What do you want to know about the search for a COVID-19 vaccine? KUT held a live conversation with Jason McLellan, an associate professor of molecular biosciences at UT Austin, answering those questions.
KUT's Jennifer Stayton hosted the first episode in our series, "Now What?" weekly livestreamed events in partnership with UT and the Dell Medical School, focusing on what the coronavirus pandemic means for our lives now and in the future.
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Each week, KUT reporters will talk with leading scientists, researchers and thinkers from across the university about what we need to know about COVID-19. You can watch the video live on Facebook or KUT.org, and the video will be available later on YouTube and via podcast.
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The following transcript has been edited lightly for clarity:
KUT:The novel coronavirus pandemic has prompted lots of questions and uncertainty this year. How is the virus transmitted? Am I at risk? What is safe to do? But in addition to those immediate concerns, the pandemic is changing our lives forever in ways that are only now we're starting to grasp.
I'm Jennifer Stayton with KUT 90.5, Austin's NPR station. Welcome to "Now What?" a series of livestreamed events from KUT in partnership with the University of Texas at Austin and the Dell Medical School, focusing on what comes next as we grapple with what the coronavirus pandemic means for our lives now and down the road. Each week, we'll talk with scientists, researchers and thinkers from across UT Austin to get the latest about COVID-19.
This week, we're talking with Jason McLellan. He's an associate professor of molecular bioscience at UT Austin. He also was a postdoctoral researcher at the National Institute of Allergy and Infectious Diseases Vaccine Research Center. Today, we're going to be talking about the search for a COVID-19 vaccine.
Thanks so much for joining us today, Jason.
McLellan:You're welcome. Thanks for having me.
KUT:All right. So, first of all, I have to ask: obviously, the scene behind you is not in your office; it is a depiction. Describe what we're seeing in the scene behind you. What is that?
McLellan:Yeah, it's an artist's rendition of coronavirus virions, probably inside an infected lung. My laboratory determined the first atomic structures of the spike proteins, which are the white projections on the surface of the virus. So we've been working with several companies to try and make some of these visuals as accurate as possible. There have been some movies and animations made.
And this can be helpful in kind of understanding what it is we're going up against, what's causing the pandemic. And I think these types of visuals can be helpful.
KUT:And we're going to get to all of that as we talk today about your research and also about where we are on the road to a vaccine. First of all, I'm going to ask the question that I'm sure you get asked a lot, and what everybody wants to know: When you hear hopes or promises about a vaccine 12 months from now, 18 months from now, or there's even talk of rushing by the end of this year, the administration has Operation Warp Speed is any of that talk realistic for a timetable for developing a vaccine for COVID-19?
McLellan:Yeah, I think it is. I think early earlier this year, in January and February, we were thinking maybe optimistically 18 to 24 months, but things have progressed really well. Some of the data that's come out has looked very good, so we're already basically through with a phase one clinical trial for one of the groups, Moderna, which is developing a vaccine in partnership with the National Institutes of Health based on an antigen that my lab designed. And the phase one looks good; they're starting a phase two. And I think a phase three in July that could be wrapped up by the end of summer.
The early data looked good; the vaccine appears to be safe at the lower doses and is eliciting the types of immune responses we were hoping for.
Then it just becomes a matter of trying to scale up and making millions, tens of millions, hundreds of millions of doses; how to distribute them; who gets them first. But I think we'll have multiple vaccines developed and be optimistic.
KUT:Is that a problem if there are multiple vaccines developed? I mean, if they're developed different companies, different countries, sort of all on different timetables is that a scenario that is helpful or is that a scenario that could create more complications or confusion?
McLellan:I think it will be helpful. I think the benefit is that if we only had one, we'd be putting all of our eggs in one basket. If there is a single issue of a supply chain, then there's no doses. So you probably don't want to have 100 different vaccines. But two, three, four different types of vaccines, all hopefully similar efficacy I think that allows us to get vaccines to more people quickly and less likely to have any potential issues with manufacturing.
KUT:Now, you were describing a timetable that's been under way since early this year, I'm assuming that's faster than normal vaccine timetable development? I mean, usually we're talking about years, if sometimes not a decade or more.
McLellan:Yeah. Historically, it's been closer to decades one to two decades.
One of the vaccines that I worked on as a postdoctoral fellow at the National Institutes of Health at the Vaccine Research Center is a vaccine for respiratory syncytial virus. There we created the vaccine antigen in 2013, and it's now just in phase two clinical trials, seven years later, and still probably a couple of years away for phase three. So, that's the type of normal decade-long progression. So to try and make a vaccine and do phase one, phase two, phase three and then start manufacturing all within one year is pretty phenomenal.
KUT:So you mentioned research that you're a part of about antigens and that's related to a vaccine that Moderna is working on. Tell us about that research and what's going on there and how that informs development of that particular vaccine.
McLellan:Yeah, so the idea with a vaccine is to expose the human body to the pathogen, either the entire pathogen that's been weakened or inactivated or killed, or a portion of the pathogen. For coronaviruses, the portion of the virus that we want to expose ourselves to is the spike protein, the little white dots on the surface of the virions behind me. That spike protein is responsible for first binding to receptors on our cell surface. And then after binding, the spike protein undergoes this really large conformational change that fuses the membrane of the virus with our membranes, and that allows the contents of the virus to enter the cell.
What we want to do is raise an immune response against the spike and prevent it from working. So, if we make antibodies against the spike, those will bind to the spike, prevent receptor binding, prevent membrane fusion, and then that particle can't infect us.
When you're thinking about that, these proteins can exist in multiple conformations (shapes), and what's the optimal conformation? Well, the optimal conformation is the shape that it exists on the surface of the virus. My lab has been involved in determining the structures of these spike proteins and then, based upon the structural information, rationally engineering in mutations into the proteins that lock them and that confirmation that's shown behind me.
And then when you present it to the immune system, your body recognizes it and makes antibodies. Then when it actually encounters the infectious virus, it's primed and ready to recognize the spike protein as it exists on the surface of the virus. My lab does a lot of the structural biology of the viral glycoproteins and then the protein-based engineering to try and lock them into a particular confirmation that we think is optimal for vaccine development.
KUT:In general, how much do you have to know about a particular disease in order to develop a vaccine? Because, you know, this is a novel coronavirus. This is new. Everything is happening fast. How much knowledge do you need about it before that vaccine work can proceed?
McLellan:Yeah, I think there's a whole range. People have developed vaccines for decades longer knowing very little about the actual pathogen and what our approach is, is to try and really use a very rational engineering approach.
So even though this is a novel coronavirus, it's not the first coronavirus. And we've known about coronaviruses since the late 1960s. My lab has been working with Dr. Barney Graham's lab at the Vaccine Research Center at the NIH studying coronaviruses since around 2013. And we did a lot of work determining the structures of coronavirus spike proteins with along with Dr. Andrew Ward's Lab at Scripps Research Institute. So we determine the first structures of these spike proteins. We designed mutations. It worked very well for the MERS coronavirus. And for the first SARS coronavirus.
And so we had all this background knowledge about how to design the antigens, how to present them. And once this novel coronavirus emerged, we could just quickly translate all that prior knowledge. We knew what stabilizing mutations that put into the spike protein and start vaccine development. If we hadn't known that, it could have set us back months or years.
KUT:So that sounds like a bit of an unusual situation, but in a good way that there was already this work done ahead of time and there was kind of a base of knowledge to work from when the novel coronavirus came along.
McLellan:Yeah. And that's an extremely important point: the idea of basic science research getting funding from the federal government and from philanthropies and associations to broadly study disease, infectious disease, cancer and others. It's very difficult to predict where the next breakthrough is going to come or where the next outbreak is going to be. And so it's really important to broadly study.
Just like having the Zika outbreak several years ago. We need people working on these things before the pathogens emerge. That's not the time to begin five to 10 years worth of basic science research. That's why we need to already know a lot about it so we can quickly begin developing interventions.
KUT:I imagine that's a bit more of a challenge when there's not an immediate public health emergency, though, when vaccines are being talked about a lot and development of them and things are moving quickly. I imagine that between those episodes, that's a lot harder to kind of generate interest for.
McLellan:Yeah, it can be. And that's somewhat our job as researchers and in trying to sell our ideas. And there's limited grant funding, and it's a competitive environment. So we have to put forward a strong case to research the things we're interested in. In our case, we felt pretty confident about coronaviruses. We started working on it after the MERS coronavirus emerged in 2012. That was the second one that emerged into the human population after the first SARS coronavirus in 2002.
We felt at the time that there would likely be additional coronavirus outbreaks. And so we wanted to start working on it. And it turned out that there was another one and we were reasonably well-prepared in terms of the science.
KUT:Can you remind us a little bit about those other two outbreaks? Because we have been hearing a lot about those in conjunction with the novel coronavirus. Just remind people briefly what those two outbreaks were.
McLellan:Yeah. So the SARS coronavirus emerged in 2002 in China. The primary reservoir for the human coronaviruses are bats these horseshoe bats. It's likely that the bats, the primary reservoir for SARS coronavirus, then had a secondary reservoir of palm civets, these cat-like creatures. And then that led to an outbreak. The case fatality rate was higher. So about 10% of all confirmed cases led to a fatality, which is actually quite high. And it affected around 8,500 people.
So it was able to be relatively well contained to within China, although there was some spread outside. So it was more of an epidemic rather than a global pandemic.
For the Middle East Respiratory Syndrome (MERS) coronavirus. That emerged in 2012 in the Arabian Peninsula in Saudi Arabia. That's an even more lethal virus it has a 35% case fatality rate with only around 2,500 people have been infected. It doesn't spread easily person to person, as this novel coronavirus, SARS-CoV-2, spreads.
KUT:We actually have a question from somebody on Facebook asking about herd immunity. Did we ever get herd immunity for any SARS virus or any coronaviruses of non-SARS type? Did herd immunity ever come about for any of those?
McLellan:So there's now seven human coronaviruses, three of which have caused the more serious diseases: SARS-1, SARS-2 and MERS. And then there's four that circulate seasonally. They cause mostly mild respiratory illness, like the common cold. And so for those four, we generally have some degree of herd immunity. Most people have been infected. And that causes then follow up reinfections to be less severe.
For the first SARS, again, only 8,500 people were infected. So there's really no herd immunity. There is no additional transmissions after 2003. Same thing for MERS. And now with SARS-CoV-2, we're still, I think, relatively low percent of people have been infected. Of course the estimates are ranging due to testing issues, but we're probably below 10 percent and it's thought for herd immunity for SARS-CoV-2, we might need to be closer to 60% or 70%.
KUT:I want to get back to the vaccine development process a little bit because we hear about people who have gotten injected with a vaccine in a few of the trials that have already happened. How is it determined when a vaccine is successful? What is the flag in a trial that says, all right, we're ready now to go into that mass production that you were talking about? What signifies that?
McLellan:It first has to pass safety tests and so the phase one clinical trial is really looking at safety. And so that's generally in tens of people, let's say 40 people or so, I think the Moderna vaccine is 45 people. Then everybody, the 45 people, they're all getting vaccines. So there's no placebo. And it's generally escalating doses. So that the first people get the lowest dose, might wait a week or two and see how they respond. That looks OK. The next people get the higher dose. So we're just trying to get an estimate of safety and the dosing.
And then what you really want to look at then is for efficacy, the ability to prevent severe disease or prevent infections. And that's where you really need something like the larger phase three clinical trial where you have thousands of people. One group is receiving placebo. The other group is receiving vaccine. And then you expect to see some difference between the two groups.
The flag itself, it depends a lot on how the particular phase three clinical trial is constructed. There will be primary endpoints, secondary endpoints. People have to decide what they are. Are you trying to decrease infections? Are you trying to decrease severity of disease? Days in hospitalization? Deaths? Those are all different potential endpoints or secondary endpoints. And that needs to be looked at. If you achieve the threshold you are going for and that people think could be useful, then potentially you move forward and begin licensure and manufacturing distribution.
KUT:So I'm curious about those steps. I want to ask a little bit more about each one that that initial step, that safety step, as you were describing that, I just started thinking, well, that's a that's a particular kind of person who would sign up to be a participant, to be a volunteer for that first round of testing. Have you talked to some of those folks before?
McLellan:I haven't personally talked to them, but it's pretty cool in the current age. Some of them are on Twitter and some have actually been tweeting about it. One of the people who had a more severe adverse reaction to the highest dose had a story and kind of tweeted about that a little bit. So it's been interesting to actually obtain some of this information in real time. I think a lot of people were excited to be a part of this.
I think depending on the vaccine in general, we aren't expecting really too many too severe adverse events. Generally, some redness and some other things, maybe fever. But yeah, I think theyre pretty brave people to volunteer to do this.
KUT:Talk a little bit more about then the second step, the efficacy step. You said there are three different groups and getting a placebo and different doses. Talk about, then, exactly more specifically how that is tested. What are researchers looking for in that efficacy step?
McLellan:Some of the things we can do initially, even in the phase one, is we can draw the blood of the vaccinees and see if they're making antibodies against the virus or against the protein that are potentially neutralizing. So we know that with the vaccine, we're trying to elicit an antibody response and particularly an antibody response that can neutralize or inhibit the virus from entering.
And so we can get the concentration of those antibodies, the titers, we can get a sense of how well we're working. We know that people that have been infected with SARS-CoV-2 and recover, they have a certain concentration of antibodies. We would like the vaccine to elicit a similar concentration or potentially even higher. So we can get some of that initial information.
For some of the trials, it's looking quite good. We are eliciting those types of antibodies. But ultimately, you want to know whether there's protection, whether we're protecting from severe disease. And that's where you might look if you had several thousand people in one group received placebo and one group received the vaccine, you could potentially look at, after several months, the number of people hospitalized in each group and compare those and see if there's a statistical significance. Or days in the hospital, those are the types of metrics you're looking at.
KUT:I want to veer off the vaccine course for just a second, because when you mentioned antibodies, I know people who have been following your research and following some of these developments closely are probably thinking about research they may have heard about involving llama antibodies. Now, that's for a treatment, not for a vaccine. But talk a little bit about your research there, because obviously it's llamas and people are interested in what on earth are you studying llamas for and how is that related to all of this?
McLellan:I think broadly you can think about interventions for viruses, for this particular coronavirus, in three different modalities: vaccines, antibodies and small molecule inhibitors. So for vaccines, as I mentioned, we are trying to inject a virus or a portion of the virus into a person and then let their body generate an immune response. Antibodies and T cells. So that's an active immunization. It requires the vaccinee to actively make an immune response.
For antibodies, we can actually purify antibodies from either a llama or from a human and express them and then inject them into a person. And immediately after injection, the person then has a very high concentration of this protective antibody circulating in their system, and they should be protected. The concentration of the antibody will wane over time because their body isn't making more of it. And so then they might need a boost every one to two months.
But this can be useful, for instance, for protecting health care workers, for people that we know are going to be exposed to a lot of virus. You could immediately inject them with an antibody and have them protected for a certain amount of time and potentially they can be used for treatment. If somebody gets infected or is likely to have been infected, you could then administer the antibody and hopefully that would resolve the infection or decrease this disease severity.
So there's a lot of work going on now to isolate monoclonal antibodies from people who have survived COVID-19. And then we've also been working with with llamas. Llamas make two types of antibodies. One is very similar to antibodies we make, conventional antibodies. Another is a much smaller antibody that is really unique to the camelid family. So camel llamas, alpacas. And the portion that recognizes the virus is much smaller than the human homolog. This allows it to fit into small pockets and crevices that maybe the conventional antibodies can't, and then these small antibodies can be really stable. They can potentially be nebulized into an inhaler delivered directly into the lung, into the respiratory tract where the infection takes place.
And we've known that camelids can make these types of antibodies for decades. There's entire companies started around this type of technology. And we began working on this in 2016, trying to isolate a camelid nanobody that broadly binds to all coronavirus-like proteins.
We failed in that aspect of it, but we were able to isolate these nanobodies that can find and neutralize MERS. And the first SARS coronavirus. And it turns out that then one of the ones that binds to the first SARS coronavirus also binds to the spike protein of SARS-CoV-2, and it can neutralize. And it looks really well. It's finding a pretty conserved site. And our colleagues in Belgium are rapidly moving that forward for preclinical development.
KUT:So, Jason, you use a word fail in talking about an earlier attempt with this or attempt to sort of get something ready for all coronaviruses. But I imagine that the word fail probably has a different meaning in your line of work, because a failure here, though, might open a door somewhere else or lead to knowledge for something else. So I imagine that something that may seem like a failure isn't always necessarily a failure, though, when you're talking about research and vaccine development.
McLellan:Yeah, you know, we actually feel a lot in science. There's a lot of things we're trying to do, trying to get experiments to work and they just keep failing. And then eventually there's a breakthrough and we move it. That's a little bit of how science works. And you kind of get used to that. A lot of people coming into the field are used to always being successful. And it takes a while to realize most of your experiments are going to fail. But there's usually net progress, and that's what works. In this case, we didn't achieve our our main goal, but we ended up still making some molecules that look efficacious against coronaviruses and one that potentially could intervene in this pandemic.
KUT:Do you have any concerns about the timetables here that we're hearing about? You said you are optimistic about something being developed maybe within this year, but then we also chatted about how that is a very compressed timeline compared to usual vaccine development. Does that concern you at all that this is going so quickly because obviously we have a public health crisis under way right now? Do you have any concerns about that, that compressed timetable?
McLellan:You're always concerned about safety. But again, we're leveraging a lot of prior information, both on coronavirus vaccine development that's occurred for about the last decade, people making SARS-1 vaccines, MERS vaccines. Those have never been licensed. But there's been a lot of animal work and some early clinical trials. The different modalities of vaccines, whether it's an mRNA-based vaccine, DNA-based, adenoviral-based.
There's a lot of research on those platforms in general. So we know quite a bit about that. We know generally the safety profile, and we are going through the steps, phase one, phase two, phase three, being cautious. And we're learning as we go. I think there's always some concern, but we're not doing this for the for the first time. There is a lot of prior research where you're able to leverage.
KUT:Jason, I feel like I should ask you: we're talking about vaccines, we're talking about safety. I imagine you encounter on social media and other places people who have concerns about vaccines, don't believe they work, have worries about them. How do you respond to people who don't believe in vaccines at all as a vehicle for help in this arena?
McLellan:Yeah, we don't really deal in beliefs. There's science, there's data that shows they're safe and effective. I think that's the best thing we can do as scientists is generate the data. Whether people believe it or not is not something we can really control.
KUT:So I don't want to pin you down to a particular number, but you said you're optimistic about the timetable for this year, about something happening this year. Could you put a percentage to that or a likelihood that by the end of the year we might see a vaccine? I think this is something that people are obviously very focused on and very concerned about and hopeful about.
McLellan:Yeah. I think it's likely 90% that that a one or more vaccines will be approved. Now, that's different than having everybody vaccinated by the end of the year. That could still take another year or two to generate enough doses and distribute them all.
KUT:So let's talk about then that step in the process, which you had mentioned earlier, which is once a vaccine is developed, it's approved, it's safe, it's ready to go, what happens then? Obviously it has to be widely distributed and administered,.
McLellan:Yeah, it has to be manufactured and distributed. Right. And a lot of that's going to depend on the companies, what their capacity is, whether other companies will help out the manufacturer, you know, sort of mergers and groups working together on that. I think some of the targets are initially generating a million doses per month by the end of this year, ramping that up to 10 million doses per month next year. But we still have 300 million plus people in the country. So that's still going to take a long time. And we've got to figure out who gets it first in an orderly fashion. And I think those are discussions that probably are happening now and should happen.
KUT:So we have another question from the audience regarding vaccines. Is there any guarantee that all of this work will lead to a vaccine? Or is it possible that it could take a very, very long time or that there just might never be one?
McLellan:I think it's unlikely there would never be one. I think it will lead to a vaccine. What we don't know, for instance well, I guess, one of the big questions is the duration of immunity afforded by the vaccine or even the natural infection. So we know that people infected, they generate an immune response. But we don't know how long after that they could potentially be reinfected. So that's a big question. It's not going to be the same for every person.
We see that people are making a range of immune responses, some fairly weak, some fairly robust. People with more asymptomatic infections would be generating a weaker immune response than people with severe disease who've been exposed for a long time to a high amount of virus.
So I think that's one of the things that we're really most interested in in terms of vaccine development: how long would you need a vaccine? Every year? Could you go every couple of years? And I think that's one of the major questions. But all the data suggests so far that several of the vaccines being developed are immunogenic, are eliciting antibody titers and immune responses that are comparable to what's been observed by natural infection. And that's a very good sign.
KUT:Jason, you're talking about that response. I know people know what you're mentioning. You know, there are vaccines that you get once in your lifetime. There's a flu shot you're supposed to get every year, and there's some in between. So part of this work must be figuring out what kind of response is generated and what kind of vaccine we would be looking at.
McLellan:Yeah, part of that is we might just have to wait a little bit to see whether you can get reinfected after a year or after two years, and maybe some of those studies can start to be done in animals to give us a sense of that. But it's true for influenza, the virus changes a lot. It kind of evades our immune response. So when you're getting vaccinated each year, it's not exactly the same vaccine components. It's changing to try and predict the changes of flu.
We know this coronavirus is changing a little bit. Spike proteins may be accumulating one mutation per month. It's a very large molecule. We don't expect it to escape from vaccines being developed now anytime soon. But these are all things we're sort of investigating, trying to figure out as the virus evolves. And what sort of antibody responses and vaccine responses we're getting from each of the different vaccines that are being developed.
KUT:I was just going to ask you about that change, if you've seen the coronavirus changing, this novel coronavirus changing. You said it's changing about once a month or what is that part looking like right now?
McLellan:Yeah, there's really great studies going on. When people are infected, the virus can be isolated from them. The entire genome can be sequenced. And we can start to look at the changes in the genome that are accumulating and how they diverged from one of the very first strains. And for the spike protein itself, we're seeing some mutations occurring. Maybe one particular substitution seems fairly prevalent, like maybe it's been selected for. And it's something to keep an eye on and see just how many changes the surface of the spike is accumulating because that could affect vaccine and antibody responses. But so far, it's not changing too much where we're worried about it.
KUT:So, Jason, I want to ask you to step back a little from the specifics of your work. And I'm just curious: the kind of work that you do, especially now, you're researching, you're working on a vaccine, development is rolling along. And right now, we also know that the death toll from COVID-19 in the United States is very close to 100,000 people. And I'm wondering if you could just talk a little bit, I guess, more personally about what it's like to work on projects in research like this that literally are life and death. What is that like for you?
McLellan:We find it very interesting, which is why we do it. We potentially could work on anything, and I've chosen to investigate infectious disease and trying to develop interventions for it. It's nice that our lab may have a role in helping to combat this pandemic, whether it's a vaccine antigen design and vaccine development, or we're doing a lot of work with the antibody isolation and characterization. And, yeah, it's been hectic.
The students and postdocs in the lab have just been working nonstop. We've got some people just working around the clock trying to get things out, shipping reagents and plasmids to researchers all over the world to try and help them. We've shipped out well over 100 packages of some of our proteins and plasmids to try and facilitate other people's research. So it's been interesting. It's been good. This is the type of research we want to do.
KUT:And just talk a little bit more about what it's like to be working in this field right now. When you talk with your colleagues, what kinds of stories do you all share? What what do you all talk about?
McLellan:We haven't found that much time to talk. We're all pretty super busy. We'll catch up later.
KUT:Jason, thank you so much for your time and your discussion today.
McLellan:Thanks for having me. It was fun.
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Several COVID-19 vaccines are in the works, though one medical professional says a vaccine wont likely be available until 2021.
Several COVID-19 vaccines are in the works, though one medical professional says a vaccine wont likely be available until 2021.
Pennsylvania Auditor General Eugene DePasquale on Wednesday hosted Dr. William Klimstra with the University of Pittsburgh via Facebook Live to discuss COVID-19 vaccines.
Klimstra works in the Department of Immunology and Microbiology and Molecular Genetics Department at Pitt, is a member of the Center for Virus Research, and has been involved in several previous vaccine designs.
Since the end of January, Klimstra said his team of scientists and researchers have been tirelessly working on a COVID-19 vaccine.
We were among the earliest to do this, he said.
His team is currently working on three separate vaccines, but he said there are six or seven vaccines right now that are at the point of being in human clinical trials. Those undergoing human clinical trials would have to show initial safety of the vaccine and then efficacy after that, Klimstra said.
The process really is that people had to identify a virus, know what the pieces of the virus they wanted to express in the vaccine look like, synthesize those in the laboratory and then immunize animals initially, and show first and foremost that the vaccine was safe, he said.
Delays in getting vaccines into the market place are mostly because of determining the safety of the vaccines, Klimstra said. Safety is foremost really at every level of the process.
Coronaviruses are not new. In fact, Klimstra said they are extremely diverse, but COVID-19 is more dangerous than other similar viruses, like the flu.
Coronaviruses are found in many organisms, Klimstra said.
There are whale coronaviruses and seal coronaviruses and hawk coronaviruses, he said. These have been known and existed for many, many years.
Klimstra said the current coronavirus also likely originated from an animal, but then was mutated.
What has happened with the current coronavirus is it was most likely a bat coronavirus that underwent some mutations in a particular setting, perhaps in one of these animal markets in China, and that mutation allowed it to grow in humans, which is one of the reasons why it is more dangerous than, for example, influenza, he said.
While some folks tend to view the flu and the coronavirus as nearly the same, they are actually quite different, according to Klimstra.
Influenza essentially has been circulating in humans for hundreds of years. Everybody has had exposure to a kind of influenza. When a new one comes along, even though you might get sick, youre a little bit immune to it, he said.
But the novel coronavirus COVID-19 is different.
With this coronavirus, really people havent seen a virus like this before. They are completely unprotected from it, which is one of the reasons it gets more severe, Klimstra said. The coronavirus is one that just happens to do this kind of thing a lot, that has been understood from the original SARS outbreak ... that these things can jump between species.
Klimstra said creating a vaccine is important because a virus of this magnitude is likely to return.
This thing is likely to happen again, he said. We need to have things on the shelves shelf-ready to respond to this kind of outbreak, because it will happen again.
COVID-19 vaccine could be ready by end of this year: Dr Anthony Fauci | Photo Credit: iStock Images
Washington: A vaccine for the novel coronavirus infection could be ready by the end of this year, according to Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. The top US epidemiologist said in an interview on Wednesday that if all things fall in the right place, we might have a vaccine for Covid-19 by November and December.
According to the World Health Organization (WHO), more than 100 vaccines are being developed across the world, with a handful of candidates already in human trials. Till date, Chinas CanSino adenovirus vaccine, Oxford Universitys adenovirus vaccine, Modernas mRNA vaccine emerged as the top most promising vaccine candidates for COVID-19.
I still think that we have a good chance, if all the things fall in the right place, that we might have a vaccine that would be deployable by the end of the year, by December and November, Fauci, a key member of the White House coronavirus task force, told CNN.
Meanwhile, a leading US epidemiologist, Robert Schooley, a professor of medicine with the Division of Infectious Diseases and Global Public Health at the University of California, San Diego, told Xinhua in a recent interview that the results of Chinas COVID-19 vaccine trial are very impressive.
According to a study published by the medical journal The Lancet, the phase 1 trial of an Ad5 vectored COVID-19 vaccine in Wuhan, China, has been found to be safe, well-tolerated, and able to generate an immune response against SARS-COV-2 that causes COVID-19 in humans.
Fauci said although there are a lot of variables when it comes to dealing with vaccines, development continues to proceed. He said a second wave of coronavirus outbreak could happen, but the country (US) can prevent it if they open correctly. It could happen, but it is not inevitable, Fauci said.
The US top infectious disease physician also said hes not sure whether hydroxychloroquine should be banned as a treatment for coronavirus. However, he said that the scientific data quite evident now about the lack of efficacy for the anti-malarial drug touted as a game-changer by President Donal Trump. Testing of hydroxychloroquine as a possible treatment for COVID-19 has been halted by the WHO citing safety concerns.
Currently, theres no specific antiviral agent or vaccine for COVID-19, which has claimed at least 352,494 lives worldwide and infected about 5,638,190 people in 196 countries and territories.
Patients in clinical trials are usually faceless. But as the experimental Covid-19 vaccine being developed by Moderna Therapeutics has begun advancing through studies, it has found a much more visible advocate: trial volunteer Ian Haydon, a 29-year-old in Seattle.
Haydon has spoken about the vaccine on CNN and CNBC. He even said hed volunteer to be exposed to the novel coronavirus, SARS-CoV-2, if researchers want to test to see if the vaccine was actually effective. But up until now he has left out a key detail: He is, apparently, one of three people in the trial who had a systemic adverse reaction to the vaccine.
Twelve hours after receiving his second dose, he developed a fever of more than 103 degrees, sought medical attention, and, after being released from an urgent care facility, fainted in his home. He recovered within a day.
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He has not brought up the side effects previously, he said, out of an abundance of caution.
I understand that sharing the story, its going to be frightening to some people, he said. I hope that it doesnt fuel any sort of general antagonism towards vaccines in general or towards even this vaccine.
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But he decided to speak now because he hopes his story counterbalances the desperation that some people feel to push a vaccine to market regardless of the consequences. Haydon points out that the whole purpose of the study he was in, known as a Phase 1 clinical trial, is to find the right dose of the vaccine going forward. That means to find a dose that causes the body to produce antibodies, but does not result in too many side effects.
As we rush to get a vaccine developed as quickly as possible, the reality of vaccine development is that it can only be rushed so much and the trial still needs to take place, Haydon said. They have to move at the speed they move at. And stories like what happened to me, they matter because they shape the approval process.
In the 45-person Moderna study, four participants experienced what are known as Grade 3 adverse events side effects that are severe or medically significant but not immediately life-threatening. Neither the company nor the National Institute of Allergy and Infectious Diseases, which is running the trial, have previously detailed the nature of those incidents, but Moderna did disclose that three, likely including Haydon, received the highest dose of the vaccine that was tested, and had reactions that involved their whole bodies. A fourth received a lower dose and had a rash at the injection site.
Such side effects are noteworthy, but it doesnt stop the train, said William Schaffner, a professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center. The goal of studies is to establish a threshold at which something might go wrong.
With drugs, Schaffner said, patients tolerate the risk of side effects because they want to get better. In contrast, Schaffner said, we give vaccines to healthy people in anticipation that they might contact the germ, the virus, down the road. But because we give them to healthy people, actually our standards for safety are higher than they are for drugs.
In Haydons words: The point of the Phase 1 trial is to look out for health problems. He said he received great medical care, and though he felt more sick than he ever has before, he was never afraid for his long-term health. I dont regret the decision I made to enroll in this study.
Haydon, a communications manager at a university, initially found out about the study, which was being run in Seattle, from a colleague who sent him a link. He, along with thousands of other people, applied. They called him 11 days after he applied.
He went to the trial site for a physical, and signed a 20-page consent form. The vaccine, it told him, could conceivably cause severe anaphylactic shock, and there was no way to predict exactly how his immune system would respond to the new vaccine. Hed looked at research on other Moderna experimental vaccines, which work via an entirely new technology that uses messenger RNA, the bodys key envoy of genetic information inside cells, and thought they seemed relatively safe. During the physical, researchers took blood; the lab work came back a week later, and he received his first dose of the vaccine on April 8.
Haydon doesnt like needles, and was as worried about the blood draw which uses a bigger needle than the actual shot. He remembers waiting, and being told that the reason he was waiting was because researchers were giving doses in ascending order, and he was to receive the high dose of the vaccine. But the injection was uneventful. If his eyes were closed, he said, he would not have felt it. He was given a paper log on which to write down any symptoms, a digital thermometer, and a small ruler to measure any reactions at the injection site.
He had arm pain the next day, like being punched in the arm, he said, and for a day he had trouble lifting his arm at the shoulder. But within days he was back to normal.
Haydon said he was slightly nervous before the second dose. He knew that second doses were given to increase the immune systems response, and wondered if he might have more side effects. His arm became sore much more quickly this time. He got home from the clinic at about noon. At around 10 p.m., he started to get chills. Hes normally too hot at night, but he bundled up in sweats. His fingertips felt cold. He fell asleep, but woke up a few hours later with a raging fever.
At 1:30 a.m., his temperature was 103.2 degrees. At 3:45, it was 103 degrees. He was nauseous, and his muscles hurt.
The clinic where he was vaccinated had given him a 24-hour phone number to call, but hed been reticent. His girlfriend, with whom he lives, called. They said to go to urgent care. It was a 10-minute drive. They arrived at 5 a.m.
The doctors met him in what looked like space suits. Even though hed had a vaccine, he was also a potential Covid patient. They took him into an exam room, took a lot of blood, and gave him a nasal swab. He asked them to avoid his left arm, where hed gotten the vaccine, but they ended up taking blood from both of his arms. His fever had already fallen to 99.8 degrees. They gave him Tylenol. The physician taking care of him offered to try to get him admitted to a neighboring hospital, but he decided to head home.
He and his girlfriend arrived home at 7 a.m., and he slept until noon. His temperature was 101.5. He got up to go to the bathroom, and became so nauseous he threw up. On his way back from the bathroom, he fainted. His girlfriend caught him and kept his head from hitting the floor.
She then called one of the doctors working in the study, and asked what they should do. The doctor told them he could go back to urgent care, or call 911, and reminded them that all his medical costs would be covered by the study.
But he got to a couch and was given sports drinks. He spent the afternoon there, with a wet towel on his head, fighting the fever. By 9:45 p.m., it was back down to 99.1. It tapered off. He says he felt better within a few days, and has had no side effects since.
Haydon said the experience left him as sick as hed ever felt. But standard flu-like symptoms that resolve within a day are not necessarily considered a reason not to use a vaccine that prevents a more serious illness.
Given the stakes of a Covid-19 vaccine, the side effects described in the Moderna release would likely be seen as acceptable even if they turned out to be seen in future studies. The severe effects were only seen at high doses that are not being taken forward. The other vaccine for which early data are available caused fever in almost half of recipients.
But its also not clear what will happen as the vaccine moves into larger studies. Humans have a very diverse immune system, said Larry Schlesinger, the president and CEO of the Texas Biomedical Research Institute, a nonprofit. And then you add on top of that diabetes or, you know, age 70 and you can imagine that the immune response will be very, very different.
The difficulty, Schlesinger said, is that right now we are only getting tidbits of information about the new vaccine.
Tidbits of science are always dangerous for the public to read because they give a false understanding, or a false sense of security, that were making progress or not, Schlesinger said. And then tomorrow we hear something completely opposite. And before you know it, the credibility of the scientific process is undermined and people stop listening.What does he think now? Its just not enough information at the current time. Thats why we need clinical trials and volunteers like Ian Haydon.
Microsoft co-founder Bill Gates' increased media presence lately has made him the target of conspiracy theories.
Fighting misinformation and conspiracy theories about the novel coronavirus has almost been as hard as battling the pandemic itself. And a new survey has found that one conspiracy theory aboutMicrosoftco-founderBill Gatesis taking hold.
A conspiracy theory that Gates is planning to use a future COVID-19 vaccine to implant microchips in billions of people in order to monitor their movements has gained supporters particularly among Fox News viewers and Republicans, the survey found.
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The representative survey of 1,640 US adults by YouGov for Yahoo News found that half of respondent Americans who say Fox News is their primary television news source believe the conspiracy theory. It's the largest group responding this way, followed by self-described Republicans and "Voted for Donald Trump in 2016" -- 44% of both those groups said they believed the conspiracy theory was true. Twenty-six percent of respondent Republicans said it was false, and 31% said they weren't sure.
Representatives for Fox News, the Republican Party, the White House and the Trump 2020 campaign didn't immediately respond to requests for comment. The Bill and Melinda Gates Foundation, which the namesake founders use to fund medical research and vaccine programs around the world, also didn't immediately respond to a request for comment.
Yahoo and YouGov's survey didn't find that everyone believed these conspiracy theories though. Just 24 percent of independents, 19% of Democrats and 12% of people who "Voted for Hillary Clinton in 2016" believed the conspiracy theory about Gates. Instead, forty-five percent of independents, 52% of Democrats and 63% of Clinton voters said they don't believe it. The rest said they were not sure.
Keep track of the coronavirus pandemic.
The survey findings underscore the level at which conspiracy theories have overtaken public perception of the coronavirus. The virus, which has infected more than 1.6 million people in the US and killed nearly 100,000 Americans, has upended daily life since it was first detected in December of last year. Governments around the world have ordered citizens to isolate themselves and shelter in place in an effort to slow the virus' spread and reduce strain on hospitals and morgues.
As people adjust to these efforts, they've also begun reading and spreading conspiracy theories about the coronavirus. Such theories address everything from the political ambitions of people involved in the response to whether the coronavirus is as deadly as governments and health agencies are reportingto how and where the virus originated (expertssay it came from wild animals). So many people wrongly believed5G wireless played a rolein spreading coronavirus that theyvandalized nearly 80 cell towers in the UKover it.
Facebook, Twitter and YouTube have all said they're responding to conspiracy posts, adding links to more information and in some cases pulling down content that the companies believe could lead to people unknowingly harming themselves.
Gates has become a center for attention among conspiracy theorists in part because of his high profile efforts to vaccinate people around the world, as well as his recent media appearances over the past couple months. He's also criticized government responses to the crisis, such as in a March editorial published in The Washington Post.
"There's no question the United States missed the opportunity to get ahead of the novel coronavirus," he wrote in a column published March 31. "The choices we and our leaders make now will have an enormous impact on how soon case numbers start to go down, how long the economy remains shut down and how many Americans will have to bury a loved one because of COVID-19."
One analysis done by The New York Times and media watcher Zignal Labs in April found misinformation about Gates was the most widespread of all coronavirus falsehoods.
Aside from conspiracy theories about Bill Gates, Yahoo and YouGov's May survey also found that only half of Americans now say they intend to get vaccinated "if and when a coronavirus vaccine becomes available." Twenty-three percent of people say they won't, and 27% say they're not sure.
If you have anyone in your life whos old enough to remember, there was a time, in the first half of the 20th century, that might draw comparisons to life today. There was fear, uncertainty and lots of concern for public health.
It wasnt the novel coronavirus, of course, the current pandemic sweeping the globe. It was an epidemic called paralytic poliomyelitis, or infantile paralysis -- perhaps best known as polio.
In fact, polio was once one of the most feared diseases in the U.S., according to the Centers for Disease Control and Prevention, which goes on to say online that in the early 1950s, before polio vaccines were available, polio outbreaks caused more than 15,000 cases of paralysis each year.
Parents were scared to let their children go outside; travel and commerce between cities were sometimes restricted, and quarantines were imposed.
Polio wreaked havoc on communities.
I might not remember what I went to the kitchen for today, but I can remember everything about the day I went with my family to get the (polio) vaccine, said Gary Tietze, who lives in the San Antonio area and is the father to one of the co-authors of this story.
Once vaccines were introduced specifically, trivalent inactivated poliovirus vaccine (IPV) in 1955 and trivalent oral poliovirus vaccine (OPV) in 1963 the number of polio cases fell rapidly to less than 100 in the 1960s and fewer than 10 in the 1970s, according to the CDC. Thanks to a successful vaccination program, the United States has now been polio-free since 1979.
But back to those old enough to remember, like Tietze: Have you ever heard the stories of people rushing out for their sugar cubes? (That was the way some of the oral vaccines were given).
Jan Smolinski, of Michigan, recalls that time in her life vividly.
She was 20 years old, and preparing for her wedding.
The day of my wedding shower, which must have been on a Sunday in April -- my whole wedding party, we went, and it must have been to a community center (or) a church or a school, Smolinski said. And wed wait and there were doctors, nurses and volunteers. And youd receive your sugar cube. And then you got the second dose a couple months later, because that was the day after (our) wedding. My husband and I went to St. Regis Church in Detroit and got a second dose. That was 1964. The next day, we reminded everyone, Go get your sugar cubes tomorrow! And that was before we left on our honeymoon.
It was Jonas Salk who became a national hero, the Science History Institute said, when he quelled the fear of the dreaded disease with his polio vaccine, approved in 1955. His came first, and then Albert Bruce Sabin introduced an oral vaccine in the United States in the 1960s that replaced Salks. [Read more about Salk and Sabin.]
Smolinski took the oral version, hence, the sugar cube.
It must have come as a relief to have a vaccine after all those years.
People with more serious polio symptoms could experience the sensation of pins and needles in the legs; develop meningitis, an infection of the covering of the spinal cord; and paralysis. Of the 57,628 reported cases, there were 3,145 deaths, according to the website Healthline. Franklin D. Roosevelt, the 32nd President of the United States, was diagnosed with polio, in 1921, at the age of 39.
No one is certain of the circumstances leading to FDRs contraction of polio, but many believe he was exposed to the virus at a Boy Scout camp in New York. It was uncommon for a middle aged person to contract polio, according to the FDR Library. Most cases of the disease were acquired by children. [Read more about Roosevelts circumstances.]
Tietze, who was a young boy at the time, said there were people he knew who ended up paralyzed or dead from the virus. A cousin who lived across the road from his familys dairy farm was hospitalized with polio.
We didnt see him for a long time, Tietze said of his cousin. When they finally got out of the hospital, they were quarantined. They lived close to us, and we didnt see them for maybe a couple years. He was (paralyzed). He was young when he got it -- 8 or 9.
Tietze admitted that whats happening right now is different in many aspects, but, he said, in the same regard, living through the time of polio was scary -- even traumatic.
He spoke of the iron lung, used on some polio patients, and remarked on how frightening they looked.
In the image below, two young children are in an iron lung, a type of pressure ventilator that began use in the 1920s. It was intended for polio patients whose chest muscles had been effected by the virus, which led to problems breathing. The iron lung would create different pressures, stimulating breathing in the patient.
Smolinski spoke of the iron lung, as well. Her husband had a friend in one.
You were totally encapsulated, Smolinski said. It was quite noisy.
The now-76-year-old said what sticks with her especially is the fear that surrounded the disease. In a lot of ways, her experience sounds a bit like Tietzes.
When Smolinski was little, in the late 40s or early 50s, she had two cousins who got polio. They were both hospitalized -- and they recovered, but it was a stressful time for the family.
I remember my mom and dad being nervous, Smolinski said. It didnt affect my daily life, but I remember being very scared for my cousins.
There was one summer she remembers specifically as being very bad. Many grew concerned about children playing outside, and people even referred to it as polio season. Smolinski said she was probably 9 or 10 years old when polio concerns were incredibly high.
She wonders about how a vaccine would be distributed today. Its a similar situation in some ways to whats going on with the novel coronavirus, but also so different. Its a new era.
But as a little girl, Smolinski thinks back mostly on the situation with her cousins. Its always a little more real when something touches your own family, isnt it?
My parents were very upset, Smolinski said. It was their nieces. It was (also) like, it could happen in our own family. Thats where the fear came in.
Related/read next: How does an iron lung work? Polio survivor, 82, among last to use breathing equipment (2018 report) | Discover Magazine: The deadly polio epidemic and why it matters for coronavirus
Acclaimed American public health expert Ashish Jha has told former Congress president Rahul Gandhi that three vaccine candidates are showing promising results in the fight against the raging coronavirus disease (Covid-19) and expressed confidence that there could be a new vaccine by next year.
Three vaccine candidates are showing promising results. These are from America, China, and Oxford University. For now, they all seem promising and maybe one or all of them may turn out to be effective. Im confident that the vaccine will be available by next year. India has to prepare a plan on how to avail the vaccines for its population, he added.
Jha is a professor of Global Health at TH Chan School of Public Health and director, Harvard Global Health Institute. He made the remarks during his interaction with Gandhi, who has been holding a series of dialogues with global experts on various aspects of Covid-19 via video-conference since the viral outbreak.
Coronavirus outbreak: Full coverage
Asked by Gandhi, if the Bacillus CalmetteGurin (BCG) vaccine, which is used against meningitis and tuberculosis in children, is helpful and the virus doesnt operate in hot weather, Jha said: BCG vaccine can be helpful. There is some circumstantial evidence that these vaccines can be helpful, but its not very good evidence. New testing is underway and well know in the next few months if these vaccines play a major role. There is some evidence that the weather makes a difference. There is less transmission of the disease in being outdoors than indoors.
He added: Its a new virus. There is new testing. New studies are going on and in the next couple of months, well know much more. Some nice randomised trials are being carried out. I suspect that in the next three months, well know much more if these vaccines will play a major role. Im personally sceptical that the BCG vaccine will be an important mediator. I dont know, but well know soon. But theres certainly not enough evidence to make policy as of now.
Jha said there is some evidence, which shows that the weather makes a difference. Theres going to be easy transmission if 15 people are staying in one small room. But once these people are outdoors, and theres the air that would make the situation a bit better.
Jha claimed that the world is entering an age of pandemics.
Im confident that this is not the last large global pandemic you and I are going to see in the next 20 years. We got lucky that in the 2009 H1N1 swine flu didnt cause that much harm, even though it was declared a pandemic. A virus that gets started somewhere spreads very quickly globally, he added.
There are also big environmental changes. All of this economic growth that you see in China and India and many other places have lifted people out of poverty. But the growth also led to deforestation and rampant encroachment on animal habitats. Most pandemics that come to humans jump from animals. This virus has existed in bats but there was a small change probably in the genome and all of a sudden it became suitable for human hosts. I think climate change is going to make many of these things worse, he said.
The other thing that has happened with economic growth is that people are eating a lot more meat, which means more interactions between humans and animals. Put all of it together. If you look at the last 100 years, youll see the increasing frequency of these kind of outbreaks and Covid-19, of course, is the worst in a hundred years. But, Im confident that were going to have more global pandemics in the coming years and decades. We have to ask ourselves: how we are going to better prepare for the next one? Jha asked.
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How long until theres a Covid-19 vaccine? Its the question of the year, and one that Barrons tackled in this weeks cover story. Now, Bernstein Research is out with its own take on the question. Its answer? Late this year or early next year at best, though the vaccine wouldnt be widely available until later next year.
We are cautiously optimistic vaccines will work (to some extent), wrote Vincent Chen, the lead author on the note and one of the experts quoted in our cover story. We would not expect the first generation of vaccines to be perfect game-changing vaccines. If COVID-19 continues to be a problem, we would expect future generations may improve upon the current crop.
Chens note comes after a week in which shares of Moderna (ticker: MRNA) rose 19% on Monday on news that the company was seeing promising early data in the Phase 1 trial of its Covid-19 vaccine, and then fell 10% on Tuesday as experts noted that the press release contained little data.
Also in the news was AstraZeneca (AZN), which announced a commitment of up to $1.2 billion from the U.S. government to manufacture the Covid-19 vaccine developed by an Oxford University lab.
In his note, Chen wrote that it was hard to pick winners among the many Covid-19 vaccine programs. He flagged the coming manufacturing challenge, but said there could be enough of the messenger RNA-based vaccines available in 2021 to treat up to 1.5 billion people, and enough of the adenovirus vector vaccines in 2021 to treat up to 2.5 billion people. He said that there could be around one billion doses of the protein subunit vaccine being developed by Sanofi (SNY) and GlaxoSmithKline (GSK) in 2021.
But thats if all of the leading programs work. Keep in mind mRNA and adenovirus vaccines have never been marketed, let alone manufactured or commercialized at global scale, Chen wrote.
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com
America hit a somber benchmark in the coronavirus pandemic, with the U.S. death toll reaching 100,000. USA TODAY
Doctors, scientistsand epidemiologistshave made strides in their research to learn what they can about SARS-CoV-2and the illness it causes, COVID-19.
Multiple vaccines are in different stages of development asinstitutions scrutinize the effectiveness of existing drugs to treat coronavirus patients in clinical trials. Social distancing restrictions and lockdown measures have flattened the curve in parts of the country, and states have begun reopening in phases.
But experts say that there's more to learn about the virus, and as theUnited States surpasses 100,000 deaths, many wonder if that learning curve is just too steep.
The loss is staggering:Honoring the 100,000 lives lost to the coronavirus
Lets take a moment to honor the lives of those we have lost, and begin to comprehend the wound they leave behind.
These are the top 10 questionswe hope to have answers to in the next 100 days.
This is the number one No. 1 question on everybody's mind. Unfortunately, the answer is complicated.
President Donald Trump announced this month the launch of Operation Warp Speed,a government coordinating effort aimed at securing acoronavirus vaccine by the end of the year.
But vaccine experts have consistently urged caution in presuming a vaccine will be available soon. The White HouseCoronavirus Task Force's Dr. Anthony Fauci has said that a vaccine islikely within the next year or two, and the process takes time.
"You can rush vaccine development,but only when you understand theres no way around it you are trading safety for speed," saidDr. Greg Poland, director of the Mayo Clinic's Vaccine Research Group.
Oxford University in England andMaryland-based vaccine company Novavax seem ahead of the global race as their vaccine candidates have shown success in animal trials.
But many experts say the process will be even longer as mass production to make the vaccine widely available to everyone at once is nearly impossible. The government will be forced to decide who will receive the vaccine first and allocate doses accordingly.
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While testing has accelerated since the Centers for Disease Control and Prevention stumbled in its initialrollout, it's still not perfect.
Many parts of the country still reserve tests only for patients who present symptoms.
"If you are symptomatic with a respiratory illness, that is an indication for a test and you can get a test. If you need to be contact traced, you can get a test," said Adm. Brett Giroir, the assistant secretary for health at the Department of Health and Human Services.
But studies have shown that many infected people never present symptoms, and public health experts have called for enough testing to reveal the asymptomatic carriers of the disease.
Trump said 300,000 tests are now being donenationwide every day. But last week, areport from theHarvard Global Health Institutefound that the U.S. should be doing 900,000 tests a day by May 15 to safely reopen.
According to their model, more than 40 states have not reached the level of testing needed, including four Colorado, Florida, Georgia and Texas that have already reopened.
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Experts say people should be careful about how they interpretresults of COVID-19 antibody teststhat haven't been validated by government regulators asmanufacturers flooded the U.S. market withtests that vary widely in accuracy.
The U.S. Food and Drug Administration made therush to market possible by allowingCOVID-19 antibody test manufacturers to self-validate their products without first submitting the data to regulators.
Amid criticism of that policy, theFDA changed coursein early May. Citing unnamed unscrupulous actors marketing fraudulent tests, the agencysaid manufacturers must meet new accuracy standards and submit proof of testing quality.
At that point, the FDA had given emergency use approval to 12 out of more than 200 antibody test manufacturers.The FDA is working with other government officesto assess the performance of antibody tests. Results have not been made public.But even if antibody testing gets more accurate with the FDA's new guidelines, experts still can't confirm the presence of antibodies mean immunity to the virus.
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As experts race to find a treatment for COVID-19,the experimental drug remdesiviris showing some promise. Data from a global study released at the end of Aprilfound patients given the drug recovered faster and may be less likely to die.
The study, conducted by the U.S. National Institute of Allergy and Infectious Diseases, found patients who received remdesivir had a 31% faster recovery time than those who received a placebo.
Remdesivir is an experimental antiviral drug from the American biotech firm GileadSciences. It was originally tested as a treatment for Ebola and other coronaviruses including SARS and is now being tested as a possible COVID-19 treatment.
Many scientists caution, however, against drawing any conclusions about remdesivir and say other recent studies found no clinical benefits to the drug.
As coronavirus spreads, people are getting more cautious and creative with their social interactions. USA TODAY
Convalescent plasmaandimmunomodulators liketocilizumabhave been given to patients with COVID-19 in clinical trials, but remdesivir is the only treatment that has been shown tohave even a potential effect on the disease.
Trump confirmed to reporters May 18that he hadbeen taking the anti-malaria drug hydroxychloroquinedaily for the past week and a half;however, there has been no solid evidence ofthe drug's effectiveness. In fact, doctors caution against using hydroxychloroquine outside of its intended purpose or in clinical trials as the long list of side effects can be harmful.
Concern for reinfection was initially raised after reports out ofSouth Korea that some people were becoming reinfected with SARS-CoV-2, the virus that causes COVID-19.
The countrys Centers for Disease Control and Preventionreported more than300 such cases.South Korea has one of the worlds most extensive COVID-19 testing programs, so its data is considered strong.
South Korean researchers now believe theywere seeing false positives, in which the tests detected old particles of virus in patients no longer causing disease,Reuters reported.
Its still not known whether having had COVID-19 gives long-term immunity to the virus, but immediate reinfection is now less of a worry.
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As states gradually reopen, the questionthat loomsin the coming weeks is whether increased resident mobility leads to a surgein new coronavirus cases.
Texas could be a telling case. The state became one of the first to take aggressive measures, allowing restaurants and retailers to reopen to limited customer capacity May 1. On May 14, Texas reported its highest single-day increase of new cases, with 1,448,according to the Johns Hopkins University data dashboard.
Fauci, director of the National Institute of Allergy and Infectious Diseases, warned May 12 in a Senate committee hearing that reopening the country amid thecoronavirus pandemic may lead to "some suffering and death."
But experts say it'sunlikely we'llsee a rise in cases in the next few weeks as states reopen for the summer. Officials say we'remorelikely to see that surge in late summer or fall because the coronavirus incubation spans from about five days to 11 days.
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Even as states reopen, officials warn residents that life won't be as they knew it.
Instead, they should expect a "new normal" where sports stadiums remain emptyand national parks offer limited services for their visitors.
TheTransportation Security Administration announced changes to its screeningprocess to include social distancing measures, relaxed carry-on liquid requirements and boarding pass etiquette.
Restaurants were forced to think creatively as they reopened. Some are allowing customers to sit outside on their deck or patio at 50% occupancy. Cities in Florida, Nevada and Maine temporarily closed their streets to allow diners to eat comfortably and safely on the street.
A restaurant in Ocean City, Maryland,created special tables with oversized inner tubes to keep all clients at least 6 feet apart.
"It's like a bumper boat, but it's actually a table," owner Shawn Harmon said. .
The health care landscape has drastically changed since the pandemic arrived in the United States.
Doctors restructured office waiting rooms and now greetpatients who are daring enough to keep regular visits wearing masks. Hospitals cut elective surgeries, limited visitors and scrambled to provide protection for workers.Tests and annual checkups have been postponedor converted to virtual visits.
Precautions affectingthe way most Americans access basic health care are expected to last. Without a vaccine not expected even optimistically until sometime next year the risk of transmitting thevirus that causes COVID-19 remains high.
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So what will the future of medicine look like as the U.S. adapts to the new pandemic landscape? Expect more remote doctor visits, tenuous hospital care in rural areas and increased preparedness.
For years, weve talked about the promise of telemedicine and its opportunities, said Mark Holmes, professor at University of North Carolina Gillings School of Global Public Health. But what the last two months has shown us is that it could really be a game-changer.
Elections are still being heldthroughout the country even as the threat of infection looms over the heads of voters.
Wisconsin's Supreme Court overturned the state's stay-at-home orders, and April's primary resumed;some voters stood in line for hours in the midst of a pandemic.Thousands of absentee ballots either werent sent outor ended uplost in the mail, and others were returned too late to be counted.
Five states allow voters to cast their ballots from home in all of their elections: Colorado, Hawaii, Oregon,Washington and Utah.Those states send registered voters a ballot at least seven days before an election tofill it out at their convenience, and voterseither mail it back or drop it off at any center that's closest to them.
While a vote-at-home system may be more efficient overall, the startup costs of implementing itcould be substantial. But experts say theymay becheaper over time as the cost of poll workers are much lower.
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And so far, states that use vote-at-home have seen increases in turnout.In a 2019 studyof Utah, 21 out of 29 counties conducted general elections by mail. Voter turnout in that 2016 election was 8.7 points higher in the counties that implemented vote-at-home than in those that had not.
Trump has repeatedlytweeted his oppositionto such plans and just this week threatenedto cut off federal fundingto two states, Michigan and Nevada over mail voting. Trump and other Republicans have argued that a vote-at-home system has tremendous potential for voter fraud.
But advocacy groups such as the National Vote at Home Institute and the Brennan Center for Justice strongly dispute suchclaims.
Before the outbreak, the U.S. Census Bureau had planned to hire as many as 500,000 workers to knock on doors and get households that didn't respond to answer the survey.
While those hiring efforts are underway online, the agency was forced to suspend field operations in March and only recently restartedthose operations in phases. As of May 18, a handful of Area Census Offices made the list.
Agency officials continued to urge people to respond to the Census online, by mail or by phone. Invitations to respond started arriving in households last week.
"We recognize that many people plan to access the 2020 Census through other response modes, such as phone or paper, which is why the 2020 Census has such a nimble design,'' the agency said in a statement.
Plans forthe nationwide count have been underway for years. The population survey is key to apportioning Congressional districts and determining the distribution of billions in federal fundsforschools, infrastructureand health systems.
Contributing: Deborah Barfield Berry,Elizabeth Weise, William Cummings,Kevin McCoy, David Heath, Joel Shannon, Lorenzo Reyes and Doyle Rice, USA TODAY; and Patricia McKnight, Milwaukee Journal Sentinel. Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
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