Episode 182: The Vaccine Confidence Crisis

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. As the US continues to wrestle with the measles outbreak in Texas and rising cases in multiple states, a new national tracking poll indicates that myths and false claims about the measles mumps rubella vaccine are making their way into the mainstream and causing confusion for the public. And while a large majority of those polled said they're confident that the MMR vaccine is safe, at least half of respondents said they didn't know whether the false claims, some of which have been promoted by the secretary of the Department of Health and Human Services, are true or false.

Chris Dall: Now, surveys are just a snapshot in time of public opinion, but the findings are noteworthy because 2025 is on track to be the worst year for measles in the U.S. in more than two decades. And they raised the possibility that we could start to see a further erosion in MMR vaccination rates in this country, if myths about the safety of the vaccine persist. The ongoing measles outbreak and the threat of declining vaccination rates are among the topics we'll be covering on this May 1st episode of The Osterholm Update. 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 status of the Novavax COVID vaccine bring you the latest on COVID and H5N1. Answer an ID query about the Trump administration's new COVID website and tell you about CIDRAP's new Vaccine Integrity project. 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. We so appreciate you, not just for these moments spent together on the podcast, but also for all the information you share with us your cards, your emails. It's really very, very helpful to us and understanding what we can do to do a better job at this podcast. And we're trying. And I also want to acknowledge the podcast crew who, but for them his would be just a shell of what it is in terms of information dissemination. So, thank you very much to them. For anyone who might be listening for the first time, I hope we're able to provide you with the kind of information that you're looking for. It's clear that in the minds of many, we provide many different types of information, some noteworthy and welcomed, and some kind of can you just skip through that section? So, but unfortunately, you're stuck with all of it. Chris, as you noted in your introduction, we have a lot to cover in this episode. And frankly, we could make it a much longer episode, but we're trying to do this in bytes for all of you. Things are changing quickly at the federal level, which has caused a fair amount of chaos and confusion among other institutions whose missions, funding and futures depend on what trickles down from HHS and other federal agencies. For example, institutions of higher education millions of dollars flow annually from research funding agencies such as the NIH or the National Science Foundation to universities and academic medical centers.

Dr. Osterholm: With budget and division cuts at the NIH, they've had to cancel more than $2 billion in federal research grants. These funds have gone towards clinical trials, drug development, cancer research, stroke therapies and so many other lifesaving medical research programs. Who will suffer as a result of these cuts? Certainly, the researchers who work was dependent on these large grants. Professors, postdocs, graduate students, lab assistants and technicians and research coordinators have suddenly had their salaries clawed back with no hope for the completion of the work that they've dedicated their careers to. For those in health research careers, the next steps are now extremely limited. A survey of 1600 scientists found that 75% are now considering pursuing opportunities to work internationally. Make no mistake about it, this work has fueled the research engine of this country and made it what it is today. The number one research and development country in the world. Also suffering are the participants of the suddenly halted clinical trials. Think of the cancer patient whose last hope for remission lies in acceptance to a novel clinical trial. The pain, physical, mental and emotional that they must endure to keep waiting for news on the future of their trial, hoping that delays don't lead to termination. Whether it's a childhood cancer, Alzheimer's, autoimmune diseases or heart disease, these study participants lives are at stake here. Ultimately, it will be the health of people across the globe that suffer from generations to come. A 2023 journal of the American Medical Association study found 99% of drugs approved by the Food and Drug Administration between 2010 and 2019 had ties to research or work funded by the NIH.

Dr. Osterholm: Universities and research institutes outside the NIH receive approximately 80% of the NIH annual budget. Without sufficient funds for these institutions, the medical field and we as patients will suffer. It's hard to wrap my mind around all that's being impacted here. Grants are terminated. Careers are stalled. The future of life saving research is uncertain. I see hope in the universities and research institutions who are banding together and pushing back in the defense of the critical work and research they do. I know many at the NIH want to see these grants restored too. The work is too important for us to give up. So, who is it and what is it that I dedicate this opening to? Today, frankly, I'm dedicating it to all of us. All of us. We all, one way or another, will be impacted by what's happening right now at the federal level. Many of us who are listening to this podcast will one day not have the drug or the vaccine that we desperately need at that time, because these funds were arbitrarily cut. I can't say enough times how much this is going to be a generational issue if we postpone for four or more years, the funding of basic training for doctoral students, for postdoctoral students, for medical students also doing lab research. We will set back the entire research portfolio of this country, and that will translate directly to loss in people's lives.

Dr. Osterholm: I dedicate this to all of us. Well, let me move on to a little bit of a brighter topic. The moment that of course I love in this podcast, some of you can turn away here for a couple of minutes. I'm very happy to report on this first day of May a day that I love. May is my favorite month. It's when green really starts to get green. And today in Minneapolis Saint Paul, the sun rises at 6:01 a.m. Sunset is 8:19p.m. 14 hours, 17 minutes and seven seconds of sunlight. Wow. And we're still gaining more sunlight at about two minutes and 43 seconds a day. Now, let me remind you, this is a big difference in what we had just a few months ago, on December 21st, when we had only eight hours and 46 minutes of sunlight. We've gained over five hours of sunlight since that time. And now to our colleagues Down Under in Auckland, New Zealand, specifically at the Occidental Belgian Beer House on Vulcan Lane. Yep, it's getting a little darker there. Your sunrise today is at 7:34 a.m., your sunset at 7:14 p.m. You have 11 hours and 40 minutes and 46 seconds of sunlight. You're losing sunlight at about two minutes and 19 seconds a day. Well, all I can say is that we're in a very generous mood. We're very happy to share our sunlight with you. And I can't wait to see all the different versions of green explode in the next several weeks here in Minneapolis.

Chris Dall: Mike, we're going to start again with the latest on the US measles outbreak. What are the most recent numbers?

Dr. Osterholm: Chris, this outbreak is continuing to grow rapidly. As of this past Tuesday, there have been 923 measles cases reported in the United States so far this year. We know that that's likely a major undercount, specifically when looking at the outbreak in Texas and New Mexico. We continue, however, even with reported cases to be on track to surpass the 2019 measles case count of 1274 cases in the very near future, which then will make this the biggest measles year in the United States we've seen since 1993. And what it very likely means is we will also lose our designation as a measles elimination country, meaning we no longer have stopped toutine circulation. Cases have been reported across a total of 30 US jurisdictions, and 93% of cases are outbreak associated with the Texas outbreak, continuing to account for the majority of cases. Most of the cases are in persons 19 years of age and younger, but a very important number 30% are in those over 20 years of age. 97% of cases are in unvaccinated individuals or those with unknown vaccination status. Sadly, 11% of the cases have been hospitalized, 20% for those under age five and 7% for those five years of age and older. As I just noted that 30% or more of the cases are now in those over 20 years of age. I think we're about to see another change in the epidemiology of measles in this country. For so long, many individuals who have been born and raised in the last two decades who did not get vaccinated against measles have basically enjoyed freedom from exposure to that virus because so many others did get vaccinated.

Dr. Osterholm: But now that that number has dwindled, we're now seeing widespread transmission. And for the first time, we're going to see more and more cases in this adult age group. In prior decades, very few people would have made it to their 20th birthday without becoming infected and therefore protected from that moment on. However, today with so many not vaccinated, they are at risk. They're vulnerable to this virus. And what does that mean for those who are now of childbearing age, who have not been vaccinated, have not been infected previously, but now could be. Well, first of all, obviously they're at risk from getting infected and potentially having a serious illness. Second of all is the fact that that baby that is now born has no maternal antibody protection, something that individuals who had previous measles vaccination or infection did afford their newborn child. So, the first six months of life are no longer a free six months, get out of jail card against measles. And I think we're going to start seeing more and more younger cases that we hadn't seen literally in decades. So, this is really a major changing situation and one of grave concern. Let me just add that we're seeing similar trends internationally. The European CDC reported over 35,000 measles cases in 2024, compared to nearly 4000 in 2023. About 87% of all these cases were reported in Romania, and 22 of the 23 measles deaths reported in Europe in 2024 were in Romania. In the Americas, measles has increased 11-fold in 2024 compared to 2023, with the United States cases largely driving this increase.

Dr. Osterholm: I'm very concerned, by the way, that this outbreak, as it continues to grow, also has other implications that people don't realize. The fact that we now have seen so many infected adults, as I just noted, is a very ominous sign. Since measles immunization in the United States is generally given through the MMR vaccine. It is likely that the adult population is similarly susceptible for rubella infections, including pregnant women who could become infected and pass the infection on to their child. Namely, congenital rubella syndrome. Congenital rubella syndrome can cause devastating birth defects, pregnancy loss, and newborn loss. During the last rubella epidemic in the United States before vaccination became available in 1964 and 1965, 11,000 pregnancy losses occurred from rubella. 2100 newborns died from rubella, and an additional 20,000 were born with congenital rubella syndrome, which can cause a range of birth defects including deafness, heart defects, and low birth weight. If our adult population is not protected against measles, then we have no reason to believe that they are protected against rubella and these devastating impacts to rubella during pregnancy. If you are an adult and you are not vaccinated for measles, mumps and rubella during childhood, nor did you have previous infection, please know that it is not too late to protect yourself against these dangerous infections. We will continue to update you on this outbreak and any potential rubella outbreaks as they unfold. Sadly, I think we're going to see things get much worse before they get any better.

Chris Dall: I'd like to get your thoughts now on that survey published last week by KFF. Among the findings was that 63% of respondents had heard the claim that the MMR vaccine causes autism. Even more concerning is that at least half of respondents were uncertain whether that claim, or the claims that getting the vaccine is more dangerous than getting measles, or that vitamin A can prevent measles, are true. And there were significant partisan gaps. Mike, this does not seem to bode well for childhood vaccination rates in this country going forward.

Dr. Osterholm: Chris, let me first just add an editorial comment to this entire issue. It's hard for me to imagine that in a world where we have more and more tools in the public health toolbox, namely vaccines to reduce infections that used to ravage populations, that I now sit in the 50th year of my career, and I'm seeing conditions worse than I saw when I got into this business in the mid-1970s. This is the wrong direction, absolutely the wrong direction. But it's one that's a reality. Chris, the results of this survey support that, and they're incredibly concerning. The survey was conducted by KFF between April 8th and 15th of 2025 to assess American’s opinions on measles and the MMR vaccine. The results show a moderate awareness of the current measles outbreak, with 56% of Americans aware that measles cases this year are higher than usual. Concerning awareness is even lower among parents than it is among the entire adult population, with only 48% of parents aware of the increase in measles cases. Both college education and being a Democrat were associated with greater awareness of the outbreak, with 72% of college educated adults aware of the high number of measles cases, compared to only 47% of adults without a college education, and notably, 71% of those describing themselves as Democrats were aware of the increase, compared to only 49% of those indicating they were Republican. As you mentioned, Chris, 63% of survey respondents stated they had heard the claim that the MMR vaccine causes autism. This is not particularly surprising to me, considering how much this myth circulates on social media and has now been promoted by our own Health and Human Services secretary.

Dr. Osterholm: I'm far more concerned by how many of the respondents believe that this claim could be true. 25% of Americans believe that the MMR vaccine definitely or probably causes autism. And there is a clear partisan gap here to 10% of Democrats believe this claim, compared to 35% of Republicans. Even more concerning, 19% of respondents believe that measles vaccine is more dangerous than measles infection. Namely 11% of Democrats and 20% of Republicans. And in addition, 24% believe that vitamin A can prevent measles infection. Again, 14% of Democrats and 29% of Republicans. Those without a college education were also more likely to believe these false claims, believing these myths have real consequences. 24% of parents who believe at least one of these three myths have reported delaying or skipping childhood vaccinations, compared to 11% of parents who don't believe those claims. And while delaying vaccination may seem like a relatively harmless way to encourage hesitant parents to vaccinate their children, it is important to remember that, especially during an outbreak, any delay in vaccination increases the amount of time that a child is vulnerable to this very dangerous infection. This isn't the only recent polling data that reflects the rise in vaccine hesitancy and partisan differences in vaccination attitudes. Surveys from Gallup poll found in 2024, 20% of Americans believe vaccines were more dangerous than the diseases they are designed to prevent, compared to 6% 23 years earlier in 2001. Further, in 2001, there was little difference between the opinions of Democrats and Republicans. 6% of Republicans believe vaccines were more dangerous than the diseases they prevent, compared to 5% of Democrats. Almost identical numbers. But by 2024, there was a clear partisan gap similar to what was found in the KFF survey.

Dr. Osterholm: 31% of Republicans believe vaccines were more dangerous than the diseases they prevented, compared to 5% of Democrats. The bottom line is we are in a vaccine confidence crisis and one that is becoming increasingly partisan. It's difficult to say where things are headed, given the unprecedented times we're in. With the current administration promoting anti-vaccine beliefs, it's possible that we could see this become an even more Partisan issue. That said, it's worth acknowledging that this country just cannot write this off as a Republican issue. Vaccine confidence, even among Democrats, is also concerningly low, with just 65% of Democrats reporting that they are very confident the MMR vaccine is safe. Confidence, specifically among parents, is even lower, 49% of Democrats and 25% of Republicans. We should be aiming for much higher vaccine confidence from people of all political ideologies, and especially the parents who are making vaccination decisions for their children this very day. There is no simple solution to this crisis, but I hope that our Vaccine Integrity Project at CIDRAP, something I'll talk more about in a moment, will play a role in restoring some of the trust in vaccines in this country, but sadly, I think it will take us decades, if not longer, to fully understand why this lack of confidence is occurring and what we can do to recover from it, particularly as we see the rise of anti-science and the promotion of anti-vaccination rhetoric from our nation's top health officials. I can only describe this in reflecting on my 50 years in public health and with real honesty. This is a crisis.

Chris Dall: Let's turn to the job cuts and restructuring we've seen at federal health agencies. Last episode, we discussed the potential impacts on drug reviews and food safety. This episode, we're going to look at sexually transmitted infection testing and surveillance. Mike, do we have any sense yet of how that might be impacted by these cuts?

Dr. Osterholm: Chris, this is what you might call an entire stadium full of issues that we could pick from, and we're just picking them one seat at a time. But Chris, this is a critical area where cuts can have a devastating impact. On April 1st, which we referred to in previous podcasts as April Fool's Tragedy, the CDC eliminated their sexually transmitted Disease Laboratory Reference and Research brands, which conducted critical sexually transmitted infection surveillance and research. All 28 full time employees of this lab were fired. And unlike other situations where some workers were brought back, as of today, none of these workers have been brought back, nor is there any movement to restore this laboratory capacity. The surveillance work at this lab was simply essential for informing best practices on sexually transmitted infection testing and treatment throughout the U.S., the lab performed susceptibility testing in over 20,000 Neisseria gonorrhoeae isolates per year to assess antimicrobial resistance trends, which have been a significant challenge with gonorrhea in recent years. These isolates have then been used to develop new diagnostic tests and treatments for gonorrhea, which can cause permanent damage to the reproductive tract if not properly treated. This was also the only lab in the country with the capacity to use PCR testing for syphilis. Other laboratories use other diagnostic methods. Despite what this administration has said to defend these types of cuts to the CDC, this was far from wasteful government spending.

Dr. Osterholm: We need these laboratories now more than ever. Syphilis cases in 2023 were the highest they've been in the US since the 1950s. Going along with the comment I made about the changes I've seen in my 50-year career. Congenital syphilis, which can cause stillbirth, neonatal death, and both short- and long-term health complications in infants, is also on the rise, with cases the highest they've been since 1992. This is not the time to scale back our public health laboratory capacity. Finally, surveillance capacity will likely also be more limited at the state and local level because of dramatic cuts to state and local health departments around the country. Perhaps the most concerning aspect of all of this is because our surveillance capacity could become highly limited. We may never know the extent of the damage caused by defunding these labs. And this is not just one area of infectious diseases we're seeing these impacts. I wish I had a more optimistic spin that I could put on this, but the reality is that we had these public health systems in place for a reason. And so, it is no surprise that if we suddenly dismantle them, then we could feel the effects for years to come. Such a tragedy.

Chris Dall: Mike, as you mentioned, and I think we should note for our listeners, over the last few weeks, we found that some of the people who were fired from federal health agencies have been rehired, and that some of the programs that were reported to have been cut have actually been reinstated. There's also a lot that's tied up in the courts. So that's some good news. But does this kind of uncertainty also have an impact?

Dr. Osterholm: Absolutely, Chris. Yes. It is good news that some people are being called back. But I really feel for the people who are being tossed around in this scenario. Again, as I stated in the previous podcast, what we're watching are decisions being made on efficiency and cost reduction quality outcomes in a way that I don't think would pass an eighth-grade class in business. And top of that, I think we have the challenge of how it's being done, where a scalpel could be used to strategically identify areas that we could get more return on investment from, versus this wild machete swinging where basically whatever gets hit gets cut. And then on top of that, we can even use the imagery brought on by the administration itself, we're just going to get chain sawed. So, this is really a critical area. The uncertainty caused by all this back and forth absolutely has an impact. It clearly illustrates how poorly thought through the cuts were to begin with. There was no rhyme or reason to the positions they cut, combined and moved around. Or we wouldn't be seeing all this backtracking. Can you imagine being turned away when you got to work on April 1st, only to be asked to come back and do the job that somebody didn't think mattered enough in the first place? In the days following the April Fool's tragedy, the health Secretary stated that 20% of cuts were a mistake and the people would be reinstated.

Dr. Osterholm: It’s not that clear exactly who had been rehired and in what capacity. So it is hard to say what impact this will have. However, I want to draw attention to one program that was cut and then reinstated, which is the Women's Health Initiative. This large study, which began in 1992 and is aimed at preventing disease in older women, an aim that supports the administration's goal to address chronic disease. I am so relieved that the decision to terminate funding of such an important topic was actually reversed. This study will continue to have positive impacts for the decades to come. But just know there were many, many studies that were cut and will never again see the light of day. And yet, those are the studies that held the promises for our future in reducing morbidity and mortality.

Chris Dall: Now for our Respiratory infectious Disease update. Mike, what is the latest with COVID and flu?

Dr. Osterholm: Well Chris more good news. Fortunately, the COVID-19 activity is still low and continues to decrease. The national wastewater level is considered low in every region. The South is the only region with a slight increase in wastewater concentrations. Emergency department visits for COVID are still very low and decreasing. Hospitalization data has been updated, and over the past week, 0.7% of inpatient beds, which is about 4700 and 0.7% of ICU beds, which is about 715 patients, were occupied by COVID patients. This is 32% lower than a month ago. Remember, we did not have updated hospitalization data during our last episode. Weekly deaths also continue to decline. And as I said last week, I suspect that when we have data for recent weeks, those totals will be significantly lower than the 442 deaths the week of March 29th, which is the most recent week with complete data. Now shifting over to flu. Remember that outpatient visits are below the national baseline of 3%, so the flu season is considered over. But that does not mean that we're not seeing some flu activity. 2.3% of outpatient visits last week were for respiratory illness. Rhode Island is considered to have high flu activity and New York is considered to have moderate activity. Four other states are low and the other 44 are minimal. Emergency department visits resulted in influenza diagnoses are at 0.7%, down from 1.1% during our last episode. New hospital admissions are down nearly 45% compared to our last episode, with 3600 new admissions this week. There have been 16 additional pediatric deaths reported since our last episode, bringing the season total to 204 pediatric deaths. Among the most deadly seasons for children in recent years, it's only behind the 207 deaths during the 2023-2024 season and the 288 deaths during the 2009-2010 season. In short, we can say that we have largely put COVID, influenza and RSV into our rear-view mirrors. Not completely gone, but for all practical purposes, almost gone. Now we're all sitting here wondering when will the next shoe drop?

Chris Dall: And Mike, what's the latest on the H5N1 avian flu outbreak?

Dr. Osterholm: You know, Chris, things are generally eerily quiet on the H5N1 front. As of early this week, there have been a handful of additional H5N1 detections among poultry and dairy cattle reported by the USDA. The agency last updated their numbers for commercial and backyard poultry flocks on April 24th, when they reported two positive flocks one in a live bird market in Queens, New York, and another in a poultry facility in North Dakota. The estimated number of affected birds in these four outbreaks is just 54, which I fear is an underrepresentation of reality among the poultry. On the dairy cattle side. The national total is reached 1032, and of the 12 reported herds since our last episode, nine have originated from Idaho and the others in California and in Arizona. In fact, since the beginning of this year, all but one detection among dairy cattle has been in far western states. This trend could be attributed to a number of factors, but we can't be certain exactly why. We're also keeping a close eye on the effects of northern bird migration on continued H5N1 spread. While there is no evidence reported to date about new outbreaks or novel viral mutations, it is critical to keep continuing monitoring. Our big question is what kind of monitoring is actually occurring relative to all the cuts that we've seen both at the Department of Health and Human Services and also at the USDA.

Dr. Osterholm: As time goes on, I am less and less sure we are getting a remotely clear picture of the ongoing H5N1 situation across all affected species, including humans. An updated risk assessment published by the CDC in late February categorized U.S. populations in contact with infected animals as quote, moderate to high risk unquote, which we know is supported by human cases and positive serology among farm workers and veterinarians. So, my question is, is the year-to-date case count of four a reliable estimate, or are we missing cases due to a lack of testing? I don't believe we're likely missing severe cases of influenza like illness that might be caused by H5N1, and surely not missing clusters of cases like this. But we could be missing these milder infections, notably conjunctivitis like illnesses. We just don't know. And speaking of uncertainty, it was recently reported the FDA was suspending their milk quality testing programs amid cuts to the agency's workforce. Sound familiar, right? Well, the state agencies and processors will conduct their own testing to meet industry standards. There will be less federal oversight. However, this lack of transparent regulation to protect against issues that cross state lines concerns me as it relates to the general food safety and our ability to track H5N1 in milk.

Dr. Osterholm: And let me just conclude on the avian influenza front, I just want to remind people that even if H5N1 never becomes the next influenza pandemic virus, there will be an influenza pandemic virus one day, or there could be a coronavirus pandemic virus. And as much as we focus on what's happened with H5N1, I remain extremely concerned about the lack of attention being paid to future pandemic preparedness, notably the whole vaccine issue, which I've talked about on multiple occasions. We as a global community would be grossly unprepared for an influenza pandemic any time in the next weeks, months or years if we continue to maintain this inadequate vaccination response situation. So, we surely want to keep our eye on the ball of H5N1. But now what we're seeing are cuts being made to critical vaccine research, therapeutic drug research for influenza and coronaviruses that, frankly, I think one day we're going to look back and say, how could we have been so ignorant of what we needed to do to better prepare ourselves for what is going to be an eventuality.

Chris Dall: All right, Mike, now we have a few COVID vaccine items we need to tackle. We're going to start with the Novavax COVID vaccine. So last episode, we discussed some uncertainty around FDA approval of the vaccine, which to date is still being administered under emergency use authorization. Now, the situation seems even more uncertain, with recent reporting by the Wall Street Journal indicating the FDA wants the company to conduct another phase three randomized trial of the vaccine. Mike, this seems unprecedented and like it could have an impact on other COVID vaccines.

Dr. Osterholm: Well, first of all, Chris, let me just emphasize one word that you just noted: unprecedented. There was a time when we had a few unprecedented things happen in our world of public health, and everyone took note of them because they were so significant. Today, unprecedented is a common everyday event that unfortunately continues to challenge us. Last week, as you said, I thought we were out of the woods. Remember last episode we dissected the uncertainty around Novavax created by two factors the FDA's missed approval deadline, plus HHS Secretary Kennedy's nonsensical claims about the ineffectiveness of a single antigen vaccine. Once again, I want to make it clear that a single antigen vaccines, have been and will continue to be effective against respiratory viruses, and Novavax COVID-19 vaccine is no exception. So, let's review the timeline of the last few days that has left a wake of confusion in its path. In a press release from Novavax published on April 23rd, the biotech company stated that they had received formal communication from the FDA via an information request for post-marketing commitment to generate additional clinical data. The key word here is post-marketing, meaning the FDA anticipates approving this vaccine and they want more information through studies or clinical trials as the vaccine is being used. Novavax went on to say that they'll be providing the data expeditiously. I don't doubt this development is a relief for them as much as it was for other folks like myself, who tend to prefer Novavax for COVID vaccination. Then, over the past weekend, the FDA commissioner Marty Makary took to social media claiming that the vaccine would require new clinical trials before approval to measure efficacy because the vaccine is considered different from the one previously approved in 2021.

Dr. Osterholm: This requirement would cost the biotech company millions of additional investment, and likely delay the release past the wave of infections caused by the circulating COVID variant. In other words, the Novavax vaccine would come too little, too late. This change in tone threatens the process of annually updating COVID vaccines as is done with influenza. And it just doesn't make any sense. As I pointed out before, our traditional method of approving influenza vaccines has been what we call a strange change, meaning that the vaccine is the same one. We're just updating the virus that's included in that vaccine. Well, this would be the very same principle that we see here for the Novavax vaccine. And yet, somehow now they're making the claim that this needs additional information. I think this is terribly unfortunate and not based on good science. While we're on shaky ground here without clear and definitive messaging from the FDA. I will continue watching this issue and as always, share the latest updates with our listeners. All I can say right now is that this is a huge challenge. And finally, I just want to also add that if in fact, this rule now is going to apply to Novavax, we need to be mindful will also apply to Pfizer and Moderna with their mRNA technology vaccines. And it's not flu it's COVID. So, in fact, would this be similar to what we're seeing with the situation with Novavax? Either way, all I can tell you is it's a real mess and one that's an unforced error on the part of regulatory science and public health.

Chris Dall: Mike, as you said, this is kind of a moving target right now. But just to be clear, a lot of products, after they are approved, the FDA asks for post-marketing data. So, data that the companies acquire after the product has been approved. This would be an entirely new clinical trial before approval. Is that right?

Dr. Osterholm: Yes. You nailed it, Chris. This is such a different approach than we've used successfully for the past decades with influenza vaccine. And frankly, it worked very well through three years of the COVID vaccine. So, I don't understand what is motivating it, other than we keep hearing that they are trying to use a gold standard of science, which I don't believe that right now, the spokespersons, at least for HHS and in this case FDA, really understand what a gold standard type of science means. Let me be really clear that the post-marketing approval is a reaffirmation that the platforms that we use for these vaccines, which have been used for flu for decades and for COVID for the last four years, are in fact well documented, safe and effective platforms. All we're doing is inserting a new change of virus. Think of it this way. You have a flashlight. Every so often, you have to change batteries. Doesn't mean you have to go buy a new flashlight or reevaluate your flashlight. You just have to get new batteries. That's all we're doing here. What they're suggesting is we need to go and test the new flashlight before we can even use the new batteries. This makes no sense. And so, Chris, I hope that we're not finding ourselves behind the eight ball when we need COVID vaccines or we need flu vaccines. And because of some arbitrary decision at the FDA not based in great science, now takes over and leaves us without the critical vaccines that we need.

Chris Dall: It was reported last week by Politico that the Department of Health and Human Services Secretary Robert F Kennedy Jr, is considering pulling the COVID vaccine recommendation for children. Now, this reporting has not yet been confirmed, and it does not mean that kids would not be able to get the vaccine. But what do you make of this?

Dr. Osterholm: Well, before I get into sharing some of my thoughts on this, let me just start out by reiterating a couple of points you made here, Chris. They are really important. First of all, we really don't know if this will end up actually happening. Now, according to the story, which was published in Politico last week, Secretary Kennedy has discussed the possibility of removing CDC's recommendations for COVID vaccines in children. This by itself is a huge story because never have we had a secretary of Health and Human Services overriding the science expertise of the CDC or the Advisory Committee on Immunization Practices, the outside experts brought in. However, at this point, specifics are lacking. In fact, one HHS spokesperson who was asked about this possibility said, quote, no final decision is made, unquote. So, here's another example of uncertainty that I talked about earlier. With the second point. I just want to emphasize something again up front so we're clear. Even if this recommendation was ultimately reversed, it does not mean that children would be barred from receiving a COVID vaccine. But I can tell you right now, if this were to happen, there would be consequences as a result. And that's really why I wanted to include this in the podcast, because we need to think about or anticipate these things and consider their downstream effects.

Dr. Osterholm: Remember, the childhood immunization schedule is what health care providers throughout this country rely on for guiding vaccine distribution and keeping children our next generation protected as a result. It's a resource that provides critical information about which vaccines should be given and when should they be administered. But it's not just providers that pay attention to it. Insurers, for example, also monitor the immunization schedule and use it to determine which vaccines to cover. So, there are significance to being part of the schedule. And there is a legitimate reason for that because the information it contains is thoroughly vetted by the best and brightest among us. Every vaccine that's part of the schedule is scrutinized to the nth degree by the ACIP or the Advisory Immunization Practices, which is that independent panel we've talked about many times of leading medical and public health experts tasked with evaluating all of the available evidence, their effectiveness, safety profile, etc., before making a recommendation on its use. It's a process that typically takes months, if not years, of reviewing data, discussing risks and benefits, and considering all the various factors. But even the ACIP recommendation isn't enough to be part of the schedule, the recommendation also has to be approved by the CDC and, frankly, supported by various healthcare organizations such as the American Academy of Pediatrics.

Dr. Osterholm: It's a rigorous process, and it's not set in stone. Recommendations are reviewed and reconsidered over time based on new data and evolving circumstances. So, suffice it to say, these decisions are not made overnight, and they should not be made singly by a Secretary of Health and Human Services who has no expertise in the area of vaccinology and infectious diseases. These decisions should be made by leading experts whose sole focus is the health and well-being of the public, particularly children. So, at this point, all I can say is, again, this would be a very critical interference in our review process. And frankly, for many, I think it would only lead to more distrust of vaccines, to think that a Secretary of Health and Human Services, without the expertise necessary to adequately evaluate these vaccines, was making a decision. So, Chris, we'll have to wait and see. Another moment of confusion seems, like a theme right now, doesn't it? But the bottom-line message is we've got to basically demand man that the scientific review of these vaccines holds true, and they are not left to some political decision.

Chris Dall: All right. One final COVID vaccine item. Republican legislators in Minnesota last week introduced a bill that would designate mRNA vaccines as, quote unquote, weapons of mass destruction and make possessing or administering them a crime. Now, this bill is not going to become law. But, Mike, you've noted that this is an example of how people who might otherwise feel powerless can do something. Explain.

Dr. Osterholm: Well, Chris, as you noted, I don't see this bill making it very far in the Minnesota legislature, but I don't think we can dismiss it entirely, as it's indicative of a much larger trend nationwide that threatens the development of mRNA technology and public health as a whole. Remember, there are a number of states that have enacted bills recently and signed by their governors into law that basically really challenge the basic science nature of vaccines. The bill here in Minnesota references mRNA injections and products. Any human gene therapy product for any infectious disease indication, and nanotechnology or nanoparticles that alter genes. Just a quick read of the bill, and you can tell that none of the authors had a solid understanding of the science. In fact, the bill's language is very similar to one drafted by a Florida hypnotist and anti-vaccine conspiracy theorist. But as unfortunate this bill is, we can't write it off given the nationwide context. As I just noted, multiple states, including Texas, Idaho, Iowa and Kentucky have introduced legislation to restrict the use of mRNA vaccines and other products. This represents a growing public fear of mRNA based on mis and disinformation, and threatens further developments of this emerging area of science. While COVID-19 vaccines are surely an important piece of the puzzle that would be impacted, I want to bring up two other concerns I have limiting mRNA technologies, new therapeutics, and pandemic preparedness.

Dr. Osterholm: There are some really promising trials occurring that utilize mRNA as vaccines and therapeutics, especially for cancer, right here in Minnesota at our own Mayo Clinic, mRNA therapy has been shown to help patients with more advanced cancers that aren't responding to immunotherapy alone. An effort at the National Health Service in England is creating personalized mRNA vaccines that assist cancer patients in remission to prevent recurrence. In addition to cancer, mRNA therapeutics are showing promise against genetic conditions like cystic fibrosis, as well as cerebrovascular diseases like Alzheimer's disease. Restricting research and development on mRNA technologies pushes us further and further away from making progress in these conditions. Frankly, I believe it actually represents the modern dark ages of science. Pandemic preparedness is another area where mRNA research and development is incredibly important. I've said it before and I'll say it again we will have another pandemic. One of the most critical factors to our ability to respond to the next pandemic relies on the speed that we can develop and produce an effective vaccine. Not only do mRNA vaccines provide an important platform for broadly protective vaccines, but the speed we can manufacture them is a major advantage over other methods. 1 to 2 weeks to produce mRNA or DNA vaccine, three weeks to produce a viral vector vaccine, and two months to produce a protein-based vaccine.

Dr. Osterholm: From strain selection to administering a vaccine, if we're producing an egg-based platform, it takes approximately six months, not to mention the bottleneck of having enough supply of embryonic chicken eggs. We simply won't be able to rely on egg-based vaccine production for a pandemic. I am incredibly frustrated that such an important area of scientific development has become a Partisan issue. When you have an end stage renal cancer or in the throes of an influenza pandemic, it doesn't matter what political party you belong to. You deserve to have a therapy or a vaccine that could save your life. It is in this light that I challenge the podcast family. What's going on in your state? Where are these bills being introduced and what are you doing in response? Are you attending legislative hearings addressing the inaccuracy of these bills? Are you rallying other public health and medical officials to also address these? So, for your task, I urge you to know what's happening in your state legislature, in your city councils, in your school board meetings. Find out what types of proposals are being made that are based on an anti-science approach, and organize around them. You have to help us keep these from becoming reality.

Chris Dall: Now it's time for our ID query. This week we received an email from a listener about the changes made by the Trump administration to the COVID.gov website. This listener wrote, tonight I ran into the COVID.gov website and I am amazed this is being published on an official US web property. Thought it was a good idea to share with you and hear your feedback on it. So, Mike, for our listeners who aren't familiar with what he's talking about, can you explain what the COVID.gov website now looks like and share your thoughts?

Dr. Osterholm: Well, first of all, Chris, let me just be clear that I've said for years now that the lab leak discussion has become nothing but political theater. I think this website's situation is proof of just that. Nearly two weeks ago, the federal government changed many of its COVID websites, including COVID.gov and COVID.gov test, to redirect to a white House web page titled Lab Leak: The True Origins of COVID-19. I have addressed this issue on multiple occasions. I do an exhaustive review of it in my new book coming out this summer. The bottom-line message is we will never know. I don't know whether it's a lab leak or it's a spillover. And all I can say is, is that from that perspective, it doesn't matter what it was relative to us being prepared for the future, because the future includes either one of those. The next pandemic could be caused by a lab leak, or the next pandemic could be caused by a new spillover from the animal population. So, from my perspective, we're really wasting valuable time by doing this. And of course, by taking the information off the website of CDC has put together about COVID is really unfortunate. It's censoring information. It's censoring data that in fact, all of us would like to have.

Dr. Osterholm: I would argue that it would have been at least a little better had they left those data on the internet, and then added the additional information that they wanted to on the lab leak, but by actually replacing one with the other. In a sense, it is just pure censorship. So, all I can say right now is, again, we need to move on. We will not know. There will never be adequate evidence to convince people of reasonable mind which one it was. And it doesn't matter for us to get prepared for the future. We have to prepare for both. So, for those that went to the lab leak website, I will just tell you there are many of my colleagues who absolutely vehemently disagree with the statements made there. Some of my colleagues who also feel strongly that there was a lab leak. And all I can tell you is with all the disagreements and arguments and debates we have; it almost seems to me like arguing about how many angels can dance on the head of a pin. Yes, it matters. We had a pandemic. It was tragic. But how it started will never be decided and it causes us to defer, I think, critical planning towards the future.

Chris Dall: Mike, we've talked a lot this episode about vaccine information and concerns about potential changes to vaccine approval and recommendations. So, now's a good time to discuss how CIDRAP is trying to address these issues. What can you tell our listeners about CIDRAP newly announced Vaccine Integrity project?

Dr. Osterholm: Well, Chris, I promised our podcast family that we would come forward with very meaningful actions that address the times that we're in, and this is an example of just that. I recognized, as you know, from this podcast the week after the election, that in fact, we're going to see a very different public health play out in this country. And I was certain that the 2025 plan that had been put forward through the election would in fact not only see the light of day, but become the guiding principle. And if you read that you knew that we were in for some huge changes. So, one of the first things that we were concerned about was what would happen with the CDC and its activity, specifically the Advisory Committee on Immunization Practices. Well, when it became clear that Robert F. Kennedy Jr. was going to become the next secretary of HHS, with all the challenges that this audience is so well aware of in terms of his beliefs and statements, there surely could be an impact on CDC and the ACIP. In addition, we didn't even anticipate at the time that with the government cuts to employees and funding, that that would have an even greater impact on what was going to happen in public health. So it was shortly before the inauguration, when it was likely that we were going to see this wholesale change in public health approach, that our group at CIDRAP got together and said, what happened if CDC no longer becomes a trusted source of information for vaccines and vaccine use, what happens if the ACIP is compromised? What happens if we see information coming out of the federal government that we know is scientifically unfounded, not correct? And in fact, if anything, dangerous to the public's health.

Dr. Osterholm: And so, we came up with this concept of what I call the vaccine Integrity Project. We established the Vaccine Integrity Project with the goal of ensuring that no matter what is happening at the federal level, there is reliable, comprehensive and authoritative information for evaluating and determining vaccine science, policy and utilization. As with almost any kind of insurance policy, we hope we never have to be used. But as you've heard me say on this podcast for the last several months, we find ourselves in the unfortunate reality where the systems we rely on to make vaccine recommendations is under serious threat. So, the Vaccine Integrity Project is our attempt with our activity to respond to those threats. We at CIDRAP are not alone in this work. So far, we've established a steering committee of eight public health and policy experts. Our steering committee co-chairs are incredible. Doctor Harvey Feinberg, the current president of the Gordon and Betty Moore Foundation, past president of the National Academy of Medicine, and former dean of the Harvard T.H. Chan School of Public Health. The other co-chair, Doctor Peggy Hamburg, a former FDA commissioner and current co-president of the Interagency Partnership, an international consortium of national academies of science, medicine, and engineering. In addition to myself, the steering committee members include Doctor Jeff Duchin, former Seattle King County public health officer with experience at the CDC, the Infectious Diseases Society of America and the National Academy of Medicine.

Dr. Osterholm: Asa Hutchinson, the 46th Governor of Arkansas with extensive legal and health policy expertise. He is the former undersecretary of the Department of Homeland Security and a recent presidential candidate. Doctor Mark Feinberg, president and CEO of the international AIDS Vaccine Initiative and former chief public health and science officer with Merck Vaccines. Fred Upton, former member of Congress representing Michigan who was highly involved with health research and drug policy during his time in the Congress. And finally, last but not least, Doctor Anne Zink, senior fellow at the Yale School of Public Health and a former chief medical officer for the state of Alaska. It's our responsibility as vaccine science, public health and policy experts to respond to this moment by ensuring that recommendations for vaccine use remain grounded in the best available science, free from external influence, and focused on optimizing protection of individuals, families and communities against vaccine preventable diseases. To identify how best to accomplish this. We are now embarking upon eight facilitated focus groups over the coming weeks to hear from people and organizations across the vaccine enterprise, including but not limited to, professional medical associations, health care systems, vaccine manufacturers, health insurers, health media experts, policymakers and citizens. These discussions will help shape the potential scope, membership criteria, and operating factors for the future of this effort. One thing I want to make clear is that this is no replacement for the Advisory Committee on Immunization Practices that formally develops recommendations on the use of vaccines for the CDC to carry out.

Dr. Osterholm: Our first, second and third preference would be for the ACIP to be entrusted to carry out its mission free from the influence of political appointees and vaccine skeptics. The Vaccine Integrity Project does not seek to replace the ACIP, but rather serve as a type of insurance policy for the integrity of vaccine recommendations, should the ACIP mission be compromised. Since we publicly announced this project, we have been flooded by messages of gratitude and excitement for this work. Mostly, I've gotten offers from top experts and large organizations to contribute to this effort. Engage with our work. It has proven to me how necessary this type of effort is during these unprecedented times. I do want to make one additional mention. This project is supported by an unrestricted gift from Alumbra, which is the foundation of my dear friend Christy Walton. Christy has been an incredible supporter of our activities at CIDRAP, someone who is all about investing in the common good. Thank you very much to Christy and her foundation. There will be lots more to come as we progress through the facilitated sessions and convene our steering group to dig down and really identify what is needed in this vaccine space and how can we ensure a success in longevity. I'll share updates on this project and even more that we have in the works, so stay tuned for now. We can do something. CIDRAP is going to help lead something here that can be done that is so important. So, remember, we all can do something.

Chris Dall: Well, speaking of ACIP, that body is the subject of our This Week in Public Health History segment, this episode. So, Mike, what can you tell us about ACIP?

Dr. Osterholm: Well, we just covered the really exciting CIDRAP project that focuses on bringing experts together to guide our understanding and use of vaccines and fight misinformation coming out of our existing HHS. But I want to make it clear, as I said before, we're not trying to be a shadow ACIP or replace ACIP. So, here's a bit of history and context on this vital group, and why we want to ensure its functions are fully protected. Throughout the 20th century, the US Public Health Service relied on a variety of ad hoc committees as new opportunities and threats to public health emerged. When Jonas Salk introduced the first licensed polio vaccine in 1955, an expert group of researchers, clinicians and public health professionals came together to discuss how vaccines could be implemented across the country. That same year, an event known as the Cutter Incident occurred when a batch of polio vaccine was not fully inactivated and resulted in polio infection, paralysis, and even death in some who received the product. The Surgeon General brought together a similar expert group to discuss new standards for vaccine safety and monitoring. Coming in the 1960s, the world entered a new era in vaccines with the introduction of new vaccines for measles, mumps, rubella and more. The idea began with HHS Secretary Anthony Celebrezze. But the committees were officially initiated and chaired by the CDC director, Doctor James Goddard, in May of 1964, titled the Advisory Committee on Immunization Practices, or ACIP. The committee was charged with advising the Surgeon General and CDC regarding biologic products that could be used to prevent and control infectious diseases. The committee would advise on immunization schedules, specific populations that would require prioritization or special guidance, implementing nationwide vaccine campaigns and furthering vaccine research. While the wording of its initial charter has been updated over the decades, its primary function stays the same.

Dr. Osterholm: To guide the CDC on how to best use vaccines to protect the public's health. It plays a critical role in forming what vaccines are to be included in the vaccines for children program, which provides free vaccines for almost half of the children across the United States. Its recommendations are also followed by Medicare Part D to ensure Americans can receive needed vaccines at no cost. Major insurance companies tend to follow these recommendations as well. The committee is comprised of 19 voting members serving as volunteers, and who have expertise in a wide variety of areas related to vaccine science, policy and community engagement. A steering committee reviews new applications for members, but the final decision for appointments is up to the HHS Secretary. The current ACIP has only 15 active members, meaning the HHS needs to fill four empty seats to reach the full membership. Additionally, four more members will be completing their terms in June. That means RFK Jr. may have the opportunity to bring in almost half of the new committee. We know the sort of connections he has in the anti-vaccine movement, and I anticipate some of these actors will find their way into this important body. Even with the most qualified people as members on the ACIP, it is very likely that its recommendations and agenda will be compromised by the current leadership at HHS. While I'm incredibly disheartened to see what the current ACIP is facing right now, I'm very grateful that CIDRAP and our Vaccine Integrity Project will be able to monitor everything is going on and call balls and strikes so we can maintain as robust a vaccine infrastructure in this country as possible. Our lives depend on it.

Chris Dall: Mike, we have covered a lot of territory today, but what are your take home messages?

Dr. Osterholm: Let me first of all, just start out with some context. I remember very, very well some years ago, having the good fortune, having dinner with the author Tom Clancy. And we were having this long discussion about what might have happened around 9/11 and all the things that could happen after that. And he looked at one point and said to me, young man, never forget. The only difference between reality and fiction is that fiction has to make sense. Well, I've come to understand that in a whole new set of terms. In fact, reality is something that is unbelievable sometimes. And but for the fact that it's actually happening, you wouldn't believe it. First of all, look at what's happened within our federal government. We're cutting positions in the US government with machetes and chainsaws, with no real attention to improving effectiveness, improving efficiency, improving outcomes, cost, anything. It's just slash and burn. We're eliminating major funding for research and public health practice around the country, making us highly vulnerable to another infectious disease challenge. And while we keep talking about trying to make America healthier again, we're cutting many of the very research programs that were aimed at doing that very thing. And finally, we're creating a new dark age for training with our number of researchers, clinicians and public health professionals, leaders of tomorrow, not having the opportunity to get the training that they need today. This will provide a generational impact. It's amazing how many of our current senior researchers who are working on truly groundbreaking issues that are now made to shutter their laboratories. And finally, we don't really even know for a fact what will be the final disposition of so many of these funding issues between the court battles the administration saying, oh, never mind, I'll try this, but oh, there's more coming.

Dr. Osterholm: We don't even know with this uncertainty what's going on. So, the first point I want to make is expect the unexpected, not by the day, but by every hour. And that's where we have to be right now. Second point is the Vaccine Integrity Project is our first major effort to address head on what's happening. But we're not done and we'll have more announcements for you in the near future. CIDRAP will bend, it will bend and it will bend, but we will not break. And we are bound, determined to do what we can to make this world a safer place for our kids and grandkids. And finally, as I noted in the discussion about the bill and the Minnesota legislature on mRNA and the other legislative pieces are moving throughout the country. Please get involved. Please form groups that actually keep track of what's happening in the legislatures or in the city councils or the school board meetings. You can have a big impact. Show up. Know what you're talking about and address it. If there was anything right now that we need, we need the citizen leadership to help do that. And so, I ask you right now, for the sake of my kids, my grandkids. For your kids, your grandkids. Please take this on. Don't let legislation get passed in states. Don't let bills get approved in city councils, which in fact will set us back, not move us forward in this day and age.

Chris Dall: And finally, what is your closing song for the week?

Dr. Osterholm: Well, Chris, we're going to use a song today that we've not used before, but it's one I think that really fits the moment. The song is by Cassandra Monique Betty, now known professionally as Andra Day and who is an American R&B and soul singer, songwriter and actress. She is a recipient of various accolades, including a Grammy Award, a Children's and Family Emmy Award, and a Golden Globe Award, along with nomination for Academy Award. The song Rise Up is one that I believe is anthem for the moment. So here it is. Rise up by Andra Day. You're broken down and tired of living life on a merry go round. And you can't find the fighter. But I see it in you. So, we're going to walk it out and move mountains. We're going to walk it out and move mountains. And I'll rise up. I'll rise up like the day. I'll rise up, I'll rise unafraid. I'll rise up. And I'll do it a thousand times again. And I'll rise up high like the waves. I'll rise up in spite of the ache. I'll rise up. And I'll do it a thousand times again. For you. All we need. All we need is hope for that we have each other. For that we have each other. And we will rise. We will rise I will rise up.

Dr. Osterholm: Rise like the day I'll rise up. In spite of the ache, I will rise a thousand times again. And we will rise up high. Like the waves. We'll rise up in spite of the ache. We'll rise up and we'll do it again a thousand times for you. Andra day, rise up. Thank you so much for being with us for this podcast. I know we covered a lot of material, and unfortunately, I wish we could spend more time getting more into the depth of some of these topics, but hopefully you were able to get some information that's helpful to you. Uh, again, I just want to thank the podcast family for your support. Your feedback to us is so important, and we appreciate it very, very much. And all I can say is that we're in this together. We're staying the course. We won't change. And at the same time, while I share with you all the angst of the moment, we must never forget the foundation that will keep us all together is the kindness. Now is the time more than ever to be kind. It also means being involved, but surely also means being kind. So, thank you so much. We appreciate you. We love hearing from you. And until the next podcast, be safe, be kind. 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.