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, joins "Forbes Newsroom" to discuss HHS Secretary Robert F. Kennedy Jr.'s new directive to require placebo testing for new vaccines.
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00:00Hi, everyone. I'm Maggie McGrath, senior editor at Forbes. Health and Human Services
00:09Secretary Robert F. Kennedy Jr. is proposing a change in how vaccines are tested. Could
00:16this affect flu and COVID season and when booster shots are available? Joining us to
00:22discuss is Dr. Peter Hotez. He is the co-director of the Children's Hospital Center for Vaccine
00:28Development and dean of the National School of Tropical Medicine at Baylor College of
00:34Medicine. Dr. Hotez, thank you so much for joining us.
00:37Maggie, thanks for having me.
00:39So you are an expert in vaccine development. I want to start with what might sound like
00:43a basic question, but what exactly is HHS Secretary RFK Jr. proposing and how is this different
00:49than his predecessors? How do vaccines normally proceed in order to be available to us in the
00:55fall for flu and COVID season? Well, you know, it's a little, it's a bit of a head
01:00scratcher, Maggie, because he makes it sound as though this is something new. We've been
01:06testing vaccines with placebo controls for the last 75 years. That's how we do it. That's
01:14how just about all the childhood vaccines are tested, like MMR vaccine and others tested against
01:21placebo controls. So, you know, it's the way he presents is though this is something really,
01:27really novel. It's not that that's what we've been doing. In fact, what I've done in my social
01:33media posting on my both on X and Blue Sky, I just put up doing kind of a random PubMed National
01:41Library medicine search of randomized placebo control trials. And I, you know, just pick seven or eight
01:48childhood vaccines. And there they are for any, anybody could do this. It's a, it's, it's open
01:53access. You can do it, do it yourself. So, so the, the first point, why he felt the need to come up
01:58with this announcement to me, that was confusing point one. Now the only point of question is whether
02:09he's only talking about new vaccines, which is what we've been doing for the last, I don't know,
02:1570, 75 years, as I've mentioned, or whether he's also raising this issue for updating vaccines for
02:26which we've, they've been initially tested through placebo randomized control trials, but then there's
02:34either an annual or semi-annual need to update them. And that's because these viruses vary their
02:42antigen at makeup over time. And therefore to improve the vaccine to cross-react against the
02:50new variants, you have to slightly alter its composition in terms of the, of terms of the
02:56antigens that the, the, the vaccine is producing. Mostly it's 99% the same or close to it, or at least 90%
03:06the same, but there's some variation. So let me give you a couple of examples. So we, you know, we ask
03:12Americans to take an annual influenza vaccine. So for that influenza vaccine, which is a virus
03:20typically grown in eggs or sometimes cell lines, those were all tested through randomized placebo
03:25controlled trials. But for the updated version, in some cases, maybe, maybe not. We use what are
03:34called bridging studies showing that the antibody does, uh, uh, um, that the antibody levels are
03:42similar to the, to the, uh, initially approved vaccine. And the better example that people will
03:48know about are a COVID vaccine. So for, um, the mRNA vaccine, each time an mRNA vaccine is updated,
03:55now we're doing it on an annual basis. It's pretty close to what it was originally. Um, but now we use
04:02bridging studies for that. If you had to do a brand new randomized placebo control trial for every
04:08updated vaccine, um, what that would mean is, um, first of all, because so many people by now have been
04:15immunized with COVID or infected with COVID to, to measure it for effectiveness, it would be a million
04:22person study or hundreds of thousands of people, which would be prohibitively expensive. Um, and, uh,
04:29and, and, and probably therefore not, not even practically feasible. And then you have to wonder
04:37about the ethics of it because it would take so long to do, um, that you couldn't rapidly have another
04:44mRNA variant in time. So it would essentially squash the program. So I think we need some clarification
04:50from the Department of Health and Human Services, what they're talking about. If it's to mandate that
04:56all new vaccines, um, uh, that haven't gone through placebo control trials to reaffirm that they go
05:04through placebo control trials while we've already doing it. So I don't see the need for, uh, um, you
05:11know, this is same old, same old we've, we've already been doing that. And it, you know, in,
05:15and the exact placebo is worked out iteratively between the vaccine producer and the FDA. And it's
05:21worked well for, as I say, 75 years. But if he's also talking about updating it, uh, I think, um,
05:28asking, uh, asking for a new brand new randomized placebo control trial, one, it's a question of
05:36feasibility question of whether it would be available in time and whether it really makes any sense at
05:40all. For your first scenario where it's a brand new vaccine, what you're saying is placebos are
05:47already part of the process of bringing something like that to market. For the second scenario for
05:52an update, it sounds, my question to you is, is there scientific or medical evidence or reason
05:59for RFK Jr. to have proposed this? Or do you think it's a delay tactic from a noted vaccine skeptic?
06:07Yeah, it's, it's hard, you know, it's hard to say what his motivation is. Um, but I, I,
06:13I would just question the scientific rationale for, for what he's, um, proposing to do. And it really
06:20depends on how significant a change it is from the updated vaccine to the previous one. Um, in some
06:27cases it would make sense to do a randomized placebo controlled trial. Let me give you an example. So
06:33the first polio virus vaccine that was made available to Americans was the Salk inactivated, uh, polio
06:41vaccine, uh, eventually, uh, was switched over to, uh, an oral live attenuated polio vaccine from the
06:50laboratory of Dr. Albert Sabin in Cincinnati Children's Hospital. Sure. That's a significant
06:55enough difference to warrant doing a new, a new set of randomized placebo controlled trials, but that's
07:02very different from slight variation in the genetic makeup of an mRNA vaccine, say from the
07:11BA1 Omicron variant to say an XCC Omicron variant. To me, I don't necessarily see the rationale of
07:20doing a brand new placebo controlled trial. I think a bridging study is, is adequate and, and I don't
07:26know that it's even feasible to ask to, to even do a brand new randomized placebo controlled trial. So,
07:32so I, so the, the, at multiple levels, his statements or recommendation, uh, don't, don't seem to be
07:41well-grounded in science to me. If he does proceed with a full randomized placebo study of the flu shot
07:49and the COVID booster, what would that mean for consumer access to these vaccines? I'm used to seeing
07:56advertisements in local pharmacies starting in September, typically, would, would they be available
08:02on their regular timeframe? Yeah, that's a good question. I think it might be really problematic.
08:07Remember the, um, it's a pretty carefully orchestrated dance getting the, that new flu vaccine,
08:14um, out in September. The, the vaccine producers, um, need six months to, to confirm that they can even
08:23grow the virus in whatever medium they're using, whether it's, um, chicken eggs or, or whether it's,
08:29uh, on cell lines, they have to get an adequate amount of virus, what we call titer of virus. And,
08:36and then you still, the vaccine still have to go through safety studies. It's pretty impressive
08:41that they can do all that as it is, um, given the short timeline that they've got, you know,
08:47basically, basically making the decisions in, in oftentimes, uh, in, in the early part of that
08:54year and getting it out as a safe and effective vaccine, uh, by the late summer, early fall. It's
09:00and, and they do that carefully orchestrated dance every year. Now, if you require extensive
09:06additional studies, effectively speaking, I would imagine that would mean that they couldn't have that
09:12vaccine available in time. And, and the same with, with the mRNA. I mean, mRNA technology
09:17is, is useful because it's pretty quick, but it's not that quick. You still, you still need time and
09:24you still, we still need to do the safety testing and everything else. So, so again, I, I, I don't
09:30understand. And, and I guess it's fair enough to ask for clarification because maybe that's not what
09:36he means, you know, the, the way the statement was put out, uh, seemed to be somewhat, uh, ambiguous
09:43as well. The ambiguity can lead to anxiety, especially among those who are immunocompromised
09:50and or elderly and or otherwise in a position of wanting and needing that booster as soon as it's
09:56available. If someone within that patient population is watching this and is concerned,
10:01do you have a message for them? Is there anything they can do at this point in time to protect
10:06themselves or to get access to a vaccine that they feel and their doctors feel that they need?
10:12Well, hopefully the vaccine producers, um, will come to some, uh, uh, get some clarification from
10:19the FDA. That would probably be the first step. So, um, hopefully, you know, cooler heads will prevail
10:26and, and some sound decisions will be made. So I wouldn't, I wouldn't panic, um, uh, just yet. Um, uh,
10:34and the hope is that, that updated vaccines will be made available in the United States.
10:39If they're not available in the U S and this is perhaps a speculation question, but could we start
10:45seeing medical tourism where Americans go to Europe to get the boosters that they need? If we can't have
10:52access here.
10:53So what does that white house press secretary always say? I'm not going to engage in hypotheticals.
10:58Uh, that seems to be the, that seems to be the line of the year for 2025. And, uh, yeah, I mean
11:04that, that, that, that could be an option, you know, to go to Canada or to go, go to Europe,
11:09but hopefully it won't come to that.
11:11Hopefully it won't come to that. Now you mentioned that six month timeline. So at this point in time,
11:15it's May, 2020, probably more than that, right? Because, because remember how it works. The, um,
11:20the, uh, oftentimes the decision on the, so let's go through the timeline, say for influenza vaccine.
11:28So the, the decision on which strains of virus are going to go in. And typically there are two
11:35influenza type a strains in H3N2 and an H1N1 and an influenza B that's often based on what's seen in
11:44the Southern hemisphere the summer before. So let's, let's, let's fast forward to the summer,
11:51for instance. Um, so you'd be looking to Australia and New Zealand, what's happening with flu down
11:56there because their summers is, is, is, is like our winter. Um, and then some decision would be made
12:04perhaps by the end of this year of what would go into the flu strains the following fall. So, um,
12:12and then the, you have to grow the virus after, you know, procuring the source of eggs or the,
12:20or the cell lines ensure that you can make enough of the virus because the replicative ability of
12:25the virus can vary from strain to strain. And then it's, uh, it's probably starts to be made in that
12:33spring. And then all of the, and there's still a lot of human testing that has to be done, um,
12:38for safety and immunogenicity that occurs over, um, the following say five, six months.
12:46And so to have it ready by the end of the summer. So that that's typical timeframe. And if you now
12:51add an effectiveness, uh, randomized placebo controlled trials, whether it's for efficacy
12:58or everything else, well, one, it's not always easy because by the time you're ready to make it,
13:03there's, there's not, there's not enough influenza around to test for F effectiveness.
13:10And so you're really obligated to do bridging studies. Um, the timeline is a little more
13:14compressed likely for the MRNA vaccines, because it's a matter of just simply varying the nucleotide
13:22sequence, but you still have to go through all that human safety, uh, and immunogenicity testing
13:27by immunogenicity. I mean, you, you, uh, inject, uh, uh, uh, inject human volunteers and show that
13:35you're still getting a robust immune response to, to what, to what you're making.
13:39So in a normal cycle, we'd be in that testing and safety phase right about now in May. And the big
13:46question mark is whether there's going to be a randomized placebo study tacked onto that effectively.
13:53Effectively. And, um, and, and which case, yeah, I can't imagine how, well, it's not easier said than
14:01done. And then what are you doing the randomized placebo control trial for? Are you doing it for,
14:07um, uh, safety again, or which in a sense you're already, already doing that anyway, or you're trying
14:13to measure effectiveness and, and then, you know, oftentimes you'd have to wait quite a long time
14:19to do an effectiveness study. So that's the nitty gritty on the COVID vaccine and the flu shot,
14:26but I want to zoom out because before we started recording, you were talking about how the flood of
14:31statements that have come from RFK creates work for you. You effectively, every time he says something
14:38about vaccines, what happens? Do you have to go on social media and clarify, or do you get patient
14:44an influx of patient questions? What's been the life in Dr. Well, I had been hoping after, you know,
14:51as COVID started to wind down that I could retire my TV career and just stay focused in the lab and
14:58doing my writings. And, but Mr. Kennedy seems determined to call me out of retirement. Um, um,
15:04and, and, and, and yeah, so he's every few days, he's just coming out with some zinger. So for
15:10instance, you know, a few days ago, he says the, the MMR vaccine is, uh, I mean, we can go through
15:17the list. He says it's, it's, I don't know, something like it's got, uh, aborted fetal debris
15:22or something along those lines. Well, first of all, the MMR is three viruses. The, the first two M's
15:29are measles and mumps, and those are grown, uh, in, in, in, in chick embryo cells. So there's
15:36certainly not. And then the R, the rubella, the virus that, um, that that's from a cell line that's
15:42been propagated for more than 60 years. It originally came from, I believe, two aborted fetuses back in
15:51the early 1960s, but they're propagated on cell lines, uh, over decades. And there's certainly no
15:57aborted fetal material. And the Vatican is weighed in on this and, and they're very comfortable with
16:03that. And so he just makes this very reckless statement about aborted fetal debris. And it's,
16:09I think it's irresponsible and it frightens people. And, and, and, but then the continues,
16:15then he made a statement that the, that the, um, uh, protective immunity, first of all, he said the
16:21MMR vaccine's a leaky vaccine. Uh, I'm not even sure I know what that means. I guess he means that
16:27it's, you know, it has, uh, unreliable effectiveness, which is nonsense. It's one of the most effective
16:33vaccines that we have, you know, Maggie, when I, as a vaccine scientist, it develops low-cost
16:39vaccines for parasitic diseases and made a low-cost COVID vaccine reaching a hundred million people.
16:43When we're doing our vaccine design, my aspiration is to, uh, um, make a vaccine as good as the MMR
16:51vaccine. It's one of the most effective vaccines. We have 90% one dose, uh, 97% two doses.
16:57So it's not leaky at all. And then he says it declines, uh, with 4% protective immunity,
17:03um, talking about the measles epidemic every year. It's, it's absolute nonsense. I mean, there was,
17:08uh, if it declines at all, there was one study, uh, modeling study where it declined 0.04% a year.
17:18So that's a hundred fold less, but then he continues, you know, it, it, you know, he starts make,
17:24drawing this false equivalency between getting the MMR vaccine and this useless cocktail of,
17:30uh, interventions, budesonide and vitamin A and, and clarithromycin, um, you know, appealing to the
17:38health, wellness and influencer industry. Um, he says the measles hospitalizations are due to,
17:44um, uh, are, are, are due to, uh, quarantine or isolation when it's nonsense. These are sick
17:50kids in the hospital. We've already had two pediatric deaths and otherwise well school-aged
17:56kids who were denied access to vaccines. And so it's just becomes this exhausting exercise to
18:01continue to have to debunk things that he says on a regular basis.
18:07Would you go as far as saying it is undermining public health?
18:12Well, it, it erodes trust in our, in our nation's vaccine ecosystem, which has been highly effective
18:20has led to the elimination of multiple childhood infections. I mean, when I was a pediatric house
18:27officer, a resident in Boston, um, I was admitting a child every couple of weeks with Hib meningitis,
18:34Haemophilus influenza type B meningitis, a bacterial meningitis was devastating. Kids died,
18:39um, permanent neurologic injury was devastating for families. It was devastating for the house
18:43officers taking care of those kids. Um, every couple of weeks, I was admitting a child with
18:48that on my pediatric service in Boston. And now the disease has been eliminated. It's disappeared and,
18:54and it disappeared just over a few year period. I don't want to bring that back. Um,
18:59and measles, we eliminated measles in the year 2000. Um, and, uh, now we've got, had,
19:06have had sustained measles transmission, um, in my state of Texas and the Western part of
19:12Texas, West Texas and the Panhandle now moving into neighboring areas of New Mexico and Kansas and
19:19Oklahoma. And, and, and it doesn't seem to have an end in sight. It's still going pretty strong.
19:25And if it continues for many more months, we'll lose our measles elimination status as a country,
19:31which was a hard fought gain. So, um, you know, with him piling on making these reckless statements,
19:37um, it has no positive benefit and only serves to undermine public health.
19:44Dr. Peter Hotez, thank you so, so much for joining us and explaining the way vaccines are developed and
19:51are effective. We really appreciate your time today. Thanks very much, Maggie.