This webinar covers the latest updates and addresses common questions regarding COVID-19, Influenza, and RSV vaccines, helping clinicians navigate recent changes and clarify areas of confusion. A live Q&A with Dr. Paul Auwaerter follows the presentation.
Topics Covered Include:
* Current and prior FDA/ACIP recommendations
* Challenges regarding receiving immunizations
* Potential future barriers for vaccine approvals
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Okay, because we do like to keep these right on time and be aware of everyone’s commitments that they have throughout the day, I will go ahead and get us started. I want to thank everyone for joining us today. My name is Courtney McNolte. I’m the content solutions manager at Unbound Medicine. Welcome to today’s webinar. We have Dr. Paul Alwater who will be discussing the latest updates regarding CO 19 influenza and RSV vaccines. So with that, please allow me to introduce our esteemed speaker. Dr. Alwater is a professor of medicine at the John’s Hopkins University School of Medicine serving as the clinical director for the division of infectious disease and the director of the center for environmental infectious diseases. He also currently serves as the executive director of the John’s Hopkins Pocket Center and is a key contributor of the John’s Hopkins antibiotic guide which is published and distributed by Unbound Medicine. At the end of this presentation, we will have time for a live Q&A. If you’d like to ask a question, please feel free to do so in the chat or Q&A box at any time. And with that, Dr. Outwater, thank you for taking the time to share this presentation with us and I will hand it over to you. Okay. Yeah, thank you so much Courtney and thank you so much for joining this afternoon. Uh what I thought I would do is spend a few minutes just giving a little bit of a snapshot for each of these three important respiratory uh viral infections and then a little bit about some of the uh immunization status and recommendations which have certainly in in some quarters here caused a fair amount of uh confusion and which may not be entirely settled yet uh I’ll say as well. So um future changes may be coming. So I’m going to go ahead and share my screen here. So I’m hoping uh to just uh give a little bit of information about you know why is important these are important for our patients some of the vaccine recommendations as mentioned. I’ll mention I have no direct disclosures relevant to any of these uh current vaccines. Uh it’s perhaps no surprise to anyone that uh one of the important squelli I think of the pandemic has been the changing landscape of recommendations that were often very on short order and not always communicated effectively or even later on perhaps as balanced at times that has uh caused a great deal of upset and distrust. And I just wanted to focus on some things which I’m sure all of you probably know but just to highlight that some of the basis of this is that especially for the covid vaccines the mRNA was a a new technology uh that people were unfamiliar with um you know it was hurried through thankfully with I think spectacular results uh but it was not a formally FDA approved vaccine and concerns have been raised about whether there’s long-term safety given the novelty of the vaccine andor just whether there were too many immunizations given and and there’s a host of other ones more specific as well and and there are many barriers that I think have only been amplified more recently uh both in social media other uh uh people that will say they have uh expert advice and so on that has sort of fostered I I think an increase in vaccine hesitancy uh a sense that there’s danger in this and um perhaps also in terms of co that’s no longer really that important and so we’ll just focus on some of these I think will be helpful when you’re perhaps uh uh ask questions or you’re making a recommendation for our patients. So uh some preliminary uh data from uh the last year two from the centers for disease control that uh you know were from this past summer uh still shows that there’s a significant burden from SARS Kovv2 uh here in terms of total infections uh hospitalizations as you can see are substantial and deaths which certainly at least rival or at least neck and neck sometimes a little worse, sometimes who knows a little bit better than seasonal influenza. And of course, the difference is uh this isn’t traditionally a respiratory season pathogen as it seems to be uh year round uh often at uh different levels. For example, this summer was certainly another surge uh especially in areas on the west coast, but also the northeast and other parts of our country based on wastewater surveillance. And what has also been true is that the vaccine uptake has been reduced uh for COVID vaccines with estimates last year that less than a quarter of adults received immunizations and uh fewer uh children. Um now what what does the vaccine get you if you’re immunized? Well, uh much like seasonal influenza vaccine, uh perhaps its vaccine efficacy is certainly diminished from uh the first trials. Uh estimated, you know, um uh less uh and who knows if it’s 30, 40, 60%, does depend, you know, on your immune status and age and so on and so forth. What you sort of see here is that it prevents uh ED and urgent care visits uh in about a third. But in terms of severe illness, much again like seasonal influenza, immutations do help prevent severe illness um in both uh imunocmpromised and immunompetent uh patients and and those over 65 that end up being at higher risk and you get the benefit where it’s clearly reduces the chances of long COVID. Now in terms of just hospitalization risks which was really an old surrogate that’s very hard now to prove with studies just given the fact that the severity of illness is generally declined now that many people most people have immunity. Uh the burden of illness is clearly shifted. It’s highest at the extremes of age as you see on the right hand side especially in um the 50 and older group but especially 75 85 and older is where mortality is the highest and then also in infancy uh uh there whereas you know children for the most part and young healthy adults are at less risk uh if they’re immune competent and don’t have significant health problems. Now for the uh severe influenza season uh just by shifting in comparison last year uh uh influenza certainly uh was deemed quite severe and you can sort of get a sense of the neck andneck aspects and and how both uh COVID and influenza are beginning to mimic a little bit uh like one another with the exception that influenza still uh causes much more disease. relatively than covid in in children and and young adults. So uh the co recommen recommendations that we had been uh following last year just to refresh everyone what they were uh in the United States everyone six months and older was recommended to receive it. uh you could delay it uh if you had recent COVID because that’s sort of your own immune booster as it were uh against this virus and um you needed two doses or two doses were suggested in uh patients who are immune compromised and you could spread them apart by two months or if you were over 65 uh you would spread them by six months but I would say uh and I do some primary care myself along with infectious diseases. I’d say it was hard to get many of my atrisisk patients um uh to uh older patients to get those two vaccines. I think many people are just thinking of it as a a seasonal uh respiratory vaccine getting it with influenza. Now, just looking at the WH took a different tact in many countries that may have lesser resources. uh they sort of viewed things as you know who to prioritize you know uh people over 75 people over 50 with co-orbidities any adult with coorbidities and then special groups such as pregnancy healthcare workers and immune compromised um so you know clearly uh the United States u had a little more of a u or had a lot more of a just sort of a a blanket recommendation there uh because there were benefits to smaller numbers there but uh the sense was this is a a a safe vaccine so that was the approach given what’s transpired uh of course uh what I call the new world at least in the United States is that um uh there was FDA approvals that are different now for this updated uh uh vaccine which uses a a J N uh.1 lineage component for this next year uh season. So or the next year. So this is different than um uh the last one which is probably no longer available in in pharmacies and unless if you have some still left in your freezer. So uh there are two mRNA products uh that at least on FDA approval basis have universal recommendations for 65 and over but then are limited to those with health conditions at younger ages. And uh the one difference is that uh uh the um uh uh Novivvax which is of course the non mRNA proteinbased vaccine is only approved in ages 12 to 64 um whereas um the others are at younger ages including uh the Moerna vaccine which could be given as young as six months. Now what’s what’s a lot of people feared from the ACIP which held its meeting uh earlier uh this month was that uh there would be some kind of strict requirement or doctor’s prescription and this has proven not to be the case although I’ve certainly had pharmacists or patients ask me for a prescription or else their drugist wouldn’t give it to them but that could have been uh perhaps now less of a concern but they’re supposed to be shared decision making uh for everyone uh in all these conditions. Uh so it’s um how this will be handled is uncertain uh there and we’ll we’ll talk about it in a moment but uh you’re supposed to have shared decisionmaking with the emphasis on higher risk people uh there and uh it’s still awaiting uh now uh a week plus from this meeting for formal adoption because the CDC director to sign off on it and I think It’s interesting. Uh we can all agree that this hasn’t happened yet and whether the uh true recommendations will change and not perhaps be in line with the ACP ACIP recommendations. So uncertain why this hasn’t really been signed off since we’re now certainly heading uh into a a season with a vaccine at this point. So here are the key issues as I see them. Yes. 65 and older and people with coorbidities, but you’re supposed to do shared decision making in some form before receiving it and you don’t need a prescription. Um so uh the thought is probably if you’re under 65 you may need to attest to a health condition um but not proof of it there and that you have to have some degree of discussion but it can be with a health care professional uh could be nurses, pharmacists, PAs, advanced practitioners, n uh primary care uh docs uh uh specialists But still, if that’s a requirement somehow, it’s also unclear if there’s been a verbal uh, you know, acknowledgement that you’ve done this. Do you need to attest to it? Um, there is some confusion there. I think most people uh believe that all insurers will pay for vaccines. Certainly Medicare Medicaid patients but uh the American hospital insurance uh uh group the insurance group uh there has said that they pledged they would cover it. United is not part of that but have said that they would also uh agree to cover vaccines but some of the mechanistic uh mechanisms and I’d be interested if anyone wants to comment on this that’s listening today in the Q&A um uh what they’re sort of seeing and facing would be sort of helpful to share. Now moving to influenza. Um this is a little easier and a little more certain at this point. Uh but just to look back at last year, it was uh considered the highest severity year short of the 2009 pandemic. Uh with um 13,000 deaths um 280 pediatric deaths. So the highest uh ever recorded except in that 2009 period. and that most of the children that succumbed unfortunately were unimmunized uh and uh but half were healthy. So it meant um you know there’s certainly risks and that’s uh always been true for influenza with the average age of death being just seven years. uh there were many hospitalizations which is why it was judged of great severity even though the death toll wasn’t perhaps as high as in some other years with a high percentage needing ICU admission and that was mainly an influenza A year uh with H3N2 as well as the old pandemic strain still circulating and importantly at least on an antiviral standpoint uh osult tamavir and the an alternative bloxave really did not show any significant resistance in the CDC influenza surveillance system. So for influenza uh the ACIP was sort of the older panel and and so there aren’t really uh before there were changes and so there’s not much change there still remains universal immunization at six months or more uh much like last year all are trialent with just a single B um uh component and two A’s and uh immunization remains best um either in September or October uh before we head into the November December holidays and the typical uptick in influenza. So, what’s new this year? It’s not a lot. The recommendations have generally stayed the same, but happy to answer any questions. Um there is a new self-administration uh of the uh live attenuated influenza uh nasal vaccine there. So you don’t have to have it given in the setting of a um pharmacy or an a medical office. Uh the second so you can pick it up and and then administer it uh to folks at home that may be bedbound or or not easily uh gotten to uh pharmacies or or pediatricians offices. uh the uh re combinant influenza vaccine uh has now been approved by the FDA for as young as nine years and uh with a lot of fanfare but little impact um all vaccines were declared to be primarisol free which was really mostly the case anyway. And the last is perhaps the underappreciated respiratory sensitial virus. Um I you know we we certainly have a lot still people doing co home antigen studies. There are also combination COVID and influenza uh home testing as well. And of course you have rapid testing both molecular and antigen testing for influenza in primary care offices frequently and urgent care. But RSV is generally not uh investigated until you might end up in an emergency room and requiring admission uh which is when it’s often part of that panel. So I think we don’t really appreciate how much this occurs at least in the adult population and certainly for children um you know this is the season of RSV uh which has varied a bit following the pandemic um uh but seems to be returning to its customary role with the onset of school and a big uptick in RSV most severe in the under two age set but for adults there’s a growing recognition that people over 65 and and certainly over 75 and healthy uh are at risk for hospitalization. Same as with COVID and influenza. Uh but there’s also risks uh in the 50 plus group especially if there’s comorbidities. Uh estimates are at at least as far as we can tell that RSV might account for anywhere from 60,000 to 160,000 hospitalizations a year. and uh 6 to 10,000 deaths. So, it’s less than seasonal influenza, less than COVID, but still substantial. And if you’re ill enough to be hospitalized, the thought is the fatality rate is probably about 5 to 10%. Not necessarily always from the virus itself, but because this virus will exacerbate an underlying health condition such as congestive heart failure, for example. So there’s three RSV vaccines with the newest kit on the block being the mRNA vaccine. So this is a bit of a little a larger landscape here. And there’s a couple of distinguishing features, but generally when these were first FDA approved, um they were approved for uh people 60 and older. And so that’s sort of what the initial recommendation was. But I think many uh like Andy Pavilla and others that really study the field uh of this and adults thought you know generally healthy uh adults in their 60s even up to 70s without health problems are not really at risk for this being uh a severe illness and I think there was recognition and compilation of data such that last year the ACIP changed the recommendation so that it’s recommended for all adults over 75 because that’s really where risk risks were the highest and uh adults uh 50 and older in that group up to 75 at increased risk generally because of card cardopulmonary conditions uh and so on. And that the recommendation is you can use any of these three vaccines. There’s no uh special one. Um and it’s not annual. That’s very frequently asked question from my patients. Do they need a booster? at the moment um RSV uh uh data from Fizer I believe if I remember correctly uh shows good three-year protection data to date. So what are some of the differences here? Um are that uh uh both Madna and Fizer do have an FDA indication as low as age 18. Uh so um that’s not the ACIP recommendation but the the vaccine can be given as um to uh adults all adults potentially if they have a health condition. So uh what are some of the nuances here that you should know about? Well, on the left hand side is uh pregnant uh pregnancy and this is for the protection of uh infants and it’s only the Fiser vaccine uh that uh is approved for this and it’s given in the third trimester uh to protect infants. Um and this is uh an alternative to the monoconal antibbody infused into infants that might be judged high-risisk is having congenal heart disease for example. So it get offers much wider protection there. Now, uh, for our adults, which was the focus of this webinar, um, we talked about how if you’re 75 and older, that’s easy, but then you need a a risk factor, uh, in the 50 to 74 group, uh, generally uh, cardopulmonary diseases, for example. Uh, and then, uh, if you’re between 18 and 49, you can use uh the mRNA or the Fiser product, but uh, the ACIP does not currently recommend. So this is where you might need a prescription and uh insurers may not pay for it. So there may be out-ofpocket expense and at least for pregnant people uh again the window for administering this is usually September to January uh at least here in North America to offer that uh protection from the vaccine which is transmitted by maternal antibodies to the infant. Um and then just here’s the risks uh for RSV. There’s also the standard list of other comorbidities uh beyond what I’ve mentioned. Liver disease, obesity, uh imunocmpromise, uh people living in institutions um or you know there is at least the FDA gave this uh uh proviso that any health condition that a practitioner may be determined to place them at risk of disease. timing is, you know, if anything, it’s great to get it in August or before uh the fall uh season if possible, but it could be given at any time and no boosters required as I mentioned with three years of data. I’ll just finish with uh two quick slides uh hearkening to uh my first slide that is uh the issues of increased vaccine hesitency. uh there’s no doubt making a strong recommendation uh from you uh is the most important. I will also mention it’s important to have the staff on board. I can’t tell you how many times that patients will ask one of our, you know, uh medical assistants like what do you think of the vaccine? Should I get it? And I think if you don’t inform your staff, you know, there could be some cross purposes there just to answer questions and and make sure they’re also on board with what you’re thinking. But for people that are hesitant, can you actually move the needle? And it may not be in that visit. It could be others, but it’s to try to ask them what they think of the vaccine. What have they heard? Uh try to use motivational interviewing, which I have a quick slide on coming up. and and try to you know you don’t want to give them the data behind the recommendations like I did here and you know why it’s important and and all of that because on an individual basis they’re usually worried about safety and you know all these vaccines have generally been safe with only very rare complications um which I can happily address if people have concerns during the Q&A uh and and and basically opening the topic and I know we all have compressed visits Now it’s very hard to get into this uh but to begin the discussion I think is important because this is one of the best uh strategies to prevent illness that’s also the least expensive and for motivational interviewing um this is really rather than a top- down approach you ask open-ended questions hear what they have to say you would try to summarize it back to them and say I understand this is what I’ve heard for example um you know, do you acknowledge their concerns? Uh is there some potential misinformation? Ask would they like to hear what our thoughts are on some of this and so on so forth. Summarize and then go back to them and say, “Well, what do you think of that?” and and so on and so forth. So that’s uh been viewed as one of the stronger ways if um when you have the time uh to sort of dedicate to this, which can be accomplished in as little as you know two to five minutes. So in summary, as I mentioned, a strong recommendation remains the best chance to immunize our patients. Uh for those that are uncertain or hesitant, especially with mRNA vaccines, uh you know, the motivational interviewing techniques are very helpful. uh please don’t confront and you know you don’t want to say you want to clear up information but you want to just understand what they understand and see if you can bring any of the information that you are aware of and actually I share patients stories I find that very effective you know because I do both inatients where I see people on ventilators and so on or if you have family members that have you know had problems and so on and so forth are all very helpful because stories tend to be much more convincing to people in front of you than data. And then lastly, I just wanted to mention, of course, that uh the Johns Hopkins antibiotic guide uh we keep up to date with information. Um I’m still waiting to update our COVID module to see what the CDC director says and our COVID vaccines. Um so, uh I’m waiting to see what happens on the sign off and so on. Uh, but I’ll be sure to have older data available so people know what was previously recommended as well as current um ones that might impact um insurers and so on for your patients. So, thanks so much for listening. I’m going to stop sharing and I I think we have some time for questions. Yes. Thank you so much, Dr. Alwater. That was a fantastic presentation. We do have quite a few questions. Hopefully, we will be able to get to as many of those as possible. The QR code that was just shown does offer a 14-day free trial to the Johns Hopkins pocket guide. You can also get that information by going to the Unbound Medicine website and filling out a form and we will be able to get you set up with access there as well. I’ll put I’ll put it back on at the conclusion. Does that make sense? Okay, that’s perfect. Thank you. And so the the first question that we have is Dr. water. Have you done any comparisons of the influenza severity between the US and Canada? No. No, I haven’t. Um, not that I’m aware of. Um, that I that I know of. I I it’d be interesting to know what the basis for that question was or was it more on vaccine penetration issues or something? So, I’m not familiar with that data to be honest, but thanks for the question. Perfect. Thank you. And then our next question was regarding flu mist and I apologize if I’m not saying that correctly. The understanding is that self-administration ordering must go through the manufacturer and pharmacists cannot do that at this time. Is that correct? I’m sorry. Say the question again. Sure. My understanding for Flumist is that self-administration ordering must go through the manufacturer but that pharmacies cannot do it at that time. At this time currently that’s true. Yeah. For pickup. Yeah. Mhm. And then the next one is with the newer RSV vaccines, do they have a lower AIB risk than the original? A lower I’m sorry. AIB risk than the original. Oh, AIB risk. Yes. So the little Yeah. Um so with the mRNA, it looks like that’s a little different than the protein adgivants uh there. Um, but it’s it’s it you know that’s something that’s been raised and I have to say uh I I haven’t seen much about that recently. Um uh so um I think that’s uh you know that’s something that I I tend to just mention to patients. I think if anyone has paroxismal aphib or they’re tenuous um it’s important but I I also will say RSV itself will be worse in these patients than the vaccine right so uh but you know I I think in full acknowledgement especially in people with you know uh cardiovascular conditions it’s good point to bring up and in the space of the time limited you know obviously there was a lot of topics we didn’t cover. Yes, I think we have time for two more questions. So, the next one we will get to is what is the goal for the COVID vaccine since the LP8.1 lineage is no longer dominant? Yeah. Well, so this is always an excellent question like we’re we’re make they made those decisions were made a while ago, right? And it’s no longer dominant. So, you know, the protection obviously won’t be quite as good, but there’s still cross protection. Um, and so, uh, uh, and there could be also T- cell responses and other aspects here, and this has been true obviously where we’re sort of always behind this particular corona virus. So, yeah, I mean, I and we’ll see how well it performs, right? Um, it depends a little bit how the lineages diverge. Uh so far that’s been it hasn’t been the dramatic ones that we saw earlier years ago, right? So uh you know we’ll just see how well it works but it’s the best you have. You have to make a decision, right? Make the vaccine. So uh it’s it’s always a very valid point. We’ll see how it goes. Thank you. And for our last question, it is almost a combination of quite a few. You mentioned patient stories. Is there a particular story that you found helps reassure persons about the safety of vaccines in general or specific to COVID? Yeah. No, I mean I I think what I mean for me it’s usually I immunize my family to be honest. Um you know both my even my adult children you know do get vaccines and you know they’re in their 20s for example. um you know I I’ll just mention my own personal stories there uh that I I do get immunized um and and why you know and uh you know and that I labeled concerns um I also at least to health professionals tell the story uh because I understand it when the Vericella vaccine came out I was afraid when I had my oldest at that time was five when it came out and they were like well it’s a new vaccine I really don’t want to take it and of course then he got you know vicella it was terrible you know and the vaccine of course was safe but we were sort of nervous so I I do understand uh that especially with the mRNA vaccines but I I also try to couch that story by saying you know if I had known what I know now you know and so I say it encourages me to tell people we’ve had such a vast amount of data with mRNA immunizations you know just millions and you know millions of doses that we’re not really seeing any significant safety signals now especially since many people have immunity. So um and of course there’s still always rare events. I you know of course that’s true for any vaccine but I I tend to personalize it as much as possible and plus I at least for my primary care patients I I know them well enough so I try to you know uh uh uh pitch the story a little bit. So wonderful. Thank you so much. I apologize that we did not have time to get to all of the questions. Please feel free to reach out to again webinars at unboundmed.com and we’ll see if we are able to answer those in a more one-on-one capacity and hopefully share those in the future as well. Again, this QR code can be scanned for the 14-day free trial to the John’s Hopkins pocket guide where you’ll be able to view more information such as that which Dr. Alwater presented on today in addition to other topics. And we look forward to hosting you again in the future for one of our other webinars which will likely also f feature this wonderful speaker, Dr. Paul Outwwater. So, thank you all and thank you Dr. Outwwater. Okay, thank you very much for listening. Hope everyone has a great rest of the day. Take care.
