Narrator - Dr. Abel 00:00 Welcome to HelixTalk, an educational podcast for healthcare students and providers, covering real life clinical pearls, professional pharmacy topics and drug therapy discussions. This podcast is Narrator - ? 00:12 provided by pharmacists and faculty members at Rosalind Franklin University, College of Pharmacy. Narrator - Dr. Abel 00:17 This podcast contains general information for educational purposes only. This is not professional advice, and should not be used in lieu of obtaining advice from a qualified health care provider. And now on to the show. Dr. Sean Kane 00:31 Welcome to HelixTalk. Episode 152 I'm your co host, Dr. Kane. Dr. Khyati Patel 00:35 I'm Dr. Patel, and today with us, we have our very favorite immunization expert, Dr, Lauren Angelo. Dr, Angelo, thank you so much for being back with us. Speaker 1 00:46 Oh, it's such a pleasure to be part of this conversation. Thank you for inviting me. Dr. Khyati Patel 00:50 Well, the title of our today's episode is Stranger Things, pneumococcal vaccine updates. So we're talking about strains here. Dr. Sean Kane 00:59 And just for completeness sake, we did use the word strain in the title, because we couldn't possibly pass up on a pop culture reference of Stranger Things. But when we talk about Streptococcus pneumoniae, we're actually talking about serotypes, not strains, which is a different term. And of course, this is related to two new pneumococcal vaccines that have been recently FDA approved and are now being evaluated by ACIP and the CDC vaccine schedule. So we're focusing on PCV 15 and PCV 20, these new ones, and putting it in the context of where this fits in with what we've already had on the market in terms of pneumococcal vaccines. Speaker 1 01:35 Well, it's interesting, Dr. Kane, that you talk about PCV 15 and PCV 20 as our new vaccines. But I think for the listeners, it's important to point out that these are conjugated vaccines, and so we'll explore how these differ from our 23 valent polysaccharide vaccine as we go throughout the podcast. But I think it's important to keep in mind the advantages that these might offer when we talk about the new recommendations that come about Dr. Khyati Patel 02:00 and applicability purposes, we do have a case for our audience. So let's say we consider a 24 year old female with chronic pain, anxiety and tobacco use disorder who comes to your pharmacy for recommendations regarding NicoDerm patches for smoking cessation, and you say, congratulations, that's awesome. You're starting that journey, but then you also advise her considering some preventative vaccine like influenza or pneumococcal she doesn't have her vaccine history. You know, she doesn't know that definitely. And so the question in front of you is, what would be the most appropriate pneumococcal vaccine with the updated recommendations for this patient? And so before we kind of answer the question, let's go through the details of who, what, when and why, and then we'll come back to the case again. Dr. Sean Kane 02:45 When we say the word pneumococcal disease, we're specifically talking about one particular species, which is Streptococcus pneumoniae. So pneumococcal means Streptococcus pneumoniae, and this is a gram positive bacteria that is in your normal flora, especially in your upper respiratory tract. So a lot of Healthy People will have this in their nose and in their mouth. And there's a bunch of different kinds of serotypes. Some are more associated with infection, some less, but can be a carrier for these serotypes that do and don't cause infection without actually being infected. Dr. Khyati Patel 03:18 And so the 8020 rule here too, Dr. Kane. You know, there are more than 100 serotypes known, but not all of them are causing invasive disease. About 20 of them are related to causing more of the invasive pneumococcal disease the IPD, we call it, and we focus particularly on them, because they are related to some morbidity and mortality. Transmission of this bacteria happens via respiratory droplets. This is constituted with direct person to person contact or auto inoculation occur as well where a person is a carrier in their upper respiratory tract, and some event kind of triggers them. And so the normal Flora becomes more of that invasive Flora enters the ear canal, the lungs and the bloodstream to cause infection, Dr. Sean Kane 04:02 then also these can be secondary bacterial infections after a viral infection. So as an example, someone who gets influenza or other upper respiratory tract viral infections, they can get a secondary bacterial infection. Strep pneumo would be an example of one of those. Speaker 1 04:19 And as we go through, you know, exploring pneumococcal disease, and we talk about how it's transmitted, and we talked about respiratory issues, and respiratory droplets being the primary mode of transmission. It's important to start thinking about, then, who's at highest risk for getting these and as we talk through those kind of keep that in the back of your mind, and then it helps explain who's getting the vaccine and who will be looking for in terms of making sure they're they've got these vaccines on board. The other thing to think about is, we talk about transmission. There's different factors that play a role. You know, we don't really think of this as a seasonal vaccine like we do with influenza. While it is more common in winter and early spring, it can have. Been year round, and so this is a vaccine we do just want to get on board. We're not waiting for a specific season, and then different environments might increase someone's risk, and we'll explore those, as well as some of the comorbidities that a patient might have. Dr. Sean Kane 05:14 So Dr. Angelo, in terms of how this disease presents when we say pneumococcal disease, there's a bunch of different kinds of pneumococcal diseases out there in terms of how they present. Can you give us a sense, especially from a literature perspective, of what kinds of endpoints might be out there when it comes to using a vaccine to prevent this thing called pneumococcal disease? Speaker 1 05:34 And this is a really important point, Dr. Kane, and we could probably spend all day talking about it, but you've got to be able to classify pneumococcal disease in really two buckets. You've got non invasive disease, and we even consider pneumococcal pneumonia, when it's isolated to the lungs, as a non invasive disease. We can also see otitis media as a non invasive disease and sinusitis. But those really aren't the things that we focus on when we're talking about vaccination, we really explore invasive pneumococcal disease, and this is where the bacteria has entered the bloodstream. So we see things like bacteremia, and you can have pneumonia with bacteremia, and we might see meningitis involved with this. And so when we're looking at a lot of times the vaccine approvals, or the studies that have been done, or some of the surveillance data, most of the time, they're looking at invasive disease and whether these vaccines are effective in preventing invasive disease, and these are the more serious ones. As Dr. Patel just mentioned, we talk about morbidity and mortality, it's really due to that invasive layer that we've added in terms of this bacterial infection. Dr. Khyati Patel 06:40 So thank you for that explanation, because it's really important to understand what are the outcomes and what are the target symptoms or the diseases we're looking at in terms of prevention, you mentioned earlier, Dr. Angelo that there are certain risk factors that puts a patient at a higher risk for contracting or getting the invasive pneumococcal disease. Can you provide a few examples of what they are that make patients eligible for getting the vaccine? Speaker 1 07:06 Absolutely and again, we're talking about invasive disease, mostly. So one of the things we think about are the lungs, when we talk about pneumonia and pneumococcal pneumonia, and then that potentially becoming an invasive issue. And so really anything like COPD and asthma and even smokers as adults, those are things that we look at in terms of who gets the vaccine, but there are other things. This is an encapsulated bacteria, and so we need a spleen to help filter that out. And so anyone who doesn't have a spleen, or if their spleen doesn't work as well, are going to be at higher risk for invasive pneumococcal disease. But we're going to add in other comorbidities or situations. So alcohol use disorder, we talk about cerebral spinal fluid leaks, heart disease, we talked about lung disease, a little bit, liver kidneys, but even cochlear implants, it could be an issue for invasive disease, because again, we talk about that nasal pharynx, you know, being a carrier and potentially migrating to the ear canal patients who are immunocompromised, you know, that has been a huge factor. We talk about our vaccine recommendations, and then diabetes would be another group of patients we would want to consider when we talk about vaccines for prevention children. This is a vaccine that we routinely use in all of our children, because they tend to be not just high risk for disease, but also carriers of the disease, and tend to give this to other people. So they're little vectors, and to help, you know, get them vaccinated helps prevent transmission to the rest of the population. And so we focus on children mostly when we're looking at the routine recommendations for these vaccines. Dr. Khyati Patel 08:45 And these are some great examples. And you know, hint, hint to our patient, cigarette smoking is also a risk factor, so keep that in mind as we work through the case towards the end. Dr. Sean Kane 08:56 I think you know, in order to understand where we're at now in 2022 we have to go back to understand the historical context of where all of these pneumococcal vaccines came from, right? So if we go back in our time machine all the way back to 1984 that's actually when the first pneumococcal vaccine came out. That was the ppsv 23 vaccine, and this was a polysaccharide vaccine, which means that it's based on a sugar molecule, as opposed to like a protein based antigen there, and it got its name, ppsv 2323 meaning that it has 23 serotypes that it vaccinates the patient against. This was never used in young children because they don't respond as well to the polysaccharide vaccine. They need a conjugate vaccine. Speaker 1 09:39 So what we've done to conjugate it is you take that, that large sugar molecule, and you tack on a protein. And when we do that, it shifts the body's immune response. And so in polysaccharide only vaccines, we're really only relying on that T cell independent so it's mediated by these B cells. And basically, young children, they're. Immune systems are not mature enough to mount a proper immune response to polysaccharide vaccines, and so we give them, usually starting ages two and older. But we mentioned that children are the or the population that we want vaccinated, and so by again, adding a protein to this polysaccharide, and that's what we mean by conjugated it changes it to what we call T cell dependent immune response, and so it just has a better ability for the body to react to it and mount an immune response. And in some situations, they tend to last a bit longer and just work a little bit better than pure polysaccharide vaccines. So then in 2000 along comes our first conjugated pneumococcal vaccine. It covered seven serotypes. So again, we're talking, you know, as we talk about strings Stranger Things being the title of this, we've got seven serotypes covered in that original conjugated vaccine. But really, we're able to use that now in children, which was a huge win when we talk about pneumococcal disease prevention. Dr. Sean Kane 11:05 And just for completeness sake, we have seen this scenario played out with the Meningococcal vaccine. So there was a non conjugated or polysaccharide vaccine called minimum that was actually discontinued in 2017 in favor of a conjugated version. There's a couple different brand names of that, but it's a quadrivalent, or four different serotypes conjugate vaccine that, again, replace that polysaccharide vaccine. Speaker 1 11:29 And I think it's important to point out the serotype right? So they all covered four serotypes. This was very easy to say, okay, hey, polysaccharide you're not working that. Well, we've got this conjugated vaccine and we're covering the same zero type. We're just going to move over to using conjugated vaccine for all of our populations. We're not there yet with the pneumococcal vaccines because of that serotype coverage. And we'll talk about that a little bit further with the polysaccharide. And that's 23 serotypes versus our newer ones that cover 15 and 20 respectively. Dr. Khyati Patel 12:01 And before we jump to the 15 and 20, we had number 13. So in 2010 a PCV 13, which, you know, protects against 13 different serotypes of streptococcus pneumonia, was introduced, and this was indicated in kids, adults 19 and 64 with various immunocompromising conditions and in 2014 you know, CDC also came out and recommended it for 65 and older. And this I remember very specifically, because it stirred up this confusion as to who gets what vaccine in the presence of that ppsv 23 and now the PCV 13 being available. And I still remember California public health department produced this really nice schematic that I used to use to kind of clear that confusion for my colleagues in the in the clinic. And talking about confusion, you know, I feel like that was the goal with the new vaccine recommendation that CDC had, was to simplify it and lo and behold, we'll clarify that in a little bit. But when we talk about all these different vaccines, and you know, what do vaccines really do for prevention of that morbidity and mortality? Well, we couldn't have found a better success story. And you could find surveillance data as well as the ABC reports, and you can visibly see as these different vaccines were introduced. We're talking ppsv 23 for the PCV seven and the PC PCV 13 and the recommendation of PCV 13 in different age groups. We saw the disease activity decrease. We saw the invasive pneumococcal disease rates also decrease in population, all across Speaker 1 13:42 the other layer to this too, that you know, has factored into some of the newer vaccine recommendations is, again, we talk about kids transmitting disease to our older patients, and so as all these kids are getting vaccinated with, you know, in particular, PCV 13, but historically, PCV seven, rates dropped in adults even if they hadn't been vaccinated. And so it was, you know, the serotypes that were found in those vaccines that were being prevented in adults. And so it's working, right? And in terms of, you know, vaccinating one population to protect another population. And so I think you know, as we increase our vaccination rates in kids. You know, they're already really good, as we see that improve. You know, maybe we're not going to be vaccinating as much in the in the older adults. And you know, that's something to pay attention to as time goes on. Dr. Sean Kane 14:34 So, Dr. Patel, we have PCV 13, the conjugate ppsv 23 we've got really good data saying that we're doing a good job of preventing this invasive disease. We'll pat ourselves on the back. Why on earth do we need more pneumococcal vaccines if we already have this really good success story with what we've already had historically? Dr. Khyati Patel 14:53 And I think that's why we bring in the expert right to talk about why is there a need to bringing two more conjugated. Seen on the planet. Speaker 1 15:01 Well, as we talk about the serotypes, got that polysaccharide covering the 23 serotypes. So, yes, it covers the most serotypes. However, effectiveness against preventing we talked about invasive disease has only been about 60 to 70% in fact, there was a study done in Germany focusing on one specific sero Well, looking at different serotypes, but one of the serotypes that emerged from that study was sero group three. So it's kind of been a new focus, as some of these vaccine manufacturers are looking at their studies, but really had no protection against that sero group three. And unfortunately, serogroup three was a predominant cause of invasive disease in adults 60 years and older. So okay, we've got polysaccharide vaccine doesn't work quite as well as a conjugated vaccine, and that sero group three protection wasn't awesome. So what else can we do? And we look at again, that conjugated vaccine effectiveness and data overall has been pretty good, but again, we don't have the same coverage. So when we're only talking about those 13 zero type versus something that maybe would be more coverage. You know, you've got to balance the pros and cons. And so we can look at different populations. And I think, Dr. Patel, you're talking about the adult data that we we tend to look at as well when, when ACIP is making those recommendations. Dr. Khyati Patel 16:19 And so talking about the data with the PCV 13 vaccine. Doctor Angelo, you know, we have the surveillance report published from CDC recently that looked at from 1998 to 2019 they looked at the rate of invasive pneumococcal disease that was caused by the PCV 13 serotypes among various different population. And we can see that there was a good trend of decrease. So if you look at 65 years and older patients, there were, you know, back in 1998 45 cases per 100k population, it went down to six cases per 100k population. You know, we have examples of similar success in ages 19 to 64 and even younger kids as well. And so again, this kind of speaks to our conjugated 13 valent vaccines success story. Dr. Sean Kane 17:11 But again, one of the problems is that we're only covering 13 of those serotypes, and since 2011 we have seen an increase in certain serotypes that are not covered by PCV 13. That almost makes intuitive sense, right? So we're kind of preventing some of these serotypes, and then the ones that we're not preventing are more likely to kind of take up shop in the normal floor of your population. Dr. Khyati Patel 17:32 And I think in one study that Dr. Angelo you mentioned, that looked at population in Germany, and serogroup three was one of the groups that was not covered kind of emerged as an evidence. We do have another study. It was a large study, prospective that included about 12,000 adults 18 and over who had confirmed community acquired pneumonia between 2013 and 2016 and we found that significant number of patient we're talking 27% of pneumonia cases, these are radiographically confirmed cases of community acquired pneumonia that were positive with serotypes that are covered by PCV 20 vaccine. And so there is a significant portion of patients who weren't getting covered with the traditional or the previous vaccine recommendations we had in place. Speaker 1 18:23 So I think that created the argument for Okay, for adding these additional serotypes, and it's helping to prevent disease that are in the serotypes, not in 13, but are found in particular, PCV 20. You know, therein lies. I guess the decision to consider that vaccine as part of our recommendations. Dr. Khyati Patel 18:43 While it's good to look at the rates of IPD decrease, we got to look at the vaccination rates too. So there is a 2018, vaccine coverage survey by CDC that looks at how many people got how many doses of pneumococcal vaccine. And you'd be surprised to review the numbers and find that we have lots of people unvaccinated still, and so I'll give you one example, 19 to 64 year old patient population with underlying condition, those who received more than two doses of either vaccine, were only 7.5% what are we doing with the other patients? Right in that particular group, the rate were a little bit better in 65 years and older. So overall, vaccination rate was 69% but those who received two or more doses again of either vaccine, we're referring to ppsv 23 or PCV 13 were only 32.3% and you could look at this survey and find more data in regards to how there was discrepancy based on, you know, different racial groups and stuff like that too, where we found the non white patients to have received less vaccine than you know, their white counterparts. Dr. Sean Kane 19:54 And just to reiterate that this is a huge opportunity for pharmacists, right? So pharmacists in the community, who enter. Interact with patients, either the 18 to 64 year olds that have certain health conditions, we're not vaccinating them well at all, and even among the older patient population, many of those patients are only getting one vaccine when they would be indicated for two. So certainly, there's a lot of opportunity here for both education and helping patients understand that they are at risk for an invasive disease, and there's a vaccine to help with that. Dr. Khyati Patel 20:22 And so fast forward to today. We do have, as Dr. Angelo mentioned earlier, two new conjugated vaccines, the PCV 20 and PCV 15. So let's kind of dive into the details and the nitty gritty of what the clinical evidence has been and how has FDA approved it, versus what the ACIP recommendations were for them? Dr. Angelo, let's get started with PCV 20. The brand name is Prevnar 20. I believe this was approved by FDA in June 2021, but we didn't quite put in practice just then, because we were waiting for a group called ACIP to ponder its evidence. Can you provide a little bit more detail? Speaker 1 21:02 Absolutely, so I think it's important to back up a little bit Dr. Patel and explain how this all unfolds. Right? So you've got a vaccine that comes to market following FDA approval, but we're probably not going to be putting it in patient's arms right away, because there's this other group called the Advisory Committee on Immunization Practices. They meet several times a year, and in their meetings, they're reviewing the data when new vaccines are approved, to determine where they go with that information. And then that's still not final. So they'll vote at the ACP meeting, and it's really neat. You can go to their website. You can look up the ACIP meetings. You can see their meeting minutes, you can see their presentations, you can see how they voted. And so that usually creates a lot of talk and activity out of that, but we still have to wait for the CDC to sort of finalize that recommendation. And so that's usually the next step that happens once ACIP makes the recommendation and then moves on to the CDC to basically make it a policy. And so when these vaccines were both PCV 20, and then we'll talk about PCV 15 in a minute, were both approved in the summer. They weren't discussed until the October 2021, ACIP meeting, and at that point a vote was made. And at this time, both vaccines were only available for adult patients, so they only focused on the recommendations in adults. And then fast forward to CDC final approval. And now if you pull the schedules that were launched, I think end of January, early February, for the year, you'll now see these two new vaccines listed in the adult schedules for patients. And so we're going to break that down, talk about who gets what and how that unfolds. And so again, that PCV 20, which is that conjugated vaccine that covers 20 serotypes. What was interesting is they got approval for invasive disease, but also for pneumonia. So it sort of expanded their approval a little bit, but this was for only adults who are 18 and older. So this is not a vaccine that's currently approved for children. Dr. Sean Kane 23:08 And then in terms of how it got approved, what were the typical endpoints in the clinical trials to prove that this is an effective and safe vaccine? Speaker 1 23:16 So a lot of times they're looking at, well, what are the recommendations we currently have available. How well are those working? And then, what does this add to it? And so starting, really, with older patients, there's one study that they use 60 years and older, comparing it with the 13 valent conjugated vaccine. And so you could get PCV 20 or PCV 13, but we'll also include that ppsv 23 because that was part of the current recommendations for a lot of our older patients to get both vaccines and so. So it sort of leveled the playing field a little bit by comparing the 20 valent conjugated with the 13 plus the polysaccharide. So they were looking at, you know, healthy or immunocompromised patients you could have other underlying medical conditions, which, again, is good that we're looking at that, because that's who's getting these vaccines. But they're they're really only looking at geometric mean titers, and so they're not looking at in these studies, are these vaccines preventing actual disease occurrence? They're looking at the body's immune response once you give a dose of the vaccine. So it's hard, right? And it's going to be probably another year or two before we have more data in terms of vaccine we call effectiveness versus in these studies we're looking at, we call vaccine efficacy, and so really looking at non inferiority, so saying, okay, the vaccine is no worse off than the vaccines we currently have available. And so that's how you know, a lot of the the manufacturers move forward with FDA approvals, again, looking at the body's immune response, not again, the effectiveness, which is preventing disease, but efficacy, which is the vaccine's ability to. A mountain immune response and making sure it's not inferior to the vaccines that we currently have available. So that's sort of what they were looking at in that population. They also looked at 18 to 59 years old, sort of the same process, saying, Hey, if you get the new vaccine, 20 valent and conjugated vaccine versus the vaccines that we already have, which would again, PCV 13 plus or minus ppsv 23 what are we looking at? And again, you know, they're not showing that it's any worse off, and in some situations, might be a bit better. The other layer, you always say there's safety and efficacy, right? So they'll look at efficacy, but they also have to look at safety and making sure there's no alarm signals that come out of these trials. And so with the conjugated vaccine, even though it's additional coverage, very similar adverse effects. You're going to have pain at the injection site, potential muscle aches and pains, fevers, headaches that are all self limiting, typically go away, you know, in a day or two. Dr. Sean Kane 26:01 So in terms of, again, the kind of clinical efficacy data we're primarily looking just at, you know, the amount of antibodies in your blood, the specific serotypes we're not yet looking at clinical outcomes. Is that different than what we saw with the PCV 15 data that was submitted to the FDA? Speaker 1 26:18 Not really. So, again, they're just looking at, what does your body do when we put the vaccine in your arm. So similar approach, actually very similar trial designs in terms of what they're comparing it to. I think the big difference, though is with PCV 15, that brand name is Vaxneuvance. Keep in mind, it only has two additional serotypes that aren't in the PCV 13, and that's really been the focal point. So you'll hear over and over again, 22F and 33F as kind of being the focus because those serotypes aren't in PCV 13, and that vaccine is now approved for children. So that was one big difference. When we talk about PCV 20, we've got PCV 15 available for ages six weeks and older. So it does open up that option when we talk about vaccinating children. We'll explore those vaccine recommendations here in just a minute. But again, they're looking at, you know, taking the 15 Valent vaccine, comparing it to PCV 13, looking at various populations. And then again, they're just, they're measuring the geometric mean titers response to that vaccine and making sure it's not worse off. And so again, non inferior to PCV 13 that we already have available. Dr. Khyati Patel 27:37 Thank you for that perfect review. Dr. Angelo, what went behind and what was reviewed, as far as clinical data when FDA approved it, and what kind of outcomes did ACIP consider and their deliberations, just for the completeness, like the audience should know that both of these vaccines are available in pre filled syringes. Makes job a little bit easier, and the dose is point five ml given im usually in deltoids. And the unique thing about both of these vaccines is that they're kind of milky opalescent suspension that has to be shaken. So you have to kind of suspend by shaking them prior to the injection. So it's a little bit different than your other pre filled syringes, where you attach the needle and then off you go. So something for administration purposes, we need to keep that in mind. The storage requirements are that you store them at refrigerator, and the PCV 15 requires protection from light, so the handling requirements are pretty similar among both of the vaccines. So Dr. Angelo, you know, you provided a really good clinical review of you know what outcomes ACIP considered when they endorse the vaccine. Let's now provide audience the overview of how CDC adopted the recommendation into the adult schedule. And we can't talk about the new recommendation without pondering how bad and complicated the older recommendations were, Speaker 1 29:04 it has been confusing, just sort of a point of reference, ACIP, over the past 10 years, has either changed or revised their recommendation 10 times. So for those of us working in the vaccine world, just keeping up with that has been a challenge, so it's great to have podcasts and webinars and other educational initiatives just to figure out what's going on. Dr. Khyati Patel 29:26 And so absolutely. Dr. Angelo, it is confusing, but I would have to give props to CDC for giving us clinicians two tools to lessen the confusion. One other tool is a schematic of, you know, when to give what vaccine depending on what the patient has received in the past. And the other tool everybody is up on technology is using a phone app. So there is a phone app just specifically designed for figuring out the pneumococcal vaccine recommendation from CDC, and we'll be putting the links to both of. These tools on our show notes and reference section, Speaker 1 30:03 and the app is great listeners as you follow along, you can use the app to help solve the case, to figure out what vaccines our patient needs. It works well. I love it. It's definitely a good resource. So thanks Dr. Patel for mentioning that. Have to wonder if that's part of the reason why we see vaccination rates so low in that 19 to 64 age group with comorbidities or other underlying conditions is we're just not putting the word out there that they also need the vaccine. We do a pretty good job with our older folks and our kids, but we're also missing that group. So I just want to walk through that one more time in terms of who's in that that range, because that factors into the new vaccine recommendations. When we look at folks who are 19 to 64 years and again, we're looking at what puts them at higher risk for getting invasive pneumococcal disease, we're looking at heart disease, and that includes congestive heart failure and cardiomyopathies, and we don't include hypertension in that. There's nothing about hypertension that increases someone's risk for pneumococcal disease, but other heart conditions we look at lung diseases, COPD emphysema, smoking, asthma, chronic liver disease, alcohol use disorders and diabetes are all factored into this group. And so Dr. Kane mentioned earlier, great role for pharmacists, pharmacy technicians, to be looking for these individuals as you're filling prescriptions based on maybe their drug profile. You know, they could be good candidates for this vaccine. So over the years, they were getting ppsv 23 which is the polysaccharide vaccine. And then when they turned 65 we would give them the conjugated vaccine, and then they would get another dose of that, ppsv, 23, one year after that. And so making sure there was a five year interval between both polysaccharide vaccines, I probably lost half of you by now already, because already we're confusing, but that's what we've been trying to do. Then there's this other whole population when we talk about being immunocompromised. And so you've got anyone 19 years and older with immunocompromising conditions, or if they have a spleen that doesn't work, or they don't have a spleen, then they are sort of at this higher risk. And so they got the conjugated vaccine that was PCV 13, and the polysaccharide 23 Valent vaccine. And there was really an only eight week interval in between the two doses, because we wanted these vaccines on board to make sure they were well protected. Then this group, because they're at such high risk, got another dose of that polysaccharide vaccine five years later. And I think as I'm telling the story, you can kind of follow through that this conjugated vaccine just seems to work better. So usually it's a once and done. When we're talking about adults, when we talk about polysaccharide vaccine with shorter duration of immunity, we are having to redose or boost every few years. So then you've got this younger population who then will eventually get older, and so when they turn 65 we're going to give them another polysaccharide vaccine, and again, making sure at least five years have spanned since that last dose, there's a whole nother population that is also at high risk that we talked about, and those are cerebrospinal fluid leaks or cochlear implants. So a little bit different than that immunocompromising group, but if they are 19 and older with either of those conditions, they did get the PCV 13 and the polysaccharide ppsv 23 eight weeks later, but they didn't read dose in five years, so that that was only just the two. And then when they hit 65 they then got another dose of the 23 Valent vaccine. So again, just again, keeping track of who got what, when and what were their medical conditions were. That was fine. That's what we were trying to keep up with. That's what we were trying to do. And then along comes 2019, and some new ACIP recommendations. And so we talked early on about how well these vaccines have worked in kids to prevent disease in older adults, and I think that data was starting to be apparent. So ACIP looked at that and said, Well, hey, maybe in our 65 years and older, as long as they don't have immunocompromising conditions, maybe they don't necessarily need both vaccines. And so they instituted what we call shared clinical decision making, and so this is where we look at the patient's risk factors and decide, did they really need both vaccines or not? Okay, so we were doing that, trying to keep up with all those things, and then we've got, now two new vaccines on the market, and that was kind of that's been a game changer in terms of what we've done with recommendations. Dr. Khyati Patel 34:41 So Doctor Angelo, as you were saying all this, my head was spinning. And I can't believe all these years we practice with this confusing recommendations, and when they really introduce that clinical decision making, it muddied the water even more. So I'm excited to see if our head can start spinning now with the. New recommendation. So let's lay that out for our audience. I would say they're simplified. Speaker 1 35:06 They are, but there is a complicating factor in that we have now two new conjugated vaccines. My rule of thumb hands down, when you look at our patients and we're talking about our older folks, or 19 to 64 with risk factors, make sure they have a conjugated vaccine on board. Start there, and then figure out what that vaccine was and what they need to do, but hands down, conjugated vaccine. So that's always the first question to ask. The second layer, you look at then age, and then you look at their underlying medical conditions or situations that determine what to do next. So we've got, say, our group that's 19 to 64 years old with some of these high risk conditions. So you've got a couple options. You can give the conjugated vaccine that covers the 20 serotypes, so that's PCV 20, and call it a day, you're done, or you can give PCV 15, which covers the 15 serotypes, but keeping in mind, it's not as many as 20 and not nearly as many as that 23 so what we'll do with that PCV 15 group is that that's the vaccine we opted to use. They then still need the ppsv 23 just to get more coverage, and we'll give that to them a year later. You could consider your very high risk immunocompromised patients a shorter window of time between doses at an eight week interval, just like we were doing previously. But that's really up to the clinician and patient to decide. Dr. Sean Kane 36:40 So Dr. Angelo, just to kind of summarize for the audience and for me, because my head is still spinning, the newest recommendations are, if you are younger, 19 to 64 with immunocompromising conditions, or you're older, 65 years or older, regardless of immunocompromising conditions, both camps have the same effective recommendations, which is, you either get PCV 20 one time, or you get PCV 15 plus, ppsv 23 either eight weeks later or a year later, depending on your risk Speaker 1 37:12 factors, correct, and I would insert not just immunocompromising conditions, but all of those high risk medical conditions we've been talking about. So any of those patients would qualify. So your diabetes, your smokers, your asthma, alcohol use disorders, heart, lung, kidney, all those diseases still factor in. So that group is there. It's just the immunocompromising group. We could say, shorten that interval to eight weeks, but all of those patients fall into this category. And then, Dr. Kane, as you mentioned, 65 and older, same recommendations. So it does make it a lot easier. Conjugated on board, which conjugate did you use? Was it the 20 or 15? If it was the 15, they're going to get the polysaccharide vaccine, typically a year later. Dr. Sean Kane 37:59 So Dr. Angelo, are any of these patients getting redosed with ppsv 23 because earlier on, some of the recommendations were getting two to three doses in a lifetime of ppsv 23 Speaker 1 38:10 so if we're following these new recommendations, and sort of similar to the case that Dr. Patel presented at the beginning, where they haven't had the vaccines, or we don't know their vaccine history, then no that we're just doing that ppsv 23 that one time, typically a year later, after the PCV 15, if we gave PCV 20, then we don't even bother with the polysaccharide vaccine. I think right now, where it's going to get confusing is if patients have been previously vaccinated. So we do have to look at their vaccine history, and that's where we're saying, okay, maybe someone did get PCV 13 already. Now, what do we do? The recommendation currently is we're going to follow the old recommendations. So if you do have someone with PCV 13, it is possible we're going to follow that more complicated series of the ppsv 23 vaccination, and then the repeat in five years, repeat at age 65 just depending on their situation. And so if you do have a group like that, you do have to go back and use the old recommendations. Dr. Sean Kane 39:14 And then we're not focusing on kids today, but very briefly, in terms of the pediatric recommendations, you'd mentioned that PCV 15 is indicated for children, but PCV 20 is not yet indicated for children. Could you just briefly comment Speaker 1 39:28 on that? Yeah, so when that came out, where now we have PCV 15 available for ages six weeks and older, ACIP had that discussion at one of their recent meetings over the summer, so they voted. Now we're just waiting for the CDC to adopt that recommendation, but the vote at this time was that PCV can be used in these young kids as part of that routine series, so it'd be an alternative to PCV 13, but they're not giving any preference to one back. Vaccine or the other. So you would use basically what you have available, whether it's PCV 15 or PCV 13, but no preference given to either vaccine, Dr. Sean Kane 40:10 and no PCV 20, because it hasn't been studied in that very young age group yet. Correct, correct. Speaker 1 40:15 So they're probably working on some studies, and we'll probably see some of those new approvals, you know, in couple years time, but right now, we're working with 20 is only available for 19 and older, and then we've got PCV 15, six weeks and older. Dr. Khyati Patel 40:34 So I love simplicity, and I know that with the PCV 15 and the 20, we're simplifying the schedules a little bit for all the different populations out there, which is a good thing. So what do we do if we have the stocks of PCV 13 and 23 toss them out the door. What's the utility of those two older vaccines? Dr. Angelo, Speaker 1 40:55 we're not going to be using PCV 13 in adults at all. So that's shouldn't be picking them up and vaccinating anyone with it. That's not recommended. But in your young kids, you have the option. You can use PCV 13 or PCV 15. So if you do have stock remaining, because there is no preference, you could use that ppsv 23 we're still going to use again, if we have any patients that have previously been vaccinated with PCV 13, we need to follow the old recommendations for ppsv 23 if we choose to use PCV 15 in our adult patients, then we will also use ppsv 23 a year later. Dr. Khyati Patel 41:37 So not, don't toss your ppsv 23 yet you might be using them. So that's that's a good thing to know. All right, so for kind of completeness sake, if we kind of bring our patient who we talked about earlier, this patient was a 24 year old female with chronic pain, anxiety and tobacco use disorder, coming to receive recommendation on what NicoDerm patches to use for smoking cessation, and you strike a conversation, you identify the younger age patient with high risk condition who were missed from getting the vaccine. So good job on identifying that this patient needs a vaccine, and kind of listening to recommendations from CDC and ACIP as to what vaccine should this patient get. And so let's acknowledge that the qualifying condition for this patient is the age group, and the fact that patient was smoking cigarette, although they're willing to quit, they still carry the risk. And with not having the history of vaccination known, we can go with the recommendation of either getting that one time PCV 20 and and call it a day, like you said, Dr. Angelo, or if we choose to do the two series, PCV 15 plus one dose of ppsv, 23 a year later, those are the options we have for the patients. And we could go on and on and talk about, you know, one time vaccine series versus, you want to bring a patient back and do another a year later, and the complications of the adherence issues that are involved with that, but these are the recommendation we have on hand so far. Speaker 1 43:11 I think there are pros and cons to either approach the once and done, or if you're going to use one plus one vaccine a year later, you really need to have good reminder and recall systems in place to bring those patients back, but it's also a good opportunity to bring the patient back. And so if you're dealing with your older patients and you need to do an annual wellness visit, or you've got a patient who you need you know back in the office a year later to do a physical or check up on them because of their high risk conditions, you just have to factor all that into the timing, the equations, your appointment scheduling, and just really deciding what works best for the pharmacy or your practice site. Dr. Khyati Patel 43:51 So for clinical and strategic decision purposes, Dr. Angelo for a clinic that you and I volunteer at, which is, you know, predominantly serving underserved patient population. You know, one may have to consider cost of acquiring one vaccine, so PCV 20 and call it a day versus acquiring two series is so PCV 15 plus ppsv 23 kind of put that in perspective as well. So, yeah, you're right. Lot of different factors that go into deciding which one we are going to give it to our patients Absolutely. Dr. Sean Kane 44:24 So with that, I think this wraps up today's episode nicely. We have some key concepts and show notes on our website at HelixTalk.com again. This is episode 152 we also release those clinical pearls on Twitter at HelixTalk. If you want to get those in your Twitter feed, please go ahead and follow us, and we love the five star reviews in iTunes or Apple podcast. So if you could provide some good reviews and comments, we would love to hear from you as well. Dr. Angela, thank you so much for your time and your expertise. We really appreciate it. It was great to Speaker 1 44:54 join you both, and we'll keep on this as recommendations are bound to change with new approvals. Dr. Sean Kane 45:00 So year 11 is coming up, and I'm confident that in year 11 and 12 we're going to have another round of pneumococcal vaccine updates. So we will certainly tap you at that time for your expertise as well. I can't wait. So with that, I'm Dr. Kane and I'm Dr. Khyati Patel 45:15 Dr. Patel, and once again, thank you, Dr. Angelo. And to our audience, study hard. Narrator - Dr. Abel 45:21 If you enjoyed the show, please help us climb the iTunes rankings for medical podcasts by giving us a five star review in the iTunes Store. Search for HelixTalk and place your review there Narrator - ? 45:32 to suggest an episode or contact us. We're online at HelixTalk.com thank you for listening to this episode of HelixTalk. This is an educational production copyright Rosalind Franklin University of Medicine and Science.