A Bright Future: Tackling a Global Pandemic
June 9, 2021 | Webinar
Back by popular demand, Dr. Mark McClellan, former FDA Commissioner and Director of the Duke-Margolis Center for Health Policy, joined the Travelers Institute to provide an update on the fight against COVID-19. Nearly six months since the vaccine rollout began, Dr. McClellan shared lessons learned about effective distribution, fighting an evolving virus and what life may look like for families, businesses and schools in the second half of 2021 and beyond.
Watch the Replay
(DESCRIPTION)
Title card, Wednesdays with Woodward (registered trademark) Webinar Series. A Bright Future, Tackling a Global Pandemic. Logos, Duke Margolis Center for Health Policy. Travelers Institute, Travelers. Partnership for New York City. Video feed, Joan Woodward.
(SPEECH)
Hi. Welcome, everyone, and good afternoon. Thank you for joining us today. I'm Joan Woodward and I'm honored to lead the Travelers Institute, which is our public policy and educational arm of Travelers. Today's program is part of our Wednesdays with Woodward series that we launched last year to explore issues impacting your personal and professional lives in these really uncertain times.
(DESCRIPTION)
Slide, Text, Join our mailing list institute@travelers.com, Connect LinkedIn, Joan Kois Woodward, Watch replays, travelers institute.org. Hashtag Wednesdays with Woodward.
(SPEECH)
We're pleased you're here with us today. We hope you'll stay engaged. You can do that by joining our mailing list, institute@travelers.com. Connect with me directly on LinkedIn or watch our webinar replays at the TravelersInstitute.org.
So before we get started, I'd like to share our disclaimer about today's webinar.
(DESCRIPTION)
Slide, About Travelers Institute Webinars. Wednesdays with Woodward educational webinar series is presented by the Travelers Institute, the public policy division of Travelers. This program is offered for informational and educational purposes only. You should consult with your financial, legal, insurance or other advisors about any practices suggested by this program. Please note that this session is being recorded and may be used as Travelers deems appropriate.
(SPEECH)
We have a really special program for you today. And as always, we'll save time at the end to answer your questions. So put those questions, submit them through the Q&A function at the bottom of your screen.
(DESCRIPTION)
Returns to title card.
(SPEECH)
And you can send anonymously if you don't want me to read your name. But I like to read the names of all my agent and broker friends out there, so please put your question in. Don't wait till the last minute until we're at the end of the webinar. Earlier the better.
So we're thrilled to be joining our partners today presenting this program, including the Partnership for New York City and the Duke Margolis Center for Health Policy led by our speaker today, Dr. Mark McClellan. So a huge thanks to both of these partners for the work they're doing and helping us put these programs on for you.
I'm truly honored to welcome our guest, Dr. Mark McClellan, back to our Wednesdays with Woodward series.
(DESCRIPTION)
Slide, Speaker, Dr. Mark McClellan. Image.
(SPEECH)
He first joined us in January of this year--so really, just six months ago. And we've asked him to come back to update us on what's happening with the pandemic and the vaccine rollouts. So Dr. McClellan is currently the Robert J. Margolis Professor of Business Medicine and Policy and the founding Director of the Duke Margolis Center for Health Policy at Duke University.
The Center draws upon Duke's research, education, and engagement capabilities to help inform policy makers in Washington and around the world to create a better health care system. Dr. McClellan is also a member of the Board of Directors at Johnson & Johnson.
Prior to joining the Center, Dr. McClellan served as Commissioner of the US Food and Drug Administration, the FDA, under President George W. Bush, and thus, has really intimate knowledge of what it takes to develop, approve, and distribute of new vaccine. In addition, Dr. McClellan is a former Administrator of the Center for Medicare and Medicaid Services, which is all of Medicare and Medicaid around the United States. It's a really big job, and probably--I don't know if it was more difficult, Dr. McClellan, than the FDA, but certainly as important.
In these roles, he helped to implement major reforms in health policy, including adding the Medicare Prescription Drug Benefit, Medicare and Medicaid Payment Reforms, and the FDA'S Critical Path Initiative, which is the public-private initiative to develop better information of quality and cost of health care.
He also serves as a member of the President's Council of Economic Advisors and a Senior Director for Health Care Policy at the White House. And he's Deputy Assistant Secretary for Economic Policy at the Department of Treasury. So he held a lot of roles during the Bush administration. He holds a PhD from the Massachusetts Institute of Technology, as well as an MD and an MPA from Harvard.
As many of you know, Dr. McClellan joined us, as I said, in January. So his predictions were remarkably prescient for us all to understand what happened in the last six months.
(DESCRIPTION)
Slide, Text, United States Vaccine Investment. Table. Vaccine companies are listed in the companies column on the left and vaccine information fills the rest of the columns to the right, such as US investment in billions, trial phase, results of phase 3 testing effectiveness, US FDA approval, Doses ordered millions, vaccine delivered millions, vaccine administered millions. Companies, Moderna, Johnson and Johnson, Pfizer Biotech, Astra Zeneca Oxford, Novavax, Sanofi Glaxo Smith Kline. Bottom row, Total, $16.5 billion, 1,300 million doses ordered, 372 million vaccines delivered, 303.6 million vaccines administered. Source, CNBC, NBC, Washington Post, Bloomberg, Pfizer, Moderna, CDC.
(SPEECH)
So over a year into this pandemic, the US has invested nearly $16 billion, as you can see on our chart here, into research for COVID vaccine development and the grant of the emergency use authorization to Moderna and Pfizer-BioNTech, and J&J vaccines.
And as you can see on my chart, never before in the history of the United States government has the FDA--has the government pre-bought, let's say, and asked the companies to pre-manufacture drugs even before they were approved by FDA. So as we head into the summer, we find ourselves in an entirely different situation and truly much better than we had Dr. McClellan on our Wednesday sessions in January.
So the fundamental questions still remain, doctor. How will the US and should the government support this global fight and how will that look like? How should parents protect unvaccinated children? When can we expect children to be approved under 12 years old? There's lots of questions. Should we expect another surge as winter comes about later this year? So Dr. McClellan, there's lots to talk about. I want to turn it over to you for some opening remarks, and again, thanks so much for being with us.
(DESCRIPTION)
Video feed, Mark McClellan. The slides disappear. The two video squares side by side.
(SPEECH)
Hey, Joan. Thanks very much for having me back. And it's great to be with you and the rest of the Travelers community. Looking forward to discussing all of those issues. I guess just to start with, boy, Joan, what a difference six months makes. Since the last time we were here, we talked about how vaccines could potentially lead to a transformation in the impact of the pandemic. And great news, is we're really starting to see that happen.
I think summer in the United States looks very good. It especially looks good for people who have been vaccinated. The vaccines look very effective, not only against the COVID that we face so far, but against some of the variants that are continuing to emerge. That plus the good weather and people being out more I think is going to make the summer prospects look very good.
We're already down to well under 30,000 cases per day, numbers that we haven't seen since before, the big surges of last summer. 300 or fewer deaths per day. That's not yet crushing the virus. It's still with us. They're still a significant number of people who haven't been vaccinated. There's still some spread of the virus going on, and that's part of the reasons to be a bit worried for the future with what may happen in the fall.
As the weather gets tougher, people get even more time closer back together. We certainly haven't solved the COVID problems around the world where with much less availability of highly effective and safe vaccines. We're still seeing continued serious outbreaks and the continued emergence of very worrisome variant forms of the virus, which inevitably make their way back around the world. So those are still some things to be on the lookout for.
We're not done, but we are at a point where I think we can all take a deep breath, take the mask off in many more places, and look forward to much better times ahead without anything like those kinds of big, acute surges and high rates of hospitalization that we've seen in the past. Hopefully those are well behind us.
Well good. It's interesting how the Biden administration came in and he asked us all to wear a mask for another 100 days. And then, of course, there was some shifting, and then the CDC, surprisingly, all of a sudden said, it's OK, we can take off our masks. And I think a lot of people were thinking the CDC was too slow, and then all of a sudden, maybe too fast in taking off our masks.
So how do we kind of balance? There's lots of signs on restaurants and different shops you go into. If you had your vaccine, you don't have to wear your mask and many, many states. And there's kind of messy middle that we're in right now. How are you thinking about this for society at large in terms of is it OK to go to those summer picnics, indoor, outdoor, without masks if you've been fully vaccinated, knowing that there might be people in the room who have not been vaccinated who also don't have a mask on? How do you think about that personally?
It is a little bit messy. And be sure to get me to come back to how I'm thinking about this personally. But first, to set a little context, CDC has been kind of criticized on both sides along the way. For a while they were criticized of not moving their guidance fast enough and they came out with some guidance on wearing masks with a chart that had a whole bunch of compartments for different kinds of people and different kinds of settings that's very hard for people to follow.
I think some of that plus some more accumulating evidence on how people, especially have been vaccinated or doing the real-world, Joan, that's what led to that change in guidance. So we now know not only are the vaccines available widely now here in the US, very effective in preventing any kind of serious infections, are also very effective in preventing symptoms, but they're also very effective and just keeping you from even acquiring levels of the virus, let alone producing enough, even if you're asymptomatic, without symptoms to make people around you infected.
And it's that evidence from large numbers of people in the United States and Israel and in countries that have gotten to fairly high levels of vaccination and seeing big drops in transmission, not just among really eliminating serious infections, except very rarely in people who have been vaccinated, but also protecting people who aren't vaccinated from picking up cases from being around them.
That's what led to the change in the CDC guidance. And I think it's right. Basically if you've been fully vaccinated for at least a couple of weeks, the chance that you're going to have an infection that's serious is very, very low. It does happen. We have seen a few deaths in nursing homes and elsewhere among high-risk people who have been vaccinated who had so-called breakthrough infections, but is it very low rates. One per 10 or 100,000 of such cases. And those cases are getting much rarer because there is so much less transmission.
So if you've been vaccinated, you can be pretty confident that you're not going to have any serious consequences wherever you are from the COVID cases that are still circulating at this much lower level in the United States. On the other hand, if you're not vaccinated, you are still at risk. And what we've seen in those hospitalizations that are unfortunately still taking place and the deaths that are unfortunately still taking place.
That shifted to people who are younger who are vaccinated at a lower rate. Something like 85% of our 65-plus population has gotten at least one shot, three-quarters or fully immunized. We're seeing much relatively less hospitalizations and those high-risk groups. More of them are in younger people, including younger people with chronic diseases or obesity or something like that who aren't vaccinated. So the vast majority of hospitalizations and deaths now are among people who aren't vaccinated.
And that's why the CDC also tried to be very clear about if you haven't been vaccinated, the evidence is now pretty strong that you may be OK outdoors if you're not around other people in close contact, but if you're indoors in a situation with lots of other people around you, that's still a risk.
So it's a big change in guidance, but I think it's reflecting the fact, Joan, that we're in a much less serious phase of the pandemic where we're actually trying and should be trying to do a lot more things that were like the things that we used to do in the past. It's still not the case that there's no risk. But based on your vaccination status, based on whether other people in the area close to you have been vaccinated or not, and then based on the rate of cases in the area, most parts of the US now are down to fewer than five cases per 10,000 people. That's a very low rate compared to what it's been in the past. And all of those means that the risk isn't zero, but it's pretty low.
So back to what I'm doing personally. Outdoors, not around anybody closely. Of course I'm not wearing a mask. I'm indoors, if I'm in a setting where I'm pretty confident that they're not people who aren't vaccinated around me, gatherings things like that, I don't wear a mask. In settings where there maybe is a mixed group, more people close together, including some who may not be vaccinated, I try to be a little bit more careful.
And that's why I think you're still seeing federal guidance for on airplanes and other sort of congregate places where people come together, including a number of people who haven't been vaccinated yet, I think that's why you're still seeing some CDC guidance suggesting masks in those contexts.
OK. That's very, very, very good advice for us. And thank you for speaking to us about what you're doing personally. I think a lot of us follow the lead of people like you and others in public policy who know what you're doing, so thank you. So are these lifting of restrictions here to stay? Or come the fall or winter, are we going to hunker down and maybe close down the economy again? Or are we thinking that we need to get these booster shots maybe later this year? Or is that a next year phenomenon in terms of getting the annual kind of booster?
Well, I think for the short-term, the summer looks very good. So I think people should be getting on with their lives. But we are definitely not done with the pandemic. So in the United States, while we've gotten a lot of people vaccinated, over 300 million shots delivered, and especially for people in older age groups, we still have about 64% of adults that have gotten at least one shot. That means 36% who haven't.
Now many of those people are actually immune. Some of the people who haven't gotten vaccinated did get COVID. We've really underestimated the number of total COVID cases in the US, and at least for a while, those people have immunity, too. And that's why I think we're seeing very low spread rates in many parts of the country right now.
But it doesn't mean that we're beyond the pandemic yet. So I think as a business, paying some attention to things like distancing turns out to be a bit less important than we thought about--we thought it was early on because there is a possibility of airborne spread, especially from someone who's not vaccinated and is infected.
So air circulation in an office, i think it's something that everybody should be paying attention to. It's good for reducing risk of COVID now even though that risk is lower, but also other respiratory infections. Again, keeping this culture in place of not coming into work if you've got symptoms or fever or things like that.
So not we're not stopping everything. We're also continuing as a nation to monitor cases around the country, including the variants. One reason the cases haven't gone down even lower with all this vaccination is that unfortunately, the variants we're seeing now, they're just more contagious, and some of them are more serious in terms of the symptoms and complications they cause than the variants we're dealing with just a few months ago. So we have to keep a close eye on that.
And we also have to keep a close eye on how well the vaccines keep working and how long immunity lasts for people who were infected but haven't been vaccinated. So the government's watching this closely. I expect to see--they're certainly preparing, having enough additional vaccine doses available so that everyone could be vaccinated again if need be.
Fortunately, the durability of the vaccines so far, including the durability against variants, seems to be holding. So no rush to go off and get a booster now, but people should expect that at some point, they may need another shot, especially if they're in a higher-risk group that is more at risk of these serious complications.
And then the other thing I watch hitting in the fall is we have a lot of people who were infected last summer, last fall, this past winter. We don't think that immunity overall is as good for people who have been infected as it is for people who have gotten shots. So that immunity could start to drop. In fact, in some people who had very mild cases, they can get reinfected by a variant. And so that's another reason why we're kind of worried about what could happen in the fall.
So I think the most important thing we could do for preparation for the fall now, though, Joan, is keep working on our vaccination outreach efforts. There are certainly many Americans who have thought about it and decided pretty clearly they don't want it. A few of them are still changing their minds as they see more of this experience, as businesses take steps to--either incentives or in some cases requirements to get vaccinated.
But there's still a chunk of Americans who think they want to get vaccinated, just haven't gotten around to it yet. May think, well, cases are going down, summer looks good, I'll do it later. I think the more we can get those individuals vaccinated as well, the safer we're going to be for the long-term.
OK. Terrific. All right, now we're going to mix it up. For all of you listening in today to us, we're going to try something new technology-wise, hopefully it works. So right now on your screen, you should see a window pop up with an audience polling question. Hopefully that happens. And so please be honest. Your responses are anonymous. We promise you that.
So here's the question.
(DESCRIPTION)
Text. Do you think the economic rebound will be dependent on more people getting vaccinated in order to reach herd immunity?
(SPEECH)
Do you think the economic rebound will be dependent on more people getting vaccinated in order to reach that herd immunity, yes or no? So do you think the economic rebound is really dependent on herd immunity. And let's see what the audience is telling us here.
It looks like, to me, 73% of us think that's true, the economic rebound is dependent on more people getting vaccinated to reach herd immunity. So 27% of us, Dr. McClellan say, no, we don't need to do that. The economic rebound is going to happen even if we don't reach herd immunity. What are your thoughts here?
I actually voted yes on this one, Joan, but I can see why people would vote no. We were seeing a very good economic recovery taking place right now to the extent that for many jobs, it's hard to find people who want them. It's hard to get the economy going again as fast as some employers would like. And that's with well below levels of herd immunity, as I was talking about earlier.
That said, I think there are going to be pockets of outbreaks in the United States. Maybe some people not doing as much in terms of getting out there, eating indoors, doing big events, maybe traveling quite as much if they still see this level of infection taking place on an ongoing basis. It's low, but it's there. There's still some risk there. That's going to make some people anxious.
But I think the question was focused on the United States. The fact of the matter is, from the standpoint of our long-term and comprehensive economic recovery, we have to contain COVID all over the world. And that is just not happening yet. We're nowhere near even high--decent immunization levels, let alone anything like herd immunity on most of the planet.
In Southeast Asia and parts of the Asia-Pacific and parts of Africa, and especially in parts of Central and South America that our economy does depend on, and recovery globally is going to depend on, we're just not close to being there yet. And that's going to be a bit of a drag on the economic recovery globally for sure and the US to a more limited extent.
Yeah. The global question, and all of us are deciding, you know can we plan that European vacation this summer? And I think most of the folks I'm working with and talking to, people are very hesitant to go abroad for obviously the reasons you say. But we do want to plan for next summer. Right, and so getting the global population to anywhere near herd immunity is a huge, heavy lift.
So I want to get to that in a second, but I want to ask our audience one more question on this topic of masks on, masks off. So here's another audience polling question for everyone. And select all that apply here.
(DESCRIPTION)
Text, Which of these activities, if any are you engaging in:
(SPEECH)
Which of these activities, if any, are you engaged in? So indoor gatherings without a mask, indoor shopping without a mask, air travel for business, have you taken a vacation yet, air travel for pleasure, or none of the above?
So again, check everything that applies here, and let's see what some of these results are going to look like. Who's doing what? So all right. We have 76% of us say they're doing things inside without a mask, including shopping. About 50% of us say we're shopping without a mask. Air travel for business. Look at this. Interesting for all of my agent broker and other insurance professionals on the line.
So only 6% of us have taken that first business trip. And that is going to be very interesting to watch for all the fall conferences that we're planning and hoping to execute fall and winter. Air travel for pleasure. So people don't mind getting on a plane, Dr. McClellan, for a little vacation, but maybe more hesitant on the business side.
And then 17% of us said we're not doing any of these. We're still considering this maybe risky behavior. So what do you make of these results? And maybe speak to the business community, too, about how fast reopening and getting our folks back in the office, which you know is obviously a daily question for everyone.
Sure. I'll try to cover all of these. On the first two, I do think it's--for me, it's back to what I was saying before, is it depends. And for business travel, too, some of that is coming back, and I think, again, for all of these, if you've been vaccinated, you are you are very, very unlikely to have any--have an infection, number one, to have any serious consequences of that infection for sure.
So I've actually done, Joan, all of these. I actually just got back from a business trip recently where I traveled with a mask on in the plane per requirements, but went to an indoor meeting of a group that was completely vaccinated, and it was just like old times. We were sitting at the table, we're having good discussions, no masks and no evidence of any--and I think the CDC would agree--no evidence of any worries there.
Wasn't a mass gathering of hundreds of people, some of whom many of whom may not be vaccinated. In those settings, I would still--if I went to them, I would still wear a mask but that's more to protect people who haven't been vaccinated than concerns for me. And for indoor shopping, it depends, too. If it's a good air circulation, not that crowded, and you've been vaccinated, that's getting to be more of the norm around the United States. A lot of major retail chains have dropped their mask requirements. They are asking you to pay attention to whether you've been vaccinated or not as to whether you mask up.
If you look at surveys, though, a lot of people who have been vaccinated aren't wearing masks. Something like that half and half. They're actually the group that's at the biggest risk at this stage in the pandemic. And I am doing some air travel for pleasure. We have a family trip coming up that we're going to fly. We'll be masked in flight. We're going to an area where we're not going to be in big crowds. It's a great summer for seeing the great outdoors around the United States. And Joan, I actually have some travel coming up to Europe later this summer.
And for international travel, I say very much depends on the situation in the country that you're going to. It's quite varied across the world. Looking at Europe, they are mostly not as vaccinated as we are in Western Europe versus the United States, but those numbers are increasing rapidly, and we're going to see case rates continue to go down, even in countries in Europe that have been hit harder by some of the new variants, like the so-called Delta variant.
But if you're vaccinated, wear your mask on the plane and going to some place that has a low-- very low case rate that's doing a good job of tracking outbreaks, including even if there are some of the variants there, but doing a good job of containing outbreaks. I think a good deal of international travel is OK, and I think that's going to not be back anywhere near 100% this year, just like business travel won't be, but I expect it to continue to pick up over the course of the summer.
OK, terrific. So let's talk about children just for a moment. We know that it's been approved--the vaccine has been approved for 12 to 15-year-olds. Trials are underway now for six months to 12-year-olds. What's the take-up rate now for children 12 to 15? Are they out there getting their vaccines?
They are. They're not yet at the rate that we're seeing for adults, but basically the further down you go the age distribution, the lower the vaccination rate is. But the 12 to 15-year-olds are catching up. I'd say that the numbers now--it's hard to get exact numbers, but it's definitely a minority, maybe 15% to 20% in that age group that have been vaccinated. Many of them--there's a push and we saw an increase just in the last couple of--the last week or so in that age group I think related to summer camps starting and summer trips starting where if you're adolescent and have been vaccinated, same things we were just talking about with masks. You can do a lot more safely without the mask than you could otherwise.
So I think that number is going to continue to increase. I don't expect most school districts to require vaccination, but to be maybe required in some, strongly encouraged in many as we head into the fall. And Joan, as you mentioned, there are studies underway now for vaccination effectiveness and safety in younger kids under 12, all the way down to six months.
Pfizer and Moderna have announced that the doses that they're using, this as a little bit complicated in that kids have quite strong immune responses. So they need lower doses, not just because they've got a lower body weight, but because they, you want a strong response, but not so strong that you get allergic reactions or avoidable side effects.
So people are going to be careful about these dosing studies, and that's going to take a little bit of time to sort out. So I think it's probably going to be some months before we see any clear definitive results and FDA decisions about vaccination in the under 12 age group, but I would expect to see some recommendations on vaccination. I think we're going to find doses that are safe and effective for kids in that age range probably before the end of the year, by the end of the year sort of time frame.
OK, great. Let's pivot a little bit and talk about incentives. So states like Ohio are giving you a chance to win a million dollars. States like Maryland, West Virginia are just giving you $100 to get your vaccine. So do these incentives work? And what lessons can we learn from them? And a lot of businesses are starting to do this. What is your kind of advice if you're talking to a CEO who's worried about getting people back in the office or people are worried about coming back in the office, going on public transport to get to the office is a big concern. Do these incentives actually work?
You know they do work, Joan. People like free donuts or free beer with their shot or other gifts. They especially like cash. So some of the financial incentives for younger people. A chance of winning a savings bond or a free college education, that's great. The lotteries, you mentioned, a growing number of states are using some of their federal funds, actually, to support lotteries, and some people have criticized that. But the evidence is that it does get people's attention. It does help get those people maybe been on the edge and they think it's OK to get a vaccine, they just haven't taken all the steps to do it yet, it does make a difference.
And here, employers really can help. We've done a lot of work at our Center at Duke on what steps employers are taking that can support vaccination. Some of it isn't even financial incentives or gifts so much as it is the incentive of just reducing the difficulty of getting vaccinated. So doing a vaccination program at work or close to work. There are enough vaccines available now that you can usually work with your local state or local public health authority to find a partnership to do it.
There are many community organizations that likely are connected to your employees who could help support an event. We're seeing these happen all over the country in partnerships with community organizations and with state and local public health. Also with pharmacies and health care organizations, they can set up a clinic.
So bringing the vaccines to the workers is a great way to do it. Make it easy for the workers to get to the vaccines. Many employers have offered free transportation or time off from work for the shot plus the recovery period, and the day or so that it might take to get over the symptoms in some people.
Right now for until July 4th, you can actually get a free trip to and from a vaccine via Uber or Lyft. They're offering free vaccine transportation. All you gotta do is use the app, they'll tell you how to do it. So it's telling employees about how easy it is to get vaccinated. And there is a vaccination site available close to you. You can just text on your phone Get Vax with your zip code. So whatever that six-letter--I keep forgetting the specific six numbers. But Get Vax, put in your zip code, text it, you'll get a list back just on your phone of places where you can get a vaccine close by. And then the Uber ride or the Lyft ride if you need transportation.
The other things that I think we're going to see employers doing more going forward are maybe having some incentives or even requirements. So we've seen some of the airlines like United say that for new hires, they have to be vaccinated. And for some health care and other organizations, including Memorial Baptist in Houston, they're requiring their workers to be vaccinated.
Some universities are doing that. Duke is doing that for its students, and I wouldn't be surprised if we end up by the fall having a requirement for our staff and faculty, too. There are some federal regulatory issues. You can't just make everyone get vaccinated. You have to account for things like religious preferences and medical or other scientifically appropriate reasons why people might not want to be vaccinated.
But I think we're going to see these incentives in the coming months, especially as the new--as the Pfizer and Moderna vaccines and eventually the J&J get vaccine get approved for full use--so full approval, not just emergency use. I think we're going to see more employers putting requirements in place.
But right now, what really does work is publicizing information, making sure people know there are places they can go to get more information if they've got questions. Their health care provider, local resource groups, probably people a trust from their community. And it's very easy using lots of great examples of setting up vaccine clinics or connecting people with close-by vaccine opportunities to make this as easy as possible.
OK, terrific. So for lay people like us, people who don't have a PhD or have a medical degree, what is the difference between emergency use authorization and kind of regular authorization? Without getting too technical on us, but what is the actual difference?
So practically, there's not that much difference when it comes to vaccines. What the emergency use authorization gives the FDA the ability to do is in a public health emergency, like this one, it can approve medical products with less comprehensive evidence then the agency might normally require.
And that meant that FDA did some faster approvals, especially for treatments for people who are really sick, especially earlier on in the pandemic when we didn't have that much to offer them based on quite limited evidence. So for example, I saw on the chat a couple of questions about, what do I do if I or somebody I know is immune-compromised? And so doesn't have--isn't unlucky enough not to have a good response of vaccine. Well, those people probably do need to be more careful about where they're going and also wear a mask for their own protection.
But it's also important to remember that we actually have treatments that work now if you get them soon enough after you're infected. So if you're in a high-risk group--for example, someone who's immune-compromised, and you think you might have COVID, you've got symptoms, get tested. It's not--testing isn't quite as widely available as it used to be, but you can get it from your local pharmacy and many health care providers close to where you are.
If the test is positive, get referred to receive monoclonal antibody treatment. This is an infusion or injection. It's not something you can--it's not just a pill you can take yet. We're working on that. But it's really effective. And FDA last year approved the availability of those monoclonal antibody treatments based on studies in just a limited number of people because it was so important for people who are at high risk to prevent hospitalization and death.
In contrast for the vaccines, FDA recognized that the vast majority of people who would be using them are people who are healthy. And so that's a different proposition. In that case, you really want to be sure that the vaccine is safe as well as effective before you start using it more widely.
And you've seen over the past six months a lot of efforts by FDA and CDC and other government agencies and health care providers and the manufacturers not only to make sure the vaccine was effective-- it really does prevent the complications even getting COVID, like I was talking about before, but also really understanding the safety.
And so FDA didn't authorize these vaccines until very large clinical trials on tens of thousands of people have been done, and it's continuing to watch while the vaccines are in use for very rare side effects, like this rare side effect in the J&J vaccine which is something like three per million people who have this condition where they have some blood clotting in the presence of low levels of the products in your bloodstream that normally cause blood to clot.
And that's important, both because it's a rare condition, but also because it can be treated. You just need to know the right treatment. And so those kinds of steps help the FDA get the sort of large-scale, long-term use evidence that goes into a full approval, as well as, Joan, just watching to see, you know how long does the vaccine last on the shelf? Well, you haven't had time to look at these long-term issues like how long a vaccine lasts.
And we now have increment data on hundreds of millions of people literally have gotten vaccinated here and around the world. So that's the additional evidence that will go into a full approval. But I have a-- because there's just not that much difference from what went into the emergency authorizations, I think we're not going to learn a whole lot more about the safety and effectiveness of the vaccines between now and when those full approvals happen. The FDA set a very high bar for vaccines for emergency use authorization.
OK. Thank you. Thank you for explaining that. It's a very, very interesting behind-the-scenes look at the FDA. So we're going to open up to audience questions now, but first, I want to take one more shot at this on the global response. And so you felt strongly enough, Dr. McClellan, to write an open letter calling on the Biden administration a few weeks ago to provide, quote, urgent high-level US leadership to address the global vaccine crisis. So you and I think 10 other leading scholars on health policy. But why did you do that and what has anything happen since then?
Well, Joan, that's really, I think, the most important really big and challenging next step that we need to take to really move beyond the pandemic here in the US, but also for the rest of the world. So what I'd like to see is something like what we did in the US with Operation Warp Speed to really ramp up the production of a very effective, safe, high-quality vaccine. It is hard to manufacture these vaccines. We are incredibly lucky that we have multiple vaccines here in the US and Western Europe that work. It's a testament to the effectiveness and innovation in our biotechnology sector.
But most of the rest of the world doesn't have access to that. And unfortunately, as we've seen in this country, it's not so simple as just saying, well, let's share the patents or share the IP and hope for the best. What worked here was investing a lot in increasing capacity, and we're doing some of that now.
For the reasons that we talked about before the US is, I think, understandably creating more manufacturing and supply of these very good vaccines than we're likely to need here in the US because we want to be ready just in case. We want to be ready. If there's a variant that requires boosters sooner. We want to be ready with the capacity to make a modified vaccine. If there's a very worrisome variant that comes along, we want to be ready. If one of the manufacturers--manufacturing capacity goes down a bit, we want to be ready for all of those things.
Fortunately, we're probably not going to see all of those bad things happen, and therefore, we're going to end up with a lot of extra doses of really good vaccines. And what we don't have yet, Joan, is a systematic way to work with our allies. And then President Biden is over at--heading over to G7 right now. So these are the other countries that have the benefits of the same kind of vaccines that are working here and are taking the same kinds of steps that we are. In some ways, a little bit behind, some of them a little bit ahead, maybe. But that's going to create, by our estimate, potentially a billion extra doses of vaccines over the next six months.
And that means we need a real plan to get those shots into arms where they're so badly needed across the world. If we take steps to make these vaccine supply available, if we maybe ramp them up--J&J, you mentioned I'm on the board, is doing a partnership now that was sponsored by the US government, the Government of Australia with an advanced manufacturer in India called Bio E that's aiming to have a billion-dose production capacity using J&J know-how and working side-by-side getting that up and running over the next six months.
Vaccine production is complex. You've got to do it exactly right, as we've seen with all the issues with the so-called emergent facility here in the US. You've got to do it right, but we can do more of that. So steps like that in Africa as well with the US government, our allies, and the really good vaccine manufacturers working together to increase capacity. That could give us the ability to get a large share of people throughout the world vaccinated this year.
And looking ahead, Joan, I think the good news is, globally we're going to have a lot of vaccines by 2022. We should be able to vaccinate, if we stay on track, everybody who wants to be vaccinated from these high-quality vaccines. Pfizer, Moderna, J&J, AstraZeneca, Novavax, CureVac. Everybody in your chart is ramping up supplies, and they have the capacity probably to 11, 12 billion doses in 2022.
But we need to accelerate that as much as possible given the horrible situation that we've seen in India in the last few weeks and many parts of South America right now. That's all avoidable if we just take the steps that work here and apply them globally. One of the things I've mentioned here that's important is just like we've seen in the US, it's not enough to have good vaccines. You have to have a real plan to get those shots out into arms.
So you need vaccinators. You need distribution programs, and that's hard for some of these vaccines that have to be stored at ultra-cold temperatures. And the world has never done a vaccination program for adults on this scale. The closest thing was probably polio vaccination a generation or so ago in kids.
And so most countries, we looked and we did a study on this. Most countries don't yet have that capacity in place. So we could be in a bad situation in a few months, Joan, where we've got more of these really good vaccine supplies available, but no reliable way to get those shots into arms. We've already seen that happen in a few countries where the COVAX, this international collaboration, has distributed some of these good vaccines to countries that weren't actually able to distribute them, and they either were wasted or they had to be sent back.
That's not a solution, and that's the kind of collaborative effort that we called for. The US led an effort like this in the early 2000s when I was in the White House working with President Bush. The President's emergency plan for AIDS relief brought literally billions of doses of medications for AIDS to Sub-Saharan Africa, Asia, other parts of the world where AIDS was rampant despite the fact that we had really effective vaccines--really effective treatments, I'm sorry, that had been developed in the US. We just didn't have a plan to get them in place.
And it took US leadership--it was some billions of dollars, but in the scheme of things, it wasn't huge amounts of money when the benefit on the other side is not losing millions of lives, not losing the opportunity for the rest of the world's economies to recover. So we've got some real work to do there to move past the pandemic globally.
OK. To the audience questions, we have a lot coming in, as you see. So let's try to do rapid-fire here.
First one coming in from Sarah Rose. You mentioned the mass majority of deaths are people who are not vaccinated. In the clinical trials, we did not see any deaths of people who are fully vaccinated. So, are we starting to see deaths of people who are fully vaccinated in the general population, and what is the outlook for this?
Very, very rarely. So even a vaccine that is almost perfect, as you said, had no deaths in the clinical trials, and tens of thousands of people had rates just a few percent of people having serious consequences, very low rates of hospitalization. There have been a few deaths. There is a nursing home outbreak not that long ago in the Midwest where unvaccinated workers brought in some cases of COVID that spread to some of the other people in the nursing home.
Remember, we're dealing with tougher variants now. They're more contagious and can cause more consequences. And there was one death in that case. But the CDC has looked at the total data in the US-- we're seeing this in other countries, too, Joan. The rates of that happening are so, so low. It's down--it's up there with getting struck by lightning or something like that.
And so there's no medicine that's completely perfect, especially for people who are very high risk, but these are about as close as we've ever seen medicine be able to do. And those risks for people who are vaccinated are so low, that it shouldn't stand in the way of their getting out and getting back towards enjoying at least some of their life as we talk about before.
I would feel even better, as we said, if more people get vaccinated. I mean, there'd be less chance of those cases to spread, less chance for variants to move around, and that's just going to protect everybody--people are vaccinated, people who are unvaccinated. And especially in areas where there are unvaccinated people.
You still need to be careful. Some testing, some distancing, some- paying careful attention to air circulation. All of those are still good steps to reduce risks in indoor higher-risk settings.
OK. Another question coming in from Marilyn West. Should evidence of vaccinations be required for travel and other purposes such as return to work? How do you balance this requirement against HIPAA protections? Excellent question.
It's a great question, and different countries are going to come out in different places on this where they have different societal approaches to how they deal with privacy concerns versus social population concerns. So if you were in Singapore now, they're keeping track of where you're going, not just to know whether you've been vaccinated and can do more, but also to continue to be able to track outbreaks and things like that.
Israel kind of in the middle. When they were at an earlier stage, they ramped up fast on vaccination. It made a lot of news for getting up to a significant share of their population being vaccinated by the February, March time frame. They saw their rates of infection, including with these worrisome variants, go way, way, way down. And they had sort of a vaccine pass that they use for a while. This is a green or red check you could get on your phones whether you're vaccinated.
And they made the rules different. If you were--back to, Joan, what we were talking about earlier. If you were vaccinated and you go to a mall, be in crowds, go to a concert with really no significant risk associated with it. The risk of both spread and the risk of complications is much more in people who are unvaccinated.
Well, since then Israel has seen the case rates go way down and they've relaxed those restrictions. Even though they didn't get to quite herd immunity levels, they're at about 60% or so of their adult population who's been--of their overall population who's been vaccinated. So over 70% of adults. And at least for now, in the summer, warm weather, et cetera, that's been enough to keep the infection rates really, really low, and so they're allowing some more flexibility they're still encouraging masks and people who aren't vaccinated.
In the US, the federal government's made a decision. That they're not going to impose any kind of passport. Once several states are supporting these kinds of efforts--New York--and more states have enabled businesses to implement these kinds of requirements. If you're trying to go to a baseball game in Southern California, you can get better seats, closer together with all your friends if you can demonstrate that you're vaccinated. So there is going to be a role for these vaccine passports.
So there's another question about cruises in here. So that's another place where businesses have thought it was good business, at least for many of the cruise ships, to not only vaccinate require their crews to be vaccinated, but also require all--or almost all of their passengers to demonstrate proof of vaccination before getting on the cruise. Because again, it makes for a very, very low-risk environment.
But there are some US states, including Florida, that have state restrictions, actually, on imposing on businesses imposing any mandates about vaccine passport use. And basically the state of Florida said, if you're a business, you cannot use these passport approaches. That has not worked out yet. So we'll see how the cruises go out of Florida in July. There may be a live flashpoint for this issue.
I think in from a public health side, having these programs be available to businesses if they want to use it is helpful. It's certainly going to be helpful for reopening the Duke campus and other Catholic college campuses with confidence this fall. That's why we're requiring vaccination and proof of vaccination to be on-campus, and so I think you can see a lot of businesses in that category. But it is mixed in the United States. We're definitely using this approach less than other places.
One other place you may end up seeing it is in international travel. If you want to go to Paris, a lot of people miss that over the past year, France just announced I think today that they're reopening for foreign visitors if you have proof of vaccination or you can do the PCR tests and prove that you're not infected.
OK. A couple other questions here. And I'm very impressed that you can speak and also read the questions in the chat. Well, not all of them. I need your help.
You're sifting through the questions and speaking with other questions, so impressive. So there's a couple of folks here, anonymous, saying, what are the options for people who got allergic reaction to that first shot, they feel like they're going to have to wear a mask forever? What do they do if they had the allergic reaction to the first shot? And obviously you're not going to--it sounds like they're not going to get the second shot.
Talk to your doctor. So there are different levels of allergic reactions. The good thing about allergic reactions is they are very treatable. They happen right away, and they're very treatable if you're observing carefully. So that's why if everybody has been vaccinated, you have to wait 15 minutes there just to make sure you're not going to have a very serious anaphylactic shock-type reaction.
There are a lot of people who have had allergic reactions that are milder than that. And I think for those individuals, it's worth a conversation with your physician about whether there's a way, by using an antihistamine treatment or another treatment, to moderate that allergic reaction, you could still go ahead and get vaccinated.
The number of people who have truly serious enough allergic reactions not to be able to use one of the vaccines is very, very low. And another thing to ask is remember that we've got now several different vaccines available. There probably will be more available soon, back to your chart. So important to ask your physician. Even if you had a fairly serious allergic reaction to one type of vaccine, we're lucky to have several different kinds of vaccines where you may not have a reaction to the others.
OK, great. So what about people who are pregnant? This has come up a couple of different times. Is there a better outcome for individuals in their first trimester or second trimester or third trimester to get the vaccine? Is there any difference?
Yeah. The risk of the vaccine looks very low. So we haven't done those same really, really large randomized clinical trials that give us such definitive evidence in other populations. But from studies of people now, tens of thousands of pregnant women who have gotten vaccinated, at each stage in their pregnancy, the results look very good. No signs of any serious adverse effects. And actually, benefits in two ways.
One is people who are pregnant and get COVID do have more serious outcomes, and that is actually a threat to early labor and other complications with the pregnancy. And second, the antibodies that you make in response to the vaccine are transmitted across the placenta and in breast milk. And so that does help provide some immunity for your infant and the baby before it's born.
OK. On the flip side of that question, Nicole Lockwood asked, what about women's fertility? Any negative side effects? Was there any testing done with fertility after you get the vaccine?
None that have been detected. The thing about vaccine side effects, Joan, is they can be rare, but it's--I would say you never want to say never. But almost unheard of that there would be a long-term effect of a vaccine, a side effect of the vaccine that you don't see beginning to show up in the short-term.
So most of these reactions are really fast, within the first day or two, like the allergic reactions that we talked about. Some of them, like that those very rare reactions to the J&J vaccine with the clotting, those happen within the first six to 15 days. So just a couple of--within a couple of weeks of vaccination. We haven't seen any evidence on any vaccines of longer-term effects that didn't show up in some form in the short-term. So I don't know of any evidence to suggest issues with fertility from the vaccines at all.
OK. A couple more questions before--
--other prior vaccines either.
Right, right, right. I'm going to ask you a question--I'm going to give you a minute to think about a big picture question, then I'm going to ask you a very specific. It's actually an insurance question. So from one of our agents coming in on insurance and liability question. And I'm going to ask that first.
But I want you to think about, if you were president or if you were able to change one or two things in our current health care system of delivery--so whether it's managed care or Medicare or Medicaid, single payer, paying for prescription drugs or vaccines, or anything else--this telemedicine we've experienced all now through COVID.
There's lots of trends out there longer-term for health care delivery, but if you were kind of president sitting and can wave your magic wand, what would you think there's one or two things are we could change in society so health care delivery will be more efficient, less costly, you name it.
I think the most important thing, Joan--this is obviously a longer question, but to me, it's changing the way that we pay for health care to focus more on value, to focus more on the things that matter most for people. So you mentioned telehealth, you've seen a big shift of telehealth. But what's really mattered isn't just telehealth by itself, but telehealth combined with data that people can track on their own using digital trackers about how their own health is doing, especially if you've got a chronic disease. You can be much more in charge of your health, too.
And you can work more effectively with your doctor if you all are sharing that data. Getting--using remote monitoring from home, using team-based approaches of care, including things like, hey, if it's the most effective thing for your health. I'd love to see more health plans covering those trips to the--getting a vaccine.
Some of the health care organizations that are into this value based care approach are also doing things like reaching out to their beneficiaries who haven't gotten vaccinated yet, finding out what their questions are. So there's a question about hesitancy. For many people, it's just this happened too fast. Is this really safe? Is this really effective?
Where if you talk to your health professional that you trust, you can get those questions answered. Or if there's someone in your community who's been vaccinated who you trust, and there are lots and lots more people like that, you can get those questions answered. So good health systems will facilitate all of that, and that means changing the way that we pay, the so-called value based payment. Paying more for outcomes. Not just paying a lot because a drug is new or something like that, but paying because it's really having an impact on our health.
OK, fantastic. We're going to end with an insurance question. So do you see a legal liability for larger venues as they reopen. So stadiums, concert halls, bars, if you will. I mean, there's a lot of--this is an insurance crowd and people worried about being sued, and how is that going to be handled going forward? This is, as you said, COVID is here to stay, or another variant of COVID, another pandemic in the future. So this is a big question.
This is a longer answer. In a public health emergency, there are some protections for businesses that reopen in compliance with EEOC, with guidance related to an employer--OSHA and related CDC guidance. Looking forward, I think as long as there are clear disclosures around the additional risk for people who aren't wearing masks and the like, I don't see a big liability issues arising. Like I said, I'm much more concerned about just trying to get the infection rates even further down and helping people who are unsure about the vaccine getting access.
Well, with that, we are going to thank you. So tremendous to have you back for our session. We had record turnout. We're thrilled that you're able to share your wisdom and insights with us. And again, thank you for all you've done in the public health arena and for your public service. And we're just grateful again to have you with us. So thank you, Dr. McClellan.
Thanks for all you're doing. I hope everybody stays well.
(DESCRIPTION)
Joan Woodward and Dr. McClellan appear. Slide, text, Upcoming Webinars.
(SPEECH)
OK. And with that, my friends, I'm going to just give you a couple of teasers on our upcoming webinars. Next week we have behind the scenes at the New York Stock Exchange, everything you want to know about stocks, IPOs, direct listings with my friend, Amanda Hindlian, who is the Head of Global Capital Markets at the NYSE.
And then in two weeks we have June 30th, the connection between ESG issues and a company's long-term sustainability with former SEC Commissioner Paul Atkins and our Travelers own Chief Sustainability Officer Yafit Cohn. And then on July 14th, you can listen in to understand how you can innovate like a unicorn with our own Travelers’ Chief Innovation Officer talking a lot about innovation and insurance, Kevin Smith, Alchemy Crew’s, Sabine VanderLinden, and Beth Maerz, the Head of our Customer Strategy and Personal Insurance.
Then on July 28th we're going to hear from Dr. Rob Hartwig. He's a well-known figure in insurance market insights. So register for all these programs at the TravelersInstitute.org. It's also in the chat if you want to click on those buttons. So I invite you again to connect with me on LinkedIn. And with that, wear your mask, get your vaccine, get ready to open up this economy. It's going to come roaring back and we're all ready and standing ready to insure all the new GDP we're going to create together.
So again, Dr. McClellan, thank you a million for joining us. Be safe, my friends, and have a great week.
Summary
The State of the Pandemic
In the United States, as of June 1, 2021, COVID-19 infection rates have dropped to well under 30,000 new cases per day and a 7-day average of around 300 deaths per day, numbers not seen since summer 2020. Dr. McClellan shared a positive outlook for summer 2021, particularly for those individuals who have been vaccinated, with summer camps resuming and family vacations being scheduled.
He emphasized what a difference six months makes, reflecting on his January 2021 appearance on the Wednesdays with Woodward® webinar series, where he discussed the race to distribute the newly authorized vaccines. Dr. McClellan credited them for preventing severe illness, hospitalizations, death and even transmission.
Encouraging Vaccinations in the U.S.
Despite this good news, Dr. McClellan cautioned that we have not beaten the virus, with many people in the U.S. and globally still unvaccinated, and COVID-19 infections and variants still spreading around the world.
In the U.S., where vaccines are readily available, he highlighted creative incentives offered by state governments and even businesses to encourage people to get vaccinated, including cash, lotteries and even free donuts and beer. “They do work,” he said. “The evidence is that [these incentives] get people’s attention.”
He also highlighted the role of employers in encouraging vaccinations. He noted instances of businesses hosting clinics in partnership with their state or local public health departments, at or near their workplace to make vaccines more accessible for their employees.
Supporting Global Vaccination Efforts
Addressing COVID-19 vaccinations on a global scale is “the most important, really big and challenging next step to move beyond the pandemic here in the U.S., and also the rest of the world,” according to Dr. McClellan. He estimated that, thanks to investments in manufacturing capacity, the U.S. will have potentially one billion extra doses of COVID-19 vaccines through the end of 2021.
Dr. McClellan underscored the importance of not only manufacturing the vaccines, but also having a plan to “get those shots into arms,” considering manufacturing, storing, distributing and administering them. He pointed to the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), an effort launched in the early 2000s to distribute billions of doses of AIDS medication to sub-Saharan Africa, Asia and other parts of the world, as an example of a large-scale, U.S.-led medical relief program.
“The benefit is not losing millions of lives, not losing the opportunity for the rest of the world’s economies to recover and [being able] to move past the pandemic globally,” concluded Dr. McClellan.
Presented by the Travelers Institute, the Duke-Margolis Center for Health Policy, and the Partnership for New York City.
Speakers
Mark McClellan, MD, PhD
Former Commissioner, U.S. Food and Drug Administration; Robert J. Margolis Professor of Business, Medicine, and Policy, and founding director, Duke-Margolis Center for Health Policy, Duke University
Host
Joan Woodward
President, Travelers Institute; Executive Vice President, Public Policy, Travelers
Join Joan Woodward, President of the Travelers Institute, as she speaks with thought leaders across industries in a weekly webinar.
FULL DETAILS