The COVID-19 Vaccine Rollout

The COVID-19 Vaccine Rollout

Jeenah Moon/REUTERS
from State and Local Webinars

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United States

Coronavirus

Public Health Threats and Pandemics

State and Local Governments (U.S.)

Pharmaceuticals and Vaccines

Vin Gupta, chief medical officer of global COVID-19 response at Amazon.com; Margaret (Peggy) Hamburg, former commissioner of the U.S. Food and Drug Administration; and Clarion E. Johnson, co-chair of the public-private partnership initiative of the National Academies’ Global Health Board, discuss the COVID-19 vaccine rollout across the United States.

Learn more about CFR’s State and Local Officials Initiative. 

Speakers

Vin Gupta

Chief Medical Officer of Global COVID-19 Response, Amazon.com

Margaret (Peggy) Hamburg

Former Commissioner, U.S. Food and Drug Administration

Clarion E. Johnson

Co-chair, Public-Private Partnership Initiative, National Academies’ Global Health Board

Presider

Irina A. Faskianos

Vice President, National Program and Outreach, Council on Foreign Relations

FASKIANOS: Welcome to the Council on Foreign Relations State and Local Officials Webinar. I'm Irina Faskianos, vice president for the National Program and Outreach here at CFR. We're delighted to have participants from fifty U.S. states and territories with us. We thank you for taking the time from your busy schedules to join this discussion, which is on the record. As you know, CFR is an independent and nonpartisan membership organization, think tank, and publisher focusing on U.S. foreign policy. Through our State and Local Officials initiative, we serve as a resource on international issues affecting the priorities and agendas of state and local governments by providing analysis on a wide range of policy topics. CFR is also the publisher of Foreign Affairs magazine. We are pleased to have with us Drs. Vin Gupta, Peggy Hamburg, and Clarion Johnson. We previously shared their bios, so I'll just give you a few highlights.

Dr. Vin Gupta is a critical care pulmonologist and chief medical officer of Amazon.com's global COVID-19 response. He is also affiliate assistant professor of health metrics sciences at the University of Washington's Institute for Health Metrics and Evaluation. Dr. Gupta is a deployable critical care physician for the U.S. Air Force Reserve Medical Corps and a term member at CFR. Dr. Peggy Hamburg was the twenty-first commissioner of the U.S. Food and Drug Administration. She recently retired as foreign secretary for the National Academy of Medicine and completed her terms as president and board chair of the American Association for the Advancement of Science. Dr. Hamburg held previous roles as founding vice president of the Nuclear Threat Initiative, health commissioner for New York City, and we're fortunate to have her serve on the CFR Board of Directors. And Dr. Clarion Johnson is co-chair of the Forum on Public-Private Partnerships for Global Health and Safety at the National Academies. Previously, he served as global medical director of Exxon Mobil Corporation and remains a consultant to the company. He sits on numerous boards and has the U.S. Department of Health and Human Services appointment to the National Institute of Occupational Safety and Health Advisory Board. So welcome, Drs. Gupta, Hamburg, and Johnson. Thank you very much for being with us.

We are now ten months into the coronavirus pandemic in the United States and around the world. And fatality rates here in the U.S. are higher than they have ever been. This is obviously an immensely difficult time for our country, and we look forward to hearing your thoughts on the vaccines that have received Emergency Use Authorization from the FDA, what's on the horizon, and the challenges we face on distributing the vaccine. As we know we've gotten off to a slow start here in the U.S. So, Dr. Hamburg, I'm going to turn first to you to talk a little bit of the process that these vaccines have gone through to get the FDA approval and what else is on the horizon. I know there's several more on the verge of breaking through. So over to you.

HAMBURG: Great, well, thank you very much. It's a privilege to be part of this distinguished panel and always enjoy working with CFR and, you know, really so glad to engage with state and local officials and people working on the frontlines. Because that's, you know, where we really make the real and enduring difference because even though tremendous things have happened developing the vaccine, making sure it actually gets distributed to those who need it and gets used properly is what will make the difference in our ability to control this devastating pandemic. So let me talk a little bit about where we are with vaccines and what to expect. I'll try to be brief so we can have lots of time for Q&A.

But it has been a remarkable achievement, really the scientific research and development community has come together across disciplines, across sectors, and across borders to really move the science forward in remarkable, unprecedented ways in less than a year from the time that the virus was actually identified in its genome posted on the web by Chinese scientists. We actually had developed a range of vaccines that some of which are now authorized for use in this country and elsewhere. As many of you probably know, vaccine development normally takes a long time, often a decade or more and it's done in a very staged way with sort of pauses in between to sort of assess. It can be a high-risk undertaking; a lot of vaccines fail. And it can be a costly undertaking. But in order to respond to the demands of this unfolding pandemic, the regulatory authorities, like the FDA and the research community, both industry and academia, really worked quite closely together to design studies that could accelerate the process and compress the normal stages of vaccine development without compromising safety and efficacy. And so we have seen a number of vaccines in development in this country and beyond.

Right now, there are over hundred vaccine candidates that are in the pipeline in animal studies. There are about twenty that are in the final stages of large-scale testing here in the U.S. We have two vaccines that are authorized for use, and we anticipate a third probably being authorized when the full data analysis is done later this month, early February. That's the Johnson and Johnson vaccine, which actually is a one-dose vaccine—the others are Pfizer and Moderna. You've all been hearing about this. And there are two-dose vaccines with more complex supply chains, as well, requiring, you know, significant freezer storage and transport, especially Pfizer, and they are using a completely novel technology what's called messenger RNA or mRNA. In the course of development in this country and other countries, there have been many different categories of vaccines that are being developed, and that's been a good thing. First of all, we didn't know which types of vaccines might work most effectively and prove safest, but it's also good to sort of diversify your portfolio because there may be vaccine types that work better in certain subpopulations or others. So there's a huge enterprise going forward and huge progress that's been made. As I mentioned, here in the U.S., two have been authorized for use. This is not approval. This is an Emergency Use Authorization, which is a specific category that's been developed in, you know, fairly recent times in response to the recognition of public health crises, either naturally occurring or deliberately caused where you may really need to move products out when you don't have as much information about them as you might like, but you can assess the relative risks and benefits. And that's what has happened here. But there will be continuing study of these vaccines, even the ones that are going out for use as we speak with more data collected as part of the final approval process.

And it's important to also recognize that as part of really making these vaccines real in terms of getting them to the people that you are working with every day in states and localities, the distribution of these vaccines is crucial to get them where they need to go to make sure that people get their second dose of the right vaccine in the right time frame. And also from the perspective of a regulatory authority like the FDA, the ability to track who's gotten vaccine and monitor their real-world experience with the vaccine in terms of deepening our understanding of efficacy, how well-protected our people. We know that the vaccines that are authorized for use now reduce severe symptoms and serious disease, but we don't know for sure how completely they protect against infection—asymptomatic infection—and the ability to spread. We need to learn more about that. We also need to learn about the duration of protection from these vaccines and will we need annual boosts or will they last longer. And so all of that is critically important and, of course, the ability to track and monitor for any emerging safety concerns. So far, these vaccines that have been authorized show remarkable efficacy. Far higher than I think any of us expected of, almost 95 percent. The FDA had set a bar of 50 percent, which everyone recognized wouldn't be desirable, but it would be adequate in a situation like this but much, much higher. And the safety issues so far that have been identified really are part of the initial exposure, the reaction to the vaccine itself in terms of pain at the site, some fever, headache, fatigue. There have been some reports of more serious anaphylactic reactions that have responded well to epinephrine but really quite remarkably safe so far. But as more people take it, we want to monitor and learn more. So I guess that's a good sort of opening, I don't want to talk too much longer and happy to answer questions you may have.

FASKIANOS: Terrific. Let's go next to you, Dr. Gupta, to talk about the misconceptions that you're seeing about these vaccines. You're on the frontlines in the ER and how you think we should consider the outreach to get the general population to accept receiving them.

GUPTA: Absolutely, Irina. Thank you. And just to amplify what Commissioner Hamburg mentioned, really just an honor to be here with such distinguished co-panelists. I'll touch on a few things. One is, I know, Dr. Hamburg mentioned vaccine efficacy, so what are the clinical trials showing us in terms of the ability of these vaccines to avert severe illness leading to the ICU? And then the concept of vaccine effectiveness, which I'll touch on here, which is what actually happens when you deploy these vaccines in the real world and really issues of how people are conceiving of their trust in these vaccines and the scientific process that undergirded it, and what are those issues, to the behavioral ones that are really going to impact vaccine uptake? I'll touch on that. And then I'll briefly touch on just operationally the challenges of scaling vaccination, in my case for a global workforce for Amazon, and what that might mean for those listening in and for your communities.

And so, to start with, just putting on my clinical hat, I'll say that what I've heard the most from patients, from people that reach out, is why should I get this vaccine? And was the process of R&D politicized, and did that in any way impact the quality of this vaccine from an efficacy standpoint, so averting serious illness? And Dr. Hamburg already touched on that. These vaccines are remarkably efficacious when it comes to actually preventing really terrible pneumonia that would lead you to see somebody like me in the intensive care unit. And that's really what we want. The issue that's challenging that a lot of us are perceiving is, well, if you get the vaccine, does that mean you don't have to socially distance or mask anymore? And can you get on a flight to Hawaii and start planning your vacations? And I think that's going to—I'm at least noticing that from a workplace health and safety standpoint, that that's a really difficult message. People want to get the vaccine so then ten days after the second dose, if it's a two-dose regimen, ten days after that second dose they can normalize their life. And right now, we just don't know. There's a lot of uncertainty on whether these vaccines protect against transmission as well as those serious impacts from the virus. And it's really hard to, you know, I think about this often, and it's hard for me to sort of conceptualize that. I can only imagine how hard it is for individuals are not immersed in public health all the time to think about that. How does a vaccine protect against severe manifestations of the disease but not asymptomatic transmission?

We're learning more as we speak. Moderna, when they presented their vaccine for Emergency Use Authorization, in the briefing documents there was an appendix that talked about the efficacy of their vaccine to avert this asymptomatic transmission phenomenon, this carrier state. And it looked like it was reasonably efficacious. We think that that vaccine actually might be active against mitigating transmission in addition to protecting against severe illness. But we don't know that yet, for sure, which is why it's really important to continue to mask, distance, avoid non-emergency activities like travel for leisure. But that message is sometimes hard for people to understand and to accept. And then what I've noticed at least is that the question that naturally comes to all, is why should I get the vaccine if it's not going to allow me to normalize life? And so messaging on that is going to be really important at the local level, at the state level, and just amplifying that same consistency until we learn more. So that's one.

I will also emphasize that there are, just in general concerns, about, well, what vaccines should I get? Should I get Moderna? Should I get Johnson and Johnson? Why can I wait for the Johnson and Johnson one-dose vaccine, I'd rather get one shot than two? And this notion, can somebody choose? Or is there one set of vaccines that are better if you have a certain underlying pre-existing condition? And the truth is, at least the guidance I've been giving, and I know most of my colleagues in public health has been giving, is get the vaccine that you're eligible for as soon as possible and that's the most important piece. But people are discerning and are asking these questions, and I think we're going to learn more about the comparative performance of these vaccines head to head, and we might be able to get more nuanced guidance. But right now, because we have rationing of supply, it's really, the message to individuals across the country should be get the vaccine that you're offered for as soon as possible whenever you can get your hands on it.

And then I will just quickly say that what I'm noticing from a global and a national lens is the following, at least from putting on my Amazon hat. Countries like Dubai, for example, several countries across Western Europe, they are actually owning the entire process of distribution of the vaccine at the federal level. And so as a private organization, we are essentially recommending our employees in those various countries to follow their national guidelines and go through whatever process has been put in place. It's very different here in the United States as everybody here knows on this call where just like state and local governments are trying to assemble their own strategies for distribution of the vaccine, large private employers are having to do the same thing. So we are tasked to the United States to partner with CVS, Walgreens, or third-party clinical groups to procure our own vaccine supply and to make sure our essential frontline, couriers, and associates are protected. And so the onus is very much on private employers, just like it is on state and local governments to do the job of distribution. I think that's going to change with the incoming Biden administration, of course, but there's very different strategies being employed globally versus nationally, and I think that's just illuminating about the challenges ahead for us.

FASKIANOS: Thank you. And I'm going to turn now to Dr. Johnson to talk about the role that public-private partnerships are playing and should play in distributing the vaccine.

JOHNSON: Thank you very much. And again, I would like to start by saying it's an honor and a pleasure to be here and to be part of a panel like this, which is really focusing in on state and local government officials and what they need to think about. And I'm going to also bring up three cases that I think serve as examples. But first of all, before you convene a group, you have to believe. You have to believe that what you're doing is the right thing to do. When I think about the fact that 6.5 million or so people don't get smallpox because we have a vaccine, people since 1980, 2.5–2.6 million people a year, don't die because of measles, that means a lot. In fact, if you look at it and combine all the vaccines together, we save about one person every six seconds in the globe. So I believe vaccines work, which I think is incredibly important.

Are there examples that show how people can reach out? Let's begin by starting with a university. Yale University had the opportunity to come out with their School of Public Health with something called SalivaDirect, now used by the NBA for its players, etcetera, etcetera. That broadened their reach, gave them luminescence in the community. That led to contact tracing, that led to interacting with other aspects. And let me begin by saying one thing that's been alluded to—public health. Public Health is extremely important. If this were a movie and we were going to bring up public health, we would say, "I know a guy." Okay, public health makes things happen. I mean, they think quantitatively and in business arena, that can be extrapolated to the ROI, okay, on what you're investing in what you're going to get back. But Yale has used that opportunity to really work and to those who are challenged financially to just one aspect of your community. So again, that's an academic institution that's done well, and that's just one. You look at the University of Chicago that's worked with Moderna, but there are lots of academic sites.

Another instance I would like to use is a company that just came out and said, "We're going to do something because it's the right thing to do." And that would be Medtronic. Medtronic just came out and said, "We're going to give you our respirators." The patent for their ventilator. They just distributed their patent for their ventilator—250,000 people have downloaded that patent. So that means my Uncle Ralph and my Aunt Ellen, all [inaudible] in the vacuum cleaner business are maybe making ventilators on the side. I don't know. But it's a possibility that that's going on. But again, it reaches a broader population of people. Those ventilators were used at the Javits Center when they decided in New York that they might have to expand. Not only that, they added two other additional elements. They brought into play a remote adjuster of the respirators so when the people who were monitoring them and managing them, the technicians didn't have to go into the room with the patient. That was new. They also set up a system whereby they would train people how to use ventilators. So again, we're talking about a company that did something that was very positive.

But what do you need? If you had to ask what are the seven things before you sit down in a public-private partnership, I think Dr. Sands really brought this up and that is that you need seven things that I counted. You need the scientific, you need the clinical, you need the logistical, you need community, you need human rights, you need to think in terms of behavioral aspects, and the communication facets of any of the problems we have, whether they're local or global. So again, it's not an easy proposition, but it really requires understanding your constituencies, those that are in politics. [Inaudible] has always pointed out the fact that people who are voted in and out of office may not be there, may not see it in the same context you do, but you've got to remember them. And you cannot, you cannot forget that these are people. Now one of the things I would have to say as a Black physician, and I'm in the Moderna study group, is that one of the side effects is when you come home and tell your family that you volunteered for a vaccine study, they’ll say, "You did the what?" So again, I've had to live with that. Again, but I think it gave me some credibility when I volunteer on a public-private partnership that I'm involved in every week. I volunteer at a free clinic where 80 percent of the people speak a second language, and I need to convince them that a vaccine is important with all of their concerns. And lastly, I would say that in the international arena I had an opportunity to put together a program, which actually stopped first tests, caused no deaths for several years, and stopped very simple thousand cases of malaria, again, which is a public-private partnership with companies in Scotland, the French army, and others. So again, it can be done. You need to know the players and when you sit down to do it, realize that you need to listen. And I'll stop at that. Thank you.

FASKIANOS: Thank you all. That was terrific overview and now we can dig in and get to everybody's questions. You can raise your hand icon on your screen. When you're called upon, please accept the unmute prompt and state your name, affiliation. and your question. You can also put in the chat. I see a few in there right now. I may just call upon you to state your question yourself. So I'm first going to call upon Mayor Kathy Catazaro-Perry and she's the mayor of Massillon, Ohio. So if you can unmute and ask your question, that would be great.

 

Q: Hi, good afternoon, everyone. Can you hear me?

FASKIANOS: We can.

Q: Great. Well, I'm a nurse, my husband is a physician as well, and we live in the state of Ohio. And I would like to know, we're really frustrated, we have the opposite. Our people want to get the vaccine. We don't have enough and so we just had eighty and above that we're allowed to give the vaccine to and people were calling—one of my residents said two and a half hours to our health department—trying to get an appointment and when they did get through all the appointments were given away already. So I just want to know your thoughts on the rollout of the vaccines to the different communities throughout the nation.

FASKIANOS: And I'm not sure who to direct this question to because I know you all have thoughts and have different insight into it. So maybe since this is, I think this is universal across states that people are anxious not getting it, maybe you can each give your perspective to something like that. So Dr. Hamburg, why don't we start with you?

HAMBURG: Okay, great. Well, thank you for your comments, and, you know, it's just frustrating for all of us, I think, to see this incredibly valuable public health tool not getting out as rapidly as it needs to. And it's encouraging that people want it. You know, stepping back, it's remarkable how fast it's gone and that there's as much vaccine as there is. And that's because, you know, there was huge public-private investments in making large quantities of vaccine. You know, tens of millions, hundreds of millions of doses, even before we knew which vaccines would be successful and authorized. But that doesn't give comfort now when we, in fact, don't have enough to meet demand and we don't also have a distribution system that's adequate to get it where it needs to go and there hasn't been enough clarity about what to expect on the ground. I think that efforts are definitely underway to try to address both increasing volume and there are negotiations underway to enhance manufacturing of the existing authorized vaccines, and if another vaccine comes into the marketplace pretty soon, that will help—the Johnson and Johnson vaccine I mentioned. And there are several other vaccines that look promising that won't be that far behind, we hope. So that will definitely help. But we really do need a much more coordinated system in terms of how much vaccine there is, where it's going. You need to be able in your community to know what to expect, you need to have a system to be able to align what's coming with the people who want it and, you know, hopefully an interoperable system so that you can be making appointments and letting people know where they are in the queues, so to speak, with some certainty. But that kind of a system will also enable us to make sure they get their second dose and to make sure we can do the sort of tracking I mentioned, the pharmacovigilance, to make sure that people who get vaccine are, you know, doing okay to learn more about the real-world experience and any concerns that may need to be addressed. So we really need a plan that's laid out very clearly that's integrated, starting with thinking about what's needed on the ground locally in terms of the context for actually delivering the vaccine but working all the way back to matching supply with what's needed on the ground. And we can only hope that it will get better, and the feedback from people like you is essential in order to make sure that the on-the-ground problems are being addressed.

FASKIANOS: Thank you, then Dr. Gupta, do you want to go?

GUPTA: Sure, Commissioner Hamburg I thought was very comprehensive. So just to add on, I do think hope and relief is on the horizon. And as Dr. Hamburg mentioned, what I'm hearing and just talking to senior officials focused on vaccine coordination and the incoming administration is that they're really going to focus on various channels to get the vaccine out to the public to more people, more eligible groups quickly. And so that hundred million doses in the first hundred days, you're going to see federal dollars go towards investments and just infrastructure. So more clinics at stadiums and community centers leveraging the network of federally qualified community health centers that, generally speaking, serve underserved populations across the country.

That's one, so just having more infrastructure. Then two, train the trainer and other types of programs to get more immunizers out there. You know, ultimately, you don't need to be a health-care professional, in my opinion, to give this shot. You do need somebody to actually oversee it, that’s a trained health-care provider if there's an adverse reaction. But those are ways to not overleverage, say, pharmacists, who we really been leaning on in this initial phase IA to deliver shots and nurses, but to actually get more shots out. You need more people to do it. And so that's going to be part of that as well. And I think that they're keeping an eye towards making sure that there's equity in terms of distribution. So, you know, there's going to be a natural bent towards urban and suburban areas when it comes to vaccine distribution upfront. And so these mobile clinics that I know the Biden administration is talking about, making sure that there's that rural reach, that exurban reach, is going to be vital as well. So it may not feel like it right now, but in the coming two to three months, just to manage expectations, there is going to be a much more rigorous effort that's going to scale and I think allow us to achieve that hundred million doses in the first hundred days with the new administration.

FASKIANOS: And I'm just reading through the chats in the comments and the questions. Lisa George, from New York State Senator James Sanders, "Do you see such things as mobile vans in the Biden plan to administer the vaccine and also using houses of worship and community centers?" Is that being part of their approach?

GUPTA: So I feel like I'm just the messenger here from what I've heard, and I think we're going have more tonight, but yes, that is the strategy that I've heard. Essentially leave no stone unturned in terms of potential sites to safely administer the vaccine. A lot of this is going to be just nitty-gritty details. Where do people park their cars? I mean, I can say this when I've been thinking about our own vaccination clinics in the Amazon world for our warehouse workers, where is there space to actually monitor individuals for up to fifteen minutes? And how do you think about that holding area and making sure you have enough eyes on it that there isn't an allergic reaction, let's say. I mean, those logistical ops details will need to be worked out, but yes, community centers, places of worship, all of these are under consideration. They're really thinking big. I'll lastly say, I feel like the National Guard has been deployed in seven states right now, in forty-three it has not, for some type of COVID response. In addition, there's only so much the federal government can do. They really need state governments to play ball here when it comes to deploying the National Guard. And then I do think that Biden administration should leverage the military branches that they have available to them, the four branches of the military that have tons of medical expertise that can do mobile clinics and that can set up triage tents. I mean, that is the expertise of our military medical branches. I say that from firsthand experience. I just hope they start to leverage those capabilities as well.

HAMBURG: But just to jump in quickly. I mean, I think it's important to understand, and all of you working at the state and local level, I think, do appreciate this, that the federal government can provide critical support, can provide a sort of a framework for action, and they can provide some hands-on activity, but it's the coordinated approach with a sort of mutual commitment amongst all partners to make progress that is really going to provide success. So, you know, at the state and local level, you know better than the feds about what kinds of resources you have, what you can mobilize from, you know, mobile vans to fora that might be suitable for setting up vaccination clinics. You also, obviously, need some financial resources that have been, you know, slow to come and I hope that there'll be more for that as well, because you're stretched so thin. But I think that, you know, it's really this sort of notion of looking at what resources and opportunities you have. Also what special needs in terms of particular communities at risk and then how to align that with what's happening at the federal level. And I hope that the incoming administration will be very, very clear about what they're doing and how and why, because that'll make it easier for all the moving parts to really align.

FASKIANOS: Dr. Johnson, I want to ask you to restate your seven priorities. Somebody asked—we will be sharing the link to the transcript and the webinar after the fact. But if you could just state them again, and then I'm going to go to ask Representative Diane Pauer to ask her question. So over you, Dr. Johnson, and then we'll go to the representative.

JOHNSON: Okay. The seven things that I mentioned were this and I'll try to read them slowly. You need a scientific background, a basis. You need to think in terms of the clinical, the logistical, as just mentioned, and the community. You need to think in terms of human rights, again, churches can play a role in that, the behavioral and the communication facets on distribution of health care. So those are the seven you really need to look at.

FASKIANOS: Thank you. Okay, let's go to Representative Pauer.

Q: Good afternoon, everyone. Thank you for taking my question. My name is Diane Pauer and I am a New Hampshire state representative. And my question has three parts. Dr. Hamburg stated the necessity of tracking people who receive the vaccine in an effort to qualify the vaccines of efficacy, duration of protection, as well as any potential adverse reactions. Constituents of mine are concerned about privacy. So my questions are as follows: I'd like to understand what body is the clearinghouse for this information? Would it be the CDC? Two, what types of patient data will be required to be collected and by whom? Would it be at the state level, federal level, and how will that information be dispersed? And three, I'd like to understand is the refusal to receive the vaccine, would that be defined as a vaccine event and would this be recorded? Thank you.

HAMBURG: Well, that sounds like a question that I should at least start with. You know, it is routine that vaccines are monitored in the real world in order to better understand safety, probably first and foremost, but also appropriate indications for use. And it's done through a number of different mechanisms. The FDA has an important responsibility for ongoing monitoring and monitors databases from patients’ health records and insurance and other things that is de-identified. But it's a large database so you can get information about, you know, emerging issues or concerns or query the database if you need to. Also, FDA works with companies and with patients and health-care providers. Everyone is urged, whether a provider or a patient, to report any unusual conditions that might be related to vaccination. Many reports turn out not to be things happened medically that might coincide with having gotten a vaccine but have nothing to do with the vaccination itself. But things do get investigated and patients that are concerned or their health-care providers report and companies also are doing ongoing monitoring as part of studies they've been asked to do or that are ongoing or because they hear from patients and health-care providers. And CDC also has a vaccine reporting mechanism that they do in coordination with FDA. So those exist and they're always out there in place helping to make sure that vaccines are as effective and used as safely as possible. In this situation, because the vaccine, frankly, has been made, you know, more rapidly than normal in the context of an evolving outbreak and because we are giving it to, you know, many more people in this country and around the world than you normally give a vaccine and much more quickly, the importance of monitoring is really enhanced.

And so, you know, really making sure that we don't lose people through the cracks is going to be more important. And I think it's in the interests of individuals and communities as well as really understanding the science and appropriate use of vaccines, and whether we need to be modifying our vaccines, for example, with new variants of this virus, you know, really are emerging and take hold that might impact the benefits of the vaccine. Right now we don't believe that's the case, but we need to be monitoring that. So this notion of monitoring is, you know, at the individual patient level, but it's also much more significantly at the population level to really understand trends and potentially emerging issues or concerns.

If you refuse it wouldn't be considered a vaccine adverse event, but it would be of concern, I think, in the context of the health-care delivery and public health system and, you know, hopefully, people that have questions about the vaccines will have an opportunity to talk to people that are knowledgeable about the vaccines and people with whom they have a relationship and have trust and confidence. As Dr. Johnson was saying, it's very important that people can go to individuals that they trust and know to get the information they need.

FASKIANOS: So there are a lot of comments in the chat or questions about supply and demand and the demand is outpacing the supply. Do we have a number on how many doses the federal government still has and what's been sent out to the states? Or is that still kind of murky?

HAMBURG: Sadly, it's very opaque and that's part of the problem. You know, clearly, at the get go, there was a disconnect that didn't really make sense and it partly represented, I think, poor communication about what was happening, but also perhaps lags in reporting on vaccinations, etcetera, but where it appeared that more vaccine had gone out than was actually being used in terms of administration. I think, as we've already heard today, those who are on the ground trying to deliver vaccine are feeling frustrated that they don't have the supply they actually need. But I'm not in a position, no longer being in government, to really clarify what the existing supplies are but it's a critically important question. And maybe Vin, as part of his activities, has been better, you know, sense of where we are.

GUPTA: I would just add to Dr. Hamburg's comments that at least what I'm hearing, just especially in conversations with the main clinical providers that are operationalizing vaccination, so CVS, Walgreens, and a few other entities, that they were, to your point, were very much supply constrained. There's been about, I think, just 150,000 individuals, including myself, one of the lucky ones to get the two doses so far. I believe there's about twenty-seven million doses out there, a third of which have been administered. At least one dose has been administered to about a little less than ten million individuals. Dr. Hamburg mentioned the Johnson and Johnson vaccine that's likely going to get Emergency Use Authorization sometime in early February we anticipate, which is going to dramatically make supply chain distribution a lot easier just because it's a vaccine that requires one dose and can be transported in ambient temperatures, room temperature, and then stored just in any typical refrigerator that might already exist at a health-care establishment. So that's going to make a lot of things easier, but unfortunately, it looks like they are supply constrained. We were anticipating hundred million doses by sometime in the late spring, it looks like that won't happen until early to late June. But there is expected to be more doses coming from Pfizer and Moderna. It's unclear how many, but it looks like there's not going to be any issues with getting the second dose in more people's arms since now the second dose is not being withheld. So the actual numbers, though, are not clear.

I will finally say that, at least the employees that I'm charged to protect their health and safety—grocery store workers, couriers, you name it—every state right now has different rules. And so Virginia, for example, is following ACEP guidelines to a T versus, you know, New York State, Washington State, for example, they're doing things a bit differently. And so actually not having fifty different approaches, and the Biden administration hopefully being able to coax all fifty states to follow ACEP guidelines, will make things a lot easier when it comes to vaccine distribution, transparency, following, you know, tracking who has and who has not gotten the vaccine. Because right now, it's one thing to say one cohort should get the vaccine—grocery store workers. But it's another thing to say, well, Virginia is only going to give grocery store workers the vaccine if they're above fifty, but Washington State is going to give all grocery store workers the vaccine regardless of age limitations. It just gets really confusing and lobbying bodies that are trying to advocate for these various different cohorts, it gets complicated quickly. So I think fifty states need to align on ACEP guidelines ideally.

FASKIANOS: There are a couple questions on the science of it, if you have any insight into the research underway for the vaccine for children under sixteen, as well as the effects on pregnant women? I'm simplifying the question, I'm sorry, I want to keep it short. But you—

HAMBURG: I think I suggested it and I think I'm the right person probably to answer it, which is that when the studies were initially structured, certain important subpopulations weren't included in the studies and that included children and pregnant women. Also, the significantly immune compromised. But those are all very important populations in terms of our overall management of the pandemic. So what we need to be doing now, and this work is going forward, is drill down more specifically into those subpopulations to ask and answer these important questions. And that doesn't mean doing huge elaborate studies, you know, with 40,000 people like we went through for this initial authorization, but it does mean doing what we think of as the sort of basic safety and dosing because, for example, with kids it's likely you're going to want to use a lower dose, and then bridging studies to feel comfortable moving them into broader uptake and usage of vaccine. Now, one of the important things here is that we still don't actually know what it is about the components of the human immune response that protect you against this virus both severe disease but also infection, period. And we call that “correlates of immune protection.” But everybody, you know, mount some kind of immune response to some degree or another but, in fact, to different vaccines into the natural infection, the profiles of what types of antibodies and components of the immune system are somewhat different. We really need to do those studies to understand what are the things that really matter in terms of immune protection, and then you can move very, very swiftly in these kind of bridging studies. Because you know what really matters in terms of what that individual needs to show in response to the vaccine in order to know that it's going to have those longer-term benefits and match the experience to date with the vaccine. So there's still important research that's going on. It is underway, and we're going to learn more and we're going to learn more from the actual experience with these vaccines in the real world. And that's why the other work that I mentioned earlier in terms of tracking and monitoring is so important as well.

FASKIANOS: Let's go to Rachel Ventura next.

Q: Yes, hi, my name is Rachel Ventura. I'm a Will County Board member in Illinois, and I'm the chair of public health. And our concerns are that when we vaccinated for H1N1 back in 2009, we vaccinated only fifteen thousand people and had about $2 million in funding to do so. Right now our county has 750,000 people. More than forty thousand have signed up on our survey that we've created for them to get the vaccine. We've collaborated with twenty-two different organizations like Walgreens, the Red Cross, etcetera, to help administer this vaccine. But we are feeling extremely overwhelmed. So I have three questions. The first is, you know, how can we put pressure on the federal government to actually be the ones to help us roll this out? We don't have the National Guard here, but we're the fourth largest county in Illinois. And if we are, you know, feeling underwhelmed, I can't imagine how some of these smaller counties who don't have a health department, for example, or a strong public health team to help do this. And then my other questions are, what other options do we have of working with people to get the vaccines out? And we're thinking about hiring a director of vaccinations to help get this out and if we go that route, is there a pool of people who are best suited for this? How do we find someone that we can hire to help us get this out? And then, of course, the last thing is we're going to need funding. If it costs $2 million to get fifteen thousand people vaccinated, we just can't even begin to fund 750,000 vaccinations. Thank you.

FASKIANOS: Who wants to take that one? You can each answer a strand of that?

HAMBURG: Well, I suggest you start with Dr. Johnson because it's going to require public-private partnerships for one thing.

FASKIANOS: Right. And there is also another question in the chat that I want to roll in and throw at you, Dr. Johnson, about, sort of, the, where was it—which, well, why don't you start answering and I'll find it because it builds on this too.

JOHNSON: Again, I think the best people to really speak the language would be your public health officials as this young lady is and knows a lot about that. I think that that's where you begin to sit down, write down what you need, and who the players you are, who you think have to sit at the table. Again, you may not have the National Guard, but having, you know, my love of working with large groups of people comes from my seven years on active duty when I learned how to treat large groups of people. I would talk to other people in other cities and other towns that may have similar programs, maybe you can coalesce and work together on that. I will also go to universities. What sort of universities you have that are local, what do they have? Do they have medical students? Do they have other people who can help you roll out your program. But do not leave any stones unturned and look to those examples, which may be smaller or may be larger that are successful. Again, and do not—there's nothing wrong with being turned down. Hearing "no" is only a problem if you stop there. You have to keep going.

FASKIANOS: Yes, I found the question from Justin Bielinski, on behalf of Wisconsin State Senator Chris Larson. "There's so many [inaudible] for vaccination—public, private, large health systems, small clinics, etcetera. It's very confusing for students to know how to get vaccinated. Is there one model that you all think works to get people to sign up and vaccinated most quickly. You know, a state-led, a single-stream approach?" Maybe, Vin, with your Amazon experience and the public-private, as well as what you're seeing in the—because you're also in the academic context at the University of Washington and in the health system. So maybe you could bring all those threads together.

GUPTA: Sure. I can just offer my own experience that when, as an ICU doctor, our health system got the vaccine, we were given—the University of Washington uses its own software system to actually send out an email to sign up for an appointment. And then once you do that, twenty-one days later, you're tasked to sign up for that follow-up shot. It's not a software—the software cross talks, I believe, with a central database that the state Department of Health is actively managing so they can keep track, as Dr. Hamburg points out, of who has gotten vaccinated and who has not. And then also, importantly, there's a mechanism by, which I can say, I have had an adverse event. They encourage individuals to actually track what adverse events you might be experiencing. So that that can also be reported up. What I have noticed, and I'll say on my Amazon side, at least, CVS and Walgreens have their own software, and as to other third-party clinical groups that can operationalize vaccination, I mean, just literally doing these clinics and running them in a safe way. From my vantage, this seems really complicated. And maybe this to too simplified and I'd love to defer to Dr. Hamburg on this and Dr. Johnson, but it just seems like we have way too many software platforms, way too many scheduling platforms that we hope will cross talk into one central repository that, say, state DOH is going to look at. But it just seems like a lot of hoops here versus using one standardized software, at least at the state level. And so that seems like the gap, but at least the user interface that I experienced in my own health system was quite user friendly, it made sense, and it allowed for that email reminder twenty-one days later. But there's many different approaches, many different tech platforms and standardization will be helpful.

HAMBURG: And I think we need to simplify, you know, we need to use many different strategies and take advantage of resources that may look different in different parts of the country and in different communities. But, I think, as much as we can we want to make it easy for people. We want clear information about how to get registered and what the vaccine is. We need to try to offer it in places that people can access easily and feel comfortable going. We do want to have these kinds of data systems that Dr. Gupta is just talking about, that lets, you know, try to make them as simplified and aligned as possible. And, you know, we also really need from the federal to state to local level to have that kind of transparency and harmonization of approaches and accesses. Dr. Johnson said to information from other places about best practices, strategies that work, and I think reinforcement of how to do the best job possible.

FASKIANOS: Thank you. Let's go next to Brian Mech, who has had his hand raised for a long time. So we'll go to you next.

Q: Hi, first, I want to thank all of you for your time. It is appreciated, everything you're sharing. I have two questions and they're sort of more on the clinical end. I'm hearing that the vaccine protects from serious impact but it's unknown about transmission, so, and again, this is more of my lack of being able to process all this information, not that you didn't share it, but does the vaccine prevent contracting the virus? That's one and then two, does this vaccine have any impact on the second strain that we keep hearing about from the UK?

FASKIANOS: I think I'm going to go back to Dr. Hamburg.

HAMBURG: Okay, well, we still don't know as much as we want about these specific vaccines and, of course, you know, we hope to be learning more all the time about the new vaccines that are coming in. But you know, vaccines don't always prevent you from getting infection but can help reduce the severity of disease and seriousness of the consequences. And it looks as though these vaccines so far are really, you know, very, very effective at reducing serious disease. There's a lot of reason to think that they do protect against infection to some degree, but we are still collecting that information. And importantly, not just does it protect against asymptomatic infection, but what's its impact on your ability to spread, to what we call "shed the virus" and put others at risk. And that's why the recommendations that you have heard about in this discussion and probably elsewhere about, you know, even after you're vaccinated, you should still be taking those public health precautions—masking, social distancing, avoiding large gatherings, especially indoors, to protect yourself and to protect others against potential spread. But, you know, we will be learning more and the more people that get vaccinated and the more we reduce the levels of community spread through both vaccination and public health measures, the better off we'll be. The vaccine will be more beneficial if we have less of the virus moving around in communities.

And lastly, to your variant question. The UK variant clearly is enhancing ease of spread. And that's a huge concern. And that's why we have to be doubling down during this period to really follow those public health prevention measures because we've seen how quickly that variant took over in the UK and there are predictions by the CDC that it could become the dominant strain here by March if we aren't as vigilant and aggressive in limiting spread as we can be. There's another strain from South Africa that actually seems to be affecting some components of the virus in terms of how it enters the cell to cause infection and the role of the spike protein and the vaccines are directed against that spike protein. And so that also merits very close monitoring. Right now, the vaccines that are in use and being developed produce a broad response against components of the spike protein, and it doesn't look like any of the changes will lower the efficacy. But we need to watch that, we need to really ramp up our monitoring of the different strains where they are and what they look like using advanced science of genomics, but that's, you know, very accessible now in organizations and institutions across the country and through the federal government. But we also need to be studying what those variants may mean for vaccines.

FASKIANOS: Dr. Johnson, you were in a clinical—you were in the Moderna study. If you could offer your perspective and amplify.

JOHNSON: Well, two things. First of all, it's a great question. I love Dr. Hamburg's response. But I would say one other thing. I've talked about public health, but don't forget the role of your own personal physician who is definitely seeing lots of patients like yourself. That should be your triage person. The onus is on me with the patients I see to have a certain basic background of knowledge to answer your questions, and if I don't know the answer to questions, to get back to them with the right answer. So again, your primary care physician plays a major role in concert with a public health person.

Joining the study was incredibly important because it gave me some credibility in the communities that I work in and through interacting with patients to talk about side effects, what sort of things was I concerned about. It may sound very simple, but to be able to tell somebody there's only one Moderna vaccine, because people will say, "Did you get the good vaccine? Is there an A vaccine? Is there a top Moderna? Is there a medium Moderna? Is there a low-level Moderna?" They think like that and you have to realize, "No, there is only one vaccine." "Are you sure?" "Yes." When I get there, I get there thirty minutes early. "Did they treat you differently from other people?" "No." I see how they treat people. It's really putting yourself in their position. Again, "Why would you get it?" "Because I think it's important. I think it keeps me from infecting other people. It allows me to go to work." Okay. So again, you have to put yourself in their position and what their fears are. I can tell you one of the greatest fears I saw growing up in the housing projects in Brooklyn was the fear of health and medicine and health care.

FASKIANOS: Dr. Gupta, any last words?

GUPTA: Nothing substantive. I thought Dr. Hamburg and Dr. Johnson really nailed it.

FASKIANOS: Great, we've run a few minutes over. I apologize I could not get to all your questions. We clearly need to continue to have this conversation, especially since the information is changing as more is understood about this disease and as the vaccines are rolled out and we see the side effects and how people are protected from it. So we will continue this conversation, please. Thank you, Dr. Gupta, Dr. Johnson, Dr. Hamburg, for sharing your expertise with us today and for all that you do. It's been really inspirational to hear and to be with you today and to all of you out on the frontlines and really working to help your constituents navigate what is very hard and challenging as we're all hunkered down in this pandemic, so thank you. Vin Gupta is on Twitter. You can follow him @VinGuptaMD. I don't think, Dr. Hamburg or Dr. Johnson, you're on Twitter, otherwise I would share your handles.

HAMBURG: We're a different generation, I'm afraid.

FASKIANOS: You can follow CFR.org and ForeignAffairs.com and ThinkGlobalHealth.org. Come to us for more information, expertise, and analysis on COVID-19 as well as a host of other international issues. And we will send the recording of this webinar and transcript to you all so you can review it again, share it with your constituents. And please feel free to reach out to us with questions and anything else you need and how we can support all of you. You can email at [email protected]. So stay well, stay safe, and thank you again.

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