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Many Americans have expressed strong reservations about vaccines in general and a COVID-19 vaccine in particular, and remain unsure about whether to be vaccinated against the coronavirus (SARS-CoV-2). In this episode, guest host Claire Wulf Winiarek speaks with Janet McUlsky, convener of the COVID-19 Vaccine Education and Equity Project, and Susan Winckler, a former Chief of Staff to the FDA Commissioner and current CEO of the Reagan-Udall Foundation for the FDA, about these concerns and the potential messages and messengers that may help improve understanding.
JC Scott, President & CEO of the Pharmaceutical Care Management Association, discusses the latest trends, public policy developments, and political challenges impacting drug pricing and healthcare.
You'll hear the nation's top thought leaders, policy experts, and political analysts on topics like how employers, unions, and others use Pharmacy Benefit Managers (PBMs) to drive value for their members in the face of growing healthcare costs. You'll also learn about advancements in gene therapy, biologics, other cutting edge therapies, and the patient benefits and cost challenges that come with them.
The Pharmacy Benefit will also analyze the latest news from inside the industry and give you an educated perspective on where things currently stand and where we think they're headed.
Claire Wolfen Yarik (00:08):
Welcome to The Pharmacy Benefit, a podcast that highlights the role of PBMs in serving millions of patients and consumers throughout the country. I'm Claire [Wolfen Yarik 00:24:36], in for JC Scott.
Claire Wolfen Yarik (00:18):
Today, we're talking about the COVID-19 vaccine, an extremely top-of-mind issue for all of us right now, particularly since so many stared receiving the vaccine only last month. According to the CDC, approximately 200,000 are being vaccinated each day. Impressive as that figure is, it's far below the goal of 1 million vaccinations a day that we really need to get to that goal of herd immunity. Today we're pausing to talk about the vaccine itself, to give our listeners as much information as we can, and about equitable distribution or ways we can all ensure that people who need it most are getting it.
Claire Wolfen Yarik (00:58):
Joining me today are two guests who can offer great guidance and perspective. Janet McUlsky is a nationally-recognized expert and innovator in the field of stakeholder alliance development and programming. Her background encompasses work on Capitol Hill, campaign and issue management, and strategic communications, as well as working side-by-side with healthcare and patient advocates across the country, experiences no doubt crucial as she now leads the COVID-19 Vaccine Education and Equity Project. For nearly a decade, Jen had helped Pfizer establish long-term, trusting partnerships with nonprofit patient advocacy organizations. These partnerships help build a louder, impactful, incredible voice on behalf of critically ill patients.
Claire Wolfen Yarik (01:43):
Susan Winckler is CEO of the Reagan-Udall Foundation for the Food and Drug Administration. The foundation is a nonprofit organization created by Congress to advance the mission of the FDA. Previously, Susan served as Chief of Staff to the FDA Commissioner. Serving both Republican and Democratic commissioners as their senior most staff advisor, Susan analyzed complex policy challenges and represented FDA with myriad government entities and stakeholders alike. Prior to her leadership of the Reagan and Udall Foundation, Susan served as President at the Leavitt Partners, a national healthcare strategy firm founded by former governor and Health and Human Services Secretary Mike Leavitt. She also held top posts at the Healthcare Transformation Task Force, Food and Drug Law Institute, and American Pharmacists Association.
Claire Wolfen Yarik (02:30):
Susan and Janet, thank you so much for joining us today. We're so delighted to have you, such an important conversation. I think we should just dig in, such a timely topic. Susan, we'd love to start with you, in talking about the vaccine itself and the really historic factors behind its development. When compared against other virus outbreaks and pandemics, moving from identifying the disease to a safe and effective vaccine, that's taken years in some cases, but here we are less than a year and we have our vaccine on our doorsteps. It's really extraordinary. Would you agree?
Susan Winckler (03:08):
Absolutely, and it's extraordinary for a number of different reasons. It was the top priority for scientists and public health professionals, for companies and regulators. We had extraordinary, to use your descriptor which I think is apt, collaboration to identify targets for a vaccine, what we wanted to have happen. Then recruiting for clinical trials was easier because there were lots of people eligible for those trials. The manufacturers made the vaccine, they manufactured it at risk before they had even gone under regulatory review so that we would be ready, should the vaccine be authorized that it would be ready to be distributed. And then you had literally hundreds of FDA staff members reviewing the regulatory package simultaneously to move it as quickly as possible. So what a result of focused effort by a number of individuals and organization.
Claire Wolfen Yarik (04:10):
Absolutely. Susan, it strikes me, it sounds a lot like a lot of the typical steps in this process, which of course you've all mentioned, they were all just happening at the same time. Did that really drive the speed of this effort
Susan Winckler (04:23):
It really did. It's one of the things is if we think about this as a process, if you had a horizontal line, what happened is we compressed a whole lot of things into a much shorter, fatter line where we could do things simultaneously. We had lots of people working on things to move them simply much more quickly than you would in a typical vaccine development process.
Claire Wolfen Yarik (04:47):
Just so incredible. Now, Janet, help us understand the process of it. What was the review, the oversight, all that was really involved to ensure the vaccine that's getting into folks' arms today is safe and effective and does exactly what we all need it to do?
Janet McUlsky (05:04):
Thank you for that question, because I think it really is probably the one that people think about. I don't want to say worry about, but think about the most right now. I think you have to look back at the FDA's longstanding reputation as really the gold standard for the world. They work with the pharmaceutical companies to develop the standards that are necessary in executing a clinical trial, which was done at light speed on these vaccines. So, you have the FDA really monitoring and focused on what the companies are doing as they're proceeding with their vaccines.
Janet McUlsky (05:49):
Candidly, you also have a lot that was built into the system that we have had a number of pandemics, none of them like this pandemic. But when you look at SARS and a number of the other real infectious threats that we've had in the last decade or two, there's been a lot of research that's been done, both within the government and in private sectors and academia to really help position us to be able to move with the speed of science to move forward.
Janet McUlsky (06:20):
You have hundreds of thousands of individuals that stepped up in a really courageous way to be part of the clinical trials and said, "I want to help us move to the point where we can have a vaccine that can return our world to what we want it to be." So you have all of those individuals in the clinical trials, and now you have what? 10 million people already having been vaccinated. That's a pretty exciting thing when you do look at it as all being done within less than a year, and with the really thorough oversight of the FDA scientists, researchers, physicians, and everybody involved.
Claire Wolfen Yarik (07:01):
It's really incredible, such a historic Herculean effort that really was successful because of this tremendous experience and coordination as you both have shared. Now we have moved into another phase, haven't we? From vaccine development to mass immunization, and it's a similarly historic Herculean effort with a lot of moving pieces. So let's kind of dig in there. We're a few weeks into this effort to get every American, really every global citizen, vaccinated just as quickly as possible, and this is a question for both of you, how are things going?
Susan Winckler (07:41):
Claire, I'll jump in and say things could be going better, but we are getting vaccine out of vials and into arms. And now we've got to figure out how do we do more of that? Where can we get vaccine into willing individuals? Where we can, let's do it. So deploying health professionals at fairgrounds or stadiums, wherever necessary. Now's the time to get the vaccine into individuals and to have the conversations with those folks who are hesitant or have some concern about the vaccine. Let's have those conversations so they have enough information to make their own decision about whether or not to receive the vaccine.
Janet McUlsky (08:25):
Susan, I completely agree with you on that. I mean, I think that what we have to do is get the information out to as many people as possible. And then, honestly, if you look at the data from polling of who was willing to roll up their sleeve and get the vaccine, how much has shifted since even September, October? And in large part, because at the time we didn't know how efficacious it was. We didn't know it was going to be over 90% effective in being able to protect you. And we didn't have the full amount of data on what the side effects might or might not be. So we now look at it as a safe, as much as we can tell, but as I say, with 10 million people having been vaccinated, you begin to get a dataset that really shows you the safety and efficacy, and that's really exciting.
Janet McUlsky (09:18):
Unfortunately, Christmas and New Year's were in there, which I think is an issue. But I think we've now all, governors, counties, state health departments are all really focused on how do we get this in as many arms as possible to protect particularly the most vulnerable at first and then the rest of the general population.
Claire Wolfen Yarik (09:38):
It does beg the question, knowing what we know now and having about a month of experience in, where should our focus be turning? What types of maybe different approaches should we be thinking about to get to that next phase of really much broader vaccine access?
Susan Winckler (10:00):
I'll jump in and note that this is where we really have to expand not only awareness about the vaccine, but that we invite and respond to questions about the vaccine. We know there's hesitancy to receive the vaccine, particularly in minority communities and essential workers. We conducted a project to speak specifically to them. They had questions about how could the vaccine possibly be developed so quickly, concern and distrust of the government that politics and economics might be prioritized over science, and then just the reality of historic and current racial and ethnic disparities. We have to respond to those questions. We have to have conversations to explain how the vaccine was developed so quickly, to explain that scientists and career public health officials, not politicians or their appointees, made the decision to authorize the vaccine, and to underscore that the clinical trials were quite diverse to make sure that the vaccine works for everyone. But those are conversations that we need to have.
Janet McUlsky (11:17):
I agree, Susan. I think the conversations that are going on with some of the black and brown healthcare professionals have also been a huge help in building a level of understanding and, little by little, a comfort that this is something that's safe and effective for all the communities. I think you're absolutely right also to point out that the clinical trials were done in a really exceptional way, including not only race, ethnicity, but age. I mean, given that we see so many of the mortality rate being so much higher within the older population, it was really important that there be a large number of people within those populations to be tested in the clinical trials and to show that it is safe and effective for them.
Janet McUlsky (12:07):
But I think the more that the professionals within the healthcare community, the religious community, sort of all of the... And you've done some great research on this, Susan, as to who are the messengers that are most likely to be trusted and what are the messages that would resonate the best within the communities that have historical distrust for the healthcare industry. But I think that's what's going to move us forward.
Claire Wolfen Yarik (12:37):
Susan, if we could, as Janet noted, there has been just an extraordinary effort led by the Reagan-Udall Foundation to identify the best ways to promote awareness, the top messengers, the top messages. In your findings, what does seem to work best when trying to get the word out about the vaccine and does that differ at all for different people?
Susan Winckler (13:03):
Yeah. I'd say the most important thing is to listen. So that's this concept if folks are hesitant or they have questions, we have to listen and we need to respond to those questions, and we need to respond with trusted messengers. Our project showed that local healthcare professionals, so the physicians, the nurses, the pharmacists, along with health experts in FDA were all credible messengers to answer questions. They were far more trusted than where we might typically go, which would be to celebrities. Now, I think celebrities have a role in raising awareness, but we shouldn't be surprised that celebrities aren't well-positioned to answer questions about the vaccine development process. That should be from healthcare professionals who I know, who look like me and can help me understand that, in fact, I am getting the same vaccine as other people. It was tested in people who look like me and have the same social experiences like me, so it should be effective in me.
Susan Winckler (14:21):
We need to have those conversations and share what we know about how we got here so quickly, who made the decision, as well as be candid about the fact that we're still continuing to learn about the virus. But what we know today is that the vaccine and having a number of individuals getting that vaccine in their arms is our best path to protecting our family and others from having to face this infection.
Claire Wolfen Yarik (14:54):
Susan, it sounds so much like the old approach of meeting people where they are, speaking really directly one-on-one. Is that in many ways what the foundation has found, is these just have to be really personal conversations?
Susan Winckler (15:11):
Very much so. Including we had one person in a listening session who said, "I want to see somebody who looks like me get the vaccine and then see that they're okay." That's part of what we need to show. Now, as Janet noted, it's no longer a question of being first to receive the vaccine, we know of millions of people who have received the vaccine. We have to talk about that and then make sure that we can deploy and get tens of millions more to have their questions answered and ready to roll up their sleeve.
Janet McUlsky (15:47):
I would just say, Claire and Susan, the coalition that I'm working with or the project, which is the COVID Vaccine Education and Equity Project, it's a mouthful, I'm sorry, has put on their website a discussion guide, which is very much what Susan's talking about is how can you talk about this with your family members, with your neighbors? How do you begin to build that trust? To know that all the Is have been dotted, there've not been any shortcuts. It might've been done quickly, but there were not shortcuts. It was just done with an extraordinary amount of effort at every level. In the discussion guide, it talks about how do you talk to your grandparents? How do you talk to the different racial and ethnic minorities within the country? How do you show them the data of how many people were involved in the clinical trials that do look like them? Per Susan's comments.
Janet McUlsky (16:48):
The other piece of it is anybody that has some health issues, there's been a lot of questions. "If I'm on infusion therapy for my cancer, should I get the vaccine or not?" So you want some of the cancer groups to be part of this project, to really talk about what are the implications. If you have arthritis and you're on medications, should you be getting the vaccine? What you'll see in the project is over 120, I think, we have voices now from the Hispanic medical to the black nurses, to really the whole panoply of organizations really speaking with one voice and trying to answer those questions in a thoughtful and comprehensive way of why the risk/benefit is clearly weighing on the side of getting a vaccination.
Janet McUlsky (17:42):
Because the number of people that are dying disproportionally within the black and brown community is unacceptable, and we need to really encourage and work with these communities to develop a level of trust and confidence that the vaccine is really right for them. Right, I put it in air quotes, but is the thing that they should be doing to protect their health, their parents' health, their grandparents' health.
Claire Wolfen Yarik (18:10):
Janet, it really sounds like we have to have an all hands on deck approach. It's not just the vaccine makers and government officials and the traditional public health authorities, but so many within the private sector and beyond amplifying these core conversations and the need and importance of them. Janet, the COVID-19 Vaccine Education Equity Project that you lead currently includes more than 120 partner organizations, ranging from patient foundations to industry associations. Can you share an example from these partners of how the private sector is helping to promote vaccine awareness?
Janet McUlsky (18:53):
Interesting. Good question. I think you see a lot of work being done actually through the chamber of Commerce, through the NAM, through the BRT in trying to help employers try to figure out how to, without doing mandates, really incentivize and share information. I think all three of them have materials on their website. I think you see BIO, the trade association representing so many of the companies that are working on these vaccines and developing, they've got some really fabulous materials on their website to share and to be passed around to the community, to just give more facts and data that can make people feel more confident. So I think you see a lot of people really digging in to try to help people feel calm and confident that we have done as a country, as a healthcare system, what needs to be done to assure that these vaccines are as safe and effective as possible, and that we can return our lives to where we'd like them to be and protect the public health of everybody.
Susan Winckler (20:03):
I'd add there, those are great examples, and the private sector effort here has been really impressive, but I think each healthcare profession is also looking at how do we... It's not only empowering their members, members of their profession to talk about the vaccine, but giving them the information that they need. If we found that they were the trusted messengers, they have to be confident in the information and look at it a little more carefully. So they will want to know why is it a two-dose regimen? And what should I tell people to expect? How do I answer that question about if I'm a patient with cancer or a patient with arthritis and what are the risk factors for me?
Susan Winckler (20:49):
I've really been appreciative of the healthcare professions digging in. And really, anybody who works in healthcare, I'm going to guess that all three of us have gotten questions about healthcare and for sure about the COVID-19 vaccine that you just wouldn't expect. But we are the defacto health experts in our social circles. That's an opportunity. So whether you're actively in healthcare or it's in that text that comes and says, "Should I get a vaccine?" we should be prepared with that answer or the opportunity to share resources and help people get those answers.
Claire Wolfen Yarik (21:31):
Absolutely. We all have a role to play as the defacto health expert and backseat expert or not. Before we wrap up, I think this has just been such an excellent conversation and no doubt we could probably spend quite a bit more time going through where we are and where we're going. But as we look ahead, I just want to ask you both one closing question. What is one thing, one message that you hope our listeners will take away from this conversation and try to apply to their own vaccine promotion efforts, as it were?
Susan Winckler (22:05):
Janet, I'll jump in.
Janet McUlsky (22:06):
Please.
Susan Winckler (22:07):
I'd say it took an extraordinary effort to yield a vaccine, and now we need to use it, and recognize that that's going to take conversation and dialogue, not dismissiveness. We have to hear concerns and respond and empower individuals with the facts to decide whether or not to get the vaccine. And now's the time to have those conversations.
Janet McUlsky (22:33):
I agree, Susan, and I think the facts and the data is there. The more people that get the vaccine... I mean, I've heard even healthcare professionals say, "Yeah, I'd like to wait six months and make sure it's all good." But the good news is we're almost at six months, people have been getting these vaccines in their arms for six months. Every week that goes by it's another hundreds of thousands. And so I think we can also be hopeful that the confidence level that this is really accomplishing what needs to happen will grow exponentially. As long as we all try to be thoughtful, respectful. We've talked a lot about this within the misinformation, the disinformation, and there are two very different things. I think we want to really be respectful in the dialogue and the discussion and share with people the data that shows the real confidence that the healthcare system has that these vaccines are doing the safe and effective job that they were really designed to do.
Claire Wolfen Yarik (23:44):
Well, I can tell you I was already quite excited to be able to leave my home and get vaccinated. My seven-year-old who is usually, "No shots, no vaccines, I cannot," he is also truly excited, but now I am even more ginned up. So Susan and Janet, thank you both so much for having this very important conversation with us. I do want to note for our listeners, Janet in particular mentioned some really excellent resources, including a discussion guide. We will be linking those resources mentioned in the episode notes, so be sure to check it out and use it in your own conversations.
Claire Wolfen Yarik (24:22):
Well, thank you all for listening today. I encourage you to subscribe to The Pharmacy Benefit and download all of our podcast episodes. You can do that on Google Podcasts, Apple Podcasts, Spotify, or wherever you find your favorite podcasts. I'm Claire Wolfen Yarik, thanks so much for joining me.