As pharmaceutical companies zero in on viable COVID-19 vaccine candidates in their phase III clinical trials, new challenges have arisen regarding efficient and equitable vaccine distribution.
For insights about the process and the existing logistical challenges, the team behind the Public Health On Call podcast from the Bloomberg School of Public Health reached out to Ezekiel Emanuel, an oncologist, bioethicist, and senior fellow at the Center for American Progress. He was recently appointed to President-elect Joe Biden's Coronavirus Task Force, which has been charged with coordinating a federal response to the ongoing—and worsening—coronavirus pandemic.
In the latest podcast episode, Emanuel discusses the equity issues, shipping logistics, and IT infrastructure that will be necessary for an effective U.S. vaccination effort.
Zeke Emanuel. Thank you so much for joining me.
My pleasure. Good to be here.
So today we're going to talk about the distribution of COVID vaccines, once we get an approved COVID vaccine. I'd like to ask you first about who will be getting it and how it will be distributed, but let's start with who.
Well, we don't know is the short answer. At least at this point, the bodies that control it haven't made a final decision. We do have some recommendations from the National Academies and other groups. The official word, as it were, has not been determined, but the National Academy has suggested that we start off the list with frontline health care workers, other first responders, and then we move down the list in terms of vulnerability.
You're an ethicist. So talk to me about where you think we should be distributing the vaccines and to whom.
There are two primary foci, as it were, and some of this is going to depend upon the vaccine characteristics. One of the foci is mortality and premature mortality—people who are vulnerable to getting the virus and getting very, very sick and potentially dying. We know that there's a very strong age correlation, so the older you are the much higher your risk of death is. We also know that there's a strong correlation with comorbidities, so that people who have serious illnesses like diabetes or heart disease are also at very high risk of dying. Obviously age is age, but comorbidities span the age spectrum. And so you get a very different pool of potential vaccine recipients if you focus on comorbidities.
There's also the issue of reducing transmission, which is different. You might not impact mortality directly, but you'll do it indirectly. And if you're trying to impact transmission, the age distribution could look very, very different. For example, we know that in influenza, young children are the spreaders, even if they're usually not at high risk given influenza. Similarly in coronavirus, they may be the spreaders, even if they're not at high risk themselves of getting sick.
I would think that it might be simple enough to give the vaccine to older people, right? You say everybody over 65, you're first in line, but it seems to me it's a much more difficult proposition to say, OK, everybody over 65 and those with diabetes and those with heart disease, you get it. I mean, how does one develop a system like that?
Well, I think you're pointing to two different dimensions that need to be considered. One dimension is an ethical dimension. Who ought to get it? And that in some ways is separate from the practicality dimension—how do we do it efficiently with the minimum intrusion and the minimum judgment calls? And I think what you're pointing out is, look, it's easy to determine someone's age. They come in with a driver's license or some other ID and that's a relatively easy determination to make—not bureaucratic, pretty objective. On the other hand, "do you have comorbidities?" requires some medical judgment.
Now in the past when it's been done, it has typically relied on self-attestation—I have diabetes—but you can imagine that there could be some serious problems of, who's got, say, two comorbidities? Do we want to rely on self-attestation? How good is self-attestation in actually identifying the high-risk people who you want to get it? And remember, that's not a trivial concern, because if the goal here is to reduce the number of people who are dying prematurely, then if you rely on self-attestation and it's not very accurate, you're not going to be achieving your goal. So I think you have raised a practical issue which impinges on the ethical and ultimate concerns we have in distributing a vaccine.
I might say one of the things which might distinguish this vaccine from many others in the past is the fact that we have such a huge pool of people who are hesitant. And so we're spending—bioethicists, health policy people, public health people—a lot of time worrying about prioritization and who ought to get it, and what are the criteria we should use. And it may be that we're going to throw the party and no one comes, or very few people come.
I have to say, it's been a dream of mine, or it's coming in dreams, that you've got this vaccine and you've got 15, 16 million doses, and you give it to first responders who you can relatively easily identify at the hospital, EMTs, et cetera. But then you might have a pool of millions of doses, and people are hesitant—"Give it to him first or her first and I'll watch. But then if it looks safe, you know, then I might be inclined." And so we could have this crazy situation of this life-threatening illness and we have a vaccine that has been proven at least to the satisfaction of an independent advisory committee and a lot of other people, and yet the public could still be sufficiently hesitant that there's vaccine waiting for people, not people waiting for vaccine. And I think that's an issue we just don't know, but I think it's not an implausible scenario that could happen. As I say, it literally is a dream that's woken me up several times—we could be sitting on millions of doses and people won't take them.
And we do know that in H1N1 a decade ago, we did produce a lot of vaccine and then it sort of passed and the urgency disappeared, and we ended up having a lot of vaccine.
In the case of this coronavirus, minority communities are disproportionately impacted. Is it also more challenging to reach them in some ways?
Well, I think there are, again, two issues—an ethical issue and the practical issue. The ethical issue is you want to target or reserve a number of vaccines for minority communities on the idea that they have been at high risk of getting cases, high risk of hospitalization, and high risk of death. And if your goal is both to reduce transmission and to reduce mortality, there would seem to be a good ethical justification for targeting them. And then there's a practical consideration of, well you might target them, but again, there's a lot of vaccine hesitancy and worry, I think, within that community. The trust level for many, many good reasons going back many, many decades—people often say going back to Tuskegee, but it's way before Tuskegee that that community has been mistreated or poorly treated—that raises a lot of suspicions and lack of trust.
I know that the Black Physicians Organization has set up its own independent group to look at the data and evaluate it. And I think that's terrific. If that's a way that's going to enhance trust in the community, absolutely. But this points out that distributing a vaccine and administering it requires more than just having it and having it in syringes. There's a communications strategy, there's a trust-building strategy, there's getting it out to people who are influencers and opinion leaders. I think in this situation, it's going to be absolutely pivotal that celebrity sports stars, hip-hop recording artists, prominent Black politicians, all of them endorse it. Look at the data, look at committees that have reviewed the data, get it themselves and get it themselves pretty prominently. It's kind of the analog of the Get Out the Vote push that has occurred in this 2020 election. We're going to need that kind of big campaign, big communication strategy, that's targeted to very different communities to overcome the hesitancy.
The other question is distribution, right? The actual physical act of getting these doses out into the community, like how do they get delivered and are there syringes and do we have the right freezer if certain vaccines are approved? I saw that the CDC estimates that state and local officials need $6 billion to do that. So that's a question that we haven't heard a lot of answers to.
Well, we at the Center for American Progress—my colleague Topher Spiro and I—created a report about the challenges and where the potential barriers are related to the distribution. Just manufacturing a vaccine does not solve problems, right? You have to actually put it in a special glass vial that's temperature sensitive. You have to have enough stoppers. You have to have what's called fill-finish capacity—it has to be put in those glass vials in a supersterile manner so that there's no fungal or other infections growing on it. You then have to ship it out. Different vaccines require different temperatures. So the Pfizer vaccine requires minus-70, minus-80 degrees Celsius—more than liquid nitrogen temperature. Other vaccines are minus-20. Those kinds of temperatures, certainly the minus-80 degrees Celsius, physician offices can't handle that, many pharmacies can't handle that.
And so you will need a special distribution system for that. And I know that Pfizer has been working extremely hard to have that network, and it isn't going to go through the usual network set up by the government through McKesson. And so this is a whole other very important problem. A challenge. And establishing the stability and potency of the vaccines during transportation is going to be absolutely pivotal. Having a vaccine that becomes impotent and administering it defeats the entire purpose.
So how will we overcome that?
Part of it is money. And as you point out, part of it is logistics. We have the world's best logistics here in the United States, between Amazon and UPS and FedEx and Walmart and the military—there is terrific logistics. But getting the logistics married up with the health care system, married up with the cold chain, this is a big challenge. It's going to be a challenge to the government when this happens. Hopefully we'll have solved all the barriers there to making sure it works.
It seems though that we are not just waiting for approval of a vaccine, but we are waiting to make sure these steps are in place. So even if you get an approval for a vaccine, it's not like the next day we're going to be able to start handing it out.
Yes, and again, the public may or may not appreciate that between the end of a trial or after the data safety monitoring board says, "Oh, we've got a signal that this is effective," putting the paperwork, sending it to the FDA, having the FDA—both the independent advisory committee, the career officials, and then the commissioner—approve it, that's going to take time. That's not going to happen instantaneously, even with people working their hearts out because they know how important this is.
And then, as you point out, between that approval and shipping is also going to be a challenge. Production has, in many cases, preceded approval. People talk about producing the vaccine at risk. Nonetheless, that's different than shipping it to the point of administration. It's different than having enough people who are ready to administer it. It's different than having a communication strategy that's in place to get the right people to show up at the right time. It's also different than having the technology to track people.
Remember one of the challenges of this vaccine, we haven't talked about it, is it won't be a one dose vaccine, at least the initial vaccines being tested Pfizer and Moderna and AstraZeneca. They're shots in the arm. The J and J is, I believe, a one-shot vaccine. And I know that Merck is working on an oral vaccine. So those are also going to be having the tracking system and the electronics and the IT infrastructure to track people, to contact them if they don't show up for the second shot. Those are all really important infrastructure elements too, and we'll be testing that since a lot of that IT infrastructure will be new as well.
I guess we also have to track to see if people get sick from it.
The safety element is huge. Say you've got 30, 40, 50,000 people in the trials, right? You'll have a signal control group and then a signal from the people who are getting the vaccine as to how different the side effects are. Now some of the side effects could be the same here. Everyone's going to get an injection in the arm that causes a little pain, might cause some fever, but the sort of longer-term side effects, we won't know. And we're going to have to follow people and really find out and monitor. So it's not a haphazard system, but it's a systematic system, and that's going to be pretty important.
Public Health On Call is produced by Joshua Sharfstein, Lindsay Smith Rogers, Stephanie Desmon, and Lymari Morales. Audio production by Spencer Greer, Nial Owen McCusker, Cian Oatts, and Matthew Martin with support from Chip Hickey. Distribution by Nick Moran.