Rae Woods: From Advisory Board, we are bringing you a radio advisory. My name is Rachel Woods. You can call me Rae. Rae Woods: The COVID-19 landscape continues to evolve and change, and so does the status of vaccination. It's frankly a lot to keep track of, so I wanted to bring on two vaccine experts, Pam Divack and Gina Lohr, to talk about some of the puzzle pieces that we are still trying to work on and some of the questions that are still currently unanswered. Rae Woods: We recorded this episode on September 16th, and over the weekend we got two updates on vaccination in the US—just proving there is never a slow news cycle in health care. You are going to hear me jumping into the conversation with Pam and Gina with those updates. Alright, let’s get into it. Rae Woods: Hey Gina. Hey Pam. Gina Lohr: Morning, Rae. Pam Divack: Hi Rae. Rae Woods: Have either of you ever been on a podcast before or will this be your first time? Gina Lohr: I am a podcast newbie, but podcasts are the primary way I get new interesting information, so I'm super excited. Rae Woods: I mean, same. That should be obvious, but same. What about you, Pam? Pam Divack: It is my first time, but I feel like I'm talking about vaccines or COVID 24/7, so excited to bring the conversation out. Rae Woods: That's exactly what I was going to say, is that you too, while you are new to Radio Advisory have been in the background for a while helping us make sure we're staying on top of all things COVID-19 and all things vaccination, so I'm excited to finally bring your voices to the podcast. Rae Woods: If I'm honest, I feel like we're reaching a kind of new stage of maybe undefined territory with vaccines, or at least a moment where, once again, we have open questions that we are trying to answer. But of course as always, right, this is Advisory Board. I'm hoping that we can provide some takeaways, some action steps to our listeners. Rae Woods: I want to start big picture. What is the biggest thing that has changed since we last spoke about vaccines on this podcast? Pam Divack: I think the biggest thing is that we have mandates now. For a while, I know companies and employers were really acting on their own, but with President Biden's announcement two weeks ago, I think this really creates a turning point for where we are and how we might be able to increase vaccinations in the future. Gina Lohr: Yeah, I mean, I think not only hitting on all the federal workforce, but looking at healthcare settings, looking at large employers, that very much could be a game changer and needs to change the way we're talking about vaccines. Rae Woods: And this is something that I think gives the three of us and a lot of folks in healthcare some hope that we are closing the gap for the unvaccinated. But I know that's not been everyone's reaction. What kinds of reactions are you tracking in the healthcare space? Gina Lohr: Personally, I'm hearing from healthcare leaders who are worried about staffing and trying to figure out how to keep employees. They're worried that when the mandates go effect, they're going to lose, especially those staff at lower education levels like technicians, that that's going to put a big gap in the hospital workforce, and they're trying to figure out next steps there. They're kind of concerned, although I think there's others who are really happy that they have covered now, that they're not going to be competing with the hospital down the street for that labor force if one hospital says we do have a mandate and another says we don't. And so, they have been worried about an exodus there and it does kind of put everyone on equal playing fields. Rae Woods: And didn't I actually even see that the American Hospital Association put out a similar warning, right? It's not just small hospitals in upstate New York that have to close down their maternity ward. Didn't they see the AHA say something about this as well? Pam Divack: I think the American Hospital Association said that a federal mandate might leave hospitals even more short-staffed. But on the other hand, I do see a lot of health care experts and doctors applauding the mandate, so it's really an interesting kind of turning point. Rae Woods: I actually really appreciate this pushback, because I don't think we want to get down the path of listening to the most vocal group of people in the room who are the naysayers. At the same time, I don't want to discount the very real staffing problem that so many hospitals have, and that the reality that some might have to come to a decision of resisting the mandate for a little bit, right? Because it won't even go into effect until mid October. Is that correct? Gina Lohr: That's what I've seen kind of speculation. Rae Woods: Right? And so if folks are kind of dragging their feet, maybe wanting to push back a little bit, maybe they're doing that because of impossible trade-offs they have to make about keeping beds, keeping their labor and delivery board open, et cetera. But at the same time, we have to remember that there is still a world in which healthcare leaders, hospital leaders specifically, can actually use their focus on safety to say, "We care about our employees, come work with us, because we actually do want to mandate vaccines." And I have to believe that will work for some people. Gina Lohr: And Ray, I think there's another nuance in the safety conversation. Our workforce experts, who I have been checking in with, say that amidst the shortages, amidst the wrestling that they're having right now, the best thing to message to your employees is we care about you. But for some, that comes in the message of we're all going to be vaccinated, so you can feel like this is a safe place to work, and for others, that needs to be a more nuanced message to help them feel like the health system cares about them as they're working through their own vaccine questions. Rae Woods: Maybe the takeaway there is to then make sure you're actually doing poll surveys and understanding how your employees actually feel, both about mandates and maybe vaccination in general, but also about the state of the pandemic, what their staffing ratios are, what their capacity is like, and really understand at a specific and deep level how all of these things are affecting your own employees. Gina Lohr: Any and all data is helpful for these to understand the big picture, but then when it comes down to actually shifting people closer to comfort with the vaccine, it may even go below the poll survey level to the individual level, and sort of setting the tone from the top that it's okay to have these conversations, it's okay to have questions, and that from the top, all the way down to the frontline managers, they should be engaging in conversations about vaccine, about hesitancy, about safety, about how the health system cares, how staff in the health system care for each other. Rae Woods: We're talking about mandates. I'm not sure that we could have had as in-depth of a conversation about this a few weeks ago or a few months ago. I think one of the reasons why we can have this in-depth conversation about mandates is because we now have a fully approved Pfizer vaccine. Is that one of the reasons why folks like the Biden administration, big corporations, feel like they have the armor to say, "We're mandating this."? Pam Divack: I believe so. Just when you look at the timing of everything with the recent FDA full approval, it makes sense. I think we're also at an interesting point in the pandemic where the FDA approved the vaccine. We're seeing cases rise and the timing of it all makes sense. Rae Woods: There are more approvals that we are waiting for and watching for, and that's a big open question. What are you seeing in terms of full authorization for the Moderna or the J&J vaccine? Pam Divack: We know that Moderna submitted for fall approval in August. J&J has not submitted yet, but we expect they are going to apply later this year, but we know the process can take months, so we'll just have to keep watching. Rae Woods: So, maybe it's not right around the corner, but soon, hopefully soon? Pam Divack: I hope so. Rae Woods: Pam, what do we know about the state of approval for booster shots for all three? Pam Divack: We know that Pfizer and Moderna have both submitted documents to the FDA to ask for authorization for the boosters. At the time that we are recording this podcast, the FDA has yet to evaluate the data and come to a recommendation about the authorization of boosters. I know a lot can change between now and then, so it'll be interesting to see what happens. But based on some of the early documents that we've seen, it's unclear whether experts are actually in favor or not of the boosters. Rae Woods: Oh, really? Why is that? Pam Divack: So on the one hand, data from Pfizer has shown that efficacy wanes over time, and I think that's not because of Delta explicitly, just of the prolonged period that we've had since first roll out. But it sounds like the FDA experts are really taking a kind of cautious or neutral stance, so they know that on the one hand, the two doses are effective, especially when you're looking at severe impact on hospitalizations, but some also think the impact of boosters might be limited. We'll see what happens in the next few days, but I think we're at a really interesting point in terms of what happens with boosters. Rae Woods: Quick update here – on Friday September 17th, a panel of experts in FDA’s Advisory Committee recommended offering Pfizer booster shots for people ages 65 and older, and for “high risk” individuals over the age of 16. But this was a result of a pretty intense debate over the current data. In fact, the experts voted not to recommend the boosters for all eligible Americans, citing lack of data to know for sure whether boosters are necessary in other groups. Of course, this decision isn’t binding, but usually FDA follows suit. We’ll be watching for the official FDA decision and CDC guidance on rollout, but this news raised a bunch of questions for Pam and I about the future of boosters– so check out the show notes for our latest post on the status of boosters. Rae Woods: How does that compare with what we're seeing with other countries? I'm thinking about Israel specifically. I think that they're preparing for a possible fourth dose. Gina Lohr: What I'm hearing is just that the tension between are we trying to protect our people from sort of any symptoms, any disease, versus I would say the bigger global question about is it actually in all of our best interests for more people around the world to get vaccinated so that you don't have, I mean, little COVID variant factories all around the world amongst the unvaccinated population. I mean, I think getting up to speed on boosters for me has felt like a full-blown biology course. It's been really fascinating to learn about the T cells and the B cells and how the vaccines can sort of prime our deeper immune system, but the way that they work doesn't always get up into our respiratory tract where the virus might first find itself and start to replicate, and so that might be why somebody has symptoms might test positive, but is protected from the more severe disease. That was sort of, I don't know, I found to be a fascinating tangent. Gina Lohr: But on the timing of doses to your question, Rae, I recently heard Dr. Fauci talking about this and said it may be that the COVID vaccine sequence ultimately ends up kind of like what we have for hepatitis B, where the full course of the vaccine is a three-shot series over six months, and that you really need that to activate that full and enduring immunity. And so, it's not that this is a booster shot and we're going to need booster shots every six, to eight, to 12 months across the future. It's not like we're going to need an annual COVID shot like we have an annual flu shot. It may be that the full immunity is really garnered through that three shot series. Which I think about my son and his vaccines as a kid, many of those vaccines are at like a three, four, or five shot series, and so it's not unheard of that you just need those additional boosters to get to enduring immunity, which then persists. Rae Woods: And you're right, that this is not unheard of. There are plenty of other clinical examples in which this kind of sequence makes sense. But let me reveal my own kind of fear here. That's that there are a lot of vaccine resistors still left, and I get afraid that as we kind of shift the conversation around boosters, and around timing, and around approvals, which we still need to come back to, that that might fuel, unintentionally, the quote-unquote evidence for vaccine resistors to say, "See, they don't actually know what they're talking about." Is that a concern that you have, too? Pam Divack: I definitely have that concern. I think that's something that we've seen throughout the entire pandemic, which is as new evidence emerges or new approvals are happening, it does create confusion. But I think the point that I personally want to emphasize is that it's okay for our knowledge to keep changing as new evidence emerges. It means that we are developing a greater understanding of how the vaccines work, and for who, and at what time, and keeping that in mind, that'll just help us fight the pandemic better in the future. Rae Woods: And there's that clinical open question, right, that we are talking about right now of what is actually the best timing? But there's also, maybe it's an ethical open question, which you brought up earlier, Gina, which is, should we be focused on protecting our own people and from anything. Is it from symptoms? Is it from severe disease? Or should we be trying to vaccinate the globe? Right? If I think about timing of doses, even in the two dose options, right, there were other countries, who several months ago said, "We're actually going to prioritize getting as many people one dose rather than making sure that everybody gets their second dose three or four weeks apart," which is kind of a second question that we need to answer for ourselves as a country and as a medical community. Gina Lohr: I'll be really excited and interested to see what comes out from Britain. Are they tracking? Are they using that expanded timeframe as another sort of trial and tracking the outcomes there? Rae Woods: I want to get back to this question around approvals, because we know that we're still waiting on full approval for Moderna and J&J. Open question about the boosters. But what about the age limits? I think a lot of folks, especially parents, are eagerly awaiting younger people to be approved to get this vaccine. What timeline are we seeing there? Pam Divack: We know that Pfizer is on track in the coming weeks, they said, to get approval for their vaccine for five to 11 year olds. Rae Woods: Oh, in a few weeks? And I think in a few weeks. Pam Divack: Yeah, and I think Moderna is expecting to have that data by the year's end. Rae Woods: Interrupting again with a quick update. Just yesterday, September 20th, Pfizer released new data showing lower doses of its Covid-19 vaccine are safe and shows 'robust' antibody response for 5- to 11-year-olds, without any serious safety issues. Pfizer said these data will be included in a "near-term submission" for EUA, and they’ll keep collecting data needed to file for FDA approval. Regulators have said they’re going to try to approve this data ASAP, and an approval by Halloween may be possible. Rae Woods: What about even younger kids? Pam Divack: I know that both companies are testing their vaccines down to, I think, six months, but those results will probably come a bit later. Rae Woods: So no timeline there? Pam Divack: Not at the moment. Gina Lohr: Yeah, I've heard end of year tossed around, but I'm never quite sure if that's real numbers, real dates, or if that is to appease parents. I also heard beginning of the school year at some point of last year. Rae Woods: That's right. Of course. How old are your kids? Are they excited about getting vaccinated? Do they know that this is an option? Gina Lohr: I have a seven year old, and he, I remember, I didn't realize how much he was processing about the pandemic and vaccines until Pfizer got the original emergency use authorization back in December and he had a full-blown party in the kitchen. He was like, "Oh, we're seeing your light at the end of the tunnel." I was like, okay, he's he's tracking and he sort of understands what's going on here. Gina Lohr: I think it's really interesting with the pediatric vaccines is just figuring out how to get the dose right, like hearing that Pfizer was testing out three dosage levels, and you're remembering that kids [crosstalk 00:17:18]. Rae Woods: So not timing, the actual dosage of the material? Gina Lohr: Yes. Right. How much do you pull up into the syringe and put into a child and what's effective? Rae Woods: I think the broader conversation that we're having about timing, about boosters, about the stress of what it means to be a parent and have kids in school, it speaks to the fact that some folks in America are maybe a bit desperate to boost their immunity. Desperate might be a hyperbolic term, but I'm wondering if people are going to start pushing to mix and match vaccine types. Maybe their their perception of the vaccine that they got in April or May or June isn't good enough and they're going to be seeking out a different one. Do we know if it's okay for that kind of mixing and matching? Pam Divack: Well, I'm definitely not here to provide any clinical advice, but based on the data that I've seen, it seems that there's no harm in mixing and matching. I know that the city of San Francisco began offering mixing and matching about a month or a month and a half ago. I've seen data from researchers in the UK that said that people who mix and match doses only have slightly more severe side effects. But I think there's been conflicting information right now about whether we should move forward with mixing and matching and continuing to collect real-world data and real-world evidence on it will be really important. Rae Woods: Yeah, to me, this just brings up a whole host of downstream consequences. Right? Months ago, we did an episode and wrote a blog post about this concept of vaccine hunters, people who were seeking out and kind of doing everything they could to get their hands on a vaccine. I almost wonder if we are somewhat back to that place. It's just that now folks are hunting down that booster shot or hunting down a different dose than what they had the first time. How does that impact our ability to measure and even just understand vaccination rate here in the US? Gina Lohr: I mean, it certainly is a confounding factor. I think it will make measuring harder. We haven't had perfect data from the beginning. I think the vaccines are being tracked on a state level, but not necessarily on a national level. And so, you can certainly see a scenario in which people vaccine seeking for boosters could mess with the data a little bit. Do we really know what we're going toward here? Are we moving toward a certain threshold and do we trust the numbers to tell us when we've hit that threshold? I'm not sure that's really realistic. Rae Woods: Especially with all of the different access points to get a vaccine now. It's not just hospitals, mass vaccination, sites and CVS. I mean, you can get a vaccine at an airport or at a baseball game. My fear is that it really messes up our ability to track vaccination rate, which will impact our ability to assess the level of risk that we have right now, or six months from now, when it comes to this virus. Gina Lohr: Yeah. I mean, I think it's interesting that it feels like it comes back down to the same kind of communication challenge as we see with even people who are vaccine resistant, but this time it's on the other end of the spectrum. Vaccine resistant, all of the changing data makes them want to stay away or some people want to stay away from the vaccine. Other people, all the changing data, it makes them want to go out and just get all the vaccines at the end of the day. Rae Woods: Yeah, you're right. You're right. Gina Lohr: It makes the challenge harder. Rae Woods: Yeah. The the messiness of the data both pushes people towards inoculation and away from it. What a fascinating and completely unhelpful insight. Gina Lohr: Anybody out there in healthcare communication [crosstalk 00:21:09] here? Rae Woods: Well, maybe this comes back to Pam's point about capturing real-world evidence, that it's not just about the exact dosage or the exact timing that we're finding out in clinical trials, but really understanding how do these things work in the real world. Like I said, the data gets really, really messy, but what is the role of healthcare organizations, of governments, manufacturers? What's the role of the industry in capturing this real-world evidence so that we can actually make informed decisions? Pam Divack: I think there needs to be a little bit more coordination than exists today, at least in the US. We need to be able to understand how vaccines are working in different subpopulations or in different communities. Right now, we're turning to a lot of great data coming out of Israel, for example, but I think if we're better able to collect it, analyze it here that might help with future decision-making. Rae Woods: Can I ask you a philosophical question? With all the moving parts about dosing and boosters, do we need to actually change our definition of what it means to be fully vaccinated? Pam Divack: That's something I've been grappling with too, especially when you look at places that are now requiring proof of vaccination, or we all have the apps downloaded on our phone with our vaccine cards. What happens next? I'm really not sure, but I think it's something that we as a healthcare industry need to start grappling with. Rae Woods: When it comes to data collection, I'll tell you my own doctor, right, every time I go in, I have to check the same information about COVID-19 exposure and vaccination status. And just the other day, I pulled up my portal and I literally went, "Whoa," because they asked about if I'd had a third dose and they asked about the timing, how if I was under eight months or over eight months from my second dose. Maybe that shows that we're moving at least better in the data collection space, and maybe ultimately it will change how we think about our own status as vaccinated people. Gina Lohr: But I think that we need to remember that this is something that will probably be in flux for years now as well. Rae Woods: Absolutely. Gina Lohr: I mean, I think about the vaccines that I probably received as a small child and how those vaccine regimens have changed over time over the last decades, and that probably they're going to be fine tuning this for years to come, even though Pfizer has a full approval already. Rae Woods: And to Pam's point, how do we make sure that we're communicating that that is normal and okay? Rae Woods: Well, we've been talking about a lot of these open questions. We talked about changes to vaccine mandates, the various changes to approvals, mixing and matching doses, boosters, the timing of it all, what it means for us in the US versus the globe. There are a lot of open questions, and I also believe that we've only begun to scratch the surface. What else are you watching for that we haven't talked about today? Pam, let's start with you. Pam Divack: I think there's two main things that I'm watching kind of on the topic of real-world evidence and understanding how these vaccines work in the real world. I think there is a really big opportunity to look at the data we have to see how certain vaccines have worked better for subgroups. I know that we're thinking a lot about age. There's a lot of data coming out that looks at how vaccines work in 50 to 59 versus 60 to 69, for example. But I think we can also get at other characteristics, like your background, or your race, or your ethnicity, or different co-morbidities that you might have. And as we start to have these vaccines nearing full approval, I think that data will be really helpful for kind of allocation efforts. Rae Woods: Gina, what about you? Gina Lohr: I think there's still a lot of factors outside of vaccines that could really change the shape of the pandemic, whether it is new variants, whether it is treatments that are being tested out that may come online and prove effective. While we thought at the beginning of the summer that the pandemic was winding down, Delta show showed us that that was not the case and we don't quite know what twists and turns are coming up next, either. Rae Woods: Well, given all of these open questions, I still want to make sure that we are giving our audience an action item. What is the one thing that you want our listeners to focus on right now? Gina Lohr: I mean, for me, as I've been thinking about these things, one of the kind of connection points that I have been making as we talk about healthcare communication, as we talk about those who are vaccine hesitant, is that there is, at the core of a lot of it, is a distrust of conventional medicine. We see overlap between the communities, some communities that are vaccine hesitant and those that may also have, say, later diagnosis of critical illnesses like cancer. This may relate to access to care, but it might also stem from a distrust of conventional medicine and healthcare providers. And so, how are we as healthcare leaders facilitating a broader conversation than just take the shot? But we care about you, we want you to be healthy and try to re-engage folks in those broader healthcare conversations. Pam Divack: Gina, I completely agree and would echo what you said, but I think there is a really important role that not just healthcare leaders need to play in this communication and building trust, but any community leader. We've spoken with a lot of leading programs that are really increasing equitable access to vaccines, and they prioritize have your local leaders lead conversations about the vaccine. Really get into your community, have those one-on-one conversations, and I think that could really move the needle. Rae Woods: Well. Pam, Gina, thanks so much for coming on Radio Advisory. Pam Divack: Thanks, Rae. Gina Lohr: Thanks, Rae. Rae Woods: For me, the most important thing to remember is that everyone in the healthcare space needs to balance the necessary flexibility that comes with a quickly changing environment. But at the same time, make sure you're doubling down on what you know works. Do not let up on your communication strategy on a single source of truth for your clinicians and your physicians to share with the broader population. We have to make sure we're being flexible and we're being resilient if we're going to get through this. And remember, as always, we're here to help.