Episode 184: Fool's Gold: Reframing the Science

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. Early last week, leadership at the Food and Drug Administration laid out what they called an evidence-based approach to COVID-19 vaccination in an article in the New England Journal of Medicine. In the piece, FDA Commissioner Doctor Marty Makary and FDA center for Biologics Evaluation and Research Director Doctor Vinay Prasad said that moving forward, the agency will limit access to COVID-19 vaccines to people 65 and older and those who have certain conditions that put them at high risk of becoming severely ill if infected. For all other groups, vaccine manufacturers will be required to conduct randomized clinical trials to prove safety and efficacy. The new framework is a significant departure from the policy that has governed COVID-19 vaccination policy in the US.

Chris Dall: Under that policy, updated COVID shots have been introduced on a yearly basis and have been recommended for everyone ages six months and older. Quote the FDA's new COVID-19 philosophy represents a balance of regulatory flexibility and a commitment to gold standard science, Makary and Prasad wrote. The FDA will approve vaccines for high-risk persons and, at the same time, demand robust gold standard data on persons at low risk. The new COVID vaccine framework, and what it means for everyone who wants to get an updated COVID shot in the fall, is among the topics we'll be discussing on this May 29th episode of the podcast. We'll also discuss and expand in warning that the FDA has requested of makers of mRNA COVID vaccines. Provide an update on the US measles outbreak. Bring you the latest on COVID and H5N1 avian flu. Examine a new White House Executive Order on gold standard science and answer an ID query from our listeners. We'll also bring you the latest installment of This Week in Public Health history. But before we get started, we'll begin with Doctor Osterholm's opening comments and dedication.

Dr. Osterholm: Thanks, Chris, and welcome back to all the podcast family members. It's great to be with you again. And for those who may be joining for the first time, I hope we're able to provide you with the kind of information you're looking for. Needless to say, this has been a very challenging couple of weeks since our last podcast in terms of the types of information we're going to cover today and what they mean or don't mean. And in particular, I want to acknowledge the fact that each and every day we see something new happening somewhere as it relates to public health, that is frankly, challenging. Let me move right into my dedication today, because I think it covers a lot of the issues that I just referred to. I'd like to dedicate this episode to all the recent graduates throughout all the schools and training facilities throughout the country. Each diploma, awarded in cap and gown donned, is a symbol of hundreds of hours of hard work, time spent memorizing and writing, rushing to meet deadlines, and thinking critically about the past, present, and future. And all of this work was accomplished while navigating an education system that was shaped by pandemic politics and massive social shifts. So let me start with a heartfelt Congratulations. You made it. Whether you studied economics, art, engineering, social work, or any of the dozens of fields that help shape our world today, we honor you. But I want to pause and speak directly to a particular group of graduates who, of course, I feel particularly connected to those who are stepping into the field of public health.

Dr. Osterholm: I was recently asked to give the commencement address at the University of Minnesota commencement, and now I'd like to share some of the thoughts I offered those graduates with all of you. First of all, just by way of background, I've now had the privilege of teaching at this School of Public Health here at the University of Minnesota for 50 years. I experienced a lot in that time. I never forgot that public health is among the noblest of professions, steeped in achieving a healthier and safer world for all, regardless of race, gender, age, religion, sexual orientation, economic status, or partisan views. My love for public health and all it represents is a fire that burns hot in my belly every day, and there is never a risk that the woodpile will run low. But now the elephant in the room. The state of public health in 2025. And will you as graduates, have a job? Will public health as we know it become an absent art of yesteryear? Some of my students urged me not to mention this topic in my address, so as not to bring everyone down. And some of my students urged that I must cover this because, in fact, telling the truth to these students was an important milepost of where they were at and where they need to go. Let me give you my view of where we're at today in public health.

Dr. Osterholm: That may not seem obvious initially. It's about a building or buildings. It all revolves around the World Trade Center tower, which took almost a decade to build but was destroyed within minutes during the September 11th attacks in 2001. In fact, before many of the graduates were even born. One of my other titles is author, and in 1999, my coauthor, Mark Olshaker, and I were writing an article for The New Yorker and the risk of bioterrorism in the US, we stood in the main lobby of the World Trade Center towers. We realized how easy an aerosol released bio attack in that space could expose and subsequently kill over a million people. But then it was not until shortly after the attack on the World Trade Center towers that I realized what the real devastation was all about. I visited the smoldering pile as a consultant to the Department of Health and Human Services several times in the following weeks. The death and destruction was so overwhelming, I could never imagine anything ever arising from the ashes of those two towers. Certainly not in my lifetime. But I was wrong. Was I wrong. Today, One World Trade Tower, which is the main building of the old center, is now the tallest building in the Western Hemisphere and frankly, is just stunningly beautiful. That tower has come back even more magnificent than before. And with the respect and reverence of knowing the sacredness of this hallowed place.

Dr. Osterholm: Well, to all you graduates, I am confident that public health will come back in the next iteration bigger, more consequential and more appreciated for its goodness. People will know what a world with reduced public health capacity looks like, and realizes the immense benefits of the public health practice that you have been trained to do is priceless. I'm certain of that. We just need to get through the next three and a half years, and I know that they will not be easy years, and I don't want for a moment to pretend otherwise. But I also am confident there are many creative ways that we can help our fellow colleagues, people who had jobs in public health and lost them, and people who are searching for the first time to find a job. And one of the things we're going to do in our podcast in the future is actually address some of these very issues of how we as a public health community can help each other, help the world. And I know that that world will clearly, clearly benefit from coming back from the ashes, that right now, far too many of us feel so. Just know in this time of instability, it's easy to want to step back. But what we need now are people who will step in with clear eyes, steady hearts, and the conviction that protecting public health is not just possible, it's non-negotiable. We need you.

Dr. Osterholm: The world needs you. And whether you can find yourself in government, research, consulting, organizing or forging a brand-new lane entirely, don't forget this is your time. I can't wait to see what you accomplish. I frankly believe the next 50 years of public health will far outshine the last 50 that I've participated in. Graduates, congratulations. We need you. Now, let me move into that segment of the podcast where we have those who love it and those who don't. And I happen to be in an event this past week when a very nice couple came up to me who I had never met before, and the first thing they said to me was, we're going to the Occidental Belgian Beer House in Auckland, all because of the podcast. Well, I'm happy to report today, May 29th, that sunrise in Minneapolis is at 5:31 a.m., sunset at 8:50 p.m. we're at 15 hours, 18 minutes, and 57 seconds of sunlight. We're still gaining light at about one minute and 34 seconds a day, close to that June 21st date when we'll peak. And to my dear friends in Auckland and all those at the Occidental Belgian Beer House on Vulcan Lane today your sunrise is at 7:22 a.m., sunset at 5:13 p.m., nine hours, 51 minutes and three seconds of sunlight. And you're still losing sunlight at one minute and seven seconds a day. But just know it won't be long and that's going to start turning around.

Chris Dall: Mike, let's start by clarifying the new COVID vaccine framework laid out by FDA leadership, because there are a lot of questions. But we also have to address some news that broke earlier this week when HHS Secretary Robert F Kennedy Jr., FDA Commissioner Martin Makary and NIH Director Jay Bhattacharya announced on social media that they had removed the COVID vaccine for healthy children and healthy pregnant women from the CDC's recommended vaccine schedule, even though pregnancy is one of the conditions listed under the new FDA framework as warranting COVID vaccination. So, there are two different issues we're dealing with here the FDA approval process and the CDC recommendation process. Bottom line here, Mike, for those of our listeners who are planning to get an updated COVID shot in the fall, what is this new framework and the change in recommendations mean for them, and what questions does it raise for you?

Dr. Osterholm: The late author Tom Clancy once said to me, the only difference between reality and fiction is that fiction has to make sense. And I now understand those words in ways I could never have done before. Let me just add one comment that serves as kind of the foundational understanding of vaccines, and who and where we're at in this very interesting time. A study that was done by the CDC recently estimated the vaccines for children program alone prevented 30 million hospitalizations and 1 million deaths from 1994 to 2021. Let me repeat that here. In this United States, the CDC estimated that the vaccine for children's program alone helped prevent 30 million hospitalizations and 1 million deaths from 1994 to 2021. You know, we were doing something right, that's for sure. So, what's happened now? Well, we have watched almost the complete demolition of a public health system that we had in place for understanding what vaccines could do, assuring their safety and effectiveness, making sure that they could be available to the public, and dealing with issues such as potential adverse events. That system had worked quite successfully for many, many years. What we saw happen a little over a week ago was this new framework, which was published in the New England Journal of Medicine. It came from FDA Commissioner Doctor Martin Makary and the director of FDA's center for Biologics Evaluation and Research, Vinay Prasad. These were individuals that were brought in by Secretary Kennedy to address what he believed were the issues that we are so well aware of with regard to vaccine.

Dr. Osterholm: What they proposed in this New England Journal of Medicine piece and would now be considered FDA policy, was so different in terms of anything we'd seen before. First of all, it was a major departure from normal protocol, as these vaccine recommendations and policies typically come from the Vaccine and Related Biological Products Advisory Committee, the FDA, or what is known as VRBPAC, and the Advisory Committee on Immunization Practices, or ACIP, which comes from CDC. The FDA's lane has always historically and legally been that of determining our vaccines effective and safe. If they get the stamp of approval from the FDA, then the CDC with the ACIP takes up who should receive the vaccines and under what conditions and under what schedule. And that system has really worked very, very well over the years. Suddenly they just decided that they had the authority, the two of these individuals, without outside consultation and at best, very limited consultation internally to just say this is what we're going to do now. As I stated in a STAT news article last week, this whole system to date has been a wonderful check and balance on putting forward the best science and vaccines. But now, instead of going through this long-standing process, this new framework was published in two days prior to a scheduled VRBPAC meeting and a month ahead of the ACIP meeting. I can only tell you that there was no doubt about it that they decided that they no longer had use for these advisory committees and therefore just decided to do what they were going to do.

Dr. Osterholm: As you noted, they then came up with a basic system of vaccine approval, which in fact makes no sense and frankly, is one that has major challenges from the standpoint of ethical follow up. What I mean by that is that they suggested that, well, the vaccine had already proved its effectiveness for those who had risk factors for severe disease with COVID, and therefore they would still continue to approve them for that group. Also, for those who were 65 years of age and older. Now they presented no data to support that. Well, wait a minute. If those groups qualify with the studies that have been done to date, shouldn't all the recipients of the vaccine, including otherwise healthy adults, also be considered as in fact having a vaccine that had been studied for safety and effectiveness? Nope, not according to them. For now we have a system for those of you that are younger than 65 and for which you don't have one of the listed special conditions that would put you at increased risk for serious disease. Those vaccines appear to now have to go through new randomized controlled trials every time we make a change in one of the antigens. Wow. This just absolutely makes no biologic or policy sense. What will happen is by not having these vaccines recommended as such, the payers, whether they be health plans, insurance companies, Medicaid, whatever. Now, we're going to have major challenges, for those of you who still want to get the vaccine to get it. Well, that just changed today.

Dr. Osterholm: We're in a little over a minute YouTube announcement. Secretary Kennedy came out and said, we are no longer going to recommend the vaccine for those under 65 without a special condition and for children. Oh, and by the way, we're not going to recommend it for pregnant women, even though they are on that list for special risk groups for serious illness, hospitalizations and deaths, as well as the fact that we know that by vaccinating pregnant women, you can actually have maternal transfer of antibody to the unborn child and actually render a fair amount of protection to that child in the first months of their life. Now, again, there was no attention paid to any of the advisory groups. There was no evidence at all that there had been any consultation on this. And frankly, all I can say is this is absolutely a policy disaster. Who is it that gives these people this authority to do this within the government? We're going to see over the next several weeks efforts to deal with this from a legal perspective, calling into question the authority that they have to do this. Now, let me just make a couple of points here because people will say, well, okay, maybe we should add the pregnant women, but in general, what is it with children? Well, you know, children up to six months of life have a comparable hospitalization risk for COVID, as do 65- to 74-year-olds. It's hard for me to imagine ignoring the fact that 40%, 4 in 10 children and adolescents hospitalized with COVID between October 2022 and April 2024 did not have an underlying health condition that would have identified them as being at risk for serious COVID.

Dr. Osterholm: And specifically, we in this country, have prided ourselves in the efforts that we have taken to vaccinate our children for influenza, a very important disease. Again, this year, over 230 deaths have occurred in pediatric populations from influenza. And guess what? COVID had a very similar rate of hospitalizations and serious illness in this country during the same time period. How can we recommend to the public to get your kids vaccinated for flu? But oh no, you don't want to get them vaccinated for COVID, even though the risk is similar for serious outcome and the vaccines protected about the same level. This just makes no sense. This past week, the American College of Obstetricians and Gynecologists came out strongly supporting the continued vaccination of pregnant women, in contrast to what was stated by the FDA and as well as the American Academy of Pediatrics came out strongly supporting the fact that vaccine be made available for kids. Now, mind you, none of us are talking about having this be a mandated vaccine. We're just saying if a parent wants to vaccinate their child, if in fact a pregnant woman wants to be vaccinated because of the serious implications for her health, if she should develop COVID and not be vaccinated, why would we stand in the way of that? No one is making them get vaccinated, but through education, we're hoping that we can accomplish that. So, Chris, all I can say right now is this is an absolute policy mess.

Dr. Osterholm: It is not based on gold standard science. And we're going to talk more about that in a moment. It's just the opposite. This is in fact not science at all. This is basically a group of individuals who have it out for childhood vaccines, in particular for COVID vaccines in general, and they're doing whatever they can to dismantle those. And this is so hard for me because wasn't it Secretary Kennedy in his hearing to become secretary of HHS, that actually he said, oh, I will never take a vaccine away from someone. This past week he did that. He just did that. And then on top of that, he made it unlikely that a vaccine for otherwise healthy people under 65, even if they want to get it, will ever get it because of the constraints that the companies making these vaccines will have to deal with in terms of additional studies, randomized controlled trials. This is one that we will pay very close attention to. You're going to hear a lot more about this because this is just simply wrong. It's wrong, wrong, wrong. And this has nothing to do about politics. This has nothing to do about our concern of whether we have safe vaccines, and how we can make sure that we can assure those safe vaccines. It has everything to do with people who are motivated for completely other reasons than protecting the public's health. But trying to make it look like that is, in fact, what they're doing.

Chris Dall: Mike, you and your colleagues on the Vaccine Integrity Project published a viewpoint in response to the new framework in which you wrote that you support a fresh look at COVID vaccines and vaccination policies. But the viewpoint also pointed out, and you mentioned this in your last answer, that the way this new framework was rolled out does not follow the typical process. Can you talk about why you find this so concerning?

Dr. Osterholm: Well, Chris, to me it's concerning for several reasons. And that was really our primary objective with the viewpoint report, to lay out what exactly the new framework means and to share why I and so many of my colleagues see it as a troubling departure from the norm. The full report is available on the CIDRAP site and linked in our show notes for anyone interested in reading it. But let me touch on a few of the key points here. First, I just want to reiterate a point that you made in the lead up into the question, and I addressed just a moment ago with regard to my answer to the first question. Chris, I think this is really important, and that is all of us involved with the Vaccine Integrity Project who put the viewpoint, report together, understand and support the idea of reexamining the recommendations for COVID vaccines. We have been in the forefront of that. We are not afraid to address challenges with vaccines in terms of their effectiveness and their safety. That's really a fundamental piece of this whole scientific process. Clearly things change, whether it's the virus, the immunity levels in the population, our understanding of the risk, etc. etc. etc. And so with new data or circumstances, the approaches we take might also change. This happened a lot with COVID, especially in the first couple of years. But in a situation like this, we're talking about a vaccine. How we do that matters because there is a standard process in place which unfortunately, this administration not only wants to bypass, but virtually destroy.

Dr. Osterholm: Typically, any type of change like this, as I noted, would go through the FDA's VRBPAC committee, which is that group of independent experts tasked with discussing and reviewing all the evidence related to the safety and effectiveness of a product like a vaccine. VRBPAC members are highly qualified to do this work, and their independence from the FDA is an important check that really adds another layer of credibility to VRBPAC’s role as an advisory group. It's also worth noting that VRBPAC meetings are open to the public, and there's a public comment period leading up to the meeting. So, there has always been transparency and opportunity for input. Although the FDA is technically not required to follow VRBPAC’s advice, it typically does because they've surely combed through the data and considered all the different nuances involved. So that's the regulatory side of FDA basically deciding whether to authorize or approve a product for use. But when it comes to making actual recommendations about who should receive a vaccine and when, that's actually the response with the CDC, which has its own independent group of experts known as the Advisory Committee on Immunization Practices, or ACIP. And they, too, pore over all the data and have ongoing, detailed discussions held publicly that lead to specific recommendations, with the CDC director ultimately decides whether to approve. I know that's quite a bit of background information, but the point I'm trying to get across in this is that there's already a system in place that seeks out the best science in a transparent manner and, importantly, allows for checks and balances.

Dr. Osterholm: The leadership at HHS is now proposing a new framework that was introduced and examined in a public meeting, but instead through a single paper published in the New England Journal of Medicine or a one-minute YouTube video this past week, there was no discussion with VRBPAC, which met just two days after the paper was published, and no opportunity for other experts or the public to weigh in. In fact, one of the authors flat out said they were only two people who worked on the paper. That's highly unusual, and frankly, it undermines transparency and trust in the process, which is ironic given the public commitments that have been made by new leadership to those very principles. When you also take into account some of the other public statements that have been made by new leaders at FDA prior to their appointments, it's not necessarily surprising. For example, the current head of the Center for Biologics Evaluation and Research, CBER, Vinay Prasad, posted a tweet in 2022 that described VRBPAC meetings as a show trial. The same year, the new FDA commissioner, Marty Makary, referred to the ACIP as a kangaroo court in an op ed piece published by Newsweek. So, when you see those types of comments and then you watch all this unfold, I think it's hard not to think about what this might mean moving forward. And it's not just me who's concerned. Bruce Gellin, who actually served on VRBPAC, was quoted in an article on STAT saying, in reference to the VRBPAC committee, quote, this is exactly the kind of policy shift that they take to their advisors to get input before finalizing.

Dr. Osterholm: And Doctor Paul Offit, a well-known expert on vaccines and currently serving on VRBPAC, was quoted in a Politico story saying the following: quote, they made the decision for the CDC. It's really not theirs to do. The FDA is a regulatory body. The CDC is a recommending body, unquote. And that's the crux of it. The FDA is a regulatory agency, but in this new framework, they are taken on the recommendations as well. They are now, in a sense, the king holding court. In addition, what makes this even more troubling is that the ACIP was already planning to discuss this exact issue, whether its COVID vaccine recommendation should be universal, or shift to a more risk-based approach in their upcoming meeting in June. But by undercutting this process, it's not clear to me how this will play out. Frankly, I no longer see a role for ACIP. If, in fact, the FDA can just assume responsibility, and I might add, it doesn't help that we don't have a permanent director at the CDC at this time. So, I can't even tell you who's in charge down there right now. We understand that things change. I'll be the first to say that policies should evolve as science does. But at the end of the day, there are processes in place for this. And if we actually want to restore public trust and maintain confidence in the system, then the system has to operate in a way that's consistent, transparent and grounded in expert input.

Chris Dall: On another COVID vaccine note, the FDA last week asked Moderna and Pfizer, the two companies that make the mRNA COVID vaccines, to make updates to safety warnings on those vaccines. Mike, can you explain what the FDA is asking and what concerns you about this?

Dr. Osterholm: Chris, I will do my best to apply logic to this illogical new requirement, but it's like trying to fit a square peg in a round hole. Let me first start going back a few years ago, the ACIP first assessed at that time the adverse events data that emerged from a three month study following Moderna's phase three clinical trial. This is now before they're actually approved for use. The frequency of serious adverse events was virtually the same in the vaccine versus placebo group, but researchers did find an association of conditions myocarditis, or inflammation of the heart, and pericarditis information around the heart in subjects who were younger and male. The observed frequency in this population subset was about 65 cases per 1 million doses, and the conditions were categorized as mild to moderate, resolving within 1 to 3 days. No one at any time was seriously ill. Myocarditis was more common 0 to 7 days after receiving the second dose of mRNA vaccine in the two-part program, particularly when the second dose of vaccine was given as early as two weeks after the first dose. The ACIP reviewers recommended a longer period between the first and second dose, which is thought to reduce risk. Moderna added the necessary safety label to their vaccine to warn of the risk to male recipients aged 18 to 24, and Pfizer added the same safety label for males 12 to 27. Another study reported among 18- to 29-year-olds, administration of Pfizer's vaccines led to an additional 22.4 myocarditis cases for every million vaccinations, while Moderna vaccines led to an additional 31.2 million.

Dr. Osterholm: But the most important finding in this study was that across all age groups, the risk of hospitalization and death from COVID significantly outweighs the risk of transient, post-vaccination heart inflammation. This is why, time and time again, experts have emphasized the benefits of getting the vaccine outweigh the risk. So, what is the FDA requesting now? They want both Moderna and Pfizer to update their warnings to apply to 16- to 25-year-olds, rather than 18- to 24-year-olds. The letters, which were posted more than a month after they were allegedly written, appeared just before the Homeland Security and Governmental Affairs Committee hearing on how health officials downplayed and hid myocarditis and other adverse associated events with COVID-19 vaccines. What does this all mean? Well, first of all, let me just be really clear about myocarditis. It turns out that myocarditis occurs both with vaccination, but also it occurs amongst those who get COVID. Several major studies have demonstrated that the risk of developing myocarditis after COVID is anywhere from 7 to 16 times higher than from developing myocarditis after vaccination. On top of it, the cases of myocarditis among COVID cases was much more severe, leading in some cases to death as well as very serious illnesses. So, the fact of the matter is, is that again, from a risk assessment standpoint, you actually reduce your risk of developing myocarditis by being vaccinated.

Dr. Osterholm: Now, the FDA wants these manufacturers to put on the vaccine label that myocarditis is common. Well, it is not common. And in fact, since the doses of vaccine were spaced out and more people had been vaccinated so you're no longer dealing with the first and second dose only. We actually have seen almost no myocarditis in vaccine recipients over the course of the past three years. So why now put a label said common. So, I'm telling you right now that this is a vaccine, that myocarditis is an incredibly rare event. When it does occur, it is relatively mild without serious illness. And yet, the FDA wants now to put on that label that myocarditis is common associated with getting vaccinated. And to me, that is just a scare tactic. That is just another example of trying to minimize the public's desire to get this vaccine. If you're telling me that a risk right now that is possibly in, you know, several people per million doses of vaccine is common, my I have a bridge to sell you too. And I think that's the challenge we have right now is just the facts. Just what do we know and what we know right now? Myocarditis, even in young adolescent boys, is not a serious challenge relative to the benefits of being vaccinated.

Chris Dall: One last item on vaccines. The White House recently released a report called the Make Our Children Healthy Again assessment, which summarized the findings of a commission headed by Department of Health and Human Services Secretary Robert F. Kennedy Jr. The report identified potential drivers behind the rise in childhood chronic disease, including poor diet, environmental chemicals and lack of physical activity. But it also highlighted one of Mr. Kennedy's longtime issues: the childhood vaccination schedule. Mike, what do you make of this?

Dr. Osterholm: Well, it's not unsurprising that this report was filled with myths and disinformation about a number of topics, including childhood vaccination. And again, let me emphasize, all of us in the public health community want to do whatever we can to improve on the health of our children. This is not a case of us saying there aren't problems. There aren't issues that need to be addressed, but we have to do it with the full faith of information that is scientifically sound. Childhood vaccination was covered in the section on the report focused on the overmedicalization of kids. Specifically, the report focused on the growth of the childhood vaccine schedule as a potential contributing cause of childhood chronic disease. Most of the claims made to support this argument were misleading, if not entirely false. I want to walk you through some of the major arguments to help you understand why their claims are misleading, and to hopefully help you navigate conversations about this report in your own life. And let me just remind everyone this idea that you may have doubled or tripled the number of vaccine doses and therefore somehow have done something to your body's immune system to overwhelm it. Your body's immune system are taking insults from so many things day after day, and that these vaccines are literally like a bucket of water in the Mississippi River. It's not causing a challenge there. So just that alone is an important point that many of the opponents of vaccines tend to stress. The authors of the report expressed concerns over the fact that the US has greatly increased the number of vaccines included in the immunization schedule since 1986.

Dr. Osterholm: It is true that the number of vaccines given to children have increased since the 1980s, but the fact that we have vaccines that protect against more causes of childhood morbidity and mortality is a really good thing, not a conspiracy. We should be celebrating the fact that children today are protected against diseases like varicella, hepatitis A and rotavirus, even though children 40 years ago were not. This is true scientific progress. The authors claim that the increase in vaccines in our immunization schedule is concerning because we recommend more vaccines than some European countries, but they failed to consider that goes both ways. There are also vaccines recommended at young ages in some European countries that aren't recommended until much older ages in the US. For example, meningococcal vaccination is recommended for young children in the UK and Italy, but it isn't recommended until adolescence in the United States. The authors of the report also share their concerns about the lack of a trial, comparing the safety of the US vaccine schedule compared to that of other countries. But such a trial would be highly impractical. Comparing rates of disease and adverse events across different countries is always challenging, considering the vast differences in case definitions and reporting structures in public and private health systems. The reason trials like this have not been conducted is because, among other things, there would be so many limitations in any methods used that it would not yield meaningful results about the relative risk of any adverse events associated with these vaccines that differentiate one country from another.

Dr. Osterholm: The report also emphasizes the point we discussed in our last episode about a lack of clinical trials involving inert placebos. As we discussed two weeks ago, clinical trials for vaccines today are tested against control groups that receive the current standard of care. This means that many of our vaccines were tested against existing vaccines already being used, and in fact, to have tested against a placebo when a protective vaccine was already available would be highly, highly unethical. So, we like other drugs, for example, cancer drugs where when one's looking at a new cancer drug, you don't stop the patients from being on any drugs as a placebo. You basically use the current drug as the standard to see did it improve beyond what the current drug only did? That's what we do with vaccines. So, in fact, it is important to note that vaccines on the schedule can be traced back to a trial against an inert placebo at some point. So, it is not as though inert placebos have never been used. Remember two weeks ago I noted 111 placebo-controlled trials that have been done on vaccines used in this country. For opponents of vaccines to say these have never been done is just simply not true. The report outlines concerns about the process for vaccine injury reporting and liability. The authors claim that many health care providers do not report adverse reactions from vaccines to theirs, because they are not mandated to do so. This is strictly false. Health care providers are required to report several different reportable events if they occur within a specified time period after vaccination, even if they don't suspect vaccination to be the cause of those events.

Dr. Osterholm: Additionally, the report claims that the National Childhood Vaccination Injury Act of 1986 creates financial disincentives for vaccine manufacturers to identify safety issues. This couldn't be further from the truth. The National Childhood Vaccination Injury Act simply provides an alternative to traditional lawsuits to compensate individuals for adverse events following vaccinations. There, we said it. There are some that do occur. Therefore, we have to adequately compensate these people. But remember also that vaccines already have a relatively low profit margin to begin with compared to other drugs. Without a system like this, drug companies would be further discouraged from spending time and money on vaccine development, and the process for receiving compensation for vaccine injuries would be far more complicated for the rare cases in which individuals do experience adverse events. This is really a win-win for both vaccine manufacturers and consumers. The lose-lose would be we'd drive all the vaccine manufacturing companies out of business. Then see what happens to our population's health. Finally, the report raises concerns about medical freedom. The authors claim that the American Medical Association's policy that ensure licensing boards have the authority to take disciplinary action against health professionals for spreading health related disinformation, prevents healthcare providers from discussing the risks and benefits associated with vaccines. Again, this is simply untrue. Providers absolutely can and do have honest discussions with their patients about the relative risk and benefits of all medical treatments, vaccines included. The fact that Secretary Kennedy and this administration believes that rules against disinformation will prevent them from spreading their message about vaccines is incredibly revealing of the evidence, or really, the lack of evidence they have to support their dangerous claims.

Dr. Osterholm: And I might add another new note from this past week. On Tuesday, Secretary Kennedy announced that he was considering banning any federal agency from published articles in the New England Journal of Medicine, the Journal of American Medical Association, or the Annals of Internal Medicine. Three of the leading medical publication venues in this world. And his whole point is that these are biased and not trusted sources of information. Now, telling a federal agency that they cannot publish critical health related information in one of these journals is the very worst in censorship and in fact talk about medical freedom and information. This would be a terrible, terrible, unfortunate issue should this actually come to fruition. The bottom line is, Chris, that this report is just filled with misleading information and in some cases, just outright disinformation. None of this is surprising considering the administration's agenda, but it is concerning nonetheless. I hope the information we have shared here can help you navigate conversations about this report that may come up in your lives as you continue to advocate for vaccines with your family, friends, and community. And remember, we in public health will always looking for ways to improve that public's health. And if that means dealing with issues around vaccines, we will do that. We welcome this examination all the time, anytime. It is what is the very foundation of good science.

Chris Dall: One more item out of Washington, then I promise we'll move on. But I think it gets to an important theme here. Last week, the White House issued the latest in its series of executive orders, and this one appears to have the fingerprints of Kennedy, Makary, and NIH Director Jay Bhattacharya all over it. It calls for returning to a gold standard of science, quote, to ensure that federally funded research is transparent, rigorous, and impactful, and that federal decisions are informed by the most credible, reliable and impartial scientific evidence available, unquote. Mike, every bit of communication from these departments mentions that term gold standard science. What is the message they're trying to send with this constant invocation of gold standard science?

Dr. Osterholm: Well, Chris, first of all, let me just frame this discussion with the following facts. I think they say a lot about gold standard of science. To date, 174 scientists, either at NIH or whose research has been supported by the NIH, have been the sole or shared recipients of 104 Nobel Prizes. That is remarkable. The world looks at that with envy. Is that not gold standard science? Well, so moving on from that very point, what the White House is trying to set up really here is an altered rationality, meaning that if they're telling you there is the best science, and this is this Madison Avenue PR tagline they're using about the gold standard of science, you won't see all the flaws and all the major errors in what they're doing. If you tell people enough times that the Earth goes around the moon, eventually they come to believe it. So, there is nothing about what they have stated to date about this idea of science as being a gold standard that they're bringing to that field versus what we've had in the past. And so all I can say is, is that this executive order is in fact, meaningless in terms of what it's going to do to improve our research and outcomes for the public. What it really is all about is covering up the flaws that I have already just laid out in some detail with their approach to improving our health, particularly with vaccines.

Dr. Osterholm: It's just simply not true that when they, in their press release, said about the executive order that the administration blames inconsistent standards and research is a reason for America's lost trust in science. That's just simply not true. Today, we surely have challenges with science and trust in that science process. But we also are the incredible beneficiaries of so much of the very positive things that happen because of that science. So, I think we're going to continue to be confronted with the gold standard of science. It almost reminds me of a phrase that became common during the first Trump administration about the world of alternative facts. You have your facts, I have mine, and we both know that you can't have alternative facts. They're not facts then. So, Chris, I will only say at this point, get ready to keep confronting this issue day after day after day about we're the ones doing gold standard of science. And every time you have to say that, just know there's a reason why you're saying it, because it's covering up some deficiency in what it is you're doing or trying to convince people of.

Chris Dall: Now on to our infectious disease updates. Let's start with the US measles outbreak. Mike, what's the latest?

Dr. Osterholm: Well, Chris, the outbreak is continuing to spread, although more slowly. Last week, the US added 22 more cases similar to the 23 reported the week before. And this is down from a peak of 116 cases reported the week of March 30th. Clearly good news. As of Thursday, the total tally was 1046 cases from 30 states and New York City. 92% of cases have been part of 14 outbreaks. For comparison, 285 cases were reported in all of 2024 and only 59 were documented in all of 2023. If the US keeps up this pace, we will surpass the record of 1274 infections set in 2019, the most since measles was eliminated in this country in 2000. And so far, 96% of the people infected have been unvaccinated against this preventable disease. The US outbreak, which began in West Texas, is still centered there. On Friday, Texas reported six more cases since May 20th, pushing the state's total to 728, most of them in Gaines County. Another 22 cases so far don't appear to be linked to the main outbreak. Also in Texas, Williamson County reported its first measles case this last week in a school aged child. The Texas outbreak may be slowing, perhaps in part because of the vaccination campaigns and the increasing immunity from ongoing infections.

Dr. Osterholm: We can't afford to be complacent, however. Cases have been popping up in other states in the region, including four more in New Mexico last week, for a total of 78 in that state. Elsewhere, an unvaccinated child in Alaska was infected, and Colorado officials issued an alert about a potential exposure at the Denver airport after they were notified of an infectious out-of-state traveler who flew in and out of the airport. North Dakota has documented six more cases, a total of 21, and Iowa has seen its first case since 2019, in an unvaccinated adult. Cases have also been diagnosed in Virginia and Kansas. Canada has been affected even more than the United States, with a total of 2500 measles cases so far this year. Last week, the country reported 350 more cases from five provinces, mostly Ontario and Alberta. Cases in Alberta's Southern District have become so common that officials have stopped listing specific exposure sites and instead have issued a standing advisory across the entire area. I'm very concerned about the profusion of cases, especially because we're on the cusp of a busy summer travel season. It takes only one person visiting a destination with endemic measles or an outbreak to ignite a new outbreak elsewhere.

Dr. Osterholm: I might also add that some people have the mistaken belief that measles is a seasonal virus, most notably going to occur in the winter time. While we surely can have increased case transmission in the winter time as an airborne virus, we can in fact see measles year-round. While most infections have occurred in children and teens, over a third have now been in people 20 years of age and older. If you're an adult who didn't receive the measles, mumps and rubella vaccine as a child, or if you don't know your vaccination status, you can ask your health care provider or your local health department to vaccinate you now. Also, if it's possible that you may be coming pregnant, you also want to make sure you're vaccinated because that maternal antibody that you have will actually protect your new child after birth for those first months of life that can be so critical. I hope that public health leaders and communities with wastewater monitoring are able to keep an eye on virus levels as an early warning system. They should be launching measles vaccination campaigns and reviewing testing protocols and capabilities, should they start to see the virus in their wastewater. This is no time to let down our guard.

Chris Dall: Turning to COVID-19, we haven't really needed to talk about new COVID variants in a while, but over the past week, there has been some reporting on a new variant that has caused a surge in COVID cases in Hong Kong. Mike, what do we know about this new variant?

Dr. Osterholm: Well, Chris, it feels like it's been a lifetime since we talked about a new variant for at least one that was raising some eyebrows. But this new variant NB.1.8.1 is an offshoot of JN.1 and has gained some attention, especially in Asia, and has been designated as a variant under monitoring by the W.H.O., but still with a low risk assessment. Hong Kong, China and Taiwan have all seen recent surges associated with the rise in NB.1.8.1. Hong Kong has just experienced their highest rates of hospitalization in a year, with reports that pediatric units are full of unvaccinated kids. We've also seen anecdotal reports that one of the symptoms of this new variant is what has been called razor blade throat, which patients reporting feeling like they've swallowed shattered glass or razor blades. A very severe sore throat situation. Despite these surges and changes in symptoms, there is no evidence that NB.1.8.1 is more severe and is only slightly more immune evasive than LP.8.1, which is currently the dominant strain in the US. NB.1.8.1has been detected in several US states dating back to the late March time period. These states include California, Hawaii, New York, Ohio, Rhode Island, Virginia, and Washington State. Of course our monitoring of SARS-CoV-2 activity has also been limited by the changes to federal and state funding for surveillance. I expect surveillance to only get worse, not better. I really don't anticipate this moving the needle much here in the US and causing an Omicron like surge. Our upcoming vaccines will still provide coverage against this variant because they still target JN.1 descendant LP.8.1, which will cross-neutralize with other circulating variants, including this new NB.1.8.1. It's notable here that, in fact, we can expect with waning immunity in humans and a new variant to actually increase activity sometime in the future. What that will look like we're not sure yet, but we're not done with COVID yet. But we'll never see COVID as we know it now from this particular SARS-CoV-2. Do another pandemic like presence, but don't be surprised if we see an uptick somewhere down the road. That will still be a challenge.

Chris Dall: And do you have any updates for us on H5N1 avian flu?

Dr. Osterholm: As mentioned last week, we don't know what we don't know about H5N1. I suspect there is major underreporting of the disease in animal populations, intentional or not. For this episode, I will just cover the most recent detections that have been publicly reported by animal health departments and the USDA. The cumulative total of H5N1 detections among dairy cattle herds has now reached 1072, in 17 states. The virus has left an impression in Idaho, where they have now had positive cases in 17 new herds, just since our last episode, the state's cumulative total is now 107, with 70 new detections in the state just since late February. Since the last episode, there have been several more positive poultry flocks reported across the US. These include a commercial turkey meat facility in South Dakota affecting 30,900 birds, a backyard flock in Pennsylvania affecting 30 birds, and finally a commercial table egg layer facility in Arizona affecting over 2.1 million birds. This last one is especially detrimental, and it represents the largest outbreak in commercial poultry since the Ohio flock reported in late February. The USDA reported an H5 detection at a domestic cat in Aurora County, South Dakota. It's unclear how this animal contracted the virus, but we have seen spillovers before in cats as a result of eating contaminated raw pet food, exposure to infected birds, or possibly consuming raw milk in dairies with the virus. We will continue to monitor the situation and provide updates to you, our listeners, when possible. Meanwhile, let me just say nothing looks to be changing here. Something that, as you may recall, over a year ago, I added to our podcast. I did not know what this virus was going to do. H5N1 has continued to fool us and fool us and fool us. And for those who thought that the pandemic was imminent, it surely hasn't moved in any way towards that kind of a picture over the course of recent months, could change in a heartbeat, and it could happen, but it also may never happen.

Chris Dall: Now it's time for our ID query. And this week we received a few more emails suggesting the podcast has become too political. Mike, we have addressed this issue in a previous episode. Is there anything more you'd like to say?

Dr. Osterholm: Well, sure. It's always something I like to say when we get this kind of feedback. The feedback that we very much welcome, and I want to reiterate that we are listening and appreciate all that feedback we get, both supportive and constructive. We've gotten many, many emails of appreciation for staying on top of all the political changes over the past few months, but we still have gotten a few messages from listeners that say that the podcast has just become too political. We call all of you our podcast family for a reason. And just because your family doesn't mean you always have to agree. And this may be an area where we'll have to agree to disagree. We are the Center for Infectious Disease Research and Policy. This means we must engage in a sense, politically. We surely can be nonpartizan. We can surely call balls and strikes. But you have to be in that political arena in this kind of a setting. We can't talk about measles without covering the misinformation coming from the federal political appointees and limits to funding for local outbreak response. We can't talk about HIV, malaria and tuberculosis without covering the abrupt drop-in support for global programs that will limit our ability to test and treat communities for years to come. We just can't separate policy from public health. We surely can stay nonpartizan, calling balls and strikes, but in fact, we cannot avoid that if we're going to talk about the consequences of improving our public health. I've been complimentary in critical leadership on all sides of the aisle throughout my career, and I will continue to do so.

Dr. Osterholm: That is my commitment to you, our podcast family. We don't care who's up to bat. We're just following the ball and watching the strike zone. From our side, following the ball will mean staying observant and reporting about both what is being said and what is being done regarding public health. We will be announcing some major new CIDRAP efforts on this front in the next podcast. Many of you have reached out to ask what we can do. Well, you've made it to step one, which is to stay informed. I also encourage you to continue to follow policy at your local level. County, city, even school board, show up at those meetings. Listen. Provide a voice of reason when needed. Do the same among your friends and family. Listen without judgment. Ask questions and be a voice of reason. And I'm happy to report that we're working right now on a list of organizations at the state level, at the local level, that you can contact to join, to help survey what's going on in your community and helping to impact on the positive kinds of outcomes that can happen when the community comes together. We'll have that information for you also in the next podcast. We will continue to walk with you as we navigate a new landscape of public health. We will be sure to share any opportunities and strategies to communicate, organize, and act in the weeks and months to come. We really must respond to this. Our lives depend on it.

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

Dr. Osterholm: Well, Chris, I love these sections of the podcast. You know, they feel informative and they make me proud to be part of public health. It's been a while since we've provided a biographical overview of a public health figure, so I'm looking forward to highlighting a really dramatic duel in public health. 170 years ago on May 29th, 1855. David Bruce was born to Scottish parents who themselves had a background in science and medicine. After attending medical school, he worked briefly as a general practitioner, where he met his wife. But Mary Bruce would be far more than a personal companion to David. Having grown up in a medical household herself, she was fascinated by science and was an incredibly diligent and detailed worker. David Bruce joined the Royal Army and served both in the field as a surgeon as well as teaching pathology. Throughout his time in the Army, David and Mary had multiple international posts. Starting in Malta and then throughout Africa. He had a particular interest in zoonoses. Starting in Malta, he investigated an outbreak of undulant fever in both British soldiers and goats. After careful examination of the spleen during autopsy, he discovered a bacterium which would eventually be named in his honor.

Dr. Osterholm: The Bruce couple continued working in the laboratory together. David investigating under the microscope, and Mary as a technician and illustrator for all their discoveries. While investigating the cause of sleeping sickness, a serious vector borne infection found in many countries in Africa, Mary dissected more than 10,000 tsetse flies. Sir David Bruce published more than 173 scientific articles, with Lady Mary as a contributor on many. Mary passed away in 1931, and during her memorial service four days later, David followed her. They were buried together in Stirling Castle. Today, Brucellosis, the disease resulting from an infection with Brucella bacteria, results in approximately 1 to 2 million cases globally, including around 100 to 200 cases in the U.S. each year. Unpasteurized dairy products, primarily from sheep and goats, are the primary source of infection. For cases in the United States, most infections can be traced to dairy products originating in Mexico or for professionals working with diseased animals, particularly swine. For the discovery of this bacteria and their numerous other scientific and medical accomplishments, Thank you, David and Mary Bruce. What an incredible legacy for a marriage and a partnership. You inspire us still.

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

Dr. Osterholm: Well, I guess I can start out by saying, fasten your seat belts. We are living in turbulent times. Never in my 50-year career have I ever thought that we'd be at a place like this, where the reality of science is challenged in such a way as to almost make it seem as if it's Alice in Wonderland. The fact that we're watching public health come under assault in a way that greatly limits our ability to protect that public's health. As I said in the dedication, public health is the noblest of all professions. It is where we try so hard to help all humankind. So just know that this is going to be a very rocky road. We're here. We have made it very clear we will stay here. As I shared with you in a previous podcast, our motto at CIDRAP is we will bend and we will bend, but we will not break. And next podcast, you're going to get a great deal of additional information on just some of the efforts that we're undertaking. Beyond that of our Vaccine Integrity Project. All I can say is please stay the course, stay the course. And we all need to focus on calling balls and strikes. Don't get into a political argument. Get into a science data description and discussion. That's what we need to do. Stay the course. Finally, Chris, my third point is keep our eyes wide open on COVID. I don't know that what we're seeing right now with this new variant is going to be a fundamental game changer. But I do believe we're going to see some tough days again ahead with COVID, with waning human immunity and a new variant showing up. Is this the one that's going to do it? I don't know, but we will have some tough times. Again, I will emphasize they will never be like we saw during the pandemic, at least with this strain of virus. But it in fact still doesn't mean that we can't have some tough days ahead.

Chris Dall: And finally, what closing song have you chosen for us today?

Dr. Osterholm: Well, Chris, we're going to use an oldie but goodie one from May 16th of 24, one year ago. It was an episode 157 Lungs and Udders, and this particular, uh, song really fits with the dedication that I provided earlier about our new graduates, and I wanted to leave them on a positive note, even though I know that the skies are gray. This is a song from the Disney movie Brother Bear in 2003, written and sung by Phil Collins at that time of Genesis. So here it is on my way from the Brother Bear soundtrack. Tell everyone I'm on my way. New friends and new places to see. With blue skies ahead. Yes, I'm on my way. And there's nowhere else I'd rather be. Tell everybody I'm on my way. And I'm loving every step I take. With the sun beating down. Yes, I'm on my way I can't keep this smile off my face. Because there's nothing like seeing each other again. No matter what. The distance between and the stories that we tell will make you smile. Oh, it really lifts my heart. So tell them all I'm on my way. New friends and new places to see and to sleep under the stars. Who could ask for more? With the moon keeping watch over me. Not the snow, not the rain. Can change my mind. The sun will come out and wait and see. And the feeling of the wind in your face. Can lift your heart. Whoa. That's somewhere I'd rather be. Because I'm on my way now. Well and truly I'm on my way. Now I'm on my way now.

Dr. Osterholm: Oh, I'm on my way now. Tell everybody I'm on my way now. And I just can't wait to be there. Just can't wait to be there. With blue skies ahead. Yes, I'm on my way. And nothing but good times to share. So, tell everybody I'm on my way. And I just can't wait to be home. I just can't wait to be home. With the sun beating down. Yes, I'm on my way. And nothing but good times to show I'm on my way. Oh yes, I'm on my way. Phil Collins. On my way. Well, thank you again for spending time with us. A lot of heavy information this time I realized that, and it surely is a challenging time for all of us in public health. Frankly, it's a challenging time for many of us in life in general, and all we can do is just hang together. I've said many, many times, to paraphrase the great Ben Franklin, we must hang together. We surely shall all hang separately. And I hope as the podcast family, we see that and feel that. Right now, if there was ever a time to be kind, it is now. It is. And just know the dividends that that will pay in a world that is troubled is priceless. So, thanks for being with us. I hope the information we provided was what you were looking for. Again, we welcome your comments. Constructive comments in particular. So, we look forward to hearing from you. Thank you. Thank you, Chris. Thank you to the podcast team and I hope you all have a safe two weeks.

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.