 All right, so welcome to the first health policy and bioethics consortium of the 2021-2022 academic year. My name is Aaron Kesselheim. I'm a professor of medicine at Brigham Woods Hospital and Harvard Medical School. And I run the program on regulation, therapeutics and law in the division of pharmacopademiology and pharmacokinomics at the Brigham. You can see our icon there on the screen in the lower right-hand corner. And I am one of the two co-organizers of this consortium series. And I wanna turn it over to my co-organizer, Leah, and let her introduce herself. And then we can begin today's activities. Thanks, Aaron. And I wanna reiterate the welcome and thanks to everyone. And on the next slide, we have some of our logistics for the event, which is that we will be doing questions through the Q and A feature on the bottom of the Zoom screen. So any questions you have for the panelists throughout the event, you can type those into the Q and A box, as well as we tweet. And so you can find us on Twitter using the hashtag policy ethics. And should any technical issues arise, the chat feature will be used for addressing tech issues, as well as you can find out about upcoming events at the Center for Bioethics website or through the portal website and subscribe to get updates on future events. So this is the sixth year that we've been doing this consortium. And we're always honored at the really great experts that we're able to get to join us to talk about some of the key intersections between health policy and bioethics. Just to, I like to begin each session with the objectives for the day. Our objectives for the consortium in general are to try to articulate key issues in the healthcare system and public health that involve ethically challenging policies or practices, bring together experts with different perspectives or experiences to consider and these issues and propose solutions. And then obviously to stimulate conversation and academic study to help advance the field. And in addition to today's discussion which I think will be a really great one on vaccines for COVID, if folks wanna mark their calendars, we're gonna be talking in October about psychedelics and their potential role as therapeutics and then in November about the issue of health misinformation and how to deal with that. But for today's topic, I want to introduce our moderator who will introduce the topic in a bit more detail and then we'll introduce our two guest presenters for the day, Hussain Lalani is a primary care doctor and clinical research fellow at Portal. He also serves on the National Steering Committee for Doctors for America's Drug Affordability Action Team and is the co-founder of This Is Our Shot campaign to try to promote equitable uptake of the COVID vaccine. So Hussain, thank you for joining us today and I will turn the floor over to you. Thanks so much, Aaron. It really is an honor to have the opportunity to moderate this webinar in session today. Really excited for what's ahead here. The only other piece of background that may be helpful to add is that I was a former Doris Duke research fellow and I lived and worked in Eldred Kenya for about a year. So the global health issues are a particular tie to me and I want to especially thank Aaron and Leah for their hard work in really organizing this entire consortium series and today's session. I'm gonna share my slides here, excellent. So in the midst of the worst global pandemic in more than a century, we've seen remarkable promise of science in the form of vaccine innovation paired with the inequitable, distasteful and really unethical vaccine nationalism leaving low and middle income countries behind. On December 31st, 2019, the first case of COVID-19 was reported in Wuhan, China and 12 days later, China publicly shared the genetic sequence of the SARS-CoV-2 virus. This was the beginning of the global scientific community joining forces with public health officials, governments, civil society, pharmaceutical and biotechnology companies and philanthropists to do everything possible to develop a vaccine against the novel coronavirus. And in less than one year's time, multiple safe and effective vaccines against COVID-19 were developed and rigorously tested drawing on more than two decades of significant public investment in basic science research and mRNA vaccine technology. And while three vaccines are primarily being used in the United States, an additional five vaccines are being used globally. The United States has invested over $18 billion of public funding to date via Operation Warp Speed starting back in May of last year to really accelerate the development of six specific vaccines against COVID-19 with funding for clinical testing and vaccine manufacturing. This funding was instrumental for vaccine development building on the previous public funding. And one of these vaccines in particular, Moderna received such critical funding and support from the National Institute of Health and the US government that the US government actually has joint ownership of the intellectual property associated with Moderna's vaccine or the NIH Moderna vaccine. Yet despite this remarkable innovation, an effective vaccine is of little use if it can't reach those in greatest need of protection and of the roughly 5.4 billion vaccinations that have been administered globally to date, less than over 80% of those, as we can see on this chart here, have been in high and upper middle income countries while less than 1% have been administered in low income countries. Part of what makes these inequities challenging and frustrating to accept is that the international community and global leaders and vaccine advocates recognize early on that no one was safe until everyone was safe. And in April, 2020, they called for a global solution to address the crisis. This led to the birth of COVAX, the World Health Organization's Access to COVID-19 tools accelerator co-led by GAVI, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovation, CEPI, which really aimed to pool global financial resources and candidate vaccines to maximize the likelihood of success and to ensure fair and equitable access to COVID-19 vaccines by investing in research, development, and manufacturing of vaccine candidates as well as negotiating prices. While high income countries like the United States and Canada and the UK were making significant advanced pre-market vaccine purchases, the COVAX advanced market commitment was focused on ensuring that 92 middle and low income countries that could not afford to pay for the vaccines themselves would still be able to get equal access with the aim of supplying at least 2 billion doses of the vaccine by the end of 2021. Unfortunately, the program has struggled mightily with funding constraints and vaccine supply. The United States in particular did not participate in COVAX until under the former administration until President Biden joined the international call on January 20th and later pledged about $4 billion over two years. The harsh reality, as of September 3rd at least, is that COVAX has shipped over 236 million vaccines to 139 participants and we have a long way to go to reach the 2 billion goal in the first year. Meanwhile, much of the conversation domestically has been focused on donating vaccines, excess vaccines as a form of vaccine diplomacy. The United States has donated a little over 120 million vaccines to 65 countries. We heard some updated numbers yesterday and purchased an additional 500 million doses of mRNA vaccine specifically for COVAX with plans to deliver about 200 million of those by the end of the year. The first of these shipments were sent to Rwanda about three weeks ago and then a subsequent shipment to South Africa was sent just about two weeks ago. You can see some pictures here of a few different countries just to see what this kind of looks like. And yet the World Health Organization has estimated that nearly 11 billion vaccine doses will be needed to vaccinate about 70% of the world's population against COVID-19. So in short, we do have a long way to go. And on May 5th of this year, the U.S. Ambassador Catherine Tai announced support to waive the intellectual property rights protections for COVID-19 vaccines, also known as the TRIPS Agreement at the World Trade Organization after significant consumer advocacy, essentially doing so would allow countries to share the recipe of how to make all COVID vaccines with the rest of the world and for member states to license these to local manufacturers to produce the vaccine. However, to date, no formal agreement has been reached in part due to holdups with the European Union and some unclear action from the United States after the announcement by Ambassador Tai. So last week, India actually called for an early ruling on the TRIPS waiver for COVID-19 vaccines. So the issue is taking hold as COVID ravages across the world. To help us learn more about this and to understand the rich and complex topic here, we're joined by two incredible expert speakers. Each speaker will share some opening remarks for about 20 minutes. And so now I'll go ahead and introduce our speakers. So first, Dr. Lisa Wallette is a professor of law and the Justin M. Roche junior faculty scholar at Stanford Law School. She's also a senior fellow at the Stanford Institute for Economic Policy Research. Dr. Wallette is a nationally recognized intellectual property law expert and explores policy issues, including the patenting of publicly funded research under the Bob Doyle Act and the integration of intellectual property with other lovers of innovation policy, specifically as it relates to the COVID-19 pandemic. And then after her, we'll have Dr. Paul Farmer, the co-locatronist, university professor and chair of the Department of Global Health and Social Medicine at Harvard Medical School. Dr. Farmer is also chief of the Division of Global Health Equity at the Brigham and Women's Hospital and co-founder and chief strategist at Partners in Health, a global nonprofit organization restoring social justice by bringing quality healthcare to the most vulnerable around the world. Partners in Health also collaborates with national governments in at least 11 countries and employs over 18,000 staff. I'm really looking forward to this conversation. So Professor Wallette, the floor is yours. Great, thank you so much for that kind introduction and for inviting me here. Let me just share my slides, can you see them now? So I wanna note at the outset that my thinking on COVID is based on work I've done with a number of wonderful co-authors, including work on vaccine innovation with Claire Shway, who's an outstanding JBTHD student at Stanford, work on the relationship between innovation incentives and access with Daniel Hemmel of University of Chicago Law School and a long series of blog posts and forthcoming book chapter on COVID innovation issues with law professors, Rachel Sacks, Jacob Sherkow and Nicholson Price. We're meeting later today to talk about our 40th blog post. So I'm grateful to all of these co-authors for helping me think through the legal issues here. So before I turn to the global vaccine access issues, I wanted to start by noting that vaccines are different from many health technologies in a lot of ways, including that there's a even stronger case for government intervention in vaccine development. In general, as I'm sure many of you know, there's good evidence that biomedical innovation is a driver of improvements in global health over time and that innovation will be underproduced by the free market because of the public goods nature of knowledge. And in the vaccine context, this underinvestment problem is even worse. So one problem comes from the positive externalities of vaccination, meaning that vaccination has large social benefits beyond the benefits for the vaccinated person like reducing community spread of infection. And there are other problems coming from the fact that a firm's profits for a vaccine will be lower than for a repeat use treatment, all else equal. Some of the pioneering theoretical and empirical work on this was done by economists, Michael Kramer and Christopher Snyder using data from US markets and Claire Shui and I expanded on these ideas to explain some problems that also stem from behavioral economics. So the standard solution to these kinds of market failures is that governments should step in to correct them. And they have a broad toolkit of innovation policies to pull from to do that. In work with Daniel Hemmel, I've written about the differences between these policies and why no one innovation policy is optimal in all circumstances and why there isn't really a tradeoff between incentives and access and we can use multiple policies to accomplish both. I won't go into all those details now, but I do wanna highlight the way public policy is designed to increase use of medical technologies also provide an incentive to create those technologies in the first place. I mean, the first study empirically demonstrating this was by Amy Finkelstein in the US vaccine context looking at policies like childhood vaccine mandates and increases in Medicare vaccine coverage. And Rachel Sacks has written a lot about this in the insurance context. And it's one of many ways that policy makers can offer high powered incentives for developers while also making the resulting products free to patients. So you might say, okay, great, the government has lots of tools to fix the vaccine innovation problem. At the start of the pandemic, we weren't off to a great start. Before COVID, public health scholars had long been warning that the world had made insufficient R&D investments in vaccine development and manufacturing infrastructure. And part of the problem is that all of the market failures I described also have corresponding political failures that political institutions generally underinvest in long-term infrastructure, including because voters tend to underestimate the risks and any payoffs are longer than an electoral cycle. So the public sector hasn't invested in vaccine infrastructure enough itself, left most of the vaccine human capital and facilities in the private sector. And governments also haven't made vaccines sufficiently profitable for the private sector to encourage enough infrastructure there. Now, once the threat of COVID became apparent, we did end up getting some vaccines authorized in record breaking time. The development of most vaccines takes over a decade, but the first two vaccines were authorized in the US in less than a year for COVID. And part of that success was getting lucky with the science. Part of it was effective FDA regulation, like setting clear standards to dive clinical trials. And part was a substantial public investment in the vaccine development. And it's interesting that in a reverse of typical funding patterns where the public sector tends to focus more on basic research and then transfers technologies to the private sector, in this context, public funding for both of these vaccines was more focused on covering the final stages of development and manufacturing costs. And it's built on substantial private investments in early stage research on the mRNA platform. So this was largely a success in terms of getting vaccines through clinical trials in record breaking time, but vaccines are not vaccinations and the rollout has been far more uneven. We're seeing the cost of not focusing enough on manufacturing capacity and distribution. And before I turn to the global issues with this, I think it's worth emphasizing that vaccine distribution in the US has had plenty of problems, including a disastrously slow initial rollout and continued stark inequalities by race and income in terms of who's vaccinated. The exact nature of this problem has changed over time as domestic vaccine supply has increased, but two of the big problems have been inadequate federal funding and a lack of federal coordination. In the US, our public health governance structures are largely decentralized at the state and local level and they're way underfunded due to the same kinds of political dysfunction that I described in the vaccine infrastructure context. So there's a lot going on now in terms of expanding vaccination in the US, including the new mandates that President Biden announced yesterday. There are many academics working on different aspects of this problem. Just among my colleagues at Stanford Law School, Michelle Mello had a piece in the New England Journal of Medicine last week explaining the legal challenges to vaccine mandates and other public health orders. Stan Ho has been working with our county, Santa Clara County on randomized trials to try to figure out the best way to improve testing and vaccine administration in vulnerable communities. And there are lots of other issues and initiatives going on across the country. It's already mentioned that our moderator, Dr. Elani, co-founded that this is our shot movement to combat vaccine misinformation. So there are a lot of ways to learn more about this and help with the problem in the US. But as bad as vaccine distribution has been here, the picture is even leaker when you look at the rest of the world. Here's the latest map showing the global vaccine rollout so far and you can see that the US and Europe are a lot greener than many other countries. And Dr. Elani gave a lot of details on this in his introduction. It's just one other way of looking at this problem. The New York Times has a nice visualization of how stark the disparity by country income level is. So far only 0.4% of doses have been administered in low income countries. And this is a tragedy and expanding global access to COVID vaccines is a moral imperative that hasn't gotten nearly enough public attention here in the US. So I'm not an expert in political mobilization. I think that even in a country that has never invested enough in foreign aid or done enough to address global health inequalities, it seems like it ought to be possible to convince Americans that vaccinating the rest of the world is also in the US's interest in terms of bringing the pandemic to an end and reducing the likelihood of an even more dangerous new variant and building goodwill. I've been glad to see news in the past week about Biden calling for a global vaccination summit and some members of Congress launching a global vaccination caucus. So maybe this will be getting more mainstream political traction. Do I worry about how this will interact with the new push for boosters and continued US hoarding of vaccines in that context? So what can be done about global vaccine access if we can develop a political will to do it? The legal option that has gotten the most attention for approving global vaccine distribution is a WTO waiver of COVID related IP. And I'll briefly describe what's going on here, but overall I've been sorry to see how much oxygen this debate is sucking up compared with its likely impact, especially since a lot of other options aren't getting enough attention. So the World Trade Organization or WTO is a international organization that administers treaties, including trips, the agreement on trade related aspects of intellectual property rights. And essentially trips requires all but the least developed countries to offer certain IP protections like patents to inventors from any other WTO members. Trips does allow countries to engage in compulsory licensing, including for exports to other countries that don't have manufacturing capacity, but there are a lot of barriers using these provisions, they haven't been used much. So last year, India and South Africa proposed waiving the IP protections in trips for all COVID related medical products, which is different from compulsory licensing. So this would mean that if an IP waiver goes through, then if a certain country chooses to change its domestic IP laws, then another country couldn't initiate a formal WTO dispute against it. Now the WTO dispute resolution process is currently in crisis because the US has been blocking nominations and WTO sanctions are far from the only constraint on domestic IP laws. But the idea here is that this could make countries more comfortable producing IP protected technologies that are important to fighting the pandemic. And as Dr. Lalani mentioned in his introduction, the US has supported a more limited version of this waiver focused just on vaccine IP. Now, even with US support, it seems unlikely that anything will happen soon. WTO decisions are generally made by consensus and many major economies remain opposed to IP waiver, negotiations stopped at the end of July without any clear progress being made. And the most optimistic predictions I've seen are that a limited waiver might go through at the next ministerial conference in December and then it would take additional time for individual countries to change domestic IP laws. But even if a WTO waiver does go through, it's unclear whether it would have any real world effect. So some supporters of a WTO IP waiver have pointed as a model to compulsory licenses on patented HIV AIDS drugs in the 2000s, which were successful at increasing generic production and driving down prices and thus increasing access. But there are important scientific and legal differences between those AIDS drugs, which are known as small molecule pharmaceuticals and COVID vaccines, which are a type of complex biologic. So for small molecule drugs, it is relatively straightforward to make a generic version that's a exact copy. So patents really are the key hurdle to production. For biologics, the generic version is known as a biosimilar and it's harder to show that a biosimilar is similar enough to the original to be able to rely on its clinical trial data. There are some biosimilar versions of therapeutic drugs now, but the FDA and its counterparts abroad haven't even issued guidelines on the regulatory steps that would be needed for biosimilar vaccine approval, either in general or in the COVID context. So the key barrier here to expanding vaccine manufacturing isn't patents, it's the trade secrets and know-how and scarce physical supplies needed to get a new manufacturing plant up and running. Moderna already waived its patent rights last year, said it wouldn't enforce the patents for others who are making COVID vaccines, but other manufacturers still aren't able to use Moderna's technology without active cooperation from Moderna. Now it's possible that a WTO waiver would be able to help some with some of these trade secret issues, such as by making it easier for countries to try to force vaccine developers to disclose confidential information, but this kind of forced trade secret transfer would be unprecedented. It's not clear whether it would work and it's not clear that the confidential written disclosures provided to regulators would really be enough for a independent manufacturer. So I think that this issue of how to expand manufacturing capacity, that that is really the key question policymakers should be focused on. And to the extent this involves knowledge transfer, this can happen now, regardless of what's going on with the WTO negotiations. The hurdles to vaccine manufacturing knowledge transfer is a issue we've seen coming. My co-author, Nicholson Price, has lots of nice work on trade secrecy and biologics manufacturing, extending before the COVID issues. And his work includes this piece on COVID vaccines from about a year ago before any of them were authorized. And as he and his co-authors explained, the options basically range from forced open disclosure of all essential information to purely private mechanisms with a array of intermediate positions like financial incentives for early transfer to third parties. In the US, which is the legal system, I know best, the Biden administration has already invoked the Defense Production Act to increase vaccine production and it could use this authority to force additional knowledge sharing. It's not clear from the statutory language that the Defense Production Act could be used to force transfer to manufacturers outside the United States, but the federal government has numerous other sources of leverage that could use to encourage and broker these kinds of partnerships. I saw Chris Morton among the participants here. He's been one of the leading voices thinking about things like US government IT rights over the vaccines and how those could be used for leveraging these discussions. And these actions to expand manufacturing capacity need to happen now, I mean, or really yesterday, like getting a new manufacturing plant up and running takes time, even when you have full cooperation from the original manufacturer. So it can't help in the very short term. I mean, for that, for spending access right now, really the only thing we can do is try to more equitably distribute the existing doses, such as all the excess doses currently held by the US. I think the US should also increase funding for this problem, both in terms of supporting the development of manufacturing infrastructure in other countries and in terms of just buying more vaccine doses for other countries. Maybe the extent of our vaccine donations has been woefully and adequately compared to the problem. At the price we paid for Pfizer and Moderna vaccines, the US could buy vaccines for the entire population of the world's least developed countries for less than we spend annually on foreign aid, which is not a lot compared to the costs of this pandemic. Just in the US, COVID has been estimated to add $10 billion per day to the federal deficit. So I think a lot of the concerns about spending more money to address the pandemic have reflected a real failure to understand magnitudes and priorities. I don't have expertise in the legal or political systems of other countries, so I won't pretend to offer advice to their policymakers. And even for US policymakers, I don't know whether the best approach is to just focus on one of these strategies or all of the above, but I think the decision should be guided by figuring out the fastest way to get more shots in arms around the world. So I'll just conclude by noting that our policy choices shouldn't just be focused on getting through this pandemic, but also in being better prepared for the next one. Here's a cover from time in 2017, which is just one of many warnings before COVID about the very real threats of a lethal and economically devastating pandemic. But for the most part, all of the experts' reports on this got about as much policy traction as the reports on climate change do, which is not very much. And unfortunately, the fact that we're living through this now doesn't make it less likely to happen again soon. But maybe we can use this as an opportunity to improve our legal systems for biomedical innovation. You hear a lot about drug prices being too high in the US. It seems like there's some political support for addressing this, but too high doesn't mean anything in the abstract. The real problem is that the money US taxpayers spend on new drugs often isn't aligned with their social value. So it can be very profitable to launch a drug that doesn't offer a clinical benefit above existing treatments or where there isn't adequate evidence of clinical benefits at all. But there isn't enough funding for things like vaccine infrastructure or preventatives and public health measures in general. But the goal overall should be to get the marginal private value of R&B investment to equal the marginal global social value of that investment. And there are a lot of legal tools involving health technology assessment that can be used to shift biomedical funding in the right directions. And I think it's also important for policymakers to recognize that issues of innovation funding are distinct from issues of access to those innovations and that describing innovation policy as creating a trade-off between incentives and access is a false framing. Like a key conceptual mistake that keeps getting made in access to medicines discussions is not distinguishing between the out-of-pocket costs for patients and the entirely separate question of the financial rewards for developers. Vaccines can be free to patients even if the developers receive large financial rewards. And there are plenty of policies that increase both incentives and access. So far I think the main strategy of many access to medicines advocates has been to focus on limiting IP rights and encouraging competition from generic manufacturers which is an effective strategy for some kinds of medicines. But there are plenty of off-patent drugs that have faced shortages and high prices and other access barriers. And the connection between patents and access is more complicated than simplistic economic models suggest. So I think it's important to broaden our understanding of access to medicine among academics and advocates and politicians to include reforms beyond the current playbook. So I will stop there but look forward to hearing your questions later. Excellent. Thank you so much Professor Willett for your presentation and for describing the role of intellectual property on vaccine access and highlighting some of the technical challenges that we face in increasing vaccine access. I'm looking forward to the discussion portion and the Q and A. There's a lot of stuff to unpack and a lot of things to kind of delve into. But before we do that, Professor Farmer we are really excited to hear from you and the floor is yours. Thank you very much. And in terms of discussion I don't imagine that Professor Willett and I are gonna have a lot of debate. I'm really grateful for the way she framed this and also for pointing out that the focus on the trips waiver has often sucked a lot of the air out of the room when we have to be doing multiple things at the same time. And she summarized that beautifully as well. Right now our options are to embrace the kind of hard-hearted, well it's gonna happen when it happens and ignore the fact that we have too much vaccine stockpiled in some settings and none at all in others. So there the issue is distribution and I'll get back to that in a second. And we should have, as she said we should have been having the discussion on manufacturing. I'm particularly concerned about the continent of Africa. We should have been having that discussion more than a year ago. And I'm happy to say that some people on that continent have been having that discussion including our colleagues in Rwanda were trying to move forward the agenda of on-continent manufacturing of mRNA vaccines for a number of reasons, the most obvious ones all around us. But there's real potential for these technologies that we haven't seen with other ones. So I'm just going to, I'm also like to note that as welcome as Ambassador Tai's statement was and we did speak to her as well, Jim Kim and I and Jim Kim as many of you know was the president of the World Bank for quite a while. We were grateful and proud but it's important to step back and look at the map of opposition to these waivers in addition to understanding why they might not be magical levers for us to pull. The opposition to the trips waivers is almost entirely the map of colonial rule and empires. So every country in Sub-Saharan Africa that's a member of African Union has signed on to requested the waiver and the opposition, which was perhaps expected from the United States given our history, the opposition is largely from Europe. And working in between Rwanda, West Africa, Harvard, Haiti it is seen an entirely that way by most of the people I speak with about it on the continent is of course there is this objection. Of course it's coming from the expected quarters and of course we'll have to have multiple strategies to advance all efforts to slow the pandemic. And just to get back to a couple of them and the reason that I was invited not because of any deep knowledge of patent law not even shallow knowledge of patent law but because of implementation capacity. And I'll just make an argument that we can be doing multiple things at once. We can be working with partners on manufacturing capacity. We can be working with COVAX on how to speed up donations. We can be working with individual states looking at state to state vaccine diplomacy. I guess what I'm saying is any ideological objection to all of these mechanisms has the unintended effect of slowing down the vaccine rollout at a time where every delay means more disease and more death. So for example, if you're working in a place like Eldorette, Kenya where Hussein has worked you are able to do an analysis to say, okay, what are the top five barriers to a rollout now? What are the top five barriers to a rollout next year? Those could change. And my worry is that our default explanation too often goes to vaccine hesitancy or too quickly. I mean, just to give an example from implementation work if you're on the Rwandan-Kongali border at the close of an Ebola outbreak in the Congo where there is finally an effective vaccine when you cross the border you don't cross into an area where people are speaking a different language or have different views of the world whether the invisible world of viruses and vaccines or other worlds, you don't have that at all. What you do have is a sharp drop in the acceptance of vaccines. So on the Rwandan side of the border to prevent the incursion of Ebola, vaccine uptake was pretty much anybody who was offered it wanted it. Just a few miles away on the Kongali side of the border it was hard to reach levels of 40% just in the contact tracing effort around documented cases in the Congo. So I mean, what is that? Well, our default answer is we shouldn't be so quick to invoke people's beliefs, attitudes, practices and cultures. And as an aside, I didn't mention this but I'm also an anthropologist. And so long interested in just these kinds of questions but we put too much agency, too much assumption of the ability to make rational choices or whatever they may be called choices. We're foisting that onto people who haven't expressed vaccine hesitancy so much as the inconvenience of trying to get a vaccine. And that inconvenience is of course absolute in many of the places that we're describing as low income countries, right? They're just look at the vaccination coverage. You could have all of the resilience and desire you might like to get a vaccine and to protect your family and neighbors. But if there's no vaccine there, again, we should have started the conversation about manufacturing a year ago. And just to go to the question of a rollout and this is where I have some experience in rolling out new technologies whether they're preventants like vaccines or diagnostics or therapeutics. The conditions of a rollout are different in any different time and place, right? So Haiti, where I've worked for a long time when we were working on the vaccine rollout we didn't know that about the day we were to launch it that the president of Haiti would be assassinated. And you can imagine even before there was another earthquake and another hurricane that Haiti's rollout capacity has been much compromised by these recent events, right? So it's different now than it would have been a year ago. And in Rwanda, similarly where you have a very strong national health program and even health insurance, you would expect even though it's also a rural largely agrarian society with a history of violence you would expect a very different rollout and indeed that's what we've seen. So again, I don't think that we should disparage certainly we should be pushing for a trips waiver but we should also hear Professor Willette when she says it's not even clear that that will speed things up in the way that is desired so ardently by a number of activists who are making the right points but we also need to think about again vaccine diplomacy not as something terrible but it's something that could really save lives in the short term. Whether we're talking about Israel and Rwanda or the United States and Haiti or the United States and Rwanda you send half a million doses or more and you're making a big difference. It was mentioned already that Partners in Health has more than 18,000 employees. And so in order for hospital systems in a number of places, Rwanda, Haiti parts of West Africa it's really critical that our staff becomes as vaccinated either already or in the days to come well before they'll be manufacturing capacity regardless of what happens with WTO discussions going forward. And I would just underline that fact that even though we may all have our preferred pet policy to tackle the need right now is urgent and we're going to have to rely on mechanisms that are new and untried like COVAX on state to state vaccine diplomacy and on pushing forward this agenda of manufacturing even as the legal discussions at the WTO and other places go forward. So let me stop there and I would be more than happy to discuss the specifics of rollout challenges based on not speculation, but on experience today with what vaccines we have had or with other novel vaccines in previous rollouts. Thanks so much Professor Farmer for sharing those insights. I'm gonna invite Professor Bullett back so we can have this Q and A and I just wanna thank the audience for sharing their questions and please do continue to use the Q and A function so that we can try to get to as many questions as possible. So Professor Farmer, if we could start with you just kind of building off of what you left off there because I think the implementation piece is particularly important. There has been quite a bit of criticism and you can tell us whether you feel it's appropriate or not that even if vaccines were available that the logistics distribution and rollout within specific countries is a barrier. So could you tell us what we've learned? What do you think about what we've learned currently on the ground? And maybe if there's any lessons from particularly the AIDS pandemic where we were eventually able to deliver millions of doses of medications globally what have we learned from that and how can that apply here? First of all, who's saying thank you for the don't let me forget to go back to the lessons learned from HIV rollouts. Of course, any implementation challenges is just that, an implementation challenge. To do something in medicine or public health including a vaccine rollout, you have to have the staff you need, you have to have the stuff whether that syringes alcohol, vaccine or much more. So your staff stuff, you have to have the space to do it. This is an airborne pathogen. You wouldn't expect the space for administering having a campaign with an airborne pathogen would be the same for a contact born pathogen like Ebola. These are different challenges. So staff stuff, space systems, well, that's what vaccines are about. They're about, as Lisa said, they're unique in many ways as public goods, right? But they're really a system and probably the best system we have alas for preventing illness and death and ongoing mutations. So the system itself is, if I could put it this way, trying to do a rollout in the middle of a chaotic situation like Haiti right now actually can strengthen the health system. And if we learned one lesson from the AIDS rollout including the president's emergency plan for AIDS relief but also the global fund, it's that in these clinical deserts where you don't have staff stuff, space systems and support that you need, introducing them to do something new, instead of taking attention away from ongoing challenges to strengthen the health system can in fact reinforce the health system. And I think that's in many ways, I mean, the first lesson about HIV and about AIDS drugs in general is that it was false to claim it couldn't be done, it could. It also averted a massive pandemic, a bigger pandemic of HIV among adults and children. When I was in medical school, we all assumed that HIV would be a leading infectious killer of American children and it's not. And the reason is because of drugs. And again, people forget that we're also using the same drugs to prevent transmission, right? And even though a biologic is in every way from what I understand more difficult to produce than a small molecule, the delivery part of it is much more complicated than a vaccination program, right? Because it involves ongoing care. And another lesson that we learned that we are still struggling with COVID is that community-based care is more convenient to patients and gives better return on the investment of diagnosis and treatment. And we know a lot about how to do that. The majority of Partners in Health's employees, and I think it's more than 20,000 now, the majority are community health workers. They're living and working not too far, very often from where they were born and raised, sometimes not, but very often. And they are the living links between hospitals and clinics and homes, right? And what we call communities, right? When we talk about a medical home in the United States, we're not even talking about the home. We're talking about another clinical facility, right? That's the medical home. But the medical home is really the home. That's where the majority of caregiving takes place for COVID-19 and pretty much any other malady. And that's true in the clinical desert, which Rwanda is no longer, but Sierra Leone is. And it's also true in the clinical deserts within the rich world, like we see in the United States now. So I really worry that not only do we have a default tendency to bring up vaccine hesitancy before vaccine nationalism or vaccine distribution or supply, I worry about that. I also worry that we're making it sound like rocket science, is there electricity or not? If there's not electricity, and a lot of parts of the world where I work are not electrified, then a different kind of cold chain is required. But it's not rocket science. It always involves staff, stuff, space systems and support. Sometimes that support is the families who are living in difficult circumstances and are afraid to go out. Sometimes that support is to the vaccination programs, which are, as Lisa said, they have a long history of divestment, not just under investment, but divestment. And that's true in the United States. It's true in many other parts of the world. So yes, they need support as well. Ministries of Health, as they're often called, and their vaccination programs tend to be the least well supported of many programs. So I think that whether we're talking about vaccine manufacturing in Rwanda, say, or Senegal or South Africa, or whether we're talking about a rollout of a vaccine that is delivered by plane from a donor nation or a multilateral group like COVAX, we still need staff, stuff, space systems and support. And again, I'm just gonna go back to Lisa's point. When you think it's expensive to do this, just think how expensive it's proving not to have done it. Thanks so much, Professor Farmer, for sharing those insights. When I listen to that, it really reminds me of the importance of the positive framing here. I heard you say a lot that initially in the AIDS pandemic as well, there was a focus on we can't do this, it's too challenging, and how this is not necessarily rocket science. And kind of pairing that with the learned lessons that we have from distribution on the ground of medications globally. And it really leads me to kind of think, with all this resistance that we've faced and seen, why not just have this multi-prong approach that you talked about that Professor Willett referenced as well, like pairing the release of the intellectual property through the trips waiver plus a tech transfer along with investment in manufacturing and capacity, and then continuing to fortify our systems of distribution on the ground. Do we, Professor Willett, do you see any challenges to kind of that joint, that kind of multifactorial effort being effective or not? It seems like it potentially could be, but I'm curious to hear what you think. Yeah, I think it potentially could be. And I wanna clarify that I'm not opposed to a trips waiver. I'm briefly looking at the questions in the Q&A, some of which seem to suggest that. My point is just that we shouldn't expect that we can put our eggs in that basket and that by having a trips waiver, suddenly that will solve all the IP problems and there'll be vaccines for everyone. It's not clear to me that it will expand vaccine manufacturing and that doesn't mean that it's going to create a problem, but I think policymakers need to be thinking proactively about like what can we be doing right now outside of the WTO discussions because all of these things that countries can do, I mean like compulsory licensing and like the patent issues can be dealt with even aside from WTO countries can be the threat of a WTO formal dispute is actually not that significant of a barrier compared to the other political issues here. So I think policymakers should be focused on like how can we expand manufacturing capacity? Where are the key bottlenecks now and what can we do about them? I think one, I mentioned a bunch of the different techniques that U.S. policymakers should be thinking about including forcing knowledge transfer which like that isn't going to happen from the WTO waiver alone, but the U.S. policymakers can do more to encourage knowledge transfer from the current manufacturers to other new manufacturers. It's increasing the amount of funding that we have for vaccines and thinking about the like gross oversupply that we have in the U.S. and what to do with them and there are additional legal complications related to them. There's a really nice Washington Post op-ed from Govind Prasad and Holly Fernandez Lynch from July on the like what to do about all of the vaccines that are going to be expiring in the U.S. because the U.S. has far more vaccines than it can use. There are some potential legal barriers there including contract language in the purchase agreement saying that the vaccines may only be used in the U.S. which was added because of liability concerns like the concerns about liability for manufacturers because in the U.S. there are specific statutes protecting vaccine manufacturers from liability while also providing compensation to people with vaccine related injuries and different countries have different frameworks for regulating that. But as they noted in that op-ed there are a lot of potential solutions to dealing with those legal hurdles. So those are the kinds of things policy makers need to work out to deal with all the doses that we have now. Thanks for sharing that Mr. Willett and I'll just kind of build on that and say that at least from what I've been seeing in the media reports at least it does seem like there is a multi-pronged approach being considered and being pushed by some government leaders including in the United States but certainly a lot more can be done to fortify each of these realms as we talk about both legal financial distribution manufacturing. So there's an interesting legal question for you here that you may be able to help us with. So one of our participants asked about the legal precedent of Jacobson and how at some point individuals are obligated to kind of give up their own concern autonomy in favor of supporting the public good and that this may be something that could be extended to corporations and corporations in this dire like once in a century pandemic. Do you, how do you see that? And do you see any barriers or challenges to that? Yes, I mean, I don't think there's going to be strong like legal argument in a private right of action that's gonna force this but I mean, I think there are strong many legal tools that the US government, the federal government could use to force knowledge transfer from vaccine manufacturers including the Defense Production Act that I mentioned earlier or using its own IP as a source of leverage or things like that. And I mean, I think ultimately this is a political problem but the concern is not whether there are the laws to do that but is there the political will to do that? How can we have a political discussion in the US where one of the core problems throughout our pandemic response has been getting people to focus on broader social benefits outside their own individual liberty. I'm not an expert in communication about this or political mobilizations I don't know what the best approach is there but I think that's the core problem. And we're seeing that coming up again now with this current debate about vaccine boosters that like giving current supply constraints it is hard to argue that the US can roll out boosters to everyone in the US without that coming to the expense of people who haven't had their first shot. And as there's increased discussion about boosters I think it'll be harder to get the US public focused on the problems of global vaccine access. I think Dr. Farmer has far more experience with the like actual political ecosystem there but that's how I see the core problem. Yeah, Professor Farmer would you like to kind of share some thoughts about this? Maybe we could also frame it in the context that there is a global, you know the UN General Assembly meeting coming up next week and the week after and kind of in their reports that there's calls for a global summit on COVID response but how have you seen, I mean political will unfortunately is not a new problem and it's quite tragic as both of you mentioned that that is one of the major barriers here but how have you seen this play out in the past and what kind of tools can help overcome this issue? Well, some of this has come up in the chat as well. You know, why, how is it that and this is an empirical question a friend of mine, Brook Baker, you know could write books about this, he's on but how is it that the George W. Bush administration came to embrace the most, you know, a significant I'm just gonna say it, anti-colonial endeavor to take care of people who were already sick on another continent and large because it was largely about one continent, not all how did that happen, right? And, you know, what can we learn from it? And as was pointed out by Lachlan Faro in the chat, you know, the word evangelical to me is just like a confusing morass of a lot of different things as well but the, to use the shorthand the evangelical Christian component or one of them, you know clearly pushed for this idea of I guess compassionate conservatism again, I'm aware of the shortcomings of all these terms but so there was an executive position that involved a lot of new money I didn't even know what new money was, you know I didn't understand 20 years ago how the international financial institutions do their little accounting tricks and governments, large powerful government so I didn't know what that meant new money but we did learn that it wasn't money that was allocated from some other promise made or some other program but it also had some fairly widespread social support that was deemed non-partisan. And, you know, again it's kind of like vaccine hesitancy or skepticism you know, we talk about it so much you know that we must be talking about it too much, right in the face of these, you know our biggest hesitancy clearly is to share the stuff that we have that's the vaccine hesitancy that we're really talking about today, right the hesitancy of the powerful and, you know, going back to the example, you know when I read the newspapers like you guys do, you know I'm learning new things like I wasn't surprised but was pleased that a warm reception for Afghan refugees seems to be a bipartisan kind of agreement I mean, that is an article in the New York Times about it I'm not, I don't know anything about it but I don't find that surprising more than half of all American households donated to earthquake relief in 2010. So I think just assuming that, you know we're facing a hostile nation it wasn't hostile, it's not hostile to, you know Obamacare or universal healthcare, you know because some politicians are hostile to it doesn't mean the population I don't even like using terms like general population so some of the insights I have are not just from the implementation side and again, a lot of vaccine rollouts on top of much more complicated endeavors but also the experience of being in that strange place between academic medicine, the day job and working with implementation agencies which is the volunteer work I've seen over all these decades some pretty remarkable acts of generosity including some that were unprompted or unasked for so I'm thinking we should adopt this multi, you know what Brooke point put in the chat we should be fighting for all of these things at once in coalition with lots of other groups and at the end to assume not the best not to forget history but to understand, you know who's opposed to this and why, who's for it and why and not because we would give up our opposition to the opposition but rather because we're trying to move forward this very complex set of interventions so again, I don't want that to sound milk toast in any way I just have been more impressed sometimes by the opposition that comes from within academia or public health circles I mean, it wasn't the American population that was saying no, you can't treat AIDS in Africa doesn't work there it's not cost effective, not sustainable, not prudent that came from experts often within universities or think tanks or in multinational bureaucracies and that was a bigger obstacle in my view than some of the other ones we saw Thanks for sharing all that Professor Farmer, I think what really stood out to me is what you said is, you know it's not necessarily vaccine hesitancy on the ground but it's the hesitancy of the powerful to share what we have it seems kind of crazy when there's thousands of people dying around the world from this leak, you know from this new virus that that is, you know where the hesitancy lies and but that's what we're seeing and so and professor will let you referenced how there may be, you know the possibility of utilizing tools to compel tech transfer including things like you mentioned the utilizing the existing IP that the US government has to, you know to compel additional technological secrets to be released so that manufacturing can be scaled up and supplemented with funding could you talk a little bit about how you see that could play out and what that may look like recognizing that it is, you know something that hasn't necessarily been done but we are in unprecedented times. Yeah, so I'm not sure exactly what it would look like I mean, I think it's worth recognizing that the patent landscape here like if we're focused on patents as opposed to other kinds of IP the patent landscape is really complicated and like it is that's true for most biologic medicines that there's a lot more patents on each one than on small molecule drugs it is probably true that both the Moderna and Pfizer vaccines are from a patent perspective infringing many more patents than those that are owned by Moderna and Pfizer and that the issues of like who's gonna have liability for that are gonna be worked out in litigation than years down the road. I don't think that any of those patents that are being infringed by Moderna and Pfizer or that would be infringed by a new manufacturer are a core hurdle to manufacturing in the US, a court isn't going to grant an injunction against one of these manufacturers just given the test under patent law like when you would grant an injunction versus awarding damages and how you calculate those damages that they're not going to in the middle of a pandemic enjoying a stock production of a new manufacturer whether it's Moderna and Pfizer or someone else. So in that sense that like patents are really about how the financial awards of this are going to end up being distributed among all the people who made scientific technical contributions to the mRNA technology. And I suspect that those issues are gonna be worked out in litigation for years to come. And some of those patent rights are owned by the US government. The US government has historically not done a lot of vigorous enforcing of its own patent rights. It's through things like the FIDOL Act and Stevenson-Widler Act use patents as a incentive for developing new technologies. This is something I've written about in my other scholarship I'm thinking about like does it make sense for university researchers who are publicly funded to have patents on that publicly funded research and in limited circumstances where the public sector isn't involved in developing that maybe so but it's not the only option and it's not clear that like granting that the US not being more vigorous and using its patent rights to focus on actually expanding access rather than not doing anything with them but that's the right approach. Maybe to build on that, would you say that it was a question from one of our audience members as well and it kind of goes back to the financial implications that we were talking about if there really is a perceived hurdle with the patent itself, could buying the patent itself just be a potential method for eliminating that issue altogether and increasing access to technologies? Yes, absolutely. If there were a patent that were a key hurdle like it's not clear to me that there are patents that are key hurdle like as I said I think that the key hurdles are the trade secrets and know-how and like physical supplies that are needed and that kind of IP is what we need transfer of but absolutely we could buy a patent and I've seen some scholars say like the US government should just like buy out Moderna completely and release their vaccine recipe like using that. And again, I don't know what the best answer is here like I think this should be guided by what is the fastest way to expand capacity and I don't think it is obvious like what the right answer is in terms of the many policy options for getting there. Professor Farmer, do you have any thoughts about this and what can be prioritized as well as in addition it sounds like the potential role for frontline health providers and advocating for the equity piece of this and that making sure that we're doing everything we can as researchers, academics, frontline doctors recognizing the justice issue and how it also end up eventually affects us as well. So... Well, I mean, first of all, I just wanna say again to Lisa in front of everyone, that kind of humility we need more of that in policy circles to acknowledge that we don't know what the unanticipated consequences of a policy are, we don't know even here which levers to pull to get the result we want, which is expanded access. So if that is the case and it's refreshing and true to hear it, then we really do need a multi-prong advocacy approach and implementation approach. Obviously, if you have advocacy not linked to implementation and you get the critics also saying, see, we told you that they didn't have the absorptive capacity. Another expression that deserves deconstruction. So I can, you can tell already that my experience or my views on this have been shaped by previous decade struggles for health equity and whether that's gonna be something everybody agrees is a novel technology or something like an unconditional cash transfer, right? That people are very keen not to patent. We can't just focus on one part of this. And again, I'm lucky because I was in Haiti last week and I expected to hear a lot about the political situation and did not. Again, I was in the earthquake zone or at the hospital, but I'm just saying my colleagues and friends and former students were all focused on the earthquake response and not on the political situation. And even then, one of the first things I heard in a hospital that was badly damaged in the earthquake was how can we get the staff vaccinated? So again, I'll bet there are already a bunch of papers on vaccine hesitancy in Haiti and its relation to Voodoo or something like that. But what I have seen again and again, whether it's Sierra Leone or Rwanda, which is so well organized or Haiti is we're nowhere near meeting demand. So the short-term demand is gonna come from already manufactured doses if we're concerned with those people who are in harm's way right now. And an event like an earthquake or a storm, there's so much social mixing that goes on. Obviously you're talking about the destruction of buildings and people getting crowded into other buildings, but these are all related to the future shape of the pandemic there as well. And I think it's okay that we keep going back to new variants and saying, well, if we don't hurry, we're gonna have more bad surprises. That's true too. Well, thank you for reminding us that natural disasters and local strife and calamities do certainly impact the sentiment and kind of what people are thinking about and responding to. And you mentioned the multi-pronged advocacy approach that would be necessary here, paired with the distribution and logistics. And could you, and I sense that you're reflecting on the tremendous advocacy that was required to make treatment for HIV and AIDS accessible and affordable and kind of the decade that that really, the decades over which that played out. And so- It's important to add that in the majority of places where the national AIDS treatment program is effective, it's not sold at all. It's a public good for public health like a vaccine, you know, or like these vaccines. And as Lisa said, it's possible to reward manufacturers quite handsomely without having the cost passed on at the point of service, that's what makes things work. And if you wanna do complex economic analyses about people going back to work and caring for their families, I mean, that's one of the great things about working the same place decade after decade. You see your former patients who were dying of AIDS and TB 20 years ago and now they're not, right? So the return on that, it just is huge. And so it will be with COVID. But the components I'm talking about are manufacturing on continent, particularly I'm talking about one continent, but I'm sure others will know more about other continents, right? We don't even have enough manufacturing capacity here to keep up with the promises made if I understand it or at least the broad outlines of the other components, one of which is COVAX. Like, do we really wanna get rid of COVAX because it's not performing as well as we think it should or do we wanna improve the performance? I would go with the latter because, as a number of WAGs have said about the World Bank or the UN, if you didn't have them, you'd have to create them anyway. And so although I have very limited faith in a lot of these multi-lateral endeavors, they're important. Like the Global Fund to fight AIDS, tuberculosis, malaria is very important even though we also had PEPFAR, which was not a multi-lateral, but a bilateral program, right? Between the United States and a partner government. So manufacturing, much neglected, COVAX. And again, I'm suggesting that if you're on the receiving end of vaccine diplomacy right now, that must feel pretty good to patients, staff, the elderly, I've read these things that you've all read, like how many ministers of health in Latin America got canned this last year, as sometimes for advocating for a vaccine for their mother, elderly person, right? A minister of health, I think in Peru or Ecuador, one or the other, they went down for that, right? And it's a good thing to fight for a vaccine for your elderly mother, right? Too bad she's the mother of the minister of health in the eyes of the population, but I'm saying to me, that's also a problem. We need to be advocating, and this is the case for boosters. Like I don't wanna feel guilty if I'm telling patients of mine from the United States who have immune deficiency and not necessarily HIV disease, but just some other reasons. When you get into my age, you find plenty of reasons. I don't wanna feel bad about saying, hey, booster probably is a good idea if you're not mounting an adequate response to the first two doses. So I'm saying, I wouldn't write off vaccine diplomacy. I mean, it's always a tool, that's what diplomacy is to represent a state, but we can be clearheaded about this. And then finally, all of this talk about the obstacles to rollout. We should be saying, okay, yes, those are obstacles. Here's the freezer you need to do that. Here's the money you need to pay the community health workers who should have been paid anyway to help with the rollout. Here's some things we need for the communication to be effective. So I think we can do all that. And I think as Brooke Baker said in the chat, I think the activists behind this, and I count myself as one of them, are aware of the, and I didn't even mention the therapeutics, but other people are gonna mention them, right? Your elderly mother gets sick, you're gonna be asking about monoclonal antibodies, right? And why shouldn't you, right? That's why everybody's obsessed with hydroxychloroquine and ivermectomins is because people are getting sick every day and getting really sick and the sick always seek one thing and that is care. Yeah, powerful words. And it's like you said, it's clear that we need both advocacy and diplomacy here. I do also wanna share, there's been quite a few comments in the chat. So if folks haven't had a chance to look at that, I would recommend it, but I will say that Professor Chris Morton has chimed in and shared a couple of articles that talk a little bit more about the US government's authority to negotiate a new agreement potentially for a tech transfer from Moderna to the WHO utilizing their existing license for the vaccine that they have. And he also shares a couple of additional steps here that we had talked about as well with the Defense Production Act, as well as additional authority under HHS and Moderna contracts. So thank you for sharing that, Professor Morton, as well as multiple articles for folks to reference that could discuss this a little bit further. So I wanna take a moment to just kinda thank you both for the time and for this interesting conversation, engaging conversation. And we do have about 10 or 12 minutes left, so I'd encourage folks to continue sharing any additional questions that they have. And there's a question in the audience about going back to COVAX and how we talked about it's incredibly important to kind of maintain a system that was designed to make vaccine equitably distributed, but that the goal initially was 2 billion doses in this first year. And so are there any, what would it take to reach that goal this year in particular? Given where we are somewhere around 230 million. So I'd say that to Professor Wollett, maybe you can share some insights first and then we'll go to Professor Farmer. Yeah, it's a great question. And I'll say again, I don't know what the best way to reach that goal is. I don't know if you offered a contract if you told Pfizer or Moderna or other manufacturers, like if you get this many doses by this time, like whether that would be sufficient incentive to spur additional transfer beyond what's happening now or whether, I mean, that this year is rapidly running out. So like the time it takes to get new manufacturers online is hard to ramp up production too much in that time. But I also don't think we need to focus just on like what can we do by the end of this year? I think it's, as Dr. Farmer said, like looking at all of these strategies that and because we don't know which one works, like we should be pursuing all of them and we should be like both making sure that we are getting as much manufacturing from these manufacturers as we can and that we are doing what we can to where there are new firms that want to manufacture that they're not facing bottlenecks, whether those are IP related bottlenecks or materials bottlenecks or financial bottlenecks. And that overall, as I said before, the amount of money we have put at this problem has been like tiny compared to the social costs of the pandemic and that like we should be willing to spend more to make this happen. Thanks. Thank you for sharing that, Professor Farmer. Any thoughts about this? I just, as they used to write in the notes at the Brigham so that the attending physician didn't have to do the work that the infectious disease fell that I would say about Lisa's comment, agree with above. Yeah, and it's so important in this crisis to keep all of those avenues open. And again, this is another reason to have a broad based coalition. And I think the major gains in global health equity, and of course that doesn't mean far away. It means Alabama, Massachusetts, everywhere else, even Silicon Valley. So global health equity to make an advance in a desired social goal like ending apartheid, fighting back against Jim Crow. These have always required social movements. And I know that some of us are very interested in patent law and how it affects access. Others are not, but they may be interested in drawing on the kind of sentiments that appeared to have inspired PEPFAR as opposed to only the fear factor. Like if we don't do it now, if everyone's safe, no one's safe, the mutants are gonna come get us, whatever. Those should be echoed and amplified to the extent that they're true. But there's a lot of other things that could drive this agenda forward. And if we saw, and Alakland made this point in the chat, if we see a broad based movement, and it's not unthinkable, right? It's the first pandemic in a century like this. Everybody's lives upended. Most people know someone close who died. I mean, I have family who died of COVID. And most people in the United States probably are not that far away from direct familiarity, a rank familiarity with this disease. And I'm just saying, I think there are lots of other things to draw on besides the policy toolkit. And that's what we're talking about a policy toolkit that does not forget organizing, learning from other people and other lived experiences and sharing. That's the moment calls for a very broad based response. It is the economic, political and environmental catastrophe that we thought it would be and then some. So I really want us to keep that alive too. And that's true for academics. I mean, if we're gonna get involved in advocacy, we might as well reach broadly beyond the traditional circles in which we move. I agree with all of that. And can I just add that I think one thing policymakers and academics in particular should be focused on that we haven't talked as much about is thinking about how to get answers to these questions about what policies are most effective. And that applies both in policies for expanding rollout. I mean, I talked about that in a small scale randomized trial my colleague Dan Ho is doing in Santa Clara County and trying to expand testing and vaccine rollout. It also applies to like figuring out what works in terms of vaccines and therapeutics more broadly and like the amount of waste we have had since the beginning of this pandemic of spending a lot on giving people drugs that like aren't in the context of any kind of trial where we can learn whether that's actually effective. It's a heartbreaking amount of waste we've spent there. And there are some examples like my co bloggers and I have written about the UK's recovery trial and the way that that use took advantage of the UK's system to have to learn more about treatments because it was more centralized and able to work quickly and able to have randomization them. But like clinical trial design like can we learn from this pandemic in a way to have better, more flexible platform trials in the future so that we're not wasting as much the next time we're dealing with a pandemic or for the rest of us. Yeah, thank you both for sharing that. It's clear that thank you Professor Farmer for making that clear call to action to all advocates really of not all levels of the community and the population really in the United States to really push forward the push the US government to do its part and make the financial investments and really show the global leadership that's clearly required to help coordinate this tremendous response and to utilize really the measures that are existing in place internationally to really make some significant progress. And I would just add that with the UN General Assembly taking hold in very soon in New York, actually I think believe it is virtual but with that act coming up and the meetings coming up it's a tremendous opportunity really for this advocacy that you mentioned. And there have been quite a few groups as you mentioned the broad coalition that have historically and currently continue to elevate the conversation and really push for this change but certainly more and more the more diversity and the broader base of this coalition as you mentioned for a social movement would be tremendous. So some of those groups include like HealthGap and the university's Allied for Essential Medicines and ACT UP which is a tremendous particularly during the AIDS coalition during the AIDS pandemic and many others who are really engaging in that work. So thank you both for sharing that and certainly Professor Wollett and there's no question that the post-mortem on this pandemic and learning from the failures of our health system, of the distribution, the rollout there's gonna be, there is a tremendous need for that as well and I really do hope that there is gonna be significant time and resources invested both from academics but also from agencies and other independent groups to really rigorously evaluate what we did, what went well, what did not go well how can we really prepare for the next pandemic but also how can we do better in the short term? And so I just wanna give both of you a chance here to share any final parting thoughts as we kind of close the session. So I'll go to you first Professor Wollett. Yeah, I guess my parting thoughts were part that we should be thinking about the next pandemic and designing our biomedical innovation systems in a way that's trying to better align the things we are funding with the things that are actually contributing to people's health and social value and recognize that we can fund innovation and provide broader access and that we should be working on policies that can accomplish both. And Professor Farmer. Well, again, agree with above. And it's clear and I really liked Lisa's slide of the Time Magazine cover and then pointing out the date. And those of us who've been academic Cassandras and prophesying this for a while are certainly not feeling in any way satisfied. You know it had to happen. I think if I were to underline one last thing I would go back to the caregiving and care question. First of all, this is a caregiver's disease. You know, it spreads in families. It spreads in clinical settings where there aren't is an adequate PPE. So that was true also of Ebola, right? But what we never really got out of the Ebola story was how hard people fought to save their family members their parents or children, their neighbors, you know and that's how the transmission occurred with Ebola. And here again, we see a catastrophic loss here in this country and also uniquely poor performance. More Americans and again, we're talking, you know we're linking up to American universities. More Americans are aware now of the, you know implications of mean spirited policy than ever before. And so I think remembering that this is about caring for other people, whether that be medical care or protection with a vaccine or safe policies in buildings or purifying upper air in a room whatever it is, you know, it is about caring. And, you know, we also have to think about the caregivers. I can tell you that many are very tired, you know and, you know, worn down by this. So the coalition I'm talking about is and I know you weren't saying, we're saying that it's gonna be just about the UN General Assembly. I'm talking about women's groups, teachers unions, Boy Scouts, Girl Scouts, you know all labor unions in general civil society including universities and students, you know getting on board for a much more, a much broader take on this, you know if the United States government wishes to be known for having, you know, taken extraordinary steps to stop the pandemic to the benefit of the whole world then it would have to act very soon to catch up with even the long-promised objectives. Thank you. Thank you so much for that. I wanna turn it to Professor Kesselheim. Well, thanks to all three of you for a really great discussion for the and I've really learned a lot in the last hour and a half and we are over time. So I will let everyone go and hope to see people back again next month. But again, thanks to everybody for taking the time to talk to us today.