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 Narrator - ? 00:11 is 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. Unknown Speaker 00:27 And now on to the show. Dr. Sean Kane 00:31 Welcome to HelixTalk episode 85 I'm your co host, Dr. Kane, I'm Dr. Schuman. Dr. Khyati Patel 00:35 I'm Dr. Patel. And today's episode title is sharp updates from the needle world, vaccination updates of 2018 we're very thrilled to have Dr. Lauren Angelo back with us. She's an associate professor at College of Pharmacy. We recorded last update of vaccination in December 2014 so definitely, we're due for some new and exciting things in the vaccination world, in addition to being an associate professor at our college, she travels nationally to educate pharmacists on immunization and publishes relevant updates to this topic. So with that said, we're going to talk some important things about vaccination. Dr. Angelo, welcome back. Unknown Speaker 01:15 It's great to be back. Thank you for having me. I missed you all. Dr. Sean Kane 01:19 So one thing that prompted this episode, for me, at least, was I learned a little bit about the new shingles vaccine, mostly from kind of the grocery store pharmacies advertising it. And I wanted to get Dr. Angelo on to kind of talk a little bit more about this new vaccine and why it's different than the old one, and what the new recommendations are for that. Speaker 1 01:36 Yeah, this has been sort of a game changer in our shingles world for vaccines. The new vaccine that was on the market back in the fall is inactivated. So when we compare it to the shingles vaccine we've had for several years now, which was a live vaccine, this does work differently. It is also a recombinant vaccine, and it is adjuvanted. So the adjuvant added to this vaccine is intended to boost the immune response. When this vaccine was first approved, it was then brought to the Advisory Committee on Immunization Practices, and that's a group that meets three times a year at least to talk about vaccine changes and updates. And from this committee is where we get our recommendations for what we do with vaccines. And so this particular vaccine was approved for those 50 years of age and older, and ACIP has supported that approval. And so that is what we are recommending for individuals to get this vaccine. We compare it to the live vaccine that was approved and recommended for what was recommended for individuals 60 and over although it was approved for ages 50 and older. Speaker 2 02:45 And I imagine that that comparison between live and then inactivated is it's pretty big deal, because a lot of times you talk to individuals who have concerns, and there's always this idea about, you know, oh my goodness, something that it's live, it's dangerous. And hopefully this kind of fights against some of those, those may be misconceptions or fears. Speaker 1 03:02 So we have quite a few live vaccines on the market, and that's not really a concern to be worried about with the live vaccine, because the way it is made is not intended to cause disease. However, because it is a live vaccine, there are individuals who cannot get live vaccines, and those would be the patients who are immunocompromised, or children under the age of one, with the exception of rotavirus, who we do give to young kids. Dr. Sean Kane 03:28 So because this is kind of different in many different ways, from the original shingles vaccine, is the storage the same? Because I know that one kind of annoying thing about the old one was that it had to be frozen, not just refrigerated. Where are we at with this one? Speaker 1 03:42 So this one is refrigerate only. In fact, if it is frozen, needs to be discarded. So this is kept in the refrigerator. It is reconstituted. So you've got two different vials that do need to be mixed together in order to get the appropriate vaccine and dose that is needed for patients. And so that is something we need to remember to do when we're preparing this particular vaccine. Dr. Khyati Patel 04:05 So Dr. Angelo, you just talked about ACIP, which produces the updates for recommendation on vaccination practices. And you mentioned that they prefer this vaccine versus the the live vaccine, the Zostavax. What are some of the basis for this recommendation when we look at the efficacy, the safety, or the other outcomes, Speaker 1 04:26 data presented to ACIP around this new vaccine was rather compelling, so when they looked at efficacy and effectiveness, which are two different ways that we Look at how a vaccine prevents disease, when the recombinant Zoster vaccine trials used for that, they looked at the efficacy data, and again, it's not been around, so we don't have many years of data to look at, but after three years, the efficacy rates for this particular vaccine in those ages 50 and older was 97% so. When data regarding the Zoster vaccine live at about three years, the effectiveness for that was around just shy of 40% and so again, that was in ages 50 and older. Dr. Sean Kane 05:13 So when you say effectiveness of 97% versus 39% does that mean that that's the risk of not getting the infection, or is that more like a serologic end point of we tested your blood, and you should have an immunization toward, in this case, zoster. Speaker 1 05:28 So when they look at especially with effectiveness, that's based on real world data, so that's how the vaccine is being used in practice, and looking at disease outcomes. And so when we look at effectiveness of vaccines, that's typically, did patients get disease or not? And there are some instances where we look at other outcomes, such as hospitalizations or other types of events that could happen related to the vaccines efficacy. It really depends on the trials used. In some cases, it's whether or not disease occurred, and sometimes they are looking more at those geometric mean titers and serological markers with the vaccines. And so it's important as practicing pharmacists and we're looking at data around vaccines and how well they work to really drill down. Is it efficacy data? Is effectiveness data, and what are the outcomes being reported? Dr. Sean Kane 06:20 So at least that 97% versus 39% knowing that they weren't a head to head comparison, but still like that is a dramatic numerical difference that I don't even know if you really need the head to head to really make a recommendation, like ACIP did, then correct Speaker 1 06:34 and they looked at again years out. And so with the live vaccine, the ZVL, which stands for Zoster vaccine, live by year eight, effectiveness had decreased to 32% so it was a drastic drop over that time period. It'll be interesting to follow the recombinant Zoster vaccine, and as we now have this on the market, we're using in patients years from now to see if there are any changes in at this point, effectiveness of the vaccine. Dr. Sean Kane 07:02 So Dr. Angelo, now we have two shingles vaccines that used to be you could just say, Hey, have you gotten your shingles vaccine to a patient? And there was only one right? So especially from a patient perspective, what's the best way to kind of communicate one vaccine versus the other for the patient? Speaker 1 07:17 So just just to clarify the differences between the two, our recombinant vaccine is the Shingrix vaccine, and so as we're seeing some marketing and advertisements around Shingrix, that's the vaccine that is this recombinant inactivated vaccine, whereas Zostavax is the vaccine we've had around for some time, and that is our live vaccine. Dr. Sean Kane 07:36 So clearly, like no one wants to get shingles, right, but there are other complications of getting shingles that are probably just as important in terms of preventing these other bad things from happening, right? Dr. Khyati Patel 07:47 And so those other bad things are your post-herpetic neuralgia, or shortly, PHN, and that's one of the outcomes that was looked at when they performed studies for the new Shingrix vaccine. So what do we have as far as the data, is there any better outcomes for the post-herpetic neuralgia, or is it about the same with the older vaccine, the Speaker 1 08:08 outcomes for post-herpetic neuralgia look better as well. And so when we look at the recombinant Zoster vaccine, that was around 91% for those ages 50 and older, and when we look at even the older population. So 70 years and older, that number is still pretty strong, at around 89% with the Zoster vaccine live and post-herpetic neuralgia. And think that data was around 60 years and older, we had about 66 and a half percent. So there is a difference as far as how well it works in someone who gets shingles and whether or not they get post herpetic neuralgia as a result. So just Dr. Sean Kane 08:48 to put the number into perspective, when you said 66% for the Zoster vaccine live, that means that of the 100 people who got shingles, 66% of them did not get post herpetic neuralgia. Speaker 1 09:01 Well, they have to factor in those who received the vaccine versus those who didn't receive the vaccine, right? And that's how they drill down and get the data that is being reported. Okay, so Speaker 2 09:11 then what is it moving forward then? So what is the recommendation as far as individuals who have had the live vaccine, is this? Is this now? Is, let's go right into this as an option. Speaker 1 09:19 It's a great question. So if someone has had the Zoster vaccine live in the past, they still need to get this new vaccine. And so it is recommended two doses, which is a difference from the Zoster vaccine Live, which was only one dose. Individuals who are now getting this new shingles vaccine need two doses, and we typically give those anywhere from two to six months apart, so they would need to return to the pharmacy to get this particular vaccine. Speaker 2 09:46 And I'm sure that, you know, a lot of times when we talk about, you know, concerns with one of the things comes up is injection site reaction. So I'm assuming that still is something we want to be careful of, or at least let people know about. Speaker 1 09:57 That's a good point, especially with adjuvanted vaccine. We know adjuvant and vaccines do a great job with respect to boosting the immune response, but we tend to see more reactions where the vaccine was injected. And so this one is sort of similar to other things we've seen with adjuvant vaccines. And so about 82% of individuals have reported injection site reactions with this pain, redness, swelling around where the vaccine was given, and so one recommendation is we're vaccinating patients with this vaccine is ask them if they're right handed or left handed, and give the vaccine in the arm that they're not going to use as frequently, so that way, if they do have pain, it's not affecting their day to day activity. Speaker 2 10:40 As a lefty, I always like the idea of giving the option rather than assuming. Dr. Sean Kane 10:44 And of course, you know, the pain associated with the injection site is going to very likely be minuscule compared to the potential pain of post herpetic neuralgia that could be a chronic condition. So yes, it's going to be painful in a lot of cases, but way less painful than a chronic condition that you'll get if you get shingles and have post herpetic neuralgia. Speaker 1 11:03 That's a great education point for patients. Dr. Kane, Dr. Khyati Patel 11:06 and with this higher numbers of injection site reaction, you know, here I'm thinking it's a two dose vaccine, so if they had reaction on the first vaccine, what do you do to bring patient back for the second dose? Right? There could be likelihood of getting a response saying, I'm not getting the second dose. That was a terrible vaccine for me. Speaker 2 11:25 Or even if they do, they did respond well to it, still, yeah, how do logistically? How do you manage this kind of part one, part two situation? Speaker 1 11:33 Well, it definitely comes back down to the education points that Dr. Kane raised. And so if they're only getting one dose, whether that's going to protect them, against getting shingles, against getting post-herpetic neuralgia, we really don't know. The recommendation is two doses of this particular vaccine, and so explaining the importance of still getting the second dose, and maybe when they come back in, they schedule the appointment around activities or things in their day to day life, where if their arm is a little bit sore, it's not going to affect them. So if they have a tennis tournament that weekend, okay, don't vaccinate them before their tennis tournament. Or if they use their arm a lot at work, so don't do it before they need to go in for the work day, Dr. Khyati Patel 12:19 and with it being the second dose, or, you know, two series, two part vaccine, we need to probably think about improving the adherence, or the compliance, to that second dose. And so involving some sort of a phone reminder system, you know, if you're practicing in a community setting, is involving your technicians to keep track of when, when did the patient get the first dose? Do we have any call, you know, patient calls to make as their second dose is coming up on the schedule? Speaker 1 12:46 That's a great point. Having a good reminder or recall system is not only recommended by the CDC, but it's a good practice for us as pharmacists who will be giving this vaccine and needing to bring patients back for that second dose. I love your idea of including technicians in the role Dr. Patel, I think that's a great opportunity to enhance the technician involvement with our vaccine practices. Speaker 2 13:09 So then moving forward, what would be the role, then of Zostavax? Is that something that will be anticipated to be off the market or coming off the market soon again, for those that are, you know, anticipating purchasing should that still be on your kind of wish list. Speaker 1 13:22 It's difficult to say we have had some supply challenges with this new vaccine. And so the recommendation is really, if you have the recombinant vaccine in stock, that's what we need to be giving patients. If there is a circumstance where the patient has to have the shingles vaccine right away, and we don't have the recombinant vaccine in stock, and we only have the live vaccine in stock, we'll give that knowing that we still need to bring the patient back to get the two full doses of the recombinant vaccine. Supply issues are supposed to be resolved. That's the information that we seem to be getting from the manufacturer. Beefing up what's available, they have place supply or order limits for pharmacies and other practices to sort of control the supply and demand aspect of that for the time being. Dr. Sean Kane 14:12 So speaking of two dose vaccination regimens, it sounds like there's a new two dose regimen for hepatitis B, which is typically a three dose regimen. So could you tell us a little bit more about this new two this new two dose regimen for hepatitis B? Yeah, this Speaker 1 14:25 was an exciting change in the Hepatitis B field. So this is also recombinant adjuvanted vaccine. It is approved for those patients who are 18 years of age and older. And historically, we've had the three dose vaccine series for probably at least three decades now. And so this is definitely something new that we haven't been doing in the past. And so this would be two doses. They're given one month apart. So just as a reminder, the hepatitis B vaccine is recommended to be given at birth. So this is one where new baby born gets the HEPA. Tititis B vaccine series started right away, so we'd be picking up with those 18 years and older that didn't get it as a birth dose and are at high risk for Hepatitis B infection. Dr. Khyati Patel 15:12 So it would have been nice to have the two dose vaccine when I was getting my Hepatitis B series, so I wouldn't have passed out during my third dose like I did. But better late than never. It's good to have less injections and equal outcomes for a vaccine. Speaker 1 15:27 And you talked about adherence and coming back for those doses, it's very difficult to get adolescents and adults back for a second dose, let alone a third dose. So something like this does give us options, so that way we are adherent to a vaccine series. Dr. Sean Kane 15:41 And just to highlight you, said that this new two dose regimen is only for 18 and older. So this wouldn't apply to the newborn regimen. Then correct Speaker 1 15:49 the birth dose, and infants will still be getting a three dose series. Dr. Khyati Patel 15:55 And then to clarify the brand names for all the hepatitis B vaccine. So the traditional three dose series, we have two brand names, Engerix-B, which also is available in four dose for those patients going under hemodialysis. And then we have Recombivax HB, while the new vaccine, that is the two dose vaccine given one month apart is Heplisav-B, Speaker 1 16:20 correct and not to muddy the waters with all the Hepatitis B vaccines available, but you brought up Recombivax HB, this has been approved as a two dose series for a specific subset of individuals. These would be adolescents between the ages of 11 and 15 years of age. So if you do have an adolescent within that age group who is high risk for Hepatitis B infection and needs the vaccine. We do have that two dose series option. Dr. Sean Kane 16:44 So in terms of vaccinations, the one vaccine that I think is probably the most popular is going to be the influenza vaccine. And reviewing to prepare for this podcast episode, I was shocked at the number of options that we have now for influenza vaccinations, and that's something that I think we should definitely talk about, because patients are probably going to be as equally confused as I was when I was going through the website on the CDC to kind of look at what the options were Dr. Khyati Patel 17:10 and what's the whole big deal about, like taking away the intranasal live vaccine away, and then they're saying, no, no, it's okay to put back on. That's been really confusing. If you can shed some light there, sure. Speaker 1 17:21 So we'll start with, I think, the live vaccine. And so that's been an interesting one to follow. Over the years, they have had some challenges with that particular vaccine, and looking at how well it works against the H1N1 virus. And so there was a period of time where the data we had demonstrated that it just wasn't as good as some of the other vaccines we had. So at that time, the CDC opted to take away the recommendation to use this particular vaccine. At past couple ACIP meetings, the manufacturers have brought data forward around the live vaccine and some changes that they have made in the manufacturing process of it focusing mostly on the H1N1 virus. And so with this new data, the ACIP felt comfortable in adding back the recommendation, and so it is now included in options that we have for the influenza prevention this coming flu season. Now what we don't have is the outcomes data. So what again, you brought up earlier, Dr. Kane, some of the trials and what they're looking at was more based on some of the serological outcomes, and not true influenza like illness that we might see in practice. So using, I guess, this particular flu season to gage how well this vaccine works with the changes made to the vaccine strains that the manufacturer has used. Dr. Sean Kane 18:45 And of course, the live vaccine is something that someone may consider, because it's an intranasal vaccine, right, as opposed to an injection, which kids, I'm sure would be more interested in that than an injection. But of course, if it isn't as efficacious or effective in real world scenario, then clearly, you know that benefit is not there, we would be picking the injection instead Right, correct. Speaker 1 19:08 And so we'll be watching, I guess, as we go through this next flu season and individuals who get this particular vaccine and how well it works. Speaker 2 19:16 And then I think it's my also my understanding that this one may be a little bit less effective on influenza A so the H3N2 type of strain, is that correct? Speaker 1 19:25 Well, when we looked at just overall effectiveness, vaccine effectiveness for the past couple flu seasons, H3N2 has definitely been a challenge to keep up with. And so that one when H3N2 is is the strain circulating the vaccines that we have and for the most part, just don't work as well. And so there's been some focus now on new technologies used to make the influenza vaccines. We have recombinant we have cell cultured, and there are some thought that these might bypass some of the. Issues that we have, which with the h3 and two efficacy and so when these vaccines are made or manufactured, they don't rely on eggs. In the manufacturing process where the egg based vaccines, there seems to be a genetic mutation that occurs at the hemagglutinin level, in particular, H3N2, that lowers the efficacy of those vaccines. Dr. Sean Kane 20:25 And this probably is obvious, but just to point out, if it's not a an egg cultured vaccine, then you're good to go, whether you have an egg allergy or not for those particular vaccines, right? Speaker 1 20:35 So our cell cultured and our recombinant vaccines used for influenza because they don't include the egg process, aren't really a concern for those with egg allergies. Now, to back up a little bit, our recommendations have changed around the egg allergy and so really the only time we're concerned is if someone has had a true anaphylactic reaction after consuming egg product where we they would still be able to get the vaccine, an egg based vaccine, but we would do it in a setting with providers who are equipped to handle an anaphylactic reaction. Speaker 2 21:09 That's good to know, because, again, you're always looking at the risk versus benefit piece, and if we're arguing for the overall benefit for a long period of time with these to then say, well, we just can't use it. It seems it's a bummer. Dr. Sean Kane 21:22 Now, in terms of how common these newer technologies are, are most vaccines that you would get if you went to your kind of corner store pharmacy? Are they going to be giving the egg based one, or are the recombinant and the in the cell cultured? Are these becoming more commonplace, where those are kind of the the ones that you're going to get regardless. Speaker 1 21:43 That's difficult to say. It really depends on what the pharmacy has chosen to order. And so there might be cost differences that they factor in with respect to what they're getting or what they're stocking. And so for patients who are interested in different types of vaccines, it's always worth probably the phone call or or using the flu vaccine finder on the internet to identify what and where vaccines are stocked, right? Speaker 2 22:08 And I'm assuming then that there should be some recommendations again, rolling out again, kind of helping to navigate this scenario, because of all these different ones and patient specific factors. So where are we at as far as dissemination of new guidance. Dr. Khyati Patel 22:21 So ACIP produces the influenza vaccine related recommendation, usually by end of August. So usually, typically say, if the season starts around September, October, it's a good time for us to look out for those ACIP recommendations Dr. Sean Kane 22:35 and for the listener so that they know we're recording at the end of August right now, which will be released later, but by the time the listener hears this, these newer recommendations may have become available. That we don't know, because we haven't gotten our time machine in the mail yet, right? Speaker 1 22:49 I check every day, Dr. Kane, I'm waiting for these recommendations to be released, and I haven't seen them yet, but any day now. Dr. Sean Kane 22:55 So, so moving on to the second question that we had. So we kind of dealt with some of these newer technologies. When I was on the CDC website, I was shocked at the kind of variants and variations that you can have with respect to the inactivated vaccine, whether it's the trivalent, the Quadrivalent, whether it's the high dose, the standard dose, whether it had the adjuvant or not. There's kind of a menu now, as opposed to you just walk in and you get your influenza vaccine. So where does the where are the recommendations standing with respect to picking an agent, and are there any patient specific factors? Where, as a pharmacist, Dr. Angelo, you would encourage a patient to pick a particular regimen that is available. So let's Speaker 1 23:35 start with your trivalent and quadrivalent examples you brought up. And so as you watch the different vaccines available each influenza season. I think we've seen a shift from majority of trivalent vaccines available to now mostly Quadrivalent vaccines available. And with the Quadrivalent vaccines, what they've done is added an extra B strain, so to cover two of the A strains and two of the B strains within the Quadrivalent so it's likely that the trivalent will be phased out over time, would be my guess, and we'll only have quadrivalent available. So it'll be interesting. I'm not sure what pharmacies are stocking across the board, whether they're ordering trivalent or quadrivalent, or as a patient, if you ask for one or the other, what are your options? I don't know. One thing that is interesting to follow is, as we get into the thick of flu season, and we know what strains are circulating, we can better pinpoint what vaccines are going to protect a patient. And so if we're seeing we don't typically see a lot of the B strains circulating relative to the A strains, but if we do see more of the B strain that is in the Quadrivalent vaccine, perhaps we lean towards using that and so really, we'll have to wait and see what our flu season looks like. The others that we have available, we have a high dose vaccine, and we have an adjuvanted vaccine, and right now, those are both approved for our older patients, with the thought that as we age, our immune systems don't work as well. So we're going to need maybe a boost with the influenza vaccines that we're giving, and so by the high dose, which is four times the antigen as the standard dose, or the adjuvanted vaccine, again, we talked about adjuvants, and adding an adjuvant to this particular vaccine might boost the immune response. Those are options for our older patients, but the CDC or a CIP does not have a recommendation as far as using one over the other, and so we recommend that anyone six months or older get vaccinated. There really is no one right option for those patients, unless we start factoring in things like cost circulating strains and some of the efficacy data that we'll be, I guess, following as time goes on. Dr. Khyati Patel 25:46 So again, we should be looking out for these ACIP updates by the end of August. But I think the bottom line over here is that currently, we don't have any preference of using one over the other, and that's that's something that our audience should take home as a take home point. Dr. Sean Kane 26:00 I would assume, though, that the more fancy things you add to your influenza vaccine, cost must go up to some degree, right? So it could simply come down to cost for a patient of Do you want to pay X amount more to get your adjuvant or your quadruple dose or not? And it probably does depend primarily on cost and your risk factors for getting influenza, or your risk factors for not doing well if you do get influenza, if you're kind of that chronically comorbidly Elderly type patient that you might end up in the hospital with influenza, that might be a better patient then. Dr. Khyati Patel 26:31 So in addition to what we talked about regarding the influenza vaccine, I think the HPV update guarantees our attention as well, and we have some recommendation and updates that we haven't talked since 2014 December. Speaker 1 26:45 So I think one of the exciting things around HPV is the two dose option for our adolescents, as we know with the three dose series, it's been a challenge getting them back for the third dose. I mean, the second dose has been hard as well, but it's nice to know that the recommendation for two doses is available as long as we start the series before the 15th birthday, and that the individual does not have any immunocompromising conditions. And so it allows us to give one dose and then six to 12 months later, second dose, and they're done. The other thing that will be interesting to watch around HPV is there are currently studies underway to extend the age range. Right now, we use this vaccine for both males and females through age 26 years. It's not approved after age 26 and so there are trials looking at extending this out to 45 years of age. Dr. Sean Kane 27:37 Dr. Lange, if I'm not mistaken, that 26 year old cut off, dealt with basically trying to capture patients before sexual activity happened, as opposed to something related to their immune response to the vaccine. Is that correct? Well, it's correct. Speaker 1 27:52 And so really, we want to get this vaccine on board earlier, and so we're looking at 11 to 12 years of age. Is when this vaccine is recommended. However, if we miss giving it at that age, we have up until age 26 and a lot of that comes around to this is what the studies were looking at. The studies didn't go beyond that age, and so we couldn't I guess the FDA couldn't approve the vaccine, so that's why now they're looking at older individuals. And I Dr. Sean Kane 28:20 remember when I was a student learning about HPV vaccine, the brand name is Gardasil, that at that point, it was only women, young girls, that were getting vaccinated. And I understand now even men are being vaccinated, and that's been around for a while, correct? Speaker 1 28:34 It has. And so when the vaccine was first approved, it was the focus was really around cervical cancer. And so Cervarix, if you remember, which isn't on the market anymore, was specifically for cervical cancer prevention. We also have Gardasil, which Gardasil had some extended indications with regard to genital warts. But as time has gone on, and more data around HPV has been available, there are other cancers we have to worry about, so anal cancers, oral, pharyngeal cancers, and for that reason, both males and females are candidates for this vaccine, just to afford additional protection. Speaker 2 29:12 And that's a big education piece, because, again, there may still be that misperception about why I don't need it because I'm and then fill in the blank about behavior you don't engage in. But so that education piece, we've had individuals who have come to us, fortunately, and said, you know, this is my life's, you know, concern. These are my concerns. We've been able to educate on the vaccine. But I think for everyone to remember that again, as you said, outside of, just the outside of beyond the cervical cancer prevention piece, right? Speaker 1 29:35 And it has to be on board to work. And so if we wait too long and someone has already contracted HPV, then it's not going to have the protection it should. So. Dr. Sean Kane 29:45 Dr. Angelo, the other reason that we had you on the podcast is that we were kind of doing some leg work ahead of time, and we kind of came to discover that there is a newer ish Meningococcal vaccine that we weren't aware of, at least, that is approved in specific group. A patient. So it's not every patient that should get it. Would you mind just giving us a brief overview of what it is and who would be appropriate for this newer vaccine for meningococcal disease? Speaker 1 30:10 Sure. So this would be the meningococcal B vaccine, which was approved back in the summer of 2015 and so two vaccines are available for prevention of meningococcal B, specifically, and that's Trumenba and Bexsero. And so the meningococcal B vaccine we see, we're going to use those mostly for individuals who are at high risk for contracting meningococcal B, and so that would be during an outbreak, or, in particular, those without a spleen. And we can also use this for individuals ages 16 to 23, years of age, just based on clinical decision making between the provider, the patient and perhaps the parent of the patient fits deemed that this vaccine would be appropriate. Dr. Sean Kane 30:52 Just to clarify, meningococcal B is different than the other meningococcal vaccines that we have on the market, which Speaker 1 30:58 covers A, C, w and y. Yep, correct. And so that one's been around for a while. Right now we have the conjugate vaccine. The polysaccharide vaccine has come off the market, and so we just have the conjugate vaccine available to cover those strains. Dr. Khyati Patel 31:13 So it's great that we talked about these new vaccine and what are the ACIP CDC recommendations related to that? But as being immunizers. You know, we're increasingly providing this preventable disease protection to our patients, and we need to know about certain safety related issues. So SIRVA, which is the shoulder injury related to vaccine admin, has been in the limelight. What do we have there? Dr. Angelo, Speaker 1 31:38 the ACIP, as well as some others in the CDC have been following reports that have been submitted to VAERS, which is the vaccine adverse event reporting system. And what's been interesting is the uptick in shoulder injury. And so because of that, they've come out with this new term SIRVA, which is the shoulder injury related to vaccine administration. And the advice then, is, as we're vaccinating, is to do what we can to prevent cerva. And so a lot of times, cerva is caused by injecting the vaccine too high, so either too high within the deltoid muscle or too high entering the joint space or the bursa of the shoulder. And so patients who end up with SIRVA have severe pain, oftentimes, immobility, sometimes they need surgery to correct it, and so we need to pay close attention to how we vaccinate our patients and some of the recommendations around avoiding SIRVA to make sure you're sitting alongside your patients, so both the patient and the provider should be sitting so that the deltoid muscle is at eye level and you can visualize where you need to inject the vaccine. So don't stand over the patient, as some people do. Make sure you sit down next to your patient and that you can visualize the thickest part of that deltoid muscle. Dr. Sean Kane 32:53 And is this with all vaccines? Or in particular, we've seen kind of the most common ones, like influenza. Speaker 1 33:00 I think a lot of the data has been with the influenza vaccine, just because that's the one we're giving so much of but really it's with any intramuscular vaccine that's going into the deltoid muscle, and so again, paying close attention to where it's being administered, as well as needle size or length, to make sure this is done in The safe fashion. Speaker 2 33:21 And then with the the new Shingrix vaccine, having this, this I need to reconstitute, is that I assume is possibly a concern as well regarding some, some injury. Speaker 1 33:30 Well, maybe not so much injury, as opposed to errors, with regard to this particular vaccine. And so the other with this new vaccine on the market, closely following availability errors were starting to surface with this vaccine around not giving it in the right place. So the live vaccine was given subcutaneously. This vaccine is given intramuscularly, so making sure we're putting it in the right place, reconstituting the vaccine and so both have to be mixed together to make sure that we are giving the correct dose of the vaccine. Dr. Sean Kane 34:05 You also mentioned the age difference, right? So 60 years of age was the old vaccine recommendation, and now 50 is the new recommendation. So potentially giving patients just the wrong information right of you're not indicated when you actually are indicated for the vaccine Correct? Speaker 1 34:21 Or vaccinating individuals below age 50 has happened too, and so not adhering to the 50 years of age as being the starting point for when this vaccine is recommended. Dr. Sean Kane 34:31 Well, Dr. Angelo, I really appreciate the time that you've had on the episode, just to kind of wrap up a couple key points that at least we've taken away from today's talk, I think, first starting with the shingrix vaccine. So some of the new changes, in terms of how much more effective it is, is a really big deal. The fact that it's I am instead of subcutaneous is really important. And also the age cut off, so now it's 50 instead of 60. That's a big deal, and a change in practice that I'm sure we'll be seeing a lot more of this as we understand how. Much more effective it is. Dr. Khyati Patel 35:01 And something pertinent to look out for are the August 2018 ACIP recommendations regarding the influenza vaccine, which we don't have available as we're recording this session right now. However, the bottom line for the audience to know is that one is not preferred over the other when we consider trivalent versus the Quadrivalent high dose versus the standard dose, or using the vaccine with the adjuvant, without the adjuvant. Speaker 2 35:26 I think a third point is looking at the HPV vaccine again, one of the points of emphasis is that it's beyond the risk of cervical cancer, but also anal cancer and oropharyngeal cancers, as well as a target. So we're looking at expanding the scope of the individuals to whom we're recommending this looking at the two dose recommendation of first first dose before the 15th birthday, if the individual is immunocompetent at that point. And then also potentially looking forward at expanding, I think there's future studies looking at expanding beyond 26 years of age into individuals that may still benefit from it. Speaker 1 35:59 Just to put a final spin on all of this, I think we're talking about updates, and even as we're talking we know that things are changing in the vaccine world. So as individuals and pharmacists providers involved with vaccines, it's so important to stay up to date and keep current with the recommendations, since this is such a rapidly changing field. Dr. Sean Kane 36:20 So I think that wraps things up nicely. This is episode 85 if you want to kind of view our show notes on what we've covered and links to the CDC guidelines. It's available at HelixTalk.com we love the five star reviews in iTunes. We're on Twitter at HelixTalk. And thank you again, Dr. Angelo, for your time and your expertise. We really appreciate it. You are most welcome. It's been fun. So with that, I'm Dr. Kane, Dr. Khyati Patel 36:43 I'm Dr. Schuman, I'm Dr. Patel, and always study hard. Narrator - Dr. Abel 36:47 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 - ? 36:58 to suggest an episode or contact us or 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.