned, these large stocks of vaccines. And so in effect, though, we might have several different vaccines

available. Which vaccine will a different country choose? And will that be determined by what might be available in terms of just the sheer number of vaccine stocks that are already pre-purchased? Yeah, I think, Aaron, that that's going to be one of the complex parts of this role. out as different vaccines emerge with different characteristics and different efficacy and different price, you'll have preferences by different countries for these pieces. So for example, many of us will probably remember where we were when we first heard that there was a COVID vaccine that worked. The first one that we heard about was the Pfizer vaccine. And that vaccine reportedly has over 90% efficacy, which is really, really good. It's also a complicated vaccine to deliver in terms of some of

its characteristics. It requires what's called ultra-low temperatures. It's required to be stored at negative 70 Celsius. Most vaccines are stored between 2 and 8 degrees Celsius, which is like your kitchen refrigerator. Some vaccines are stored at negative 20 Celsius, which is more like your freezer of your kitchen refrigerator or your or your downstairs freezer negative 70 is dry ice. You got to wear oven mitts when you handle it. You got to have a special supply chain for it. It also is administered in a 0.3 ml dose. Every other vaccine is administered as 0.5 ml dose. And so it requires a little bit of special training, a little bit of special handling, an ultra cold chain delivery system. it's going to be more complicated.

On the other hand, it's going to deliver 95% efficacy and have a differential price point from other vaccines. So that complex mixture of can I afford it, can I get it, when can I get it, how much can I get it, can I manage the complexity of the ultra-cold chain pieces, those are all going to figure into the decisions that countries make and the plans that countries make in order to roll those vaccines out to everyone. If we think about low and low middle income countries, ironically, they have some of the most experience working with ultra-cold chain vaccines. The early Ebola vaccines required negative

70 as well. And so countries like the Democratic Republic of Congo and Rwanda, Uganda, Guinea, Sierra Leone, Liberia, these are actually countries that have experienced using in small volumes, ultra-cold chain requiring vaccines. But that complex set of factors is what I think will go into the decisions that countries make and the rollout plans that they make with the vaccines. That's interesting. That hadn't really occurred to me before, but that completely makes sense. And so it seems like on the surface, it's great to have different options for a successful COVID-19 vaccine, but then you start to think about the logistics and how if the vaccine requirements are different, both in terms of the number of doses required

or storage requirements, then you have to just like, you know, bulldoze forward with one of those options. Is that what we might end up seeing for some of these countries? Or do you think it might be, oh, well, we'll have to just kind of create a different supply chain or a different deployment chain for each one of these in case one ends up working better than the others or one is cheaper than the others or one is going to be more available than the others? I think early on, Aaron, there's probably going to be a intention wherever possible. to supply a country with a vaccine rather than to have multiple vaccines flowing through countries. Now, if it's a big enough country and each sub-geography is large enough, you might think about

that. But ideally, because these vaccines aren't going to be interchangeable with one another, you're going to want to simplify, I think, that part of the supply chain. And then from there forward, say, everybody in this country is getting either this MRI vaccine or this live vaccine or this inactivated vaccine, those decisions to kind of supply a country with a single vaccine simplify some of the logistics that would become way more complex if there are multiple vaccines flowing around at a subnational level. Yeah. So earlier you touched on how there was an anti-vaccine movement or an anti-COVID vaccine movement even before there was a COVID

vaccine. And of course, a lot of this mistrust or skepticism that surrounds vaccines has been growing in general in the past few decades. And especially from some communities that might already be, you know, rightly distrustful or mistrustful of the medical system. So could you talk about how that plays into not only vaccine development, but administration? And also, what are some of things that could be done to rebuild trust in those communities? Honestly, one of the things that keeps me up at night is the demand side of this. As a person who spent my career working in vaccines, I literally think vaccines have an opportunity to save the world, right?

Like the thing that is keeping us from interacting is that we have a virus for which all of humanity lacks immunity. And vaccines have the potential to confer that immunity to all. all of humanity, but only if people are willing to accept them, only if people are ready to be immunized. And to do that, people have to trust their health system. They have to trust their medical providers. They have to trust the process by which the vaccines were carefully manufactured, carefully regulated to make sure that they're safe and potent when they come out. And any of us who's a human, knows that trust is slow to build and quick to erode.

And in the most recent era, we've had an erosion of trust on many levels. Some of it related to vaccines specifically and some of it more generally in institutions and in science and many other things. So I hope we can use vaccines actually as an opportunity to restore trust. And that restoration probably starts with listening to people. there's been too much, in my view, polarizing, yelling at each other and not enough listening to one another. So I'm really hopeful that one of the things that will, a side effect, if you will, be to get people to listen to one another.

Yeah, that would be the dream. That would be fantastic. In terms of vaccine specifically and maybe vaccine deployment or administration on a global scale, you know, what do you think are the major lessons we've learned or how will this have changed the way that we view either emerging infectious diseases or vaccines in the future? I think there's a lot of opportunity. I keep trying to look for silver linings in all of this. And I think there is some opportunity going forward. Let me give you one of the examples of the opportunity. I think the rollout of COVID vaccines offers us. In many cases,

communities where we work, young adults may not be very engaged in their health system. They may not be regularly getting preventive care. They may not be getting screened for some of the concerns that they have or getting access to family planning or other preventive services. I wonder if in the execution of our rollout of COVID vaccines, if we integrate COVID vaccination, the package of services that they want and value. If we won't, if you will, draw into the health system a large set of people who've been needing or potentially benefiting from health interventions, but who've been not accessing

the system in the future, in the past. And so if we can use the act of engaging with them around COVID vaccination to engage with them around a broader set of health prevention and health conditions, it could be that the rollout of COVID vaccines helps impact people's health well beyond conferring immunity. I personally can't wait for us to get to the point where we're successful rolling out vaccines. I haven't seen my mom and dad in nearly a year, and I want to be able to hug my mom and dad without worrying about sharing a deadly virus with them. So my interests are both global. and equity and, you know, partly deeply personal as well. And thanks for, you know, sharing these kinds of

stories and this information with your listeners because I think they're a big part of making this a success. Thank you so, so much again, Dr. Sundaram and Dr. Levine. It was so great to talk with you, and we really appreciate you taking the time out of your incredibly busy schedules to help us all get some more info about vaccines. Yes, we learned so much. So much. So as always, in these COVID-19 episodes, we want to summarize with five key points that we want you to take away from this episode. So, number one, we learned that there are at least three different vaccines that are very close to approval or in some cases have been approved already in the U.S. and the UK and a few other countries. So these are the ones that we've focused on for this episode. These are the Pfizer vaccine,

the Moderna vaccine, and the AstraZeneca vaccine. And importantly, none of these vaccines contain the entire SARS-CoV-2 virus. They all contain what are essentially instructions of one kind or another to make one protein or antigen that is specific to SARS-CoV-2 that our body can then recognize and respond to in the case of a future exposure or infection. So what that means is that none, I repeat, none of these vaccines is capable of giving somebody COVID-19, which I think is so important. While it is normal to have some mild side effects after a vaccine, like a health. headache or maybe pain where you got the vaccine shot or even a mild fever or just feeling kind of

cruddy. These kind of symptoms don't mean that you have COVID-19 and they don't mean that you're infectious to others either. They just mean that your immune system is doing its job and responding to the vaccine, which is awesome and what we want your immune system to do. Yes. Number two, These vaccines have gone through the same exact safety and evaluation steps that other vaccines like the seasonal influenza vaccine or the measles, mumps, and rebella vaccines also had to go through. All of the same regulatory and safety questions were asked about the COVID-19 vaccines as they were for these other vaccines that were more familiar with. The difference is that with these COVID-19 vaccines, we were able to ask and answer these questions in a much shorter. time frame, which was made possible by the sheer amount of people and resources committed to this project. And like those other vaccines, we will continue to monitor the safety of these COVID-19 vaccines, both in the people who were involved in the clinical trials, as well as everyone else

who takes them. Tens of thousands of people were involved in these COVID-19 vaccine clinical trials, and the results have been very encouraging, not just in terms of efficacy, but also in terms of safety. Some mild side effects such as headache or fatigue might be expected, as you mentioned in point one, Aaron, but so far it doesn't appear that there are major adverse events associated with the vaccine. And our incredibly robust vaccine adverse event reporting system means that any and all side effects of these vaccines will be cataloged and closely examined. And if there do emerge more severe side effects later on, we will catch them like very quickly. Really early. Yeah. Immediately. And one thing I keep coming back to is just how much is at stake with these vaccines.

Yeah. The companies and the governments that have invested so much time and resources into vaccine development, public support for vaccines, there's a lot to lose here and so very, very much to gain. A misstep could be incredibly costly in many ways. And for that reason, there are many, many, many people ensuring the safety and, efficacy of these vaccines. Absolutely. And speaking of efficacy, point number three, just how effective are these vaccines? It turns out very. So we learned from Maria that effectiveness is looking at how much protection these vaccines are going to provide in the real world, not just in a clinical trial or a very controlled setting. And in the case of these trials that have been conducted already, it seems like the vaccine candidates we have appear to be 90 or 95% effective, which is amazing. Truly amazing.

Really. We also know from these studies that immunity seems to be durable at least for a few months, which is great that we know that it lasts for at least a little while, although we still don't know exactly how long immunity will last. And this is also true for infection. We know that immunity after infection last, for at least a few months as well. But especially in the case of these vaccines, immunity isn't immediate.

Because all the vaccines that we have that are close to approval are two-dose series, meaning you have to get one dose and then another three weeks later, full immunity isn't expected until at least five weeks or longer after the first vaccine or two weeks after you get that second dose. And because these are not live virus vaccines, and they're given in our arms rather than through like our nose, like some of the live flu vaccine nasal sprays. We're not positive about the amount of mucosal immunity that they provide.

So it's at least theoretically possible that even after vaccination, somebody could harbor the SARS-CoV-2 virus in their mucous membranes. And even after a real infection with SARS-Co-2, people can shed virus for a really long time after infection. And that is why it's so important that even after vaccination or infection, we continue to practice all the same control strategies we've discussed at length, like wearing a mask, social distancing, etc. Yeah, it's just one more layer of that Swiss cheese situation. Point four, developing effective vaccines against the virus that causes COVID-19 was just the first necessary step. It was hugely important, but it's still just the first step, because we still need to get these vaccines to the people who need them.

If you've been keeping up with the news, we've already started the rollout of vaccines here in the U.S. and in the U.K., as well as some other places, to the highest priority recipients like frontline health care workers and those residing in long-term care facilities. But the logistics of vaccine rollout are enormously complex and will require the construction of a lot of different moving parts. For instance, all of these vaccines that are close to approval or have been approved are two-dose series, which does make their rollout a bit more challenging to make sure everyone gets both doses in the proper time frame. Fortunately, some countries have the supply and deployment change already in working order from past vaccine campaigns, but the existence of three different vaccines that may vary in their storage and administration requirements could lead some countries to build up a system around one of the types of vaccines. And I mean, all in all, it's kind of a good problem to have. Like we'd rather be choosing among several effective vaccines rather than none at all. But it does mean that some places will have to put their resources towards one of these vaccines over the other. And finally, point number five, which I think is one of the biggest take-home points for me especially.

Vaccine hesitancy is an important issue, especially for these new COVID vaccines. But hesitancy in the face of something as new as this vaccine, it's really understandable. And it's important for us, you know, as educators or even if you're just talking with friends and family, to address people who may be hesitant or have questions about this new vaccine with empathy. Maria Sundaram had, I think, some really good advice, which was to start any conversation by trying to find a place of common ground, whether that be concerns about getting sick yourself or concerns about spreading disease to loved ones, whatever it might be. But by starting from a place of common ground, it's at least possible to have a conversation, whether about vaccines or honestly, this is

just good advice for life. And from Oran's interview, and this is important, especially on a community and kind of larger scale, we can't just assume that there's going to be a demand for this vaccine or any of these vaccines. We have to have good, honest, open communication surrounding these vaccines and the development process and everything surrounding them and encourage that people get it and make it really easily available rather than just assuming that people are going to want a vaccine or will seek it out on their own. Yeah, that's definitely true. I feel like now it's more important than ever to maybe have these conversations and, you know, practice this empathy. It's crucial right now to do that. Yeah. A huge thank you again to Dr. Sundaram and Dr. Levine for taking

the time to chat with us about these amazing COVID-19 vaccines. We learned so much. We did. Also, a huge thank you to Diane Scott and Amber Zettis for helping to set us up to chat with Dr. Levine. Yes. And if you want to learn even more about these COVID-19 vaccines and other vaccines in development against the SARS-CoB-2 virus, there's an amazing, amazing vaccine tracker that was developed by a huge team of brilliant people, including Dr. Sundaram, at McGill University and also at the University of Minnesota, among other places. It's an incredible resource with tons of great information, and you can find it at COVID-19.trackvaccines.org.org. and we will also post a link to it in our show notes as well as on our website. Yeah, I think this is a great resource either for you or maybe to send to friends and family that might be asking questions. It's just a really comprehensive resource. Thank you so much to Bloodmobile, who provides the music for this episode and all of our episodes. And thank you to the exactly right network, which we are a very proud member of,

and without whom this podcast would not be possible. This podcast would also not be possible without you, dear listeners. So thank you so much for listening to it all. Thank you, thank you, thank you. Until next time, wash your hands. You filthy animals. I'm Amanda Knox, and in the new podcast, Doubt the Case of Lucy Letby, we unpack the story of an unimaginable tragedy that gripped the UK in 2023.

But what if we didn't get the whole story? The moment this has been made to fit. the moment you look at the whole picture, the case collapsed. What if the truth was disguised by a story we chose to believe? Oh my God, I think she might be innocent. Listen to Doubt, the case of Lucy Letby on the IHeartRadio app, Apple Podcasts, or wherever you get your podcasts. This is Special Agent Regal, Special Agent Bradley Hall. In 2018, the FBI took down a ring of spies working for China's Ministry of State Security,

one of the most mysterious intelligence agencies in the world. The Sixth Bureau podcast is a story of the inner workings of the MSS and how one man's ambition and mistakes opened its fault of secrets. Listen to the Sixth Bureau on the IHeart Radio app, Apple Podcasts, or wherever you get your podcasts. I'm Clayton Eckerd in 2022. I was the lead of ABC's The Bachelor. But here's the thing. Bachelor fans hated him. If I could press a button and rewind it all I would. That's when his life took a disturbing turn.

A one-night stand would end in a courtroom. The media is here. This case has gone viral. The dating contract. Agree to date me, but I'm also suing you. This is unlike anything I've ever seen before. I'm Stephanie Young. Listen to Love Trapped on the Iheart Radio app, Apple Podcasts, or wherever you get your podcasts.