National Vaccine Advisory Committee Meeting: September 2024

All right, welcome back for our last working session for today. Our next activity is the National Strategy Charge Working Session. Ann's going to work us through the next few minutes providing guidance and responding to discussion questions in response to the charge from Admiral Levine to provide input on the development of the next vaccines national strategy. Ann, you have the floor. Thank you, Bob. So, we are a little off schedule. We will get you out on time, I promise. We have a second session tomorrow where we can resume things. So, we're not going to go according to plan and we'll just go ahead and get started here. So, for this meeting over the course of the two days, I'm hoping that we can go through two parts of the charge. So, earlier, I had sent you guys a list of the charge and some other documents that you might find helpful, including the slide deck. And so, these two pieces, if you want to look at the charge, go right ahead. Our goals for this meeting are to really look at whether or not you think that we should keep the goals that we have and the indicators that are there, whether we should propose new ones, should we edit them. So, currently, there are five goals, ten indicators, and three developmental indicators in the plan that came out in 2021. Of the indicators, there are five pediatric indicators, and I've got them here on the slide, four adult indicators, one indicator for people six months of age and older, and then the three developmental indicators I mentioned earlier. And the reason why they're developmental is we didn't think that we had the data at the time. So, that could be something that could be discussed as we move through this. Just as a reminder, Admiral Levine requested measurable indicators that will help determine if the goals and objectives of the plan are achieving their desired outcome. And then the second sort of assignment here is to recommend and prioritize, I'm going to say, up to three objectives, because there's one goal that only has two objectives currently, within each goal of the goals, each of those five goals, that we think are poised to make the greatest impact on the U.S. immunization system in the next five years. And just as a reminder, Dr. Sinead Okaykay from our team, he was here at the last meeting, gave a nice overview and presentation of the history and the current plan. But just as a reminder, it's a five-year plan. It's supposed to be a roadmap for the coordination of vaccine development and use in the United States. The last plan was the first time we'd really taken a life stage or a lifespan approach with the goals, objectives, strategies, and indicators. And the objectives and strategies offered in the plan are intertwined and overlapping to a very great deal. So sometimes you can have something that you're working on that really could fall under three different goals or two different goals and may be used to make progress towards more than one goal. And then we have a very aspirational dream, which I hope sometime in my lifetime I get to see this, maybe not, but that the United States will be a place where vaccine-preventable diseases are eliminated through safe and effective vaccination over the lifespan. And so the current goals are, and I think we're just going to focus today on goals. I think that's all we'll have time for. So the first goal, one, is to foster innovation and vaccine development and related technology. Goal two is to maintain the highest possible levels of vaccine safety. Goal three is to increase knowledge of and confidence in routinely recommended vaccines. Goal four is to increase access to and use of all routinely recommended vaccines. And goal five is to protect the health of the nation by supporting global immunization efforts. And so this brings me to our discussion and questions. I don't think we have to necessarily go in this order. I'm going to read them off just so you kind of know where I want to go with this. And it might be easier to talk about, well, removing goals might be the easiest thing to start with and then maybe editing. But do you recommend removing any of these goals? Do you recommend adding any new goals? Do you recommend changing the wording of any of these goals? And should communications, immunization, equity, or syndemic approaches be highlighted as separate goals? Or should they be integrated? This is something that's been discussed repeatedly and added as themes throughout or not highlighted. So I will leave it there. And Dr. Hopkins, let's get right ahead. So would you go back to the last slide, please? I appreciate that. At least in my opinion, I think that the goals that are laid out are appropriate. The place that I see potentially some need for some modifications are at the next level of our objectives within the goals. And I think in those objectives, we certainly have to think about syndemic issues. We certainly have to think about equity. And I think there are some opportunities for doing those things within the objective piece rather than in the overall goals. And just my thoughts. Just a thought as I was thinking this through coming in, the goals are people, that's the first thing people look at. And so equity is going to be something that people are looking for. So just a one little tweak in goal four could help there in terms of increased equitable access to. And then somewhere in the plan, we need to define equitable. And that's just race, diversity, people with disabilities. So people are looking for themselves in the plan. So as we put descriptions together, we could guide that way. But I think just having some certain keywords, people are going to be looking for that. And that might be just a way to handle it. But I like the five that are here. Geeta. Yeah. So on trying to keep goals as concise, but to the point, I like the idea about inserting the words like that and equivalent. But on number four, given the things we talk about in shared decision making and so forth, I think the way that's written, it sounds like it's all about things that we're going to do and not really thinking about what the community is doing. So when you say access to and use, that's directed to providers, right? As opposed to saying something like increased access to use and acceptance or uptake. Because then it comes back around to not just what we are doing, but what we want to see happen as well. Jill, please. I agree with the previous comments. And going to this point about what the public does is looking at goal three, knowledge of and confidence in might be more related to all of us, to people. So there's something there that could potentially be tweaked up, but I agree with your point. And then based on Admiral Levine's request around how we measure this, I would wonder whether or not some of these goals might actually indicate that we are measurably increasing or something where it shows that we have a goal and we also have a goal to show that we are making progress or intention to make progress on it. Any other thoughts? So it sounds from what I'm hearing, that you kind of like the five goals, you may think that the language needs to be tweaked a bit. Does anybody want to disagree with that? So one thing, Anne, I might, you know, as we think about the goals and the theme, go back, sorry, I might, you know, as we, as we look at this set of goals, do we need to think about the ordering of these slightly differently? So access, you know, knowledge and confidence probably needs to be first, in my mind, followed by safety, and then access. And then I'm going back and forth in my mind between innovation and global, you know, and that might be important from the, from the prioritized piece, as well as anything else, at least from my thought. Karen? I'm new, so I might need a little bit convincing on goal number two. I'm not sure what kind of discussion, do we have a CDC rep? But I just wanted to understand a little bit of the thought behind, I mean, if there is an example where we could have done better, is there, is that what is coming? Well, the reason that safety was prioritized in this list was when we were developing this report four or five years ago, we were already hearing a lot about concerns about is our safety system that we have now optimized? You know, not only is it optimized, but are we communicating out that the safety of our vaccines that we're using is as good as it can be, or we need to make it better, or we need to communicate that safety message better. So that, I think that's what led to this being one of our goals. Okay, Bob, I think you hit it right on in terms of, and then given what we've gone through with the pandemic, you know, safety goes aligned with vaccine confidence. And so I think that's something that has to be visible. And actually, Rebecca and I were just talking, is safety one? I mean, because really, even if innovations, people don't think we're pushing innovation because of some other reasons. So is it really, we're concerned about a safe, effective vaccine system in the United States? Is that the message we want to put out to the public? Does that answer your question? Yeah, as long as the CDC rep is okay. Melinda, are you on? I see you. I am. Did you want to make a comment about that? Hello. So, I mean, I think having a goal focused on vaccine safety totally makes sense for the vaccines that have been described. I do wonder about the specific wording here, but it does feel like given how important vaccine safety is for programs overall, having a goal focused on it feels appropriate to me. Yeah, I was just going to echo the comment about the very first one being about innovation and related technologies. It makes it sound a little bit more like this is not exactly public health focus as much as research and development focus. Important, I don't think the goal should go away, but I do think if we talk about safety, knowledge, confidence, equitable access, right, innovation and development seems to come, I think would be nicer to come later. I promise this is not an intent to wordsmith. Given where we have been with COVID and considering how much we talk about vaccine confidence and COVID-19 vaccine today, is the goal to increase confidence in routinely recommended vaccines or confidence in vaccines or confidence in vaccination? Confidence and acceptance of vaccination. At least in my mind. And this was to my point earlier, it gets a little muddy as to which goals go where. And so access sort of aligns with acceptance. There's a lot of things that can go into goal four. It's pretty, maybe the broadest one of all of them. And goal three used to have a little bit more of a communications focus, which I think is a little, my opinion is a little bit missing from this, but obviously with everything that's going on with confidence and we want people to be making informed decisions based on misinformation, disinformation. So it's just, it is a challenge to kind of boil this up into something that really makes sense and is helpful for people. So if anybody has any other thoughts about those, that'd be helpful. I think you can, the goals are broad enough that on your objectives, that the whole communications would fall under the objective or tactic to get to that goal. So it's what's nice is it gives us enough flexibility to build, make a movement towards achieving these goals. Any other thoughts, anyone from online? Hey, this is Steve. I totally agree that these five goals are still very pertinent today as they were five years ago. I agree with the rearranging the order that Bob had suggested, and I think that would show the purpose a little bit better as things stand right now. Introducing equity, immunization equity, I think it'd be good to have that word in with goal four, even though it will be integrated in probably all the goals as we get further along in the objective part. But I think having a word within that goal to start things off makes a lot of sense. The one other thing, routinely recommended vaccine in the era of shared clinical decision making, it's kind of muddied the water on what routinely recommended vaccines are. So we may want to stick to something maybe a little different in that regard, maybe just recommended vaccines, just thoughts. Steve, great point about the shared clinical decision making. I reckon I was here talking the same thing, and it could just be routinely recommended to all available vaccines, or even recommended, it depends who's recommending it, because there's FDA, there's CDC. So can I pose a question to the group? In my mind, and Jewel and I've just been talking about the issue, I think I would, rather than access to and use of vaccines, I would make it more an action goal, vaccination or immunization, because the Bill Schaffner statement of a vaccine on the shelf does no good. And vaccination in the arm is really what gets us the benefit. I think we really need to go aim at vaccination or immunization. I would certainly welcome anybody else's comments, but at least in my mind, I think we need to have the action rather than just the product. Melinda? Going back to the comment about routinely recommended vaccines, it is totally true that we refer to routinely recommended vaccines and mean, and sometimes mean several different things. Sometimes we mean vaccines on the schedule versus travel vaccines that aren't on the schedule. Sometimes we mean age-based recommendations as opposed to other kinds of recommendations. We mean different things when we use the word routine. I think depending on what the committee's intent is, this could be defined as the vaccines on the immunization schedule. Thank you, Bob. Can you hear me? I'm clear. Thank you. I just wanted to highlight that I totally agree with Dan's earlier comment that there isn't a communication piece present in any of these goals. And I think it's vital that we have something that's very clearly worded about supporting effective communication because we can do all the work we want. And if we don't get our message to the people that need vaccines, again, there's not going to be the shots in the arms that are needed. Thank you. Other comments or questions? So I'm going to call my question about vaccination or immunization. You know, as would there be, is there anybody that has an objection or would prefer us keep it at vaccines as opposed to the action verb? Molly? Well, not that necessarily. But come on now. With the use of monoclonal antibodies, I would recommend using immunization instead of vaccination. Okay. I call that a friendly amendment. That would have my support. This is Steve. Thanks, Steve. Melinda, your hand is up. Is that just left up or is that a comment or question? Yeah, sorry. That is because I failed to lower it. Mitch? You're swaying me over in my thinking over here. The immunizations, I can't go with that. Just thought to put on the table, is it immunizations and immunization services or vaccination services? So it would be both. I think for the goal, it's immunization, but we might have one of the next level would be including immunization services there. Because we've got to think about the counseling piece. We've got to think about the vaccine administration. We've got to think about those kinds of pieces as well. Again, my bias. So this has been a really good discussion. Like I said, we're going to try and keep on time. We'll resume tomorrow. So if people have continued thoughts about this, you can certainly bring it to the discussion tomorrow. And just as a wrap up, we have a note taker who's going to work really hard to get us notes from this meeting pretty quickly, and then we'll submit it out. So we can do wordsmithing and things like that after. But it's just really helpful to get kind of your input beforehand, and we'll put it together. And it may not be completely right. And people may have different ideas as they move through it, and that's totally fine. So we'll work to get it edited for you. And I also just wanted to mention that this is one piece of the process of getting ready for these new national strategies, as Sinead mentioned at our last meeting. We have four plans coming out of our office. They're being very tightly coordinated. And Maureen Goodenow, Dr. Goodenow, behind us is working on that with Dr. Akeki and others. And so there are going to be listing sessions that folks are going to do, not specifically for NVAC. But if other people want to have input, they can use an email called, and I'm going to just say this, but it's pandemics, C-Y-N-D-E-M-I-C-S at HHS.gov. And so if you want to get invited to one of those, you certainly can. And then when they get to the point where they have a draft ready to go, it'll go through, you know, a notice, and people can definitely provide comments on that. There's also public comment here. So if people wanted to leave public comment at an NVAC meeting while we're discussing this, that's fine as well. And so with that, I'm going to turn it over to, I believe we have one public comment. And I believe your name is Charles, is that correct? Oh, Timothy. Timothy, are you on? Can you just repeat that email address one more time? I sure can. Pandemics, C-Y-N-D-E-M-I-C-S, plural, at HHS.gov. And I can send it. I can send it out to folks here too. Yeah. And Bob's going to put it in a summary tomorrow. So we'll get you guys covered. Timothy, are you on the line? You may have to dial star six. Star six will unmute you. We can't hear you. Can you unmute him? No. Yeah. Yeah. Timothy Sestaro, if you're on the line, could you hit star six to unmute so that we can hear your public comment? Timothy, you can submit a public comment, a written public comment of three pages to NVAC at HHS.gov, which you've already used. Or you're welcome to give a public comment tomorrow at 1245. But we'll give you one last chance to unmute yourself. And we'll follow up with you over email. I would like to make a comment. All right. We'll figure it out. One second. Okay. Hi, my name is Tim Sestaro. I'm scheduled to make a public comment today. Hi, Tim. We hear you. You have the floor. I appreciate it. I don't know if Dr. Roxana Giba is in the room or on the phone. She's not, but Brenda Holbrook is on for HRSA. Okay. I saw that she's in charge of the advisory committee for childhood vaccines. And yeah, so basically, I thought it was a vacant spot for an injured parent of an injured child. And, you know, I hear everybody talking on this floor, and a lot of great thoughts, challenges to overcome. And, you know, everybody's talking about making sure everybody's getting immunized and all that good stuff. But you don't hear the word, making sure everybody gets safely immunized. And I think that's part of the challenges that you guys have, making sure everybody gets vaccinated or immunized, to make sure it's done safely, because that's where you lose the public confidence. I have four kids, and my last little guy was injured by every childhood vaccine he got. Sorry, trying to set up a stock at the same time here. So, you know, you look at what pediatricians should be looking for in a kid that not every kid is ready to get some of these vaccines at the time frame that they want. You know, I'm a police officer here in Nashville County. And, you know, we talk about Medicaid, Medicare, making sure providers get paid. You know, that's all great. What if police officers were getting paid by each arrest they make? You think that would make for a good society? It's food for thought. So, my son was showing severe signs of an immunodeficiency. Give me one second, big guy. No, whatever you need to do. I don't know. Is there time tomorrow to continue this? Is anybody there? Yeah. You can do three minutes of public comment tomorrow at 1245. At 1245? That'd be a lot better. I'm trying to get this all out, and I got 10 kids I was supposed to be running practice for. Thank you guys so much. You know, there is definitely some things where there's gaps to be filled in this process for a little infant that's showing severe signs of immunodeficiency. And when you hear pediatricians say the live rotavirus vaccine should be given when a kid is sick, well, let's think about that for a second. The CDC is saying otherwise. So, why is pediatrician saying something different? So, there is a lot of gaps to be filled. And, you know, I would like to be a part of the process to make sure this doesn't happen to another kid what happened to my son. You want to talk about challenges. Challenges are trying to figure out how your son is going to survive in the planet without you. And he's severely brain damaged now. So, you know, when I'm not trying to start a soccer practice, if I could have another minute and a half tomorrow at 1245, I'd appreciate it. That's that's certainly fine. We will call it 1245 tomorrow. All right. Thank you guys so much. I appreciate it. This will look forward to that time. First day of our meeting, we will reconvene tomorrow at 9am for the second day of our September impact meeting. Thank you all for attending those in the room as well as those that are on the live stream. And we will move to our second day of our September impact meeting tomorrow. Produced by the U.S. Department of Health and Human Services.