The Race to Distribute a COVID-19 Vaccine

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Text, Wednesdays With Woodward (registered trademark) A Webinar Series, The Race to Distribute a COVID Vaccine. Below are logos for the Duke Margolis Center for Health Policy, Travelers Institute, Travelers, Partnership for New York City, and SBE Council, Small Business & Entrepreneurial Council. There is a video box to the top right with Joan Woodward speaking.

(SPEECH)
All right, terrific. Good afternoon, everyone. And thank you so much for joining us today. My name is Joan Woodward, and I'm honored to lead the Travelers Institute, which is the public policy division and educational arm of Travelers Insurance.

It's great to be back with you this year as we continue our Wednesday With Woodward Series with a fantastic line of speakers, especially today, to explore issues impacting our personal and professional lives, and living through these very difficult and uncertain times.

So today, we're thrilled to be joined by the Duke Margolis Center for Health Policy, the Partnership for New York City and Kathy Wylde, and our Small Business and Entrepreneurship Council for partnership in this program. We're really pleased that you're here today with us, and hope you'll stay engaged with us throughout the year.

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Join our mailing list, institute@travelers.com, the LinkedIn logo, text, Connect, Joan Kois Woodward, Watch replays, travelersinstitute.org, #Wednesdays with Woodward.

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You can join our mailing list by emailing institute@travelers.com to be added to the email list to get our invitations. You can also connect with me on LinkedIn or watch replays of past webinars on travelersinstitute.org.

So before we get started, I'd like to share a disclaimer about today's program.

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About Travelers Institute Webinars, Wednesdays with Woodward is an educational webinar series 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. Travelers Institute, Travelers.

(SPEECH)
Today's topic is a very timely one, the race to distribute a COVID-19 vaccine. To date, two vaccines have received emergency use authorization from the US FDA-- one from Pfizer and one from Moderna.

Distribution of these vaccines has started, beginning with health care workers, the elderly. Although this week, additional groups may be added as well. It's certainly a milestone in the world's fight against the coronavirus and one that many of us have been really eagerly anticipating.

But now that we have the vaccine, we face the challenge of distribution. And distribution, as you know, whether it's insurance distribution of products, it really critical in understanding how to manage the supply chain. How do we get from here to inoculate the vast population in the United States, and in fact, the world?

Hee to help us today to understand why this might look like is Dr. Mark McClellan. Dr. McClellan is former FDA commissioner under President George Bush. So Mark, welcome. And we're so thrilled to have you here.

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Picture of the doctor on the left, text on right, Speaker, Dr. Mark McClellan, Former Commissioner, US Food & Drug Administration, Robert J. Margolis Professor of Business, Medicine, and Policy, Founding Director, Duke-Margolis Center for Health and Policy, Duke University.

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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 on Duke's research, education, and engagement capabilities to help inform policymakers and create a better health care system. 

Most notably, the center is addressing the COVID-19 pandemic as a member of the COVID collaboration. Now, this is a group of the nation's leading public health education and economic experts who are working with state and local leaders to help stop the spread of coronavirus, and safely and sustainably reopen our businesses, our schools, and our communities.

Prior to joining the center, Dr. McClellan, as I said, served as the head of the FDA under Bush. And thus, has really intimate knowledge of what it takes to develop, approve, and distribute a new vaccine in the US. In addition, Dr. McClellan is a former administrator of the Center for Medicare and Medicaid Services. And if you don't know what that is, it's under the Department of HHS, and it is all of Medicare and all of Medicaid.

So in these roles, he implemented major reforms in health policy, including adding a prescription drug benefit in the Medicare program, Medicare and Medicaid payment reforms, the FDA'S critical path initiative, and the public private initiatives to develop better information on the equality of cost and care.

He also served as a member of the president's council of economic advisors, senior director for health care policy at the White House, and Deputy Assistant Secretary for economic policy at the Department of Treasury. He holds a PhD from MIT, as well as an M.D. and an MPA from Harvard. Dr. McClellan also currently serves on the board of Johnson & Johnson and of Cigna, as well as a few other private companies.

Before I hand it over to Dr. McClellan for a quick note, we're going to have time at the end of this program for your audience questions. But please don't hesitate and wait to submit your questions. Please do it as we're speaking. You can do that by the Q&A function at the bottom middle of your screen. And if you don't want me to read your name, you can send it in anonymously. So we're truly honored to have you with us Dr. McClellan today, and we really appreciate your time.

Hey Joan, great to be with you and your colleagues on, I guess, the special Thursday edition of Wednesdays With Woodward. But a lot of these days kind of look the same anyway, I guess.

They're all running together. Yeah, we throw a little curveball to start the year. So you know what? Let's just kick off right away with a procurement of vaccine doses. And we have a slide here for you to kind of talk to. So early on, the federal government pre-purchased these vaccines, then candidates before they were even approved, including 100 million from Moderna, 100 million from Pfizer.

And companies move forward with manufacturing these.

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United States Vaccine Investment, A chart with 7 columns. Row 1, Moderna, $4.1 billion investment, Trial Phase 3, 94.5% effectiveness, Was approved by FDA 12 out of 18, 200 million pre-ordered doses, and 300 million optional doses. Row 2, Johnson & Johnson, $1.5 billion investment, trial phase 3, effectiveness to be determined, was not approved by the FDA, 100 million pre-ordered, 200 million optional doses. Row 3, Pfizer, BioNTech, $4 billion investment, trial phase 3, 95% effectiveness, was approved by the FDA 12 out of 11, 200 million doses pre-ordered, 400 optional doses. Row 4, AstraZeneca, Oxford, $1.2 billion investment, trial phase 3, 90% effectiveness, was not approved by the FDA, 300 million doses pre-ordered, 0 optional doses. Row 5, Novavax, $1.6 billion investment, trial phase 3, effectiveness to be determined, not approved by the FDA, 100 million doses pre-ordered, 0 optional doses. Row 6, Sanofi, GlaxoSmithKline, $2.1 billion investment trial phase 2b, not effective, not approved by the FDA, 100 million doses pre-ordered, 0 optional doses. Total investment, $14.5 billion, 1,000 doses pre-ordered, and 900 optional doses.

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Was that unprecedented? Had companies to ever move forward with manufacturing hundreds of millions of doses even before the FDA approved? Or is this a first-time thing?

Joan, this is unprecedented in many respects. Prior to this pandemic, we did have national stockpiles for some emergency response activities, but never anything at this scale. This level of commitment to manufacturing.

Even before we knew whether the vaccines would work or not enabled us to go from what has been a very linear and uncertain process for vaccine development where you do pre-clinical testing, and then small clinical studies, and large ones.

Then only after you figure out if things really work, you do this kind of large scale manufacturing to a really hyper parallel process, so a lot of things could happen at once, a concerted effort to do large scale clinical trials, even as large scale manufacturing was underway.

So we've never seen a pace of vaccine development like we've seen in this pandemic less than a year from when the virus first started spreading to having millions of shots in arms. It's really an unprecedented achievement.

So how does this all work? Give us the background of how these purchasing options and kind of deals are reached? I mean, how do the companies themselves decide well, kind of to deal with the US government for 200 million doses? What about China, the UK? I'm sure countries are just lined up all over the world demanding these doses. And how do the companies kind of think about allocation?

Well, because of the scope of the pandemic, I think you saw the companies all coming forward not just because they saw a business opportunity here in terms of manufacturing effective vaccines, but this is an unprecedented public health emergency. And we've seen, as a result, a lot of collaboration between companies, including all the ones you have listed here, the US government, and governments around the world to respond.

What most of these agreements involve is the company going at risk to some extent, spending a significant amount of their capital and investing in additional manufacturing capacity and the purchasing, there are a whole lot of advanced purchase contracts that go along with the vaccine. You've got to have like glass vials to put it in and I have confidence that you're going to have the complementary supplies when you need them like needles, syringes, et cetera.

So that only is possible really with a significant level of government involvement, not only sharing some of the financial risks with the companies by giving them contracts where they get paid some for the manufacturing even if the vaccine doesn't work out, not all, so it's a joint risk, but also the governments making contracts for everything you need to go along with vaccination at this scale. The protective equipment, the needles, the syringes, the glass vials, et cetera.

That's happened in the US. It's happened in other developed countries, in the EU, Britain, Australia, Japan, et cetera. And it's also happened in other parts of the world with other manufacturers besides the ones that the US government is working with so closely.

So there are several Chinese vaccinations in emergency use in some parts of the world now that went through kind of a similar process. Chinese government investing, in some cases working with other countries to make supplies available.

Russia's developed a vaccine. I'm not as convinced by its supporting evidence. But collectively, that means there are going to be hundreds of millions of doses of vaccines with pretty good evidence behind them that will be available this year.

So those numbers of doses, again, 200 million from Pfizer and 200 million from Moderna. And we'll talk about some of the other companies under development. But those are 400 million doses. Where is that compared to where we need to be to vaccinate our whole population?

Well, I mean, partly it depends on whether the additional vaccines that haven't yet quite completed their clinical development turn out to work as well as these first two-- the Moderna and the Pfizer BioNTech vaccines. As you've got on the chart, that's 400 million doses expected by the end of the second quarter.

So that's enough for potentially 200 million people. Actually, that's by later this year. So potentially, 200 million people by later this year since it's two doses for each person. The J&J vaccine is on track and on the board, but no private knowledge here.

The way these clinical trials work is there's an independent group of clinical experts that oversee the trial. When they see enough events of related to COVID happening in the trial, they get to take a look at how many of those events happen in the group that got the vaccine versus the group that was randomized placebo.

And then they determine well, does it look like there's a strong enough effect that we can end the trial now. That first look for the J&J vaccine is on track for happening maybe in the next week or so. These clinical trials have gone pretty fast in part because there are just so many COVID cases out there around the United States and other parts of the world where the trials are taking place.

J&J, there was some news on this week. Maybe it's running a little bit slower than I had hoped for the February doses, but should have close to 50 million doses available by the end of the first quarter, 100 million as you point up here by the end of the second quarter. That would get us a long way to having enough doses for the US population.

Novavax also in your chart has these advanced so-called phase III trials. Underway now, they're a little bit further behind. Probably, March or so before those trials or are completed. But Novavax could also be in the US market at significant scale in the second quarter. Collectively, that's enough to vaccinate the US population by later in the second quarter this year. At least everybody who wants it.

As you can see, there's potentially even more doses on this list. And that's because the government, working with the companies, wanted to have some insurance policy. Not put all their bets on one vaccine when we didn't know which one, if any, were going to work.

So if there are additional doses available, that can potentially be kept to some extent in a reserve if needed. But also, could be used to expand access in the rest of the world. And other countries that have enough money to do it, basically, are taking a similar strategy. They invested in several vaccines. Typically, they're aiming to get enough for their population, so as soon as possible in 2021.

But if all of those global vaccination contracts with high income countries do, in fact, come through if all of these vaccines end up working, that'll make a lot of additional doses available for the rest of the world.

Finally, there's an effort underway in low and middle income countries supported by an international effort called COVAX, that some countries, not the US, has contributed to, that is on track for, maybe, a couple of hundred million doses this year, which is not nearly enough for the remaining 4 or 5 billion people in the rest of the world.

So there's additional ramp up of supply expected. For example, J&J is expecting to produce a billion plus doses this year. Pfizer has increased their capacity to get to the billion-dose level. And if these vaccines all work, we could also have significant vaccine availability in low- and middle-income countries by the second half of 2021, but probably extending well into 2022 before the very broad availability of vaccinations globally.

Great. Thank you so much for that overview. We're very hopeful that all the other companies are as successful as the first couple here.

Yeah.

So it's one Tuesday the Department of Health and Human Services really did change course in announcing these two major changes in distribution. First, they recommend that states open up the vaccine to everyone over 65 and young people with certain health conditions. Second, it says the government no longer hold back the second dose and vaccinate just everyone.

So talk to us-- and I know Joe Biden, tonight, President-elect, is going to roll out his plan for vaccination. So talk to us about the distribution process and challenges we've seen to date. And how has this impacted the decision to speed these things up and the Trump administration. And do you think this is going to work-- this new strategy?

Yeah. This is a really challenging implementation program, the US has never before-- some of you may remember, polio vaccination in the 1950s, the US really has never before had a public health implementation program at this scale-- whole population, multiple vaccines, multiple doses in the midst of a raging public health emergency, pandemic. That's challenging.

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Two video boxes, Joan Woodward on the left and Dr. Mark McClellan on the right.

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And we've talked about, Joan, all of these remarkable steps in terms of doing the clinical trials, quickly, without cutting corners doing the large-scale manufacturing. The federal government, backed by the US military, has set up a distribution system for these early vaccines, while they're in limited supply, where basically, the states can connect to the federal government, which monitors on ongoing basis, the vaccine inventory. And then distributes it out to where the states wanted to go according to these priorities.

There was a pretty extensive effort led by the Centers for Disease Control and their independent expert group, their advisory committee, on immunization practices to lay out who should get vaccinated first. They came up with a whole priority list, I'm sure many of you have heard of, starting with the so-called group 1A of frontline health care workers and people in nursing homes. Nursing homes having been so hard hit in the pandemic.

And then group 1B was going to include other very high risk groups-- elderly people over 75, some frontline workers like grocery store workers, who have also had high rates of COVID, also other essential workers like teachers, who really need to get kids back in schools.

And there was going to be a group 1C that included other people at high risk, people over 65, people with other serious chronic conditions that put them at elevated risk.

What we've seen happen is the initial distribution led to some gaps. Not the distribution out to the states and where the governor said they wanted the vaccine to go, but that last mile from the hospitals or the public health agencies that we're going to administer the vaccines, that last inch, maybe, into people's actual arms, that's where it's been challenging.

The hospitals, right now, that are trying to vaccinate their frontline workers are also facing absolute peak levels, highest levels we've seen, of COVID cases, hospitalizations, deaths. So they are really stretched. The nursing homes, it takes some effort. These are typically not huge institutions. So doing 80 or 90 nursing home residents and workers in a day would be quite an achievement. So that's ended up taking some time.

And in addition, public health workforces have been really stretched too. There are some public health, local agencies, you've see them on the news. They've tried to open up vaccination clinics, but they get so much more demand that they can't meet at all. And they have a limited amount of staffing. I can't answer all the phones and so forth.

So we've had these gaps emerge. Right now, probably, about 40 million doses or totally available, have been manufactured. More than 20 million of those have been distributed to states, probably, on the order of 22 or so million today, probably, about 10 million or so actual vaccinations. And the vast majority of those are the round one vaccination, just starting to get to round two now.

And that's led to a lot of pressure to open it up availability of vaccines more widely. And, Joan, that's what led to the announcement, on Tuesday, by HHS, who said, sort of like the strategic advice from Mike Tyson. Everybody's got a strategy until they get hit.

There is so much pressure, in all seriousness, from the high level of cases and spread and new variants, that it really adds to the pressure. It just get as many shots in arms of as many people at elevated risk as quickly as possible without so much of a careful mechanical distinction of all of these levels.

So HHS, basically, said, if you're over 65 or if you have a chronic condition or if you're an essential worker, you should be able to get access to a vaccine. And states, get those shots in arms as quickly as possible. So what that's done is opened up some more avenues for distributing vaccines and kind of simplified the process for determining if you're eligible.

So some proof that you're a teacher or an essential worker, that you're over 65, you can get a vaccine. And Joan, as you might guess, there probably or-- well, there definitely are tens of millions of Americans in those categories that really want a vaccine.

And I think for the coming weeks, we're going to be working through that whole set of people who-- we've heard a lot about vaccine hesitancy and it's a real issue. But for those tens of millions of Americans in high risk groups who want the vaccines now, they're going to try to get it as quickly as possible.

And that's why you're seeing more steps opening up access-- events at Disneyland, football stadiums, more vaccines being distributed to pharmacies that can give out shots in communities all over the country. We started out maybe doing a couple of 100,000 immunizations per day. By today, we're probably up to 700,000, 800,000 range.

The Biden administration said they had a goal of a million vaccinations per day for each of the first 100 days. We may be at that number before next Thursday with this kind of opening up of capacity. And that's a good thing from a public health standpoint when they're in the midst of a pandemic. The more people who are immunized, the fewer hospitalizations you're going to get, the less stress on the health care system. That's really important.

The challenge here, the downside, Joan, is that those more nuanced groups really tried to get the vaccines first to not only the people who wanted it the most, but the people where there was for impact on the economy reasons or health reasons, the very biggest value for the vaccines or, at least, their judgment about the biggest value.

And what we're probably going to see is for the next couple of months, lots and lots of people getting vaccines, opening up of new capabilities for delivering those vaccines, trying to meet that demand. So I'd be surprised if we don't get closer to maybe two million doses a day at some point in February and into March.

But there's still a lot of Americans who are more hesitant. And they're disproportionately represented among rural populations, among low income populations, among minority populations for a whole host of reasons. Those are some of the populations that actually been hardest hit by the pandemic.

And so what we'll probably see is some disparities emerging with high rates of use in some population groups, in some areas, and bigger gaps than others. And we're not really going to have this pandemic under control until we get to high levels of immunity in every group in our population, particularly, workers and others in neighborhoods, where there have been a lot of outbreaks. So this is some hard work ahead.

You mentioned the Biden administration, they're going to announce sort of the outlines of the main Biden COVID response plan later today. It's going to include a lot of economic elements, additional help for people with income, additional checks, additional unemployment insurance, additional help for businesses that have been hard hit and continue to be hard hit. But also some further steps on vaccinations and other policies.

The other policies include a lot more support for testing, including testing in schools and some of these high risk workplaces over the next few months before we get to broader immunity, a public health core, many more public health workers to help with these activities.

More spending to increase the effective vaccine supply, so that you can more confidently not hold back and reserve all the vaccines you need for the second dose. Think of it as just in time manufacturing and distribution, so that you can ramp up the supply further.

I think the estimated cost for that is going to be $160 billion just for these vaccination, testing, and other direct COVID response components. And a lot more for steps like reopening schools, including a goal of getting K through eight reopen nationwide by March, and testing and other steps to support that. And then all of those economic steps.

That program is probably going to build on what we've already seen-- being flexible about who can get the vaccine, at least, within these broad risk groups. If some additional people use some of the extra shots, well, we'd like to prioritize it. But the main goal is just getting lots of shots in arms fast. So I think you're going to see an even more doubling down on this approach as the new administration comes in.

1. OK, that was a lot, though. It was just really terrific. I know you're on the inside baseball of all of this, so it's just so great to hear your perspectives. But I have a question, coming from a medical perspective. So what sort of drop off are you going to expect to see from the first to the second dose for this shot? What are the protections afforded to you? You just get one dose. I mean, I know the shingles dose, there's a couple other vaccinations out there that you have to get the second dose for it to be highly effective.

And then when you speak about the rural population, do you think there'll be some sort of public awareness campaign to get the Hollywood stars involved, to get some level of really just awareness about how critical it is for people to get these vaccines to create this herd immunity that we'd like to see in the population? And what's your view of herd immunity? Is it 60%, 70% of the population being vaccinated?

So there are few things unpacked there. But first, with the two doses. I do think we're going to do pretty well, at least, for this initial phase of vaccination and getting people back for the second dose. That's what some other countries, like Israel, are experiencing so far.

And part of the reason for that is that people are getting vaccinated now are the ones who really want it. They've had it with COVID, they trust the vaccine, they want to move beyond this. And so that is a strong motivator to get back and get the second dose.

You mentioned like the shingles vaccine, some others involve, boosters a couple of months apart, these are even tighter together. So as long as we don't flub it up, as long as there is plenty of supply for people to go back to get it, I think, at least, initially, we should do pretty well on the adherence to that two-dose strategy.

And people are going to get help with this. Health care organizations will administer it to their own workers. They've got a strong interest in making sure their workforce isn't going to be compromised going forward, given how much burden they're facing right now. Nursing homes, same thing. And then a lot of these very motivated individuals who want to make sure they get the immunity.

Where I worry more about that, Joan, as I was saying earlier, as we get beyond the people who really, really want the shot to the ones who are unsure right now. And if they do it, you probably need to make it easier for them. A lot of people who can easily drive to go to a drive-thru, and then have it in car. I may not easily be able to make an online appointment or something like that.

And as we get to that stage, that's where things are going to get more complex for getting the second dose. Some of the highest rates of outbreaks have been in homeless shelters or in jails. And if people are there, temporarily not there the next month, we don't have any great mechanisms for following them. So probably, you'll see more of these challenges around second doses emerging a little bit later on.

And then in terms of this question about herd immunity, it does look like the vaccines are really effective. As you know, if we can get immunity, that not only protects us from getting symptoms, but also protects us from getting infected, and then transmitting that infection along, that's really critical for herd immunity.

And the one thing, one important thing that we weren't able to determine that you normally determine if we weren't in a public health emergency it's a vaccine became available, is just how protective are these vaccines in terms of-- they're clearly very protective and keeping you from getting even minor symptoms, let alone hospitalized or worse.

But we don't know yet, because it just takes time is whether they also prevent you from even getting COVID asymptomatically at all and being able to transmit it to other people. The way they we're going to answer that question is by tracking lots and lots of people who have been fully vaccinated, they've been there weeks beyond their second shot and comparing them.

We have to screen them using the usual COVID tests. Since they're probably not going to have any symptoms at all, screen them and compare them to another, to a match population that hasn't been vaccinated for whether or not they are more likely or hopefully significantly less likely to pick up the virus, and then be able to transmit it.

So we'll know the answer to that, hopefully, within a couple of months. And I'm fairly optimistic that-- I mean the vaccines look so effective, that they should give you a good deal of what's called a mucosal immunity. The virus can't even take up shot, let alone cause serious symptoms.

So I'm fairly optimistic, but we don't know. And in the meantime, it's really important to-- even if you've been vaccinated, it's good that you are reassured that you're not going to be, at all, likely to get sick. But very important to keep up the distancing, keep up the mask. In the workplace, it's same thing-- distancing, mask, washing hands, all the things that we know are really critical. And then hope that we get a good answer to that question with experience with the vaccines over the next couple of months.

OK, terrific. Let's talk about these newest strains of the vaccine. So if a virus is constantly mutating-- coming from different countries, now I understand there's a new US version of the mutation. All these existing vaccines, so people are saying they're going to offer the same protection, but are you worried about that in terms of the strains?

Yeah. I am concerned about it, Joan. Not so much for the vaccines that we have available now, unless we see a good deal more rapid mutation than has been the case so far. But over time, viruses, they do mutate.

Everybody knows that they have to get a flu shot every year because the influenza virus is just very different from year to year. So your immunity to last year's flu is still there. It's just not relevant anymore because the virus has changed so much. And what we're starting to see--

Is it too late to add a flu vaccine? And are you recommending highly that people--

Getting to be too late, but not too late right now. We'd encourage, if you haven't gotten one, this is a good year to get one and avoid having any symptoms that look like COVID and putting any more strain on our health care system. But you should do that right away.

For the COVID vaccines, though, what the vaccines have created is reaction against a number of different parts of the virus. And some of those parts of the COVID, the so-called Sars-CoV-2 virus, do change pretty rapidly, but some of them don't.

And the vaccines have been developed for deliberately designed to go against multiple sites on the virus. So hopefully, what we've seen so far is that these individual virus mutations, which are real and are causing more rapid spread in lots of parts of the world.

England is on lockdown in significant part because of a more transmissible version there. South Africa is having a raging out outbreaks in that country even in the middle of winter-- I'm sorry. In the middle of summer. It's middle of summer there when people should be out and apart and so forth, should be less transmission, because they've got a really tough variant. And they're starting to spread in the US.

That's partly what led to the revision in these vaccination strategies, is we are running a very fast race in time against the spread of these more contagious versions. So we need to get as many people vaccinated as quickly as possible.

But those individual changes are probably not going to render the vaccines ineffective. On the other hand, over time, as these add up, and now the virus has been pretty much spreading unchecked for the past year, now, we're starting to fight back.

And because these mutations do come along because the virus is so widespread all over the world, we're going to be selecting more as more people get vaccinated, that the strains that stay around are the ones that get around that. So we're going to see more of these, probably, emerge in the months ahead.

So really important will be to keep an eye on those. Keep checking to make sure the vaccines we have now are protective against the variants. Over time, hopefully, not rapid time, but over time the vaccines that we take are likely to become less effective against the form of COVID that's out there.

The common cold virus is another coronavirus, so we know that these viruses can change in ways that kind of keep them coming back. So to prevent that, Scott Gottlieb and I wrote an Op Ed in the Wall Street Journal this week about how important it is to have a national, really a global, surveillance system, where we're not only checking to see if there are outbreaks of COVID, but doing the so-called gene sequencing of each of a sample of the viruses that are turning up in all parts of the country to see if there are these variants emerging.

And to test those against the vaccines that we have, and also the treatments like the monoclonal antibodies because they will get less effective over time because the viruses do mutate. What we don't know yet is how rapidly that's going to happen. But we need to get prepared now for just like we do with the flu, having sort of a base vaccine platform, but one that we can modify pretty quickly to keep up with the changes in the virus.

So talking about changes of the virus, both the Pfizer and Moderna are only approved for adults. I think Pfizer is over 16 years old and Moderna's over 18 years old.

Yeah.

So what do we think about our children? And how is this going to impact the schools in the next fall? Are the companies doing clinical trials on children these days? Or when are we going to expect our children to be vaccinated?

They are. And I think, Joan, doing it in mind with fall going back to school time frame. So fortunately, kids are much less likely to have serious consequences from COVID. That's why all these early first vaccine studies were not on kids. We want to get a good idea about the effectiveness of the vaccine and the safety of the vaccine in populations that really were facing more risk and would benefit more, personally, from taking the vaccine.

Now that we know that we have vaccines that look very effective and also quite safe, there are studies getting underway. And children under 16, they're going to probably include some modifications in the vaccine to be more suited to younger bodies. And they're probably not going to be as large as the trials that we have already.

They'll probably focus on things like, are there any safety issues, any serious side effects in kids that we didn't see in adults. There's no reason to expect any, but you'd like to be sure. And do kids mount as strong of an immune response to the virus as the adults did. The answer to those is yes, they appear just about as safe in kids. And yes, the vaccines can be formulated in a way that gives kids a strong immune response.

I would expect to see an authorization for vaccine for these potentially reformulated vaccines in children, probably, sometime first half of this year. Not right away, but by late spring, summer with an eye towards having much more vaccination available in children by the time they go back to school in the fall.

School reopening this year, look at the Biden announcements coming out today. This is a super high priority for him. Not just because it's so important for kids' education, but so important for the workforce, especially women to be able to get back to work and to get us back towards normalcy.

So we're not going to count on kids being vaccinated then. Kids do transmit the virus. There's some evidence that younger children are less likely to transmit than older children. Although some of the new variants seem-- they don't make people sicker if they don't make it more likely that kids will have serious consequences, but they do seem to transmit more in children.

So school reopening this year is going to have to happen with some special measures in place like masks and the like, both to prevent spread among children and from children to adults or from children back to people at home. So masking, more testing, steps like that to give some confidence about schools reopening for part of this spring.

And maybe in the summer, there's some calls for, maybe, continuing school on into the summer since there's so much evidence of so many kids falling behind this academic year. But then hopefully, the vaccinations will work out and be a more important part of containment in kids and schools by the fall.

1. I have two quick questions for you. And then we're going to open it up to audience. We have a ton of questions coming in from the audience here. But we want to get your perspective on something that's really important for the business community. And I know every single company is kind of grappling with this.

So how likely or important do you think it's going to be that employers will require COVID vaccines prior to their workforce kind of coming back into the office? I mean we require kids to get vaccinated already to come to school in most of the country. And most of the school districts require a certain level of vaccination.

But now with this COVID, a lot of employers are very worried. And we see it in our business of selling insurance to different businesses. But what are your thoughts on mandating that employees get it except for certain people who have health conditions? And are we really going to be able to reopen the whole economy without kind of this herd immunity of people being vaccinated up to 80% of the population, for example?

Yeah. I think we can get to herd immunity without mandating vaccines in the short term. Just to do the math for what it's going to take, we've got probably 10 million Americans, or pretty close to it, infected so far. Sorry, close to 30 million Americans infected so far, 25, 27 something like that.

And really, probably, many more than that haven't had an official detection of their infection. I think most of the epidemiologic estimates now or maybe we're at 18%, 20% of the population that's actually been exposed. Given this really horrible surge, we're in the midst of now, that's probably going to be 25% or more by the end of January.

So if we can get another 40%, 50% of people to take the vaccine throughout our country, so not just in certain areas, but broadly, that's a pathway to something like herd immunity or certainly, at least, health care systems not being overburdened and so forth, even if we don't get that mucosal immunity like I was talking about earlier, even if that's not full.

You can see that happening before summer, by the end of the second quarter if things keep on track as we've been talking about. So we can get to a level of herd immunity if we do things right from here. But in terms of mandatory vaccinations, I absolutely expect that to happen, at least, in high risk workplaces over the coming months.

So right now, there are very few places that do it. At Duke University, we've made it available to all of our frontline health workers. And some have said no, and that's OK for now, we're leaving. We've got sort of full precautions in place anyway-- PPE, distancing, et cetera, et cetera.

And we have very good confidence in our workplaces, that we're not seeing any people that are showing up with COVID because we've got COVID all over the place, but we have very good confidence that we're containing spread within the workplace under these very modified conditions.

If you want to go back to a workplace that is less modified, you need to be very confident that you've got high, high levels of immunity in your worker population to relax some of those measures. And that's probably not going to happen in the next few months because we need to keep these measures in place anyway for all the reasons that I said and because we're still early on with the vaccines.

But both Pfizer and Moderna are very much on track to complete their longer term clinical studies and do all the manufacturing stability, all that dotting the I's and crossing the T's that's necessary for a full approval, not just an emergency approval by sometime this spring. And J&J will be aiming for that as well, assuming studies go well from here.

So by the second half of this year, there should be several vaccines that are not just emergency approved, but fully approved with very good safety track records, regulatory data, and so forth. And I think after that point is when you'll start seeing more requirements for getting vaccinations when people really want to move forward with reducing some of the distancing measures and getting more groups back together and things like that.

But I think it's much easier when you're not dealing with sort of emergency use, but you're dealing with normal FDA approved vaccines.

OK, and my last question is actually one we got from the audience. So I'm going to read from Susan, the girl at HUB international. So what is your advice, Mark, for those who are skeptical about receiving the vaccine? And again, is there going to be this public awareness campaign about the value of getting the vaccine coming from the Biden administration?

Yeah. There are a lot of people out there like that. So it's a really good question. I mean, if you believe the surveys that are out there now, only about half or so Americans are going to get a vaccine, even when they're offered to it. They offer the vaccine for free, which everybody will be.

So that is a challenge. As I said, we have, going for us, in terms of herd immunity, we've had such poor control so far. There are a lot more people who are already immune. Unfortunately, those people are probably disproportionately represented than the ones who are not supportive of the vaccine, probably, also not supportive of mass and some other things too.

But there are important subgroups-- the different reasons for the skepticism. One big reason that there's a contingent of anti-vaccination views out there, which is fairly prevalent in the US. 10%, 15% of the population doesn't matter if it's COVID vaccine, any vaccine. It's going to be really hard to convince them to take it.

In addition, we're just coming off a very political year. Feels like it's still 2020, at least, for another week or so. But very political year where there are strong differences by political party and views and confidence in the vaccine, that started to normalize a bit with people who lean Democratic, getting more positive views. But a lot of Republicans, actually, are still skeptical. A lot of skepticism in rural areas.

And another very important group are people from racial and ethnic minority backgrounds, where long history of distrust of health care for totally understandable reasons combined with the extraordinarily rapid pace of approving this vaccine misleading and the politics leading some concerns that there have to be corners that were cut here, all kinds of rumors out there on social media that are totally unfounded.

And so we have a lot of work to do to reach many of those groups to get to national herd immunity, to reach many of the groups that I just described, getting at least another 20% or so of the population vaccinated, especially in rural areas and neighborhoods that have been hard hit.

We were totally not there yet. And what's likely to happen over the next couple of months is we're going to kind of open up the availability of vaccines as much as we can-- pharmacies, football stadiums, big events, and so forth.

And so we'll drive up our total numbers, but that's mainly going to represent people in that half of the population that really want the vaccine now. It's not going to, by itself, bring along that other half of the population that's skeptical or hesitant for the reasons that I just described.

So the education outreach, going forward, is really needed and really needs to focus on those group-- engaging those people where they are, making sure they get the facts about the vaccine. It's one thing for me to believe that-- I was FDA Commissioner, so I've a lot of trust in this process being done well.

A lot of people are not coming from that background, and we really do a lot more to reach them. There will be a bigger CDC government-led public education campaign coming soon. I think the Biden administration is going to ramp that up as well.

You mentioned earlier, Joan, that I'm part of this group called the COVID collaborative which is kind of a network of across industries and others. I encourage people to Google it. That's partnering with the ad council on the biggest public education campaign the ad council has ever done.

Over $50 million in investment plus a lot of unpaid time and effort to get messages to lots of different groups, especially those that are skeptical and/or having a bit of trouble getting the facts about the vaccine. This is an area where, frankly, a lot of business engagement will be really helpful. And personalizing, making this information as relevant and engaging to these groups as possible.

If that doesn't happen, what you're going to see is numbers of people vaccinated going up, looking really good for a while million, maybe even will hit 2 million people per day being vaccinated. And then come February, March, those numbers will start to tail off, not because vaccines aren't available, but because it's harder to reach these additional groups.

They'll see, well, we're getting a bit-- there's not many infections as there used to be. I wasn't keen on doing this before, why should I get one now? And you can see how this could really get to a state where we have a lot of kind of chronic COVID activity if we don't get more effective outreach and engagement with a broader part of the US population.

OK, thank you for that. Another question coming in from my friend Sue Espinoza at Lovitt & Touché. She wants to know if she can choose which vaccine to get, the Pfizer or the Moderna, at this point. And I assume J&J and one other hit the market.

And that's a question that a lot of people are asking right now and understandably, so. The short answer is yes, in terms of what would make you go one way or another. I mean, honestly, I haven't seen much to distinguish the Pfizer or the Moderna vaccines in terms of effectiveness and side effects. One's three weeks apart. The other one's four weeks apart. But not much else in the way of difference.

Because of the storage condition differences, Pfizer's a bit tougher with that ultra-cold storage. In some parts of the country, it's probably going to be easier to get access to the Moderna vaccine. That's fine. If you're not super hurried-- and this is not a J&J marketing plug, this is just reality. If you're not in a super hurry to get vaccinated or you're not in one of those very high risk groups, I'd at least wait for the J&J readout results, which should come within the next couple of weeks and see how that looks.

The bar for these vaccines is now very high. 95% effectiveness in terms of suppressing even any kind of symptoms. They're very effective in preventing hospitalizations and serious consequences. What we're seeing with some of the other vaccines, like some people may be thinking about an AstraZeneca vaccine, that's available in other parts of the world now.

They had some sort of serious bumps in the execution of their clinical trials, especially in the US with two good vaccines available, the FDA wanted them to kind of correct that and get more complete evidence. So that'll be happening over the next couple of months too. But that vaccine, with its current dosing and current levels of dose and two dose patterns, something like 70% effectiveness. So that doesn't sound that good compared to 95%. And I guess it doesn't.

But if you look closely, the AstraZeneca vaccine looks actually very effective in preventing serious cases of COVID. So when that one becomes available, if the further data tracks with what we know so far, you might have a bit higher risk of having minor symptoms-- headaches, aches for a few days, cough. But probably, very good protection, almost as good or about as good as the other vaccines against serious consequences.

And it has the advantage like the J&J vaccine of being easy to store and transport. J&J is one dose, not two. So that might distinguish it as well. That's going to make both J&J and AstraZeneca very popular in the low- and middle-income countries of the world too, where storage and maybe getting people back for a second doses is an even bigger problem than it is here.

But absolutely, all of these have been fully financed by the government and under federal law. Every health plan is required to pay for their administration with no co-pay. So you should have your choice of any of them.

OK, another question coming in from Elizabeth Bass Dr. McClellan have you been vaccinated? And how was it?

I have not been vaccinated yet. I am not in one of those high-risk groups. I guess, lucky for me, for now. So I can't tell you how it was. What we do hear, from people who have been vaccinated, is it's maybe a bit tougher than you might expect from a flu vaccine in terms of the side effects you get. So maybe a bit more of an ache, fairly prevalent aches and pains for maybe a day, maybe a little bit of fever, headaches, but nothing that lasts much more than a day.

1. Sarah Williams coming in now. If you receive the vaccine, will you still have to do a COVID test before you fly to certain areas? And do you think we're going to have to be able to prove that we've had our COVID test, which we should be carrying along some sort of paper or an app? Is there going to be an app to say you got the COVID test and all airplanes or other folks could just put your name in some sort of database?

Yeah. I think we're going to get to something like that. We're not there yet. So you may have seen the US government just required a COVID test within three days for international travel. And what you're supposed to do is go get the test, bring the proof with you to the airport, and the airlines verify it before they allow you to board the flight.

That's a little bit clunky. And that you've got to go get the test and bring this piece of paper with you. So clearly, there's some room for making that go more smoothly and easily. So two ways that that's going to happen is first, there are a number of organizations that are trying to develop apps, exactly as you said, to automatically capture test results, and for that matter, proof of vaccination too.

One of them is the Commons project, which is backed by Apple, Microsoft, some of the tech companies. You can Google them. So they intend to have an app coming. There's some partnerships with the airlines and so forth for that. You can see this, maybe, also being required or something like it to get into a club down the road or a concert or a play or something like that too.

The other thing that's coming is more rapid and easily available testing. So if you're flying to Hong Kong now, you will go from the airport to a convention center, basically, get a rapid test. And then you still have to isolate for a few days because these tests aren't perfect. But it's getting built in more to the way that people travel, and then by extension, I think to the way they do other things.

So some combination of rapid testing and proof of vaccination or proof of test results, I think, are going to become much more the norm in the months ahead. For now, though, as I said before, we don't even know if you're vaccinated, if that really prevents you from spreading the virus. So even being vaccinated, you're going to have to wear, for now, a mask on the plane. All those usual measures aren't going away in the next few months.

1. I got a couple of questions coming in on the same topic. Are there groups of people that should not be vaccinated? For example, people who are pregnant. What are the CDC guidelines on people who are pregnant? Should they get it or not?
   Well, there are very few people that are contraindicated for vaccination. So we talked before about kids. So if you're under 16, definitely, the recommendation's against getting vaccinated. And if you've had a reaction to a vaccine before, you're advised to talk to your doctor about it, so you can understand it.

The most significant side effects we've seen from the vaccines or these serious allergic reactions that are very rare, but they happen. They seem to be happening at a rate of about 11 per million people vaccinated with the two vaccines that are on the US market for emergency use now.

So if you've had a vaccine reaction before, not just a food allergy or an egg allergy or something like that, but a vaccine reaction, definitely talk to your doctor, your health care provider about it before you get the vaccine. And even then, it's not necessarily a contraindication for those rare cases. It's pretty treatable. A few people had to get epi shots, but you know we'd like to avoid that.

And then for pregnant women, it's really sort of, officially, it's your decision. Personally, if it was my wife of childbearing age, I'd urge her to go ahead and get it. We don't have definitive studies. In that population, they were people who were expected to be pregnant or actually excluded early on. You can understand why we didn't have any idea whether the vaccines worked or not.

There are some supplemental studies getting underway now, evaluating the vaccines in pregnant women, but there certainly are lots of women, at this point, with ten million plus people being vaccinated in this country alone. Lots of women who've become pregnant on after recently receiving a vaccine or maybe didn't know they were pregnant got vaccinated and haven't seen any significant adverse associations there.

But it is kind of a gap in knowledge, so the official advice is talk to your health care provider and weigh the evidence.

1. Last question for you. And it's really about people with immune deficiencies. My daughter has immune deficiency, this person ask, and is receiving weekly IgG subcu treatments for her immune deficiency. When should she think about getting the COVID vaccine? And do you advise that for people with extreme autoimmune deficiencies?

Yeah, I'd advise talking to her doctor, right now, about it. So there are some vaccines that are contraindicated in people who have weakened immune systems. They're typically made of modified viruses rather than the way that the new mRNA vaccines are made and some of the vaccines that are coming up are made.

So the J&J vaccine is a modified cold virus, essentially, which is really good for getting your immune system to respond, but does have a few issues and reasons for caution in people who are very immunocompromised. But there are other vaccines, for COVID here and coming, that don't have that problem. The Novavax vaccine that will be on the market later this spring if things go well. It's just a protein, so it can't cause any adverse infections in immunosuppressed people.

And the vaccines that are on the market now, the mRNA vaccines, basically, what that's doing is injecting a segment of RNA that matches certain pieces of the virus into your system. It goes into your cells. It doesn't get into the nucleus, not into your DNA or anything like that.

And basically, tells your cells hey make some of these virus, proteins. And it's not a whole virus, so it's not anything that can hurt you. But it is enough protein in your system to stimulate your immune response.

Now, there's some people who are so immune suppressed that they can't stimulate a response. But this is actually a good thing for people who have weakened immune systems, who might otherwise be more susceptible to COVID related problems. So definitely, worth talking to a doctor about that case.

1. OK, well thank you. That was a very specific one. And we really appreciate your expert advice on that. I cannot thank you enough, Dr. McClellan, for joining us today, and for sharing your precious time. I know you're so busy out there. So we really, really appreciate it.

We had thousands of people on the line listening to you today, and I would love to just invite you back later this year, if you'd be so willing to come back and talk to our employees and our clients and our brokers and agents, and share your expertise. So this has been terrific.

We will have a replay up very shortly on our website. Dr. McClellan, thank you so much. We're so grateful to you for your public service over these many, many years. I know you and your brother when I was on Capitol Hill. Just very, very thoughtful family. So we appreciate your time.

Thank you very much.

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Text, Wednesdays with Woodward, A Webinar Series, Upcoming Webinars, January 27, On the Horizon, The Future of Autonomous Vehicles, February 3, Geopolitics and Global Hot Spots for the New Administration, February 10, iGen at Work, Understanding Risk-Taking, Motivation and More Across Generations, February 17, Meeting the Moment, The Changing Face of Insurance Distribution, March 3, Crash and Learn, An Inside Look at the Insurance Institute for Highway Safety, March 17, Are you Recruiting Military Spouses Yet? Travelersinstitute.org

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And folks, we have a number of webinars coming up. And I hope you join us for these. They're going to be on your screen now. So January 27, we're going to talk about the future of autonomous vehicles and what to expect with insurance. Geopolitical hotspots for the Biden administration will be on February the 3rd. And we'll have a former Navy Admiral talking with us about that.

So you can see all of them on our website-- travelersinstitute.org, and register for those or watch our past replays. So again, a special thank you to Dr. McClellan. I cannot thank you enough. And stay safe out there, my friends. Wear your mask, social distance, wash your hands. And this is going to pass soon. It's going to be over. At least, it's going to be better this year for us. So happy new year, my friends. And please join us on January 27. Take care.

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Replays Now Available, Weathering the Storm, A Behind the scenes look at the Insurance Institute for Business & Home Safety, Leading Through Crisis, Resilience in Times of Uncertainty, And many more, travelersinstitute.org