CDC and FDA Recommendations for SARS-CoV-2 Booster Shots

Video

Experts in the management of SARS-CoV-2 educate on CDC and FDA recommendations for approaching administration of booster vaccines, including those for special patient populations.

Dr. Rodney Rohde: Hello, and welcome to this Peer Exchange titled, “COVID-19 Expectations on the Roll-out of Booster Shots.” My name is Dr. Rodney E. Rohde. I am a regent’s professor, research dean, and chair of the Clinical Laboratory Science Program at Texas State University and the College of Health Professions in San Marcus, Texas. It is my honor and joy to join you guys today. Joining me today in this afternoon are my colleagues, and I'll let each one of them introduce themselves quickly.

Dr. Jacinda Abdul-Makkabir: Hi, everyone. My name is Dr. Jacinda Abdul-Makkabir, but I go by Dr. Jam or Jam. I'm currently an assistant professor at Loma Linda University in Loma Linda, California.

Dr. Madeline King: Hi. My name is Dr. Madeline King. I'm an infectious disease clinical pharmacist, and I currently practice as an outpatient infectious disease pharmacist at Cooper Hospital in Camden, New Jersey.

Dr. Wendy Wright: And hi, everyone. I'm Dr. Wendy Wright, an adult and family nurse practitioner, and the owner of two nurse practitioner owned and operated primary care clinics located in New Hampshire. It's truly my pleasure to be with all of you today.

Dr. Rodney Rohde: Yeah, outstanding. It's great to meet everyone and your backgrounds. And as I mentioned, our discussion today will really be focused on providing an overview of some of the recently approved SARS-CoV-2 booster shots, really highlighting some of the current recommendations and how to discuss these vaccination options with patients. Welcome, everyone, and let's get started. Our first segment of this panel will be talking generally an overview around SARS-CoV-2 and the variants that are involved in that outbreak and pandemic. Dr. Jam, I think I'll start with you and ask if you would like to discuss the difference between the original SARS-CoV-2 strain, which now has been about two and a half years ago, and the subsequent sub-variance that have been percolating out through society since that time.

Dr. Jacinda Abdul-Makkabir: Thank you, Rodney, for that question is when I get often, but when we think about the differences between the original COVID-19 strain or what we call in the community, the OG COVID strain, and then comparing that to the sub-variance that we currently see, we think about the fact that it's really just a matter of mutations, so genetic mutations that multiply and then cause these sub-variance to be prevalent. Then I come into this place of, well, how are these sub-variance identified or how is it that we named them and so on and so forth. This was really a learning moment for me. I know that we used the Phylogenetic Assignment of Named Global Outbreak where the pain go nomenclature. That's how we end up with these B1 and B5, and then so on and so forth. And then actually the World Health Organization designates specific names to the variant. At this point, we're what? Fifteen letters into the Greek Alphabet at Omicron, so they start with Alpha and then so on and so forth. That's the differences that we see in terms of our original COVID-19 strain and then these now sub-variance that we're seeing here.

Dr. Rodney Rohde: Yeah. Thanks for that explanation. As a virologist, I'm often answering those questions as well because as many of you know on the panel and out in listening world, a lot of these viruses sometimes will get named from their origin. And so, we've tried to stop doing that so that we can quit placing a geographic location, for example, or even some other nomenclature that might be looked upon as a stigma or something like that. That's really the reasoning behind some of that, so thank you Dr. Jam for that information. Madeline, can you talk a little bit about in your work, do you talk about the differences between a variant of concern or variants of interest or that type of information around these types of strains?

Dr. Madeline King: Yeah, it's a great question. I would say in the clinical setting if I'm talking to patients, I'm not really going to talk about the scientific names of anything. I might bring up the current circulating variant is Omicron or Delta, because those are names that people hear in the news all the time. But for right now, what we're seeing a lot of in the United States is the BA.5 variant. And there's a new one that's starting to stick out its ugly head, the BA.4.6 variant which it seems like the current vaccine, the new booster is going to have some coverage of based on what I've seen. But yeah, we don't typically use the scientific names too much in clinical practice, more so in the science and lab areas. But the ones of interest right now, BA.5 is still the most prevalent in the United States.

Dr. Rodney Rohde: Okay, great. Thanks.

Dr. Wendy Wright: If I could just jump in a little bit and just give a little bit of my patient population. And that is, we do talk a lot about the different variants, at least in primary care. Because patients are coming in and saying, is this the new bivalent vaccine, and is it the one that I've heard that's targeting the Omicron and its variance? And so, I think we do talk about it, at least in my clinical practice, because people want to know that they're getting that vaccine that is really targeting those circulating strains. And then the other thing that we use the variants to talk about is how genetically different it is today from what it was two and a half years ago, making it a little bit less recognizable by those native vaccines that we gave and why it's so very important that our patients get the booster shots that are really targeted toward what we're seeing today. Because I think too, the other thing I love to talk about with them is they have this impression that Omicron is this mild illness. And while it may be for some, we know it's so contagious that hospitalization rates are actually up, and particularly, if you're zero to four years old, you've got a five times greater risk of being hospitalized from it. I just wanted to take from my end that clinical piece back and say, we do use this to have a conversation about what we're seeing so that I can push people to get a vaccine, and particularly the boosters that are out now.

Dr. Rodney Rohde: Yeah. Thank you.

Dr. Jacinda Abdul-Makkabir: And I would like to add, if I may if I don't take up too much time, that I'm definitely in agreement with Wendy and it's definite – We actually use variant of concern and variant of interest, and I try to make sure that I can make the people that I talk to stakeholders of these terms because, at the end of the day, they impact all of us. So, it's a matter of explaining exactly what they are. But as Wendy stated, it's important that we reinforce just how serious these variants are, but then really walking the community through, okay, a variant of interest is when we may see a bit more mutations than what we saw in – It's something that we're not really worried about in terms of COVID-19. At the end of the day, we expect viruses to change themselves a bit. But when we get to the various of interest point, now it's, we're interested, we're looking at this, and then I tell them, well, now, this is something that they're going to look for more in laboratory testing. Are they going to continue to see these strains with these same types of mutations? And then I explain to them, well, now we're at the point with Omicron. These are variants of concern. This is a variant of concern because now it's changing how easy that that variant can go from person to person to person to person. And as Wendy and Madeline stated, well, this is now why we have to have these bivalent vaccines because we've gone from that variant of interest, now we're at that variant of concern. Now, this is a problem that we have to deal with. I think that it's important that we do continue to use these terms, but when we do, that we make the folks that we talk to stakeholders of what it is these terms mean and how serious they can be in terms of COVID-19 and how it's changing.

Dr. Rodney Rohde: Yeah. Thank you all. In my experience, I'm a credentialed specialist in virology and microbiology as well as public health. My background is in testing and some of the molecular testings that Wendy was talking about, and Dr. Jam. So, it's interesting to hear you guys talk about it because when I speak to the public, which is what we're doing right now I cannot overemphasize how critically important it is for good science communication and good health literacy. And just to be clear the CDC and the WHO do have these designations of variant of interest. Those are the ones on our radars, right? We're watching those, just to be clear. Concern is happening right now. Something we're going to keep our eyes on a little closer. And then the one we haven't seen and we don't want to see is the variance of high consequence. That means we've entered the world of vaccines are not working, therapy's not working, things are spreading out of control. You might have thought about that early, early, early on in the pandemic. We never really got there, but we probably were close before we had those vaccines roll out. So, thank you for defining those in your patient populations and in your research and elsewhere. It's I think, really critical that the public continues to understand that as we move forward. Do you think – and any of you can jump in here, do you think that there is a particular impact of these different variants when you start thinking about the challenges they present to vaccination? Certainly, the public thinks that. Do you have a way to explain that to your populations?

Dr. Wendy Wright: For me, if you don't mind, I'll jump in on this one. I think that it has posed a huge challenge. First and foremost, providers are fatigued. We are vaccine’d out right now. I just saw someone today who's on her fifth vaccine, and she said, when is this going to end? And I wish I had a magic wand, but I think that those variants have really made it tough for us to keep pushing people to continue to booster, booster, booster, et cetera. I'll say to you, I think we made a mistake when this vaccine – when this virus first came out, we started giving the vaccines. I think we needed to have a three-dose primary series and not call these booster shots. I think many experts will say, we probably needed to give one, and then a month later give another, and then six months later give a third like we do with many other vaccines out there. Because when people hear booster doses, it makes it really tough. And I will also say that I feel like for the last two years we've been chasing these variants. We've got to find a way to get ahead of these variants, which I think is what we're trying to do with the more targeted bivalent vaccine that just launched in August, September timeframe. But I think it's made it very, very challenging for all of us not only clinically, but for patients also, they don't necessarily know what to do. And I had a woman say to me today, she said, I'm going to be very frank with you. I'm only taking this vaccine if you tell me I need it. I'm done with the government. I don't trust them. And we're hearing this resounding that people are now, they don't trust science. And so, she said to me, if you tell me you want me to have it, I promise you I'm going to have it. And that'll be a nice segue later on. But also, I think it's just really hard on people and they don't always feel good when they get these vaccines either.

Dr. Madeline King: Yeah, that's a great point, Wendy. I think in speaking about that, you made me think about our messaging when we talk about the flu vaccine as well. I'm afraid that people are going to hear this booster shot with new variants, and they're going to think, oh, I have to get a flu shot every year. I'm going to have to get a COVID vaccine every year. And a lot of people don't get their flu shot anymore because they don't – they think it's not effective. People still get the flu. And I feel like a lot of that messaging is going to be crossed. And so, I fear that people are going to get the same impressions with these COVID vaccines going forward.

Dr. Wendy Wright: I think you're right. But I do think one thing, I think the best thing that's happened from COVID is we're now changing the way we're communicating about vaccines. And what we're saying is not that it's going to protect you from the disease, we're saying that the efficacy of these vaccines is really around hospitalizations moderate to severe disease. And I believe that's what we need to do with changing our flu messaging as well. And maybe COVID has set the stage for that to happen.

Dr. Rodney Rohde: Dr. Jam, do you have any comments on this area?

Dr. Jacinda Abdul-Makkabir: I do have comments on this, and it may actually interface into what it is that we'll talk about moving forward. But I think that Madeline and Wendy were very spot on when they talked about it's communication strategy. And I think, Rodney, you said it in a previous topic that we had talked about, it's communication strategy. At the end of the day, we have to be intentional about how it is that we communicate with the public on what these vaccinations are for, what it is that these variants are, why increased vaccinations are necessary. And we have to position scientists as those individuals that are the experts. We can't have anyone other than trusted scientists like we have Dr. Wolinsky, we have Dr. Fauci who have just been at the macro level, so important for our communication strategies and really increasing vaccine uptake. But I think that part of the question that you asked was just so important, how does vaccination efficacy differ for these boosters or the bivalent or the sub-variance anyway? What do we notice with the vaccine efficacy as time progressed as we saw the Alpha, the Beta, the Gamma, these different variants come to be? And I think that's what's most interesting, and that's what I continue to explain to patients when that conversation of, do I have to get these additional boosters comes up? Well, I say, well, originally, we had a ton of protection. We saw ridiculous efficacy rates when we looked at Moderna and the Pfizer mRNA vaccines. Things that we could have never imagined in this lifetime to see. But guess what? When we saw the Alpha variant come along, well, now we didn't see as much efficacy. When we saw the Beta variant – , the delta variant, which we distinctly remember being such a barrier to care. As these sub-variants occur, then we end up in this place to where we need to have more protection, we need to make sure that we can do what we can to build those antibodies back up. I think it's the conversation, it's the messaging. It's how we package why it is that these boosters are necessary. I think that it's bold to say, hey, patient, I know that we originally told you you needed two or one vaccine if you want to do Johnson & Johnson, but guess what? Now we want you to get two additional boosters on top of that. And then now we have the bivalent. I think that it's important that we have to educate alongside these rollouts.

Dr. Rodney Rohde: Yeah. All great points. And again, isn't it funny, I think the common theme today will be science communication. It's certainly something I've been focused on in the two and a half, three years, and really my whole career for that matter talking about infectious diseases. Just one quick comment that I would add to this. As someone who works in this realm of virology, one of the things I talk about with the public, and again, talking to a level meeting where they are with respect to what a virus really is, and it's really just a diabolical creature that is always ahead of us. To Wendy's point, so I don't know if we'll get ahead of it, but we are definitely light years away, way ahead of where we were a decade ago. The mRNA technology allows us to adjust and pivot. I know some people are still some vagueness and some misunderstanding around mRNA technology. It's actually been around for over 20 years. And it's a fantastic technology that's going to allow us to probably stay ahead of that. And also, to be clear, in a new Lancet publication in the last few weeks, it absolutely over 1.5 million patient data points now in that study show that those vaccines absolutely have kept hospitalizations, severe COVID, and deaths down if you were vaccinated. Just to be clear. And we know all about some of the issues around vaccination and some of the hurdles people have to get them, but it's certainly showing that it's still critical to have them moving forward. That lets us segue into the next section of our conversation, which is really looking at this new bivalent vaccine and this evolution as we've already been alluding to around shots. Dr. Jam, do you want to characterize a little bit, maybe again, about how these vaccines are protecting us and are they demonstrating any type of waning or reduction and protection in the real-world population?

Dr. Jacinda Abdul-Makkabir: Right, absolutely. Thank you so much, Rodney. And thank you so much for interjecting on the previous questions. I think –

Dr. Rodney Rohde: I can't help myself.

Dr. Jacinda Abdul-Makkabir: It's been so educational for me listening to you speak and I'm picking up little things that I can use. I use my engineer husband for my analogies, but I like yours, so I have to take a few. But I think that when I think about the vaccines, and one thing that you talked about was just the mRNA technology, I am so blown away because I am a [INAUDIBLE] scientist, so I'm traditionally trained and in vitro research and the fact that we can't pivot so quickly. But ultimately, when we think about the efficacy that we saw or effectiveness that we saw in these trials in Pfizer and Moderna, it's astounding. When these vaccines rolled out against its original COVID-19 strain, when we saw these studies in December 2020, you were 19 and 20 times likely to be protected against COVID-19 when compare Moderna and Pfizer respectively. That's astounding. And then when we thought about severe COVID-19, when we looked at the Pfizer study, there was one case. When we looked at Moderna, there were no cases in that vaccine group of folks that had severe COVID-19. We were seeing just ridiculous protection levels. Even when we think about J&J, irrespective of the protection not being exactly the same as what we saw with the mRNA technology, we saw great effectiveness with Novavax. We see great effectiveness. We would've screened that 60% had these vaccines rolled out, 60%, 70% had these rolled out. Initially, we would've said, absolutely, these are amazing. Let's jump on this. But I think that your analogy was amazing. The virus is always going to be ahead of us. It's always going to be 25 steps ahead and we have to consider that. So, we have to consider that these clinical trials were conducted at a point where we weren't seeing meaningful mutations. Now that we are, there has been waning response, even when individuals receive their first booster. Initially, like a month after that first booster, we see that maximum amount of protection. But then three months later, per a study that looked at those individuals that were hospitalized in the emergency – that were in the emergency department or the ICU and had been infected with COVID-19, they saw waning responses. About three months after individuals would have received that booster, so that was when we saw Alpha and Delta that booster was suppose to boost up the protection that we had from that original COVID-19 strain. It was only 60% effective. And then as we go further out from where individuals received those booster vaccines, we end up in this place where we are constantly just losing how effective these vaccinations are, in terms of keeping folks out of the hospital. That means that we just have to think about how do we provide that maximum protection. Now, that's where we are with these bivalent vaccines really trying to target those circulating subvariants that we're seeing right now, and hoping that we don't continue to see the responsive waning that we saw previously with the original vaccines.

Dr. Wendy Wright: And I think like any virus, its job is to change itself to escape the immune system. It's survival of the fittest. That's what it's trying to do. I think the important take away and I tell this to patients all the time, is the longer it stays in our nose and in our airways, the more likely it is going to mutate. And as Dr. Offit recently said, this virus is here. It is not going away. And it is here for our generation, our children's generation, and our children's children's generation. We've got to find a way that A, we can try to get a little bit ahead of it or at least be on par with changing up the strains like we do every year with influenza. We can argue that the flu shots they're efficacy is not fabulous. Often times either but when we see 60%, we jump for joy. As I tell my patients, a 100% of zero is zero. If you don't get it, you don't have any chance of a protection. I think that these bivalents that are targeting what we're seeing are our next phase into moving from that pandemic into that endemic status like we're all kind of expecting we're going to.

Dr. Rodney Rohde: Madeline, do you see – have you seen in your patient populations have you seen an actual reduction in current cases? Or is it kind of stayed the same? I guess the question I'd like to ask is, if you're seeing people who have had the booster, the bivalent. Have you seen any direct affect on cases right now? Is that to soon for any of you to really see right now?

Dr. Madeline King: Yes. I think it's too soon for us to see. On the out patient side, I'm not seeing patients, I'm really just doing stewardship. I do still do some in patient work. We haven't seen hospitalizations increased over the past few weeks or decreased. They've stayed the same where I am. We don't always have the strain that someone has available to us. I think it's really hard to say since the booster has only been out a few weeks. If it's really making a huge difference or not. There's really good data on how many people are being vaccinated. There's a lot of maps from the CDC showing that booster rates especially in the area I'm in in New Jersey are high for how many have been available so far. I think we're not doing a worse job at getting people boosters than we did with the initial vaccines. We just have to kind of stay on it. Like Wendy was saying and Jan was saying, we're not going to be able to stay ahead of this. I think as we adapt and create more vaccines with different variants, we'll get faster at developing the new strains. Going forward, we may be able to create a vaccine against new strains less quicker than we did this time. That's kind of my.

Dr. Wendy Wright: I don't think the public realizes that it took Moderna one hour, one hour to design their vaccine. I don't know how long it took Pfizer but that technology is unbelievably exciting. To be able to just change that on a dime is really, really exciting. I think it really, these will be the future of vaccinations.

Dr. Rodney Rohde: In my conversations and I appreciate you guys bringing this up. I do think it's critical again for the public to understand this kind of battle going on between the virus and technology. Certainly, I think the one of the major good things to come out of the COVID pandemic so far has been that knocking down that red tape. The whole roll out of kind of pushing that technology forward. Even though we kind of knew about it but we really cranked it up when things started getting worse. In my lifetime, I never would have dreamed a vaccine would be ready in three to six months the way they did it originally. Part of that is the regulatory piece of it and all of this was safely done. I think we just got better at it. To Wendy's point, I think the way – we may never get ahead of the virus. Again, I'm speaking from the virologist standpoint. It's just going to be difficult. They're just a little bit ahead of us all the time. We certainly should be able to be right there with them now and pivoting quickly. It is that unbelievably awesome that companies can now pivot and use molecular tools to just tweak the genetics of a particular strain. Then mass produce it. Don't forget we also have to amplify that, ramp it up. Now, that we have these lanes of getting vaccine out, we need to get better at vaccine equity across the United States as well as the world. We need better supply chains. We need to stop relying on one type of chain and maybe getting off on a tangent here a little bit. It all adds up together. It's a synergistic effect. Switching a little bit to kind of this constant evolution of these variants. Does anybody want to comment on? Wendy kind of touched on this. Does anybody else have any other final comments around how some of the manufacturers adapted these booster shots? As the pandemic kind of rolled on? Anybody have any other comments around that?

Dr. Madeline King: The one thing that I just wanted to point out which I didn't realize until I was looking into some of the more research for this. Was that, it's really the first time that we had these vaccines that were approved without having to be tested in humans. We had in vitro studies for the new variants. We had human studies for the old variants. I'm wondering if that's going to set any type of precedent on approvals for future variant vaccines. Which would be amazing. Which obviously makes the turn around much faster.

Dr. Wendy Wright: Madeline, I think that has posed an issue though patient wise. These people are very savvy. People will say to me, it hasn't really been studied, has it. It has but it's been studied differently. It's been studied in the form of neutralizing antibodies. We have had some bridging studies in other vaccines over the years where we extended down to let's say five to 12 years of age based on bridging studies. There has been a little bit of precedence set. Patients are really savvy. They'll say, I just read online they studied 600 in vitro, neutralizing antibodies. They didn't test it in 30,000 people like they did the original. How do I know it's safe for me. As great as it is that we have this technology that can pivot on a dime. People are nervous about that technology that can pivot on a dime. They're scared to put it into their arms.

Dr. Jacinda Abdul-Makkabir: I also think it's important though, I'm in agreement but it's important to really explain what those studies that Pfizer, Moderna what they did with those. While they weren't designed to – they actually did test it in humans. While the vaccines were tested in humans, they just weren't the BA4, BA5. Then that becomes more of the conversation. It allows for us to really go in depth in explaining just what these sub variants are. What the mutation to this protein are. Really sometimes how similar they can be amongst these sub variants and these lineages of sub variants. While they did test Pfizer and Moderna because we have to remember, Omicron has been with us since December 2021. When Omicron was listed as – we're concerned about this. We see increased transmissibility. We have to be – you transmissibility. We have to be worried about this. At that point, they said let's take BA.1 which is what's circulating out here. Let's formulate that 50% BA.1, 50% original COVID-19 vaccine. Let's formulate that combination and then we have like you said, these set of patients that we can go ahead and enroll and then test this booster that we have versus the additional boosters that we had been telling folks to take, of the original vaccine. Are we seeing anything there? While they didn't look at, are we seeing decreased infections, they were trying to focus on, are we seeing an increase in the antibodies or protection that's being developed? And they did see that when they compared BA.1 and the original COVID-19 strain, that formulated together, versus the boosters of the monovalent vaccine. But then we end up in this place of, it wasn't BA.4, BA.5 and you're telling me to take BA.4, BA.5. That was the hand that went up this Saturday. Wait, you told me that it was going to be these. Then I had to explain to them, the spikes of BA.4 and BA.5 are almost identical. And it's also very similar to BA.1. I think Madeline brought up that very good point of now we're becoming more flexible, a little less ridged in how it is that we have to approve everything that happens. I think and I think Wendy you alluded to this, it allows for us to really exercise our scientist brain. To really think about, these two they look quite similar. Can we say, that we'll likely see the same things that we saw with therapy BA.1 and the original COVID-19 strain study. Can we say that. Without consequence almost because we think about just the safety and efficacy that we saw with the original strains. We're able to make these deductions. I think that like you guys said, of course we don't have a ton of information. I think we have enough to be able to as sough maybe those fears that the public may have. To also say, can we be a little less ridged in science. Can we use our scientific brains to really go ahead and make these and very important decisions.

Dr. Rodney Rohde: Again, communication. I'm sitting here thinking because I've been so involved in this pandemic since the beginning. That I can remember maybe you guys remember, doesn't it seem like yesterday that also forever ago when we were talking about Delta and other things. One of the things that I often smile about when I hear you guys talking about stuff like this. Is that all of a sudden in my world in interacting with the public and family and colleagues, everyone and I mean without a doubt, everyone was an expert in what a false positive was. What flattening the curve meant. What a monotone antibody did versus poly clonal. Neutralizing anti bodies, passive, active, immunity. They were basically experts and part of our challenge I think and part of our duty as practitioners and researchers and scientists is to take the time again, it's frustrating at times. We do need to take the time to make sure people understand those nuances. Then it is sometimes OK to not put them into people and still trust it. For example, every year most people will often take a flu vaccine again which has new strains in it. They haven't went out and tested that in ten million people or 15 thousand people. We know the technology that's been used. I think again part of this was early messaging and people not really understanding that MR and A technology was already out for a couple of decades. We know that. Again, poor messaging I think. I think that's a big lesson that we've learned. I think you see a little of that learning happening with the current monkey pox outbreak. We tend I think to be doing a little bit better job on messaging. We can always improve. I do think that will continue to be an issue. I'm not sure we did this, let's make sure we cover it for our audience. What exactly is a bivalent vaccine. Let's just get down to the basic vocabulary. Who wants to tackle a bivalent vaccine.

Dr. Wendy Wright: Sure. I explain it to patients – I'm going to use the language that I explain it to patients in. I say, what it has in it is, two strains. Basically designed to protect you against a particular strain of a virus. A lot of times people have said, I'll say to them, you're aware that I give you the flu shot. That has four viruses in it. It's a quadrivalent vaccine for designed to try to provide you with the best protection that we can. Today we're giving you a vaccine that has two different strains in it with the goal of trying to target and protect you against those strains. I think that most of the vaccines that we give are multi-valent. We've gone to quadrivalent with flu. We've got the MCD4, four different strains of Nigerian meningitis in the meningitis vaccine. We've got nine in the HPV 9 vaccine. I think people are pretty familiar with knowing that many vaccines have different strains of protection. That's how I explain it. I'm wondering if any of you use any other different language or have thoughts about it.

Dr. Jacinda Abdul-Makkabir: I'm in agreement. I explain it very much the same. In terms of the COVID-19 vaccine, I always – I try not to use micrograms. I know that can be intimidating. It's intimidating for me to go through measurements. I typically say, all you all need to know is that for Pfizer the dose is 30. Then I tell them that when we think about the bivalent vaccine we have half is the original strain. Fifteen is that it in 15 is the BA.4, BA.5. The circulating Omicron strains. Then with Moderna, I tell them once again no micrograms. All you need to know, don't skip 50. Then they get halves or 25 being the original strain. Then 25 being the BA.4, BA.5. I love how you explained it Wendy and I'll be taking bits and pieces for how it is that I go ahead and communicate that as well.

Dr. Wendy Wright: I'm not sure from a vaccine efficacy or vaccine hesitancy that knowing that information makes much of a difference with people. I just think that by them understanding what we're trying to do is give them strains that are going to optimize their protection. There was a really interesting study that was done on HPV vaccine. The more we deep dived into science with patients, the less likely they were to take the vaccine. I often will say to people, I'm sure, I'm to the point. I give a strong recommendation. I want out. The more we deep dive into science with many people not with everyone if we go down that rabbit hole, it sometimes makes people feel like we're trying to convince them. Versus making a recommendation to them. We are their trusted source of information. I don't know that knowing the bivalent, trivalent, quadrivalent makes much of a difference. Unless you're moving from one vaccine to the next. Like you're going from the four to the nine. Then it's helpful to explain that it's five additional oncogenic cancer producing strains to give you better protection.

Dr. Madeline King: I agree Wendy. I think that was a really good point that you made. I think maybe doing that deep dive sometimes in some patients might scare them. Some of the more intricate detailed science terminology we use with them might just be scary. They either don't understand it so there's a fear of it. I also think a lot of people don't realize that we give multiple strains of other things. They forget that there's multiple strains of influenza in the influenza vaccine or HPV in the HPV vaccine. The pneumococcal vaccines. People don't think about that because we just tell them this is the pneumonia vaccine. This is the HPV vaccine. We don't go into all of the difference. I think people forget that. I think it's a good point to remind them that you get a lot of vaccines that have multiple things in them. This one is just something you're hearing on the news a lot about.

Dr. Rodney Rohde: In my expectation, sometimes when I'm discussing this type of thing with people. The bivalent, the multi-valent I do think you can do it at a level that can make it interesting. Like Wendy said. You can keep it relatively simple. It's just different types of flu strains and because of that we're covering your protection in a different way. Sometimes, I think also we need to make this point because I hear this a lot. Including with sometimes people that should know this information but it's still pops up is that, in many incidences people still think they're getting a live virus. Or they're getting something that can change their DNA or something like that. We all know that's absolutely untrue. Absolutely untrue. That we can use terms like this is a dead agent or this is a sub unit. This is not even anything that can multiple in you. It's just a piece of a protein or it's something else that's going to tease your immune system. It's going to challenge your immune system and give you some protection. Again, I think that language becomes really critical. To Wendy's point, I love that you mentioned this. I think we've lost it. I think we've lost this little bit in our country and society. We are the experts. If you are a strong recommending being positive and using that language with patients and others. I think that goes a long way. So many people are looking to us for that. It's just like in my experience it's just like if you're having surgery. You don't want a surgeon to be like, what do you want to do? No. I want my surgeon to be – I want her or him or whoever to say, I've got this. I've done 100 of these. I'm the expert. We're going to knock this out and everything's going to be OK. To the extent you have to be that type of person. You certainly want to give them all the information when they ask. I just think we've lost some of that and people kind of dived down that hole a little bit.

Dr. Wendy Wright: I think we have too. And I think that there's been so much changing that it's hard for the average on the ground clinician who's dealing with – me in primary care. We have 6000 guidelines to be responsible for. We're trying to give flu shots and trying to do well visits and follow-ups and sick visits and then trying to keep up on everything that's going on. Keep it simple, be concise, be clear, and be consistent. Concise, clear, and consistent. It's what I tell the people in my office because the studies are very clear that if we are, the majority of people will take the vaccines from us if we give them that recommendation.

Dr. Rodney Rohde: Absolutely. Let's transition a little bit here. I'm gonna slide over here to our local pharmacist in the house and ask this idea around the CDC and the FDA has kind of recommended the administration of these booster shots about two months after the primary or previous booster vaccine. From a pharmacist perspective, do you have any kind of comments around those recommendations, how you explain them and why they're needed for particular reason?

Dr. Madeline King: Sure. I can go ahead and start, and I know JM looks like she has some information to input as well. I think the key thing going back to our topic of communication is reminding people why they need multiple shots in the first place. Letting them know that when they get that first shot of the COVID vaccine at all, the very first one, that's just kind of priming their immune system. Those subsequent injections we're giving them are really making the immune response more robust. Pointing out that there's two months in between your most recent vaccine and this new bivalent booster, I think it's important to point out that if you don't wait that long, you're not gonna get as robust of an immune response as you would if you do wait that long. It does take the immune system a while to kind of build up antibodies and then recover so you don't wanna give the vaccines too close to each other or you're not gonna get the full benefit of those.

Dr. Jacinda Abdul-Makkabir: I'm in agreement with Madeline, of course. I really try to start from the standpoint of just where we are with COVID-19 in general so I'd start with just the overall lay of the land in terms of the virus and how it's impacting the community but really I target minoritized communities. That's who I serve in terms of increasing vaccine uptake. I really deep dive into how it is that the virus is impacting minoritized individuals and we continue to be disproportionately impacted by the virus. When it comes down to the uptake of the booster vaccines, they are not what it is that we would love to see in these communities that are being disproportionately impacted. They are in fact significantly lower than the majority population. I make sure to explain that first, and then I do that dive into the information that Madeline gave. Of course, you wanna explain to them why it is that it takes that time to build the immunity or the protection. I also say because they can wait two months, and then also the FDA previously said, well, the CDC has recommended that if you are not a person that's immunocompromised, or if you're not a person that's 50 or older, then potentially you can wait for three months and really allow for your body to make the maximum amount of protection or those increased antibodies. I also offer that advisement as well so I let them know, if you are in this particular age group, then yes. If you're two months out, then you wanna go seek the bivalent vaccine. If you're in this particular age group and you don't have an immuno-compromising disease state, then you can wait three months and then get this vaccine.

Dr. Wendy Wright: I think that while we focus a lot on science, I think that the other part of this is, yes, here's the science piece, but the other part is this is a virus that's out there. It is circulating, there are more and more infections so the thought was also, can we get this on board as these kids are going back to school and as we're heading into those winter months to give people optimal protection when they're inside unmasked now because people aren't wearing them and give them some protection to get them through these winter months. I think here's the antibody piece, but here's the practicality of what's happening in this nation and let's do what we can to get these on board as fast as we can.

Dr. Rodney Rohde: Again, I think and I'm hearing all of you kind of say this, again, to be clear and I know the audience, they're listening to this, a lot of people will say this is that it is confusing. At times it is confusing around these age groups. Remember, for many, many months and year, I guess we were waiting for the lower-aged children to be able to be vaccinated and pregnancy and other types of comorbidities immunocompromised states. I do think it's important again, to have that conversation with your healthcare practitioner. It's certainly always good to do your own type of reading and understanding around immunization schedules for your children and then so forth. At the end of the day, if you're confused a little bit, it's okay to sit down with a physician or sit down with someone who might be an immunization expert and kind of ask those questions because I have two elderly parents, I have two children that are just out of college. Everything was a little different. Again, I'm gonna go back to this messaging piece. I think the country is in this moment where they don't like the gray answer. We're a society of yes, no, tell me what to do and with the virus, that isn't the way they work. They're gonna change, they're gonna do different things. As soon as we think we have the answer, then guess what? Now we have a different thing to worry about. Testing's the same way. We're not talking about testing a lot today, but in my world of testing, this has been a constant reminder for people to understand that testing is part of controlling a pandemic. If you don't understand the virus is changing, your tests can start failing and begin false positives and false negatives. Again, the science has to be there, but you also have to find a way to communicate that type of information.

Dr. Wendy Wright: One of the things we've done in our clinic is we've separated Moderna and Pfizer vaccines and we do what we call Moderna Monday and Pfizer Fridays because there are so many idiosyncrasies to each of the different dosing. Our fear is giving the wrong dose to the wrong person. I wanna talk to all of you, our pharmacists here because in many states, pharmacists can't vaccinate every single age group. What we are seeing is a lot of primary care providers are saying, this is way too much work. We are not taking any of these on, you need to go to the pharmacy. Well, pharmacists are just as burdened as we are, with all the workload, if not more. I think as a country, what's most important is that we all work within our systems to create novel ways to get these vaccines on board.

Dr. Jacinda Abdul-Makkabir: I will say from the pharmacist standpoint, we are of course vaccinating most age groups at this point due to special pandemic orders and so on and so forth. Over 70% of individuals that have received vaccines have received them from pharmacists. Myself, I am in the community and I vaccinate. I only vaccinate with Pfizer so when I go into the community, I only take Pfizer with me. That being one Moderna has a ton of doses in the vial and the climate of uptake is just changing and I don't feel comfortable wasting the amount of doses that I would waste should I take Moderna with me into the community. I explain this to the community members, of course, and then I offer that information in terms of the heterologous. Can you receive two different vaccines? Can you receive a different booster? That is a conversation that I consistently have. I consistently discussed the study in which there were 400 individuals enrolled, and then we had individuals that got Pfizer-Pfizer, received Moderna or Johnson and Johnson or Pfizer, and they wanted to see if in terms of immunogenicity, what did we see there. Of course, we saw similar responses with the mRNA vaccines, but a lower response with J&J which is why it's the recommendation that if you have J&J you boost with the mRNA vaccines. That is the conversation that I have with my patients. I know we talked about dumbing the science down, but I believe in really making the community stakeholder so I explain it in a way, hey, this is how this goes but I want them to know I'm not bringing Moderna for this reason, but I'm not compromising your protection as I don't bring it because I think that's a good thing you bring up Wendy. We have so many different doses. We have so many different caps at this point, 17 different colors. It becomes a matter of how can I do this, maximize the vaccinations of how do we keep it safe. Then I end up in the community and patients ask me, can I get the flu vaccine? Can I get it at the same time that I'm getting this COVID-19 vaccine? It becomes that really comfortable place for when I only have the Pfizer COVID-19 vaccine. If I bring the influenza vaccine with me, it then becomes a bit easier too to only have to manage those two different types of vaccines but then I get that conversation of, well, do I get the vaccines in the same arm? Then I explain to them one, this is mRNA technology, you can definitely, receive other vaccines because it's kind of equivalent to an inactivated vaccine. It's not live so you can receive two different inactivated vaccines or alive inactivated vaccine. You just can't get two live ones at the same time. I do offer this advisement, do not get them in the same arm. I say and I don't know, you guys may have different advice, but I usually say go two separate arms. I did it in the same arm last year, and I still regret, I still have phantom pain.

Dr. Wendy Wright: I think that a couple of things I would add, I think heterologous boosting has become sexy. I love talking about that with people. I'm like, in Europe, they've been doing this for a long time. Let's mix it up and you may actually have some better protection. Just one thing I would add, we do do two live vaccines at the same day. We do MMR and varicella. They just have to be separated by a month if they're not done on the same day. That doesn't matter with these. People can get other vaccines, but don't do them in the same arm. We're giving flu in one and we're giving the COVID in the other and we're saying, you're probably not gonna like us tomorrow, but then you're miserable and your misery is over. Take some acetaminophen if you need it and you'll be done with your vaccines.

Dr. Madeline King: I think that's a great point. We are starting to give our flu vaccines here where I work, and a lot of people are like, just give them to me both at the same time. If I'm gonna feel bad, I wanna feel bad just once. It's a good point to remind people that if they feel bad, it's not because they've developed the infection which I've heard the whole adage that people that got the flu shot, got the flu from it. It's hard to dissuade people that believe that, that they didn't actually get the flu from it. I think it's important to reiterate to people that your arm is gonna be sore and you may feel fatigued and a little out of it for a day but that's just your immune system waking up and kind of figuring out what it's doing and not to worry that you've acquired COVID or influenza from the shot that you've gotten. That's something that I always try to point out if I'm giving both vaccines at the same time, is you're gonna feel kind of bad, but it's okay, you don't have the disease.

Dr. Rodney Rohde: Right on. I think the hashtag here from Wendy is mix it up. Let's start a new campaign.

Dr. Wendy Wright: Or heterologous boosting is sexy. That's the other one. Hashtag is sexy.

Dr. Rodney Rohde: That's a long hashtag. That may not work. It's interesting because when you guys were talking about actually vaccinating, I have a ton of friends who are first responders, firemen, and another thing, everybody. Again, one of the highlights and really feel-good moments for me during the last two and a half, three years is people did get out there and did their part with respect to kind of helping immunize people. I remember taking my parents, we drove 60 miles to Brenham, Texas, and my parents are both immunocompromised. My mom's a recovering cancer patient. My dad's got some diabetes issues, and they're both older. We drove them and we had them in our car, and we drove into this community and it literally was thousands of cars and it was so exciting to see them get their shots. It's easy to forget that. That was not that long ago. I think we have to remember how amazing the country did respond. We certainly tripped over ourselves sometimes and we made some mistakes, but overall we kind of stepped up when we had to. I'm glad you guys talked about flu and COVID. I think that's one thing we really do need to make sure people understand is that it is safe. It is safe to get both vaccines. I'm kind of one in each arm myself, kind of guy. I think that helps. I'm also a fan of if you've had issues, I had some issues with some of the second – I've got four different shots for COVID. It's okay to take a little acetaminophen after you take that vaccine. It might make you feel a little better. Why feel horrible? That's what medications are for. I tell people all the time, that's why you're taking a vaccine. It's also why we take medication and you don't need to suffer. It's okay if you're doing it correctly according to the directions and things will be a little easier for you. I think that's really important. The last point before I move on that I just wanted to kind of mention and kind of cement y'all guys talked about a lot was that mixing and matching became so critical and the data did show. If you're still out there wondering, Johnson and Johnson in hindsight, remember we were desperate to get people vaccinated and so we were looking for a one-shot option because Moderna and Pfizer were both two shots about three to four weeks apart. In hindsight, Johnson and Johnson should have been a two or maybe three-vaccine series to win this. Learned some lessons, but again, remember one shot was better than no protection when this thing was raging two years ago. Let's kind of switch gears a little bit here. What do you think about when we're talking about really all of the boosters and all the different options we have on some of the concern people might have around long-term data relating to the efficacy and the safety? Do you guys have any science and/or experiential learning over a couple of years now of where you think these are in the realm of safety and efficacy?

Dr. Wendy Wright: I have one quick point, and I tell them it's the best-studied vaccine ever in the history of the world. It's the best-studied drug. People will say to me, I don't think it's the best-studied. I said, well, I'm just here to tell you that that statin you're taking was studied on 3,000 patients for approval. We have a hundred million doses that have been given out or 200 million or 600 million I think is the number may be out there. I don't know. It's some incredible number. I say to them, it is the best-studied vaccine ever to roll out in the history of our country and of the world. I use that as ammunition. I also say, it's not just being monitored here in this country. Patients can self-report adverse events. We know that from the various data and people can report that out. We've got V-safe, we've got organizations all around the world, including the UK and Australia, who are monitoring the safety of these vaccines. In terms of long-term efficacy and long-term safety issues, it was really interesting. I got my first vaccine December 18th, 2020. I just got a V-safe update today and said, how are you doing? Any new health issues to report? There is that ongoing monitoring, but I think we can rest assured that the vaccines and this is the point I drive home every day, vaccines are safer than the native disease. No matter what study you look at, yes, you don't feel good, but I would take that any day. Your best protection against lung COVID, 30% of the US population is affected by lung COVID is to be vaccinated. The more boosters you get, the less likely you are to develop lung COVID. I try to use that information as I'm educating people.

Dr. Madeline King: I think it's hard to say that we don't have long-term data. We do have a lot of data and a lot of patients, but we don't have long-term just because the disease hasn't been out long enough and we just couldn't possibly have more than two years' worth of data at this point. I think it's important to drive home some of the points that you mentioned, Wendy, about we have so many patients that have been vaccinated and very minimal reports of side effects. I think it's also another good point to remind people to complete their V-safe text messages. I got mine today too. I think people don't realize the importance of them, but that information gets used. That's how we know a lot of what we know is by people responding to that. I think it's really important to kind of push that point as well.

Dr. Jacinda Abdul-Makkabir: I agree. I think it really comes down to driving that home with patients that anytime a drug enters the market, we never stop looking at that drug after it enters. After we give it to patients, it's not that we just say, okay, we're gonna get this vaccine to a hundred million people, and then that's done. We hope everyone's doing really great afterwards. No, we continue to have them report any adverse events that they have, and we'll continue to do that with these boosters. As Wendy said, even when we think about those initial COVID-19 studies, it takes 10 years to enroll 20,000 patients. When we think about HPV, there were a little less than 30,000 individuals included in that study that we used for that vaccine. It took 10 years to get those people in that study. It took us less than one to get the amount of individuals. It was 30,000 for Moderna, about 40,000 for Pfizer. There were so many people that we saw in those initial trials. I think that when we think about these bivalent boosters, at the end of the day, we can say the FDA and CDC scientists felt comfortable enough to say, okay, let's have these bivalent boosters because we did have that strong data with the original vaccines. And as Wendy said, it took them a short time, and Rodney reinforced this to pivot, to add that updated BA.4, that BA.5 to update that vaccine. I think we have to draw on the fact that we saw so many of these doses go out with the original series. We saw the protection it accorded, we saw the safety and efficacy so we expect that to be the case with the bivalent boosters. But also, we're not going to stop reporting on these side effects that we may have. And then technology may be a barrier for certain communities. I know with VAERS, it wasn't super user-friendly for some of the older patients. Let me fall in that category as well. I am terrible with QR code, so sometimes it could be a barrier. So, communicate with your primary care provider, communicate with your pharmacist so that that information can be uploaded, they can guide you and making sure that that's submitted. But once again, let's reinforce the necessity of communication strategies from us as providers at the micro level, and then at the macro level, ensuring that VAERS is something that we continue to push as we push these new vaccines out.

Dr. Rodney Rohde: Yeah, all excellent points. I just did a V-Safe too. It's been several weeks ago, but I remember signing up for that. And again, I'm going to say that again to the audience. If you didn't realize that as a citizen you can participate in these types of things, ask. Ask when you get a vaccine or ask when you're doing something, there’s often a simple app, you can do it on your phone. It might be you go to a computer where you're getting the vaccine. There's just different ways to do it. And you can absolutely sign up and you can report that you had a rough headache and you had a sore arm or whatever happened after the vaccine. And that's important information. That's data that we are collecting. I would also mention, you can also if you didn't know this for our audience, you can actually participate in clinical trials. That is out there. And some people are willing to do that. That's how we get efficacy and safety in our – not only in our vaccines but also in our medications and our cancer treatments. And one of the things that I would use speaking to Wendy's point, talking to patients about, it's the most studied vaccine ever. One of the things I was using in the middle of the pandemic, again, with people that were a little hesitant at times. And I would say to them if you don't get this vaccine – and you saw this happening, right? I'd show examples. If you don't get it and you end up with severe COVID and you end up in the hospital and maybe you're going to be ventilated and then you're going to approve EUA monoclonal therapy, it's the same thing. It's emergency use authorization. What if you were dying from cancer and you had no options and the physician came to you and said, we have an experimental cancer drug that's showing outstanding effectiveness in cell culture, in vitro, would you like to try it? We can get this under a special order. There are things that happen all the time in medicine and you certainly can rest assured that people are going to do it the safest and most careful way. There are some risks, of course, but again, it's better, I think than ending up on a ventilator or mortality happening. For me, that was something I would use because again, I think analogies and examples like that are so critical because people sometimes just need to be told, what are you doing? You're refusing something that has been the most studied thing in the world and it's relatively safe. Keeps you out of the hospital. Great conversation so far. Let's transition a little bit to our next segment, which is really, I think going to be a fun one with several of you. And this is talking about conversations with our patients. We've been – this has been the theme I think of this conversation, which is a good one. Let's talk about conversations with patients and maybe even others that are just considering getting vaccines or other types of things surrounding COVID. Let's talk about in your opinions, how would you or how should healthcare practitioners, in general, communicate with their patients to determine maybe which booster shot is best? Do you comment on composition? Do you get down into the weeds of that booster? Do you talk about safety data? How do you initiate conversations with your patients?

Dr. Madeline King: Yeah. I think you have to include all of those things, but I think you have to include them in terms that the patient will understand. Because if you're using terminology above a level that they can understand, they're going to tune you out or they're going to be afraid to ask questions. So, it's really important to understand the audience that you're talking to and speak to them on that level. I think it is important to tell them why the vaccine is important, how it protects them, why the booster is important, how it keeps them out of the hospital, and the safety data that we do have. I think it's really important to emphasize that no, we don't have beyond two years of data, but the data we have is really good. And I think just reinforcing all of those points. And the other thing that I would point out, I was volunteering giving COVID vaccine in the beginning at a clinic where most of the patients were Spanish-speaking. And I think a lot of the issues that I came across were being able to communicate to patients in a language that they understood. Not even on a level that they understood, but in a language that they understood. And I think we have a lack of interpreters and translators in some of the healthcare settings that the three of us probably work in. If you're not in a hospital with an interpreter phone or an interpreter iPad, if you're out in the community, that may be really challenging. And I think we could maybe do a better job of having people that can tell patients in a language that they understand what they're getting and why they're getting it. And that might increase vaccine uptake. If we can just speak to people on a better level.

Dr. Wendy Wright: I'm a little less scientific. I say we do Moderna on Monday, we do Pfizer on Friday, I'm looking at your vaccine record and it appears you're due for your COVID booster. Which day would you rather have your vaccine, Monday or Friday? And then we'll say, put them on the schedule for their vaccine. I'm a little bit less formal scientific-wise. And then if they ask me, then I'm prepared to answer. But I'll say, you know what? You're also due for your flu shot. Let's get that on board today. You can certainly have it when you come back, but we can get it today, and then we'll book you for the COVID vaccine. The World Health Organization issued a statement about a month ago, and they said, and I'm not going to quote it exactly, but they said, there are 25 million children who have missed vaccinations as a result of this pandemic. This pandemic has taken us back in the world of pediatric vaccines by 30 years. It has been our biggest backslide in the last 30 – last decade or two or more. We as providers need to vaccinate at every opportunity. We need to find ways to make it easy for our patients. For months, two years, we gave vaccines in the parking lot in our office because people were too fearful to come in. We would do it in their car, we would do it in a tent, we had a tent set up. Making that strong recommendation, meeting them where they're at, presenting the recommendation, and then if they offer up questions, let me answer them. Someone said to me today, you're recommending this for me. Have you had it? I said, of course, I have had it. I would never recommend for you anything different than I would recommend for me and my kid. And I always say I love my kid most days. I have a team, but what I'm recommending for you is what I recommend for my family. And I would never do anything different than that. Okay. Get me signed up. And sometimes it's that personal appeal. Like I play the mom card. I'm not afraid to play the mom card, but I use different cards depending upon the person that I'm talking to.

Dr. Jacinda Abdul-Makkabir: I think that for me, because I do vaccinate in the community and I only vaccinate with Pfizer, I run into just the conversation of, well, I've done X amount of COVID-19 doses with the Moderna vaccine, so I don't want to get Pfizer. Then I have to be just very intentional in my messaging. I use that heterologous, right? Vaccines are sexy. I use that hashtag. But no, I explain to them just how it is that they can mix the vaccines and so on and so forth. I get the question of, well, are these new vaccines made any differently than the original vaccine? That's been the consistent question that I've gotten in the field. And then I informed them, no, not at all. We use the same lipids that were previously used to package that mRNA technology, it's the same thing, the same things that we saw previously. The only addition is just that strain, which we previously talked about, is very easy to add to that original COVID-19 strain. I really just try to, of course, have intimate conversation. It's always my goal to connect with the patients that I serve and to make sure that I walk them through the process of selecting the vaccine. But I also come at them from the point of, I only have this, so let's talk about if this is the vaccine that you would like. Should it not be the vaccine that you want, then I will help you find where it is that you can access the Moderna vaccine. However, I only have Pfizer here and this is what we're going to have to do. Typically, though, the folks will get Pfizer if they wanted Moderna. I'm able to have that decent conversation exchange. But then also, with communicating, I have to take into account that I know that I'm a trusted messenger in my community. I can't take advantage of that. I always make sure, and they know when they ask me, I'm going to give them statistics. I'm going to give them the numerical rundown. I'm going to tell them how it is that these vaccines are performing because I want them to know that I have your back and you can trust that I'm going to be studied up and I'm going to take this particular position that I'm in the community seriously.

Dr. Rodney Rohde: Right on. That's our duty to our patient at all times. One of the things that I thought about, and I just mention this because Wendy mentioned a childhood vaccination slippage. The other thing – and so, the other part of my world that I work in, part of my research is antimicrobial resistance. And we've also seen huge backslides in antibiotic resistance, antimicrobial resistance just because of, if you didn't realize this when we were going through all of these processes the past two years at that beginning of the pandemic when patients were dying, and we didn't always have the time to test confirmatory testing to find out if it was true bacterial pneumonia versus SARS pneumonia. We would often be giving empirical antibiotics to patients to help make sure. And we understood that. But the consequences of that, of this massive pandemic, and as it's went forward, not being a good solid vaccinated population is that you still have to do those sorts of things. And we have to get back, right? We've suffered in cardiovascular disease and diabetes. Everything you can put your finger on this pandemic has touched in ways that many people don't realize. And maybe we're just now starting to see those ongoing effects. The other thing I would add just to this part before we move on is, something I've learned really in the past decade or 15 years of my life since I completed my research for my dissertation is meeting people where they are. And so, I'm not someone, I'm not a physician, so I'm not dealing with patients per se, but I'm dealing with a public and I'm sure Dr. Jam and others on this panel would agree with me, that not everybody should always look like me, or to Madeline's point, speak like me in a certain language. We need a massive calling for diversity in our professions across all areas, from testing to physicians to pharmacy to nurses to physical therapists. You name it. We need people in allied health. If you're out there listening and you've got kiddos or people that are going to college, send them our way, right? We need these people and we're tired. We need more of these.

Dr. Wendy Wright: Yes, we're tired.

Dr. Rodney Rohde: We're not even talking about healthcare. The next pandemic is healthcare professional burnout; massive issues across all of our sectors, so we'll hold off on that. Maybe perhaps that'll be another sponsored panel someday because that is an ongoing crisis right now. Let's talk about the elephant in the room. We've been bouncing around it a little bit. Let's talk about vaccine hesitancy and how you guys address that in education standpoints as well as how that can impact actual vaccination compliance or maybe resistance. What's your language? What's your methodology around noticing that? And do you actually notice it? Do people say it to you? Do you feel it? And how do you work down that road to try to convince people to get a vaccine perhaps?

Dr. Wendy Wright: This is my baby, this is my doctoral work, so I love this stuff. A couple of things that I want people to know is that studies are pretty clear these days that even people who are vaccine proponents now feel the need to question science and question vaccines. I would tell every provider out there, expect what used to be a 32nd recommendation to now be five minutes because people feel the need to ask the questions about it. Even though they're going to take it, they feel the need. There is some more vaccine hesitancy, there's more vaccine hesitancy out there. The other thing I would say is we talked about strong recommendations. We call it presumptive versus participatory. And in a study, they followed providers who said, Johnny, how do you feel about getting your shots today? Well, it shouldn't surprise you that less than 10% of people Johnny's took their shots, but when the provider said, you're due for two shots today, it's okay to give them together, 80% of people took those vaccines. And I guess my last thing on vaccine hesitancy is you have to be prepared that people are going to ask about it, take a deep breath, and answer their questions. There are going to be 4% of the population that are vaccine-refusers. And I've learned from all of my research, you will never move those folks. They believe in something that none of us can really even fathom, but they come up with it. If they want to believe something, they're going to Google it and they're going to find research to support their beliefs. You're never going to move them. It's the movable middle that we have to focus on. And that is about 40%, 20% to 40% of the population who will go based on, you mentioned this Jem, a trusted source. And they will listen if they trust you and you make that recommendation. Focus on the movable middle, the ones that march in and say, what vaccines do I need? Give them to me. Those are our provider’s dream. Sure, give me everything I need. It's those people that are in the middle that – and we just have to take a breath. We have to meet them where they're at, be honest with them, and give them what they're asking, and don't go into too much detail.

Dr. Madeline King: Yeah. I think I've also seen people talking about how sometimes it takes more than one interaction with a patient to convince them. Maybe they come in and you tell them you need this vaccine today, and they're like, absolutely not. But by the end of the appointment, they're like, well, tell me more about it and I'll think about it for next time. And we definitely see this with patients in the clinic. I'm in with other vaccines as well. I'm not ready to get five vaccines today, but I'll get one next time. And we're like, Okay, we'll take what we can get. Let's just start off on the right foot. Sometimes it takes persistence and patience, which we don't all have at this point in the pandemic. But I think there are people that can be swayed if we just take the time and ask them multiple times and not give up on them.

Dr. Wendy Wright: Yeah, we use a ZCode in our charts. It's a vaccine refusal by patient or vaccine refusal by parent, and that's a signal to the nurse practitioner who sees them next that there's been a vaccine that they hadn't gotten the last time. Take a look at the note and try to follow up on that conversation.

Dr. Jacinda Abdul-Makkabir: With me, I'm in the community, so I work with primarily minoritized communities, so black and Latino, Latinx. COVID-19 vaccine uptake is really where I'm centered. But to Rodney's point, I'm also an infectious diseases researcher, so I'm on the benchtop but antimicrobial resistance researcher. I'm always looking at just like the intersections of racism and antimicrobial resistance and then vaccine uptake. That's really what I take with me into how it is that I approach vaccine uptake here. At Loma Linda, we previously had the largest vaccination mass site in San Bernardino County. We would vaccinate anywhere from 1,000 to 1,900 individuals per day. And this was in January of 2021. However, we were seeing that only 3% of these vaccinees were members of the black community. With that being said, we developed a team that would go out and vaccinate and I serve as the lead clinician and pharmacist of this team, but we collaborated with two church organizations and then one community organization. So, congregations organized prophetic engagement Inland Empire Concerned African-American Churches, and then LSO who was with the Hispanic and Latinx community. And we've collaborated to form this group to where we increased vaccine uptake. What this looks like though is myself as an educator alongside a behavioral psychologist, and we provide a webinar before we conduct each and every vaccination effort. This webinar is so that we can provide the education. I'm a little bit different and I do provide very detailed education to my patients before they ask. But I do this because, one, I'm just verbose, right? And if I have you in a webinar, you have to listen. No, I'm kidding. I provide – but I think it's important that we make the community stakeholders, especially because I target a minoritized community. So, it's my responsibility to let them know that I'm not only the pharmacist that's giving you this education, but I'm the pharmacist on the ground at each and every clinic. I've done probably 30 or so clinics at this point. We vaccinated more than 3,000 Black and Latino, Latinx individuals in the San Bernardino County area through our collaborative. We find that having this format of education in addition to providing easily accessible vaccination opportunities where we are paper-based. So we allow the patients – they don't have to worry about technology, they can come right there into the clinic. We make this very accessible. Because we have to think about how do we ensure equity amongst these vaccinations. What – we have to remove these barriers. The barriers of not having a provider that's racially concordant. Well, hey, I'm here, and then it's a student-run clinic. We have students that are representative of the community that we serve. Then it's 'OK now we have to take away their technology.' Well, now you have this paper-based sign up form. Then we have to think about the language barrier. We all work very hard to have translators there that are able to – I live in Southern California. I moved from Michigan, so this is new for me. But more than 50% of the population is Spanish speaking. I think that we as providers have to think outside of that box of, we know vaccine hesitancy is going to exist. We have to think from an empathetic standpoint, why does it exist. How do we connect with our community members to ensure that we have their interest at heart. How do we provide them this education to get them to make that next step. I'm not going to say that I've gotten everybody – I could do one webinar. Everybody's going to be vaccinated. I have folks that we've done probably 40 or so webinars at this point. I've had people that have had to come to maybe ten before they decided that they wanted to be vaccinated. That's OK. At the very least, they didn't just have information from cousin Johnny. They had factual information from a trusted person. That they were from TikTok but they have factual information from someone that they could trust within the community. I think that's important. Along side creating these opportunities for the vaccines, we have to provide education. We have to remove these barriers to equity because unless to Rodney's point, we are seeing an increase rates of anti microbial resistance. We are seeing increased hospitalizations. Who's going to be on the receiving end of this these individuals that live in these areas of lower social economic status. Which are more often are no where tired communities. I communicate that with the patients and I tell them, I traditionally am going to answer microbial resistance researcher. What do you think this outlook is going to look like as we continue to move through COVID-19. I think it's important as well to have those really intense and realistic conversations with our patients.

Dr. Rodney Rohde: Right on. Your conversation Doctor Jen, reminds me a couple of weeks ago I went to one of my biggest professional organizations, the ASCP. The American Society for Clinical Pathology Conferences in Chicago. One of our key notes was Michelle Obama. It was super impactful. One of these phrases I've been using it since I've gotten back because again as an educator, these are really things that are really important to me these days. Is to try to be inclusive of that and understanding of that. She said something that really hit me. She said, if you can't see it, how am I going to be it. For healthcare practitioners, that's right on. We need to learn I think and to your point before we move on. I think this is a calling for healthcare curriculum. For healthcare practitioners and continuing education. It's across all sectors in society, make no mistake about it. Certainly in healthcare, some people need to understand that in a deeper way. It's not a 30 minute video that can teach you how to be that way. You have to kind of experience it. I really applaud your efforts Doctor Jen. I think you're modeling something that I think everybody should be thinking about. I know there's a lot of other people doing that but kind of thinking you personally. I just think it's really important for someone like me to hear that. I'm an educator. I need to say that. I need to be that. I need to teach that to the future healthcare practitioners. As we move forward looking ahead, as we get closer to the end of our conversation here. How do you see COVID-19 vaccines evolving moving forward? In your opinion, do you think we might end up with some type of universal type of vaccine? Or do you think boosters are going to continue onward and onward and onward? I know in my estimation there are some clinical trials going on with the military and some private corporate pharmaceutical companies that are looking at some like trivalent vaccines that would cover flu, COVID and RSV. My hope and maybe you guys can comment on this is, that MRNA technology and the things we're moving forward on is that we can be creative and maybe we will find a way to get ahead of the viruses as Wendy wants us to.

Dr. Wendy Wright: I'm excited about that. I do believe that we're going to come to a point where we will shift from the pandemic to the endemic status. I do believe we're going to offer this every year. That's my gut. I believe that with the MRNA technology that we'll be able to modify these vaccines on an annual basis. There are combo vaccines out there. RSV, metapneumovirus. A respiratory panel vaccine that's being developed with flu. My patients are saying to me, I'm excited for that. It's one and it's done. What they're more excited for is an universal flu that they never have to get again in their lifetime. Wouldn't that be amazing. I tell people, with all of these conversations about vaccines, how lucky are we. A hundred years ago, people didn't have these options. I remember my mom going to our pediatrician and saying to him, give my daughter the small pox vaccine. He's said, ma'am I don't have it any longer. I have gotten small pox. My younger sister was aged out of it. My mom said, when we were older she said, I saw people with small pox and I was scared to death for my kids. While these conversations are really tough, I like to put it into perspective. Look what vaccines have done. Even though vaccines have become harmed by their own successes. Kids having babies today, have never seen polio. They've never seen chicken pox. We just had a kid with chicken pox completely unvaccinated. Sixteen years old. The only two of us in the whole office that knew what it was was us 50 year old menopausal women. The 24 year old MP's have never seen it before. Look at what they've done. We're in a really good place. We just have to keep up the fight and not get tired. Not get burned out. To remember it's not YouTube that people trust. They don't trust the CDC. We studied that here in New Hampshire. It was the organization they most distrusted was the CDC. When I talk to people about vaccines, I never breath the CDC. I say, Children's Hospital of Philadelphia. American Academy of Peds wants you to vaccinate your kids. American Academy of Family Practice wants you to vaccinate. We've come a long way. It's a hard time. How lucky are we that we're in a country where we have options like this. We can move that pendulum if we all work the same, in a multitude of different ways, but to get people all to the same place. I'm excited for the future. We just have to get them in the arms. All the vaccines in the world are only good if they're out of our refrigerator and into the arms of our patients.

Dr. Madeline King: Yeah, that's a really good point. I think with the MRNA technology and research that's gone into a universal flu vaccine, I think we probably do have the knowledge and the technology or we're right on the cusp of it, to have a universal COVID vaccine in the future. As well as, the universal flu vaccine, which would hopefully get more people to take it than currently do. I think until that point, we spoke about earlier, we can turn around these new variant vaccines pretty quickly now. It will get even faster. I think for the next several years, we're having to do like we do with the flu shot and administer COVID vaccine with a different strain. That's what we'll do. I don't think it's out of reach to think that we'll get a universal flu and a universal COVID vaccine in the near future.

Dr. Jacinda Abdul-Makkabir: I agree. I think Wendy made a statement earlier that I really like. It was, at the end of the day, COVID is going to be here for us for our kids and our kids’ kids. We have to do the best that we can to ensure protection. I appreciated that. I think it was a very true statement. One that I often share with my patients, COVID isn't going anywhere. I would rather be on that front end of prevention rather than trying to figure out how I manage it. Should I end up with this severe presentation.

Dr. Rodney Rohde: From that perspective again, I think one of the things I often talk about when we discuss these types of things going forward. Is that, we are a victim of our own success. That my grandmother lived to be a 100 years old. I still remember her talking to me about losing a child to polio. Or worried sick about MMR. All these things again, that I think we take for granted. It's not my children's fault. They just haven't seen it. To that point, you can do some history lessons. You can talk about different things. I think unfortunately, history is on the verge of repeating itself. We're seeing polio back. Measles has been raging again. African swine is out there. My message is that we are living in amazing times. We do have the technology and the brilliant scientists to do these things. We should embrace it. How exciting is it that we have MRNA technology and other types of genomics and proteomic tools that we might even be able to look back and go, you know what let's tackle tuberculous. Let's tackle HIV in a different way. We may be able to find a vaccine that's so adaptable that we can really make impacts. The other piece that I would add to this again, I think kind of pulling this together as we get close to the end is that, we really need to continue to think about vaccine equity. If you have pockets of virus or pockets of antimicrobic resistance. Or pockets of bacterial infection in other parts of the world or parts of our communities for that matter. Where you have massively unvaccinated people. Then you've got a problem. Pockets of unvaccinated people are problematic for everyone. Just like the analogy that it's in the refrigerator, it's no good. It's also no good if only the U.S. has the vaccinations. We need to better stewards and better sharers and think about how we can help in that way. I know it's going to cost money and all those sorts of things. One of my ongoing arguments before we close is that, I hope in my lifetime that we will see Public Health and Healthcare funding at the level and infrastructure and people, professionals at the level of department of defense types of significance. Microbial enemies are more dangerous than almost any other human enemy or terrorist for that matter. The data is there. They killed more people than almost all wars combined. It's really something we need to kind of think about as a community. I'd like to thank each of my panel members. I've learned so much from you. What a great panel. I'd like to thank really all of you for this rich and informative discussion for this expert panel today. Thank you for watching this peer exchange discussion. If you enjoyed the content, please subscribe for our E newsletters to receive upcoming peer exchanges and other great content right in your inbox. Thanks again and have a great afternoon.

Dr. Wendy Wright: Thank you.

Dr. Madeline King: Thank you.

Dr. Rodney Rohde: One of the things I'd like to ask each of my panelists. I'll start with Wendy. Is do you have a specific take home message that you would like to relay to your healthcare practitioner colleagues or others?

Dr. Wendy Wright: I'd like to call on my healthcare provider colleagues. My NP PA physician colleagues. I would just say this, every single one of us in this country needs to be actively involved in educating and immunizing our population. If we're going to make a dent in this pandemic and the next one to come because there's surely is one. We cannot rely on pharmacy alone to administer these vaccines. As a community, we all need to take it on. We need to work as a team to make sure that everyone has opportunity to get these vaccines. Thank you.

Dr. Rodney Rohde: Madeline?

Dr. Madeline King: I think just to add to Wendy's point that healthcare providers really need to be aware of the patients needs. Making vaccines and healthcare in general more accessible. Whether that be from going out in the community. Like Jan is doing. Or having more interpreters and translators in clinics to explain to patients what they need. I think just meeting patients where they are in those types of arenas is really the key thing that we can do.

Dr. Rodney Rohde: Doctor Jan, do you have any advice?

Dr. Jacinda Abdul-Makkabir: One, I want to say it was a pleasure to join you all. I learned so much. I hope that that's the advice, watch the video. Also, I would definitely say, that we as a country have to continue to keep equity at the forefronts of our mind and not just equity within the United States but global equity. I think that we see just how important that is with the Monkey pox virus. How we're now seeing it here at the – in the United States. That's how important equity is. That's what ensures that we don't continue to see pandemics and public health emergencies in the way that we've seen it. With COVID-19 and with these – what we're seeing currently. That's one thing that I would advise. Another thing that I would advise is to, treat not only ourselves as colleagues kindly but to treat our patients kindly. This isn't an easy decision for everyone to make in terms of being vaccinated. I think that's something that we have to keep in mind. So often I would have patients that would come and they would be ready to be vaccinated but would be shaking the entire time as they were preparing to receive that vaccine. That reminds me to make sure that I'm cognizant of that and we all have to be cognizant as I stated, our roles as trusted messengers within the communities. We have to take that seriously as healthcare professionals.

Dr. Rodney Rohde: Thanks Doctor Jan. Thank you all. I think if I had a message as we wrap up here. It would be that viruses are going to virus. Microbes are going to continue to show up on our shores. We're a global community. I think we all need to realize that. I would hope as a country and a world, that as we move forward with that we stop thinking about outbreaks in terms of politics. It's nothing to do with that. Viruses absolutely do not care who you are. They don't care what you look like. They don't care where you live. They don't care how much money you make. It's just simply a biological agent that's trying to harm you. And I think we're stronger together. I know that's kind of a cliché that we've used a lot, but it's true. We all need to step forward and be more kind, be more empathetic. I think we've all agreed upon that today, and just support each other. Certainly, we can do that without any cost to ourselves. Thank you all for joining us today.

Transcript Edited for Clarity

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