Bernie Sanders Roundtable on Vaccines and Public Health

22 Jan 2025

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[Senator Sanders]

Introduction to Roundtable

I've convened this roundtable today to get a better understanding and help the American people get a better understanding about the importance of vaccines and the role they have played decade after decade in improving the public health of our nation and the world we live in. In just a few moments, we'll be hearing from Dr. Paul Offit, a pediatrician and expert on vaccine, who serves as director of the Vaccine Education Center and professor of pediatrics at Children's Hospital in Philadelphia. Dr. Joshua Sharfstein with the Johns Hopkins School of Public Health. Dr. Greg Gonsalves with the Yale School of Public Health. And Catherine Kennedy, the president of the National Nurses Union and the California Nurses Association. And again, we thank them very much for being with us today.

Roundtable Format

After they are finished making their remarks, every senator will have an opportunity to question them.

[00:01:06]

Scientific Consensus on Vaccines

Let us be clear, there is an overwhelming consensus in the scientific community that vaccines have saved millions of lives, prevented massive human suffering, and stopped the spread of infectious diseases like polio, smallpox, and measles. In fact, studies have shown that over the past 50 years, vaccines have saved lives of more than 150 million people around the world. In August, the Center for Disease Control reported that over the past 30 years, routine childhood vaccinations in America have prevented over 1.1 million deaths, more than 500 million cases of illness, and over 32 million hospitalizations.

Increasing Questions About Vaccines

And yet, despite these enormous achievements, an increasing number of Americans have started to raise questions about vaccines that I hope our panelists will be able to answer today.

[00:02:15]

For example, why is it so important that our children receive so many vaccines at an early age? That's what parents are asking. Why is it so important for everyone to get vaccinated? If he doesn't want his kids to get vaccinated, why? What's the problem? He should have that choice. What could go wrong if we rolled back or eliminated childhood vaccine mandates that exist in every state in our country? What could go wrong if the Vaccines for Children program that has provided free vaccines to millions of kids was scaled back or eliminated? What's the problem with that? What kind of diseases could become common again if fewer and fewer people chose to get vaccinated?

[00:03:01]

These are not new questions, but in an era of massive misinformation, that is what we're dealing with now. Massive misinformation campaigns and growing distrust with everything associated with government. It is vital that we have an honest conversation with doctors, scientists and nurses about the importance of vaccines. And that is what today's meeting is about.

Historical Context of Infectious Diseases

It is easy to forget just how bad some of these infectious diseases were before vaccines were made widely available. It is easy to forget that because of the success of vaccines. In 1952, 3,000 people in America died from a polio outbreak and many more needed leg braces, wheelchairs and the iron lung to breathe. In the early 1900s, over 6,000 Americans died from the measles each and every year, 6,000 every year.

[00:04:01]

And what concerns me very much is that we are at serious risk in this country of seeing the return of diseases that we have not seen in decades as a result of fewer people getting vaccinated. I'm very concerned that we will see children who could be protected through vaccines get sick and in some cases die. In my view, we must not allow that to happen. So at a time of growing distrust, not only with vaccines, but of government, of science in general, who's telling us the truth? Who is the truth teller? Somebody on the internet, a truth teller? Who's read a book some place and trying to make money off a book? Or people who have done research and work for years? That's really kind of what this discussion is about. So let's begin right now.

Introduction of Dr. Paul Offit

Let's thank again our panelists. Dr. Paul Offit is a pediatrician and has worked on the vaccine issue for years, is director of the Vaccine Education Center, professor of pediatrics in the Division of Infectious Diseases at Children's Hospital in Philadelphia.

[00:05:07]

Dr. Offit, thanks so much for being with us.

[Dr. Paul Offit]

Dr. Offit's Remarks

Thank you, Senator. I'll be brief. My parents were children in the 1920s. Their parents or my grandparents were scared of diphtheria, which would kill 15,000 children a year because it would cause a thick leather-like membrane that would line the windpipe and cause suffocation. They were scared of pertussis or whooping cough, which killed 8,000 children a year. I was a child of the early 1950s. My parents weren't scared of either of those diseases because we had a vaccine. What they were scared about, as Senator Sanders alluded to, was polio, which would paralyze 30,000 children a year and kill 1,800. They were scared of measles, which would kill 500 children and cause encephalitis or swelling of the brain in 1,000, a quarter of whom would be left with permanent brain damage. They were scared of mumps, which was the most common cause of acquired deafness.

[00:06:01]

They were scared of rubella or German measles because if that virus infected women in the first trimester, you had an 85% chance of delivering a child that was blind, deaf, or had heart defects. I did my pediatric residency in the late 1970s. And when I was on call in the emergency department, I would do two or three spinal taps every night looking for bacterial meningitis because I trained at a time before there was the haemophilus influenzae B vaccine, which is a bacterial vaccine. Before the meningococcal vaccine for children, before the pneumococcal vaccine for children. I now work at Children's Hospital of Philadelphia and pediatric residents don't know how to do spinal taps because they never do them for the most part. And so when we have a child who comes in with bacterial meningitis, it's the interventional radiologist that does that tap. My children were born in the 1990s. My wife and I weren't scared of any of these diseases because we had vaccines. But that's the problem. The problem is not only that we've largely eliminated these diseases, we've eliminated the memory of these diseases.

[00:07:02]

And for that reason, parents are now more scared of the safety of vaccines, real or imagined, than the diseases that they prevent. And so you're starting to see then an erosion in vaccine confidence and as a consequence an erosion in vaccine rates. The CDC recently reported the highest rate of kindergarten vaccine exemptions ever. And as a consequence of that, in 2023, there were four outbreaks of measles accounting for 59 cases. And in 2024, there were 16 outbreaks of measles accounting for 284 cases. In 2023, there were about 5,600 cases of pertussis. In 2024, there were 32,000 cases of pertussis, which is more than pre-pandemic levels. So I'm scared that what's happening now, because parents are making this choice because they feel they can, that children are in probably the most dangerous position they've been in recent years. Thank you.

[00:08:03]

[Senator Sanders]

Introduction of Dr. Joshua Sharfstein

Dr. Joshua Schrofstein is the Vice Dean for Public Health Practice and Community Engagement at the Johns Hopkins School of Public Health. He was previously Secretary of the Maryland Department of Health, etc. Thank you very much for being with us, Dr. Schrofstein.

[Dr. Joshua Sharfstein]

Dr. Sharfstein's Remarks

Thank you very much, Senator Sanders and all the senators here for the opportunity.

[Senator Sanders]

Talk a little bit closer to the mic and make sure it's on. Is it on?

[Dr. Joshua Sharfstein]

There you go. Can you hear me better? Yep. All right. That's much better. Thank you very much, Senator Sanders and the other senators here for the opportunity to speak with you about vaccines. I'm a parent. I'm a pediatrician, as well as the former Health Commissioner of Baltimore City, the former Health Secretary of Maryland, and I was also the former Principal Deputy Commissioner of the U.S. Food and Drug Administration. Today, I'm on the faculty at the Johns Hopkins Bloomberg School of Public Health. My remarks represent my own views and do not necessarily reflect the views of my employer's past or present. I'd like to emphasize three key points. First, and this is following up on Dr. Offit's terrific statement, vaccines protect children from devastating harm.

[00:09:06]

I trained in pediatrics in the mid-90s, about a decade after the launch of the conjugate vaccine against a bacteria called Haemophilus influenzae type B. This bacteria causes a severe meningitis that throughout the 1980s killed a thousand kids a year and left thousands more with permanent brain damage. During my training in pediatrics, I never saw a single case, not one. Vaccination has essentially erased the threat of this devastating disease to children in the United States. How do we measure the impact of vaccines? One way is through the statistics that Senator Sanders quoted. Routine immunization of kids has prevented 500 million illnesses, 32 million hospitalizations, and more than a million deaths since the early 1990s, according to CDC. But when I think of vaccines, I'll tell you it takes me back to my training when I took care of a child dying of chickenpox, the virus varicella, who had cancer.

[00:10:07]

And when kids get cancer, it affects their immune system and the chickenpox virus can just absolutely devastate them. And I remember the parents, I remember the oncologist saying he was getting cured from his cancer. His chance of survival from cancer was 95%, but he picked up chickenpox from another child, and I don't know if he's going to make it, and the child died. Since routine immunization against chickenpox began, there's been an enormous decline in the number of cases, and that's protected every kid with cancer and other immune conditions. And deaths have fallen by more than 80%. Now to my second point. The process of developing safe and effective vaccines in the United States is strong. You're all familiar with how a bill becomes a law. I'm going to walk through how a vaccine becomes an accepted part of care for children. Step one, there's all the research that goes into developing a vaccine candidate and studying it even before it's ready for clinical trials.

[00:11:07]

Step two, you have clinical trials. They happen in phases, starting with just a few patients and eventually involving many more patients. Step three, the scientists at FDA carefully review the full set of data. They do raw data analysis. They look through everything submitted by the companies, not just the summaries that the companies send. Step four, the data are presented publicly to a committee of independent experts for their review and recommendation. And at this point, only if there is clear evidence that the benefits of the vaccine substantially outweigh the safety risks does the FDA approve the vaccine. But for vaccines, we're not done yet, even at that point, because there's still the question of whether the vaccine will be recommended, which is a whole other step. And we'll call that step six of step five is the approval. Step six, the Centers for Disease Control and Prevention consults publicly with a separate committee of independent scientists and works with other groups, including the American Academy of Pediatrics, before deciding whether to add the vaccine to the routine schedule.

[00:12:14]

And then in step seven, after the recommendation, after it's been made available, the agencies work together with academic experts and others in the scientific community to conduct ongoing safety assessments that is far beyond what's done for other drugs or medical products in this country. Let me just say in the various jobs that I've had, I've met people who work in every step of this process. And I know how seriously they take their jobs. They ask tough questions about vaccine candidates. Not everything by a long shot makes it through this process. They know they're working to protect their own children and grandchildren, too. Now to my third and final point, HHS, the Department of Health and Human Services, is central to the success of vaccines in this country. In addition to supporting research, reviewing applications, and making recommendations, HHS agencies make them available, make vaccines available to children across the country.

[00:13:07]

Through the Vaccines for Children Program, the CDC purchases and distributes recommended childhood vaccines at free or low cost to about half of all children in this country. Through the Vaccine Injury Compensation Program, HHS provides compensation to families affected by rare but serious adverse effects of vaccines. Through the National Center on Immunization and Respiratory Diseases, the CDC provides clear and accurate information about the benefits and risks of vaccines to the medical community and the public. Each component of the national vaccine effort is important. We cannot take them for granted. Going backwards would expose millions of children to the risk of devastating disease. We have to counter misunderstanding and outright falsehoods about vaccines so the American people can understand what's at stake. And let me just say very briefly what's at stake. Whether parents of infants too young to be immunized will be afraid of measles spreading in daycare or the mall.

[00:14:04]

Whether parents of children with cancer will fear sending them to school. Whether H flu meningitis will make a comeback in this country. Thank you very much.

[Senator Sanders]

Introduction of Catherine Kennedy

Dr. Shostin, thank you very much. Catherine Kennedy is a staff nurse at Kaiser Permanente Roosevelt in the neonatal intensive care unit. She also serves as president of the National Nurses United and the president of California Nurses Association.

Catherine Kennedy's Remarks

Thanks for being with us.

[Catherine Kennedy]

Well, good afternoon, and thank you so very much, Senator Sanders and members of the committee, for inviting me to take part in this most important roundtable discussion today. As Senator Sanders stated, I am a current working bedside nurse of 45 years, and I continue to work at a level three neonatal intensive care unit, caring for premature and term infants who require critical care. And in the past, I've also floated to pediatrics over the course of my long career.

[00:15:00]

As a bedside registered nurse caring for babies and at times children, I have a real deep understanding of the importance of vaccination and the health and well-being of our children and of our communities. In the neonatal ICU, there are many times when we are given orders to administer the first scheduled immunization to our premature babies that are still hospitalized in our unit at two months of age. The vaccinations given to infants are critical to ensuring their long-term health. They prevent diseases that can drastically alter the course of a child's life, including polio, diphtheria, tetanus, pertussis, also known as whooping cough, measles, RSV, hepatitis B, amongst others. Over the course of my life as a registered nurse, I've had a front row seat, seeing the improvements in public health and specifically children's health that has followed from widespread vaccination. But in recent years, I've also seen the negative impacts that conspiracies and myths about vaccines have had on our patients and our communities.

[00:16:05]

For example, let me give you an example. Shortly after birth, if the patient consents, the baby will receive a vitamin K injection. Vitamin K is critical to ensure that blood can clot appropriately and babies are born with very small amounts of vitamin K in their bodies, which can lead to very serious bleeding problems. Research has shown that a single vitamin K injection, a single injection at birth, prevents babies from developing dangerous bleeding, which can lead to brain damage and eventually death. Infants who do not receive the vitamin K shot injection at birth can develop what's known as VKDB, vitamin K deficiency bleeding, up to six months of age. And in recent years, and even just about a month ago, I've seen personally a parent that has refused this, to consent their baby from getting a vitamin K injection.

[00:17:05]

So it is happening even now, even in the NICU that I work at. You know, it's the doctor's responsibility to have that conversation with the parent to explain the importance of any vaccination. And as an RN, I often have to follow up after the doctor's conversation. Again, they speak of certain jargon, so we put some real simplicity to it as a registered nurse so that the parent understands what the doctor had been saying. There are still parents that continue to refuse the vaccinations for their newborn, which puts the babies at risk. Vaccination hesitancy is leading to a resurgent of previously eradicated disease, as was spoken by the two physicians before me. And in just recent years, cases of measles, polio, pertussis have exploded all around the world. It is so important that the federal government officials, especially those charged with the duty to protect the health of the public, to educate the public with scientifically accurate information about vaccinations, especially at a time when technology has made it easier for misinformation to spread on social media and the leadership of our public health officials is extremely crucial.

[00:18:17]

And as a nurse, I can tell you firsthand how misinformation permeates throughout communities, in my unit, and the unfortunate consequence to vaccine hesitancy. We've had decades of experience showing that vaccines are safe. I'm a product of, I was born in 1956. I not only had measles, mumps, chicken pox, all of those things. My father was in the military, so I just stood in line and took my shots. That's important. I'm healthy. I'm of age, but I'm still very healthy, and I appreciate that. So we need to follow the science of vaccinations and combat misinformation to protect our patients' health and the health of our communities. To do anything else is to risk the lives of our children and the next generation.

[00:19:04]

So thank you for allowing me this opportunity.

[Senator Sanders]

Introduction of Dr. Greg Gonsalves

Thank you very much. Dr. Greg Gonsalves is an associate professor of epidemiology at the Yale School of Public Health. He's an expert in policy modeling on infectious diseases. Dr. Gonsalves, thanks so much for being with us.

[Dr. Greg Gonsalves]

Dr. Gonsalves' Remarks

Thank you, Senator, and thank you all for having me here. My name is Greg Gonsalves. I'm an infectious disease epidemiologist at the Yale School of Public Health, and some of you may be familiar with what an epidemiologist is, but simply put, epidemiologists care about what happens to people at the level of populations, communities, while health care workers like my esteemed colleagues on this panel worry about individual-level outcomes and patient care on a day-to-day basis. And let me tell you that vaccines are one of the greatest population health interventions in human history. We've heard about the U.S. figures, but every six minutes, every minute, six children are saved by vaccines around the world. Let's put the global impact into perspective.

[00:20:02]

In the time we are together today, over 500 children will have been saved from infectious diseases that are preventable by vaccines. Over the past 50 years, this adds up to 150 million children's lives spared from death. Okay, let that sink in. Look, I'm no spring chicken. I've never had to give a thought to catching the dreaded diseases that we've talked about today, but that wasn't the same thing for my father, who had polio during the Great Depression. And the same is not true for many members of Congress who come in contact with these diseases. And this is why many of you, Democrats and Republicans, have been champions of polio eradication across the world, and it's a real bipartisan accomplishment that you should embrace. The other thing here is to put this into a little bit of historical context. Vaccination is as American as apple pie, right? George Washington, yes, that George Washington, ordered all American troops to be inoculated against smallpox, understanding that infectious diseases, as he said, were more destructive than the sword and was the leading cause of mortality in the Continental Army, right?

[00:21:02]

This is decades, centuries of embrace for vaccination across the United States. You know, as an epidemiologist, I worry about outbreaks of infectious disease every day. You know, for many infectious pathogens, they're avoidable by following good public health practice. We wash our hands, you wake up in the morning, you pour milk into your coffee because you know people have inspected the dairy products that you're pouring into your brew at that moment. You work in buildings like this where the air and the water have been inspected for risk of contamination of bacteria. And most of us in this room have been vaccinated for infectious diseases and remember nothing about this once unremarkable experience. I don't remember the 20 injections or the 10 injections that I got in 1963, but we take this all for granted, going about our lives with this invisible shield protecting us. You know, last year there were 16 measles outbreaks in the United States with three cases or more and 40% of those required hospitalization. Outbreaks of other infectious diseases like pertussis or whooping cough are on the rise as well. And in addition to the direct health costs associated with these outbreaks, the economic costs need to be considered.

[00:22:06]

There was a measles outbreak in Clark County, Washington with 72 cases at a reported cost of $3.4 million to pay for the public health response, the direct medical costs, and the productivity losses of infected individuals. You know, with declining immunization rates, we're going to see more and more cases of childhood preventable diseases and not just in kids, right? The indirect effects of vaccination, what we call herd immunity, confer protection among people, for instance, whose immunity may have waned even though vaccinated by breaking up transmission networks. And misinformation itself, without a single policy change, right, can erode support for vaccination. We saw this with COVID-19 and it led to disproportionate deaths among people with different political affiliations in the United States, and we've seen growing misinformation on childhood preventable diseases following the wake of COVID-19. I think this took five minutes, 30 children saved around the world.

[00:23:01]

It's a collective accomplishment that we all should embrace.

[Senator Sanders]

Okay. Thank you very much, Dr. Gonsalves.

Questioning Begins

Let me begin the questioning and then we're going to go to the other senators.

COVID Vaccine Effectiveness

Let me start off with what Dr. Gonsalves mentioned. We talked about COVID. COVID took over 1 million lives in America and many millions more around the world. Worst pandemic this country has experienced since, I think, the Spanish flu. President Trump, when he was president the first time, expressed pride in Operation Warp Speed in bringing COVID vaccines to the American people. In your judgment, panelists, how many more people would have died if the COVID vaccine had not been developed? Okay. And while there may have been some side effects, did the benefits of the vaccine outweigh the negative side effects?

[00:24:13]

Dr. Offit.

[Dr. Paul Offit]

I'm on the FDA Vaccine Advisory Committee. We sat down in December 2020 to review both Pfizer and Moderna COVID-19 vaccines. And when we did that review, by the way, your heart's in your throat. I mean, you know you're looking at roughly 35,000 adults who got that vaccine and you also know that you're making a recommendation for tens of millions, hundreds of millions of people, and you always know the other shoe is going to drop because that's always true. There's always a human price to be paid for knowledge, always. The question is how severe and how rare. And so what did we learn in the first two years of the COVID vaccine? We learned that this vaccine probably saved about 3 million lives, that there were about 230,000 people who died unnecessarily because they chose not to get the vaccine.

[00:25:02]

We also knew, because we had systems in place like the vaccine safety data link, that the mRNA vaccines were a very rare cause of myocarditis, inflammation of the heart muscle, roughly 1 in 50,000, that the Johnson & Johnson vaccine, the so-called adenovirus-vectored vaccine, which was introduced in February of 2021, was a very, very rare cause of dangerous clotting, roughly 1 in 250,000, which ultimately drove it off the market two years later because we had a safer vaccine. So the question is, is the vaccine risk-free? Of course it's not risk-free. The question is, which is the greater risk? The greater risk was the choice not to take the vaccine because if you took that risk, then you were much more likely to die than the risk of, say, myocarditis, which actually was a pretty small price to pay in the sense that it was generally short-lived, transient, and self-resolving. That was an easy choice. I mean, I would argue I was an informed consumer. I read the 800 pages that we were asked to read as members of the FDA's Vaccine Advisory Committee.

[00:26:03]

I couldn't wait to get that vaccine, realizing that now we knew a few months later. And it's interesting how quickly you pick that up. Because we had that vaccine safety data link in place, you were able to very quickly pick up this very rare side effect. So the public should be reassured that you're always looking for those rare side effects. But your choice as a parent or as a citizen is to put yourself and your children in the safest position possible. There are no risk-free choices. The trick is to take the lesser risk.

[Senator Sanders]

Anyone want to add to that?

[Catherine Kennedy]

Let me tell you from a nursing perspective, since I work in acute care hospitals. When COVID happened, so many people died. And as a bedside nurse, and having to listen to my nurse colleagues that worked in the ICU and even on the med-surg floor, patient after patient died. I mean, and it was unbelievable.

[00:27:00]

I mean, it was horrific for all of us. And then to make the decision on who, you know, this person's about ready to die, so let's go ahead and take him off and give the ventilator to another person. Because we were running out of equipment. So when you're talking about, you know, if we didn't have this vaccination, the amount of money that would be spent to try to save lives would be even more than what it is now. You know, we even lost our charge nurse to this COVID. And so the toll, the amount of people that were saved and without it, we would have seen even a higher rate of death.

[Senator Sanders]

Freedom of Choice Regarding Vaccines

All right. My other question is, and I'll give it a simple one. In America, we don't like to be told what to do, right? You want freedom of choice. You want that vaccine? Great. You don't want to get the vaccine? No problem. What's the problem with that proposition? Doctor?

[Dr. Paul Offit]

I'll start out.

[00:28:00]

If you step on a rusty nail and you go to the doctor and the doctor asks you to get or advises that you get a tetanus vaccine and you choose not to get it and you get tetanus, no one's going to catch tetanus from you. It's not a contagious disease. That's not true of many other infectious diseases, including SARS-CoV-2, the cause of COVID. If you choose not to vaccinate yourself or your children, you're also making a choice for those with whom you come in contact. And there are many people in this country who can't be vaccinated. They can't be vaccinated because they're getting chemotherapy for their cancer or they're getting immunosuppressive agents for the rheumatologic diseases. Do you have any responsibility for them as a member of society? I think the answer is yes.

[Senator Sanders]

Thank you very much. All right. All right, Senators, jump in.

Senator Baldwin Questions

Senator Baldwin.

[Senator Baldwin]

Thank you. Thank you so much for being here and your presentations. I have a question about pushing back against some of the narratives that are out there, that vaccines are not well studied or surveilled after approval.

[00:29:07]

I would appreciate if you could discuss what ways we have of surveilling the safety after they are approved for widespread use. And, Dr. Offit, in your recent op-ed for the New York Times, you talked about how these surveillance systems were exactly how we caught these rare side effects for the COVID-19 vaccines. But how can we reassure folks that these are carefully watched after approval?

[Dr. Joshua Sharfstein]

So when I get this question, I usually point out that vaccines are assessed and monitored more carefully than pretty much everything else in American medicine, and that is because they're given to healthy people generally and the tolerance for side effects is very low compared to other products.

[00:30:06]

So you really want to make sure that vaccines are as safe as possible. One of the major systems that exists is called the Vaccine Safety Data Link. I'll just use this as an example, where it's possible to look at millions of records of people who have been vaccinated and people who didn't get vaccinated at the same time and see whether effects are linked to the vaccines. Because one of the common challenges with assessing the safety of vaccines is that things happen after vaccination. It could be causal, it could be related to the vaccine, or it could be a coincidence. And when you're giving vaccines to everybody, there are a lot of coincidences. So you have to be able to sort through that. And so there's a database, a process for deeply investigating any concerns that come up and figuring out whether it's truly caused or it's coincidental. And if it's caused, well, it may be a minor thing that you're going to warn about.

[00:31:01]

It may be a more serious thing that will lead to a different kind of regulatory action. But the people who work on that, they care deeply at finding the right answer. And if it's a coincidence, you can reassure people that it's been looked at and it is not related. And that's how fundamentally we know about vaccine safety.

[Senator Baldwin]

Follow up on Vaccine Safety

If you could follow up with the specific databases that are out there and who's watching, who's on the job watching for safety issues, that would be helpful because I know we're going to have to continue to push back against that narrative.

[Dr. Joshua Sharfstein]

Oh, sure. Sorry about that. The systems are supervised by the Centers for Disease Control and Prevention, by the Food and Drug Administration. They're different systems.

[00:32:00]

I mentioned one, the Vaccine Safety Data Link that's overseen by the CDC. There are also systems around the world that other regulators use that we work with them on as well.

[Senator - not named]

Senator Questions on Autism and Vaccines

Thank you so much to each of you. I have just a couple of questions. One is about the causal link between autism and vaccines. This is something that I hear a concern about quite a lot. And what, if any, information can you give us to help us push back against that? And then related to that is whether you have any suggestions regarding how to communicate. We have a large public of people who we want to respect their fears. And what, if any, recommendations you can give in terms of how we communicate in a way that both gives information but also respects the genuine fears that many parents face?

[Dr. Paul Offit]

I can start off. First of all, it's perfectly understandable from the parent's standpoint.

[00:33:00]

My child was fine. They got a vaccine. Now they're not fine. Could the vaccine have done it? The good news is that's an answerable question. And it has been answered. So, for example, in the late 1990s, there was a now discredited U.K. researcher named Andrew Wakefield who sort of brought forward the notion that the combination of measles, mumps, rubella, or MMR vaccine caused autism. He didn't study it. It was just sort of a case series of eight children who had gotten the vaccine, and then within a month of receiving it, developed signs and symptoms of autism. That paper was ultimately retracted because he had misrepresented clinical data. Some of those children actually had symptoms of autism before they ever got the vaccine. But in any case, you can answer the question. So how do you answer the question? You answer the question by doing retrospective studies, which have been done now in seven countries on three continents involving tens of thousands of children, where you look at then children who did or didn't get the vaccine and make sure that you isolate other variables like healthcare-seeking behavior, medical background, socioeconomic background, so you can isolate the impact of that one variable, receipt of the MMR vaccine.

[00:34:03]

So what I would say is that people took that concern seriously. Academic researchers, pediatricians, scientists took that concern seriously enough to spend tens of millions of dollars to answer the question. But sort of the better part of your, the more impactful part of your question is, how do you get that information out there? Because frankly, once you've scared people, it's hard to unscare them. It's hard to unring the bell. And I think that's been the challenge. And part of the challenge is there's not a clear cause or causes for autism. So when somebody like Andrew Wakefield or others sort of bring that up, or Robert F. Kennedy Jr. bring that up, it's hard to say, it would be easier if we could say, look, this is the cause of autism, because it makes it harder to defeat these other ones, which are more controllable, right? Great, I can control autism by just not vaccinating my child or younger child. And that's what's happened. There was recently an article published in the Journal of the American Medical Association showing that children with autism are less likely to be vaccinated. In addition, their younger, healthier siblings are also less likely to be vaccinated, because we keep sounding this false alarm about vaccines causing autism.

[00:35:05]

[Dr. Joshua Sharfstein]

If I could just briefly add something. When these concerns first rose, Congress asked the National Academies of Sciences to look into the question of whether vaccines is linked to autism. And the National Academies appointed a committee. No one had had any financial ties with any of the companies that make vaccines. They added extra independent layers to check, and the report found that there was absolutely not evidence to support it. In fact, the evidence disproved the connection between vaccines and autism. And today, if you go to the National Academies website, National Academies being the preeminent scientific authority where they look at every study that's been done, it states claims that vaccines cause autism are not true. And so that's not one person's opinion. That is the preeminent scientific authority in this country.

[00:36:04]

[Dr. Greg Gonsalves]

So misinformation is a firehose, right? We are seeing it on a scale beyond vaccines, right? Some of it's for profit. Some of it's about deeply held conspiracies and fundamental anti-science denialism, right? And we have to face it as a public health crisis because that's what it is. But we can fight back, right, at the level of communities. We have to have an all-of-community approach to engaging with our constituents, with our patients, with our colleagues, with our friends and families, and talk to them, engage with them, face their fears, face their questions, and treat them with respect, right? That's the only way to get to it. And it's not just about vaccines. It's about any kind of health-seeking behavior that you'd like to see. You have to meet people where they're at and engage with them in a real, constructive, honest conversation.

[Catherine Kennedy]

And, okay, so now here comes the nurse. One of the things that we do for all of our parents, and this is through the CDC,

[00:37:01]

is it's a vaccination information statement that we clearly give to the parents of the kids so that they can actually get all of the information about whatever immunization we're going to give to the child so that they are well-informed and, you know, in the correct language that they would like to see it in, whether it's Spanish or Japanese or whatever. So the information is there. So the more concrete information that we can provide to our parents on the safety and the risk of the vaccination is so important, and it's been there for many, many, many years. And any questions that they have, you know, we try to answer if the doctor hasn't done a good enough job. We break it down even more for the parents. So the information is there.

[Senator Kaine]

Senator Questions on Vaccine Injury Compensation Program

I'll ask a question about how HHS leadership is important in this whole equation, and you described this a little bit, Paul, but I really want to get into it.

[00:38:06]

And maybe in particular, the Vaccine Injury Compensation Program. So that's administered through HRSA, I guess, so within the HHS family. And a decision is made about certain vaccines, I think there's 16 now, where if you do have a negative impact from a vaccine, you go into a no-fault scenario where you can, if you can prove that, you can get compensated. That no-fault system protects the manufacturers of the vaccines from lawsuits here, there, and everywhere, which if they were subject to those, they might decide, well, we're not going to be in the vaccine business. So it's a system to provide compensation, but it's also a system to protect the manufacturers of vaccines deemed safe. Am I right that the HHS has some discretion about removing vaccines from that list if they were to choose, would that be through regs, would it be through HRSA?

[00:39:04]

Because if that were the case, I would obviously worry about, that would be one worry I would have in a set of questions I might like to ask people who are going to be nominated for positions within HHS.

[Dr. Paul Offit]

I can at least give a historical background, which you probably know as well, not better than me. In the early 1980s, the modern American anti-vaccine movement was born on April 19, 1982, with a film that was released by NBC called DPT Vaccine Roulette. It was a devastating film. I hear parents were saying, my child was fine, they got this whole cell pertussis vaccine, whooping cough vaccine, and now look at them, they're seizing, they're drooling, they have withered arms and legs, they're staring vacantly up in the sky, vaccine did it. And that precipitated a flood of litigation. Now there were studies very quickly to show that the whole cell pertussis vaccine, while it had sort of an uncomfortable safety profile, never caused permanent harm.

[00:40:00]

But nonetheless, flood of litigation, and it drove vaccine makers off the market. We went from 18 vaccine makers in 1980 to by the end of the decade, four, because they couldn't get liability insurance because they were suffering these slings and arrows of outrageous civil litigation. I think if you really wanted to destroy vaccines in this country, just pull a couple of them out of the vaccine intercompensation program and just let them be subject to litigation. Now it should be clear that if you aren't satisfied with the compensation in the vaccine injury compensation program, you can always sue the company. You just have to go through that program first. So the notion that pharmaceutical companies are protected from civil litigation is wrong. You can still always sue them, you just have to go through this program.

[Senator Kaine]

So pulling them off, crush vaccines, and does the leadership of the HHS pose any risk to the system of protecting vaccine makers?

[Dr. Paul Offit]

So now it's jury trials. Now it's jury trials. I mean, can you convince a jury? You have a child who appears to be permanently disabled, it's emotional, and that's where we got to where we got to.

[00:41:07]

So in 1986 with the National Childhood Vaccine Injury Act that included the vaccine injury compensation program, that stopped the bleeding. But take vaccines out of there, and those companies then will have difficulty getting liability insurance, and it will probably drive those vaccines out.

[Senator Kaine]

And last question, would HHS leadership have the ability to do that?

[Dr. Paul Offit]

I'm turning that over to Joshua Sharfstein.

[Dr. Joshua Sharfstein]

As a questioner of law, I don't know the answer to that question. But what I do know is that the management of the program is extremely important. For example, a few years ago there was a very long delay for families to go in, and that is really unfortunate. It makes people very frustrated. And HHS has worked really hard over the last several years to bring that delay way back down. And so there are many dimensions of management of the program that are really important, separate from whether a vaccine is covered. Congress passes the excise tax on the vaccine that makes them eligible for the program.

[00:42:03]

But whether that program is actually working is really important, because if it's not working, people will get frustrated and deserve to be frustrated, and then you're just in a different world about what to do.

[Senator Sanders]

Senator Blunt-Rocheson Questions

Senator Blunt-Rocheson.

[Senator Blunt-Rocheson]

Thank you, Senator Sanders, and thank you to the panel. I have a few questions as well. I think I'm going to pick up on Senator Kaine's question about leadership. This department has about 80,000 employees, FDA, the CDC, very important components of the system. And I'm trying to understand in what ways a cabinet secretary can reduce vaccine use through these different authorities. Are there specific authorities that a cabinet secretary can come in and reduce vaccine authority, or are there things that are in place?

[00:43:08]

Sometimes I was deputy secretary of health and social services in Delaware, and so sometimes there are things that are outside of your authority as a cabinet secretary. What are the protections and what are the ways that someone could come in and have an impact on reducing vaccine use?

[Dr. Joshua Sharfstein]

How much time do we have? There are many parts of the vaccine effort that HHS leads, and some of them are very rooted in law. Some of them really depend and have discretion at the agency level, and some of them are at the department level. Of course, the department oversees the agencies. So for any one of these dimensions, there are different things. I'll just give you one example. The core approval decisions that are given to the Food and Drug Administration, it's generally the secretary of HHS who then delegates to FDA.

[00:44:01]

Now, if the secretary of HHS were to try to get involved in that, and it has happened at times, it could potentially be thrown to the courts about whether it was a justified decision or not, but then you'd be dependent on what a judge decides about it. So it's not so easy to say what they could do, but there are potential concerns. If you had a secretary who was determined to undermine vaccination, then you could see problems across different policy options. The other point is one that Dr. Gonzalez made, is that the secretary of HHS has a very large public platform, and even telling people things that aren't true or raising fears that aren't justified could have a huge impact. We are at a very critical point as vaccination rates have fallen, that if they fall just a little bit further, we could see a lot more outbreaks. So even without actually doing things directly, there is potential danger.

[00:45:01]

[Senator Blunt-Rocheson]

Thank you. And then another question is about just the numerous emerging threats that are out there, like bird flu. Can you talk about why vaccines are a critical pillar of pandemic preparedness?

[Dr. Greg Gonsalves]

So as many of you know, and if people watching this on the live stream don't know, we have livestock infected with H5N1, bird flu. We've seen several cases, more than several cases around the U.S., some severe, right? I think one in Louisiana, one in the Northwest, right? We have vaccines for avian flu. The NIH and other partners are developing better agents for this, right? We have to do a couple of things. One is we need to support infectious disease research, including on H5N1 at the National Institutes of Health. We talk about FDA and CDC, but NIH is a crucial part of this, right?

[00:46:00]

We need to surveil for H5N1 across the country, right? This depends on CDC's resources to local and state health departments in order to do this, in cooperation with USDA and other agencies outside of the HHS purview. And if a vaccine for H5N1, a new one comes online, the FDA is going to have to review it, and CDC's advisory body is going to have to review it. So all of the HHS component agencies have a stake in any new pandemic that might arise over the next few years, next few decades.

[Dr. Joshua Sharfstein]

Okay. Jump in with a really quick point. You remember the emergency use authorizations that were done for COVID vaccines that made them available very quickly?

[Senator Blunt-Rocheson]

Right.

[Dr. Joshua Sharfstein]

When I was at FDA, I signed the first one for civilian use, when I was the acting commissioner for H1N1. It might be the case that we'd have to consider this again. There is enormous amount of discretion given to FDA. It's a different standard than regulatory approval. It's really up to the FDA to decide whether to do it, rather than if the evidence is there, they're compelled to do it.

[00:47:03]

And so that would be a really good example to your earlier question about where leadership really matters.

[Senator Blunt-Rocheson]

I'm going to close with this, if I could, Senator Sanders, the issue of misinformation and disinformation. During the pandemic, I would say truly it was the messages and the messengers. It was the pediatricians, the nurses, the pharmacists, the pastors that really made a difference. And in this moment, depending on what all turns out here, we're going to rely on everybody to make sure that we got the right information out to folks. So thank you so much for your service.

[Senator Sanders]

Senator Hickenlooper Questions

Thank you very much, Senator Hickle.

[Senator Hickenlooper]

Thank you all for being here. In terms of messenger, we haven't had enough messengers of people who've gone through having one of these dreadful diseases. I had a son, Teddy, in 2002, got his first shot at age two months. Right as he was getting his second shot at four months, the next day he was playing with a little girl who was from India and had been adopted, and she had a cold.

[00:48:06]

And we didn't worry too much about it. He got the cold after five or six days of incredible hacking. We took him to the doctor, several different doctors, because these diseases are so rare. People could not, they just said, no, it's just, he's going to come back. Don't worry about it. And he would call, finally, a doctor at Children's Hospital in Denver, Dr. Stephen Berman, said, you know, this sounds like pertussis. And so we spent two days, I spent two days, all night awake. And every time he started, about every three minutes, he would start hacking. And you had to push this button and blow oxygen into his face. And if you've lived through that, that's another piece of information that I think people need to hear. Despite all these benefits and the success in vaccination rates, as you're all describing, we're seeing that decline that is truly alarming.

[00:49:00]

So I'll start with Dr. Offit and Ms. Kennedy. In your experience as health care providers for kids, how do you counsel your patients and parents on vaccine efficacy? And I put this in the context of our work here has done a lot of work on community health centers, which are often on the front lines of patient education across the country. I helped start a community health center in Middletown, Connecticut, back in 1972. I put up sheetrock, but this guy, Mark Maselli, was the zealot who did all the work. But it's where communication happens on a lot of that level. So how do you counsel your patients and your parents?

[Dr. Paul Offit]

So I'll start. I think we ask a lot of parents in this country. We ask them to give, in the first few years of life, as many as 25 shots and as many as five shots at one time to prevent diseases that most people don't understand.

[00:50:00]

I'm sorry, prevent diseases most people don't see using biological fluids most people don't understand. So I think I think it's reasonable to have questions. I think it would be surprising if people didn't have questions, if people didn't push back on vaccines. So I guess when I sit down with parents who have these questions, the critical issue for me is what is it that they're scared of? What is it they're afraid of? And with that, usually, you can sort of show, look, so how would you address that concern? And here's information to address that concern. But you have to be really open to the notion that having those concerns, having that fear, being scared of watching your child get a shot, makes perfect sense. And so I think you just have to accept that.

[Senator Hickenlooper]

Great.

[Catherine Kennedy]

You know, and I'll and I'll say again, we have the information readily available in the form of a vaccine information statement that we give to all of the parents. So they have an opportunity to read the benefits and the risk. And it's really important for them to understand. And I mean, in a language that they understand, you know, to to be mindful of that and then to continue to talk to them and answer any questions that they have.

[00:51:07]

And so that's what we do, you know, as a bedside nurse. I'm also a public health nurse. That's something that we do in the clinics. And we've done a good job, you know, but there's still that the misinformation that's out there. And it's really important for people to really know where to go to get the information so that they can know the benefits outweigh.

[Senator Hickenlooper]

Well, a lot of that is younger people especially are going to look at this and kind of not wade through it. In other words, we've got to have to continue to evolve. And we want you to counsel us on how can we get that education to parents and patients as well.

[Catherine Kennedy]

As my daughter said, all forms of information. I like hard copy. People like electronic audio. Anything that we can do to get the information out and continue to repeat that over and over again. We don't want to see more kids in the hospital because, again, there are not enough beds.

[00:52:03]

And it's preventable.

[Dr. Greg Gonsalves]

And health education can't rely just on clinicians alone. I think Senator Brockchester is saying we have to have an all of community approach. And trying to figure out how to fund that and support it around the country is really, really important. But you also have to realize that people have good faith questions and fears about vaccines. But then there's social media which we cannot compete with, right? There's an enormous amount of information that flows to people, including young people, who we can't compete with at this current moment.

[Dr. Paul Offit]

Could I add one thing to sort of follow up on your question, Senator Brockchester? When COVID hit Philadelphia, there was a physician at Temple, an African-American surgeon named Ayla Stanford. And what she did is she took it upon herself to form a group called the Black Doctors COVID Consortium. She then went into North Philadelphia, a predominantly black and brown community, to try and give something to these people that they generally didn't have. It was a doctor that they could talk to frequently.

[00:53:02]

And so she would sit in their living rooms and talk to them. And if they didn't want to get the vaccine or didn't want to get tested, she would come back again and again, as did the other roughly couple hundred people who joined that consortium. And with that, she vaccinated 50,000 people in North Philadelphia. And see, that was that point of light during this pandemic, that it would be nice to have a thousand of those. I mean, she gave those folks, I mean, I guess the sense that, you know, all politics is local. I think all public health is local, too. Senator Hassan.

[Senator Hassan]

Senator Hassan Questions

Look, thanks for being here and for the work you do. Ms. Kennedy, I wanted to follow up a little bit on the issue of the advice we give parents about the possible side effects. Can you help us distinguish, you know, sometimes kids do, in fact, have some common side effects from vaccines. What's the difference between a side effect and a safety risk, as you see it?

[00:54:00]

[Catherine Kennedy]

Well, I'm a nurse, not a doctor. And so, you know, for me as a bedside nurse and a nurse in general, you know, some of the things that we look at, or we even ask the physicians, you know, when we are giving these immunizations, we ask to see if we can give the baby Tylenol, you know, kind of to help ease the pain of multiple injections. I mean, that's just something that we do. As far as the other part, I'm going to lean towards my physicians to ask.

[Senator Hassan]

What I'm just trying to get at is there are obviously side effects when you get a vaccine. It doesn't mean it's a safety risk, but you do perhaps feel a little bit different after you've gotten the vaccine. And so how do we talk about that?

[Dr. Paul Offit]

That is a great question, because I think the language around it is confusing. When you are given a vaccine, you develop an immune response. So the immune response means that your body is making a variety of immunological proteins to fight off this either a natural infection or to induce an immune response against the vaccine.

[00:55:03]

Some of those proteins cause symptoms like fever or headache or muscle ache. I mean, I'll give you a perfect example. I had a friend in North Carolina who volunteered for one of those early placebo-controlled prospective trials with either Pfizer or Moderna. So now he doesn't know what he's getting. He's getting either a vaccine or something, a placebo like salt water. So the next day after getting it, he wakes up and he has low-grade fever and a headache. And he looks at his wife and says, yes, I got the vaccine. See, we need to figure out a better way of characterizing these signs and symptoms that are just associated with the immune response. Because when we call them side effects or adverse events, it makes it sound like it's a bad thing, whereas actually it's your body working to protect you against a future infection.

[Senator Hassan]

OK, one other follow-up. And I will just start by saying, and members of the committee have heard me say this, my grandfather started practicing pediatric medicine at Children's Hospital in Boston in 1921. So I grew up with him telling me the difference between practicing medicine before penicillin and before these vaccines and after he stopped practicing in the mid-'80s.

[00:56:09]

So he saw this huge change. And he always said the two most important public health developments in the 20th century were clean drinking water for everybody, for all those patients, and vaccines. And so as we talk about what vaccines do and don't do, in recent weeks I've had people say to me, I'm for vaccines that prevent transmission, but if they don't prevent transmission, I'm not for them. And that seems to me to be framing the science in an odd way, as I understand vaccines. But there are vaccines, you know, we all hope that vaccines will prevent the infection in the first place. But if they don't, is there a way they are effective still in terms of reducing symptoms or transmission?

[Dr. Paul Offit]

Yes.

[00:57:00]

The goal of vaccine is to keep you out of the hospital and to keep you from dying. That's the goal. For these so-called short incubation period diseases like influenza or SARS-CoV-2 or respiratory syncytial virus, you're never going to eliminate those diseases. Even if 100% of the world was vaccinated, those viruses are still going to circulate. They are. They mutate and they're going to do this. Even if they don't mutate, they'll still circulate. You can eliminate the diseases that have so-called long incubation periods. There's reason for that, which I can go through, but just because I'm like a science nerd. So to avoid you having to be put through that, I think the long incubation period disease, you can eliminate. Measles is a long incubation period. We eliminated it from this country by 2000. It's come back because a critical percentage of parents are choosing not to vaccinate their children. Rubella, German measles, another long incubation period disease, we eliminated by 2005. Polio is a long incubation period disease. Eliminated it from this country by 1979. Smallpox is a long incubation period disease. These other diseases are going to circulate forever. Rotavirus, for example, is a short incubation period disease.

[00:58:00]

We basically eliminated the 70,000 hospitalizations from that vaccine. But that virus still circulates in the community, still causes mild disease. Still children can show up in the emergency department. They just don't get admitted. So a reasonable goal for a vaccine is to keep you out of the hospital and keep you out of the morgue. Thank you. Preventing transmission is a high bar. Thank you very much. Senator Kim.

[Senator Kim]

Senator Kim Questions

Thank you so much for coming on out here. I'm a father of a 7-year-old and a 9-year-old. A lot of active conversations with parents right now about these types of topics. And what I found interesting when I'm talking to these other parents in my community, in my neighborhood, is, you know, there's obviously a conversation about the data. But then there will also be these conversations of stories. And what I find really fascinating when we think about it, when we're talking about communicating, how do we communicate to the public, a lot of times we're talking about storytelling. And there's the quantitative aspect, the data. But then there is the qualitative aspect. And what I find is when I talk to someone who says that they know somebody in the family or in the neighborhood, in the community, in the state, or they saw in the news of somebody whose kid got autism or some other type of real safety risk, it's amazing how difficult it is to overcome that through data alone.

[00:59:20]

So I guess I just wanted to ask you, you know, with some of these cases that you've heard about of someone getting autism and people thinking maybe it's because of the vaccine or something else, have there been like high-profile studies of some particular cases to try to understand what exactly happened? You know, I know there's the data you're talking about, not showing linkages between vaccines and those particular safety risks. But I think sometimes, like, you know, having those specific instances or having specific examples of cases and trying to tell that story through that qualitative way too, you know, might be something to be able to engage.

[01:00:01]

I know you can never do that for every single concern out there and every single risk that's been raised. But I just wanted to ask you, you know, as I'm trying to think through how to tell this story, are there examples like that that we can draw upon?

[Dr. Joshua Sharfstein]

Thank you for asking that question. It's a really good question. It's a tough one. Because for an individual person, it's very hard to look and prove one thing or another. It may be that you could do a big evaluation of a particular child with autism and actually find that maybe they had congenital rubella or there was some actual known cause. But for most kids, you will never find that. And so the way we have to assess whether there's a cause is through these bigger studies and whether the kids who got vaccinated got autism versus the kids who didn't or all the different studies that have been done. So it makes it hard to go back to a story and say, you know, we can clearly disprove that in this particular case, because the nature of how you would look at this question is by looking across many, many others.

[01:01:03]

It comes up a lot with vaccines. For example, there are people who have a heart attack after the COVID vaccine. You know that so many people got the COVID vaccine, so many people get heart attacks. Then, you know, well, did it cause the heart attack? You can't look at an individual and say, well, was it the COVID vaccine that caused the heart attack? But you can look across many people who got the vaccine and say, clearly, there's no relationship. It is a coincidence and not a cause. And that's the strongest nature of the evidence against autism and vaccines. But I would say that there are other stories that we can tell. And usually when I'm presented with stories, you know, I do think it's important to engage at the level of stories. And often I will tell about my son, who I went out and purchased a vaccine that had just come on the market or was recommended because I was terrified of pneumococcus, which can cause a horrible meningitis. And I'd taken care of. I paid for the vaccine out of pocket.

[01:02:00]

And then people were wondering why I did that in the daycare. And one of the other kids got severely ill not too long after, you know. And there are many people who have suffered vaccine preventable illnesses. Their stories are really compelling. And so it's important to engage at the level of stories. It's just not exactly sometimes the story that we might wish we had.

[Senator Kim]

Yeah, well, I was thinking about because, you know, I thought Senator Hickenlooper's story was very powerful. And I think, you know, this committee and those of us in this field, I think we should be thinking more about that. You know, I will tell you, you know, if you go to someone that has doubts and you just say, you know, here's the data, it doesn't work, you know, for a lot of folks. And so, you know, you were talking about, you know, some of these outbreaks, measles outbreaks that have been happening. Like, you know, has there been the kind of like do we have the kind of storytelling there to be able to backtrack that, look back and show that that particular outbreak was caused because of a cluster of children or others that were unvaccinated? Like, is that do we have that kind of fidelity there?

[01:03:01]

Yes.

[Dr. Paul Offit]

So two things. First of all, anecdotes are emotionally compelling. They are. And it's often hard to argue that against that with statistical evidence. And I'll give you a perfect example. My wife is in private practice pediatrics. She goes into the office on a weekend is helping the nurse give vaccines. There's a four month old sitting on her mother's lap while my wife is drawing the vaccine up into the syringe. The four month old has a seizure, goes on to have permanent seizure disorder, epilepsy, and dies at age five of a chronic neurological disease. Now, if she had given that vaccine five minutes earlier, I think there are no amount of statistical data in the world that would have convinced her that it wasn't the vaccine that did it. Right. You think I'm stupid here. I give the vaccine. Now there's there's my child has a seizure and now is dead at age five. I know what I saw. I'm the mother of a vaccine damaged child. So you're right. It's hard to argue that now you can do studies with that vaccine and look to step at hundreds, hundreds of thousands of people to see that you're at no greater risk of getting, say, seizures if you got the vaccine or if you didn't. But, you know, that's less compelling than what that person saw.

[01:04:02]

But you're right. It really is a matter of telling stories. I mean, in Philadelphia in 1991, you know, we had a measles epidemic that killed nine children and caused fourteen hundred cases. I mean, people were scared to death to come into the city. It was it was a frightening time. And and and having lived through that time, I mean, I know what those deaths look like and what those children look like. And so that's what you can argue on the other side. But it's hard. It really is hard. It's sort of like your anecdote with their anecdote. It's hard. So I just want to.

[Dr. Greg Gonsalves]

This may seem like a departure, but in the early 2000s, there's a president of South Africa who said HIV wasn't the cause of AIDS and the drugs were poison. Right. Absolute science denialism said, you know, you should not take these drugs. You should think about a healthy lifestyle and eat beetroot, ginger and garlic. And what happened is there was community education. It wasn't just anecdote. The two of us on a playground, it was a systematic civil society driven health education, which turned the tide among people who had very little formal education, understood the science of HIV, understood the science of the drugs.

[01:05:07]

So we can't do this on a one on one basis. We need a public health approach to health education. And I don't know what the prospects are in the in the current environment for doing that, but it's not going to be those one on one conversations are going to be able to scale it up. So we can do it on a massive scale to push back against science denialism, whether it's vaccines or HIV.

[Catherine Kennedy]

Let me just say this, you know, when I was living in San Francisco, I this was the first time I've ever taken care of a woman who had tetanus, you know, and and it it is a something that you never really want to see. She was a young woman in her 30s, intubated, was on many vasopressors to keep her blood pressure up. It was horrific. She survived, you know, and and recognizing that, you know, it would have been if she would have had the tetanus shot, she might not have been in this particular position. So, you know, as as the doctor was saying, it's going to take all of us really to educate the public, our communities, our families and our patients, because you don't want to see what it looks like if the disease were.

[01:06:10]

[Senator Sanders]

Thank you, Senator Markey.

[Senator Markey]

Senator Markey Questions

Thank you. When I was a boy, I got a smallpox vaccination. Everyone did. No question. I was in a class. It was 60 boys, six rows of 10 apiece, 60 boys, one room. At the American Conception Games next door. Six rows of 10 girls separated. One child got measles. We all got measles. I got measles. One child got mumps. Everyone got mumps. One child got chickenpox. We all got chickenpox. Everyone accepted it. No one went to a doctor. It was just the way it was.

[01:07:00]

Everyone got it. Then a year older than me. In the class of 60 boys, one year older than me, this great boy down our neighborhood, Albert Caddy, who I looked up to. He got polio. There was no vaccine. Then one year later, Albert Caddy was in my grade, but now he had crutches and he had braces on both legs. There was no vaccine. Then they made the breakthrough, Jonas Salk. All of the children were recommended to get the vaccine. But there were some questions out there. So no parent had gone to college. So everyone was a blue collar parent. In my blue collar, my father was a truck driver. So Sister Superior wanted everyone to get a vaccine. But the key person was the school nurse.

[01:08:02]

The mothers wanted to talk to the school nurse. So it was her that my mother was talking to. And her that all the other mothers were talking to who had a concern about it. Because they needed expert advice. They didn't have that. So my question to you, Miss Kennedy, the nurse, how hard will it be to convince people to get vaccinated if the Secretary of Health and Human Services is saying vaccines may not be safe? How much harder will that make your life?

[Catherine Kennedy]

Well, you know, Senator, I've been a nurse for 45 years. And it is about relationship building and trust. And over the years, having been in the neonatal intensive care unit for 20 plus years, you know, it was important to first to get that trust of the parent.

[01:09:06]

And it is about constantly talking to them about what the expectations are. As I said when I first spoke, some of our neonates stay in our NICU for a long period of time. So they may receive their two-month immunization. So we talk to them constantly because they're coming to see their baby every day. So it's getting them to keep repeating the information, not two months, you know, just having that trust. And so it's really important. And we continue to not give up.

[Senator Markey]

Will it make it harder if Robert F. Kennedy Jr. is the Secretary of Health and Human Services? He's raising questions about the safety of these vaccines.

[Catherine Kennedy]

No, because we're trusted. Nurses are trusted. We have that relationship. Is it going to take more energy and work? Yes. But that is something that I think that we have to do because the risk, you know, to me, the benefits outweigh the risk.

[01:10:00]

And so having that constant communication and education of the parents about immunizations is very important.

[Senator Markey]

Dr. Offit, what is the impact of disseminating misinformation regarding vaccines if Robert F. Kennedy Jr. is the Secretary of Health and Human Services? How time-intensive is it to combat misinformation with your patients?

[Dr. Paul Offit]

So Robert F. Kennedy Jr., when he founded Children's Health Defense, did it specifically because he is trying to get information out there to scare parents about vaccine safety or to undermine vaccine efficacy. He's been doing this for 20 years, and he's good at it. I mean, he's definitely eroded confidence in vaccines. The mere notion that he may be Secretary of Health and Human Services has made it even harder just recently. I mean, I have many more questions from parents than I did before because before he had the advantage of having a famous name, now he has the advantage of being considered for this position. At least for me, he's made it much harder.

[01:11:03]

And I really worry about this. You're already seeing the effects of that. You're already seeing an erosion in vaccine rates. And so the question is, how bad does it have to get before we realize that we have made a terrible mistake? He means it. He's a zealot. He believes that we have traded infectious diseases in for chronic diseases. He's a believer. He sees someone on a hiking trail, and he goes up, and he's holding a baby. And he tells the parent, don't vaccinate this child. And he will say, I believe I've saved this child. This is not the person who can be the head of Health and Human Services. I'm sorry. I know I'm supposed to not swear guns.

[Senator Markey]

I agree with you 100%. This dissemination of misinformation is very dangerous. Because parents are going to be relying upon the experts. And otherwise, it's going to have to be a retail effort by doctors and by nurses in order to get out the fact.

[01:12:03]

Dr. Gonzalez?

[Dr. Greg Gonsalves]

Yeah. There will be other kinds of appointments made in this administration.

[Senator Markey]

Other kinds of what?

[Dr. Greg Gonsalves]

There will be other appointments throughout the HHS bureaucracy, into the White House, et cetera. The target here is misinformation, right? We can play whack-a-mole with Robert F. Kennedy or Dave Weldon or any of the other nominees that are in line to take over as HHS agencies. We have to have a way to prospectively and constructively fight back against misinformation. Because in four years, after this administration is gone, we are still going to have misinformation to deal with. So we need a constructive plan of moving ahead together, clinicians, epidemiologists, politicians, public health officials to do this. And so, yes, there are imminent threats, and it's not just about one person. It's about a whole set of people who could erode our confidence in vaccines, destroy key programs that are about vaccination in this country. But let's keep our target on misinformation.

[Senator Markey]

Dr. Shashti, if Robert F.

[01:13:03]

Kennedy Jr. is the Secretary of Health and Human Services, and then his philosophy is spread across the entire federal health infrastructure in our country, how dangerous would that be when it comes to the public having confidence in vaccines?

[Dr. Joshua Sharfstein]

So I have three types of concerns, whether it's Robert F. Kennedy or others who have expressed similar views. One is their understanding of how vaccines work and whether vaccines work. Because there have been statements made that vaccines haven't made a difference when, in fact, as we've all talked about today, they're so critically important. So really understanding the value of vaccines is very important. And at times, he has departed greatly from scientific understanding of the value of vaccines. The second is about vaccine safety, saying things that are false, misleading about what vaccines could do. And the third, which I think is sort of tends to come with the other two sometimes, is attacks on the people who are responsible for keeping safe and effective vaccines available and making sure vaccines are safe.

[01:14:11]

[Senator Markey]

Expand on that. I think that's an important point.

[Dr. Joshua Sharfstein]

Well, as I said before, at every level of the vaccine development process through review and approval and recommendations, it's not a big, you know, nameless, faceless bureaucracy. They're actually people at every level. I've gotten a chance to work with them. They are absolutely devoted to their jobs. They're the very people that you would want to be assessing the safety of products that we're going to give our children. They are devoted. They are thinking about their own kids and grandkids and the kids in their community. And there have been very unfair statements about whether they are corrupt or whether they are stupid and, you know, all kinds of accusations about them.

[01:15:05]

It's demoralizing to the people who do that work. And there are many people in that whole process who work at the department.

[Senator Markey]

And when you're talking about people who are demoralized, who are those people in our public health system?

[Dr. Joshua Sharfstein]

Sure. Well, they're nurses. They're doctors. They're scientists at the CDC, at the FDA, at the other parts of HHS. They wake up every day with the goal of keeping kids healthy and protected in this country. And so the things that have caused me concern about him in particular, but more generally, are effectiveness statements, safety statements, and statements that I think are totally unjustified and unfair, attacking the very people whose job it is to keep us safe.

[Senator Markey]

And I agree with you. I think Robert F. Kennedy is dangerous and unqualified to be the Secretary of Health and Human Services, especially in this era where disease can travel from country to country, continent to continent, just in a plane ride.

[01:16:11]

And we need people who can respond. And you mentioned that, Dr. Gonzalez, the bird flu, if it explodes, we're going to need to have some confidence, especially in those people who should be vaccinated, you know, that they can trust the government when they say it's safe. They can trust the medical community. And I'm just very afraid of Robert F.

Worst Case Scenario with Misinformation

Kennedy's candidacy.

[Senator Sanders]

Let me pick up on a point that Senator Markey made. Give us a worst case scenario if you have a very articulate, aggressive leadership in this country casting doubt about the efficacy of vaccines. So what? What happens? I mean, is it a big deal? Are you worried about it? Or is it just not something that we should be concerned about?

[01:17:03]

Give me a worst case scenario. What possibly could happen? What could go wrong under that scenario?

[Dr. Greg Gonsalves]

So this is beyond vaccines. We're not supposed to talk about RFK, but RFK questions the fundamental basis of German theory, right? It's going back to the 19th century and miasma, bad air that causes our health conditions from chronic to infectious diseases. So we need leadership to face. We're 42nd in life expectancy in the U.S. and we're going down. Right. You know, this is pre-COVID. We have existing public health disparities that we need to face and we need to base it on science. And if you have leadership, whether it's an HHS or it's in the White House, the question of the fundamental scientific integrity of the work we do as public health officials and as clinicians, we are in deep trouble. It's going to be hard to quantify whether it's infectious disease outbreaks or changes in public health. It's infection practices, funding to local, state and health departments.

[01:18:03]

You could make a whole list of things that could happen beyond vaccines. We're not in a good situation and sugarcoating it is something we don't want to do. But we have a major problem ahead of us and we're going to have to face it together.

[Catherine Kennedy]

And also in our in our communities, when you talk about that, there's such disparities already. And it is really important that, you know, we give the correct information and, you know, that we really think about those at risk communities. And I'm talking about lower socioeconomic communities. Communities of color. The importance of making sure that you have that information to everybody. Access is so important. So there's a lot of things. And I agree, you know, that this is just a worst case scenario.

[Senator Sanders]

Dr. Chastain.

[Dr. Joshua Sharfstein]

Sure. You heard from Senator Hassan about her grandfather who started practice in 1920.

[01:19:00]

Back then, it was not uncommon for kids to die before they were one or five. Everybody knew someone who's had a kid. I think at one point early on, a president's child died while he was in office. And today it's, you know, it's just an awful rare event when a child dies. In general, we're talking about childhood vaccination. We're talking about protecting that progress and making sure that we don't have outbreaks that are putting many kids at risk, putting kids with cancer and other immune conditions at risk, putting small babies before they get a chance to get vaccinated at risk and really changing our whole relationship to the health of children. And that's why you see so many people who are very worried about the prospect of us slipping back and having these various diseases where it's that haemophilus influenza meningitis that I talked about or other conditions coming back and taking the lives of our children.

[01:20:02]

Dr. Olson.

[Dr. Paul Offit]

Measles. Measles is the one that's going to come roaring back. It's the most contagious of the vaccine preventable diseases. So, for example, there is something scientists use called the contagiousness index, meaning how many people would you infect during the day if you had a disease and everybody you came in contact with was susceptible? So for SARS-CoV-2 influenza, that number is around two to four. For measles, it's 18. Measles, it spreads like wildfire. The example I gave earlier about the Philadelphia measles epidemic in 1991, you're pulling one child after another out of a house who had died of measles. Measles also infects the brain and can cause sort of permanent brain damage. There's also something called.

[Senator Sanders]

Let me just interrupt you. Explain to people if there is a major measles epidemic in this country in five years, what does that mean? What does it look like? It means children die. How many children will die?

[Dr. Paul Offit]

So the mortality of measles is about one per thousand.

[01:21:00]

So we're right now at about 300 cases. Get to 1,000, 2,000, 5,000 cases, children will once again die of measles. Also, one other thing about measles is our young physicians are not used to this virus. I mean, we had a small measles epidemic in Philadelphia just in the last year or so. Typically, when you hospitalize a child with measles, if they need oxygen for their pneumonia or they need intravenous fluid for their dehydration, otherwise don't hospitalize them. You don't want them in the hospital. In the hospital, you have children or adults who are immunosuppressed and are not going to be able to handle that virus, and it's very, very hard to keep that virus contained because it's so contagious. It's spread by small droplets. You don't have to have direct contact with somebody with measles to get it. You just have to be in their airspace within two hours of them being there. It's that contagious. I really fear we are about to see measles land is what I fear we're about to see.

[Dr. Greg Gonsalves]

One of the executive orders that came out recently was taking back vaccine refuges into the American military, right?

[01:22:04]

And I talked about George Washington and how he inoculated all the troops against smallpox. If we start seeing vaccine refusal take beyond COVID vaccines in the American military, we have to talk about its implications on defense. People in our military take many, many more vaccines than many of us take in our course of our lifetimes. And so this is not, yes, many dead children, but this has expansive, far-reaching consequences for American society and our place in the world.

[Senator Sanders]

And I would imagine there will be a massive cost associated with treating a measles epidemic in terms of hospitalization, et cetera.

[Dr. Paul Offit]

During that 1991 measles epidemic in Philadelphia where 1,400 cases occurred, our hospital was overwhelmed with that virus, as was St. Chris's Hospital. So just like COVID and early COVID, you know, you had trouble not only taking care of those patients, you had trouble taking care of your other patients. I mean, you canceled emergency surgeries because you were just you were so overwhelmed by that virus. Don't underestimate that virus.

[01:23:01]

It is a highly contagious and occasionally fatal disease. And there's another aspect of measles, which is it can cause a chronic infection of the brain that comes, that you see about six or seven years after the initial infection, which is invariably fatal. You just watch these children fall off a cliff in slow motion. I think if we had videos of that disease, people would be even more scared of this virus.

[Catherine Kennedy]

You know, then add to that mergers and acquisitions of hospitals. So in communities of color where they've closed, you know, services. So now put upon that, I mean, if we have a rise of measles, who gets to come to the hospital? Who dies?

[Senator Markey]

All right. Mr. Chairman, may I?

[Senator Sanders]

Yes, please.

[Senator Markey]

Thank you. I appreciate it. Dr. Shafstein talked about it, and the statistics are absolutely indisputable. In 1900, in the United States of America, 18 percent of all children did not make it to the age of five.

[01:24:03]

That means going from the Garden of Eden to 1900 in the United States, 18 percent did not make it to the age of five. And then a progressive public health movement began in the United States, and medical breakthroughs were made. It just changed the relationship, especially between ordinary families, blue-collar families, poor families, and health care. The Methuselah family always did well, even in the Old Testament. This was public health. Everyone was involved. And just going back to what you said, Dr. Gonzalez, about George Washington, I read that Pulitzer Prize-winning biography of him, and at Valley Forge, he had everyone vaccinated against smallpox. He wasn't afraid of the British. He was afraid of smallpox, because more people die from disease than from war.

[01:25:04]

And he knew he could not win the war if he lost the battle against disease. And that was the central lesson he brought to that battle at that time. So we're at a critical point right now in our country in terms of the Internet, its ability to disseminate misinformation. There's a Dickensian quality to it. It's the best of technologies and the worst of technologies simultaneously. It can enable, it can ennoble, it can degrade, it can debase, it can disseminate misinformation. And we know we're at a turning point here where that world's not changing. It's not changing. So I guess what I would ask each one of you as my final question, if you had a vote on whether or not to confirm Robert F. Kennedy, Jr. as the Secretary of Health and Human Services for the United States of America in 2025, would you vote yes or no?

[01:26:07]

Would you confirm Robert F. Kennedy Jr.?

Dr. Hoffman?

[Dr. Paul Offit]

I would vote hell no.

[Senator Markey]

Dr. Chomsky?

[Dr. Joshua Sharfstein]

I'm going to respect the fact that I'm not a U.S. Senator in answering this question and really just say that my concerns are based on how far what he has said and done departs from what's understood in science and, in particular, his attacks on the people who are trying to protect us. Ms. Kennedy?

[Catherine Kennedy]

You know, as a nurse, it's more about making sure that the public, the communities that we're really looking at their safety and the information is correct. Dr. Gonzalez?

[Dr. Greg Gonsalves]

So I'm not a Senator, but let's put this clearly. This candidate is so far out of the mainstream of previous occupants of this office, Republican or Democrat, that the case is clear about what should happen.

[01:27:03]

[Senator Markey]

And we will take that as a no, that was unuttered by the witness. But we thank you and we thank all of you. And we thank you, Chairman Sanders, for this very important hearing.

[Senator Sanders]

Conclusion

I want to conclude. I mean, it's, I think the point of what we're trying to do today is to make it clear that we potentially face a massive health hazard, maybe especially for our children. And I think the point that Senator Markey made a moment ago, what was it, back in 1900, 18% of kids never made it to five. That's just an enormous reality that has to be addressed. So in other words, we have made, with all of the problems that we have today, and there are many, we have made enormous progress in public health and in saving children's lives.

[01:28:00]

And what, in a sense, I'm hearing from all of you is that is in danger, that we may revert back to those terrible days when so many children died at the age of one or two or three. So that is where we are at. And I want to thank all of you for being with us today. Thank you so much for the enormously important work that you do every day. And thank all of the senators who joined us for this important discussion. Thank you all very much. Thank you.