NVAC | June 14, 2024 | Research Review, Member Updates, and Public Comment | Day 2, Part 3

>> Robert Hopkins: Good afternoon, and welcome back to our last session for the June 2024 NVAC meeting. Our panel we'll start off with is towards an updated national strategy, progress and priorities. Our presenter will be Dr. Chinedu Okeke with collaboration with Maureen Goodenow from the U.S. They're here today to discuss the work Admiral Levine talked about yesterday to update the vaccine's national strategy. After a presentation, we'd like to hear from committee members about your thoughts for the updated five-year national vaccine plan. Dr. Okeke, your slides are up. You have the floor. >> Chinedu Okeke: Thank you. Good afternoon, everyone. I will try as much as possible to move quickly. I know it's Friday afternoon. Some of us are already in a weekend mood. So, but thank you Ann, thank you Dr. Hopkins and the committee for the opportunity to present today. So, today's presentation, I'm going to touch on the current national vaccine strategic plans, the preliminary plans to put together another five-year plan once the current strategy ends in 2025. I will also touch on Admiral Levine's charge to this committee. Finally, a quick review of the tentative timeline that we are working with. There will be time dedicated to questions and discussions after the presentation, if any. Some of you may already know this, but I don't mind refreshing our memories. To comply with, you know, the Public Health Service Act, the National Vaccine Program and National Vaccine Advisory Committee was established in 1986 with the purpose of achieving optimal prevention of adverse reactions and human infectious diseases. Over the years, through coordination and collaboration with other federal agencies, external stakeholders, the National Vaccine Program has continued to work tirelessly to live up to this purpose. This is demonstrated by a number of strategic plans released over the years. The 1994 National Plan which was the first published plan all the way to the current plan that we have now, which is the Vaccine National Strategic Plan 2021 to 2025. Well, this slide is just a visual timeline of the program's establishments, plans, and progress over the years. As I mentioned in the previous slides, from the program's establishment in 1986 to the present as we begin to, you know, the planning of the next iteration of the strategic plan. Again, to refresh our memories on the current National Vaccine Strategic Plan, which is a five-year roadmap, but with a lifespan approach with the goals of coordinating new vaccine developments and addressing newly emerging challenges as we saw it during the planning period. And this plan with five goals, 19 objectives, and 71 strategies also aims at strengthening vaccination infrastructure across both public and private sectors to prevent vaccine preventable diseases. Again, this finished product was made possible because of collaboration and contributions from all sectors, HHS and non-HHS agencies, numerous listening sections, and community inputs. Now, focusing specifically on the current five goals, we are coming back to NVAC to request your inputs and feedback as subject matter experts in this. NVAC has long, you know, history of providing HHS with guidance and plan development. To remain flexible and responsive to the evolving landscapes, HHS plans to release an updated five-year national strategy for 2026 to 2030. Looking at the current goals, you may notice that most of the NVAC's recommendations were accepted partly or entirely. In addition, the priorities and the current plan are mostly recommended by NVAC in some variations. To go, you know, a little bit in depth into this, and in Goal 1, you maybe, you know, the three priorities were proposed by NVAC. Two out of the three priorities were accepted, including Three priorities were accepted and included in the 2021-2025 strategic plan. The same thing for goal two, three priorities proposed by NVAC and three priorities were accepted and included, and so forth. So, I'm saying, you know, this to say that we value the input of NVAC and the feedback and, you know, especially, you know, post-COVID, we want to make sure that we hear all voices, especially from the subject matter experts. A special thank you to Admiral Levine for her steadfast support of the work that we do at OIDP and also her continued support to NVAC, recognizing the important role that, you know, this committee plays in advancing vaccines safety and equity. As we move to put the pandemic era behind internally we are, you know, discussing, you know, amongst ourselves, you know, taking the time to re-evaluate, rethink, and readjust to the ways that we do things post-COVID. This is reflected in the charge given to this committee by Admiral Levin yesterday. So, essentially, the ask is for the committee to assess goals, objectives, and indicators in the current national vaccine strategic plan and see if they are still relevant for the next five years, especially post-COVID. Keep and or propose new goals if needed. prioritize three top objectives within each of the five goals. Now, the last one there is extremely important. Propose new indicators that measure if goals and objectives are achieving desired outcomes. We want to be able to evaluate these goals and our objectives, and if necessary, have some cost corrections. We also encourage this committee to seek input from diverse set of experts and stakeholders in development of its reports, especially to elicit feedbacks, [inaudible] the need of their communities. Finally, a week turnaround reports to be reviewed and voted on during the February 2020 with 2025 and back meeting. I just wanted to show, you know, our tentative timeline just to provide the basis why we are asking, you know, for this quick turnaround time for the NVAC reports. We are currently on the planning data gathering and engagement stage. The amount of work we expect for in 2025 will depend on this stage of data gathering and engagement. So, we are eagerly looking forward to this report and recommendation. And I also, you know, like to remind this committee that, you know, there are other processes going on. NVAC is one of them. We are going to conduct other, you know, listening sessions, you know, to talk to the communities. to, you know, have an RFI out there, you know, seeking inputs and feedbacks. So, but we value the input of NVAC, and we want to hear some of the recommendation, as I noted earlier on, most of the recommendation from the last time we came here was used in the strategic plan. So, I will end by speaking briefly about syndemic approach. Yesterday, there were multiple references by speakers to the complexity of infectious disease syndemics. Syndemic is a set of linked health problems that interact synergistically and contributes to excess burden of disease in a population. OIDP coordinates the development, implementation, and reporting of multiple national strategic plans and initiatives. Now, the current plans that we have were developed in concept to identify synergy within policies, programs, and research. Specifically, each of the plans call for integration and coordination across programs at all levels, local, state, and federal. This integrated approach aims to leverage resources to best address the social and structural drivers of these diseases and needs of the community. Yes, this is the end. So at this time, Dr. Goodenow and I will, you know, welcome any questions, discussions. So, the floor is open. >> Robert Hopkins: Thank you. Any questions or comments from the members of the committee? Erin, please. >> Erin Henry: Thank you. This is because we're currently in Canada redoing our strategy as well. And we also have some short timelines because the pandemic delayed us and renewing our strategy, but we're getting some pushback from some of our indigenous communities saying that our timelines are too short and also some of our harder to reach populations. So just wondering how your engagement is going with, say, the non-traditional immunization partners. >> Chinedu Okeke: Excellent question. So, like I mentioned before, this is the beginning stages where internally we are, you know, putting our timelines together, you know, making the plans on, you know, some of the people that we need to reach out to, putting up that list, the communities that we need to reach out to, talking to other federal agencies to make sure that everybody knows what's coming because this is time, you know, consuming, block out your calendars. We need all hands on deck because this is not just an HHS plan, it's a national plan. And it's not just for the federal agencies, it's a national plan. So, we want to make sure that we carry, you know, everybody along. We want all voices heard, which is one of the reasons why we came here. We want to make sure that members of the committee here, you know, go, you know, that has talked to, you know, members in their communities, you know, will bring back those perspective, you know, to bear here so that we can, you know, you know, take it back, you know, while, you know, talking about the next five years. A lot has happened during COVID. Some lessons learned. We want to make sure that we have those lessons be part of this next five-year strategy. So, you know, we have that in our mind, you know, to talk to the tribes. We have, you know, we talk to all those communities that may have some reservation about some, you know, vaccines and the way we do things. So, we have that in mind. Thank you. >> Kim Armstrong: I just wanted to add to that really comprehensive overview to mention we've been seeing some of the same problems. One of the few things that we've done so far is really to get in touch with our IHS partners who are very keen to be part of the listening sessions. And with their regional contacts, they're actually going to bring people into the listening sessions as one way of doing that. >> Robert Hopkins: So, we have a comment from Mitch Rothholz from our online folks. He said, "We certainly need to specifically look at healthcare workforce, knowledge, authority, abilities, and also what it will take to sustain accessibility of community-based vaccination." So, I think a good comment for us to put on our work list, among other things. After receiving the charge, jotted down a few thoughts that may help to stimulate some discussion. You know, in my mind, the first priority at this point is probably rebuilding vaccine demand and confidence. You know, given where we've seen declines in provider confidence as well as community confidence and uptake through the course of the pandemic. We've got to certainly leverage our successes like the WHO report that we discussed today, recent data showing HPV vaccine impacts and reduction of cancers. I think those are certainly important successes that may help us to talk forward about the positive side of vaccine impact. We've clearly got to rebuild provider confidence. We need better data linking immunizations to outcomes across multiple different vaccine-preventable diseases and communication tools to provide data-driven support for immunization. The second bucket is, in my mind, improving vaccine access for all. You know, vaccine for adults to help us affect changes in areas for economic disparities. Rural urban disparities, racial and ethnic disparities all impact our ability to vaccinate our populations. You know, even though we've got a vaccine for children program that's very effective in a lot of ways, there are still challenges in certain members of our childhood population getting vaccines without significant barriers to get to those vaccines to get vaccinated. And on the access piece, Insurance plans ability to hold off on covering a new vaccine for a year after it's recommended by ACIP is another major barrier to vaccine access and uptake for our patients. Third would be the safety piece. You know, how can we leverage and improve our current vaccine safety systems? Our recent NVAC report certainly ties into some of those topics. Could potentially artificial intelligence help us in vaccine safety as long as we can communicate when, how, and the curbs and gutters around that are there to avoid it being artificial? International collaborations to broaden our safety profiles and thinking about similar and different approaches to non-preditional vaccine products like Nirsivimab or potentially vaccines for cancer therapeutics like we talked about yesterday. Innovation, you know, thinking about the three-legged stool of traditional infectious disease vaccines, you know, looking at the last five years, we've had tremendous steps forward in traditional infectious disease vaccines. Passive immunization products are somewhat realized. We've seen nircepimab come out, but we have not seen the same level of support and engagement around COVID-passive monoclonal antibodies or other monoclonal antibody products, and then therapeutic vaccines. And then number five for me is we've clearly got to continue international collaborations on vaccine development, production, and safety, as I mentioned earlier. So just some thoughts from the Hopkins household. Others have any comments or questions? Molly? >> Molly Howell: Yeah, I actually had improving vaccine confidence written down as my number one goal as well. And then I also had access, and I agree with you on your points around access. Also looking at bundled billing for vaccines in hospitals as maybe something that could happen separately and not be bundled. And looking at if vaccines are being reimbursed at an adequate dollar amount for what they're being paid for, including by independent providers that may not have access to group purchasing. And then I agree with the vaccines for adult program or some program for adults without insurance. On the innovation, And even kind of on safety, I just want to make sure, and maybe immunization information systems can weave their way throughout all five of the topics because they, in a way, could touch all of them. And same with equity, I think, could be overlaid across all five topic areas. >> Robert Hopkins: And again, I recognize from Rebecca's presentation earlier, we don't pull research out of our immunization information systems, but perhaps de-identified data, you know, being used to help measure some of these endpoints may be helpful from the registries. Other comments or questions? Yeah? >> Kim Armstrong: I was just going to make a comment about the last NVAC meeting where there was that wonderful presentation about using AI for designing immunogens and the way you could really accelerate the early phases of research and development. And to me, that was really, really exciting. So, you mentioned AI in one context, but I think, you know, the potential for really having an impact on the research pipeline is quite large. >> Robert Hopkins: Another comment from Mitch online. We should spend some time on what a modernized immunization system looks like, and have goals and objectives that work toward a modernized immunization system. Geeta, please. >> Geeta Swamy: So, access was top of my mind. And I think one comment is certainly we talk a lot about access from the standpoint of funding, right, whether it's insurance or people without insurance or certain things. But I also think access being something that we make readily available. to anyone, any place, any time. I think that's one of our significant limits during the pandemic that, you know, all the sort of things we used to do a long time ago, you know, having health fairs, having mobile access really did work. And so, how do we figure out how to get vaccines to people where they need them, when they need them? Additionally, putting it on the onus of providers to figure out how to do it is a problem. We're talking about a national approach that we're then going down to the level of an individual provider figuring out how to do it in their office. And it seems that we need to think about these things in a more concerted effort. I feel like what we do a lot of is say FDA approves the vaccine, then it goes to ACIP to decide, but it's up to insurance companies to get another year. How do we then get all of our scientific or academic societies to put forth information and providers and what to use. We do the same thing for every new vaccine. It seems like we could have that playbook already written out for what you would be doing going forward depending on who the population is indicated for would be and to put that into motion. >> Robert Hopkins: Claire? >> Claire Hannah: I was going to say pretty much exactly that. I mean, I would just say I agree with everyone's comments, really, really great comments. And just the number of pieces that need to go together when you're implementing a new product. And let's have a mechanism in place for putting those pieces together ahead of time or talking about how they're connected ahead of time for new products. Like she said, it's the same, pretty much, process of getting insurance coverage and getting VFC, you know, getting everything, all of those ducts, let's kind of standardize that in the future would be great. >> Robert Hopkins: And another comment from Mitch, "Where do vaccinations sit in priorities within the HHS or national overall plan? Should the plan be what's desirable or what's reasonably achievable?" That's a good question. Maureen, please. >> Kim Armstrong: That is a really interesting question. I'm thinking that plans should be aspirational and that that's the place to lay out the vision and the possibilities. And then when you drill down with to the level of specific objectives, that's where you really flesh out and say this is what we're going to do. But I think having an umbrella that's very visionary and very aspirational is really the way to start. >> Robert Hopkins: Well, and perhaps to answer the comment that Erin made earlier, perhaps it needs to be a living plan, you know, with shorter term objectives, but a living plan that, It doesn't mean it's set in concrete for a lifetime, but it's got a living set of overriding principles, goals and objectives that you aim to achieve within a fixed period of time. Judy Shlay. >> Judy Shlay: Yes, hi. I think I'm excited about this next plan. One of the things we have struggled with in just vaccine delivery is all the issues of private and public vaccine. 317, we have various, you know, with the VFC, but we have private. And when we go out and vaccinate in community or in clinics, It's hard, and we need to figure out a way to simplify the provision of vaccines to make it easier to just get vaccines into arms. And I know there's lots of buckets of funding that are associated, but just at the delivery side, it is really problematic. And I want to bring that up as a real barrier. Like right at this moment, our agency doesn't have private COVID vaccines. And we have to order some, but we're sort of waiting and seeing what's going to happen. But so you go out in community and somebody has Medicaid and they're an adult, we can't give them the vaccine because they don't qualify for public vaccine because they're not underinsured or uninsured, et cetera. So I think that's an important piece in proving access. >> Robert Hopkins: Thank you. Good comment. Other comments or questions? I'm not seeing any. I think we've given you plenty, or at least a starting point, and I think we look forward to this conversation going forward. Thank you. >> Chinedu Okeke: Thank you. Those were wonderful preliminary comments. So, we are eagerly waiting for the full committee's report. Thank you again for allowing us to make this presentation. >> Robert Hopkins: Thank you. All right. We have reached the time for public comment and we do not have any public comments on, so I guess we have reached the time to adjourn. I want to thank those that are online participating in our meeting. I want to thank the members of the committee. I want to thank our OIDP staff, our sign language interpreters, and the broadcast team for supporting us. Thank you for joining us for our June NVAC meeting. I want to remind you, our next meeting will be in September, and our September meeting at the same time as the September meeting, we will have NFID flu night at the Washington Nationals game. Time to think about protecting our community with flu vaccination. Hope all of you all can join us for that as well. Wish everyone safe travels, and we will see you at our September meeting. produced by the U.S. Department of Health and Human Services. >> Male Speaker: Produced by the U.S. Department of Health and Human Services.