Episode 14: COVID-19 Vaccines Receive FDA Emergency Use Authorizations with Phaneth Keo, PharmD 
With both Moderna and Pfizer-BioNTech distributing their COVID-19 vaccines across the country to battle the ongoing pandemic, Phaneth Keo, Pharm.D., Vice President of the Medical Strategies for Innovative Therapies at FMCNA’s Renal Therapies Group, joins Field Notes to discuss the science and process behind the groundbreaking emergency use authorizations by the FDA.



Brad Puffer: Welcome, everyone to this episode of Field Notes. I'm Brad Puffer on the Medical Office Communications team at Fresenius Medical Care North America, and your host for this discussion today. Here, we interview the experts, researchers, physicians, and caregivers who bring experience, compassion, and insight into the work we do every day.

As you all know, we've had some very exciting news recently regarding COVID-19. And over the last several days, two new vaccines from Pfizer and Moderna have received emergency use authorizations from the FDA, and their rollout has been immediate. The safety of our patients, staff, and physicians is paramount to us at Fresenius Medical Care North America so these vaccines and their potential role in ending the global pandemic is critical to that mission.

So how do these specific vaccines work, and what else is in development? How were they approved in such a short amount of time? And how can we ensure our front-line care teams and patients with kidney failure get access to this important vaccine?

Here to answer these questions and more is Phaneth Keo, vice president of the Medical Strategies for Innovative Therapies Group. Dr. Keo, welcome to Field Notes.

Dr. Keo: Thank you, Brad, it's a pleasure to be here with you.

Brad PufferWell, with a doctorate in pharmacy, you've been working very closely to help us identify new therapies and treatments for our patients with chronic illness and kidney failure. And so how exciting is it for you to now see this vaccine begin to roll out at a time when COVID-19 is really peaking around the country?

Dr. Keo: You know, Brad, when we think about where we were at the beginning of 2020, as you alluded to, where we are today, earlier this year, COVID-19 was just starting to quickly spread across the world as well as in the US, and we actually had no vaccines or even treatments available. Now if you fast forward to today, what's exciting and really fantastic is that we do have vaccines and various treatments available to help patients who are infected with COVID-19.

So going back to your question, not only is this an exciting period for only the Americans, but as well as the international community. I also want to take note of truly how remarkable it's been to see and watch how scientists, health care personnel, governments, as well as pharmaceutical companies, have all come together to share information so that we can all help each other learn more about this virus that causes COVID-19. As well as helping each other work together to build and identify effective strategies to hopefully slow down this dangerous and this disastrous COVID-19.

Brad Puffer: As we roll out these vaccines, to our frontline care teams and then our patients, I know we want to make sure that this is both effective and safe for use. You've been following this development very closely. I know you followed the lengthy advisory board meeting discussing all the data. What do we know to date?

Dr. Keo: We in the medical office have been closely monitoring the progress of each COVID-19 vaccine. I do believe people can trust that any vaccine that has been authorized for emergency use by the FDA that it is safe, and it is effective. Emergency use authorizations allow the FDA to authorize any unapproved medical products such as vaccines or drug therapies to be used during public health emergencies such as the public health emergency that we are facing today with the COVID-19 global pandemic.

What's important for everyone to know is that there are no steps that have been eliminated or bypassed that is typical of a traditional vaccine development as well as a review process. These vaccines go through the same development process as any traditional vaccine. What is different is that the FDA works very closely with the manufacturing companies to understand what is needed in order to be granted emergency use authorization.

So I'd like to take a little bit of time to explain what the three criteria a manufacturing company must be able to demonstrate in order to receive emergency use authorization. The first one, the manufacturing company must be able to demonstrate that their manufacturing process is able to deliver vaccines that are of high quality and is consistent from one batch of vaccine production to the next batch of production. Secondly, the manufacturing company must be able to provide clear and compelling safety and efficacy data that shows that there is a benefit of administering that vaccine that exceeds the risk or the disadvantages of not being vaccinated.

And lastly, which should be also reassuring to everyone is that the FDA does need the manufacturing company to provide plans on how they will continue to monitor the safety and effectiveness of the vaccine even after emergency use authorization has been granted. So the work does not stop once the EUA has been granted, but the manufacturing company must continue to monitor and evaluate the effectiveness and safety of their vaccine.

Brad Puffer: Well, Phaneth, we've had the first vaccines authorized for use. There's more in the pipeline. Can you talk about these different types of vaccines that have been in development and the different timelines that they're on?

Dr. Keo: It's really astonishing, as I alluded to earlier, how many vaccines that are currently in clinical development. And when I talk about clinical development, that means these are vaccine candidates that are actively being tested in human clinical trials. What we do know is there are approximately 60 vaccine candidates that are currently in this stage of human clinical testing. And all of these 60 potential candidates have different approaches at delivering the vaccine.

What we do know is, as you alluded to earlier, the Pfizer and some of the upcoming vaccines that could potentially be added into the emergency use authorization toolbox are based off of DNA and RNA technology. How this is different from other vaccine-- the scientists are actually using genetic material to deliver cells that instructs the body to make the target protein that is seen with the COVID-19 virus and then these target proteins are helping the body to actually generate an immune response.

When we think about traditional vaccine, we actually create the virus using animal to make these viruses, and then we actually inject them. So the traditional vaccines do take a longer time, because we actually have to grow the virus, and then manufacture the virus. And that's really some of the key differences between the newer technologies as well as the existing technology.

Now when we talk about mRNA messenger ribonucleic acid vaccines, it is the first vaccine that we are hearing it, especially for the vaccine format, but it's been studied quite extensively for over 30 years. And it has been tested in looking at potentially treating other viruses such as Ebola, as well as influenza. So this is not technically new technology, but it is the first vaccine to be offered.

Brad Puffer: All really exciting news. and I want to go back to kind of our opening discussion about the excitement of the vaccine and its potential role in helping both our frontline health care workers and our patients. Why is it so important that people get this vaccine, especially those with chronic illnesses like those with kidney failure?

Dr. Keo: As many of the folks who are listening in today may have heard, both in local media as well as social media, the amount of vaccine doses that will be available initially will be limited due to the fact that the manufacturing companies, as they receive emergency use authorization, will need to build up their supply in order to meet the demands of providing vaccines to not just the US population, but as well as the global population. So in order to initially manage this-- it's a supply and demand issue-- the vaccines will need to be prioritized and distributed in a stepwise order and according to an individual's risk. And these risks are actually based on four areas.

One, what is that individual's risk for acquiring the infection? Two, what is their risk for developing severe complications? Three, what is that individual's risk for transmitting the infection to others? And lastly, what is that individual's risk if they do get infected, what is that individual's impact on society or a group of individuals impact on society?

So when we talk about health care worker, it's really important to understand who fits into this definition of health care workers. According to both federal and state authorities, health care workers are any individuals who cannot telework, must work in a health care setting-- for example, hospital or an outpatient setting. And then thirdly, they have the potential to be in direct or indirect exposure to patients who may become infected with COVID-19. Or they may be exposed to infectious materials that puts these individuals at risk for contracting the COVID-19.

So when we think about why it's important to vaccinate our health care workers, it's really important because they are our lifeline for preserving the health care system. If we don't have our health care workers present within the health care system, they will not be available to offer treatment for those who need to come in for any medical care as well as care for the treatment of COVID-19.

Now let's focus on our dialysis patient population. Similar to residents of long term care facilities, we truly believe are dialysis patients are extremely high risk for acquiring the COVID-19 infection. One, it's because of their underlying comorbid conditions. Additionally, we also know that if they do get the COVID-19 infection, they actually are at high risk for developing severe complication that may result in hospitalization and other treatments while hospitalized.

And then lastly, we do know because of our dialysis patients resident, they do have the potential to transmit the virus once they leave treatments at any of our dialysis clinics. So knowing all of this information in terms of why our dialysis patients are at high risk, we will need the help of every health care worker to help us ensure that when it comes time to our dialysis patients to be able to get the COVID-19 vaccine, they are helping us to properly educate and make our patients aware on the importance of taking the vaccine immediately when it is offered to them.

Brad Puffer: Well, I certainly expect that the majority of health care workers will be very eager to get this vaccine. There is a concern that there's a minority out there that still is skeptical of the process and just how fast this vaccine came into development. How concerned are you about that? And what are some of the common misconceptions you're hearing? And is it important to combat those?

Dr. Keo: It is a huge concern that we in the medical office are paying attention to as well as monitoring. We do know that when we look at the data that's been released on the general US patient population and their responses on how willing they are to get vaccinated; we are quite concerned about the numbers in terms of vaccine hesitancy when it comes to the COVID-19 vaccine.

To help us proactively address these issues associated with vaccine hesitancy as it relates to the COVID-19 vaccine, the medical office has implemented a COVID-19 vaccine readiness and deployment plan. A critical component of this plan is actually going to be focused on addressing and identifying educational activities where we as an organization will look to providing clear and reliable information. We know that many of our patients as well as employees will have different modes of receiving information, but we also want to be a central point where they can trust and rely on the information that they can get on the vaccine and be able to feel that with information that the company provides to them, they can feel empowered and informed about understanding what are their true benefits of getting vaccinated versus what could be the detrimental risk of not being vaccinated.

Brad Puffer: I want to ask you about the two shots, because some of these vaccines-- maybe not all, but the early ones authorized will require two shots. How does that complicate the rollout, especially around some of the storage requirements of these vaccines? This is not an easy distribution process.

Dr. Keo: Obviously, a single shot or injection would be a lot easier than having to give two shots. However, if we look at the Pfizer vaccine, I think we have to look at a couple of points here. What we do know about the Pfizer vaccine is that it was able to demonstrate that it was 95% effective in preventing the COVID-19 infection if people got two doses. What's really interesting in the study-- now it'll be interesting to see how it rolls out in real world-- but in the clinical study, we saw that 98% of those subjects who volunteered to participate in the study, they came back and got their second shot. So based on the Pfizer data, we can see that it can be done.

So knowing that some of the vaccines may require two shots, this is one of the activities that will be included in the COVID-19 vaccine readiness and deployment plan. We will ensure that we look at different strategies to help our employees as well as our patients to ensure they follow up for their second dose. We also know that different state agencies are also looking at different plans to ensure that patients are not forgetting to come back for their second dose because of that 95% effectiveness number.

To your last question, which is about storage requirements, following each vaccine's emergency use authorization, a fact sheet is always released to the public, one for patients and one for health care personnel, which provides detailed information on the storage and handling of these vaccines. This information will be included in our readiness and deployment plan to ensure that any policy and procedures that need this information will be updated where we can include this information so that proper handling and storage of these vaccines are adequately adhered to.

Brad Puffer: This has been really, really helpful information. I know things are changing pretty much every day, and so there may be new developments in it just a few days or weeks from now. But how optimistic are you about what we've discussed and what lies ahead for this vaccine to really change the course of this pandemic?

Dr. Keo: You know, 2020, like I said in the beginning, has been a very challenging year. However, I am optimistic that we will be able to reach a turning point and slowing down and eventually, hopefully stopping the spread of COVID-19. So in order for us to get to this turning point, I'm confident that the FDA's emergency use authorization as well as Operation Warp Speed will help us ensure that there will be adequate supply of vaccines available for the 330 million people living in the US.

But we will also, through these two platforms by the federal government, they will also help ensure that not only will there be vaccines available, but there will be a continued focus to ensure that therapies are available to treat those who become infected. So as you can see here, it's not just the vaccines. It's everything related to the initiative that the federal government as well as state is enacting, as well as we must remember that the vaccine is just one part of the tool that will help us stop the spread of COVID-19. We still need to ensure that we remain vigilant in properly washing our hands, properly sanitizing our countertops and surfaces, as well as maintaining social distances. Just because we have the vaccine available today does not mean that we stop doing some of these other preventative measures.

Brad Puffer: We certainly know that all that mask wearing in our centers by our health care workers and by our patients has really made a difference to control the spread among our patient population. So you're absolutely right-- that needs to continue for us to be able to get ahead of this pandemic. It's been wonderful talking to you Dr. Keo, and I thank you for all of the great insights and information about these vaccines. It's great to know we have really talented people like you working on this important project.

And to our audience, thank you for joining us. Don't forget, you can find Field Notes on the Apple Store or Google Play or right here at FMCNA.com, where you can also find our annual medical report and other feature articles. We hope you'll come back and join us, as we have many more topics to discuss in the weeks ahead. Until next time, I'm Brad Puffer, and you've been listening to Field Notes by Fresenius Medical Care. Take care, everyone.