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A summary of presentations from the weekly Summit partner webinars

August 14, 2025 – The latest Summit Summary

Summit Council Update

L.J Tan, MS, PhD, gave an update about the development of the newly forming Summit Council.

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Summit Council Update – Litjen (L.J), MS, PhD
The National Adult and Influenza Immunization Summit (NAIIS) Summit Organizing Committee (which is in essence a steering committee) began meeting weekly in early April to allow confidential sharing and harmonization of information between professional organizations. Additional partner organizations continue to be identified and invited to participate, as necessary, representing different sectors of the immunization infrastructure, including payers, physicians, pharmacists, etc. This larger group of organizations is informally referred to as the Summit Forum.

Another opportunity presented by the Summit Forum is the ability to perform contingency planning for evidence-based practices in immunization, especially considering the uncertain environment for vaccination.

Contingency Planning
The organizations in the Summit Forum agreed to make preparing for an “altered” ACIP the first contingency plan. When the ACIP was indeed changed in June, it was clear that providers would need some guidance on best practices in immunization.

  • After considering multiple options, the participating organizations asked the Summit to initiate an independent, scientific council to validate or provide evidence-based best practices in adult immunization.
    • Participating organizations (versus observing organizations) would nominate the members of the council; the initial suggestion was too have 11 members but there is acknowledgment that 11 members may not be enough.
    • The process has begun — nine organizations have submitted nominees — but is being intentionally slowed down for several reasons.
      • The Vaccine Integrity Project’s current work on the fall vaccination season
      • Various internal/administrative issues
    • More details about the process and the Council members’ roles and responsibilities are being worked through.
    • After the nominating organizations and the Summit complete conflict of interest and disclosure checks, the Summit will be seeking a home for the Council.
    • Potential funders are also being sought out.

Council Projects
The hope is that the first project for the Council will be validating or setting a framework for further discussion of the adult immunization schedule.

  • The request would be to use the February 2025 schedule as a starting point for considering new recommendations and evidence — comparing those to the already published and agreed upon schedule from February 2025. (The schedule changed in July 2025.)

Payer Participation
Various health plan organizations are aware of the effort and may be observers, and the National Alliance of Healthcare Purchaser Coalitions is aware of the work and will be briefed at their quarterly meeting.

Streams of Work
None of the streams of work are intended to replace the ACIP or serve as an alternative to it. Coordination and collaboration are essential.

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Vaccine Integrity Project Update

Bruce G. Gellin, MD, MPH, gave an update about the Vaccine Integrity Project.

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Vaccine Integrity Project Update – Bruce G. Gellin, MD, MPH
As background, CIDRAP’s Vaccine Integrity Project (VIP) is an initiative dedicated to safeguarding vaccine use in the United States so that it remains grounded in the best available science. The key question that launched the project was, If you’re not the government, are there things you can do to safeguard vaccine use so it remains grounded in the best available science? The VIP was supported for the first phase — a diagnostic approach to answer the question of what could be done — by unrestricted funds from Alumbra.

The first phase consisted of the following:

  • Creation of a steering committee, within CIDRAP, that shepherded…
    • A series of focus groups in May 2025, with ~100 people from different sectors
    • An interim update at the end of June 2025 about what was surfaced
    • A final report at the end of July 2025, which concluded the first (exploratory) phase
  • There were eight overarching recommendations as a result of the first phase:
    • Increasing communication and information dissemination for today’s environment
    • Developing and disseminating clinical tools and guidelines for the entire healthcare system
    • Building an overarching coalition for strategy and alignment
    • Stabilizing the vaccine safety system
    • Safeguarding insurance coverage for vaccines
    • Maintaining the nation’s vaccination infrastructure
    • Providing assistance to state health departments
    • Continuing the flow of data for decision-making

Next Phase of Work for the VIP
Initial focus areas for viral respiratory season include the following:

  • Rapid Response Effort to monitor and address vaccine-related misinformation in real time
  • Dissemination of Scientific Evidence so clinicians have evidence-backed guidance on key immunizations for influenza, RSV, and COVID
  • Continued Collaboration and Visibility to support better alignment, reduce duplication, and identify and address emerging issues in real time

Evidence Review: Overview
The guiding question was, What might have changed in epidemiology, vaccine science, and adverse events in the past year, since the more traditional ACIP recommendations about these three vaccines (COVID, RSV, and influenza)? There was so much confusion that there was an effort to have a science brief — a summary of the evidence — to base recommendations upon. The outputs are an evidence review by the VIP and clinical guidelines and recommendations by medical societies.

The process for the evidence review included the following:

  • A team was assembled for a systematic review on the latest evidence on safety and efficacy.
  • Joined by CIDRAP, the team reviewed 16,000+ abstracts and 1,400+ papers.
  • The team is currently extracting data.
  • The full protocol was registered in PROSPERO on July 10, 2025.

Next steps for the evidence review include the following:

  • VIP Evidence Review: panel discussion, summary, manuscript submitted for publication
  • ACP’s timeline is TBD

There was a brief overview of the VIP web page on the CIDRAP site: https://www.cidrap.umn.edu/vaccine-integrity-project.

QUESTIONS & ANSWERS (JOINT: WITH BOTH PRESENTERS)

Q: How will your nominating and observing organizations be made public?
L.J Tan (Immunize.org): We will be very clear which are nominating organizations, and which are observing organizations, and we’ll continue to evolve how those organizations participate as we proceed. We’ll be a little bit clearer with the protocol. But currently observing organizations are, for example, the trade associations for the health plans. They’re observing; they’re not going to be nominating. The Association of State and Territorial Health Officials is an observing organization. We offered them the opportunity to nominate, but they chose to stay as observers. We will continue to split that up and be transparent as we go forward.

Q: Is the VIP considering ways of working to engage scientifically with vaccine developers to review questions on the evidence being collected, and that their review is complete? The ACIP working groups did this in the past with vaccine developers.
Bruce Gellin (GUSOM): The challenge was, going into this and seeing the work that was involved…the premise was what’s in the published literature, and the basis for that. That’s not saying that there isn’t other information that would be valuable — in the same way that manufacturers present to working groups things that may not be published. And we’ve had to offer to the manufacturers…to at least allow for that. It’s not quite so simple, because it was clear that it couldn’t, in a systematic way, be embedded into the review itself. We went back and asked the manufacturers, “Tell us if there are gaps that you’re aware of for which manufacturer’s data might provide some… might fill in some of that gap.” And so far, when we’ve asked that question, the answer has been, “We haven’t seen it yet.”
L.J Tan (Immunize.org): I want to appreciate the fact that you are publishing that protocol that you use for your work, because I think that protocol will be useful, eventually, for the Summit Council to look as they decide to go forward on their evidence review in the next phase.
Bruce Gellin (GUSOM): We’ll all have to look at it to see if that’s the kind of approach going forward, because there are a million things for which scientific evidence could be valuable from now on for the next 112…165 days, I think.

Q: It is so important that the recommendations are aligned or they will create more confusion and hesitancy. Is there a good way for state and local public health to stay looped into the different organizations that are creating recommendations?
L.J Tan (Immunize.org): The reason the Council, the forum, has observer status for ASTHO as well as NACCHO is — and the Association of Immunization Managers, they’re all observing — is because we want to assure them that there is a way for the state and local public health groups to become engaged. I think that’s important. And I think the way we’re doing that is, obviously, through the state and territorial health officials, and the city and county health officials, and also through the immunization managers. And we are open to any suggestions or any other ways to work at a broader level with state and local public health. We do not have the ability to engage every single public local health department, but we do hear you. It’s an incredible group of important partners that we need to pull in.
Bruce Gellin (GUSOM): As you saw, one of the eight pieces was how to help state and local health departments and immunization programs. There are a million things in that, but that was the headline. They were part of these focus groups early on. They’ve heard a lot of these readouts, so far. They know where this is going. It’s not quite so simple, because they have different color states that have a different willingness to take some of this stuff on. I’ll leave it there, but just to know that that was another place where there might be some confusion. One thing that came up early, and maybe somebody from a state will want to raise their hand on this one, is whether states might want to take on some of these CDC/ACIP-type roles themselves, from procurement to making recommendations and the like. I don’t know the current status. The general shift was that would just add to the confusion if you had that much more fragmentation, and the hope was that, again, with this process — and this is the first baby step — it would help to, if not harmonize, at least say it’s all being put in one place, so people can then see the basis on which recommendations would be made. But I think your point from the beginning is, unless we do this right, there is the potential for confusion, and for all of us working with the societies who are making the recommendations, to make sure that they sort of look over each other’s shoulders to see how this is coming across. They’re going to do what they want with it, obviously, but I think that, even from a format standpoint, if it’s vastly different, that could add to some of the confusion.

Q: Who is working with the media and preparing talking points for partners?
Bruce Gellin (GUSOM): That’s been a core function of that kind of outreach. I often joke with Mike Osterholm that I have to get a new TV set, because it looks like I haven’t got the screen saver and my TV is on television so much. But that has not been an issue. They have a good system there through CIDRAP, and then part of the VIP, working with the media. That’s been the case with these reports. They often don’t cover reports if they’re not newsworthy, but they also know what’s coming, so I think that’s, at least on this, a slice of what’s happening next week.
L.J Tan (Immunize.org): And for the Council, one of the things is that we have been more under the radar. We’ve always argued that what we’re trying to do is use our medical organizations, our provider organizations, clinical organizations. to take whatever the Council ends up doing, wherever it’s homed, and use them to promote it back to their providers. So, an organization can say, “Hey, we agree with what the Council has done, and we’re going to provide that information back into our provider group through our communication channels.” So, everything goes back to the provider through the medical organization. So, we have not engaged the media on this, and we have not, obviously, prepared any public talking points. I think this is important and the hope is, as we move into the fall, we will coordinate with the VIP and see how we can ensure, for the public as well, that we’re not working at cross-purposes to each other and that everything is harmonized.

Q: Will there be legal issues if providers don’t follow the ACIP federal guidelines?
Bruce Gellin (GUSOM): So you get the prize, the duck comes down, you get your $100, if anybody’s ever heard, congratulations. I’d actually broaden that to legal and financial, or risk more broadly. And that’s one of the things that states are now trying to look at that may differ a little bit by state requirements. I took a deep dive with some of the pharmacies who have another set of things that they look at that, again, are state-based as well, but that’s really an important consideration. The question is going to be whether this is off-label use. Physicians can prescribe things off-label, but there is that potential risk. Then the other question is: What will happen financially? Will they be reimbursed? And what will happen, legally, if something were to happen, and would it be covered in the compensation program if they give something off-label? I’ve highlighted the issues and these are the things that need to be teased out, most likely at a state level, because there are different regulations. It’s not a core activity that we’ve taken on, other than to flag it. That came up in some of the discussions about the importance of states.
L.J Tan (Immunize.org): It has been on the surface of discussions about what’s happening at the state level, especially if a state has legislation that ties recommendations that they’re doing in-state to ACIP, CDC…what does that mean for the providers? Those are legitimate questions that have been touched upon. Again, a lot of the work that we’re doing here is at the national/federal level, and having partners like ASHTO, NACCHO, AIM, who are at involved at the state level and able to understand the granularity of what has to happen at all different states, is important. I don’t think we have a solution. We’re hoping to provide a linchpin for which some solutions could eventually be tapped to, but I think that’s about as far as I can say these efforts are going to go. And then, at the state level, I think working with state insurance, health insurance commissioners, and so on might be ways to put this into regulation further down the road.
Bruce Gellin (TBD): So, I added financial risk, too… and it’s legal risk… so I think you’ve been talking to ACIP, they’re tightly woven into your observer status. They were part of our focus groups. We had a call with their chief medical officers recently, just so they were aware of the process and the timing. But they’re holding their cards pretty close right now, and they’re going to have to start playing them out pretty soon, when the recommendations start coming. And I think the challenge will be — and we’ll have to see how it plays out — if the recommendations are different, and I would think broader than what might be coming from the government, their legal requirement is to do what ACIP says. They don’t have to do that, they’ve never had to do that, and the question is: What will they do? Lots of speculation, but they are quite aware that they’re in the crosshairs.

Q/Comment: A review of activities shows a large scope of work, if it’s a review of all recommendations beyond the respiratory viral vaccines. This is early in the process, but it’s a process of prioritization that will be very challenging.
L.J Tan (Immunize.org): We’re going to get the Summit Council stood up. We’re looking to hand that off to an organization, and we will continue to work with whatever organizations we can to figure out what level of review we’re talking about. That’s why, deferring back, we’re not saying that we’re going to use the protocol that Bruce has described — that’s in Prospero — but having something to look back to, coordinate, and maybe even align upon makes a lot of sense, because it makes it much easier. One of the things about using this adult schedule as a starting point from February 2025 is that it limits the literature review back to that time frame. So, when the Council looks at the adult schedule, and the Council is free to change their mind, my recommendation would be that they limit it to going back to where the final schedule that we’re using as a starting point is. And that has been endorsed by six of the organizations that are currently in the forum.
Bruce Gellin (GUSOM): “Challenging” should also be in caps, because this is a huge issue. And it’s really a question of scope and bandwidth. And that’s probably a separate conversation: how to pick these things off, which is either the most urgent, or the most important, or could be the most controversial. How to do this? And the issues are not limited to ACIP holding up your hands. I guess they push the buttons now as for votes. It could be about safety issues. It could be about the adverse event… the injury compensation program. There are infinite issues that could surface that would require an evidence-based response, and you can’t do everything. So, it’s important to raise that and, from our standpoint, this is our baby step, and now we’re going to see how it goes, and how to move forward, and the degree to which this might be adjustable to other things. But the kind of review we did on efficacy, safety, immunogenicity — if the question is about aluminum, you need a different set of people who are going to look at some of those things. So I think that we have to sort those out.
L.J Tan (Immunize.org): It is a baby step. Organizations are stepping up to do what they can do in a very challenging environment, and I think we are reactive. And we’re asking for grace as this happens, as well, because we’re working with all of the organizations to figure a way to move forward in a united, harmonized fashion. And I think one of the things that folks have heard me say when I’m talking to organizations is, I think we’re also asking for organizations and partners to be magnanimous, because there will be challenging points and points of tension, and we’re hoping to be able to work through that as we go forward.
Bruce Gellin (GUSOM): It’s a related question of scope, also a little bit of setting expectations. We’re a tiny fire department with a hose and a couple of hats and an axe, taking on massive forest fires, and so how do you then figure out where you’re going to have the best result?
L.J Tan (Immunize.org): Having a coordinated response to draw upon for large and small professional associations would help. So, you have our assurance here, from Bruce and me, that we’ll continue to collaborate and cooperate and move forward to try to make this easier for folks.
Bruce Gellin (GUSOM): I would trickle that down into state and community organizations, and we need to make sure everybody hears about this thing as much firsthand as possible. So you’ve got a great… how many people are on this? One hundred fifty people on this call? We’ve used, it’s not exactly the same, the ACIP layout of the core partners, at least for the respiratory viruses and that “outer ring.” But there are others, and I think the point is, if you’re involved in immunization, you need to know about this, and know what’s happening, and know how to talk about it.

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Announcements
  • Save the date for the 2026 National Adult and Influenza Immunization Summit in-person meeting: May 19 – 21, 2026 at the Crowne Plaza Atlanta Perimeter at Ravinia in Atlanta, GA.

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