00:00Hi everyone, I'm Maggie McGrath, Senior Editor at Forbes. Health and Human Services Secretary
00:05Robert F. Kennedy Jr. is proposing a change in how vaccines are tested. Could this affect
00:12flu and COVID season and when booster shots are available? Joining us to discuss is Dr. Peter
00:19Hotez. He is the co-director of the Children's Hospital Center for Vaccine Development and Dean
00:25of the National School of Tropical Medicine at Baylor College of Medicine. Dr. Hotez,
00:31thank you so much for joining us. Maggie, thanks for having me.
00:34So you are an expert in vaccine development. I want to start with what might sound like a basic
00:38question, but what exactly is HHS Secretary RFK Jr. proposing and how is this different than his
00:45predecessors? How do vaccines normally proceed in order to be available to us in the fall for
00:51flu and COVID season? Well, you know, it's a little, it's a bit of a head scratcher, Maggie,
00:57because he makes it sound as though this is something new. We've been testing vaccines with
01:04placebo controls for the last 75 years. That's how we do it. That's how just about all the childhood
01:12vaccines are tested, like MMR vaccine and others tested against placebo control. So,
01:18you know, it's the way he presents is though this is something really, really novel. It's not that
01:26that's what we've been doing. In fact, what I've done in my social media posting on my both on X and
01:31Blue Sky, I just put up doing kind of a random PubMed National Library medicine search of randomized
01:39placebo controlled trials. And I, you know, just pick seven or eight childhood vaccines and there they
01:45are for any, anybody could do this. It's a, it's, it's open access. You can do it, do it yourself.
01:50So, so the, the first point, why he felt the need to come up with this announcement to me,
01:56that was confusing point one. Now the only point of question is whether he's only talking about new
02:06vaccines, which is what we've been doing for the last, I don't know, 70, 75 years, as I've mentioned,
02:13or whether he's also raising this issue for updating vaccines for which we've, they've been
02:23initially tested through placebo randomized control trials, but then there's either an annual or
02:31semi-annual need to update them. And that's because these viruses vary their antigenic makeup
02:38over time. And therefore to improve the vaccine to cross-react against the new variants, you have
02:47to slightly alter its composition in terms of the, of terms of the antigens that the, the, the vaccine
02:54is producing. Mostly it's 99% the same or close to it, or at least 90% the same, but there's some
03:03variation. So let me give you a couple of examples. So we, you know, we ask Americans to take an annual
03:09influenza vaccine. So for that influenza vaccine, which is a virus typically grown in eggs or sometimes
03:18cell lines, those were all tested through randomized placebo controlled trials. But for the updated
03:24version in some cases, maybe, maybe not. We use what are called bridging studies showing that the
03:32antibody does that the antibody levels are similar to the, to the initially approved vaccine. And the
03:42better example that people will know about are COVID vaccines. So for the mRNA vaccine, each time an
03:49mRNA vaccine is updated, now we're doing it on an annual basis. It's pretty close to what it was
03:54originally. But now we use bridging studies for that. If you had to do a brand new randomized
04:02placebo controlled trial for every updated vaccine, what that would mean is, first of all, because so
04:09many people by now have been immunized with COVID or infected with COVID to, to measure it for
04:15effectiveness, it would be a million person study or hundreds of thousands of people, which would be
04:20prohibitively expensive. And, and, and, and, and, and probably, therefore, not, not even
04:29practically feasible. And then you have to wonder about the ethics of it, because it would take so
04:36long to do, that you couldn't rapidly have another mRNA variant in time. So it would essentially squash
04:43the program. So I think we need some clarification from Department of Health and Human Services,
04:48what they're talking about. If it's to mandate that all new vaccines that haven't gone through
04:56placebo controlled trials to reaffirm that they go through placebo controlled trials, well, we've
05:02already doing it. So I don't see the need for, you know, this is same old, same old, we've, we've
05:08already been doing that. And it, you know, and, and the exact placebo is worked out iteratively
05:13between the vaccine producer and the FDA, and it's worked well for, as I say, 75 years. But if he's
05:20also talking about updating it, I think asking, asking for a new brand new randomized placebo
05:28controlled trial, one, it's a question of feasibility question of whether it'd be available
05:34in time and whether it really makes any sense at all.
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