The Highwire with Del Bigtree - FDA BYPASSES EXPERTS, OK’S BOOSTERS FOR KIDS

Episode Date: January 13, 2022

The FDA has once again bypassed and marginalized its expert committee, and rushed ahead of the expert panel to authorize a Covid booster shot for kids as young as 12 years. With scant data and little concern for an alarming myocarditis signal in young boys, the agency’s move has caused a public uproar among experts in the medical and scientific community.#OMICRON #COVID19 #BOOSTERS #FDA #VRBPCBecome a supporter of this podcast: https://www.spreaker.com/podcast/the-highwire-with-del-bigtree--3620606/support.

Some big news just happened this week for the FDA and now also yesterday, the ASIP committee. And that was the approval of boosters for the EUA. They extended this. This was the headline at thehighwire.com news page. FDA bypasses advisors, approves Pfizer boosters for children as young as 12. These vaccines and related biological advisory committee. That's Virpac. Man.

Yep. They skipped Verpack and they just went right for it. And, you know, we've covered this before. It's not the first time they've skipped that committee and ignored them. But here's what's interesting about this. It's starting to gain some focus and it's starting to gain some attention from the wider scientific community about how wrong this is. So here's John Hopkins, professor, surgical oncologist, Marty McCari. And he took to Twitter and just blazed it out there. He says, dear President Biden, FDA is bypassing it. It says, scientific advisors to authorize boosters for all kids 12 to 15 next week. This is unconscionable, undermines the integrity of the FDA's standard process. Please require FDA to put this authorized before the Verpac advisory committee for a vote. Well, that didn't happen. So he went back and said this. It is a slap in the face to science for U.S. FDA to circumvent the standard convening of the expert advisory board. FDA is quietly doing this because their experts previously voted it down, voicing concern about medical harms. That's at, President of the United States and Dr. Janet Woodcock.

Ram Paul even got in the mix, jumping onto that Twitter thread, and he had this to say about it. This is Kentucky Senator. He said, so government is ignoring its own rules to push booster vaccines on kids for a disease that is less deadly in children than the seasonal flu. And then finally, we have this is a hematologist, oncologist, health researcher Vinay Prasad. He was on Twitter and he said this, deciding to boost millions of kids with zero efficacy. see data with no idea the risk benefit is favorable is something I never thought I would see from the FDA would not have happened if Gruber Cruz still work there. What does he mean by that? This is the scientist, Dr. Marion Gruber, director of the FDA's vaccine office and her deputy

Philip Cruz. And they stepped away from the FDA. At the time, the headlines look like this. Scientists who quit FDA criticized plan for widespread COVID vaccine boosters. And after that happened, it was smooth sailing it looked like. But what is Dr. Prasad saying in that tweet there? Let's look at the FDA's basically science by press release. This is what they gave us to, since they didn't have that expert committee. And this is the headline there, they expand expanding the use of the fires of bio-and-tech vaccine. And it says here, the FDA reviewed real world data from Israel, including safety data for more than 6,300 individuals, 12, 15 years of age to receive the booster dose.

So that's what they're basing it on. Then they go on to say, astonishingly, the data shows there are no new safety concerns following a booster in this population. There were no new cases of myocarditis, paracarditis reported to date in these individuals. Well, that's really interesting. And what that led was yesterday, the advisory committee on immunization practices. And also, CDC head Wollinsky signed off on this. And here's the headline, CDC approves use of Pfizer COVID boosters for ages 12 to 15. You know what just stands out to me as I see that.

You just did that previous slide where they say, and there wasn't a raise in the risk of myocarditis and paracarditis. I mean, how many people do we hear in hospitals when their child is now in the hospital with a swollen heart, which may be a permanent issue that could lead to their early demise, say, I had no idea that this was a side effect of this issue. And here it is clear. The FDA knows it is such an important issue that it goes out of its way to bring it up. say it's not worse than it already was than the other vaccines we gave you. So just step right up

and get it. But it shows you it's on their minds. It shows you that it's there. This is not something that, you know, antivacters are making up. They know for a fact. And everyone watching this, maybe watch this for the first time. I want you to know this. If you're one of those people that's now joining us because your child had a swollen heart and you thought that that was just crazy talk by anti-bactures, now you know the FDA accepts this as a casualty. They are perfectly okay with every one of those children out there that are getting a swollen heart, maybe even dying with heart issues, whether it's on a soccer team or on a football field or a baseball field or playing tennis, they accept that. They are looking at that. They're staring it right in the face and saying,

yeah, we don't care. Get it out there.