The Highwire with Del Bigtree - FDA APPROVES MERCK’S RSV SHOT DESPITE ALARMING INFANT TRIAL DATA

Episode Date: June 24, 2025

Del and Jefferey dive into the troubling numbers behind Merck’s new RSV shot for infants, recently greenlit by the FDA. Trial data revealed higher rates of deaths and severe respiratory illness in vaccinated babies, yet the FDA overlooked this concerning trial data.Become a supporter of this podcast: https://www.spreaker.com/podcast/the-highwire-with-del-bigtree--3620606/support.

Let's start with the global RSV market. What is RSV? This is respiratory and it's an essential virus. It's a common cold for most people, but for the elderly and the infants, it can lead to hospitalization. So we have a market now developing it with the vaccinations, and there's vaccinations and there's monoclonal antibodies. So they're both kind of competing for this market in those age groups, the older age groups and then the infants. And you can see here in this kind of overview of the market looking at the 2034

It says considering both the modalities, antibody and vaccine targeting all three key age groups, the global RSV vaccine and antibody market is expected to be worth $2.61 billion in 2024, raising to US 13.59 billion by 2030. Now this has been a market that's been historically plagued with some issues in the clinical trials in trying to get these vaccines, especially in children. So when I saw this headline from NBC Chicago, FDA approves Merck's RSV shot for infants wrapping up the competition with Sanofi and AstraZeneca. This is for newborns and infants. The FDA authorizes use in newborns during the, whether they're entering or during the first

RSV season of their life. So this is a monoclonal antibody shot. And let's look at the clinical trials for this. So all drug companies have to go through clinical trials.gov. They have to basically state their intentions and any updates on these trials. They have to post this here. And this is the final trial. This was the Merck efficacy and safety of chalcerobamab.

That's their RSV monoclonal antibody shot. And this is an infant. So just to start out here, twice as many people is a caveat in the trial group as in the placebo group. So you got about almost 20, over 2,400 people in the trial group, about 1,211 people in the placebo group, but they did use a saline placebo. So we, that is a positive. They did use an inner saline placebo on this to compare against their monoclon and by shot. So just to be clear, normally we're used to seeing randomized control trials, they're equal size. The drug group,

or in this case, the vaccine or monoclonal antibody group, you know, was twice as big as the placebo group. Is that what you're saying? Okay, so when we look in the numbers, we have to do that math and recognize that, you know, you sort of have to cut in half that sort of comparative structure. And I know you're about to take us through that. But I mean, it's weird that they would do that anyway. I mean, I don't even understand. It's almost like they just want to make a mess of things. Like, why change how we know these studies are always supposed to be done? Like one group got it, one group didn't, same science group. Here's your numbers. But, you know, I'm, you know, we're all going to get exhausted. We keep trying to question why the pharmaceutical

industry does things the way they do it. Right. But what did we find? So up at clinical trials, yeah, up at clinical trials.gov, we look at, let's look at first the deaths. Obviously, you don't want, you don't want these things to kill anybody. So from the deaths, that first column here are the Merck antibody, monoclone antibody group. Three deaths in that group. That second box is one death in the placebo group. Now let's keep going a little bit. We have all. Hold on, whoa, whoa, whoa, I don't want to go anywhere. Let's take a look at that and just explain to people what we're saying then. You cannot say that there's three times the amount of deaths because that's twice as big of groups.

What you're saying is cut that in half. So essentially what we would say is there was 1.5 deaths in the Klesrovimed or however you say it compared to the placebo group. So still worse. It still did 50% worse than not getting it at all, which I thought the whole point was to stop deaths. So at the very least, it's not even a break even. It's performing slightly worse than getting nothing at all.

Okay, got it. When it comes to death. Okay, all right, understood. And then a conversation we have with COVID vaccine, all cause mortality. Now, let's look at that with Chleserobamap. So on this first column here, we have seven, all cause mortality affected in the risk there. And then in the placebo group, we have three. So again, you cut that seven and a half because we have a double the size of that group. We're still not coming out with the greatest odds here. And that's, you know, that's why we're questioning.

So the drug is doing slightly worse, 29% to 20% to 20%? 25% as it says there. Right, right, right. And so RSV is a respiratory disease. So let's look at how it tracks with the respiratory illnesses. So the infants, the children, the kids in the respiratory, upper respiratory tract infections in that group, when they're tracking that, they had nine after receiving the treatment and only one in the placebo group.

And then lower respiratory tract infections, 15 compared to four in the placebo group. So that's a big conversation there because obviously. I mean, if the entire purpose of this thing is to, you know, keep you from having dangerous levels of R-SV or like this disease that could be problematic and in every category, but those numbers, I think smack of something different when I look at it, Jeffrey. That looks like, you know, I'm almost wondering, it's making me think about disease enhancement, right?

Why is it not just across the board doing the same amount? We're talking about how many of them got like serious upper rest? contract infection, like nine, you know, I guess, I guess four point five times the amount. And then in, you know, in the other one, it's 15. So seven times. So that's saying that this product is actually making you more likely to have a severe upper respiratory condition, which is the exact opposite. But you know what it really is bringing up for me, Jeffrey, is Peter Houtes.

Remember when we first started reporting on COVID-19 and he said there's no way to they're going to be able to warp speed this vaccine out because he's seen the animal trials and it's causing something called disease enhancement. He actually brought up RSV as the example. I want to just throw this in the mix, not to get you too far off track, but just take a look at this, because I wonder if what he stated here, even though it was supposed to be out COVID, can give us some insight into what we're actually talking about with RSV. Everybody, take a look at this. One of the things that we're not hearing a lot about is the unique potential safety problem of coronavirus vaccines. This was first found in the early 1960s with respiratory

sensational virus vaccines. And it was done here in Washington with the NIH and Children's National Medical Center that some of those kids who got the vaccine actually did worse and I believe there were two deaths in the consequence of that study because what happens with certain types of respiratory virus vaccines you get immunized and then when you get actually exposed to the virus you get this kind of paradoxes chemical immune enhancement phenomenon. When we started developing coronavirus vaccines and our colleagues, we noticed in laboratory animals that they started to show some of the same immune

pathology that resembled what had happened 50 years earlier. We said, oh my God, this is going to be problematic. These clinical trials are not going to go quickly because of that immune enhancement. It's going to take time. So there he's describing it as immune enhancement, meaning the body somehow overreacting, caused two deaths in an RSV trial back in the 1960s, which derailed that. Now we're looking at three deaths, not derailing it, nine upper respiratory infections over one and, you know, 15, you know, over, you know, four. Remember, do those in half, but still it's performed, it appears to be making you more sick. And I really, it leaves me with this. for folks, I just really want you to let this sink in for a second, what Peter Hote is saying.

We don't really know why this thing with upper respiratory conditions when we vaccinate for it, somehow, sometimes in these animal models, it looks like it makes you more sick. It has an disease enhancement, an immune enhancement. And then we had an RSV trial. We did it on kids and we did see that. We pulled out and we were working on the COVID vaccine. He was like, oh, no, hold on a second. We better to slow down because we're seeing the same thing.

Well, we're seeing it here. And are you telling me this just. got approved? That's the headline. That's what I'm reading in the headlines, just like everyone else. So we're unpacking this alongside of the investigation. We're investigating alongside everyone else in full public view here. So I want to stick on that idea of enhancement, the disease enhancement, because remember, there's monoclonal antibodies and there's also vaccines. So traditionally, that issue was in children, not so much adults with RSV. So Moderna was working on their own vaccine for RSV. It was using MRI technology.

So this was the traditional vaccine that we thought about over the last four years, you know, a lot COVID. And this is the headline that came out just in December of 2024. Safety signal in Moderna's RSV vaccine studies halt trials of other vaccines for childhood killer. And you go in here, it says in recent clinical trials, two experimental RSV vaccine for babies may not only have failed to protect them, but actually made some of them sicker when they got RSV or another respiratory virus.

So that's a pretty big, pretty big, a swat there. RSV or, you know, many other respiratory virus floating around. And at that time, so they paused it. But at that time, we had the FDA's VerPAC committee. This was before Kennedy took the helmet HHS or this was under Biden administration. And listen to what the VerPAC committee had to say about this pause. This was a very well thought out process. But again, as others have pointed out, here we are, you know, talking about a safety signal. And we, we don't really understand the mechanism why. So for me, It makes it very difficult to comment on the second question about what additional safeguards or what new ways to study this we can put in place without really understanding what we think may have happened here or why the safeguards we put in place didn't necessarily predict severe outcomes.

So I'm really hopeful that some of the additional investigations that Moderna has discussed can shed some light on this and some of the other studies that my colleagues have recommended. So for me, it makes it very difficult to really comment on that one. This is, Jeffrey, let me just jump in. And I know people are like, why do you interrupt Jeffrey so much? For those that are watching right now, I would need this to sink in for you, especially if you're brand new to this show. And you're like, oh, my God, my doctors are amazing. The CDC's FDA, they are so genius.

They are blah, blah, blah. Listen to what she just said. She just said, we don't know why this is happening. It's exactly what Peter Hotez said back in 2020 when he said, you can't rush a coronavirus vaccine. We don't know why, but in upper respiratory conditions when we vaccinate, sometimes it makes the disease worse. And we don't know why. We just showed you a monoclonal trial that has now been approved and still just know it got approved while the consensus of all the sciences. We don't know why treating this makes it more dangerous.

than not treating it all. And yet they're saying there's a, what, a $2 billion market this year, potentially $15 billion down the road. They're not stopping. And they've had this problem since the 1960s. Folks, this is where I have always jumped off the pharmaceutical train. I'm off. You are playing God.

You have no idea what you're doing. And by the way, where are the ethics? They want to talk about ethics issues of doing, you know, placebo-based trials. Well, look it right here. They are so addicted to an RSV-BAC. they keep putting innocent children into trials knowing that they don't know jack about how the immune system works around these things. They know that people die. And once again, three are dead in the trials of the monoclonal adibis. They're stopping this one down because kids are dying.

So get this. Your regulatory agencies are having trials, not having any understanding of how the immune system actually works around this. And they are killing children to try and get to their $15 billion payoff by 2030. That's how I see this. And those comments are emblematic of the medical system we are trying to move away from. That's why we brought Secretary Kennedy, HHS Secretary Kennedy of Power, and Trump brought him in the fold as well because we are voting to move away from this idea of, well, we really don't understand the fully evolving immune system of children and all its aspects.

That's what the MAHA report. I'm going to go into that in a little bit. That's what the MAHA report did when it came out from the White House. It said children are adults. So we have all these considerations. It's not just one to one. And so that's the RSV conversation. But at the same time, all this is happening.

Again, that was late 2024. The FDA is having shorter review times for drug developers. So this can be looked at it either way. I'll let the viewers do that. But U.S. FDA to shorten review time for drug developers under a new voucher program, it says the regulator said on Tuesday that the commissioner would determine whether a company aligns with health priorities such as delivering innovative medicines, a drug addressing a health crisis or unmet public health needs and increasing domestic drug manufacturing.

FDA Commissioner Mari McCarrie said that the program will allow companies to submit the lion's share of the application before the clinical trial is completed, which he said can reduce inefficiency. So I look at this with shaded glasses as positive because if they're addressing health priorities which would have unmet public health needs, I could think of a handful of those. Hopefully these companies are doing that. Yes, fast track those in a way that's safe, if that's possible, But that's one of those conversations we have here. But when it comes to the vaccine conversation, let's stand this one more moment. We have something that has been shared all over social media.

It's become very popular. It's the ICAMP placebo pyramid. And this is the previous FDA. We're going back decades and decades and generations. And the vaccines on the childhood schedule, the CDC's childhood schedule, were licensed by the FDA, not with gold standard placebo-controlled double-blind studies, but against other vaccines, against comparator vaccines. So you have this pyramid, this basically pyramid scheme. So that brings us to the next conversation. This is the US FDA's approval of

Sanofi's Meningio-Cocco vaccine for infants. Now this vaccine has been approved for children, but now they've lowered that exception. They've lowered that approval to six weeks to two years. So a six-week little infant up to two years of age. That is now the FDA's approval for this vaccine. So when I saw that, I said interesting, let's go into this conversation with that vaccine. vaccine placebo pyramid in mind. So we have MenQadfi. That is the name of this men meningococcal vaccine. We go to the package insert from the FDA and we read it. Just really quick, anybody can follow me along on this journey. The safety of men quantify in infants from six weeks of age, vaccinated with four dose series was evaluated in a study. The safety analysis set

included 1,727 participants received at least one dose of med quadfi and 867 participants receiving at least one dose of men vio. All right. Well, what's men vio? We go to men's vio. Was that approved with a placebo? You go to menveo safety insert. Safety of men's Vio in children two years through 10 years of age. You go through that and it says you have clinical trials, subjects receive menveo, or they receive comparative vaccines, menomune or menactra. All right, let's go to menactra. So safety of this is the FDA's in for menactra. Safety of menacta is evaluated in eight clinical studies. Great. This is good. A lot of people on these.

What do they receive? They received menactra or they receive menoimmune. Uh-oh, I've heard that. I've heard that name before. So let's finally go to meno-immune because this seems to be the last one list. How was that clinical trial? Well, you go to that insert. And we're almost done with this rabbit hole in three clinical trials designed to assess the safety, immunogenicity of another vaccine, manacra.

What do they use? At the bottom there, they use menoimmune. So what we have here. And I have to give them credit in this insert. This is, I believe, from 2016 all the way back here at the bottom of this rabbit hole. It even says in this insert, there's this moment of beautiful truth. It says because clinical trials are conducted under widely varying conditions, adverse reaction rates observing clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine

and may not reflect the rates observed in clinical practice. So they undid everything that they're trying to do there by saying. Let us be perfectly clear. Since we ran a bull crap study of a bull crap drug against another bull crap drug, and that bull crap drug was tested against another bull crap drug, this entire safety trial that you are looking at right now is complete bold crap, but we are going to approve it anyway, and so don't give us any crap. It's like, sorry for everyone out there homeschooling.

I try to keep it as clean as I could, but this is absolutely nuts. And for the visual learners out there, everything I just went through, check out this slide. This is what we're talking about. MNQadfi was the license based on MNVio. MNVio was Mnactra. And then MNactra, Menoimmune, kind of played around with each other. But in that whole sandbox, there's no placebo-controlled trial that we're looking at here.

And at the end of the whole thing, the vaccine that was approved for six weeks to two years now, let's go back to that insert, the one that was just approved by the FDA. You look at their serious adverse events. This is the safety trials. It says in study one and study two, following any dose in the four-dose series. So you've got to get four of these days. things by the way. Don't you love these products that they don't even work the first time? Four doses you've got to get. I mean, all right, just go ahead.

Yeah, it's repeated. So it says they're reported 5.3% of participants follow men quadfi and 3.6 participants following men VO during the entire study period. So, you know, normally when you ask somebody that- So, SAE is being serious adverse events. And serious usually means has the potential to kill you, right? If it was left unchecked, I mean, it means that- Is it serious? Right. And so when you ask people that, you know, are really involved in these trials, they say, well, we use the comparator drugs because it would be unethical to deny a child these life-saving

vaccines, even in a trial of safety. But, you know, you peel back the cover a little bit. It's also to hide some of these serious adverse events. So if you look at this, you take 5.3% minus 3.6%. And that starts to look pretty good because both of these have safety profiles and issues with them. event issues and we put them together, it doesn't start to look too bad. Well, and hold it up there because, again, I know it's math and a lot of us just our eyes roll back, but what they're saying

here, folks, is you used to hear that serious adverse events were one in a million in vaccinations. There were one in a million. Right here, this product is being approved, and it's 5.3 out of 100. So it's about 1 in 20. It's 1 in 20 is what they're accepting, a serious adverse event. So out of every 20 kids, one of them is going to have a serious adverts event. Can you imagine having 20 cupcakes in your classroom and just say one of those, your kid's going to have to be rushed to the hospital for it? Would you let your kids take that cupcake? And by the way, you should feel better because we compared it to the old product.

And that one only had about, you know, one in 30. So it used to be a little better. We're going with one that's a little bit more dangerous. We're never going to explain to you why. But folks, we are way outside of, you know, Oz and the world. the curtain's been pulled back of the one in a million, they are accepting adverse events inside of one in 20 right now and saying good enough for us.