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Over 18 million people have been infected with the coronavirus worldwide, with the U.S. leading with nearly 5 million infections. The one thing that has kept us all hopeful is a vaccine. But how realistic is it to expect one anytime soon?
Well, the U.S. has entered the first final-stage clinical trials. About 30,000 volunteers will be tested at 89 sites around the country, including 500 at George Washington University in D.C.
It usually takes years of research and testing to develop an effective vaccine, so should we be hopeful or skeptical?
Produced by Kurt Gardinier
KOJO NNAMDIYou're tuned in to The Kojo Nnamdi Show on WAMU 88.5, welcome. Later in the broadcast we'll be speaking with former U.S. Ambassador, National Security Advisor and D.C. Native Susan Rice, Author of the new book "Tough Love." But first, as we approach month five of the pandemic, there are now over 18 million COVID cases across the world with nearly 700,000 deaths. The U.S. leads the world with nearly 5 million infections and over 155,000 deaths.
KOJO NNAMDIResearchers have fast tracked developing a vaccine. And we may be getting closer to one. The U.S. has entered its final stage clinical trials. About 30,000 volunteers are now needed for trials at sites across the country including 500 needed at George Washington University. It usually takes years of research and testing to develop an effective vaccine. So should we be hopeful or skeptical? Joining me to have this conversation is Carolyn Johnson, who is a Science Reporter with The Washington Post. Carolyn Johnson, thank you for joining us.
CAROLYN JOHNSONThanks for having me.
NNAMDIAnd Dr. David Diemert is a Professor at The George Washington University School of Medicine and Health Sciences. He is also the Clinical Director of the GW Vaccine Research Unit. Dr. Diemert, thank you for joining us.
DR. DAVID DIEMERTThanks for having me.
NNAMDIDr. Diemert, tell us about this vaccine trial and how GW is involved.
DIEMERTRight. So we are one of about 90 sites across the country that is going to enroll approximately 30,000 healthy -- sorry volunteers into this study. This is a phase three trial, what we call a pivotal efficacy trials. So the results of this trial will enable -- if they show efficacy will enable the Moderna to go -- and the NIH to go to the FDA to get licensure and have it available to anyone who wants to get vaccinated.
NNAMDIWhat is your role as GW's clinical director of vaccine research in this trial?
DIEMERTSo I'm called the Site Principal Investigator, which basically means that I sign the dotted line with the FDA to say that I take responsibility for all of the volunteers who are going to participate here at GW in the study.
NNAMDIWe know developing a vaccine is normally a relatively long process. Two years is considered fast. How are you and other researchers speeding up the process for the COVID vaccine and what are the risks?
DIEMERTI think it's a combination of things. So the first is this vaccine that we're going to test it's an mRNA vaccine, which is a new technology that has -- the company Moderna and the NIH, who co-developed it, were able to come up with a vaccine in a much shorter period of time to begin with than usual vaccine development before it gets into the clinic. But in terms of speeding up the clinical development it's a lot of resources that are being put into this. We're still doing all of the steps that are necessary to show that the vaccine is safe, effective. It's just really being done in tandem rather than in, you know, consecutive order that normally it would happen in.
NNAMDICarolyn Johnson, how optimistic are you about a potential COVID vaccine in the near term?
JOHNSONWell, everyone is optimistic and hopeful and there's been really exciting early results from many of the vaccine candidates. The scientists think we're on the right path. But something that I've been talking to a lot of people about is that we have to be realistic too. A lot of people I speak to have the hope that a vaccine will drop and the world will change in a day. And even once we've done the tough job of showing the vaccine works there's going to be a whole process to get it to enough people to make the world safe.
NNAMDISo even if a vaccine is proven effective and people start receiving it, we shouldn't be thinking we're going back to pre-pandemic times just like that.
JOHNSONYeah, I mean, that's the goal for sure. We will get there. But I think the vaccine is going to be used in tandem with a lot of the other public health tools that we have been working on and developing like treatments, testing, contact tracing. And all of those are really going to be necessary to bring us to the quickest and safest end to this pandemic.
NNAMDIHere is Jocelyn in Washington D.C. Jocelyn, you're on the air. Go ahead, please.
JOCELYNHi, Kojo, thank you. I'm a student at Georgetown Law and would be pretty willing and interested in volunteering in this trial. But I'm curious what the parameters are, what your qualifications need to be and just kind of what it's going to look like for people like me. I'm 25.
DIEMERTYeah, so the inclusion criteria are adults over the age of 18. And we are especially looking at enrolling people, who are at increased risk of getting exposed to the virus in the community and also developing illness so symptoms. We call it symptomatic COVID-19 infection, because that's what the end point kind of the thing we're looking at to show whether or not this vaccine is effective if it prevents symptomatic infection.
DIEMERTSo we are especially trying to encourage participation from people over the age of 65. Although it is open to all ages. And also those who have what we call co-morbities or conditions that make them at increased of developing symptoms and especially severe symptoms and, you know, potentially mortality as well. So that's what we want to prevent. So we want to try to enroll people who are at increased risk. So that's both age wise. We know that this pandemic has disproportionately affected communities of color. So we are trying our best to make this trial open to as many different communities as possible especially those who have been most hardest hit by the pandemic.
NNAMDISo you're looking for diversity in race, age and gender. And you need 500 people to volunteer at GW for this trial. Have you reached that number yet?
DIEMERTWell, we haven't started vaccinating yet. The first vaccinations were just started countrywide last week. They've already enrolled about 2,000 people as of this morning nationwide. We're hoping to get our kind of green light activation today or tomorrow so that we can start enrolling our first volunteers at the end of this week. That being said we do have a list of over 600 people who have contacted us. We're doing pre-screening so that we're hoping that with that we'll have our quota if you will of 500 volunteers. But we won't know until we actually complete all of the first vaccinations.
NNAMDIHere's Terrie in Silver Spring, Maryland. Terrie, you're on the air. Go ahead, please.
TERRIEI would love to volunteer to take the vaccine as a test run. I would also take the vaccine whenever. I have four grandchildren and I'm 81 years old and I think it's important that we get this vaccine going. So whatever I can do I will do.
NNAMDIHow can one volunteer, Dr. Diemert?
DIEMERTSo contact us 202-994-0047. Email covid-19vaxtrial, all one word, @gwu.edu. Go to our website. Just Google gw vaccine research unit and there's a secure form you can complete to sign up. And we will contact you. We're also going into the community to get the word out, pass out, you know, flyers, bump cars, doing advertisements. We have a mobile van that we're going to go out to different parts of the city. Setup, you know, a tent to sign people up. So we're trying to go out to people and not just expect people to contact us, but you can.
NNAMDIAnd at caller Terrie's age 81, that's not a problem.
DIEMERTNo. It's not.
NNAMDIOkay. Terrie, thank you very much for your call. Good luck to you. Carolyn Johnson, in a recent piece for The Washington Post you discuss what followed after the vaccine for polio was created. How was the roll out of that vaccine in 1955 and could it be similar if a COVID vaccine is discovered today?
JOHNSONWell, it's always hard to draw a parallel. A lot has changed in the medical infrastructure since 1955. But it is instructive to look back at a similar very terrifying epidemic and how it was eventually vanquished. The vaccine was a really triumphant day. And cases of polio did really plummet very quickly, but it still took several years. There were still outbreaks occurring as the vaccine was rolled out. And there was also an incident that's become a really infamous kind of tragic thing in medical history called the Cutter incident where a manufacturing problem led to some of the doses of the vaccine not being -- actually causing disease in some children. And so that has been kind of a cautionary tale.
JOHNSONThere are many different things now about the kind of regulatory structure, but for people that I've been speaking to there's a worry that there hasn't been enough talk about kind of how to think about the limitations of vaccines. What we have to be kind of prepared for in terms of just getting it to all the people that are going to need it. If we're going to vaccinate most of the population even with all the work we're doing to ramp up manufacturing there's not going to be enough on day one for everyone in the U.S. or the world to take it. So we're going to have to really do a lot like public communication on how to think about the vaccine.
NNAMDIWe got an email from Kathy, who emails us this quote from Paul Offit, University of Pennsylvania Immunologist who co-developed the rotavirus vaccine. Quoting here, "We seem to be willing to rush a vaccine into clinical trials without extensive animal model or safety testing." How would you respond to that, Dr. Diemert?
DIEMERTI would say that the pre-clinical testing as we call before going into vaccine trials in humans has been done for most of -- well, all of the vaccines that I know that are at least being funded through the NIH testing network. We just had published results for the Moderna vaccine, the one that we're going to be doing here at GW in non-human primates. They're still doing all those studies. They are compressed and overlapped somewhat with the initial phase one trials for the vaccines. But that research and safety testing is still being done just overlapping where as it normally is done in sequence.
NNAMDILet's hear from Robin in Washington D.C. Robin, you're on the air. Go ahead, please.
ROBINI was part of the (unintelligible) vaccine experiment and trials in the early 1950s in Anne Arbor, Michigan, and I remember it well. I can still see being in a library in school and all of us lining up for our injections. I fit your criteria perfectly for the trial for COVID-19. I'm over 70. I have one of, well two of the co-morbidity issues. How do I sign up and how do I do it fast?
NNAMDIWell, we've asked Dr. Diemert to give out this information before. I think we'll have to put it out on our website. But, Dr. Diemert, in the 30 seconds or so we have left in this segment could you give that information out again, please?
DIEMERTSure 202-994-0047 or email covid19vaxstrial, with an x, @gwu.edu or go to our website. Goggle gw vaccine research unit and fill out the form.
NNAMDIRobin, thank you very much for your call. We're going to take a short break. I'm Kojo Nnamdi.
NNAMDIWelcome back. We're talking about COVID-19 vaccine trials that are entering their final stage. We're talking with Carolyn Johnson, a Science Reporter with The Washington Post. And Dr. David Diemert a Professor at The George Washington University School of Medicine and Health Sciences, he is also the Clinical Director of the GW Vaccine Research Unit. If a vaccine comes out, will you trust it or will you continue to socially distance and wear a mask? Let us know what you think 800-433-8850. Dr. Diemert, testing for the coronavirus has never been where doctors and scientists say it should be. So how confident are you that we could properly distribute a vaccine if one is created?
DIEMERTThat's a very good question, Kojo. We already have heard -- and I know Carolyn has reported on it as well. There is some hesitancy in the community as to whether or not someone -- even if a vaccine is licensed shown to be effective and safe whether or not they would receive -- and that partially stems from the speed at which we're going, even though as I mentioned we are taking all precautions. But I think it will be a challenge and we will have to make sure that we do these studies as transparently as possible and publishing all of the results as soon as they become available.
DIEMERTI'm a big proponent on that so that the community sees what's been done and there's complete transparency. And hopefully that will convince people of the need and the safety and the effectiveness of the vaccines that will hopefully come out of this huge effort.
NNAMDIAnd, Dr. Diemert, if a vaccine is created, who should it be given to first?
DIEMERTThat's a loaded question.
DIEMERTWell, so this is a personal opinion I think it should be given to those, who are at highest risk of developing severe disease and potentially, you know, dying of this terrible infection. And we just know from epidemiologic studies, who those populations are. So I think it should be offered to those who really need it.
NNAMDICarolyn Johnson, I'm assuming this vaccine would be like the flu vaccine, strongly recommended especially for the most vulnerable. What happens if not enough people get it?
JOHNSONWell, the goal of a vaccine is to get to the level called herd immunity where the virus can't really spread anymore. And so part of how many people need to get it depends on how effective the vaccine is, which we're going to find out through trials like the one Dr. Diemert is running. We will be able to tell when we know if it's 70 percent effective or 60 percent or 80 percent effective. Then epidemiological people will just do these models that will tell you how many people need to get it. But a lot of people are going to need to get it. And a lot of the regimens that are being tested in these clinical trials require two vaccinations separated by a few weeks.
JOHNSONSo this is going to definitely take some distribution kind of expertise and roll out education so that people go get their booster shot. We're going to just have to see all that happen. And one of the things we're all waiting for is to see more concrete plans from the government on how they're going to both prioritize and distribute the vaccine at scale.
NNAMDIDr. Diemert, Carolyn mentioned herd immunity. What is herd immunity and how many people will have to be vaccinated in order to reach herd immunity?
DIEMERTRight. So herd immunity refers to a percentage of the population that needs to be immunized with an effective vaccine to prevent transmission in the community. So you don't necessarily have to vaccinate 100 percent of a population in order to stop transmission in that particular community. So it basically means you're protecting even unvaccinated people if you vaccinate a certain percentage of the population. It's different for every virus bacteria. And we have yet to figure out what that level, what percentage is going to need to be vaccinated for COVID-19. But that's something we'll find out through the clinical trials.
NNAMDIHere's Rene in Washington D.C. Rene, you're on the air. Go ahead, please.
RENEHello. Thank you for taking my question. I've gotten a flu shot every single year and have rarely had much more of a side effect than a sore arm. Do you know what the potential side effects are of this vaccine even if it doesn't work?
DIEMERTYes. So this is specifically for the mRNA, Moderna vaccine that we'll be testing. So we know from the phase one and phase two data that's already available so over 600 people -- or sorry, approximately 600 people have already received the vaccine at various dosages. It's similar to what you would see with the flu shot. So pain, soreness at the injection site, a few people have tiredness, you know, fatigue for a few days, sore muscles, low grade fever, but that has only usually lasted for a day or two. So quite similar, you know, side effect profile from what we see with the flu vaccine.
NNAMDII've heard differing things, Dr. Diemert, about whether having gotten COVID protects you from getting it again. What do we know at this stage?
DIEMERTUnfortunately we don't know 100 percent the answer to that question, because it's only been less than about half a year now since the first infections have been reported. What we can say is there does not appear to be any documented case of someone becoming reinfected after an initial symptomatic reinfection. That's not to say that a year out someone might become susceptible again. All we can say is at least we know in this short period of time it does not appear that people can get reinfected. So we're hoping that's longer than six months. Hopefully a years and that we'll see the same thing with an effective vaccine. That we won't have to give continuous booster doses like you have to with the flu shot.
NNAMDIHeather in Rockville writes, "I just want to remind listeners that participation in the vaccine trial does not mean you will receive the vaccine. Half of the participants will receive a placebo and the study is double blind meaning that neither the participant nor the tester will know if he or she is receiving the vaccine or a placebo. Can you clarify, Dr. Diemert?
DIEMERTYes. That is correct. So it's what we call one to one randomization. So half of the people in the study will get the actual vaccine and half will get what we call a saline placebo. And I won't know. The participant won't know. The only people who really know will be the people in the pharmacy, who are preparing the doses and the people administering it who will not be a part of -- and have any other role in the study. The reason for that is because we need to have a comparison group. It's impossible to know if the vaccine will be effective we give it to everyone and we don't see any cases in those who get the vaccine. We wouldn't know if it's because of the vaccine or just because they weren't exposed.
NNAMDIHere now is Ray in Fairfax, Virginia. Ray, you're on the air. Go ahead, please.
RAYHi. We are so totally -- the federal response has been so horrid in response to the COVID-19. I mean, to the point where somebody famous has said both Lysol and Clorox are effective treatments. What -- I'm just thinking about the level of confidence people should have in a vaccine that is rushed? And I can take my response off the air.
NNAMDICarolyn Johnson, care to comment?
JOHNSONWell, I think that scientists running this effort are extremely serious and experienced people in the government. And then outside the government too there are just many eyes on this. So I think one thing that the public should take kind of hope from is that if this all does occur in a really transparent manner and the data is made public you won't have to trust a government official about the vaccine. I think there is just going to be so much pushback from experts in vaccine development if they see something concerning. And they are laser focused on this, because what's at stake is not just the COVID-19 vaccine. I mean, the vaccination program is a powerful public health intervention and those -- we don't want to endanger trust in that at all.
JOHNSONSo, you know, people are very focused. Outside experts are really going to yell if they think something is concerning. We're going to hear. It's not going to be a process where we don't have any confidence that outside people aren't looking at it closely.
NNAMDIAnd I'm afraid that's about all the time we have. Carolyn Johnson, is a Science Reporter with The Washington Post. Thank you so much for joining us.
JOHNSONThanks for having me.
NNAMDIDr. David Diemert is a Professor at The George Washington University School of Medicine and Health Sciences. He is also the Clinical Director of the GW Vaccine Research Unit. Dr. Diemert, thank you for joining us.
DIEMERTThank you so much.
NNAMDIGoing to take a short break. When we come back we'll be speaking with former U.S. Ambassador and National Security Advisor and D.C. native Susan Rice, Author of the new book "Tough Love." I'm Kojo Nnamdi.
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