Episode 183: Time to Organize

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 Dall, Reporter for CIDRAP news. And I'm your host for these conversations. Welcome back, everyone, to another episode of The Osterholm Update Podcast. On the first day of his confirmation hearings, Department of Health and Human Services Secretary Robert F. Kennedy Jr., amid a litany of questions about his long history of anti-vaccine statements, said to Senator Ron Wyden of Oregon, quote, I will do nothing as HHS secretary that makes it difficult or discourages people from taking vaccines. It was a statement that some of his critics found comforting. Yet in his short time as HHS secretary, we've already seen Secretary Kennedy make statements about the measles, mumps, rubella vaccine that have confounded public health experts and raised concerns that he is undermining confidence in the vaccine in the midst of a measles outbreak.

Chris Dall: He also, in a recent interview, suggested that parents, quote, do their own research on childhood vaccines. And two weeks ago, HHS announced a policy that will change the way vaccines are tested and monitored going forward, a move some believe could limit access to vaccines. The changes that Kennedy is recommending for U.S. vaccine policy and how they might impact our vaccine infrastructure if he follows through on them, are among the topics we'll be discussing on this May 15th episode of the podcast. We'll also continue our examination of the potential impacts from the latest round of federal health agency job and funding cuts, provide an update on the US measles outbreak, bring you the latest on COVID, flu and H5N1 avian influenza, and answer an ID query about the Trump administration's newly announced next generation universal vaccine platform. We'll also 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.

Dr. Osterholm: Thanks, Chris, and welcome back to the podcast family to another edition of the update. And as I say each and every time, we're so very, very fortunate to have you be part of this podcast. Your feedback, your thoughts, your ideas, and frankly, just your support means everything. And I hope that we're able to provide that to you here today. A lot to cover. I also want to thank those who are new listeners for joining us today. And hopefully, again, we can provide you with the information you're looking for. Chris, before we dive into the latest news and infectious disease updates, I'd like to use my opening dedication segment to acknowledge and celebrate two groups of professionals whose work shapes our society in profound and lasting ways. Nurses and teachers. This month marks both National Nurses Week and Teachers Appreciation Week, and so we're dedicating this episode to the individuals who work in those admirable career fields and the compassion, creativity, and dedication they bring to their work, often under difficult circumstances and limited support. Nurses are on the front lines of every health crisis, from hospital wards to vaccination sites, from community health outreach to long term care facilities. They are often the first to spot early signs of outbreaks, administering lifesaving care, educate patients and families, and coordinate with public health agencies to control the spread of infectious diseases.

Dr. Osterholm: The COVID-19 pandemic highlighted their heroism. But even outside of emergencies, nurses are the steady hands and listening ears that help build trust in our healthcare system. They are caregivers, advocates, and educators all at once. Teachers similarly play a fundamental role in our communities. Each day, teachers inspire learners to think critically, to ask questions, and to believe in their potential. I see this with my own grandchildren. A teacher's influence lasts far beyond a classroom, shaping who we are and how we see the world. Teachers do all this while managing overcrowded classrooms, outdated materials, and increasing expectations, often with far too few resources. In fact, 94% of public-school teachers in the US spent their own money on classroom supplies, according to a US Department of Education survey. Despite the challenges, teachers persevere to serve their students by creating safe spaces for growth and exploration, often serving as mentors and lifelines. I know from my own personal experience; it was the teachers of my small Iowa farm town that saved my intellectual soul. Both nurses and teachers give more than they're asked and more than they are often thanked for.

Dr. Osterholm: They do essential work that enables progress in every other field, including our field of public health and scientific research. Without healthy cared for people and without educated, empowered citizens, no health policy or scientific breakthrough could truly succeed. This episode and our gratitude, and specifically my personal gratitude is for you. Now let's move to that segment of the podcast that either you like it or you don't. Yes, indeed. This is a time to talk about light. Well, today in Minneapolis, sunrise is at 5:43 a.m., sunset at 8:35 p.m.. That's 14 hours, 52 minutes and five seconds of sunlight. We're continuing to gain sunlight at about two minutes and 16 seconds a day. Looking forward to that longest day coming on June 21^st. For our dear friends and colleagues in Auckland, New Zealand, particularly those at the Occidental Belgian Beer House on Vulcan Lane. Today you had sunrise at 7:11 a.m., sunset at 5:23 p.m., ten hours, 11 minutes and 51 seconds of sunlight. You're losing about one minute and 39 seconds a day. But as we've said time and time again, we're sharing our light with you. And we're so glad you're sitting and listening today.

Chris Dall: Mike, let's start with the proposed changes in vaccine testing and safety monitoring that were reported by The Washington Post on May 1st, based on responses from an HHS spokesperson to questions about vaccine policy from post reporters. I want to present two statements from the spokesperson. They first said, quote, all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure. A traditional departure from past practices. The spokesperson then added, quote, except for the COVID vaccine, none of the vaccines on the CDC's childhood recommended schedule was tested against an inert placebo, meaning we know very little about the actual risk profiles of these products. Now, this was not announced in an official policy. This was responses to reporter questions. But Mike, can you separate fact from fiction for our listeners?

Dr. Osterholm: Well, you know, Chris, having been in this business for 50 years, I thought I'd seen it all, but I haven't. Not until now. Let me just say that what you have just read to us is absolutely untrue and not based on any fact. This is a complicated issue, and I think it really highlights the dangers of having uninformed people in such prominent positions at Health and Human Services. Their claim has since been repeated widely over social media, often as a gotcha towards public health officials and researchers. But we can't mistake parrots for prophets here. To an individual who doesn't know much about vaccine research and the ethics involved in how clinical trials are designed, the idea that some vaccines have been put on the market without being tested against an inert placebo may seem like a surprising oversight or even a dangerous lapse in safety and efficacy testing. But that couldn't be further from the truth. First of all, let me make it very clear that, in fact, all vaccines that are ultimately recommended as part of our vaccine program in this country had, at their origin, a placebo-controlled trial that demonstrated their effectiveness. And in fact, as I'll talk in a moment on the Vaccine Integrity Project discussion, we have actually linked there to a document showing all 111 studies that have been done on the vaccines we use today that were a placebo-controlled trial.

Dr. Osterholm: However, it is fair to say that as newer vaccines become available, we in fact have not put those to the same placebo-controlled trials. But let me explain. The reason that some vaccines haven't been tested against inert placebos is because most clinical trials test new drugs against the current standard of care. In this case, whether a vaccine was previously being used before a newer one is introduced. There are two reasons for this. The first is that this new drug, or in this case a vaccine, shouldn't just be safe and effective at preventing and treating disease. It should be better than what is currently in use. The second is that when we have a safe and effective drug or vaccine available, it is considered unethical to test it against an inert placebo. It could cause harm to withhold safe and effective drugs from those who need them, in this case, children vulnerable to infectious diseases. So, when we have a vaccine that exists, but we think we have a better one, we'll test the better one against the currently used vaccine. That's not considered a placebo-controlled trial, but it's the right and ethical thing to do. Imagine if you were testing whether or not a parachute worked, and that you had a 50 / 50 chance of it working or not working when you jump out of the plane.

Dr. Osterholm: Would anybody sign up for that study? It's a placebo. You'd want to make sure you know that you could test the parachutes against the bad ones. So, in this case, what they've misunderstood and have continued to state is that, number one, they are absolutely factually incorrect about the use of placebos. Second of all is the fact they don't explain that when a vaccine is not tested against a placebo, but another vaccine, that that is in a sense is the ethical way to go. Let me give you some examples. The first polio vaccine developed by Salk were in fact inactivated vaccines. So, these were killed vaccines. Later on, when Sabin came up with the live attenuated polio vaccine, they were then tested against the Salk vaccine, not a placebo. And let me be clear the Salk vaccine was tested against a placebo, but it would have been unethical to test the Sabin or live attenuated vaccine against a placebo, because we did know that the Salk vaccine worked. The question was, did the Sabin vaccine work even better? So, in fact, we have a number of instances where we've improved on vaccines over time, but again, tested them against another vaccine or a placebo.

Dr. Osterholm: So, let me just repeat what I said earlier. In fact, there have been 111 placebo-controlled trials for vaccines, and the statement by the Department of Health and Human Services is just factually incorrect, misleading and unfortunately is confusing the public. Additionally, it's worth noting that because unvaccinated children are not included in clinical trials for some vaccines, this doesn't mean that there aren't any studies that compare the rates of various potential adverse events in vaccinated and unvaccinated children. Several large cohort studies have been conducted to study this very issue. Once vaccines are on the market, this is often called post-marketing studies, and they have contributed greatly to understanding the benefits of childhood vaccination and how they far outweigh the risks. So again, we have another set of data that we often use. This is why having individuals with very limited, if any, public health experience in these prominent roles is so important. Experts in the field spend a lot of time learning about clinical trial design and how to interpret medical and public health research as part of their training, and thus would likely not have parroted such misleading claims about vaccination. Without the proper context to understand why trials are conducted the way they are. It demonstrates to me a significant lack of knowledge not only of epidemiological methods, but also the basic principles of ethical research.

Dr. Osterholm: This is also why Kennedy's team promises to test new vaccines against inert placebos is incredibly concerning. If a new, potentially better influenza vaccine were to be developed, for example, there would be no reason to withhold influenza vaccination from a group to test its safety and efficacy when we have the option to test it against the current influenza vaccines. Secretary Kennedy sees this change as a movement towards a scientific gold standard, but this is simply wrong. The widely accepted gold standard in medical research is to compare new treatments to existing standards of care, and I can only hope that the current administration's team realizes this and changes course. And let me just add one other comment you're going to hear this term brought up often. The administration has now found a new tagline talking about the fact that they're practicing scientific gold standard science. Let me tell you, this is nothing more than a throwaway line that could have easily come from some advertiser. And it speaks nothing as to what they're actually doing. I have yet to see any definition of gold standard science that they keep promoting. And with what I just shared with you. Hopefully you can understand they are in fact leading a disinformation campaign, not, in fact, spreading the word of science.

Chris Dall: Another part of this new policy, according to the Washington Post story, will be the creation of a new surveillance system for vaccine safety. But, Mike, as you and your colleagues on the Vaccine Integrity Project noted in a viewpoint published recently on the CIDRAP website, we already have vaccine safety surveillance systems. So, can you talk about the concerns you laid out in that piece?

Dr. Osterholm: Well, Chris, this piece is actually tagged in our program notes here. And also, if you go to the Vaccine Integrity Project section of our website, you'll get even more information. Remember, this is the project that I talked about in our last podcast that we've launched at CIDRAP, with the partnership of a number of experts in the area of vaccines to ensure that vaccine policies remain grounded in the best available evidence, free from external influence, and focused on optimizing the protection of individuals, families and communities against vaccine preventable diseases. This project is not wed to one approach or to protecting existing systems. Rather, it is guided by the goal of protecting lives by safeguarding American vaccine access, safety and use. This program is all about the gift I want to give to my grandchildren. Chris, in terms of vaccine safety monitoring, the Centers for Disease Control and Prevention oversees, these two systems, the Vaccine Adverse Event Reporting System are often referred to as VAERS, which it supervises with the Food and Drug Administration to allow providers and vaccine manufacturers to report adverse health events following vaccination. And the second system, the Vaccine Safety Datalink, or VSD, which gives the agency access to electronic health records from 11 healthcare systems across the country representing more than 10 million people. Whether or not you believe that the current safety infrastructure is optimal, one cannot deny that it has been successful for decades.

Dr. Osterholm: Over and over, it has detected the smallest of safety signals, all with the goal of upholding the highest safety standards for vaccines recommended and used by Americans. In 1976, for example, out of more than 40 million people who received the swine flu vaccine, Enhanced Safety Monitoring quickly uncovered an increased risk of Guillain-Barré syndrome. In 1999, after VAERS detected just nine cases of interception, a rare bowel obstruction, following the administration of the first rotavirus vaccine in 500,000 children, the CDC Advisory Committee on Immunization Practices withdrew its recommendation and the manufacturer withdrew its license. More recently, in 2021, among millions of people who received the Johnson and Johnson COVID-19 vaccine, VAERS detected a rare but potentially fatal condition that forms blood clots, causing the CDC and the FDA to recommend a pause in its use and ultimately issue a preference for mRNA vaccines. And just this year, the CDC was alerted to five cases in which a person was hospitalized with cardiac or neurologic events after receiving a new chikungunya vaccine, prompting the agency to alert providers. VAERS can't determine whether a vaccine caused a particular adverse event. It can simply reveal event reporting trends that may suggest the need for further assessment.

Dr. Osterholm: In other words, VAERS functions like a smoke detector in alerting to potential dangers that need attention. So, Chris, improvements to the current system are most welcome, however, making big changes to vaccine approval and safety systems and potentially eliminating them needs careful thought with a clear goal of avoiding unanticipated negative consequences. Furthermore, changes require honesty about the current system and how proposed alternatives will improve performance. We worry that some descriptions of the existing systems designed to fail unusable absolutely distort reality. If the question is how can we make the current system even better, given the US Health and Human Services Secretary Robert F. Kennedy's near decade as the leader of an anti-vaccine group, the burden of proof for solutions is necessarily high. We have laid out on a viewpoint document as part of the Vaccine Integrity Project, 11 questions that we believe must be answered in terms of understanding what we should or shouldn't do to improve on our safety network. Real transparency requires answering these questions in the planning stages, not after they concoct some kind of activity. That, then, is an attempt to identify potential adverse events which actually really are not, in fact, adverse events. So proposed changes to the vaccine approval system deserve the same scrutiny. New vaccines to be required to undergo placebo-controlled trials before being deemed safe.

Dr. Osterholm: in this type of trial, one group of people will be given the proposed vaccine and others will receive a placebo, an inert substance. This raises really serious questions about how, in fact, these trials will be done. In some situations, placebo-controlled trials are ideal, for example, those in which no effective treatment or preventive intervention actually exists for the disease, and there is little potential for harm in delaying or forgoing treatment. As I noted earlier, placebo-controlled trials were carried out for all the first in class childhood vaccines. This is such an important point in this case, looking at placebo-controlled trials and how they're designed and carried out, we also, again, in our viewpoint, lay out seven questions that must be answered. In fact, if they are going to pursue this approach, it raises serious ethical issues about exposing children to infectious agents without the protection of a vaccine because they got the placebo. We know vaccination saves lives. We know the current system can detect rare, serious side effects among millions of doses administered. If Secretary Kennedy has proposed improvements, let's see them before they're implemented, unlike the most recent round of firings at HHS. If mistakes are made, they can't be undone in this situation.

Chris Dall: One other item that was noted in The Washington Post story was that the new vaccine testing policy won't apply to the yearly updates of the flu shot. They did not mention updated COVID vaccines, but FDA Commissioner Marty Makary and the newly appointed head of the FDA's Center for Biologics Evaluation and Research, Doctor Vinay Prasad, have questioned the need for yearly COVID shots, and Makary has indicated he thinks updated COVID vaccines should be treated as new vaccines. In other words, they should have randomized controlled trials. So, Mike, what does this all mean for updated COVID shots in the fall?

Dr. Osterholm: Well, Chris, let me just begin by saying chaos reigns supreme. Something that's pretty common right now in dealing with issues in this administration. First of all, you have to understand that both influenza and coronavirus vaccines are very different than other vaccines. These are the two that we constantly need to update because of the change in the virus. Remember measles vaccine one dose lifetime, two doses? Absolutely for a lifetime protection. The virus changes so very, very little. So, in order to accommodate the kind of vaccine that we need for influenza and COVID, a number of years ago, the FDA actually established an approach to influenza vaccine with what was called the annual strain change agreement. And what that meant was that the vaccine never changed. But the antigens, the part that elicited the antibody response in the host, would just be changed out for the most current one. And that has been very successful with influenza. Well, we now need this also for COVID because we have seen what happens when we get new variants that we do need to improve on the vaccines. That is also a strain change. It is not a new vaccine. What this is really all about is this administration is deadly against COVID vaccines, for reasons I don't understand. They basically came out of the original Trump administration and for them to go after COVID because it doesn't have the many decades track record of influenza, they're making it sound like, for example, these need to be tested for the first time, as if they're new vaccines.

Dr. Osterholm: Well, when you look at the three years of the pandemic that we had the vaccine around, look at the many millions and millions of people who were vaccinated at all ages, including kids. There is nothing new here. So, what we ought to be looking at is how do we do the strain change, as we have done in the past for influenza, so that we have a vaccine ready to go at late fall into the flu season in the northern hemisphere, and for COVID, where we don't have yet quite the same seasonality. But we know when new variants emerge, we need to adapt, we should be able to do the same. So, in fact, if this administration pushes the need to have COVID vaccine placebo-controlled trials, I will tell you right now, we will not have these vaccines for some time to do these trials to get the approval and then to actually then convert into manufacturing means we could be months and months and months behind the season change, or if with COVID variant changes or that appears. So, I'm only hopeful that this anti mRNA vaccine approach that this administration harbors will not get in the way of good science. And this is going to be an important issue. People's lives are at risk here again. This should not be some kind of political revenge campaign on mRNA vaccines. This should be about what is the science that supports strain changes are effective and can be done safely.

Chris Dall: We'll have more on vaccines in a little bit, but I want to turn now to the impact of funding and job cuts at federal health agencies. Today, we're going to look at the termination of the Healthcare Infection Control Practices Advisory Committee, or HICPAC. Mike, what is HICPAC? Why is it important and what does its termination mean for the general public?

Dr. Osterholm: Well, Chris, when you think about what HICPAC actually does and consider who their work is meant to protect, it's clear that this decision ultimately makes Americans far less safe. The Healthcare Infection Control Practices Advisory Committee, or HICPAC, as we just described, is a group that has advised the CDC on how to reduce the spread of infectious diseases in healthcare settings since the early 1990s. Their work informs national guidance on everything from personal protective equipment to cleaning protocols, isolation precautions, infection prevention measures in hospitals, nursing homes, outpatient clinics and more. And this is really important because, according to the latest data from 2023, there were more than 700,000 healthcare associated infections in the US and 75,000 deaths as a result, so clearly preventing these from happening whenever possible is something we should all be in agreement with, and that's what HICPAC was actually designed to do. However, earlier this month, all 14 members of the committee who represented key areas of infection prevention, medicine, public health and beyond were notified of their termination. It's a move that's penny wise and ton foolish. And I think a joint statement from leading professional societies in infectious diseases and infection control captured it very well. In it, these groups, including the Infectious Diseases Society of America, state that, quote, the decision to terminate HICPAC creates a preventable gap in national preparedness and response capacity, unquote, and warned that, quote, the abundance of this committee's guidance creates a significant void in the field, fosters uncertainty among health care facilities and puts patients at risk, unquote. And when it comes to the big picture, Chris, I think that that's the real story here. At the end of the day, this decision is dismantling a very real and critical part of our public health infrastructure was created by Congress to prevent harm to patients and health care workers, and without it, there will be real world consequences in the forms of more infections and more deaths that otherwise could have been avoided.

Chris Dall: Mike, I'll also note for the audience that we had planned to discuss the layoffs of hundreds of employees at the National Institute of Occupational Safety and Health, or NIOSH, which essentially shuttered programs like the Coal Workers Health Surveillance Program and the Respiratory Approval Program. But just within the last few days, while we've been recording, we've learned that some of those jobs had been restored by Secretary Kennedy. Clearly, he was getting some political pressure from members of Congress. That's good news, of course, but doesn't it just speak to the chaos that we're seeing at federal health agencies.

Dr. Osterholm: Well, Chris, first of all, the fact that the Secretary has brought back a few employees in NIOSH, including the director, doesn't speak to the fact that there actually will be integrity with any of the programs. So, I think it's very important to understand that NIOSH still could be severely crippled in terms of programs going forward. But I think what you see here and what we have witnessed for the past 8 to 10 weeks has been this idea we go in and cut with a machete without any real understanding of what we're doing, but we're saying we're doing something and it looks good to the public that we're tightening up government. But in fact, these particular cuts have been very, very dangerous. And now they have to go back and reinstate these people. The ideal business minded approach would be to actually plan what you're going to do, use a surgical scalpel to extract what you need to extract, but leave the rest of everything intact and ready to protect the public's health and go from there. And that's not what they've done. And so, while I'm not a business major, no one had ever accused me of that. I'm pretty sure I can tell you that anybody that proposed how to improve efficiency and cost savings in an organization at any business school in this country, if they, in fact, sold their program based on what has been happening with DOGE and our experience in the federal government, they would get an F and F and an F, and I think that this is really an important point. Please understand this is not about efficiency. This is not about improving outcomes. This is not about improving cost savings. This is just plain dangerous.

Chris Dall: We've also seen in recent weeks the release of the Trump administration's 2026 budget, which contains more massive cuts to federal health agencies. Now, Mike, we know that presidents rarely get the budget they propose. It's essentially a presidential wish list. But even so, if we see anywhere near the type of cuts laid out in this budget, what kind of impact is that going to have?

Dr. Osterholm: Well, Chris, you're right. Presidents rarely, if ever get the exact budget they put forward since it's ultimately up to Congress. But seeing what's been proposed by this administration, I can tell you right now that would be absolutely devastating to public health in this country. This past week, I had the unique opportunity to attend a major national meeting of public health agency heads, and I heard them talk about, from their own very personal perspective in their state, what this budget would do for their public health agencies. I heard words frequently like catastrophic, unimaginable, scary. That's how it's being perceived right now by the public health system of this country, and rightfully so. Just in terms of health agency budgets, we're talking about proposed $18 billion cut to the NIH, nearly 40% of its total budget. As a leading funder of biomedical research, that would stifle everything from cancer studies and neuroscience to vaccine development and rare disease research. On top of that, their proposal specifically mentions eliminating funds for a number of key branches, including the National Institute on Minority Health and Health Disparities and the Fogarty International Center. Needless to say, the NIH would look dramatically different under this proposal. Not just smaller, but reorganized in a way that sidelines entire areas of health research that don't align with the administration's priorities.

Dr. Osterholm: The ripple effects of this would be far reaching. And remember, there has been study after study showing that for every dollar of research invested in the NIH, the economy experiences anywhere from 2 to $3 in return. Meaning, just in terms of what the NIH is able to provide in terms of future medical care, whether they be drugs, whether they be equipment, procedures, etc. Like the NIH, the CDC would also be hit hard by this, with the proposed cut of $3.6 billion to its budget, or nearly 50%. Again, as part of these cuts, programs focused on chronic disease prevention, environmental health, injury prevention, global health and emergency response all would be impacted. And as I've mentioned before, a lot of CDC funds are sent to state health departments where there are crucial for their many programs. So, who knows what this would mean for them. I've mentioned this before, where at the Minnesota Department of Health, one of the crown jewels public health agencies in this country, 90 plus percent of their budget for infectious disease surveillance, prevention and control are based on federal funds from CDC, which look largely at this time to be cut.

Dr. Osterholm: Looking at their proposal, there's a whole laundry list of cuts like this that I could spend an entire episode going through. Basically, entire programs or divisions wiped away with nothing left to replace them. This is truly become one of what I have considered public health worst weapons of mass destruction. But I think the overall point is this even if the budget doesn't pass exactly as proposed, which is likely to be the case, and I certainly hope it's the case, it tells us a lot about how this administration views public health and scientific research in general. To me, it is an evident shift away from science and data and tried and true public health functions. And with that, I think we'd lose a lot of hard-earned progress, because when you pull funding from places like the NIH, CDC, etc., you're not just cutting programs, you're cutting people, expertise, infrastructure, you're cutting away those who are in training, who are going to be our health and research leaders of tomorrow. We are watching an entire generation literally be taken down. This is so hard to see, but once it's gone, it's not easy to get back. And we must never forget that.

Chris Dall: Now to the U.S. measles outbreak. Mike, what's the latest?

Dr. Osterholm: Well, Chris, we've reached a sobering milestone last week with more than 1000 confirmed cases of measles in the US. As a reminder, measles was declared eliminated in the year 2000 in the US, meaning that transmission was not continuously occurring within the country. While there was a single outlier year in 2019 with a large outbreak in New York, in the last 25 years, the US averages approximately 130 cases of measles per year. We are only five months into 2025 and we've already crossed the 1000 case threshold. This is not a harmless childhood illness. It's caused three deaths and resulted in more than 126 hospitalizations just this year. It's incredibly concerning. And to walk through the latest numbers, Texas still has the most confirmed cases of any state. As of Tuesday, May 13^th, they are reporting 709 total cases. As we discussed previously, it's very likely that there are many, many more cases out there, especially since we know many cases have occurred in a population that are hesitant to seek medical care. In Texas, approximately two thirds of cases are in children and adolescents under age 18, but one third are in adults. This is really important as we consider the changing epidemiology of this disease compared to decades in the past, when nearly all cases occurred in children, and how we might implement any public health interventions now, particularly for women of reproductive years. The outbreak that began in West Texas has spilled over into multiple other states, including New Mexico, Oklahoma and Kansas. New Mexico has the highest number of cases associated with this outbreak outside of Texas, with 71 reported cases as of Friday, May 9th. There are also a number of additional outbreaks popping up across the country. Ohio has now reported at least 34 cases and one hospitalization. North America as a whole is seeing a surge in measles.

Dr. Osterholm: An outbreak in Ontario, Canada, that began in mid-October of 2024 has surpassed 1400 cases. The Mexican state of Chihuahua has had more than 1000 confirmed cases and one death as of last week. We are in a pivotal moment nationally and globally, and need to take urgent action to curb these outbreaks and increase vaccination rates. While I wrap up this conversation on measles, though, Chris, I also want to raise the issue of rubella. The R in the MMR vaccine. I think measles is really a canary in the coal mine of what could become with vaccine preventable diseases in this country. While Rubella is less infectious and inspections and results in fewer hospitalizations compared to measles. It can have devastating consequences if contracted during pregnancy. Rubella was eliminated in the US in 2004. In each year, the US currently reports less than ten cases of rubella. Globally, however, there is still a great deal of rubella circulating. For 2023, W.H.O.’s most recent data on annual rubella counts, member states reported more than 35,000 cases of rubella and greater than 1500 cases of congenital rubella syndrome. We already know there are incredibly vulnerable communities across the United States with dangerously low vaccination rates for measles, mumps and rubella. It takes just a few sparks to get this fire going. I hope that with more coordinated efforts in public health, we can keep this thing from getting out of control before it's too late. And as we have increasing evidence of a lack of vaccination or previous infection protection in women of childbearing years, particularly younger women. I also worry that rubella could take a heavy toll if we see it reestablished here in this country. The bottom-line message on this section, Chris, is its vaccine, vaccine, vaccine. That's what we need so badly.

Chris Dall: What are you seeing in the latest COVID and flu data?

Dr. Osterholm: I am very happy to report flu season was officially declared over and all 50 states are either considered to have low or minimal flu activity. But there has been a really unfortunate milestone that we crossed since the last episode, and I want to bring it to everyone's attention. Since our last podcast, there have been 22 additional pediatric deaths reported, some of them of a few months ago and only now getting reported. But the bottom line is we are now talking about a season with 226 pediatric deaths reported to date, meaning that we surpassed the 2007 pediatric deaths reported during the 2023-2024 season. And this is the highest number of pediatric deaths in a non-pandemic season. The only season more deadly was the 2009-2010 pandemic season, which claimed the lives of 288 kids. Remember, that was during the H5N1 pandemic. COVID-19 activity is still low and decreasing across the board, from wastewater to emergency departments and hospitalizations. One metric I do want to draw attention to is its weekly deaths. The week of April 12th, the most recent week with complete data, we lost 337 Americans to COVID-19. While this is absolutely nothing to celebrate, I do want to note that the trend we're seeing is putting us on track to see the lowest weekly death total we've seen since the beginning of the pandemic. The week of June 8th, 2024, almost a year ago, there were 314 deaths, which marked the lowest total, and I'm hopeful with our current trend, we will actually get below 314 soon.

Dr. Osterholm: I do want to add one additional piece though to the COVID discussion. I know there have been many questions surrounding the upcoming COVID-19 vaccines, and I've surely given you my opinion about that, just a moment ago. I want to take this time to reemphasize that these vaccines for COVID work. They're not perfect, but they're the best we have. And it's important that we continue to encourage people to get vaccinated when they are eligible and there are doses available. Last week, there was a vaccine effectiveness study published in Nature Communications that looked at data from the US Veterans Affairs health care system to estimate the effectiveness of the 2024-2025 Pfizer vaccine. Despite very low vaccine uptake, when I say low, I mean 3.7% of the study participants were vaccinated. These vaccines were 68% effective against hospitalizations, 57% effective against emergency departments and urgent care visits, and 56% effective against outpatient visits. When limited to just individuals 65 years of age and older, the vaccine was 75% effective against hospitalizations, 56% effective against emergency room and urgent care visits, and 58% against outpatient visits. As the authors note, these vaccines work, but they can only work if people are willing to receive them. These vaccines can be life savers, particularly for those over age 65 or those with underlying immune conditions. I hope that we never get to the point where we're over getting these vaccines. For some of us, they still are a lifeline.

Chris Dall: Let's turn now to the H5N1 avian flu outbreak. We continue to get reports of infected poultry and dairy cattle in this country, but we haven't had a confirmed human case reported in several weeks. Mike, is there anything that we can read into that.

Dr. Osterholm: Well, Chris, yes, as listeners have probably picked up on over the last few episodes, there's been less and less talk about when it comes to H5N1. Don't get me wrong, cases are still being reported, but at a much slower pace than we saw six months ago. So, our case number is actually going down, or are fewer animals being tested for the virus? The truth is, I don't know. And I don't think anybody does. But my intuition is that both can be true at the same time. CDC wastewater surveillance over the past six weeks has detected H5N1 in samples from 30 sites, almost all along the west or east coast. These findings is echoed by wastewater scan data, which shows hotspots in the same areas compared to the peak of the outbreak roughly from early October to late December 2024. There are fewer sites testing positive and positive results are appearing less frequently. This suggests that there's less virus circulating than there was during the peak of the outbreak. At the same time, we all have seen the devastating budget cuts to the USDA and CDC, and those cuts just don't affect federal agencies, they ripple to state and local public health efforts, too. I think it would be naive to assume that H5N1 testing for animals, humans and the environment hasn't been affected by these changes. That being said, we are still seeing sporadic detections in animals.

Dr. Osterholm: Since our last episode, USDA APHIS has reported six more H5N1 detections in poultry, affecting an estimated 6800 birds. The largest of those was that of poultry facility in Douglas County, Illinois, along with two live bird markets, one in Essex County, New Jersey, and the other in Miami-Dade County, Florida. Meanwhile, the cumulative national total of H5N1 detectors in dairy cattle herds has reached 1053 across 17 states. The most recent cases were reported in Arizona, its fourth. Helen Branswell, reporter at STAT and a close follower of the H5N1 outbreak, recently pointed out that we still don't know whether those positive herds are epidemiologically linked or if they represent repeated spillovers from wild birds. As for human transmission, yes, it's true that there hasn't been any reported cases linked to dairy cattle, poultry or other animal exposure since early April. I think a few things are at play. As I mentioned earlier, we're probably seeing fewer human cases because there's less virus circulating in the animals, so fewer people are being exposed. But I also think there's an underreporting. Some farm workers might not come forward with symptoms due to fear of economic consequences or other concerns, particularly for those who are undocumented workers. The bottom line is we still don't have all the facts about the many aspects of the ongoing H5N1 situation, but we'll continue to monitor it and keep you informed.

Chris Dall: Now it's time for our ID query. This week we received an email from a listener about the next generation universal vaccine platform, announced two weeks ago by HHS and the National Institutes of Health. Eric wrote, this news release from NIH has some too good to be true vibes and language in the press release arouses suspicion. Eric cited words such as recalibration and decisive shift toward transparency. He went on to say, and there is no mention of what will happen to existing platforms. We need your impartial and expert commentary on this. So, Mike, what can you tell Eric and our listeners about this new platform and what are your concerns?

Dr. Osterholm: Well, first of all, Eric, thank you very much for the question. This is one that is a very important question about what are we looking at for the future of flu vaccines. And let me begin by saying, I'm going to sound like I'm kind of in the middle of the road here. And what I mean by that is I saw some of my colleagues who jumped on quickly this announcement and made it sound as if the investment that the NIH was making in this one particular vaccine was a mistake. Let me share with you what I know about these vaccines and how we at CIDRAP actually deal with this, as we are the ones that actually have the influenza vaccine roadmap activity and keeping track of what's out there. First of all, on May 1st, Health and Human Services and the National Institute of Allergy and Infectious Diseases announced that they are investing in what they're calling the Generation Gold Standard vaccine platform that can be used for influenza and coronavirus with pandemic potential. The press release states that this realigns BARDA's operations, with statutory mission under the Public Health Services Act to prepare for all the influenza viral threats, not just those currently circulating. This press release also states that by investing in these vaccines that are developed exclusively at NIH, meaning this is the government led in-house research, you'll ensure transparency. Well, let me just tell you, this is about as much hype as one can imagine.

Dr. Osterholm: And this is hype. And let me share with you why I say that. Now, in the interest of transparency, I want to dive into the reality of this announcement. But before I do, I want to make it very clear that I'm 100% supportive of investing in improved influenza vaccines. I have been screaming from the rooftops for several decades that we need to invest in improved flu vaccines. Back in 2011, we at CIDRAP published a report entitled “The Compelling Need for Game Changing Influenza Vaccines”, and we have been funded since 2021 to actually house the influenza vaccine roadmap. We have linked both the CIDRAP report and the roadmap in the episode description. So please do not take my skepticism about this specific investment as a departure from my very strong support for universal or broadly protected flu vaccines. HHS announced that they're investing $500 million transferred from project NextGen meant for improving COVID vaccines and putting it towards the development and licensure of broadly protective vaccines. They specify an NIH developed influenza vaccine candidate known as BPL-1357, along with another candidate vaccine, BPL-24910, using an inactivated whole virus platform. Where many of my colleagues responded to this very development, was the fact that this particular approach of using an activated whole virus platform was common in the 1940s and 50s, and actually fell out of favor for a variety of reasons, including its lack of effectiveness and its potential for reactions to occur with this whole cell inactivated virus.

Dr. Osterholm: And so, it's not a surprise, I guess you'd hear people saying, what are they doing? It's going back and reinventing the old Studebaker to take care of energy efficient cars today. There is some publicly available information in BPL-1357. According to sources published by the NIH researchers, the BPL-1357 vaccine candidate is a mixture of four inactivated, low pathogenicity avian influenza strains, namely H1N9, H3N8, H5N1, and H7N3. These are not influenza strains that circulate in humans. Those are H1N1 and H3N2 and currently one influenza B clade, but they share some immunologic features with seasonal and pandemic viruses and, perhaps importantly, introduce differences that may be useful in identifying universal or broadly protected influenza vaccines. In preclinical studies. BPL-1357 was evaluated for safety, immunogenicity, and protective efficacy. We will link to that publication in the show notes. If you're looking for more detail on this candidate and others in the preclinical pipeline, you can find more on the CIDRAP universal influenza vaccine technology landscape, which will also be linked to this episode description. For example, you can see in the landscape that currently there are two other research teams studying the use of inactivated whole virus platform for broadly protected influenza vaccines.

Dr. Osterholm: A 2022 paper summarizing preclinical data showing that mice and ferrets vaccinated with BPL-1357 and then challenged with a lethal dose of a variety of influenza viruses, were protected against the mismatched viruses, such as the 1918 H1N1 strain, a highly pathogenic H5N8, and the avian H7N9, in addition to the hemagglutinin and neuraminidase, is not contained in the vaccine. In other words, the preclinical evidence suggests the potential for broad protection against novel influenza strains that do not yet circulate. BPL-1357 has also been studied in phase one clinical trials in humans. A small trial evaluating safety and immunogenicity. Further clinical trials will be needed to further evaluate the safety, immunogenicity, and efficacy of this vaccine, but currently there is no other data in the public domain for this vaccine approach. Interestingly, the research on BPL 1357 is being led by experienced NIH researchers Jeffery Taubenberger and Matthew Memoli. If these names sound familiar, it's because Taubenberger was named acting chief of the National Institute of Allergy and Infectious Diseases in late April, and Memoli was picked by Trump to lead NIH until Jay Bhattacharya took over and named Memoli his principal deputy. So, we have an in-house research dual who have some authority with NIH and the National Allergy and Infectious Diseases, and also note that Taubenberger is listed as a lead investor on one of the two patents for the vaccine. This is typically a rigorous application and proposal process to receive NIH funding, especially when it is such a large award.

Dr. Osterholm: So, as you might imagine, some eyebrows and questions have been raised in the research community about the manner in which this award was given. We're in unprecedented times, so it is not necessarily surprising to me that we're seeing unprecedented decisions being made. But I wouldn't be truthful if I didn't say it raises some real red flags for me. While the HHS press release stated that this investment would improve transparency, that's not what we see at this point. I fully support the investment in improved influenza vaccines, but I really hope the goals and process for investing the $500 million in a single, broadly protective vaccine R&D are shared publicly. I want to emphasize that there are currently over 200 influenza vaccine candidates worldwide, including universal, broadly protective and next generation approaches in the R&D pipeline. And many of these have promise for the future of improved influenza vaccines and could be considered for continued support through initiatives such as Generation Gold Standard. I worry that, in fact, this $500 million is going to be invested largely in the special pet vaccine project at NIH, and we won't see the kind of support going to these other 200 candidates, of which one of them may be, in fact, the best chance for a universal, broadly protective vaccine.

Chris Dall: Now it's time for this week in public health history. Mike, what are we celebrating today?

Dr. Osterholm: We're going to dive into the history of another very important federal organization that has been a casualty to this administration throughout the 1800s. The Industrial Revolution introduced an entirely new era in the need for worker safety, and opened a potential role for governments to offer protection when private companies put profits over people's health. Federal safety legislation began taking off after the Civil War, and began to set standards for the health protection of railroad workers and miners. World War II created additional challenges in a burst of industrialization and an expansion of the chemical revolution that introduced new substances into the manufacturing setting, as well as into American homes. By the late 1960s, it was clear that there was a need for more coordinated efforts to protect the environmental and occupational health at the federal level. In 1970, the Occupational Safety and Health Act of 1970 was established, and with it the National Institute for Occupational Safety and Health, commonly referred to as NIOSH. This independent institute was created to conduct research on a range of occupational health and safety topics to inform regulatory agencies like OSHA on best practices. NIOSH would also conduct educational programs, especially on the proper use of health and safety equipment like respirators.

Dr. Osterholm: In its first ten years, NIOSH published its first Toxic Substances list and developed a pocket guide for chemical hazards, which is still updated and used widely today. The resulting years focused on research and development of standards and educational materials for a variety of topics, including asbestos, bloodborne pathogens, rubber latex allergens, indoor air quality, and more. In 2011, when the US established the World Trade Center Health Program, the NIOSH director led the effort to develop programs to provide medical care to the first responders and survivors of the 9/11 attacks. In what we refer to in our podcast episode as April Fools Tragedy on April 1st, 2025, more than 90% of the staff at NIOSH received layoff notices, including longtime director John Howard. I have a special appreciation for environmental health, sciences and occupational health as it encompasses the Division I serve in as a faculty member here at the University of Minnesota. I have such great respect for the work at NIOSH and by my colleagues in environmental and occupational health. We will continue to fight for you as best we can and advocate regarding the importance of your work for you, but most importantly, for the general public.

Chris Dall: Mike, as we have for the last several episodes, we've covered a lot of material today. What are your take home messages?

Dr. Osterholm: Well, Chris, actually, my messages are not going to be related to the one, two, three summary of the podcast, but rather I want to summarize, I think, a very important role that you all can play. And that is what can you do. You know, we're taking on the issues right now, the Vaccine Integrity Project to make sure that we do everything we can to support scientifically sound vaccine recommendations and the availability of these critical vaccines. But I hear from many of you, you want to do something and thank God you are in that place. So, here's what I'm suggesting. What can you do? The first is organize, organize, organize, organize, reach out to others. Reach out to your book club colleagues. Reach out to those you sit next to at church. Reach out to those you play sports with your kids. Learn what is happening in your community and do it as a group. Give everyone an assignment to understand what's going on. For example, and this is just a scratching the surface, but I think it speaks to the significance of this. There are so many issues right now happening at city councils, at school districts, at county commissioners, at state legislatures that you can help yourself and your community by organizing, getting together, even if it's two people initially, one even to start and then growing that. For example, in Iowa right now, there's a bill that actually providers face fines of up to $500 for administering mRNA vaccines. This was actually approved already by a committee in the Senate. Will it become law? It's not clear.

Dr. Osterholm: What is happening in Iowa, who's organizing around that? In Idaho, there's been in the legislature a ban on mRNA vaccines for ten years. 16 counties already restrict health departments from delivering these vaccines. What are we doing in Idaho to organize? In Minnesota, I shared with you the fact that there's been a bill to declare that mRNA vaccines are weapons of mass destruction. That is not likely to go anywhere right now. But there are many locations around the country where this kind of information is going on. Start your own network. Understand what the policies are at all these different locations, whether the city council monitor them, and if unscientific information is being shared, or if in fact, types of legislation or any kind of bills are moving in your locations. How do you organize to help local and state health departments and others deal with that? Remember, many state and local health departments right now are stretched to the max and oftentimes are not in a position to be able to comment. So, I want to leave you with the fact that there is so much more we all can do. We'll continue to do our bit, but we need you to also be involved. And I appreciate your expression of concerns about this. I appreciate you wanting to do something, but now is the time to find a way to do it rather than talking about it. And I really, honestly believe the word of the day. The word of the week, the word of the month is organized.

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

Dr. Osterholm: Well, after a podcast like this, I decided we got to do something good. Okay. We got to lift up this podcast family. So, I actually picked a song that is actually very near and dear to my heart. It's one that we used in episode 167. That was October 3rd of 2024. This is a song by American singer songwriter Natalie Merchant. It was released in her first single from her second studio album in 1998. It became a radio hit in North America, peaking at number 18 on the US Billboard Hot 100 airplay, as well as number one on the Billboard Triple A chart and number 19 in Canada. This song is one that really, I think speaks to many of us today and what we're feeling, what we're thinking, what we're hoping for. So here it is, Natalie Merchant, kind and generous. You've been so kind and generous. I don't know how you keep on giving. For your kindness. I'm in debt to you for your selflessness. My admiration for everything you've done. You know I'm bound. I'm bound to thank you for it. You've been so kind and generous. I don't know how you keep on giving. For your kindness. I'm in debt to you. And I never could have come this far without you. For everything you've done. You know I'm bound. I'm bound to thank you for it. Oh, I want to thank you for so many gifts. You gave the love, the tenderness. I want to thank you. I want to thank you for your generosity, the love and the honesty that you gave me.

Dr. Osterholm: I want to thank you, show my gratitude, my love and my respect for you. I want to thank you. Oh, I want to thank you, thank you, thank you, thank you. Natalie merchant. And that is exactly how I feel today about you all. I just want to thank you so much for being part of this, for giving us your feedback, for your support, for your ideas, and for you. In some cases, critical comments that are very, very important to us. And I also want to let you know that like many of you out there, we're all in a time of trouble. This is a difficult period, but we will, in fact, get through. I'm really finding a period of introspection. Next Monday, I'm scheduled to give a commencement address to the graduates of the School of Public Health here at the University of Minnesota. And I am working hard, struggling to say the least, about how do I provide a message of honesty, of kindness and one of hope when we are living in a time like this? So, I'm going to be doing a lot of thinking over the next couple of days to try to put that together for these graduates who deserve the kind of appreciation and the opportunities in the future. We need them. So please be kind. Be thoughtful. Thank you for being with us. We welcome your feedback. Thank you.

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.umn.edu/support The Osterholm Update is produced by Sydney Redepenning and Elise Holmes. Our researchers are Cory Anderson, Angela Ulrich, Meredith Arpey, Clare Stoddart, and Leah Moat.