The Highwire with Del Bigtree - FDA HAS LOST ITS WAY

Episode Date: May 30, 2022

The FDA authorized Covid vaccines for 5-11 year- olds this week, via press release. With concerning safety signals and low risk from infection, experts are questioning the move, suggesting the embattled agency has lost its way.#FDA #PeterMarks #kids #SafetyFirstBecome a supporter of this podcast: https://www.spreaker.com/podcast/the-highwire-with-del-bigtree--3620606/support.

This is the FDA's latest emergency use authorization. They're authorizing boosters for kids. The first booster, FDA authorizes Pfizer COVID booster dose for kids ages 5 to 11 years old. None of this could happen if it wasn't for Javier Bacera. He's the secretary of HHS and he extended. We reported this about a month ago. He extended the COVID public health emergency for another 90 days. that was in the headlines. And what that did was it allowed these emergency use

authorizations for vaccines to stay valid and also for them to do what they just did with the FDA is to push more through for these kids. So even though there is no emergency for kids, we've covered the numbers, there's no hospitalization emergencies, there's no mortality emergencies associated with COVID-19. These kids have almost zero percent risk on those two factors and a low case correlation to that. But let's go right. Okay, so let's go right to the FDA press release because we didn't get a VIRPAC meeting on this one. We received a press release. Coronavirus update FDA expands eligibility of Pfizer COVID-19 vaccine booster doses for children, 5 through 11 years old. Let's dig into this great press release. It says here the safety.

Now, how did they determine the safety? The safety of a single booster dose with the Pfizer Biointech COVID-19 vaccine in this age group was assessed in approximately 400 children who received a booster dose. So there you go. You're going to send it to about a million. plus children throughout the United States. Now it says here, the FDA did not hold a meeting of its vaccine-related biological products advisory committee on today's action, as the agency previously convened the committee for extensive discussions regarding the use of booster doses of COVID-19 vaccines. And after review of Pfizer's EUA request, the FDA concluded that the request did not raise questions that would benefit from additional discussion by committee members. There you go, committee members.

It's so terrifying where we're at now. We're talking about a vaccine and brand new technology. I'm just going to try to recap like the last two years of our lives. A brand new technology that killed animals in the animal trials had a serious problem that no one could figure out to overcome. We warp speed the vaccine and then we do something called an emergency use authorization, meaning just give it to everybody, just make it available to everybody because it's just such a big problem.

This cold is killing, you know, nearly 0.26% of those that are capped. We got to get on this. And so they rush this vaccine out without a long-term safety trial. No idea of the long-term safety effects. Can you imagine if we keep doing this with every product that the pharmaceutical industry makes? We're all going to die if, you know, if this isn't the vaccine or the drug that kills us, this approach towards medicine will be. And now they've gone a step further. Now are they not only rushing these things out, the one little kind of stopgap you had was this, you know, well-paid, you know, insider group that you would have to live. least addressed, most of them work for Pfizer or Merck or Sinofia Bentis, we've been complaining

about it, Burbank, but at least they were getting in there and hopefully making some comments, and they've made some comments, right, that were not like that positive. Even though they're funded by most of these industries, they kind of came out and said, I don't know about this, and then they just cut them off completely. Now it's like, it's just like we're just going to make decisions without any scientific debate over the, you know, and if there's debate, we're going to skip it. I mean, it's such a dangerous precedent and what we're watching here. What's interesting about that press release is it, they slapped every one of those members in the face. I hope, members, if you're watching this or if you, if you read that press release,

you have just been disrespected by the agency that you're supposedly advising. They said all of your, all of your, the letters in front of your name, doctor, right, immunologist. That means nothing. You can add nothing to this discussion, they said to you. And so let's look at what the FDA in all its wisdom looked at, and let's see if this would offer a discussion. It says here, this is for the effectiveness.

Antibody responses were evaluated in 67 study participants. Okay. So not even the 400. There's like 67. Not even a 400. Okay. Small fraction. Who received a booster dose seven to nine months after completing a two dose primary

series of the Pfizer biointech COVID-19 vaccine. The antibody levels, which levels we don't know, the antibody level against the SARS-CoV-2 virus one month after the booster dose was increased by how much we don't know compared to before the booster dose so there you go shut up and deal with it so luckily we can go back to the future here back in time and go back to when the FDA did have its independent expert committee deliberate on the two doses for that same age group so this was before the booster dose they talked about two doses for ages 5 to 11 this was in October 26 2021 take a listen to to what Michael G. Corrilla, he's an immunologist. He had some interesting questions he brought up at that

time. Take a listen. And while the benefit here is assumed to be prevention of severe disease, which is what we're all hoping for, my one concern I have is that particularly for that population that has children that has undergone previous, as it has experienced a previous COVID infection, which CDC estimates is 40% of this population, which I think is probably a floor. I think it may actually be higher than that. The question really becomes, does this vaccine offer any benefits to them at all? Are they actually very well protected? And the other aspect here is for children who have undergone, for example, a delta infection,

does now vaccinating them with a strain that goes back, almost two years from the vaccine, from the time they're getting the vaccine, does that actually help or hurt their current immune system with regard to ongoing variants? I don't think we know that. We have no idea. I think for many children who have experienced COVID already, they're probably more than adequately protected. One dose may be sufficient.

I think for the high-risk children, it's very different, but I will emphasize again that this dosing interval, the way it was put together, is suboptimal in terms of durability. And I think that there can't be any expectation that the antibody decay rate is going to look any different from the adults. And then these children are going to be expected to have a booster in another six months. And I think the focus on cases, reducing cases, is really what's going to confound us because I don't think we're going to be able to do that. We're going to see vaccine breakthroughs in this population. And it's going to cause all the same problems that COVID does whether or not they're vaccinated.

What a wise sage. I mean, here we are. Like you said, six months later, we're just about seven months later, voting on the booster, no voting at all. And he talked about the zero prevalence. They said at that time, there was 40% of those kids in that age group. Right. Now, we, we covered last week, the CDC's own MMWR said about 75% of kids zero to 17. I mean, all that's really encapsulated really what Jennifer Ashton was talking about. 75% of this country, these kids have probably high tighter rates. They also the T cells and B cells. And as Gerevan Bosh has pointed out, they are immune to the current Omicron.

You're going to now vaccinate them with the old alpha, the Wuhan strain vaccine? Like what possible benefit? That can have no benefit. So what if their antibodies are going up? If they're useless antibodies that don't recognize the current strain, you reported on this last week, Peter Marks basically, you know, telegraph that he was going to do this thing. I don't care if the rates are below 50% in effectiveness, which was that milestone we told they would always stay above.

We will recommend it for kids anyway. They did it. I mean, it's just, you know, can we bring up a picture of Peter Marks? I just, I just have to make the, do we have a photo of Peter Marks? I think we have to remember this moment in history because this is the guy. This is the guy that has made decisions under all these situations where we know. The death rate is virtually zero amongst children that catch COVID. He already admitted that this vaccine is totally ineffective.

We know that. They are seeing no better benefit that we're seeing with the adults. Everyone's catching Omicron. The vaccine isn't working. And now with a 75% technically, that's herd immunity. When you have that much natural infection in this group, those kids are living at the space we should all be at for herd immunity. Now you're going to subject them to all the dangers of the blood clotting,

all the myocarditis, all of the issues that you know exist. This is no longer hypothetical. You know there are children being put at risk. I just want to say, don't ever forget the face of, you know, Mr. Marks here, Peter Marks. And with all due respect to Dr. Carilla, saying really just the obvious, anybody that looks at any of the science could have said that as well. He did abstain from the voting. He was the only one that abstain from the voting during the two-dose recommendation,

emergency use authorization for those five to 11-year-olds for the Pfizer vaccine. But let's look at what the journals say. Let's look at what the medical journals are saying. This is the journal of the American Medical Association or JAMA. They came out with this study just recently titled Association of Prior BNT 162B2, that's Pfizer's vaccine, COVID-19 vaccination with symptomatic SARS-CoV2 infection in children and adolescents during the Omicron predominance. Now, this is important because the Omicron predominance is the one we're talking about here.

And symptomatic. So we're always being told the kids are always asymptomatic, that you can never tell what's going on. they looked at symptomatic cases. And let's look at the conclusion that this study found. Among children and adolescents estimated vaccine effectiveness for two doses of BNT162B2 against symptomatic infection was modest and decreased rapidly. It's exactly what Carilla said. That's exactly what we knew. And let's look at this in a chart. We see this on the left side. That's the adjusted vaccine effectiveness as a percentage. And then at the bottom is the month since second dose. Now remember, those kids just started getting vaccinated during the time of

this study so you have the five through 11 year olds that are now ready for the boosters they have just it's peaking under 30% effectiveness but we had those 12 to 15 year olds who's had the vaccine for quite some time they start around 60 but uh-oh they go under zero and when you go under zero that means you get into a negative and that means you're more at risk of symptomatic infection after those two doses and so for people that are watching this for this first time let me be perfectly clear you see it orange line going across right there at about four months it's nearing the zero line and then once it goes negative into then down it looks like negative 20 by seven months out that really means you can flip that over that's a 20% increased risk of developing a COVID infection you were increasing your risk so these days

where people wrap your head around this the days of this idea that your kids going to get a vaccine and then they'll be protected for life are over this prediction is lasting months meaning somewhere down the road you are increasing the risk of your child being infected, increasing the risk of them being a carrier that's going to spread it to their classmates, increasing the risk of infections throughout schools, increasing the risk to those that have autoimmune issues and couldn't get vaccinated. So forget about this argument. It is gone, it is dead, that you're vaccinated in order to protect those that can't vaccinate to create this cocoon. You're doing anything but you are putting us all at risk for being around your infected

child that's going to be more infected because you gave them the vaccine. Let's not mistake what we're seeing here scientifically.