Episode 198: Gaps in the Safety Net

Chris: 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 Dahl, reporter for Cidrap news, and I'm your host for these conversations. Welcome back, everyone, to another episode of the Osterholm Update podcast. We've had a heavy focus on vaccines in recent episodes, and with good reason. In our last two episodes, we've discussed the changes made to a CDC website page on vaccines and autism and the recent decision by Health and Human Services Secretary Robert F Kennedy Jr's hand-picked Advisory Committee on Immunization Practices to limit the use of the hepatitis B vaccine in newborns. But if you thought the Trump administration and Kennedy were done taking a sledgehammer to the US vaccine infrastructure, the unfortunate reality is that they might just be getting started shortly after the ACIP meeting ended on December 5th. President Trump signed a memo to Kennedy and the acting director of the CDC to review the childhood vaccine schedule and consider recommending fewer shots to align with what other developed countries do. Then last week, an HHS official told The New York Times that the Food and Drug Administration was expanding its review of deaths potentially linked to Covid vaccines. This broad assault on vaccine access, as Doctor Osterholm has called it, is among the many topics we'll be covering on this December 18th episode of The Osterholm Update. We'll also discuss some recent studies on efficacy of Covid vaccines. The emerging respiratory virus season. The accelerating US measles outbreak, the infant botulism outbreak linked to powdered infant formula, and two new antibiotics for gonorrhea. We'll also answer an ID query on New World Screwworm and bring you the latest installment of This Week in Public Health history. But before we get started, we will begin, as always, with Doctor Osterholm's opening comments and dedication.

Dr. Osterholm: Thanks, Chris, and welcome back to the podcast family. It's very special to have you with us on this last podcast before Christmas and during the time of Hanukkah, we've really very, very much welcome the chance to share this one last time with you. Also, for those who are new or have only listened to us occasionally, I hope that we're able to give you what you're looking for and that in this holiday season, with so many things going on, there's something in here worth listening to. Now, as I have in every previous holiday related podcast, I've noted that these are the best of times and the worst of times. You know, having been raised in a family where food was often a gift, not a everyday expected event, I know what it was like at Christmas time to be alone, to be afraid, to be concerned. And I've also had the opportunity, as I've grown older, to spend wonderful Christmases sharing it with children and grandchildren and my partner, and feeling the very best of life. So I do understand wherever you're at today, we're with you. And for those that are having a hard time right now, we're here. Think of us as being your partner, even if we're not necessarily physically there. We're here. And for those having a great time, hey, celebrate. This is a wonderful time to live life.

Dr. Osterholm: Anytime you can celebrate the holidays, it's a special time. Having said that, let me get to our opening comments today. Yep. It's true. December was a month that we associate with family connections and gatherings. At least for most of us. It's a month we try to slow down, although sometimes I think we're even busier. It's also the time in which you love to spend moments with your loved ones. We are here today to surely celebrate the holiday season. So as I reflect on what this holiday season means, the month of December also means something very special to me and has for a number of years. It's within the spirit that I just talked about that we recognize December as Global HIV Aids month and December 1st as worlds Aids day. Established in 1988 by the World Health Organization, world Aids day became the first global Health Awareness Day with the mission of bringing visibility to the HIV epidemic, to remembering the lives lost, and to stand in solidarity with those living with HIV, and to remind the world of the importance of care, compassion and activism. This time of year has carried deep meaning for communities affected by HIV and Aids. It has been a moment to mourn and to honor chosen family members, to acknowledge the resilience of survivors, and to recommit ourselves to a future rooted in dignity, access to care and justice.

Dr. Osterholm: The red ribbon has become a global symbol of remembrance, love and resistance to stigma or shame. This year, that remembrance carries additional weight. Funding for HIV Aids programs has been reduced, prevention and treatment initiatives have been scaled back, and health workers have been called home from the field, interrupting life saving, outreach, testing, education and care. Remember, this comes at a time too, and we've made some amazing advances with the drugs that now make it possible for someone to live longer and healthier lives with HIV. We're now taking those away. These cuts tremendously slow progress. They widen gaps in access, and they place global goals for HIV prevention and control further out of reach, particularly for the most vulnerable communities. At a time when the world has the tools to end this epidemic. And for the first time since world Aids day began in 1988, the white House did not formally recognize the day, breaking a long standing tradition of national acknowledgment. And yet, we know this movement has never waited on a single institution. It lives in communities and families, biological and chosen, and in this shared responsibility we carry for one another. So today we dedicate this episode to those who we've lost. Those living with HIV, the workers and the advocates whose efforts continue despite uncertainty, and the communities holding one another up when systems fall short.

Dr. Osterholm: As we gather in this season of connection, we remember that care and community must extend to everyone always. That should be our holiday message. Now, let me make the transition to what is actually a very interesting time in our sunlight episode. I've heard from a number of you this past week. You're taking a bit more interest in the sunlight issue as it relates to this time of the year, and you're noticing some big differences in sunlight in your community. Today in Minneapolis Saint Paul, the sun rises at 7:46 a.m.. It sets at 4:33 p.m.. That's eight hours, 46 minutes and 30s of sunlight. I'm very happy to report that today actually begins the march with the longer afternoons on December 17th. Yesterday the sun set at 432. That's the earliest it sets in all of the year. Today it's set at 433 and it's going to keep getting longer. Now, it's also notable that we will be at eight hours and 46 minutes of sunlight today. Think about the fact we're on our way, marching back to June 20th, when in fact will be at 15 hours and 36 minutes and 50s of sunlight. Now, some of you may ask, well, wait a minute. If the sunlight is getting longer in the afternoon, why is December 21st the shortest day of the year? Well, it's the shortest day of the year because between now and January 5th, we'll continue to see the sun rise later each morning.

Dr. Osterholm: And it was actually on January 5th, when the sun rise will actually get to be earlier and earlier, and then it really starts to take off. So for all you sunlight worshipers out there, yes, these are dark days, but they're going to get better. And how about our dear friends in Auckland at the accidental Belgian Beer House in Vulcan Lane? Today? Your sun rises at 5:56 a.m., sun sets at 8:38 p.m.. That's 14 hours, 41 minutes and 13 seconds of sunlight. You're gaining about 14 seconds of sunlight a day for the rest of this week. And then guess what? You start getting darker. Now, one last perspective. If you think these days are dark in the Northern hemisphere and it's hard to imagine living like this year round. Think what it's like in Prudhoe Bay, Alaska today. They have no sunrise. The best they get is nautical twilight, roughly from 9 a.m. until early afternoon. They do not see the sun. It never gets above the horizon. So, you know, it could be worse. Just know our sunlight is returning. That's exciting.

Chris: Mike, I want to start with this memo from President Trump, issued shortly after the ACIp meeting to review the US child immunization schedule and align it with, quote, other peer-developed nations. This is an idea that several ACIP members talked about with a lot of comparisons made to the schedule in Denmark. Is there any validity to comparing our vaccine schedule to those of other peer nations, and what shots would no longer be recommended if we were to have a schedule like Denmark's?

Dr. Osterholm: Well, Chris, let me just be really clear. The short answer to your question is a simple no, no, no and no. There is no validity to comparing our vaccine schedule to most other nations. This is because when it comes to our healthcare system, we simply differ too much from our peers in a number of very critical ways. First, most high income countries have universal healthcare systems, meaning that all people have access to affordable prenatal care and screening. We don't have that. Further, European employment policies reduce the barrier of prenatal care due to inability to take time off of work, which is a reality of most Americans. Additionally, the US is far more geographically dispersed compared to many European countries, so traveling to appointments is much more likely to be a barrier than it is in Europe. Denmark has nationalized healthcare in addition to universal healthcare, meaning that the entire country uses a single record system, which means that hepatitis B screening results are readily available across all hospitals and clinics here in the US. Results from one healthcare system may not be accessible at another, which means clinicians may not always be aware of a pregnant woman's hepatitis B status, even if they had access to prenatal screening. Children in the US are also much more likely to enter daycare to younger age and be vulnerable to infectious diseases there, as we lack the same paid parental leave policies that are widespread in Europe. In short, as I said in the New York Times last week, we don't have Denmark's healthcare system.

Dr. Osterholm: They have a safety net that we don't have. Our net is full of big holes. Therefore, it's impossible for us to achieve the same kind of protection for all women with hepatitis B infection and their unborn child in this country, like they can do in Denmark. To put it simply, Chris, we just shouldn't compare other countries vaccine schedules to the US schedule because other countries have vastly different healthcare infrastructure. Meaning when can children access the system? How well will they be followed in accessing the system, and will the appropriate vaccines be given on time and the records provided so that we'll always know what vaccines the child needs. Now, moving on to the second part of your question. What shots would no longer be recommended if we adopted a schedule like Denmark? In addition to hepatitis B, Denmark also does not recommend hepatitis A, varicella, or rotavirus vaccination. Let me be clear. They don't recommend them, but they're surely available. Well, these may not be as consequential as infections as polio or measles. They still at best create significant challenges for parents who must take time off of work to care for their children, and at worst, can still cause severe disease in rare cases. I hope that we can drop the European comparisons because until we have a social and healthcare infrastructure with a very comprehensive safety net, we just can't expect that our vaccine recommendations are going to effectively control diseases like hepatitis B as a result of exposure to an infected mom.

Chris: Mike, I want to ask you about some recent news, and it doesn't come as any surprise, but the CDC has now officially adopted the recommendation by ACIP for parents to use individual-based decision-making about the birth dose of the hepatitis B vaccine. This was a decision that was made despite no new safety data about the birth dose, and without regard to the benefits of the birth dose of the hepatitis B vaccine. Your thoughts?

Dr. Osterholm: This decision was not a surprise. This script was written well before the ACIP ever met. We knew they wanted to limit hepatitis B vaccination of children following delivery. This decision just reaffirms the fact that this ACIP will continue to do whatever they can to discourage, if not eliminate, the possibility of vaccination. And I think it's something that we just have to recognize that the current ACIP is scientifically corrupted and you cannot trust anything that comes out of there, or for that matter, what comes out of CDC. Related to the ACIP meetings?

Chris: Another item that I did not mention in the introduction was a petition from anti-vaccine group Children's Health Defense, a group founded by Kennedy to FDA Commissioner Marty McCarthy to revoke the licenses of Pfizer and Moderna's Covid vaccines. Mike, is that something the commissioner would even have the power to do?

Dr. Osterholm: Well, Chris, this is a frustrating situation, particularly given that our extensive reporting showing that these vaccines, while not great vaccines, are good vaccines. They provide meaningful protection against hospitalizations and death even if they don't prevent infection or some illness. Setting aside the misinformation that CHD is promoting about vaccine safety and effectiveness, the practical and legal implications of revoking an existing vaccine are much more complex. The short answer is yes. The FDA commissioner does have the authority to initiate a license being revoked, but only through a formal legal process with some specific conditions being met. One of the other areas that they can do is limit the vaccine's use, even though it is still available. We are fearful that that will be a reality in the near term. The FDA has made public statements to the effect that they're going to issue a black box warning for Covid vaccines, which is a warning that suggests that there is a real risk of serious illness and even death using this particular vaccine. This would be a tragedy because it surely is not supported by the data that we have. As a reminder, the FDA reviews the safety and efficacy of vaccines before they enter the US market and continues post-market surveillance to monitor real world effectiveness and possible safety concerns. Over time, the FDA can revoke licenses and remove vaccines from the market if new and compelling evidence shows that a product does not meet safety or potency standards. Let me just point out that the actual monitoring of vaccine safety is something we take very seriously in this country.

Dr. Osterholm: And despite the fact that Children's Health Defense suggests that it's haphazard or doesn't exist, and that we don't take vaccines off the market, that's just not true in my lifetime. I watched in 1976 with the swine flu influenza program. An association between that vaccine and Guillain-Barré syndrome not only brought the national vaccine program to a screeching halt, that vaccine was pulled off the market. Then in 1998, we saw a situation with rotavirus vaccine, the one at that time that is in fact the 1998 version, not the current one. That vaccine was associated with blockage of the intestinal tract of young children. That was removed. And then in 2009, we had an episode with the pandemic H1n1 vaccine in Europe, a vaccine only available there that resulted in increased risk of narcolepsy in individuals. That vaccine was removed in 2010. And then finally in 2020, we had the J&J situation with the blood clots with the Covid vaccine. I point all these out because they demonstrate the kind of monitoring that was in place to quickly pick these kinds of situations up so they could surely lead to a vaccine being removed because of an acute event. But do I see that in fact, there are any data support? The Covid vaccines should come off right now. Absolutely not. So for them to do this, the FDA is going to have to have concrete evidence of harm, not speculation, which is all they have now.

Dr. Osterholm: Chris, you actually reported on a recent incident also happening back in August when the FDA removed a previously licensed vaccine after post-market data reveals some real, genuine safety concerns. In contrast, the CHD petition just does not stem from any reliable evidence of harm. So what can be done if the FDA chooses to move towards revoking the license of these vaccines? First, the FDA commissioner would need to formally notify the manufacturers of their alleged safety concerns and intent to revoke their license. Then, an administrative adjudicator, a member of the executive branch, would oversee a hearing with the FDA and manufacturers to present each of their evidence and arguments. If the case from the FDA seems especially weak, manufacturers may pursue further legal action. Even if manufacturers did not challenge the decision, medical society, states or community groups may be able to provide their own legal challenges. One of the points also that is really missed in this discussion is the concept of risk. You know, there could be several deaths in children due to Covid vaccines that are related to some kind of adverse event, particularly a potential myocarditis. And we can focus on that. But if these same vaccines saved several thousand children from becoming seriously ill or dying because they in fact prevented that myocarditis, how do we weigh the benefit? I've used this example before, but think of the individual that's in an automobile accident and their seatbelt sticks. They can't get out, their car catches fire and they burn to death.

Dr. Osterholm: What a tragedy. What a horrible situation. But would any of us say we have to eliminate seatbelts at this point? Because in fact, how many lives they do save every day? No, we would never automatically just assume. Therefore we shouldn't use seatbelts anymore. If these vaccines do cause harm, we want to know that if it's significant harm in terms of numbers and serious health outcomes, that's an important piece of information, but then that's also got to be put up against what are the risk factors for that particular vaccine relative to the prevention of serious illness and outcome, serious illness, hospitalization versus causing that? And right now, there is none of that discussion in the FDA, which just demonstrates their inability to really understand basic epidemiologic principles. So while I'm concerned about potentially losing the licensure on these vaccines, I want to be clear that it's not the only way we lose access to protection from Covid 19. The federal government is also reducing vaccine access and uptake by continually spreading misinformation, making recommendations very unclear and cutting public health programing that provides critical access. Many of us in public health saw this coming from a mile away. When Mr. Kennedy was elevated to the highest level of health policy leadership in this country. I want to applaud all the individuals and organizations that continue to fight for evidence based public health, whether that's in the clinic, in the courtroom, or even in the classroom. We need you all more now than ever.

Chris: Ironically, the petition to pull the Pfizer and Moderna Covid vaccines came the same week as a large study in France on Covid vaccines and mortality rates and a study by the CDC itself on the effectiveness of Covid vaccines in US children. Mike, what did we learn from those studies?

Dr. Osterholm: Last week, The New York Times reported that without any evidence, the FDA had expanded its investigation to deaths possibly tied to the Covid 19 vaccine, to include adults as well as kids. Already under the Secretary's guidance, the federal government has scaled back its Covid 19 vaccine recommendation. And late last month, Vinaya Prasad, director of the FDA's center for Biologics Evaluation and Research, spurred the inquiry into deaths by claiming without evidence that Covid vaccines killed ten children Despite the fact that this information was provided in November, there has been absolutely no verification of this information in the public since that time. That claim from an internal memo in the FDA, which we are certain was meant to be leaked, triggers a swift rebuke from former FDA commissioner, US congressional representatives and a broad swath of scientists and vaccine experts who cited that Prasad's memos inaccuracies, misinformation, unsupported claims regarding the agency's regulation of vaccine, and asserting an unproven link between Covid 19 vaccine and pediatric deaths. As we've already noted, the Children's Health Defense calls to pull them from the market, which would be a public health catastrophe. Kennedy and the FDA staff ignore the fact that Covid infection is far more likely than vaccines to cause severe disease and death. The vaccines are credited with saving millions of lives and averting severe illness and death during the pandemic. Sadly, the data tell us that fewer people getting vaccinated will mean more, will get gravely ill, need hospital care, and die unnecessarily of Covid. As you noted, Chris, in just the past week, a number of studies were published showing the importance of Covid vaccination in preventing poor clinical outcomes. A national study from France, published in Jama Network Open, found that Covid vaccination was linked to a 74% lower risk of Covid death and a 25% lower risk of death from any causes for four years.

Dr. Osterholm: This is a remarkable finding. In another study, this one in Morbidity Mortality Weekly Report, CDC researchers estimated that last season's Covid vaccines were 76% effective against severe illness in preschool kids. They also cut the risk of an emergency room, department or urgent care visit by 56%. Remember, these are kids. These are the ones that we keep hearing aren't at all ever at risk of serious illness. And yet look at the amount of serious illness these vaccines are preventing. And finally, a large study from Israel in the International Journal of Infectious Diseases suggested that hospitalized Covid survivors were at a 69% higher risk of death than their uninfected peers for at least two years. The W.H.O. also released a new analysis finding no link between vaccines and autism. Not a surprise. On top of that, our own Cidrap Vaccine Integrity Project recently conducted a review of more than 500 published studies on Covid, flu and RSV vaccines, which concluded that they have reassuring safety profiles consistent with those of previous evaluations. You can find that report on our website. So despite an abundance of data demonstrating the safety and efficacy of Covid vaccines and Mr. Kennedy's promise not to take them away, we are in danger of losing access to them should Macari revoke their licenses. Initially, vaccine access may be restricted to off label use that may require a prescription and insurance coverage dropped, meaning the cost would be out of pocket. Of course, the decision will likely be followed by lawsuits from healthcare associations and vaccine manufacturers. All of this not only creates confusion for patients, healthcare providers and families, it seriously undermines Americans trust in vaccines that could save their lives. And that is simply a tragedy.

Chris: One more item here that's linked to the administration's attacks on vaccines. And I promise our listeners, this is the last question for this episode at least. But Reuters reported last week that the FDA is also going to review the safety of two recently approved preventive therapies for respiratory syncytial virus, RSV. These two products are called fortaz and emflaza. These are monoclonal antibody therapies that have helped reduce RSV hospitalizations in infants and have a good safety record. Mike, what is this based on?

Dr. Osterholm: Yes. Chris reporting last week surely indicated that the dominoes begin to fall when senior FDA adviser Tracy Beth Hoeg, a political appointee, began to raise questions about the safety of RSV therapies as early as June. These internal discussions then prompted the FDA's center for Drug Evaluation and Research to have a call with the three pharmaceutical companies that produce the treatments Merck, Sanofi, and AstraZeneca. This meeting was supposedly to tell the companies to expect further safety questions from the office of the FDA Commissioner, Marty Makary. Reuters sources indicate that the tone of the call was very serious, though brief, and did not specifically address the data, which would be requested to investigate. Safety concerns by Fortis given to infants to protect from RSV, was approved in July 2023 and influenza in August of this year. As you mentioned, Chris, both therapies are monoclonal antibody based. This kind of protection is extremely important because while traditional vaccines may take a few weeks to produce the protective immune response, monoclonal antibodies work nearly immediately. It is critical to prevent RSV infection in infants because it commonly progresses to severe illness involving breathing problems and pneumonia, which may become life threatening. Annually, 2 to 3 out of every 100 infants under six months of age in this country are hospitalized with RSV.

Dr. Osterholm: These therapies are effective against severe outcomes for by Fortis. It reduced hospitalizations by 43% and have demonstrated strong, strong safety profiles. All of these considerations led the anti RSV monoclonal antibody therapies to be incorporated into recommended childhood vaccine schedules. So why is the FDA trying to churn up doubt surrounding these life saving products? I've learned to stop trying to apply reason to unreasonable arguments, but I am I'm confident this is just another step in this administration's efforts to undermine trust in science and to limit access to vaccines for their own personal agendas. Of note, Hogue was just appointed acting director for the center for Drug Evaluation and Research on December 3rd. The FDA press release features quotes from both Makari and Hogue, promising transparency, honesty, and rigorous science as the center is, quote, fully modernized. But since the administration has taken power, we have little evidence to support any belief in these lofty and vague claims. This is exactly why the Vaccine Integrity Project will be there. We will continue to very closely monitor this situation and push back wherever we can, and with whatever means we need to.

Chris: Since we're on the topic of respiratory viruses, let's talk about our emerging respiratory virus season. And for listeners out there who think that I may sound like I'm coming down with something, I think you might be right. But I want to start with flu, which has hit the United Kingdom and Japan quite hard. Are we seeing that type of activity here yet?

Dr. Osterholm: Well, to the listening audience, I must tell you, the Chris I think does have the early stages of a developing respiratory infection. He happens to be isolated in his recording area in his home. So I just want to report to you he's not putting anyone at risk, but he is a brave man to be doing this today. And so for all of you, I hope you will take a moment to think of Chris and the fact that his work is never done, even when he's sick with one of these respiratory illnesses. So to answer your question, Chris, we've had a much slower and later start to the flu season than usual. And also compared to other countries around the globe like the UK and Japan, which had earlier and more severe starts that are season than usual. As I said in our last episode, we were being given a grace period to go get our flu shots before activity inevitably increased. But unfortunately, Chris, that grace period is almost now over. So please. This is the last week. I think you can get your vaccine and hope to have much protection. Last week, 3.2% of outpatient visits were for influenza like illness, which is above the national baseline of 3.1% for activity to be considered high. Test positivity has increased now at 8.1%, up from 5%, which we reported on during our last episode. Wastewater concentrations are still low but increasing across the country. It is notable that four states Colorado, Louisiana, new Jersey and New York are considered high. And we are hearing, particularly in the New York region, of a number of seriously ill cases and increased hospitalizations. To note, in addition to those four high states, eight are now considered moderate Ed visits and hospitalizations continue to increase as well.

Dr. Osterholm: Laboratory confirmed influenza hospitalizations are highest in the 65 and older age group, followed by the 0 to 4 year olds. Sadly, since our last podcast, we've had our first pediatric death of the season. One additional pediatric death from last season was also reported last week, bringing last season's already record high number of pediatric deaths to 288 children, 288 children died last year from flu. Very few of those kids had previously been vaccinated. The vast majority of US influenza cases are caused by the H3n2 strain of the H3n2 viruses that were sent for further genetic characterization. 89% were this new subclade K that we discussed a few episodes back. If you remember, subclade K is an antigenically drifted version of H3n2 virus that was selected to be targeted in our vaccine, which was called subclade J. This raised both questions and concerns about how effective our vaccines would be this season, especially because compared to the H1n1 dominant seasons. H3n2 dominant seasons historically caused more severe illness, especially in the older age populations, and vaccine effectiveness is typically lower. Early data from England estimates our vaccines are now 70 to 75% effective against hospitalizations and kids, and only 30 to 40% in adults. While this is lower than we'd like it to be, it is still much, much better protection than no vaccine at all. Flu season is here, and while the pediatric population may see a less severe season than an H1n1 season, that is not the case for adults. So please, please, please get your flu shot if you have not already done so. These vaccines remain the best tool that we have to reduce serious illness, hospitalizations and deaths.

Chris: And how about Covid and RSV?

Dr. Osterholm: Covid activity remains low, but we are starting to see some initial signs that may be starting to increase. Wastewater levels are low but increasing in every region of the west. Concentrations are highest in the northeast, which is considered moderate. 11 states now fit into this moderate category. Connecticut, Nebraska, and Vermont are all considered high. In Indiana is very high. The remaining states are all low or very low. Hospitalizations are increasing slightly, while Ed visits are steady at about 0.4%. Test positivity is also increased at 3.6% last week, compared to 3% a month ago, which was the lowest it had been in over a year. The CDC is only providing monthly variant updates. There is nothing new to report that since our last episode, the FCG makes up 70% of the cases and FCG 14.1 accounts for 10%. In short, nothing is really changing with the virus. Now what does this all mean to you in terms of infections? I think you're watching another wave of Covid begin to build, and I wouldn't be surprised that sometime in the next six weeks or so, we start to see major Covid activity increase in this country. Another message get your vaccine. The RSV picture sounds similar. Activity is low but increasing. The national RSV wastewater concentration is considered very low, but increasing in both the South and the West. Kentucky is considered high and Louisiana and Wyoming are both very high. Test positivity is increasing at 2.9%, up from 1.5% a month ago. Ed visits and hospitalizations are low but increasing, especially among 0 to 4 year olds. Remember that picture we just talked about with RSV, and what you can do to assure that your child or grandchild does not experience serious illness. Overall, it has been quite a period for respiratory viruses, but it's not a period that I expect to last much longer. The metrics are increasing across the board, and we're in the midst of the holiday season as families are gathering and people are traveling. The best thing you can do is get your vaccines. Stay home when you're sick and don't let your guard down. Get ready.

Chris: We've been talking about measles all year, ever since the large outbreak in West Texas began last January. Measles cases slowed in the summer, but they have really picked up again, especially in South Carolina and along the Utah and Arizona border. What's going on in those two spots?

Dr. Osterholm: Well, as we close out this year, it is striking to look back to January and remember how alarming it was to see this monumental outbreak unfold in West Texas. It quickly surpassed recent records from measles in this country, and reminded all of us that even once eliminated infectious disease, threats are still a risk without widespread vaccination globally. Although that major outbreak has slowed, the threat of measles in the United States is far from over. As you mentioned, Chris, there are substantial outbreaks occurring in South Carolina and along the Arizona Utah border. The common thread between these outbreaks are pockets of low vaccination that can make one case take off, like a wildfire in upstate South Carolina. The most notable outbreak began in early October, and case counts have continued to accelerate. Transmission has been linked to exposure at a church in multiple school locations. As of December 12th, there are 126 confirmed cases associated with the outbreak. 11 schools with possible exposures and more than 300 people are currently in quarantine. Most cases have occurred in school aged children between 5 and 17 years of age. One of the first schools identified with a case, a K-8 charter school, reportedly had an MMR vaccination rate around 40%, far below the level needed to prevent any kind of sustained transmission. State and local public health are closely monitoring cases and running mobile clinics to improve MMR vaccination rates.

Dr. Osterholm: Importantly, community members have reportedly been cooperative with isolation and quarantine guidelines, and are making some slow progress towards improving vaccination rates. The measles outbreak in the southwest also has taken hold in a community with alarmingly low vaccination coverage. Cases began in the town of Colorado City, Arizona, where one of the implicated schools had a kindergarten MMR vaccination rate of 7%. Let me repeat that 7%, not 70%, but 7%. When the measles virus finds a vulnerable pocket like this, rapid transmission is inevitable. The border between Arizona and Utah has reported an estimated 250 cases. It is home to a long standing fundamentalist polygamist religious group that has been extremely insular for years. Community norms, shaped by the teaching of a leader who is now imprisoned, discouraged engagement with outside institutions, including doctors, and explicitly opposed vaccination with family size sometimes greater than 20 children. This distrust has made a lasting impact on local health infrastructure. In fact, one nearby clinic actually stopped purchasing MMR vaccine years ago because all the doses would expire before having a chance to be used outside of this more isolated community. Utah wastewater surveillance in nearby areas have also identified measles viruses, signaling a wider spread in the region. This is surely something to watch closely.

Dr. Osterholm: Let me just make a crystal ball prediction here of what is about to happen in this country, and I hope that I'm really wrong with this. I will be the very first to not only acknowledge that, but celebrate it. And that is, if you look at where Canada was a little over a year ago, there were approximately 110 cases of measles reported in Canada at this time. Remember, Canada only has 40 million people compared to our 340 million people, which means our population is eight and a half times larger. Now. Canada's 6000 cases for this year could be where we're at next year, because we seem to be about one year behind in the epidemiology of the spread of measles in each country. Imagine if we actually saw not 6000, but 6000 times eight. That's not something that is just scary information. That would be the Canadian outbreak now imposed on US demographics. And I think that's really a possibility. I hope I'm wrong. I hope it doesn't happen. But we have to understand the days of outbreaks of a couple of cases which were at one time. Every fire alarm rang. Everyone went running to the measles fire. Think of what it would be like if, in fact, we were talking about many thousands of cases every year.

Chris: Mike, we've talked about the outbreak of infant botulism linked to powdered infant formula on the podcast recently. Do you have an update for us?

Dr. Osterholm: Well, as of December 10th, we are now up to 51 infant botulism cases from 19 states. Thankfully, no deaths have been reported. All but 51 infants have required hospitalization. The large jump in cases since our last outbreak is mostly due to CDC investigators updating the date range in the outbreak case definition, which they did in collaboration with the California Department of Public Health's Infant Botulism Treatment and Prevention Program. Now, the date range for outbreak linked to the by infant formula goes all the way back to December 2023. You might be wondering if infant botulism cases in this outbreak date back to December 2023. Why did it take public health officials nearly two years to determine the source of this outbreak? Well, to be frank, I think we have to go back and look at this one very carefully. This should have been one I believe, that we could have picked up earlier. Why? Because, first of all, infants aren't eating lots of different food. If you're on infant formula, you can already assume that there's going to be a limited number of food items that that infant is consuming, and therefore just assessing a case of infant botulism. Food history would likely turn up after even several cases at most the buy infant formula.

Dr. Osterholm: Ty again, this is a product that had a very, very small percentage of the market share. And so I do hope we go back and take a look and see why did it take us so long to pick up these cases? And what can we in local and state public health do to improve on that issue? And let me just conclude this discussion by saying, the good news is that by heart has recalled all infant formula products back to November. I hope based on this particular new updated data on cases, they actually even look for possible product that's still in people's shelves that date even before November. The message is clear that public health officials recommend that all parents and caregivers immediately stop using any remaining by heart infant formula products, if in fact they are in possession of them. We hope that these public health measures are enough to put an end to this outbreak. Symptoms of infant botulism can take several weeks to develop, so caregivers should stay vigilant. We promise to keep our listeners updated with any new information as it becomes available. And I want to thank all of those who wrote to us about this very important public health issue. This was such an unfortunate situation.

Chris: Mike, I mentioned two new antibiotics for gonorrhea in the introduction, and this is another topic that I'm going to handle since this is an area that I have been covering for Cidrap news. So why is this worth discussing on the podcast? Well, globally, gonorrhea is one of the most common sexually transmitted infections, with more than 82 million cases a year. And for the last four decades, treatment for gonorrhea has relied on the antibiotic ceftriaxone, either in combination with other antibiotics or on its own. This has become a problem over the last decade, as the bacterium that causes gonorrhea has become increasingly resistant to ceftriaxone, particularly in countries in Southeast Asia, but really in every country. In fact, ceftriaxone is just one of several antibiotics that gonorrhea has become resistant to. And until this past week was essentially the last remaining acceptable antibiotic option, which raised the prospect of untreatable gonorrhea infections. If left untreated, gonorrhea can cause pelvic inflammatory disease in women and infertility in men and women. It can also increase the risk of ectopic pregnancy, which is the implantation of the fertilized egg outside the uterus, and it can increase risk of HIV infection. This is why the W.H.O. has labeled drug-resistant gonorrhea a serious and urgent public health threat. But last week, the FDA approved two new antibiotics for gonorrhea zoliflodacin and gepotidacin. Both of these new antibiotics are oral, as opposed to ceftriaxone, which is delivered via injection, and both are entirely new classes of antibiotic that use different mechanisms to kill the gonorrhea bacterium than other antibiotics that have previously been used.

Chris: So that means the bacteria have never seen these drugs before, which is important because gonorrhea is notorious for developing resistance to antibiotics quickly. And a lot of the antibiotics that have been used to treat gonorrhea are from antibiotic classes that the bacterium is familiar with. So these two novel oral antibiotics should, in theory, be effective treatment options for gonorrhea for decades. This is big news for sexual health, public health and antibiotic stewardship. But it's also big news for antibiotic development, which has faced numerous challenges in recent years due to the fact that antibiotics are expensive to develop but don't make a profit compared with drugs that you take for chronic conditions. Zoliflodacin, for example, was originally developed by AstraZeneca before that company shuttered its antibiotic division because of the financial challenges of antibiotic development. It could have died on the vine, but another company saw promise in the molecule, then collaborated with a nonprofit, the Global Antibiotic Research and Development Partnership, also known as Gardp, to complete the development of the drug. Gardp in fact ran the phase three trial for Zoliflodacin and in return received the rights to register and commercialize the drug in more than three quarters of the world's countries. That includes all of the low and middle income countries that often don't have access to newly approved antibiotics. So, Mike, there are many who believe this type of public private partnership will be really critical for the continued development of much needed antibiotics.

Dr. Osterholm: Well, Chris, thank you so much for that. And again, I just want to compliment you on your incredible reporting on the whole area of antibiotic resistance, antibiotic availability, antibiotic stewardship. Your reporting has really been cutting edge. And this is great news. And I think you've done a wonderful job of laying out just why it is great news. So thank you very, very much.

Chris: Now it's time for our ID query. Over the past few weeks, we've received several emails regarding New World Screwworm, a flesh eating parasitic infection that is affecting people in Mexico and has prompted action by the USDA because of its implications for the US animal agriculture industry. Mike, what can you tell us about New World Screwworm?

Dr. Osterholm: Well, even though a New World screwworm might sound like a heavy metal band, you're right, Chris, this is a very, very nasty parasitic fly that once wreaked havoc across the livestock industry. The larvae, or maggots of the screwworm fly require healthy living flesh to survive. In contrast to other fly species that are scavengers of dead animal carcasses and the decayed flesh of living ones, the disease can affect any warm blooded animal, including humans and birds, and results in significant morbidity and complications leading to death if left untreated. Oftentimes, as a screw worm burrows deep into human flesh, it actually causes a subsequent bacterial infection to also occur, which can be the reason why an infected animal or human will ultimately die. So why haven't people heard about Screwworm in the 1930s? The parasite was mostly confined to the American Southwest, but spread to the southeast after a shipment of infected livestock arrived. The outbreak devastated the cattle industry, and the USDA was flooded with pleas for help. This became a textbook case of a successful, multifaceted response. The federal government funded farmer education deployed Civilian Conservation Corps members for biosecurity and invested in research and development for better larvicides. These efforts curbed infestations, but the real breakthrough came in the 1950s with the quote, sterile insect technique, quote releasing sterilized male screwworm flies that produce no viable offspring. This strategy proved so effective that the US eradicated the disease by 1966, Extending a protective barrier into Mexico. Eventually, the government realized it was more cost effective to extend these efforts all the way to Panama. The skinniest part of the North and South American bridge, so they could form a protective barrier against a smaller area of land and stop screwworms from traveling north.

Dr. Osterholm: Working together with our neighbors to the south is essential in keeping up our status for American farmers. The benefits? These eradication efforts exceed well over $1 billion annually, however, and that is an important. However, in 2024, New World Screwworm steadily advance northward through Central America, with cases now in Mexico in both humans and animals, while cattle imports through the southern US. Ports of entry are currently suspended due to the threat of New World, Screwworm actions by the current administration will only make disease outbreaks worse. Major factors contributing to the recent increasing threat are. Inconsistent cattle import policies aimed at lowering beef prices, coupled with earlier Doge budget cuts that greatly reduced funding for USAID screwing programs without strong monitoring evaluation, the US remains vulnerable and more preventable outbreaks are likely in coming years. And I might note, we actually do have a human case now in the United States, although it was acquired in another country. I'm often asked the question, how does a screwworm fly actually introduce larvae or maggot into healthy tissue? Oftentimes it enters through a cut or an abrasion on the body, and then it deposits the eggs there, which then hatch and causing the larvae to develop. And once it's in the flesh, then it can burrow down deeper and deeper. So this is a significant issue. It's one that we surely would never have thought of it coming back anytime soon. But again, like so many other infectious diseases, we live in one global world with one potential global infectious disease challenge.

Chris: Finally, Mike, I thought you could update our listeners on a project you mentioned a few months ago, Cidrap partnership with the New England Journal of Medicine. What can you tell us?

Dr. Osterholm: Well, first of all, let me say I'm really excited to announce that yesterday we launched this joint program, Public Health Alerts, a joint effort between Cidrap and the New England Journal of Medicine. And I want to note right at the beginning of this story, how grateful I am for the support that Cidrap has received to make something like this possible during a time where funding for public health is so limited. As listeners of this podcast are well aware, the CDC is really a shell of its former self, and it can be difficult to trust if the information coming out is accurate and complete. This includes critical CDC publications like the mMWR or, as we know, Morbidity and Mortality Weekly Report that clinicians and public health professionals rely on to understand the current public health threats our country is facing. We announced a few months ago at the Idweek conference in Atlanta, that we will be launching Public Health alerts as a joint effort with the New England Journal of Medicine. Evidence. This is to fill the gaps left behind by the changes to the MMR in recent months.

Dr. Osterholm: Public Health Alerts serves as a platform to which experts can submit manuscripts or even short notes. They'll be rapidly peer reviewed and published for the public to read on both the Cidrap and New England Journal of Medicine website. All these publications will be open access and we are committed to never putting anything behind a paywall. I'm very happy to share that the first two public health alerts, which focus on mpox and influenza, were actually up on the sites yesterday. Going forward, we'll link our public health alerts in the podcast show notes each week so you can all easily access this exciting new information. We have to acknowledge we can never replace what the old CDC did, but this is a promising step in the right direction to keep public health information moving forward, despite the best efforts of the federal government to dismantle it. I am proud and humbled to be part of this team leading this incredible effort, and I in particular want to thank the New England Journal of Medicine for their very close collaboration and wonderful support.

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

Dr. Osterholm: Today we're celebrating the life and time of a scientist whose research helped the world understand HIV and Aids in a time when it was needed most. Doctor Flossie Wong-staal accomplished many things in her lifetime, but most notably, she is known as the first person to clone the HIV virus, a major step in proving that HIV is the cause of Aids. She was born in China in 1946. Fearing the Chinese Communist Revolution, she and her family fled to Hong Kong. There, she attended a Catholic school where the American nuns asked her to pick up a new English name. Taking the opportunity in stride, she named herself Flossie after a famous typhoon that hit the region. It was a fitting name, as she would later become a force in the field of molecular biology. After gaining her PhD at UCLA, she joined Doctor Robert Gallo's lab at the National Cancer Institute. The two worked remarkably well together and coauthored more than 100 journal articles. But it was in the early 1980s, when HIV was first identified, that her most influential work began. As I mentioned earlier, Doctor Wong-staal was the first to clone HIV and determine the function of its genes, a major step in proving that HIV is the cause of Aids.

Dr. Osterholm: She also discovered molecular evidence of micro variation in HIV, which led to the use of combination antiretroviral therapy to more effectively manage the disease. In addition, she provided the molecular biology necessary to develop the second generation of blood tests for HIV, improving screening and safety. Thanks in large part to these discoveries, she became the most cited female scientist of the 1980s, hoping to develop new treatments for HIV. She left the National Cancer Institute for the University of California, San Diego to launch the new center for Aids research. Her work there, building on her previous discoveries, has undoubtedly prevented cases of HIV and saved countless lives from Aids. This is why it is so important to remember Flossie Wong-staal during the HIV Aids Awareness Month, in a time when science is under attack. We need to remember the scientists who dedicated their lives to fighting HIV. It's easy to forget, but cures, therapies and treatments aren't made quickly. They're developed over lifetimes with the help of countless scientists who dedicate themselves to their field. In honoring her work, we reaffirm the importance of science itself and the responsibility we share to protect and support those who carry it forward.

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

Dr. Osterholm: Well, trying to boil it down to three messages. Let me just say that the first one covers a number of different, uh, questions we addressed tonight. And that is vaccines are under attack. Boy, are they under attack. And, uh, we will continue to stay very involved with this, particularly through our work with the Vaccine Integrity Project. We understand the seriousness of this situation and the number of lives that could be lost, literally, because of what is happening right now with regard to vaccines and the oversight by the current Department of Health and Human Services. Tragic. Simply tragic. Second of all, I just am excited by the availability now of public health alerts. Uh, this joint effort that we have with the New England Journal of Medicine, where we are full partners with them in and producing these reports. They'll be simultaneously published on both the New England Journal 11 and the Cidrap sites, and there will never be a charge for reading them. They'll always be in front of the paywall. Uh, this will now allow us to have a way to communicate quickly, in a comprehensive manner, without political editorial oversight, the important issues of the day in public health. And finally, the respiratory season is here. Unfortunately, uh, you don't really have much time. Tomorrow would be not too soon to get those shots, particularly influenza and Covid right now. So I hope you'll avail yourself to them.

Chris: So, Mike, it is that time of year and I'm guessing for our closing, we're going to be going with an oldie but goodie, am I right Chris?

Dr. Osterholm: We're going with a real oldie but goodie. I think many of you know that I had the good fortune to actually read to my children on Christmas Eve in 1985. The Polar Express. It was a book written and illustrated by American author Chris Van Allsburg. This was the first year that the book was available publicly, and I'm very, very happy to report that some 40 years later, I will again get the opportunity to read this book on Christmas Eve to my kids and grandkids. I can't tell you how much this means to me. It is one of the highlights of my entire year and frankly, collectively, the highlights of my life. There is such love and such hope expressed in that book. And to Chris Van Allsburg, to his wife, Lisa, our warmest greetings to you. Thank you, thank you, thank you for the gift you've given us.

Children: Grandpa, can you read us Polar Express? Grandpa can read this blog post.

Dr. Osterholm: The Polar Express, written and illustrated by Chris Van Allsburg. On Christmas Eve many years ago, I lay quietly in my bed. I did not rustle the sheets. I breathed slowly and silently. I was listening for a sound, a sound a friend had told me I'd never hear. The ringing bells of Santa's sleigh. There is no Santa. My friend had insisted. But I knew he was wrong. Late that night I did hear sounds, though not of ringing bells. From outside came the sound of hissing steam and squeaking metal. I looked through my window and saw a train standing perfectly still in front of my house. It was wrapped in an apron of steam. Snowflakes fell lightly around it. A conductor stood at the open door of one of the cars. He took a large pocket watch from his vest, then looked up at my window. I put on my slippers and robe. I tiptoed downstairs and out the door. All aboard! The conductor cried out. I ran up to him. Well, he said, are you coming? Where? I asked. Why? To the North Pole, of course, was his answer. This is the Polar Express. I took his outstretched hand and he pulled me aboard. The train was filled with other children, all in their pajamas and nightgowns. We sang Christmas carols and ate candies with nougat centers as white as snow. We drank hot cocoa as thick and rich as melted chocolate bars. Outside, the lights of towns and villages flickered in the distance as the Polar Express raced northward. Soon there was no more lights to be seen.

Dr. Osterholm: We traveled through cold, dark forests where lean wolves roamed, and white tailed rabbits hid from our train as it thundered through the quiet wilderness. We climbed mountains so high it seemed as if we would scrape the moon. But the Polar Express never slowed down. Faster and faster we ran along, rolling over peaks and through valleys like a car on a roller coaster. The mountains turned into hills, the hills to snow covered plains. We crossed a barren desert of ice. The great polar ice cap lights appeared in the distance. They looked like the lights of a strange ocean liner sailing on a frozen sea. There, said the conductor, is the North Pole. The North Pole? It was a huge city, standing alone at the top of the world, filled with factories where every Christmas toy was made. At first we saw no elves. They are gathering at the center of the city, the conductor told us. That is where Santa will give the first gift of Christmas. Who receives the first gift? We all asked. The conductor answered. He will choose one of you. Look! Shouted one of the children. The elves outside we saw hundreds of elves as our train drew closer to the center of the North Pole. We slowed to a crawl. So crowded were the streets with Santa's helpers. When the Polar Express could go no further, we stopped and the conductor led us outside, repressed through the crowd to the edge of a large open circle in front of us to Santa's sleigh.

Dr. Osterholm: The reindeer were excited. They pranced and paced, ringing the silver sleigh bells that hung from their harness. It was a magical sound, like nothing had ever heard. Across the circle, the elves moved apart and Santa Claus appeared. The elves cheered wildly. He marched over to us and pointed to me, said, let's have this fellow here. He jumped into a sleigh. The conductor handed me up. I sat on Santa's knee and he asked, now, what would you like for Christmas? I knew that I could have any gift I could imagine, but the thing that I wanted most for Christmas was not inside Santa's giant bag. What I wanted more than anything was one silver bell from Santa's sleigh. When I asked, Santa smiled. Then he gave me a hug and told an elf to cut a bell from a reindeer's harness. The elf tossed it up to Santa. He stood holding the bell high above him and called out, oh, the first gift of Christmas! A clock struck midnight as the elves roared their approval. Santa handed the bell to me and I put it in my bathrobe pocket. The conductor helped me down from the sleigh. Santa shouted out the reindeer's names and cracked his whip. His team charged forward and climbed into the air. Santa circled once above us, then disappeared into the cold, dark polar sky. As soon as we were back inside the Polar Express, the other children asked to see the bell. I reached into my pocket, but the only thing I felt was a hole. I had lost the silver bell from Santa Claus's sleigh.

Dr. Osterholm: Let's hurry outside and look for it, one of the children said. But the train gave a sudden lurch and started moving. We were on our way home. It broke my heart to lose the bell. When the train reached my house, I sadly left the other children. I stood at my doorway and waved goodbye. The conductor said something from the moving train, but I couldn't hear him. What? I yelled out. He cupped his hands around his mouth. Merry Christmas, he shouted. The Polar Express let out a loud blast from its whistle and sped away. On Christmas morning, my little sister Sarah and I opened our presents. When it looked as if everything had been unwrapped, Sarah found one last small box behind the tree. It had my name on it. Inside was the silver bell. There was a note. Found this on the seat of my sleigh. Fix that hole in your pocket. Signed, Mr. C. I shook the bell. It made the most beautiful sound my sister and I had ever heard. But my mother said, oh, that's too bad. Yes, said my father, it's broken. When I'd shaken the bell, my parents had not heard a sound. At one time most of my friends could hear the bell. But as years passed, it fell silent for all of them. Even Sarah found one Christmas that she could no longer hear its sweet sound. Though I have grown old, the bell still rings for me, as it does for all who truly believe the end.

Children: Merry Christmas grandpa.

Dr. Osterholm: I wish all of you the gift of hearing the bells this Christmas. Believe it is so important now more than ever to believe. So thank you so much for spending your time with us. Chris, I hope you're starting to feel better soon. And I just want to thank all of you for the past year. You've been there for me. You've been there for our entire podcast team. Uh, we so appreciate you. Your cards, your letters, your emails. They mean the world to us. You you really do sustain us in ways I can not fully explain, but. So thank you. And, uh, we look forward to being back, uh, right after Christmas. And we, uh, hope you all have a very, very happy holidays. And for those that may be having a struggle, remember this conversation right now that it will get better. It will get better. And that's what we're all about. Getting better. Thank you, thank you, thank you. You're so kind. Thank you.

Chris: Thanks for listening to the latest episode of the Osterholm update. If you enjoyed the podcast, please subscribe, rate and review wherever you get your podcasts, and be sure to keep up with the latest infectious disease news by visiting our website cidrap. This podcast is supported in part by you, our listeners. If you would like to donate, please go to cidrap. The Osterholm Update is produced by Sydney and Elise Holmes. Our researchers are Corey Anderson, Meredith Arpi, Leah Mote, Emily Smith, Claire Stoddard, Angela Ulrich, and Mary Van Beusekom.