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What did he find, and why does this discovery matter? Watch the jaw-dropping interview on CHD.TV’s daily show, ‘Good Morning CHD’ to find out! # Transcript __Mary__ Well, welcome, Dr. Kevin McKernan and Dr. Brian Hooker. I'm really thrilled to have both of you here with us. Brian, you're, of course, our Science Director here at Children's Health Defense. And Kevin, you have an incredibly impressive background in science. Would you just give us the quick highlights so that our viewers know how extensive your scientific credentials are? __Kevin McKernan__ Oh, certainly. Well, I guess I'll shoot myself in the foot and tell you I dropped out of a PhD program, so I never got my doctorate. But I have been working in the genomics field for 25 years now. I started on the Human Genome Project with Eric Lander down at the Whitehead Institute at MIT, was managing the research and development team there through the scale-up of the Human Genome Project. And then after that, spun a bunch of companies. At least Agencourt is one company we spun out of MIT that builds magnetic DNA purification tools, which may play a role in this story, and we also built some PCR tests there and had a genome center. That company got acquired by Beckman Coulter, and then we spun another company out called Agencourt Personal Genomics that built the SOLiD sequencer. That one got acquired by Applied Biosystems, and I worked with Applied Biosystems for five years building various DNA sequencers, including some semiconductor systems. I have done some clinical sequencing. We had a CLIA lab for a while that was doing sequencing of epilepsy and mitochondrial disease in kids, and that's kind where I first ran into a lot of parents telling me about vaccine injuries. And then we went into the cannabis arena where we're sequencing cannabis genomes, because many of the epileptic parents were looking for safe and effective cannabidiol, which was helping with seizures. So we got interested in that field and somehow I ended up here, sequencing a vaccine by mistake, and found something that people seem to be interested in. It's a long, winding road to where I'm now. __Mary__ Super. Tell us about this study that you did, where I think you were using these vials of the Pfizer and Moderna vaccines as controls. Is that right? __Kevin McKernan__ Yes. __Mary__ And you've stumbled on an incredibly important finding. __Kevin McKernan__ Yeah, we're trying to sort out the pathology of a viroid that's devastating the cannabis field, so we were doing RNA sequencing and the pipeline broke. Mary Well, wait. Let's go back. Viroid? Tell us what that is, Kevin. __Kevin McKernan__ Oh, a viroid is a naked piece of RNA that is infectious in itself. It doesn't have any protein code around it, so you can synthesize these and actually put them into plants, and they create some RNA interference and there's some pathology that results from this. They don't affect mammals, but they infect plants and they can be devastating. It's probably knocking down the yields in plants like 40% in this industry. Everyone's trying to understand this 256-letter piece of sequence that's a pathology in plants, at least in the cannabis plant right now. When we were sequencing the RNA of the cannabis genome to see what was happening when it got infected, we started getting all this sequencing data back that didn't look like it was concentrated on genes, and that's a sign that your RNA purification system might be broken. So the way to solve that and figure that out is to spike in a pharmaceutical grade RNA to see if you find out where it's broken. And I figured, well, these are probably pharmaceutical grade if they're injecting them into people. I'll use one of those. It has a polyA tag on it. It should stick to our magnetic beads, and it should tell us if we have an RNA prep problem or if something else is wrong. What I didn't expect to get out of the experiment was the contaminant that I then was pregnant with to tell the world about, that okay, it worked as a control. It taught us that we had a DNase problem in our RNA sequencing pipeline, but now I see there's a plasmid in here that I can't hide from and I've got to put it public as quickly as I can, as responsibly as I can. And so we chose to do that by releasing all of these really rapid Substack articles, because we just couldn't see this getting through the peer review process in a timely manner given the political nature of it right now. And so that's where we ended up. __Mary__ Great. I'm mindful that I'm ignorant. I'm not a scientist. Walk us back a little bit. Explain to our viewers, what is a plasmid? What did you find here? What does that mean for us? __Kevin McKernan__ When the clinical trials with... I want to be clear. This is mostly pertaining to Pfizer. We sequence Pfizer and Moderna, but there's different background to them. Pfizer's trial started by generating, you need to make this RNA. In order to make this RNA, you need to feed a DNA template to read the RNA from. It's called an in vitro transcription reaction. You present an RNA polymerase with a piece of DNA and it starts making RNA off of it. It's the ink for your Xerox machine, if you will. They started the clinical trial with DNA that was amplified with PCR, which is really clean DNA, because when you amplify it, it raises the amount of DNA from background a millionfold. There's no residual background. You get a really clean piece of DNA that you can make your RNA from. That was what the trial was run on, is called Process 1. Retsef Levi and Josh Guetzkow have a good paper on this in the BMJ. Then after the trial was done, they did the bait and switch and they changed the manufacturing process for scale-up by taking that piece of DNA that they PCR'd and used as a template in Process 1. They plugged it into a bacterial plasmid, which is just a circular piece of DNA that allows a bug like E. coli to replicate it every 30 minutes. That means they can have an infinite supply of their DNA. They just have to keep growing the E. coli day to day, and they don't ever have to use PCR again, so it's a real massive cost reduction for them. But it comes with some additional risk, is that you now have this DNA being replicated in E. coli and it's not good to inject people with E. Coli, so you have to get the DNA out of E. coli. And the process of getting that DNA out of E. coli comes with inherent contaminants that weren't in the original trial. The plasmid DNA is one of them, which is a large, 7,800-base pair piece of DNA, and then there's also the potential for endotoxin to come through from the E. coli. So, there's the material difference between the trial and what people actually got, and that's an important part of the story that everyone needs to know. Now what we're trying to do is figure out, what is the consequence of this plasma DNA being in there? They knew it was there. They tried to get rid of it by chewing it up with an enzyme, but they didn't get rid of it completely. They got it halfway chewed up. __Brian Hooker__ Why didn't they get rid of it completely? I mean, they use an enzyme called DNase, and DNase breaks down DNA. Why wouldn't that completely eliminate it? Two questions. Why wouldn't that completely eliminate it, and did FDA approve both processes, both the process for the proof of principle as well as the process for production, or were they involved in the second part? __Kevin McKernan__ I'll answer the second part first, which is that there was some discussion in the EMA. I don't know what's happened at the FDA, because we have less visibility there. __Brian Hooker__ Sure. __Kevin McKernan__ But there's some information at the EMA that I am superimposing on the FDA in Health Canada, because I think similar things may have occurred there. But at the EMA, they had an equivalency study that they were supposed to do, measuring 252 patients done with Process 1 and Process 2. And as best we can tell, that data was never matured and was never required for release. They asked of it, but when Pfizer couldn't produce it, they kind of looked the other way. __Brian Hooker__ Okay. __Kevin McKernan__ Josh has a good writeup on that on Twitter, and I'll point you to his work and Retsef Levi's work on this. But your first question, which is, "Why isn't the DNase killing this?", it comes down to, I think, two reasons. One, the way that they're measuring what's there has some blind spots. And the second thing is, they probably didn't anticipate that the modifications they made to the RNA inhibit the DNase from doing its job. So when they do this in vitro transcription reaction and they make this RNA, they put in a different nucleotide known as N1-Methylpseudouridine. __Brian Hooker__ Right. __Kevin McKernan__ This altered nucleotide is actually what really got the attention of the Nobel Prize. All right? They put in a different nucleotide so that the RNA was less labile to an RNase L that's in the human genome. The human body makes RNases that destroy RNA. The way RNA behaves is your DNA is like your hard drive, your RNA is like the task manager of all the programs that are opening and closing off that hard drive. The cell needs to have a system to not only turn a gene on, but to turn it off. If it can't turn it off, then you have a problem. The way a lot of these things get turned off is there are RNases that make sure that when a gene is expressed, it's only expressed for a certain period of time and it gets decayed. Well, they put in this other base that stops that process from happening, so that the RNA doesn't degrade as readily. __Mary__ They put in something that turned off the off switch. Is that correct? __Kevin McKernan__ Yeah. The RNA is harder to degrade, and they wanted that so they ensured they got production of spike protein long enough to matter. And there's a big debate as to whether it's too long right now, because we're finding these RNA stick around for way too long. They thought it was only 48 hours. People can sequence out of plasma. 28 days later, it's in breast milk now. __Brian Hooker__ Right. __Kevin McKernan__ So it's really a big train wreck, in my opinion. They didn't need that. But because of that base, that base also is published to radically change the melting temperature of DNA. That means that it's much stickier. It's much harder to peel apart from DNA. I think Callum Parr has a paper on this showing if you just put four of these nucleotides into 25 meric, it raises the temperature 9C, the melting temperature. __Brian Hooker__ Oh my goodness. __Kevin McKernan__ That's an enormous melting temperature shift for four bases of these things. That means that this RNA is extraordinarily sticky, and that means it's very likely that it's making RNA-DNA hybrids, that when the RNA polymerase is copying the RNA off the DNA, what you end up with is a triple helix. You end up with RNA kind of tangled up with DNA, and a nuclease doesn't know how to get rid of the DNA in that context. And this is really evident actually in Moderna's process. Moderna, if you look at our paper, there's a hundredfold more spike DNA contamination than the plasmid DNA, the backbone that doesn't have any RNA similarity. That's a real clear set sign that the nucleus can destroy the DNA that doesn't have any complimentary to RNA, but it can't destroy the DNA that has complimentary to the RNA that they're making. There's something I think they didn't see and anticipate. Because they changed the space, they didn't realize the enzymes they typically use to get rid of this contaminant are no longer functional. And so they now have to probably engineer different enzymes for this, and DNase XT is a good idea. Maybe T5. There's a host of these nucleases that might do a better job at this. But I think with the Warp Speed program, they didn't have time to really investigate this. That's one reason why the DNase is there. There's a second reason. The tools that you use to measure this differ based on the size of the DNA that's around. So if you use something like fluorometry, this is a tool that uses a dye that is an interpolating dye that binds to the minor groove of DNA. These tools will measure DNA as small as five to 10 bases. It just has to be complimentary at room temperature. That can be a 10-base pair piece of DNA you can get some SYBR Green study or signal from, or RiboGreen signal from. qPCR needs at least 100 bases to amplify, so all the DNA that's smaller than 100 bases, it can't see. So, they're using qPCR to monitor the DNA. They're using fluorimetry to measure the RNA. They're kind of playing some games there because they want to get really high RNA numbers and really low DNA numbers, because the EMA regulations aren't really a fixed amount of DNA. They're a ratio of how much RNA you have to how much DNA. __Mary__ They're using two different processes to measure the DNA and the RNA. But if I understand you correctly, they could be using one process for both, or they could use both processes for both. __Kevin McKernan__ Absolutely. __Mary__ Is that correct? __Kevin McKernan__ In fact, this- __Mary__ And then you have more reliable data. Is that right? __Kevin McKernan__ Yeah, that's absolutely right. And I think anyone who's familiar with these bench tools knows the fact that they're deviating this is a game, because they had to make PCR primers to measure the spike DNA and all they have to do is change the polymerase to measure the RNA, and they didn't do that. They opted to go get a whole nother assay with a different instrument, with a different fluorometry-based readout to measure the RNA. They bent over backwards to measure the RNA differently. They already had all the primers and tools they needed to measure it with the PCR assay they're using to measure the DNA. You just swap the polymerase out and you get the answer the same day. __Mary__ This suggests gamesmanship, is that correct? __Kevin McKernan__ Exactly. Intent to deceive. __Mary__ Intent to deceive. Okay. Got it. And this data that you've uncovered has been replicated around the world. Is that right? __Kevin McKernan__ Yes. Many labs now. We put the primers public on our Substack and in pre-prints, and now people can just order those from IDT and make their own primers. We have shipped also primer lots that we have here when people didn't want to wait for IDT to remake these. It can take IDT maybe a couple of weeks sometimes to make these, so when people urgently want them, we'll ship them vials of our primers. Philip Buckholtz has confirmed this work by using our primers down on vials in South Carolina. He also went on to do Oxford nanopore sequencing to confirm our work, just not to trust what we told him was working, was doing what our primers were doing. He said, "All right, your primers' clearly giving me signal on my vaccine lots. I'm now going to sequence them and make sure I can find the sequences of your primers inside my vials." And he went and did that and confirmed that the DNA that he actually has in his vials matches the primer sequences we gave him. Dr. Sin Lee did this at Milford Molecular with Sanger sequencing. He amplified. He made his own primers and amplified. He amplified some large fragments too, like 366 base pair fragments, to show that there's bigger fragments in there. And Sanger sequenced those to prove that it's in fact in the vials. And now the most recent study... I heard of one in Germany. I don't have the data from one in Germany, but Brigitte Konig claims to have found it in four vials out there as well. There's a group in Japan, Hiroshi Arakawa, I think, I may be fumbling his name, but they've been doing some work on this as well.They've reassembled our data and been looking at some PCR protocols. But the most recent one is out of David Speaker's work out in an Ontario where he's got the largest study to date. He went through 27 vials and he even did some XBB.1.5s and those still have the DNA in them. Now, there's two different methods that we used in the paper with David just to try to emulate what Pfizer's doing is we measured it with qPCR, in which case the DNA is under the limit on everything he looked at. A couple of them are getting really close to the line. That limit is somewhat arbitrary and we'll touch on that. Then he also measured it with fluorometry to show that they're like 100 foot over the line if you pick a different tool to really emphasize that this game of cherry-picking different methods is a racket and that you can get vastly different numbers if you measure this thing with different tools. But I think the interesting part of David's study is they took the vaccine lots, sorted them based on DNA quantity and then Jessica Rose dug into VAERS and showed that there are higher adverse events reported in VAERS, the lots that have higher amounts of DNA. Now it's a small dataset. There's a lot of confounders there. It's really just a hypothesis. We have to study more lots to make sure that there aren't other confounders that are skewing that association. But it does seem to line up with Philip's data. He has numbers that are over the limit and have high adverse events. We had numbers over the limit that have high adverse events. And there's another lot that was recorded in some EMA documentation, FL0007, that has really high adverse events and has really high DNA as well. So there's a couple other pieces of data that aren't in our paper because they were done at other laboratories that reconfirm, at least with Pfizer, more DNA is trending with more adverse events. We're not seeing that with Moderna, which is interesting. The correlation seems to go the other direction there, and they are doing a better job getting rid of it. They're probably at a log scale lower amounts of DNA, so they may be below the amount that matters and something else is driving their adverse events. __Brian Hooker__ So now we've found and confirmed in several different labs including Phil Buckholtz’s labs and Sin Lee's labs. You've confirmed the presence of double-stranded DNA and in sizable quantities. I mean, we're talking about nanogram per milligram quantities or 100s of nanogram per milligram quantities of DNA. First of all, what are the implications of just having double-stranded DNA in those vials medically? And then second of all, what is in that DNA? I mean, what is hiding in that DNA? What elements do we need to be concerned about? __Kevin McKernan__ Well, hiding is a good point because I do think there's been some intent to deceive here as well, particularly on Pfizer's behalf, if you were to take the DNA sequence, which apparently they did give the sequence to regulators, but they only annotated certain pieces of it and not others. And that's very bizarre because if you take their sequence and plug it into a standard software tool like SnapGene, it will annotate everything. So someone had to actively go and delete these annotations and then hand something to the regulators. And the piece that they deleted, I think is the most controversial piece. It's this SV40 promoter that is known to have a nuclear targeting sequence in this. This is a tandem repeat of 72 bases, about 144 bases in size, that binds transcription factors and drags any DNA attached to it into the nucleus. __Brian Hooker__ This is an enhancer of the SV40 promoter? SV40 was used in... The SV40 or the promoter, but they never reported the enhancer's presence. Is that correct? __Kevin McKernan__ They didn't report any of the SV40 components. __Brian Hooker__ Wow. __Kevin McKernan__ In fact, I can pull up what they did report here. So what you see on the right is what they presented to the EMA. I suspect this is what went to Health Canada as well. And they're somewhat shocked by this from the most recent email I saw from them. But you'll notice it annotates the spike protein, the ori, the kanamycin gene. It has this five base pair cut site down here that linearizes the plasmid. A couple other small pieces. If you take their sequence and just shove it into something known as SnapGene, it annotates all the stuff automatically over here. This SV40 just pops out. So I didn't find SV40. SnapGene found it by default. __Mary__ I'm going to pull us back. So on the right, the ori and the kan R and the S protein, explain to us what is that showing us on the right and then what did they have to take out to get to what you showed us through SnapGene on the left? __Kevin McKernan__ Okay. So the bacterial origin of replication is here in blue. So when you put this in E. coli, it will double with E. coli. It probably runs the copy number to 50 to 100 copies in the cell, and then the cells double every 30 minutes. So it's a great Xerox machine for DNA. But to make that happen in E. coli, you have to put a kanamycin resistance gene in there so that only the E. coli cells that have the plasmid survive. That way you knock out all the background. So this is the kanamycin gene. Now, this kanamycin gene won't work on its own. It needs a promoter that they've materially omitted here. __Brian Hooker__ Omitted. Right. __Mary__ Oh, interesting. __Kevin McKernan__ That's missing- __Mary__ So graph on the right seems very strange because that kanamycin wouldn't work without a promoter? __Kevin McKernan__ Yep. __Brian Hooker__ Correct. __Kevin McKernan__ And the other thing about the SV40 promoter is it is active in mammalian cells and you really don't want mammalian promoters in any injectable. They don't need this because they have... If you look very carefully here, there's also an AmpR promoter that's kind of obscured over here in the left. That's what Moderna uses to drive the kanamycin gene. Pfizer has it too. They just happen to also have this mammalian promoter that is superfluous and shouldn't be there. And they know it because they deleted it from the annotation. __Mary__ That's an intent to deceive? They actually are omitting that information? __Kevin McKernan__ I believe so, because any annotation tool that annotated this plasmid that got down to T7 promoters, it found the bacterial origin, it found, I think this F1 origin down here, it would've found the SV40 origin. There's no reason- __Brian Hooker__ So this was deleted. This was deleted. __Kevin McKernan__ This was intentionally deleted. __Brian Hooker__ Right. Right. __Mary__ And let's just do a little background, gentlemen, on SV40. Maybe Brian, can you give us a little bit of background in the vaccine context of what SV40 really is? And then Kevin, we [inaudible] with you. __Brian Hooker__ And Kevin, correct me if I'm wrong, but the SV40, simian virus 40, was an artifact of the polio vaccine, the oral, the live polio vaccine in the 1950s and 1960s, and it is oncogenic. SV40 itself as the virus is associated with certain tumors, certain forms of cancer, certain aggressive forms of cancer, and that it was a contaminant in the oral polio vaccine, the live virus polio vaccine, for many, many years. And so having these elements, including the SV40 promoter would in itself, I believe, would be oncogenic, and then that SV40 element, that 72 base pair element, has been shown to tie with other oncogenes in vivo and act as an enhancer, enhances its ability to form cancers. __Kevin McKernan__ So I'm very new to SV40. I've been learning this just in this last year as to what's going on in the field. Now we don't have the whole SV40 virus, which is 5.2 kilobases. We have about 420 bases or so of it, which consists of four pieces. We have the SV40 origin, the promoter, the enhancer and the poly(A) signal that are in there. SV40, I think instructs it to put a poly(A) signal on a messenger RNA. For some reason that's sitting in the vector as well. I haven't studied as much on what the poly(A) signal, why they need the poly(A) signal in this vector. That seems to be... I think that's needed... If they want to express these plasmids of mammalian cells, it's good to have something that puts a poly(A) signal on it. And so I think they put that on the F1 origin for other reasons. So that being said, a lot of pushback is, "Hey. This doesn't have the T antigen. The tumor antigen is what is deemed to be the carcinogen in SV40. And so you guys are conflating SV40 with the virus and you're spreading fear porn and all that." But I think an important thing to know is that a large portion of the population is SV40 positive from the polio vaccine. So they presumably can make T antigen. And why is that important? Well, T antigen is what actually initiates the DNA replication on the SV40 promoter that's in the vaccine. So if a certain part of the population makes T antigen and you inject them with a lot of these promoters, they're going to have the machinery to turn that promoter on wherever it lands. So there's- __Brian Hooker__ In other words, if- __Kevin McKernan__ We don't know the implications of this. __Brian Hooker__ Right. Right. In other words, if you've been vaccinated with the oral polio or the live virus polio vaccine, then essentially you could have the T antigen already in you. __Kevin McKernan__ Right. Right. And that's something that I can't really... I think right now we have data here that shows there's a legal problem here, more so than we have evidence of a clinical problem. The clinical problem, we still need more data from. We need to find out if this DNA is actually in other people post-vaccination and people who haven't been vaccinated to see is it associated with a lot of this adverse events. Right now, this is just hypothesis generation. We don't really have it. We have a lot of reasons to believe this is a bad idea. They don't need this DNA in there. They didn't tell the regulators about it. And it's inside of an LNP and it's going to get to the nucleus space and the sequence that's in there. So all of that is a train wreck. If you're putting in 200 billion of these molecules per shot and you're doing them five times a year... I don't know how many times people are taking them, but if you think of your schedule, you should be past your fifth by now. So there's a cumulative dosing problem here. There's a high number of these fragments in there. Even though the nanograms might seem low, the fragmentation of them makes them like buckshot and makes them much more potent as integration tools because you have more active ends of DNA. It's the ends of the DNA that have phosphates and hydroxyls on them that make them sticky. Those are kind of like the Lego pieces of DNA, if you will. So you'll see an FDA documentation on guidance documents that look at DNA, that they base these nanogram limits based on genomic DNA. 10 nanograms of genomic DNA might be like 1200 copies of DNA, but we're dealing with really small pieces, which means we have 100s of billions of these pieces. And they even allude to the fact that if you were dealing with not mammalian cell contamination, which would be 3 gigabase genomes, but you're dealing with viruses, well, then the copy number is so damn high that you might need femtogram or attogram limits on the amount of DNA that could be around. There's other guidance documents that also speak to the fact that the 200 base paired limit is maybe not really pertinent if you're dealing with promoters. Maybe it should be down at seven bases, because seven bases could integrate and cause problems even in a VDJ circumstance with certain parts of the genome. So there are guidance documents that need nuance and conceptualization and contextualization. They put out guidance documents before LNPs were round saying, "We think there's going to be mammalian cell DNA. We can tolerate this much of it based on this copy number based on us not knowing much about it," but the moment you start getting into high copy number contaminants that have bioactive elements to them and they're inside LNPs, the whole game changes. And- __Brian Hooker__ It's really astounding. When you look at these genomic insertion events, and I've done genetic engineering before, primarily in genetically modified plants and bacteria, it's like you're going to Vegas. You're looking for the one in a million event, but there are enough errant strands of DNA around there for that to actually happen. Is that correct? __Kevin McKernan__ Yeah. Philip Buckholt put up an interesting paper on his Twitter recently about the rate when you get a million transfection like this, the rate of cells that stably integrate was like seven... It was down below 7%, but 7% is a huge number when you're dealing with billions of LMPs. __Brian Hooker__ Right. __Kevin McKernan__ So this is- __Mary__ LMP is lipid nanoparticle, is that right, Kevin? __Kevin McKernan__ That's right, yeah. These are packaged in these LMPs. We know that. That was part of our most recent papers. If you use a nuclease on the vaccine, it won't get rid of the DNA that's there because it's protected. It's inside this lipid nanoparticle. The guidance documents the FDA have for DNA contamination, they're just ancient relics. They're outdated. They actually started before the NCVIA, which is this National Childhood Vaccine Injury Act. They were at 10 picograms back then. After that act, they went up a thousand-fold over the course of 10 years. We're now at the stage where we've tolerated a thousand times higher. Now we're switching to LMPs that bring these things directly into cells with nuclear targeting sequences. __Brian Hooker__ We were told that this would not target the nucleus. We were told that this would not enter into the nucleus. Is the nuclear targeting sequence, is that the SV40 enhancer? __Kevin McKernan__ That is. It's been published as a great gene therapy tool because it's so effective at bringing things to the nucleus in hours. David Dean has great work on this, and Health Canada has just admitted that they found it. It's in the vaccine. All these arguments about our vials are from dumpsters and everything, Pfizer gave sequence to Health Canada that has it in there so there's no more argument of it being in there. __Mary__ Let's move to the legal issue that you flagged for us, Kevin. Health Canada has acknowledged that this DNA contamination is in the vials. We now have a major government of the world acknowledging this, and Children's Health Defense on Friday last week, published a story quoting Health Canada as saying, "Health Canada expects sponsors to identify any biologically functional DNA sequences within a plasmid such as an SV40 enhancer at the time of submission." But we know that that didn't happen. To your mind, as a scientist who's long been involved in this area, should that be enough to now force all of the governments around the world to take these vials off the market until they've been investigated? __Kevin McKernan__ I would think so. If they don't do this, what are they there for? This is like every time someone breaks a rule, they just change the rule. What do we need regulators for if they're not going to stick to these rules and guidelines they put forward? Now, unfortunately, in the same breadth of that email, I think they reiterated the safe and effective psalm. Like, okay- __Mary__ They did, but that's nonsense as people say. They say the risk benefit profile continues to support the use, but if they didn't know this and they don't acknowledge it, then how could they assess the risk benefit profile? That seems just nonsensical. __Kevin McKernan__ It's circular. It's very circular for them to state that, that you don't actually... I mean, an important point to that risk. They waived the genome toxicity studies in the trial so how can they know risk? __Brian Hooker__ Right. They did. They don't know that there's risk because the trials were never done. How can you get away with... It seemed like when you look at the plasmid submission to the FDA, there are unknown sequences. There are big black boxes. There's a big unknown where the SV40 promoter went. Why did they tolerate this in the first place? __Kevin McKernan__ I don't know because there's other things in that sequence. There's other points in that sequence that should have rung alarm bells. If you turn on any sort of ORF finding tool, so to paint where the open reading frames are, you can identify where the spike is. But the thing that will blow your mind is that there's an ORF on the reverse strand of the spike that is 252 amino acids long. That should have been a red flag. That tells me that no one opened this in a tool. They got the sequence and probably just said, "Pay your user fee and we'll put it in a file and move on." What an ORF finder does is it looks for open reading frames. If you turn it on, it will look for start codons and stop codons and it instantly finds the spike protein. If you ask this to look on both strands of the DNA, it will find another ORF that runs the entire direction on the other strand of the spike protein for 1,252 amino acids long. I don't have it visualized here because I picked up the wrong screen here, but I do have it on my substack and people can see this. Now, anyone who is regulating this should have put this into a tool like SnapGene to say, "Show me what's in this plasmid," and it annotates all these pieces for you. It would've shown you that there is a mysterious ORF of unknown origin that encodes the entire opposite strand of the spike protein. What the hell is that? Why is it there? Moderna doesn't have it. The virus doesn't have it. __Mary__ It's unknown? They don't know what it is? __Kevin McKernan__ Unknown. I mean, I've blasted this thing against NCB, I didn't get many hits. The only hits I can find it in UniProt are to a gene or protein that's in silk and in collagen and in some other fibroin thing. I don't know what this does, but I know that this is an artifact of their codon optimization that should not be there and is a massive risk and they should get rid of it because it's actually a massive Sudoku puzzle for someone to actually figure this out. How do you get a 1,273 amino acid open reading frame at one strand and how do you get one on the other that doesn't have a stop codon anywhere? It seems like a computation. __Mary__ Wow, that's very… __Brian Hooker__ What are the implications of having that ORF going in the opposite direction and then injecting that into humans? __Kevin McKernan__ I don't know if it's going to get expressed. That's the thing, is that this [inaudible] answer is a bi-directional promoter. Presumably, it makes RNA in both directions. If for some reason it spans this polyA region in the plasmid, it could go and start making RNA over that unknown, that mysterious ORF. I don't know what that's going to do in the cell. I don't know if there's a Kozak consensus sequence there. It's very difficult to informationally screen for internal ribosomal entry sites so I can't tell you that the ribosome is definitely going to translate this thing. But I can certainly tell you that if I were a regulator, I would tell them to get rid of it because it's risk with no gain and it's unnecessary. __Brian Hooker__ Do you think they really even look at this? __Mary__ Sorry, [inaudible]- __Kevin McKernan__ There's no way they did. If they looked at this, this would've rung out to them and likewise, the SV40 omission would've rung out to them. So it's clear to me they didn't look. I think they collected their user fee and put the thing in the file. __Mary__ So the regulators were asleep on the job. It sounds like what you're saying because they didn't catch SV40 that they could have easily caught through SnapGene and they also didn't tell us about this open reading frame 1,237 base pairs. Is that right? __Kevin McKernan__ Yeah. The open reading frame is 1,273 for the spike, and on the reverse side there's a 1,252 amino acid open reading frame. I could see someone writing it off being like, "Oh, it's Messenger RNA, it's going to be single stranded. The reverse strand won't be there when it's in RNA form." But they didn't anticipate the DNA is going to come with it. Now we have both strands there and the other strand codes for something. If any of this stuff integrates, it's likely to be an open reading frame of a foreign peptide that your immune system's not going to like. The point is it's a very open reading frame rich plasmid. There's not a lot of stop codons. __Brian Hooker__ We've got millions and millions of lipid nanoparticles that are floating around physiologically and basically, the lipid nanoparticles contain what appears to be transfection soup. How do people not get transfected by this? __Kevin McKernan__ I think the numbers are probably in the billions to trillions from what I've read on the LMPs, which is a large number. Yeah, they probably have the RNA and the DNA in them from the measurements we've made. They're packaged, and their nucleus resistant and they're ending up in cells. Now, what a lot of people push back is like, "Okay, any cell that gets transfected is going to die, so who cares if this car goes in there?" But that's not really true because we see this spike protein and the spike sequence persisting at least 28 days. People have sequenced mRNA or DNA, we don't know which one it was, but they got sequence of the vaccine 28 days later in plasmid. They have found it in breast milk five or seven days later. The protein itself, they have found, Patterson found it four months later on exosomes, I think. Sorry, that was Bancel. Patterson found it like I think 200 days later in macrophages. So something is persisting, and I don't think every cell that gets transformed is a 100% killed instantly. There's something going on where people can't clear this and maybe it's hitting immune privileged cells, and that's why it sits around forever. I think it is a risk if there's DNA floating around, it's going to add to the persistence of this 'cause it could integrate and continually express these other foreign peptides. __Brian Hooker__ Exactly, and what about the implications? When I think of DNA disrepair, I think of cancer, and so I get very, very concerned about that. Just not specifically on, "Oh, we're making people into genomically stable spike protein production factories," but also just the other bits and pieces of DNA that are getting integrated into the genome, and what are they doing? What are they enhancing or what are they silencing? __Kevin McKernan__ Well, what made me nervous is when we saw... So Philip's work, I think showed a couple billion of the amplicons from just PCR. PCR measures a hundred base per amplicon. We have one that actually targets the SV40 promoter. If there's a billion copies of just that region in every injection, that's carpet bombing a genome with a billion promoters. Where those land and what efficiency is an open debate, but wherever they land, they're going to be active promoters of a million cells. I think that alone is an issue because you're just dropping these things that make RNA into the genome randomly, and if you happen to put one on a proto-oncogene, a host of issues. Now there's other areas…There are genes that if you hyper express them, they can drive to excess cell growth. They call them proto-oncogenes. If you put an active promoter in front of that, it turns out it's not good. The other thing that can happen is you can break a gene that slows down cancer like P53. P53 and BRCA are these DNA repair enzymes, and if you happen to put a different part of the plasmid inside of those, it could disable those- __Brian Hooker__ Disrupts them, yes. __Kevin McKernan__ ... then you don't have this repair mechanism that you need. Now, most people have two copies of all these genes. So many people you break one of them, maybe okay. But there are subsets of people that have BRCA mutations and P53 mutations and they're haploid, so they have one bad copy and one good copy. You come in with this vaccine, you can knock out the only other good copy. There's a whole host of rare genetics that you have to consider in this, and perhaps why this may not be something you'd be seeing in all patients. There's another dimension of which vaccine lots have more of this versus less of this, like the Schmeling paper you look at has 4% of the vaccine lots having, I don't know, the majority of the adverse events. We have a lot of Venn diagrams here of things to consider. There's a lot of people who probably took these and don't have any harm at all. There's maybe a subset of people that take these bad lots that in fact have some genetic reason why they're more susceptible to the harm than others. __Mary__ Kevin, you've mentioned I think today and in the past that this promoter, the SV40 promoter in particular, is used in gene therapy, and yet this was not reviewed as a gene therapy, it was reviewed as a vaccine. Is that an issue in your view? __Kevin McKernan__ Yeah, I think that is actually a very serious legal issue. This here is the SV40 enhancer that is published to bind all of these transcription factors and drag this sequence into the nucleus. There's two of these copies of these 72 base pair pieces of DNA. And this is what they're putting on plasmids to get them to do perform gene therapy. So the sequence that they omitted is a bioactive sequence according to Health Canada, and it is used in gene therapy. There's just no debate anymore. The plasmids that are in there are gene therapy tools, and they're injected into billions of people. __Mary__ So not only was there no informed consent for anybody, and this was emergency use authorization, so, by law, they weren't able to give truly informed consent, but it looks like this was a gene therapy, and people were not told that this was a gene therapy. Is that right? __Kevin McKernan__ That's right. And now, they may not have meant for it to be this, but they certainly, in my opinion, hid it. The fact that that SV40 region is the only origin missing on the vector means whoever ran the annotation program there probably had three origins show up, the F1, the bacterial, and the SV40, and decided to remove the SV40 because it was an unpopular name, and they knew it was controversial. __Brian Hooker__ Incredible. __Mary__ There's a long literature in mainstream scientific journals about SV40. Isn't that right, Brian? __Brian Hooker__ Absolutely. It's such a strong promoter, and it's a mammalian active promoter. And so you would expect, if you put that promoter and especially if you have that 72 base pair enhancer region, that you're basically... You've got a nuclear localization signal, and so that is its job. It basically will take the DNA sequence behind it, and it will deliver it into the nucleus. It's absolutely incredible that this is there. It's absolutely incredible this whole thing was hidden from view. Wouldn’t that raise…Again, maybe I'm beating a dead horse, but just the absence of that information, wouldn't that raise some type of red flag with the EMA and the FDA? __Kevin McKernan__ You would hope so, that they would feel deceived by this. That this is not something that it's clearly in their rules that you need to declare these things, and now they find out years later that they weren't shared this information. So I- __Brian Hooker__ So, you've been…Right, right. You've been looking at this for quite a while now, Kevin. And so if you don't like the message, you shoot the messenger. So what's happening with you? __Kevin McKernan__ Oh, well, I've already been character assassinated for my choice to get into the cannabis field, so I'm kind of bulletproof from that standpoint. __Brian Hooker__ That's almost as bad as looking at vaccines in general, so yes. __Kevin McKernan__ Yeah, exactly, yeah. __Mary__ Well, Kevin helped us in the past. I want to point out that Kevin generously gave us a declaration in a case that we filed against coercive PCR testing of children in New York City schools, and we're very grateful for that. So you're not worried about the character assassination that goes along with this, Kevin? __Kevin McKernan__ No, they already assassinated my character a decade ago when I decided to start studying cannabis. So they'll continue on that front. And yeah, we get harassed on Twitter and all the usual social media nonsense, but I don't think this is... I don't think it's very effective. It oftentimes, I think, has the reverse effect, as people see who they're attacking. And you can see our pre-print on Thursday's got like 72,000 downloads now, probably because the Streisand effect of everyone who's hating on us on Twitter. __Mary__ What's your Substack, so that we can have everybody follow you on it? __Kevin McKernan__ It's named after the active compound in catnip. I'm a cat person, so nepetalactone. So, it's unfortunately really horrible to tell somebody in order to spell, but lactone is the last word. If you ever get confused, just look up the active ingredient in catnip, and it will give you that long-winded name. I taught people how to take the Pfizer sequence as if they were given it as if they worked at the EMA or Health Canada. This is the tool that you would probably use to open it up and look at it. This is called SnapGene. It's a free tool. Download it, open the file, and it will instantly paint you the SV40 regions. So this shows you that someone had to go in and actively delete this because the standard tools in the industry paint this thing. So, I don't get credit for finding SV40. SnapGene found it. It painted it the first time I loaded the sequence in, which is why I was really confused to see that it was not in Pfizer's plasmid map 'cause that told me somebody had to go erase it. That's not an, "Oops, I forgot it." That's a "I clearly wanted to deceive you" type of move. __Brian Hooker__ Right. __Kevin McKernan__ And this is just a picture of that second origin [inaudible] is going the opposite direction. And teaches people how to go and look for these yourselves and some of the genes that that thing hits. They're not really strong hits, but I'm like, "This is really weird." It's a protein in silk that shows- __Brian Hooker__ Oh my goodness. It is. It is a protein in silk. And these intervening sequences, these SV40 sequences, it's not just you. It's Health Canada now, right? __Kevin McKernan__ Yeah, they confirmed in that email that "Yes, we were given the sequence from the plasmid, but we were not specifically annotated the SV40 that was in that sequence." They annotated all those other pieces and just decided to not tell them about the SV40 in the sequence. __Brian Hooker__ But they have the sequence itself- __Kevin McKernan__ ... a huge in a page in there, and not telling them that you slipped something in there. __Brian Hooker__ So they have the sequence themselves. They can run SnapGene just like anybody else. __Kevin McKernan__ In theory. I suspect that they did until we published our work. __Brian Hooker__ Right. Oopsie. __Mary__ You've identified for us, Kevin, that the FDA and Health Canada and the EMA potentially could allege that they were deceived, and perhaps they were deceived, and that perhaps opens the door for them, right now, to take much more dramatic action. __Kevin McKernan__ I think that's fair because if you look through the volume of data that Pfizer's handing over, it's almost this drown the regulator in material, so they can't possibly read it all. And that's really easy to do with sequence information. You hand them a file of 7,800 bases, and unless they have the time to set someone aside and say, "Annotate this and look at this and tell me if there's anything weird in it"... They're then also buried in all the PCR data, all the LPS data. Pfizer even went out and engineered a new mass spec method of DNA sequencing to try to show them that their Poly(A) signals in the vaccine were the right length. They did all of this work that I thought was fairly unnecessary and looked like a tactic of drowning regulators in data, that that's probably what's occurring here. __Mary__ They snowed them. Well, this is incredibly enlightening. Kevin, thank you so much for taking the time to explain this to us. I certainly have a much clearer picture, and we can send people to your catnip, nepetalactone. Is that right? Newsletter to get all the latest and look at it in greater detail. Again, thank you both so much for doing this. __Brian Hooker__ Thank you. Thank you so much, Kevin, and we look forward to your further research. __Kevin McKernan__ Thank you for having us to get the word out.59:Tc10a,Shocking and potentially deadly: during in-depth testing of the contents in COVID-19 injection vials, scientist Kevin McKernan stumbled upon identifying contaminants with severe consequences for the human race. What did he find, and why does this discovery matter? Watch the jaw-dropping interview on CHD.TV’s daily show, ‘Good Morning CHD’ to find out! # Transcript __Mary__ Well, welcome, Dr. Kevin McKernan and Dr. Brian Hooker. I'm really thrilled to have both of you here with us. Brian, you're, of course, our Science Director here at Children's Health Defense. And Kevin, you have an incredibly impressive background in science. Would you just give us the quick highlights so that our viewers know how extensive your scientific credentials are? __Kevin McKernan__ Oh, certainly. Well, I guess I'll shoot myself in the foot and tell you I dropped out of a PhD program, so I never got my doctorate. But I have been working in the genomics field for 25 years now. I started on the Human Genome Project with Eric Lander down at the Whitehead Institute at MIT, was managing the research and development team there through the scale-up of the Human Genome Project. And then after that, spun a bunch of companies. At least Agencourt is one company we spun out of MIT that builds magnetic DNA purification tools, which may play a role in this story, and we also built some PCR tests there and had a genome center. That company got acquired by Beckman Coulter, and then we spun another company out called Agencourt Personal Genomics that built the SOLiD sequencer. That one got acquired by Applied Biosystems, and I worked with Applied Biosystems for five years building various DNA sequencers, including some semiconductor systems. I have done some clinical sequencing. We had a CLIA lab for a while that was doing sequencing of epilepsy and mitochondrial disease in kids, and that's kind where I first ran into a lot of parents telling me about vaccine injuries. And then we went into the cannabis arena where we're sequencing cannabis genomes, because many of the epileptic parents were looking for safe and effective cannabidiol, which was helping with seizures. So we got interested in that field and somehow I ended up here, sequencing a vaccine by mistake, and found something that people seem to be interested in. It's a long, winding road to where I'm now. __Mary__ Super. Tell us about this study that you did, where I think you were using these vials of the Pfizer and Moderna vaccines as controls. Is that right? __Kevin McKernan__ Yes. __Mary__ And you've stumbled on an incredibly important finding. __Kevin McKernan__ Yeah, we're trying to sort out the pathology of a viroid that's devastating the cannabis field, so we were doing RNA sequencing and the pipeline broke. Mary Well, wait. Let's go back. Viroid? Tell us what that is, Kevin. __Kevin McKernan__ Oh, a viroid is a naked piece of RNA that is infectious in itself. It doesn't have any protein code around it, so you can synthesize these and actually put them into plants, and they create some RNA interference and there's some pathology that results from this. They don't affect mammals, but they infect plants and they can be devastating. It's probably knocking down the yields in plants like 40% in this industry. Everyone's trying to understand this 256-letter piece of sequence that's a pathology in plants, at least in the cannabis plant right now. When we were sequencing the RNA of the cannabis genome to see what was happening when it got infected, we started getting all this sequencing data back that didn't look like it was concentrated on genes, and that's a sign that your RNA purification system might be broken. So the way to solve that and figure that out is to spike in a pharmaceutical grade RNA to see if you find out where it's broken. And I figured, well, these are probably pharmaceutical grade if they're injecting them into people. I'll use one of those. It has a polyA tag on it. It should stick to our magnetic beads, and it should tell us if we have an RNA prep problem or if something else is wrong. What I didn't expect to get out of the experiment was the contaminant that I then was pregnant with to tell the world about, that okay, it worked as a control. It taught us that we had a DNase problem in our RNA sequencing pipeline, but now I see there's a plasmid in here that I can't hide from and I've got to put it public as quickly as I can, as responsibly as I can. And so we chose to do that by releasing all of these really rapid Substack articles, because we just couldn't see this getting through the peer review process in a timely manner given the political nature of it right now. And so that's where we ended up. __Mary__ Great. I'm mindful that I'm ignorant. I'm not a scientist. Walk us back a little bit. Explain to our viewers, what is a plasmid? What did you find here? What does that mean for us? __Kevin McKernan__ When the clinical trials with... I want to be clear. This is mostly pertaining to Pfizer. We sequence Pfizer and Moderna, but there's different background to them. Pfizer's trial started by generating, you need to make this RNA. In order to make this RNA, you need to feed a DNA template to read the RNA from. It's called an in vitro transcription reaction. You present an RNA polymerase with a piece of DNA and it starts making RNA off of it. It's the ink for your Xerox machine, if you will. They started the clinical trial with DNA that was amplified with PCR, which is really clean DNA, because when you amplify it, it raises the amount of DNA from background a millionfold. There's no residual background. You get a really clean piece of DNA that you can make your RNA from. That was what the trial was run on, is called Process 1. Retsef Levi and Josh Guetzkow have a good paper on this in the BMJ. Then after the trial was done, they did the bait and switch and they changed the manufacturing process for scale-up by taking that piece of DNA that they PCR'd and used as a template in Process 1. They plugged it into a bacterial plasmid, which is just a circular piece of DNA that allows a bug like E. coli to replicate it every 30 minutes. That means they can have an infinite supply of their DNA. They just have to keep growing the E. coli day to day, and they don't ever have to use PCR again, so it's a real massive cost reduction for them. But it comes with some additional risk, is that you now have this DNA being replicated in E. coli and it's not good to inject people with E. Coli, so you have to get the DNA out of E. coli. And the process of getting that DNA out of E. coli comes with inherent contaminants that weren't in the original trial. The plasmid DNA is one of them, which is a large, 7,800-base pair piece of DNA, and then there's also the potential for endotoxin to come through from the E. coli. So, there's the material difference between the trial and what people actually got, and that's an important part of the story that everyone needs to know. Now what we're trying to do is figure out, what is the consequence of this plasma DNA being in there? They knew it was there. They tried to get rid of it by chewing it up with an enzyme, but they didn't get rid of it completely. They got it halfway chewed up. __Brian Hooker__ Why didn't they get rid of it completely? I mean, they use an enzyme called DNase, and DNase breaks down DNA. Why wouldn't that completely eliminate it? Two questions. Why wouldn't that completely eliminate it, and did FDA approve both processes, both the process for the proof of principle as well as the process for production, or were they involved in the second part? __Kevin McKernan__ I'll answer the second part first, which is that there was some discussion in the EMA. I don't know what's happened at the FDA, because we have less visibility there. __Brian Hooker__ Sure. __Kevin McKernan__ But there's some information at the EMA that I am superimposing on the FDA in Health Canada, because I think similar things may have occurred there. But at the EMA, they had an equivalency study that they were supposed to do, measuring 252 patients done with Process 1 and Process 2. And as best we can tell, that data was never matured and was never required for release. They asked of it, but when Pfizer couldn't produce it, they kind of looked the other way. __Brian Hooker__ Okay. __Kevin McKernan__ Josh has a good writeup on that on Twitter, and I'll point you to his work and Retsef Levi's work on this. But your first question, which is, "Why isn't the DNase killing this?", it comes down to, I think, two reasons. One, the way that they're measuring what's there has some blind spots. And the second thing is, they probably didn't anticipate that the modifications they made to the RNA inhibit the DNase from doing its job. So when they do this in vitro transcription reaction and they make this RNA, they put in a different nucleotide known as N1-Methylpseudouridine. __Brian Hooker__ Right. __Kevin McKernan__ This altered nucleotide is actually what really got the attention of the Nobel Prize. All right? They put in a different nucleotide so that the RNA was less labile to an RNase L that's in the human genome. The human body makes RNases that destroy RNA. The way RNA behaves is your DNA is like your hard drive, your RNA is like the task manager of all the programs that are opening and closing off that hard drive. The cell needs to have a system to not only turn a gene on, but to turn it off. If it can't turn it off, then you have a problem. The way a lot of these things get turned off is there are RNases that make sure that when a gene is expressed, it's only expressed for a certain period of time and it gets decayed. Well, they put in this other base that stops that process from happening, so that the RNA doesn't degrade as readily. __Mary__ They put in something that turned off the off switch. Is that correct? __Kevin McKernan__ Yeah. The RNA is harder to degrade, and they wanted that so they ensured they got production of spike protein long enough to matter. And there's a big debate as to whether it's too long right now, because we're finding these RNA stick around for way too long. They thought it was only 48 hours. People can sequence out of plasma. 28 days later, it's in breast milk now. __Brian Hooker__ Right. __Kevin McKernan__ So it's really a big train wreck, in my opinion. They didn't need that. But because of that base, that base also is published to radically change the melting temperature of DNA. That means that it's much stickier. It's much harder to peel apart from DNA. I think Callum Parr has a paper on this showing if you just put four of these nucleotides into 25 meric, it raises the temperature 9C, the melting temperature. __Brian Hooker__ Oh my goodness. __Kevin McKernan__ That's an enormous melting temperature shift for four bases of these things. That means that this RNA is extraordinarily sticky, and that means it's very likely that it's making RNA-DNA hybrids, that when the RNA polymerase is copying the RNA off the DNA, what you end up with is a triple helix. You end up with RNA kind of tangled up with DNA, and a nuclease doesn't know how to get rid of the DNA in that context. And this is really evident actually in Moderna's process. Moderna, if you look at our paper, there's a hundredfold more spike DNA contamination than the plasmid DNA, the backbone that doesn't have any RNA similarity. That's a real clear set sign that the nucleus can destroy the DNA that doesn't have any complimentary to RNA, but it can't destroy the DNA that has complimentary to the RNA that they're making. There's something I think they didn't see and anticipate. Because they changed the space, they didn't realize the enzymes they typically use to get rid of this contaminant are no longer functional. And so they now have to probably engineer different enzymes for this, and DNase XT is a good idea. Maybe T5. There's a host of these nucleases that might do a better job at this. But I think with the Warp Speed program, they didn't have time to really investigate this. That's one reason why the DNase is there. There's a second reason. The tools that you use to measure this differ based on the size of the DNA that's around. So if you use something like fluorometry, this is a tool that uses a dye that is an interpolating dye that binds to the minor groove of DNA. These tools will measure DNA as small as five to 10 bases. It just has to be complimentary at room temperature. That can be a 10-base pair piece of DNA you can get some SYBR Green study or signal from, or RiboGreen signal from. qPCR needs at least 100 bases to amplify, so all the DNA that's smaller than 100 bases, it can't see. So, they're using qPCR to monitor the DNA. They're using fluorimetry to measure the RNA. They're kind of playing some games there because they want to get really high RNA numbers and really low DNA numbers, because the EMA regulations aren't really a fixed amount of DNA. They're a ratio of how much RNA you have to how much DNA. __Mary__ They're using two different processes to measure the DNA and the RNA. But if I understand you correctly, they could be using one process for both, or they could use both processes for both. __Kevin McKernan__ Absolutely. __Mary__ Is that correct? __Kevin McKernan__ In fact, this- __Mary__ And then you have more reliable data. Is that right? __Kevin McKernan__ Yeah, that's absolutely right. And I think anyone who's familiar with these bench tools knows the fact that they're deviating this is a game, because they had to make PCR primers to measure the spike DNA and all they have to do is change the polymerase to measure the RNA, and they didn't do that. They opted to go get a whole nother assay with a different instrument, with a different fluorometry-based readout to measure the RNA. They bent over backwards to measure the RNA differently. They already had all the primers and tools they needed to measure it with the PCR assay they're using to measure the DNA. You just swap the polymerase out and you get the answer the same day. __Mary__ This suggests gamesmanship, is that correct? __Kevin McKernan__ Exactly. Intent to deceive. __Mary__ Intent to deceive. Okay. Got it. And this data that you've uncovered has been replicated around the world. Is that right? __Kevin McKernan__ Yes. Many labs now. We put the primers public on our Substack and in pre-prints, and now people can just order those from IDT and make their own primers. We have shipped also primer lots that we have here when people didn't want to wait for IDT to remake these. It can take IDT maybe a couple of weeks sometimes to make these, so when people urgently want them, we'll ship them vials of our primers. Philip Buckholtz has confirmed this work by using our primers down on vials in South Carolina. He also went on to do Oxford nanopore sequencing to confirm our work, just not to trust what we told him was working, was doing what our primers were doing. He said, "All right, your primers' clearly giving me signal on my vaccine lots. I'm now going to sequence them and make sure I can find the sequences of your primers inside my vials." And he went and did that and confirmed that the DNA that he actually has in his vials matches the primer sequences we gave him. Dr. Sin Lee did this at Milford Molecular with Sanger sequencing. He amplified. He made his own primers and amplified. He amplified some large fragments too, like 366 base pair fragments, to show that there's bigger fragments in there. And Sanger sequenced those to prove that it's in fact in the vials. And now the most recent study... I heard of one in Germany. I don't have the data from one in Germany, but Brigitte Konig claims to have found it in four vials out there as well. There's a group in Japan, Hiroshi Arakawa, I think, I may be fumbling his name, but they've been doing some work on this as well.They've reassembled our data and been looking at some PCR protocols. But the most recent one is out of David Speaker's work out in an Ontario where he's got the largest study to date. He went through 27 vials and he even did some XBB.1.5s and those still have the DNA in them. Now, there's two different methods that we used in the paper with David just to try to emulate what Pfizer's doing is we measured it with qPCR, in which case the DNA is under the limit on everything he looked at. A couple of them are getting really close to the line. That limit is somewhat arbitrary and we'll touch on that. Then he also measured it with fluorometry to show that they're like 100 foot over the line if you pick a different tool to really emphasize that this game of cherry-picking different methods is a racket and that you can get vastly different numbers if you measure this thing with different tools. But I think the interesting part of David's study is they took the vaccine lots, sorted them based on DNA quantity and then Jessica Rose dug into VAERS and showed that there are higher adverse events reported in VAERS, the lots that have higher amounts of DNA. Now it's a small dataset. There's a lot of confounders there. It's really just a hypothesis. We have to study more lots to make sure that there aren't other confounders that are skewing that association. But it does seem to line up with Philip's data. He has numbers that are over the limit and have high adverse events. We had numbers over the limit that have high adverse events. And there's another lot that was recorded in some EMA documentation, FL0007, that has really high adverse events and has really high DNA as well. So there's a couple other pieces of data that aren't in our paper because they were done at other laboratories that reconfirm, at least with Pfizer, more DNA is trending with more adverse events. We're not seeing that with Moderna, which is interesting. The correlation seems to go the other direction there, and they are doing a better job getting rid of it. They're probably at a log scale lower amounts of DNA, so they may be below the amount that matters and something else is driving their adverse events. __Brian Hooker__ So now we've found and confirmed in several different labs including Phil Buckholtz’s labs and Sin Lee's labs. You've confirmed the presence of double-stranded DNA and in sizable quantities. I mean, we're talking about nanogram per milligram quantities or 100s of nanogram per milligram quantities of DNA. First of all, what are the implications of just having double-stranded DNA in those vials medically? And then second of all, what is in that DNA? I mean, what is hiding in that DNA? What elements do we need to be concerned about? __Kevin McKernan__ Well, hiding is a good point because I do think there's been some intent to deceive here as well, particularly on Pfizer's behalf, if you were to take the DNA sequence, which apparently they did give the sequence to regulators, but they only annotated certain pieces of it and not others. And that's very bizarre because if you take their sequence and plug it into a standard software tool like SnapGene, it will annotate everything. So someone had to actively go and delete these annotations and then hand something to the regulators. And the piece that they deleted, I think is the most controversial piece. It's this SV40 promoter that is known to have a nuclear targeting sequence in this. This is a tandem repeat of 72 bases, about 144 bases in size, that binds transcription factors and drags any DNA attached to it into the nucleus. __Brian Hooker__ This is an enhancer of the SV40 promoter? SV40 was used in... The SV40 or the promoter, but they never reported the enhancer's presence. Is that correct? __Kevin McKernan__ They didn't report any of the SV40 components. __Brian Hooker__ Wow. __Kevin McKernan__ In fact, I can pull up what they did report here. So what you see on the right is what they presented to the EMA. I suspect this is what went to Health Canada as well. And they're somewhat shocked by this from the most recent email I saw from them. But you'll notice it annotates the spike protein, the ori, the kanamycin gene. It has this five base pair cut site down here that linearizes the plasmid. A couple other small pieces. If you take their sequence and just shove it into something known as SnapGene, it annotates all the stuff automatically over here. This SV40 just pops out. So I didn't find SV40. SnapGene found it by default. __Mary__ I'm going to pull us back. So on the right, the ori and the kan R and the S protein, explain to us what is that showing us on the right and then what did they have to take out to get to what you showed us through SnapGene on the left? __Kevin McKernan__ Okay. So the bacterial origin of replication is here in blue. So when you put this in E. coli, it will double with E. coli. It probably runs the copy number to 50 to 100 copies in the cell, and then the cells double every 30 minutes. So it's a great Xerox machine for DNA. But to make that happen in E. coli, you have to put a kanamycin resistance gene in there so that only the E. coli cells that have the plasmid survive. That way you knock out all the background. So this is the kanamycin gene. Now, this kanamycin gene won't work on its own. It needs a promoter that they've materially omitted here. __Brian Hooker__ Omitted. Right. __Mary__ Oh, interesting. __Kevin McKernan__ That's missing- __Mary__ So graph on the right seems very strange because that kanamycin wouldn't work without a promoter? __Kevin McKernan__ Yep. __Brian Hooker__ Correct. __Kevin McKernan__ And the other thing about the SV40 promoter is it is active in mammalian cells and you really don't want mammalian promoters in any injectable. They don't need this because they have... If you look very carefully here, there's also an AmpR promoter that's kind of obscured over here in the left. That's what Moderna uses to drive the kanamycin gene. Pfizer has it too. They just happen to also have this mammalian promoter that is superfluous and shouldn't be there. And they know it because they deleted it from the annotation. __Mary__ That's an intent to deceive? They actually are omitting that information? __Kevin McKernan__ I believe so, because any annotation tool that annotated this plasmid that got down to T7 promoters, it found the bacterial origin, it found, I think this F1 origin down here, it would've found the SV40 origin. There's no reason- __Brian Hooker__ So this was deleted. This was deleted. __Kevin McKernan__ This was intentionally deleted. __Brian Hooker__ Right. Right. __Mary__ And let's just do a little background, gentlemen, on SV40. Maybe Brian, can you give us a little bit of background in the vaccine context of what SV40 really is? And then Kevin, we [inaudible] with you. __Brian Hooker__ And Kevin, correct me if I'm wrong, but the SV40, simian virus 40, was an artifact of the polio vaccine, the oral, the live polio vaccine in the 1950s and 1960s, and it is oncogenic. SV40 itself as the virus is associated with certain tumors, certain forms of cancer, certain aggressive forms of cancer, and that it was a contaminant in the oral polio vaccine, the live virus polio vaccine, for many, many years. And so having these elements, including the SV40 promoter would in itself, I believe, would be oncogenic, and then that SV40 element, that 72 base pair element, has been shown to tie with other oncogenes in vivo and act as an enhancer, enhances its ability to form cancers. __Kevin McKernan__ So I'm very new to SV40. I've been learning this just in this last year as to what's going on in the field. Now we don't have the whole SV40 virus, which is 5.2 kilobases. We have about 420 bases or so of it, which consists of four pieces. We have the SV40 origin, the promoter, the enhancer and the poly(A) signal that are in there. SV40, I think instructs it to put a poly(A) signal on a messenger RNA. For some reason that's sitting in the vector as well. I haven't studied as much on what the poly(A) signal, why they need the poly(A) signal in this vector. That seems to be... I think that's needed... If they want to express these plasmids of mammalian cells, it's good to have something that puts a poly(A) signal on it. And so I think they put that on the F1 origin for other reasons. So that being said, a lot of pushback is, "Hey. This doesn't have the T antigen. The tumor antigen is what is deemed to be the carcinogen in SV40. And so you guys are conflating SV40 with the virus and you're spreading fear porn and all that." But I think an important thing to know is that a large portion of the population is SV40 positive from the polio vaccine. So they presumably can make T antigen. And why is that important? Well, T antigen is what actually initiates the DNA replication on the SV40 promoter that's in the vaccine. So if a certain part of the population makes T antigen and you inject them with a lot of these promoters, they're going to have the machinery to turn that promoter on wherever it lands. So there's- __Brian Hooker__ In other words, if- __Kevin McKernan__ We don't know the implications of this. __Brian Hooker__ Right. Right. In other words, if you've been vaccinated with the oral polio or the live virus polio vaccine, then essentially you could have the T antigen already in you. __Kevin McKernan__ Right. Right. And that's something that I can't really... I think right now we have data here that shows there's a legal problem here, more so than we have evidence of a clinical problem. The clinical problem, we still need more data from. We need to find out if this DNA is actually in other people post-vaccination and people who haven't been vaccinated to see is it associated with a lot of this adverse events. Right now, this is just hypothesis generation. We don't really have it. We have a lot of reasons to believe this is a bad idea. They don't need this DNA in there. They didn't tell the regulators about it. And it's inside of an LNP and it's going to get to the nucleus space and the sequence that's in there. So all of that is a train wreck. If you're putting in 200 billion of these molecules per shot and you're doing them five times a year... I don't know how many times people are taking them, but if you think of your schedule, you should be past your fifth by now. So there's a cumulative dosing problem here. There's a high number of these fragments in there. Even though the nanograms might seem low, the fragmentation of them makes them like buckshot and makes them much more potent as integration tools because you have more active ends of DNA. It's the ends of the DNA that have phosphates and hydroxyls on them that make them sticky. Those are kind of like the Lego pieces of DNA, if you will. So you'll see an FDA documentation on guidance documents that look at DNA, that they base these nanogram limits based on genomic DNA. 10 nanograms of genomic DNA might be like 1200 copies of DNA, but we're dealing with really small pieces, which means we have 100s of billions of these pieces. And they even allude to the fact that if you were dealing with not mammalian cell contamination, which would be 3 gigabase genomes, but you're dealing with viruses, well, then the copy number is so damn high that you might need femtogram or attogram limits on the amount of DNA that could be around. There's other guidance documents that also speak to the fact that the 200 base paired limit is maybe not really pertinent if you're dealing with promoters. Maybe it should be down at seven bases, because seven bases could integrate and cause problems even in a VDJ circumstance with certain parts of the genome. So there are guidance documents that need nuance and conceptualization and contextualization. They put out guidance documents before LNPs were round saying, "We think there's going to be mammalian cell DNA. We can tolerate this much of it based on this copy number based on us not knowing much about it," but the moment you start getting into high copy number contaminants that have bioactive elements to them and they're inside LNPs, the whole game changes. And- __Brian Hooker__ It's really astounding. When you look at these genomic insertion events, and I've done genetic engineering before, primarily in genetically modified plants and bacteria, it's like you're going to Vegas. You're looking for the one in a million event, but there are enough errant strands of DNA around there for that to actually happen. Is that correct? __Kevin McKernan__ Yeah. Philip Buckholt put up an interesting paper on his Twitter recently about the rate when you get a million transfection like this, the rate of cells that stably integrate was like seven... It was down below 7%, but 7% is a huge number when you're dealing with billions of LMPs. __Brian Hooker__ Right. __Kevin McKernan__ So this is- __Mary__ LMP is lipid nanoparticle, is that right, Kevin? __Kevin McKernan__ That's right, yeah. These are packaged in these LMPs. We know that. That was part of our most recent papers. If you use a nuclease on the vaccine, it won't get rid of the DNA that's there because it's protected. It's inside this lipid nanoparticle. The guidance documents the FDA have for DNA contamination, they're just ancient relics. They're outdated. They actually started before the NCVIA, which is this National Childhood Vaccine Injury Act. They were at 10 picograms back then. After that act, they went up a thousand-fold over the course of 10 years. We're now at the stage where we've tolerated a thousand times higher. Now we're switching to LMPs that bring these things directly into cells with nuclear targeting sequences. __Brian Hooker__ We were told that this would not target the nucleus. We were told that this would not enter into the nucleus. Is the nuclear targeting sequence, is that the SV40 enhancer? __Kevin McKernan__ That is. It's been published as a great gene therapy tool because it's so effective at bringing things to the nucleus in hours. David Dean has great work on this, and Health Canada has just admitted that they found it. It's in the vaccine. All these arguments about our vials are from dumpsters and everything, Pfizer gave sequence to Health Canada that has it in there so there's no more argument of it being in there. __Mary__ Let's move to the legal issue that you flagged for us, Kevin. Health Canada has acknowledged that this DNA contamination is in the vials. We now have a major government of the world acknowledging this, and Children's Health Defense on Friday last week, published a story quoting Health Canada as saying, "Health Canada expects sponsors to identify any biologically functional DNA sequences within a plasmid such as an SV40 enhancer at the time of submission." But we know that that didn't happen. To your mind, as a scientist who's long been involved in this area, should that be enough to now force all of the governments around the world to take these vials off the market until they've been investigated? __Kevin McKernan__ I would think so. If they don't do this, what are they there for? This is like every time someone breaks a rule, they just change the rule. What do we need regulators for if they're not going to stick to these rules and guidelines they put forward? Now, unfortunately, in the same breadth of that email, I think they reiterated the safe and effective psalm. Like, okay- __Mary__ They did, but that's nonsense as people say. They say the risk benefit profile continues to support the use, but if they didn't know this and they don't acknowledge it, then how could they assess the risk benefit profile? That seems just nonsensical. __Kevin McKernan__ It's circular. It's very circular for them to state that, that you don't actually... I mean, an important point to that risk. They waived the genome toxicity studies in the trial so how can they know risk? __Brian Hooker__ Right. They did. They don't know that there's risk because the trials were never done. How can you get away with... It seemed like when you look at the plasmid submission to the FDA, there are unknown sequences. There are big black boxes. There's a big unknown where the SV40 promoter went. Why did they tolerate this in the first place? __Kevin McKernan__ I don't know because there's other things in that sequence. There's other points in that sequence that should have rung alarm bells. If you turn on any sort of ORF finding tool, so to paint where the open reading frames are, you can identify where the spike is. But the thing that will blow your mind is that there's an ORF on the reverse strand of the spike that is 252 amino acids long. That should have been a red flag. That tells me that no one opened this in a tool. They got the sequence and probably just said, "Pay your user fee and we'll put it in a file and move on." What an ORF finder does is it looks for open reading frames. If you turn it on, it will look for start codons and stop codons and it instantly finds the spike protein. If you ask this to look on both strands of the DNA, it will find another ORF that runs the entire direction on the other strand of the spike protein for 1,252 amino acids long. I don't have it visualized here because I picked up the wrong screen here, but I do have it on my substack and people can see this. Now, anyone who is regulating this should have put this into a tool like SnapGene to say, "Show me what's in this plasmid," and it annotates all these pieces for you. It would've shown you that there is a mysterious ORF of unknown origin that encodes the entire opposite strand of the spike protein. What the hell is that? Why is it there? Moderna doesn't have it. The virus doesn't have it. __Mary__ It's unknown? They don't know what it is? __Kevin McKernan__ Unknown. I mean, I've blasted this thing against NCB, I didn't get many hits. The only hits I can find it in UniProt are to a gene or protein that's in silk and in collagen and in some other fibroin thing. I don't know what this does, but I know that this is an artifact of their codon optimization that should not be there and is a massive risk and they should get rid of it because it's actually a massive Sudoku puzzle for someone to actually figure this out. How do you get a 1,273 amino acid open reading frame at one strand and how do you get one on the other that doesn't have a stop codon anywhere? It seems like a computation. __Mary__ Wow, that's very… __Brian Hooker__ What are the implications of having that ORF going in the opposite direction and then injecting that into humans? __Kevin McKernan__ I don't know if it's going to get expressed. That's the thing, is that this [inaudible] answer is a bi-directional promoter. Presumably, it makes RNA in both directions. If for some reason it spans this polyA region in the plasmid, it could go and start making RNA over that unknown, that mysterious ORF. I don't know what that's going to do in the cell. I don't know if there's a Kozak consensus sequence there. It's very difficult to informationally screen for internal ribosomal entry sites so I can't tell you that the ribosome is definitely going to translate this thing. But I can certainly tell you that if I were a regulator, I would tell them to get rid of it because it's risk with no gain and it's unnecessary. __Brian Hooker__ Do you think they really even look at this? __Mary__ Sorry, [inaudible]- __Kevin McKernan__ There's no way they did. If they looked at this, this would've rung out to them and likewise, the SV40 omission would've rung out to them. So it's clear to me they didn't look. I think they collected their user fee and put the thing in the file. __Mary__ So the regulators were asleep on the job. It sounds like what you're saying because they didn't catch SV40 that they could have easily caught through SnapGene and they also didn't tell us about this open reading frame 1,237 base pairs. Is that right? __Kevin McKernan__ Yeah. The open reading frame is 1,273 for the spike, and on the reverse side there's a 1,252 amino acid open reading frame. I could see someone writing it off being like, "Oh, it's Messenger RNA, it's going to be single stranded. The reverse strand won't be there when it's in RNA form." But they didn't anticipate the DNA is going to come with it. Now we have both strands there and the other strand codes for something. If any of this stuff integrates, it's likely to be an open reading frame of a foreign peptide that your immune system's not going to like. The point is it's a very open reading frame rich plasmid. There's not a lot of stop codons. __Brian Hooker__ We've got millions and millions of lipid nanoparticles that are floating around physiologically and basically, the lipid nanoparticles contain what appears to be transfection soup. How do people not get transfected by this? __Kevin McKernan__ I think the numbers are probably in the billions to trillions from what I've read on the LMPs, which is a large number. Yeah, they probably have the RNA and the DNA in them from the measurements we've made. They're packaged, and their nucleus resistant and they're ending up in cells. Now, what a lot of people push back is like, "Okay, any cell that gets transfected is going to die, so who cares if this car goes in there?" But that's not really true because we see this spike protein and the spike sequence persisting at least 28 days. People have sequenced mRNA or DNA, we don't know which one it was, but they got sequence of the vaccine 28 days later in plasmid. They have found it in breast milk five or seven days later. The protein itself, they have found, Patterson found it four months later on exosomes, I think. Sorry, that was Bancel. Patterson found it like I think 200 days later in macrophages. So something is persisting, and I don't think every cell that gets transformed is a 100% killed instantly. There's something going on where people can't clear this and maybe it's hitting immune privileged cells, and that's why it sits around forever. I think it is a risk if there's DNA floating around, it's going to add to the persistence of this 'cause it could integrate and continually express these other foreign peptides. __Brian Hooker__ Exactly, and what about the implications? When I think of DNA disrepair, I think of cancer, and so I get very, very concerned about that. Just not specifically on, "Oh, we're making people into genomically stable spike protein production factories," but also just the other bits and pieces of DNA that are getting integrated into the genome, and what are they doing? What are they enhancing or what are they silencing? __Kevin McKernan__ Well, what made me nervous is when we saw... So Philip's work, I think showed a couple billion of the amplicons from just PCR. PCR measures a hundred base per amplicon. We have one that actually targets the SV40 promoter. If there's a billion copies of just that region in every injection, that's carpet bombing a genome with a billion promoters. Where those land and what efficiency is an open debate, but wherever they land, they're going to be active promoters of a million cells. I think that alone is an issue because you're just dropping these things that make RNA into the genome randomly, and if you happen to put one on a proto-oncogene, a host of issues. Now there's other areas…There are genes that if you hyper express them, they can drive to excess cell growth. They call them proto-oncogenes. If you put an active promoter in front of that, it turns out it's not good. The other thing that can happen is you can break a gene that slows down cancer like P53. P53 and BRCA are these DNA repair enzymes, and if you happen to put a different part of the plasmid inside of those, it could disable those- __Brian Hooker__ Disrupts them, yes. __Kevin McKernan__ ... then you don't have this repair mechanism that you need. Now, most people have two copies of all these genes. So many people you break one of them, maybe okay. But there are subsets of people that have BRCA mutations and P53 mutations and they're haploid, so they have one bad copy and one good copy. You come in with this vaccine, you can knock out the only other good copy. There's a whole host of rare genetics that you have to consider in this, and perhaps why this may not be something you'd be seeing in all patients. There's another dimension of which vaccine lots have more of this versus less of this, like the Schmeling paper you look at has 4% of the vaccine lots having, I don't know, the majority of the adverse events. We have a lot of Venn diagrams here of things to consider. There's a lot of people who probably took these and don't have any harm at all. There's maybe a subset of people that take these bad lots that in fact have some genetic reason why they're more susceptible to the harm than others. __Mary__ Kevin, you've mentioned I think today and in the past that this promoter, the SV40 promoter in particular, is used in gene therapy, and yet this was not reviewed as a gene therapy, it was reviewed as a vaccine. Is that an issue in your view? __Kevin McKernan__ Yeah, I think that is actually a very serious legal issue. This here is the SV40 enhancer that is published to bind all of these transcription factors and drag this sequence into the nucleus. There's two of these copies of these 72 base pair pieces of DNA. And this is what they're putting on plasmids to get them to do perform gene therapy. So the sequence that they omitted is a bioactive sequence according to Health Canada, and it is used in gene therapy. There's just no debate anymore. The plasmids that are in there are gene therapy tools, and they're injected into billions of people. __Mary__ So not only was there no informed consent for anybody, and this was emergency use authorization, so, by law, they weren't able to give truly informed consent, but it looks like this was a gene therapy, and people were not told that this was a gene therapy. Is that right? __Kevin McKernan__ That's right. And now, they may not have meant for it to be this, but they certainly, in my opinion, hid it. The fact that that SV40 region is the only origin missing on the vector means whoever ran the annotation program there probably had three origins show up, the F1, the bacterial, and the SV40, and decided to remove the SV40 because it was an unpopular name, and they knew it was controversial. __Brian Hooker__ Incredible. __Mary__ There's a long literature in mainstream scientific journals about SV40. Isn't that right, Brian? __Brian Hooker__ Absolutely. It's such a strong promoter, and it's a mammalian active promoter. And so you would expect, if you put that promoter and especially if you have that 72 base pair enhancer region, that you're basically... You've got a nuclear localization signal, and so that is its job. It basically will take the DNA sequence behind it, and it will deliver it into the nucleus. It's absolutely incredible that this is there. It's absolutely incredible this whole thing was hidden from view. Wouldn’t that raise…Again, maybe I'm beating a dead horse, but just the absence of that information, wouldn't that raise some type of red flag with the EMA and the FDA? __Kevin McKernan__ You would hope so, that they would feel deceived by this. That this is not something that it's clearly in their rules that you need to declare these things, and now they find out years later that they weren't shared this information. So I- __Brian Hooker__ So, you've been…Right, right. You've been looking at this for quite a while now, Kevin. And so if you don't like the message, you shoot the messenger. So what's happening with you? __Kevin McKernan__ Oh, well, I've already been character assassinated for my choice to get into the cannabis field, so I'm kind of bulletproof from that standpoint. __Brian Hooker__ That's almost as bad as looking at vaccines in general, so yes. __Kevin McKernan__ Yeah, exactly, yeah. __Mary__ Well, Kevin helped us in the past. I want to point out that Kevin generously gave us a declaration in a case that we filed against coercive PCR testing of children in New York City schools, and we're very grateful for that. So you're not worried about the character assassination that goes along with this, Kevin? __Kevin McKernan__ No, they already assassinated my character a decade ago when I decided to start studying cannabis. So they'll continue on that front. And yeah, we get harassed on Twitter and all the usual social media nonsense, but I don't think this is... I don't think it's very effective. It oftentimes, I think, has the reverse effect, as people see who they're attacking. And you can see our pre-print on Thursday's got like 72,000 downloads now, probably because the Streisand effect of everyone who's hating on us on Twitter. __Mary__ What's your Substack, so that we can have everybody follow you on it? __Kevin McKernan__ It's named after the active compound in catnip. I'm a cat person, so nepetalactone. So, it's unfortunately really horrible to tell somebody in order to spell, but lactone is the last word. If you ever get confused, just look up the active ingredient in catnip, and it will give you that long-winded name. I taught people how to take the Pfizer sequence as if they were given it as if they worked at the EMA or Health Canada. This is the tool that you would probably use to open it up and look at it. This is called SnapGene. It's a free tool. Download it, open the file, and it will instantly paint you the SV40 regions. So this shows you that someone had to go in and actively delete this because the standard tools in the industry paint this thing. So, I don't get credit for finding SV40. SnapGene found it. It painted it the first time I loaded the sequence in, which is why I was really confused to see that it was not in Pfizer's plasmid map 'cause that told me somebody had to go erase it. That's not an, "Oops, I forgot it." That's a "I clearly wanted to deceive you" type of move. __Brian Hooker__ Right. __Kevin McKernan__ And this is just a picture of that second origin [inaudible] is going the opposite direction. And teaches people how to go and look for these yourselves and some of the genes that that thing hits. They're not really strong hits, but I'm like, "This is really weird." It's a protein in silk that shows- __Brian Hooker__ Oh my goodness. It is. It is a protein in silk. And these intervening sequences, these SV40 sequences, it's not just you. It's Health Canada now, right? __Kevin McKernan__ Yeah, they confirmed in that email that "Yes, we were given the sequence from the plasmid, but we were not specifically annotated the SV40 that was in that sequence." They annotated all those other pieces and just decided to not tell them about the SV40 in the sequence. __Brian Hooker__ But they have the sequence itself- __Kevin McKernan__ ... a huge in a page in there, and not telling them that you slipped something in there. __Brian Hooker__ So they have the sequence themselves. They can run SnapGene just like anybody else. __Kevin McKernan__ In theory. I suspect that they did until we published our work. __Brian Hooker__ Right. Oopsie. __Mary__ You've identified for us, Kevin, that the FDA and Health Canada and the EMA potentially could allege that they were deceived, and perhaps they were deceived, and that perhaps opens the door for them, right now, to take much more dramatic action. __Kevin McKernan__ I think that's fair because if you look through the volume of data that Pfizer's handing over, it's almost this drown the regulator in material, so they can't possibly read it all. And that's really easy to do with sequence information. You hand them a file of 7,800 bases, and unless they have the time to set someone aside and say, "Annotate this and look at this and tell me if there's anything weird in it"... They're then also buried in all the PCR data, all the LPS data. Pfizer even went out and engineered a new mass spec method of DNA sequencing to try to show them that their Poly(A) signals in the vaccine were the right length. They did all of this work that I thought was fairly unnecessary and looked like a tactic of drowning regulators in data, that that's probably what's occurring here. __Mary__ They snowed them. Well, this is incredibly enlightening. Kevin, thank you so much for taking the time to explain this to us. I certainly have a much clearer picture, and we can send people to your catnip, nepetalactone. Is that right? Newsletter to get all the latest and look at it in greater detail. Again, thank you both so much for doing this. __Brian Hooker__ Thank you. Thank you so much, Kevin, and we look forward to your further research. __Kevin McKernan__ Thank you for having us to get the word out.5a:T4252,### Highlights ## Cross-cutting statements - During the last months, the world has witnessed a range of shifts that have profoundly impacted the health and development sectors. - The current political and societal developments jeopardize global health, including vaccination programmes worldwide. - SAGE underlined the major contribution of vaccination to improved global child survival and health, while being one of the public health measures with the highest returns on investment. - SAGE expressed its deep concern about the current situation with the diversion of resources away from public health, which creates a risk of further backsliding just when countries are recovering from the impact of the COVID-19 pandemic. This could adversely affect the ability of global immunization programmes to sustain the tremendous gains it has made and progress towards the goals of the Immunization Agenda 2030 (IA2030). ## Session 1: Global & regional reports ### Report from the Department of Immunization, Vaccines, and Biologicals - The report underscored the massive impact and progress made in global immunization to save lives and enhance health while acknowledging the unprecedented challenges ahead. - As requested by SAGE, the report provided detailed insight into WHO’s role in accelerating critical opportunities and overcoming key gaps that will enhance the impact of vaccination. - Specific areas across the immunization value chain included WHO’s role in the TB vaccine accelerator, strengthening vaccine regulatory capacity, regionalization of vaccine manufacturing, accelerating the rapid introduction and scale-up of malaria and HPV vaccines, innovations to break through the glass ceiling on immunization coverage, and reaching unvaccinated communities. - However, the report also highlighted the severe strain and threat to immunization programmes at global, regional and country levels with recent abrupt changes in donor budgets and capacity in global health and decreases in fiscal space domestically. - Most prominent are the threats to measles vaccine coverage improvements, disease surveillance, laboratory networks and outbreak response capacity, which are being acutely affected by budget cuts. WHO continues to provide leadership, coordination, country support and capacity strengthening as part of the Measles and Rubella Partnership, making all possible efforts to avert increases in preventable cases and deaths across countries that will result if the threats further materialize. - Through strategic prioritization, innovation, and global collaboration, WHO supports countries in building resilient, equitable, and sustainable immunization programmes now and for the next 50 years and beyond, to harness safe, affordable and effective vaccines. Update from Gavi, the Vaccine Alliance - The Gavi strategy 2026-2030 (Gavi 6.0) will be launched in 2026 with a focus on introducing and scaling up new vaccines, strengthening country programmes, supporting optimization and prioritization processes, ensuring sustainability, providing tailored support, and reducing zero-dose children. - The HPV initiative is on track to immunize 86 million girls by 2025, and significant progress has been made in rolling out malaria vaccines. - Gavi's new Health Systems Strategy focuses on equitable and sustainable immunization efforts through differentiated country support, consolidated funding, innovations, partnerships, and improved measurement. - Polio eradication remains a priority, with Gavi investing US$ 800 million in inactivated polio vaccines under the current strategy (Gavi 5.0), and the hexavalent vaccine[1] introductions planned for this year. - Gavi has allocated US$ 5.6 million to address the mpox crisis and looks forward to establishing a vaccine stockpile as part of Gavi 6.0 and document how the vaccine can contribute to broader disease control efforts. - In 2024, Gavi approved 49 outbreak response requests and plans to support the use of diagnostics to strengthen data availability and decision-making. Regional reports - Three regional reports highlighted the resurgence of measles and the need for urgent actions to mitigate the risk of large outbreaks while noting the challenges with improving routine coverage and timely preventive vaccination activities. The problems could be further exacerbated with a shift in resources away from health, if current programme performance cannot be sustained, let alone further enhanced. The number of zero-dose children has increased in some regions even after the restoration of routine immunization programmes following the COVID-19 pandemic response. While the Big Catch-up has helped, it has only partially addressed the problem and further efforts are required to fill immunity gaps. - The report from the South-East Asian Region struck a positive note and reported on the successes with scaling up HPV vaccination; SAGE recommendations for the use of a single-dose schedule have made an important contribution to the scale-up. ### Session 2: Immunization Agenda 2030 (IA2030): country-led monitoring - Though many countries remain off track against key metrics for measuring progress against IA2030 indicators, there have been notable achievements such as the Big Catch-up and the scale-up of malaria and HPV vaccination. - The IA2030 Partnership Council has proposed three pivots in the IA2030 strategy: to increase advocacy, enhance a country-centred approach, and intensify inter-agency partnership and collaboration. - A review of 51 national immunization strategy (NIS) documents from low- and middle-income countries showed that countries are setting specific targets to reach IA2030 goals. Linkages to primary health care have been strengthened and NISs are increasingly being used to demonstrate country ownership and for resource mobilisation. - The NIS is an opportunity to strengthen country data use for monitoring programme performance, implementing action cycles for programme improvement, and increasing accountability. - Immunisation data systems in many countries lack the granularity, context, nuance or perspicacity to inform actions required to improve programme performance. - Country-centred, continuous quality improvement processes supported by sufficiently capacitated WHO Regional and Country Offices, along with key partner engagement, are required to enable the required changes in programme monitoring. ### Session 3: Pneumococcal vaccination of children - SAGE reaffirmed that achieving high coverage of three doses of pneumococcal conjugate vaccines (PCVs) using either a 3p+0[2] or a 2p+1[3] schedule is the most effective way to prevent childhood pneumococcal disease. An update to the review of evidence from 2019, continued to show no conclusive advantage for either schedule over the other; the choice of schedules should be based on local epidemiological and programmatic factors. - In addition to two currently WHO-prequalified vaccines, PCV10 (Synflorix ®, GlaxoSmithKline) and PCV13 (Prevenar13®, Pfizer), recent evidence supports the use of a third WHO-prequalified PCV10 (Pneumosil®, Serum Institute of India) for routine immunization of infants using either of the two recommended 3-dose schedules. - Countries considering switching to recently licensed higher valency PCV product (e.g., PCV14, PCV15, PCV20) to broaden serotype coverage must consider trade-offs that may exist, particularly the potential reduced direct and indirect protection against serotypes in common with PCV10 / PCV13, noting that antibody concentrations tend to be reduced as the number of serotypes in the product increases. - Countries with mature PCV programmes that have achieved adequate levels of herd immunity can consider one of two cost-saving strategies: (i) the use of a reduced dose 1p+1 schedule[4]; or (ii) the use of a 40% fractional dose of PCV13 (the only product for which evidence supported fractional dose use). Both strategies require high vaccination coverage, and careful impact and coverage monitoring with contingency plans to revert to full 3-dose schedules if indicated. - In settings with evidence of or suspected insufficient population immunity (e.g., high disease burden, persistently low vaccination coverage, and humanitarian emergencies), multi-age cohort (MAC) campaigns with a single dose of PCV should be considered; MAC campaigns should not replace or divert resources from routine programmes for immunization with PCVs. - Establishing capacity for pneumococcal surveillance (disease and/or carriage) in early-adopter countries, ideally a few representative surveillance sites in each WHO region, is desirable to generate real-world evidence of the effectiveness of new pneumococcal vaccines and alternative dosing strategies. ### Session 4: Mpox - A second mpox public health emergency of international concern (PHEIC) was declared in August 2024 related to the emergence of a new virus clade (Ib), and its spread across African countries. While mpox continues to be reported in all WHO Regions, the number of cases is increasing in Africa.  - Five African countries have initiated vaccination and over 582 000 vaccine doses have been administered in the Democratic Republic of the Congo alone as of 16 March 2025. However, with the acceleration of vaccination activities, vaccine supply is again constrained. - Current WHO recommendations allow for the “off-label” use of a single dose or an intradermal fractional dose of MVA-BN in supply-constrained outbreak situations; SAGE recommended consideration of these strategies if indicated. - SAGE noted that while pre- and post-exposure vaccination to control the ongoing outbreak was appropriate under the current circumstances, the next phase should focus on preventive vaccination. However, evidence gaps remain to inform strategies for preventive vaccination implementation, and research is ongoing to fill these gaps.  - SAGE expressed concern about reduced funding for HIV/AIDS control programmes, which could lead to a resurgence of HIV infections and a rise in the number of people living with undiagnosed or uncontrolled HIV, who are particularly vulnerable to severe mpox. ### Session 5: Varicella & Herpes Zoster - Varicella and herpes zoster cause significant morbidity worldwide. The cost-effectiveness of vaccination based on current vaccine prices would vary between countries and would only be considered cost-effective in most countries based on overall economic benefits, including productivity loss of caregivers. - SAGE recommended that the use of varicella vaccines using a 2-dose schedule with a minimum 4-week interval between doses be considered for the prevention of varicella in children in populations where varicella is an important public health problem. - Countries introducing the varicella vaccine should define vaccination coverage targets, guided by criteria including national and subnational disease burden, affordability, cost-effectiveness, seroprevalence rates and age of infection acquisition to avoid the theoretical risk of a shift in the age of infection resulting in higher morbidity if coverage is low or modest. - SAGE also recommended consideration of varicella vaccination of special populations, including certain groups who are at risk for severe disease. Vaccination may be offered to immunocompromised and those living with well-controlled HIV infection and adequate CD4 counts. - Further, vaccination is recommended for health care workers without documented evidence of prior VZV infection or vaccination. The aim is to avoid onward transmission to susceptible patient groups, particularly when caring for immunocompromised persons, as well as for personal protection, particularly if caring for children. - SAGE recommended that the use of the recombinant herpes zoster vaccine in a 2-dose schedule with a minimum 2-month interval between doses, for the prevention of herpes zoster in older adults, those with chronic conditions and the immunocompromised, be considered in countries where herpes zoster is an important public health problem. SAGE advised countries to conduct cost-effectiveness analyses to inform decision-making. ### Session 6: Global progress in the National Immunization Technical Advisory Group (NITAG) strengthening - There has been remarkable progress with the establishment and functionality of NITAGs globally. However, NITAGs in many middle-income countries face challenges that impede optimal functionality, including inadequate secretariat support. SAGE noted the increasing importance of NITAGs in advising governments on vaccine introduction prioritization, vaccine portfolios and immunization schedules optimization, as well as their role in programme monitoring. - SAGE encouraged efforts to sustain and further enhance the capacity of NITAGs, advocated for periodic evaluations of their capacity and functioning, and reiterated the need for sub-regional immunization technical advisory groups to serve countries with small populations and inadequate breadth of technical capacity. - SAGE called for countries to demonstrate their commitment to NITAGs by increasing domestic funding to support the NITAG secretariats and their operations, including through enacting legislation that recognizes the role, importance and functionality of NITAGs. - SAGE applauded the strong coordination of NITAG support through the Global NITAG Network and called on WHO and partners to continue supporting this initiative. ### Session 7: Prioritization of new vaccine introduction - In the context of an increasing number of available vaccines, SAGE emphasized that each country should be empowered to prioritize these vaccines and determine the timing of the introduction of the vaccines into national programmes. These decisions should be made using a systematic, country-owned process based on the local context. - SAGE acknowledged that NITAGs play a crucial role in leading a deliberate evidence-based approach leveraging available tools such as multi-criteria decision analysis (MCDA) and engaging relevant stakeholders. - SAGE called on countries to engage their NITAG in providing recommendations on the prioritization of new vaccines for introductions and optimization of vaccination schedules and portfolios in close consultation with their respective national immunization programmes. These recommendations need to be aligned and integrated with the priorities in their NIS and health sector strategy and regularly updated. - SAGE noted the challenges countries face with access to evidence to support informed choices and called on WHO and all partners to strengthen coordination in this area. ### Session 8: Poliomyelitis - SAGE was highly concerned about the continued transmission of wild poliovirus in Pakistan and Afghanistan and the overall lack of efforts towards a transformative change in strategy to complete poliovirus eradication. - SAGE expressed concern about the continued circulation of vaccine-derived poliovirus type 2 and its expansion into new areas, including European countries as demonstrated by environmental surveillance, and stressed the urgent and compelling need for increased improvements in routine immunization coverage and to reach zero-dose children with catch-up doses. SAGE reiterated its support for the safe eventual global cessation of bOPV and agreed with plans for pre-cessation bOPV vaccination campaigns based on the proposed methods to determine the need for such campaigns. - SAGE endorsed the proposed risk-grading framework as a guide for discussions with countries considering transitioning to IPV-only routine immunization schedules in advance of a global bOPV withdrawal and urged WHO to initiate consultations on this topic with its Member States and Regional Offices. - SAGE reviewed updated evidence and concluded that a polio vaccination schedule with a minimum of three doses of the IPV (-containing) vaccine, such as the IPV-containing whole-cell pertussis hexavalent vaccine, starting at 6 weeks of age or later is adequate, without the need for a scheduled IPV booster dose (4th dose) and revised existing recommendations accordingly. However, SAGE emphasized that if schedules do not programme a 4th dose as a booster (which may serve as a possibility to catch-up children that have missed previous doses), it is essential that children receive all 3 doses. This recommendation does not change WHO’s existing recommendations for providing booster doses of other antigens in the second year of life, namely diphtheria-tetanus-pertussis containing vaccines. [1] Containing diphtheria toxoid, tetanus toxoid, whole-cell pertussis, recombinant hepatitis B surface antigen, Haemophilus influenzae type b (Hib) conjugate and inactivated poliovirus vaccines. [2] 3 primary doses without a booster dose [3] 2 primary doses with 1 booster dose [4] 1 primary dose with 1 booster dose5b:T4252,### Highlights ## Cross-cutting statements - During the last months, the world has witnessed a range of shifts that have profoundly impacted the health and development sectors. - The current political and societal developments jeopardize global health, including vaccination programmes worldwide. - SAGE underlined the major contribution of vaccination to improved global child survival and health, while being one of the public health measures with the highest returns on investment. - SAGE expressed its deep concern about the current situation with the diversion of resources away from public health, which creates a risk of further backsliding just when countries are recovering from the impact of the COVID-19 pandemic. This could adversely affect the ability of global immunization programmes to sustain the tremendous gains it has made and progress towards the goals of the Immunization Agenda 2030 (IA2030). ## Session 1: Global & regional reports ### Report from the Department of Immunization, Vaccines, and Biologicals - The report underscored the massive impact and progress made in global immunization to save lives and enhance health while acknowledging the unprecedented challenges ahead. - As requested by SAGE, the report provided detailed insight into WHO’s role in accelerating critical opportunities and overcoming key gaps that will enhance the impact of vaccination. - Specific areas across the immunization value chain included WHO’s role in the TB vaccine accelerator, strengthening vaccine regulatory capacity, regionalization of vaccine manufacturing, accelerating the rapid introduction and scale-up of malaria and HPV vaccines, innovations to break through the glass ceiling on immunization coverage, and reaching unvaccinated communities. - However, the report also highlighted the severe strain and threat to immunization programmes at global, regional and country levels with recent abrupt changes in donor budgets and capacity in global health and decreases in fiscal space domestically. - Most prominent are the threats to measles vaccine coverage improvements, disease surveillance, laboratory networks and outbreak response capacity, which are being acutely affected by budget cuts. WHO continues to provide leadership, coordination, country support and capacity strengthening as part of the Measles and Rubella Partnership, making all possible efforts to avert increases in preventable cases and deaths across countries that will result if the threats further materialize. - Through strategic prioritization, innovation, and global collaboration, WHO supports countries in building resilient, equitable, and sustainable immunization programmes now and for the next 50 years and beyond, to harness safe, affordable and effective vaccines. Update from Gavi, the Vaccine Alliance - The Gavi strategy 2026-2030 (Gavi 6.0) will be launched in 2026 with a focus on introducing and scaling up new vaccines, strengthening country programmes, supporting optimization and prioritization processes, ensuring sustainability, providing tailored support, and reducing zero-dose children. - The HPV initiative is on track to immunize 86 million girls by 2025, and significant progress has been made in rolling out malaria vaccines. - Gavi's new Health Systems Strategy focuses on equitable and sustainable immunization efforts through differentiated country support, consolidated funding, innovations, partnerships, and improved measurement. - Polio eradication remains a priority, with Gavi investing US$ 800 million in inactivated polio vaccines under the current strategy (Gavi 5.0), and the hexavalent vaccine[1] introductions planned for this year. - Gavi has allocated US$ 5.6 million to address the mpox crisis and looks forward to establishing a vaccine stockpile as part of Gavi 6.0 and document how the vaccine can contribute to broader disease control efforts. - In 2024, Gavi approved 49 outbreak response requests and plans to support the use of diagnostics to strengthen data availability and decision-making. Regional reports - Three regional reports highlighted the resurgence of measles and the need for urgent actions to mitigate the risk of large outbreaks while noting the challenges with improving routine coverage and timely preventive vaccination activities. The problems could be further exacerbated with a shift in resources away from health, if current programme performance cannot be sustained, let alone further enhanced. The number of zero-dose children has increased in some regions even after the restoration of routine immunization programmes following the COVID-19 pandemic response. While the Big Catch-up has helped, it has only partially addressed the problem and further efforts are required to fill immunity gaps. - The report from the South-East Asian Region struck a positive note and reported on the successes with scaling up HPV vaccination; SAGE recommendations for the use of a single-dose schedule have made an important contribution to the scale-up. ### Session 2: Immunization Agenda 2030 (IA2030): country-led monitoring - Though many countries remain off track against key metrics for measuring progress against IA2030 indicators, there have been notable achievements such as the Big Catch-up and the scale-up of malaria and HPV vaccination. - The IA2030 Partnership Council has proposed three pivots in the IA2030 strategy: to increase advocacy, enhance a country-centred approach, and intensify inter-agency partnership and collaboration. - A review of 51 national immunization strategy (NIS) documents from low- and middle-income countries showed that countries are setting specific targets to reach IA2030 goals. Linkages to primary health care have been strengthened and NISs are increasingly being used to demonstrate country ownership and for resource mobilisation. - The NIS is an opportunity to strengthen country data use for monitoring programme performance, implementing action cycles for programme improvement, and increasing accountability. - Immunisation data systems in many countries lack the granularity, context, nuance or perspicacity to inform actions required to improve programme performance. - Country-centred, continuous quality improvement processes supported by sufficiently capacitated WHO Regional and Country Offices, along with key partner engagement, are required to enable the required changes in programme monitoring. ### Session 3: Pneumococcal vaccination of children - SAGE reaffirmed that achieving high coverage of three doses of pneumococcal conjugate vaccines (PCVs) using either a 3p+0[2] or a 2p+1[3] schedule is the most effective way to prevent childhood pneumococcal disease. An update to the review of evidence from 2019, continued to show no conclusive advantage for either schedule over the other; the choice of schedules should be based on local epidemiological and programmatic factors. - In addition to two currently WHO-prequalified vaccines, PCV10 (Synflorix ®, GlaxoSmithKline) and PCV13 (Prevenar13®, Pfizer), recent evidence supports the use of a third WHO-prequalified PCV10 (Pneumosil®, Serum Institute of India) for routine immunization of infants using either of the two recommended 3-dose schedules. - Countries considering switching to recently licensed higher valency PCV product (e.g., PCV14, PCV15, PCV20) to broaden serotype coverage must consider trade-offs that may exist, particularly the potential reduced direct and indirect protection against serotypes in common with PCV10 / PCV13, noting that antibody concentrations tend to be reduced as the number of serotypes in the product increases. - Countries with mature PCV programmes that have achieved adequate levels of herd immunity can consider one of two cost-saving strategies: (i) the use of a reduced dose 1p+1 schedule[4]; or (ii) the use of a 40% fractional dose of PCV13 (the only product for which evidence supported fractional dose use). Both strategies require high vaccination coverage, and careful impact and coverage monitoring with contingency plans to revert to full 3-dose schedules if indicated. - In settings with evidence of or suspected insufficient population immunity (e.g., high disease burden, persistently low vaccination coverage, and humanitarian emergencies), multi-age cohort (MAC) campaigns with a single dose of PCV should be considered; MAC campaigns should not replace or divert resources from routine programmes for immunization with PCVs. - Establishing capacity for pneumococcal surveillance (disease and/or carriage) in early-adopter countries, ideally a few representative surveillance sites in each WHO region, is desirable to generate real-world evidence of the effectiveness of new pneumococcal vaccines and alternative dosing strategies. ### Session 4: Mpox - A second mpox public health emergency of international concern (PHEIC) was declared in August 2024 related to the emergence of a new virus clade (Ib), and its spread across African countries. While mpox continues to be reported in all WHO Regions, the number of cases is increasing in Africa.  - Five African countries have initiated vaccination and over 582 000 vaccine doses have been administered in the Democratic Republic of the Congo alone as of 16 March 2025. However, with the acceleration of vaccination activities, vaccine supply is again constrained. - Current WHO recommendations allow for the “off-label” use of a single dose or an intradermal fractional dose of MVA-BN in supply-constrained outbreak situations; SAGE recommended consideration of these strategies if indicated. - SAGE noted that while pre- and post-exposure vaccination to control the ongoing outbreak was appropriate under the current circumstances, the next phase should focus on preventive vaccination. However, evidence gaps remain to inform strategies for preventive vaccination implementation, and research is ongoing to fill these gaps.  - SAGE expressed concern about reduced funding for HIV/AIDS control programmes, which could lead to a resurgence of HIV infections and a rise in the number of people living with undiagnosed or uncontrolled HIV, who are particularly vulnerable to severe mpox. ### Session 5: Varicella & Herpes Zoster - Varicella and herpes zoster cause significant morbidity worldwide. The cost-effectiveness of vaccination based on current vaccine prices would vary between countries and would only be considered cost-effective in most countries based on overall economic benefits, including productivity loss of caregivers. - SAGE recommended that the use of varicella vaccines using a 2-dose schedule with a minimum 4-week interval between doses be considered for the prevention of varicella in children in populations where varicella is an important public health problem. - Countries introducing the varicella vaccine should define vaccination coverage targets, guided by criteria including national and subnational disease burden, affordability, cost-effectiveness, seroprevalence rates and age of infection acquisition to avoid the theoretical risk of a shift in the age of infection resulting in higher morbidity if coverage is low or modest. - SAGE also recommended consideration of varicella vaccination of special populations, including certain groups who are at risk for severe disease. Vaccination may be offered to immunocompromised and those living with well-controlled HIV infection and adequate CD4 counts. - Further, vaccination is recommended for health care workers without documented evidence of prior VZV infection or vaccination. The aim is to avoid onward transmission to susceptible patient groups, particularly when caring for immunocompromised persons, as well as for personal protection, particularly if caring for children. - SAGE recommended that the use of the recombinant herpes zoster vaccine in a 2-dose schedule with a minimum 2-month interval between doses, for the prevention of herpes zoster in older adults, those with chronic conditions and the immunocompromised, be considered in countries where herpes zoster is an important public health problem. SAGE advised countries to conduct cost-effectiveness analyses to inform decision-making. ### Session 6: Global progress in the National Immunization Technical Advisory Group (NITAG) strengthening - There has been remarkable progress with the establishment and functionality of NITAGs globally. However, NITAGs in many middle-income countries face challenges that impede optimal functionality, including inadequate secretariat support. SAGE noted the increasing importance of NITAGs in advising governments on vaccine introduction prioritization, vaccine portfolios and immunization schedules optimization, as well as their role in programme monitoring. - SAGE encouraged efforts to sustain and further enhance the capacity of NITAGs, advocated for periodic evaluations of their capacity and functioning, and reiterated the need for sub-regional immunization technical advisory groups to serve countries with small populations and inadequate breadth of technical capacity. - SAGE called for countries to demonstrate their commitment to NITAGs by increasing domestic funding to support the NITAG secretariats and their operations, including through enacting legislation that recognizes the role, importance and functionality of NITAGs. - SAGE applauded the strong coordination of NITAG support through the Global NITAG Network and called on WHO and partners to continue supporting this initiative. ### Session 7: Prioritization of new vaccine introduction - In the context of an increasing number of available vaccines, SAGE emphasized that each country should be empowered to prioritize these vaccines and determine the timing of the introduction of the vaccines into national programmes. These decisions should be made using a systematic, country-owned process based on the local context. - SAGE acknowledged that NITAGs play a crucial role in leading a deliberate evidence-based approach leveraging available tools such as multi-criteria decision analysis (MCDA) and engaging relevant stakeholders. - SAGE called on countries to engage their NITAG in providing recommendations on the prioritization of new vaccines for introductions and optimization of vaccination schedules and portfolios in close consultation with their respective national immunization programmes. These recommendations need to be aligned and integrated with the priorities in their NIS and health sector strategy and regularly updated. - SAGE noted the challenges countries face with access to evidence to support informed choices and called on WHO and all partners to strengthen coordination in this area. ### Session 8: Poliomyelitis - SAGE was highly concerned about the continued transmission of wild poliovirus in Pakistan and Afghanistan and the overall lack of efforts towards a transformative change in strategy to complete poliovirus eradication. - SAGE expressed concern about the continued circulation of vaccine-derived poliovirus type 2 and its expansion into new areas, including European countries as demonstrated by environmental surveillance, and stressed the urgent and compelling need for increased improvements in routine immunization coverage and to reach zero-dose children with catch-up doses. SAGE reiterated its support for the safe eventual global cessation of bOPV and agreed with plans for pre-cessation bOPV vaccination campaigns based on the proposed methods to determine the need for such campaigns. - SAGE endorsed the proposed risk-grading framework as a guide for discussions with countries considering transitioning to IPV-only routine immunization schedules in advance of a global bOPV withdrawal and urged WHO to initiate consultations on this topic with its Member States and Regional Offices. - SAGE reviewed updated evidence and concluded that a polio vaccination schedule with a minimum of three doses of the IPV (-containing) vaccine, such as the IPV-containing whole-cell pertussis hexavalent vaccine, starting at 6 weeks of age or later is adequate, without the need for a scheduled IPV booster dose (4th dose) and revised existing recommendations accordingly. However, SAGE emphasized that if schedules do not programme a 4th dose as a booster (which may serve as a possibility to catch-up children that have missed previous doses), it is essential that children receive all 3 doses. This recommendation does not change WHO’s existing recommendations for providing booster doses of other antigens in the second year of life, namely diphtheria-tetanus-pertussis containing vaccines. [1] Containing diphtheria toxoid, tetanus toxoid, whole-cell pertussis, recombinant hepatitis B surface antigen, Haemophilus influenzae type b (Hib) conjugate and inactivated poliovirus vaccines. 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