Dr. Peter Hotez, Co-director of the Texas Children’s Hospital Center for Vaccine Development and dean of the National School of Tropical Medicine at Baylor College of Medicine, joined "Forbes Newsroom" to discuss Sec. RFK Jr.'s decision on vaccine testing.
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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.