The Highwire with Del Bigtree - ACIP MAYHEM OVER NEWBORN HEPATITIS B SHOT

Episode Date: December 11, 2025

Day one of this week’s Advisory Committee on Immunization Practices (ACIP) meeting revealed a stunning shift in the hepatitis B debate. For the first time, panel experts openly acknowledged they do not have the data to justify giving every newborn a hepatitis B shot on their first day of life. Hear how this new advisory group challenged inflated risk assumptions, admitted the evidence for newborn safety is surprisingly weak, and questioned why infants are expected to bear the burden for failures in adult screening and prevention. This pivotal exchange is reshaping the national conversation around vaccine policy—and the science that must support it.Become a supporter of this podcast: https://www.spreaker.com/podcast/the-highwire-with-del-bigtree--3620606/support.

I want to go now to the story of the day. This is the CDC's ASIP community, the advisory committee on immunization practices. They're meeting right now as we speak. The entire day today is devoted, is devoted and we'll be voting on the hepatitis B recommendation, the first shot given to babies' first day of life in this country. And I want to make some points here that you made right at the top. We have the previous chair, Martin Koldorf, he has now left. So the chairman of the ASIP previously has now left for an HHS job.

So he's becoming now the chief science officer within the HHS planning and evaluation office. So that's kind of like the major think tank in HHS. So he's moved on to that senior position. So now we have Dr. Robert Malone as the vice chair. Dr. Kurt Milhoun, he came in on a Zoom call. So essentially Robert Malone, you'll see from the video. He's facilitating the entire meeting, and I'd say he seems like he's doing a great job. So I want to talk about the hepatitis B vaccine was,

was on the docket for last ASIP, the last ASIP meeting months ago. And this is Robert Malone introing today's ASIP meeting just this morning to talk about that. Take a listen. Okay. Many of you will recall that in September, ASIP deferred a vote on proposed changes to the hepatitis B vaccination schedule. That decision was not about hesitation or reluctance. It was about standards. Several data elements the committee requested were incomplete, and the evidence did not yet meet the level of clarity required for a confident, evidence-based recommendation. When gaps in the evidence aburge, the responsible action is not to push forward. It's to pause, review, ensure that we fully understand what the data can and cannot support

and then formulate independent advice to the CDC director. This is our charter. So there you, and the reason we're playing these clips, and again to the audience, we're watching this in real time making these clips shooting these out so we can report in near real time on this meeting that just happened this is the most up-to-date broadcast you're going to hear on this right now this is this is ongoing so he's saying we tried to vote on this and we did we had incomplete evidence our our teams that were looking at this they couldn't they don't have the data that we needed to make a vote on this so the reason i i am showing that is it's not rfk junior it's not trump trying to do this This is a team of researchers and scientists at a federal government agency saying we don't have the data.

We want to change this. We want to evolve this conversation, but we just don't have it. So we have to defer this vote. So now it brings us to today. So the discussion, which was really great to see publicly, was back and forth. It was, as they would say, robust discussion. And one of the topics was about horizontal transmission of Hep B. Now, that's not from a parent to a child, a mother to a child.

at birth. Horizontal transmission are the IV drug users, the unprotected sex, the exposure to infected blood. And so I want to bring in this conversation here and see if you can, see if you can pick out some of the pieces here. Take a listen. Okay. Yes, it can occur among certain high-risk immigrant communities, but the evidence for horizontal transmission among most U.S. children is very, very sparse, and really all these years has been based on a fit to seropositivity data that really wasn't statistically significant. And a final point is that the 16,000 cases per year, predicted by Armstrong at all, are not supported by the surveillance data. I'm showing here children age zero to nine before the universal birth

dose, which is the vertical red line, there were about 400, acute cases per year reported, 400 compared to the 16,000. And keep in mind also that of the 400, many are probably resulting from perinatal infection. So just a final note on horizontal transmission in childhood. The informed consent action network, ICANN, ask the CDC through their lawyers, and I believe one of them is testifying tomorrow here, for documentation sufficient to reflect a case of transmission of hepatitis B in a school setting. The CDC's response, a search of our records failed to reveal any documents pertaining to your request. It reminds me of the models that were projected during COVID, right? It's what they do. They just explode these numbers, 16,000 potential infections.

Actually, when we looked at it, it was 400. I mean, just a slight miscalculation. This is how they've done all the signs, all the fear porn that they push out there based on models that aren't anywhere close to the actual conversation that's happening. And finally, instead of just getting fear porn at ASIP, we are getting both sides. Like, actually, that was a bloated number. When we actually chopped it down, we're talking about maybe 400 cases this is happening in all of the United States of America. Right.

We're knocking out assumptions. And all of the people who helped make ICANN what it was, everyone that donated, you have forced facts into the highest conversations in public health in this country right now. You've forced them to accept these facts through the legal action you funded. You heard her say the legal action of informed consent action network. We force the CDC to admit this that they don't have the studies on horizontal transmission. So that's a big hat tip to our audience. And I want to go on now.

And people, by the way, they'll say, Jeffrey, what do you get from it? I mean, do you win money when you have these cases? Do you win money? No, we don't win anything except we win the opportunity like moments like this to be in an ACIP meeting. And when they try to say, oh, the science. have been done or the evidence is there or there it is, actually, no, it doesn't exist because informed consent action network spent money that nobody thought they would ever waste on a case like this to prove you're all lying.

You're lying. You don't have a single case of horizontal transmission in a school, anywhere in America, which I guarantee you would have known about. It would have been a headline because it doesn't exist. It's an imaginary problem, and you've made a product making billions of dollars to solve an imaginary problem. Absolutely. And that's the big conversation. Mothers are tested. We can figure that out if they have that so they don't give it to their child. There's precaution that's to be taken. So the horizontal transmission is the big question that I guess we're giving this shot to every child that comes onto this earth. So it goes on. But this this whole ASIP committee with back and forth because we're talking about is there is are the benefits outweighing the risk. What are the risks of the happy vaccine giving it on the first day of life to every infant? So these are the conversations that we're having. So the question of. The evidence, where's the evidence of harm came up?

Take a listen. Okay. The question is, is there any evidence of harm? There is clearly evidence of benefit. Is there any evidence of harm to giving the neonatal hepatitis be? My basic answer would be that the safety evidence is very limited. And I wouldn't want to speculate on safety or harm that the IOM has concluded that we don't know any, any we have any reason to reject or or claim causality on a wide range of conditions

there is concern for something that is as profound as you know a universal immunization of every American infant at the moment of birth to to address a condition that many of them will not be at risk for, the safety evidence should be rock solid. With all due respect, I don't think that that's the right question. And I want to phrase another relevant question, which is, I think if we want to understand the quality of the evidence, then you need to ask hypothetically, suppose that there was a harm of that rate, of a certain rate, would we be able to detect it with the level of monitoring and surveillance that we applied to the issue?

And I think that given the data that was presented to here, very, very low numbers, very short follow-up time, and not really comparing to placebo, the answer is that could be major signals out there that our surveillance and the way we monitor and measured would not have detected them. So I think that the question is there evidence to harm cannot be untangled from what was actually measured. And I think that that's something we tend to do not only in this particular question. We tend to do that more broadly when we think about safety. So the first other question is, what do we believe, given our monitoring system, given what we actually monitored and checked, we would be able to detect? And I think that the answer is basically nothing.

Thank God for Retz of Levy there. I mean, he makes the point we made on the show over and over again. The trials for HPV, I mean, hepatized B vaccine, 154 children with five-day safety review. So if this is a one in a thousand injury, is 154 kids going to pick it up? No. If it's an injury that only takes a month or maybe even a year to develop, is this going to capture that? no. So when we're talking about safety, what do we know about the safety? What will we have ever captured with the way this science has been done? He says, basically, I would say, not a god damn

thing. That's what we would find out. And we've been told, we know this, because we've watched all the ASIP committees, we've been quite a few of them as well, that we've had the most robust safety monitoring system in the world that's been drilled into our heads. And now we're getting the truth. Finally, we have, again, we're watching the evolution of public health and the evolution of, I would say, courage to have these discussions publicly. And what they're saying is, we don't know because we don't have, we don't have the robust safety monitoring system that we thought we had to catch these things. And this is what goes on to the point of the studying you mentioned. Tracy Beth Hoag was at this meeting as well. And she made a comment regarding the evidence, the evidence of harm,

the safety of the Heppe vaccine. Take a listen to this. All right. Dr. Hogue, now acting director of the Center for Drug Evaluation and Research. Over? Yes, that's right. Thank you, Robert. I just want to add to what Retz-F, Dr. Levy, just said that it's really important to keep in mind that the U.S. is an outlier in recommending a universal birth dose of the hepatitis B vaccine compared to other high-income nations.

And the data that we used to approve the hepatitis B vaccines, there's two, Angurix and recombia vaccines for infants, were based on studies that had very short-term follow-up and no control group. It wasn't like, you know, it wasn't like it was a randomized control trial against, you know, another vaccine. No, there was not even a control group. It was just an observational study. We would never approve a vaccine based on data like those today.

So that's important to keep in mind. And then we have these five randomized control trials that were identified by the CDC at the last ASIP meeting that we discussed. And these are also short-term randomized control trials where the hepatitis B vaccine recombavax was given and compared to other vaccines, so not compared to placebo. So we are working with very low, low level evidence here. And we have very limited confidence in what we say when we say these vaccines are safe. Wow. And so this is, these are the conversations that we're having. And I want to talk about one last, one last clip from, there's so many clips.

I recommend everyone watch this. And tomorrow, 9.30 a.m. Eastern Aaron Siri testifies against, not against, but to look at the U.S. vaccine schedule, the entire childhood schedule, against what other countries are doing to talk about that, compare and contrast that. But when it comes to this Hep B vaccine, we have really horizontal transmission kind of up in the air from the quote we just talked about. They said about 400, really not the 16,000 that was projected. By the way, they make it really clear because we can't show every clip that that 400 sits really directly in an Asian immigration population. I think as specific as Hmong peoples, I think is how they're referring to.

to them, but that are coming into this country with high hepatitis B rates, living amongst each other, sleeping with, you know, in close proximity and eating, that it does not represent at all any other population in this country. So it was so specific where those numbers are coming from. I just wanted to make that point. And, you know, I think it's important. Yeah. And we're screening pregnant mothers. Probably could be doing a better job of that. That's what they mentioned at the ASIP committee. So what's happening is instead of trying to look more at these at-risk populations, the mother's better screening, just like during COVID, closing schools, vaccinating infants, we're putting the burden on babies, first-born babies, and saying, you know what, just give it to

everybody, give it to every single person, every single infant coming in because we're not doing a good job on the other aspects of public health here. So the babies have the burden. And this is exactly what someone mentioned, thank God, at this meeting, and now it's in the public record. Take a listen. Okay. Regarding the opportunity to identify infants at risk, in obstetrics, our American College of OBGYN gives us guidance for hepatitis B screening early in pregnancy. And so I find it very concerning to see the statistics that we have reviewed in our workgroup

anywhere between 84 to 87% of women being tested or results being issued before delivery, which is even more concerning knowing that in 2002, the MMWR morbidity and mortality weekly report reported that we were very good at testing women at a rate of 96.5%. And so between 2002 and now, what happened? You know, how did this screening gap widen? And so this speaks to an opportunity for us to close the gap in prenatal care, and should we be pushing this off to the babies? That is my concern.

You know, the term safety net that is being applied to this program that's being put, on the babies, I mean, is it fair, you know, is it incumbent on the babies to save us from this when this really may be more of an adult problem? We could implement universal screening in pregnancy rather than asking the babies to kind of close that gap. Let me put this in terms because she's being really nice about this. How about, how about instead of giving 99.95% of our babies that do not need this, vaccine, a hepatitis B vaccine on day one of life.

They're not planning on sharing heroin needles or sleeping with prostitutes for a very long time, hopefully never. Why instead of putting that burden on our day one old babies? And by the way, so serious that I get calls all the time, they're calling in child protective services on me because I'm just trying to leave Cedar Sinai, which is like Alcatraz right now, because I just don't need this vaccine, I don't want this vaccine. This is how serious this is. They put the burden to the point where they're threatening to take.

take your child away if you don't give them a vaccine they don't need instead instead of threatening parents and putting the lives of infants at risk how about how about here's my idea how about you are going to lose your license as a doctor if you don't get the blood test of the mother that is giving birth just that simple instead of 88 percent here's one thing how about a hundred percent blood testing not 100 percent vaccine uptake by a bunch of children that will never need it. This is her point. Why? I'll tell you why. Because Merck doesn't make billions of dollars on you making sure that everyone's getting a blood test. They're making billions of dollars over this vaccine program. And this is where you can figure out where this whole scam is

happening. Who's been driving ASIP and why they're so shocked right now, probably upholding this vote because pharma is freaking out. We're about to lose our stranglehold on a vaccine program that was making us billions that nobody needs. And that is why we're playing these clips. This isn't Trump. This isn't Kennedy. This isn't an anti-vax conspiracy theory. When someone hears that they can't unhear these facts,

this is common sense, and these are people, these are educated, some of the top educated people in the country sitting on this independent panel, asking questions and presenting facts that need to be heard by the American public. So let's bring it back up to current present moment here. The hepatitis V-B vote was supposed to have, happen today, they're going to either keep the universal recommendation, put it in every arm of

every infant coming into this world, or they're going to have no recommendation anymore, or they're going to do what they did with the COVID vaccine and say, you talk to your doctor. It's called an individual decision-making process. It's between you and your doctor, as medicine probably always should have been. So that was delayed. That vote now has been delayed. It was deferred. It was voted to be deferred until tomorrow morning. So we're going to keep an eye on that. Follow, obviously our X channel, our Instagram, our Facebook. We're going to be posting up-to-date results on that vote. That will happen tomorrow morning.

So that is the latest on the ASEP committee.