Are Vaccines Tested Enough? Examining the Evidence

[00:00:00]This is kind of interesting. But, when you hear this, you would think, "Aren't they doing that already?"

[00:00:06]So, this they're talking about the flu vaccines, which come out every year, supposedly. Oh, there's a new strain of the flu, and we got this vaccine that's going to fix, you know, that'll immunize you against it.

[00:00:17]And apparently, they they weren't even tested it. They're just like, "Hey, this is the new the new vaccine."

[00:00:25]And so, Bobby Kennedy is saying, "We're going to start testing this stuff." In other words, the vaccine company's got to prove to prove to us that it actually works.

[00:00:35]Because, unfortunately, lots of people get their flu vaccines every year, and they die shortly after that.

[00:00:41]And in other words, the vaccines are killing them.

[00:00:45]>> This week, we saw a big sell-off in biotech stocks, following these reports of the FDA, which you used to run the first part of the Trump administration, is now going to require one study to clinch approval of vaccines. You were one of the former commissioners who put out this really extraordinary editorial in the New England Journal of Medicine, arguing that the FDA and top vaccine regulator, Dr. Vinay Prasad, are changing policies in a way that should slow down new and better vaccines.

[00:01:15]What specifically is the problem you see? Cuz this isn't just have be This This is the vaccines of the future you're saying just won't be created.

[00:01:24]>> Right. So, Vinay Prasad, who is the head of the biologic center, also oversees vaccine division, who also has been appointed as head of biostatistics, the chief medical officer of the agency, and the chief scientific officer. So, he occupies a lot of positions, put out a memo saying that they're going to do away with or move away from what they call immunobridging studies. These are studies that allow you for well-validated vaccines, like the flu vaccine, to be able to demonstrate each year that the vaccine, the new vaccine that's formulated against a circulating strain, can elicit antibodies that are effective against that particular strain, and that can be the basis of approval rather than requiring new outcome studies every year to prove the vaccine actually reduces the instance of influenza. For established vaccines where we know that antibody production is a good correlate for immunity, this has been a long-standing practice. It's We do it for a flu vaccine. We do it in COVID, certainly. We do it for um things like pneumococcal vaccine, the vaccine for pneumococcal disease where we look at serotypes, uh circulating bacterial serotypes. This allows us to update vaccines as these viral and bacterial strains change and as the composition of the strains change in time to provide protection for the fall respiratory season. If they move away from this, which is what we said they plan to do, we're just not going to be able to update vaccines each season as we've done historically to accommodate whatever the circulating strain.

[00:02:45]>> So, the what he was saying is the way it's going to be done going forward is the vaccine companies have to basically show proof that they test it and show that yes, the new vaccine does cause the correct antibodies to be made in your body, whereas I guess the way they did in the past was they would say, "Hey, just trust us.

[00:03:07]Here's this new vaccine." They would give it to everybody, and then after the fact, they would look and say, "Well, how well did it prevent people from getting the flu?"

[00:03:16]>> It sounds like just okay. I think he's mad because he can't keep printing money, basically.

[00:03:21]>> Yeah, so now you got to prove that it actually stimulates the immune system and to prevent the person from getting sick, whereas before, it's like they just mass vaccinated everybody and go, "Yeah, we'll just look at all the data to see how it worked."

[00:03:35]Now you're they're basically up front having to prove that it works instead of letting them just say, "Hey, well, they get the flu all the time. It's an annual thing, so we'll just trust it's going to work. It's slightly modified, and then next year we'll look at the data and know whether or not it worked, which is basically the humans are the guinea pigs.

[00:03:55]You would think common sense that they're already doing that, but no.