The Highwire with Del Bigtree - FDA PANEL PUSHES RISKY RSV SHOT FOR PREGNANT MOTHERS

Episode Date: June 4, 2023

An advisory panel to the FDA has recently voted in favor of a vaccine for RSV. Despite some safety signals of fetal demise, the advisors green-lit the new shot for pregnant women, taking a wait and see approach for safety monitoring. #RSV #Myocarditis #FDABecome a supporter of this podcast: https://www.spreaker.com/podcast/the-highwire-with-del-bigtree--3620606/support.

Right now, the FDA is in the middle of approving a whole new class of vaccines, and that's the RSV vaccine. And if you remember, we reported on this just a couple of years ago. There was an RSV is a respiratory syncytrial virus. It usually comes during the wintertime. It's a respiratory virus. And it was coming off season. So the people with the COVID shots were out and people were locked down and you had this, you had this virus that was spreading in the summer instead of during the winter. where it usually spreads. Here's the headlines from that time. Why the respiratory disease

RSV is having an off-season surge. One of the first in several years, and people were saying, well, you know, it's the immunity gap. People were locked down. They didn't develop the immunity against this. And then when we were, you know, when the lockdowns were released in certain areas, then people were just getting this. But they noticed that other diseases, respiratory disease, like the flu, were not surging. So people are kind of scratching their head. But no one in the media, except us, really was reporting on the fact that in Modernist COVID trials, from the six-year-old six-month-old to five-year-olds were having increased RSV cases when they were in these trials compared to the placebo arms. No one talked about that. So now we fast forward to currently this month,

60 and up was approved. So FDA approves world's first RSV vaccine, a shot for adults ages 60 and up. And that brings us to this headline. Vaccinating, this is their next kind of venture. Vaccinating pregnant women against RSV helps prevent severe illness. and newborn study shows. This is a Matisse trial. This was fully funded by Pfizer and then published in the New England Journal of Medicine. The FDA, the Virpac committee spoke about this. This is their bivalent protein-based vaccine.

And we go into the article here to talk about this. And the article is kind of just like a press release from Pfizer. There were no major safety concerns with the vaccine, although 5.6% of pregnancies in the vaccine group ended in premature delivery compared to 4.7 in the placebo group. That's kind of a big deal. It's a big deal. That's like, you know, so is that 20% maybe like somewhere around 17% increased risk of, of preterm delivery? But hey, let's just look the other way. Nothing to see here. Right. Huge. And we're vaccinating pregnant mothers. This is, you know, this is kind of a big deal.

So Pfizer came to this came to here with a phase three trial. They presented defer back. They did not have it adequately powered, meaning there was only about a little over 3,000 pregnant women in the vaccinated group and the placebo group. respectively. So they didn't have a power to figure out if that that preterm delivery issue, what they could find if it's statistical anomaly or if this was really a big issue. The study also although it said it was supposed to, the study didn't include breastfeeding data, which clearly would have some type of impact on vaccine efficacy. But yeah, let's go on. We go back to this article. It says this. Very important point. The reason the shot is given to pregnant women and not the babies themselves is because the newborn immune system is.

so immature. Oh, Russo explains. The idea is that we'll vaccinate pregnant women and they'll make the antibodies that will cross the placenta and offer the baby protection for the first few months of life. Amazing, Dell. They're finally admitting this. This is a point we've been making at both ICANN and the high wire for years. So we're going to vaccinate the mother because the first couple months, the baby's immune system is so immature that they're not. Basically, they don't, they don't, they don't have an immune system that can learn anything. So all those vaccines you're giving in that first year of life are absolutely useless because they don't create memory. There's not an immune system there to memorize it. And so now they're vaccinating the mothers, which I don't like that

either, but the point being they're admitting a problem that we've been pointing out for years. Can we just dump all the vaccines as being in the infants because they're useless and pointless and don't actually work? Yeah. And so let's look at the CDC schedule. Let's look at those first two months they're talking about that they don't work really in infants and you got with this two uh two shots of have be rotavirus dTP uh polio that's about eight shots there so will you stop giving these to babies because their immune systems aren't fully developed yet can we have this conversation now right anyway back to the back to the story so there's a lot of vaccine makers rushing this space we have fyser we have johnson johnson and we have gsk so this is something that was not brought up during the verpak

conversation is GSK halted three, this is Reuters, GSK halts three trials of respiratory virus vaccine and pregnant women. Well, that's interesting because that's just what Pfizer told us was really a great vaccine. And now we go to the BMJ to look at this little further analysis. Maternal RSV vaccine, further analysis is urged on preterm births. It's the BMJ. It says in February 2020, GSK halted enrollment and vaccination across three, phase three trials of its maternal RSV vaccine candidate citing a safety signal in one of them. It emerged that the concern was about an increased risk of preterm birth in the vaccine arm. And get this. It says in a document submitted to the FDA, GSK's data showed 238 preterm births out of 3,49 or 6.8% in the vaccine arm, and 86 out of 1,739 or 4.9%

in the placebo arm. Around one extra preterm birth for every 54 vaccinated mothers, there were 13 neonatal deaths in the vaccine arm and three in the placebo arm. Obviously, huge, huge concerns there. And similar, right? So similar to the Pfizer. What Pfizer is telling you is there was a, you know, it was about 70% higher. This, I don't know, this is probably 25 or 30% higher. But you're seeing the same problem.

What you're seeing, what it should be triggering to, as, as Pierre Cori had said, every single peer-reviewed paper right now should be saying, hold on a second. Pfizer's having the same problem. We poll GSK. Why aren't you polling Pfizer? Because it's only, you know, killing fewer babies. It's only hurting, you know, 20%, not 30%. I mean, this is the problem.

Scrap it, dump it. The thing is causing problems. And that's just in the small group you're looking at. God knows what the long-term effects of this are going to be. Not adequately powered studies to even figure out, even answer this question. And so here we get to this story, Epoc Times. FDA advisors. This is the Burpac committee. FDA advisors back maternal RSV vaccine as Pfizer says safety concerns can be study post approval. So here we go again. We have to approve it to determine

whether it's safe or not. Why? Because Pfizer, a multi-billion dollar company didn't come to the table and do their homework. So this is now going to go to the FDA to see if they approve it or not. And then we're going to talk about the CDC and ASIP at that point. But we're going to be on this every step of the way, Del, because this is no minor thing. This is a major thing. This is a major deal. We're talking about pregnant mothers or vaccinating with shots that have questionable, questionable safety issues here. And so folks, just so you understand what this scam is, as soon as the FDA approves it, they say, oh, we'll study it, you know, post-marketing once everyone's getting it, that erases the ability for ever being a placebo group again. That is what this is about. If you say,

you know what, we need more studies, go back to the drawing board, do a larger powered study against the placebo group, meaning a group that are getting a saline injection compared to vaccine, and let's follow them more long term since there's clearly a short-term problem. Let's see if there's a long-term problem as soon as they get it approved. As soon as FDA says, oh, nope, approved. Placebos can never be used again. Now it's unethical. And now you're just stuck with what Pierre-Cory is saying.

You're going to have to look at the giant population that say, oh, it's similar to the background rate, just as we saw in the trials. And we're all moving on. And only if there's pit sporks and blazing, you know, torches outside the walls of the CDC, will they then go and produce a fraudulent study, manipulate the heck out of it, and say everybody go on business as usual. I mean, it's incredible. It's over and over and over again. All right.

Well, look, you've been warned. For everybody, tell your friends that are pregnant, tell them they don't need this RSV vaccine. This is something that, you know, we've all had children, RSV didn't kill our babies. This is insane. You should not be putting that risk. You don't want to be increasing your risk of preterm birth and probably neonatal death. that's necessary. All right, I'm going to just say that right now and this product is untested and they're never going to do the proper tests now that they've approved it because then they be

held liable.