COVID-19 vaccines: regulation, allocation, & hesitancy

[0:00:00]

RICK WEISS: Thank you, Josh. And welcome, everyone, to this SciLine media briefing. For those of you who are not familiar with SciLine, we are a free service for journalists and scientists. We have one overarching goal, which is to get – help you get more research-backed, credible evidence into your news stories. We are philanthropically funded. We’re based at the nonprofit American Association for the Advancement of Science. We have a number of services I invite you to check out on the website, sciline.org, but I will just mention probably our most popular service, which is our on-deadline matching service in which you can get in touch with us, let us know what kind of a story you’re working on and what kind of an expert you need. We have a large database of knowledgeable and articulate scientists we can connect you with to help you get that evidence into your stories.

Media briefings like this one is another thing we do. And today’s briefing focuses on a topic that is, I think, on everyone’s mind this month, which is now that some of the first COVID vaccines are coming close to becoming available in the United States, at least for some people, how is this now going to play out? What will the process be not just for initial approvals, but for longer-term tracking of safety and efficacy? Who is going to decide who is eligible for the first doses, and how are they going to make those decisions? And what about this nation’s epidemic of vaccine hesitancy, particularly in marginalized communities, which are among the most at risk from COVID and yet also, understandably, have high levels of mistrust of the health care system?

To address these and related issues, we have brought together three extremely well-qualified people to make short presentations and then take your questions. I’m not going to take time to go through their extensive bios. They’re on the SciLine website. But the essentials of what’s going to come up here is that you will hear first from Dr. Margaret Hamburg, better known as Peggy, who, among other responsibilities, has served as the commissioner of the Food and Drug Administration and the commissioner of the New York City Department of Health and Mental Hygiene and who I should mention is also a past president of the American Association for the Advancement of Science, where SciLine is based. Then we’ll hear from Professor Alta Charo, professor of law and bioethics at the University of Wisconsin-Madison, who has a long history of detangling difficult bioethical issues in her service on various commissions in the White House, at the National Academies of Science, Engineering, and Medicine and elsewhere.

And third, we will hear from Dr. Michele Andrasik, who is applying her years of experience in the HIV vaccine field by now serving as director of the COVID-19 Prevention Network based at the Fred Hutchinson Cancer Research Center and is an assistant professor at the University of Washington. And she will address some of the pressing social and behavioral science issues relating to diversifying participation in COVID vaccine clinical studies and increasing COVID vaccine acceptance, including something that I think every journalist needs to pay attention to these days on this topic, which is how best to communicate about vaccine risks and benefits. So with that, I want to just get started and turn it over to Peggy Hamburg. It’s all yours, Peggy.

[0:03:23]

PEGGY HAMBURG: Well, thank you very much. I apologize that there’s a leaf blower outside my window, but hopefully you can hear me. You know, there have been many huge disappointments in the response to COVID-19 without question. But one area that has really stood out in all the devastation has been the response in terms of the galvanization of the biomedical research community to help harness science and technology to produce critical medical products, including vaccines. The vaccine effort has moved at a pace unlike with any other vaccine. Normally, it takes years, often more than a decade, to make a successful vaccine. Most vaccines in development actually fail before they make it over the finish line.

But the rapid information about the genome of this virus, the coming together across sectors and across borders to work on the challenge of vaccine research and development and the engagement of regulatory authorities like the FDA in the process have made it possible for us to be where we are now, where we will likely see the broader use of a candidate vaccine within less than one year of the recognition of this novel virus. Why is it important that the regulatory process actually began as the research and development efforts began? And I’m going to talk about how it follows through the whole lifespan of the use of the vaccine because it is crucial that we understand how these important public health tools, vaccines, work in terms of their efficacy and that we also understand everything we can about their safety because we’re giving vaccines to people that are otherwise healthy in order to protect them from getting disease and to help address this devastating public health challenge.

So the studies were done in a way that enabled dramatic acceleration of the research and development process as sort of compressing of some of the traditional stages of vaccine development in new ways, but always with the regulator and the researchers working together to make sure that the critical questions got asked and answered. In this case, another marked difference in terms of how vaccine was developed was that even before we knew which candidates might make it over the finish line in terms of authorization or approval, significant investments by government and industry were made to start manufacturing the vaccine, scaling up and making very, very large volumes of vaccines so that if and when they were authorized for broader use, we’d be able to move vaccine out as quickly as possible. And that was called manufacturing at risk, although that meant financial risk, not safety or efficacy risk. And we’re now in a position as we’re starting to see data from the final stages of the clinical trials about vaccines that look like they hold enormous promise.

FDA early on set clear standards for efficacy, saying that the vaccine had to be at least 50% effective. And that was sort of based on, you know, what we see with flu vaccine. It’s not a perfect vaccine, but it’s better than nothing, and it can reduce the severity of disease and the length of symptoms and disease as well. So that was what FDA was expecting with vaccines against a previously unknown virus and some new vaccine approaches. Well, the initial data coming in shows that these vaccines are much, much more effective – you know, somewhere around 94% efficacy. The data from the first two studies that have made it through the pivotal stages of testing – the Moderna vaccine, the Pfizer vaccine – have now been – they’ve submitted their request for emergency use authorization to the FDA. Next week there’ll be a vaccine advisory board meeting for the Pfizer vaccine, the following week for the Moderna vaccine.

Why is this important? This is very important because it’s an opportunity for all of the data to be looked at and discussed – FDA scientists, the industry, the company scientists and a panel of independent scientific experts. There will be an opportunity for the public to engage as well, and all of the information will be posted on the Web for access. So it can help assure that the vaccine does what it claims to do. There’ll be an opportunity to really review the use of the vaccine in different subpopulations at risk for COVID and to inform FDA with a broad range of scientific and consumer input before they make their final decision. Emergency use authorization is not a full approval. It’s a capability that was given to FDA after 9/11 and the anthrax letters to enable in a crisis situation, such as the one we currently are experiencing, to approve something based on known risks and known benefits. And do the benefits outweigh the risks when it’s a serious, life-threatening disease or condition and when there aren’t other alternatives?

So that’s the decision that FDA will be making. They will also likely be making recommendations about indications for use, which subpopulations the data supports use in, et cetera. So that’s going to be crucial, and that will be all happening soon. Then the distribution will start. We’ll be talking more about that momentarily with a strong emphasis on reaching out to the populations most at risk. But FDA’s role, the regulatory oversight role, doesn’t stop then because as the vaccine is distributed, there has to be systems in place for tracking vaccine, both to make sure that people get their appropriate second dose, but also so that we can continue to collect data about the experience of the vaccine in the real world in terms of how well it’s working, for whom, how long does protection last and, very importantly, ongoing information about whether there are any unexpected safety issues that may start to emerge.

So this vaccine, though it has been accelerated in its development and will be going out more quickly than vaccines that we’re more familiar with, I really think that we can have confidence that the studies were done well, that the studies did not cut corners, despite the name Operation Warp Speed, and that there will be ongoing mechanisms to ensure data collection, monitoring and oversight about how well the vaccines are working and if there are any reasons for concern. So why don’t I stop there? And I apologize for all the information jammed in, but complex but important topic. Thank you.

[0:11:42]

RICK WEISS: Actually, that was just a perfect introductory overview of the system. Thank you, Peggy. Thank you very much. And let’s just move over to Alta Charo. Oh, and you’re on mute, Alta.

R. ALTA CHARO: There we go.

RICK WEISS: Great.

[0:12:05]

R. ALTA CHARO:  Sorry about that. OK, so I wanted to start first by just helping people situate themselves in terms of the many different areas in which there’s been advice given about how we should be distributing the vaccine. Most of these are guidance only. You’ll have a lot of academic publications that are coming out of places like the Hopkins Center for Health Security. There are previous epidemics and pandemics where we now have a track record and have a system that we’ve used in the past for distribution. But what you’re probably hearing more about is a report first from the National Academy of Medicine that was requested by NIH and CDC. I want to just take a moment to say that I was a member of the committee, but whatever I say here is my own opinion and not on behalf of the committee. That committee report laid out a framework, which I’ll show you just a moment, but it is not definitive.

The Center for Disease Control has a standing Advisory Committee on Immunization Practices. One of its jobs is, indeed, to come up with proposals for how to distribute things like vaccines, and it took into account in its ongoing work the National Academy of Medicine report, but also other sources of information, including the ones already mentioned. When the CDC finally approves a particular set of recommendations, it’s shared with state health departments all over the U.S. But here’s really where the rubber hits the road because it’s the state health departments and all of their subunits at the county or municipal level that are going to truly be deciding what to do when they get their batch of vaccines. The current plan, as I understand it, is that the federal government will distribute the first batch of vaccines to states in proportion to population, at which point each state gets to decide what it’s going to do next, probably following the ACIP from the CDC, but not necessarily precisely.

Figuring out how to distribute these things can actually be tricky because it’s important to figure out how you’re thinking about notions of fairness and justifiability. There are many ways you could imagine doing this. You could, for example, say, we don’t have a particular goal that we’re going to preference, and use any one of these, which is either completely random or, in many ways, simply a first-come, first-served or preferential for those who have a good network. Nobody’s seriously considered this, but it’s still there as a possibility. More seriously considered is an emphasis on looking at those people that are simply the most vulnerable. These are the people who have a high risk of being exposed, and so they’re more likely to get infected – people in service industries, for example, with lots of personal contact. They’re unable, like us right now, to work remotely.

Then there are those that are most likely to die – they’re older, they have other diseases – and those who simply can’t protect themselves because they’re not in a position to change their living arrangements. And that would include people in congregate settings like nursing homes and prisons and detention centers. Of course, a different way of thinking about this is not to simply try to limit the number of hospitalizations and deaths but rather to try to keep the country running. And in that way, you might say, well, let’s not focus on how many people will get sick and die; let’s focus on keeping healthy the people we need to continue working. So you can talk about essential services. I want to take just a moment to say that you’ll often hear people talk about essential workers, and it’s really misleading because every worker’s essential. It’s just that some of the jobs they do are more critical than others.

And certainly, it’s always a mistake to do what we did with the meatpackers in the spring and basically treat them as disposable workers in an essential service, but they were, in fact, working in an area that needed to continue. The food supply generally needs to continue. And so you can say from a societal point of view, let’s emphasize these people as well as try to slow the pandemic generally by focusing on those that are most likely to infect others. And you will sometimes see proposals to actually go for the younger ages here because if you save a single person from death, you may save 60 or 70 life years as opposed to five or 10 for the elderly. But then it’s really important not to forget that this pandemic has really highlighted the inequities in our health care system in a way that I don’t think we’ve ever noticed before at this level of this kind of vividness.

We are now seeing certain racial and ethnic minority communities suffering at three, four, even five times the rate of the rest of the population from infection, serious illness or death, and they have long suffered from inadequate health insurance, partly due to the kind of jobs they work. And so maybe another way of thinking about what’s justifiable is to say those who have been treated the worst in the past and are having the worst time now should come first in line. Any one of these systems could be adopted. The National Academy of Medicine’s committee decided that we were going to work on two goals simultaneously rather than choosing a single one. The first was the reduction of serious morbidity and mortality. That means hospitalizations and deaths. And the second was trying to keep society running, so trying to limit the negative societal impact. That means that you can’t pick any one of those things just mentioned, but you have to combine them.

So in our own proposals, we had a jump-start phase that focused on high-risk health workers, those people that are not only working in the health sector but are also highly exposed – could be physicians that are working with infected patients, could be janitors cleaning the rooms of infected patients. And the idea was that in the very first stages, when we have the smallest amount of vaccine to go around, we focus simply on keeping the health care system functioning for the rest of us. After that, the idea was that you focus on this combination of people who are highly vulnerable because of where they live – nursing homes and other overcrowded settings – coupled with the fact that they have comorbidities or age that makes them very likely to suffer a serious form of the illness. And this would mean that, for example, nursing homes and the people who work in nursing homes would likely come into Phase 1b.

After that, a series of phases that begin to work through teachers, critical industries and the workers there, people who’ve got some degree of vulnerability, but only moderate. And here, you also begin to recognize all the other settings in which you have people that are living close by one another or have difficulty protecting themselves, and that includes homeless shelters and detention facilities and prisons. And it wouldn’t be until the later phases that you would get to the people who are at the lowest risk – young adults, children and people that are working in industry areas that can afford to stay closed for a while. I need to emphasize that in any one of these, it’s important to also pay attention to whether or not you’re addressing the inequities that we’ve been seeing in the minority community.

And particularly as you hit phases where the number of people who could fall within this category exceeds available vaccine, it may be that you need to then figure out within that phase, how do we get to some people first? And the proposal had been to use the CDC’s own Social Vulnerability Index, which allows you to identify geographic areas where you have more people at higher density that are really in greatest need, so it was an effort to have this as an overlay across all of the different phases. Now, the CDC’s advisory committee, ACIP, had an emergency meeting earlier this week, and it went to discussion of at least the very first phases, and it approved by nearly unanimous agreement that, at least at the very beginning, the first people to get the vaccine should be health care personnel as well as residents of long-term care facilities. This is very similar to what the National Academies had suggested and, frankly, is very similar to what you’ll see in things like the academic centers and their proposals that were published in journals.

It’s a combination, again, of needing the health care system to function, as well as wanting to identify those who are both situationally and medically vulnerable because of their age, health status and living in nursing homes or other congregate settings. No matter what framework you pick, though, there are going to be a lot of variables that will change how you think about allocation at any particular time. It’s not only the number and timing of available doses, but it’s also whether each individual vaccine that gets approved or authorized has different showings of efficacy within the clinical trials and then effectiveness in the general population once we watch how it works in real life. It may be that some vaccines will have a higher level of effectiveness in some groups than others. Obesity, for example, is one medical condition that can reduce the effectiveness of some vaccines. It’s possible some will work better than others in that particular group. And so it may be over time that we identify subpopulations that are better suited for one vaccine or another not only for efficacy and effectiveness, but also for safety.

There are also logistical issues. The vaccines that are coming down the pike first look like they’re going to be two-dose formulations. This can be challenging in a community setting where you’re not sure somebody will come back for the second dose. So working with, for example, the homeless population may be very difficult with that vaccine. And the side effects may lead people to decide not to get the second dose. So maybe this is more easily used in settings like nursing homes or, later, prisons, where you know where people will be three weeks from now.

And, of course, you’ve probably heard lots about the cold chain that’s needed for some of these vaccines. The Pfizer one has the probably most rigorous needs in terms of cold storage. And although that’ll probably be available in most places, there will be some where that poses a problem. It’ll also be a question of whether you’ll have an outbreak somewhere because some amount of vaccine will probably be held back to deal with sudden outbreaks. And then finally, things like what is essential in a particular locale – states will have their own plans. I’m sitting here in Wisconsin, and as we enter the winter season, it’s pretty clear to me that snowplow drivers are going to be essential workers because if the streets aren’t cleared, the ambulance can’t get through. If this were summertime and it was Arizona, air conditioning repair would probably be an essential service because people literally die from heatstroke.

So there’s a rationale to the states having more local control over how they take the guidance from the ACIP and implement it on the ground. Last and absolutely not least, the vaccine uptake, which will be discussed next in this panel, is going to, more than anything else, tell us how many people in any one of these theoretical phases will actually get the vaccine. This slide has a lot of words that are very small. You’ll have the slide sets right after this panel discussion, so my apologies for that. But I wanted to make sure that the notes were there. Very personal prediction about the areas where we’ll have the greatest diversity of approaches among the states – I think one is going to be when teachers come into play. We’ve seen tremendous diversity about school opening or closing not only among states, but even within states as between two adjacent counties. And because schools function both as a crucial setting for education for children, many of whom really cannot educate properly at home, as well as serving, frankly, as babysitters so that parents can go to work, there are going to be very different opinions about how urgent this is compared to some of the more medically vulnerable people that might otherwise get the vaccine earlier.

But still here, not enough research necessarily on the degree to which the children pose a risk to their teachers, which would be part of the calculation about whether or not to put teachers toward the head of the line. And then next, prisoners – now, many prisoners will already, by their own – by definition, fit into some of the higher phases because they do have comorbidities or they do exist in a setting in which there is a high rate of exposure. But from a political point of view, one can easily anticipate that there will be pushback if a state announces that it’s going to focus one of its earliest phases of vaccination on prisons before it makes it available – before a vaccine’s available for the general population. And yet, this would make a lot of sense in many ways. There have been prison outbreaks in hot spots.

Prisons also are part of a vector series – prisoner to correctional officer to the general community and back from the community through the correctional officers to the prisons. So we are, in fact, all in this together. But nonetheless, we’re already seeing in places like Colorado some pushback on the idea that we give any kind of preference here. So watch this space to see if these turn out to be the hot points of discussion. Finally, just I’ll leave you with these links to some of the things I’ve been citing here – the CDC, the National Academies and the Hopkins Center for Health Security. Thanks very much.

[0:25:58]

RICK WEISS: Thank you, Alta – fantastic. And again, for reporters, those slides will be available very quickly after today’s briefing. We’ll move now to Michele.

[0:26:08]

MICHELE ANDRASIK: Hi. Thank you so much for having me today. So I’m going to talk about our pivoting to the CoVPN. As Rick mentioned before, many of the NIAID-funded HIV prevention and therapeutic networks pivoted early on in the COVID pandemic to focus on getting the COVID-19 vaccine and therapeutic trials through the pipeline. And as I talk about these trials, I think it’s important for everyone to know that the CoVPN is responsible for moving the Moderna, AstraZeneca, Johnson, Novavax and Sanofi trials through the pipeline. And as we have pivoted, we’ve utilized the community-based participatory research approaches that we have fine-tuned in our HIV work to really ensure that we’re understanding conversations and issues and challenges faced by the priority communities that have already been well described by Dr. Alta Charo – excuse me.

And so what we have really done, we have really leveraged the relationships that we’ve had in communities, building new relationships, identifying new communication channels and also convening scientific expert panels that have been modeled after NIH review sessions. So each of our expert panels represents priority populations, and each one of them have reviewed the protocols and provided input and feedback, guidance, direction in terms of how we better serve priority populations. And I think it’s really important to underscore that in the efforts that I’m talking about, the short-term goal has been the enrollment of individuals into trials, and the medium and long-term goals have been acceptability and uptake of therapeutics and vaccines once they’re available because creating a vaccine is an incredibly important step, and what will be critical is the acceptability and uptake of that vaccine.

So in all of this, we have really been focused on that. And in our efforts not only with our scientific panels, but with our community working groups and our stakeholders and community partners, we’ve really ensured that what we are doing is not only comprehensible, but inclusive and respectful. And many of the lessons that we have learned specific to COVID are around really ensuring that what we’re providing is information that can be comprehended by everyone in the general public, you know, ensuring, for example, that the efficacy results that came out weeks ago are readily understood. What we have found is that people automatically assumed that what we were talking about was the prevention of infection.

We fielded many emails and have had multiple discussions on the differentiation between the prevention of COVID disease and prevention of SARS-CoV-2, and I think that’s a really important distinction and one that has caused some confusion – so really ensuring that we make sure that that communication is understood. One of the other great lessons learned and a really important vaccine literacy point is understanding the importance of safety pauses. Earlier on, when Johnson and AstraZeneca had pauses, it was really important to, you know, really underscore the fact that that is a sign that the safety mechanisms in place are working and what that actually means and the implications of a safety pause and, you know, what happens during a safety pause – all of those very nuanced details, but incredibly important to engender trust and to really address uncertainty and fear, two things that we’ve seen quite a bit of in our efforts.

Also, you know, understanding how the trials are expedited – as Dr. Margaret mentioned before, Operation Warp Speed doesn’t necessarily engender, you know, this comfort and ease with the process, and there have been many of our community members and stakeholders who have consistently, you know, brought up concerns about the speed at which we are moving forward. So really, it’s been really important to tease apart what processes are being sped up and how corners are not being cut and what safety mechanisms are in place that really ensure safety and, you know, how the structure of these trials and the funding and the collaboration are allowing for expedited processes. It’s also really important to ensure that the communication and the messaging that we’re engaging in is inclusive, and so the language that we use is incredibly important.

You know, when speaking about Native and Indigenous people, Native, for many of our Indigenous peoples, only includes the 48 states, and so ensuring that when we are talking about Native, Indigenous peoples, tribal communities, that we’re using the correct language, making sure we’re inclusive. The same is true in our language and communication to our Hispanic and Latino communities and Asian and Pacific Islander and African American and Black communities – very, very important. As Dr. Alta Charo mentioned before, these communities have been hardest hit by COVID-19, and there are many historical reasons for communities to mistrust science, to mistrust the scientific process. So the onus is really on us to engender trust and to prove ourselves as trustworthy, and ensuring that we are inclusive and respectful in our language and our communication is incredibly important and something that those of us who have been involved in HIV for many years are really attuned to, given the huge disparities that communities face in HIV as well.

The other thing is really utilizing respectful language. When we first began, we noticed that many of our colleagues were referring to older adults as elderly, and that was called out very early by our older adult panel that, you know, elderly is not, you know, a term that, you know, really conveys respect and inclusion and that the appropriate language is older adult. And by older adult, we need to be clear that we’re talking about people who are 65 and older, the people who are experiencing huge disparities in hospitalization and severe disease. And also, you know, I think it’s also important – as you’ve no doubt noticed, I’ve been talking quite a bit about priority populations. You know, not targeting different groups, but we have specific priority populations because of the disproportionate impact and the inequities faced by these communities that – again, I think Dr. Alta Charo did a really great job of outlining why these communities are so disproportionately impacted and why they need to be prioritized.

And so in many of our materials – and I, you know, I put this here so you can all see. You know, much of our materials, obviously, are trying to drive people to our website, making sure that people know that there’s a registry that they can sign up for to be part of the therapeutic and the vaccine trials. And what we’ve done is included information and educational resources to really ensure that we are addressing vaccine literacy and health literacy generally. So what is a clinical trial? What are the phases of clinical trials? What to expect when you’re in a vaccine trial. We have slide sets that really walk through why we see the inequities that we see in Native and Indigenous communities, in our Latino and Hispanic and Latinx communities, Black, African American, Asian and Pacific Islander. I think it’s really critical to understand the social and economic factors that are placing these communities at differential risk. And so we have all of that here.

We’ve made it publicly available on a Dropbox with a password so all of our community partners and our clinical research sites have access to this. And we’re updating it with new information and new resources as they become available and as our partners inform us that they need new information. We also have Facebook and Instagram. And I think it’s really important for me to note that in our Dropbox, we’ve also created a folder with social media bursts so that some of our community partners have access to ongoing social media updates because that was something that was requested early on.

So I think, you know, it’s really critical that our communities have the resources available to make informed decisions – not only informed decisions about participation in a clinical trial, but informed decisions about therapeutics and vaccines once they become available, and not only decisions for themselves, but for their families and for their communities. And I also wanted to provide some other resources which I think are really, really great resources. The Johns Hopkins Center has a really great Coronavirus Resource Center. Our team provides a blog that is updated weekly on here to sort of give you the – all of the information that we have with, you know, the vaccine development as it seems to change daily. Also, the Tribal Health Research Office out of NIH has worked collaboratively with Johns Hopkins to develop materials for tribal use. And these are incredibly helpful for individuals who are working with and within tribal communities.

And then I’ve also offered the HHS site. This is really new, and this has great links to all of the therapeutic and the vaccine sites. And then, you know, just wanted to give a plug because I’m here in Washington state to our Washington Department of Health, who we’ve been working with. And they have created incredible commercials, and two of them aired prime-time, NFL Monday Night Football, which was really, really exciting to see. And they provide really great, to-the-point, informative information about COVID and COVID vaccines. So hopefully, these materials will be helpful to you. And I’m happy to answer any questions. Thank you for your time.

[0:39:05]

RICK WEISS: Thank you, Michele – really interesting. And as a former reporter myself, I really appreciate a couple of the subtleties about language you mentioned there, and I want to hammer those home. It’s very interesting that – you know, to not use the word targeting a population for a population that’s already feeling like they’ve been mistreated historically in this country. And similarly, the difference between preventing infection versus preventing illness is important because if this vaccine is only preventing illness but not preventing infection, it could mean that people are still infectious and may still need to be wearing masks and so on, even after being vaccinated. So some really important points there. Thank you. OK, I’m going to start with the Q&A. And by the way, I think we can run till about quarter after today, so we’re going to try to get in as many questions as we can from reporters. Again, you can click on the Q&A icon to do that.

RICK WEISS: The first one here is for Peggy Hamburg. It’s from Tina Saey at Science News. Can you clarify the difference between emergency use authorization and full approval?

[0:40:05]

PEGGY HAMBURG: Yeah, important question that has been coming up a lot. As I mentioned, emergency use authorization is a legal regulatory pathway that was actually created back in, I think, 2004, early 2000s, following the 9/11 event and then the anthrax letters with the recognition that there could be catastrophic biological threats. Then, they were thinking mainly deliberate, but also recognizing the possibility of Mother Nature as a terrorist, but that would require moving products more quickly through a system of evaluation and assessment because it would be a clear demand, few other options or no other options, and it would be, you know, in this setting of a true declared crisis. It’s been modified a bit over time, bringing in the pandemic threat more clearly.

But it is a tool FDA has used in the past not so much for vaccines – only one EUA ever for a vaccine, which was an anthrax vaccine back in that post-9/11, post-anthrax letters period. And it was an approved vaccine, but not for the indicated – but not for the use of inhalational anthrax, but for diagnostics and for therapeutics. And the criteria are not, you know, really, really well delineated, but it does assume that it’s a serious, life-threatening condition where there are not other meaningful alternative therapies or approaches and where the known information in human populations about benefit outweighs known or anticipated potential risks. It does give you leeway in terms of how data is applied and how much certainty is required, but it does ask FDA to undertake, you know, a significant dive into the available data, preclinical and clinical, and make this risk assessment.

A full approval means that it actually meets all of the regulatory requirements. It’s approved for use in the broader population and can be marketed and commercially available. With an emergency use authorization, the authorization does not persist once the crisis, the context for that authorization, is over. It’s not ongoing approval in the way that a standard approval is. And it cannot be marketed. It is authorized for use under certain conditions for certain populations.

[0:43:40]

RICK WEISS: Peggy, is there a difference in the kind of safety and efficacy follow-up from regulators or companies demanded if it’s just an emergency use, or are – the phase 4 follow-ups are basically the same for both?

[0:43:52]

PEGGY HAMBURG: You know, with an emergency use authorization or a full approval, FDA can ask the company to provide ongoing data to further inform understanding about the medical product and its use. With the emergency use authorization, those requirements likely are more explicit with more attention to making sure that the work goes on in a timely and appropriate fashion. But it’s not really, as I understand it – you know, I’m not a lawyer, and I’m not as steeped in regulatory law as I once was. It’s not a distinguishing feature of the emergency use authorization.

[0:44:49]

RICK WEISS: Great. OK, thank you. Question here for Alta Charo. Once the priority groups are defined, who’s going to really decide how to apply those rules to members of the public? Will this ultimately be left to individual physicians to decide? And a related question here from Greg Miller (ph) – Twin Cities PBS in Minnesota. How will the older population be parsed? And how will individuals know which phase they belong in?

[0:45:18]

R. ALTA CHARO: Yeah.

RICK WEISS: I’m not sure those are answerable at this point, but…

[0:45:22]

R. ALTA CHARO: Yeah. In fact, I’m not sure they are either. The bottom line is that that’s going to happen very close to the ground with your state health department, your county health officers and even your municipal health officers. Part of it will depend on how they’re distributing it. They might be distributing it primarily through clinics and pharmacies, or it may also be that individual physicians are able to obtain supplies. And that will determine a lot about the kind of discretion that’s available. Knowing what phase you’re in to present yourself, saying, I want to be vaccinated, I think is, in fact, going to be a little bit tricky because I think a lot of people will think of themselves as in need when they aren’t.

And there will be others who desperately need it, but, as Dr. Andrasik was talking about, will be hesitant or even refusing to use it. And that’s going to be part of the public education campaign that is already being prepared in many, many states, trying to help people figure that out. I doubt that there would be a zero error rate in this. I’m sure there’ll be some people who pressure their physicians enough to get slightly ahead of the line. But the idea is to try to limit that as much as possible.

[0:46:35]

RICK WEISS: Thank you. Question here for Dr. Andrasik. This is from Mark Olalde from The Desert Sun in Palm Springs. The area I cover is home to a large population of Latino farm workers and a large population of LGBTQ+ residents, and I often see the mistrust that you mentioned. In addition to the use of nuanced language, what concrete real-world steps can be taken to get better vaccine outreach to these communities, especially with the likely need for two doses?

[0:47:06]

MICHELE ANDRASIK: Yeah. That’s an excellent question. So we have been partnering with the National Heart, Lung, and Blood Institute and the National Institutes of Minority Health Disparities. They have a CEAL initiative, Community Engagement Alliance, that is using community health workers, promotoras, to get the information out into communities. And these are trusted health workers that work with and within those communities. We are also working in partnership with the National Hispanic Medical Association and UnidosUS. We’ve had multiple town halls, one that included Tony Fauci, on Univision. And continuing those efforts, one of the underlying tenets of the work that we’re doing is that the communication and messaging needs to come from trusted voices.

So we’ve really been working with and within communities to identify trusted voices and to work with them in partnership to ensure that they have the resources and the information needed to really ensure that the information is available and available in a way, again, that is comprehensible, respectful and inclusive to the communities that need it most. And we continue to reach out and develop new partnerships. We recently partnered with the Mexican Consulate. And we are working with them and their – I’m going to say it wrong – Ventanillas de Salud. And we – they actually developed a script for one of their novelas. And an episode of their novelas was on vaccine uptake and acceptability, which was really exciting to see. So we are actively working to make sure that the message is coming from trusted voices and for – and from all levels – at the grassroots level, the medical provider level and some of the community organization level.

[0:49:31]

RICK WEISS: Very cool. That’s great to hear. This is a question that I think might be best at least to start with you, Peggy. It’s from Nicholas Gerbis at KJZZ Public Radio in Arizona. How concerned should we be that the three leading vaccine candidates use different standards for measuring efficacy, in particular the dosage differences between the U.K.’s and Brazil’s evaluations of the Oxford-AstraZeneca vaccine?

[0:50:00]

PEGGY HAMBURG: Well, these are different classes of vaccines being done by different companies and in somewhat different contexts, so it’s not surprising that the vaccine studies are structured somewhat differently. Efforts were made to try to make sure that certain critical questions were asked and answered by these studies in terms of how they were structured. But different studies approached some of this a little bit differently, though still with measures of efficacy and systems for identifying safety. The Oxford-AstraZeneca dosing issue was, unfortunately, not fully intended in the original study. There was an underdosing with the first dose for some of the participants in the study because of a manufacturing error that wasn’t identified earlier on. That mistake may actually help to reveal certain new scientific understandings about how the vaccine works. We don’t know. But it will require, you know, I think a pretty careful evaluation.

Those datasets will have to be examined, and there will need to be, you know, a very close look at that. But it’s important to realize that there have been many different categories of vaccine that have been under development and are advancing in their stages of study. I think there are seven or eight different sort of classes of vaccine, and they will be administered differently, they’ll have different characteristics, and they are being studied somewhat differently as well. But it’s good. We want more than one vaccine. Almost certainly, different vaccine categories will be better for different subpopulations. And one of the things that’s been really exciting about the work that’s been done is that the Pfizer and Moderna vaccines, the so-called mRNA vaccines, actually are a novel vaccine platform, a novel vaccine approach in terms of there’s never been a vaccine fully developed and approved using that strategy, but it looks enormously promising not just against COVID-19, but potentially against other infectious diseases and maybe even other categories of disease, including cancer.

[0:52:57]

RICK WEISS: Great. Thank you. Question here that I think I will throw to you, Alta, for starters. And it’s from Nadine Shubailat at ABC News. President-elect Joe Biden just tweeted that once approved, COVID-19 vaccines will be made available equitably and free of charge to all Americans. Is that regardless of health insurance status? You didn’t mention, I think, health insurance in your presentation. Also, does that apply to immigrants and undocumented immigrants?

[0:53:30]

R. ALTA CHARO: So there are a variety of programs already in place that provide vaccines at no cost to the vaccinee. There are Vaccine for Children’s programs. There are some special provisions under the CARES Act, Medicare, Medicaid, the VA. So we have a complicated kind of combination of programs. One concern up until now has been that although the vaccinees may not have to pay out of pocket, the providers are not completely covered in terms of the cost of actually managing to receive, store and administer these vaccines. And I’m under the impression that that is still a matter of discussion about how to manage that. If that doesn’t get handled by one of these public programs, that may very well be where the private health insurers are going to be picking up the bill.

That is part of the cost of the vaccine will be this kind of transaction cost that will be covered by the insurance companies. I am unclear, I have to say, about exactly what will happen with undocumented persons because their coverage under some of these programs doesn’t even exist, but there is also the commitment that has been made publicly by the federal government to make it free to anybody. But I’ve not seen the statutory provision that’s going to ensure that that is possible. And on top of that, many states have their own version of some kind of state-based insurance plan. In Wisconsin, we’ve got BadgerCare ’cause we’re all badgers here. And there are other states that have things like that, which may also be picking up some of the costs that are not covered otherwise.

[0:55:13]

RICK WEISS: All right. And I will move over back to you, Michele, with this question from Kavin Senapathy, who’s a freelancer. Why should relatively – even relatively vaccine-literate people, especially nonwhite people, trust these vaccines, even if they understand that corners have not been cut and that there is a push for equity? To what degree can effective communication engender trust if the underlying historical reasons for distrust are legitimate?

[0:55:43]

MICHELE ANDRASIK: Yeah. Well, I think, you know, the first part of that is, you know, acknowledging that mistrust is legitimate and, you know, and starting there. And then, you know, what we have really worked to inform individuals about are the various protections that are in place. We talk a lot about the Helsinki Declaration, the Belmont Report and all of the various safeguards that have put in place to ensure ethics going forward, you know? And one of the things that I also point out is that, yes, there have been instances where scientists have been unethical, and now there are these safeguards that are in place to really limit the ability of any one scientist in being unethical. And I think that that is really clear. And we’ve put a lot of information on the website and tried to, like, sort of create infographics about the various safeguards that are put in place.

And also, you know, one of the things that we have really been trying to do is ensure that, again, the trusted voices that are out in communities are able to discuss these things as well. One of the things that came to our attention early on was that in our faith initiative, our faith ambassadors and clergy consultants had questions around immunology and vaccinology. So we provided a training, you know, for all of the faith ambassadors and clergy consultants on immunology, vaccinology and also the ethics that are in place with regard to research so that they can then communicate that to their constituents and people in their communities. And I think that’s really important to build that capacity so that individuals can take that back into their community and have those discussions with individuals and families in the larger community.

[0:58:06]

RICK WEISS: I have a couple questions here that are a little bit more on the medical side, and I’m going to throw these to you in combination, Peggy. One is from Lydia McMullen-Laird at WNYC Public Radio in New York. For vaccines that incorporate viral genetic material, mRNA, which is not what we usually see in vaccines, as you mentioned, how do we know the long-term health implications? Could the vaccine potentially lead to autoimmune problems, like some long COVID patients are experiencing now? So that question is about risk of autoimmunity, but I want to sort of pair it with another question that we had from Susanna Speier, a freelancer. Am I correct in understanding that the upcoming vaccines will not be safe for people who require immunosuppressants to manage chronic medical conditions? And do you anticipate vaccines that could be tested on people who are on immunosuppressants like Remicade or Humira?

[0:59:04]

PEGGY HAMBURG: Both, you know, excellent questions and complicated questions in terms of, you know, what do we know about this virus, the disease it causes and these vaccines? We really have to keep remembering that it was only back in early January when we first started to hear about the reports of disease and when the genome of this virus was first posted. And all of this work has gone on since then. And we’ve been learning a lot more about the virus, about all of the range of complications of infection with SARS-CoV-2 and manifestations of COVID-19. And now, you know, we’re still pretty early days in understanding these vaccines. The kinds of questions that that have been posed are ones, though, that people were thinking about from the very beginning. We will, of course, be learning much more about the mRNA vaccines. But the particular issue raised is not one that people are, you know, really highlighting as a concern.

But we want to learn more. And we will learn more as we track these vaccines over time and in broader use. In terms of the use of vaccines in immune-suppressed populations, there early on was a decision not to include a lot of immune-suppressed individuals in the studies in order to learn more about the immune response in people that might have varying immune responsiveness because of age or other accompanying medical conditions. But it was felt that the first groups to be studied, that would be an additional, unnecessary complication. HIV-infected patients were included fairly early on, though, in the studies. I don’t know about for all of the study designs. But I think for the moment – but I’m not – I don’t absolutely know the answer. So I should – you know, I probably should stop there. But the feeling is that individuals that are on immune suppression are a very important subpopulation, that we need to sort of figure out how best to manage them and certainly during COVID need to be taking extra precautions to make sure that they are not exposed to individuals with COVID or in settings that might put them at higher risk for COVID infection.

[1:02:01]

RICK WEISS: Great, thank you. I’m going to try to squeeze a few more questions in here before we end at quarter after. This – I’m going to start with you, Alta – others might be able to weigh in – because you did mention the issue of the two-dose difficulty. But does anyone know if there may be plans – and I’m sorry. This is from Leah Rosenbaum at Forbes. Does anyone know if there may be plans on how to track who has gotten a COVID vaccine, similar to the WHO carte jaune – the yellow card – in France? Alta.

[1:02:32]

R. ALTA CHARO: Oh, the carte jaune, huh? I still have one in my passport. So vaccines of all types tend to be the subject of registries, both within health care systems and at the state level. The registries are not perfect, but they are capable of talking to one another. One of the challenges is making sure they talk in real time, particularly across states as well as institutions, so that if you get your first dose at a Walgreens in Palo Alto, Calif., that’s on a record that can be identified if you come into your second dose in Boise, Idaho, at a – you know, at a physician’s office or at a local clinic.

But those records are going to be a focus of a lot of attention, if only because, to follow on what Dr. Hamburg said, there’s a need to be tracking who gets the vaccine, what we know about them and what kind of experience they had with it in order to be able to develop the data needed to move from – not only to make sure that there’s corrections, course corrections if needed, but also so that once the pandemic emergency declaration is over, we can move then to the question of whether these can be approved. And all of that post-authorization information is going to be very, very important for that. So you also have national-level registries, and you also have registries at the national level specifically to capture information about adverse events that doctors as well as patients themselves can enter and the sponsor – you know, the company making it – can enter so that there’s an accumulation of reports about adverse events.

[1:04:11]

RICK WEISS: And Peggy, I’m just going to actually ask you to tack on something to this ’cause we got a question from Paul Monies at Oklahoma Watch wondering for some – wanting some clarification on the science behind the two-step vaccine. Do we know what happens to people who don’t come back for the second dose? Is it not going to be effective?

[1:04:30]

PEGGY HAMBURG: It’s not going to be as effective. Not all of the vaccines are going to require two doses. But if you’re getting a vaccine that does require two doses, that’s because you need that second dose; you need that boost in order to mount the level of immune response that the vaccine can provide. And that second dose really does make a difference, so we really want to make sure that as these vaccines are distributed, that they are distributed to people in a way that enables the ongoing medical care, the appropriate second dose and the ability to track in terms of if there are safety issues or to learn more about efficacy.

[1:05:29]

RICK WEISS: Got it. I have a question here from Madeline Heim, USA Today Network in Wisconsin, although I’m not sure this is really for you, Alta, despite you being a Badger. But what do you think are the most important questions for reporters to ask their local health departments at a county or city level about how rollout will go after the state decides where to go with the first batches? Actually, that could be you, Alta, but I’ll turn that to any of you to start with. What should reporters be asking their health departments about how rollout is going to go?

[1:06:07]

R. ALTA CHARO: I can start, but I think Dr. Andrasik probably has even more information on this than I do because she’s talking about when people actually go in to get the vaccine. They need to start by finding out how the health department does it. You know, in our particular state, we have a State Disaster Medical Advisory Committee. It created working groups first on principles for allocation. Now they’re working through the nitty-gritty of the phases. Find out then how much discretion there is at the county level, and then ask – you can ask very specific questions, like, how frequently will you be revisiting these allocations as new vaccines come online or as new information is developed or as you’ve had experience in seeing what uptake you’re actually getting in the targeted populations at any one level?

I would ask them whether or not they are able to layer on this question about social vulnerability index to make sure that when there’s insufficient vaccine for any particular phase that you’re trying to use, that you make sure you get it to the people who really do have the largest combination of risk factors. They work in places where they can’t avoid getting exposed, and they’re more likely to get very sick if they get exposed, and they’re more likely to transmit it to others because they live in high-density housing; in other words, they’re probably minimum wage workers. And they’re probably disproportionately members of historically disadvantaged communities – African American, Hispanic, Alaskan Natives and Pacific Islanders particularly.

So those are the really kind of nitty-gritty questions. And then I would say, ask them, how are you going to make sure that you’re doing a good job of tracking who’s gotten it and who’s left? Because that’s a huge challenge, and that’ll probably be happening largely at the county level, I suspect. But I’ll turn it over to Dr. Andrasik because she knows more about what happens when you actually try to get people to come in and get the vaccine.

[1:07:59]

MICHELE ANDRASIK: Yeah. I think an important piece will be to do largely what we’ve been doing in, you know, the trials, which is to go out into communities, you know, ensuring that satellite clinics are enabled with vaccine products. We have been utilizing mobile units. So are we still going to be utilizing units to go out into communities for vaccine distribution and dissemination? You know, I think those are really critical in states that have been utilizing these mobile units. How might they be utilized in that dissemination process? The other thing I would really encourage you to do – I mean, all the – a lot of the states have already distributed their written plans. And I have found that when I read through the plans, more questions come up than answers.

So I’ve been jotting down the questions and reaching out to the DOH to say, you know, I didn’t see this answered in your report, and can you provide information about this? So – and we’ve been really encouraging our community stakeholders to do that as well, to ensure that they understand their state plans. So – and also, I would say, you know, for these states that also have, you know, contacts with Indian Health Services and – or community health workers and the promotoras, how are they going to be utilizing these longstanding institutions and community workers that have really strong relationships in their communities? I haven’t seen – and I’d be interested, Professor Alta Charo, if you’ve seen any of the IHS plans. I know that there had been some discussion, but I haven’t heard what that’s going to look like.

[1:09:55]

R. ALTA CHARO: I haven’t seen the plans, no. Sorry about that. But I’m going…

MICHELE ANDRASIK: OK.

R. ALTA CHARO: …To just add one very quick thing to what you did say, which is that there are some states where there’s one or two very dominant provider services like the Kaiser system in California. And because they have electronic health records, they are capable of doing record review that would identify those people that need to be notified, hey, you are the kind of person we want to get in now as soon as possible. So in some states, we’re going to be able to see a really good collaboration between state department – health departments and these large providers and large systems in identifying and particularly kind of pulling in the people that need it most.

[1:10:36]

RICK WEISS: Great. In a moment, I’m going to ask each of our three panelists just to wrap up and give a take-home message to reporters that they can really take to the bank and use in their stories. But before I do that, I want to remind or tell all the reporters who are on this call that one of the several services that SciLine offers is something we call office hours, where we grab some experts and make them available for 90 minutes or so, and you can sign up for 15 minutes of an individual, one-on-one interview with them and capture the video and keep that for your own use.

We have some excellent experts set up for Monday that can address some COVID-related issues, including how people being stranded only dealing with each other through Zoom windows, like the ones we’re on, are affecting their mental and physical health and how to prepare for the holidays in the season of COVID. And if you’re interested in signing up for one of the slots to interview these folks, please email us at sciline@aaas.org. And now let’s just make a final round and hear from each of you something – most important thing you want people to walk away with today as reporters go back to their desks here. Peggy, I’ll start with you.

[1:11:56]

PEGGY HAMBURG: Great, thank you. Well, it’s enormously exciting, the progress that has made on – been made on vaccines. And we are really at a critical inflection point in terms of really having vaccines that appear to be safe and effective to help us control this devastating global pandemic. But people have to understand this is not a magic wand. You know, once the vaccine starts to go out to priority populations, that doesn’t mean that suddenly we can abandon all of the other activities that are so important in terms of reducing rates of infection and controlling spread. It’s going to take time for the vaccine to get to everyone that needs it. And also, the vaccine will not be fully protective against infection and disease. So we are still going to need to do those things that work – wearing masks, social distancing, avoiding large, congregate settings. And there’s going to be a period of transition. And people need to appreciate that. But we are making real progress, and it is, you know, really important that we all pull together during this critical period.

[1:13:17]

RICK WEISS: Thank you. Alta.

[1:13:22]

R. ALTA CHARO: So for takeaway, I would say that as soon as these things start rolling out, we need to anticipate, there’s going to be confusion. There will absolutely be confusion. And it’s going to be incredibly important that at the federal level, there is a single, clear message about what steps are taking and what steps come next and to have experts speak with authority and without a cacophony of dissenting voices lurking behind them. The second is at the state level, where you’re actually going to see the allocations on the ground. The state officials have to be really open and transparent about why they’re choosing some phases first and not that – you know, why do some groups go first, and another doesn’t? – how they’re making these decisions and then, crucially, that these are not fixed in stone, that these will change as new vaccines come online with different profiles for risk and benefit for different groups as we see outbreaks here and there or uptakes that are, you know, large and small, that we need to recognize there’ll be change.

And change doesn’t mean we were wrong. It means that we are adapting on the fly as situation changes, which is what a responsible health department would do ’cause the only way to get trust is for people to understand that some amount of change and some amount, frankly, of confusion doesn’t mean that the system is untrustworthy.

[1:14:46]

RICK WEISS: Thank you – and Michele.

[1:14:49]

MICHELE ANDRASIK: I would say that this is an incredible opportunity for all of us to increase health literacy. This is – you know, for the first time in my life, we have a sustained attention on public health. And I feel like this is an incredible opportunity for us to get out there and really ensure that individuals understand the true public health crisis that we are in and how all of us can work together to get through the other side and what that means. And, you know, a lot of this is, you know, really following on what my two colleagues have stated – you know, that we really need to understand the implications of the vaccine, the implications of the therapeutics and what it means for us to make decisions about our own health and the health of our larger communities. And that requires transparency and requires that we present things in a way that can be comprehended by everyone regardless of their educational level, their experience in health and, you know, the health care system. So, you know, I think this is a really great opportunity for all of us to work to ensure that as a society, we’re increasing our health literacy.

[1:16:19]

RICK WEISS: Fantastic. And hopefully, many of the reporters on the line today will be part of that effort and that cause. I want to thank all of you, our presenters and the reporters, for being on today. For the reporters, please, as you log off, you will notice a prompt for a short – really short, three questions, 30 seconds – survey. I know we’re all sick of surveys, but it really helps us stay on track for giving you what you want and what you need in your work as journalists. So please take the half a minute or so to fill out that quick survey. Visit us at sciline.org. Follow us at @RealSciLine. And once again, thank you all – Peggy, Alta, Michele – for a really informative, fantastic set of presentations and Q&A. We’ll see all of you another time and on our next SciLine media briefing. That ends this briefing. And thank you all very much.