[RUSH TRANSCRIPT BELOW] Recently, the CDC’s Advisory Committee on Immunization Practices (ACIP) met for the first time after Health Secretary Robert F. Kennedy Jr. replaced its entire membership with new picks.

In this episode, I’m sitting down with two new ACIP members, Dr. Robert Malone and MIT professor Retsef Levi, for a deep dive into all things ACIP.

“They basically impact billions of dollars of revenue for the pharmaceutical industry. So there’s big money at stake here. There’s big policy at stake,” says Malone.

“One of the problems that we had in the context of vaccines, and more broadly maybe pharmaceutical products, is that debate was considered confusing to patients and something that we should avoid,” says Levi.

We take a look at some key discussions during the recent meeting, from thimerosal in certain flu vaccines to RSV shots for children, and what may happen with this committee moving forward.

“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,” Malone says.

Views expressed in this video are opinions of the host and the guest and do not necessarily reflect the views of The Epoch Times.       

RUSH TRANSCRIPT

Dr. Robert Malone, Professor Retsef Levi, such a pleasure to have you on American Thought Leaders.

Dr. Retsef Levi:

Thank you, Jan. It’s a pleasure to be here.

Dr. Robert Malone:

Thanks, Jan. It’s a pleasure to be here again. And I’m so pleased with how American Thought Leaders has been growing and to be part of this yet again.

Mr. Jekielek:

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 ACIP panel that’s been put together, two of eight. Why don’t we actually start with this? This is a committee that actually has quite a bit of influence in decision-making, but most people haven’t actually heard of it until very recently. So bottom line, what is ACIP in the end?

Dr. Malone:

ACIP is an acronym that stands for the Advisory Committee on Immunization Practices. This is a federal advisory committee. It’s the product of the Federal Advisory Committee Act [FACA]. Another FACA committee that matters in this space is the Vaccines and Related Biologicals Advisory Committee [VRBAC], and that’s the one that advises the FDA [U.S Food & Drug Administration]. So there are these two key federal advisory committees. 

Both of them are voluntary, by the way. So we’re not getting paid big money to advise the CDC [Centers for Disease Control and Prevention] 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. 

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 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 an infectious disease, although that’s rarely, if ever, considered.

What it’s supposed to do is convene 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 newly licensed products from the FDA. The charter is that the ACIP 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. 

The flow of work is that the VRBAC advises the FDA, the FDA makes decisions on whether or not to authorize the marketing of a new product. And then at the next following meeting, the ACIP is supposed to take that up and make it 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 that Congress has authorized a program called the Vaccines for Children Program [VFC]. The VFC has 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 the availability of the products to underserved populations. 

If the ACIP votes and the CDC director approves, then those products are automatically purchased by the CDC and the federal government and distributed to the tribal nations, to underserved communities all across the United States. That gives the ACIP unusual responsibility and authority relative to other FACA committees. 

But what has happened over time is that the various professional societies, the medical professional societies, have aligned themselves with the ACIP. They actually serve as an unofficial advisory component. And they typically align their recommendations with the CDC/ACIP recommendations. The consequence of that is that, functionally over time, the ACIP has developed into the body that establishes the standard of care for medical practice as it relates to vaccines, antibody 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 we’re in ACIP and the CDC functionally establish the standard of care, that triggers the insurance industry to decide whether or not these products are going to be covered. Basically, they follow the ACIP recommendations. 

Once a product is established as standard of care 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 functionally go against that. Or if they do, they put themselves at risk for liability, basically for medical malpractice lawsuits. By the way, the recommendations that the ACIP made, and by extension, the director of the CDC, who’s the one that actually makes the recommendations, we just advise directly, but they basically impact billions of dollars of revenue for the pharmaceutical industry. 

So there’s big money at stake here. There’s a big policy at stake. And as many people have come to recognize, particularly during the COVID crisis, all of this feeds into a 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 happening right now with the changes that have happened in the composition of the ACIP. 

Mr. Jekielek:

I’m absolutely going to dive into some of that controversy. I'd love to talk about that. But before we go there, Retsef, you know, you were very, very important for me in terms of my understanding of all sorts of policies around the pandemic. 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 specific policies, whether that’s products that are being used as interventions because of disease. And frankly, I’ve actually expanded it quite a bit further than that now. But tell me, why do you think that you were invited to join ACIP, of all things, and how does your particular acumen fit into working on this committee?

Dr. Levi:

Thank you, Jan. Just to build on what Robert said, I think that in my mind, the ACIP role is to translate a generic approval by the FDA to a set of more detailed recommendations that take into consideration risk-benefit aspects that could be different for different subgroups of patients and recommend both public policy as well as standard of care. It’s a great honor and very humbling to be part of the ACIP, but 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 in academia since 2006, and I have a PhD in operations research from Cornell University. 

This is a discipline that is focused on trying to use data and models to inform complex decisions that involve risk-benefit trade-offs. And that’s kind of the purpose of this discipline. So it’s using a lot of statistics, a lot of artificial intelligence, a lot of machine learning, a lot of data, and a range of methodologies to essentially develop decision support tools in different contexts to inform complex decisions that involve nuanced trade-offs of risk and benefits. 

Specifically, I’ve been working thousands of hours with clinicians on the ground in healthcare systems on thinking about various issues related to the design of care, design of operational processes, design of healthcare systems, and how to optimize those to provide the best care for patients. I also did research on epidemiological models, on manufacturing biologic drugs, and how you can use data to improve their safety and quality. 

I did work on post-marketing safety surveillance, but also on other areas related to human health, like food, water, agriculture, access to healthy food, and food safety. Beyond my academic experience, it’s fair to say that I’ve been thinking about risk since the age of 18, when I became a part of the Israeli Defense Forces and spent almost 12 years as an intelligence officer. 

I have a strong belief that there is no one discipline that can capture the complexity of these decisions. So this is why it’s very important that a committee like ACIP will have people from different backgrounds, from different perspectives, and from different experiences. And I’m a strong believer that the collective wisdom of a team is far stronger than the wisdom of an individual. And I also hope and believe that that’s the plan, that 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.

Mr. Jekielek:

You know, looking at—I didn’t watch the entirety of the many hours of the ACIP meetings that happened just recently. But what I did see was some, you know, constructive discussion. Of course, there were also, you know, people making quite different decisions, and some of those things I‘d like to actually dive into a little bit later in the episode. 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 being part of ACIP and perhaps why he was picked. 

Dr. Malone:

First, I want to address the issue of the modest Dr. Levi. What he didn’t mention is that he’s bloody brilliant. He is a full professor at the Massachusetts Institute of Technology in data science and data evaluation. That’s no small achievement. Furthermore, he was quite brave and bold throughout the coronavirus crisis. In speaking his truth, he has revealed himself to be an independent thinker and not swayed by proven narratives or conventional thought. I think that the nation is really blessed by having such a mind with these capabilities serving in this way. I don’t know that there has been this level of capability in data analysis before. 

It’s complemented by the other members, but in particular, Dr. Martin Kulldorff, former professor of epidemiology at Harvard and arguably one of the top epidemiologists in the world, who was dismissed from Harvard because he refused to accept the COVID vaccine product, which is a major travesty. So the narrative that’s been promoted by corporate media that this is a committee composed of anti-vaxxers that are completely unqualified is clearly a gross misrepresentation. 

In my own case, of course, there’s been a focus on this history of what I did when I was 28 and the origins of the mRNA vaccine technology, the patents that are behind me, etc. But that was only early on in my career. I’ve been working in infectious disease, virology, and immunology literally since I was an undergraduate working in the laboratory at UC Davis that did a lot of the pioneering work having to do with what we now call HIV and the related virus, simian immunodeficiency virus. 

There are few people that I know of that have worked deeply in government positions, non-governmental organization positions, such as the Aeras Global TB Vaccine Foundation, funded by the Bill and Melinda Gates Foundation, in industry for Solvay vaccines, in the contract support industry, both in a vaccine-focused clinical research organization, and in a regulatory submissions shop located close to the FDA. I’ve kind of done it all in terms of working closely with the government on the HHS side and on the DOD side in relation to infectious disease, biodefense pathogens, biodefense countermeasures, influenza. 

I was the clinical director responsible for over $300 million in BARDA [Biomedical Advanced Research and Development Authority] contract funding for the building of a cell-based influenza vaccine under Solvay. I’ve been doing this for 30 years. For some reason, the media only focuses on what happened in the last couple, but I’m very facile with modern immunology, modern vaccinology, and modern vaccine technology. 

Of course, I also am very familiar with the current secretary of HHS. I consider him a friend and a colleague. I will never forget the day that he called me in my home and asked me some questions and then asked me to assist in editing the book, The Real Anthony Fauci. It’s been my privilege to build a working relationship with him since then. I’m grateful for the selection. I didn’t anticipate it. I absolutely did not want to join the administration in a functional role of having significant responsibility for a sub-agency. But I’m very grateful for the opportunity to serve my country in this volunteer role at the ACIP. 

Dr. Levi:

Jan, if I may just inject another thought. You know, disciplines are important, but I think that equally important is the culture of team dynamics. More broadly, I think that one of the problems that we had in the context of vaccines and, more broadly, maybe pharmaceutical products, is that debate was considered confusing to patients, as something that we should avoid, which in many ways goes counter to science. It goes counter to, I think, the complex nuances that exist when you consider risk-benefit considerations with respect to a patient and how a patient has to think about the trade-off of whether to take a pharmaceutical intervention or not. 

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 away from debate; the discussion is equally important beyond the decision that was made. If anything, I hope that this committee will change that, not only in the narrow context of the ACIP discussions but maybe more broadly on how we think as a society, as scientists, as public policy, public health policy people, about the process and the principles of the process that should guide us in making decisions. 

Dr. Malone:

This interview is basically another demonstration of our personal commitment. Remember that Retsef and I are speaking in our personal capacity right now. I just want to note that we are not representing the U.S. government, and we’re not representing the ACIP. We’re representing only ourselves. 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. Hopefully, that will help build back the confidence that has been lost by this kind of insular, one might almost say authoritarian approach that is characteristic of the federal public health enterprise during the COVID crisis. 

Mr. Jekielek:

I think one of the things that this committee, at least so far from what I’m hearing, is accomplishing is turning committee meetings into a kind of spectator sport. I think one of the themes, Retsef, that you mentioned here, I think you were suggesting, is that having the patients or having people play a much more active role in their own health care and also being given the correct information to be able to make these decisions themselves. There seems to have been this kind of strange culture that has developed, almost where that information isn’t presented very effectively, presumably, you know, kind of to protect the patient in a way from having to deal with too difficult decisions. 

Dr. Levi:

Yes. So to me, the core interaction of healthcare should always be kept to be the intimate interaction of a patient with their consulting physician and/or clinical professionals and medical professionals. My view is, I guess that’s kind of my personal view that being a member of the ACIP committee, the main role that I will try to help with is 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 that I would like to highlight is personalization. The one thing that I think is a staggering contrast is that, in most areas of healthcare and health management, we are emphasizing personalization. In fact, we are talking now about therapeutics that are 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 them as one size fits all, both on a single vaccine as well as, even worse, on all vaccines, right? 

To me, the interplay between these personalized considerations and the intimate interaction between the patient and the medical professional to allow them to make the best personalized decisions for themselves, considering the risks and benefits that they have to face, is the single most important thing that we need to enable as a committee. 

Dr. Malone:

A lot of the decision-making at the CDC and in American Public Health, as follows those with three of the masters in public health [MPH], please understand that the MPH 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 co-doctors or medical practitioners or have any experience in that. The essence of the MPH 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 MPH but of modern public health in the United States. This utilitarian greatest good for the greatest number approach is fundamentally socialist, in my opinion. I believe that we need to swing back to 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. 

It’s an open question what the role of the physician and the medical care provider is in that environment. Do we really want to have our medical care determined by algorithmic, artificial intelligence, utilitarian decision-making implemented through insurance agencies and very large health maintenance organizations? Or do we want to have a situation in which individuals have sovereignty over their own bodies and those of their children to make informed decisions?

The challenge there is that they’re not medical professionals. How do you communicate complex medical decisions to a layperson? But it’s achievable. It can be done. It takes a little more effort, and it is very threatening to many medical care providers.professionals and public health officials, including CDC staff, to have their opinions questioned. 

Now, Retsef and I have lived for most of our careers in the academic world, being subjected to peer review. Retsef, bless his heart, still does. And 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 susceptible to strange quirks in data oversight, overlooking confounding variables. The only way that I know of to effectively immunize yourself from that is to subject your work to peer review. 

I’m sorry to say, historically, the CDC and those who are doing the analyses for the ACIP have not had their work subjected to peer review. The Morbidity and Mortality Weekly Report [MMWR], the monthly report put out by the CDC, is not a peer-reviewed journal. The MMWR is not peer-reviewed. It represents the opinions of a group of people often strongly biased by CDC personnel. Why shouldn’t 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 will make for better science and better medicine.

Dr. Levi:

One of the exciting aspects of becoming a member of ACIP is the opportunity to work with the CDC staff and other academics to really pursue together the truth based on the data. And I think the CDC, my impression from the first meeting, has very passionate staff members who are very hardworking. So I personally look forward to building those professional relationships and really engaging with them and others to pursue the truth.

One of the things that I really liked about Martin Kulldorff’s opening statement is that he really mentioned the analogy of airline safety, especially when you are considering giving medical intervention to healthy individuals, let alone healthy children and babies. I think that your approach to both safety and efficacy should be guided by the caution that you would have when you think about sending an airplane on a flight carrying hundreds of passengers. 

The analogy is that when you recommend something to be used broadly, you are launching a flight with potentially billions of children or millions of children, right? I think that adopting the safety paradigm or the safety approach of airlines is going to be very, very important going forward. And I thought that it was very inspiring to hear Martin speaking about this at the opening of the meetings.

Mr. Jekielek:

Let’s talk about one of the decisions that was made. The vaccines related to influenza were mentioned, actually a very prominent decision, one that’s been given a lot of play in the media: this removal of thimerosal from these multi-vial influenza vaccine decisions. But let me ask a few questions right off the bat, even when it comes to the basic data. I mean, I’ve heard that influenza vaccines just aren’t effective at all or have negative efficacy. I’ve seen some papers that suggest that for some years that they’ve been applied, they have that. 

I’ve seen people say, thimerosal has been removed mostly from these vaccines in the first place. Why is this such a big deal? And of course, thimerosal is mercury. And so for some people, it’s even shocking to discover that there was mercury in the first place. So why don’t we just start off? Can you kind of unpack influenza vaccines for us? Which, by the way, ACIP approved the use of in general or recommended the approval of. So a lot of different pieces here. 

Dr. Malone:

We were presented with language without really an opportunity to debate that language, endorsing universal influenza vaccination, as well as the nuance of which specific influenza virus sequences would be included in the recommended upcoming vaccine year for the vaccine. And 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. There tends to be one recommendation for the Northern Hemisphere and one recommendation for the Southern Hemisphere, because the flu strains circulate in contrary seasons, having to do with the fact that when it’s winter here, it’s summer there. 

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 strains to be included in the following year’s influenza vaccine. And by the way, those influenza vaccine campaigns will kick off in August, depending on the vaccine platform, and continue through the winter. So we were basically presented with a fait accompli in terms of the language recommended to us regarding influenza vaccination as the first resolution, and then a series of second, third, and fourth resolutions having to do with this really nuanced quirk of removing thimerosal from the influenza vaccine multi-dose vial. 

Jan, you have raised a key issue, and you’ve used that forbidden term, negative efficacy. This is, just for context, I personally lost two jobs in the past working in the influenza vaccine industry for even raising the issue of negative effectiveness of immune imprinting and original antigenic 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 makes good sense, even the logic, or whether 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 an 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, what happens with influenza vaccines is it’s teaching your immune system to fight the last war, largely. And there is data, and it’s been a hot subject of debate in the vaccine community now for decades. Annual boosting, or in the case of the COVID product, much more frequent than annual, is actually counterproductive. It’s driving the immune system towards categories of responses that are counterproductive. We'll just leave it at that and recommend that people Google immune imprinting and original antigenic sin if they want to get more information. 

But this is a topic that has been anathema in 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 decisions have to happen. The public committee is basically a forum for presenting the data that has come out of the subcommittees and then debating that data among ourselves, including people who 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.

Retsef is going to chair the 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 COVID and the various COVID 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. I mentioned in the meeting that it’s my intention that these issues of immune imprinting, original antigenic sin, etc., will be discussed and strongly considered in upcoming meetings. 

But in terms of the decision that we were faced with, we were presented with essentially language that was already approved 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 had to do with, as you point out, this nuance of multi-dose vials containing mercury of the standard influenza vaccine, mercury in the form of a preservative called thimerosal. And just to calibrate this, because this is something the press has latched onto and has made a big deal about, what we’re talking about is that 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. What that does is minimize 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 multi-dose vial. 

Multi-dose vials 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 bacterial contamination, etc. It could be a fungal contaminant. That’s why in a multi-dose vial, you have to put in some sort of preservative. And there are other approved preservatives other than thimerosal. 

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 multi-dose vial today are likely to be the same ones that get it from a multi-dose vial next year. So the mercury doesn’t get excreted very well, and there is a cumulative effect. 

The committee, I think wisely, voted to just say no to thimerosal-containing multi-dose vials. 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 thimerosal is a crisis for the entire vaccine industry and their academic and media supporters. I don’t get it, but that seems to be the meme. 

The strange thing is that it’s Left-media and pharma arguing in favor of injecting mercury into Americans. It is just horrible optics. It’s not the right decision. And I think I applaud the committee for having the temerity to just say no at this point in time.  And by the way, unfortunately, influenza vaccines are not the only products that contain thimerosal. There are other vaccine products that are still on the schedule that contain thimerosal. 

I suspect the industry sees the writing on the wall. Since the committee said no, just said no to thimerosal-containing flu vaccines, one might speculate that in the future there might be a tendency to say no to other thimerosal-containing vaccines, but that’s forward-looking, 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 the teep.

Mr. Jekielek:

Retsef, I want to get you to comment here as well, but just before, can you just explain why it’s a problem to be injecting even tiny, tiny amounts of mercury into people? 

Dr. Levi:

First, I just want to acknowledge that Robert and I are expressing our own opinions about that. 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 U.S., more maybe developing countries where the current state is not that 97% of the vaccines that are being administered are free of mercury. So this is nuanced. 

I think that this is actually a great question because it’s really kind of a point where I think we need, when we consider risks, we need to really go beyond a single vaccine or a single episode of administering a vaccine. Because if you just think about a one-time vaccine, you could argue that the amount of mercury in a single dose of a single vaccine is probably small and you could argue potentially that it poses no significant risks. 

The problem is that you don’t take one shot, you actually take a shot every year and moreover you are actually being exposed to mercury from other sources in your life, from food, from fish, from other sources. So when you want to consider risk here, you need to adopt a system-level kind of thinking and really think about not only this isolated episode, but rather than what is the overall contribution to the overall risk, to the overall exposure. And if you do that, I think it’s going to be sensible that given the fact that mercury is a highly toxic compound, nobody debates that, and it accumulates in the body. I think it’s going to be sensible, at least in my mind, to say that if we can control and eliminate some controllable sources of mercury, we should do that. 

Speaking more broadly, and because you also asked about the efficacy of flu vaccines, I think it’s again an area where I think current evidence that we have is rather low quality. And again, we are thinking about this question only year by year. Like every year 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 are super important because at the end of the day, we are not managing one year, we are managing a horizon of years. 

We really want to think about essentially the immune profile of the population. And to some extent, that immune profile is the shield for the most vulnerable people in our population, right? To some extent, the more resilient the immune profile of the population is, the less chance there is for the virus to hit 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 not sure that we have been thinking 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 at observational data from the field. We also need to look at research that is conducted to understand the biological mechanisms that take place once we vaccinate people. I know that there are great concerns about potential radical changes that this committee would recommend to or would cause. And on the other hand, there is maybe an impatience by others that radical changes have to happen immediately.

My philosophy in life, and actually, I teach that when I teach 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 why people make decisions the way they are now before we are going to recommend changes if and what changes we are going to recommend. I think it’s a very important aspect that may not make us popular, but I think we are all determined to be thorough and take the time to study and not to make rash decisions.

Dr. Malone:

Can I pick up one of the threads that Retsef just introduced? We could call it immunotoxicity or immunotoxicology or fundamentals of immune responses to introduced antigen. One of the, so part of what happened during this recent ACIP meeting was we had an opportunity to gently query, and we were very diplomatic about it across the board. Even the Atlantic Monthly and their attacks on me acknowledged that I was very polite in my questions to the CDC staff. But we were able to directly query in a way that really has not been done in the past by the senior staff of the CDC that were presenting these data. 

One of the questions I happened to have put forth, but Retsef could have, or anybody, was whether or not the CDC has metrics and processes in this. Track whether or not there are toxicities 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 or broader way by these interventions? 

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 immunoglobulin class switching, which sounds like a big mouthful of immunobabble, 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.

I’m going to introduce a controversial topic that we didn’t talk about 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 immunologically 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. 

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 routines that they get into are a bit antiquated. They’re kind of old school, to start 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 to issues concerning the CDC, public health, FDA, and the NIA. 

Important topics get lost in that chasm. If I had a general recommendation to give at this point to the secretary of HHS, it’s 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. 

Dr. Levi:

We need to generate better data, and in many cases, that better data should be the output of well-designed and appropriately designed clinical trials that we have avoided. And we basically left them only for the, or almost only for the pharmaceutical companies to conduct. Let’s just think about the influenza vaccines, right? There are many types of influenza vaccines. And currently, our way to measure efficacy or benefits is based on some serology kind of proxies that the connection between them and actual efficacy is not established to the best of my knowledge. 

There are many other examples where I think more often than not, critical decisions have to be made in the absence of reliable data. And what I also teach my students is, 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 to use. You can use the most sophisticated models, bring AI, bring whatever you want, bring state-of-the-art technology. If the data that you’re using as input is not very good, your decisions are not going to be optimal in all likelihood. 

Thinking about how 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 what people call the AI revolution is actually the ability to sense systems better than ever. If you think about this in the context of human health, I currently carry a Whoop watch. I’m not trying to advertise Whoop now, but these devices, and there are many types of devices, are allowing us to now know the vitals of a human 24/7. Yes, this is another product and there are many vendors. 

My point is, we need to advance our monitoring systems and data. The first-order enabler is being able to collect good data. And one of the 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. 

Mr. Jekielek:

Just to spin off of this a little bit, I had a conversation some months ago with Kim Witczak, who served on a committee 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. 

Dr. Malone:

This is one of the core critiques of the CDC as it relates to the vaccine enterprise, is the CDC, like the FDA, the USDA, the FAA, etc., is 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 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? The drunk says, I lost my keys on the other side of the street, but this is where the light is. That’s functionally modern science, as we look where the light is. We don’t necessarily look where the problems are, the car keys in this case. And that leads us to a whole range of biases. 

What Retsef was talking about a moment ago, let’s just illustrate this and bring it home. He was talking about the bias of assessing outcomes based on certain immunologic endpoints that are easy to analyze. The tech for looking at antibodies. 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 modifications. They have their own kinetics. And they’re all in a great big mishmash. 

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, we know so much about the immune response, and we are still in diapers. We are still grossly naive about the complexity of adaptive and innate immunity in not only humans, but animals in general. 

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 COVID. They said, the animal studies show that it’s cleared within the limits of what they were trying to detect in animal models within a short time frame, and that the distribution is relatively modest. 

But 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 in my world, wisdom is 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 saying that was actually mentioned during the ACIP 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, complicated stuff. And anytime you try to oversimplify it, you risk 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 that’s kind of what we’re up against. We'll probably break some teeth. 

But the ACIP now under Secretary Kennedy is composed of freethinkers that are willing to challenge those existing paradigms and 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.

Dr. Levi:

Just to add a few thoughts to that, but before, I just want to make sure, because I mentioned the Whoop and other devices, and I think Secretary Kennedy also mentioned that and kind of generated a lot of concerns. I just want to clarify, in my mind, that data is personally owned by the patient and should be used only under the consent of the patient, just to make sure that I’m a strong believer that patients should own their own data and have full control of their data. That said, I do want to highlight some of the inherent challenges of vaccine safety, as well as more broadly drug safety. Let’s just take RSV [respiratory syncytial virus] as an example, because it has been discussed during the meeting. 

When you actually think about the benefit, and I think about it now from the perspective 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 need really kind of intensive care. So that’s very well-defined and clear in their mind. So when you talk about the benefits, the potential benefits, especially when you narrowly define reducing the rates of RSV hospitalization, that’s very clear, relatively easy to measure, and well-documented. In contrast to that, when you consider different potential adverse events of a product, including the RSV products that are currently in the market, you are actually talking about something that has potentially variable timing, very nonspecific appearance, and more often than not, not very well documented.

Dr. Malone:

And very rare, very small numbers. It’s really hard to do good [inaudible].

Dr. Levi:

Of course, it’s a challenge, right? Now, 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. If that happens, I think that the civilian systems that we have should detect it. However, we need to recognize that this is actually quite limited because there is some implicit assumption that the harmful vaccines 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, 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 taking it for granted from the benefit side. But for some reason, when it comes to the harm side, we are only limiting ourselves to looking at a short period of time after vaccination. That’s, to me, something we should move away from and really start to think about safety in a much more holistic way. 

And I want to acknowledge the challenge. This is not a trivial thing to do because the data that we have is currently, at least, not very amenable or makes it easy. In fact, it makes it very hard more often than not to detect those kinds of signals. And that makes, again, going back to the need to purposely be able to collect data, both in the form of long-term 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 types of signals if indeed they exist. 

To me, there is a fundamental transformation that we need in the way we think about it. To some extent, I think I also alluded to that in the meeting, so I’m just going to repeat what I said about the COVID vaccines; that it’s important to look at what happens 21 days after each dose, 42 days after each dose. But if you have strong evidence that at least in some patients, the mRNA, the spike, the nano lipids stay in the body for months, if not years, and they distribute potentially randomly to different organ systems in your body and cause a range of potentially toxic, immunotoxic, and autoimmune reactions, then that’s clearly not going to be detected with approaches that look only at 42 days after vaccination.

Dr. Malone:

Retsef is specifically talking about a recently published peer-reviewed Yale study that, as I recall, indicated that at least one patient continued to produce spike protein for up to 700 days after administration. So that’s not consistent with traditional vaccines. That’s very different. And when confronted with that at the ACIP, the CDC specialist appeared to not even be familiar with that study and denied that there was any issue about long-term production and stability of either the pseudo-mRNA product or the engineered spike protein. So that did not inspire confidence.

Dr. Levi:

Okay, I had a slightly different impression of the reaction from the CDC folks. I think that I did not get the sense that there is a disagreement that it is very important to consider those long-term effects. I think I got the sense that there is a real understanding that that’s challenging. And I fully understand that that’s a real challenge. I think, though, that some of the issues we are discussing are not isolated to what ACIP is going to do or not do or what the CDC is going to do or not do, but rather to all the agencies that include the FDA, CDC, NIH [National Institutes of Health], and others. 

We have to develop better strategies to collect the right data and do the right research. And that research is not going to just be about analyzing traditional healthcare data. It will also have to do with more research about the biology, including autopsies, looking at biobanks, and really going to other data sources that will allow us to hopefully get a better understanding of what is happening. Because again, one of the things that I think breaks trust is if the narrative that public health agencies are telling to the public stands in complete contrast to the experience of patients and medical professionals, right? 

When you say, this is really safe and effective, nothing to be worried about, and all of us, and this also came in many surveys in the public, patients feel, and many of them are convinced that they themselves or close ones to them experience serious, sometimes serious adverse events in this context, the mRNA vaccines or COVID vaccine, continuing to double down on that narrative, I don’t think it’s going to help us build trust. 

We need to listen carefully to what patients and medical professionals are telling us. That should be a major input in driving our hypotheses and what kind of research questions we are exploring and what kind of safety questions and hypotheses we are exploring. And you cannot just stick to one-size-fits-all or kind of repeated analyses that you do again and again and again that give you answers that seem to stand in contrast to the experiences that people are expressing.

Dr. Malone:

But what you’re pointing to, Retsef, is that underneath that is the same theme that we need to recognize the individual and the sovereignty of the individual, the sovereignty of the physician-patient relationship, and the sovereignty of parents in relation to their children. And we need to stop this kind of paternalistic messaging of, we know best, and you’re not allowed to question what we believe to be true.

Dr. Levi:

Maybe at a more fundamental level, 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 is your starting point. Now, the patient might not always be right. Let me just say that, but the patient is reflecting a reality, and ignoring those realities, and, let alone, patronizing and gaslighting those realities is the single most devastating thing you can do to destroy trust. 

Dr. Malone:

When I was 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 drummed 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, crazy, or anything else; the patient’s chief complaint has to be at the center of your treatment strategy.

Mr. Jekielek:

This has been an absolutely fascinating conversation thus far. I want to touch on one of the votes that happened where there was, I know, Retsef, you had a divergent view. So I wanted to explore this a little bit. You mentioned RSV. This was around the RSV question. In the end, both of you had different opinions on this topic. So I wanted to explore why that might be. And maybe, Retsef, if you could kind of explain your thinking and just kind of remind us what the question is. 

Mr. Jekielek:

Yes. Just to acknowledge, I think that, again, as a result of the transition that we had, this was a situation where essentially the last ACIP meeting had to vote on a new product by Merck of monoclonal antibodies for RSV, which is a similar product to a product that was already approved by the previous committee by Sanofi that basically is immunizing babies. 

Dr. Malone:

Or can we say something other than immunizing because people get confused? 

Dr. Levi:

Sure, go ahead. Why don’t you explain that?

Dr. Malone:

I just want to underscore that we’re talking about a monoclonal antibody that does provide 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.

Dr. Levi:

That’s a technology that has been used in various settings, in fact, also to treat COVID. That was one of the streams that were actually quite successful. But so far, it was mostly administered to someone who was already sick. In many cases, it was administered to someone who was already sick and helped boost their immune system to fight a disease. There is a product currently on the market that is being used on high-risk babies against RSV that you basically administer with a shot every month throughout the season.

Dr. Malone:

That was first licensed in 1988, so it’s been around for a long time.

Dr. Levi:

But this is the first time that we have products that are trying to prevent it and are given in advance. Again, I think if we could have controlled everything, it would be good to discuss all of these two products that are already on the market together. I think that the committee was kind of put in an awkward situation when essentially you have to discuss a sort of new product where there’s already an approved product that is essentially identical, right? So I fully acknowledge that. 

However, I think that when I read the material, I felt that we had two sources of issues that made me very concerned. It was concerning enough to vote against the recommendation to give it to all babies. And again, I want to emphasize this because I would have been okay with recommending it to high-risk babies. And we can talk about this in a bit. But the two things that concerned me were process issues and substance issues. 

Let me start actually first talking about the process issues because I actually am a process person. So I believe that when your process is not good, then I think that your chances of making the wrong decision are much higher. So I just want to highlight multiple flaws that I think we can correct going forward, and hopefully, we can also revisit in the context of the RSV product. 

The first thing is that we tend to have clinical trials that are not powered to really detect significant safety signals. So it’s almost by design. You are not going to detect any safety signals at a statistically significant level unless it’s a gigantic signal. You’re not going to detect it. But worse than that, I think that even the quantification of the benefits should have been more nuanced. And let me explain. 

The main purpose of these RSV products is to reduce the risk of hospitalization. In fact, in the U.S. and developing countries, and developed countries, the risk of really dying from RSV 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 it’s really about reducing the risk of hospitalization. 

Now, when you think about hospitalization, again, as someone who has 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 have six kids, and one of them had to be in the hospital in the NICU [Neonatal Intensive Care Unit] twice in his early stages of life. And that was a horrible experience as a parent, like very, very, very, very stressful. 

But not all hospitalizations are the same. Sometimes you hospitalize a baby to monitor them just to make sure that they don’t deteriorate. But sometimes you hospitalize them, and you really need to provide them with intensive care, and you need to hospitalize them in the intensive care unit and give them breathing support, oxygen support. So I felt that we need to be far more refined in defining exactly what we are averting and to what extent.

Moreover, we should not only look at how many babies were hospitalized, but also at the time they spent in the hospital and the intensity of care provided. In fact, the trial protocols actually prescribe that the vendor should report on those metrics. Strangely enough, there were some initial reports on the very first part of one of the trials that actually did not look that good. After that, there was 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 in a nuanced enough, personalized enough way.

Now, the other thing is there are two doses; in one of the products, there are two doses. In the Sanofi products, there are two doses: 50 milligrams and 100 milligrams. In the Merck product, there is only 100 milligrams. 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 is that if you look at the five clinical trials that were conducted on these two products, essentially in four of them, in which death occurred among the babies—not from RSV, but from other causes—there is an imbalance of the deaths that goes in the wrong direction. For example, in one trial, there were five deaths in the immunized babies versus the placebo. In another trial, there were five in the immunized group and one in the standard care group. In another one, there were seven to three, and in another one, eight to four.

Now, these ratios should be adjusted by the ratios of the participants because, in some of these trials, the ratios are not one-to-one but two-to-one. But even after you adjust for that, you see higher rates of mortality in all of these trials among the immunized babies. You also see some serious adverse events that are involved, and more often than not, they involve hospitalizations or very intensive care and life-threatening conditions. You see an imbalance of nervous systems and serious adverse events of gastroenteritis.

So when you look at all of this, I think you must be concerned that there are some unknowns here or some concerns that are not clear. To be honest, the fact that the presentation given to us did not include any thorough discussion of this did not make me, to say the least, more comfortable with it. Because if you just read this presentation, 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. That’s my last comment before I let Robert react to this. 

I also think that we need to be cognizant of the fact that RSV is a very tricky virus that has fooled us multiple times in the past with very unexpected, unintended consequences. Coupled with a new therapy in the sense that it’s the time that is given at scale to healthy babies, it can really create immune responses in the sense that it can elevate the antibody levels in the baby’s body in a potentially personalized way. 

I felt that going ahead and giving it to all healthy babies will be something that, if I were to put myself as a scientist and also as a father of a newborn baby, if I have a healthy baby, if I have a baby that was born on time, if I have a baby that is breastfed—right, we also know that that actually provides protection against RSV—I’m not, I actually don’t think, as a parent and as a scientist, I would recommend that we would use a new product that we actually don’t know yet well the safety profile of.

I would think about it very differently if the baby was born early and had some underlying health conditions that could make them very vulnerable, not only to exposure to RSV but also to getting severe RSV, particularly being in the ICU and getting breathing support. I would think about it differently. I didn’t feel that the recommended version of the recommendation that was put in front of us captured these nuances and the lack of knowledge that we have on safety. So that’s why I voted no.

Mr. Jekielek:

Robert, and of course, you voted yes on this issue. Can you kind of provide us with your rationale as a juxtaposition here to what Retsif has discussed? I’m trying to model a little bit of some of the considerations that people coming from very different backgrounds might have when assessing all these products. I might also add that, frankly, the committee actually accepted most of the CDC recommendations as well, which is kind of in stark juxtaposition to the fears that are appearing in the legacy media and so forth. But please continue.

Dr. Malone:

The truth is that we concurred with every single one of the recommended language points that had been submitted by the subcommittee. 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 who are asserting that we voted in some way to endorse the COVID vaccine products, and that is a lie. We did not do that. The RSV recommendation was debated extensively within the community of the ACIP members. 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. Remember 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? Put a pin on that. The metric that’s used, which has 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.

In the case of the RSV antibody product, which, as Retsef 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 for RSV. By the way, the fusion protein has been the problematic part of respiratory syncytial 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 an RSV vaccine product that was moved into clinical trials in children. It resulted in clearly more children dying who had received the product than those who didn’t receive it. So it has been an example of what can go wrong in a worst-case scenario in the vaccine industry. Only recently has there been some progress in identifying what happened. In fact, 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. It’s been learned that one can engineer the spike protein so that it stays in an open conformation. If you do that, you can raise antibodies against that open conformation as opposed to the...

Dr. Levi:

You meant fusion. You said spike.

Dr. Malone:

Did I misspeak? 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 COVID vaccines is also engineered to maintain it in the open conformation, which was the strategy that was used with the fusion protein for RSV. It’s based on the fact that these new monoclonal antibodies and the two different products attack slightly different places on the open conformation fusion protein. That’s a lot of science. 

The key takeaway is that they’re slightly different, and that matters if there is viral evolution. It makes it so that one of them is less effective, and we'll still have the other one in the quiver. That’s the logic. The underlying nature of what’s being done here in the quality-adjusted life year per death calculation came out to north of a hundred thousand dollars per life saved. Now, that’s right on the border of what is generally considered to be acceptable expenditures in public health. 

For every one person’s baby whose life is protected by these products, which are not completely effective, 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, be 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 are hospitalized from RSV disease fit into known high-risk categories. They have other forms of disease that make them more susceptible. It’s an easy call, as Retsef is pointing out, to say that those ones ought to get this product. We can all agree on that. The difference is the other 80% of cases of RSV hospitalization and death. 

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 that data. So unfortunately, 80% of the deaths in disease from RSV occur in completely healthy, normal newborns. I wish that we could do what Retsef proposes, have a PCR test or something that we could apply a dipstick to the child’s urine that would say, you have risk factors for high probability for disease or death from RSV. But we don’t. 

Another key thing to understand about RSV is that we all get it. We get it again and again and again. There’s no one-and-done lifetime natural immunity associated with RSV. Kind of like the flu. It doesn’t happen. And your child, if they manage to get through the first six or 12 months of life without getting infected, will at some point in time get an RSV infection and develop some level of RSV disease. Okay, so are we just kicking the can down the road if we give every child a jab with this product? 

Here’s the thing. In the newborn, and particularly in the premature child, the very end part of the respiratory tube—remember it branches like a tree; it’s called arborization—and way down at the bottom, there are little tiny sacs 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. 

With the tiny little babies, particularly the preemies, 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 syncytial 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. 

The thing that happens is when the child grows, so do their lungs, so do their airways, so does the size, 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, which 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, had a manufacturing partial failure, and there was a restriction in supply in the prior year. And so having two producers, slightly different products, and different manufacturing processes gives redundancy in the system—or so the logic goes—to help parents and their physicians prevent the development of respiratory syncytial 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 we suggest be done for today’s babies. These are good points. I just want to point out that I think that the statement about not having indicators is probably more true for hospitalization, but I wonder to what extent it’s true for really intensive care.

The other thing is that even if it’s not a binary comprehensive statement, I think that it’s still valid that the risk, a priori risk of a healthy baby that was born on time and maybe is also breastfed is probably different than a baby that was born preterm 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. Risk means that everybody has some chance of having some severe outcomes. 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.

One of the other things that we need to check is, in the trials, we actually administer these products on average at age three months. What is the impact of delivering it on the first day of life? We need to also look at what the long-term effects of that are. So there are many open questions there. And I still believe that the fundamental risk level of a healthy baby is different from an unhealthy baby. 

I’m not disputing what you said. I don’t think that what you said is contradictory to what I’m saying now. It’s just different levels of risk. And when you look at the risk, it’s not looking retrospectively at the outcome; it’s looking prospectively. What are the chances that you’re going to end up with really severe RSV that will require you to be in the intensive care unit and get breathing support, invasive oxygen support.

Every hospitalization is bad, and you know, but they are not the same. I think that having all of these voices as input to an ultimate decision, because at the end, you need to recommend or not recommend. While I would probably make a different decision, I believe that the wisdom of the group is a very powerful thing that, over the long run, 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 work that needs to be done and bring more opinions and more perspectives.

Mr. Jekielek:

Again, absolutely fascinating discussion here. 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 RSV products, which are not vaccines, actually, as you highlighted, I think in some detail. It also presents a lot of information that will contribute to further decision-making around these products and studies to be done to actually evaluate if the decisions made now were the correct decisions or not. We’re getting a kind of a window into what it’s like to be a part of one of these committees or specifically ACIP. This has been an incredible discussion. I’ve wanted to cover 15 other things, I think, but 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.

Dr. Malone:

Thank you, Jan, and thank you for the opportunity to have this discussion. I think that the audience in the public is being given, as you say, a little window into what actually goes on, at least in this version of the ACIP. I am honored for the opportunity to be here and to participate in both this discussion and ACIP. I am particularly honored for the opportunity to spend this quality time with Dr. Levi, who continues to stretch my boundaries, both bioethically and in terms of the data analysis. 

I look forward to four more years, quite literally, of these 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, but it’s a path that I welcome. And I really look forward to walking together with my other ACIP peers. Thank you. 

Mr. Jekielek:

Retsef, a final thought?

Dr. Levi:

I’ve been working in teams since the age of 18. I’ve been part of teams. And I’m a great believer that the great things in life are accomplished by well-functioning teams. And I’m honored and humbled to be part of this team. I also want to say that I already kind of got a very strong impression about the level of dedication and passion of not only the committee members but also the CDC staff. I think my impression is that these are good people, qualified people, talented people. 

One of the exciting things for me would be also to work with them very closely, because I think we all have a common goal in mind, which is the health of our children, our parents, our friends. And my sense is that we are serving the patients and the medical professionals in helping them in their intimate interactions, thinking about their health-related decisions, about the health of babies, the health of patients, and how to make those best, tuned, and personalized to the specific individual. 

Every individual is different. And to me, that’s who we serve. There is a lot of noise from the media and from other directions. I hope to ignore the noise and just stay focused on interacting with my colleagues on the committee, with the CDC professionals, in serving the patients and the medical professionals.

Mr. Jekielek:

Professor Retsef Levi, Dr. Robert Malone, it’s such a pleasure to have you on the show.