Bruce Y. Lee, MD, MBA, discusses the recent developments for a COVID-19 vaccine, the challenges of the current pandemic, and what questions have yet to be addressed.
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Bruce Y. Lee, MD, MBA, is a professor of Health Policy and Management at the City University of New York (CUNY) Graduate School of Public Health & Health Policy, executive director of PHICOR (Public Health Informatics, Computational, and Operations Research), and a senior contributor for Forbes.
TRANSCRIPT:
Leigh Precopio: Hello, everyone. Welcome to another installment of Podcasts360, your go‑to resource for medical news and clinical updates. I'm your moderator Leigh Precopio with Consultant360 Specialty Network.
More than 250,000 people in the United States have died from COVID‑19, according to the Centers for Disease Control and Prevention. Researchers have been working diligently toward a vaccine and have recently announced promising results. However, the possibility of a COVID‑19 vaccine has prompted as many questions as it does answers.
Here with us today to talk about the COVID‑19 vaccine and its implications is Dr Bruce Y. Lee, who is a professor of health policy and management at the City University of New York Graduate School; executive director of Public Health Informatics, Computational, and Operations Research; and a senior contributor for Forbes.
Thank you for joining me today, Dr Lee. What needs to be done about COVID‑19 during the presidential transition?
Bruce Y. Lee: During the presidential transition, it's important to put in place policies and measures that will help address the surge in cases that's occurring throughout the United States.
Over the past month or so, seemingly every day, there's been a record number of new daily cases, which basically means that the COVID‑19 coronavirus has been surging, as the weather has gotten colder, as the humidity has dropped, as activities have moved indoors.
This was expected because the concern all along was that the virus has seasonality, which basically means transmission picks up during certain months, and maybe decreases during certain months. There's high likelihood that transmission decreased over the summer.
We can't let that give us a false sense of security and believe that the same trends in the summer will continue into the late fall and winter. It's very important to come up with a comprehensive and coordinated and organized national plan to give guidance to all the states and municipalities and localities on how to address and control the COVID‑19 coronavirus.
Everything is connected. Therefore, community control is very important and that ultimately will affect what will happen in the clinics and hospitals.
That means making sure that social distancing is maintained, installing test, trace, and isolate programs throughout the country so that you can better identify where the virus is spreading, and potentially box in the virus.
Then making sure that all the different municipalities are coordinated in terms of how are they going to recommend or enforce things such as social distancing, what are you going to do in terms of businesses and the policies of businesses, whether you're going to allow things like indoor gatherings and what limits there'll be.
Face mask use is important, and how that's going to be encouraged, and also communication of the virus. There are still a lot of people around the country that don't understand that this is a potentially deadly virus, and this is serious. There are people out there who still believe that the virus is a hoax or being overblown. That's simply not the case.
All those things need to be organized as quickly as possible.
Leigh Precopio: What challenges have arisen and need to be addressed?
Bruce Y. Lee: One of the important things when it comes to the response and a transition is making sure that there's enough personal protective equipment, PPE, available for all healthcare professionals. This was a major problem at the beginning of the pandemic.
In March, a lot of hospitals were having shortages, and you had situations where healthcare professionals were wearing N95 masks way beyond the recommended manufacturer limits. These masks were potentially not doing their job and could have potentially been not safe to wear, because they weren't protecting the health care professionals enough.
While the stock and the available inventory of PPE has increased since then, it still hasn't gone away. It's still a continuing problem. PPE shortages is something that needs to be dealt with as quickly as possible by the current administration working with the Biden transition team.
We have to remember that there are still many healthcare professionals that don't have enough personal protective equipment, don't have enough N95 face masks. This needs to be solved as quickly as possible.
The other issue is healthcare capacity. The concern is there's many parts of the country that are reaching capacity in terms of hospital beds, intensive care unit beds, and potentially ventilators. That's been a problem for many places, even at the beginning of the pandemic.
The third thing is that a lot of healthcare professionals are getting very tired. We have to keep in mind that they've been going, in some cases, full speed since February. That's about nine, ten, and potentially more months without much of a break.
Healthcare professionals are people too. Even though many of them are very heroic and super people, we can't lose sight of the fact that they have human needs. They need comfort, they need help, they need assistance. In many cases, they've been working untenable hours and having workloads that just are not sustainable.
There needs to be a national strategy to address this problem. Otherwise, we're going to have a lot of healthcare professionals running out of steam, getting mentally exhausted as well as physically exhausted. That's going to be a big problem in the middle of the pandemic, especially with cases surging. There needs to be a national strategy to address that.
Leigh Precopio: Can you tell us more about Biden's COVID‑19 task force? What are their goals?
Bruce Y. Lee: He's released some names, including the co‑chairs of the COVID‑19 coronavirus task force. It doesn't seem to be the complete task force yet, but he's released some of the names. It is encouraging that there are health experts on the task force.
People who have medical and health backgrounds, who therefore, as a result, would understand a lot of the health issues associated with the COVID‑19 coronavirus pandemic. There are still competencies in important areas that still need to be filled on the task force. There are folks who are public health experts and people who deal with equity and disparity issues.
There's also a need, probably, for more infectious disease experts or people who have an understanding of the different policies and interventions associated with pandemic preparedness and response, and operations folks. There are needs in areas that still have to be filled.
One of the issues with the task force is that they don't have actual authority or resources currently, because it's the current administration that holds all the authority and resources. It will be important for the current administration to, as quickly as possible, transition a lot of the information and also share the decision‑making.
There needs to be a situation where decision‑making is shared, so whenever major decisions are made about the pandemic, the current administration is working together with the Biden transition team to make sure they are both on the same page and agree with how things are being conducted.
Ultimately, it will be the Biden administration that will have to handle the repercussions of what will happen over the next couple of months and, of course, the general public will have to deal with it as well. That transition needs to occur as soon as possible without delay.
Leigh Precopio: Recently, Pfizer, Moderna announced effective COVID‑19 vaccine candidates. Can you tell us more about these vaccines and other options that may be available to the public soon?
Bruce Y. Lee: Yes. There's 2 recent announcements regarding preliminary results. One was for Pfizer and the other was for the Moderna vaccine. In both cases, the reported vaccine effectiveness was 90 percent or above. The Moderna one was a little higher than the Pfizer one. It's important to keep in mind that these are encouraging results, but they are limited results.
They are based on preliminary analyses of the trials that only occurred for a few months. These essentially are reporting of effectiveness or efficacy. The way the trials are set up is in each case, you have a certain group of people who get the vaccine and another group of people who get the placebo. They're comparing the infection rates that occurred between the two groups.
One of the challenges is there's so many different factors that may affect the probability of someone becoming infected. That ranges from the prevalence of the virus in the surrounding community, whether the community has done things such as social distancing and mask‑wearing and other policies and interventions, and whether the individual has taken all of those precautions as well.
In theory, these trials are supposed to have many thousands of people, so 35, 40 thousand plus people. Some of those confounders may potentially wash out because they occur in varying frequencies with the two groups.
The trouble is when you just announce preliminary results where you haven't enrolled everyone and you haven't observed people for a long period of time, these different confounders can affect the results. I would be cautious about these numbers, these 90 percent plus effectiveness numbers. Ultimately, they may drop and be lower.
We also do know that vaccine effectiveness, when a vaccine is used in the real world, tends to be lower and sometimes much lower than the vaccine efficacy reported in clinical trials, because clinical trials are idealized situations.
First of all, don't hang your hat on the actual effectiveness numbers yet. Consider this as positive news, and be cautiously optimistic. It doesn't necessarily change the timelines that are anticipated with different vaccines.
There's talk of vaccines being available mid to late spring, generally available, or mid to late spring to potentially early summer. That timeline hasn't changed. We have to keep in mind that there's going to be several steps. Vaccines first need to be approved and then the first people who will get vaccines will be limited groups, including frontline workers and healthcare workers.
The general public is not going to receive the vaccine immediately, that's going to take a little time. Plus, there are a lot of challenges when it comes to producing and distributing vaccines at such a mass level. There's a lot of work to be done.
The other thing to keep in mind is some of these vaccine candidates like the Pfizer vaccine are employing new technology, mRNA vaccines that may require very, very, very cold storage. We're talking about potentially negative 90 degrees or lower than that, and many clinics and hospitals currently may not have the equipment to be able to handle such storage.
A lot needs to be done before vaccines can be generally available.
Leigh Precopio: What questions still remain about the COVID‑19 vaccine?
Bruce Y. Lee: There's still a number of outstanding issues that have to be addressed by the clinical trials. One is duration of protection. How long are people protected? If the vaccine induces an immune response, the concern is, how strong is that immune response and how long will that last?
There have been case reports of people getting reinfected, getting infected a second time after they recovered from an initial bout with the COVID‑19 coronavirus. Currently, if you look at the Centers for Disease Control and Prevention website, they said that reinfection within 90 days is rare.
That leaves the door open for the possibility of after 90 days, you may get reinfected, and that's with the natural virus. That's with the virus itself. The vaccine may potentially trigger a stronger immune response. Don't assume that if you can get reinfected by the virus naturally, that it will be difficult to put together a vaccine that can protect you.
It raises the possibility of how long will that protection last? If that protection only lasts a limited amount of time, then that would suggest that there's a need to get re‑immunized, periodically re‑immunized. The other issue is whether the COVID‑19 coronavirus, may mutate, and different versions of the virus may start circulating.
There has been evidence of mutation. We know that coronaviruses in general have a reasonably high likelihood of mutating. That's one of the reasons why we eventually had a pandemic strain, a strain that jumped from animals, most likely bats to humans.
There's also been evidence that different versions have emerged through genetic testing. Most recently, there's concern about a new version emerging in mink populations. That's why many minks in Europe needed to be culled because this other version was circulating among the mink population.
The question is, "Will a vaccine against the current strain be effective against other versions?" That all depends on how different other versions may be. There is some cross‑protective action against virus strains that are similar enough. We'll have to see.
These are all questions that remain, so we have to keep in mind that this is very complex. Just because you hear about results coming out about the vaccine, again, that can lend to some optimism, but the optimism has to be cautious optimism.
We don't want to go overboard. We never want to be too excited by news or too down as a result of bad news. You want to stay at an even keel and take these things in and understand there's still a lot of work to be done.
It's also important to understand that when the vaccine comes out, or if and when a vaccine comes out, it doesn't mean that you quickly abandon all the other precautions. There may be a length of time where you still have to do these other precautions like social distancing, certainly disinfecting and hand washing, and those things like that.
Also, potentially face mask use for a while. The virus is not going to disappear as soon as the vaccine comes out, regardless of how good the vaccine is. We have to remember that. We also have to remember that there's many cases in which this infection with this virus results in longer‑term health issues or problems. The problems won't go away either.
Leigh Precopio: Thank you for joining me today and answering all my questions.
Bruce Y. Lee: Thank you.