Episode 164: Only the Beginning

OU Ep 164 final.mp3

Chris Dall: Hello and welcome to the Osterholm update, a podcast on COVID-19 and other infectious diseases with Doctor Michael Osterholm. Doctor Osterholm is an internationally recognized medical detective and director of the Center for Infectious Disease Research and Policy, or CIDRAP, at the University of Minnesota. In this podcast, Doctor Osterholm draws on nearly 50 years of experience investigating infectious disease outbreaks to provide straight talk on the latest infectious disease and public health threats. I'm Chris Dahl, reporter for CIDRAP news, and I'm your host for these conversations. Welcome back, everyone, to another episode of the Osterholm Update podcast. As we move into the final weeks of the summer, the latest summer surge of COVID-19 is showing no signs of slowing down. According to the Centers for Disease Control and Prevention, most areas of the country are seeing consistent increases in COVID markers such as emergency department visits and hospitalizations, and wastewater levels continue to trend upward. And yet, last week, we received yet another reminder that COVID isn't the only infectious disease threat that we need to pay attention to. When the World Health Organization declared a second public health emergency for Mpox, also vying for our attention is the ongoing outbreak of H5N1 avian influenza, which continues to spread in US dairy cattle.

Chris Dall: And in a recent essay published in Foreign Affairs, Doctor Osterholm warned that the United States and other countries will not be able to get ahead of the next pandemic, whatever it may be caused by, if they don't start devoting the necessary resources to developing better vaccines, treatments and other countermeasures immediately. Although such efforts will be costly, failing to take these steps could be catastrophic. On this August 22nd episode of the podcast, we're going to talk about that essay and Doctor Ostrom's recommendations for what governments can do to do to prepare for the next pandemic. We'll also provide an update on COVID-19 and the latest H5N1 avian flu developments. Explain why the W.H.O. has issued a second public health emergency for Mpox and what that means. And answer an ID query on COVID vaccines. And we'll bring you the latest installment of This Week in public health history. But before we get started, as always, we'll begin with Doctor Osterholm's opening comments and dedication.

Michael Osterholm: Thanks, Chris, and welcome back to all the podcast family members. It's great to be with you again. Uh, you're a real gift to those of us here at CIDRAP who are part of the podcast. We so appreciate being able to communicate and discuss with you the issues of the day. And I must say, for this particular podcast, I feel almost as if in order to make it a timely podcast, meaning that it's short enough so that you'll actually listen to it. I wish I could go about four times the speed of my normal voice, just because we have so much to cover today, so we're trying our best to really focus on what we think are the key issues of the day, but there are a lot of them, so stay tuned. I also want to welcome anyone who may be coming to the podcast for the first time. I hope you find what you're looking for, even if it's not the entire podcast you're looking for. If there are pieces of it that serve as nuggets of information for you that you find helpful, that's great. And again, I ask you, please let us know how we're doing. We really welcome your feedback on what we're covering, how we're covering it, what we're not covering and should. And so I want you to know that we listen to you very, very carefully. And hopefully, we're reflecting back to you what it is that you're telling us you're looking for.

Michael Osterholm: For today's opening dedication segment, I'd like to talk about what I think is a really unfortunate trend I've been hearing about, including from dozens of listeners in our podcast family. It's sounding like there's another wave of misinformation regarding the COVID vaccine, this time suggesting that the 20 2324 vaccine that should currently be available has been recalled or have all expired. These inaccurate claims, which we will address in more detail later in this episode, have made it difficult for those of you who are seeking out a vaccine, as I did several weeks ago, to find available doses at your local pharmacies. And as we all know, this comes at a time for some of us who felt quite unprotected with this major surge in cases. COVID-19 vaccine misinformation has come in many forms since the early days of vaccine development and availability. I find that today's strain of misinformation to be especially frustrating because it ultimately limits vaccine access for those who are interested in receiving a dose and, frankly, should get another dose. And of course, for those actively seeking it out, they'd have to go from pharmacy to pharmacy. This is a challenge. You are the individuals who are making an effort to stay informed, stay healthy and stay protected. And these messages just jeopardize your ability to do so. But as we've learned, these types of messages travel fast and far.

Michael Osterholm: And so I have no doubt that it is also reducing interest and sowing distrust among those who are on the fence about getting the vaccine. They'd be more likely to go in for a jab if they thought what they were hearing reaffirmed the vaccine safety and availability. Instead, the message they're hearing makes it more likely for them to not pursue vaccination. While our country experiences this huge surge in COVID cases and an uncertainty about when the newer vaccines will be available. I will be covering that much more in another part of the podcast. My voice on this podcast surely does not constitute medical advice, and I hope none of you take it as such. So I'm not telling you whether you should go out and get a COVID vaccine right now, or wait for the updated vaccine. Hopefully that's a decision you'll be making by taking into account your circumstances and health history, along with the advice from your own physician. But the message I do want to convey is that if you do in fact choose to get the vaccine now, this week, the product you'll receive is not expired and it has not been recalled. I can't speak to limited access at local pharmacies, but I empathize with your frustration and your impatience on this issue. One of the goals that our podcast team makes a real priority for this podcast is to provide accurate and timely information about COVID-19 and other infectious diseases, and to do our part in battling the messengers who promote inaccurate and misleading information.

Michael Osterholm: I hope that what you learn here makes you more confident as an advocate for your health, and that you share what you learn with your communities. Today's episode is dedicated to all of you for your dedication to this shared goal, and especially for those who are fighting through all the myths and disinformation. And now on to that quote unquote light part of our podcast. Today, on August 22nd in Minneapolis, Saint Minneapolis-Saint Paul. Sunrise is at 623. Sunset is 806. 13 hours and 42 minutes and 48 seconds of sunlight. We are losing sun at about two minutes and 53 seconds a day. Today. It is accelerating and it will continue to accelerate through September 20th 21st. Now to our dear. Dear friends and colleagues in Auckland, New Zealand, particularly those at the Occidental Belgian Beer House and Vulcan Lane. Today your sun rises at 6:55 a.m.. Your sun set is at 552. You're only at ten hours, 57 minutes and eight seconds of sunlight. But. And it's an important but you're now gaining sunlight at about two minutes and six seconds a day, and that number will continue to increase. So I hope we both enjoy our sunlight today and knowing that we're in for change. But that's what makes life interesting.

Chris Dall: Mike. As I noted in my introduction, the marker is that the CDC uses to track COVID continue to climb, and some are saying that this may end up being the biggest summer wave we've seen in terms of the number of infections. We're also seeing a significant wave of cases in Europe right now. What's going on?

Michael Osterholm: That's right Chris. It is very clear that this virus has not gone anywhere. And I know so many people being infected every day. So it's not surprising to me that the summer wave, as it's now being called, is continuing. But let me be really clear again, if you look at the pandemic from its beginning in 2020 till now, you can actually see that we've had ten different surges or waves in a sense that have occurred. And if you distribute those by when they started, when they peaked, you'll see that they're distributed throughout all four seasons. So while this is clearly the summer 2024 wave as such, it doesn't mean that there are summer waves. Generally speaking, it's just I think, again, a function of when do we see waning immunity in the population, meaning that you've been at least 4 to 6 months from previously having been vaccinated or having been infected. And of course, it's with the new variants. And we're going to talk about that today. These variants keep changing relatively quickly. What we're seeing now is, I believe, the COVID of our future. We're going to see more and more activity like this as we go forward, where it won't be necessarily one season. It may actually see big increases in cases. But fortunately, as we'll discuss today, there will be fewer, more severe cases, fewer deaths, fewer hospitalizations. It doesn't mean they're done, but there'll be fewer.

Michael Osterholm: And we'll talk more about that. But let's focus right now on what's happening today. Based on the latest CDC data, the national wastewater concentrations have been classified as very high, far exceeding the level we saw last summer and nearing the levels we saw during the summer 2022 wave and the winter surge of 2022 into 2023. Three. These waves which were associated with the Omicron subvariants. Regionally, the West has seen the highest concentrations of virus and wastewater about 1.5 times the national average, followed by the South. Looking at the state level data. Levels are either high or very high in nearly all states, 43 of them and the District of Columbia, 11 are high and 32 and the district are very high, which now includes Minnesota. Based on data from hospitals that still report their COVID numbers, which is only about one third of the hospitals in the country, there are now just over 5250 Americans reported to be hospitalized with COVID. This is up from 4700 on our last podcast, and around 10% of those hospitalized are in ICUs. These hospitalization numbers are much, much lower than they were during parts of the pandemic. For example, this is a 97% decrease from the 150,000 hospitalizations we saw during the peak of Omicron. And to add some context, this is about an 89% decrease from the 46,000 hospitalizations we saw during the summer and winter of the 2022 peaks of Omicron.

Michael Osterholm: So while hospitalizations are increasing, we're in a much better position right now than we were during the last waves. I might also add, we will be seeing the hospital numbers changing on November 1st. The Department of Health and Human Services has now made it mandatory for hospitals to report COVID hospitalization data, as they were doing during the pandemic, so stay tuned on November 1st. Again, we'll go back to having numbers that are more comparable to what we saw happening during much of the pandemic. So let me just sum up the hospitalization data. However, in saying that any time we can see a 97% decrease over the peak, that's great news. And again, reminding you that we have had a 97% decrease in hospitalizations from the early days of the pandemic through the current time. Let's look at deaths. Remember, these are a lagging indicator, but they're also increasing. Last week was the highest number of reported deaths since March, with 1134 Americans lives lost to COVID-19. This is up from 652 deaths reported two weeks ago in the last episode, a nearly 75% increase and one that we predicted would happen based on what we saw was with the continuing activity at the community level. This marks the 231st week, with more than 400 deaths, and the sixth straight week with more than 500 new deaths. Now, this again reflects what I think will be the COVID picture of the future.

Michael Osterholm: We will continue to see this battle between our human immune systems, the ability that they have to fight off the virus after 4 to 6 months post vaccination or infection, and the intersection with the new variants. So this is not going to go away and it's not turning into a seasonal disease. Yes, there will be a peak in a season, but any of the four seasons could in fact be the time that that peak occurs only depending on other new variants. And what is the waning immunity status of the population? Now let's shift over to look at the international side of things and only the limited data that is available. The W.H.O. released their monthly report last week, which covers the four weeks from June 20th 4th to July 21st. This report shows a 30% increase in cases from May 20th 7th to June 23rd, and a 26% increase in deaths. While these data represent the picture from a month ago, they are still consistent with the increases we've been seeing here in the US. Similarly, during the same 28 day period, data from 48 countries who reported COVID hospitalization data showed an 11% increase in hospitalizations compared to the previous month. All this is to say that on July 21st, global COVID-19 activity was increasing. More recently, there have been continued signs of increasing COVID activity in most reporting countries in Northern Europe and Southwest Europe, as well as some reporting countries and other regions, according to the most recent W.H.O.

Michael Osterholm: Respiratory Virus Activity Update for the week ending August 4th. Looking at Europe specifically to touch on the wave you referenced in your question. Their most recent weekly update showed elevated COVID-19 activity in hospitals since late spring, but with declining trends in many countries and most hospitalizations now being for those 65 years of age and older. Last episode, we also discussed the surge in hospitalizations in South Korea from less than 100 in early July to over 500 by the end of the month. And unfortunately, with this new variant, CP3 driven surge, this increase has only continued. Last week, there were 1900 Koreans hospitalized and 220 hospitals, with most patients being 65 years of age and older. Similar to what we've seen in the US and other countries, Korea dropped many of their mandates and control measures in May of 2023. At the end of their national emergency and isolation guidelines have also been loosened over time. What is happening in Korea is happening across the globe. And to circle back to your question about being the biggest summer wave we've seen, I don't think that's the case. Yes, we're seeing a surge in COVID activity, but we're not seeing the severe disease and death that we experienced in other stages, especially summer surges. As I just noted a moment ago, I think this is the new face of COVID 2024.

Michael Osterholm: And into the future, we're going to see more and more of this interplay between waning immunity and new variants. And with that, we could see a surge in any of the four seasons. They will not be nearly as severe in terms of hospitalizations and deaths as the previous pandemic related surges of 2020 to 2023, but they will be real. They will likely be more significant than we see with seasonal influenza in the Northern hemisphere in the months of November through January, and again the winter of the Southern hemisphere. So let me just say stay tuned and be prepared to live in a world with COVID. One of the challenges we have today is how do we come to live with it? And in several of the questions coming up, we're going to address parts of that because you, as listeners have inquired of us, what does this mean? How do I live my life? Do I live in fear? Do I just accept this as any one of the other risks that I accept every day when I wake up? What does it mean? We'll try to give you more details in a moment, but to summarize, COVID is here. It's not good, but it's not nearly as bad as it was. And we're trying to figure out how to live with it. And unfortunately for all, too many were as families learning how to die with it.

Chris Dall: So a question now about uh, variants and the updated COVID vaccines. According to the CDC, KP 3.1.1 is now the leading variant in the US, accounting for roughly 37% of sequenced viruses. So do we know if the updated vaccines have been tested against KP 3.1.1?

Michael Osterholm: Well, Chris, we've all been wondering about that very same question since KP 3 1.1 came into the variant scene. The CDC variant proportion data published last Friday showed another big jump for the subvariant, and it doesn't look to be slowing down. So what does this mean for the expected performance of the 2024 2025 updated COVID vaccines? Let me, first of all, remind you that any data that we ever provide you with a newly available vaccine is likely only going to be addressing the issue of the serologic response of that vaccine in individuals, meaning, did we develop more antibody. What kind of antibody? We will not have had an opportunity to test it in the community. So while we've done all the testing we need to do for safety and generally how they work, the actual amount of protection you get from the vaccine is something we'll only know as it's used over time. As our listeners may recall, the FDA's Vaccine and Related Biological Products Advisory Group, or VRBPAC, shifted their original vaccine formula recommendation from J&J one alone to optionally including KP.2 in an effort to more closely match the antigenic profiles of the variants likely to be circulated in the coming months. We basically went from the emergence of this J&J, one variant of which then out of that came the flirt variants, which we discussed last time.

Michael Osterholm: What? Flirt means and gave us the KP.2. And now we have this new variant, KP3.1.1, which is technically not a Flirt variant anymore. So all you really need to know is listeners. Is this continued changing of the virus and the variants, and how they interact with the human body in terms of immunity is an ongoing battle, and what we know about it today may be very different than what we know about their protection tomorrow. So where are we at? Well, the KP.2 formation accounts for the close relatedness to the JN.1 its predecessor, while also including a key mutation with a high probability of sticking around. I applauded the decision of the FDA in June to allow the vaccines to be KP.2, as opposed to JN.1. I think it was the right choice. Now, data presented in a Novavax financial meeting that their JN.1 protein-based vaccine, which is different than the mRNA, actually resulted in similarly high neutralizing antibodies for JN.1 and KP3 1.1 pseudovirus, which is a virus that is actually very similar to the actual KP3.1.1. Again, these data were antibody studies with the vaccine given to human subjects.

Michael Osterholm: This study is yet to be repeated by a research group outside of Novavax, but based on the limited data, it appears that at least this vaccine will be effective in reducing severe disease and deaths associated with infection with the currently circulating variants. KP.3 1.1 neutralization results from Moderna and Pfizer's KP.2 mRNA vaccines have yet to be publicized, though I expect that work is internally underway and being considered by the FDA before it will be approved in the near term. An unnamed source from the FDA told CNN that the agency is expected to approve Moderna and Pfizer's formulation soon, though the same cannot be said for Novavax. Prioritizing safety in the approval process is the utmost of importance, but delays ultimately slow down the timeline of delivering updated vaccines to the public, especially when a growing number of vaccine seekers are opting for the Novavax protein based formula over the mRNA alternative. The more the rollout is delayed, the more opportunity of infection among high-risk populations and associated morbidity and mortality during this wave. Unfortunately, there's not a lot of transparency on the topic from federal agencies, but we continue to deliver the most up-to-date information we have as soon as it becomes available.

Chris Dall: Mike. On our last episode, we discussed a study on the use of respiratory protection in US cancer centers during the winter 2022-23 COVID surge. And that prompted an email from a professor at the University of Washington regarding the idea of establishing triggers for universal use of respiratory protection at healthcare facilities during COVID surges. Is there any agreement on what those triggers should be?

Michael Osterholm: Well, let me first of all say that I heard from a number of listeners about this very issue, and these were very thoughtful questions. But the one person who really stimulated my thought about this and ultimately resulted in a long phone conversation is Doctor Andy Bottle. He's an anesthesiologist and medical director of the University of Washington Anesthesiology Technical Services and an expert, as it's related to a number of different areas of patient care and specifically around respiratory protection. Earlier this year, Andy and I joined a group of several other authors who published a paper in Frontiers in Public Health entitled, “The Time Has Come to Protect Health Care Workers and Patients from Aerosol Transmissible Disease”. It was a great pleasure and honor to be working with Andy on this paper, but what Andy raised in his questions to me are something that I'd thought about, but not nearly enough. It's not just enough to say one should be using respiratory protection, but is that a yes or a no for life? I mean, do I use it forever? When do I decide that it's necessary? And when do I say the risk is such that I don't need to worry about that as an everyday risk factor in what I do. And so one of the challenges we have today is not only helping the public as well as those in health care institutions, long term care places where people are at increased risk for serious illness, hospitalizations and deaths.

Michael Osterholm: How do we tell you now is the time you need to be using those N95s? Or do we just say it's forever and we know this? As you say, it's forever. It probably will not be at all. So one of the challenges we have is deciding how much activity has to occur in the community before we actually make changes to the recommendation of who and how should they be using respiratory protection. So it's not about the science of respiratory protection. We know the physics. We know how well N95s work. We know how other masking materials do not work nearly as well, if at all. But what we don't know is when to make the recommendations. Yes or no. And today I can tell you if we made a universal recommendation. If everyone in a health care institution should be wearing an N95, it would be ignored by many of the administrators and medical directors of those institutions because the workers would not accept it. So we have a lot of work to do here to come back to you, the public, to come back to the leaders in our health care institutions and long term care to say this is when you should wear it and why? So at this point, I don't have an answer and nor do any of my very esteemed colleagues who are very learned in this topic.

Michael Osterholm: And so Andy and I and others will continue to pursue this issue. We will surely consider, you know, how can we marry the world of physics, i.e. respiratory protection along with the science of sociology? How do you get people motivated, and why do you get people motivated to do what they do? And when is that motivation necessary and when is it a luxury? So I'm sorry I don't have an answer for you today. For those of you who have been thinking about it, I'm sure you have asked yourself, is there a point where I know now that I should be wearing my N95? Or is there a point where I can just take it off? And where can that happen? I wish this was were as easy as looking outdoors at the thermometer on your tree to say, oh, today's a winter jacket today. Whoop, today is a sweatshirt day, etc. how can I judge what I need to do? And we owe that to you. So stay tuned. This is a topic we're going to continue to take on, and it's one that we welcome your feedback. Not on the physics of respiratory protection, but clearly on the sociology of how respiratory protection is used when, where and how.

Chris Dall: Might the spread of H5N1 avian flu in dairy cattle continues in the US? But it does appear to be slowing somewhat. Is this just a temporary lull?

Michael Osterholm: Chris, I wish I knew. Let me begin this The answer with the following quote and one. I think that is a perspective we must keep front and center at all times with this topic. Absence of evidence is not evidence of absence. We right now have a situation where if you look at what's happening in dairy herds around the United States, we have four states which now account for the majority of activity. There are now 192 farms in 13 states that have documented H5N1 in their dairy cattle for 147 of those, or 77%, are just in four states. Colorado has 65 farms, Idaho has 31 farms, Michigan 27 and Texas 24. I have every reason to believe that this is much more widespread in a number of additional states throughout the country. We just don't know where they are, because there's been a refusal largely by the dairy industry, to test. I have had conversations with a number of large animal practice veterinarians in Minnesota and states outside of Minnesota, where they have every reason to suspect H5N1 activity in dairy herds that they typically care for, where the dairy owners have forbidden the veterinarians to actually test for it, they don't want to know. And as such, it means that we have really no good idea of what's going on out there. Now, what can we do about this? Well, we want to first of all, address it, remember? Because of course, while this is not causing the dairy industry to lose lots of cattle over time, it's still an economic challenge if you have to keep animals out of the milking production.

Michael Osterholm: And there are veterinary bills that go with sick animals. So yes, the dairy industry should want to address this, but they look at this right now largely as more of an inconvenience. The animals will get better. And in fact, if we look at what's happened in Colorado, they are now reporting 21 of the 65 farms that they have documented have now fully recovered, and the animals are back to health on that herd. And those herds are no longer under quarantine. So we do recognize for the milking industry that, in fact, this is one they just want to see in the rearview mirror. Now we in public health also have a concern about could this in fact lead to a situation where you have a cow, which is mammary gland, having both two six and two three receptors, both for human and avian viruses having the occurrence of a co-infection at the same time, meaning someone working at that dairy farm brings flu into the farm, infects the cow while milking and they in turn also have H5N1. Could we see a reassortment in that mammary gland of the cow? Yeah sure could.

Michael Osterholm: We don't know. So we have a need to understand this. Now, I would love to find someone that I could hold accountable for this to say we need more information. I have done my checking, as have some others, and it's clear that the USDA does not have authority to mandate bulk tank testing throughout the country. In Colorado, for example, of those 65 farms I just mentioned, ten were picked up only after the state of Colorado mandated that the bulk tanks on the various farms be tested and found to be positive, when in fact they had not previously reported illness in their cattle. Wouldn't that be great if all at least the lower 48 states could do that? That hasn't happened, and USDA does not have the authority. Only the states could, and I don't see that occurring. In addition, the Health and Human Services, i.e. the CDC, do have emergency powers where they could actually mandate this to happen, but they would have to declare a national emergency first. And for them to do that. That means that they would have to put up 13 human infections, mild illnesses, and say, we have a national emergency. So that's not going to happen. So I think for the time being, we're stuck. We will not know what's going on out there. I do have a sense, just as we've seen the herds clear in Colorado, that over time this will happen with more and more farms where infection occurs, they will begin to clear.

Michael Osterholm: But will it continue to spread, particularly as we see additional movements of cattle in the fall and winter? I'm still very interested to learn what's happened over the past two months with all the county fairs and state fairs throughout the country, where dairy cattle were brought into those fairs, in some cases being tested up to seven days before arrival, but in many others not, and oftentimes sharing and using common milk and equipment for that particular fair activity. Boy, if you want to talk about a perfect mixing vessel to spread this through herds of cattle, just create county and state fairs So for me, I do not believe that there are only 192 farms that are experiencing outbreaks with this virus. What we don't know, however, is how do we find out about what is going on out there, giving our current legal structure of public health and egg production and the willingness of dairy farmers to test? So for now, stay tuned. We're always going to be asking ourselves, what do these data mean? And anyone could come away with a number of different interpretations and any one might be right. Again, the absence of evidence is not evidence of absence.

Chris Dall: Now to Mpox. On August 14th, the W.H.O. announced that the surge in mpox activity in Africa constitutes a public health emergency of international concern. Under international health regulations, this is the second time the W.H.O. has declared a public health emergency over mpox. The first was in 2022. Mike, I think it would be helpful to take our audience through this history and explain what's changed since 2022 and why the W.H.O. made this decision.

Michael Osterholm: Well, Chris, let me start out by saying I am quite concerned about this situation with mpox. I think we're at the beginning of the problem, not anywhere close to the middle or the end. Over the past week, we've heard in the media about the situation in the Democratic Republic of the Congo, which has reported over 15,600 cases and 537 deaths in the outbreak. And sadly, there are no signs of things slowing down any time soon. As you noted in your question, the W.H.O. declared the outbreak a public health emergency of international concern last week, making this the second mpox public health emergency in just over two years. Before I get into where we are today with mpox, I want to take a step back and look at how we got here and get into some of the reasons why today's situation differs from what we saw back in 2022. For listeners who may not be familiar with theme parks. It is an orthopoxvirus, which means it's in the same virus family as smallpox, cow pox, buffalo pox, and horsepox. Mpox was previously referred to as monkeypox until the W.H.O. changed the name of the virus back in 2022, in an attempt to reduce the stigma associated with the disease. Mpox is endemic in several countries in western and central Africa, as it circulates in the animal population in those regions. Historically, mpox has been primarily transmitted through animal spillover events and from person to person, through prolonged skin-to-skin contact, or in some cases, contact with contaminated clothing, bedding, and even in some instances potentially with respiratory droplets.

Michael Osterholm: However, this virus began behaving differently back in the spring of 2022, when cases began popping up in non-endemic countries. Instead of transmission being driven through animal contact. We mostly saw sexual transmission within a subset of men who have sex with men and who have had multiple partners in a short period of time. I don't label this as such to stigmatize anyone's sexual behaviors, but to clarify who the at-risk group was during this time and the pattern of transmission that we had to interrupt. The outbreak caused nearly 100,000 cases globally, 32,000 of which occurred in the United States. Transmission was ultimately reduced through a combination of immunity acquired through a natural infection within the at-risk group. Immunity acquired through vaccination in this group, and behavioral changes among members of this group. Notably, this outbreak was caused by the clade two. Mpox virus. For context, mpox is divided into two primary clades or genetic types. The 2022 outbreak of clade two, which is historically less deadly, concluded with a global death toll of approximately 158 which occurred in the US. Remember, this is out of over 100,000 cases globally and 32,000 cases in the US. While those deaths were certainly tragic and should not be minimized, the outbreak had an ultimately quite low case fatality rate. But as cases declined through 2023, we knew this wasn't going to be the last time we saw impacts in the news.

Michael Osterholm: First, there was a possibility of waning immunity within a subset of men who had sex with men who were at high risk of being infected. Many individuals in this community only got one dose of what was a two-dose recommended vaccine approach, and they received the vaccine intradermally rather than subcutaneously, as those dose-sparing efforts were used during the outbreak so that as many people could be vaccinated as quickly as possible. This was the right choice considering the circumstances, but it may mean that these individuals do not have longer term protection against the virus, particularly if they haven't gone back for that second dose. Doubt this, coupled with the fact that behavioral changes in response to impacts were temporary. Now creates favorable conditions for virus transmission for the clade two virus to return. We actually saw that happen in parts of this country, including LA County, which reported ten cases in a two week period earlier this summer. But even more concerning, however, was the possibility of impacts transmission on a much larger scale in parts of the world where the virus is endemic. Countries like the Democratic Republic of the Congo exist in the perfect storm of conditions that favor animal spillovers and disease transmission, making this really a matter of when and not if. For example, deforestation and climate change have pushed many animals outside of their usual habitats, often increasing their interactions with human population. Additionally, our increasingly globalized world has accelerated the rapid spread of viruses across large distances.

Michael Osterholm: And finally, the other risk factor here is the increasing number of individuals over age 40 to 45 years in the low-income countries. Remember, smallpox ended in 1978 and we stopped vaccinating for the virus the next year. So since that time, more than 40 some years, we've had no additional protection against orthopoxviruses in the population. So before 1978, smallpox vaccination itself or previous infection with smallpox gave you the protection against the other orthopoxviruses. We don't have that kind of population immunity anymore. Now we have this combination of risk factors. With the growing human population under age 40, many in the low-income countries today have no protection at all against orthopoxviruses. And because of the need for additional food sources, more and more animals are being taken from forested areas of Central Africa, allowing for individuals to have contact with these animals and the spread of the virus. So with all this in mind, in fact, what we're seeing, a large outbreak in the DRC today is unfortunately not surprising. I want to clarify to our listeners that unlike what we saw in 2022, most of the transmission we're seeing in today's outbreak is not sexual transmission. And sadly, most of the transmission is actually occurring in children, with 68% of the cases and 85% of the deaths occurring in people under age 15. Another key difference from the 2022 outbreak is that this outbreak has now consisted of cases of clade A1 and clade one B, forms of the virus different than clade two, and one that has much higher case fatality rates than clade two.

Michael Osterholm: The cause of the previous mpox outbreak. This current outbreak has now spread to countries in Africa in addition to DRC, and there was recently one case reported in a traveler back to Sweden. This is going to happen more and more with global spread of this virus. Fortunately, as I've said before, the viruses that cause pandemics are the ones that have wings, those that like coronaviruses and influenza. This one is not transmitted with airborne transmission as we think of either COVID or influenza. But it is true that it is surely possible transmission could occur with respiratory droplets very close contact. Right now, the primary means for transmission appears to be physical contact, contact with bedding, clothing, so forth and the potential for respiratory droplet transmission. So stay tuned. We still don't know where this is going to go. What is clearly a challenge, however, though, is that we are very short on the vaccine that might be effective in helping to reduce the risk. The W.H.O. declaration of a public health emergency of international concern should help kick-start this effort. The declaration can increase global awareness of public health issues which typically results in more international support for the affected countries. For example, the United States has agreed to donate 50,000 doses of the Jynneos impacts vaccine from the Strategic National Stockpile to the Democratic Republic of the Congo. Remember, we have this vaccine in our strategic national stockpile with the potential use, should smallpox ever again show its ugly face in this world.

Michael Osterholm: Additionally, Bavarian Nordic, the manufacturer Jynneos has said that in addition to the 500,000 doses they already have on hand, they could produce an additional 2.4 million doses by end of this year and an additional 10 million doses by the end of next year if purchase orders are placed. Remember, we're talking about 10 million doses over a year, and for which we also need two doses, meaning only 5 million people could be vaccinated. So what does this mean for Central Africa? Well, look at the DRC. They have almost 100 million people alone living there, not including all those at risk and surrounding countries. So we're back to a real challenge situation with impacts. We'll not have nearly enough vaccine, but we don't really understand yet is what the full dimensions of this new clade means in terms of increased mortality and its ability to be transmitted, potentially through respiratory droplets. Stay tuned. We'll keep you fully informed. Right now, the risk to the average person in high-income countries is really very limited. The risk in middle-income countries is marginal. In low-income countries, it is increasing substantially depending on where you are geographically. Stay tuned. We'll keep you alerted to what's happening here. But having been so successful in eradicating smallpox from the world, it's a real challenge to see another pox virus like this emerge and do what it's doing.

Chris Dall: It's time now for our ID query, and we're going back to COVID, because this week we've once again gotten a lot of questions about COVID vaccines. Here's one we received from Laurie, who wrote, we had an appointment with CVS pharmacy to have the vaccine today, and it was canceled after many phone calls to CVS and other pharmacies. We have been told both that they were out or that it was recalled. What is going on? Where does this leave us? Do you have any other suggestions on where we might get a vaccine, and is it safe or has its shelf life run out?

Michael Osterholm: Well, Chris, as I noted in a prior question and answer with this podcast, this is a challenging situation right now and there's a lot of misinformation floating around out there. Unfortunately, some of it's actually coming from our pharmacies. I first of all, want to thank Laurie for her question. And let me say again, as I said in the dedication, how sorry I am to you and all the listeners who are having trouble accessing these vaccines. Though I cannot give medical advice in regards to this issue, I want to clarify some of the misinformation that listeners have been reporting. The first point of misinformation I want to clarify is that the vaccine has been recalled. This is entirely untrue. I wish I could say more on this, but the fact is that it's just plain disinformation. And I'm not sure where pharmacies and clinics are even getting this from. I am incredibly frustrated to hear that so many of you have heard this disinformation coming from people you should be able to trust on this issue. The second point of what I would call potential misinformation is that the 2023-24 vaccines are expired. It is true that some of the 2023-24 formula doses have expired by now, but many have not. So if you decide to get the 2023-24 vaccine now, and your usual pharmacy or clinic tells you that the doses are expired, please keep reaching out to other locations and you should be able to find a dose that isn't expired.

Michael Osterholm: That's exactly what I did. Finally, the third point of potential misinformation that I want to address is that the CDC is not allowing individuals to get additional doses of the 2023-24 vaccine. Though not everyone is eligible for an additional dose, the CDC states that those who are moderately or severely immunocompromised may receive additional doses informed by the clinical judgment of a health care provider and a personal preference and circumstances. It's up to you and your provider whether that applies to you and whether you would benefit from getting a dose now, or waiting for the updated vaccine when it becomes available. At this point, also, it's very clear that when we look at the risk factors for COVID, age by itself is a risk factor. So when I look at that recommendation from CDC, we can assume as we grow older we may have some immune-compromised status that would warrant why we should get the vaccine. And so anyone who is clearly in their 60s and older should have access to the vaccine. The bottom line is that the misinformation on COVID vaccination coming from clinics and pharmacies is totally unacceptable, and I again want to express my support for all the listeners who are struggling with this.

Michael Osterholm: But let me also update you on new information. In the last day, we have learned that, according to several sources, when the FDA, the vaccine is likely to be approved next week and then a week later, it would be shipped out of both the Pfizer and the Moderna warehouses. Now, that's going to take time. It's not going to happen overnight that the vaccines will show up in the clinics, pharmacies, etc. and then when it does, there will be a number of people who want to be vaccinated. And so the wait time to get an appointment may be substantial. So you still may be talking about 3 or 4 weeks from now before you can get a dose of vaccine or with the new mRNA vaccine. Meanwhile, we're seeing the surge of activity. Now, I'll leave it up to you, but there is new information that I've just become aware of literally in the last day. And for this information, I want to thank my very dear colleague Kathleen Harriman, who formerly was with the California Department of Health. Retired, is now consulting with them and who at one time also worked with me at the Minnesota Department of Health.

Michael Osterholm: And Kathy actually shared with me this week that the CDC is appearing to change its recommendations. And we will provide you with a link to this document from CDC that actually says, now, with the new vaccine that will be coming out, you only have to wait two months between a previous dose of vaccine and getting the new mRNA vaccines means if you did get a dose of the older vaccine right now for more immediate protection, you could still get the new vaccine literally in some time in October. And so that would again, you know, provide you with additional protection. Then again, we're providing a link to you with the podcast notes. Take a look yourself. You can see that the CDC has made that change and this is helpful. You don't have to wait for months, but rather two months. So I hope this clarifies the issue with vaccine. Again, as many of you know, I have received my XBB dose three weeks ago. Now I'm feeling better about where I'm at protected given the surge. It's not perfect, but there's enough protection provided that for me, that was a choice I made. And I do know that those vaccines are still out there now, today, not 2 or 3 or four weeks from now.

Chris Dall: So let's talk about the op ed that you and Mark Olshaker wrote in Foreign Affairs. And for our listeners, you can find that on the CIDRAP homepage. And it is free for everyone to read. And the title of that essay is The World Is Not Ready for the Next Pandemic. Here's an excerpt from that essay. It is impossible to know when a new pandemic will arise, or which specific pathogen will be its cause. H5N1 is just one of the viruses that could mutate into something that will start a pandemic, but eventually one will happen. It is, therefore, time to move away from vague recommendations and best practices to a far larger scale program aimed at producing new and better vaccines, antiviral drugs and other countermeasures, and building the infrastructure at the scale needed to protect entire populations. Mike, what would a larger-scale program look like? And do you see any signs that the US government, or any government for that matter, is willing to take these steps?

Michael Osterholm: Well, first of all, let me just say that unfortunately, so much of what we're seeing right now with regard to both influenza and coronavirus vaccine research and the ability to manufacture these vaccines is pretty much business as usual. We didn't learn the lessons of the pandemic in terms of what it means to have a durable, effective vaccine. Game changing vaccines. Remember, the current vaccines we have are good vaccines, but they're not great. They lack durability and they wane over time. And they aren't really addressing the issue of the rapid changes and variants and influenza with the various strains. So first of all, let me just say that the US government, it actually is doing more than anybody else in the world. As some of you know, CIDRAP actually is the home of the influenza vaccine roadmap and the coronavirus vaccine roadmap. And we actually are the organization for the world that is constantly keeping track of what research is being done, who's funding it, what kind of of activities are they doing. And we actually match that up against the roadmap that we've created. Using several hundred international experts for both coronaviruses and flu viruses to say, what are the steps we need to do to get new and better vaccines, and what research needs to come first from that? Then what can we do next to go to the next research level? Let me just say that the US government, namely the National Institute of Allergy and Infectious disease.

Michael Osterholm: Along with CEPI, the vaccine research and public policy organization are really doing as much as they can with the funds that they have, and I give them great credit. They're making real advances. But for example, the total research dollars we've identified for influenza vaccine research is about 1.4 billion per year. That's just a couple of jet fighters. And yet we are at risk of a war with a new flu virus or a coronavirus, as we are with an international enemy. And we need to understand that there is that potential to find game-changing vaccines, ones that have much greater durability, that have much broader protection, ones that could actually potentially be administered in advance of a pandemic, with the idea that regardless of what virus emerges from the influenza coronavirus families, we're still going to be protected. But this is a real investment. You know, today when the Defense Department decides that it needs a new aircraft carrier, they put into motion a 14-year budget approval process at day one. They expected to take that long. They expect that they will have failures. That means that they will have to go back to the drawing board. They will have that paid for, though. Year after year, well in advance of its need.

Michael Osterholm: And we don't do that with influenza or coronavirus vaccines. We basically handle them on a biennial basis every two years. Got to justify something. And we don't have the continuity. So our piece really tries to go into the heart of what would it take for us to have the kind of research agenda, both public and private entities, governments around the world, research institutions, to actually coordinate together, to give us the kinds of research we need to develop these new and better vaccines. And then finally, what is it going to take to manufacture them? I just covered this issue with inbox. The fact of the matter is, our capability of making and distributing inbox vaccines right now are highly limited. Highly limited, not nearly what we need. Should we have that capacity, even if it has to in some years, get mothballed? What can we do to assure that when we have a crisis, we can have the vaccines? And so this article really is an attempt to go into that. And I must say we've had a lot of feedback on it, which has been actually quite reassuring. People get it now. We just actually have to enact the kinds of support and planning activities that allow us to really dig deep into this research area for vaccines, and I would add also for therapeutics and diagnostics.

Chris Dall: Now we turn to this week in public health history. Mike, who are we commemorating this week?

Michael Osterholm: This week we're commemorating a very special individual who showed extraordinary courage in the face of a terrifying diagnosis and a significant stigma. Ryan White was born in Kokomo, Indiana, in 1971. As an infant, he was diagnosed with severe hemophilia, a blood clotting disorder that makes minor cuts or bruises dangerous. His treatment required weekly infusions of factor eight, a product created by pooling plasma from blood donors. Ryan was an otherwise healthy and thriving child. He collected G.I. Joe action figures. He liked skateboarding and reading comic books. But in December of 1984, at the age of 13, he came down with a serious case of pneumonia, and after being hospitalized and obtaining a lung biopsy, he received a shocking diagnosis - AIDS. Ryan's weekly infusions of donated plasma products have been contaminated with HIV. His doctors estimated he had six months to live. Tragically, he was not the only person that this would impact. It is estimated more than 90% of persons with hemophilia who received factor eight between 1979 and 1984 were infected with HIV or hepatitis C. Most of these individuals died in the next 5 to 7 years. Luckily, Ryan's pneumonia improved enough that he was able to leave the hospital and prepare for the next school year. However, school officials and other parents in the community did not want him to return. I remember these days so painfully in a school of 360 students, 117 parents and 50 teachers signed a petition to bar him from entering the school. Many believed that HIV could be spread by casual contact, like handshakes or through the airborne route.

Michael Osterholm: Despite scientific evidence to the contrary. On August 26th, 1985, that would have been Ryan's first day of school. He was denied entry. His parents did not accept this decision and submitted appeals to the local school board and then the district court. Eventually, the Indiana Board of Education determined the school must follow the Board of Health's guidelines and allow Ryan to attend school in person on the first day in February, when Ryan could attend, 151 out of 360 students stayed home. Ryan was also a paper boy in the neighborhood. Many households canceled their subscriptions, fearing that the infection could be passed to them on newspapers. After enduring social isolation, hurled insults and even a gunshot through their living room window, Ryan White's family decided to leave town and move 40 minutes away to Cicero, Indiana. There, Ryan was warmly welcomed into a new school where the principal, superintendent and a group of students weren't afraid to shake his hand. Ryan's story catapulted him into the national spotlight. Numerous celebrities publicly recognized his bravery, including Elton John, Michael Jackson, John Mellencamp, and Indiana University basketball coach Bobby Knight. He spoke out against the stigma surrounding the diagnosis, and testified in front of the President's Commission on the HIV epidemic. I had the good fortune to be at his testimony that day and got to meet this young man. Truly an incredible individual. But without treatments of the time, Aids was still a terminal diagnosis. Although he lived five years longer than his doctors predicted, Ryan White passed on April 8th, 1990. Ryan's legacy lives on today.

Michael Osterholm: In August of 1990, President George H.W. Bush signed a bipartisan bill into law called the Ryan White CARE Act. The legislation provided more than $2 billion of funding to support cities, states, and community organizations to develop and operate robust programs that supported individuals with HIV Aids. This program became the largest provider of HIV Aids services in the United States. I hope we can all learn something from Ryan's life and story, especially as it pertains to the importance of pushing back against stigma and bringing more kindness to our communities. Let me close on this issue. While again, we are really Truly honoring Ryan White. There were many other heroes during that time that worked so closely with the hemophilia community. One of them was the late doctor Roger Edson, who was the head of the University of Minnesota Hemophilia Program. I worked closely with Roger during those days on HIV Aids as a state epidemiologist here in Minnesota. I can tell you, Roger was tireless in caring for his hemophilia family. For me, it was one of the worst tragedies. I got to know so many of these individuals on a personal level, and it was an expectation almost on a weekly basis, if not more, that one or more of these individuals would die from Aids in the course of several years. What a challenge this was. What a horrible, horrible, horrible challenge this was in the hemophilia community. Let me just say to Ryan White, thank you. You are a hero forever. Not just for those years you lived.

Chris Dall: Mike, what are your take-home messages for today.

Michael Osterholm: Well, first of all, COVID, COVID, COVID and vaccine. We're at a point right now where, you know, many of you are confused about what to do in this surge of cases. We're seeing, again, as I laid out for you from a vaccine standpoint, you know, the current vaccine that is available right now will provide you some protection against serious illness, hospitalizations and deaths within 7 to 10 days of receipt. If you wait for the new vaccines, it could be as early as a couple of weeks, but it could be even a month or more. And the question you'll have to ask yourself is, what do you want to do? And will you even be able to find a vaccine before the new vaccines come out? This is a challenge. This is one for which there is not a good single answer. Stay tuned. And what this means also, however, for getting a second dose of vaccine and how many months. Take a look at our podcast notes and read the new CDC document which talks about two months. Number two. Again, we live in a world full of diseases that are coming back, that are changing impacts. H5N1 polio and Gaza measles. I could go on and on. I feel like days were slipping backwards when I first got involved with infectious diseases in the 1970s. Who would have ever thought that measles and polio, things like this would be coming back? Impacts. So again, we need the support of the public to strengthen public health activities. We need to look at our vaccines and what do they really provide us in terms of protection? Do we need better vaccines, how do we manufacture them, etc.. So there's a lot going on right now, and all I can say is the public support for public health activities has never been more important.

Chris Dall: And what is your closing song for today?

Michael Osterholm: Chris? From my career perspective, almost 50 years now in the trenches. You know, I've had those moments of where I have been emotionally very moved sometimes in ways that made me wonder if I wanted to continue this job. Other ways that Gabe brought such joy to see the success of what we were able to do. Hiv was very hard. It was very hard. I lost dear friends and colleagues during that time. And as I just noted, I did have the good fortune to meet people like Ryan White and to understand the pain of their illness from a physical standpoint and an emotional standpoint. But one of the things that was most special was the fact that Elton John reached out to Ryan White after reading about what was going on, and became very dear friends with him. And truly, Elton John was a gift to the Ryan White family. Along with him and other entertainers, they put on several Fundraisers around the 1980s to support HIV prevention activities and social services for persons with HIV, and there was a song that became known almost as the anthem for HIV prevention and for those suffering from it, and it was originally written by Burt Bacharach and Carole Bayer Sager. It was first recorded in 1982 by Rod Stewart for the soundtrack of the film Night Shift, but it surely became much more better known for the 1985 cover version by Dionne Warwick, Elton John, Gladys Knight and Stevie Wonder. This recording was billed as being by Dionne Warwick and Friends, and was released as a charity single for Aids Research and Prevention. It was a massive hit, becoming the number one single of 1986 in the United States and winning the Grammy Awards for the Best Pop Performance by a duo or Group with Vocals and Song of the year.

Michael Osterholm: It raised more than $3 million for its cause. This song was actually sung in several different settings. One was the Dionne Warwick Foundation, and then the second one was a celebration that occurred at the Kennedy Center, for which again, those singers I just noted were there and there were a whole lot more. So today I'm sharing with us. That's what friends are for. I believe that this song is as relevant today as it was to those back in the 1980s. So here it is. That's what friends are for. Again, written by Burt Bacharach and Carole Bayer Sager, sung by Dionne Warwick, Elton John, Gladys Knight and Stevie Wonder. This is a song for the ages. I never thought I'd feel this way. And as far as I'm concerned, I'm glad I got the chance to say that I do believe I love you. And if I should ever go away, well then close your eyes and try to feel the way we do today. And then, if you can remember, keep smiling Keep shining, knowing you can always count on me for sure. That's what friends are for. For good times and bad times I'll be on your side forever more. That's what friends are for. Well you came and opened me. And now there's so much more I see. And so, by the way, I thank you. Oh, and then for the times that we are apart. Well, then close your eyes and know these words are coming from my heart. And then if you can remember.

Michael Osterholm: Oh, keep smiling, keep shining. Knowing that you can always count on me for sure. That's what friends are for in good times. In bad times I'll be on your side forever. And that's what friends are for. Oh keep smiling, keep shining. Knowing you can always count on me for sure. That's what friends are for. For good times and bad times I'll be on your side forever more. That's what friends are for. Keep smiling, keep shining. Knowing you can always count on me for sure, because I tell you, that's what friends are for. For good times and for bad times. I'll be on your side forever. Oh, that's what friends are for on me for sure. Count on me for sure. Count on me for sure. That's what friends are for. Keep smiling, keep shining. Dionne Warwick, Elton John, Gladys Knight and Stevie Wonder thank you for being with us again this week. I hope we've been able to give you some information that's helpful. We covered a lot this week. I hope not too much. Uh, there's a lot going on again in a world that is challenged right now. Be kind, be thoughtful. Uh, do one act of kindness this week that's totally unexpected for someone. And watch what happens in the world. If enough of us do that, we need that so badly. So thank you for being with us. I hope that you all stay COVID free. And, uh, I hope that the information on the vaccines helps give you more guidance. We surely are working on the trigger points for respiratory protection, so be good, be kind and thank you so much for being with us.

Chris Dall: Thanks for listening to the latest episode of the Osterholm update. If you enjoy the podcast, please subscribe, rate and review wherever you get your podcasts, and be sure to keep up with the latest infectious disease news by visiting our website CIDRAP.umn.edu. This podcast is supported in part by you, our listeners. If you would like to donate, please go to CIDRAP.com.edu/slash support. The Osterholm Update is produced by Sydney Redepenning and Elise Holmes. Our researchers are Cory Anderson, Angela Ulrich, Meredith Arpey, Claire Stoddard, and Leah Moat.