Jeffery A. Goad, PharmD, MPH, President of the National Foundation for Infectious Diseases (NFID), discussed the significant severity of RSV in older adults in an interview with _Pharmacy Times®._ Goad shared the updated Advisory Committee on Immunization Practices (ACIP) recommendations that simplify vaccination eligibility, and the high efficacy of the available RSV vaccines in preventing severe disease. He also emphasized the importance of comprehensive respiratory illness prevention strategies, including vaccination against RSV as well as other respiratory pathogens like influenza and COVID-19.
**_Pharmacy Times:_** What is the severity of RSV for older adults and those at high risk?
**Jeffery A. Goad, PharmD, MPH:** For older adults, especially looking at the age from 60 to 75 plus, there's a definite risk factor the older you get for the severity of the disease. Right now, for example, from ages 60 to 74, we look at other risk factors in addition to age to help predict how severe the disease might be in an older adult. For those over 75, age itself is an indication or risk for severe disease, but certainly other comorbid conditions put them at greater risk for this disease that oftentimes people think of as a common cold. But unfortunately, RSV can end up putting somebody in the hospital, the ICU, and eventually dying from the disease. So, it's a lot more severe than people think.
**_Pharmacy Times:_**How does RSV vaccination improve health outcomes for high-risk individuals?
**Goad:** Like all vaccines, the RSV vaccine is designed to prevent infection from progressing either to symptomatic phase, where you develop symptoms of RSV lower respiratory tract disease like pneumonia or bronchiolitis, but it also prevents the more severe. That's where the vaccines, and most of our vaccines do, focus, is preventing the more severe complications — keeping somebody out of the emergency room, out of the ICU and, of course, from dying from the disease. The efficacy, or how well the vaccine works in trials and effectiveness, which is how well the vaccine works in the real world, suggests that it has that tiered approach, right? So, that it's well over 80% at preventing people from ending up in the hospital severe disease and dying from the disease. It's a very effective vaccine at preventing RSV infection.
**_Pharmacy Times:_**In June of this year, ACIP updated its RSV recommendations. Can you give a brief overview of the updates?
**Goad:** When the vaccines were first licensed, there were 2 vaccines that came out in very quick succession. The FDA approval and then the CDC recommendation did follow quickly, but RSV season is during the winter, so these approvals came through quickly. The initial rollout for RSV vaccine was a bit chaotic. The recommendations that were in place for the vaccine prior to this year used something called shared clinical decision making. For those patients over 60 years of age, the idea was that you would sit down with your health care professional, whether that be a pharmacist or a physician, and discuss your risk and if you need the vaccine. Unfortunately, shared clinical decision-making sounds better on paper than it is in practice. As you're seeing many patients, and we use a lot of electronic systems to help us identify patients that would be appropriate for vaccination, it's very difficult when you can't use your electronic systems to identify those patients to sit down with. We had quite a rocky start for the rollout for the RSV vaccine in the before this last season. What happened, though, over the summer is that the CDC relooked at the data and really kind of rethought that recommendation of shared clinical decision making, considering all the members — the ACIP, the liaisons from the different organizations who provided really good on the ground information about how operationalizable that recommendation actually is. Then the result was a tiered approach. For adult RSV vaccines now from 60 to 74 years, it still is a recommendation. It's not a shared clinical decision making, it's a recommendation for those with high-risk conditions. For example, somebody who's immunocompromised or taking immunosuppressive drugs those who have cardiac, pulmonary, endocrine type of chronic diseases that put them at greater risk for severe RSV and again, ending up in the hospital ICU and dying from the disease. The strategy from 60 to 74 is risk based. Now, 75 and above is what we call an age-based recommendation. Those are the easiest to implement, the easiest for patients to understand, and the easiest for providers to implement. Meaning now that as soon as you turn 75, you're eligible to get the vaccine. The vaccine right now is a one-time only dose, and that's something the CDC will be looking at in subsequent seasons, because we know that it probably lasts longer. The duration protection probably lasts longer than 1 season. But it needs to be better to find how long that protection lasts to what level to get a better recommendation if subsequent boosters are necessary for that vaccine. So right now, we have a tiered approach, 60 to 74 high risks. 75 plus all adults, regardless of other health care comorbid conditions, should get a dose of the RSV vaccine.
**_Pharmacy Times:_** What are the broader implications of the new recommendations?
**Goad:** If we look back again at the shared clinical decision making, what we know is it's hard to estimate what that pool of patients who would be eligible for the vaccine actually is, because although we can look at the risk factors — and there are several systems, IQVIA for example, and a number of other systems that the CDC has access to help estimate the proportion of patients with a given comorbid condition, like diabetes or immune compromising conditions, to help estimate what that is. But we really didn't know the true impact of what the vaccination pool could be, so those eligible for vaccination because being shared clinical decision making. In essence, every interaction was a chance to get the vaccine or chance not to get the vaccine. Now, when you move to a risk-based model, you could more clearly define the denominator, in other words, the number of people who would be eligible to receive vaccination. So, going forward, I think it really makes it simpler for patients to understand. Again, if they're over 60, they need to get in and talk to their pharmacist or physician. If they're eligible for the vaccine from 60 to 74 it's going to require a little bit more activity on the bait on the part of the health care provider, to look to see what disease states, what other conditions they have that might put them at risk. But the recommendation is less of a conversation and more of a "I highly recommend this vaccine for you — you have chronic obstructive pulmonary, you have emphysema, you have chronic bronchitis. You're a greater risk for having a severe complication from RSV." I highly recommend you get this vaccine for those 60 to 74 years. Then 75 plus, now you can just look at the population of how many people turn 75 every year, and how many people are 75years old to get a better estimate of what that impact size could be for vaccination. I think overall, we're going to see better immunization rates in this next RSV season because of clearer and more implementable types of recommendations for the RSV vaccines.
**_Pharmacy Times:_** What is the potential impact of RSV vaccination for at-risk adults?
**Goad:** There are 3 vaccines available, 2 of them are protein subunit vaccines, some more conventional vaccines we've used in others. One is adjuvanted and one is non adjuvanted. The non adjuvant uses a bivalent formation to help increase immunogenicity. Then the third one is a technology people are probably very familiar with because of the COVID vaccines, which is an mRNA technology. Which because of the way the mRNA technology is developed and way it's implemented, it doesn't need an adjuvant to increase the immunogenicity of the vaccine. For the 3 vaccines available, their indications do differ slightly, which, again, all of them target the pre fusion F protein. So same target, efficacy is roughly the same. Although, they're not really compared head-to-head, but in their individual trials their efficacy is roughly the same. But when you look at the indications, all 3 can be used for those over 60, right? The pharmacy clinic has a choice of which vaccines to stock, and patients have a choice of which vaccines they may want to get.
**_Pharmacy Times:_** What are effective strategies to prevent respiratory illness in the current landscape?
**Goad:** I mean, we call this respiratory season, and in fact, the CDC has changed some of their terminology to call it the respiratory season, to really recognize that people are at risk for influenza, COVID, RSV, and don't forget pneumococcal, so streptococcus pneumoniae, or pneumococcal disease, usually accompanies an influenza infection or COVID. We do now have sort of a crowded space for pathogens that cause respiratory disease, and those are just the ones that we have vaccines for. Certainly, there are lots of other viruses and bacteria that we're seeing rise, including pertussis and mycoplasma. There are all different types of organisms during these winter months that we see a rise in. As a general strategy for people, they need to think about how these are transmitted. Almost all these diseases are transmitted, but. it's called the respiratory season by respiratory route; this is coughing and sneezing. Some are transmitted more effectively. For example, COVID. We've learned throughout the years that its distance, its ability to hang in small particles within a room, is much greater than influenza or pneumococcal disease. Understanding that when people are close together, all the diseases can be spread. When you're in a room and during respiratory season, you might think about masks, right? So, you'll start to see people now on airplanes — I was just traveling recently, probably 20% people were wearing masks on the airplane. I think you're going to start to see people using their own personal strategies. Especially those who are at high risk for respiratory diseases, those who are immune compromised or have chronic medical conditions or older, should consider wearing masks in crowded situations, like an airplane or another crowded venue. Certainly, one of the things that the National Foundation Infectious Diseases (NIFD), is really a strong proponent of and has several campaigns and messages out, is simple hand washing. Although I said respiratory is a very common route, when people sneeze, what do they do? They put their hand on their mouth. When they cough, they put their hand. So, all these bacteria viruses, end up on their hands. Simple hand washing eliminates it. You don't need complicated chemical disinfectants for your hand. Simple soap and water have been shown to work very well, as long as you give it enough time. Some people use the happy birthday song, it has a length of time to make sure that you're washing your hands. I think a combination of personal hygiene, keep washing your hands whenever you can, making sure that if you're in crowded conditions, you wear a mask — and it's a high-quality mask, especially if you are at risk for complicated and more severe disease, like RSV and those with chronic pulmonary diseases. If you fall into that category, certainly consider wearing a mask in those conditions. In terms of the other respiratory strategies, some of them are just not implementable. We're starting Christmas time, staying away from people's probably not an ideal solution. We have the holidays coming up, people are going to be getting together. Using your personal protection strategies are probably a bit more effective. But the number one effective strategy for those diseases for which we have vaccines, which is RSV, influenza, COVID, pneumococcal disease, get vaccinated. Vaccination has been shown to be the most effective strategy at keeping you safe and healthy from those diseases.
**_Pharmacy Times:_**Is there anything you would like to add?
**Goad:** Two things. One is, although people are probably more familiar now with pharmacists’ involvement in immunization, it's important to note that in all 50 states and territories, pharmacists can give vaccines. It's become a very convenient location for patients. We know that people's intent to vaccinate has a lot to do with their access to vaccination, to convenience. We want to make sure that people know that there are options for our independent, our chain, our different types of outpatient pharmacy scenarios where pharmacists at different hours, weekends, evenings, things like that, are available. And of course, your conventional, your physician's office, clinics, public health, there are so many options for vaccination now that we hope the convenience issue and the changing the intent to vaccinate to the actual vaccination is much improved, having pharmacists involved in vaccination. And lastly, just to point out that the NFID partners with many organizations, including the American Pharmacists Association and the CDC, to really put out science-based messages, and certainly at any time, and probably no more important than this time. Making sure that we have science-based messages, trusted messengers for people to receive immunization information from authoritative sources that they can trust is going to be critical for them to make decisions that are in their best interests. In other words, getting vaccinated, getting their family vaccinated to protect them during the respiratory season. But it's on us as health care providers and organizations like NFID to make sure that that message is clear, is transparent and is authentic for the patients that we serve.