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State of Biotech 2022: Lessons from the COVID Crisis
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State of Biotech 2022: Lessons from the COVID Crisis
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ALEX PHILIPPIDIS: Thanks for joining me at The State of Biotech. I'm Alex Philippidis, senior business editor with GEN, honored and glad to be spending the next several minutes with Peter Hotez, an MD, PhD who is dean for the National School of Tropical Medicine and professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine. Peter is author of the book Preventing the Next Pandemic, Vaccine Diplomacy in a Time of Anti-Science, available where you buy books online.
ALEX PHILIPPIDIS: And he's an outspoken expert on COVID-19, appearing almost daily on TV during the pandemic to educate people while co-leading a major vaccine development effort himself. Peter, thanks so much for being one of our featured guests on The State of Biotech.
PETER HOTEZ: Thanks so much for having me.
ALEX PHILIPPIDIS: Now, the past 2 and 1/2 years have been simply incredible. Where are we today in the COVID pandemic?
PETER HOTEZ: Well, right now, we're in this BA.5 wave, and BA.5 is a subvariant of Omicron, of course. And it's probably the most transmissible subvariant that we've seen, and lot of people are becoming infected currently in the United States and many other parts of the world. It's slowly, slowly coming down with a very long, long tail. So in the last few weeks, we've just-- well, it looks like we might have turned the corner on the number of new cases and hospitalizations, and it's starting to go down.
PETER HOTEZ: The big question then, if it fully continues to decline, what happens next? And all the Omicron subvariants and the Delta variant arose out of unvaccinated populations in low and middle-income countries, and we're still underachieving in terms of vaccination rates globally. So there is a possibility we'll see yet another entirely new variant arise later in the fall.
PETER HOTEZ: So kind of sitting here, waiting for the other shoe to drop and trying to encourage people to max out their vaccinations. It's still a serious wave. It's true we're not losing the 2,000 to 3,000 Americans a day like we were during the Alpha wave or the Delta wave, but we're losing 400 to 500 Americans a day. It's still third or fourth leading cause of death on a daily basis. And I think we're not fully cognizant or appreciative of that, of how serious COVID-19 continues to be.
PETER HOTEZ: We've gotten a little bit complacent. So I think that's an important message, that we still need people to stay up to date on their COVID vaccinations and boosters and the importance of boosters, and we can talk about what might come next in terms of that as well.
ALEX PHILIPPIDIS: So what do you attribute the complacency? Is it simply fatigue, or are there policy decisions that come into play here?
PETER HOTEZ: Well, I think it's three things. I think, definitely, everyone's exhausted. I think we always heard a lot of optimistic projections this will be the last wave, and then another wave comes along. So that's profoundly disappointing. I think the other is the messaging from the US federal government around the importance of boosters. They still clung to this outdated concept that two immunizations constitutes full vaccination, and that was never the case.
PETER HOTEZ: And so we've done a terrible job encouraging the American people, for instance, to get boosted. Only about 30% of Americans have gotten one boost and far less, two boosts. And now soon, we're going to ask some Americans to get a third boost. And I don't hold out much hope for that. So I think those are two big issues. The third is we have a very aggressive level of anti-vaccine activism in the United States that disparages vaccinations every chance we get along with other COVID prevention measures, and wraps it all up with false conspiracy theories about the origins of COVID.
PETER HOTEZ: And I'm the victim of a lot of those attacks as well. And so those three issues create a pretty toxic mix that prevent us from really vaccinating our way out of COVID-19. And so although the deaths and ICU admissions are not as dramatic as they were, they're still really serious. I mean, if we had started the COVID-19 pandemic with 400 to 500 deaths a day and this level of hospitalizations, it would be front-page news.
PETER HOTEZ: But somehow, we've become a bit resistant to even want to accept some of the new information. But it's still a pretty serious epidemic in the United States and still a serious pandemic globally.
ALEX PHILIPPIDIS: I guess, yeah. How far is this COVID-19 surging? And we've seen, for example, more recently in parts of China, the island province of Hainan, for example, or parts of the United States reporting increases. You'll hear that, well, there's fewer deaths than there were with some of the original Wuhan strain or some of the earlier variants. Why is that not--
PETER HOTEZ: I mean, clearly, the hospitalization and the number of deaths is not as high as it was in the Alpha and Delta waves in 2020 and 2021, and even the Omicron wave, the initial BA.1 Omicron wave, in the beginning of 2022, but it's still pretty serious. And I think part of that may be because by now, almost 85% of the US population-- may be higher-- has either been infected with one of the previous variants, most likely Omicron because that was the most widespread, the BA.1, or vaccinated, or both.
PETER HOTEZ: And that, clearly, on a population level, has had some mitigating beneficial effects. But on an individual health consideration, I think that could be very misleading. So what do I mean by that? So for instance, let's say you became infected with Omicron, the BA.1 subvariant back in January of this year, eight or nine months ago. You might say, hey, hospitalization's down, deaths are down.
PETER HOTEZ: I'm good because I was previously infected. Well, no. If you've not been vaccinated, you, yourself are still at significant risk of hospitalization or ICU admission or worse, and you still need to get vaccinated on top of your previous infection. So I think the problem is that the two issues get conflated. By the two issues, I mean, one, looking at the overall level of hospitalization and death rate in the United States and trying to project that onto your individual health decisions.
PETER HOTEZ: It's a big mistake, and I think that message doesn't come through enough.
ALEX PHILIPPIDIS: Now, given that we've seen the original Wuhan strain, Delta, Omicron and it's subvariants like BA.5 most recently, how possible is it that additional but more virulent SARS-CoV-2 strains could emerge to set things back?
PETER HOTEZ: I think it's possible. We still don't know fully what's out there. We're underperforming in terms of full global surveillance in genomic sequencing, particularly in low and middle-income countries. Some countries are doing practically zero surveillance. So we don't exactly know what's lurking out there. And right now, the BA.5 subvariant in the US is just starting to come down in the last few weeks.
PETER HOTEZ: But as I say, I use the term long tail, meaning it was 95,000 new cases per day a couple of days ago. Now, it's 92,000, then it's 89,000. And all of those numbers, of course, we have to take with a grain of salt because now, so many of the cases are being revealed by home antigen testing, and those are not being fed into any state health reporting information or federal.
PETER HOTEZ: So even in the best of times, the reported number of new cases a day was probably an underestimate of 4, maybe 5. Now, it's probably 7 to 10, and it's a bit of a guess exactly how much. And this makes it problematic to recommend the best booster strategy as well, and we could talk about that.
ALEX PHILIPPIDIS: Sure. Go right ahead. What sort of a booster strategy would prove effective?
PETER HOTEZ: Well, the way I parse it out is as follows. For instance, I was at the White House COVID vaccine meeting earlier this summer, and I think there's a long-term approach to looking at creating universal coronavirus vaccines or universal sarbecoV vaccines, in fact, in addition to our COVID vaccine that's now been given to 70 million doses in India. We're also developing a universal coronavirus vaccine, and there's interest about looking at alternative delivery mechanisms, either intranasal, sublingual, or skin patch delivery.
PETER HOTEZ: And all that's in place. And I see most of those strategies at least a year, maybe two years away, some say three to five. I'm a little more optimistic, but a ways away. So the question is, how do we navigate all of the conflicting information over the next two years? And I think that's where we, both as a country, we lack clarity, and I think globally.
PETER HOTEZ: And certainly, not only lacking clarity but lacking consensus. I think what the USFDA has decided to do is they want to move forward with a bivalent booster, meaning not only an mRNA that not only contains one encoding the original lineage but one with BA.5. And I kind of get it as an interim strategy. The thinking is, OK, even if BA.5 starts to go down, and let's say it's potentially gone by the time it's rolled out, maybe the next variant will smell more like BA.5 than it would the original lineage.
PETER HOTEZ: And this is a way to sort of move towards a more universal coronavirus vaccine. The only weakness with that is the messaging is very muddled. And because if you're really going to make a new universal coronavirus vaccine, that's a new product and has to go through all the regulatory filings. This way, I think the FDA can move on in bridging studies. But it's not really clear what the role of BA.5 is going to be moving forward.
PETER HOTEZ: I think the hope is that between the original lineage and BA.5, it's more likely to capture through an immune response whatever might come next, which is kind of interesting, right? I mean, I don't know that we've ever done that using a crystal-ball approach like that. It's easy to throw darts at it and criticize it, and I've done a little bit. On the other hand, it may be right. I don't know.
PETER HOTEZ: It's anybody's guess at this point. I've proposed something a bit different. I've said one of the concerns that I have is the mRNA as a booster technology is not as durable as I would like to see. And this is based on data published in the MMWR by the CDC showing that protection, even against hospitalization and death, is starting to decline significantly after four or five months.
PETER HOTEZ: And so I'm asking the question, would we be better off, rather than continually boosting with mRNA, looking at a protein-based vaccine, for instance? So we've got one that we've developed at Texas Children's Hospital. Our Center for Vaccine Development has developed a protein vaccine technology which in India is the vaccine known as CORBEVAX, which is looking really strong.
PETER HOTEZ: As I say, 70 million doses have been administered to date to adolescents, or potentially, Novavax. Would that heterologous boosting strategy give you more durable and long-lasting protection? Because when you give boosters, at least with our pediatric vaccine experience, the way that works is you give a series of primary immunizations. You wait six months to a year and then boost, and then you get 5, 10 years protection or even longer.
PETER HOTEZ: And that's not happening with mRNA. So would we be better off with heterologous boosting? And I think that's something that we need to look at. So from that White House meeting, I think that we do have a path for the long term or on universal coronavirus vaccines' alternative delivery. What's less comforting and less clear is how we proceed now over the next year and a half or two years until those strategy rolls out.
PETER HOTEZ: And I think there's more uncertainty than certainty at this point.
ALEX PHILIPPIDIS: You raised--
PETER HOTEZ: And the fact that, if I'm saying there's uncertainty, that's clearly being reflected by people voting with their feet because only about 30 plus percent of the American people have taken even one booster. I took the second booster. But the percentage of the American people accepting two boosters, even those over the age of 50, is quite small. And now we're looking at asking the American people to take third and fourth boosters.
PETER HOTEZ: And every time we ask them to take another booster, the percentage that actually agrees to do it gets smaller and smaller. So I think this is going to be not an easy sell to the American people, this combined original lineage plus BA.5. I mean, I'll take it, mostly because I'm intellectually curious about it, and I understand the rationale. But I may be-- I'll likely be the exception.
ALEX PHILIPPIDIS: Now, you mentioned the issue of durability of the mRNA-based vaccines like those of Pfizer and BioNTech and Moderna, and yet, those have seen billions of doses administered worldwide. What lessons from that should be applied as vaccine development continues? Is this a reason not to look further at mRNAs? And why is there this difference in durability?
PETER HOTEZ: I don't think we know. It's a brand new technology. And in an ideal world, we would have had a much smaller epidemic and vaccinated a much smaller population, and then had time to get familiar with the performance features of the technology. And unfortunately, we didn't really have that luxury. And so we had a rollout vaccinating very large populations, billions of doses early on with the hope that it would be as durable as we're seeing it.
PETER HOTEZ: And so I think the lesson is whenever you roll out a new technology and rely heavily on innovation, one, you get some really interesting vaccines; two, you do advance the field; but three, you introduce risk and uncertainty, and stuff happens. And in this case, the stuff that happened is one, some level of myocarditis in response to mRNA among young adults, and that seems to be manageable at this point.
PETER HOTEZ: But the other big one is the durability of the technology may not be as strong as we like. And by the way, there was the onerous visa requirement. The good news is, like any new innovative technology, as we get more familiar with it, as the scientific community starts working on it, we fix problems, right? So five years from now or maybe sooner, the way things are going, maybe we will have an mRNA vaccine that's stable at room temperature or just requires just routine levels of refrigeration.
PETER HOTEZ: And we will likely figure out what the parameters are for why we're not seeing that same level of durability. But that's going to take time. And so I think the message is innovation is great, but it's also nice not to rely exclusively on the shiny new toys, to have a few of the old matchbox cars standing by. And that's what we did.
PETER HOTEZ: We developed a matchbox car. It's our vaccine, which in India is known as CORBEVAX produced by Biological E. It's an old school recombinant protein vaccine using yeast fermentation technology, similar to what is used to make the recombinant hepatitis B vaccine that's been around for decades on alum. And the advantage of that is it can plug and play into low and middle-income country vaccine producers because many LMICs, Low and Middle-Income Countries, make their own recombinant hepatitis B vaccine; India, Indonesia, Bangladesh, and China, and Brazil, and the list goes on.
PETER HOTEZ: And so our thinking is for health equity, for vaccine equity. It would be good to have a vaccine like that. And that's really worked out well. So the question now is to get through these next few months. Can we mix and match some of those strategies?
ALEX PHILIPPIDIS: How did you and-- check me on the name-- Maria Elena Bottazzi from Texas Children's come to develop CORBEVAX?
PETER HOTEZ: I think you pronounced that well.
ALEX PHILIPPIDIS: OK.
PETER HOTEZ: So Maria Elena and I have worked together for two decades, 20 years, and we co-direct Texas Children's Hospital Center for Vaccine Development, which is part of our National School of Tropical Medicine at Baylor College of Medicine, where I'm also dean. And we've been working primarily on parasitic disease vaccines for low and middle-income countries. We've developed vaccines for Chagas disease, and schistosomiasis, and hookworm infections, and others.
PETER HOTEZ: But about 10 years ago, we partnered with a group at the New York Blood Center and the Galveston National Laboratory who had some ideas about a safe and effective coronavirus vaccine for SARS and MERS using the receptor-binding domain. So we worked together, applied for an NIAID NIH grant which was awarded. And we made SARS and MERS vaccines and worked out the technology, how to maximize productivity, doing things like engineering it without the N-terminal asparagine because it was glycosylated and interfered with the immune response, and without a free cysteine so we wouldn't get aggregation and/or molecular disulfide bond formation.
PETER HOTEZ: And so then, when the COVID-19 sequence came online in January 2020 on bioRxiv, we were able to pivot pretty quickly and hit the ground running. Unfortunately, we were on the outside looking in of the Operation Warp Speed funding and other G7 support. So we had to raise a lot of that money privately here in Texas, which we were able to do and move pretty quickly to make a very successful vaccine, a great protection in nonhuman primates upon virus challenge.
PETER HOTEZ: And now we've licensed it to Biological E in India and Bio Farma in Bangladesh-- I'm sorry, Bio Farma in Indonesia, Incepta in Bangladesh, and ImmunityBio, which is working to accelerate production in Botswana. And it's gone quite well, especially in India now where it's, as I mentioned, 70 million doses in adolescents. And now it's been approved as an adult booster.
PETER HOTEZ: And we're hoping for WHO prequalification pretty soon. They've inspected the factory of BioE, and it's all going well. So it's kind of interesting. I think the approach was-- the thinking out of Operation Warp Speed or the other G7 support was only the big pharma companies had the chops to pull this off. And I think, now, we've shown the world that there are alternative pathways of doing this, how academic partnerships working with vaccine producers in low and middle-income countries can produce really good, safe, affordable vaccines that are appropriate for resource-poor settings.
PETER HOTEZ: And hopefully, moving down the road, when calls for support come out that we just don't only incentivize the big pharma companies to do it. There's nothing wrong with the big pharma companies. I don't have a problem with them. I mean, they do a lot of good and provide a lot of vaccines for the Gavi Alliance. I just think the vaccine ecosystem is maybe going a little too full tilt, thinking that only the multinational pharma companies can pull this off, and we've got to balance the ecosystem out a bit more.
ALEX PHILIPPIDIS: Now, you mentioned the need for private donations in the development of this. From who or where or what institutions? Who stepped up to--
PETER HOTEZ: A lot of Texas-based organizations. The Kleberg foundation based in South Texas, they were really important. JPB Foundation based in New York. It's not only Texas funding. MD Anderson Foundation, which is important here for our Texas Medical Center. The Dunn Foundation. Now, the problem is when you start getting into naming, you always wind up leaving one out, so apologies ahead of time.
PETER HOTEZ: Tito's Vodka came and supported us, and so we're very grateful for that as well. And so we cobbled together-- I mean, it wasn't the billions, but it was about $8 or $9 million that we were able to piece together. But when you think about-- one of the things they told me at the White House vaccine meeting, if you put in the numerator, the number of public dollars you received or all dollars received, and divide it by the number of doses we've administered now, it comes out about $0.20-$0.30 a dose as opposed to the hundreds or thousands of dollars a dose for the others.
PETER HOTEZ: So we think we broke all records in terms of financial efficiency at getting a vaccine out, which was fun to hear.
ALEX PHILIPPIDIS: One factor, and I reckon a key factor in CORBEVAX's affordability, is that it's patent free. Why did you and Maria Elena and the team at Texas Children's and Baylor opt to forego these sort of payments and royalties, which obviously a pharma, small or large, wouldn't do?
PETER HOTEZ: Well, there is both practical and humanitarian reasons. Practical because it's expensive. And if I have money to spend, I don't want to spend it on patent attorneys. I'd rather spend it on hiring more scientists because that's always our limiting step. And as I say, I mean, I think when your house is on fire, you don't call the patent attorney. You call the fire department, and we wanted to be the fire department.
PETER HOTEZ: It just simplified things. And also, we put everything out in the public domain. So you can read all of our publications on PubMed as well as the clinical trials on medRxiv from BioE and basically reproduce everything yourself. So you don't even have to engage us in principle. I mean, we make it easy by providing not only the know-how but the production cell bank of the yeast isolate that's producing the vaccine and optimized accordingly.
PETER HOTEZ: And we provide the instructions for scale up in production, and the assays in the assay development. So we make partnering with us as easy as possible as a consequence.
ALEX PHILIPPIDIS: How is CORBEVAX being scaled up to produce the quantity of doses that are needed in developing countries?
PETER HOTEZ: Well, Biological E is not as well known as some of the others, like Serum Institute of India, but they're right up there. And they have eight or nine WHO prequalified vaccines, and they're an outstanding organization. Fantastic scientists to work with. And so they're one of India's big vaccine producers, and so we were able to work very quickly with them. We have a lot of confidence in their abilities and a great working relationship.
PETER HOTEZ: And now, the hope is that if this gets WHO prequalified, then they can export it to other countries as well. They have the ability to produce over a billion doses a year, probably you could even do more than that if the demand is there. I've had some frustration around the fact that because we couldn't raise anything close to the level of funding that Moderna or Novavax or some of the others have gotten, that slowed us down.
PETER HOTEZ: And also, WHO has been kind of slow walking the other next generation of vaccines after the mRNA and adenovirus went through, and that's been kind of frustrating as well. So we could have moved a lot faster and I think could have vaccinated the world a lot faster. But at least we're making a lot of progress and getting recognition for it also.
ALEX PHILIPPIDIS: Given the work, any path toward bringing CORBEVAX into the US?
PETER HOTEZ: It's funny you mentioned that. We've had discussions with FDA and with BARDA and others. There may be. I mean, right now, we don't have a US industry partner, so that's a hurdle. But what I've been recommending to the agencies is, look, since we have repeatedly immunizing the people with mRNA, it's increasingly less palatable to the American people. Let's at least look to see what CORBEVAX does as a booster for people who've gotten mRNA and bring it either through one of the vaccine trial evaluation units of NIAID or find another mechanism.
PETER HOTEZ: Let's at least look at it and get educated, and maybe there are advantages. BioE itself, with the Indian government, has now, in addition to the adolescents, has approved it as a booster for adults in India, and that's moving forward. The issue is in India, they don't use the mRNA vaccine technology at all. So it's being looked at as a heterologous booster, what they call a precautionary dose for either the COVISHIELD, the AstraZeneca vaccine that they make in Serum Institute, or for COVAXIN, which is an inactivated virus vaccine.
PETER HOTEZ: So we don't know what it would look like as a booster for mRNA. So we'd like the US government to at least take an interest in it, and let's see. And if it turns out that it does something gangbusters, then we can worry about how to move that forward. So those discussions have at least started and hopefully, make some progress.
ALEX PHILIPPIDIS: Since CORBEVAX is protein-based as is Novavax's vaccine, wouldn't Novavax seem to be an industry partner for your group?
PETER HOTEZ: Potentially. Or you can say, well, why not just boost with Novavax? I think the issue with Novavax, it has some similarities between our vaccine but some differences as well. First of all, the clinical trials of Novavax look great. Hands down, it looks like a really good vaccine. I think because of the particle formation step, it's kind of slowed down production. And there were a couple of false starts in the US in terms of trying to make it, and now, Serum Institute is starting.
PETER HOTEZ: But I think the last number I've looked at, only about a million people have gotten the Novavax vaccine as opposed to 70 million for ours. So I just don't know how the level of doses that can be scaled at this point. You'd have to ask them. So the point is, could we be an alternative to that, given that it's an older, yeast-based recombinant protein technology?
PETER HOTEZ: There's no limit to the amount you can make. And it's probably the least expensive of all the COVID vaccines. I think in India, it's 145 rupees a dose, which is about $1.90. So as a global health vaccine, it checks a lot of boxes. But I think it could be useful for the US as well.
ALEX PHILIPPIDIS: Now, you mentioned earlier issues of communication as well as potentially, policy. And it's come up recently where the director of the CDC, Rochelle Walensky, had acknowledged a mix of failures on both fronts by the agency. What grade would you give her, and what should CDC be doing that it hasn't done or isn't doing?
PETER HOTEZ: Well, she inherited a-- I can't imagine anything tougher than doing change management at a federal agency, and god bless the people who are willing to take that on. I think there have been some failings from the CDC. I think there's no way around it. And they they missed the entry of the virus from Southern Europe into New York, in the diagnostic testing they struggled with, in genomic sequencing and modeling, and in leading a federal response.
PETER HOTEZ: So I think there was-- and then not communicating really that well about what fully vaccinated is and the boosters. And I think Rochelle Walensky has appropriately recognized that they need to figure out how to maybe modernize the agency and maybe make it more focused around pandemics, lesser on some of the other things that they do. And in the few times I've spoken to her, I've recommended that.
PETER HOTEZ: And then she came out, and I know others have spoken to her. So she solicited a lot of input from the scientific and medical and public health communities. And I think now, she, a couple of weeks ago, has come out and said, we're going to really look at the agency from top to bottom and see what we need to do to modernize it. And I think, to her credit, that she's got that underway. It's a daunting task, though. I mean, as I say, with any federal agency, we always talk about-- President Trump used to talk about deep state, but he meant it in terms of Republicans or Democrats.
PETER HOTEZ: The real deep state is these agencies cling to their cultures of how they do things, so trying to get the CDC to do something differently is not easy. But I think it's necessary because I think they've got to get their mojo back in terms of really leading a pandemic response. There's been talk about creating a pandemic threat office within the ASPR, the Assistant Secretary of Public Health Emergency Response.
PETER HOTEZ: I've said, don't do that. I said, the American taxpayers are paying $15 billion a year to the CDC. Let's fix the CDC and put them front and center because that's what we're paying for. And the problem with having it in Washington, as we saw in the last administration, the problem of what happens when you put the West Wing of the White House in charge of a public health response, it gets too consumed by political expediencies.
PETER HOTEZ: And what if? Who knows who's going to be the next president of the United States? And you don't want to leave that to chance. So I think the leadership of a pandemic response in the US needs to be in Atlanta, needs to be led by the CDC. And if we have concerns about the CDC or their competencies in doing it, well, then you fix the CDC and make them stronger.
PETER HOTEZ: And I think that's the way to go.
ALEX PHILIPPIDIS: Now to what extent did the CDC hurt itself, including recently, by this changing of and relaxation of its mask guidelines, it's distancing guidances. How much did it jump too soon on these, and to what extent did that result in COVID persisting?
PETER HOTEZ: Yeah. I mean, some of it was unforced errors. A lot of it was not their fault. So what do I mean by that? Well, if you remember when the COVID-19 vaccines were first approved in the fall of 2020, they were approved on the basis of pretty large clinical trials, 40,000 to 60,000 people that showed they were interrupting symptomatic infection, right, and 90%-95% protection against symptomatic infection, symptomatic illness, I'm sorry.
PETER HOTEZ: What then came about was studies out of Israel had shown, hey, wait a minute, these vaccines, this Alpha wave, are not only halting symptomatic illness. They're actually stopping asymptomatic infection and transmission 90%. That was really exciting news, and I think that was the basis for lifting the mask mandates. I think what happened was a few things. One, protection waned after two doses, and I think that was disappointing and unexpected.
PETER HOTEZ: And then we moved over to the Delta variant. And so suddenly, now we lost that performance feature of the interrupting asymptomatic infection transmission, and then masks had to come back on. And by the way, we had to give a booster. And I think that could have been messaged better in a number of ways. One, I think, there could have been that anticipatory guidance saying, hey, look, when you give two doses so close together-- Pfizer at three weeks, Moderna, four weeks-- our past experience with pediatric vaccines says when you give a series of primary immunizations, you still have to give a big boost six months to a year later, and we should anticipate that this could be a three-dose vaccine.
PETER HOTEZ: I mean, I said it, but it wasn't backed up by the federal government. And had there been that kind of anticipatory guidance, I think it would have helped a lot in maintaining confidence because then you could say, remember those were our underlying assumptions. So it doesn't look like they're waffling back and forth. So some of it was not their fault that there was new variants coming along and the length of protection for mRNA didn't hold up.
PETER HOTEZ: And the first thing you lost was the performance feature around interrupting asymptomatic transmission and infection. But some of it could have been anticipated and messaged a bit better.
ALEX PHILIPPIDIS: One of the CDC's current challenges, and the same across the public health sphere, is monkeypox. Are you surprised by this latest outbreak, or was it inevitable that something else was going to follow on the heels of COVID-19?
PETER HOTEZ: Well, I wrote a book that got published last year in 2021 called Preventing the Next Pandemic that says that, basically, since the year 2014-2015, that stuff's happening. There's a bad moon on the rise.
ALEX PHILIPPIDIS: [LAUGHS]
PETER HOTEZ: And it's happening because of climate change as a factor but also this confluence of social determinants, such as war and political collapse and urbanization and deforestation. And those are combining in unique and interesting ways to bring back emerging or re-emerging infectious diseases. And I gave some case studies out of the Arabian Peninsula, and Venezuela, and central Latin America, and the Boko Haram areas in Nigeria, and even Texas in the Gulf Coast.
PETER HOTEZ: So that there is a new normal because people are saying, hey, what's going on, COVID-19 and monkeypox, and now polio? And my response was, yeah, this is what we've been talking about for the last few years, that things have changed in unique and interesting ways. Now, could I have predicted specifically monkeypox? No. But it could have-- if not monkeypox, something else. And now the number of cases is rising significantly.
PETER HOTEZ: I think the worry is that right now, it's restricted to a single population, people with at-risk behavior. But eventually, if the force of infection continues to rise, we should expect it could spill over to other populations and even gain, now that it's in the wastewater, maybe even gain access to animal populations and gain more of a permanent foothold.
PETER HOTEZ: And I'm not only worried about the US and Europe. I'm particularly worried about Latin America because if you look at the number of cases in Europe, once you go past the UK, the largest number are in Spain and Portugal. And historically, when that happens, it gains a foothold in Latin American countries and Brazil. And historically, when things pick up in Brazil, they really pick up, given what happened with HIV/AIDS, and Zika, and dengue, and so many others.
PETER HOTEZ: And so I'm very worried, for instance, about monkeypox becoming a permanent fixture in countries like Brazil, so watching that very closely.
ALEX PHILIPPIDIS: Do we have an adequate vaccine available for monkeypox, or is this an area that needs additional investment and prioritization?
PETER HOTEZ: Well, we think so, right? I mean, it's a vaccine, the JYNNEOS vaccine, which is modified vaccine. The Ankara was approved on the basis of immunobridging studies and animal challenge studies using respiratory challenge virus. Now this virus, this monkeypox is being-- and that was for smallpox, which is like an ortho-- it's another orthopoxvirus, very similar. This vaccine is being asked to protect against infection and illness from a different mode of transmission.
PETER HOTEZ: So it should work, but you don't know till you know. And now we've added this other complexity of doing fractional dosing, trying to spread one dose into three, four, or five doses by giving it through the intradermal route. And there's one published study that I'm aware of, around 500 people showing you can do it. But that's a big leap going from a study of 400 or 500 people to now setting it as a national policy.
PETER HOTEZ: So it's a pretty audacious move. I think I would have liked to have seen that rolled out among, well, at least one city as a pilot introduction study before doing it. So I think it could work, but it'll be very interesting to see. In the meantime, until we can get enough vaccine doses in hand, I think we need to look at the drug tecovirimat, the T also in this TPOXX.
PETER HOTEZ: Anecdotally, we're hearing it works really well in people who are getting treated. They do extremely well with it in terms of rapid resolution. But I'm asking whether we can look at it more for post-exposure prophylaxis or even as a form of PrEP, pre-exposure prophylaxis. And so I think that may be a place where we can also optimize.
ALEX PHILIPPIDIS: Another public health challenge is the return of polio, a disease thought to have been eradicated not too long ago. It doesn't help that 7% of the US population, some 20 million people, has not been vaccinated against polio. How much will fighting polio be hamstrung by the switch when we went from oral to back to injectable vaccine? And how much of a threat is this?
PETER HOTEZ: Well, the bigger threat is the fact that we've allowed anti-vaccine activism to go unchecked, and it really accelerated during COVID-19. In fact, my new book that I've just finished and submitted to Johns Hopkins University Press has the working title Anti-vaccine Kills, and it remarks on the fact that 200,000 unvaccinated Americans during the last half of 2021, during the Delta wave needlessly lost their lives because they refused the COVID vaccine despite its widespread availability.
PETER HOTEZ: They were victims of what I call anti-vaccine or anti-science aggression coming from members of Congress and amplified on Fox News at night, as well as a cadre of contrarian intellectuals that did a lot of damage and caused the big loss of life. And now I think this is spilling over globally. So I just had a paper come out in Nature Reviews Immunology saying, will the US anti-vaccine activism affect global goals, millennium development goals, sustainable development goals?
PETER HOTEZ: And I think the answer is yes, and we're seeing that now with polio and return of measles not only in the US but globally. I think we should not underestimate the damage how the anti-vaccine groups that became so empowered during this time of COVID-19 and gained political support from the far-right. I mean, now you've got The Proud Boys marching in anti-vaccine rallies.
PETER HOTEZ: This is a full-on political movement. Now it's got strength, it's got power, it's got money, it's got organization. This is a formidable force. And I say, when we think about the big social things that we combat like global terrorism or nuclear proliferation or cyber attacks, well, heck, anti-vaccine activism is killing more Americans and more people globally than all those other things combined, and yet, we don't frame it in that way.
PETER HOTEZ: And trying now how to reverse it, I think, is going to be really daunting. And I don't think the health sector knows what to do at this point. But this thing is a deadly force, and now it's potentially bringing back polio globally. We've seen now polio in the wastewater in the UK and the US. We've had the case of acute flaccid paralysis among an unvaccinated individual in New York.
PETER HOTEZ: We're just going to continue to see more of this until we finally decide that we want to come to terms with what this is and combat it appropriately.
ALEX PHILIPPIDIS: How much is anti-vax reaction to incidence of reactions to the vaccine, whether it's individual and no matter what the number, being small or not? How much is that fueled by that in addition, and is that a kernel of the resistance?
PETER HOTEZ: Well, Health and Human Services maintained a policy for years saying, we're not calling attention to it. We're just going to ignore it in hopes that it goes away. And in fact, I remember, I wrote a piece in The New York Times in 2017 describing the situation here in Texas, which is sort of the epicenter of the anti-vaccine movement where I live and work. And I've been going up against it because I have a daughter with autism in one of my four adult kids and wrote a book called Vaccines Do Not Cause Rachel's Autism, and wrote this piece in The New York Times.
PETER HOTEZ: It was a companion piece called How the Anti-vaxxers Are Winning. And I remember getting rebuked by people at HHS saying, Peter, we're not talking about this now because you're going to give it oxygen. I said, guys, this has got all the oxygen it needs. And you have to stop thinking of the American people as everybody's got a compact computer and dial-up modem and uses Ask Jeeves as your search engine.
PETER HOTEZ: The world has moved on, and this is a deadly and potent force. And now, we're trying to play catch up. I think the US Surgeon General has recognized it in Vivek Murthy. I think he's a good surgeon general. But it's mostly focused around switching up social media algorithms on Meta and Facebook and Twitter and that sort of thing. And that's useful.
PETER HOTEZ: I don't want to dismiss the importance of that. But it doesn't get to those sources who are generating the content, and that's where Health and Human Services still doesn't want to go and the Biden administration doesn't want to go. And even the World Health Organization really doesn't want to go. They'll talk about the infodemic. But actually going to the sources of it and dealing with the extremists in the US that are generating this garbage, nobody seems to want to go there with me.
ALEX PHILIPPIDIS: How have you coped with the criticism you've gotten as an advocate of vaccination, especially in the last couple of years of COVID? And how can the anti-vax view be fought and countered?
PETER HOTEZ: Well, criticism, I don't mind. I'm an adherent of what Ben Franklin says, critics are friends. I don't mind the criticism. It's the graphic descriptions of my untimely death [LAUGHS] that I have a problem with and having to bring in the Houston Police Department-- and they know I'm Jewish-- and bringing the anti-defamation league to track down those who are making very specific threats.
PETER HOTEZ: That's the big, big concern. I mean, the far-right press and even Fox News, when they get tired of beating up on Tony, Dr. Fauci, I'm sort of Fauci lite, and they go after me. And then there are a lot of unwell people who actually believe what they read in the Daily Caller, and Breitbart, and Fox News, and the anti-GMO websites, and things like that. And it's very dangerous, so I'm very concerned about it.
PETER HOTEZ:
ALEX PHILIPPIDIS: What should HHS and other agencies be doing that they haven't?
PETER HOTEZ: Well, I think now, this has gotten so big. And I said, I don't think the health sector knows what to do anymore. I mean, I can't even say I know what needs to be done anymore, but I've made the point. There are people who do, and the people who do are the Department of Homeland Security, and the Justice Department, and the Commerce Department, and the State Department because of the role of Russian propaganda, using this to divide our country.
PETER HOTEZ: And get advice from experts who are going up against global terrorism and things like that because it's reached that stage now. And let's learn what our options are to really combat this and really wall it off and recognize it as the threat that it is because it's only getting worse. I think what's happened with COVID-19 is the warm-up act, and I think we're going to see sharp declines because of the expansion and spillover of anti-vaccine aggression into low and middle-income countries.
PETER HOTEZ: I'm worried about bringing back measles and polio and even reversing sustainable and millennium development goals. That's how serious this is. And by the way, it's not stopping just at the vaccine space. I think all biomedical science is under threat. They're going to go after CRISPR-Cas9. They're going after all of the conspiracy nonsense around gain of function and COVID origins.
PETER HOTEZ: That's a huge piece of this as well. So I think biomedical science as a whole is under threat, and that's a big component of the book. And one of the things that I call for is protection of scientists, not only federal government scientists but all scientists from the threats, and maybe looking at something like a Southern Poverty Law Center equivalent for biomedical scientists.
PETER HOTEZ: I mean, the climate scientists have been dealing with this now for about 10 years. They've created a Climate Science Defense Fund. Maybe something along those lines. But we've really got to take this very seriously.
ALEX PHILIPPIDIS: You mentioned Dr. Anthony Fauci earlier. He's announced that he's stepping down as director of NIAID, which he's led since 1984. What would you like to say about Fauci's contributions as a scientist and as a public health official?
PETER HOTEZ: Well, Tony's been a mentor to me over the years. We both went to the same medical school, Cornell Medical School. And now he's 17 years older than I am, but he's been a mentor for me since I finished my MD, PhD at Cornell and Rockefeller in 1987. So we're going 30, 40 years, and he's been a friend and mentor. And what he's done with the National Institute of Allergy and Infectious Diseases is extraordinary and made it the premier infectious disease research and policy institute globally, and with a tremendous track record of helping to respond to new pandemic threats like HIV/AIDS, and H1N1, and Ebola, and Zika, and COVID 19, now monkeypox, but also keeping his foot on the gas for the ancient scourges like malaria and neglected tropical diseases.
PETER HOTEZ: So it's an extraordinary legacy that he's built in keeping infectious diseases in the public eye and convincing the planet that these are as important threats as war and terrorism and anything else. So extraordinary legacies he left for public service.
ALEX PHILIPPIDIS: Great. And winding it down, September marks 2 and 1/2 years since COVID-19 was declared a pandemic by the World Health Organization. As you look back, how well or poorly did the scientific community, the biopharma industry, the public health establishment, and our nation's leaders respond to the pandemic?
PETER HOTEZ: I think it's hard to simplify, giving a single-letter grade or a number. There were unpleasant-- there were pleasant surprises, and there were unpleasant surprises. I think in terms of accelerating innovation, I think there was extraordinary progress in launching new vaccine technologies, new drug technologies that's very exciting. On the other hand, I think the emphasis on innovation needed to be buffered with better levels of communication on what we should expect from those new innovations.
PETER HOTEZ: They could have balanced some of the older technologies a bit better, I think. And not paying enough attention to the warnings that I sounded about how anti-vaccine and anti-science groups will attempt to undermine all of this. So I would say a mixed and devastating loss. I mean, a million Americans lost their lives. And in my book, I'll say that at least a third of them, maybe up to half, were needless deaths because they could have been prevented had we managed the messaging and countered the anti-science aggression.
PETER HOTEZ: And globally, we're up to probably close to 20 million deaths. And a lot of lives lost could have been averted through greater attention to equity and standing up to the anti-vaccine aggression, so a very mixed response. And I worry we still haven't learned those lessons. I say that because look at what's happened to monkeypox vaccine.
PETER HOTEZ: The same hoarding and vaccine nationalism still continues, and we still have not learned the lesson of standing up to the anti-vaccine aggression.
ALEX PHILIPPIDIS: Great. And your second book, how soon before we see that?
PETER HOTEZ: Actually, it will be my fifth.
ALEX PHILIPPIDIS: [LAUGHS] OK.
PETER HOTEZ: You don't think I'm moving to Houston to become a writer? I think it was because I moved to Houston 12 years. I think it's probably because being in New Haven or Cambridge, Massachusetts or New York or Washington where everybody's a writer, I just felt too intimidated to do it. But there was something liberating with coming to Houston. So I'm hoping first quarter of 2021.
PETER HOTEZ: But the University Presses were having--
ALEX PHILIPPIDIS: '23.
PETER HOTEZ: I'm sorry, 2023. The University Presses are having some issues around supply chain management, so there's a global paper shortage and ink shortage for book covers and that sort of thing. And of course, when the supplies are available, the big five publishers, Simon & Schuster, and Penguin, and HarperCollins, they get first dibs. So hopefully, it won't be delayed too long because of that.
ALEX PHILIPPIDIS: Great. Peter Hotez of Baylor College of Medicine, thanks so much for sharing your insights on COVID-19 and public health with The State of Biotech.
PETER HOTEZ: Well, thanks. It's not often that I get to have some long question and answer format to really explain to people how I'm thinking about this rather than trying to squeeze it all into a 3 to 4-minute interview. So I do appreciate these opportunities from GEN to be able to really articulate what I think the big picture issues are.
ALEX PHILIPPIDIS: Great. And thank you for taking the time to watch and enjoy the other panels and fireside chats and the keynoters here at The State of Biotech. Alex Philippidis, take care. [MUSIC PLAYING]
Segment:0 .
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ALEX PHILIPPIDIS: Thanks for joining me at The State of Biotech. I'm Alex Philippidis, senior business editor with GEN, honored and glad to be spending the next several minutes with Peter Hotez, an MD, PhD who is dean for the National School of Tropical Medicine and professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine. Peter is author of the book Preventing the Next Pandemic, Vaccine Diplomacy in a Time of Anti-Science, available where you buy books online.
ALEX PHILIPPIDIS: And he's an outspoken expert on COVID-19, appearing almost daily on TV during the pandemic to educate people while co-leading a major vaccine development effort himself. Peter, thanks so much for being one of our featured guests on The State of Biotech.
PETER HOTEZ: Thanks so much for having me.
ALEX PHILIPPIDIS: Now, the past 2 and 1/2 years have been simply incredible. Where are we today in the COVID pandemic?
PETER HOTEZ: Well, right now, we're in this BA.5 wave, and BA.5 is a subvariant of Omicron, of course. And it's probably the most transmissible subvariant that we've seen, and lot of people are becoming infected currently in the United States and many other parts of the world. It's slowly, slowly coming down with a very long, long tail. So in the last few weeks, we've just-- well, it looks like we might have turned the corner on the number of new cases and hospitalizations, and it's starting to go down.
PETER HOTEZ: The big question then, if it fully continues to decline, what happens next? And all the Omicron subvariants and the Delta variant arose out of unvaccinated populations in low and middle-income countries, and we're still underachieving in terms of vaccination rates globally. So there is a possibility we'll see yet another entirely new variant arise later in the fall.
PETER HOTEZ: So kind of sitting here, waiting for the other shoe to drop and trying to encourage people to max out their vaccinations. It's still a serious wave. It's true we're not losing the 2,000 to 3,000 Americans a day like we were during the Alpha wave or the Delta wave, but we're losing 400 to 500 Americans a day. It's still third or fourth leading cause of death on a daily basis. And I think we're not fully cognizant or appreciative of that, of how serious COVID-19 continues to be.
PETER HOTEZ: We've gotten a little bit complacent. So I think that's an important message, that we still need people to stay up to date on their COVID vaccinations and boosters and the importance of boosters, and we can talk about what might come next in terms of that as well.
ALEX PHILIPPIDIS: So what do you attribute the complacency? Is it simply fatigue, or are there policy decisions that come into play here?
PETER HOTEZ: Well, I think it's three things. I think, definitely, everyone's exhausted. I think we always heard a lot of optimistic projections this will be the last wave, and then another wave comes along. So that's profoundly disappointing. I think the other is the messaging from the US federal government around the importance of boosters. They still clung to this outdated concept that two immunizations constitutes full vaccination, and that was never the case.
PETER HOTEZ: And so we've done a terrible job encouraging the American people, for instance, to get boosted. Only about 30% of Americans have gotten one boost and far less, two boosts. And now soon, we're going to ask some Americans to get a third boost. And I don't hold out much hope for that. So I think those are two big issues. The third is we have a very aggressive level of anti-vaccine activism in the United States that disparages vaccinations every chance we get along with other COVID prevention measures, and wraps it all up with false conspiracy theories about the origins of COVID.
PETER HOTEZ: And I'm the victim of a lot of those attacks as well. And so those three issues create a pretty toxic mix that prevent us from really vaccinating our way out of COVID-19. And so although the deaths and ICU admissions are not as dramatic as they were, they're still really serious. I mean, if we had started the COVID-19 pandemic with 400 to 500 deaths a day and this level of hospitalizations, it would be front-page news.
PETER HOTEZ: But somehow, we've become a bit resistant to even want to accept some of the new information. But it's still a pretty serious epidemic in the United States and still a serious pandemic globally.
ALEX PHILIPPIDIS: I guess, yeah. How far is this COVID-19 surging? And we've seen, for example, more recently in parts of China, the island province of Hainan, for example, or parts of the United States reporting increases. You'll hear that, well, there's fewer deaths than there were with some of the original Wuhan strain or some of the earlier variants. Why is that not--
PETER HOTEZ: I mean, clearly, the hospitalization and the number of deaths is not as high as it was in the Alpha and Delta waves in 2020 and 2021, and even the Omicron wave, the initial BA.1 Omicron wave, in the beginning of 2022, but it's still pretty serious. And I think part of that may be because by now, almost 85% of the US population-- may be higher-- has either been infected with one of the previous variants, most likely Omicron because that was the most widespread, the BA.1, or vaccinated, or both.
PETER HOTEZ: And that, clearly, on a population level, has had some mitigating beneficial effects. But on an individual health consideration, I think that could be very misleading. So what do I mean by that? So for instance, let's say you became infected with Omicron, the BA.1 subvariant back in January of this year, eight or nine months ago. You might say, hey, hospitalization's down, deaths are down.
PETER HOTEZ: I'm good because I was previously infected. Well, no. If you've not been vaccinated, you, yourself are still at significant risk of hospitalization or ICU admission or worse, and you still need to get vaccinated on top of your previous infection. So I think the problem is that the two issues get conflated. By the two issues, I mean, one, looking at the overall level of hospitalization and death rate in the United States and trying to project that onto your individual health decisions.
PETER HOTEZ: It's a big mistake, and I think that message doesn't come through enough.
ALEX PHILIPPIDIS: Now, given that we've seen the original Wuhan strain, Delta, Omicron and it's subvariants like BA.5 most recently, how possible is it that additional but more virulent SARS-CoV-2 strains could emerge to set things back?
PETER HOTEZ: I think it's possible. We still don't know fully what's out there. We're underperforming in terms of full global surveillance in genomic sequencing, particularly in low and middle-income countries. Some countries are doing practically zero surveillance. So we don't exactly know what's lurking out there. And right now, the BA.5 subvariant in the US is just starting to come down in the last few weeks.
PETER HOTEZ: But as I say, I use the term long tail, meaning it was 95,000 new cases per day a couple of days ago. Now, it's 92,000, then it's 89,000. And all of those numbers, of course, we have to take with a grain of salt because now, so many of the cases are being revealed by home antigen testing, and those are not being fed into any state health reporting information or federal.
PETER HOTEZ: So even in the best of times, the reported number of new cases a day was probably an underestimate of 4, maybe 5. Now, it's probably 7 to 10, and it's a bit of a guess exactly how much. And this makes it problematic to recommend the best booster strategy as well, and we could talk about that.
ALEX PHILIPPIDIS: Sure. Go right ahead. What sort of a booster strategy would prove effective?
PETER HOTEZ: Well, the way I parse it out is as follows. For instance, I was at the White House COVID vaccine meeting earlier this summer, and I think there's a long-term approach to looking at creating universal coronavirus vaccines or universal sarbecoV vaccines, in fact, in addition to our COVID vaccine that's now been given to 70 million doses in India. We're also developing a universal coronavirus vaccine, and there's interest about looking at alternative delivery mechanisms, either intranasal, sublingual, or skin patch delivery.
PETER HOTEZ: And all that's in place. And I see most of those strategies at least a year, maybe two years away, some say three to five. I'm a little more optimistic, but a ways away. So the question is, how do we navigate all of the conflicting information over the next two years? And I think that's where we, both as a country, we lack clarity, and I think globally.
PETER HOTEZ: And certainly, not only lacking clarity but lacking consensus. I think what the USFDA has decided to do is they want to move forward with a bivalent booster, meaning not only an mRNA that not only contains one encoding the original lineage but one with BA.5. And I kind of get it as an interim strategy. The thinking is, OK, even if BA.5 starts to go down, and let's say it's potentially gone by the time it's rolled out, maybe the next variant will smell more like BA.5 than it would the original lineage.
PETER HOTEZ: And this is a way to sort of move towards a more universal coronavirus vaccine. The only weakness with that is the messaging is very muddled. And because if you're really going to make a new universal coronavirus vaccine, that's a new product and has to go through all the regulatory filings. This way, I think the FDA can move on in bridging studies. But it's not really clear what the role of BA.5 is going to be moving forward.
PETER HOTEZ: I think the hope is that between the original lineage and BA.5, it's more likely to capture through an immune response whatever might come next, which is kind of interesting, right? I mean, I don't know that we've ever done that using a crystal-ball approach like that. It's easy to throw darts at it and criticize it, and I've done a little bit. On the other hand, it may be right. I don't know.
PETER HOTEZ: It's anybody's guess at this point. I've proposed something a bit different. I've said one of the concerns that I have is the mRNA as a booster technology is not as durable as I would like to see. And this is based on data published in the MMWR by the CDC showing that protection, even against hospitalization and death, is starting to decline significantly after four or five months.
PETER HOTEZ: And so I'm asking the question, would we be better off, rather than continually boosting with mRNA, looking at a protein-based vaccine, for instance? So we've got one that we've developed at Texas Children's Hospital. Our Center for Vaccine Development has developed a protein vaccine technology which in India is the vaccine known as CORBEVAX, which is looking really strong.
PETER HOTEZ: As I say, 70 million doses have been administered to date to adolescents, or potentially, Novavax. Would that heterologous boosting strategy give you more durable and long-lasting protection? Because when you give boosters, at least with our pediatric vaccine experience, the way that works is you give a series of primary immunizations. You wait six months to a year and then boost, and then you get 5, 10 years protection or even longer.
PETER HOTEZ: And that's not happening with mRNA. So would we be better off with heterologous boosting? And I think that's something that we need to look at. So from that White House meeting, I think that we do have a path for the long term or on universal coronavirus vaccines' alternative delivery. What's less comforting and less clear is how we proceed now over the next year and a half or two years until those strategy rolls out.
PETER HOTEZ: And I think there's more uncertainty than certainty at this point.
ALEX PHILIPPIDIS: You raised--
PETER HOTEZ: And the fact that, if I'm saying there's uncertainty, that's clearly being reflected by people voting with their feet because only about 30 plus percent of the American people have taken even one booster. I took the second booster. But the percentage of the American people accepting two boosters, even those over the age of 50, is quite small. And now we're looking at asking the American people to take third and fourth boosters.
PETER HOTEZ: And every time we ask them to take another booster, the percentage that actually agrees to do it gets smaller and smaller. So I think this is going to be not an easy sell to the American people, this combined original lineage plus BA.5. I mean, I'll take it, mostly because I'm intellectually curious about it, and I understand the rationale. But I may be-- I'll likely be the exception.
ALEX PHILIPPIDIS: Now, you mentioned the issue of durability of the mRNA-based vaccines like those of Pfizer and BioNTech and Moderna, and yet, those have seen billions of doses administered worldwide. What lessons from that should be applied as vaccine development continues? Is this a reason not to look further at mRNAs? And why is there this difference in durability?
PETER HOTEZ: I don't think we know. It's a brand new technology. And in an ideal world, we would have had a much smaller epidemic and vaccinated a much smaller population, and then had time to get familiar with the performance features of the technology. And unfortunately, we didn't really have that luxury. And so we had a rollout vaccinating very large populations, billions of doses early on with the hope that it would be as durable as we're seeing it.
PETER HOTEZ: And so I think the lesson is whenever you roll out a new technology and rely heavily on innovation, one, you get some really interesting vaccines; two, you do advance the field; but three, you introduce risk and uncertainty, and stuff happens. And in this case, the stuff that happened is one, some level of myocarditis in response to mRNA among young adults, and that seems to be manageable at this point.
PETER HOTEZ: But the other big one is the durability of the technology may not be as strong as we like. And by the way, there was the onerous visa requirement. The good news is, like any new innovative technology, as we get more familiar with it, as the scientific community starts working on it, we fix problems, right? So five years from now or maybe sooner, the way things are going, maybe we will have an mRNA vaccine that's stable at room temperature or just requires just routine levels of refrigeration.
PETER HOTEZ: And we will likely figure out what the parameters are for why we're not seeing that same level of durability. But that's going to take time. And so I think the message is innovation is great, but it's also nice not to rely exclusively on the shiny new toys, to have a few of the old matchbox cars standing by. And that's what we did.
PETER HOTEZ: We developed a matchbox car. It's our vaccine, which in India is known as CORBEVAX produced by Biological E. It's an old school recombinant protein vaccine using yeast fermentation technology, similar to what is used to make the recombinant hepatitis B vaccine that's been around for decades on alum. And the advantage of that is it can plug and play into low and middle-income country vaccine producers because many LMICs, Low and Middle-Income Countries, make their own recombinant hepatitis B vaccine; India, Indonesia, Bangladesh, and China, and Brazil, and the list goes on.
PETER HOTEZ: And so our thinking is for health equity, for vaccine equity. It would be good to have a vaccine like that. And that's really worked out well. So the question now is to get through these next few months. Can we mix and match some of those strategies?
ALEX PHILIPPIDIS: How did you and-- check me on the name-- Maria Elena Bottazzi from Texas Children's come to develop CORBEVAX?
PETER HOTEZ: I think you pronounced that well.
ALEX PHILIPPIDIS: OK.
PETER HOTEZ: So Maria Elena and I have worked together for two decades, 20 years, and we co-direct Texas Children's Hospital Center for Vaccine Development, which is part of our National School of Tropical Medicine at Baylor College of Medicine, where I'm also dean. And we've been working primarily on parasitic disease vaccines for low and middle-income countries. We've developed vaccines for Chagas disease, and schistosomiasis, and hookworm infections, and others.
PETER HOTEZ: But about 10 years ago, we partnered with a group at the New York Blood Center and the Galveston National Laboratory who had some ideas about a safe and effective coronavirus vaccine for SARS and MERS using the receptor-binding domain. So we worked together, applied for an NIAID NIH grant which was awarded. And we made SARS and MERS vaccines and worked out the technology, how to maximize productivity, doing things like engineering it without the N-terminal asparagine because it was glycosylated and interfered with the immune response, and without a free cysteine so we wouldn't get aggregation and/or molecular disulfide bond formation.
PETER HOTEZ: And so then, when the COVID-19 sequence came online in January 2020 on bioRxiv, we were able to pivot pretty quickly and hit the ground running. Unfortunately, we were on the outside looking in of the Operation Warp Speed funding and other G7 support. So we had to raise a lot of that money privately here in Texas, which we were able to do and move pretty quickly to make a very successful vaccine, a great protection in nonhuman primates upon virus challenge.
PETER HOTEZ: And now we've licensed it to Biological E in India and Bio Farma in Bangladesh-- I'm sorry, Bio Farma in Indonesia, Incepta in Bangladesh, and ImmunityBio, which is working to accelerate production in Botswana. And it's gone quite well, especially in India now where it's, as I mentioned, 70 million doses in adolescents. And now it's been approved as an adult booster.
PETER HOTEZ: And we're hoping for WHO prequalification pretty soon. They've inspected the factory of BioE, and it's all going well. So it's kind of interesting. I think the approach was-- the thinking out of Operation Warp Speed or the other G7 support was only the big pharma companies had the chops to pull this off. And I think, now, we've shown the world that there are alternative pathways of doing this, how academic partnerships working with vaccine producers in low and middle-income countries can produce really good, safe, affordable vaccines that are appropriate for resource-poor settings.
PETER HOTEZ: And hopefully, moving down the road, when calls for support come out that we just don't only incentivize the big pharma companies to do it. There's nothing wrong with the big pharma companies. I don't have a problem with them. I mean, they do a lot of good and provide a lot of vaccines for the Gavi Alliance. I just think the vaccine ecosystem is maybe going a little too full tilt, thinking that only the multinational pharma companies can pull this off, and we've got to balance the ecosystem out a bit more.
ALEX PHILIPPIDIS: Now, you mentioned the need for private donations in the development of this. From who or where or what institutions? Who stepped up to--
PETER HOTEZ: A lot of Texas-based organizations. The Kleberg foundation based in South Texas, they were really important. JPB Foundation based in New York. It's not only Texas funding. MD Anderson Foundation, which is important here for our Texas Medical Center. The Dunn Foundation. Now, the problem is when you start getting into naming, you always wind up leaving one out, so apologies ahead of time.
PETER HOTEZ: Tito's Vodka came and supported us, and so we're very grateful for that as well. And so we cobbled together-- I mean, it wasn't the billions, but it was about $8 or $9 million that we were able to piece together. But when you think about-- one of the things they told me at the White House vaccine meeting, if you put in the numerator, the number of public dollars you received or all dollars received, and divide it by the number of doses we've administered now, it comes out about $0.20-$0.30 a dose as opposed to the hundreds or thousands of dollars a dose for the others.
PETER HOTEZ: So we think we broke all records in terms of financial efficiency at getting a vaccine out, which was fun to hear.
ALEX PHILIPPIDIS: One factor, and I reckon a key factor in CORBEVAX's affordability, is that it's patent free. Why did you and Maria Elena and the team at Texas Children's and Baylor opt to forego these sort of payments and royalties, which obviously a pharma, small or large, wouldn't do?
PETER HOTEZ: Well, there is both practical and humanitarian reasons. Practical because it's expensive. And if I have money to spend, I don't want to spend it on patent attorneys. I'd rather spend it on hiring more scientists because that's always our limiting step. And as I say, I mean, I think when your house is on fire, you don't call the patent attorney. You call the fire department, and we wanted to be the fire department.
PETER HOTEZ: It just simplified things. And also, we put everything out in the public domain. So you can read all of our publications on PubMed as well as the clinical trials on medRxiv from BioE and basically reproduce everything yourself. So you don't even have to engage us in principle. I mean, we make it easy by providing not only the know-how but the production cell bank of the yeast isolate that's producing the vaccine and optimized accordingly.
PETER HOTEZ: And we provide the instructions for scale up in production, and the assays in the assay development. So we make partnering with us as easy as possible as a consequence.
ALEX PHILIPPIDIS: How is CORBEVAX being scaled up to produce the quantity of doses that are needed in developing countries?
PETER HOTEZ: Well, Biological E is not as well known as some of the others, like Serum Institute of India, but they're right up there. And they have eight or nine WHO prequalified vaccines, and they're an outstanding organization. Fantastic scientists to work with. And so they're one of India's big vaccine producers, and so we were able to work very quickly with them. We have a lot of confidence in their abilities and a great working relationship.
PETER HOTEZ: And now, the hope is that if this gets WHO prequalified, then they can export it to other countries as well. They have the ability to produce over a billion doses a year, probably you could even do more than that if the demand is there. I've had some frustration around the fact that because we couldn't raise anything close to the level of funding that Moderna or Novavax or some of the others have gotten, that slowed us down.
PETER HOTEZ: And also, WHO has been kind of slow walking the other next generation of vaccines after the mRNA and adenovirus went through, and that's been kind of frustrating as well. So we could have moved a lot faster and I think could have vaccinated the world a lot faster. But at least we're making a lot of progress and getting recognition for it also.
ALEX PHILIPPIDIS: Given the work, any path toward bringing CORBEVAX into the US?
PETER HOTEZ: It's funny you mentioned that. We've had discussions with FDA and with BARDA and others. There may be. I mean, right now, we don't have a US industry partner, so that's a hurdle. But what I've been recommending to the agencies is, look, since we have repeatedly immunizing the people with mRNA, it's increasingly less palatable to the American people. Let's at least look to see what CORBEVAX does as a booster for people who've gotten mRNA and bring it either through one of the vaccine trial evaluation units of NIAID or find another mechanism.
PETER HOTEZ: Let's at least look at it and get educated, and maybe there are advantages. BioE itself, with the Indian government, has now, in addition to the adolescents, has approved it as a booster for adults in India, and that's moving forward. The issue is in India, they don't use the mRNA vaccine technology at all. So it's being looked at as a heterologous booster, what they call a precautionary dose for either the COVISHIELD, the AstraZeneca vaccine that they make in Serum Institute, or for COVAXIN, which is an inactivated virus vaccine.
PETER HOTEZ: So we don't know what it would look like as a booster for mRNA. So we'd like the US government to at least take an interest in it, and let's see. And if it turns out that it does something gangbusters, then we can worry about how to move that forward. So those discussions have at least started and hopefully, make some progress.
ALEX PHILIPPIDIS: Since CORBEVAX is protein-based as is Novavax's vaccine, wouldn't Novavax seem to be an industry partner for your group?
PETER HOTEZ: Potentially. Or you can say, well, why not just boost with Novavax? I think the issue with Novavax, it has some similarities between our vaccine but some differences as well. First of all, the clinical trials of Novavax look great. Hands down, it looks like a really good vaccine. I think because of the particle formation step, it's kind of slowed down production. And there were a couple of false starts in the US in terms of trying to make it, and now, Serum Institute is starting.
PETER HOTEZ: But I think the last number I've looked at, only about a million people have gotten the Novavax vaccine as opposed to 70 million for ours. So I just don't know how the level of doses that can be scaled at this point. You'd have to ask them. So the point is, could we be an alternative to that, given that it's an older, yeast-based recombinant protein technology?
PETER HOTEZ: There's no limit to the amount you can make. And it's probably the least expensive of all the COVID vaccines. I think in India, it's 145 rupees a dose, which is about $1.90. So as a global health vaccine, it checks a lot of boxes. But I think it could be useful for the US as well.
ALEX PHILIPPIDIS: Now, you mentioned earlier issues of communication as well as potentially, policy. And it's come up recently where the director of the CDC, Rochelle Walensky, had acknowledged a mix of failures on both fronts by the agency. What grade would you give her, and what should CDC be doing that it hasn't done or isn't doing?
PETER HOTEZ: Well, she inherited a-- I can't imagine anything tougher than doing change management at a federal agency, and god bless the people who are willing to take that on. I think there have been some failings from the CDC. I think there's no way around it. And they they missed the entry of the virus from Southern Europe into New York, in the diagnostic testing they struggled with, in genomic sequencing and modeling, and in leading a federal response.
PETER HOTEZ: So I think there was-- and then not communicating really that well about what fully vaccinated is and the boosters. And I think Rochelle Walensky has appropriately recognized that they need to figure out how to maybe modernize the agency and maybe make it more focused around pandemics, lesser on some of the other things that they do. And in the few times I've spoken to her, I've recommended that.
PETER HOTEZ: And then she came out, and I know others have spoken to her. So she solicited a lot of input from the scientific and medical and public health communities. And I think now, she, a couple of weeks ago, has come out and said, we're going to really look at the agency from top to bottom and see what we need to do to modernize it. And I think, to her credit, that she's got that underway. It's a daunting task, though. I mean, as I say, with any federal agency, we always talk about-- President Trump used to talk about deep state, but he meant it in terms of Republicans or Democrats.
PETER HOTEZ: The real deep state is these agencies cling to their cultures of how they do things, so trying to get the CDC to do something differently is not easy. But I think it's necessary because I think they've got to get their mojo back in terms of really leading a pandemic response. There's been talk about creating a pandemic threat office within the ASPR, the Assistant Secretary of Public Health Emergency Response.
PETER HOTEZ: I've said, don't do that. I said, the American taxpayers are paying $15 billion a year to the CDC. Let's fix the CDC and put them front and center because that's what we're paying for. And the problem with having it in Washington, as we saw in the last administration, the problem of what happens when you put the West Wing of the White House in charge of a public health response, it gets too consumed by political expediencies.
PETER HOTEZ: And what if? Who knows who's going to be the next president of the United States? And you don't want to leave that to chance. So I think the leadership of a pandemic response in the US needs to be in Atlanta, needs to be led by the CDC. And if we have concerns about the CDC or their competencies in doing it, well, then you fix the CDC and make them stronger.
PETER HOTEZ: And I think that's the way to go.
ALEX PHILIPPIDIS: Now to what extent did the CDC hurt itself, including recently, by this changing of and relaxation of its mask guidelines, it's distancing guidances. How much did it jump too soon on these, and to what extent did that result in COVID persisting?
PETER HOTEZ: Yeah. I mean, some of it was unforced errors. A lot of it was not their fault. So what do I mean by that? Well, if you remember when the COVID-19 vaccines were first approved in the fall of 2020, they were approved on the basis of pretty large clinical trials, 40,000 to 60,000 people that showed they were interrupting symptomatic infection, right, and 90%-95% protection against symptomatic infection, symptomatic illness, I'm sorry.
PETER HOTEZ: What then came about was studies out of Israel had shown, hey, wait a minute, these vaccines, this Alpha wave, are not only halting symptomatic illness. They're actually stopping asymptomatic infection and transmission 90%. That was really exciting news, and I think that was the basis for lifting the mask mandates. I think what happened was a few things. One, protection waned after two doses, and I think that was disappointing and unexpected.
PETER HOTEZ: And then we moved over to the Delta variant. And so suddenly, now we lost that performance feature of the interrupting asymptomatic infection transmission, and then masks had to come back on. And by the way, we had to give a booster. And I think that could have been messaged better in a number of ways. One, I think, there could have been that anticipatory guidance saying, hey, look, when you give two doses so close together-- Pfizer at three weeks, Moderna, four weeks-- our past experience with pediatric vaccines says when you give a series of primary immunizations, you still have to give a big boost six months to a year later, and we should anticipate that this could be a three-dose vaccine.
PETER HOTEZ: I mean, I said it, but it wasn't backed up by the federal government. And had there been that kind of anticipatory guidance, I think it would have helped a lot in maintaining confidence because then you could say, remember those were our underlying assumptions. So it doesn't look like they're waffling back and forth. So some of it was not their fault that there was new variants coming along and the length of protection for mRNA didn't hold up.
PETER HOTEZ: And the first thing you lost was the performance feature around interrupting asymptomatic transmission and infection. But some of it could have been anticipated and messaged a bit better.
ALEX PHILIPPIDIS: One of the CDC's current challenges, and the same across the public health sphere, is monkeypox. Are you surprised by this latest outbreak, or was it inevitable that something else was going to follow on the heels of COVID-19?
PETER HOTEZ: Well, I wrote a book that got published last year in 2021 called Preventing the Next Pandemic that says that, basically, since the year 2014-2015, that stuff's happening. There's a bad moon on the rise.
ALEX PHILIPPIDIS: [LAUGHS]
PETER HOTEZ: And it's happening because of climate change as a factor but also this confluence of social determinants, such as war and political collapse and urbanization and deforestation. And those are combining in unique and interesting ways to bring back emerging or re-emerging infectious diseases. And I gave some case studies out of the Arabian Peninsula, and Venezuela, and central Latin America, and the Boko Haram areas in Nigeria, and even Texas in the Gulf Coast.
PETER HOTEZ: So that there is a new normal because people are saying, hey, what's going on, COVID-19 and monkeypox, and now polio? And my response was, yeah, this is what we've been talking about for the last few years, that things have changed in unique and interesting ways. Now, could I have predicted specifically monkeypox? No. But it could have-- if not monkeypox, something else. And now the number of cases is rising significantly.
PETER HOTEZ: I think the worry is that right now, it's restricted to a single population, people with at-risk behavior. But eventually, if the force of infection continues to rise, we should expect it could spill over to other populations and even gain, now that it's in the wastewater, maybe even gain access to animal populations and gain more of a permanent foothold.
PETER HOTEZ: And I'm not only worried about the US and Europe. I'm particularly worried about Latin America because if you look at the number of cases in Europe, once you go past the UK, the largest number are in Spain and Portugal. And historically, when that happens, it gains a foothold in Latin American countries and Brazil. And historically, when things pick up in Brazil, they really pick up, given what happened with HIV/AIDS, and Zika, and dengue, and so many others.
PETER HOTEZ: And so I'm very worried, for instance, about monkeypox becoming a permanent fixture in countries like Brazil, so watching that very closely.
ALEX PHILIPPIDIS: Do we have an adequate vaccine available for monkeypox, or is this an area that needs additional investment and prioritization?
PETER HOTEZ: Well, we think so, right? I mean, it's a vaccine, the JYNNEOS vaccine, which is modified vaccine. The Ankara was approved on the basis of immunobridging studies and animal challenge studies using respiratory challenge virus. Now this virus, this monkeypox is being-- and that was for smallpox, which is like an ortho-- it's another orthopoxvirus, very similar. This vaccine is being asked to protect against infection and illness from a different mode of transmission.
PETER HOTEZ: So it should work, but you don't know till you know. And now we've added this other complexity of doing fractional dosing, trying to spread one dose into three, four, or five doses by giving it through the intradermal route. And there's one published study that I'm aware of, around 500 people showing you can do it. But that's a big leap going from a study of 400 or 500 people to now setting it as a national policy.
PETER HOTEZ: So it's a pretty audacious move. I think I would have liked to have seen that rolled out among, well, at least one city as a pilot introduction study before doing it. So I think it could work, but it'll be very interesting to see. In the meantime, until we can get enough vaccine doses in hand, I think we need to look at the drug tecovirimat, the T also in this TPOXX.
PETER HOTEZ: Anecdotally, we're hearing it works really well in people who are getting treated. They do extremely well with it in terms of rapid resolution. But I'm asking whether we can look at it more for post-exposure prophylaxis or even as a form of PrEP, pre-exposure prophylaxis. And so I think that may be a place where we can also optimize.
ALEX PHILIPPIDIS: Another public health challenge is the return of polio, a disease thought to have been eradicated not too long ago. It doesn't help that 7% of the US population, some 20 million people, has not been vaccinated against polio. How much will fighting polio be hamstrung by the switch when we went from oral to back to injectable vaccine? And how much of a threat is this?
PETER HOTEZ: Well, the bigger threat is the fact that we've allowed anti-vaccine activism to go unchecked, and it really accelerated during COVID-19. In fact, my new book that I've just finished and submitted to Johns Hopkins University Press has the working title Anti-vaccine Kills, and it remarks on the fact that 200,000 unvaccinated Americans during the last half of 2021, during the Delta wave needlessly lost their lives because they refused the COVID vaccine despite its widespread availability.
PETER HOTEZ: They were victims of what I call anti-vaccine or anti-science aggression coming from members of Congress and amplified on Fox News at night, as well as a cadre of contrarian intellectuals that did a lot of damage and caused the big loss of life. And now I think this is spilling over globally. So I just had a paper come out in Nature Reviews Immunology saying, will the US anti-vaccine activism affect global goals, millennium development goals, sustainable development goals?
PETER HOTEZ: And I think the answer is yes, and we're seeing that now with polio and return of measles not only in the US but globally. I think we should not underestimate the damage how the anti-vaccine groups that became so empowered during this time of COVID-19 and gained political support from the far-right. I mean, now you've got The Proud Boys marching in anti-vaccine rallies.
PETER HOTEZ: This is a full-on political movement. Now it's got strength, it's got power, it's got money, it's got organization. This is a formidable force. And I say, when we think about the big social things that we combat like global terrorism or nuclear proliferation or cyber attacks, well, heck, anti-vaccine activism is killing more Americans and more people globally than all those other things combined, and yet, we don't frame it in that way.
PETER HOTEZ: And trying now how to reverse it, I think, is going to be really daunting. And I don't think the health sector knows what to do at this point. But this thing is a deadly force, and now it's potentially bringing back polio globally. We've seen now polio in the wastewater in the UK and the US. We've had the case of acute flaccid paralysis among an unvaccinated individual in New York.
PETER HOTEZ: We're just going to continue to see more of this until we finally decide that we want to come to terms with what this is and combat it appropriately.
ALEX PHILIPPIDIS: How much is anti-vax reaction to incidence of reactions to the vaccine, whether it's individual and no matter what the number, being small or not? How much is that fueled by that in addition, and is that a kernel of the resistance?
PETER HOTEZ: Well, Health and Human Services maintained a policy for years saying, we're not calling attention to it. We're just going to ignore it in hopes that it goes away. And in fact, I remember, I wrote a piece in The New York Times in 2017 describing the situation here in Texas, which is sort of the epicenter of the anti-vaccine movement where I live and work. And I've been going up against it because I have a daughter with autism in one of my four adult kids and wrote a book called Vaccines Do Not Cause Rachel's Autism, and wrote this piece in The New York Times.
PETER HOTEZ: It was a companion piece called How the Anti-vaxxers Are Winning. And I remember getting rebuked by people at HHS saying, Peter, we're not talking about this now because you're going to give it oxygen. I said, guys, this has got all the oxygen it needs. And you have to stop thinking of the American people as everybody's got a compact computer and dial-up modem and uses Ask Jeeves as your search engine.
PETER HOTEZ: The world has moved on, and this is a deadly and potent force. And now, we're trying to play catch up. I think the US Surgeon General has recognized it in Vivek Murthy. I think he's a good surgeon general. But it's mostly focused around switching up social media algorithms on Meta and Facebook and Twitter and that sort of thing. And that's useful.
PETER HOTEZ: I don't want to dismiss the importance of that. But it doesn't get to those sources who are generating the content, and that's where Health and Human Services still doesn't want to go and the Biden administration doesn't want to go. And even the World Health Organization really doesn't want to go. They'll talk about the infodemic. But actually going to the sources of it and dealing with the extremists in the US that are generating this garbage, nobody seems to want to go there with me.
ALEX PHILIPPIDIS: How have you coped with the criticism you've gotten as an advocate of vaccination, especially in the last couple of years of COVID? And how can the anti-vax view be fought and countered?
PETER HOTEZ: Well, criticism, I don't mind. I'm an adherent of what Ben Franklin says, critics are friends. I don't mind the criticism. It's the graphic descriptions of my untimely death [LAUGHS] that I have a problem with and having to bring in the Houston Police Department-- and they know I'm Jewish-- and bringing the anti-defamation league to track down those who are making very specific threats.
PETER HOTEZ: That's the big, big concern. I mean, the far-right press and even Fox News, when they get tired of beating up on Tony, Dr. Fauci, I'm sort of Fauci lite, and they go after me. And then there are a lot of unwell people who actually believe what they read in the Daily Caller, and Breitbart, and Fox News, and the anti-GMO websites, and things like that. And it's very dangerous, so I'm very concerned about it.
PETER HOTEZ:
ALEX PHILIPPIDIS: What should HHS and other agencies be doing that they haven't?
PETER HOTEZ: Well, I think now, this has gotten so big. And I said, I don't think the health sector knows what to do anymore. I mean, I can't even say I know what needs to be done anymore, but I've made the point. There are people who do, and the people who do are the Department of Homeland Security, and the Justice Department, and the Commerce Department, and the State Department because of the role of Russian propaganda, using this to divide our country.
PETER HOTEZ: And get advice from experts who are going up against global terrorism and things like that because it's reached that stage now. And let's learn what our options are to really combat this and really wall it off and recognize it as the threat that it is because it's only getting worse. I think what's happened with COVID-19 is the warm-up act, and I think we're going to see sharp declines because of the expansion and spillover of anti-vaccine aggression into low and middle-income countries.
PETER HOTEZ: I'm worried about bringing back measles and polio and even reversing sustainable and millennium development goals. That's how serious this is. And by the way, it's not stopping just at the vaccine space. I think all biomedical science is under threat. They're going to go after CRISPR-Cas9. They're going after all of the conspiracy nonsense around gain of function and COVID origins.
PETER HOTEZ: That's a huge piece of this as well. So I think biomedical science as a whole is under threat, and that's a big component of the book. And one of the things that I call for is protection of scientists, not only federal government scientists but all scientists from the threats, and maybe looking at something like a Southern Poverty Law Center equivalent for biomedical scientists.
PETER HOTEZ: I mean, the climate scientists have been dealing with this now for about 10 years. They've created a Climate Science Defense Fund. Maybe something along those lines. But we've really got to take this very seriously.
ALEX PHILIPPIDIS: You mentioned Dr. Anthony Fauci earlier. He's announced that he's stepping down as director of NIAID, which he's led since 1984. What would you like to say about Fauci's contributions as a scientist and as a public health official?
PETER HOTEZ: Well, Tony's been a mentor to me over the years. We both went to the same medical school, Cornell Medical School. And now he's 17 years older than I am, but he's been a mentor for me since I finished my MD, PhD at Cornell and Rockefeller in 1987. So we're going 30, 40 years, and he's been a friend and mentor. And what he's done with the National Institute of Allergy and Infectious Diseases is extraordinary and made it the premier infectious disease research and policy institute globally, and with a tremendous track record of helping to respond to new pandemic threats like HIV/AIDS, and H1N1, and Ebola, and Zika, and COVID 19, now monkeypox, but also keeping his foot on the gas for the ancient scourges like malaria and neglected tropical diseases.
PETER HOTEZ: So it's an extraordinary legacy that he's built in keeping infectious diseases in the public eye and convincing the planet that these are as important threats as war and terrorism and anything else. So extraordinary legacies he left for public service.
ALEX PHILIPPIDIS: Great. And winding it down, September marks 2 and 1/2 years since COVID-19 was declared a pandemic by the World Health Organization. As you look back, how well or poorly did the scientific community, the biopharma industry, the public health establishment, and our nation's leaders respond to the pandemic?
PETER HOTEZ: I think it's hard to simplify, giving a single-letter grade or a number. There were unpleasant-- there were pleasant surprises, and there were unpleasant surprises. I think in terms of accelerating innovation, I think there was extraordinary progress in launching new vaccine technologies, new drug technologies that's very exciting. On the other hand, I think the emphasis on innovation needed to be buffered with better levels of communication on what we should expect from those new innovations.
PETER HOTEZ: They could have balanced some of the older technologies a bit better, I think. And not paying enough attention to the warnings that I sounded about how anti-vaccine and anti-science groups will attempt to undermine all of this. So I would say a mixed and devastating loss. I mean, a million Americans lost their lives. And in my book, I'll say that at least a third of them, maybe up to half, were needless deaths because they could have been prevented had we managed the messaging and countered the anti-science aggression.
PETER HOTEZ: And globally, we're up to probably close to 20 million deaths. And a lot of lives lost could have been averted through greater attention to equity and standing up to the anti-vaccine aggression, so a very mixed response. And I worry we still haven't learned those lessons. I say that because look at what's happened to monkeypox vaccine.
PETER HOTEZ: The same hoarding and vaccine nationalism still continues, and we still have not learned the lesson of standing up to the anti-vaccine aggression.
ALEX PHILIPPIDIS: Great. And your second book, how soon before we see that?
PETER HOTEZ: Actually, it will be my fifth.
ALEX PHILIPPIDIS: [LAUGHS] OK.
PETER HOTEZ: You don't think I'm moving to Houston to become a writer? I think it was because I moved to Houston 12 years. I think it's probably because being in New Haven or Cambridge, Massachusetts or New York or Washington where everybody's a writer, I just felt too intimidated to do it. But there was something liberating with coming to Houston. So I'm hoping first quarter of 2021.
PETER HOTEZ: But the University Presses were having--
ALEX PHILIPPIDIS: '23.
PETER HOTEZ: I'm sorry, 2023. The University Presses are having some issues around supply chain management, so there's a global paper shortage and ink shortage for book covers and that sort of thing. And of course, when the supplies are available, the big five publishers, Simon & Schuster, and Penguin, and HarperCollins, they get first dibs. So hopefully, it won't be delayed too long because of that.
ALEX PHILIPPIDIS: Great. Peter Hotez of Baylor College of Medicine, thanks so much for sharing your insights on COVID-19 and public health with The State of Biotech.
PETER HOTEZ: Well, thanks. It's not often that I get to have some long question and answer format to really explain to people how I'm thinking about this rather than trying to squeeze it all into a 3 to 4-minute interview. So I do appreciate these opportunities from GEN to be able to really articulate what I think the big picture issues are.
ALEX PHILIPPIDIS: Great. And thank you for taking the time to watch and enjoy the other panels and fireside chats and the keynoters here at The State of Biotech. Alex Philippidis, take care. [MUSIC PLAYING]
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