Episode 189: Are We at Risk of Losing Our Vaccines?

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. According to data posted by the centers for Disease Control and Prevention last week, vaccination rates among children entering kindergarten continues to fall in the United States. To cite one example, the percentage of children who received the measles, mumps and rubella, or MMR vaccine fell to 92.5% in the 2024-25 school year. That's down from 92.7% the previous year and from 95.2% in 2019-2020. And it's not just the MMR vaccine, uptake of the diphtheria, tetanus and acellular pertussis, or DTAP vaccine, and the varicella and polio vaccines also fell last year. 

Chris Dall: Meanwhile, the percentage of U.S. kindergartners seeking exemption from one or more vaccines rose from 3.3% to 3.6%, hitting a new high for the fourth straight year. At this moment when preventable diseases are on the rise, we need clear, effective communication from government leaders recommending immunizations as the best way to ensure children's immune systems are prepared to fight dangerous diseases. American Academy of Pediatrics President Susan Kressly said in the statement that implied that we are not currently getting that type of communication from federal officials. What kind of challenges are declining U.S. childhood vaccination rates going to pose in coming years? That's among the topics we'll be discussing on this August 7th episode of the podcast. We'll also dive further into the topic of vaccine exemptions. Bring you the latest from CIDRAP’s Vaccine Integrity Project, provide updates on the future of the PEPFAR program and National Institutes of Health funding. Discuss the latest COVID data. Answer an ID query about COVID vaccines and revisit a study on aluminum containing vaccines. We'll also bring you the latest installment of This Week in Public Health history. But before we get started, as always, we will begin with Doctor Osterholm opening comments and dedication.

Dr. Osterholm: Thanks, Chris, and welcome back to everyone in the podcast family. It's great to be with you again. I want to, in particular, thank a number of you who have sent us notes, cards, emails over the past several weeks providing us with your feedback on what you would like to hear on the podcast, and how we might make it more useful for you. We're listening. In addition, I want to welcome anyone who might be new to the podcast. I hope you're able to find the kind of information that's helpful to you. And if you do that, you'll come back and visit us again. Chris, as we step into August, we mark National Immunization Awareness Month, an opportunity to reflect on the crucial impact vaccines have had on public health, and to recognize the many individuals who make that impact possible. Consider all the people, institutions and processes that have had to be put in place for a vaccine vial to arrive at your clinic or pharmacy so that you can receive your annual flu shot, or your newborn can stay on top of their immunization schedule. This episode is dedicated to everyone working across the vaccine enterprise. A very broad landscape of participants from researchers developed the next generation vaccines to the scientists and coordinators running clinical trials from those setting public health guidelines and defending immunization policies to the frontline clinicians, pharmacists, nurses, community advocates and local and state public health officials. We're staring down a new school year and the fall respiratory virus season, making National Immunization Awareness Month all the more timely. With measles outbreaks, COVID-19 uncertainties and new RSV protection available.

Dr. Osterholm: It's clear how critical vaccines are in many areas. School entry vaccine mandates remain a foundational driver of immunization coverage, but mandates alone aren't a silver bullet. Integrating mandates with other interventions such as education initiatives, reminder systems, insurance coverage alignment, and accessible school-based clinics yields by far the best results. It goes to show that vaccine heroes just don't work in labs or wear white coats. They're also working in government, advocating for insurance coverage and working to host community vaccination clinics. Of course, the Immunization Awareness Month begins before a backdrop of renewed attacks on vaccine safety and science. Unlike anything I have seen in my 50-year career, it's hard to stomach the near-daily myths and disinformation spread by even government leaders and others who have access to the largest microphones. To be sure, vaccines are arguably the best public health success story in all of human history. Vaccination programs have saved over 154 million lives over the past 50 years, significantly reducing infant mortality and improving survival rates across generations. Vaccines are cost effective, reduce health care costs, and prevent millions of hospital stays and deaths. It's no surprise that we'll come back to the topic of vaccines several times throughout today's episode, we'll look at declining vaccination coverage among children, vaccination exemptions, COVID-19 vaccine guidance, and the latest on what the Vaccine Integrity Project has been up to. As an infectious disease podcast, It's rare to hear an episode where you don't highlight the importance of vaccines and the people who develop, research, test, approve and deliver them. We have so much gratitude for the dedicated individuals whose lifework it is to make sure that people around the world are protected from preventable diseases.

Dr. Osterholm: Let's all be sure to take advantage of this great resource and advocate for the continued access to lifesaving vaccines. Well, let me make the transition now into that segment for which some of you would likely excuse yourself for a minute. I'm happy to report today for August 7th in Minneapolis-Saint Paul. Sunrise at 6:05 a.m. Sunset at 8:30 p.m. That's 14 hours, 25 minutes and one second of sunlight. We're losing sunlight. Now, unfortunately, about two minutes and 35 seconds a day. I might also add that this past week has been a challenge with sunlight, because it's been blocked out by dense smoke coming from the forest fires of Canada. Three times this past week, we've been in the top three cities in the world for most dangerous air quality because of this smoke. There are times in the Twin Cities where we could not see even a city block because of the smoke. I sure hope this does not become a pattern that we see summer after summer. I'm happy to report in Auckland today at the Occidental Belgian Beer House on Vulcan Lane. Sunrise there was at 7:13 a.m., sunset at 5:40 p.m. That's ten hours, 26 minutes and 49 seconds of sunlight. Yeah, we still got you beat by four hours, but you're now gaining sunlight at one minute and 49 seconds a day, and that number only get larger, faster. So, it won't be long and we'll be passing each other somewhere around September 21st with equal sunlight.

Chris Dall: So, Mike, in this vaccine heavy episode, let's begin today with that CDC data on the decline in US childhood vaccine coverage. Now, some people might hear these numbers and think that 92.5% MMR vaccine coverage sounds pretty high, or that a decline from 92.7 to 92.5% uptake doesn't really seem like that big a deal. So, can you provide some perspective on these numbers for our listeners?

Dr. Osterholm: Chris, you're absolutely right. This decline may seem insignificant to many, but it's absolutely a cause for concern. As you said, MMR coverage in US kindergarten students declined from 92.7 to 92.5%. Yep, this decline is relatively small, but it is continuing a pattern of slow but steady declines in MMR coverage that we've observed since 2017, when coverage at that time was at 95.2%. And while you're also correct that 92.5% coverage may seem high to many, it sadly is not nearly high enough. 92.5% coverage is well below the 95% threshold likely needed for herd immunity or community wide protection against measles transmission. Even more concerning, though, is that this 92.5% coverage is not uniform across states or within states, which means that we have pockets of even more unvaccinated populations that are highly vulnerable to measles outbreaks. This is what happened in the Texas outbreak. Measles entered a community with much lower vaccination uptake than the nationwide or statewide average. Transmission exploded within that community, and then the virus spread like wildfire to other parts of the country that also had large under vaccinated populations, and based on current vaccination patterns, we can expect this to happen again and again and again.

Dr. Osterholm: Despite the nationwide coverage rate of 92.5%, 16 states have vaccination rates below 90%. Of those states, three have vaccination rates below 85%, including our neighbor here, Wisconsin at 84.8%, Alaska at 81.2% and Idaho at 78.5%. If we look within the states, there are pockets of even more under vaccinated communities. Look at Minnesota, for example. We have a statewide MMR vaccine uptake of about 86.5% in kindergarten students, but several schools have vaccination rates well below 50%. What this is really explaining to us is that we're often measuring with a single number. The idea that your heads in the freezer, your feet are in the oven, but on average your temperature is just right. It is these areas right now of largely unvaccinated pockets that serve as the explosive node for future outbreaks. The bottom line is that this slow but steady decline in MMR vaccine uptake is very concerning. We're already seeing a significant increase in measles cases, the most we've seen in over 20 years, and yet that is not driving people to get their children vaccinated. I think we'll soon see surges in mumps and rubella cases to follow. Chris, we have the tools to prevent these tragic illnesses. We need to use them and we need to use them now.

Chris Dall: So, on the issue of vaccine exemptions, the American Academy of Pediatrics last week issued a revised policy statement calling for an end to nonmedical vaccine exemptions, which cover religious and philosophical objections to vaccines and account for the vast majority of exemptions issued. Mike, this seems like a political nonstarter in this country, but does the AAP have a valid point.

Dr. Osterholm: Chris, as you just noted The American Academy of Pediatrics, AAP, put out a statement last week reaffirming policy statements they made in 2016 and 2022, which calls for an end to nonmedical exemptions, which includes religious and philosophical or personal belief exemptions for vaccines mandated in schools. These non-medical exemptions greatly limit the impact that school mandates can have, as many parents don't truly perceive vaccines as required if they are able to sign a form to opt out of the requirements for their child without needing a medical reason. Though the removal of non-medical exemptions may seem like a political nonstarter, maybe even a hand grenade, it certainly is in many states. But it is worth noting that five states currently don't allow non-medical exemptions for vaccination. West Virginia, California, New York, Connecticut and Maine. Other than West Virginia, these states all introduce policies removing non-medical exemptions in the last ten years. California in 2016. New York in 2019 and Connecticut and Maine in 2021. This was promising in the sense that even during the pandemic, some states were able to pass this legislation. But with the rise in anti-vaccination and anti-science around the country, it will only become more difficult to pass legislation like this in the future. In fact, Mississippi, which previously did not allow non-medical exemptions, just recently introduced them back in 2023. So, I strongly support what the AAP is trying to do here.

Dr. Osterholm: While others recognize that this will be a difficult policy to achieve in many states. We also need to recognize that removal of non-medical exemptions is just one piece of the puzzle here. Many other factors can limit the impact of school mandates, including provisional enrollment policies that allow unvaccinated children to attend school, sometimes for indefinite periods of time. Parental decisions to homeschool children rather than comply with mandates, and a general lack of enforcement of mandate policies with schools. I have to add a footnote here. On September 2nd, my new book, The Big One, will be hitting bookshelves around the country. And in The Big One, I go into real detail about the things we should have learned from the COVID pandemic, and one of them was about vaccine mandates and the challenges that they pose and what they could mean in terms of society's acceptance of vaccines. And one of the points that I make is I don't believe all vaccines are created equal relative to actually demanding a mandate. I will tell you that MMR, to me, is a perfect example of a vaccine that should be mandated. One: It does cause serious disease. Two: it is highly infectious, transmitted easily between individuals, but it has durable protection almost for a lifetime. So, once you're vaccinated, you're not back getting re vaccinated every two or 3 or 4 months.

Dr. Osterholm: These criteria, I think, can help us understand, well, a lot of vaccines are not like that. A lot of vaccines we need to get them over and over and over again. Or they only provide partial protection against the disease in which they also do not have any impact on transmission. I discussed in The Big One a need for us to go back and rethink which vaccines should be mandated. So, this is not an anti-mandate statement at all. As I just pointed out, I very strongly support the mandates to vaccinate children for childhood vaccine preventable diseases like MMR where we have a highly protective, durable protective vaccine. So, I think this is going to be an area that we're going to see a lot more discussion on over the upcoming days. We surely can't go back to just willy-nilly whoever wants to get vaccinated can, and whoever doesn't can't. It's all about protecting our kids. And we know that when we have a situation where we're not requiring vaccines, we're going to see, in fact, very low levels of vaccination. So, I hope that over the days ahead we can have this very intelligent yet I know charged discussion about when, how and where we put in place vaccine mandates and that we don't just blanket all vaccines as mandated, but that also we do put the teeth behind those that can really make a difference in our children's health.

Chris Dall: Let's stay with vaccines for the moment and get an update on this vaccine integrity project. What can you tell us, Mike?

Dr. Osterholm: Well, Chris, first of all, let me just say things are staying extremely busy with the Vaccine Integrity Project. I gave an update during the previous episode, but I'll recap briefly where we're at now. Currently, there are 25 researchers from top institutions around the entire country working on a systematic review and meta-analysis of the latest publicly available data on COVID-19, RSV and influenza. Of course, these are the seasonal viral pathogen vaccines that we will be needing recommendations for in short order. This structure review of the data will help to answer clinical questions regarding vaccine safety and efficacy. We're prioritizing these vaccines given the urgency of the upcoming fall respiratory season. This review will serve as a resource for medical societies to develop and share their own immunization recommendations in the coming weeks. Of course, we're bringing these societies and other relevant medical associations along as we work through the development of this science brief to make sure our partners are well informed of all of our progress and early findings. The team has moved from screening more than 17,000 abstracts to screening more than 1400 full text articles, all in duplicate. Now they're hard at work extracting the data from these studies and getting started on an analysis to get a sense of what the latest data says about COVID, RSV and influenza vaccines along with disease burden. I can't say enough about the motivation and dedication of this team. It's simply remarkable. In fact, it is true. They are literally working around the clock to get this information available by mid-August, so that we can get this in the hands of the medical associations.

Dr. Osterholm: Again, who will make the recommendations for vaccines. All I can say with great humility is that this effort has been a masterclass in collaboration and scientific excellence, despite challenging deadlines and external pressure. I'll be happy to share more about the findings of the Science Brief as the team gets further along in their analysis and shares the results publicly. I do want to add one caveat to this. We keep hearing from people who are thinking that we, at CIDRAP, are going to be making recommendations for vaccine use, we are not. Our task is to do what the ACIP would normally have done provide this very detailed, in-depth review of what we now know about the vaccine since their last review by the ACIP. And so, what we're doing is turning over these science briefs with this exhaustive understanding of what has been published in the past several years, so that they can make the recommendation. Who better than to make recommendations for children? The American Academy of Pediatrics. We see this with ACOG and their unique relationship with pregnant women, etc. we do look forward to sharing this information with the medical societies, and we know that it'll help us all be better prepared for a science-based vaccine recommendation season, regardless of what comes out of the Department of Health and Human Services.

Chris Dall: Now for some news out of Washington. Mike, we probably shouldn't be surprised that on the very day we celebrated the news that the President's Emergency Plan for AIDS relief, or PEPFAR, had been spared a significant funding cut, The New York Times reported that the Trump administration has been mapping out plans to shut the program down within the next few years. Mike, your thoughts on this plan and what it would mean for global HIV/AIDS response?

Dr. Osterholm: First of all, Chris, the key phrase in your question was we probably shouldn't be surprised. This administration keeps taking swings at critical public health programs. So, you're right that we shouldn't be surprised by this report from the New York Times. On the last podcast episode, we covered the restoration of $400 million in PEPFAR funding. However, this may be short lived, as officials at the State Department have been carving out a plan to shut down PEPFAR over the next few years. The documents, obtained by The New York Times, suggest that this administration is planning to transition low-income countries away from U.S. assistance and instead form bilateral relationships focused on an outbreak detection and response that could threaten the United States. While there are several issues with this plan, the most fundamental is the assumption that HIV is not a threat to the United States. We have said this time and time again, Chris, that infectious diseases know no borders. In 2022, there were 31,800 estimated new infections in the US and 1.2 million people living with HIV, according to the CDC. While PEPFAR primarily operates internationally, insinuating that the United States is immune to the threat of HIV is not only incorrect, but dangerous. The proposed changes to PEPFAR by the State Department include a 42% reduction in budget.

Dr. Osterholm: This would be absolutely devastating to the global HIV/AIDS response. However, PEPFAR budget is decided by Congress, not the executive branch. PEPFAR has benefited from bipartisan support in Congress over his 22 year history. Former President George W Bush, the Republican who launched PEPFAR 22 years ago, previously stated, and I quote, I believe that spending less than 2/10 of 1% of our federal budget to save millions of lives is in the moral, the practical, and the national security interest of the United States, unquote. Although the future of PEPFAR is uncertain, I'm hopeful that Congress will continue to fund this monumental global public health program that has saved an estimated 25 million lives and reduced AIDS related deaths by 64%. But then I realize, as they would say, it's not over till it's over. Every time we have a good piece of news that may come out of a court decision or even an action in Congress, we have to take into account that that all may be changed tomorrow by what goes on within the administration. So, we'll try to keep you as well informed as possible. But I must tell you what a job it is today to stay up minute by minute. Who's on first? What's on second? Whatever.

Chris Dall: Another story that changes day to day is the issue of National Institutes of Health grants and funding. As we've explained in previous episodes, NIH grants fund most of the medical and scientific research that is conducted in this country at places like the University of Minnesota and universities around the country. But NIH, under the Trump administration, has severely curtailed the issuing of grants. Administration officials have threatened to withhold money from the NIH that's already been approved by Congress, and the administration has proposed significant cuts to the agency in its 2026 fiscal year budget. But Congress does not appear to be on board with those cuts. Can you give us a sense, Mike, of where things stand at the moment?

Dr. Osterholm: Well, Chris, I'll certainly try my best. But acknowledging right up front, I don't think anyone really knows. I just answered the previous question about what's happening with resources within the administration and how every day they change dramatically. We have to understand that that's the same here. Everything could be very different with this funding that you just talked about with the blink of an eye. So, keeping up with this is a primary cause of severe whiplash. We just don't know what's going to happen tomorrow. Just last Tuesday, the white House announced the NIH funding to researchers across the country was being paused indefinitely. As a result, almost $15 billion was frozen at the drop of a hat. Remember, this was money that had previously been frozen and then unthawed. And this funding again represents the lifeblood of critical biomedical research and innovation happening at so many institutions. Notably, it had already been appropriated by Congress, which has the power of the purse. So, we're talking about money intended to support things like cancer research, Alzheimer's research, etc. much of this work literally cannot happen without NIH funds and, of course, to set off alarm bells. A statement by Barbara Schneider, who serves as the president of the Association of American Universities, included the following. And I quote. This is undeniably and unforced error, since this will not only harm current and future American patients, but the disruptive and chilling effect of the sudden holding back of promised funds will further jeopardize the future of the American medical research enterprise, unquote.

Dr. Osterholm: So, you can get a sense of what was at stake. But then the very same day that Tuesday, the decision was all of a sudden reversed. The freeze in NIH funds was lifted. According to reports, there was pushback internally, and a number of senior White House officials intervened. So, the good news is that in this case, the pause didn't last very long. But importantly, it serves as another example of all the uncertainty that exists when it comes to research in this country. Anyone who has ever submitted a grant proposal for NIH funding knows how much time and effort goes into that process. These are projects that are carefully designed and oftentimes sensitive. In many cases, it's the primary source of funding for the researcher and their team. But now there's this lingering concern that funds could one day just stop. Maybe be reinstated the next day and then stopped again. How do you plan around that? If I received a NIH grant to conduct a clinical trial with dozens or even hundreds of participants, do I suddenly have to think about what I would do if the funds just went away? This hectic, back and forth approach is challenging and disruptive, and it is no way to run a business, let alone the entire backbone of research in this country.

Dr. Osterholm: Now, one thing I'm watching closely is the budget that Congress will eventually set for NIH and other health agencies. Again, if you look at the proposed budget put out by the white House several months ago, the NIH budget was slashed by 40%, and the CDC has cut in half. Now the question has been, how will this budget proposed by the administration compare with Congress has in mind? Well, needless to say, it's early and a lot can happen. But I think it's worth mentioning that a bill passed last week by the Senate Appropriations Committee basically left out any major cuts to NIH or CDC. In fact, the bill, which moves to the Senate floor after a 26 to 3 vote, actually opts to increase the NIH budget by $400 million. And several senators who are members of the committee were quite vocal in their support of for scientists, with one Patty Murray, Democrat from Washington, literally saying to them, Congress has your back. Again, a lot can still happen since the bill will need final approval from the full Senate and will have to align with the House's version and ultimately require the president to sign it into law. But at the very least, it's a positive sign and hopefully indicates there will be some more stability moving forward in the next several years.

Chris Dall: Let's turn now to the latest COVID data. In its update last Friday, the CDC indicated that several parts of the country are seeing increased COVID activity. Mike, what can you tell our listeners?

Dr. Osterholm: That's correct. Chris. We're starting to see some signs of increasing activity across much of the US, but specifically in the South and the West. Wastewater concentrations are increasing across the entire country in every region. Levels in the south and west are considered moderate, while the Midwest and Northeast are low. Nationally, the levels are still considered low, but are approaching the threshold for moderate. Six states have high concentrations, including Alabama, California, Delaware, Florida, Kentucky, and Louisiana. Three states, Alaska, Hawaii, and Texas, are considered very high. Emergency department visits are now considered low rather than very low, and continue to increase. Many of the states with high and very high wastewater concentrations are also experiencing increases in ED visits, including Alabama, Alaska, California, Florida, Hawaii, Louisiana, and Texas. Unfortunately, weekly deaths increased slightly the week of July 5th, with 165 deaths that week, up from 152 the previous week, which was the lowest weekly total since the beginning of the pandemic. So, we're still at a very low level, but unfortunately it looks like it could increase. The CDC still has not updated the variant proportions since the end of June, so we're relying on the CDC's traveler-based surveillance for variant data. The week of July 6th, which is the most recent week with data. XFG accounted for 61% of samples, and the NB.1.8.1 accounted for 18%. Remember, now, these are people coming into the United States with foreign travel. This doesn't really reflect necessarily what's happening here, but rather what's happening around the world. I do think there are signs that the COVID-19 activity could increase across the country in the coming weeks and months. But nothing is ringing alarm bells to me that makes me concerned that we're going to see another major surge in the coming months.

Chris Dall: That brings us to our ID query. Over the past few weeks, we've heard from several listeners about their inability to get additional COVID shots. Some listeners have been told that they can't get one because they already received two doses this year, and others are being told that their pharmacies aren't carrying the vaccines at all anymore. Now, we cannot speak to what individual pharmacies are telling people. But Mike, can you review current CDC guidelines on who can or should receive additional COVID-19 vaccine doses?

Dr. Osterholm: Well, let me just say at the outset, there's a tremendous amount of confusion about COVID vaccine in the community. By far, the vast majority of Americans have indicated they're not going to get a COVID shot, no matter what. But for those who are at increased risk of serious illness, we've seen a lot of angst because they're concerned about what they can and should do and what this means. First of all, let me just say I'm growing concerned with the number of people I've heard being denied additional COVID vaccines. And I'm hoping that it can be resolved quickly. What I suspect may be happening is the 2025-2026 recommendation has not yet been approved. So, we're still operating another 2024-2025 recommendation. The 24-25 recommendation approved one additional dose of the 24-25 formulation for anyone six months to 64 years of age, or two doses for those over 65 or immune compromised. Thus, if you have received those two approved 24-25 doses, the pharmacy is not able to give them a third. However, additional doses of the 24-25 vaccine are approved upon shared clinical decision making, meaning that you can consult with your doctor to decide whether you should receive additional doses. I think this is a very unfortunate recommendation, only because of the fact that how many people have a physician they can readily just get into and have a conversation with. The challenge we have today is that so many people are getting their vaccines in places like pharmacies, where they don't have a medical doctor there that can consult with them.

Dr. Osterholm: So, all I can say right now is good luck, and we'll put a link to this current CDC recommendations on the show notes, so you can look at those. And let me just add, that is now at the beginning of August, six weeks after the ACIP meeting. And we still do not have a formal recommendation for the fall. However, we expect that when the recommendation is finalized, anyone six months to 64 years of age with at least one immunocompromised condition, and anyone 65 or older will be eligible to receive an updated 25-26 vaccine. Now, when will that be? I wish I had an answer and I hope the answer was very soon. But unsurprisingly, this administration seems to be in no rush to finalize their updated recommendation. I will note that if you visit the CDC website for COVID-19 vaccines, you'll find the 2024-25 recommendation, along with the red box at the top of the page that reads COVID-19 vaccine recommendations have recently been updated for some population. This page will be updated to align with the updated immunization schedule, unquote. And then there is a link to what's called Learn More. If you go to that page, you'll see there is no additional information to be found on the updated recommendations. I wish I could say I'm shocked, but unfortunately, it's just another display of the chaos happening under this new leadership. It's becoming more and more clear that the goal is to limit access to and confidence in vaccines. And unfortunately, I'm afraid they're actually doing that.

Chris Dall: Now let's address another item here on the COVID vaccines. Given that several officials in the Trump administration have called into question their safety. In a study published last week, researchers in Denmark assessed serious side effects in more than 1 million people who received the mRNA COVID vaccines containing the JN1 lineage in 2024-25. Mike, what did they find?

Dr. Osterholm: Chris, they found just what we would have expected them to find, that the mRNA COVID vaccine used this past season showed no elevated risk of any of the 29 serious adverse effects they studied, including myocarditis, pericarditis, stroke, aneurysm, and Guillain-Barré syndrome. The Statens Serum Institut researchers, an organization which, like our CDC, followed all Danish adults recommended to receive the JN1 containing booster vaccine, meaning those age 65 or older or those in high-risk groups who had previously received three or more COVID vaccine doses. For 28 days the team monitored for hospital visits for any of the 29 adverse outcomes adapted from priority lists of special interest to COVID vaccines. The authors caution that although no statistically significant differences were found for any of the 29 adverse events, a few were so rare that the statistical precision was low and some couldn't be compared at all. This study comes two months after a decision by US Health and Human Services Secretary Robert F Kennedy Jr, removing the recommendation that healthy children and pregnant women receive COVID vaccines. Just the week before, the FDA published an opinion piece in the New England Journal of Medicine that included a CDC graphic listing current or recent pregnancy as risk factors for severe infection. These decisions have done just what RFK promised not to do: take vaccines away from people who want them, not just by removing the recommendation, but by giving insurance companies the reason not to pay for them. This further erodes confidence in health authorities who have the public's best interest at heart. Giving vaccine skeptical people another reason to forego lifesaving vaccinations. What's more, these policy decisions are not evidence based. Nothing in the science has changed. No groups have weighed in with new data. Sad to say, our nation's health now hinges on what I believe are dangerously uninformed individuals bent on pursuing a personal agenda. This is why the VIP data that we're generating is so important. It will provide the definitive statement around the issue of risk of adverse vaccine effects with COVID. We're looking forward to sharing those data with everyone.

Chris Dall: Now, speaking of Danish vaccine studies, in our last episode, we discussed a Danish study that found no association between aluminum salts in childhood Vaccines an increased risk of early childhood conditions, including autism. That study was widely covered in the media, including CIDRAP News. Now, since that study was published, anti-vaccine groups have been challenging the findings and critiquing the methods used by the researchers, and Secretary Kennedy has added his voice to those critiques. Mike, it appears anti-vaccine groups are using very familiar tactics here. Can you explain what's going on and what they're saying?

Dr. Osterholm: Well, Chris, you're absolutely right. Unfortunately, some of the reaction we're seeing to the study has really followed a very familiar pattern that the anti-vaccine groups have used to discredit scientists and undermine results that they disagree with. Now, as a quick reminder of what the study was all about, researchers in Denmark looked at the vaccination and medical records for more than 1.2 million children across a period of 24 years to investigate whether the use of aluminum as an adjuvant in certain childhood vaccines might be linked to more than 50 different conditions, including autism and asthma. The group that conducted the study was also based out of the Statens Serum Institut I mentioned in the previous question. The results showed no statistically significant connection between aluminum and vaccines in any of the 50 plus conditions that they looked into. Now, this was important for a number of reasons, with one in particular being a previous study out of the US in 2023 would suggest that aluminum and vaccines might increase the risk of childhood asthma. So, this latest study, which was much, much larger in size, greater than 1.2 million kids versus the previous study of 327,000 kids and investigated a whole number of various conditions alongside asthma, which was really important in terms of clarifying that there's no risk in using aluminum adjuvants and asthma. In fact, one of the authors of the 2023 study has celebrated the results of the latest Danish study, and stated that it should give parents confidence that vaccinating their children according to schedule is safe.

Dr. Osterholm: In many ways, this is an example of science at its best. Asking questions, even if sometimes are uncomfortable. Conducting a thoughtful study or experiment to investigate, and following where the data takes us. However, in this case, we're also seeing individuals and groups with a history of anti-vaccine views mobilize and call the study into question. Now, in some cases, critiques of the study have been reasonable and are worthy of further scientific discussion. For example, questioning certain methodological decisions or pointing out that Denmark's childhood vaccine schedule does differ slightly compared to the US schedule. In that regard, I think the study authors have gone above and beyond in terms of explaining their methods, responding to the scientific questions and critiques. However, in many cases, the responses have been fairly dismissive or have even accused the researchers of intentional misconduct. Of course, one thing that has been latched on to is a correction made to the original publication, which updated supplementary material. It turned out that the wrong table got submitted with the paper for publication. When the correct table was then submitted and added to the paper, the results are exactly the same. There was no difference, but somehow individuals, including those connected to the Children's Health Defense came forward saying ha! The data has now been manipulated, which is just simply not true.

Dr. Osterholm: The critics have pointed out what they suggest are statistically significant associations with things like autism. However, a closer look at their claim show that they selectively cherry picked a single subgroup from the study with very small numbers, which makes it look like there's a clear risk. Even more challenging is the fact that several accusations and attacks have come from people in leadership positions, including HHS Secretary Robert F Kennedy, who has publicly asserted that he thinks the study was designed not to find harm and has accused the authors of being intentionally deceptive and ripe with conflicts of interest. Finally, it reached a point where the senior author of the study responded to Mr. Kennedy's accusations in a very thoughtful, detailed response, answering effectively every issue that had been raised. Suffice it to say, the reactions to the study follow a broader pattern. We've seen time and time again where instead of open, honest scientific discussions, we're seeing baseless accusations and ongoing attacks. In situations like this, it seems to be more about ideology than data, which is unfortunate. Remember, in the end, this is all about protecting our kids from life threatening infections. And here we are playing a game of disinformation.

Chris Dall: Mike, we've had some news break while we've been recording the podcast and fittingly, it is vaccine related. The Department of Health and Human Services has just announced that it is terminating $500 million in investments in 22 mRNA vaccine research projects under the Biomedical Advanced Research and Development Authority, a move that effectively ends federal investment in mRNA vaccine development going forward. In a statement, Secretary Kennedy said the decision to wind down mRNA vaccine development was made, quote, because the data showed these vaccines failed to protect effectively against upper respiratory infections like COVID and flu, unquote. Mike, what do you make of this decision and the justification and what does it mean for pandemic preparedness efforts?

Dr. Osterholm: Well, Chris, first of all, let me begin by saying that nothing should surprise us anymore in terms of these last-minute announcements that have no background preparation, no information provided other than just a declaration. And this is not the first time this has happened, nor do I think it's the last time. Let me just put this into some perspective. Having been in the public health business now for 50 years, having served the last seven presidential administrations before this last Trump administration, and having been involved with a number of international related public health challenges, including, of course, COVID. I can't think of a more dangerous, irresponsible and without basis recommendation than what we've just witnessed with the announcement from Secretary Kennedy. Number one is it fails to understand just how important mRNA technology is to our future in protecting us against other pandemics. Let me give you the example of which I highlight, by the way, in my new book coming out, the big one is the fact that globally today, our capacity to make influenza vaccine on an annual basis is somewhere right in the neighborhood of about 4 billion doses, or with two doses per person, 2 billion people. That's if we crashed it and did everything, we could to get vaccine production done. Remember, influenza vaccines today are made largely with the embryo chicken egg model. Well, imagine now being in a pandemic where in fact we don't have 3 or 4 years to get enough vaccine manufactured for the world.

Dr. Osterholm: mRNA technology holds such promise for allowing us to potentially fill the world's vaccine needs in the first year, based on the use of that technology. Now, the secretary noted that the benefits did not outweigh the risk, which first of all, there was no information provided on what his risk were or what the picture he saw. There was nothing about the benefits issue in terms of while as you've heard me say many times on this podcast, both influenza and COVID vaccines are good vaccines, but they're not great vaccines. Great vaccines would allow for durable protection over many years. They would also keep you from getting infected, let alone getting ill and potentially seriously ill. But what these vaccines do do, and we have demonstrated that. And that's how we know they've saved millions of lives. They greatly reduce the incidence of serious illness, hospitalizations and deaths. And I got to tell you, I'd take that any day of the week over even a vaccine that might not be there because some administrative decision was made not to have it. So, from the perspective of where I sit, mRNA technology has tremendous potential for the future. We already know of a number of other infectious disease research projects that are ongoing using mRNA. We also know that there are several very important studies on going right now with chronic disease, particularly cancer and mRNA vaccine technology, and to just unilaterally just dismiss this is really, I think, a totally unprofessional and lacking in evidence-based action.

Dr. Osterholm: Now, I will say that when the Secretary said that the risks outweigh the benefits of mRNA technology. Was he referring to the currently licensed vaccines also that have come out of the Trump administration FDA? Remember, originally, the authorization for COVID vaccines were made by the Trump administration, FDA back in 2020 and 21. So I find it difficult to understand the consistency and in messages from a vaccine that was heralded as being so critical to one now that the risks are outweighing the benefits. So, you can just see the illogical nature of this discussion. We need to have a system that is not left up to one individual with a very well recognized bias against a number of issues around vaccines, but particularly against mRNA technology. And we will pay a price. You know, I just remember echoing in my ears the fact that this administration has continually insisted that it wanted to be America first. Now, you know, I don't weigh into those kinds of politics. I haven't weighed into those politics. But I can assure you that should the next pandemic begin and we've not done our work on mRNA technology, the rest of the world will have done some.

Dr. Osterholm: And instead of being at the front of the line for those vaccines, we will be at the end of the line. I have no doubt about that and that at that point it will be too late to change the outcome. But we'll all realize, wow, what an absolutely irresponsible decision this was. So, for some of you may sound like I'm very harsh, I'm being political. I'm not. I'm trying to express to you on a public health scale just how absolutely challenging this announcement is. And our hope is that somehow there can be some semblance of scientific expertise brought to bear here. And let me just point out also that the NIH continues now to pursue this wholesale vaccine approach that they believe is that, you know, this is an approach that has been looked at for more than 50 years. And at this point, there is no evidence that somehow this vaccine is going to be superior, if even equal to the vaccines we currently have. So please also don't rest on the fact that somehow, you know, by ridding ourselves of mRNA technology, we will find the advantage in the work that they're now doing with other vaccines. So, Chris, I'm heartbroken as a scientist, quite honestly, I'm angry as a grandfather that this in fact decision is now compromising the potential health of millions and millions and millions of people around the world.

Chris Dall: Finally, it's time for this week in public health history. And Mike, as the person who covers antimicrobial resistance for CIDRAP news, this one is near and dear to my heart. Who are we celebrating today?

Dr. Osterholm: Well, Chris, this one should be near and dear to your heart because it is a fundamental historic moment in all of infectious diseases. I figure you'd really be excited about this one. This week's Public Health History segment is truly an inspirational story, reminding us all the value of collaboration and humility in science. Our story starts with Alexander Fleming, born in August 6th of 1881. Fleming was a Scottish microbiologist and physician best known for his discoveries of the antibiotic penicillin. Though Fleming was an incredibly skilled and hardworking researcher, the discovery came about somewhat by accident. Fleming was studying the properties of the Staphylococcus aureus bacteria when he left for a well-deserved vacation in the fall of 1928. Upon his return, he found that one of his culture plates was contaminated with mold. To his surprise, the colonies surrounding the mold were destroyed, while those that were further away from the mold thrived. That mold of the genus Penicillium transformed science and medicine as we know it. Fleming conducted additional experiments confirming the antimicrobial properties of the mold discovered. It also inhibited the growth of several other bacteria that cause a wide range of human illnesses, from diphtheria to gonorrhea. After considering the names mole juice and the inhibitor for several months, Fleming finally landed on the name penicillin. But the revolutionary impact of penicillin did not come instantaneously.

Dr. Osterholm: It wasn't until over ten years later, when scientists Ernst Chain and Edward Abraham proposed the exact molecular structure of the antibiotic, that it became closer to the drug we know today. Upon the publication of the results, Chain’s Department and head Howard Foley informed him that Fleming would be visiting to discuss their findings. Chain reaction to a surprise, stating Good God, I thought Fleming was dead. Soon after, scientist Norman Heatley suggested a way of transferring the active ingredients of penicillin in such a way that significant production of the drug for animal and eventually human testing could occur. Despite Fleming's invaluable contribution to his work, which earned him, along with Chain and Florey, a Nobel Prize in 1945. He remained humble, calling his contributions to the discovery of penicillin the Fleming myth. But Sir Henry Harris, an Australian professor who studied under Florey, summed it up best without Fleming, no chain, without chain, no Florey, without Florey, no Heatley, without Heatley, no penicillin. This was an incredible team effort, and the humility shown by all involved represented the best of science and humanity. It is estimated today that over 500 million lives have been saved by penicillin. This is truly one of the greatest public health achievements of the last century.

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

Dr. Osterholm: Well, Chris as you can appreciate my top three issues of have surely changed in the last few hours as we've learned more about Secretary Kennedy's decision to rescind any additional funding in BARDA for mRNA technology. That has to be the number one take home. This is a dangerous road we're taking. It is not based on science of any kind. It continues to misrepresent to the public just how good these vaccines are and what they can do. And, you know, as I've said time and time again, vaccines are really, really important, but they don't become the ultimate importance until they become a vaccination. And at this time, if I were in the public and not knowing more, hearing what Secretary Kennedy just said, I would think, oh, well, I'm not sure I want to get these vaccines anyway. This is so dangerous. Now, the second thing I would just say that we have to stay on top of what's happening with federal support for research for state and local public health agencies, etc., and the unknown is something that's really challenging. Almost every week we have some new major decision about somebody is going to get funding or now they're not going to get funding.

Dr. Osterholm: You know, a temporary restraining order is removed, whatever, and we'll try to stay on top of that. And finally, the third piece is just COVID. I don't know where COVID's going to go right now. I do think we're going to see an uptick in cases. As I pointed out earlier, I don't think it's going to be a major uptick in cases. But the challenges around COVID and vaccine are a real issue. Should you go and get your COVID shot now, for those particularly at high risk for serious illness, hospitalization and death, when in fact there may be a new one coming down the pike? As I pointed out, we don't know when that new one might show up. So, in conclusion, I would just say I would surely consider getting a booster dose if it's been more than six weeks. If you start to see case numbers really shoot up and not wait for what may not show up in terms of new vaccines.

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

Dr. Osterholm: Well, Chris, this one is a very, very special song. This is more than a golden oldie. Okay? This is a very specific song of my heart. This week's closing song is one we use just once before on the podcast and episode 44 Hurricane Warning on February 18th, 2021. I so well remember this episode. It's been a long time since we had this one, as we're now at 193 episodes, including this week. This song focuses on an issue we discussed several times today vaccination. You may recall, for those who are true veterans of the podcast, this song was written and performed by Peter Lake, an anonymous musician who does not share his face or identity publicly. Lake wrote the song back in 2019, inspired by his mother, who had said she chose to vaccinate him with love. Though the song was not specifically about COVID-19 vaccine. Lake released the song in 2021, in light of the pandemic under the title Vaccinate with Love, dedicated to Doctor Osterholm. The song also features guitarist Richard Fortis of Guns N roses and drummer Charlie Drayton. The opening words of the song were A message I have shared at the end of one of my podcasts, and royalties from the song directly supported the Frontline Family Fund, an effort to support families of healthcare workers who died of COVID. Thank you. Thank you. Thank you, Peter Lake, for your incredible music and for the support of the Frontline Families Fund. So here it is. Vaccinate with Love by Peter Lake. Be kind. Please be kind. Even when it's hard to be kind. Be kind. Be tolerant. This is our COVID year. We're going to get through this. We just have to get through it with as much grace in class as possible. Be safe. Be kind.

Dr. Osterholm: Can't touch me now. That life strike skips me no harm. I'll tell you why I did not cry. Your love. It fortified my heart. I'm floating here, I told you. Fill me with that cure. Vaccinate with love. Shield me. Vaccinate with love. It's getting real. Vaccinate with love. Vaccinate with love. Vaccinate. Don't hesitate. So, touch me now. No light. Strike into my arms. I'll tell you why I did not cry. Your love. It fortified my heart. I'm floating here I told you. This is me. Vaccinate with love. She'll be vaccinated with love. Let's get it real. Vaccinate with love. Your true. Vaccinate with love. Vaccinate. Don't hesitate. Touch. Me. Vaccinate with love. Inject me. Shield me. Vaccinate with love. Vaccinate with love. Vaccinate with love.

Dr. Osterholm: Thank you everyone for joining us again this week. I hope you're able to get some of the information you're looking for. As surely as a difficult, if not crazy time in public health. But we're in it for the long haul, and all I can say is that your support means everything to us. As I've said time and time again, our work here at CIDRAP is obviously challenging. We will bend and we will bend, but we will not break. And let me just say, by far, this is one of the most important efforts I've ever worked on in public health. And we're going to stay the course. So, thank you. I hope you have a good two weeks. Be kind right now if you can be kind. And just remember, we'll be back. 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.