Vaccines and public health: Development, regulation, and safety

[00:00:34]

SARA WHITLOCK: Hi, everyone. Welcome to SciLine’s media briefing on vaccines and public health. We’ll discuss the diseases curbed by vaccines, the causes and effects of declining vaccination rates, and the role of the federal government in vaccine development and regulation. My name is Sara Whitlock, and I’m SciLine’s manager of scientific outreach. If SciLine is new to you, we’re an editorially independent nonprofit based at the American Association for the Advancement of Science. And everything that we do is free, since our funding is entirely from philanthropies. We work to make scientific expertise more readily available to reporters so you can report the news with evidence and deeper context. We can help you with scientific angles from a wide range of fields related to vaccines, from the biology behind how vaccines work to the psychology behind people’s vaccine choices. All of our resources are outlined on sciline.org, including our toolkit for reporting on the major issues of 2025. You can also request an expert source to answer your specific questions by clicking the blue, “I need an expert” button. And we’ll look for a source with the right background who’s available to speak with you. A couple of logistics. I’m joined here by two panelists who have researched vaccines, vaccine policy, and decision making in medical regulation. I’ll let each of them introduce themselves. Dr. Fuller, would you go ahead?

[00:01:48]

DEBORAH FULLER: Yes. My name is Dr. Deborah Fuller and I’m a professor here at the University of Washington School of Medicine. My research is focused on studying vaccines, how they work. Developing new vaccines and trying to improve the existing ones.

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SARA WHITLOCK: Great, thank you. And Dr. Schwartz, would you introduce yourself as well?

[00:02:06]

JASON SCHWARTZ: Hi, good afternoon, everyone. My name is Jason Schwartz. I’m an associate professor of health policy at the Yale School of Public Health. I study vaccine policies and policymaking, how evidence is used by public health officials, scientists, and their expert advisors in the regulation, development, and evaluation and vaccination programs here in the United States and around the world. It’s great to be with you.

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SARA WHITLOCK: Great, thank you both. So I’m going to ask our panelists a couple of questions first, and then they’ll be taking your questions. You can submit your questions at any time. Just click the Q&A icon at the bottom of your Zoom screen to ask your question. And I will make sure to note if you’d like it directed to any specific speaker. A recording of this briefing will also be available on our website later today, and a transcript will be added in the next day or two.

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SARA WHITLOCK: So I’m going to go ahead and get started. Deborah, doctors and scientists talk about vaccines saving lives and preventing disease. So at this stage, would you provide examples of diseases impacted by vaccines and how vaccines are relevant to public health broadly?

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DEBORAH FULLER: Yeah, sure. I actually teach a course in vaccines here at the University of Washington. One of the first things I always tell my students is that vaccines are an ounce of prevention and a pound of cure. Collectively, I think vaccines have saved more lives than all other medical interventions around, including antibiotics. And so just a few examples, let’s go back in history to the smallpox. It was one of the deadliest diseases in history, killing hundreds of millions of people. And then when that vaccine was introduced, by 1977, there was a complete eradication of smallpox worldwide. This was the first disease ever to be eradicated by a vaccine, and it became a model for what vaccines could potentially do. So then flash forward to the 1960s, we had the measles vaccine. And this is one of the most transmissible diseases in the world. It causes severe symptoms. But it also has one of the most effective vaccines. It’s 97% efficacy, which is pretty amazing. So prior to the introduction in 1963, there were like millions, about 4 million cases each year. And then after that vaccine was introduced, there’s only a few hundred cases, mostly in unvaccinated and immune compromised people. And now flash forward to more modern times, COVID-19 vaccine. Of course, before COVID was introduced in December of 2020, within less than a year after the pandemic started, already there were already 500,000 hospitalizations and 350,000 deaths in the United States alone. Within only two months after that vaccine was introduced, hospitalizations were reduced by at least 50%. By 2023, it’s estimated that these vaccines have prevented over 120,000 deaths, 700,000 hospitalizations, and saved us $700 billion in costs. So hugely impact. So, vaccines have an enormous outsized impact in protecting the population. And recent studies actually suggest even more.

There is a strong link between vaccination protection against other diseases, chronic diseases, such as cancers. And more recently, there was a study reported a strong link between vaccination and a 30% to 40% reduction in the rate of Alzheimer’s disease. Why is that? Alzheimer’s disease is associated with inflammation. And we know that vaccines, in preventing infections actually prevent inflammation. So you could say that vaccines not are just a pound of cure, but maybe a thousand pounds of cures if you take into account not just what the infections they prevent, but potentially other diseases as well.

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SARA WHITLOCK: Wow. Yeah. Thank you for sharing that incredible history. And all that context about Alzheimer’s is so good to know. So, what do we know about trends in vaccination rates? And then how might declining vaccination rates lead to fewer outbreaks? Or to more outbreaks, I should say.

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DEBORAH FULLER: Yeah. Yeah. I mean, there are some serious diseases that we have very, very effective vaccines for that really quickly become a serious problem when we have lower vaccination rates when they start to drop. Like measles, pertussis, influenza, pneumonia, just to name some of them. You know, measles in particular is one that gets a lot of attention. As I mentioned, it has one of the most effective vaccines. But it’s almost always the first disease to emerge when vaccination drops even a tiny bit. And that’s because it’s so highly transmissible. And a lot of people don’t realize that before the measles vaccines, I mean in the last 10 years, what has this vaccine done? It’s estimated that it’s probably prevented over 500 million cases of measles and tens of millions of hospitalizations and at least a million deaths. And I remember reading in one case that a single measles case can be estimated to cost from $10,000 to $100,000 per person. And so you can imagine the financial impact this single vaccine has had. So when vaccination rates drop, it’s a serious situation.

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SARA WHITLOCK: Wow. That’s incredible. During the pandemic, we heard a lot about mRNA vaccines. So can you explain what these are and how they’re different from other types of vaccines?

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DEBORAH FULLER: Yeah, sure. So prior to the mRNA vaccines, the primary types of vaccine we had were these inactivated vaccines, which is basically a dead pathogen. We had live attenuated vaccine, that’s a weakened virus that will stimulate an immune response without causing a disease. And we had protein vaccines. So that’s just a single part of a pathogen that gets injected in the body to induce immune response.

And so mRNA vaccines differ from these because all you need is a sequence, a genetic code of, say, the protein from the particular pathogen. The mRNA gets injected into your body, and instead, your own cells are harnessed to actually make your own vaccine. So here’s the cool thing about what that means, is that actually when mRNA vaccines start to express their proteins in your body, they launch not only antibody responses that actually block and protect us from infection, but also a T cell response. It’s like a second layer of immunity that it launches in your body. And those T cell responses, what they can do is they can find infected cells in case the virus gets past the antibodies and actually destroy them. And so you’ve got two arms of immunity. It’s believed that this T cell response is why, despite the fact that SARS-CoV-2, the virus that causes COVID-19, kept changing and we saw breakthrough infections, we still had significant protection from hospitalization because the vaccine was still able to accelerate clearance of those infected cells from our body. Now, what’s happening now with mRNA vaccines is that particular ability of mRNA to induce those T cell responses. Those are the same types of responses that are important for clearing tumor cells from our body. And so you’re going to see a lot more advances in the future with mRNA vaccines being used to actually vaccinate against cancer or treat cancer. So that’s really an exciting move forward.

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SARA WHITLOCK: Wow, that’s really fascinating. So if I’m understanding you correctly, it sounds like the mRNA vaccines induce two different types of immunity that maybe a traditional vaccine didn’t. Can you say a little bit more about how these T cells might protect us from cancer or how that might be used in the future?

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DEBORAH FULLER: Yeah, yeah. A lot of times cancer cells, they emerge because our immune systems actually naturally clear cells that could become tumors. And what happens when we get cancer is a lot of times, our immune system is not able to see that cancer cell and then it can grow. And so what mRNA vaccines are being developed to do right now is actually be able to trigger and harness our body’s own immune system to better recognize cells as they’re becoming tumor cells and eliminate them before they cause a tumor. Or in people who already have cancer, to be able to target and actually eliminate those tumors from our body.

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SARA WHITLOCK: Thank you. That’s so fascinating. So my last question for you is, which diseases is vaccine research underway for? And if you had to say what have been the biggest innovations in vaccine development in the recent past?

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DEBORAH FULLER: Yeah, in addition to the promise of mRNA vaccines we just talked about, I think there’s several areas of vaccine research and progress that are really exciting. One of the first ones that I want to talk about is really, there’s a lot of effort going on in the research community, including in my lab, to develop what we call universal vaccines. So this is a type of one and done vaccine that could improve our protection against highly variable viruses that quickly change like influenza, like SARS-CoV-2. So this type of vaccine, what we’re trying to do is design it so it induces immune responses that can provide more durable and broad-spectrum protection against a whole bunch of different viral variants. So no matter how that virus changes, from one year to the next, we’d still have a level of immunity against it. And this is going to be really important to protect us against not only new emerging strains, but it could protect us against a future pandemic like could be caused, for example, by avian influenza, which we’re all hearing about now. So as an example of how this is made that I’m really excited about is a new approach in vaccine design that is happening right here at the University of Washington, it leverages AI. So this is a strategy that’s based on principles that were established by the recent Nobel Prize-winning scientist right here at UW, David Baker, and his protege, Dr. Neil King, as starting to use AI to design these new universal vaccines that provide broader protection, but they’re also better vaccines in that they induce more robust and effective immune responses. And I would say one final area that is really, really important in vaccine development that is really gaining traction is that right now, I don’t think a lot of people realize it, we have no vaccine for any fungus anywhere, okay? And yet just a few years ago, the World Health Organization announced that fungal infections are on the rise, and we are very ill-equipped to handle them because we just don’t really have any vaccines and very few treatments for fungal diseases. So a lot of groups are now beginning to really focus on trying to develop new vaccines that could protect against fungal diseases.

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SARA WHITLOCK: That’s so fascinating. I’m curious, do you think it’s possible to have some sort of fungal pandemic in the future?

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DEBORAH FULLER: Yeah, there’s sort of, in a way, a fungal epidemic that is emerging right here in the United States. So yeah, that is a good example. And one is, it’s called valley fever. It’s caused by a fungus called Coccidioides, and it’s found in the soil, okay? And when we have, like, forest fires like we saw in California. The fungus likes to propagate in there, and it actually gets—you get a windstorm or something, it gets in the air. Farmers get it in their lungs, dogs get it in their lungs, and it causes very serious disease, a very serious—almost very much like COVID-type symptoms, but it takes a very, very long time to recover. And in certain cases, it can cause really severe disease if it gets in your nervous system, if it gets in your bones, a lifelong disability or even death. So this is something that’s actually spreading. It was mostly localized in Southwest United States, but it’s starting to spread both northward and eastward, and they’re predicting by 2030, over half the United States is going to be impacted by this fungal disease. So it’s really kind of very concerning. So just a few years ago, there was a note sent to the National Institute of Health from Congress asking them to develop a vaccine against this fungus within the next 10 years. And out of that was formed four Valley Fever Centers for Excellence that are all focused on trying to solve this problem. So yeah, fungal disease, that’s just one example out of many others worldwide that we are concerned about.

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SARA WHITLOCK: Wow, I’m really glad that folks are working on that. That’s great to hear. So I’m going to move over to you now, Jason. To start off, would you speak generally about the process of vaccine research, explaining how long it takes for that process, and highlighting the role of the federal—different federal agencies in this process? And then also, who pays for vaccine research?

[00:14:45]

JASON SCHWARTZ: No, it’s a great question. Vaccine research and development, it’s kind of like a symphony with lots of moving parts, lots of different pieces involved from the earliest kind of research that often happens in universities, like the one I’m sitting in now, or Deborah is, or universities around the country with the work that’s often supported by the National Institutes of Health that does some of the foundational discovery that can lead to potential promising vaccine candidates. From there, often the work moves to either smaller biotechnology firms or some of the larger multinational pharmaceutical and vaccine manufacturers, names that we know and see on our television and commercials, supported often through those private funds, through those pharmaceutical manufacturers.

National Institutes of Health supports that early work. But as a product starts to make its way into being a potential vaccine candidate, that’s where the FDA, the Food and Drug Administration, will come in, closely working with—overseeing the vaccine clinical research, the clinical trials. Trying to understand whether the kinds of evidence that can be developed during that work can show that a vaccine hopefully is safe and effective. And when that happens at the end of a process that often takes many, many years, the FDA will decide to license, approve that vaccine for use. Following that, the next piece of the puzzle, the next piece of the federal puzzle is usually the work of the CDC, the Centers for Disease Control and Prevention. And they take the conversation from which vaccines are available, that’s the FDA’s purview, to which vaccines should be used and how. So the work of the CDC is providing the kinds of guidance, the kinds of recommendations, the kinds of evaluations that suggest the optimal use of those vaccines that have made their way through this very long research and development and regulatory puzzle. And then throughout this period, from the earliest stages of research, through the launch and implementation of vaccination programs well into the future, vaccine safety is an effort that is continuously monitored by the Food and Drug Administration and the CDC jointly, trying to ensure that vaccines have been shown to be safe in those clinical trials. And then as they’re administered to millions, tens of millions of individuals over the years, that they continue to demonstrate safety. So the federal agencies are deeply integrated with private institutions, academic research, and pharmaceutical research and development to get us, when we’re successful, so many of the vaccines that we now have in our toolkit.

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SARA WHITLOCK: Great, thank you. So we saw rapid vaccine development and approval during the recent COVID-19 pandemic. How do these regulatory processes adapt during crises, such as the rapid approval of COVID-19 vaccines? And then what is the role of different federal agencies in this process?

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JASON SCHWARTZ: It’s a great question. The COVID-19 experience really did sort of turn over an incredible new chapter in terms of the speed by which vaccines can be developed and introduced. Often, the story has been that this vaccine development story could be measured in years, sometimes even decades for some of our vaccines that we widely use today, with lots and lots of failures along the way. There are dozens of unsuccessful vaccine strategies for every one that does cross the finish line.

As we saw with COVID, that period of time was compressed into about 11 months from when we first identified the genetic sequence of the SARS-CoV-2 virus in January or so of 2020, until when that first vaccine was licensed here in the United States in December of 2020. How did that happen? It happened by accelerating the key steps and processes that often slow down vaccine development. Investing in lots and lots of different strategies, recognizing that some of them may not work, and the federal government supported that through the investment of literally billions of dollars. So investing in a wide portfolio of potential vaccines just to increase the odds that one would cross the finish line successfully. By supporting the kinds of research, providing the funds to help the nitty-gritty of the research trials to be carried forward as quickly as possible. And to accelerate the kind of production of the vaccines, the factories, the stockpiling of vaccines, even before we knew they were effective. So that if they were effective, there wouldn’t be those long delays that often follow the approval of a vaccine to actually translate it from a clinical trial environment to the mass vaccination. So the key was to throw a lot of money at the problem, to accelerate some of the steps that can slow down the process, but to not sacrifice the key kinds of characteristics, the size of the clinical trials, the amount of time by which individuals were studied, the quality of evidence that was fed into those existing regulatory systems that we’ve used for generations to evaluate evidence by the FDA and the CDC to bring them forward. So it was a master stroke of efficiency, gave us these incredibly transformational products that we had in short order, and really did change the trajectory of the pandemic, all within a year, I mean, it was a remarkable success story.

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SARA WHITLOCK: It was an incredibly quick timeline and just amazing to see all of that play out. So along those lines, how are vaccines deployed during outbreaks? And what do you see as the role of the federal versus state versus local governments that are in this deployment?

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JASON SCHWARTZ: Right. You know, those of us in public health often think a lot about partnerships. Obviously, there’s lots of attention to changes at the federal government over these past weeks and months. And they’re an important part of our public health and our vaccination systems. But they’re a key collaborator with state and local health departments in our communities who do so much of the day-to-day work in promoting public health, promoting vaccination. So those relationships are critical. And a lot of the support for state and local health departments comes from our federal partners, from the CDC, from other federal organizations. So those relationships are important in all times. They’re particularly important in outbreaks. During the COVID experience, of course, that was a, hopefully, once in a lifetime unprecedented campaign to launch and distribute and allocate and quickly vaccinate tens of millions of Americans in short order, setting up unique vaccine delivery infrastructure and shipping and administration to meet the moment of the pandemic. But we have lots of outbreaks that aren’t quite thankfully at the level of COVID. We’re seeing outbreaks of measles in many of our communities around the country. We’ve seen outbreaks of pertussis. We’re seeing outbreaks of other vaccine preventable diseases, many of which are associated with under vaccination. And in those, outbreaks, those incidents, often there is a quick partnership. The federal government is invaluable at helping support the surveillance, the evaluation of the scope of the outbreak. State and local health departments will accelerate their efforts to vaccinate unvaccinated members of those affected communities and to try ultimately to stamp out an outbreak before it spreads beyond those immediate circles in which we see. So it’s a critical work. It involves lots of coordination and collaboration like so much of our public health systems do, but we see it uniquely in these outbreak situations.

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SARA WHITLOCK: That’s amazing. Thank you. And I want to jump back to something you mentioned a little bit earlier, which was talking about sort of the movement from a clinical setting into production of a vaccine for mass consumption. What kind of was the main bottlenecks in that process? And have any of those been addressed since the COVID-19 pandemic?

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JASON SCHWARTZ: Yeah, making vaccines is hard. You know, there’s a lot of art and science to manufacturing vaccines in ways that are potent and pure and effective. And often, purpose-built factories have to be built to manufacture particular vaccines. It’s not to say that pharmaceutical manufacturing doesn’t have its own challenges. But to make vaccines at the scale of our national vaccination programs is a unique challenge. And it’s different than to produce enough vaccine to use in a clinical trial where we might be thinking about 20,000 or 30,000 research volunteers for a clinical trial. So some of those things sometimes, took time. One of the ways in which the COVID-19 experience helped accelerate and literally built some of these facilities, hoping that the vaccine would be successful for each of them. And if they weren’t, those factories were going to go unused, the same thing with the supplies that were made.

So we’re still—there’s work to be done. Obviously, the COVID experience was unique in that. There are often issues that come with short term supply shortages for some recommended vaccines, in part because of the fact that many of our vaccines are manufactured by only one or in some cases, two manufacturers here in the US. But generally, vaccines face a lot of challenges these days. Usually, some of the supply delays or shortages is a relatively small one amid some of the other impediments to our effective vaccination programs.

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SARA WHITLOCK: Yeah, that’s really interesting to hear. And you mentioned that oftentimes factories have to be purpose-built for specific vaccines. Is there anything different? Or would that not be true for mRNA vaccines? Or do they still need kind of their own factory?

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JASON SCHWARTZ: No, the mRNA vaccine manufacturing process was remarkable. It often involved multiple countries, unique facilities to make those lipid nanoparticle vaccines, the unique storage and handling and shipping characteristics. So the mRNA vaccines were an exciting new innovation because of the platform they provided. They were uniquely suited to getting us a vaccine to enter clinical testing as rapidly as it did. It created some challenges for manufacturing. It created some challenges, as folks might recall, with some of the storage and handling. But there are similar stories. Even for some of our more familiar, older vaccine technologies, there are still unique challenges that go into vaccine manufacturing production. So that’s an important part of the story that’s often under the hood, but it exists around the country, around the world to help distribute and deliver the vaccines that ultimately are recommended for our populations.

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SARA WHITLOCK: Thank you. So my last question for you right now is, what is known about the role of vaccine mandates in schools and workplaces in maintaining high vaccination rates? And then have changes to these mandates affected vaccination rates?

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JASON SCHWARTZ: Yeah, there’s probably no issue in vaccine policy that is more contentious than vaccine mandates. The required vaccines usually are associated with school attendance that have raised really for decades, a lot of anxiety, a lot of opposition, a lot of concern around vaccination programs. It’s important to remember these are state policies here in the United States. The federal government, with respect to our school vaccination programs, that’s not a federal piece.

They do the recommending and then state governments, through their health departments or state legislatures, are responsible for thinking about the schedule of vaccines that should be required for school attendance, for daycare attendance, for different school age groups. And a lot of work happens there at the at the state levels. These mandates for generations have been a critical safety net in sustaining high vaccination rates in our communities. Of course, for most childhood vaccines, we want kids to be vaccinated well before they attend daycare or school. We want them to be vaccinated, usually in the first few years of life. That’s what the recommendations suggest. But having these requirements in place when kids do enter daycare, enter pre-K, enter kindergarten, provide an important way to sustain and support vaccination in areas where those access to care barriers may have existed. There may have been obstacles along the way. They’ve been shown to be critically important in high vaccination rates. And in cases where we see vaccine preventable disease outbreaks, it’s usually almost always associated with individuals who are unvaccinated, kids who are unvaccinated, in part because of the availability, in most states, almost all of them, of exemptions from these requirements for reasons other than a medical reason why a child can’t be vaccinated. So almost all states, about 44 or 45 at last count, allow families to exempt their child from these requirements on the basis of either a religious belief or a non-religious moral or philosophical, sometimes called a personal belief exemption. And these rates of exemptions are growing. We’re seeing concerning trends that more families are availing themselves of these non-medical exemptions in recent years. So vaccination rates are going down and we’re seeing, unfortunately, a pattern that epidemiologists have shown for decades, that when that happens, we see increasing numbers of vaccine preventable disease outbreaks, particularly in those communities, where there are clusters of families of individuals who have who have chosen not to comply with those vaccine requirements. So that’s an interesting and ongoing challenge. There’s lots of litigation happening in state legislatures around the country regarding the scope, the extent, the availability of these non-medical exemptions. Some perhaps trying to widen their access, other states trying to narrow their access. It’s going to be something we’ll continue to see a lot more of movement of because it’s a really critical and controversial issue in vaccine policy.

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SARA WHITLOCK: Thank you. I have a few follow up questions I want to ask you. But first, I want to remind reporters on the line that you can submit questions using the Q&A box at the bottom of your Zoom screen. And we will ask those questions shortly. But I wanted to ask you a quick follow up about how things actually get added to the list of childhood vaccination requirements. You know, what sort of checkpoints do they have to pass? How can parents feel really comfortable that this is going to be safe for their kids?

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JASON SCHWARTZ: Sure. So there’s two steps. And just to take one step back that all the states, when they’re thinking about their schedule of the required vaccine, they take guidance from the recommended vaccines that the Centers for Disease Control and Prevention has developed literally since the 1960s. There’s a key group of advisers, the Advisory Committee on Immunization Practices, that works with the CDC to evaluate all the evidence around vaccines, the populations for whom it’s most useful. And develops these gold standard vaccination schedules for generations that have been seen as setting the model for the optimal use of vaccines. So state governments watch those recommendations from the federal partners, from the CDC, from their expert advisers very carefully. And then state health departments or state legislatures think about their populations. They think about particular vaccines that might be more important for the preschool population, others that might be more important for the early school age group. Those that might be more important for adolescents in line with those recommendations, and make the evaluations about which and when a particular vaccine should be required. Now there are some variations from state to state, but generally they’re in pretty broad alignment. So many of the vaccines that we have thought about and might come to mind, the measles, mumps, rubella, and polio, and hepatitis, and diphtheria, tetanus, pertussis, and meningitis, a lot of those sort of familiar diseases that we often hear about in the news, almost all states require them for their school children. And there are processes that can be done either through legislation or through the administration actions of health departments that can either add doses, remove them, or change those schedules as the recommendations change. But they really do take their starting point from the federal guidance in terms of the recommendations, in terms of how states then bring those to the question of requirements for school entry.

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SARA WHITLOCK: Great, thank you. So as we move into questions from reporters, I want to first ask both of you about the news coverage you’re seeing about vaccine safety claims and changing vaccine policies during the recent administration. What are reporters doing well, and what could they be doing better? So Dr. Fuller, I’ll direct that to you first.

[00:30:07]

DEBORAH FULLER: Yeah, I think that one of the biggest concerns I have is the increasing sort of polarization of the media in terms of information and where people get their information. There seems to be a disconnect there. Like if you’re a person who just doesn’t know much about vaccines and worry about their safety, and you go on whatever media or the internet, to find information, you can very quickly end up going down a rabbit hole that allows you to just continue to affirm—suddenly believe, well, vaccines are not safe. And then you can find more information and more information and then come out of the other end of that rabbit hole completely misinformed. And I don’t know the solution to that. I don’t know how you actually disrupt that. But I think one of the other things that I see, particularly for vaccination, is a loss of collective human memory about what it was like before vaccines came out. And there’s just not enough stories about that. We have, I think, for many people questioning vaccines, they just don’t have—they weren’t alive then, so they don’t have that memory. But I think it’s important onus on the media to ensure that we don’t lose that collective memory, that history together as people.

[00:31:24]

SARA WHITLOCK: Thank you so much. Dr. Schwartz?

[00:31:26]

JASON SCHWARTZ: Yeah, vaccine safety is in the news. It will be in the news for the months to come. And this is a challenge for how we talk about what we know and what often might be sort of being raised about the safety of vaccines. It’s worth noting there is no medical product that is more extensively studied for its safety than vaccines, particularly childhood vaccines, because for generations, the public health and medical communities recognize that there can be no corners cut, there can be no compromises when it comes to assessing vaccine safety. So we have an enormous body of knowledge about the safety of our recommended vaccines. There are a vast array of ongoing programs to scrutinize and monitor that safety to ensure that the story continues to hold and to respond quickly when potential signals emerge. So there is a vast history and apparatus that provides the confidence that you often hear from so many members of the public health community when they talk about the safety of vaccines. Now, that’s going to be challenging to sort of put that in the context as happens from time to time. And we’re seeing it happening in some of the public conversations and media coverage in recent months that is raising doubts about how adequately vaccine safety is studied, how complete our vaccine safety knowledge is, the credibility of the government institutions that monitor vaccine safety. And I think the challenge, this is not the first time that these issues have gotten public attention and the media has had to cover them.

We have examples from the 1990s when Andrew Wakefield published his since retracted paper linking the measles, mumps, rubella vaccine to autism. We have plenty of examples of when the media has to sort of think about how to cover these vaccine debates. And I think one thing that’s happened that I’m grateful to see in recent years is that these debates while giving attention, as I think we’ll have to, to public figures raising doubts or questions about the vaccines is to recognize that it isn’t a one side says this, the other side says this, and that there’s equal weight or equal voices on both sides. I think it’s—I’ve seen, thankfully, a lot of attention to recognizing just how debunked some vaccine safety hypotheses in the news these days have been. And I see that mentioned in media coverage. I see attention noting to the sort of consensus view of a wide array of public health and medical organizations documenting the safety of vaccines to put that as a counterpoint when others may question issues that are widely seen as settled. But keeping that sense of perspective, in terms of what we know and what we don’t know in the face of what I suspect will be a rising climate of raising fresh doubts or uncertainty beyond what the science suggests will be a really foremost challenge for the folks in the media trying to help provide clarity into what I think is going to be, frankly, a confusing period for the public as they think about the safety and the value of vaccines.

[00:34:20]

SARA WHITLOCK: Thank you. And I know you mentioned this a little bit, but one thing that I think a lot of people have had questions about, particularly when it comes to the COVID-19 pandemic was the speed with which a lot of these vaccines were deployed. Do you have anything that you can say to kind of assure people that nothing was left out during the regulation process and that these vaccines were still really safe despite their speed?

[00:34:40]

JASON SCHWARTZ: Yeah, the key trials that were used to give the initial thumbs up to the COVID vaccines were every bit as large as any trial that has been used for previously licensed vaccines. And every vaccine trial itself is well larger, much larger, I should say, than most pharmaceuticals, precisely because a larger number of research participants gives us a better sense of safety that we’re able to see perhaps some of those less common safety signals before a vaccine being licensed. So that was true for COVID.

And the period of time in which those individuals were monitored covered the period of time where decades of evidence has shown that if there is going to be a rare adverse event associated with vaccines, a rare safety problem, it happens, right? Nothing in medicine or in life is free from risks, but we know that the risks associated with vaccines are very rare, they’re very limited, and they emerge in the initial days or weeks after a vaccine is administered. They don’t show up for the first time months or years. So by continuing that follow-up period that we have seen time and again is the window in which any potential allergic reactions or other kinds of rare adverse events emerge for the COVID vaccines, we were able to move forward with introducing them. And then we, of course, have the experience now of several years and literally billions of doses of ongoing safety monitoring to affirm that story. So that’s true for COVID and it’s true for all of our recommended vaccines, that the totality of the evidence before licensure and that ongoing post-licensure real-world evidence that has given us such confidence in the safety of the vaccines, particularly as it relates to some of the chronic diseases, the autoimmune conditions, the autism spectrum conditions that have been alleged to be associated with vaccines. There’s just not an evidence base to support that. And the evidence has been very clear for many years about that.

[00:36:27]

DEBORAH FULLER: Yeah, and I would just add to that, that I think the mRNA vaccine seems suddenly to just come out of nowhere. But the reality is that there was already 30 years of research behind those. There had been mRNA vaccines already through phase one and phase two trials for other infectious diseases. So when COVID came, it was actually kind of like that technology was already on the verge of becoming the next generation vaccine. So it was the right type of technology ready for when this pandemic came. It became a plug and play. I mean, there was a mRNA vaccine in phase two trials for flu and it was just actually, let’s pop out the gene for influenza, let’s pop in the gene for COVID-19. So there’s all that leverage of research of many, many decades of research that went into the mRNA vaccine. So they seemingly were sudden, but really there was a great body of research already behind it. And a lot of safety studies and clinical trials as well that could be built on.

[00:37:27]

SARA WHITLOCK: That’s great to hear both that we have that regulatory window that we were following for the COVID vaccine and to hear that that was actually something that was really being developed for quite a long time. It must be very satisfying for all the scientists who work in that field to see that happen. So a question that’s a little bit related to this for both of you is, what vaccination reports and trends are you watching this year? What should reporters have their eyes on as well?

[00:37:51]

DEBORAH FULLER: Well, I personally have my eye on avian influenza. That’s just kind of my area of research in terms of developing vaccines for emerging infectious diseases, that was while my lab was able to get involved in the COVID-19 vaccine efforts. And I didn’t mention before, my lab is actually focused on nucleic acid vaccines, including RNA, as well as another related one called DNA vaccines. So we’ve been working for years on influenza, before covid. We thought influenza would be the next pandemic. So because there has always been influenza pandemics in the past. So it’s always a question of not if, but really when. And so we’re keeping an eye on avian influenza. And it’s in animals mostly, but we know how prior pandemics for flu had started. And it’s just something we’re keeping an eye on and preparing for as well.

[00:38:54]

JASON SCHWARTZ: And I’m watching—I’m watching measles. I’ll jump in here. Measles, I think is often the sort of canary in the coal mine for our routine vaccination programs and its weaknesses. Measles is uniquely effective at spreading from person to person. It’s uniquely, more than any other of our vaccine preventable diseases, capable to infect those who are susceptible around it. As many as 90% of individuals who may be unvaccinated or susceptible to measles, are likely to be infected if they are exposed to it. So these measles outbreaks, the one we’re seeing in Texas, every day, the number seems to increase by 5 or 10. I literally can’t keep up with it. And we’re seeing isolated cases all around the country as well. And measles, those measles cases, those individual cases and the outbreaks that emerge are often sort of a barometer for how well our vaccination program is doing overall, because we’re going to see measles cases first as a sign of the effects of under vaccination in our communities. And that will be a signal, measles that it’s not the benign rite of passage that is sometimes suggested by folks who are more skeptical of our vaccination programs. It can be a really serious, potentially fatal, often leading to hospitalization kind of disease. So the measles cases that we’re already seeing, and I suspect, and I’m afraid we’ll continue to see, will often be the way that so many of our communities really come face to face with the effects of hesitancy, of doubts, of skepticism around our routine childhood vaccination programs.

[00:40:25]

SARA WHITLOCK: And I’m curious, what does research show about the factors that are influencing these changes in vaccination rates? So why might people feel—be feeling more hesitant about MMR vaccines?

[00:40:35]

JASON SCHWARTZ: Yeah, I’ll start and throw some ideas out there. It’s worth remembering that often we see a lot of attention to individuals who are really strident in their skepticism or opposition to vaccines. So often we’ll see folks who are protesting on state capitals or writing letters to local media outlets, but those individuals who are the most sort of fervent in their questioning, or even opposition to vaccines are really a very small portion of the broader spectrum of what we refer to as vaccine hesitancy or vaccine confidence, to give it a sort of glass half full view. The majority of individuals are parents who are trying to figure out how best to take care of their children. They’re hearing lots of noise. They’re hearing it in the media. They’re hearing it from our public officials. They’re hearing doubts and concerns. They might be hearing it at the playground from fellow parents about vaccines and what the right thing to do is, and what’s the safety and what are potential harms. And more often than not, they’re trying to just figure out how to make the right decision for their children and trying to sort through all the noise. And it’s that group of those folks that are sort of in the middle that’s been growing in recent years, in part fueled by lots of hypotheses and theories and things that circulate on the internet and elsewhere, as Deborah mentioned. And it’s unfortunately a larger segment of those parents who aren’t assured, reassured by what they hear, or reassured by their physician or provider. Most of them thankfully still do vaccinate their children, but an increasing number are saying, you know what, I’m going to delay, I’m going to skip, I’m going to space them out. I’m just not sure. And I think it might be safer just not to vaccinate my child, which is not a fair reading of sort of how we think about risks. That group is growing. And that group is increasingly in small numbers, it’s worth noting, in small numbers, but meaningful ones, shifting into not vaccinating their children against some or all diseases. And even small increases lead to increases in susceptibility. So even small increases can make a difference, even if in most places, the vast majority of parents and families continue to believe in the importance of vaccines and our vaccination rates show that overall, even with these concerning increases in unvaccination and exemptions over the past few years.

[00:42:47]

DEBORAH FULLER: Yeah, and I would just add to that. I think it’s really that loss of collective memory of the history of what it was like. I mean, back when the polio vaccine was successfully developed, you didn’t have parents go, “Oh, golly, should I get –” because they knew a neighbor or a friend or whatever whose child was afflicted by polio. It was a devastating disease. Yet we don’t see that. And I think for a lot of parents, it doesn’t seem like such a risk. So I think that, again, it’s kind of the loss of that. Even I hear from people kind of already forgetting about covid. You know, it’s like if you can believe that. So and that was more recent history. So I think there’s some of that I think as well. And so that’s another factor.

[00:43:32]

SARA WHITLOCK: Yeah, it is kind of incredible how quickly those things can sort of fly out of all of our collective minds. So to kind of follow up on that, when states are either rolling back vaccination requirements or doing less outreach to kind of support those parents who might be a little bit on the fence about whether or not to vaccinate their children. Are there some segments of the total population that are affected from like a medical perspective more than others? Maybe people with preexisting conditions or other things like that. Maybe, Dr. Fuller, you can start on this one.

[00:44:00]

DEBORAH FULLER: Oh, yeah, certainly. We see a lot of people who—different demographics are much more susceptible to certain infections and particularly, of course, the immunocompromised individuals, people who may have had a transplant or something like that. And they’re on immunosuppressive drugs. My dad was one of those. And he never could go out during flu just because even with a flu vaccine, he was more vulnerable to those infections. Pregnant women are actually much more vulnerable and their babies, also. They tend to actually develop much more severe disease when exposed to various infectious diseases. And, of course, very young children, their immune systems are not fully developed. And so they’re going to be much more susceptible as well. So I mean, those are just to name a few.

[00:44:46]

SARA WHITLOCK: Great. Anything to add there, Dr. Schwartz?

[00:44:48]

JASON SCHWARTZ: No, well said. I’ll leave it there.

[00:44:50]

SARA WHITLOCK: Amazing. And maybe to kind of follow up on that. Are there any people for whom it’s not actually recommended to get vaccinated for various diseases?

[00:45:01]

JASON SCHWARTZ: Sure. So I’ll start with a little bit. I mean, one of the things that often gets attention, of course, is that routine childhood or an adult, an adolescent vaccination schedules, which are well developed and provide sort of the top line summary of the best approach to vaccination. But embedded in those recommendations often included as part of them are a whole host of additional recommendations for special populations, folks who are immunocompromised, individuals who are pregnant, individuals with other conditions for whom particular vaccines, in some cases, live vaccines, in some cases, other vaccines should be delayed or doses should change. These are one of those cases where there are—there is often a critique of our vaccination program that it is a “one size fits all approach to vaccination.” And really, that doesn’t hold up with the evidence. There’s lots and lots of guidance, both from our public health officials and, of course, from our health care providers who are ultimately the ones stewarding individuals’ decision making with vaccines to recognize that for some individuals, immune conditions, other things might mean there’s a tailored approach to vaccines. But those are relatively small in number in terms of individuals who have true medical contraindications, medical reasons not to receive a vaccine. But for the vast majority of the population, the gold standard recommendations or the framework that health care providers, physicians, pediatricians, pharmacists or others use to work with families to think about the best approach to vaccination for kids, adults, or adolescents.

[00:46:32]

SARA WHITLOCK: That’s great. So you mentioned the huge role that various agencies play in making these types of determinations. And we have a question about Robert Kennedy Jr., who has a history of vaccine skepticism, who has been confirmed just recently as the secretary of Health and Human Services. So given the role that Health and Human Services and other agencies play, what extent can the leadership of this agency help or hinder the development and distribution of vaccines?

[00:46:56]

JASON SCHWARTZ: Yeah, I’ll start. It’s an enormous role. I think we shouldn’t—it’s hard to overstate how important the Department of Health and Human Services and by extension, its leader is in every aspect of the vaccination program, those stages I talked with from the beginning of our conversation today, the organizations and their priorities in terms of research, in terms of regulation, in terms of recommendations. It’s a far-reaching mandate that ultimately flows back to the secretary of Health and Human Services. So there’s lots of things that could be done in terms of research priorities that might change at the NIH, both for vaccine preventable diseases and other concerns. There might be actions that the Food and Drug Administration might take regarding safety studies in terms of the kinds of evidence that is seen or no longer seen as sufficient to support the safety of vaccines.

Or the kinds of work that the CDC does in terms of the recommendations for which vaccines are recommended. So there’s far reaching, direct sort of policy levers that flow back to the secretary of Health and Human Services. And beyond that, I’ll say the other thing as we talk about sort of uncertainty and clarity and understandings, as Deborah and I both have, just the platform that comes with these positions, our national public health leaders, the ability in statements, in messages, in the questions they ask, in the priorities they identify itself can help to either clarify or add to public understanding, public confidence in vaccines. So the bully pulpit factors that are—this incoming group of public health leaders, both the new secretary as well as the individuals who may lead those particular agencies, can do a lot to either support or to complicate our vaccination efforts even beyond the sort of policy tools at their disposal.

[00:48:41]

DEBORAH FULLER: Yeah and I would just add to that on the research level, in terms of funding to support foundational research for vaccines and vaccine safety, that’s a real concern. I’ve heard reports about, oh, we want to now shift more of our resources to studying and curing chronic diseases. And do less with infectious diseases without—and that’s really a naive sort of understanding because a lot of our chronic diseases are actually caused by infectious diseases. You cannot separate those two out. So hopefully there’ll be much—a lot of information out there to ensure that people understand that you can’t stop vaccine or infectious disease research and solve the problem of chronic infectious disease. They’re very closely intertwined with one another.

[00:49:38]

SARA WHITLOCK: And could you expand a little bit on what types of diseases might be intertwined, which sort of infectious diseases lead to chronic diseases?

[00:49:46]

DEBORAH FULLER: Well, let’s start with cancer, for example. There’s a number of cancers that are actually caused by infectious diseases, for example, cervical cancer. That’s what our human papillomavirus vaccine is for. Liver cancer, hepatitis B vaccine is as helpful in preventing that. And there’s other cancers that we still don’t even know about, but are suspected to have been caused by a virus. So a little start there.

I mentioned earlier about Alzheimer’s. There’s strong and growing link between inflammation or what we call inflammageing; as you get older, you get more inflammation. And there’s a strong link between inflammation and the buildup of the types of proteins in the brain that are believed to be associated with Alzheimer’s. And so that’s why we’re starting to see studies to support that link between increased vaccination rates, which helps to prevent inflammatory responses to infections and a reduction in your susceptibility to diseases like Alzheimer’s. Long Covid is a really good example of a direct connection between an infectious disease and a chronic condition that many, many people are still suffering years after the Covid pandemic. And I could go on with a lot of other ones, but there is—and there’s probably a lot of things we don’t know yet. And that’s really where the foundational research is in understanding what are the causes of the chronic diseases, because you cannot cure them unless you understand the causes. And often that brings us right back to infectious diseases and an important role in vaccines and helping to reduce the incidence.

[00:51:25]

SARA WHITLOCK: That’s great. So you mentioned the human papillomavirus vaccine, and do we have data now to show how effective this has been at preventing cancer in adults?

[00:51:35]

DEBORAH FULLER: I was thinking Jason would have that.

[00:51:37]

JASON SCHWARTZ: Happy to. I don’t have the statistics off hand, but there’s been a remarkable success story in terms of the human papillomavirus and its prevention of cervical cancers. We’ve had these vaccines now in the United States for almost 20 years, and we have now seen through the generation of individuals, women and men now who have been vaccinated. Remarkable decreases, particularly in cervical cancer, but in all the other genital and other conditions for genital warts and additional conditions that those vaccines prevent. So it’s been a real success story. It’s a vaccine that no doubt had lots of controversy and attention when it arrived on the scene as a vaccine against a sexually transmitted infection. The one that was recommended and is recommended for pre-adolescent girls and boys. But those vaccination rates have slowly but steadily climbed close to the public health targets. Not quite there yet, but close to that 90 percent level that we’d like to see them at. But the benefits in terms of preventing the precancerous lesions and the cervical cancers now are beginning to come through in the US and around the world. And it’s been a real triumph in terms of cancer prevention.

[00:52:44]

SARA WHITLOCK: That’s so great to hear. To jump back to something from a little bit earlier, Dr. Schwartz described growing rates of parents who are not quite anti-vax, but who are opting to delay, space vaccines further apart, et cetera. Do we see that the parents who are following that pattern tend to actually get vaccinations for their kids or does this pattern translate into unvaccinated children and adults?

[00:53:04]

JASON SCHWARTZ: Yeah, I’ll start a little bit. I mean, there are very few children who are so-called zero dose kids. There are very few parents who decline every vaccine. The story is more nuanced than that, that there might be concerns about the hepatitis B vaccine at birth or concerns that the varicella, the chickenpox vaccine is not essential or concerns about the measles, most rubella vaccine. You’ll often see this sort of tailored hesitancies. And there’s challenges for health care providers, many of whom have had to wrestle with how they sort of think about their own principles, their own beliefs, their own advocacy for the children they care for in terms of how to treat these kids. So we see that the story varies from vaccine to vaccine. We see stories that have gotten attention in recent years of adolescents who, when they become—hit the age of adulthood, choose to get the vaccines that their parents had insisted they do not get. So we see as those individual decision-making cases come up. So you’ll see stories along the way. I don’t think we have great visibility across the board, but we are certainly seeing more of this delaying and declining or spacing out issues, which creates a period of time where kids are at greater risk during that critical period of time in the first few years. There’s a reason why the vaccine schedules are designed the way that they are, is to minimize that period of time in which kids are unprotected. And to delay doses, to space them out, to extend them means that there’s a longer period of time in which kids are unprotected. And there’s a greater likelihood that a parent, because life is complicated, may miss an appointment or miss a dose and ultimately fail to catch up. So these stories have implications when folks try to sort of think about, sort of improvise alternative vaccination schedules.

[00:54:49]

DEBORAH FULLER: Yeah, now I’ll add a little bit to that, because one of the things I often hear from people questioning whether they should give their kids a vaccine or not is like, why don’t I just let them be exposed naturally and just get natural immunity? So I mean, the answer to that is that we know that pathogens I mean, they have evolved to wreak havoc on our bodies. They can have long reaching impacts. We talked about some of the chronic diseases that we can be more susceptible to. And they can cause like, for example, the long Covid is a great example of something that—you do not want to get that pathogen. So when making choices and saying no, no, natural immunity is not better than the vaccine, okay? Because once the virus is gone, the effects of that pathogen are not done with your body, you can have long reaching effects on that. And a lot of the newer vaccines, including the mRNA vaccines, I mean, they are really being designed to be exceptionally effective. And so those are things that I keep getting asked all the time, but I think is a source of confusion for parents as well.

[00:56:04]

SARA WHITLOCK: Thank you so much. So we have one more question, which will give both of our experts a chance to offer some concise takeaways. But first, I want to mention to reporters who are on the line that you’ll be getting a quick survey after this briefing ends. And if you have even 30 seconds to give us feedback on whether this briefing is useful to you, it helps us to plan our programming to deliver what you need. So for our final question, can each of you in about 30 seconds tell us what your take home message is, your key things you want reporters to know who are covering vaccines and vaccine policy? I’ll let Dr. Schwartz start this one.

[00:56:38]

JASON SCHWARTZ: Thanks so much and thanks to everybody for joining, and to our host. I think there’s been an election. There’s a change of administration. There will likely be a change of federal policy. But the science and evidence for vaccines doesn’t change with the votes of an election or a change of appointees. There is a vast body of science and evidence, a vast array of expertise that doesn’t reside in those agencies that have—that are changing hands that can help provide the kind of clarity around why vaccines are seen as so valuable, so safe, so important, so effective. And trying to capture that amid, I think, lots of questions and concerns and frankly, policies that might suggest the contrary will be the really important work for all of us going forward. So I think that’s the message I would try to underscore as we all sort of move ahead in these interesting times.

[00:57:26]

DEBORAH FULLER: Yeah, I totally agree with that. And thanks, everybody, for being here, for listening, and to Sara as well. But, yeah, I agree with that. I think my take home message is a pound of cure, a thousand pounds of cure, if you like. And I think that as reporters, you’re sort of at the front line, really, of helping to get the message out there of the importance of vaccines. And I think that now more than ever, your job is going to be really critical and in ensuring that the research that we do, the vaccines we develop, the truth gets out there. And that people have access to that information.

[00:58:07]

SARA WHITLOCK: Excellent, thank you so much. I want to thank our panelists for sharing their expertise and insight today in a time when understanding vaccines and the vaccine regulation process is so crucial. And we’re grateful to all of you journalists who are on the line, who took the time to hear these reporter perspective—researcher perspectives and to deepen your coverage as the story evolves, deepen that coverage with evidence. So good luck with your reporting. And I hope we’ll see you at our next briefing.