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Bruce Y. Lee, MD, MBA: “We have to remember that infection control and prevention is not just dealing with the pathogen itself but dealing with the consequences and the downstream effects of what happens when you are dealing with the pathogen.”
Because he’s not on the frontlines battling coronavirus disease 2019 (COVID-19), the short answer from the internationally known healthcare expert Bruce Y. Lee, MD, MBA is no. “I would like to see data for a longer period of time to make sure that we have a better handle in terms of efficacy and the safety of the vaccine,” Lee tells Infection Control Today® about the Pfizer/BioNTech COVID-19 vaccine that began rolling out to hundreds of distribution centers this week. In a wide ranging discussion with ICT®, Lee talks about whether hospitals should mandate that its employees get the COVID-19 vaccine (proceed with caution, he says), what the overall response to the pandemic in the United States has been (not so good), and where exactly might infection preventionists fit into all of this. “We have to remember that infection control and prevention is not just dealing with the pathogen itself but dealing with the consequences and the downstream effects of what happens when you are dealing with the pathogen.”
Infection Control Today®: OK, Doctor Lee. We’ve got the vaccine. What now?
Bruce Y. Lee, MD, MBA: Getting the vaccine available is just one step along a long series of complex steps. So next, the vaccine needs to be produced. We've seen shipments come out, meaning that the vaccine is being produced. But ultimately, you’re going to have to produce a lot of the vaccine. We’re talking about millions upon millions of doses within a fairly short period of time. And that’s not a small feat. We’ll have to see how production goes. And then there’s the whole issue of transporting the vaccine. So normally, transporting a vaccine is in itself complex, because you really have to figure out how to get it through a series of steps called the supply chain, all the way to the places where it’s going to be administered. And that includes a wide variety of places. It could be hospitals, it could be clinics, or health departments. But there may also be other locations, such as schools or churches or what have you; workplaces, that aren’t necessarily easily reachable by standard clinics and healthcare facilities. That poses a major challenge for any type of vaccine, but especially for this vaccine. Because this vaccine requires special storage requirements. It needs to be stored at freezing temperatures, so way freezing temperatures. Not just below zero centigrade or below 32 Fahrenheit. But super freeze
conditions, negative 80, negative 90 degrees. And many facilities aren’t already set up to handle those types of temperatures. Not just the facilities, but the transport devices and transport vehicles. That needs to be addressed, and addressed throughout the country, because if you have certain locations that just don’t have those facilities or don’t have that equipment, they may not be able to handle the vaccine. Then there’s the issue of, as you alluded to, vaccine acceptance. And we know that even with traditional vaccines that have been tested for years, they’ve been proven to be effective and safe, there can be the challenge in convincing people that it’s the right thing to do. To get vaccinated. We’ve seen over the past two decades, emergence of very active and vocal anti-vaccination movements. And so, people need to understand, all the data and all the science behind the effectiveness and the potential risks of this vaccine. Because everything, every product has some risks. The key is whether the risks are high enough to justify concern. That needs to be done. We really need to engage the public. And when I say engage the public, I don’t mean just select the people who happen to read certain things. It has to be everyone. Because if we’re going to be able to control the pandemic, then every person matters. As long as the virus is still circulating somewhere, it’s still a threat. And then, keeping in mind the results. The results are early results, and they’re from the initial months of the trial. We still need to keep an eye on what happens with the clinical trial because the decision was made by the FDA based on these initial results. And, of course, they were weighing the risks and benefits of the vaccine. But these trials are continuing. We need to keep an eye on these things. All professionals need to say, “OK, let’s look at the reports. Let’s follow the scientific publications.” And the other thing is now we’re going to have other sets of data emerge. When people get the vaccine, they presumably will be tracked with vaccine surveillance systems in place. Then we need to follow the data that emerges from that. And we also have to look at studies that may crop up here and there, because more and more people are getting vaccinated with time and see what they have to say. Science evolves, and science emerges. We’re learning new things about this COVID-19 coronavirus each day. Sometimes seemingly each hour. We have to keep track of this news. I know it’s very tough, especially if you’re a busy professional, and you’ve got tons of things to do, you’ve got patients to see. But it’s really important that we find ways to keep people abreast of emerging news because things can change.
ICT®: Are you going to get the vaccine?
Lee: That’s a good question. I think there’s the target group with certain initial frontline workers. I think it’s important to really … so I've been carefully reviewing the data that has emerged. I would like to see … there are still unanswered questions. There are still questions about the duration of protection. There are still questions about how will the efficacy hold up as the risk of the of transmission goes up during the winter months. Because there’s an increasing transmission during the colder months and during when the relative humidity goes down. One of the concerns that I’ve had is we want to make sure that the science and the data really justifies any conclusions that we have about the vaccine, and we just need to make sure that we see as much data as possible. I’ve always been a proponent of making sure that things…. Don’t rush before you have enough information. And if you rush, then you potentially could cost time elsewhere. Sort of the tortoise and the hare situation. I would like to see data for a longer period of time to make sure that we have a better handle in terms of efficacy and the safety of the vaccine.
ICT®: And when you say longer period of time, how long are you talking about?
Lee: Well, it’d be good to see it over the winter months, or at least part of the winter months. And also, it would be good to see … right now, the safety data are over a two-month period. Maybe over an additional month or two would be helpful.
ICT®: Any advice for hospital administrators as far as whether they want to mandate that employees get this vaccine or not? Can they legally do that, I wonder?
Lee: Well, I think there are several things. One is anytime anyone imposes a mandate they need to follow it themselves as well. Think about it this way. If you yourself are comfortable taking the vaccine, then if you want to impose a mandate, then you need to really feel comfortable yourself about taking the vaccine. It’s not really very good optics to insist that others take it when you yourself are not taking it. It’s a very complicated issue in terms of the mandate. I understand that there’s the concept of trying to protect the patients and make sure that the virus doesn’t spread. But there are other options right now to actually prevent the spread of the virus. Of course, personal protective equipment and social distancing, and those can’t be forsaken in lieu of a vaccine. This is very complex. We need to have the layers of precautions in place. And they need to continue even though the vaccine is available. And it’s a combination of seeing and understanding how the virus is actually spreading in the communities and the facilities. One of the dangers is that there is optimistic news about the vaccine. It’s not as if once the vaccine rolls out that suddenly things will return to normal. And that we can then forsake all other types of infection prevention and control measures. These are very complex issues. And we need to make sure that all these types of precautions are in place, and how feasible all of these layerings may be in different facilities before we’re talking about mandates. This needs to be really organized. And my concern is that we want to make sure things aren’t rushed. Sure, the vaccine is available, as I mentioned, but we also want to make sure that we follow the data as it continues to emerge. And there’s a balance in terms of risks and benefits. For some folks that are on the frontlines, it might be determined that the benefits really outweigh any of the uncertainty right now and it’s worthwhile taking the vaccine. And for others, maybe because there are other things in place, then then it’s worthwhile to wait. This needs to be done in a very organized manner. And there needs to be a complex strategy [because this is a] complex situation. I think broad mandates are … we really have to kind of look at the risk/benefit ratio as well.
ICT®: How concerned are you about the virus mutating? And can we quickly respond and create different types of vaccines for those mutations?
Lee: As I mentioned, there are still existing questions about the vaccine. One of them is duration of protection. It’s a big difference if you have to get this vaccine repeatedly, over time versus a single time or once a year. We need to answer those questions. And the other question, as you mentioned, is the possibility of the virus mutating. And so how much cross protection does the vaccine offer across different variants of the virus? That’s a question that still remains. If we have a mutation, how significant or substantial does that mutation need to be to no longer be covered by the vaccine? And that’s not clear yet. There are still questions out there. And again, the vaccine being available, and the vaccine being rolled out, doesn’t mean that the questions and the investigations should end. We really need to figure out all aspects of the vaccine. And the other thing we need to figure out is does the vaccine offer different protection from risks for different types of folks? Folks with different clinical backgrounds, underlying conditions, ages, demographics, those type of things.
ICT®: I think you told me that if you were a healthcare worker on the frontlines you might be more inclined to get the vaccine. I know you’re a healthcare scholar and healthcare expert, but are you actually working on the frontlines now? If not, what if you were working on frontlines again? Would that that figure into your calculation about whether or not to get it?
Lee: I’m on the public health end so I’m helping with the operations and planning and those types of areas. I’m not in a situation where I’m directly regularly seeing patients who may be infectious or contagious with the COVID-19 coronavirus. Whereas there are people who are on a daily basis. And there are also people who are in situations where they don’t have the personal protective equipment and those type of things. I think it’s weighing the risks and benefits at this moment. And so, yes, certainly if you’re in a situation where you are at higher risk—because we have to remember being exposed to the virus itself can carry significant risk—so that may tip the decision making over on that side. But you really have to kind of look at your individual situation to decide at what point does it make sense to get the vaccine.
ICT®: You’re a healthcare expert so let me ask you a Monday morning quarterback question. How would you have rather seen our reaction to COVID differ than it has actually played out? Or do you think it just progressed the way it was going to progress anyway?
Lee: You mean the overall response?
ICT®: The overall response.
Lee: We have to keep in mind: look at the different countries throughout the world. There’s a significant difference in what’s happened. Regarding the pandemic around the world, there are some countries where it’s very well controlled, and other countries where it isn’t. This isn’t a situation where the virus spreading widely was inevitable. We’ve known for years that there are many public health interventions that you can take, even when the vaccine is not available or specific treatments are not available, to control the spread of the virus. And there have been countries that have done that. Very extensive surveillance, testing, contact tracing, rapidly isolating people, and quarantining people when they’ve been exposed or test positive. Social distancing, appropriately. Having reactive closers of places where if you know the virus is spreading someplace, then you might close locations in that area. I’m not talking about full-scale shutdowns all the time. But closing things when appropriate and then reopening when appropriate. Those are things that have been done in other countries and have not been done well in the United States. We saw a long period of time in which different political leaders were downplaying the seriousness of the virus, and downplaying its threat, and not really responding to the spread of the virus. We can’t have that type of situation. And there have been many situations in our country where science has been bypassed. And politics and business agendas have superseded science and public health interests We have to keep in mind that the road to any type of economic recovery is through science, is through public health. If you can’t control the spread of the virus, you will not be able to return to normal, and you will not be able to, quote unquote, recover economically. Everything’s connected. And that’s been a big problem in our country. That there hasn’t been that recognition. The other thing is each of these steps need to be approached in a very systematic, organized way. We can’t have each of the different states do different things. There has to be a national organized strategy. It has to be coordinated and needs to be comprehensive. And even with the vaccine, we have to be careful, because I think one of the impressions is that, OK, the vaccines roll down, now everything will return to normal. That’s just not the case. We have to be careful about the messaging, make sure people’s expectations are realistic. And we’ll also need to make sure that there’s not the perception or optics that the vaccine was rushed in any way. And also, all these things need to be in place in terms of the vaccine distribution, and really understanding how these different things fit together. Distribution and supply and administration all need to be coordinated. And as I mentioned previously, there has to be organized plans on who should get the vaccine, and who potentially should wait. And this needs to be driven by science. It can’t be driven by politics. It can’t be driven by other types of jobs.
ICT®: Let me play devil’s advocate. What do you say to people who argue that the focus on COVID cumulatively is making our healthcare worse in this country?
Lee: That’s been another problem with the response. You know, responding is not just responding to the virus and finding ways to control the virus. It’s also developing new ways to deal with the potential consequences of having to make changes to daily activities. This is something that we looked at a decade ago. I remember during the 2009 pandemic, when school closures were being considered, we ran computer simulations to determine at what point was it worthwhile to close schools and we determined at the time it wasn’t worthwhile because the cost would be too high. And at the time, there was a vaccine on the way. And we were dealing with a different strain back in 2009 of the flu virus. It’s not like it was completely novel. A new class of viruses or something like that. The COVID coronavirus is the coronavirus, but it is a novel virus that doesn’t really have an analogous virus. But at the time, we also determined that, “OK, if you’re going to do things that close schools and close businesses, you need to have countermeasures to then compensate for the potential problems that may emerge from doing those different types of things.” You have to say, “OK, well how are we going to continue learning? How are we going to take care of the fact that maybe kids can’t get school lunches?” Things like that. The same thing applies for everything that’s going on. There are ways to compensate. There are programs that you can set up to then take care of the folks who are then affected by these measures. For instance, if the restaurant industry is affected significantly by decreases in customers and hours and all those type of things, can you set up situations where the restaurant industry is providing food to frontline healthcare workers? Or providing food in different ways? These are things that can be set up, and we need to be much, much more adaptive and innovate about these things. Times change. Every decade times change. The industries can’t remain the same. And we need political leaders [and others] to help find ways to help industries change so that they can adapt. I absolutely agree that we have to think about those types of consequences. Even with healthcare, now we're seeing more telehealth in reaction to this. That’s a positive development. That’s a positive way of compensating for the fact that you may not be able to go to the clinic. That’s just one example of how you can make changes to then compensate for all these problems that may emerge. We have to remember that infection control and prevention is not just dealing with the pathogen itself but dealing with the consequences and the downstream effects of what happens when you are dealing with the pathogen.
ICT®: Any final thoughts for infection preventionists?
Lee: I want to re-emphasize that it’s so important to have science guide all decision making. These decisions are complex. You can’t have decision making being done in absence of scientists and absence of experts and an absence of people who really know the medicine and the science, because they’re all interlinked. And one of the things that I’ve heard is that there are separate lanes when you make these decisions. There’s the economics lane, and then there’s the public health lane, and then there’s the infection control lane. Or however you want to divide it. And I strongly disagree with that thinking, because all of these things affect each other. As I mentioned, economics are affected by how well you’re controlling the virus. The rollout of the vaccine should be driven in ways that like, “Oh, who’s the target population? Who should get this? How should it be rolled out?” All these things intersect. And I think we’ve reached a point in our society where a lot of decision making is just far too siloed and separate. All these things really need to be integrated. And I feel that physicians and other healthcare professionals should have played larger roles in the decision making throughout the pandemic and should play larger roles in many other decisions in society going forward. We need to leverage the expertise. Now you can’t learn this stuff overnight. If you have an infectious disease specialist who’s been trained for a number of years and who has practiced for a number of years, you can’t replace that expertise. You need that expertise at the desk; that decision-making desk so that you can make the right decisions. The same applies for public health experts and people throughout medicine and science.
This interview has been edited for clarity and length.