Speaker 1 00:05 All right, welcome to HelixTalk, a podcast presented by the Rosalind Franklin University College of Pharmacy. Narrator - Dr. Abel 00:11 This podcast is produced by pharmacy faculty to supplement study material and provide relevant drug and professional topics. Speaker 1 00:19 We're hoping that our real life clinical pearls and discussions will help you stay up to date and improve your pharmacy knowledge. Narrator - Dr. Abel 00:27 This is an educational production copyright Rosalind Franklin University of Medicine and Science. Speaker 1 00:32 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. Narrator - Dr. Abel 00:47 And now on to the show. Dr. Sean Kane 00:51 Welcome to Episode 19 of HelixTalk. I'm your co host, Dr. Kane, Unknown Speaker 00:55 I'm Dr. Patel, I'm Dr. Schuman, and Unknown Speaker 00:57 I'm Dr. Angelo, and I wanted to Dr. Sean Kane 00:59 welcome our special guest today. Dr. Angelo, did you want to tell us a little bit about your bit about yourself? Narrator - ? 01:03 Thank you. I've been here at Rosalind Franklin University for a little over two years. My background has been in immunizations, which is what we will be talking about today. We've got a couple of hot topics for vaccines. So I've been brought into the mix today. Dr. Sean Kane 01:16 We're talking about two specific topics which are in the news related to vaccinations. The first topic is going to be the high dose influenza vaccine, and then the second topic is going to be the PCV 13 or Prevnar 13 vaccine, which both of which are kind of new recommendations that have come out recently. Speaker 2 01:33 And so when we talk about the recommendation, what's the governing body? It is Advisory Committee on Immunization Practices, ACIP, it's actually a subcommittee of CDC who publishes periodic updates in vaccination practices. Narrator - ? 01:48 So ACIP actually exists of a variety of medical and public health experts in the field. There are 15 voting members on this committee, and they meet about three times a year. They may meet more often if there are special recommendations or topics that need to be discussed, as in the case of PCV 13 and ppsv 23 along with the 15 voting members, there are 30 liaison members, and we do have someone who represents the American Pharmacists Association who attends these meetings. His name is Steven foster he's been a great resource in providing updates to our field in pharmacy and keeping us abreast of what's going on with the various ACIP recommendations and discussions. Dr. Sean Kane 02:28 So what you're saying is ACIP is part of the CDC, or a subcommittee of the CDC, correct? Narrator - ? 02:34 So, and this is basically our go to resource, and they work with these other liaison and ex officio members when they're making recommendations and publishing the schedules for our vaccines. Dr. Sean Kane 02:46 So that must be why, then the ACIP recommendations are on cdc.gov, as opposed to an ACIP website on its own, correct? Speaker 2 02:54 So that is one place we can go and get most up to date information. If you are an APhA member, APhA does public ACIP update webinars, and those are free to the members, so you can access those webinars and podcasts there as well. Speaker 3 03:07 One disclaimer here is that we're recording this information on the ninth of December, 2014, so things may change within the next few months or years. So be sure to always check that CDC website, cdc.gov/vaccines or just Google, CDC vaccines and check that for updates. Narrator - ? 03:22 Michael, you make a great point. The other resource I use routinely is immunized.org This is the Immunization Action coalition's website, which is supported by the CDC. And you can join the listserv through the Immunization Action Coalition as well as CDC, and get these updates fed to you, which I would highly encourage those in the field to do so. Dr. Sean Kane 03:42 The first topic of two is going to be the high dose influenza vaccine. And the actual product name for this is Fluzone high-dose seasonal influenza vaccine. So as the name would suggest, it's basically the influenza vaccine, but we made it better by giving more and Speaker 2 03:58 so when they say high dose, what is exactly it means? Is it more potency, more effectiveness? Speaker 3 04:05 Well, what they did is, it's based upon the antigen content. So this one has four times the antigen of the regular flu vaccine, so you would expect, then that there's going to be a little bit more of an ability then to develop a response to that antigen. And so we'll see whether or not that held true based upon the data. And so the data and so the data was in this trial that was published August 14 of 2014 in the New England Journal. Dr. Sean Kane 04:26 Dr. Angelo, my impression is that this Fluzone, or high-dose Fluzone, was actually on the market before this New England Journal article was even published. Narrator - ? 04:35 Correct. It has been in the mix for a while as one of our options during flu season, and what we can give to our patients in the older population, and it is approved for ages 65 and older. ACIP at this time has not made a preference between the two, and we can talk about that data a little bit and what this trial showed. So before this came out, and before it was published, the data was still presented to ACIP for consideration, and so they've had this information prior to the rest of us getting it through the literature. And so what they found was, when they did this study, there were over 31,000 patients enrolled, and these were split into two groups, so little over 15,000 close to 16,000 received the high dose vaccine, and just under 16,000 received the standard dose vaccine. And when they looked at the data comparing those two groups and overall influenza like illness, not a lot of people got sick, it was good to see that the both vaccines worked very well in these patients. When we look at the high dose data, 227 patients came about with influenza like illness. This was about 1.4% and with our standard dose Fluzone, 300 patients ended up with influenza like illness, so that was 1.9% so when you compare those two, in my opinion, the vaccines both work great in these populations, and there is not a big difference between the two when we break down that data Dr. Sean Kane 06:08 and just again thinking about the kinds of patients and when they were included, this was over two different flu seasons, 2011 and 2012 and they were all elderly patients, so greater than 65 years of age. One of the things that I think is really interesting about the trial is just the incidence rate in general. I think that when we hear about flu in the news and things like that, we get really worked up about, you know, everyone must be getting the flu. We actually have numbers here, and we have a cohort of data that shows that your risk of getting influenza if you get vaccinated, and if you're greater than 65 is less than 2% Narrator - ? 06:39 and I think what we've seen in some of the media reports is this relative risk reduction. I've seen reported the 24.2% or 24% in this trial as well, and that has been what has reported. But when we break down the data again, we're really only looking at a true point 5% difference between the groups when we look at actual influenza like illness. So I would still argue that both of these vaccines work great, and when we talk about the clinical significance, as opposed to our statistical data, there probably isn't a huge difference between the two groups. Speaker 3 07:15 I think that's an important lesson for any students or anyone that's starting to really look take a critical eye just to looking at efficacy studies, is that when you have two end points or two different studies, and they both have pretty small percentages in there, you can see a pretty big relative risk reduction. But again, that clinical significance from taking subtracting the two numbers, you may, may see a small percentage of actual benefit, and thus you would have, in this case, a number needed to treat that might be a little bit bigger. So in this case, an NNT of 200 Dr. Sean Kane 07:43 so in other words, it means that we would have to take 200 elderly patients who have not been vaccinated yet, give them the high dose vaccine in order to prevent one patient from getting influenza that season by giving them high dose instead of standard dose. Speaker 2 07:57 And this was actually a superiority point over the standard dose vaccine as well. Narrator - ? 08:04 Dr. Schuman, you brought up the point that it is there is more antigen in the high dose vaccine. So because of that, we do see more adverse effects. And so we've seen more localized reactions, pain, redness and swelling at the injection site with the high dose vaccine as opposed to the standard dose vaccine, Dr. Sean Kane 08:22 even on top of that, looking at the titers. So when you look at the blood to see how good the antigenic response was, we do see a higher amount of titer, meaning that the bigger dose did elicit a better immune response. And it's probably demonstrated by that adverse effect profile as well. And thinking about other endpoints of interest, I think that people generally don't want to get influenza, but there's other things that influenza cause that are also relevant in terms of probably more important than preventing influenza, like illness could be hospitalization or death or other adverse effects secondary to getting influenza in the first place. As far as the trial was concerned, did we see any of these other clinical endpoints Speaker 2 09:02 of interest. So the trial did consider secondary endpoint of death from influenza, and they found that there was not much of a difference between the two groups. It was about point 5% in both standard dose and high dose groups equally. Speaker 4 09:16 Sounds like both work. Well in that regard, right? These secondary endpoints. That's great. Dr. Sean Kane 09:21 So Dr. Angelo, you mentioned the ACIP hasn't really taken a firm stance yet in terms of, should they recommend a high dose to the elderly patient population or not? I think that we can go back and forth in terms of adverse effect profile versus an absolute risk reduction of influenza like illness and 0.5% or the 24% relative risk reduction. Have they evaluated the data yet? Do you think that in five years, that their stance may change? I think this is probably the best we're going to get in terms of the data. I don't know that we're going to get more data for high dose influenza. Narrator - ? 09:54 I would support that. I know that ACIP has this data, and this was present. It at one of the meetings not too long ago, and as of that point, they had not changed their recommendations. I don't think the data is strong enough to say that one is substantially better than the other. At this point, they both work well, and so there isn't a preference right now for one vaccine over the other, unless we get data that tells us otherwise. I don't see that changing, Speaker 2 10:24 and we already discussed some of the effects versus the side effects when it compared to the standardized dosing. And we all know flu vaccines for patients 65 and olders are covered by Medicare Part B, but if you are an institution or a pharmacy and considering purchasing cost and having this high dose vaccine on your formulary, your decision will be based on, obviously, the cost of it, and we know high dose vaccine is more expensive than the standard dose. Dr. Sean Kane 10:51 So moving on to the next kind of controversial or hot topic is PCV 13 or Prevnar 13, and this is traditionally more of a pediatric pneumococcal or Streptococcus pneumoniae vaccine. But more recently, it's come under the light for vaccination in adults, not just in the pediatric population. Speaker 2 11:10 And just so the audience knows, they're about two different type of pneumococcal vaccines out in the market, the pravnar 13 and the Pneumovax 23 they just have different variety of the serotypes when it comes to Streptococcus pneumoniae or the pneumococcus, the Narrator - ? 11:26 big difference between the two is whether it's conjugated or not. So the 23 valent is polysaccharide vaccine, and 13 valent is a conjugate vaccine. And when they conjugate a vaccine, they attach a protein to it, and by attaching that protein, it seems to work better than the polysaccharide vaccines. And so we use the conjugate vaccine in our young kids. And so that is a childhood standard recommendation. All children should be getting PCV 13. And Dr. Patel, you pointed out that the pneumococcal 23 vaccine exists as well. That's going to be for our older population or those in high risk groups. And with PCV 13, we will also see that used in adults, and it was recently approved by the FDA for those ages 50 and older, and most recently approved for those with immunocompromising conditions. And so we've been seeing uptake with that. And then the newest recommendation is what we'll be talking about today, Speaker 2 12:26 just so we also know what these numbers mean. Again, Prevnar 13 has 13 different serotypes versus the Pneumovax. 23 has 23 serotypes, out of which 12 are similar or in common with the PCV 13. Dr. Sean Kane 12:41 Dr. Angelo, what you're saying then is that even if you have the same serotypes between the two vaccines, because one is a conjugate vaccine, it may convey a better immunity. Even if it's the same exact serotype between the two different vaccines, Narrator - ? 12:55 it sure does. And that leads into this newest change that we've seen with adults 65 and older, it is now recommended that they get both the conjugate vaccine and the polysaccharide vaccine. Ideally, we get the conjugate vaccine on board first, wait six to 12 months, then give them the polysaccharide vaccine. And the thought process here is that that conjugate vaccine is going to work a little bit better, but yet we don't have all of the serotypes covered, so we're missing some serotypes. We need to make up for that with the polysaccharide vaccine. Dr. Sean Kane 13:26 So Dr. Schuman, what kinds of infections are we really worried about when we talk about pneumococcal infections? Is it things like strep throat, or is it a different kind of strep that we're worried about? Speaker 3 13:36 Yeah, and one thing to notice with this is that what we're really focusing on is gonna be things like pneumonia and meningitis, and particularly we're talking about pneumococcal pneumonia. Even though this does cover for a large variety of pneumonias, there are still going to be those caused by atypicals and other kinds of bacteria, mycoplasma, for example, that may not be covered. So we still have to exercise caution and keep out, you know, if you know so you're somebody that is prone to infection, or you have your immunocompromised, you still need to go ahead and practice a lot of other ways of modifying your risk beyond just having this vaccine. Dr. Sean Kane 14:09 So you're saying the big target here is more of the invasive pneumococcal infection, as opposed to the more run of the mill outpatient kind of infection act. Narrator - ? 14:17 And I think too, Dr. Schuman, you were bringing up using caution with some of these patients, and we do have a whole slew of high risk patients, and we know that smokers and patients who have asthma are at high risk. And so these polysaccharide vaccine is recommended for patients 19 and older with both asthma and those who smoke, and we can include a whole variety of chronic conditions as well. I know we see COPD in the mix and some heart and lung conditions, Unknown Speaker 14:46 as well as some cardiac issues and diabetes as well. Dr. Sean Kane 14:49 So just to clarify, before these new ACIP recommendations came out, which they were published in September of 2014, before that time, if you. Were 19 or older and you had a chronic medical condition, or if you were 65 or older, regardless of your medical history, you got Pneumovax 23 the 23 valent polysaccharide vaccine. Correct, correct. Then tell me about the new recommendations and how that's different than what we were doing previously. Narrator - ? 15:17 So the polysaccharide recommendations have been on board for a bit, and then the newest recommendations with the conjugate vaccine started with those who had immunocompromising conditions. So we started seeing individuals getting both vaccines. And then we saw with this recent change, and this is why the ACIP had to meet in August for a special meeting to talk about a lot of this data that had come about. One of the trials that is really was game changing with this was the Capita trial, which is yet to be published, but the data was presented to ACIP to support this change in recommendations. And so we're seeing now the PCV 13, you recommended for 65 and older. Dr. Sean Kane 16:04 So if we have someone who's never, ever been vaccinated with the pneumococcal vaccine, regardless of type, what is the vaccine that we should be giving first, as it relates to PCV 13 or Pneumovax 23 vaccine? Speaker 3 16:16 Well, if they're over 65 years of age, current recommendation is to give the PCV 13, and then six to 12 months later you can give the PPSV23 (minimum 8 weeks). Timeframe is actually about eight weeks, Dr. Sean Kane 16:27 and that PPSV23 is the Pneumovax 23 vaccine. Speaker 2 16:31 Okay, and if they got the PPSV23 then wait one year, and then give the PCV 13. Dr. Sean Kane 16:39 And Dr. Angelo, like you said, we really don't have access or a full knowledge base of this new trial that is coming out because it's yet to be published, so it's a little bit difficult to fully understand kind of the overall benefit and really digest all of the material that's available. But once it's published, I'm sure that this will kind of hop back up into the news in terms of, what were the results of the trial, and what were some of the strengths and limitations of the trial and things like that. Narrator - ? 17:05 Sure, and you know, I think right now, these recommendations are only until 2018 so I think that's important to remember. We've got a few years with these, and then it's going to be revisited. And so the ACIP will meet again to decide moving forward, do we want to keep these recommendations in place, or do we need to make changes to them? I think we're seeing with the PCV 13, as we mentioned, it's a childhood vaccine, and we may see herd immunity with the children being vaccinated and serving that indirect protective effect for our older patients, and maybe we don't need both vaccines a few years down the road, once we have more individuals vaccinated with the 13. Dr. Sean Kane 17:47 Again, just to give historical context, and please correct me if I'm wrong, but my impression has been that Prevnar didn't used to be Prevnar 13. It used to be Prevnar seven. So it's not like this is something that is set in stone, that is never readdressed, and in fact, it's frequently readdressed. I think Prevnar 13 came out in 2010 something like that. Narrator - ? 18:04 I think so we've had it for a few years now, and there was that transition period. Kids who got PCV seven, if they were in the appropriate age group, got PCV 13 at least one dose to catch them up, because it covered additional strains that we weren't seeing in the 7-valent vaccine. Dr. Sean Kane 18:20 So at least from my point of view, the idea of Prevnar 13 or Prevnar seven seems like a big win, in addition to the other vaccines that we have, in the sense that we've really dramatically improved the care in terms of invasive pneumococcal vaccines and kind of the pediatric patient population, specifically with meningitis, you know, it's really changed the kinds of bacteria that we see, and even if strep pneumonia does cause meningitis in an infant, the serotype is usually not the one that we would find in the vaccines that we're getting. So if you are one of the astute pharmacy students that goes to cdc.gov and wants to take a look at all of the new recommendations, you'll notice that the new recommendations related to PCV 13 or Prevnar 13 are not yet posted on the document that you would typically pull up to see the vaccination schedule. Speaker 2 19:07 That's the adult immunization schedule that has still to be reflected. Speaker 3 19:11 In addition, the veteran the federal government, the VA system has actually kind of is holding out on some more of that data to come up before they release some updated guidelines on it as well. Narrator - ? 19:22 That's interesting. I know we've seen an impact from a billing perspective. Right now we know that Medicare will only cover one pneumococcal vaccine in the patient's lifetime, and so if two pneumococcal vaccines are being recommended for these patients, there might not be coverage for that from an insurance perspective. And so it typically takes about a year for CMS to catch up with the ACIP recommendations. So there are patients right now probably aren't getting both, and we are waiting either for additional guidance from the health system or from our coverage and insurance entities. Dr. Sean Kane 19:57 So clearly, a moving target that will. Be seeing everything from new clinical recommendations to billing recommendations to other things from the CDC, probably within the next year that are going to be relevant to clinical practice. So with that, we had a few closing comments. One is that we're going to be on hiatus until about mid January because of the holidays and things like that. So be sure to check HelixTalk.com or find us in iTunes for an episode that will be resuming in mid January. We're going to start releasing every three weeks, instead of every two weeks, just because of some scheduling reasons, but kind of in the meantime, what we'd really like the listeners to do is go to helix, talk.com Find the Contact Us section and email us about topics that you really want to hear about any topic is fair game if we don't know that much about it, we're going to find a content expert like Dr. Angelo to help us out a little bit. And we would really appreciate any feedback or comments or suggestions from the listeners, kind of in the meantime, during our period of being on hiatus. And with that, I'm Dr. King, Unknown Speaker 20:57 I'm Dr. Patel, I'm Dr. Schuman, and Narrator - ? 20:59 I'm Dr. Angelo. Thank you for asking me to participate in this discussion. It's been a lot Speaker 2 21:04 of fun. We value your feedback. Dr, Angelo, thank you for the input. You're welcome, and as always, even during those holidays, study hard. Narrator - Dr. Abel 21:13 Thank you for listening to this episode of HelixTalk. For more information about the show, please visit us at HelixTalk.com. You