ACIP September 2025 Vaccine Updates: What Clinicians Need to Know
The Consultant360 Multidisciplinary Roundtable on the September 2025 Advisory Committee on Immunization Practices (ACIP) updates brought together leading vaccine experts, including Yvonne Maldonado, MD Arthur Reingold, MD and William Schaffner, MD, to discuss the implications of recent changes to the committee’s structure, transparency, and vaccine policy decisions. Moderated by Consultant360, the in-depth conversation focused on the clinical impact of the September ACIP meeting, key shifts in vaccination guidance, and strategies for preserving clinician and public trust in immunization.
Clinical Brief: September 2025 ACIP Vaccine Policy Updates—Implications for Clinical Practice
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Concerns Over Committee Restructuring and Process Transparency: Panelists noted that recent changes to the Advisory Committee on Immunization Practices (ACIP) membership have introduced uncertainty regarding vaccine policy development. Experts expressed concern that the loss of vaccine-specific expertise and exclusion of liaison organizations (eg, AAP, ACOG, ACP) from working groups have disrupted the long-standing harmonization of recommendations across professional societies. This has led to confusion among clinicians, fragmented guidance, and diminished confidence in national vaccine policy.
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COVID-19 Vaccination and Coverage Implications: The ACIP’s vote to move COVID-19 vaccination for all ages to shared clinical decision-making was widely viewed as a step back from a universal recommendation. Experts cautioned that this shift—combined with delays in CDC director approval and inconsistent payer commitments—could reduce vaccination rates, particularly among older adults, pregnant women, and children. Panelists emphasized that COVID-19 vaccines remain safe and effective in preventing hospitalization and death, urging clinicians to maintain strong vaccine advocacy during respiratory virus season.
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Preserving Proven Immunization Strategies and Clinician Trust: The group underscored the importance of maintaining universal hepatitis B vaccination at birth and separate MMR and varicella vaccines for the first dose to sustain public confidence. Panelists warned that deviations from evidence-based recommendations could reintroduce disparities in vaccine access and outcomes. Clinicians were encouraged to counter misinformation by reinforcing data transparency, sharing personal vaccine endorsement, and leveraging motivational interviewing to maintain trust and adherence to established schedules.
Additional Resource
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Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices (ACIP) meeting information. Centers for Disease Control and Prevention. Updated 2025. Accessed October 28, 2025. https://www.cdc.gov/acip/meetings/?CDC_AAref_Val=https://www.cdc.gov/vaccines/acip/meetings/
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Consultant360: Hello, and thank you so much for joining us today for Consultant360’s Multidisciplinary Roundtable on the September 2025 updates from the Advisory Committee on Immunization Practices or ACIP. Today's roundtable will focus on what changed after September's meeting, what did not, and how these recommendations should guide day-to-day clinical practice. We're thrilled to have an outstanding panel with us today for this discussion. Let's have you each introduce yourself starting with Dr. Maldonado.
Yvonne Maldonado, MD: Hi, I am Bonnie Maldonado and I'm professor of global health and infectious diseases in the departments of pediatrics and epidemiology and population health at Stanford University School of Medicine. I'm a pediatric infectious disease physician, clinician, and a vaccine researcher.
Arthur Reingold, MD: Yeah. Hi, I'm Art Reingold. I am an emeritus professor of epidemiology at the school of public health at the University of California Berkeley. While I'm trained as a physician in internal medicine, I have spent pretty much my whole career working on vaccines and vaccine policy. I had the privilege of serving on the ACIP and in fact chairing the working group that developed the evidence to decision-making framework that ACIP has been using for several years.
William Schaffner, MD: I'm Bill Schaffner. I'm a professor of infectious diseases and preventive medicine here at the Vanderbilt University School of Medicine, and as an internist and infectious disease doc, I have a particular interest in vaccines vaccine policy. I'm a former ACIP member and have been associated subsequently with the Advisory Committee on immunization Practices as a consultant. It's called a liaison representative.
Consultant360: All right. Thank you all and thank you all for sharing your time and your expertise with us today. First, Dr. Maldonado, let's get started with you. How was this ACIP meeting different than others in the past, and what do you feel are the key clinical takeaways?
Dr Maldonado: That's a great question. Let me just say first that I have been a liaison representing the American Academy of Pediatrics, where I was the chair of the committee on Infectious Diseases for four years as a non-voting liaison from 19 20 18 to 2022. And more recently, I was a member of the ACIP until June of 2025 when my position, along with 17, the 16 other members of the ACIP were terminated and replaced by two new members within the last couple of months, 12 new members. But to put all of this in perspective, the ACIP has been in place at the Centers for Disease Control. It makes a vaccine recommendations and recommends policy to the CDC. The CDC director generally takes those recommendations into account. And over the course of those 60 plus years, only 14 of the decisions that have been made by the ACIP have not been taken on by the director, which shows you how well aligned the directorship has been with the ACIP.
In turn, the ACIP is made up of 19 members right now. It has 12 members and up to 30 non-voting liaisons from medical societies in the United States that really are primarily involved with patient care, including physician organizations and nurse organizations and allied health provider organizations as well as public health organizations. Now, what's very different, first of all, is the process by which the new members were brought in. So in the last, from when the 17 ACIP members who had been in place up through June, 2025 were terminated, most of us had spent about one to two years getting confirmed and vetted to be on this ACIP based on our expertise and our letters of recommendation from other subject matter experts in the field. At that point, within 48 hours, seven new members were appointed, eight and one had to recuse themselves, and then another five have been added on since then.
Most of these individuals, we don't really understand how they were appointed, but it seems that they were appointed directly by the secretary rather than through the normal CDC process. What is really striking about this committee now is that the expertise of the group, many of them have advanced degrees actually, all of 'em have advanced degrees in different areas, but there's a real dearth of vaccine expertise mean all object expertise, statistical analysis, expertise, public health expertise, and frontline clinical expertise as well. So, a lot of the expertise on this panel does not really address the issues that generally come up at the ACIP. In particular, four areas that we noted that have happened since the new membership started in June and September of this year include four areas that is, this group has really lacked removal of choice of vaccine options for parents and families.
And adults around the US have looked at a focus on unfounded and theoretical vaccine harms based on either no data or very poor-quality data. And really the focus on just vaccine harms has been very unusual for this group. The third is the loss of expertise. As I mentioned, we are missing expertise in many, many areas that have been, as you can see reflected here among my peers who have many, many years of vaccine policy and implementation experience. And then finally, really, and probably most importantly, a reduced sense of transparency and independence of the group. It's not clear where recommendations are coming from some of the guidance that Dr. Reingold put together called the evidence to recommendation and others are absolutely not being followed now. And then within that, there were work groups that were put together that would focus on one pathogen or vaccine.
Those appear no longer to be in place or are very limited in scope and membership. And most of the work actually of ACIP is done at the work group level where hundreds, if not thousands of hours are spent reviewing vaccines, reviewing pathogens, reviewing epidemiology before they come to the ACIP meeting. So by the time you see the meeting hundreds and hundreds of hours with dozens or more people, CDC staff and experts including ACIP members, have spent time reviewing data on evidence to recommendations, which is a very structured format to understand the feasibility, acceptability, equity resource use, et cetera, around vaccines and implementation and operational issues. That has been completely, completely absent for the last two meetings with the new ACIP. So this, I don't know what will happen in the future. Perhaps they will reinstitute evidence recommendations, which is really the foundation of how we make vaccine policy at the ACIP and therefore for the federal government and the United States population. But I really hope that those will come back.
Dr Schaffner: Well, Bonnie, I would just add to that, that if you look at the members, there's really only one I think who has substantial experience with vaccines having worked both with the American Academy of Pediatrics and is a former ACIP member. And if we look at how both meetings have evolved, that person often speaks up about the historical background of vaccines, how decisions were made, and how valid that thinking was at the time. So, I'm glad that there's at least one member of the committee who has some perspective, but that person often speaks kind of in a lonely way. He's out there as a lone wolf.
Dr Reingold: So if I might make two points to build on what Bill and Bonnie have said, first of all, the approach that we developed a number of years ago for evaluating all of the available evidence and being completely transparent in what evidence was available in support of a decision in tables that were available to anyone, everyone was meant to ensure that all the evidence would be taken into account and that there would be very clear what evidence was underlay any particular recommendation. And that process does not seem to have been used for the past two meetings. And so, the lack of transparency, I think is of concern, number one. And number two, as Bonnie has alluded to already, and as Bill, we really don't want a lot of confusion and arguments between organizations that the clinicians and others need to rely on. And so the liaisons that Bonnie mentioned being in the room when ACIP meets providing their own wisdom and knowledge and input is an incredibly important part of trying to ensure that not only all voices are heard, but that if at all possible, the American Academy of Pediatrics and all the other groups will not be wide discrepancies between what they are recommending and what the ACIP is recommending because that creates confusion and uncertainty on the part of clinicians at patients and parents.
So I think the most recent meetings, there really was not a good process in place for taking into account the very valuable contributions of the liaison members.
Dr Schaffner: The term of art and pun intended, is actually harmonization. What we try to do is harmonize the recommendations of the ACIP and all the professional groups that has worked so well for 60 years because the representatives, the liaisons from those professional societies participated fully in the discussions, particularly in the work groups. That's where the so-called sausage is made where all the discussions take place. People listen to each other very, very carefully. The liaisons are now excluded from the work group participation. And so, we have already seen in the first two meetings of this newly constituted ACIP, that there are deviations from what the ACIP has decided and what certain professional groups are advocating. Those are the sorts of questions I'm getting left, right, and center constantly. There's confusion among both patients and providers.
Dr Maldonado: And because of this confusion and this really uncertainty about how this particular group is moving forward, I would say even within the committee, it's very clear that this committee does not understand what they're doing. Now, most of us, and you can see the three of us here have been members, but we didn't just join this organization and hit the ground running. As they say, many of us have spent decades working in these areas before we joined ACIP. So, we understand how the process works. We understand how vaccine trials are run. We understand all of the implementation issues around public health, et cetera. This group has almost no understanding of any of that. So they're unfortunately asking questions at the meeting that we call Epidemiology one oh one. I mean, this is college level under understanding of what's going on or less. And that's very dangerous.
It would be, I can't imagine if you were at the Department of Defense or the State Department and you're trying to make data policy decisions on global issues, and you've never been in a room like that before or have worked in that area. These are really important issues around public health, and you need people who have had previous experience with these frontline issues. So, it's led to not only confusion for us as providers and policymakers, but even at the table, it's very clear that amongst themselves, it's not clear that they know what they're doing or that the questions are being formulated in ways that can be answered properly and with evidence and confidence. And so, because of that, most organizations now include, especially the liaisons that sit at the table. First of all, the American Academy of Pediatrics has decided not to sit at the table.
They have no confidence. And they've said that officially they have no confidence in this group now, and they are not going to be, unless changes are made, they are not going to come back to the table. They are going to continue making their own recommendations. I'm a member of the American Academy of Pediatrics since I was a medical student, and that organization has been making science-based vaccine policies since 1935. So 30 years before ACIP will continue to do so. And it's 67,000 members by and large, really depend now primarily on the American Academy of Pediatrics to understand what vaccine recommendations to take into consideration. And I suspect that's happening with other organizations as well, like the American College of Obstetrics and Gynecology, the American College of Family Physicians, the American College of Physicians, the National Association of Nurse Practitioners and others. So what we are seeing is really unfortunately, a splintering of the way recommendations are made. And prior to this time, ACIP made recommendations to CDC were published by the CDC and the MMWR and virtually all these organizations followed and harmonized with those recommendations. And that's no longer the case, which is going to lead to continuing splintering of recommendations by specialty and lack of really trust at this point in the ACIP until they decide to try to go back to that basic evidence to recommendation foundational principles.
Dr Reingold: And if I could just make two other quick points. One is, I think you now see this very unfortunate proliferation of state level vaccine advisory groups that have taken, because basically states, many states don't trust what's coming out of ACIP at the moment. So you have this utter confusion of one state setting up this one state, setting up that three states combining for this. And so, you have a lot of confusion based on that. But obviously the other issue for many patients is going to be the reimbursement issue and how vaccines are paid for. And because the ACIP recommendation is historically and legally has been fundamental to payment for vaccines for children and for elderly through Medicare and the Vaccines for Children program, there's an enormous amount of uncertainty at this point about exactly who's going to be paying for which vaccines. And that's a very large concern.
Dr Maldonado: So around that. So again, as a practicing pediatrician, I can tell you that this is a critical issue because we know that the ACIP also provides a vote for something called Vaccines for Children. Vaccines for Children covers recommended ACIP. And CDC recommended Vaccines for Children who don't have health insurance. Now in this country, about 50% of children have that need for VFC. So, if we go forward and the vaccines are not recommended or not covered by VFC, by the ACIP and the CDC, that means that half of the children in this country will not be able to afford to pay for their vaccinations. In addition, there's a recent study by a group of epidemiologists that showed that three in four children, three in four children in the United States under the age of 18 have had some gap in insurance coverage in their lifetime. So, we're talking about virtually all children in this country are going to be at risk for some degree of access to these lifesaving vaccines.
Consultant360: So, let's talk about some of those recommendations that came out of that meeting with this context in mind. First, let's go through COVID the votes around COVID. Dr. Reingold, ACIP, moved COVID-19 vaccination for all ages to shared clinical decision-making. What are the clinical implications of removing a universal recommendation, particularly for older adults? And what approaches can health systems and practices use to preserve coverage in the highest risk groups?
Dr Reingold: Well, so first, just to note that COVID-19 vaccination has been shown and boosters have been shown to reduce the risk of severe illness, hospitalization, and death from COVID. So, we have very good data that these vaccines still have value even in 2025 in this coming respiratory season. So that's an important point to make. But given that context, we would like to improve vaccine coverage in various groups, including the elderly, the children, healthy pregnant women, and the like. Because at the moment it's not very good. And so, this will, if anything, almost certainly lead to further reductions in vaccine coverage and an additional loss of opportunity to prevent some severe illnesses, hospitalizations, and deaths. So, I think that's lamentable at a population level because we know that shared clinical decision making, while it sounds good in theory, raises some challenges in the frontline clinical world where clinicians typically don't have a lot of time to have a prolonged conversation with patients. And I think the result will certainly be a further drop in COVID-19 vaccine coverage pretty much across the country.
Dr Schaffner: Yes. Yeah. So let me add a couple of footnotes to what ART has just said. The first is that that was indeed the vote, but that vote has not yet been accepted by the CDCs acting director. So, at the moment as we record this, we're in a bit of a limbo. There's another problem here because this year the Food and Drug Administration, when it licensed its updated COVID vaccine, rather than just saying, this is a safe and effective vaccine, now use, it actually got into ACIP territory because they license it with certain restrictions. They said they were licensing it for everyone age 65 and older and under than age 65, those with chronic medical conditions. So you can see we have a disparity between what the FDA said and what the ACIP voted on. So we're kind of stuck there. And furthermore, let's just say you're 52 years old and you're healthy and you go into a pharmacy, and I do say pharmacy because about 90% of the COVID vaccines that have been given, been given in pharmacies.
So, you go into a pharmacy, and you say, I'd like to roll up my sleeve and get COVID vaccine. Will the pharmacist ask for any documentation that you've actually spoken with a healthcare provider? At the moment, the large pharmacy chains have spoken on this, and the answer is probably not. But it turns out they're waiting for the CDC director to make a final decision. So, there were many uncertainties. And of course, I'll reinforce the one that art mentioned before the funding. The insurance company group has said, if you want a COVID vaccine, we'll pay for it. Whether that's true for absolutely every medical insurance plan that's out there remains uncertain. So, we're in a pretty murky area when we would all have expected clarity and precision at this point.
Dr Maldonado: And so just to add to that, one of the biggest companies, and I won't say which one it is, one of the biggest insurance companies has not yet said that they will cover the vaccine. And this company is very large, and so they haven't said one way or the other. Now, the other thing I want to bring up is that the FDA members of our own HHS leadership published a paper in the Newland Journal where they declared that pregnant women were a high-risk group that needed COVID-19 vaccines. And yet, this is the other thing that's very interesting. The secretary of HHS unilaterally without any input from anybody, made the COVID recommendations before the vote happened. So, he took the vaccine away from pregnant women, essentially did not recommend it for pregnant women, and it continues to not be recommended for pregnant women. Now, that's a problem because pregnant women we know, and they stated themselves in their own paper in the New England Journal of Medicine this year that pregnant women have more complications than the non-pregnant population from COVID.
They have a higher risk of premature birth. That data came from UCSF years ago now, and not only that, but their babies have a higher risk of hospitalization. And we know that babies under six months of age who can't get vaccinated anyway, are already at the highest risk, have the highest incidences of hospitalization of any age group except for people 65 and older. So, they have equivalent hospitalization rates if they get sick from COVID. And yet those are two populations that are not recommended to get this vaccine at this point. And again, what I mentioned before about coverage, vaccine coverage is a really big problem because many of these groups are not going to have vaccine access or be able to pay for vaccines.
Dr Reingold: And if I might just point out, if all of this uncertainty was present in June, you could say, well, there's time to figure all this out, right? Respiratory season is several months away, et cetera. This is September 29th, and we'd kind of like to be giving vaccine to people over the next month or six weeks because we know COVID is already going up in virtually all parts of the United States. And so, this continuing uncertainty when we really, at the time we'd like to be delivering vaccines to people is just not helpful.
Dr Maldonado: Well, so a little bit of a, let me give you a bright piece of bright news here. I know we don't want to be all doom and gloom. The Kaiser system is giving vaccines to everybody who wants them six months and older. And my understanding here in California is that the lines are out the door for walk-in clinics. The appointments are booked; people are getting their vaccines. So, I know that people are getting vaccines. And while the vote wasn't taken for flu, let me talk about respiratory season. It turns out we just have new data that suggests that the current flu vaccine in the southern hemisphere, which precedes our season, is actually about 50 to 60% likely to prevent serious hospitalizations from flu. So, we generally tend to follow the trend of the Southern hemisphere. So, we know that the flu vaccine is also going to work. We need to get those messages out. But as you heard, if we don't have a decision from the CDC director, it's very hard to get messaging out. Now people are trying, but we do need the federal government to back up those messages so people can get vaccinated soon.
Consultant360: Dr. Maldonado, I'll circle back to something you mentioned earlier, which is the importance about transparency right now. ACIP emphasized strengthening informed consent to include specified risks and uncertainties around the COVID vaccine. How can clinicians be transparent while maintaining confidence in vaccinations for those likely to benefit?
Dr Maldonado: Well, it's simple. These vaccines are incredibly safe. It's really easy to say, here are the risks. Now, we know that there are risks for myocarditis in a small group of young males between 16 and 33 years of age, but the risks of myocarditis or heart inflammation is much higher in all age groups if you get COVID disease. And so those are risks that we have been known. What came up at the meeting was interesting because they brought upside effects that have either low evidence, no evidence, or I don't even know what some of these syndromes were that they mentioned in terms of the side effects. So, some of these things are actually either spurious or very low evidence, whereas the data that we already have in place is highly studied, very, very rigorous. Data has demonstrated safety. So, I think the CDC may go back and review what they write for risks and benefits, but those risks are still going to fall well below the threshold for risk, for risk compared to the benefits of getting the vaccine.
And I think CDC will start to work on those. I don't know when those will come out. We don't even have, as we heard, we don't have a director's approval of these resolutions. But in the meantime, we have very, very good transparency from the previous years of giving COVID vaccine. I hope that the recommendations coming out will be balanced. Now, the good news here is that the vote was to ask the CDC to write the data. So, the CDC staff are incredibly competent and loyal and hardworking and data-driven. And so, I'm hoping that they will continue to do the same job that they've done before in making it very clear what the informed consent looks like in terms of risks and benefits.
Dr Schaffner: Miranda, what I always do when talking to patients is that I say all those wonderful things and then I bridge to something more personal. I say, I've received the vaccine. My wife has everybody in my family, including my grandchildren, get this vaccine every year, try to make it kind of a norm and to give patients a sense of comfort and reassurance that I walk the walk as well as do the talking.
Dr Feingold: And I would just add base, going back to what Bonnie was saying, that we have more data about the safety of COVID-19 vaccines from not only what were previously existing systems for monitoring safety, but several new ones putting into place specifically to monitor COVID vaccine side effects and safety than we've had for any other vaccine in history. So, it's not as though it hasn't been studied. It's not as though we don't have data and that we can't tell people exactly what the risks and benefits are. So, the notion that somehow, we haven't studied this carefully enough, we need to do more studies, but to be sure is simply not based on the historical record.
Dr Schaffner: And we have a US centricity about this. Let's step back a little bit. Our sober cousins just to the north of us in Canada approve and use this vaccine. It's used and approved throughout Europe. Our Australian and New Zealander cousins have used this vaccine. The World Health Organization approves this vaccine. We have the data from all the safety surveillance systems of all these other countries that we can add to ours, and they all reinforce each other. They all say the same thing,
Consultant360: ACIP deferred any changes to the universal Hepatitis B birth dose. The recommendation remains administration within 24 hours of birth. What evidence supports maintaining the birth dose safety nut? And how should clinicians interpret the decision to table changes?
Dr Schaffner: Well, I hope that decision to table or not do anything about that recommendation chain doesn't go into effect back in 1991. Well, let's take a step back. What's the goal of hepatitis B vaccination? It's not just to reduce or control hepatitis B, but it really is to interrupt transmission. We could be using this extraordinarily safe and extraordinarily effective vaccine, actually interrupt transmission from one generation to the next. And so, we tried before 1991 to make sure that we could interrupt transmission from the often unknowingly infected mother to her newborn baby by trying to identify those infected mothers. That did not work. We've done that experiment. And so, we decided back then the ACIP through careful discussion to do something that is wonderfully American. It was generous and it was comprehensive. We said that didn't work. We cannot tolerate even a single newborn being infected with Hepatitis B because they have a high risk, 90% risk of developing chronic hepatitis. We are going to vaccinate every child at birth. That has been a brilliantly, brilliantly successful program. Hepatitis B transmission from mother to child has essentially stopped the acquisition of hepatitis B infection during childhood and adolescence has essentially stopped. And each year that that cadre of vaccinated children grows older. We have a progressively protected population.
The early cohorts that starting to be vaccinated, imperfectly, I'm sure back in 1991, are now in their early thirties. But look at hepatitis B in the decade of the twenties. If you're 20 years old through 29, the rates have come down, I mean, dramatically. Why? Because those children vaccinated at birth with follow-up doses have progressively gotten older. They've carried that protection with them through adolescence into young adulthood. That's the time when people start being sexually active when some people start sharing needles. And there are other modes of transmission also. And so, this is a wonderfully successful program that's now being imitated by other countries. It ain't broke. We should not fix it.
Dr Maldonado: Yes, absolutely. There was the data that were presented at the ACIP meeting was stunning data. I mean, I don't use that term lightly. It was stunning. This program works very well. It is a universal strategy. Risk-based strategies are very specific for certain diseases and generally don't work for diseases like Hepatitis B for all the reasons Dr. Schaffner mentioned. But this is a cancer vaccine prevents cancer in the most vulnerable people. 90% of children who are born to are born to hepatitis B infected women and don't get the vaccine or immune globulin are going to develop chronic hepatitis, and almost a quarter of them will go on to develop life-threatening cirrhosis and liver cancer. We can prevent that. We have gone from 18,000 cases a year of liver disease. I've seen these children in the past in my practice, liver disease requiring liver transplants to less than 2000 children in the last couple of years.
And most of those came from mothers who did not have prenatal care. So, we also have to deal with the fact that we have a healthcare system that doesn't serve equitably around every patient. So, we have women who don't have prenatal care, don't have time to get tested or won't get tested. So, this universal approach really does help support the prevention of disease in those children. And we also know that children may not always get the disease from their mothers at the time of delivery. They may get it in their household when they go home. And delaying that birth dose really increases the risk that those babies might be able to be exposed in outside of the labor and delivery setting.
Dr Reingold: And if I could just reinforce what Bonnie was saying. So ,in terms of what Bill was saying, fundamentally with this vaccine and this strategy, we could eradicate Hepatitis B, by which I mean none of it existing on the planet. It would take a few, but that in theory is possible. But to reinforce what Bonnie was saying, the simplistic notion that all we need to do is test pregnant women and vaccinate the newborn babies, if their mother is determined to have Hepatitis B simply doesn't work in our fractured, incomplete healthcare system. So, we know that many women get no prenatal care and come in active labor. The same problem exists for congenital syphilis, that fundamentally we have a system that says, we'll just test all pregnant women and only vaccinated birth. If it's the baby of a woman we know to be infected, we know is going to miss out on a number of opportunities to prevent vertical transmission.
Consultant360: Dr. Maldonado, I'll ask you to expand on what Dr. Reingold is touching on here. ACIP did vote to recommend universal Hepatitis B screening in pregnancy. Can you respond with your thoughts on that recommendation?
Dr Maldonado: Well, they actually, yes, they voted on something that's already being done, and that doesn't really work that well. So it was a ridiculous vote, I'm sorry to say that. But they clearly, again, a very good example of how these people don't understand what the real world is. The real world is that this is already a practice that's mandated to be done. So they added a vote for, excuse me, something that is already supposed to be done. But the reality is we all know is real world people who do this work in the front lines is it doesn't happen all the time. Many of these women come in the door, deliver their babies and leave, and you don't get those tests, or you don't get 'em back in time. So, they're gone and the opportunity to vaccinate the baby's loss, that is why we haven't eradicated the disease yet. We've done a great job, but it's not gone yet.
Consultant360: ACIP recommended against using MRV for the first dose in children under four years because of higher febrile seizure risk compared with separate MR and varicella vaccines. How should clinicians counsel families and structure visits to implement this change while minimizing burden?
Dr Schaffner: Well, it is a change, but no new information was presented at ACIP, and many of us wonder why this was brought up. Every pediatrician and family doctor knows that MMRV if given to a very young child in that first dose, has a higher risk of febrile seizures. And I would hope that as they discuss with parents whether their child should get MMR and V separately or together if they choose to get it together, that the parents are fully informed about this risk of febrile seizures. Febrile seizures are known to every pediatrician and family doctor, and as was stated very clearly at the ACIP meeting, they have no consequence for further seizures. They're frightening to the parents undoubtedly, but nonetheless, in terms of objective medical consequences, they really have none. So, this has been well known. It's been part of the ACIP recommendations, which have emphasized and preferred giving the two separately.
But some parents, to spare their children, another inoculation have chosen to get the combined vaccine for the first dose. Now, what the ACIP has said and followed up with a vote for vaccines for children, which say they won't pay for it, that this combined vaccine should not be used for the first dose. The data were presented that only about 15% of parents had elected to get the combined vaccine. So, I hope that this does not affect actual practice in any substantial way, and that young children continue to get vaccinated with both of those vaccines once they reach four years of age, where the risk of febrile seizures drops to almost inconsequentially. Getting the second dose of that series can be the combined vaccine.
Dr Maldonado: So, in practicality, what you're doing is you're essentially going to also limit the availability of the MMRV for the second dose, because most practitioners are probably not going to want to carry three different vials, MMRV, MMR, and V, and then must decide which one to use it when. So, the practical matter is that we will not have that additional choice, and that's important. But the main issue that I think is really being stirred up, and I think the main issue that the message that's being given here is don't trust your vaccine schedule, don't trust it. And that is the message. Again, that was pervasive throughout the meeting. Again, all of the issues that were brought up were, even though the presentations by the CDC staff were tremendous and showed amazing ability to reduce infections, the committee itself focused almost exclusively on harms that again, were either unsubstantiated, no data shown, or based on one or two cherry pick papers that were poorly done and of very low quality. So, the idea here with MMRV in many people's minds is to chip away at the confidence of vaccine schedules, and that's really harmful.
Consultant360: Dr. Reingold, how might the shift to shared clinical decision making and the MRV first dose guidance affect access for patients across socioeconomic groups? And are there strategies that can mitigate disparities?
Dr Reingold: So, we already know that we have disparities in virtually every health outcome and in the United States, and they haven't disappeared. And that's certainly true in terms of vaccine coverage. And so the deep concern, particularly because of potential influence on funding and pain for vaccines, number one, and number two, people's trust in healthcare providers and the vaccines that they want to deliver, I think unfortunately is almost certainly going to increase disparities in coverage by socioeconomic status and probably by race ethnicity, which is connected to socioeconomic status in our country. And I fear that disparities are going to grow worse rather than shrink in terms of some magical solution to that problem. I'm afraid I'm not smart enough to have a magical solution to that problem. Obviously putting more burden on healthcare providers, nurse practitioners, physicians, and the like to try and keep those disparities from growing is in theory a nice idea. But in practice, I think is going to be extraordinarily difficult because of the added burden on providers.
Dr Maldonado: And it also serves to fragment the healthcare system again, where you're going to have regional, state and local approaches to trying to cover. So, for example, in the West Coast and probably in the east coast as well, there will be alliances that will try to provide coverage for vaccines for children who may not be able to get them through the ACIP and CDC recommendations. But then that means that only certain parts of the country will have access to some vaccines and others may not. And that is really unfortunate that we will have disparate care based on who happens to be your government and your legislature at the local or state or regional level.
Dr Schaffner: Art and Bonnie have described something that is profoundly said, it's an unrecognized triumph that what we have done in this country is almost eliminated disparities by income, race, urban, rural location, by which language you happen to speak at home in this country when it comes to vaccine delivery almost. And we've reduced that almost very little. And that's because we have provisioned for vaccinating essentially all our children. And if we take a step back, that would be shameful if these differences begin to recur in that population.
Dr Reingold: I was just going to add quickly that I think the other concern in terms of disparities is urban versus rural. And the fact that in many parts of our country, people, children, adults as well are going to have shrinking access in rural areas to providers, and that it's going to make it even more difficult to get people vaccinated in areas where there aren't really adequate providers in proximity to the people we need to vaccinate.
Dr Maldonado: I just wanted to mention put this all in like higher level context. In 1940% of children did not live to their fifth birthday. That was 125 years ago. It wasn't that long ago. We don't remember that. And most of those children died from pneumonia, tuberculosis, and diarrheal disease. Can you imagine if today 40% of children under five are precious children in this day and age did not make it to their fifth birthday from diseases that we know we can prevent? We in fact, from 1900 to 2000 have doubled our lifespan as if you want to think about adults as well. We have doubled our lifespan. Do we want to really go back to the days when we are dying from diseases that we know are treatable or preventable? And certainly, many of these diseases are not treatable, really. They're preventable though. And so, I think part of the problem here is people don't realize that what they've had is so passively built into the system that they don't have to think about the fact that these things could happen, but they in fact could really happen to our families.
Miranda Manier: So, Dr. Schaffner, as discussed during this round table early on, there has been some divergence between ACI P'S recommendations and guidance from professional societies this fall. How should clinicians navigate potential lack of harmonization this virus season?
Dr Schaffner: Easy question to ask and a difficult question to answer. I think those differences we have discussed extensively already are there, and they're causing a great deal of confusion. We're all going to have to work our way through this as we determine what the ACIP recommendations are, what the recommendations are from professional societies, what the recommendations are in the public health arena. And as Bonnie has said, there are already amalgamations of states, particularly in the Northeast and on the West coast that are issuing their own recommendations. Add to that, which recommendations are going to be followed by the insurance companies and by other structures that are sometimes by statute keyed on ACIP recommendations. And then also, once we get to the pharmacy, we adults want to roll up our sleeves, will the pharmacy chains honor which recommendations? It's going to be very confusing out there.
Dr Reingold: And I would just point out that at the state level, not at the federal level, but at the state level, certainly in California, and it's my understanding in virtually every state, there are any number of regulations and laws that specifically reference ACIP recommendations. In many states, we now may need to look at changing laws through the legislature because of a lack of trust in what the ACIP is recommending.
Consultant360: So finally, I'll ask this question to you, Dr. Maldonado, but I'd really like to turn it to the entire panel. What communication strategies or advice can you suggest to clinicians to help maintain trust in vaccine recommendations and evolving guidance, particularly for families expressing hesitancy?
Dr Maldonado: Well, that's really the bottom line, isn't it? And it is, again, as my friend, our friend, Walt Bernstein says, A vaccine in a vial doesn't prevent anything. It has to be given. And I just came back from the American Academy of Pediatrics Conference where we talked about this with our firm blank providers. They're doing a fabulous job. They understand all these issues very well. They are the key communicators. If you look at the Kaiser Family Foundation survey recently done, and these continue to be done, they continue to show that pediatricians, frontline providers and nurses are the most trusted source of health information. Not even TikTok ranks up there with these three providers. And so, we still have the trust of the people in our hands because we work with people face-to-face. And there are a number of techniques that people can use if they want to understand how to communicate better.
First of all, they're pretty good at it already, but there are a lot of resources on different websites. And I would guide people in particular for pediatricians to the American Academy of Pediatrics website, aap.org. They have a number of ways where providers can actually use motivational interviewing and interactions with families to understand very simple ways to engage with families, listen to them. And there are a variety of different strategies that people can use. There's a whole series of approaches that many people already use but can actually bone up on understanding how to do those even during these confusing times. I think the main key takeaways is really to build on that trust that your family has with you to not dismiss them. And these are things that I think providers know already, but just to restate them that really listening to what their concerns are and really building on the knowledge that you have, and as Dr. Schaffner said earlier, bring that personal note in. I do this because here's the data. What are your concerns? Tell me why you feel a certain concern. So, there's a whole bunch of opportunities that we can have to build on the communication skills. The other area for families is a healthy children.org website where they can go and get information from the American Academy Pediatrics. Well, I know there are other websites for other organizations, the National Foundation for Infectious Diseases, the Infectious Disease Society of America. I know providers are so busy, it may be hard for them to get to all of these, but if they just keep touch with their local chapters of their medical societies, they will also provide information. And then the other area that I think we can do communication is working within our communities. It's really important to realize that we have to leverage our relationships with our community leaders, our trusted local community leaders, what are their faith-based or others, teachers, et cetera. They are all really committed to these issues as well. And building those bridges is going to be even more important.
Consultant360: Dr. Reingold or Dr. Schaffner, anything you'd like to add there?
Dr Reingold: Well, that was, I like to point out, I don't actually inject vaccines into people, so I'm probably not the best person to answer that question.
Dr Schaffner: Well, I would just say what Bonnie has said is beautiful and to the point. And I think some of the things that all of us can do in addition to that, speaking to patients on an individual basis, is to encourage our colleagues as providers, not to give up the good fight, but to stay in there and keep promoting vaccines, as I like to say, disease bad vaccines. Good.
Consultant360: Well, on behalf of Consultant360, my thanks to Drs Maldonado, Reingold, and Schaffner for sharing their expertise and to our audience for joining us for more conversations like this. Stay with us at Consultant360.