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ACIP and What Comes Next · The SHEA Podcast

• 0:06
  SPEAKER_00: Good day and welcome to Shay's podcast.
• 0:10
  SPEAKER_00: I'm Dr.
• 0:10
  SPEAKER_00: David Weber, the 2025 SHA president.
• 0:14
  SPEAKER_00: I'm excited to serve in the role of today's moderator as a former liaison to ACIP from SHA from 2014 to 2020.
• 0:23
  SPEAKER_00: This is a particularly important topic to me.
• 0:25
  SPEAKER_00: As we get started, I'd like to introduce you today's speakers.
• 0:28
  SPEAKER_00: First is Dr.
• 0:29
  SPEAKER_00: Pradi Mahutra, Senior Medical Director, Division of Infect Control, Hospital Epidemiology at the Silverman Institute for Healthcare, Quality and Safety, the Division of Infectious Diseases, Fifth Israel Deaconess Medical Center at Harvard Medical School.
• 0:45
  SPEAKER_00: She is a hospital epidemiologist and practicing adult and pediatric infectious disease clinician.
• 0:50
  SPEAKER_00: And Shay's currently a zone to the ACIP.
• 0:54
  SPEAKER_00: Our second speaker is Dr.
• 0:55
  SPEAKER_00: Marcy Dries, Infection Prevention Officer and Hospital Epidemiologist for Christiana Care.
• 1:01
  SPEAKER_00: And also formerly a zone to ACIP on behalf of Shay, who served during COVID.
• 1:07
  SPEAKER_00: Welcome to the podcast on ACIP.
• 1:09
  SPEAKER_00: And what comes next, Dr.
• 1:11
  SPEAKER_00: Smarcy and Drees.
• 1:13
  SPEAKER_00: I'm very excited to talk to you about this very important topic.
• 1:17
  SPEAKER_00: For our first question, uh, most of the audience knows what the Advice Screen Immunization Practices does.
• 1:23
  SPEAKER_00: What does the liaison work entail?
• 1:26
  SPEAKER_00: And provide a brief introduction about the ACIP.
• 1:30
  SPEAKER_00: Greeting, thank you very much.
• 1:32
  SPEAKER_01: Thanks so much for having me, everyone.
• 1:34
  SPEAKER_01: So, you know, the Advisory Committee on Immunization Practices is an incredibly important and well-regarded committee.
• 1:41
  SPEAKER_01: It was established in 1964 and incorporated by the Federal Registrar in 1972 as an official advisory committee and provides essentially guidance on vaccination programs of all kinds and shapes and sizes for the United States.
• 1:58
  SPEAKER_01: There are committee members of really well-regarded backgrounds in vaccinology, in operations, in immunology, in health services research who serve on the committee, and they are appointed by the HHS.
• 2:15
  SPEAKER_01: In addition to those committee members, there are liaisons from professional society organizations.
• 2:22
  SPEAKER_01: And so I am the non-voting member, as are all of the liaisons from professional societies, who uh also provide input from their representative organizations.
• 2:36
  SPEAKER_01: And there's also members from outside of the appointed members and non-voting members from other departments within HHS.
• 2:45
  SPEAKER_01: And we all come together, and those is those are who you see on these public meetings that ACIP held about three times a year.
• 2:55
  SPEAKER_01: Separate from those public meetings are essentially meetings where there are several work groups and chains that are created where we meet to review the data to talk about real-world implementation of vaccine programs.
• 3:13
  SPEAKER_01: And so two work groups that I participate in are the COVID-19 work group and the uh schedule immunization schedule work group.
• 3:22
  SPEAKER_01: Um in the past, Jay has participated on other work groups as we might feel it's relevant.
• 3:28
  SPEAKER_01: Those work groups meet at a fairly regular cadence.
• 3:31
  SPEAKER_01: I mean about every other week for the COVID-19 work group and once a month for the immunization schedule work group, and that schedule is subject to change depending on um other needs that might arise.
• 3:43
  SPEAKER_01: And so it's in those sessions that we review a fair amount of data that is then ultimately presented uh at the at the public meetings that we all see.
• 3:54
  SPEAKER_00: Thank you, Dr.
• 3:54
  SPEAKER_00: Dries.
• 3:55
  SPEAKER_00: Do you have some uh comments?
• 3:57
  SPEAKER_02: Yeah, I mean, I I agree with everything that Pree just said.
• 4:00
  SPEAKER_02: I think you know it is important to to again emphasize that we are non-voting participants, but that our input is highly valued.
• 4:08
  SPEAKER_02: You know, Shay, of course, is asked to be have a liaison specifically to talk about healthcare personnel vaccination.
• 4:16
  SPEAKER_02: So that's that's you know, when there's a specific question about that, is when they look to us.
• 4:21
  SPEAKER_02: However, that doesn't mean you're not allowed to comment on anything else.
• 4:26
  SPEAKER_02: I mean, I'm also a practicing HIV provider.
• 4:28
  SPEAKER_02: So, you know, when there were opportunities to comment on, you know, things relative to that population, you know, they were definitely happy to hear, you know, and and you really are just asked to participate, like she said, in the relevant um work group.
• 4:43
  SPEAKER_02: So when I was on, I obviously was part of COVID as well.
• 4:47
  SPEAKER_02: There are two kind of standing work groups, the the immunization table that you know updates it every year.
• 4:53
  SPEAKER_02: And then there's a um a general clinical practice, which just gives general guidelines on how to administer vaccines.
• 5:00
  SPEAKER_02: So that one I was on as well.
• 5:02
  SPEAKER_02: And then we also were participating in the hepatitis vaccine work group, which has since been closed because there wasn't, you know, it was leading up to the vote for prehibrio, prehibrio.
• 5:14
  SPEAKER_02: Um, but once that vote occurred, there was no need at the time to continue that work group.
• 5:19
  SPEAKER_02: So they are they all are very task-oriented.
• 5:23
  SPEAKER_02: And when there's not an upcoming vote to be had, other than those two kind of standing work groups, they'll they'll close them down and then they'll they'll just open them back up when there's a new vaccine or a new decision to be made.
• 5:34
  SPEAKER_00: Thank you very much.
• 5:35
  SPEAKER_00: Our next question is uh some of the critique has been that the work group's work is done in private.
• 5:41
  SPEAKER_00: Can you share your thoughts on this, starting with uh Dr.
• 5:43
  SPEAKER_00: Drees?
• 5:44
  SPEAKER_02: Sure.
• 5:45
  SPEAKER_02: I mean, I think, you know, again, like the all the work groups are very they have a goal.
• 5:50
  SPEAKER_02: You know, it's often, you know, set, you know, we know that a certain vaccine is coming.
• 5:55
  SPEAKER_02: We know, and and they'll set the the vote date, you know, often well in advance, you know, a year and a half is when, you know, the FDA approval is anticipated.
• 6:05
  SPEAKER_02: And thus, you know, as soon as a a new product is FDA approved, then ACIP will chime in on how to use that approved vaccine.
• 6:14
  SPEAKER_02: So they will have they will know that well in advance.
• 6:17
  SPEAKER_02: And so it's it's really, you know, all the work group work is really like you know, all the stuff you do when you're preparing a presentation at home.
• 6:25
  SPEAKER_02: Like you wouldn't want, you know, that to be public, right?
• 6:28
  SPEAKER_02: Because you're, you know, you're tossing, you're reviewing the data.
• 6:31
  SPEAKER_02: You know, they do ask the pharmaceutical companies to present their data before it's presented publicly.
• 6:37
  SPEAKER_02: Part of that is to obviously to inform the vote.
• 6:41
  SPEAKER_02: You know, the the work group will typically decide like what votes are gonna be offered to the broader work group or to the broader ACIP.
• 6:49
  SPEAKER_02: Um, not that they couldn't can't be changed, they often are changed in the moment in the public meeting, but it a lot of it too is to give them feedback of, okay, well, this is the study that you did.
• 7:00
  SPEAKER_02: Can you answer these other questions that we know the the broader ACIP is gonna ask?
• 7:06
  SPEAKER_02: Or, you know, this is unclear.
• 7:07
  SPEAKER_02: Can you can you clarify that?
• 7:09
  SPEAKER_02: And it helps them to improve their presentations.
• 7:13
  SPEAKER_02: But I would say the the bulk of the workgroup work is going through, you know, what's the evidence to recommendation or ETR process, which has six domains, you know, risk, benefit, equity, uh, implementation.
• 7:28
  SPEAKER_02: And I don't have it in front of me, so I don't remember all of them off the top of my head.
• 7:31
  SPEAKER_02: But basically, you know, they are looking for what data is available to inform each of those domains that will then be publicly presented.
• 7:41
  SPEAKER_02: So there's um, you know, often dozens and dozens of CDC work work uh employees who are working on the data to inform those different domains.
• 7:51
  SPEAKER_02: And all those presentations are reviewed uh at the work group level so that again, so that they can be clarified, they can be condensed or expanded, you know, just so that they are the best possible presentation and most accurate possible presentation of the data that's available.
• 8:07
  SPEAKER_00: Thank you.
• 8:08
  SPEAKER_00: Dr.
• 8:08
  SPEAKER_00: Mahocha, your thoughts?
• 8:10
  SPEAKER_01: Uh that was a really great summary.
• 8:12
  SPEAKER_01: I mean, I think that like Marcy mentioned, much of the dialogue is with information that's being presented from um pharmaceutical companies, for example.
• 8:22
  SPEAKER_01: And there's a really rich dialogue and commentary that happens about their presentation so that the data can be sharpened or refined or presented.
• 8:32
  SPEAKER_01: And that's ultimately what you see in those public meetings is an output from that kind of discussion about how to refine that presentation or what other details might what you want to know or the audience might want to know.
• 8:46
  SPEAKER_01: And then the second, um, which I think is really always inspiring for me, is to see the data that's presented from really the CDC's network of collaborations with research centers across the country and seeing all of that data presented, which forms the basis for a large part of kind of vaccine effectiveness data or cost effectiveness data.
• 9:05
  SPEAKER_01: And so that also is what comes through in that ETR framework that's presented publicly.
• 9:11
  SPEAKER_01: And so while the work group sessions are private, I ultimately feel like what is presented publicly is really ultimate culmination and presentation of what we've spent weeks and weeks really discussing and refining.
• 9:24
  SPEAKER_00: Thank you.
• 9:25
  SPEAKER_00: Our next question: what special expertise did each of you individually have?
• 9:30
  SPEAKER_00: And what did you learn from the ACIP as you helped review vaccine data?
• 9:34
  SPEAKER_00: And we'll start with you, Dr.
• 9:35
  SPEAKER_00: Mahocha.
• 9:37
  SPEAKER_01: So I am, as mentioned, an adult and pediatric infectious disease physician, um, also a hospital epidemiologist.
• 9:43
  SPEAKER_01: So background really in in lots of uh vaccine counseling and giving vaccines, um, certainly as a as a pediatrician.
• 9:52
  SPEAKER_01: Um, and then as a hospital epidemiologist, I would say particularly with uh COVID expertise, really understanding the nuts and bolts of what it what it takes in implementation when you think about hospital operations or health system approaches for both healthcare workers and their patients when offering a vaccine and what are the conversations that need to happen in the background to make a recommendation that's really implementable in real life.
• 10:18
  SPEAKER_01: And that's a large part of I think what we discuss in these work groups is when we make a recommendation or when we think about a recommendation, how do we think it actually can be implemented?
• 10:30
  SPEAKER_01: Um so for me, both as a clinician and as a hot epidemiologist, it's been really telling and exciting and inspiring to see how that conversation um unfolds uh in these work groups.
• 10:43
  SPEAKER_01: I think one thing that I've really learned from this process is really the sheer amount of incredible detail of information that's presented and discussed in all of its facets, not just vaccine effectiveness, but also implementation and cost effectiveness, age range data, how many more questions you can really ask of the collaborators external and within the CDC and of pharmaceutical companies to get the data and information that we really want.
• 11:12
  SPEAKER_01: Dr.
• 11:13
  SPEAKER_00: Dries?
• 11:14
  SPEAKER_02: Yeah, I mean, I started as the liaison in June of 2020.
• 11:17
  SPEAKER_02: So if you all can remember back, like we were all very much in the midst of early COVID.
• 11:23
  SPEAKER_02: The COVID vaccine work group had actually already been meeting for a couple of months.
• 11:28
  SPEAKER_02: So they got going very, very early in the pandemic, knowing that at some point there was going to be a vaccine.
• 11:34
  SPEAKER_02: And I would say, you know, when I first joined, like I didn't feel like I had much specific expertise.
• 11:39
  SPEAKER_02: Like I'm not an immunologist, I'm not a vaccine researcher.
• 11:43
  SPEAKER_02: You know, there definitely are, you know, people on these work groups that that have that expertise.
• 11:48
  SPEAKER_02: And I was very, very humbled by them and their depth of knowledge.
• 11:53
  SPEAKER_02: But I think what what often what they're looking for us for, like like Predi said, was that on-the-ground implementation.
• 12:00
  SPEAKER_02: You know, I had, you know, I'd been a hospital epidemiologist for more than 10 years at that point and had helped run our flu vaccine campaign, you know, and I don't directly oversee uh occupational health at my institution, but had worked very closely with them and giving a lot of advice on how do you, you know, how just how do you implement a healthcare worker program and make sure that everyone's vaccinated and get them to accept vaccine and and all that stuff.
• 12:26
  SPEAKER_02: And they, they really, really appreciate, you know, all of the frontline providers that are on that are service liaisons, because I think that's something that they otherwise don't have access to.
• 12:37
  SPEAKER_02: So yeah, I think, you know, a lot of times I was just listening and and absorbing it in and didn't have a lot to contribute.
• 12:44
  SPEAKER_02: But then other times it was, I think that it was appreciated that uh, you know, we we were practicing practicing epidemiologists and and kind of knew how it worked on the ground.
• 12:55
  SPEAKER_00: Thank you.
• 12:56
  SPEAKER_00: Our next question uh during COVID, with the rapid development of the mRNA vaccines, the group was meeting quite often and reviewing data at a fast base.
• 13:05
  SPEAKER_00: Can you speak to a bit about this process?
• 13:07
  SPEAKER_00: And we'll start uh with you, Dr.
• 13:09
  SPEAKER_00: Drees.
• 13:10
  SPEAKER_02: I mean, like I said, it was, you know, I started in June of 2020, and immediately it was like drinking from a fire hose, right?
• 13:17
  SPEAKER_02: Because they, you know, even by July, I think, is maybe, and maybe it was July or August, they started to have preliminary data from the the early vaccine trials.
• 13:27
  SPEAKER_02: And so it was very fast-paced.
• 13:30
  SPEAKER_02: You know, we met at least at least weekly for an hour and a half.
• 13:34
  SPEAKER_02: Sometimes it was stretched to two hours.
• 13:36
  SPEAKER_02: And then at that point, they were doing public ACIP meetings like almost every month, um, often just focused on COVID vaccines because that you know, it just took so long to get through all the evidence to recommendation components when you had, you know, an entirely new uh type of vaccine.
• 13:55
  SPEAKER_02: So then, you know, leading up to a public meeting, they would sometimes add an additional weekly meeting.
• 14:00
  SPEAKER_02: So yeah, it was it was uh a lot of uh it was a lot of work, but it was, you know, again, really exciting.
• 14:08
  SPEAKER_02: And I think it it forced me to pay a lot more attention to kind of all the data around COVID vaccines.
• 14:14
  SPEAKER_02: And so it really helped me to become kind of the local and even kind of statewide resource for anything related to COVID vaccines because I just was forced to spend so much more time thinking about them than I would have been otherwise.
• 14:28
  SPEAKER_02: And then, you know, as you know, after the vaccines were launched, you know, a lot of it was looking at the early safety data.
• 14:35
  SPEAKER_02: You know, they they went live in December of 2020, right?
• 14:40
  SPEAKER_02: Um, and really by I think March or April is when the first safety signals came up with the J and J vaccine.
• 14:48
  SPEAKER_02: And so that was, you know, again, another like, okay, we have a signal.
• 14:52
  SPEAKER_02: Let what data can we obtain quickly to determine whether it's a real signal or not?
• 14:57
  SPEAKER_02: Um, and just watching that pro watching that process unfold was very inspiring.
• 15:04
  SPEAKER_02: Um, and it it really and it makes me sad that there's so much mistrust of this process in in the in general, because I feel like, you know, the ACIP has never been just a rubber stamp of vaccines.
• 15:18
  SPEAKER_02: Um and they they are often very critical of the pharmaceutical companies.
• 15:23
  SPEAKER_02: Often, you know, they're polite in in public, but certainly behind closed doors, they they really pushed.
• 15:28
  SPEAKER_02: Like, why don't you have better cost-effectiveness of the data or you know, whatever the whatever the case may be.
• 15:34
  SPEAKER_02: And there was, you know, really very intense work talking about J and J.
• 15:39
  SPEAKER_02: And, you know, it was a significant risk, but still the risk of COVID was also very, very high at that point.
• 15:45
  SPEAKER_02: So how do you balance that?
• 15:47
  SPEAKER_02: And, you know, the discussions that went back and forth, you know, it was, it was not, none of that was taken lightly.
• 15:53
  SPEAKER_02: Um, and then similarly with the myocarditis and mRNA vaccines, you know, it was, it was always taken extremely seriously to look at risk versus benefit.
• 16:03
  SPEAKER_02: And um and it was uh it was like I said, it was it was an overwhelming amount of stuff to look at, but it was, you know, the the CDC staff keep it really, really well organized and really on topic.
• 16:17
  SPEAKER_02: And so they just, you know, like I said, they just expanded the number of public ACIP meetings so that they could present as much data as they possibly could publicly.
• 16:25
  unknown: Dr.
• 16:25
  SPEAKER_00: Mahotra?
• 16:26
  SPEAKER_01: I think that you know, my experience really builds on you know all of the work that I think and time and energy that um that Marcy put in in on her meetings during her term.
• 16:38
  SPEAKER_01: And I mean, all of that process that that you described, Marcy, I think continues.
• 16:44
  SPEAKER_01: And it's so impressive for me to see that kind of real rigor, especially when evaluating safety and effectiveness and cost-effectiveness data.
• 16:53
  SPEAKER_01: We we probably don't meet at the same cadence.
• 16:56
  SPEAKER_01: I don't think we meet at the same cadence anymore, um, partially, which I I think I'm probably thankful for.
• 17:01
  SPEAKER_01: But uh that that kind of hardline stance of asking for more when we when we want more um data and asking uh more detailed questions or breaking down the data further.
• 17:14
  SPEAKER_01: I think, for example, over age range is another been a very common um theme recently.
• 17:20
  SPEAKER_01: But all of that continues.
• 17:21
  SPEAKER_01: And so it has been similarly very difficult to see the mistrust that's unfolded because I think all of that rigor um certainly continues, um, but uh as a especially as a consequence of all those rapid development and all those meetings that happen to review all of that work.
• 17:42
  SPEAKER_00: Thank you.
• 17:43
  SPEAKER_00: Next uh question uh what do you think about the importance of the role the ACIP plays and what hits you home for the most?
• 17:51
  SPEAKER_00: I'm gonna start off with that just to give a little background for our listeners.
• 17:55
  SPEAKER_00: So before the ACIP, they'll start looking at a vaccine, but before they make any recommendations, a vaccine in the US has to become FDA approved.
• 18:05
  SPEAKER_00: Once it's FDA approved, though, the ACIP is not bound by the uh FDA recommendations.
• 18:12
  SPEAKER_00: So for age, they can narrow it or they can enlarge it, for instance.
• 18:16
  SPEAKER_00: Uh the other difference from the FDA is the FDA only looks at the information uh that is submitted by the uh manufacturer.
• 18:25
  SPEAKER_00: The ACIP can look at any information it wants, and they always do cost benefit analyses.
• 18:30
  SPEAKER_00: The manufacturer will provide one, and the ACIP will uh have a private group uh not affiliated with the manufacturer do one as well.
• 18:38
  SPEAKER_00: And this may lead to changes, so the uh FDA could recommend a vaccine for 50 and above, but it may not be cost beneficial to 60 and above, and the ACIP may make a uh different uh uh recommendation.
• 18:52
  SPEAKER_00: So that's uh a key difference.
• 18:54
  SPEAKER_00: We already mentioned the working groups do get uh proprietary information, and that's important uh because if uh uh one wanted to set up, as you know, it's uh for instance PICPAC has been dissolved, Shay and other organizations could set up another group to to uh uh to develop uh uh recommendations for preventing infection uh infectious diseases uh uh and uh uh furthering infection prevention.
• 19:22
  SPEAKER_00: But uh the difference for the ACIP is they get proprietary information that would not likely be available to a private group.
• 19:29
  SPEAKER_00: In addition, under uh the law, uh any recommendations for the ACIP under the Affordable Care Act must be covered by insurance.
• 19:38
  SPEAKER_00: And for all the routine recommendations, they're covered under a vaccine compensations program, which is a no-fall program.
• 19:45
  SPEAKER_00: So if a patient has an injury, uh known injury for the vaccine, then they would receive financial compensation.
• 19:52
  SPEAKER_00: They don't have to sue the provider or the manufacturing group.
• 19:56
  SPEAKER_00: Again, if my private group comes up with recommendations, uh these would not automatically have to be covered by insurance and they wouldn't fall under the vaccine compensation program.
• 20:06
  SPEAKER_00: And because of the all the expertise the ACIP has and the large number of liaison organizations, we really one of the major benefits over the last several decades now is we have a comprehensive set of vaccine uh recommendations that are agreed on by all the professional organizations.
• 20:24
  SPEAKER_00: And unlike the use of antibiotics, you don't find competing recommendations from different authoritative groups and professional organizations that may or may not be uh true in the future, but uh it's really been a well-working uh, I think, uh, benefit to uh public health to have one set of evidence-based recommendations.
• 20:44
  SPEAKER_00: Dr.
• 20:44
  SPEAKER_00: Mahotra, your thoughts, and then I'll ask for Dr.
• 20:46
  SPEAKER_00: Drees.
• 20:49
  SPEAKER_01: You know, I think for all the reasons you just so um incredibly well articulated, the ACAP plays an incredibly important role in just providing what I find to be a comprehensive set of recommendations.
• 21:02
  SPEAKER_01: It's a one-stop shop where you know you can go to to find kind of independently funded um and uh you know trusted, well-regarded uh data that's been evaluated with an eye towards how to think about implementation so that ultimately this is in service to uh to patients um and and and to general population health.
• 21:28
  SPEAKER_01: And so when I think about the important role that ACAP plays, I think about just the tremendous uh bedrock of the institution that it is for for public health.
• 21:41
  SPEAKER_01: I think the work that the committee does really speaks volumes of what a testament vaccines are to uh to modern health.
• 21:49
  SPEAKER_01: Dr.
• 21:49
  SPEAKER_01: Drees?
• 21:50
  SPEAKER_02: You know, anyone who watched even part of the June ACIP meeting with the newly uh reconstituted members, like you could tell immediately.
• 22:00
  SPEAKER_02: That the tone was totally different.
• 22:02
  SPEAKER_02: You know, and I think it's unfortunate that, you know, it it was a, you know, there were the main criticism of the ACIP was that, you know, they had too many conflicts of interest.
• 22:14
  SPEAKER_02: They were, you know, too friendly, quote unquote, with the pharmaceutical company.
• 22:18
  SPEAKER_02: And we've kind of talked a little bit about companies, talked about that a little bit already.
• 22:22
  SPEAKER_02: But they certainly, you know, I would just say like the level of review of conflicts of interest is extensive, and more than there is for Congress, more than there is for the secretaries of the various, you know, agencies.
• 22:39
  SPEAKER_02: I mean, there are a lot of conflicted people on the committee now that has not been disclosed.
• 22:45
  SPEAKER_02: So, you know, I think it was a process that wasn't broken.
• 22:49
  SPEAKER_02: You know, it wasn't perfect, but it wasn't broken, but it was, it's been kind of, you know, demolished and supposedly being rebuilt.
• 22:56
  SPEAKER_02: So, you know, I think, you know, it's its functions are so important as you already outlined.
• 23:02
  SPEAKER_02: I think, you know, unfortunately, it's it's hasn't clarified anything.
• 23:06
  SPEAKER_02: Um, it's just generated more confusion.
• 23:09
  SPEAKER_02: Um, and I think, you know, and and it is like there's science, but then there's also like like has already been said, the implementation part.
• 23:18
  SPEAKER_02: And I feel like, you know, yes, sometimes our uh the ACIP's recommendations were broader than maybe all of the data supported.
• 23:27
  SPEAKER_02: But a lot of that was a very thoughtful decision based on, you know, if you make a vaccine recommendation too complicated, it then really decreases uptake and access to vaccines.
• 23:39
  SPEAKER_02: So there is always a balance between, you know, following, you know, the best available evidence, but also like taking those implementation challenges into account.
• 23:49
  SPEAKER_02: So I think that's part of what's being missed now.
• 23:53
  SPEAKER_02: Um and then, of course, you know, the decisions being made by the HHS secretary and FDA really stepping out of their lane to make vaccine recommendations, which is is not really has never been their role.
• 24:09
  SPEAKER_02: Um obviously the HHS secretary ultimately approves or not the decisions that come out of ACIP, but um kind of going around them completely and supposedly surprising everybody by these announcements, I don't think really increased transparency or helped the vaccine um process, you know, at all.
• 24:31
  SPEAKER_00: Yeah, I'll just make one comment about the conflict of interest uh forms, which were profuse and difficult uh and complex to fill out with lots of information.
• 24:41
  SPEAKER_00: You all, you both did it, as did I.
• 24:43
  SPEAKER_00: I found doing my taxes was easier than doing the conflict of interest forms for uh the federal agencies.
• 24:50
  SPEAKER_00: Our last question is uh what do you think uh the future holds for the ACIP and uh vaccine recommendations in general, and uh some thoughts about what options we have uh going forward if uh the we believe as a society, that is Shay, and as individuals, uh, that the ACIP is not serving the public health.
• 25:11
  SPEAKER_00: I'll start with you, Marcy.
• 25:13
  SPEAKER_02: Yeah, I mean, I think you know that there was a call to delay the June ACIP meeting because it wasn't fully formed.
• 25:21
  SPEAKER_02: There were only seven members.
• 25:22
  SPEAKER_02: Normally there's 17 voting members.
• 25:25
  SPEAKER_02: And so you really had a very small number of people with, like I said, a lot of conflicts, a lot of kind of pre-existing anti-vaccine sentiment making these decisions that impact the entire country.
• 25:38
  SPEAKER_02: I mean, I haven't heard since then if, you know, as as far as I know, they haven't announced who the rest of the members will be.
• 25:45
  SPEAKER_02: Um, I would hope that there'll be a little bit more balance.
• 25:49
  SPEAKER_02: But uh, you know, I mean, so I think a lot of it will depend on kind of what happens with once the full committee is is announced.
• 25:58
  SPEAKER_02: Um, you know, certainly the AMA and and others have talked about creating, you know, a different, you know, an a similar like committee that would review data.
• 26:08
  SPEAKER_02: But like you said before, like they would not necessarily have access to the propriety, proprietary data that comes from the clinical trials.
• 26:18
  SPEAKER_02: Um, or you know, all the CDC-based work that um, you know, again, dozens and dozens of studies, you know, are being done all the time or were being done that help inform those decisions.
• 26:31
  SPEAKER_02: So I think it it's very, very difficult to replicate.
• 26:34
  SPEAKER_02: You know, the the good news I think is that the um professional society for insurers has said that they will follow, you know, they're not they're they are pro-vaccine and they're gonna continue to recommend you know, pay for vaccines.
• 26:47
  SPEAKER_02: Um, so that's good news.
• 26:49
  SPEAKER_02: But I think, you know, government uh entities are really held to the ACIP recommendations.
• 26:55
  SPEAKER_02: And of course, the vaccine for children program is voted on specifically by AC ACIP.
• 27:01
  SPEAKER_02: So I think if they start to restrict those programs, um, I I you know I'm certainly worried that they'll they'll certainly will be less access to vaccines, even for those who want them.
• 27:11
  unknown: Dr.
• 27:11
  SPEAKER_00: Mahotra will give you the final word.
• 27:14
  SPEAKER_01: You know, I'm hoping um that the future at least holds that it's a it's a continued body where there will be an independent exchange of dialogue and that there's still a presentation of evidence-based um data.
• 27:29
  SPEAKER_01: I think, you know, frankly, in the weeks leading up to the June ACIP meeting, there was really a lack of clarity of whether liaisons and professional societies were still going to be able to be present at that meeting.
• 27:43
  SPEAKER_01: Um, and so I'm I'm hoping that you know our continued presence there will allow for an exchange of information to ensure that there's still evidence being presented that we think is appropriate, that we still have access to the same amount of um proprietary information that we previously had in these work group meetings.
• 28:05
  SPEAKER_01: You know, I I don't know if there are plans to have other voting members be installed onto the committee.
• 28:13
  SPEAKER_01: There there should be 17 was the number in the past, and I think there at least need to be two voting members on the work groups for the work groups to continue to meet.
• 28:24
  SPEAKER_01: The tone of the June meeting was incredibly different.
• 28:28
  SPEAKER_01: Um, and I'll say that not all professional societies were represented and chose to be present at that meeting.
• 28:35
  SPEAKER_01: And so the lack of I think um uh presence of all the professional societies together um has already changed the kind of nature of of ACIP coming together both publicly and within the work groups.
• 28:53
  SPEAKER_01: Um, but my hope is that at least in representing Shay, I can continue to ensure that there's still an independent and thoughtful review of data and hope to continue to keep Shay apprised of that.
• 29:08
  SPEAKER_02: Yeah, and I would just add, I think I was still very impressed with the quality of the data that the CDC presented.
• 29:14
  SPEAKER_02: Like, you know, I felt bad because they were being asked kind of very basic questions, you know, that by people who really didn't understand kind of vaccine efficacy or effectiveness study design and stuff like that.
• 29:26
  SPEAKER_02: But I think they were very professional, very well prepared.
• 29:29
  SPEAKER_02: You know, I feel like the data that was being presented was still excellent.
• 29:33
  SPEAKER_02: Um, so I I agree.
• 29:35
  SPEAKER_02: I hope that, you know, isn't impacted in the future.
• 29:38
  SPEAKER_00: Well, I thank you uh both uh two uh uh for these excellent discussions.
• 29:43
  SPEAKER_00: I want to thank our uh panelists, uh Dr.
• 29:46
  SPEAKER_00: Priti Mahutra and Dr.
• 29:48
  SPEAKER_00: Marcy Dries, and our coordinator, uh Ms.
• 29:51
  SPEAKER_00: Russo, for this.
• 29:52
  SPEAKER_00: I hope uh our listeners and our Shay members have found this a useful uh podcast, and uh Shay will continue to uh support uh vaccines and uh in the future have additional podcasts on this subject.
• 30:06
  SPEAKER_00: Thank you all and have a good day.
• 30:08
  SPEAKER_00: Thank you, Dr.
• 30:08
  SPEAKER_00: Weber.
• 30:09
  SPEAKER_00: Appreciate it.
• 30:10
  SPEAKER_01: Thank you.