'Behind the Blue' - Part Two: The Vaccines to Combat a Coronavirus With Brooke Hudspeth and Vincent Venditto
It has been nearly one year since the SARS-CoV-2 coronavirus changed the world. With millions of people infected and over a quarter-million dead in the United States, the novel coronavirus continues its pervasive hold on our health and well-being.
After months of stress, frustration and uncertainty, people are itching to travel and visit loved ones during the height of the holiday season, despite increasing cases of COVID-19. As the virus continues to dominate news coverage, people are clinging to the anticipation of promising vaccine trials from Pfizer, Moderna and several other companies. How will these vaccines, and potentially others still to come, change the course of the pandemic? Will we be able to return to normal and how long could that take?
On this episode of Behind the Blue, we speak with Vincent Venditto, an assistant professor in the University of Kentucky College of Pharmacy’s Department of Pharmaceutical Science, and Brooke Hudspeth, an associate professor and Chief Practice Officer for the University of Kentucky College of Pharmacy. In part two of our interview with Vince and Brooke, we discuss who exactly takes part in vaccine trials, the issues those trials may run into, when to expect some type of herd immunity and more.
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KODY KISER: Who takes part in something like this in a trial? How does one-- are these people crazy? Is it adrenaline junkies that want to live on the edge of being able to be part of a trial? Or are these just normal people that are part of this? Are people paid? Are they paid well enough to not care? How does one get involved in this?
BROOKE HUDSPETH: So there are different efforts that are in place for these specific clinical trials. I'll say I know several individuals personally that have been involved in these trials as well. So, for COVID-19 trials in particular, there are specific requirements for patients, or I guess specific factors, that are being assessed. And so there's a site where patients can enter their information or volunteer to be a part of these clinical trials.
And if they meet the criteria of what specific characteristics that these trials are looking for in a subject, in that certain geographical area, then they will be selected to participate in these trials. And so I think there is a variety of reasons that people might want to be involved in these trials. I think what I've heard resoundingly for COVID-19, for example, is almost a a level of sacrifice, or duty, if you will, to really take part in being a part or a key player in these efforts to really help combat COVID-19, and get our quality of life back to somewhat of a pre-COVID-19 level of quality.
And so that's what I'm hearing a lot. People feel an obligation, or a duty, or a sense of pride in being able to step up and serve in this way, if you will, to be a part of the solution. People are compensated as well for as usual with clinical trials. There's usually some type of incentive for first subjects or for individuals to be involved in any types of clinical trials. So that is no different with these COVID-19 immunization or vaccination trials.
KODY KISER: What will the roll-out for this vaccine or this group of vaccines look like? As we edge ever closer towards this, possibly before the end of 2020, and certainly into the first part of 2021, we're going to see these vaccines-- if they continue on to get approval-- we're going to see them introduced into the public. What's that going to look like?
BROOKE HUDSPETH: Yeah, I think that is a very key part to this entire process is the distribution and the roll-out. I think that is one of the components that is requiring the most coordinated efforts. Development and approval clearly and are very key in this entire process, but I think the roll-out and the distribution is becoming just as important.
And so you will see these delivered in a phased approach or administered in a phased approach, and clearly we have hundreds of millions of individuals that need the immunization. And while the immunizations are being produced or the vaccinations are being produced in large quantities, there is still not enough to immunize everyone that we need to immunize.
And so that is where this phase distribution approach really comes into play. So our first phase will be to our frontline workers, our health care workers that are working on the front lines, as well as some of our highest risk individuals. And so I think of our older individuals that may be living in long-term care facilities.
Those types of patients are going to be the ones that are in some of those first phases of vaccine distribution. And then as we move along into additional phases, what you will see next are your essential workers. So continued immunization efforts for our essential health care workers, for individuals like teachers, and others that have been deemed as essential.
And each state has a plan in place for what that distribution looks like. And then as we move forward, I think it's going to be later in the process that we see just general community immunization efforts. Again, we have to think about those individuals, and those recommendations have been made with a lot of thought behind them. So there's a very structured process, different layers in the regulatory realms of those who are making those recommendations for roll-out.
So CEC's Advisory Committee on Immunization said they get guidance from a group, and then they provide that guidance to the CDC, and then that has to be approved, and then communicated out to the different levels and states. And then those that are actually receiving the vaccines for administration are following that guidance in that process.
INTERVIEWER 2: I think it would be really important to point out that even though people are starting to get immunized in this phased approach, that it's going to be extremely important for people to continue to wear masks. Like, just because people are going to start getting immunized doesn't mean you can throw your mask away and, Oh goodness, we don't ever have to wear them again. That that's going to continue that we need to be safe and continue following these measures.
VINCE VENDITTO: Yeah--
BROOKE HUDSPETH: Go ahead, guys.
VINCE VENDITTO: Sorry. Go ahead, Brooke.
BROOKE HUDSPETH: I was just going to say, yeah, that is important, Mallory, that it's going to take a high level of folks getting immunized for us to really start to see these large shifts. And so it is important to still continue to practice those safe social distancing, masking practices even though the vaccine may be available, and approved, and individuals begin to get their vaccines, it's still going to be important to follow that.
Also most of these vaccines, at least the ones that are at the forefront right now, are two dose series. So that's something else that's important for individuals to recognize that there is the one vaccine that they have to get, but then the importance of the follow up to receive that second dose really needs to be communicated and thought through. And there are, again, processes in place that are going to allow for individuals to be reminded of their second dose to ensure that people are coming back to get that completion dose of the series.
VINCE VENDITTO: So there's a few things I'll touch on. So I think in thinking about roll-out, there's a number of other things that we think about. And one is the cold chain, right? So these different vaccines have to be kept at cold temperatures. And they're required to be kept at different temperatures as well.
So the Moderna vaccine, you can actually keep it at minus 20, which is your regular freezer. And every clinic, hospital, pharmacy is going to have a minus 20 freezer. They're going to have a freezer that can store this. The Pfizer vaccine, requires a much colder temperatures. So minus 70 degrees Celsius, and yes, certainly research labs have these freezers. Hospitals will have them.
But your every day clinic or pharmacy is not going to necessarily have a minus 70 freezer. So I know Pfizer is currently in the works trying to develop a cold chain mechanism that would allow them to provide vaccines in basically a cooler that goes down to that temperature. But there's a lot of infrastructure there that's needed as well to get this to happen.
And when we think about the infrastructure needed to keep these cold chain-- these vaccines at cold temperatures, normally, we talk about this in the context of-- well previously, when I was doing HIV vaccines and we were talking about getting them to these areas in Africa, where you have kind of remote locations.
But if we think about Kentucky, you have people in Eastern Kentucky and Western Kentucky that are hours away from a hospital or hours away from a place that might actually have a vaccine. But in 119 out of the 120 counties in Kentucky, there's a community pharmacy. And so our pharmacies are really important in rolling out vaccinations.
Pharmacists are approved to administer vaccinations. It's pharmacies, I think, are really going to be critical, and Brooke can say more about this. I mean, she's a pharmacist. I only try and support our pharmacists.
BROOKE HUDSPETH: That's a great job at that. But yeah, Vince is exactly right. You know, you think about the cold chain and those factors for consideration. But I think just if you look at vaccines in general, I think what you've seen over the last probably 20, 20+ years or so, is that pharmacies have been a very key player in ensuring that individuals are vaccinated.
And as Vince mentioned earlier, the impact and the importance on public health of immunizations is huge. And the ability of pharmacists to really step up into that role with their accessibility, with their training, their knowledge to really help in those efforts, I think that is the reason that we've seen some of these shifts over the past several years in that work to improve immunization rates overall. And just the importance of vaccine preventable disease and how that has shifted over time. But again, especially in a mass effort such as this, thinking about all of the players becomes very important. Then utilizing every one possible to be able to participate in these efforts is going to be critical.
But as Vince mentioned, we have pharmacies, pharmacists in these rural counties across Kentucky, and the role that they can play in helping with these efforts in a mass rollout I think is going to be huge. And so we're starting to see that recognition a little bit more nationwide. But I know in Kentucky, for example, we've had a pharmacist on the team with our State Department of Public Health to really ensure that we are maximizing the use of our pharmacies in these efforts.
KODY KISER: When these vaccines are all released, are people are going to have a choice of, like, are you going to be able to go to the doctor and say, I want the Pfizer vaccine, or I want the Moderna vaccine? I know some people probably won't care one way or the other. But for people who may be doing as much reading up on this stuff as they can. Are they going to have the option to choose whichever one that they want or will it just be based on where it's available?
BROOKE HUDSPETH: Vince, you may have more information on this. I honestly do not know the answer to that question. I would anticipate that I think that's a big question in my mind, or that I've heard across the community that still remains as far as, who will be distributed what vaccine? Clearly, as we think about that the phased approach and the groups that will receive the vaccines, those that are approved earlier on will likely go to those individuals who are in those earlier phases.
The distribution process is going to be-- to providers will also be very structured. And so you have on a more of a national scale, you've got partners with different pharmacies and other providers, and that list continues to expand, where there are those direct relationships with those different providers of the vaccine. And so they will receive those on an allocated basis based on their ability to administer the vaccine. And there is a very stringent reporting mechanism that will be utilized to distribute the vaccine.
And then there will also be relationships with the states themselves where they distribute to different providers from their allocation, that also comes from the National level, but it goes down through the states. And so, for example, right now from a pharmacy perspective, there are over 60% of the pharmacies between chains and other groups that represent independent pharmacies that are now contracted or in partnership with the national allocation of the vaccine. And then some of those other sites will be able to administer or receive vaccines from the state allocated level. And so I think, at least from what I've seen there still is a little bit of question that remains as far as what vaccine type will go to each of those respective providers.
VINCE VENDITTO: Well, so, I agree with all of that. I agree that they don't necessarily know right now, but they're putting these plans in place. So, first, obviously, as Brooke indicated, it's going to come down to allocation and how they're going to be sent to the states, and how each state is going to divide them.
And part of that is based on production, current production levels, but then I think to add on to what Brooke was saying, that once they start rolling them out in these early phases and the health care workers are getting them, they're going to continue monitoring the efficacy and the safety in these subjects. So I think that continued monitoring is really where we then may break down and say, oh, look. This vaccine does not work in this specific population, or this vaccine does not work in this specific population.
And so, the same thing that happened with the example that I gave about the haemophilus influenzae vaccine. After it was approved, but after both vaccines were approved, they found out that one did not work in a specific population. And so because of that, they then had to provide the native population with one of the vaccines over the other.
So I think that's going to happen in this case as well where we may find that the 65 and older population, one vaccine works over another and that's what's going to have to be provided to those patients. So part of it, obviously, is as Brooke was indicating, was a logistical thing of just having the doses available. And the other is going to be on a monitoring, a continued monitoring basis.
KODY KISER: So, when this rolls out and we try to get this into our population, will people get this vaccine? How do we encourage more people to get it? And I think specifically about our populations in communities of color. You can think back to events in the history of the Black community, for example. That has not been a good history with medicine, and with vaccinations, and things like that. So how do we go about this, because of all the disinformation and all of the speculation about this. How do you encourage people to get this?
BROOKE HUDSPETH: Yeah, and so this is another key component to the success of these efforts. And so I think a couple of things. I know we mentioned earlier just some of the transparency in the development of these vaccines. So I think that's a critical component to ensure that these vaccines are assessed in an ethical way.
As well as along with the safety and efficacy, I think being ethical in the development is very critical. And I think that you're seeing an increased emphasis on that, and really those efforts being transparent. And so I think that is important, and then the education piece. Getting the word out there, working through pharmacists, for example, are one of the most highly trusted health care professionals.
And so working with our health care professionals to provide that education. Working with our community workers to really provide that education to those groups where there may be some mistrust. The general population, I think, we can think there are different levels of mistrust, but as you mentioned, as we look at some specific patient populations, working with those groups.
And again, as we think about some of these groups, where there may be some history, there some mistrust. Some of those groups are also those who are at highest risk for complications from COVID-19. And so ensuring that we have advocates for our patients in these populations to provide that education on the importance of vaccines, and clearing up some of those misconceptions is going to be critical.
KODY KISER: Between people who get this vaccine and people who may already have some sort of immunity due to already being sick with COVID-19, to your best speculation or guess, or to the best of the knowledge that you have about this, when should we have any expectancy of any type of herd immunity?
VINCE VENDITTO: So I think the one thing that I'll say is getting a vaccination does not prevent you from transmitting necessarily. So there is a difference between a vaccine that is going to prevent you from getting infected and preventing you from transmitting, and a vaccine that prevents you from getting severe disease. And the way that the clinical trials are designed, or the way of the ones that I've heard about, they are designed to note symptoms and with a positive PCR test.
And so once vaccines start rolling out, as Mallory indicated previously, it's so important for us to have once vaccinated, to continue social distancing, to continue wearing masks, to not be traveling to visit our families over the holidays. Doing all the things that we're currently doing without a vaccine. Because once we have a vaccine, it's going to roll-out to the health care workers first.
The health care workers can still be transmitting the virus from to from patient to patient. So they're still going to be needing the PPE, but they're not going to be hospitalized, and they're not going to be out of work. They're going to continue working through potentially being infected. And hopefully, the infection won't last as long.
Hopefully that our immune system allows us to fight it so that we're not transmitting for such a long time. So that is all to say that herd immunity is going to be a difficult thing, right? They say that somewhere above 60% immune is going to be herd immunity. But if vaccination is still allowing us to get infected and still allowing us to transmit, it's a difficult question that I don't have an answer to.
But I think thinking about herd immunity is premature at this point. I know everybody wants to think about how do we get to herd immunity. And there are countries that decided to go the herd immunity route and not have many restrictions, just hoping that they get there. And these countries did not return immunity without having any of these social distancing things in place.
So, I mean, I think we're-- I don't know. It's a difficult question to answer, but I think coronavirus, SARS-CoV-2, is going to be with us for a while. And it may actually never really go away, the same way that our common cold coronavirus is never really go away. But it's always the children that are infected with them and usually have the majority of the symptoms that we see.
So I think what's going to happen is, yeah, at some point, all the adults will have been exposed, which may be several years down the road. And we don't really have these symptoms anymore, but children continue to have these symptoms and continue to transmit. So it's a difficult question but—