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Forbes senior editor Alex Knapp speaks with Dr. Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia, about how HHS Secretary Robert Kennedy Jr.'s changes to a key vaccine advisory committee could threaten the health of millions of children.
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00:00Hello out there. I'm Alex Knapp. I'm Senior Editor for Science and Healthcare at Forbes,
00:08and I'm speaking with Dr. Paul Offit. He's the Director of the Vaccine Education Center at the
00:14Children's Hospital of Philadelphia. Dr. Offit, thank you for coming on today.
00:19Thanks for asking.
00:20Yes. And Dr. Offit, we're going to be talking about the Advisory Committee on Immunization
00:26Practices, which met earlier this week. And before we really dive into it, though, for the benefit of
00:33our audience who may not be into the nitty-gritty of health policy, could you explain what the ACIP
00:39is and does? Right. So the Advisory Committee for Immunization Practices, or ACIP, was created by
00:46Congress in 1964. So it's been around for more than 60 years. Here's the way it works. Typically,
00:52for example, if a company thinks that they have made a vaccine that is safe and effective,
00:57they submit it to the Food and Drug Administration. The FDA then will license or not license that
01:03product. If they license it, then it goes to the CDC, which has as its recommending body, the ACIP.
01:10The ACIP then determines who should get it. So the FDA says you can sell it. The CDC says,
01:19after the advice of their advisory committee, who should get it? It's a recommending body.
01:25Got it. And in terms of the history of the body, how seriously are the recommendations taken? Like,
01:32how do they impact, you know, whether I have access to a particular vaccine, for example?
01:38Right. So when the ACIP makes a recommendation, invariably, insurance companies will then cover
01:43that vaccine. Also, there's something called the Vaccine for Children's Program, or VFC program,
01:49which pays for about 35 million children's vaccines. So once the ACIP recommends it, then
01:55the Vaccine for Children's Program springs into effect and basically purchases vaccines for more
02:00than half the children in this country. Mm-hmm. And then just in terms of finalizing those
02:06recommendations, I understand the CDC director kind of has the final word, can overrule what ACIP
02:14says. Is that correct? Yeah. The ACIP is an advisory body. So they give advice. That advice
02:21can be ignored. There was an episode during the pandemic when they had made a recommendation,
02:26but the head of the CDC at the time, Rochelle Walensky, wanted to do something different and did.
02:30But for the most part, virtually 100% of the time, what the ACIP recommends, the CDC signs off on.
02:36Got it. And I understand leading up to the meeting, you know, in the past few weeks, there's been
02:42a lot of turnover in the body where Health and Human Services Secretary Robert F. Kennedy Jr.
02:53basically fired all of the existing members of the body, 17 members, replaced them with seven new
03:01members. Has that ever happened before that kind of like drastic changeover?
03:08Purge? No, it's never happened before.
03:11So, and in terms of the new members, I think one thing that was significant to me is that
03:18most of them actually did not have any particular vaccine expertise necessarily,
03:24or even expertise in infectious disease or epidemiology. Is that unusual for there to be
03:33not lacking that particular expertise to be on the advisory committee?
03:38So Robert F. Kennedy Jr. is an anti-vaccine activist, science denialist, and conspiracy theorist.
03:45The 17 people who were on that committee at the time that he came on to be Secretary of Health and Human
03:51Services had the kind of expertise you needed, we needed as the American public to get good advice,
03:57meaning they were experts in virology, immunology, vaccinology, public health. They were clinicians.
04:03Many had seen, for example, and taken care of children with vaccine-preventable diseases. Some
04:08actually were able to advise their own practice parents about, or they were able to advise parents
04:16about infectious diseases. But the problem with that, as far as RFK Jr. was concerned,
04:22is they gave advice based on science, based on good scientific studies. And that is an anathema
04:27to Robert F. Kennedy Jr., who's basically a science denialist. So for a completely bogus reason,
04:33he fired them all. He said they were deeply in the pocket of the pharmaceutical industry. They were
04:37just rubber stamps for the pharmaceutical industry, which was completely untrue. There was not a single
04:43conflict of interest among any of those people. No one had ever voted for something because they
04:48were deeply in the pocket of the pharmaceutical industry and were trying to enrich themselves.
04:51He couldn't name one person for whom that was true. There was a person in our hospital who was
04:57on that committee. It just came onto that committee. She had absolutely no conflict. So I don't know what
05:02he was talking about. What he was really talking about is he wants to put in there people who,
05:06like him, have an anti-vaccine bias. That's what he did. A couple of the people there on that
05:11committee served as expert when it's for him in lawsuits against pharmaceutical companies.
05:16There is a person on that committee who has lobbied against school vaccine requirements from
05:22state to state. No one, really, with the exception of one person, Cody Meisner, had any sort of
05:28expertise in the areas that they're asked to give advice on. So I think the ACIP just took a giant step
05:35backward. And I think for the most part, the medical and scientific community is going to do their
05:39best to ignore them because I think at this point they can only do harm, which I think is practically
05:44what we're in the midst of watching happen. Yeah. And to that point, I know that the
05:51American Academy of Pediatrics just like would normally sit in an advisory capacity on the committee
05:58and refuse to sit down this time. Do you expect more medical bodies to follow that lead?
06:05Well, it's a very difficult decision because on the one hand, you want liaison representatives who
06:11can speak up and say, no, what you've just said is untrue. This is the truth. And that did happen a
06:17few times during the committee. But on the other hand, do you really want to be part of this clown
06:21show, which I think is only going to hurt the American public? I certainly understand how the
06:25American Academy of Pediatrics could reach that conclusion. But in some ways, I'm sad that their
06:30voice isn't around the table. Yeah. And speaking of the committee itself, were there any particular
06:39moments that stood out to you? We presented on a number of different topics. And I think
06:44there were a few things that I'm talking about, the COVID vaccines in particular, where some of the
06:53questions that were being asked by members of the committee just seemed out of left field and
06:57completely baseless. And I'm curious what thoughts you might have on maybe the COVID vaccines in
07:04particular to start with. Right. What worried me is that some of the committee members didn't
07:08understand how these studies were done, how one would do a study on COVID vaccines. And so the CDC
07:15people tried their best to explain that. I think there were certainly misstatements about the COVID
07:19vaccine. So for example, one of the voting members said that the protein that's made by that
07:26messenger RNA, you know, can stay in the body for 700 days, which is completely false. It's really
07:31only a few days. And that's been clearly shown doing the right kinds of studies. There's a lot
07:36of bad studies out there that show that it's there much longer. But the studies that really truly do
07:42look at the spike protein don't show that at all. So you just, this is what happens when you have
07:47anti-vaccine activists. The person actually who made that, it's there for 700 days statement,
07:52has also testified in front of Congress that the mRNA COVID vaccines cause cancer,
07:57heart disease, and autoimmune disease, which is completely untrue. This is the kind of advice
08:02that we're now getting from this committee. It's really hard to watch. Yeah. And I'm curious,
08:08kind of historically speaking, you know, we had in this meeting scientists from the CDC presenting
08:15the data that you're speaking about. And I, you know, how rigorous is, I mean, I know you've got
08:24an unknowledge, how rigorous are those studies? Like, you know, how long does it take to, for those
08:30working groups to put together that data to present to the committee for them to ask questions?
08:35Right. Sometimes months, but the, and they do it, they do a superb job. And when you present before the
08:41committee, especially for, before a vote, you have the so-called ETR, evidence to a recommendation.
08:46So anything that you present is going to be reviewed by subject matter experts to make sure that the
08:51presentation is highly accurate, because when you vote, that has an enormous impact on whether you,
08:56whether you do or don't vote for a particular vaccine. And the, the lack of that, when they brought
09:02one person up for a vote to, to present to the ACIP showed just how bad this can get. I mean,
09:09there was a woman named Lynn Redwood, who's been an anti-vaccine activist for 25 years,
09:13who got up and talked about thimerosal, this ethylomerectomy containing preservative that is in
09:19multi-dose files that are given to adults, or at least some multi-dose, all multi-dose files will
09:24contain a preservative, but there are many influenza vaccines that aren't given in multi-dose files
09:29that don't require a preservative. But anyway, she got up there and proceeded to just misinform with
09:35sort of misrepresentations of studies or pointing to a study at one point in her previous slides that
09:40didn't exist. She said something about the California public health folks saying one thing when they'd
09:45said exactly the opposite. So her slides obviously were never reviewed by subject matter experts. And so,
09:51and she was the one, this anti-vaccine activist that was presenting data on this ethyl mercury
09:56containing preservative vaccines that led to a vote of at least five of the six voting members voting
10:01against it. So that to me was the most egregious example of how this body is now being manipulated
10:08to serve as a forum for anti-vaccine activists and science denialists and heaven help us.
10:14Yeah. And I'd love to talk about that thimerosal vote because the committee did, as you mentioned,
10:21vote to not recommend any vaccines that contain this preservative. Can you talk, first of all,
10:27like what that preservative does, like why it matters, and then what we know about the safety
10:34of that preservative? Sure. So when you have a multi-dose vial and you keep it in the refrigerator
10:40and you violate the rubber stopper again and again and again, it's possible you could have
10:45inadvertently introduced bacteria or fungi into that vial so that the person who gets the eighth,
10:50ninth, or tenth dose could then be inadvertently injected with bacteria or fungi, which can cause
10:55cellulitis, which is, say, a skin infection, or abscess, which is a collection of pus, or a bloodstream
11:02infection, sepsis. So for that reason, really starting in the 1930s, thimerosal has been added
11:07to multi-dose vials and has safely then prevented all that. This came up, I was on the advisory committee
11:14for immunization practices between 1998 and 2003 when this came up, because as we were adding more and
11:21more vaccines to the schedule, you had the DTAP vaccine, you had the hemophagic influenza B vaccine,
11:27the pneumococcus vaccine, the hepatitis B vaccine, many of which were contained in multi-dose vials
11:33that had this preservative, people were worried that it was too much mercury. Now, the thing is,
11:38is the mercury that is thimerosal is ethylmercury. The mercury that's in the environment is methylmercury.
11:45So assuming you live on this planet, and we've never met each other, but I'm going to assume you live
11:49on this planet, you know, you are going to be exposed to methylmercury all the time. It's in
11:54anything made from water. Therefore, it's in breast milk, it's an infant formula, it's, we all have
11:58methylmercury in our bloodstreams. So the question is, was ethylmercury a significant contribution to
12:04the burden of what we already have with mercury anyway? And so there were studies done looking at
12:09children who got thimerosal-containing vaccines, this ethylmercury-containing preserver event found
12:15that there were, that if you looked at their bloodstreams before or after getting those vaccines,
12:18it didn't increase because ethylmercury is excreted from the body far more quickly than
12:23methylmercury, so it doesn't accumulate. So it was really a trivial or arguably non-detectable
12:28contribution to what you already have mercury-wise. Nonetheless, there were studies done looking at
12:33children who received thimerosal-containing vaccines as compared to those who received the
12:38same vaccines that didn't contain thimerosal to see if there was any evidence for neurodevelopmentally
12:43poor outcomes like autism. And study after study after studies, about nine studies at this point,
12:49have shown that there was no problem. So it was never harmful. So why bring this up? This basically
12:54resolved, settled issue, why bring it up? And the reason is that Robert F. Kennedy Jr. wants to scare
13:00people about vaccines. That's the goal. So when he talks about what we're doing is to maintain the trust
13:05in the public, it does exactly the opposite. And he knows that. He knows that because for 20 years,
13:11through groups like Children's Health Defense, he has been trying to scare the public to lose trust
13:17in vaccines. That's who he is. And I think we are going to suffer him. And the more that this goes on
13:23with this particular committee intact, we are going to suffer what is, I think, likely poor advice.
13:29Got it. And I do know that, you know, in a few months, this committee is going to meet again,
13:37and I think specifically to discuss COVID vaccines and others. And I'm curious, after the last couple
13:43of days, and you're speaking to people in industry, whether it's the medical industry, also the
13:48pharmaceutical industry, insurance companies, do you think that, you know, the healthcare system is
13:56still going to follow the advice of ACIP? Or do you think that it may just make itself irrelevant?
14:03I think that they won't follow their advice. And I'm encouraged by, for example, groups like the
14:09American Academy of Pediatrics has their own advisory committee. It's called the Committee
14:13of Infectious Diseases of the Red Book Committee. And I know that people in the AAP, American Academy
14:18of Pediatrics, have been talking to insurance companies to make sure that if they make a recommendation,
14:23even if it's counter to the recommendation made by this sham ACIP, that the insurance companies would
14:30follow the AAP's recommendation, and they've generally been reassured about that. That's the
14:34good news. I think that what worries me is when the AAP advisory committees make decisions, they base it
14:41on data that the CDC presents. I mean, the CDC is the principal epidemiological body in this country.
14:47You count on them to do surveillance, surveillance for diseases like COVID or RSV or influenza.
14:54And if you can't count on them because they're being perturbed by the Secretary of Health and Human
14:59Services, I think we're in trouble. I think what worried me the most was when a 13-year veteran
15:05at the CDC named Fiona Havers quit. So why did she quit? She quit because in April of this year,
15:11she presented data to the advisory committee for immunization practice when there still was an
15:16advisor, a real ACIP. She presented data to that group showing what was the impact of COVID on
15:22children this past year. And what she found was there were about 7,000 children hospitalized,
15:27that one in five of those children who were hospitalized ended up in the intensive care unit,
15:32virtually all were unvaccinated, half were previously healthy, and 152 children died.
15:38She was making a case for the fact that we still need to have a primary recommendation for COVID for
15:42children. And what happened was days after she made that presentation, Robert F. Kennedy Jr. appeared
15:49on a one-minute video with Marty McCary for FDA by his side, as well as Jay Bhattacharya from NIH by his
15:57side and said, we are no longer recommending COVID vaccine for children, and we're no longer
16:02recommending COVID vaccine for pregnancy, when we're the only country in the world that doesn't consider
16:07pregnancy a high-risk group for COVID. So what he did was completely ignore her data, if he ever saw
16:12it. Unilaterally made a decision. This is a man who said he was going to usher in a new era of
16:17transparency when he made this decision unilaterally. And she quit, and she said, and I think she gave an
16:23interview to the New York Times then on CNN and said, I think that this administration is a danger to
16:29American children. I think that they are going to increase the risk of vaccine-preventable diseases
16:33in American children because they just ignored all these data.
16:38Got it. Well, it's certainly something that I think we all need to be keeping an eye on
16:44in the months to come, and especially when or if we get a CDC director, which is a position still
16:51unfilled at the moment. But in the meantime, Dr. Offit, I very much appreciate you coming on and
16:57sharing your expertise with us, and we will probably be in touch later on down the road.
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