Experts in the Hot Seat! Powering Up Vaccines in Your Pediatric Practice

 

[00:13:54]

 

Vaccines Are Held to a Higher Safety Standard

 

So, as we all talk about, vaccines are held to a higher safety standard because we are, as you know, giving them to young babies, young generally healthy babies and healthy older children and adults. So this is something that we want to give across an entire population. So the risk/benefit ratio has to be really important. Really a big consideration for families.

 

For - for that reason, tolerance for adverse events are really lower than for products that we use to treat sick people. They're closely monitored and assessed to distinguish vaccine-induced adverse events from unrelated or coincidental adverse events.

 

And serious adverse events are generally rare, and by contrast, side effects are universal, for example, for chemotherapy. So again, the patient population is really important when you're talking about these kinds of issues.

 

Vaccines are generally tested in tens of thousands of individuals in order to increase the likelihood of detecting rare adverse events. And I don't have time to go through the statistical basis for this. But you basically know that if we're looking for outcomes such as efficacy, you can actually use maybe hundreds or maybe a couple thousand patients. But if you're trying to look for safety signals, you really want to look at more than a few thousand patients, because some of these safety signals won't show up in less than, say, 5000 or 10,000 patients.

 

And the FDA, by the way, uses a definition of a rare safety signal as 1 in 1000. So we need at least a 1000 people and generally more than that. So that's the threshold that the FDA has for rare. And some might argue that that's not rare enough, but that is their threshold. Vaccine producers generally go well beyond that 1000 number, by the way.

 

And so the risks of adverse events with a vaccine is lower than the risk of complications with the vaccine preventable illness in order to move forward. And we'll talk a little bit about the next steps here.

 

[00:16:02]

 

Vaccine Development

 

So this is really a very nice schematic of what happens. But this particular schematic looks simple. But as you can all imagine, it is not a simple process. This process can take 5 or 10 years or more from the top, all the way back to a licensed vaccine.

 

In fact, the point between basic research, discovery and preclinical work, which is done generally in a laboratory, either by a pharmaceutical company or by academic institutions or other research laboratories, those studies getting to preclinical and clinical trials. Actually, many people call that the valley of death because most products don't make it that far.

 

And so 1 of the things that we hear from people is, well, everything that comes to the federal government is immediately approved. That is actually not true. These are products that have been tested for 5, 10, maybe 15 years.

 

RSV vaccines, for instance, the current vaccines we have, we got to this point because of 60 years’ worth of vaccine research. I don't have time to go through that, but we have been trying to get an RSV vaccine for 60 years. So these processes don't happen overnight, and they are not automatically rubberstamped when they get to the FDA or to the CDC.

 

The point between the research—that top basic research point and the first clinical trials point takes a long time. And then you need clinical trials, which I'll talk about in a bit, phase I, II and III trials. At that point, the manufacturer is in discussions with the Food and Drug Administration, and what they are doing is they're showing their data, their preliminary data, and asking what kinds of outcomes and safety outcomes do you want us to include in our studies?

 

So they know before they start off in this $100 million—actually, and it takes about $100 million to $300 million to get to a point where you are even close to getting FDA approval. So there's a lot of money and time involved in this. And so the companies, the manufacturers generally want to know what is it that you want us to look at in terms of outcomes, not only for effectiveness or efficacy, but especially for safety. Safety is the number 1 consideration.

 

And so by the time they get to that point, they've had discussions with the FDA. They go on ahead. And if the phase I and II and III clinical trials, I'll talk about in a bit, actually look successful, or they feel like they're moving in the right direction, then they get a biologics license application that is submitted at that point. And then at that point, the product, usually a vaccine, but other products as well, will come to the FDA.

 

Now, for the FDA and vaccines, there's a group called the VRBPAC, the Vaccines - the Vaccines Advisory and other Biologics Advisory Group. And several of our colleagues—there are many— people from many different backgrounds, including epidemiology, infectious disease, immunology, statistics, public health, many different people who are on these FDA advisory groups. And then they, along with the FDA, review these data, and then ultimately they vote. The Advisory Committee votes, much like the ACIP votes for vaccines, to recommend to the FDA what the outcome should be.

 

And the FDA obviously makes the final decision and then either disapproves the vaccine or tables it for more studies or will give approval.

 

At that point, there is a mandate by the Affordable Care Act that—sorry, the 21st Century Cures Act that once the FDA has approved a vaccine, it must be discussed at the very next ACIP meeting. So that is why it's really important for ACIP and CDC to be involved in this process all the way from the beginning, because they have to know what products are coming along the pipeline. By the time it gets approved, everybody knows it's coming up for a vote, and everybody's already been made aware of this.

 

And how is that happening? Through ACIP work groups. So there are work groups that are put together. Some of the work groups that we've been on are comprised of maybe 20 people, but most of them are 30, 40 people or more, because you have to have experts from many different areas. And they are set up well before a vaccine is even at the phase of getting a biological license application. So again, when we hear people say these vaccines are rubber stamped, they're not. It's that they've gone through this entire process.

 

The ones that have made it to this point have already been thoroughly reviewed for many, many years to that point. So by the time it gets to the ACIP at CDC, there is already a pretty good structure set up to understand how to analyze it. And the CDC staff are really the world's experts, literally the world's experts at knowing how to look at the evidence for approval or not approval of a vaccine in terms of which population is going to use it.

 

So the FDA will tell you, you can use it. Here's the data from clinical trials and here's what we recommend. But the CDC and the ACIP are the ones that say, as you all know, here's how you give it. Here's when you give it, here's how many doses you give. Here's what to do if you miss a dose, here's what to do if you have—you don't know what their schedule is like or which brand they got. What do we do about that? What about immunocompromised individuals?

 

All of those deliberations come up at the ACIP. ACIP makes a recommendation. And then at that point, generally, the CDC Director will make a final decision. Now, out of all of the decisions that have been made since the ACIP was founded in 1964, 14 decisions have not been concurrent. So it is there have been times when the ACIP makes a recommendation that the Director does not approve. So it's not that—again, they're all rubberstamped, but generally they've already been talking about these for a long time.

 

So after the recommendation is made, then you see VFC votes approved so that you can get VFC coverage as well. And then these then go to our liaisons such as the American Academy of Pediatrics, the American College of Physicians, and all the other liaisons, ACOG. And at that point, we don't - the government doesn't stop monitoring these vaccines. They continue to do what we call phase IV studies, and they look at post-marketing surveillance.

 

And so that continues forever. So we continue to look—for example, even today, I know that in April, when we were still on the Committee, we were reviewing pneumococcal vaccine outcomes. And so we still look at vaccines that were licensed 10, 20, 30 years ago to see whether there's a change in epidemiologic landscape, whether the vaccine recommendations need to be different and whether they are still as efficacious as they were, because maybe the disease epidemiology is different. So these continue to be monitored over the length of the life of the vaccine product.

 

[00:23:10]

 

Clinical Trial Development Stages for Vaccines: Safety Examined at ALL Stages

 

Now, as I mentioned, the clinical trials are really set up in this pretty as, yeah, stereotypical way, which is you start off with phase I studies, which really are maybe a few dozen to a couple—you know, a few dozen to maybe a 100 or so people. Different age groups. And they generally are really meant to establish safety in patient populations.

 

So in general, most of these studies are started in older people and then moved down the age groups to younger people. If the vaccine is going to just have a pediatric indication, they're started in older children, adolescents, and then they move to younger children and then toddlers, and then, if necessary, infants and neonates, depending on what kind of vaccine it is.

 

So the first phase is always a safety trial. And it's also generally a dose finding study as well, which doses seem to be associated with more adverse events or less adverse events. And that's where they move on to then phase II, which really are still meant to evaluate safety but some degree of effectiveness or efficacy. So just seeing whether in general strokes, the vaccine seems to be working in a particular population compared to the placebo or the control group.

 

And so some studies—because of this, you'll see that phase II trials will be in hundreds to thousands of people. And you can see there have been many vaccines that have gone through the process where they've gotten through phase I and had tremendous results in phase II. But then when building the phase III trials, they strike out because they didn't really work when using larger numbers of patients.

 

And so in the phase III trials, you're really looking for, again, safety is the primary signal. But efficacy, how well does the vaccine work in preventing whatever it is that you're trying to prevent, whether it's infection or symptoms or hospitalization or other symptoms. These outcomes have to be clearly spelled out. And they’re powered to do that. And the FDA then reviews the company's proposed manufacturing process as well at that time, because it looks like this vaccine could be potentially licensed after these trials are done.

 

And in these trials, in the phase III trials, these are trials that involve, you know, 30,000, 40,000 patients at some time. Not all trials do that, but they do generally involve thousands of patients, maybe 3000-5000 for vaccines that are being used to replace older vaccines that are already in place. But if you're using a new vaccine. So, for example, with the COVID vaccines, virtually all of the trials included at least 40,000 to 50,000 patients. So we're talking about tens of thousands of people, by and large, for brand new and brand new pathogens.

 

And then we talked about the phase IV, which again, we generally don't see in the public, but it's really what the CDC primarily does in the back - in the back room. If they're monitoring all the data coming in—and I'll talk about the data that they get—to monitor primarily safety but also efficacy. And it's really important, especially in the early days to monitor the safety signal. So for example, the first rotavirus vaccine, RotaShield, came out in 1999, that vaccine had a safety signal of intussusception in young babies, and that vaccine was taken off the market in 6 months. So that was a pretty rapid assessment.

 

It didn't come up. I was actually on the FDA Review Committee that looked at the vaccine before it got licensed, and we did see what looked like it might be a signal, but it wasn't statistically significant. In cases of intussusception in the control group vs the vaccine group, the numbers were not - they were not significantly different. But we weren't - we weren't seeing tens of thousands of kids in those trials.

 

And so once the vaccine was licensed and it started being used in thousands of children, the signals popped up very quickly and that vaccine was shut down. So that's an example of how the system works.

 

[00:27:10]

 

ACIP Vaccination Review     

 

So vaccine review by the ACIP. Just briefly the ACIP is charter allows up to 19 members. We were 17. Currently, I think there's 12 members of the Committee right at this moment. And they review vaccine safety and efficacy data. They develop vaccine recommendations and schedules on timing, dose and contraindications. And they utilize a really—and again, this is what we did prior to June of 2025. I can tell you right now that it's not clear where we're headed, but this is what the charter tells us to do and what we have been - what we have been doing.

 

ACIP: Evidence to Recommendations Framework

 

We used a very strict evidence to recommendations framework. And what does that mean? Well, this is a really interesting concept that not - that is not always used in other parts of the world. This is above and beyond what the FDA tells you when they license a vaccine for approval. This is a way that we can look at all of the different factors that go into using a vaccine in the community. You are all probably aware of some of these factors. You all deal with these every day.

 

What we try to do at ACIP is to try to quantify the impact of this vaccine on each of these factors and vice versa. So the factors are, number 1, state the public health problem. What is the problem that you're trying to solve with this vaccine? Are you trying to prevent infection? Are you trying to prevent hospitalization? Are you trying to prevent death? Sometimes you're not trying to do all 3 of those. You might just be trying to prevent 1 of those things.

 

And so you need the state - the problem needs to be stated right up front. And in the end, what we're really trying to weigh overall is benefits and harms. And what are the benefits and the harms? And this is where the work groups for each of the vaccines for each of the pathogens come up. These again work groups work together for months, if not years to try to come up with benefit and harm decisions regarding not just efficacy and safety, which is the FDA data, but they come up with other data and other studies and surveys around values. How important is this vaccine or this disease in communities around the country in subpopulations?

 

For example, a Native American population, certain vaccines might be much more important because the prevalence of a disease might be higher in that population. Mpox, for example, might be much higher importance in the LGBTQ community because of risks around transmission. And so those values need to be stated and understood. And those populations are surveyed to understand what the impact might be on those populations.

 

The issue of equity, how well can we get the vaccine? How - who's going to pay for it? Are there populations at higher risk for this disease that might have an inability to access care? And how do we build that into the way we message this vaccine?

 

Resource uses. How many resources are we using for this vaccine compared to other vaccines? We have to weigh the entire vaccine schedule. As you all know, you know, you've got lots of vaccines out there. Producing those vaccines, paying for those vaccines, using resources to distribute those also have to be taken into account.

 

So there's a particular federal budget for vaccines, we have to understand. If we use—let's just say I'll use hepatitis—I'm sorry, HPV vaccine. When we first started—if any of you remember when we first started using the vaccine, it was a 3-dose vaccine. And that was—first of all, it was expensive. And secondly, you know, getting people back for 3 doses during that age group, that pre-adolescent to adolescent group was very difficult.

 

And so there was a lot of resources for all of you and for the federal government to try to get those people back to finish the series. Well, lo and behold, over time what we found in other studies around the world and from the US as well, 2 doses worked just as well as 3 doses did. So there was a vote then to come back to HPV and say, you know, we're going to use less resources and we get the same benefits and less harms or the same harms, if you will, by using 1 less dose.

 

And actually, before June of this year, we were actually talking about considering the use of 1 dose of HPV vaccine. It is being used that way in many parts of the world, because we have lack of access to HPV vaccine outside the US. And even in the US, we're a bit constrained, but not the way they are outside the US. So that was going to be another topic for this next coming year or so.

 

And so it may be that at some point the vaccine will be dropped to 1 dose. So again, vaccine policy is constantly being reevaluated.

 

Feasibility. How easy would it be to really get this vaccine into your population? And acceptability, kind of those 2 go together. Will people accept the vaccine? And you, as providers, would you feel that it's feasible to give 1 more dose of X, Y, Z? So a lot of these surveys have to do with providers being asked, what do you think about this vaccine? Does this schedule wrong?

 

Meninge is a great example. How hard is it to give meninge? I mean, it still is 1 of the things that bothers me the most is we still haven't been able to figure that out. We're doing the best we can, but it's a low incidence but high impact disease. So we need to have it available. But how do we do it in the best way possible? And so we continue to try to think about these so that we can make it easier for patients, their families and for you as providers to really get the vaccines that are needed out and not overutilize your busy time with vaccines that may not be as important.

 

And by the way, these are things that happen with every single vaccine. And we have to do this. I have not seen any of this happen in the last 2 ACIP meetings. They're not doing this at all and we have called for it over and over. It's not happening yet. Our hope is that if we keep asking for it, that they will go back to this model because it's much more comprehensive, and it really takes into account all of the things that it takes to make a vaccine program successful.

 

[00:33:29]

 

Posttrial Surveillance: Expanded Safety Monitoring Systems and Programs for COVID-19 Vaccines

 

So what are the different methods that we use? And I'm going to speed up a bit here. You'll have these slides later. I'm not going to go through all of these, but suffice it to say that these are all of the formal federal safety monitoring programs, and these aren't all of them. These are just the major ones that we have in the US. And you can see that they involve many agencies, not just CDC. So CDC, FDA, the Department of Defense, the VA, and the Indian Health Service, to name just a few, really get involved in a lot of active and passive surveillance. And we'll talk about the differences in a bit.

 

But CDC's gold standard to me is the VSD, the Vaccine Safety Datalink. That is an amazing group that I'll talk about in a bit. And it really takes records from different health - large health organizations around the country and looks at vaccinated vs unvaccinated people to see differences in uptake, differences in outcomes for the disease that is being prevented by the vaccine, etc really guides the safety use of all of the vaccines we use.

 

The FDA also has their own surveillance system. And then you see 1 called V-safe. That's an active surveillance program as well that is utilized by 3 of these federal agencies, along with CDC and FDA. So you can see that all this data comes to CDC. So CDC ultimately works in partnership with FDA to channel this data in and really understand through active and passive surveillance if there are safety signals that need to be addressed, not only in the immediate licensure and recommendation of a vaccine, but as I said, over time, if we find signals that are popping up now for older vaccines, this - these systems will pick them up.

 

[00:35:13]

 

Types of Vaccine Surveillance

 

So types of vaccine surveillance include 2 things, passive and active. Passive surveillance has to do with just reporting. So anybody can report whatever they think. If somebody went in, got a vaccine, and then the next day they got hit by a car. You know I'm just using that as an outlier, right? You could technically say that happened because somebody might say, “Well, I was dizzy. I was not feeling well the next day and I got hit.” So the provider or the person might say, “You know, I think I was dizzy from the vaccine because that's the only thing that was different about my day.”

 

And I mean, I'm exaggerating there. But the point is, you can basically just write - and these reports are easy to get in online, and you can file these very quickly so that we can look for safety signals from general reporting that anybody can do. And those include the VAERS system and the VA and the Defense Health Agency’s Immunization Division.

 

So these are open access - open access. Actually, the VAERS is available to the public. You can open it and take a look at it any time you want and try to analyze it if you have the time and interest.

 

The active surveillance is really proactive. That's much more focused on answering a specific question and looking at specific populations in a much more statistically nuanced way. And that includes the VSD program, which includes many health organizations around the country that pull their records out and have the volume of records, in this case, hundreds of thousands of patients, to see whether the vaccine works or doesn't work and also, are there safety signals that we're missing.

 

[00:36:44]

 

Vaccine Adverse Event Reporting System (VAERS)

 

So VAERS, again, early warning system that monitors for potential vaccine safety problems. It is comanaged by the CDC and the FDA, and providers and manufacturers are required by law to report certain adverse events following vaccination to VAERS. And the website is there, easily accessible online.

 

[00:37:04]

 

Vaccine Safety Datalink (VSD)

 

Vaccine Safety Datalink conducts population-based monitoring. It's managed by CDC in collaboration with healthcare organizations. And at this point, there's an interesting issue because these data are actually owned by the organization. It's not by the CDC. So these organizations can keep their own data. They're not obligated to give it to CDC, but they do provide it, and they will analyze it and give it to the CDC.

 

So some examples of VSD studies include prenatal and infant exposure to thimerosal from vaccines and autism. Those were done by VSD as well as others. Safety of flu - of influenza and Tdap vaccines in pregnancy. And then newly licensed vaccines such as recombinant vaccine zoster vaccine in adults. And myocarditis and possibly pericarditis risk among people receiving the mRNA COVID vaccines.

 

The reason these are much more robust is because you can actually look at hundreds of thousands of patients and compare patients by age group, by gender, by other risk factors, and see control groups, those who got vaccinated vs those who didn't get vaccinated, and to see if there's different signals of under - other disease conditions. So very robust system.

 

[00:38:19]

 

Sentinel Biologics Effectiveness and Safety (BEST)

 

And then there's a Sentinel Biological - Biologics Effectiveness and Safety data set. I'm not going to spend too much time here. But it's very similar. It conducts active surveillance of biological products not just vaccines and is managed by the FDA.

 

[00:38:34]

 

Poll 4

 

So let's - we have - I'm going to take a little break here and ask you 2 more poll questions. And then we're going to wrap up my section. So in your practice, what do parents or caregivers ask most often about vaccine safety? Is it:

 

1. Are vaccines safe;
2. Do vaccines cause disease;
3. Why does my child need so many vaccines;
4. Will vaccines overwhelm my child's immune system; and
5. Is natural immunity better than vaccination.

 

I'm sure they ask all of these questions, but which one is the one that stands out to you? When you start dancing up here. That music is very cheerful.

 

[00:39:36]

 

Poll 4: Results

 

Here we go. All right, so our vaccine safe? Yeah, that makes sense. Do vaccines cause disease? I'm glad that's a lesser query. Why does my child need so many vaccines? Yeah, that makes sense. And then will vaccines overwhelm my child's immune system, at 20%. So that's a nice kind of display of what we get as well in my practice where we, you know, get the same kinds of questions.

 

Okay. Well, let's move on to the next question.

 

[00:40:07]

 

Common Misconceptions Around Vaccines

 

Oh, wait, I thought I had a second question. No. Okay, good. So, yeah. You passed. All right. So thank you for that information, by the way. It really does help us to hear what you're experiencing because, you know, when you're in 1 part of the country, you might only be hearing from your little bubble.

 

So common misconceptions. Data from the National Immunization Survey reports that parents who delay or refuse vaccination, of course, were more likely to believe that vaccines can overwhelm a child's immune system or that a child receives too many vaccines.

 

And an increasing number—this is really fairly new actually, I think, given that I've been in practice for a long time. But in the last say 8 or 10 years, believe that natural immunity is better than vaccination. And we've especially heard that after COVID, I think. So this is a pervasive theme that I think many - how many of you have not heard that? Not. Because I know you're all going to raise your hands and say, yes. Everybody says.

 

[00:41:07]

 

“Children receive too many vaccines”

 

Well, okay, so children—so I'm going to talk about the first 1. Children get too many vaccines.

 

[00:41:10]

 

Current Pediatric Vaccine Schedule Has More Vaccines but Fewer Antigens

 

We've talked about this a lot, but I want to make sure that you see it again. Children are actually getting less antigens than they did before. And why is that? Because we can purify the antigens and we can produce them using recombination techniques, etc, rather than having to give whole cell vaccines that we used to have to give in the past. And we've also done a better job, meaning industry has done a better job at purifying the product. So you get a much purer form of the product.

 

So in 1980, even though we only had 7 vaccines, there were over 3000 antigens in those vaccines. And by the way, the children did okay there, but there were still a lot of fevers and sore arms in those days. But in 2021, we had - I can't count now, but there's many more than 7 vaccines there and about a 10-fold reduction in antigens.

 

So we have done a better job in reducing the number of antigens. And what does this do? Obviously the safety is important, but that's already being monitored. But it also reduces the number of reactive reactogenicity of the vaccine. So you'll see less side effects because there's less other things to cause fevers and fussiness and sore arms.

 

[00:42:27]

 

“Giving multiple vaccines at the same time can overburden a child’s immune system”

 

So the corollary to that too, is given multiple vaccines at the same time can overburden a child's immune system because people will say, “Well, we're giving so many more vaccines now.”

 

[00:42:39]

 

A Child’s Immune System Has the Capacity to Respond to Multiple Vaccines at Once

 

But we have—and there's a paper down at the bottom that you can look at. But the  immunology population has really looked at this kind of issue in children's immune systems. And as you all know well, I mean, children are exposed to thousands of antigens in their short lifetime. But this is the first time they're seeing all of these antigens. Their T-cell and B-cell repertoire is not as good as an adult, but it is very good at managing these antigens early on.

 

And so it does have the capacity to respond well. A number of studies have been done in this area. We did a lot of work in my lab with my colleague Ann Arvin at Stanford around measles vaccine and response to measles. And we see that the pediatric and the newborn T- and B-cell response is quite robust.

 

And there are some limitations, but we take those into account when we recommend certain vaccines. So by that I mean, for example, we don't give measles before 12 months of age for a lot of reasons. But the main 1 is the T- and B-cell response in a 12-month old is much better than a 6-month old or even a 9-month-old. It evolves over time.

 

And newly vaccines are tested alone or in combination, and we measure the antibody response, the immune response of B-cells and T-cells, and they are fully capable of handling this and more. So they don't weaken the immune system. They still have robust responses to other external antigens or pathogens. They protect children from vaccine preventable illness and secondary infections. And there have been a lot of studies looking at this issue, looking at when you vaccinate a child, do they have more illnesses than children who aren't vaccinated? And that has not been shown to be the case.

 

[00:44:29]

 

“Natural immunity is safer and more effective than vaccination”

 

And then the last point I have is natural immunity is safer and more effective than vaccination. Well, it could be effective. Absolutely. I mean, that's how we all got through, you know, the last, you know, whatever, 10,000 years of human evolution. One of my favorite cartoons is sad but true as 2 cavemen sitting in a cave and they're talking and one of them says, “You know, we eat clean food, we have clean air, we have clean water, but all of us die before 30.” So yes. Yeah. If you survive that measles infection, yeah, you're immune for life. Good for you. But the death rate is 1 in 3000 children under 5. Do we really want to have that risk?

 

40% of children did not make it to the age of 5 years of age in 1900 in this country. We have doubled our lifespan in this country in the last 100 years. Now when you're as old as I am, that's not a long time. So I think we don't remember those times because none of us were around back then. But we have really elevated ourselves into a really clean and healthy first world country.

 

Now, do we have problems? Absolutely. We need to clean up food and, you know, all kinds of other things. But we are living longer because we are saving ourselves from natural immunity.

 

[00:45:43]

 

Vaccines Are the Safest Way to Acquire Immunity

 

And so, yes, infection can provide natural immunity, but it may be variable or it may not be as long lasting. And also vaccine preventable illnesses cause disease. That's why we're giving the vaccine in the first place, because they can kill children, or they can put them in the hospital and cause short and long term complications.

 

In the last 30 years, almost a billion—0.5 billion children have been saved illnesses and 1.1 million deaths have been averted in the US alone just from vaccination. That's just in the US.

 

And so I will stop there and thank you for your attention. Sorry I ran over time.

 

[00:46:14]

 

Experts in the Hot Seat: Panel Discussion and Learner Questions

 

Dr Tan: Panel discussion. The questions are vaccine safety standards are higher than for other medications, but how can we effectively share this with parents and caregivers and how has the COVID-19 vaccination campaign, despite its success undermined public perception around vaccines? And how can we reclaim the narrative?

 

And there are some other questions that you guys sent in. One of them is regarding COVID vaccine development. How does safety compare with other vaccines? So, Bonnie, do you want to start?

 

Dr Maldonado: Sure. So thank you. So let me start off with the first. So the vaccine safety standards are higher. How can we share this with parents and caregivers?

 

I think, you know, you are all the experts. We're - you know, we're just reinforcing your expertise. I know for me, when I hear somebody else say something that I believe or that I do, I think, “Oh, good, I'm not the only one who's thinking this way.” And I think the first time I realized social media had an impact on the way I was going to practice was back in the like early 2000, in the aughts when I had a child with pneumococcal meningitis who came in, 6-month-old pneumococcal meningitis, and the child already had bilateral hearing loss and had come in for - you know, for antibiotics. And fortunately, it was not in the intensive care unit.

 

But I live in the Silicon Valley. So I say that because when I walked in the room, the dad was sitting there with a laptop and he had all these references and he said, so I hear and here's the data and, you know, all of this stuff, and we didn't have all the Prevenar vaccines that we have now, but he had all the data at his fingertips. That's great.

 

I want to encourage families to be partners with, as I'm sure you all do the same thing. And so that's how we partner with families. I think the problem that we have is that when there's social - with social media in the aughts was not what it is today. I mean, it's - I don't even think it's very social anymore. We should call it something else. So I think the challenge is really making sure that the families trust what you say.

 

And we know from poll after poll Kaiser Family Foundation just published a poll they trust nurses and nurse practitioners by—and who are kind of the step next to us of physicians. So they trust their providers more than anybody else, even the government or especially the government I guess nowadays, I don't know, I didn't ask about their spouse, but that could be variable too.

 

But they definitely trust you. They trust all of you. So the idea is really to feel - you know, stand firm in your beliefs. With all my years of training and sitting up here, I question myself all the time and it's okay to question yourself and go back and review the data. But once you've done that and you feel comfortable, you have the expertise.

 

And your goal is really to make that family understand that you have done your homework, and that you are there for them and they know that. I hope they know that. But if they don't remember that, you know, remind them. I mean, I have 3 kids, so I remember what it was like sitting in front of my pediatrician.

 

But I knew a lot of stuff. If a lot of these families don't know, and all they're hearing is from TikTok and other places, crazy stuff. I mean, some of it is really nuts. And so they will listen to you. And I think if you just share that kind of - the kind of information that I just talked about, they'll - I think they will understand.

 

The other thing is around COVID. This happens—I mean, I think we went through a history, a historic traumatic event, global traumatic event. I mean, this probably hopefully will never happen again in our lifetimes, I hope. But everyone is still traumatized. And you all know how to deal with patient trauma. And you know that it doesn't stop right away.

 

In fact, it probably accumulates. People are in denial for some time and it pops up later on. So we're still going through that, I believe. And so I think, again, the issue here is really to help people start to rebuild that sense of security that they have with you and that sense of trust. So there's no magic bullet.

 

The other thing that we used to do before the pandemic, I mean, I've been doing vaccine work forever and giving vaccines and doing clinical trials. And I remember that there's always been an anti-vaccine group. And it's normal for people to be contrarians. There's just some people just don't trust in the same way as others.

 

Benjamin Franklin was an anti-vaxxer, and it's sad. But he said that was the 1 regret of his life when he probably should have had more. But that was 1 regret of his life. But that regret was that his son died of smallpox. And he said, “I should have listened”, but it was scary. It was a new concept. I don't know if you've seen the cartoon of somebody getting the vaccine and little cows popping up all over their body.

 

So I think people naturally are skeptical of new things sometimes. And I think that's your place. And you all are so good at helping people transition into more trust. So I do think that those populations, there are some people that are just not going to listen, and you already know, walking in the door, you know who they're going to be, I bet.

 

I bet how many of you know when they walk in that they're not going to listen? Yeah. So you know that population and you still have—I mean, many of us still work with those families in other ways because you want to protect their children. But I spend most of my time trying to talk to the people in the middle who really do have good questions and just want to understand and reassure the people who already understand and just want to be reassured that that they're working with you in partnership. So I know it sounds pretty simple, but I think trust goes a long way.

 

Dr Tan: Yeah. And 1 other question here is, how can we explain in layman terms that there are less antigens in that the child is receiving when you're giving more vaccines?

 

Dr Maldonado: Yeah. So I think it's important to put it in context. Like I teach undergrads and I teach medical students. And when I go back and look at the history of—you know, I teach a class on the history of plagues, which is—I mean, I only just do a couple lectures on that. It's a little scary. But we see that over time, we had different methods back in the old days. Right?

 

In the old days these kids are like 2000, right? 2000 or maybe 1990s. But if you go back when we were first giving vaccines, our technology was a good technology and we were really screening for safety. But why not make something better? Look at - and we get new iPhones? It feels like I just bought my iPhone and now we have a new iPhone. So we're always improving on things that are really good already.

 

I mean, I think my iPhone is much smarter than I am already. I don't need another 1. But I mean - and so I think trying to put it in terms that people can understand, we use the best technology that we had when we had it for MMR, for DPT. By the way, MMR is still made the same way as it was back then, so we still did a pretty darn good job. So you can say, “Look, most of them were great”, but if we were able to refine the process, we did refine it. And even when we use those old methods, we still tracked safety. We've always tracked safety.

 

So I think 1 of the things we can always tell families is that safety is always the first - the primary outcome we look at with any of these trials, and we're just able to build even safer vaccines that have less side effects, and that the side effects we're talking about for these vaccines are really mild compared to—I mean, again, febrile seizures we know came up recently with MMRV, but we all know as pediatricians and pediatric providers that we've seen febrile seizures for lots and lots of reasons and we know how to deal with them and how scary they are. But we know that we can get the families through to the other side.

 

Dr Tan: So you want to go to your key takeaway points.

 

[00:54:38]

 

Key Takeaways

 

Oh, yes. Sorry. Yes. All right. So let's go to my key takeaways. So vaccine hesitancy, as we all know, is a public health threat. It really is a public health threat. We've seen measles outbreaks now. We've seen a polio case in the US which we thought we would never do. And papers that I've written and other people have written around the country that have—we've modeled what's going to happen in the next few years.

 

We think that with current vaccination levels, we are going to see millions of illnesses from measles, rubella, polio and diphtheria because of current coverage levels dropping. We are going to see potentially measles return to this country in the next 6-10 years and polio as well. So we don't want that to happen. And I don't think families want that to happen, but I don't think they understand the context the way you all do.

 

So vaccine safety concerns contribute to hesitancy, which is why your primary question that your families ask you is, are vaccines safe?

 

Safety is a priority throughout vaccine development and approval. Trials involve tens of thousands of patients with multiple monitoring systems, even after the vaccines are licensed. And they don't overburden a child's immune system and they are absolutely a safe - safer alternative to natural infection.

 

And you might hear somebody say, “Well, you know, I had the measles or we all got measles in my day, or I got the flu, and I'd rather get that.” But you're playing with—you're gambling with something because the risks are maybe 1 in 1000, 1 in 3000. But if it happens to you, it's 100%.

 

So we want to make sure that we keep that in mind as we talk about vaccines and vaccine safety.

 

[00:56:25]

 

Posttest 1

 

So I think I have a post test. Okay. So a parent - is this one? I do this one?

 

Dr Tan: Just go ahead.

 

Dr Maldonado: Okay. A parent wants to reduce or space out their child's vaccines, owing to concerns that children today are exposed to too many vaccines and giving too many vaccines overloads the immune system and is unsafe. So all of the following are valid responses, except:

 

1. Although children are exposed to more antigens and vaccines today, the benefits outweigh the risks;
2. Immune responses to multiple vaccines are similar to vaccines given individually;
3. Newly licensed vaccines are tested alone and in combination with other recommended vaccines; and
4. Vaccines are held to a higher vaccine safety standard than other medical interventions because they are given to healthy individuals.

 

So just pick.

 

Dr Tan: They - they are going to vote again.

 

Dr Maldonado: Yeah. So you can vote again and just give us the answer that you think is not valid.

 

I think we already voted on. But this is the post test. So you're supposed to do better this time. Did pretty well last time.

 

[00:57:48]

 

Posttest 1: Results

 

There you go.

 

Dr Tan: Excellent.

 

Dr Maldonado: Excellent. Great job. Give yourselves a round of applause. Good job. All right. Thank you.

 

Dr Tan: That was absolutely fabulous, Bonnie.

 

[00:58:10]

 

Vaccine Messaging: Following the Evidence to Change Attitudes and Behaviors

 

So Jennifer's going to give us the next talk. And basically her talk is Vaccine Messaging: Following the Evidence to Change Attitudes and Behavior.

 

[00:58:21]

 

Poll 5

 

Jennifer Walsh: All right. So we start with another poll question. Which of these approaches are you using to dispel vaccine misinformation among parents or caregivers? The answers are:

 

1. Social media posts;
2. Waiting room information;
3. One-on-one discussions; or
4. All of the above.

 

[00:59:07]

 

Poll 5: Results

 

Okay, fantastic. Looks like we've got 60% one-on-one discussions, 10% social media, 0% waiting room information, but 36% all of the above. Great job.

 

[00:59:29]

 

The 5As of Vaccine Uptake

 

All right. So as we heard this morning, vaccines don't save lives. Vaccinations do. To successfully vaccinate the 5 A's are required: access, affordability, awareness, acceptance and activation.

 

Any issue with 1 or more of these can lead to a break in the chain for successful vaccination. So with access and affordability, we definitely see significant disparities across the country. We've got a lot of great programs that work to mitigate these issues, but they're currently being threatened cuts to funding nationally and by states.

 

Awareness and acceptance. Current conversations in the media and in politics, as well as changes in the traditional science-based channels of vaccine approvals and recommendations that Bonnie mentioned are threatening these components. Additionally, the success of vaccination programs in the past have reduced the public's perceived need to vaccinate. So, coupled with misinformation, vaccination rates are dropping and we're seeing this on a daily basis.

 

[01:00:54]

 

The Vaccine Hesitancy Continuum

 

So when we think about vaccine hesitancy, it really is a continuum. Most patients live in the passive acceptance or the vaccine hesitancy, right? The vast majority of our patients. We do see active demand when there is an outbreak, like recent measles outbreaks in different geographical parts of our country or during COVID, we saw that as well.

 

But passive acceptance and vaccine hesitancy are being challenged right now because of some of the messages that they're getting. It's extremely confusing for families. Current misinformation and misrepresentation of science-based data are validating prior vaccine hesitancy and vaccine refusal, just adding fuel to that fire.

 

[01:01:44]

 

Determinants of Vaccine Hesitancy Among Patients and Caregivers

 

So when we think about determinants of vaccine hesitancy among patients and caregivers, it really comes into 3 different buckets. For contextual, we have social media and politics that have significantly changed the rules of the game. Most messages are confusing and blameful. Many are outright false.

 

As for socioeconomic, we have long seen the impact of churning off Medicaid, and there's been a lot of work among many states in recent years to reduce this issue, but current Medicaid threats or current Medicaid cuts have the potential to further devastate the socioeconomic disparities.

 

And with the crisis of reduced graduating and practicing pediatric providers, both physicians and pediatric NPs, especially in rural and marginalized communities, there's even more concern for the future.

 

For individuals and groups, we know that past experience also plays a significant role in vaccine hesitancy. There's a history of unethical medical research and treatment in our nation's history, such as the Tuskegee Syphilis Study, Sims experiments on enslaved women, Willowbrook hepatitis experiments on children, and human radiation experiments.

 

Several of these so-called studies were not very long ago in our country's history and primarily targeted marginalized communities that did not have a voice. And add to that the social environment, which is very polarizing, the rapid spread of misinformation, the algorithms on social media that reinforce beliefs or misinformation. We can understand where the hesitancy comes from.

 

For vaccine specific, as I mentioned, awareness of the dangers of these vaccine preventable diseases has decreased with the success of vaccination. Americans don't fear these diseases as we or our parents once did.

 

The velocity of the COVID vaccination led to some mistrust of new vaccines and safety of those vaccines.

 

And finally, we wait with bated breath for each ACIP meeting to determine the CDC's vaccination schedule and whether vaccines will continue to be covered. It's a very hot topic right now.

 

[01:04:27]

 

What to Do Before Making a Vaccine Recommendation

 

So what do we do? What do we need to do before we make a recommendation? So many of us already practice these techniques. Pediatric providers are excellent at providing anticipatory guidance. This includes upcoming vaccines, the vaccine schedule. It's imperative that parents and families know what's coming up.

 

Providing VIS handouts or digital copies as a standard of practice and facilitating an open dialogue is essential. Determining hesitancy and/or motivation is really key to help frame our conversations. Avoiding paternalistic talk and reinforcing that we are partners in their child's health is even more imperative today.

 

[01:05:19]

 

Making the Recommendation

 

So luckily, having a healthcare recommendation is still the most important factor determining if a parent vaccinates a child. But this is being threatened by national partisan voices. Claiming listening to experts is not the democratic way.

 

I don't know about you, but I often referred patients and families to the CDC in the past. This is no longer true for me personally. Luckily, we have the AAP. We have the National Association of Pediatric Nurse Practitioners, the Infectious Diseases Society of America to lean on for high quality, evidence-based information.

 

We're going to review some motivational interviewing techniques and strategies that are very helpful in communicating with families.

 

Remaining curious is very important. As a practicing pediatric nurse practitioner and faculty teaching future nurses and nurse practitioners, I emphasize that we need to listen to understand, not to respond.

 

[01:06:35]

 

Effective Vaccine Recommendations: Presumptive Recommendations

 

So how can we increase vaccine acceptance with presumptive recommendations? So keeping the narrative clear and succinct is very powerful. Providing a presumptive recommendation such as your child needs his or her DTaP vaccine today really does go a long way in facilitating vaccine uptake.

 

Neutral recommendations such as are you interested in having your child receive the DTaP vaccine today can further perpetuate doubt and cause a default to inaction.

 

[01:07:15]

 

Status Quo Bias and Vaccine Behaviors

 

So the status quo keeps us, as individuals, doing what we've always done. But when there isn't a strong recommendation, patients may default to inaction. We know that providing clear vaccine and presumptive vaccination recommendations increases the likelihood of vaccine uptake.

 

[01:07:39]

 

Evidence-Based Messaging

 

So how can we get across this evidence-based messaging?

 

[01:07:45]

 

RULE: Motivational Interviewing Principles

 

Some key motivational interviewing principles fall into the acronym RULE. R for resist. Resist being paternalistic with a righting reflex. Understanding their motivations, what their concerns are. Asking questions to elicit their values and concerns. Again, listen to respond. Don't listen - pardon me. Listen. That's exactly the opposite. Listen to understand, not to respond. And then empower patients to look at the issues objectively and based on facts and truth.

 

[01:08:31]

 

The AIMS Approach

 

So we have several different motivational techniques, acronyms. The AIMS approach is 1 such motivational technique to improve vaccination uptake. So it starts with announcing the vaccines that are due. Your child is due for the MMR vaccine today. Inquire about their hesitancies. Can you share with me your hesitancies? What are these based on?

 

Mirror demonstrating empathy and respect regarding their hesitation. I understand that there's a lot of misinformation spread out there. It must be very scary. And then the final S, secure trust and mutual respect by providing information that is truly addressing their concerns. Let's talk about some of these concerns. Let's talk about some of the false claims that are out there regarding MMR.

 

[01:09:32]

 

The CASE Model

 

Then we have the CASE model. So C is for corroborate, find agreement. I understand that the talk about possible mercury in vaccines is confusing and even scary. A about me. I recently attended the AAP conference and I've read a lot on this issue. S is for science. We have lots of scientific evidence that thimerosal, which is not true mercury, is a safe additive. Even with this knowledge, as a precaution, thimerosal was removed from childhood vaccines back in 2001. If they want additional information, you can explain why thimerosal was even added to the multi-dose flu vaccines. But note that all - not all patients want to hear the science.

 

And then finally explain and advise. So we not only have lots of evidence that thimerosal does not cause neurological damage. The current misinformation isn't even relevant since it hasn't been in any of our current pediatric vaccinations. This is 1 of the many reasons why we are confident about the safety of this vaccine.

 

[01:10:55]

 

The OARS Model

 

And then finally, we have the OARS model, open-ended questions such as what concerns do you have about vaccine safety? Affirmations. It's really great that you're concerned about how vaccines may impact your child's health. Reflections, I'm understanding that you're unsure about your child getting this vaccine because you want to keep them safe.

 

And then finally summarizing. It sounds like you're concerned about the side effects of the vaccine, or perhaps the speed at which it was approved. Did I miss anything?

 

[01:11:37]

 

Effective Communication With Parents/Caregivers

 

So effective communication ultimately focuses on messages that should be strong and personalized. This is what I chose for my child. This is what I recommend for my family. And also respecting autonomy of the parent or caregiver. We are partners in keeping your child safe and healthy. And I can help provide you with evidence to make this decision easier with you.

 

And I just want to note that this should also be a facility or a practice policy, from the front office scheduling to the nursing staff preparing the child for the visit and administering the vaccines. We need to make sure that the message is clear and consistent from everyone that the families interact with.

 

[01:12:31]

 

Additional Resources for Discussing Vaccines

 

In the age of misinformation, there are amazing resources to support us in communicating vaccination information and misinformation and safety, as well as tackling other misinformation out there like seed oils or raw milk. AAP and CHOP both have many resources with up-to-date information for providers and families alike. We encourage you to explore some of these resources and they'll be provided in the slides upcoming.

 

[01:13:10]

 

Effective Vaccine Recommendations: What We Need to Know and Do

 

So even if we are not up for becoming a voice on social media or TikTok or speaking nationally, there's a lot we can do locally, speaking with school PTAs, local media. At my practice, 1 of our pediatricians who recently retired, John Farber, has a blog and his communication is often posted on our Instagram and Facebook page for parents.

 

Sharing what you do at your practice with others at conferences is also a great way to learn effective methods and best practices. And tell stories, let your voice be stronger and clearer than the misinformation.

 

So I have - okay. Thanks.

 

[01:14:06]

 

Experts in the Hot Seat: Panel Discussion and Learner Questions

 

Dr Tan: The questions are why is it appropriate to use default for recommendations for vaccines vs medical interventions? And do you still make a presumptive recommendation when you are aware that the parent or the caregiver is hesitant? And how do you make a vaccine recommendation in this setting?

 

Jennifer Walsh: So those are great questions. Yes, I do still make a presumptive recommendation, but I follow it up. I might say your child's due for X, Y, and Z today, but I want to address any and all concerns or hesitations that you may have first. So I go in with that mutual open conversation.

 

We know that the vaccination schedule has been well studied, and it's the safest and most effective way we know to-date to protect children as they grow.

 

Dr Tan: So there is a question here that says, mom says, I don't want my child to get any vaccines. But when you ask them why they don't have an answer, how do you approach that?

 

Jennifer Walsh: So I usually ask them where they - what they're basing their opinion on, where they have heard this? Is it from another family member? Is it from the media? Is it from friends? Learning where they initially heard this why they don't want vaccines can help start that conversation to address some of those concerns. I think first we have to realize where it's coming from.

 

Dr Tan: One other question is, why do you no longer use CDC recommendations?

 

Jennifer Walsh: You know, as Bonnie mentioned, the - the traditional process that we've all relied on for decades has - has been changed. So I'm very hesitant about what is put up on the website, what is taken down. We know there's lots of different lawsuits out there. But I want to make sure that the information communicated is evidence based. So I know that the AAP and other types of - of academies and resources are going to do that.

 

So I direct them to what I firmly believe and trust in. And I really hope I can go back to recommending the CDC in the future. I really do.

 

Dr Tan: Right. Right now, the CDC, as you heard from Bonnie, the recommendations coming out are just not valid. So really rely on AAP, you know, and all the other organizations that she mentioned because those are all recommendations that are based on science.

 

Speaker: Can you tell us what the changes are between the 2 besides maybe hepatitis B?

 

Dr Tan: Can you repeat the question?

 

Dr Maldonado: So the question is, what are the changes? So again, so just to give you a timeline, the June meeting and then the September meeting that just happened 2 weeks ago are the new ACIP members. And again, I feel a little—you know, I was on the previous committee, so I'm going to try to avoid, you know, talking about the committee members, but just talk about what happened.

 

So the votes that were held in September were—the first meeting, they didn't really—well, before anybody voted on the new committee, the Secretary of Health and Human Services told everybody that we would no longer have COVID vaccine access for anybody, that would - except for people who are 65 and older or were immunocompromised or had underlying conditions.

 

Now this despite the fact that their own people from FDA and HHS wrote a paper in the New England Journal saying that pregnant people, pregnant women were at high risk and needed the vaccine. So they contradicted their own recommendation when he went out and said nobody else can get it. At the same time, he was saying, anybody can have it, but I'm not - I'm not going to let you [inaudible], I guess.

 

And so at this last meeting, they actually had a real vote. So they voted on 3 things. They voted on MMRV, they voted on COVID, and then they talked about hepatitis B. And they - and so MMRV, what they voted on was, as we all know, MMRV has about a increased risk, a double risk of febrile seizures 8 in 10,000 vs 4 in 10,000. So they voted to not allow the first dose of MMRV to be MMRV. It has to be separate MMR plus V. Prior to that, as you all know, you could have either 1.

 

And as you know about 15% of people chose MMRV, which it's not a big issue. But the problem is it wasn't really based on new science or new data. It was just a something that they thought wanted to - they wanted it to be done.

 

The second vote was on COVID vaccines and they voted. It was 4 votes for COVID. One was to make sure that the CDC did good informed consent for family, for everybody. And they - by the way, they didn't understand at all how you actually do informed consent in your practices. They had no understanding of that, zero understanding of how you do informed consent. But they said we need to add even more things to the informed consent list, including autoimmune disease and all kinds of weird stuff that I didn't know what they were para[?] vaccination syndrome or something like that. So they wanted CDC to change the vaccine informed consent. So that was 1 vote.

 

The second vote, which didn't pass by a hairbreadth, thankfully, was to require prescriptions for COVID vaccines. That did not pass. And the third 1 was—I can't remember now.

 

Dr Tan: [Inaudible].

 

Dr Maldonado: Right. No, the third 1 was to just allow people to get COVID vaccines with shared clinical decision-making for everybody. But yeah, so everybody would be shared clinical decision-making.

 

And so then for hep B, they didn't vote because they were all confused about what - how - why - they wanted to move the dose from birth to 1 month of age.

 

Dr Tan: One month, yeah.

 

Dr Maldonado: And so people didn't really understand the concept very well. So they voted to table the vote.

 

Dr Tan: So just 1 question here, Jen. What are your most effective 1-2 liners to convince parents who are on the fence about getting vaccinated?

 

Jennifer Walsh: Well, I reissue that vaccines are the most studied in terms of—even more so than medications. They're studied before, they're studied after. They're constantly evaluated. And we know for a fact that the risk of that disease that we're trying to prevent carries so much more risk for that child than the vaccine, even theoretically could.

 

So I just kind of try to listen to them, try to educate, try to point them to the right direction. It doesn't always work. But I think most - most of our patients come to us as trusted providers, and they know that we really have the best interest of their child. I always say I'm a partner with you to keep your child safe and healthy. I don't just say healthy, I say safe because a lot of what we do. Vaccines are 1 tiny component of what we do to keep children growing up safe and healthy.

 

Dr Tan: Okay. Why don't you go on to your key takeaways.

 

[01:22:07]

 

Key Takeaways

 

Jennifer Walsh: Okay. Thank you. All right. So key takeaways. Improving vaccine confidence by simplifying vaccine messaging, using effective communication strategies and promoting vaccination.

 

Adopting evidence-based messaging, using clear, concise, consistent, presumptive recommendations, utilizing motivational interviewing. And employ strategies whichever 1 seems to work for you to help communicate with your patients.

 

[01:22:46]

 

Posttest 2

 

And I have a post-test. In discussions with parents who are vaccine-hesitant, I plan to use motivational interviewing principles.

 

1. Strongly disagree;
2. Disagree;
3. Neither agree nor disagree;
4. Agree; or
5. Strongly agree.

 

[01:23:22]

 

Posttest 2: Results

 

Jennifer Walsh: All right. Fantastic. Good job. All right. Thank you.

 

[01:23:34]

 

Vaccine Services: Removing Barriers for Children

 

Dr Tan: That was really excellent, Jen. So basically I'm just going to talk and kind of wrap up what you just heard from both Bonnie and Jen and talk about Vaccine Services: Removing the Barriers that exist so that your patients can get vaccinated.

 

[01:24:00]

 

Poll 6

 

And there is a question for you guys to think about. How do you respond to requests from parents or caregivers to delay vaccines or alter the vaccine schedule? Do you:

 

1. Inform parents that you should not deviate from the vaccine schedule;
2. Explain the risk of deviating from the schedule but to leave the decision up to the parent;
3. Work with the parent to establish an alternate schedule; or
4. Recommend the family seek care from a different healthcare provider.

 

[01:24:59]

 

Poll 6: Results

 

Excellent. You can see that, you know, you guys have different patients and basically we'll see. But it's interesting that.

 

[01:25:21]

 

In My Experience: Physician and Patient Barriers to Vaccination

 

So basically, what you need to think about, as Jen and Bonnie both brought up, is that there are barriers to vaccination, but the barriers exist both on the patient side and on the physician side. Okay?

 

So as you heard from Jen, patient barriers include the fact that there's a lack of awareness of the disease and the associated complications with it. They have a perception that vaccines are experimental, ineffective, and have no benefit, or that they themselves are at very low risk or at no risk for the disease. They feel that unnatural disease is better than receiving vaccine. And they have a lot of fear about getting the vaccines and the potential side effects.

 

But you can see there too that they're very practical issues, such as they have a lack of access to the vaccine. They are in a socioeconomic class where immunization cost would be overwhelming for them. And many times they have time limitations and they feel that they can't go and get the vaccine for their child.

 

But remember that on the physician side or the caregiver side, there are also barriers. There are some offices where they're just not comfortable giving the vaccine because they may not have the storage facility for it. They don't want to deal with the vaccine cost and the reimbursement issues, because everybody knows that you have to buy the vaccine first and then, you know, you get reimbursed for giving it.

 

And there are some people that have a lack of awareness of the vaccine recommendations and don't really understand the importance of the vaccine to protect their patients against getting disease. So but - so you can see that there are barriers on both sides that we have to deal with.

 

[01:27:49]

 

Disparities in Pediatric Vaccination Persist

 

And when you think about disparities in pediatric vaccination, these disparities continue to persist. And they actually are getting worse with regards to the new administration that has taken over.

 

There continues to be disparities in vaccine coverage based upon race and ethnicity, health insurance status, whether they're uninsured, they have Medicaid, or non-private insurance. They're in the poverty level, or they live in an area where it's very difficult for them to get the access to the vaccine.

 

And we know that all those factors don't just affect the child, but it affects the parents and the family as well as the community in general. And we know that pediatric healthcare providers play a key role in reducing all these vaccine disparities, in part by, as you heard what Jen said, providing accurate and easy to understand information to the parents and caregivers and taking the time to address vaccine hesitancy.

 

We also know that vaccine discussions are much more effective if you take into consideration cultural competence and understanding of a patient's unique experiences and beliefs, because we know that cultural incompetence can really negatively impact vaccination rates.

 

[01:29:45]

 

Addressing Disparities in Pediatric Vaccination

 

So when you try to address some of these disparities in pediatric vaccination, you want to provide culturally appropriate educational material, and you want to try to increase vaccination knowledge of the parents and the caregivers to basically dispel all the myths and the disinformation that they are seeing on social media.

 

You want to improve vaccine access by addressing financial or geographic barriers. And 1 thing that's very important is to overcome language barriers. Because if you have a patient in front of you who doesn't understand English and you're trying to explain things to them, you know they're not going to understand anything that you're saying. So you want to try to either provide an interpreter or have them bring someone with them who can translate the information that you're giving to them into their language.

 

[01:31:02]

 

Systems to Improve Vaccination Rates

 

And other ways to also improve vaccination rates are to basically, as Jen brought up, remind people that vaccinations are due. And basically the way you can do this is you can update your EMR with the patient's vaccination history so that the EMR prompts you to remind the patient that they have impending vaccines so that you can offer it to them when they come to see you.

 

The other thing is you can use different systems to notify the families that are behind on their vaccinations and remind families that they have upcoming vaccinations. And you can see there that there are a number of reminder recall strategies, combined with reminders from the healthcare provider or outreach workers. And all these will help to increase vaccination rates.

 

So you can use a text message system. You can send out letters or postcards. Many people do the automated messages from patient portals to remind patients that they have a vaccine or you can record a telephone message. So when the patient dials, basically there is a message that tells them that they need a vaccine.

 

[01:32:42]

 

Leverage Social Media to Improve Vaccine Uptake

 

And the other thing that's important is you can leverage social media to improve vaccine uptake. What's very interesting is studies have shown that fake news, misinformation and disinformation spreads 5-7 times faster on social media than scientifically sound information, and healthcare providers and healthcare organizations can leverage social media to improve vaccine rates and overcome vaccine hesitancy. And it can also be used to provide general reminders on the need for vaccines.

 

So take advantage of all the crazy social media avenues that are out there so that you can put accurate information on social media and have your patients understand when they need their vaccines.

 

[01:33:53]

 

Moving Towards Vaccine Equity by Improving Access

 

Basically, we all need to improve vaccine access. That is a major issue for many patients, especially now with all the confusing information coming out of the current ACIP, the patients don't know whether they should get the vaccine or not. So you guys really need to be strong advocates for the patient and improve vaccine access.

 

You can partner with faith-based organizations, with trusted local leaders, community groups. You can do community engagement programs where you can do health fairs, you can do vaccination drives at the local public health department, or you can do mobile clinics. And basically, sometimes we need to change policy so that if a patient needs to be on the Vaccine for Children program or they need to apply for Medicaid, we need to be able to help them do that so that they can get the vaccine either free or at a low cost.

 

[01:35:19]

 

Evidence-Based Immunization Schedule

 

And evidence-based immunization schedule, as Bonnie talked about, is extraordinarily important.

 

[01:35:29]

 

AAP Recommended Immunization Schedule for 2025: Children Aged Birth to 6 Yr

 

And the AAP has a recommended immunization schedule for this year. This shows you the schedule for birth to 6 years.

 

[01:35:39]

 

AAP Recommended Immunization Schedule for 2025: Adolescents Age 7 Yr to 18 Yr

 

And the schedule for 7-18 years. And what's important about this is that these schedules are basically scientifically sound and scientifically based.

 

[01:35:59]

 

2025 AAP COVID Vaccine Recommendations Are More Expansive Than CDC Recommendations

 

So this shows you the difference between the AAP recommendations for COVID-19 vaccine and the current CDC recommendation. And you can see that when you look at the AAP recommendation, what they recommend is that children aged 6 months to 23 months without contraindications get COVID vaccine, because we know that these younger children are at much higher risk for complications if they get the disease.

 

Also, single dose is recommended for children aged 2-8 years who are at high risk for severe COVID-19, have never been vaccinated in the past for COVID-19, have household members at high risk for severe COVID-19, or are residents of long-term care facilities or congregate settings. And a single dose for other children whose parents or guardians want to protect them from COVID-19.

 

So you can see that the AAP recommendations take into consideration all the possible problems that may occur if a child gets COVID-19.

 

If you look at the current CDC recommendations, you can see that they only recommend that children who are moderately or severely immune-compromised be vaccinated. Otherwise, you have to do the shared decision-making for children between 6 months to 17 years in order to give them a vaccine. And that's a major issue because that creates another barrier to vaccination.

 

[01:38:10]

 

Reasons to Adhere to AAP Recommended Vaccine Schedule

 

And the major reason to really adhere to the AAP recommendations. The other organizations that are coming out with recommendations is that, for AAP, they have been publishing immunization schedule since the 1930s, and the recommended vaccine schedules really take into consideration the age that a child is more likely to get a disease and get serious complications, and the age where the child will have an adequate immune response.

 

Delaying age appropriate vaccines really puts not only the child, but their family and their communities at risk for spread of the disease, as we saw in the measles outbreak, which continues to occur and there is now an outbreak occurring in Utah as well as in Arizona. So very close to here. So we need to be careful.

 

And we know that alternative vaccine schedules are not supported by evidence and are associated with a lower likelihood of anyone staying up-to-date and getting their childhood vaccinations. And changes to the recommended schedule is very much discouraged.

 

[01:39:48]

 

Responding to Requests to Alter Vaccine Schedule

 

So how do you respond to requests to alter vaccine schedules? Well, basically, as Jen brought up, you want to ask questions to find out why the parent wants to either delay or alter the schedule. And if they can respond to you, you want to listen empathetically and establish trust with them to really, you know, find out what their concerns are. And then you want to provide scientifically sound information on why vaccines are important and the reason why they need to stick to the established vaccination schedule, as well as explain what the consequences of delaying the vaccines could be.

 

And as Jen said, you want to make these recommendations strongly and you want to make them personal. So you want to say, “I gave them to my children. I would give them to all my family members.” And if a parent or caregiver refuses the vaccine, then provide them with written information that they can go over and schedule a follow up visit within 2 weeks to talk to them again about the vaccine.

 

[01:41:27]

 

Experts in the Hot Seat: Panel Discussion and Learner Questions

 

So when you look at the—basically the question. The question is, how do you navigate the divergent recommendations of ACIP and AAP and other organizations or states? And I would definitely say to do what's best for your patients, you need to look at recommendations that are scientifically based. And the current ACIP recommendations, as Bonnie told you, are not scientifically based. So you need to use AAP recommendations, the Infectious Disease Society of America recommendations, the Vaccine Integrity Project recommendations.

 

I know that there are differences in multiple states, but really stick with scientifically based recommendations.

 

The other question is what initiatives have you employed to improve vaccination rates in your community? And it's very much what Jen talked about. It really is asking questions about why parents have concerns and listening to what they're saying, and then empathetically addressing those questions and providing them with scientifically based information in order to explain to them why vaccines are so important. Do you guys have more to add?

 

[01:43:30]

 

Key Takeaways

 

So the key takeaway is that we know that vaccine equity really is important for improved health outcomes, not only for the kids, but for their families and the communities that they live in. But we know that disparities continue to exist, and vaccine disparities can be addressed through automated reminder recall systems, vaccine campaigns, and partnerships with community organizations.

 

And we know that the recommended vaccine schedules are evidence-based and designed to protect children from preventable illnesses and severe complications. And address requests for changes to the vaccine schedules with empathy and provide the parents with scientifically sound information.

 

[01:44:35]

 

Posttest 3

 

So going back to the post-test question. I have effective systems to minimize barriers to timely pediatric vaccination. Is it:

 

1. Strongly disagree;
2. Disagree;
3. Neither agree nor disagree;
4. Agree; or
5. Strongly agree.

 

[01:45:18]

 

Everyone in the Hot Seat: Patient Cases

 

Good. Excellent. Okay. So basically the next part of the symposia is going to be a series of panel discussions and audience polls.

 

[01:45:44]

 

Poll 7

 

So the first question is, how would you approach a parent who is not amenable to vaccines after you’ve addressed the misinformation that vaccines are neurotoxic?

 

[01:46:10]

 

Poll 8

 

The next question is, a parent had a severe infection to a vaccine and now refuses all vaccines for their child. How would you begin to address this parent's concern?

 

[01:47:23]

 

Panel Discussion

 

And so, if we look to Bonnie and Jen, how would you address the concern about severe reactions to vaccines?

 

Jennifer Walsh: I would start by what Bonnie mentioned about the decreased antigens in the - in our vaccines today. So that parent that had the vaccine reaction, you know, 20, 30 years ago, we're looking at much safer vaccines now. And then listening to their concerns, validating how that can be a scary.

 

Dr Tan: Well, the other thing, too, is to find out what that reaction was.

 

Jennifer Walsh: That's what. Yeah.

 

Dr Tan: Because, you know, they may say, “Oh, I had a high fever”, but they may not have had anything else that the concern was based on. And –

 

Dr Maldonado: One other thing that we've done in the past, and I know I've - you know, I get a lot of questions from practitioners around my area and other places about, you know, second dose of something like - and if you look at the data, for example, from VSD that I pointed out, they do a lot of these great studies where - because it's very hard to find somebody who's had a second reaction or even who studied that, but they can - they've taken this data where they look at people who've had vaccinations like 300, 400, 500,000 people, and then they look at the 1000 or 2000 that had reactions like more than just a fever or sore arm, something, whatever else it might be.

 

And then they look at those people and then see how many of those people had a second dose and how many didn't. And then they look at the reactions after that. And in fact, it's really rare that you see a secondary reaction after the second dose of a medication, even with pertussis, because we use acellular now.

 

So sometimes if you have a question you can actually go to tap, you know, email somebody from your chapter of AAP and they can ask the question. They either may know the answer. They'll ask 1 of us because they know us really well now. So they reach out to a lot of us who used to be on the Red Book Committee, or they can look it up in the Red book, or you can look it up there, or if it's not there, we can actually do a little bit of a deeper dive. So sometimes we can help with those questions as well, because those aren't - those are not as common as some of the normal, you know, usual questions about overall safety.

 

[01:50:00]

 

Poll 9

 

Dr Tan: So if a family refuses vaccines despite your advice, do you think it's right for clinics to have a policy of dismissing vaccine-refusing families?

 

1. Yes; or
2. No.

 

Dr Maldonado: This is real. It is very true.

 

[01:50:39]

 

Poll 9: Results

 

Dr Tan: Okay, so 62% said no and 38% said yes.

 

[01:50:50]

 

Office Policies on Vaccine Refusal/Delay

 

So there was a study that was done. And basically this was office policies on vaccine refusal or delay. And in this study, 51% of pediatricians reported that their office had a policy to dismiss families if they refused vaccines in the primary series for their children. 19% reported that their office has a policy requiring parents to sign a contract stating that their children must be up-to-date on vaccinations by a certain age, but they allow the parents to spread out the vaccines. And then 46% reported that their office will not accept patients who do not agree to vaccinate their child and follow the recommended vaccine schedule.

 

And the AAP recognizes that dismissing a vaccine-refusing parent is a very difficult decision, and dismissal can be an option after repeated attempts at educating, building trust - trust and when less dramatic alternatives are not possible.

 

[01:52:17]

 

Panel Discussion

 

So what are the appropriate practices and goals of dismissing vaccine-refusing families? Jen, you want to?

 

Jennifer Walsh: So I think working with the families, finding out if it's just vaccine hesitancy, if it's flat out refusal. And then I often ask about, you know, we're partners in keeping your child healthy and safe. This is just 1 component of what we recommend. There's many other things that we might recommend to keep your child healthy and safe, and I want you to be able to trust that I'm giving you evidence that's scientific and - and sound and everything. And just the hesitation if they don't trust, is this the right fit for them?

 

Dr Maldonado: So we really debated this issue many years ago on the Red Book Committee, the COID, the Committee on Infectious Diseases. And we really didn't want to make a recommendation actually. We didn't feel it was our place to tell pediatricians 1 way or the other, but we were told by the AAP, you have to say something.

 

And so we did write a policy, oh my gosh, maybe 10 years ago now. And we continue to reinforce it. And what we've said is basically, you know, not to pass the buck along, but it is okay to do that if you feel that that is important for your practice and you see that people - about half of practices are doing that.

 

So I do think that it is really up to your practice as a group or if you're solo—hopefully not too many solos, but if you're—you know, whatever your group does, you should make that decision together. And, you know, if people don't feel comfortable with that, then it's up to them, even within the practice. But what we wanted to do was not dictate what people should do, but that at least you have the option of thinking about that as a policy of your organization that represents you.

 

So we weren't trying to dictate 1 way or the other. We were just trying to say, yes, it's a huge problem. And this was 10 years ago when it wasn't - I don't think as big an issue as it is today, but recognizing that you need to have that back - backup from your organization, that if you do this, it is absolutely okay to do that if you get to a certain point that where you feel that's a decision you need to make.

 

Dr Tan: Yeah, I remember that meeting.

 

Dr Maldonado: Yeah.

 

[01:55:01]

 

Key Takeaways

 

Dr Tan: So the key takeaways from this symposia is that we know that vaccines are held to a high safety standard and are monitored before and after licensure for safety, and they're the safest way to acquire immunity and that the current AAP recommended vaccine schedule is very safe and evidence based.

 

And healthcare providers, all of us in this room, are the most valuable resource in addressing vaccine hesitancy. And they really should employ motivational interviewing techniques with cultural competence to understand a parent's perspective and address any misinformation that they believe in.

 

And then organizational systems such as reminder/recall strategies, social media and community partnerships can all help to improve vaccine uptake.

 

[END OF TRANSCRIPT]