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Amy Walter: It's Politics with Amy Walter on The Takeaway. Good to have you with us. It's been almost six months since COVID-19 came to dominate our lives. While many countries have curbed their total number of cases, today, the US has recorded more than 4.5 million of them and more than 160,000 deaths. One of the easiest and simplest solutions to curbing the spread of the disease, mask-wearing has instead become the latest front in the culture wars. Leadership has been woefully inadequate, starting at the very top. The White House has sent mixed messages all along about the scope and severity of the crisis.

President Trump: Within a couple of days, it's going to be down to close to zero. One day, it's like a miracle, it will disappear. It will go away. You know it is going away. It's going to go away. This is going to go away. It's going to go. It's going to leave. It's going to be gone. It's going to be eradicated.

Amy: Of course, the President himself has spread conspiracy theories about the science and the solutions to stopping the pandemic.

President Trump: She was on-air along with many other doctors, they were big fans of hydroxychloroquine, and I thought she was very impressive.

Amy: The only thing we can agree on is that a vaccine may be the only way the US can get close to returning to normal. Meanwhile, with the election looming, the President has been desperate to show that the vaccine is just around the corner.

President Trump: We will have a very successful vaccine, therapeutic, and cure, making tremendous progress. I deal with these credible scientists, doctors, very, very closely, a great respect for their minds.

Amy: Even a successful vaccine won't be a panacea for all the problems unearthed by the virus. Just convincing Americans to get a vaccine will be its own challenge. Trust in public health officials has been undermined by the President, and of course, a majority of Americans think the President has mishandled this crisis in the first place. Then, there are the challenges of manufacturing the drugs at scale and distributing them. To better understand where we are in the vaccine development process and what we could expect when one becomes available, I sat down with Carolyn Johnson, a science reporter at The Washington Post, and Umair Irfan, a staff writer at Vox.

Umair Irfan: Well, it looks like there are at least 200 vaccine candidates being investigated around the world in various stages of development. There are about two dozen undergoing clinical testing in various stages. Six are actually beginning Phase III trials. In China, the Chinese military granted approval to at least one vaccine candidate.

Amy: When we say Phase III, isn't that the phase before we actually go into production of a vaccine?

Umair: It's the phase right before the FDA approves it for a mass manufacturer. Yes, this is where you're talking about testing anywhere between 20,000 to 50,000 people, you're tracking them over time, and basically, seeing if there are any side effects, and also, any complications with other underlying health issues, things like diabetes, heart disease, or other preexisting conditions, issues that would influence spreading this vaccine across a huge segment of the population.

Amy: This has been developed in record time, how concerned should we be that this happened as quickly as it did in terms of the safety and efficacy of this?

Umair: Well, the scientists that I've spoken to have said that the unprecedented speed comes from the unprecedented level of international collaboration on this. The researchers I pointed out have said that this is actually sort of an ironclad checkpoint, that they are not going to compromise on safety at all, which is why the Cuban trials are going to be the main limiting factor in terms of how fast we get it. Basically, we need to validate that this vaccine, whichever candidate comes to fruition, is safe for a huge segment of the population. That ultimately is going to govern when a vaccine actually gets manufactured.

Amy: Carolyn, let's get to that next part, which is the manufacturing of this and then distributing it. The administration has said they'd like to have 300 million vaccines available. The Operation Warp Speed is saying that they're able to do this because they are not just developing it, but they are also currently manufacturing it. In other words, they're not waiting for it to be completed before they start the manufacturing, and if that's the wrong one, then, they'll go back and manufacture another one. As you see where we are in manufacturing this drug at the level we need to manufacture it, do you think the country and the infrastructure that's been organized by the administration is up for this?

Carolyn Johnson: They are taking these steps to manufacture before they know whether the vaccine works. The administration spent about $8 billion on various candidates to allow them to make the financial investment that's pretty risky to make a vaccine at scale that you don't know yet if it works because if it doesn't work, you have to just throw it out. That's something we are definitely doing and doing in advance so that the day that a vaccine is shown proven effective and safe, we aren't starting from scratch there because that could just introduce a huge delay in access.

It makes a lot of sense, and the companies are really the ones working on this. Many of them say they'll have tens of million doses before the end of the year. It does seem like we will have some vaccine on the shelf. Whether we know whether it works is another question, but the supply demands are something they are very focused on trying to get ahead of.

Amy: Then, there's the distribution piece of this. It seems like there are a couple of questions. The first is just getting all of those doses out, but also, deciding the order in which people get them. Do you have any sense of how that would work? Who's prioritized, for example, in getting the first of these vaccines?

Carolyn: The CDC has a committee that's devoted to this topic, and they've been meeting and discussing who would be prioritized. They're going to pick people who are at high risk of being exposed to this and having severe disease, frontline healthcare workers is one category. There's been discussion of different racial and ethnic groups that have been devastated by this pandemic and how to prioritize them, potentially. I mean, older Americans might be prioritized. Some of it depends on the characteristics of the vaccine that works. Some vaccines don't work as well in some populations, particularly, older people. If that's the case, they probably will take that into account when they decide how to prioritize people.

That's going to be a process everyone's watching. There's going to be a lot of public communication that needs to occur because there are going to people who want the vaccine but who aren't really high risk, and they're going to have to wait. There may be people who are more hesitant to take it but need the outreach to get the vaccine. At the beginning, there's not going to be enough of it for the country or the world, so these issues may not be the first problems necessarily in terms of-- They're going to have to tell people there's not enough, and that's going to be their first challenge. They also need to make sure the right people get it first because those first vaccinations are more powerful if they go to the people at greatest risk.

Amy: Do we have any sense of who those would be? I'm thinking of frontline workers and healthcare, and as you pointed out, older people or vulnerable populations.

Carolyn: Yes, healthcare workers are definitely high on the list. They are meeting about this. There's actually several different bodies meeting about it. Both the CDC has been meeting about it in a process that's public so people can be sure that it's not happening behind closed doors exactly. Then, there's also a separate group being convened, the National Academies of Medicine, that is looking at this issue too. They are still debating. They haven't finalized the prioritization.

Amy: Carolyn, let's go to something that you have written about, and it's this idea that just because we have a vaccine doesn't mean that this moment that we're in and this pandemic that we're in is over, that it really is only the beginning. Help give us a reality check on what it would mean to get a vaccine into the American public.

Carolyn: Everyone's looking to the vaccine to bring us out of this and that is the solution that will hopefully end this pandemic, but I think there's potentially not a full understanding of how much has to do after we do reach the scientific milestone, which will be a huge important uplifting day, like a mental shift in how we can think about our relationship to the coronavirus. It doesn't mean, the next day, we take off our masks and we all can hug our friends and family again because depending on how effective the vaccine is, a certain portion of the population are really going to need to get it in order to be safe, and that will take time.

It depends if we have a really, really slam-dunk the vaccine, it would be less of the population, but in any case, we're talking about a rollout that would take months to years, potentially, for the whole world to be safe. It'll be bit by bit that people feel safer because of the vaccine, but also because of other things that we can do to help contain this pandemic. There are just other things that people already have accessible to them that can really help bring down disease transmission. We've seen it in other countries where some countries-- I mean, they still have outbreaks, occasionally, which they are able to contain, but they're able to return to some level of much more normalcy than we have here because they've used more old fashioned tools.

It's most likely not going to change our lives that day, that month. We all have to get the vaccine. Most of these vaccines are two-dose vaccines at this point, so you need a booster shot about a month later. There's just a lot of logistics that are going to come into play. It doesn't mean to be pessimistic. It just means that to be more realistic, to not be disappointed if the day after, the month after the vaccine, you still are wearing a mask.

Amy: There are things that we could be doing, other countries are already doing to mitigate the spread, but we can't even get people to wear masks in this country. The idea that we will still be able to remain vigilant on that seems, to me, a very big challenge once people say there's a vaccine there. "Oh, it's okay. I don't need to wear this mask anymore. I got a vaccine."

Carolyn: That's what people are worried about. Both that people can have a sense of invincibility from having gotten one, not realizing that many vaccines are only partially effective. The flu vaccine is a really valuable vaccine, but it doesn't prevent you from getting the flu 100% of the time. It depends on the season. If the first vaccines for the coronavirus are similar, that would still be a huge public health accomplishment, but it wouldn't mean that no one got sick anymore. We'd still need treatments to save the lives of people we love from the worst ravages of this disease. Some epidemiologists said we're not going to land in Oz the day that the vaccine is shown effective. It's going to be a process.

Amy: How do we get people to get a vaccine in this moment in time? Who can be the credible messenger here?

Umair: The President recently said that he expects a vaccine by November 3rd, just after the election or just before the election. That kind of rhetoric can undermine the integrity of the process. People may think that it's being rightly or wrongly being rushed. That's what scientists are working really hard to try to counter, to basically build up this credibility that even though they're working at a record pace, at astonishing speed, they are still checking all the boxes, they have the data to back it up, that they are validating all the results, and that what they're distributing is safe and beneficial.

That requires a lot of transparency. That requires a lot of public education. That's a bit of a hurdle right now because, one, you have things moving so quickly that they're not necessarily being so forthright with the information that they have. We've seen some of these vaccine manufacturers, for instance, announce some of their latest findings through press releases rather than through peer-reviewed papers or even through preliminary non-peer-reviewed papers. It's been harder to scrutinize those results. That's something that could potentially undermine it.

The way you build that credibility is, of course, through transparency and through having good solid public messaging that through nonpartisan means, potentially, to illustrate the benefits of getting this vaccine and how it can help us return to normal. It is a process, and this public acceptance aspect of it is not something that should be underplayed. This is something that's really important to start tackling right now.

Amy: Carolyn, even without the challenging partisan moment and the politics around to this, we know there's also a very significant portion of the population that is very wary of getting vaccines or getting their children vaccinated in the first place. I'm not just speaking about anti-vaxxers but others who have questions about whether these things are safe or this particular vaccine will be safe. Is there any way to address that underlying health issue? How much is the underlying concerns about vaccines, overall, and their efficacy, problematic in terms of getting enough people this vaccine to give us some herd immunity?

Carolyn: That's definitely going to be one of the many issues. In the first days, there won't be enough so people probably aren't going to focus on that problem as the first hurdle we have to surmount, but vaccine hesitancy both from people who are actively anti-vaccine, then, also, just from many people particularly in communities that have been hardest hit by this pandemic, like the Black and Latinx communities, have very understandable distrust of the medical system. That is going to be a huge issue because those people, in many ways, if the vaccine is effective, it would be a tragedy if they don't get access to it, but we are just facing a moment of unprecedented distrust of governmental authority.

A lot of work really needs to be done to build bridges and engage those communities to understand what their concerns are, to address them, to talk about them in a really straightforward way. That's one of the huge challenges. It's playing out right now already because they are really working to make sure that the big 30,000 person trials that test whether the vaccines work have a lot of these communities represented because they don't want a bunch of people who are able to work from home, like affluent people, just volunteering. They want a really good cross-section of everyone who's going to need to benefit from this vaccine so that they know if it works.

Amy: Right. Carolyn and Umair, thank you so much for taking this time and speaking with me. Really appreciate it.

Umair: Thanks for having me.

Carolyn: Thanks.

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Amy: Making, testing, and distributing hundreds of millions of doses of a vaccine is an enormous task that will require serious coordination of the public and private sectors. Dr. Jesse Goodman is a professor at Georgetown University and the former chief scientist at the Food and Drug Administration. I asked him about his experience responding to the H1N1 pandemic in 2009 and the logistics of getting a vaccine to those who need it most.

Dr. Jesse Goodman: Even at the most simple biological level, can we make a vaccine that works? We don't know that yet. There's promising early data in humans and animals that shows antibody response where we humans make antibodies that can neutralize the virus, but we don't know how that correlates to protection. That very first principle of, will it work? We think it will, but we don't know yet and we won't know until those large clinical trials are done that show, "Is this effective in humans? Do the people who get the vaccine have less infection than people who didn't?" What's really exciting here is several of these vaccines are very new technologies, which is what enabled these first candidates out of the gate that are now in large trials to get going quickly.

Amy: Just reading back on past vaccine development, especially developments that the government and the industry wanted to get very quickly to people, whether it was polio, whether it was the swine flu in the 1970s, it seems like one of the big kinks in the whole process was the manufacturing piece. There were some really significant mistakes made at the manufacturing portion of this that went on to really injure people who got the vaccine. How much concern do you have, given how quickly this is being developed and how challenging it will be to make a lot of doses of this, that we could also be increasing the possibility of people getting doses that might not be very good for them?

Dr. Goodman: The capability and experience of the regulatory agency, in this case, FDA, is at a much more advanced sophisticated level than it was, let's say, back in the days when polio vaccines were first developed, and the state of the science including manufacturing is at a much higher level. I think some of the risks of out and out missteps and misadventures are lower and the understanding of how to prevent them is much higher. Yet, as you pointed out, honestly, in anything, this is why having a independent and capable regulatory agency is so critically important. This is also why you can speed the production of data, but you need to get the data. We need the data from those large Phase III trials, we need FDA to be able to oversee and evaluate manufacturing process.

Amy: One final thing in terms of just distributing a vaccine, how do we ensure that it gets to who it needs to get to, especially when we know that there's mistrust, the government, in many communities, including communities of color, which stems from decades of on ethical treatment and experimentation?

Dr. Goodman: Inclusion of those communities in clinical trials has not been what it should be, historically. I understand hearing from NIH and some of the sponsors that efforts are being made to enroll typical communities that are underrepresented in these vaccine clinical trials. I think that will be very important to explain to people that the data includes them. That's one point.

In terms of fairness and priority for distribution, again, that's an area where there's a lot of ways to do it. There are different committees looking at this. Again, what we did in 2009, different viruses, the priorities may be different, but on the initial short supply, focus on those who either were the most risk because of their exposure, like in healthcare and essential workers, and then, those who were at the most risk from severe outcomes, which currently would be people who are elderly and people with underlying medical conditions. If doses are limited, there needs to again be transparency about how allocation decisions are made so that people understand that.

There's also a huge mechanical and logistic issue here to potentially immunize most of or the entire population, hundreds of millions, and potentially give two doses. That's a huge logistics issue. We need a clear national immunization plan for this vaccine or series of vaccines, and we need to have that whole infrastructure in place ahead of time. I'm really concerned that the day to do that is not when the vaccine's available, it's now. While there does seem to be good coordination on the vaccine development part, we haven't yet seen what the national immunization plan for this vaccine is going to look like.

I would also mention that it's been mentioned the possibility of having the military involved. I think that needs some deep thought. The 2009 vaccine was pretty successfully distributed through a combination of normal channels through healthcare, through physicians, and public health, and both healthcare-related and then private sector distribution through pharmacies, other people can provide immunization in some public immunization sites like schools, et cetera.

Right now, public health is incredibly stressed and may not be able to take that on, but the preference would be to again use more typical distribution channels supplemented by mass immunization sites if that was needed. I worry that, as wonderful as our military is, how-- Again, in this context of rapid development, the current politicization of everything, if not done very, very carefully, that could create concerns.

I mean, this is not something where we'd want to see something like what's happened with testing app, where every single place does it differently, where one hasn't thought of, "Do you have the syringes to administer this vaccine?" All of those things are not challenging. I'm not saying it's simple for the government to do, but they are things that even if ultimately managed at the state levels, ensuring the logistic planning and capability and supplies really will require federal coordination.

Amy: Thank you, Dr. Goodman. I really appreciate it.

Dr. Goodman: You're very welcome. Take care.

Amy: Communities of color have been disproportionately hurt by the coronavirus and the economic downturn the pandemic has caused, but a long history of abuse and racism at the hands of medical professionals has made communities of color skeptical of public health resources from the government. This has the potential to further complicate treatment and prevention of COVID-19 within these communities. Gary Puckrein is the president and chief executive officer of the National Minority Quality Forum, a nonprofit whose mission is to improve the quality and safety of healthcare for people of color.

Gary Puckrein: The American healthcare system, at least the system that we currently live in, was built during a period when America accepted inequalities, inequalities in employment, education, and inequalities in healthcare. We still live in that legacy system. We speak of the disproportionate outcomes for minorities as disparities, but they're really programmed outcomes that have been going on inside American healthcare for generations.

Amy: This is everything from literally not having enough people of color in clinical trials to, of course, horror stories of experiments done on Brown and Black people without their consent.

Gary: Right. The way to think about it is when a person walks into the American healthcare system, the expectation is that the system is going to lower their risk, lower their risk for hospitalization, lower their risk for disability, lower their risk for having to go to the emergency room, lower their risk for dying, and in the process, improve the quality of their life. What's going on now is we are elevating the risk of some patients when they come into care.

We elevate that risk because they don't have health insurance. We elevate that risk because they can't financially able, and within that, there are also structured inequalities based on a person's race or gender or religion or whatever somebody thinks about. That's what we're dealing with here. What we have to do is to get the American healthcare system to a place where it understands that its fundamental purpose is to lower risk. It can't be in the risk elevation business, do no harm, and that's what minority populations face.

Amy: Let's think about coronavirus. There are so many folks who think that if a vaccine is available, this is going to be able to maybe not overnight but get our lives back to normal. It's going to require, though, that folks get vaccinated. How do you think people of color are going to respond to the government, putting out a vaccine, and asking everyone to come in and get a vaccination?

Gary: Minority populations, for historic reasons, have had reason to be concerned when they come into the healthcare system, and now, it's just elevated, particularly, as what we're doing with vaccines right now is we're not using the traditional method of developing vaccines. We have now gone through this accelerated set of protocols that no one is talking to the American public about and explaining exactly what that means and why they should have confidence in the product that come out of it.

The minority population has a set of elevated set of reasons to be distrustful, particularly, if when those vaccines come out and the decision is made that essential health workers, however defined, by some rule or law or policy or whatever, have to be vaccinated in order to continue to work. That will just really be a trigger.

Amy: What will you be saying? When this vaccine comes out, [laughs] what's your advice going to be to communities of color?

Gary: We're all about the science. The first question we would ask is, what did the trial data say? Were minorities enrolled in the trials in sufficient numbers so that we can draw scientific conclusions about efficacy and safety? If that is satisfied, then, we would of course take the position that folks ought to get vaccinated, but it's got to be by the science. Right now, I don't understand and no one is talking to us about how these new protocols work, the size of the patient population, how diverse are they, what are the endpoints that they're looking for. There are whole sets of those questions that have to be answered.

Amy: Who do you want to be telling you about how these protocols work? Who would you trust to get these answers from right now?

Gary: That's a great question. Historically, one would say, FDA, but FDA, its voice is confusing right now. It needs to reestablish its voice so that everyone can be comfortable that we're all speaking the same language, which is science. There is a scientific method that has nothing to do with politics. It's just science.

Amy: Who do you think would be a credible, trusted messenger to go into Brown and Black communities if indeed you personally felt like the vaccine was effective and pass the rigors of science?

Gary: Certainly, those minority-serving providers have to be able to talk to their patients about taking the vaccine because the patients are going to ask them, and they've got to have the confidence to say that if you inject yourself with this thing, it's going to be safe. They're going to look to the numbers. They're going to look to the science before they can confidently say that to them. Then, the patient advocacy of folks, they'll be asked as well. There's a whole education process that has to happen here, and it needs to happen simultaneously with the discovery process because everybody needs to understand how this process is working, and at the end of the day, it will be safe.

Amy: Gary Puckrein is president and chief executive officer of the National Minority Quality Forum. All right, now, it's your turn. When a COVID-19 vaccine becomes available, will you get it, and why or why not?

Mycah: Hi, this is Mycah from Glasgow, Kentucky. I probably will not take the vaccine if it's available either this year or in the beginning of next year. I feel like it's being rushed. I know it has to be rushed for health reasons, but I'm a little concerned that it's being rushed more for political reasons. For that reason, I probably am not sure that I would trust that it was safe enough to take without more studies.

James: This is James from Bellevue. When a vaccine that is approved by the CDC is made available, I absolutely will take it as soon as possible because I believe in science and trust in the CDC.

Jennifer: Hi, my name's Jennifer. I'm calling from Orlando, Florida. I would absolutely get a vaccine for COVID-19 because I simply want to be able to see and embrace my loved ones in the future.

Sharon: My name is Sharon, and I'm from Salt Lake City, Utah. Absolutely no, will not be getting the vaccine. I believe this is contrived, and it's more about dollars than it is health, sadly.

Sabina: Hi, my name is Sabina Spicer. I'm calling from Portland, Oregon. I will be the first in line for the vaccine. I'll be there with my toddler and my husband. We will camp out if we have to to get that vaccine. We will camp out like there's a new Star Wars movie coming out, and we will be there ready and waiting for it.

Mike: My name is Mike. I'm from San Diego, California. I'll definitely get a vaccine, especially if it's proven to be successful. Not only will provide me peace of mind for myself and allow me to be a little bit normal, but it'll also help in aiding the community and my fellow Americans right now.

John: This is John in Denver, and I will get a vaccine in a heartbeat provided that it's scientifically sound. I'm 63 years old and scared by the Rona.

Amy: As always, we appreciate hearing from you. 877-8-MY-TAKE, it's the number to call.

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Amy: That's all for us today. Our senior producer is Amber Hall. Patricia Yacob is our associate producer. Dina Sayedahmed is our digital editor. David Gable is our executive assistant. Jay Cowit is our director and sound designer. Debbie Daughtry is our board op. Vince Fairchild is our board op and engineer, and our executive producer is Lee Hill. Thanks so much for listening. This is Politics with Amy Walter on The Takeaway.

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