Behind the Curtain of the New CDC Panel on Vaccines: Dr. Robert Malone & Retsef Levi (Epoch Times)
YouTube video by Dr. Robert Malone (https://www.youtube.com/watch?v=KZQOuvW1Euw). Transcript is the auto-caption track — verbatim ASR, not a certified transcript.

They basically impact on billions of dollars of revenue for the pharmaceutical industry. So there's big money at stake here. There's big policy at stake. Recently, the CDC's Advisory Committee on Immunization Practices, ASIP, met for the first time after HHS Secretary Robert F. Kennedy Jr. replaced its entire membership with new picks. In this episode, I'm sitting down with two new ASIP members, Dr. Robert Malone and MIT professor Rhettz Levy for a deep dive into all things ASIP. One of the problems that we had in the context of vaccines is that debate was considered as confusing to patients as something that we should avoid. We take a look at some key discussions during the recent meeting from mercury and the flu vaccine to RSV shots for children and what may happen with this committee moving forward. This is American Thought Dr. Robert Malone, Professor Ratzf Levy. Such a pleasure to have you on American Thought Leaders. Thank you, Yan. It's a pleasure to be here. Thanks, Yan. It's a pleasure to be here again and uh I'm I'm so pleased with how American Thought Leaders has been growing and to be part of this yet again. Well, it's wonderful. Of course, you have both been on the show before. this is the first time that you're together and huge congratulations on completing the first meeting of this new ASIP panel uh that's been put together two of eight um why don't we actually start with this this is a committee that actually has quite a bit of influence in decisionm but most people have haven't actually heard of it until very recently so bottom line what is ASIP in the end so ASIP is an acronym it stands for the advisory committee on immunization practices there. This is a federal advisory committee. It's uh the product of the federal advisory committee act. And so uh the acronym for that is it's a FAA committee. Another FACA committee that matters in this space is the Verbback. That's another acronym and that's the one that advises the FDA, the vaccines and related biologics advisory committee. So there's these two key federal advisory committees. Both of them are uh uh voluntary by the way. So we're not getting paid big money to advise the CDC and the director of the CDC specifically through the advisory committee on immunization practices. We're basically volunteering and getting a very minimal stipend of $250 a day. So, we're not in this for the money. And uh what is this thing? The advisory committee on immunization practices. It's set up historically and it goes back decades to provide advice to the director of the CDC and by extension the director or the secretary of health and human services currently uh Robert F. Kennedy Jr. So the way that ACIP is supposed to work as just another federal advisory committee is that it through its subcommittees investigates issues relating to basically infectious disease countermeasures. So it's not just vaccines, it's antibodies and technically it could also cover early treatment for example uh for an infectious disease although that's rarely if ever considered. So, what it's supposed to do is conveneing these subcommittees. And by the way, the rules are that the subcommittees have to be chaired by one of the formally appointed ACIP members. But the subcommittees can include people from all kinds of places, including comments from industry. So, that's where the real work gets done. They analyze issues particularly relating to newlylicicensed products from the FDA. The charter is that the ASIP is supposed to take up the issue of whether or not the CDC will recommend the use of recently authorized FDA interventions for infectious disease, particularly biologics and vaccines. So the the flow of work is that the verbback advises the FDA. The FDA makes decisions on whether or not to authorize marketing of a new product. And then at the next following meeting, the AIF is supposed to take that up and make it a advice to the director of the CDC about whether or not the CDC would recommend and under what conditions it would recommend the use of that product. Now, the wrinkle in this comes in in that the uh Congress has authorized a program called the vaccines for children program. The acronym for that one is VFC. And the VFC has uh basically appropriations authority granted to the ACIP. So if ACIP votes and the CDC director agrees that a product should be made available through the vaccines for children program which is basically a subsidy to ensure availability of the products to underserved populations. Uh so if the ASIP votes and the CDC director approves then those products are automatically purchased by the CDC and the federal government and distributed to uh the tribal nations to underserved communities all across the United States. That gives the ASIP unusual responsibility and authority relative to other FA committees. But what's happened over time is that the various professional societies uh the medical professional societies have aligned themselves with the ACIP. They actually serve as uh an an unofficial advisory component and uh they typically align their recommendations to the CDCACIP recommendations. The consequence of that is that functionally over time the ACIP has developed into the body that establishes standard of care for medical practice as it relates to vaccines uh antibbody preparations and other biologics in particular for the whole of the United States. Now the wrinkle in this is that the federal government doesn't actually have the authority to regulate the practice of medicine in the constitution. And so what you end up with is this kind of strange soft power whereas wherein ACIP and the CDC functionally establish standard of care that triggers the uh insurance industry to decide whether or not these products are going to be covered. basically they follow the ACIP recommendations and once a product is established as standard of care and and the use of it in the way that the ACIP with its partner professional societies agree upon then that becomes basically legally the situation in which physicians can't go functionally go against that or if they do they they put themselves at risk. for uh liability basically for medical malpractice lawsuits. And oh, by the way, the recommendations that the ACIP make and by extension the director of the CDC, who's the one that actually makes the recommendations, we just advise the director, but they uh basically impact on billions of dollars of revenue for the pharmaceutical industry. So there's big money at stake here. There's big policy at stake. And as many people have come to recognize, particularly during the COVID crisis, uh all of this feeds into kind of a strange functional mandate that flows from the federal government all the way down to local school boards. And that is at the heart of a lot of the controversy that is uh happening right now with uh the changes that have happened in the composition of the ACIP. Well, and I'm absolutely going to dive into uh some of that controversy. I I'd love to talk about that. But before we go there, uh, Rutzf, you know, you were very very important for me in terms of my understanding of all sorts of, uh, policy around the pandemic. you through speaking with you quite a bit I understood that I should look at everything from the concept of risk benefit analysis whether that's um pol specific policies whether that's uh products that are being used as interventions because of disease and and frankly I've actually expanded it quite a bit uh further than that now but tell me why why do you think that you were invited to join ASIP of all things and how does your particular acumen fit into uh working on this committee. So thank you uh Yan. So just to build on what Robert said, I think that in my mind the ASIP role is to translate a generic approval by the FDA to a set of more detailed recommendation that uh recommendations that take into consideration risk benefits uh aspects that could uh be different to different subgroups of patients and recommend both public policy uh as well as uh standard standard of care. It's very it's a great honor and very humbling to be part of the AC. But I I cannot speak to why people selected me. That's something you have to ask those who selected me. But I can speak about my background and I've been uh in academia from uh 2006 and I have a PhD in operations research from Cornell University. And this is a discipline that is focused on trying to use data and models to inform complex decisions that involve risk benefit trade-offs. Um, and that's kind of the purpose of this discipline. So it's using a lot of uh statistics, a lot of uh artificial intelligence, a lot of machine learning, a lot of data and and and a range of methodologies to uh essentially develop decision support tools for uh in different contexts um to inform um complex decisions that involve uh nuanced trade-offs of risk and benefits. Specifically, I've been working for thousands of hours with the clinicians on the ground in healthcare systems on thinking about uh various issues related to design of care, design of operational processes, design of healthare systems and how to uh optimize those to provide the best care for patients. Uh I I also uh did research on epidemiological models on manufacturing of biologic drugs and how you can use data to uh improve their safety and and quality. Um I did work on post marketing uh safety surveillance. Um but also on other uh areas related to human health like food, water, agriculture, access to healthy food, food safety. Beyond my academic experience, I fair to say that I've been thinking on risk from age of 18 uh when I became part of the Israeli defense forces and spend almost 12 years as an intelligence officer. I have a strong belief that uh there is no one discipline that can capture the complexity of this decision. So this is why it's very important that a a a committee like ASIP uh will have people from different backgrounds, from different perspectives, from different experiences. And I I I I'm a strong believer that the collective wisdom of a team is far stronger than the wisdom of an individual. And I I also hope and I and I also believe that that's the plan that uh this team will also expand and have even more people and more members because I think that we really want to ensure a diverse set of opinions and backgrounds. You know, looking at I I didn't watch the entirety of the many hours of the ASIP meetings that happened just recently. Um but what I did see was some you know constructive discussion. Of course, there was also um you know, people making quite different decisions and some of those things I'd like to actually dive into a bit a little bit later in the episode. Um at this point, I'd just like to give Robert an opportunity to talk a little bit about his particular background and how that fits into into being part of ASIP and perhaps why you were picked. Well, thanks Yan and first I want to uh address the issue of the modest Dr. Levy. Uh what he didn't mention is that he's bloody brilliant. Uh he is a full professor at Massachusetts Institute of Technology in data science and data evaluation. That's no small achievement. And uh furthermore, he was quite brave and bold throughout the corona crisis in speaking his truth. He's revealed himself to be a independent thinker and uh not swayed by uh approved narratives or conventional thought. I think that the nation is uh really blessed by having uh such a mind with these capabilities serving in this way. I I don't know that there has been uh this level of capability in data analysis before and it's complemented by the other members but in particular Dr. Martin Coldorf, former professor of epidemiology at Harvard and uh arguably one of the top epidemiologists in the world uh let go from Harvard because he refused to accept the COVID vaccine product uh which is a major travesty. So the the narrative that's been promoted uh by corporate media that this is a committee composed of antiaxers that are completely unqualified is clearly a gross misrepresentation. In my own case, of course, uh there's been a focus on this history of what I did when I was 28, uh and uh the origins of the mRNA vaccine technology, the patents that are behind me, etc., etc. But that was only early on in my career. Uh I've been working in infectious disease viology and immunology literally since I was an undergraduate working in the laboratory at UC Davis that uh did a lot of the pioneering work having to do with what we now call HIV and the related virus sime deficiency virus. I have worked there are few people that I know of that have worked deeply in government positions, non-governmental organization positions such as the Aerys Global TV vaccine foundation funded by the Bill and Meinda Gates Foundation in industry for salvines in the contract support industry both in a vaccine focused clinical research organization and in a uh regulatory submissions shop located close to the FDA. Uh I've I've kind of done it all in terms of uh working closely with the government on the HHS side and on the DoD side in relation to infectious disease, biodense pathogens, biofense counter measures, influenza. I was the clinical director responsible for over $300 million in Barta contract funding for the building of a cell-based influenza vaccine under salv. I've been doing this for 30 years and for some reason the media only focuses on what happened in the last couple but I'm very fil with modern immunology, modern vaccinology, modern vaccine technology and of course I also uh am very familiar with uh the current secretary of HHS. I consider him a friend and a colleague. Uh I will never forget the day that he called me uh in my home and asked me some questions and then asked me to assist in editing the book the real Anthony Fouchy and it's been my privilege to uh build a working relationship with him since then. I'm I'm grateful for the selection. I didn't anticipate it. I absolutely did not want to join the administration in a uh functional role of uh um being having significant responsibility for a sub agency. Uh but I'm very grateful for the opportunity to serve my country uh in this volunteer role uh at the ACIP. So Yanni if I may just inject another thought we you know disciplines are important and um but I think that equally important is the culture of the team dynamics and more broadly I think that one of the problems that uh we had in the context of vaccines and more broadly maybe uh pharmaceutical products is that debate was considered as confusing to patients as something that we should avoid. uh which in many ways goes counter to science and and goes counter to I think the complex nuances that that that exist when you would you you consider risk benefits considerations uh with respect to a patient and how a patient has to think about the trade-off of whether to take a a pharmaceutical intervention or not. Um and and I think beyond the expertise, my hope is and I think that hopefully we already illustrated that as a team in the last meeting that we should not only shy not shy from debate. We actually should uh I think that actually the debate is very important and and the discussion is equally important uh uh beyond the decision that was made. uh and and I think that if anything I hope that this committee will will change will will change that not only in the context the narrow context of the ASIP discussions but maybe more broadly and how we think as as a society as as as scientists as public policy public health policy uh uh people how how do we think about the process and the principles of the process that should guide us in making decisions this interview is basically another demonstration of our personal commitment. And remember that uh Rhettz and I are speaking in our personal capacity right now. I just want to note that we are not representing the US government and we're not representing the ACIP. We're representing only ourselves. But uh what you're seeing here is a firm commitment on the part of these two volunteers. and I think the committee as a whole in trying to be open and transparent to the general public so that they can better understand why these decisions are being made, what the debates are behind them and uh hopefully that will help build confidence back that has been lost by this kind of insular uh we one might almost say authoritarian approach that has been characteristic IC of uh the federal public health enterprise during COVID crisis. Well, and I I I think one of the things that this committee, at least so far from what I'm hearing uh is accomplishing is turning, you know, committee meetings into a kind of a spectator sport. I think one of the themes rats that you mentioned here right um by I I think you were suggesting it is that having the patients or having people playing a much more active role in their own healthcare and also be given the correct information to be able to make these decisions themselves because there seems to have been this kind of strange culture that has developed that almost where where that information isn't presented very effectively presumably you know kind of to protect the patient in a way from from from having to deal with two difficult decisions. Yeah. So to me the core interaction of healthcare should always be kept to be the in intimate interaction of a patient with their consulting uh physician and or clinical uh professionals and medical professionals. And my view is that's kind of my personal view that being a member on the ACP committee the the main role that I will try to help with is to uh be able to communicate to patients and medical professionals what is the best knowledge that we have what we know and what we don't know. The second principle I would like to highlight is personalization. uh the one thing that I think is is a staggering contrast we in in most areas of healthcare and and head management we are emphasizing personalization in in fact we are talking now about therapeutics that going to be tailored to the individual DNA of a person right however when it comes to vaccines we more often than not tend to think about it as what one size fit them all uh both on on a a single vaccine as as well as even worse all vaccines, right? And so so to me the the the inter the the interplay between this person is personalized considerations and the intimate uh interaction between the patient and the medical professional to allow them to be able to make the best personalized decisions for them considering the risk benefits that they have to face is the single most important thing that we need to enable as a committee. A lot of the decision makingaking at CDC and in American public health has fallen to those with the degree of a master's in public health. Please understand that the MH degree is a two-year degree that is granted to individuals who have any undergraduate major. They don't have to be biology majors. They certainly don't have to be medical doctors or uh medical practitioners or have any experience in that. And the essence of the MH degree has to do with statistical analysis based on the thesis of promoting it's a utilitarian argument promoting the greatest good for the greatest number. That is at the core of the framework not only of the MH but of modern public health in the United States. And this utilitarian greatest good for the greatest number approach is fundamentally socialist in my opinion. And uh I believe that we need to swing back the practice of medicine to what was a prior generation in which the focus was on the patient and the physician patient relationship. We are moving into a new era of personalized medicine increasingly driven by artificial intelligence and it's an open question. What is the role of the physician and the medical care provider in that environment? And do we really want to be have our medical care determined by algorithmic artificial intelligence, utilitarian decisionmaking implemented through insurance agencies and very large health maintenance organizations? Or do we want to have a situation in which individuals have the sovereignty over their own bodies and those over their children to make informed decisions? The challenge there is they're not medical professionals. How do you communicate complex medical decisions to a lay person? But it's achievable. It can be done. And it takes a little more effort and it is very threatening to many uh medical care providers, professionals and public health officials including CDC staff to have their opinions questioned. Now Rzziff and I uh have I've lived for most of my career in the academic world being subjected to peer review. Rzziff, bless his heart, still does. uh and uh it is uh a it can be a challenging environment but it is very healthy to have outside independent oversight to ensure that we're not missing something. We're not generating an artifact to the best of our ability. And this kind of large data analysis is super duper susceptible to uh strange uh quirks in data oversight uh um overlooking uh confounding variables. The only way that I know of to effectively immunize yourself from that is to subject your work to peer review. And the CDC historically, I'm sorry to say, and those that are doing the analyses for the ACIP have not had their work subjected to peer review. The MMWR, the monthly uh report putting out put out from the CDC, their publication is not a peer-reviewed journal. Uh the morbidity and mortality weekly report uh it's not peer-reviewed. It represents the opinions of uh a group of people often um strongly biased by CDC personnel. Why shouldn't uh that the work product of the federal government's epidemiologists and data analysis also be subjected to rigorous outside scrutiny. I think it will improve public health. I think it will improve public trust. I think it'll make for better science and better medicine. One of the exciting aspects of becoming a member of ASIP is the opportunity to work with the CDC staff and and other academics to really pursue together the truth uh based on the data and I think uh the CDC my impression from the first meeting the CDC has very passionate staff members very hardworking uh so I I personally look forward to building those uh professional relationship ship and really engage with them and others uh to really pursue the truth. And and one of the things that I really liked about Martin Cordruff opening uh statement, he he really mentioned um the analogy of airline safety, especially when you are considering giving medical intervention to healthy individuals and let alone healthy children and babies. I think that your approach to both safety and efficacy should be guided with with the caution that you would uh have when you think about sending an an airplane to a flight carrying hundreds of patients, hundreds of passengers, right? So one one the analogy is like when you approve when you recommend something to be used broadly you are launching a flight with potentially billions of children or millions of children. Right? I I I think that adopting the safety paradigm or the safety approach of airline is going to be very very important uh going forward. And uh I I thought that it was very inspiring to hear Martin uh speaking about this at the opening uh at the opening of the of the meetings. Let's talk about one of the decisions that was made. Uh you uh the vaccines related to influenza were mentioned. Actually a very prominent decision, one that's been given uh a lot of play in the media is this removal of theol uh from these multivile influenza vaccine decisions. But let let me ask a few questions right off the bat. Even when it comes to the basic data, I mean, I've heard one that influenza vaccines just aren't effective at all or have negative efficacy. Some I I've seen some papers that suggest that or some years that they've been applied, they have that. I've seen people say, "Hey, theosol has been removed mostly from from these vaccines in the first place. Why is this such a big deal?" Um, and and of course, theosol is is mercury. And so and for some people it's even shocking to discover that there was mercury in the first place. So if why don't we just start off can you kind of unpack uh uh influenza uh vaccines for us which by the way ASIP approved in the use of in general or recommended the approval of. So so a lot of different pieces here. We were presented with language without really an opportunity to debate that language endorsing uh universal influenza vaccination for the following year as well as the nuance of which uh specific influenza virus sequences would be included in the recommended upcoming vaccine uh year for the vaccine. And to to provide a little bit of context for that, historically those decisions have been made at the level of the World Health Organization and then propagated down. They tend to be uh one recommendation for the northern hemisphere and one recommendation for the southern hemisphere because the flu strains uh circulate in contrary seasons having to do with the fact that when it's winter here, it's summer there. So, uh, this is the first time to the best of my knowledge since the United States government has withdrawn under the direction of President Trump from the World Health Organization that the CDC has had to act unilaterally in its recommendations for what Strange to be included in the following year's influenza vaccines. And by the way, those influenza vaccine campaigns will kick off uh August uh um depending on the vaccine platform and continue through the winter. So we were basically presented with a fat comp plea in terms of the uh language recommended to us having to do with influenza vaccination as the first resolution and then a series of uh second, third, and fourth resolutions having to do with this uh really nuanced quirk of removing thyarisol from influenza. the vaccine multid-dosese files. Now, Yan, you have raised uh a key issue and you've used uh that uh forbidden uh term negative efficacy. Uh this is uh just just for context, I personally lost two jobs uh in the past uh working in the influenza industry, influenza vaccine industry, even raising the issue of negative effectiveness of immune imprinting and of original enogenic sin. The last two being really all three of those being very technical terms that have to do with the issue of whether or not taking this type of product year after year after year is makes good sense ideologically or whether uh doing this year after year after year is somehow imprinting one's immune system in ways that are just to simplify it counterproductive or mounting a effective immune response against a new strain your body may not have encountered in the past. Basically, it's as if we're training the army. You know, you can build a strategy based on the last war. And functionally, that's what happens with influenza vaccines is it's teaching your immune system to fight the last war largely. And it it there's there are data and it's been a hot subject of debate in the vaccine community now for decades whether or not uh one this strategy of annual boosting or in the case of the co product much more frequent than annual is actually counterproductive that it's driving the immune system towards uh categories of responses that are counterproductive. We'll just leave it at that and recommend that people go Google uh immune imprinting and original anogenic sin if they want to get more information. But this is a topic that uh has been anathema in uh the influenza community including at the ACIP and the CDC. The subcommittees are where the business gets done at ACIP. Subcommittees are where the hard discussions have to happen. The public committee is uh basically a forum for presenting the data that has come out of the subcommittees and then debating that data among ourselves including people that weren't part of those subcommittees and making decisions about whether or not to endorse those recommendations for consideration by the director of the CDC. Now, Rhettz uh is going to chair the uh COVID subcommittee. So, this is super important because it means he's going to be in charge of setting the agenda for what gets discussed about CO and the various CO products and how they've been evaluated going forward. He hasn't had that opportunity in the past, but now he does have that. and I find myself having been positioned as chair of the influenza vaccine committee. So I mentioned in the meeting that it's my intention that these issues of immune imprinting, original anogenic sin etc will be discussed and strongly considered in upcoming meetings. Uh but uh in terms of the decision that we were faced uh we were presented with essentially language that was already approved and and had to make a decision about whether or not to endorse both those specific virus strains that had been vetted thoroughly and to endorse a universal influenza vaccine recommendation as has been the case for decades and the decision was that this was not the time to fight on that hill about the universal influenza vaccine recommendation. Now the other recommendations that were passed also uh had to do with as you point out this nuance of multi-dosese vials containing mercury uh of of the standard influenza vaccine mercury in the form of a preservative called and just to calibrate this because this is something the press has latched on to and has making a big deal about What we're talking about is 97% of all influenza vaccines currently administered in the United States are administered either using single dose vials. That means that it comes in a little vial and it's got the rubber nib at the top and the physician puts the syringe and the needle into that, draws out that one dose, hopefully changes the needle, otherwise the needle's a little dull and it hurts more, and then administers it to the child or the adult. Uh what that does is it minimizes the chance of introducing contamination by going through that rubber stopper that nib again and again and again which is what you do with a multid-dosese file. So multid-dosese files are a little bit cheaper, but they are considerably more risky in terms of introducing contaminants into the jar that then get drawn out and injected into another patient. That could be a virus like hepatitis B. It could be a bacterial contamination uh etc etc. It could be a fungal contamination. So that's why in a multid-dosese vial you have to put in some sort of preservative and there are other approved preservatives other than thyarisol. So um in the interest of doing our best at this stage to take another move forward in eliminating the added dose of mercury to patients that receive an influenza vaccine. remember that they're going to get a vaccine every year and the people that get it from a multid-dosese vial today are likely to be the same ones that get from a multi-dosese vial next year. So there's a cumulative the mercury doesn't get excreted very well. It's cumul cumulative effect and so the committee I think wisely voted to just say no to thyol containing multid-dosese files. Now, for some reason, the pharmaceutical industry and corporate media see this as some sort of existential threat that eliminating 3% of the influenza doses that contain thyarisol is a uh crisis for the entire vaccine industry and their academic and media supporters. I don't get it. Uh but that seems to be the meme. And the strange thing is that it's left uh media and pharma arguing in favor of injecting mercury into Americans. It just is horrible optics. It's not the right decision. And I think I applaud the committee for having the timmerity to uh just say no at this point in time. And by the way, unfortunately, influenza vaccines are not the only products that contain thyarisol. There are other vaccine products that are still on the schedule that contain thyarisol. I suspect the industry sees the writing on the wall since the committee said no, just said no to thyol containing flu vaccines. One might speculate that in the future there might be a tendency to say no to other thyarisol containing vaccines, but that's forwardlooking and we don't know that to be the case yet. So maybe that explains their existential crisis over this what I call a tempest in teapot. Rzzf, I want to get you to comment here uh as well, but just before just can you just explain what why it's a problem to be injecting even tiny tiny amounts of mercury into people? Yeah. So f first I I just want to acknowledge that Robert and I are expressing our own opinions about that. There were there was actually a different opinion in the committee and I think if I want to kind of represent that I think that some people were concerned more about other areas outside the US more uh maybe um developing uh countries where the current state is not that 97% of the vaccines are are being administered are um free of mercury. So this is nuance. I I think I think that this is actually a great question because it really kind of is a point where I think um we need when we consider risks we need to really go beyond a single vaccine or a single episode of administer administering a vaccine because if you just think about one time vaccine um you could argue that the amount of mercury in a single dose of a single vaccine is probably small. Um, and you could argue potentially that it poses not sign no significant risks. The problem is that you don't take one shot. You take actually a shot every year and moreover you are actually being exposed to mercury from other sources in your life uh from food, from fish, from other sources. So when you want to consider risk here, you need to adopt a system level kind of uh thinking and really think about not only the isolated episode but rather than what is the what is the uh overall uh contribution to the overall risk to the overall exposure and if you do that I think it's going to be sensible that uh given the fact that mercury is a highly toxic uh compound nobody debates that uh and it accumulates in the body. I think it's going to be uh sensible at least in my mind to say that if we can control and eliminate some controllable uh sources of mercury, we should do that. speaking more broadly and because you also asked about the efficacy of uh of flu vaccines. I think uh it's it's again um an area where I think the current evidence that we have uh is rather low quality. Um and again we are thinking about this question only a year by year like every year we we're trying to assess the efficacy of the vaccine in that year which is important but I don't think it's sufficient and the issues that Robert alluded to of what is the long-term impact of using multiple doses every year is super important because at the end of the day we are not managing one year we're managing an a horizon of years and we really want to think about um essentially the immune profile of the population and uh to some extent that immune profile is the shield for the most vulnerable people in our population. Right? To some extent the more uh resilience the imu immune profile of the population is the less chance there there is for for the virus to hit the the most vulnerable people. And it might be tempting to think that vaccinating everybody with the same vaccine every year is the best strategy. But I think there is actually quite a lot of evidence that suggests that that might not be the case. And I'm I'm not sure that we have been thinking uh deeply deeply enough about this to know or to figure out what the right answer is. Now the other thing that I would like to say I think that in order to answer this question like many other safety and efficacy questions we cannot just look on observational h data from the field. We also need to look on research that is being is conducted to understand the biological mechanisms that take place once we vaccinate people. I I know that there are great concerns about potential radical changes that this committee would uh recommend to or would would would cause and on the other hand there is maybe an impatience uh by others that radical changes has to happen have to happen immediately. uh I'm my my philosophy in life and and actually I teach that um when I teach in in courses that I teach I usually tell people that if you want to change something the first thing that you need to do is to fully and very deeply understand why it's set up the way it is. So you have to take the time to understand before you make changes. We are going to be very very thoughtful and thorough in first understanding what wh why people make decisions the way they are now uh before we are going to recommend changes if and and what changes are we going to recommend I I I think it's a very important aspect that may not make us popular but I I I I think we are all determined to be thorough and and take the time to to study and and not to make rush decisions. Can I pick at one of the threads that uh Reds have just introduced? Uh we could call it iminotoxicity or iminotoxicology or uh fundamentals of immune responses One of the So part of what happened during this recent ASIP meeting was we had an opportunity to gently query and we were very diplomatic about it across the board. Even the Atlantic Monthly in their attacks on me acknowledged that I was very polite uh in my questions to the CDC staff. But uh we were able to directly query in a way that really has not been done in the past the uh staff of the senior staff of the CDC that were presenting these data. And one of the questions I happen to have put forth but RTS could have or anybody uh was whether or not the CDC has metrics and processes in place to track whether or not there are toxicities uh of the immune response or system. In other words, are they looking at the big picture of how people's immune system is functioning and whether it's being altered in a larger broader way by these interventions. And what we learned was no, they do not have that. That has not been part of their thinking. That is not part of their assessment or their analyses. So these issues that are being raised in the context of COVID, whether they're true or false having to do with imogloabbulin class switching, which sounds like a big mouthful of iminoabel, but it's pretty important in terms of how healthy you are and how you're able to resist new pathogens and whether or not you're more likely to develop allergic responses. for example, uh those kinds of questions and of course there is the I'm going to introduce a controversial topic that we didn't talk during the ACIP but there are some that suggest that the COVID products are causing various types of damage to the immune response that's leading to a susceptibility to one of the most common imunologically controlled diseases that we're all familiar with which is cancer. And so the question came up and I asked it very gently whether the ACIP is tracking these issues, whether they have the data to support or refute these hypotheses. And the answer is no, they don't. So I hope that we as the ACIP going forward, you know, frankly, my impression is that a lot of the thinking at the CDC in terms of these monitoring and analyses uh routines that they get into are a bit antiquated. They're kind of old school to use common slang. And uh I think personally that the CDC will be well served and so will the public to start uh incorporating in their analyses newer frontline concepts about immune response. Now, this leads to another core topic that I think we encountered in our patient questioning and our discussions with the staff is that uh I personally think we've got a little bit of it's not my job, it's their job as it relates to issues concerning the CDC, public health, FDA, and the NIH. important topics get lost in that chasm. And I I if I had a general recommendation to give uh at this point to the secretary of HHS, it's that it would be and his team that it would be in the interest of the American public to find ways to bridge these gaps between these different HHS agencies so that key issues don't fall into the cracks in between agencies because I suspect that's happening. from time to time I think we need to generate better data and some in in many cases that better data should be the output of welldesigned and appropriately designed clinical tribes that we have avoided uh and and we basically left them only for the or almost only for the uh pharmaceutical companies to to conduct but I think um If I think let's just think about the influenza vaccines right there are many types of influenza vaccines and currently we our way to measure efficacy or benefits is uh ba is based on some corology kind of proxies that the connection between them and actual efficacy is not established in my to to best of my knowledge. Um and and there are many other examples where I think more often than not decision decisions critical decisions have to be made in the absence of reliable data and what what I also teach my my uh my students is like at the end of the day the quality of your decisions is going to be much more affected by the quality of the data available to you than the sophisticated models that you're going going to use. You can use the most sophisticated models. Bring AI, bring whatever you want. Bring the state-of-the-art technology. If the data that you're using as an input is not very good, your decisions are not going to be optimal in all likelihood. So, thinking about how do we generate the best data and that has to do with clinical trials, but also designing data collection systems that are better. And I think today with digital technologies, we have a lot of promise to be able to do that because one of the most significant enablers of the what people call the AI revolution is actually the ability to sense systems better than ever. Like if you think about this in the context human human health, I I carry current currently a Whoop watch. I don't I'm not trying to advertise Whoop now. uh but these devices and there are many types of devices are allowing us to now know the vitals of a human 24/7 right uh yeah here's another product so uh there many vendors so my point is we need to advance our uh monitoring systems and and and data collection systems both in the context of this acting clinical tri but also in in leveraging other data sources that perhaps we didn't leverage so far to uh create better data that will allow us to to make better decisions. And yes, we can evolve the models that we are using. We can use more sophisticated models. But to me, the the first order enabler is being able to collect good data. And I'm I I I I'm one of the concerns concerns that I have is that more often than not, we end up in a situation when we have to make critical decisions in the absence of good enough or appropriately good data. Just to spin off of this a little bit, um I had a conversation some months ago with Kim Witsac who served on a committee uh more in the context of psychiatric drugs, a similar committee. And one of the things that she noted I think was very very thoughtful that there seems to be an inordinate emphasis on developing data around efficacy relative to the amount of data that's being developed around the harms of particular products. So if I could uh this is one of the core critiques of the CDC a as it relates to the vaccine enterprise is the CDC like the FDA, the USDA, the FAA uh etc. is uh tasked with what's essentially dual agency. That's a fancy word for saying they both regulate the industry and they promote the industry. And in the case of the CDC, the budget for promoting vaccines greatly exceeds the budget for regulating or assessing risks of vaccines. Another related topic or thread or metaphor uh has to do with a fundamental aspect of science. We tend to focus on the data that our technology will enable us to capture which is not necessarily the data that we need. So, the metaphor is the old joke about the cop that comes up to a drunk who is searching for his car keys underneath the street light. And the cop asks the drunk, "Why are you searching here?" And the drunk says, "Well, I lost my keys on the other side of the street, but this is where the light is." That's functionally modern science is we look where the light is. We don't necessarily look where the problems are. or the car keys in this case. Uh and that leads us to a whole range of biases. So Rzziff was talking a moment ago just to illustrate this and bring it back to home. He was talking about the bias of assessing outcomes based on certain imunologic endpoints that are easy to analyze. It the tech for looking at antibodies and by the way antibodies are not one thing. They are a swarm of different things that all have their own regulation. They have their own modification. They have their own kinetics and they're all in a great vague mishmash. So, we tend to look at that thing that we have tech for and it's easy to analyze and not look at the things that we don't have tech for and it's hard to analyze. And there's a lot of indications that frankly our we know so much about the immune response and we are still diaper in diapers. We are still grossly naive about the complexity of uh adaptive and innate immunity in not only humans but animals in general. And another key aspect I heard this mentioned by the CDC when they were talking about not to pick at them but when we were talking about the window of time that they are using for analyzing the adverse events after administration of the mRNA products for CO and what they said was well the animal studies show that it's cleared within the limits of what they were trying to detect in animal models within in a short time frame and uh that the distribution is relatively modest, but uh I'm somebody who spent years and years and years doing mouse model research, eggs, and non-human primates as well as being a physician. And uh in my world the wisdom is uh mice lie monkeys mislead and the only thing that predicts immune response in humans and protection is immune response and protection in humans. There's another saw that was actually mentioned during the ASIP meeting about influenza. If you've seen one influenza season, you've seen one influenza season. These things are super complex, highly variable, geographically distributed. This is complicated data. It's complicated stuff. And anytime you try to oversimplify it, you um risk uh the bias that comes from oversimplification. And frankly, from what I've seen, that bias pervades not just the CDC analyses, but the entire vaccine industry. And uh that's kind of what we're up against. will probably break some teeth, but uh the ASIP now under Secretary Kennedy is composed of freethinkers that are willing to challenge those existing paradigms and uh ask hard questions. And I think that is what the American public deserves. And that I think is the essence of the make America healthy again movement is to go beyond accepted wisdom and ask those hard questions and rethink prior assumptions. So, uh, just to add to a few thoughts to that, but before I I just want to make sure because I mentioned the the Whoop and other devices and I think, uh, Secretary Kennedy also mentioned that and kind of generated a lot of, uh, concerns. I just want to clarify in my mind that data is personally owned by the patient and should be used only in under consent of the patient. uh ju just to make sure that I I'm a strong believer that patients should own their own data and have full control on of their data. Um that said, I I do want I do want to highlight some of the inherent challenges of of vaccine safety as well as more broadly drug safety. So, and let's just take RSV as as an example because it it has been discussed uh during the meeting. So when you actually think about the benefit and and you know and and I think about now think about it now from the perspective of a of a medical professional they have true real experiences with a well-defined diagnosis of RSV and real patients some of them are actually really sick and and need really kind of intensive care um so that's very well definfined and clear in their So when you talk about the benefits, the potential benefits, especially when you narrowly define on reducing um the rates of RSD hospitalization, that's very clear uh relatively easy to measure um and well documented. In contrast to that, if when you when you consider different potential adverse event of a product including the RSV uh products that currently are currently in the market, you are actually talking about something that has potentially variable timing, very non-specific appearance and more often than not not very well documented and and very rare, very small numbers. And it's well makes it really hard to do good that poses a challenge. Right now I I would argue that we currently have very good safety methodologies to detect signals that appear shortly after vaccination in the form of a very well-defined and repeated event. whenever if that happens I think that our the civilian systems that we have should detect it. However, we need to recognize that this is actually quite limited because uh there is some implicit assumption that the harm from vaccines is mostly come or only come shortly after vaccination. But to some extent that's a paradox, right? Because the whole notion of vaccines is that most of them that they make a lasting long-lasting impact on your immune system. That's kind of the point, right? So it's kind of striking that we are making that assumption and take it for granted from the benefit side. But for some reason when it comes to the harm side, we are only limited limiting ourselves to looking on a short period of time after after vaccination. That's to me something we should, you know, ex, you know, go away from and really start to think about safety as in a much more holistic way. And and I I want to acknowledge the challenge. This this is not a trivial thing to do because the data the data that we have is currently at least is not very amenable or makes it easy. In fact, it makes it very hard more often than not to detect those kind of signals. And that makes again going back that we need to purposely be able to collect data both in the form of long-term uh clinical trials as well as other measures that new technologies are allowing us to be able to collect long-term data that will give us a chance to expose those type of signals if indeed they exist. Uh so to me there is a fundamental um transformation that I think we need to do in our in our in the way we think about it and and to some extent and I think I also alluded to that in the meeting. So I'm just going to repeat my what I said about the COVID vaccines that it's kind of well it's it's important to look on what happens 21 days after the each dose 42 days after each dose but if you have strong evidence that at least in some patients the mRNA the spike the nanolipids stay in stay in the body and um for months or if not years then and they distribute potentially randomly to different organ systems in your body and cause a range of potentially a range of uh to toxic and immunotoxic and and autoimmune reactions, then that's clearly not going to be detected with approaches that look only 42 days after vaccination. Rediff is specifically talking about a recently published peer-reviewed Yale study that as I recall the study indicated that at least one patient continued to produce spike protein for up to 700 days after administration. So that's not uh consistent with traditional vaccines. uh that's very different and that when when confronted with that at the ASIP the CDC specialist uh appeared to not be even familiar with that study and denied that there was any issue about long-term production and stability of either the uh MR pseudo mRNA product or the engineered spike protein. Uh so that was not that did not inspire confidence. So okay I I I would I had a slightly different uh impression of the reaction from the CDC folks if so I I I think that I did not get the sense that there is a disagreement that this is very important to consider those long-term effects. I think I I I got the sense that there is um there is a real sense of that that's challenging and I fully understand that that's a real that's a real challenge. I think I think though that again some of the issues we are discussing are not isolated to what ASIP is going to do or not to do or what the CDC is going to do or not to do but rather than to the all the agencies that includes FDA, CDC, NIH and others that I think we'll have I I think we have to develop better strategies to collect the right data uh and do the right research and that that research is not going to just be about analyzing izing traditional healthcare data. It will have to do also with more research about the biology that's called it's including autopsies looking on bioag sources that will allow us to hopefully get better understanding of what is happening. Um because again one of the things I think breaks trust is if the narrative that public health agencies are telling to the public stand in complete contrast to the experience of patients and and medical professional. Right? So when you when you say oh this is really safe and effective nothing to be worried about and all of us and and this is also came in in in many surveys in the public patients feel and they are convinced many of them are convinced that them themselves or close ones to them experience serious sometimes serious adverse events by the for in in this context the mRNA vaccines or or covid vaccines that that continue to double down on that narrative. I don't think it's going to help us build trust. So I think we need to listen carefully to what patients and medical professionals are telling us. Uh that should be a major input in driving our hypothesis and what kind of research questions we are exploring and what kind of safety questions and hypothesis we are exploring. Um, and you cannot just stick to uh one size fit them all or kind of uh repeated kind of analysis that you do again and again and again that gives you answers that seem to stand in contrast to the experience that people are expressing. But what you're pointing to Rhettzf is that at underneath that is that same theme that uh we need to recognize the individual and the sovereignty of the individual, the sovereignty of the physician patient relationship uh of the sovereignty of parents in relationship to their children. And we need to stop this kind of paternalistic we know best and you're not allowed to question what we believe to be true. And maybe at a more fundamental level, I I I've been talking to many many physicians and medical professionals over the last 19 years. And I think that the best physicians will tell you you always have to listen to the patient. That should that is your starting point. Now the patient might not be always right. Let me just But the patient is reflecting a reality and ignoring those realities and let alone patronizing and gaslighting those realities uh is the the the single most devastating thing you can do to destroy. When I was trained when I was trained medically trained at Northwestern, which is an excellent clinical training program, not so big on basic science, but excellent on clinical. One of the things that was drumed into our heads was you must listen to the patient's chief complaint. No matter what it is, and you must address that chief complaint, whether or not you think it's right or wrong or crazy or anything else, the patient's chief complaint has to be at the center of your treatment strategy. So, this has been an absolutely fascinating conversation thus far. I want to I want to touch on one kind of uh one of the votes uh that happened where there was you know I know RTS you had a a divergent view. So I wanted to explore this a little bit. Um you mentioned RSV this was around the RSV question. Um in the end uh uh in the end you both of you had different opinions on this topic. So I wanted to to explore why that might be and maybe uh Rhettf if you could kind of explain your thinking and just just kind of remind us what the what the question is. Yeah. So ju just to acknowledge I think that the again as a result of the transition that we had this was a situation where essentially the ASIP the last ASIP meeting had to vote on a a new product by MER of monoc monoconal antibodies for RSV uh which is a similar product to a product that was already uh approved by the previous uh committee. um by Senufi that basically is immunizing uh babies or or can you say something other than immunizing because people get confused. Sure. Go ahead. Why don't you explain that there? I just I just want to underscore that we're talking about a monoconal antibbody uh that does uh provide um some quite a bit apparently of immune protection but it is not immunization in the sense of a vaccine product. It's a very different approach. So I think I think that that's a technology that uh has been used in various settings in fact also to to treat COVID. That was one one of the uh treatments that are actually quite successful but so far it was mostly kind of administered to someone that is already sick um uh or in many cases it was administered to someone who's already sick and help their immune system to boost to boost their immune system and fight a disease. There is a there is a product currently on the market that is being used on high-risisk babies against RSB that needs to that you need to that you basically administered on with a shot every month throughout the and that was first licensed in 1988. So it's been around for a long time but this is the first time that we have products that are uh prevent are trying to prevent it and are given in advance. Again, I I think if we could have controlled everything, I I think it would be good to discuss all of these these two products that are already in the market together. I I I I think that the committee was kind of put in a awkward situation when essentially you have to discuss a a new sort of new product where there's already an approved product that is essentially identical, right? Um so I fully acknowledge that. However, I think that when I read the material, uh, I felt that we have two sources of issues that made me very cons. It's concerned enough to vote against uh, the recommendation to give it to all babies. And again, I I want to emphasize this because I would I would have been okay with a, you know, recommending it to high-risk babies. uh and we can talk about talk about this in a bit but the two things that concerned me were process issues and substance issues and but but let me start actually first talking about the process issues because I actually I'm a process person so I believe that when your process is not good then I think that your chances of making a a wrong decision are are are much higher. So I I just want to highlight multiple flaws that I think uh I wish we can correct going forward and hopefully we can also go and revisit in the in the context of the RSV product on this by the way. Yeah. Yeah. Yeah. I I I know I I I think I think that the first thing is that we tend to have clinical trials that are not powered to really detect uh significant safety signals. So it's almost almost by design you are not going to detect any safety signals in statistically significance level unless it's a gigantic signal. Uh you're not going to detect it. Uh but worse than that um I think that even the quantification of the benefits should have been more nuanced. Um and let me explain. So the main purpose of these RSD products is to reduce the risk of hospitalization. Uh in fact in the US and developing countries and and developed countries sorry the the risk of really dying from RSV is it happens but it's very rare. It's very rare, right? In fact, I think that 97% of the deaths of babies from RSV are in developing countries and not in developed countries. So, so it's it's really about reducing the risk of hospitalization. Now, when you think about hospitalization, again, as someone that worked quite some time in hospitals, not all hospitalizations are the same. Every hospitalization is bad and it's a horrible experience for parents. I I had I have six kids and I you know one of them we had to uh be in the hospital in the NICU twice uh in his early stages of life and that was a horrible experience as a parent like very very you know very very stressful but but not all hospitalizations are the are the same. Sometimes you hospitalize a baby to monitor them just to make sure that they don't deterate. But sometimes you hospitalize them and you really need to provide them intensive care uh and you need to hospitalize them in the intensive care unit and to give them a breathing support and oxygen support. So I I felt that we need to be far more refined in defining exactly what we areing and to what extent and moreover also not only to look on how many people how many babies were hospitalized but also what was the the time they spend in the hospital and what intensity of care what was provided and in fact the the trials the the trials protocols uh actually prescribed that the vendor should report on those metrics. And strangely enough uh there were some initial reports on the very first the very first part of one of the trials that actually did not look that good and after that there is no more reporting on that. So to me that was already a red flag that we don't have even all the information about the benefits or in a nuance enough personalized enough way. Now the other thing is there are two doses in one of the products there are two doses in the Sanui products there are two doses 50 migram and and 100 migram in the mer product there is only 100 milligram so that's another nuance that we need to understand the benefits and the risks right so a lot of missing information there right now the other thing that made me very concerned that you actually look on the uh basically uh five clinical trials that were conducted on uh um these two products and essentially in four of them in which death occurs among the babies and not from RSV from other causes uh there is an imbalance of the deaths that go that goes in the wrong direction. For example, in one trial there were five deaths uh in the immunized babies versus the placebo. In another uh trial there were five in the immunized and and one in in the standard care. Uh in another one there were seven to three and another one 8 to four. Now these ratios should be adapted by the ratios of the participants because in some of these trials the the ratios are not one one but 2 to one. But even after you adapt for that you see higher rates of mortality in all of these trials among the immunized babies. And you also see some serious adverse events that are involved in all in in more often than they involve hospitalizations or really very intensive care and life-threatening conditions. Uh you see imbalance uh of nervous system serious adverse events of gastroitis. So when you look on all of these, I think you must be concerned that there are some unknowns here or some concerns that are not cleared. And to be honest, the fact that the presentation that was given to us did not include any thorough discussion of this did not make me to say the least more comfortable with that because if you just listen to the if you just read those presentation it it would come across as safe and effective, right? Great efficacy, nothing to be worried about. And that's not something I think is reflective of the current knowledge that we have now. And that's my last comment before I let Robert to react to this. I also think that we need to be cognizant to the fact that RSV is a very tricky virus that has has fooled us multiple times in the past with very unexpected unintended consequences. coupled with a new therapy in the sense that it's first time that is given at scale to healthy babies uh and and really create immune immune responses in the sense that it it can really elevate the antibbody levels that you have in the in the baby's body in a uh potentially personalized way. I felt that going ahead and giving it to all healthy babies will be something that if I would put myself as a scientist and also as a father of a newly born baby if I have a healthy baby if I have uh a baby that was born on time if I have a baby that is breastfed right we also know that that's actually provides protection uh uh against RSV I'm not I'm actually I actually don't think as a parent and as scientist, I would recommend that that would uh that we will use a new product that we actually don't know yet well the the safety profile. Um I would think about it very differently if the baby was was born early had uh some underlying uh health condition that can make them very vulnerable not only to exposure to RSB but also to get serious severe RSV uh particularly being in the ICU and getting uh breathing support. um I would think about it differently and I didn't feel that the recommended uh or or the version of the recommendation that was put in front of us capture these nuances and the lack of knowledge that we have on the safety. So that's why I voted uh no. So Robert um and of course you uh voted yes on this issue. So can you kind of provide us a bit with your rationale as a juosition here to what RTS has discussed? I mean, I'm I'm trying to kind of model a little bit of some of the, you know, considerations that people from coming from very different backgrounds might have when assessing all these products. And I also I might also add that frankly the committee actually accepted most of the CDC recommendations as well, which is kind of in in stark juaposition to to to the kind of fears that are appearing in the legacy media and so forth. But but please continue. So the truth is that we uh concurred with every single one of the uh recommended uh um language points that had been submitted by the subcommittees. Uh now we did not have any vote or any opportunity to vote on anything having to do with the COVID mRNA products. Just to be clear, there are some on social media that are asserting that we voted in some way to endorse the COVID vaccine products and that is a lie. We did not do that. Uh the RSV recommendation was uh debated extensively within the community of the ACIP members. And let me just give you a little window into that. First off, there is a system for assessing the potential cost benefit. There's not just risk benefit, but there's also cost benefit analyses performed. remembering that if the committee endorses and the CDC director concurs, then the taxpayer will immediately begin paying for these products and their distribution and functionally their marketing. So is this cost effective? To put a pin on that, the metric that's used that's been developed over decades for asking that question is quality adjusted life years. and the cost per quality adjusted life year or death for instance and in the case of the RSV antibbody product which is as RTS identifies correctly is functionally almost identical to an existing product that's already on the market it hits a slightly different place on the fusion protein which is kind of akin to the spike protein or RSV And by the way, the fusion protein has been the problematic part of respiratory sensitial virus since the 60s. Just to reel back, RSV vaccines have been one of the major failures in vaccinology since the early 60s. there was a RSV vaccine product that was moved into clinical trials in children that resulted in clearly more children dying that had received the product than those that didn't receive the product. So it has been a kind of the example of what can go wrong in kind of a worst case scenario in the vaccine industry. Only recently there's been some progress in identifying what happened back then. It's not completely understood. It has to do with changes in the structure of the fusion protein when it was denatured historically for those vaccines. So it's been learned that one can engineer spike protein so that it stays in a open confirmation and that if you do that you can raise antibodies against that open confirmation as opposed to the you meant fusion you fusion protein not not you said spike uh did I misspoke? So the the the reason for the confusion is because the same logic was applied to the spike protein in the case of COVID strangely enough. Okay. So the spike protein for the co vaccines is also engineered to maintain it in the open confirmation which was the strategy that was used with the fusion protein for RSV and it's based on that that these new antibbody monoconal antibodies were paired and the two different products attack slightly they bind to slightly different places on the open confirmation fusion protein. That's a lot of science. So the key takeaway is they're slightly different and that matters. If there is viral evolution that makes it so that one of them is less effective then we'll still have the other one in the quiver. That's the logic. Uh so that's that's kind of the underlying nature of what's being done here in the quality adjusted life year per death calculation came out to north of $100,000 per life save. Now that's right on the border of what generally is considered to be acceptable expenditures in public health. So for every one person's baby whose life is protected by these products which are not completely affected they are leaky they do not completely protect against RSV disease in all cases there will still even if you inject every single child appropriately with this product um you still will have some children dying unfortunately of RSV disease. Now, which children will those be? This is the next key thing. Unfortunately, about 20% of children who die or hospitalized from RSV disease fit into known high-risk categories. So, they have other forms of disease that makes them more susceptible. And it's an easy call, as Rhettzf is pointing out, to say, well, those ones ought to get this product that we can all agree. The difference is the other 80% of cases of RSV hospitalization and death. And I completely agree with his point that the hospitalization endpoint should have been differentiated into a more severe and a less severe hospitalization. that would have been super informative but we didn't have those data. So unfortunately 80% of the deaths in disease from RSV that happens are occur in completely healthy normal newborns. I wish that we could do what RTS proposes of have a PCR test or something that we could apply a dipstick uh to the child's urine that would say you have risk factors for high high probability for disease or death from RSV. But we don't. Now, another key thing to understand about RSV is that we all get it. We get it again and again and again. There's no oneanddone uh lifetime uh natural immunity associated with RSV. Kind of like flu doesn't happen. And your child, if they manage to get through the first 6 or 12 months of life without getting infected, will at some point in time get RSV infection and develop some level of RSV disease. Okay? So, are we just kicking the can down the road if we get give every child that a jab with this product? Here's the thing is that in the newborn and particularly in the premature child, the very end parts of our respiratory tube, remember it branches like a tree. It's called arborization. And way down at the bottom, there are little tiny sacks where the air is in very close contact with the blood vessels and that's where all the business happens for breathing. It's the truth. And with the tiny little babies, particularly the preeis, but also in the first year after birth, those terminal bronchioles, that's the fancy medical term for those very end parts of the tubes are so small that if the child gets respiratory sensitial virus infection, they tend to swell. And when they swell, they're so small they pinch closed. And if they pinch closed, it's functionally as if you're strangling the child, only you're doing it way down deep in their lungs. So the thing that happens is when the child grows, so does their lungs. So does their airways. So do the size the the diameter of those terminal bronchioles. And so after they've grown up a little bit, they can get RSV and RSV disease, but it doesn't cause that degree of severity in restriction and they tend to survive in what's a rare outcome of hospitalization or death becomes extremely rare, almost unheard of. So that's the context of the disease. It's important to understand that that's the context of the product and the other product by the way um had a manufacturing uh partial failure and there was a restriction in supply in the prior year. And so having two producers, slightly different products, different manufacturing processes gives redundancy in the system or so the logic goes uh to help parents in their physicians prevent the development of respiratory sensitial virus in premature infants and newborns. But my assessment and that of the majority was that we have to live with the data that we have imperfect as it is and make a decision today about what the guidance that we suggest be done for today's babies. These are good points. I I just want to point out that I think that the the statement about not having indicators is probably more true for hospitalization, but I wonder to what extent it's true for really intense um intensive care. Um I and and the other thing I I think that this is even if it's not a binary comprehensive statement I think that it's still valid that the risk a prior risk of a healthy baby that was born on time and maybe is also breastfed uh is probably different than a baby that was born pre-term and has some underlying conditions. And why is that important? Because I think that we need to be able to articulate to ourselves the risk benefits. It's risk means that everybody has some chance of having some severe outcomes. That that's kind of a risk, but it's also a risk that some babies can have some severe impacts from the vaccine either short-term or long term. And I think that one of the other things that we need to check is in the trials we actually administer these products on on average on age three months. What is the impact of delivering it on the first day of life? We need to also look on what are the long-term effects of that. So there there are many open questions there and I still believe that the re the fundamental risk level of a healthy baby is different than a non-healthy baby and not not disputing what I don't think that what you said is contradictory to what I'm saying now. Uh it's just a different levels of risk. Um and and when you look on the risk is not looking retrospectively on the outcome. is looking prospectively what are the chances that you're going to end up with really severe RSB that will require you to be in the intensive care unit and get uh breathing support right oxygen support invasive oxygen support uh every hospitalization is bad and and and you know but but they are not the same I I I think that having all of these voices as an input to an ultimate decision because at the end you need to recommend or not to recommend uh while I probably would make a different decision, I believe that the wisdom of the group is is a very powerful thing that over the long run will will be beneficial to rely on. And again, as I mentioned, I hope that in the future we're going to have more members that will also help to do all the a lot of work that needs needs to be done uh and bring more opinions and more perspectives. Again, absolutely fascinating discussion here. Um, and just kind of being able to think through the nuance. Another thing that strikes me here is this discussion that you've had about these uh RSV products which are not vaccines actually as you highlighted uh uh I I think in some detail. It also presents a lot of information that will contribute to further decision making around these products and uh uh and studies to be done to actually evaluate if these the decisions made now were the correct decisions or not. Um we're getting a kind of a window into into you know what it's like to be part of one of these committees or specifically ASIP. Um this has been an incredible discussion. I've wanted to cover 15 other things I think but we it's actually gone uh uh it's actually been quite a robust discussion already. So let's just get a final thought from each of you as we finish. Maybe starting with Robert. Well thank you Don uh and thank you for the opportunity to have this discussion. I think that the audience in the public are uh being given as you say a little window into what actually goes on at least in this version of the ACIP. I I am honored for the opportunity to be here uh and to participate in both this discussion and ACIP. I am particularly honored uh for the opportunity to spend this quality time with Dr. Levi uh who uh continues to uh stretch my boundaries both myioethically and uh in terms of the data analysis and I uh I look forward to four more years quite literally of these uh detailed discussions examining the science, the data, the medicine and the ethics. of the decisions that we're going to have to make three to four times a year. It's not going to be an easy road. Uh but it's a path that I welcome and I really look forward to walking together with my other ACIP peers. Thank you. And and Rzzaf, a final thought from you. Yeah. So I I I I've been working in teams from uh from age of 18. I I I've been part of teams. Um, and I'm I'm a great believer that the great things in life are accomplished by uh well functioning teams and I'm honored and humbled to be part of this team. Um, and I also want to say that I already kind of got a very strong impression about uh the level of dedication and passion of uh not only the committee members but also of the CDC staff. Uh I think my impression is that these are good people, qualified people, talented people and I think that one of the exciting things would for me would be also to work with them very closely uh because I think we all have a common goal in mind which is the health of um our children uh our parents our friends and my my my sense is that we are serving the patients and the medical professions professionals in helping them in in their intimate interaction. Thinking about the health related decisions about the health of babies, the health of patients and how to make those uh best and tuned and personalized to the specific individual and every individual is different. Uh and and to me that's kind of who we serve. Uh and there is a lot of noise from the media and from other directions. uh I I I hope to ignore the noise and just stay focused on interacting with my colleagues on the committee with the CDC professionals in serving uh the patients and the medical uh professionals. Well, Professor Ratz of Levie, Dr. Robert Malone, it's such a pleasure to have had you on. Thanks. [Music]

Summary: They basically impact on billions of dollars of revenue for the pharmaceutical industry. So there's big money at stake here. There's big policy at stake. Recently, the CDC's Advisory Committee on Immunization Practices, ASIP, met for the first time after HHS Secretary Robert F. Kennedy Jr. replaced its entire membership with new picks. In this episode, I'm sitting down with two new ASIP members, Dr. Robert Malone and MIT professor Rhettz Levy for a deep di…