Answering Your Questions: The Executive Order & More!

Chris Dall: Hello and welcome to the Osterholm update, a podcast about infectious diseases and public health featuring Doctor Michael Osterholm. Dr. 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, Dr. Osterholm draws on over 50 years of experience in infectious disease epidemiology to provide straight talk on the latest infectious disease outbreaks, counter misinformation and disinformation about vaccines, and distill the complex and ever evolving public health threats facing our world. I'm Chris Dall, reporter for CIDRAP news, and I'm your host for these conversations. Welcome back everyone to another episode of the Osterholm Update podcast every other Thursday. Dr. Osterholm and I get together with the Osterholm Update staff and hash out the topics we think are the most newsworthy and interesting for the podcast. Of course, we always include a question from our listeners for our ID Query segment, but today we're turning the episode over to our listeners. We've looked at the emails and picked out some of the topics that you've told us you would like to hear about. We can't cover all of them, but there are several topics we're going to tackle in this August 13th episode of the Osterholm Update episode number 215. Among them are the congressional hearings and continued attacks on Dr. Anthony Fauci, the Senate's confirmation of Erika Schwartz to be the director of the centers for Disease Control and Prevention, the ongoing Cyclosporiasis outbreaks, and the FDA's approval of an mRNA flu vaccine. We'll also provide updates on Ebola and US respiratory illness activity and bring you the latest installment of This Week in Public Health History. But before we get started, as always, we will begin with Dr. Osterholm opening comments and dedication.

Dr. Michael Osterholm: Thanks, Chris, and welcome back to the podcast family. Again, my every two week gift to myself, I get to talk with you, hear from you. As Chris just noted in our opening here, today is going to be a program of your making. I also want to welcome anyone who might be coming to us for the first time. I hope that we're able to provide you with the kind of information that you're looking for, and just know that you're in good hands with the podcast family if you are going to join this group. I say this each and every podcast, but I can't say it enough times how much it means to have this incredible audience out there as I travel around the country, and to be able to meet people who are on the other end of the sound machine really is a wonderful gift. And I hope that we're able to help you. Navigating through the current confusion of public health, infectious diseases, and general politics as it plays out. But today, we're here for you, and we're going to hopefully provide you with that information you're looking for.

This week, I want to dedicate the episode to anyone who is donating blood right now or helping volunteer at their local blood bank. As some of you might have heard, the American Red cross has declared a national blood supply crisis at the end of July. They announced that their supplies fell to a four year summer low. While it is typical for donations to dip in the summer, the Red cross cited the extreme heat, poor air quality and widespread foodborne illnesses contributed to even lower donor turnout this summer. They are currently calling for donations nationwide, especially for type O blood. According to the Red cross, just three additional donors at each blood drive could help end this crisis and stabilize the blood supply. This is only the second time in history that the American Red cross has declared a blood supply emergency. The first time was just a few years ago. In January of 2022, following the peak of the COVID-19 pandemic and multiple extreme weather events. If you are able to please go and donate blood, we have a link to the American Red Cross's website where you can find more information. If you're unable to donate blood, I would encourage you to look into ways that you can help as a volunteer for the Red cross. We will include a link to information on that as well. And if you've already donated or volunteered or planned to, thank you for your service. This episode is dedicated to you, and I know all those lives that you will help save for those who need that blood. They too will be very grateful.

Now moving on to my favorite topic sunlight. Okay, some of you can take a break right now, but this is going to be a little bit longer sunlight episode. So you may want to just stay to listen to what I'm about to share with you. Today I want to talk about how daylight savings time affects public health. Many people didn't realize that that was a real thing. The US House of Representatives recently passed the Sunshine Protection Act, which proposes a change to a permanent daylight savings time and an end to switching clocks twice a year. However, the Senate still needs to vote on this legislation before it becomes law. This would mean that the time that we generally have between March to November would be permanent year round. This generally means later sunrises and later sunsets across the country. For the non-summer hours, southern states would see the most benefit from this, whereas states in the middle of the country would see moderate to no benefit. Northern states, including Minnesota, would actually see a negative impact during the winter months, with most individuals feeling greater impacts from the winter darkness. For example, in Minneapolis, Saint Paul on December 21st, if we were in that permanent daylight saving time status, sunrise would not be until 8:48 am in the morning, with sun set at 5:34 pm in the afternoon. Our kids would be going to school in the dark. And in that case, that actually ties directly into what public health officials have stated about the impact of having that sunlight later in the day. So what do public health experts say on this? Well, they're on the side of permanent standard time.

Why? It really is all about sunlight in the mornings, which helps balance our circadian rhythms. This, in turn can help regulate blood pressure, heart rate, and cortisol levels. Earlier sunsets also help some people fall asleep earlier in the evening and catch up on more sleep. There are even some studies that link permanent standard time with a decrease in suicide rates. We'll have to wait and see what comes to the Sunshine Protection Act, but in the meantime, know that it's not just a simple issue of yes, we'll have the same amount of sunlight, but it does matter when that sunlight occurs in our everyday schedules. Now, I couldn't leave this topic without giving you an update on today. Here we are in Minneapolis, Saint Paul, August 13th. Sunrise is at 6:12 am, sunset at 8:22 pm. That's a whole whopping 14 hours, nine minutes, and 37 seconds of sunlight. But we are losing sunlight at about two minutes and 43 seconds a day. Meanwhile, our very, very dear friends and colleagues at the Accidental Belgian Beer House in Auckland, New Zealand. Your sunrise today was at 7:07 am, your sunset at 5:45 pm. that's ten hours, 37 minutes and 48 seconds of sunlight. You are gaining on us, and it won't be long where you'll actually pass us, and we will be wishing we had that sunlight that you now have.

Chris Dall: So, Mike, before we get to our mailbag, we need to address some news that broke earlier this week, the White House executive order on childhood vaccines, which, among other things, calls for the measles mumps rubella vaccine to be broken up into three separate shots. Mike, there doesn't appear to be anything enforceable in this order, but the amount of misinformation that was disseminated in the press conference for the signing, the order was really remarkable and overwhelming, and likely will only create more confusion for parents. How worried are you about the potential impact of this order?

Dr. Michael Osterholm: Well, Chris, I have to just start out by saying, having been in this business for 51 years, I had thought by now I might have seen everything, but I haven't. Yesterday was the most amazing example of an anti-science. Doesn't matter what the hell the truth is moment. When I watched that press conference from the white House, when I saw Stephen Miller of immigration reform fame lecturing us on vaccines and the impact that they have on the human body, I thought I'd seen it all today. Let me try to frame this in eight specific bullets, and then I'll get a bit more granular with you. But first of all, the president talks about gold standard science all the time. But what we saw yesterday was nothing but fool's gold. If parents follow what the white House put out yesterday, it will mean more American kids getting sick from vaccine preventable diseases, more kids being hospitalized and more kids dying. And those kids could be yours. Number two, that's why we're encouraging parents to continue to follow what the experts at the American Academy of Pediatrics recommends. The AAP doctors make vaccine decisions based on what the evidence says. They're following the data, not politics. Number three, the recommendations White House made yesterday are the same ones that they were rejected by the courts in March. And they're just as wrong today as they were in March. Number four, we have rules for developing vaccine recommendations that require the independent review of the best data by experts.

Dr. Michael Osterholm: The White House broke every one of those rules yesterday. Number five, the White House likes to talk about securing more products in America. This should include vaccine recommendations, which at this time they seem to be ignoring. Number six, we aren't Denmark. I'll talk more about that in a moment. America needs its own set of recommendations, ones that fit the health care and conditions we have in this country. Number seven, the President said a lot of things yesterday that are just plainly flat out wrong. For instance, there is simply no evidence that the MMR vaccine is lethal and that there is no evidence that giving measles, mumps and rubella vaccine separately is safer than the combined vaccine. What gives him the expertise to say that, and particularly making comments off the cuff about things like the measles vaccine being lethal. And finally, the eighth point. Common sense tells you that making parents take time off from work to go to the doctor to get their kids vaccinated with three separate shots instead of one, means that more kids are going to go unvaccinated. And we all know being unvaccinated means that more kids are going to get sick, be seriously ill, and some will die. Before I go on, I want to highlight two papers that have just been published this week, both on Tuesday following the White House event. One by Jake Scott that's published on the CIDRAP site. And another article that's been included in the footnotes is one by Jess Steier and her colleagues at Unbiased Science.

Dr. Michael Osterholm: I would urge you to go look at these two papers, because they will provide you with really very thoughtful, comprehensive answers to the tough questions that have been raised about the comments from the White House event. As I noted a moment ago when the president stated that measles vaccine is lethal, he was challenged by someone from the news media. At that point, he backed off and said, well, that's what he's heard. Some people have said that measles vaccine can be lethal. That is beyond anything I can imagine from an irresponsible public leader to say things like that, because that's what some parent will hear. The president of the United States told me that that vaccine I'm considering giving my child may actually kill my child. And that is what's going to lead to fewer and fewer people being vaccinated. In addition, in the press conference, they also talked about the number of vaccines that children are getting, and they made it sound like it's an entire three gallon barrel of material that gets dosed into our children. That's simply not the case. And in the papers that I just mentioned, go into that in detail and point out that in fact, today we actually are exposed to much, much fewer antigens in terms of vaccines than we were back in the 1980s. For example, in the 1980s, the pertussis vaccine of the time had over 3000 different antigens in it.

Dr. Michael Osterholm: Today, if you look at the entire antigen load that a child will experience with all childhood vaccines, it's somewhere in the neighborhood of 165 to 315 different antigens. Think of that, how much less it was than the 1980s for total. That, in fact, is a result of having made these vaccines better. And today, when you look at vaccines like mumps, measles and rubella, they really stand the test of time as a state of art. So I will just conclude by saying that anything you heard yesterday has to be taken with a grain of salt. You have to also understand that this is a punishing experience for us in public health, because we know parents will listen to this, they will hear this. They will then be questioning, is this really safe for me to give my child the vaccines that I'm not sure they're going to get sick from anyway? And that really is a very detrimental issue. All the information that was shared Monday at the white House should be totally disregarded. It is dangerous. And hopefully parents will understand that that was not a responsible sharing of information. I'm absolutely certain none of the medical societies will support it. And I also believe that most state and local health departments will stick with the current recommendation. But nonetheless, it was such an unfortunate experience. And that's not what leadership is about. What we saw yesterday was irresponsible behavior. And you got to call it for what it is.

Chris Dall: So now to our mailbag. And Mike, I think the topic that most people wanted to hear about was the congressional hearing two weeks ago and the ongoing attacks on Dr. Anthony Fauci. I will say at the outset that we're not going to spend too much time revisiting that hearing. It's clear that the purpose of the hearing was to lay the blame for the COVID-19 pandemic at the feet of Dr. Fauci, and to get him to perjure himself. It was not meant to be a discussion about what happened during the pandemic and how it might have been handled better. And that's a conversation this country needs to have. And Mike, we've discussed that in previous podcasts, but have we missed the opportunity to have that discussion? And if so, how do we prepare for the next pandemic if we can't even have an honest, good faith discussion about the lessons of the last one?

Dr. Michael Osterholm: Chris, this is actually a painful situation for me because I saw the opportunities for years ago to begin to address lessons learned from this pandemic. And so when that hearing was held, you know, there were obviously a number of different dynamics going on, both for some personality Related, some actually science related. But what was really very telling to me was we are now in a country that has no interest in really trying to find out the truth of the past and using that to learn for the future. And I must tell you, I was hopeful that that would happen in the latter days of the Biden administration. And I hold the Biden administration accountable for the fact that there was never an effort to do what we call a hot wash or a systematic review of what happened, to learn what, in fact, we should know to be prepared for the future. And we have had a classic model of how to do that right after nine over 11. The nine over 11 commission was established. It was co-led by a nationally recognized Democrat and Republican, and it was one that made every effort to understand what went wrong, why it happened, and what could be done to make sure it didn't happen again. No finger pointing, no partizan issues. That was actually led by Philip Zelikow, and he did an amazing job as the executive director of that nine over 11 commission. And I was hopeful in the last year of the Biden administration that Dr. Zelikow was going to be able to pull together another group to do a very similar review.

Dr. Michael Osterholm: As it relates to Covid, he made a legitimate effort to do that. He formed a group called the COVID Crisis Group. I was part of that after numerous attempts on the Hill as well as the White House, to pull together a formal review commission. It never happened. So we, the COVIDCrisis Group, published our own report called "Lessons from the COVID War: An Investigative Report, 2003." And while that report was surely helpful, it lacked a lot because of the lack of access to many different aspects of the government response to COVID. And so today, I am quite pessimistic that we will actually have an opportunity to go back and revisit what happened in the pandemic. And that was part of the reason why I was so upset with the hearing. It literally had come down to the fact of tit for tat, person to person, and one that was not going to be based on any aspect of the truth. And so I'm struck by the fact that now we're in a situation where we will never really learn the lessons needed. And I worry very much about the revisionist history that I see occurring. And it happened in that hearing. We kept hearing about school closings. You know what I never heard once anyone talk about the more than 1400 kids that died from COVID during the pandemic. And I'm telling you right now, in my own public health experience on the front lines, when school aged children die, it has a huge impact on that community. And in many instances, that's what it took for families to say, "I don't want my child in that school."

Dr. Michael Osterholm: This was not a simple bunch of government bureaucrats got together and just decided to close schools. There was a tremendous amount of interaction going on between the community and the schools themselves. In addition, although not mentioned, there were at least two studies that demonstrated that during the Omicron phase of the pandemic, over 80% of the transmission that occurred in households resulted from a school child bringing the virus home from school, and that transmission was critical in the sense of many families had individuals who were at increased risk for serious illness with COVID who were at home. And I just used a school closing example as one to say it's not straightforward. Yes, we should have or no, we shouldn't have had schools closed. And that's the kind of discussion we have to have now. Now is the time to be talking about under what conditions would we close schools? Why would we close them? If there are several deaths in the school and 40% of the kids are out sick? Should we in fact be closing schools? We need to have those kind of discussions and we're not going to have them. So that's what I will come away with remembering that hearing, to me was the final nail in the coffin, saying that we're not going to do anything to really be better prepared for the future. And I mourn the fact that we have wasted an incredible opportunity to improve upon our response for any future pandemic.

Chris Dall: Let's turn now to the next topic. Our listeners want to hear your thoughts on the confirmation of Dr. Erica Schwartz to be the CDC director. Jane wrote. I hear many experts urging a no vote, but it seems that she is as good as it can get. Mike, I think that's how a lot of people feel right now. Her confirmation hearing did not provide a lot of confidence, but the agency desperately needs a leader. What are your hopes for Dr. Schwartz?

Dr. Michael Osterholm: First of all, now that she's actually been sworn in as the director of the CDC this week, she's in the hot seat. And all along, I kept asking myself, what would be the one reason you would or wouldn't take a job as CDC director? And to me, it was all about, do I have a red line that if I'm asked to cross in terms of scientific principle and in keeping with scientifically sound public policy, would I survive in that job? Could I walk away? Well, with what we saw in the White House event on Monday. I cannot understand how Dr. Schwartz could avoid dealing with that this next week in terms of what CDC will be ordered to do to support the president's position. And so I'm wondering if she's going to hit her red line in the next few days, because anyone who is going to truly hold to the point that she made, that she would always honor the science, she is not going to be able to honor any science that came out of the white House on Monday. That would be a painful irony if she, in fact, loses her job in her first week in office. But this is exactly what we were all concerned about. So I will wait and see in the next week how she handles this. Let me just conclude by saying, I really hope that she can stand up to this lack of scientific public policy that is now so significant. And if she doesn't, I'm afraid her time as director of CDC, while she may keep her job, it will still be remembered for dereliction of duty.

Chris Dall: One of the issues Dr. Schwartz will be dealing with is the multistate cyclosporiasis outbreaks. Several listeners asked for an update on the current status of those outbreaks, and if the lack of leadership at the CDC is one of the reasons why the response and communication about these outbreaks has been so poor.

Dr. Michael Osterholm: Well, as someone who has spent their entire career in public health and 25 of that boots on the ground outbreak investigation, and ironically, I was the lead investigator of yet what is still the single largest foodborne outbreak ever documented in this country, when more than 240,000 people became sick from Schwan's ice cream back in the 1990s. I feel like I have an unusual view on what has happened this past summer with the outbreak of cyclosporiasis and now the outbreaks with salmonella and jalapeno peppers. I will just start out by saying this has been a disaster from my perspective, the lack of federal public health leadership Has been absolutely amazing. And I say amazing in the fact I didn't think we could get that bad. And I want to be careful in making that comment because there are some incredibly good researchers, some outstanding epidemiologists at the CDC. But the overall ability for the CDC to respond today with the team that has left in place after DOGE did what it did and their ability to actually act on public health actions with this administration really make for a huge challenge. And let me just briefly review for you the concerns that I have over what's transpired this summer. First of all, the sheer scale of these outbreaks together have made for the worst year on record for Cyclosporiasis in the US. As you know, a 15 state outbreak has been linked to contaminated iceberg lettuce supplied by Taylor Farms and consumed at Taco Bell. I am certain this was not the only outbreak occurring. I do believe that there were a number of additional cases, particularly in the Michigan area, that were likely linked also to iceberg lettuce supplied by Taylor Farms, but not served at Taco Bell.

Dr. Michael Osterholm: This was a large, large outbreak, and there surely could be additional sources of perishable food items that also played a role in this outbreak. And only time will tell as we continue to do these investigations. As you probably are aware by now, the case surge quickly overwhelmed our nation's ability to test for it. The CDC official confirmed case tally as of August 5th was nearly 10,500 cases from 47 states. I'm not yet convinced that all of those are really part of this outbreak. I think they may, in fact, be part of a produce outbreak in the same geographic region as the Taco Bell one was, but that they're not actually part of that one specific early outbreak. We have to be careful about concluding all 47 states were part of this outbreak. I believe that in the end, we will be able to demonstrate for some of these states. The cases they were dealing with were international travelers who contracted their infection while overseas. It's clear, though, that the number of confirmed infections for this outbreak is likely a vast undercount, because many infections went underreported, and testing lags have complicated capturing the true scope of the outbreak. For example, Michigan, the hardest hit state, has reported 12,485 confirmed or probable Cyclosporiasis cases, with nearly 280 people hospitalized in two deaths as of August 6th. The state reported 473 cases on August 4th. That it cautioned didn't represent a spike in illness, but rather delayed lab reporting.

Dr. Michael Osterholm: Most infections being reported now had symptom onsets earlier in the summer. This lag is due to several factors, both avoidable and unavoidable. First, as we'll discuss more in just a moment, it takes up to two weeks after consuming Cyclospora contaminated food for symptoms to begin. And then some people delay seeking care, leading to lags in reporting. Second, testing for Cyclospora on produce is tricky because it doesn't grow in culture, and its genome is too complicated for sequencing methods that work for bacteria. Also on produce like lettuce, Cyclospora is often sparse and not distributed evenly, meaning that tainted produce can end up testing negative for the parasite. Third, a surge in testing quickly depleted the nation's supply of testing reagents or chemicals used in the test, as well as sample collection kits and lab instruments. Labs couldn't keep up, and some hospitals and medical clinics ran out of tests. Fourth and most important, a lack of strong leadership and clear communication from the CDC made it difficult for both state health officials to respond and for the public to know what was and wasn't safe to eat. The absence of a timely federal response, investigation and messaging likely worsened the outbreak, with CDC not issuing a health alert network until July 14th, about ten weeks after health officials began receiving reports of a wave of infections. Then, four days later, the FDA announced that it had identified a Cyclospora positive lettuce sample, but then retracted that result the next day and didn't explain for another two days, leading people to mistakenly believe Taylor Farms had been cleared.

Dr. Michael Osterholm: They were not cleared. Understandably, people from around the entire country were confused about whether they should stay clear of lettuce during the investigation. Although telling people with impaired immune systems, such as those undergoing chemotherapy to abstain from lettuce was good advice, most people in the country could have benefited from much more targeted messaging. Remember, prior to this outbreak in the United States, we consumed about 150 million servings of leafy greens every day. Every day, over a billion servings a week. And suddenly now, people throughout all 50 states were wondering, does this apply to me? There was no clarity around that. Rather than mount an effective response, CDC, hobbled by staffing and funding cuts, essentially relied on the states which have different resource levels and can't track products at a national level to respond as they could. Fortunately, although cases are still being reported, the outbreak appears to be waning. And as I pointed out in a moment ago, I do believe that this is one outbreak associated with the Taco Bell product. But I think that there are other food items that were also likely contaminated. And again, time will tell. We needed and should have received a coordinated and timely public health response from our national leadership. What we got was a patchwork response and more confusion and fatigue for the public, who has already lost confidence in entities they used to trust. Amid the fallout, we need to be asking a lot of questions and receiving honest answers about how to prevent these missteps and give people the information they deserve to protect themselves and their family.

Chris Dall: Mike, as you mentioned, there's also a salmonella outbreak, and that's affected people in Minnesota and 26 other states. Is it fair to say that the CDC and FDA have gotten on top of this outbreak more quickly than the Cyclospora outbreak? And why would that be?

Dr. Michael Osterholm: Well, Chris, let me footnote the fact that I am going to obviously sound a bit biased in my response here, but the salmonella outbreak tied to jalapeno peppers really came to the forefront as quickly as it did because of one thing that it was occurring in Minnesota and the Minnesota Department of Health with their Team D identified it, got on top of it and solved it. And then from there, all the additional other states had received. Jalapeno peppers started following through on salmonella javiana cases and their investigation, but it was largely because of Minnesota, something that was not an unusual phenomenon. But let me just say that I think there is some nuance we need to touch on to provide context behind the statement you just mentioned. We are dealing with two totally different pathogens, Cyclospora and salmonella javiana. They both have different epidemiologic characteristics, which I'll go into more detail in a moment. And we have three main timelines to consider here. First, there is the incubation period or how long from ingestion of the pathogen to symptoms. Next there is time it takes for a diagnosis, which includes the time for an individual's onset of symptoms to seeking medical care. The time from care being established to a test actually being ordered, and the laboratory turnaround time to getting results and reporting them to the appropriate health authority. Finally, there is the time from case confirmation to outbreak detection at each of these steps. Salmonella has an advantage to be identified much quicker.

Dr. Michael Osterholm: On the most basic level, the investigation of a salmonella outbreak is a much quicker process because typically, symptoms of salmonella occur within 24 to 48 hours after ingestion, but can be quicker than that, or even longer, sometimes as long as six days. And the diagnosis takes 1 to 3 days. Once a stool sample is sent to a lab. It is also a more common pathogen, and may be more likely to be on a health care provider's radar when considering what test to order. Salmonella is also part of what is called pulsenet, which is a national surveillance system that monitors and detects outbreaks from several foodborne illness causing bacteria, including salmonella, but not Cyclospora as a pulse net. Bacteria labs analyze samples using DNA fingerprinting. The labs then update these data to Pulsenet, which then rapidly identifies clusters which are potential outbreaks, and to then alert state and local health departments of the potential outbreak for them to work to identify the source of the outbreak. The quicker the onset, the quicker the diagnosis and the fact that there is a national database to detect disease clusters all contribute to the process of salmonella detection being able to occur in just days to weeks, as opposed to many weeks to a month. The outbreak identification prospect for Cyclospora is much different and much longer. Symptoms of cyclosporiasis typically occur 7 to 10 days after ingestion, but can take up to two weeks, which right away delays the identification of an outbreak.

Dr. Michael Osterholm: In addition, identification of Cyclosporin requires a specialized test, which takes 2 to 6 days to process, again delaying the timeline of outbreak detection. The positive results from the specialized tests are shared only with state health departments rather than pulsenet. Health departments must then detect clusters of cases by patterns and timing, geography and interviews about food consumption histories. Without a national database to support this investigative process at each step in the process, Cyclospora outbreak identification is naturally going to take longer. It just comes with the territory. That is not to say that the handling of the Cyclospora outbreak was done diligently or without major flaws, as we've discussed already today and in our last episode, the issues with Cyclospora outbreak really boiled down to poor communication and a lack of national coordinated response. It took CDC nearly ten weeks to publish a health alert, or HAN, which is typically published and sent to health departments immediately upon identification of an emerging outbreak. Additionally, we did not get any kind of epi curves from these outbreak investigations for nearly two months, which could have pointed at the fact that we're dealing with multiple outbreaks, potentially with different sources. And on top of these delayed communications, we have uninformed food safety guidance coming from self-proclaimed experts and even from state health departments. There is no data to support that. You can wash Cyclospora off produce sufficiently to actually prevent transmission to someone who consumes that produce.

Dr. Michael Osterholm: Yet we saw people saying, buy head lettuce, take the upper 2 to 3 leaves off and wash it and you'll be fine. There are no data to support that. And yet we led the public to believe that would be helpful. So far in the salmonella outbreak, we're seeing more coordinated and consistent communications and messaging, which I am not necessarily surprised by, is bacterial. Foodborne outbreaks are more routine and have a national system supporting detection efforts. I commend this response, and I'm glad to see the systems we have in place for foodborne illness causing bacteria are working as expected. Most of all, I'm very appreciative of the Minnesota Department of Health. It surely showed again what a state health department with the expertise in foodborne disease can do. They actually broke apart a very complicated outbreak with these jalapeno peppers, and they were able to identify jalapeno peppers as the vehicle for this outbreak, even though it was mixed in guacamole in such a way that made other ingredients also a potential cause. We owe team D a big thank you for what they do, and we surely appreciate you. Finally, I just want to lay out one other aspect of the outbreaks that has been missed by so many. Produce is unique in terms of foodborne outbreaks. Why? Because it has a perishable shelf life. That means that the product will go through the system quickly. As I noted before, unlike corn, soybeans, so many other crops that are harvested once a year.

Dr. Michael Osterholm: Leafy green produce is being harvested 365 days a year. Fields are planted by time and location so that at the point of harvest, they are ready to go. And so from a growth category, as they come to harvest, they're ready to go. That happens over and over and over again. But that also means that if a particular set of fields are involved, they will rotate quickly through the outbreak setting, meaning that that product won't be on the shelves, it won't be in the refrigerator for more than days to a week or two. And that makes it very different than meat, fish, poultry, or other processed foods, which can literally be in freezers for months to come and can cause an outbreak for many days after. Even then, the contaminated food item is no longer in commerce. And so we do have to understand that we have an obligation to better define how do we take on produce outbreaks in such a way that, one, we detect them quickly enough to prevent additional cases, or two, that we may not identify the product in enough time to actually have an impact on people getting sick because of the recalls occur long after the product has gone through the system. But these moments can still provide us with information about what happened. Why did it occur? What can we do differently? So that doesn't happen in the future.

Chris Dall: So, Mike, these outbreaks have many of our listeners asking if there are technological solutions that could help reduce foodborne illnesses, which affect 48 million Americans each year. What's your response?

Dr. Michael Osterholm: Chris, I have spent my entire career working on foodborne disease outbreaks. As I noted earlier, when I was at the Minnesota Department of Health, I was involved in many, many different outbreaks, and I also seemed to have somewhat of a graveyard relationship with the New England Journal of Medicine in 1997. I wrote the editorial for the outbreak investigation of the first large outbreak of Cyclospora in the United States with raspberries from Guatemala. And in that editorial, I laid out a number of factors that would make Cyclosporiasis a more complicated pathogen to detect and respond to. I also laid out issues of what it would take to prevent these in the future. Well, so much for 1997. Here we are now, 29 years later, and I'm not sure we've done much better. Also in 2004, another graveyard article, I published, the New England Journal of Medicine on the role of radiation in food safety. It was a sounding board document that laid out what was food irradiation, and why would it be a unique solution to the kinds of challenges we see with produce outbreaks? First of all, let me just be really clear. The vast majority of people in this country have no real idea what food irradiation is. And the name given this process is really, really unfortunate. In my publication in the New England Journal of Medicine, there were a number of factors we had to overcome if a radiation was ever going to be used.

Dr. Michael Osterholm: First, the term irradiation is sometimes confusing or alarming consumers because of its apparent but non-existent association with radioactivity. I'll comment on that more in a moment. Second, health professionals on the media are largely unaware of the benefits of irradiating food. And finally, let me just say, the anti-radiation campaign has been conducted by certain groups because of their beliefs about food, nuclear power and agricultural economics. What is a radiation? Radiation, as a term, is energy transmitted through space in the form of electromagnetic waves, which may be considered rays or particles. Food irradiation involves the use of high energy radiation. Any of several approved forms, including one we call electron beams. Electron beams is actually no different than that old big box TV you used to have, where you had a gun sitting in there that would fire electrons at the screen, and that would give you your picture. Notice the depth you had in those TVs so that gun could cover the entire screen. These high voltage electrons are literally generated by electricity. You turn them on, you turn them off. Has nothing to do with radioactivity. Has nothing to do with nuclear proliferation, any of those things. And so overall, we still are challenged to help individuals understand what a radiation is all about. It turned out that in 1958, Congress revisited the Federal Food, Drug and Cosmetic Act of 1938 and added to the Food Additives Amendment, which classifies food irradiation as a food additive.

Dr. Michael Osterholm: Well, this is 100% incorrect, since no substance is physically added to the food. How can you call this a food additive? Well, since that time, things have not changed. It's still labeled as a food additive. But food irradiation actually will not impact the quality. The effect of radiation, in this case, high voltage electron beams on the color, the odor, and the texture of foods surely is one that is highly acceptable because one, it reduces the likelihood of spoilage bacteria. Therefore, those strawberries that used to get moldy after a few days can go several weeks now and still be edible. Don't have to throw it out. It also is a technology that can be done in a very efficient means literally an eight foot by eight foot by eight foot pallet can go into an irradiator, and the dose of that electron beam can be so precise that within literally hundreds and hundreds and hundreds of a percent difference between the outside of the product in that pallet and the inside in terms of the amount of the dose that it received, this would kill Cyclospora. And while I surely want to emphasize the real importance is to get this kind of material out of the food system completely so you don't need a radiation. I don't see that happening any time soon, because we still don't understand how these products are becoming contaminated.

Dr. Michael Osterholm: So I hope we will go back and revisit food irradiation. One it would surely make the food supply much safer. It would not only the parasites, but the bacteria and in some cases, even viruses. Number two is the fact that it would reduce spoilage and for produce. That was a big issue in terms of how people buy their produce. They don't buy too much at any one time because they don't want to see that lettuce bag turn brown 7 to 10 days later, so they'll only buy enough for a few days. So let me just close by saying, I hope that this outbreak, this summer causes us all to go back and look. How did it happen? Why did it happen? Because we do want to highlight and respond to what the problems were this past summer that caused this outbreak to happen. But in the big picture of things, I think the produce industry in particular has to wake up and understand that they have at least got to look at a kind of process like food or radiation, and realizing that that may be an uphill battle with consumers to understand what it really is and why they would want to accept it, like they would milk pasteurization. I have to acknowledge the fact that there'll be those that would never buy the product, because their fear that somehow it had to do with nuclear radiation.

Chris Dall: The FDA last week approved an mRNA flu vaccine for adults aged 50 and older. Sarah asked you to discuss the safety and efficacy of the vaccine, and Russ wanted to know when should us older folks get it?

Dr. Michael Osterholm: Well, thank you, Sarah and Russ for these great questions, which I'll cover here in a bit. But let me just start out by saying that this approval is good news. Now, there are surely still some short term unknowns, which I'll also try to lay out. But this really serves as a reminder of what science can do. Just remember, for nearly eight decades now, we've relied almost exclusively on flu vaccines grown in hundreds of millions of fertilized chicken eggs and old and slow process requires almost six months to get a finished dose. And because of that baked in time requirement, we're basically forced to lock in a best guess in February as to what strains might be circulating in that upcoming fall and winter so we can get started on production. And because of that baked in time requirement, we're basically forced to lock in a best guess in February as to which strains might be circulating that upcoming fall and winter, so we can get started on production. Meanwhile, influenza viruses will continue to mutate. Next thing you know, you might be stuck with a vaccine targeting something that looks completely different today than it did six months ago. Unfortunately, these mismatches aren't uncommon, and some of the work we've done in the past year at CIDRAP has shown seasons where flu vaccines offered only limited, if any, protection against disease with this new vaccine. Influenza is the first flu vaccine using mRNA technology, which has far fewer bottlenecks since it's built using the genetic sequence of the viral target.

Dr. Michael Osterholm: It can be updated in a matter of days, and you could have production of finished vaccine doses in just 2 to 3 months. This, of course, would buy us precious time instead of having to make a decision in February. Strain selection could theoretically happen closer to the start of the flu season, when we have a better read on the circulating strain. Ultimately, that could help reduce the likelihood of vaccine mismatches and ideally result in a more consistent and perhaps better protection. With that being said, let me get back to Sarah's question first, which asked about the safety and efficacy of this vaccine. For that, we have data from a large phase three clinical trial that enrolled more than 4000 adults 50 years of age and older. Nearly half, 48% were 65 years of age and older, and compared outcomes between participants who received either a dose of the standard flu vaccine or a dose of the influenza vaccine, compared with the standard dose. There were 27% fewer cases of symptomatic lab confirmed influenza in the placebo group, and nearly half the number of cases who sought higher levels of care for medically attended illness. It's also worth noting that the roughly 27% edge in terms of the asymptomatic lab confirmed influenza I mentioned held up for both the 50 to 64 year old age group and the 65 and over age group. However, if you look, the FDA technically only gave full approval for adults 50 to 64 and accelerated approval for those 65 and up.

Dr. Michael Osterholm: So why the distinction if it worked for both age groups? Well, remember, this group was comparing placebo to a standard flu vaccine dose for those 65 and older. The higher dose vaccine is still recommended. Now there is some data looking at antibody levels that show in placebo generated a stronger response compared to the high dose among 65 plus year-olds. And that really served as the basis for the accelerated approval. But at this point we do not yet have any head to head clinical data comparing emphysema to the high dose flu vaccine. Moderna will collect that data as part of the accelerated approval process, but that will take time. Otherwise, in terms of safety, there were no major issues or signals observed. More mild to moderate reaction outcomes did occur, such as pain near the injection site, fatigue, headache, etc. otherwise, in terms of safety, there were no major issues or signals observed. More mild to moderate reactions occurred in the placebo vaccine group compared to the standard dose group. This included pain near the injection site, fatigue, headache, etc. In all instances, any of the reactions were resolved within two days. Now to Russ's question when should us older folks get it? Well, in terms of timing, I'd say get the annual flu shot shortly before the season begins, as is typically recommended. Remember, I don't agree with getting your vaccine in August, I think you should get it just weeks before the flu season starts, which is typically in November or early December. Now, if you're interested in the mRNA vaccine, Moderna has stated that they're expecting doses will be available for the 2026 2027 flu season and arriving at select locations in the coming weeks.

Dr. Michael Osterholm: But at this point, it's not clear when, where and at what levels it'll be available. On a related note, it's important to remember that FDA approval is different from a CDC recommendation. Approval means it can be sold, but a CDC historically through the ACIP that actually guides how it's used at a clinical level and essentially dictates whether insurance has to cover it. And right now, as you know, ACIP is basically in limbo. So there are a lot of questions about what this will mean in terms of coverage. If you are 65 and older on Medicare, any licensed seasonal flu vaccine, including the mRNA dose, is covered. However, if you're in the 50 to 64 year old age group, there's no guarantee that it'll be available at no cost since the vaccine has not been recommended by ACIP. We are still looking to insurers to understand will they cover the use of this vaccine in the 50 to 64 year old age group? We'll have to wait and see. I am hopeful that they will. Clearly, there are still plenty of questions in terms of technicalities, logistics which will hopefully be resolved with the benefit of time. Otherwise, the good news I want to emphasize here is that we finally have a new tool to help fight flu, and it offers some much needed adaptability.

Chris Dall: Mike, many of our listeners are interested in the Ebola outbreak in the Democratic Republic of Congo. What is the latest on that outbreak?

Dr. Michael Osterholm: Unfortunately, Bundibugyo virus continues to spread at an unprecedented rate in the Democratic Republic of Congo. According to WHO, as of August 5th, there have been over 4000 confirmed cases, of which 1850 have died. That's a case fatality rate of 45%, meaning almost half the people infected with Bundibugyo died from the virus. The situation is dire across. Just last week, the United Nations confirmed that the virus has reached displacement camps in the Ituri province in DRC. The virus has infected 19 internally displaced people, killing five of them. Displacement camps in regions where Ebola has been confirmed host about 4.4 million internally displaced people, as the area overlaps significantly with those most affected by the current conflict in eastern DRC. These camps often lack water, sanitation, infrastructure and distrust in health services is common, creating ideal conditions for Ebola to spread. We need a vaccine and there are multiple clinical trials ongoing at the moment to measure the safety and effectiveness of vaccine candidates. As mentioned in the last episode, the University of Oxford BTBV candidate had its first phase one clinical trial participants vaccinated on July 24th. Just last week, Moderna announced that a phase one clinical trial and their investigative mRNA vaccine for the prevention of Bundibugyo virus has begun in Canada. Both the Oxford and Moderna vaccines target Bundibugyo virus specifically.

Dr. Michael Osterholm: However, last week, the WHO. Technical Advisory Group on Candidate Vaccine Prioritization recommended that Merck's reliable vaccine be evaluated in phase three clinical trials. Ervebo is currently authorized for prevention of Zaire ebolavirus, which is a different strain of Ebola than the current outbreak. But the phase three clinical trials will evaluate the effectiveness against Bundibugyo. Data from two animal studies demonstrated that the available vaccine offered protection against death from bundibugyo, but human data are needed before the vaccine can be used for the current outbreak. 500,000 doses of the vaccine are already stockpiled, some already in DRC. Given the high incidence of outbreaks in the country, if the data from the phase three clinical trials are promising, Ervebo could be deployed very quickly. There's also a number of treatments being tested on confirmed Ebola patients in Ituri province. The monoclonal antibody MBP 134 and the antiviral drug remdesivir alone and in combination. There is also an ongoing trial for the antiviral drug Zovirax for people exposed to confirmed cases to see if it can prevent disease onset. As more data become available on vaccines and treatments for Bundibugyo virus, we will update our listeners. Everyone working in public health right now, myself included, is eager for any good news that we can find in this truly devastating situation.

Chris Dall: And finally, Mike, our listeners always want a respiratory illness update. We've talked about an uptick in COVID cases the last few episodes. Are we still seeing that trend?

Dr. Michael Osterholm: We are still seeing that trend. And this update will sound very familiar because not much has changed since our last episode two weeks ago. We're still seeing a slight uptick of COVID-19 activity, but levels remain very low and we still are not seeing any signs of increasing flu or RSV activity. In terms of the COVID-19 activity, the national wastewater concentration is still very low but increasing, which is the case in every region except the West, which is now considered low. During our last episode, Alaska was the only state with moderate levels of COVID-19 in wastewater. With seven states with low levels this week, Alaska is the only state with high concentrations. Three states California, Hawaii and Kentucky are moderate, and nine states and D.C. are considered low COVID-19 related ED visits continue to increase in the youngest age groups. Less than one year and 1 to 4 years, but have remained the same in the 65 and older age group. Hospitalizations have also increased slightly since our last episode, but these increases are minimal. We do have updated variant data from the CDC, Xfg, and a sublineages account for most of the US cases with a newer variant, FCV, increasing in prevalence over the past few months. In addition, there is a newer variant, PQ 16.1.1 that is under monitoring by the WHO. and has accounted for approximately 15% of traveler based surveillance samples the past several weeks.

Dr. Michael Osterholm: It has not caused alarming increase in activity across the globe, and it's not what is driving the current uptick in activity. We still don't anticipate a major surge associated with these variants. But I bring this up just to let our listeners know that we continue to monitor the situation and are aware of all the new kids on the block, and we'll share that information with you should it become clinically relevant. The current flurry of activity is being driven by the typical cycle of this virus, of an increase every six months or so, caused in part by waning immunity from both vaccines and infections. With this in mind, we are expecting updated COVID vaccines to become available in the coming weeks, and I would encourage anyone who are more than six months from their last dose or from a COVID infection to get a vaccine when it's available. That said, and as much as I can understand the convenience behind getting both shots at the same time, I would also urge you to wait to receive the influenza vaccine until we begin seeing this increasing influenza activity to optimize your protection throughout the season. As always, I'll share with you as soon as I get my flu shot and occasion I look forward to every year.

Chris Dall: And now it's time for this week in public health history. And Mike, I believe our segment, this episode takes us back to the dedication.

Dr. Michael Osterholm: Indeed you're right, Chris. Since we talked about blood banks earlier, it seemed only right to talk about Dr. Charles R. Drew for today's history segment. Dr. Drew is considered the father of the blood bank. Born in 1904, drew was raised in Washington, D.C. he attended Amherst College, where he was the only one of 13 black students at the school, which had around 600 students total at the time. Drew went on to study medicine at McGill in Montreal, Canada, then started research at Columbia University in New York. His research focused on how best to preserve blood for transfusions. At the time, blood was usually only transferred immediately after it was donated. That meant it was difficult to transport blood during long distances or store supplies for emergencies. However, Drew discovered that blood plasma was able to preserve for much longer when the liquid blood was separated from the red blood cells. He also realized that the plasma, when devoid of cells, could be given to anyone who needed it, regardless of blood type. Additionally, Drew developed a method where the blood could be reconstituted by mixing dried plasma with distilled water when needed. These discoveries completely revolutionized emergency medicine. Drew's research and ingenuity was critical to the war effort during World War II. Thanks to Drew's work, thousands of units of plasma were quickly collected, tested and shipped to Britain starting in the winter of 1940. This saved countless lives. In 1941, Drew became the director of the first American Red Cross Blood Bank. He went on to invent what we now call bloodmobiles, the mobile trucks that collect, refrigerate and transport blood donation. The blood bank supplied to the US Army and Navy, both of whom initially rejected the blood of African Americans and drew resigned from the Red Cross in 1942 in protest. In some states, the segregated blood donation process continued into the 1960s. Drew spent the rest of his life as a surgeon, researcher, and professor. Thank you, Dr. Drew, for your incredible research, service and integrity.

Chris Dall: So, Mike, we have once again covered a lot of ground. What are your take home messages for today?

Dr. Michael Osterholm: Well, Chris, again, this was one of those choices that was difficult because there were a few things we could cover. But I think the lead point that I have to make, and I think it's probably obvious to the audience, the routine vaccine world in the US is in a mess. Just a mess. It's not just because of a lack of leadership. It's a kind of leadership that's counterproductive, that's dangerous, and we have to call it for what it is. I worry that more and more parents in this country are going to find getting their child vaccinated. A question should we or should we not? And when you see the kind of performances that we saw this past week in the White House and the messages that keep coming from this administration, this is so dangerous. So it is in public health and clinical medicine. We have our work cut out for us, but it's worth it. It's all about our children's health and even their lives. The second point is that the food borne disease prevention, control and outbreak response are truly compromised today in this country. I really regret watching what had happened over the course of the recent months with food borne disease in the country, again celebrating the fact that there are places oasis of excellence such as the Minnesota Department of Health. But on a whole, we really need to step back and ask ourselves, what is it that we need to do to provide a safe and wholesome food supply for our country? And finally, the respiratory season is threatening, but not with big guns yet. I'm happy to report that there's no evidence of influenza, RSV activity, and COVID, while it surely appears to be coming back, is not yet what might be considered the next wave of COVID activity.

Chris Dall: And Mike, what is your closing song for this episode?

Dr. Michael Osterholm: Chris, I'm going to use a song that we've used before. It's The Song of Good Hope by the late Glen Hansard. We used it once before in the podcast on August 25th, 2023. In episode 138 More Confusing Times. Glen Hansard is someone who's been in the news recently. He was an Irish singer, songwriter and actor. He originated from Ballymoney in Northern Ireland. In 1990 he co-founded the Irish rock band The Frames, which he fronted. The band released ten studio albums, four of which reached the top ten in the Irish Albums chart. Hansard was also a member of the folk rock duo The Swell Season, founded in 2005, which released three albums. In 2012, he released his debut solo album "Rhyme in Response." His second album, "Didn't He Ramble," was nominated for a Grammy Award for Best Folk Album. Hansard died in a motorcycle accident at the Strawberry Beds on the outskirts of Dublin last month. He was 56 years of age. Today we celebrate his words as they live on with the song "Song of Good Hope."

If we're going to make it across this river alive. We need to think like a boat and go with the tide. And I know where you've been. It's really left you in doubt. Or ever finding a harbor of figuring this out. And you're going to need all the help you can get. So lift up your arms now and reach for it. Reach for it and take your time, babe. It's not as bad as it seems. You'll be fine, babe. It's just some rivers and streams in between. And you and where you want to be. And watch the signs now you'll know what they mean. You'll be fine. Now just stay close to me. And make good hope. Walk with you through everything. And take your time, babe. It's not as bad as it seems. You'll be fine, babe. It's just some rivers and streams in between you and where you want to be. And watch the signs now you'll know what they mean. You'll be fine. Now just stay close to me. And make good hope. Walk with you through everything. May the song of good hope walk with you through everything.

The late Glen Hansard. Well, thank you again for joining us. I hope that we've been able to give you some information you're looking for. It's a crazy world out there right now. I want to also just say again to all the people who write into us, who send us their emails to those I meet on the streets, I meet at meetings. Thank you so much for your feedback and your support. We're here for you. We are one big family and that's what this is about. Just remember one thing kindness today is so important. Again, as I've challenged you in the past, once a day, do something kind for somebody that they had no idea you were going to do, and watch what that brings about in terms of a smile. Be safe. Be healthy. No need right now to get your COVID shot yet, per se, the new doses are coming. We'll keep you posted and just never forget how much we appreciate you. Thank you, thank you, thank you. Be well. See you in two weeks.

Chris Dall: Thanks for listening to the latest episode of the Osterholm Update. If you enjoyed 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.umd.edu. This podcast is supported in part by you, our listeners. The Osterholm Update is produced by Sydney Redepenning, Elise Holmes and Ruby Guthrie. Our researchers are Cory Anderson, Meredith Arpey, Leah Moat, Emily Smith, Clare Stoddart, Angela Ulrich and Mary VanBeusekom.