The Race to Develop a Coronavirus Vaccine

Researchers around the world are toiling to develop a vaccine for the coronavirus. But the creation of a working vaccine that can be safely distributed to a broad population requires a tremendous amount of rigor and caution, so the process is likely to take at least a year. WIRED staff writer Megan Molteni has covered the novel coronavirus outbreak since the virus was first identified in early January. This week on Gadget Lab, we talk with Megan about where our efforts to make a vaccine currently stand. We also discuss why it’s been so difficult to get Americans tested for the coronavirus.

Read more about the search for a coronavirus vaccine here. Read more about testing here. Also read Maryn McKenna on the potential dangers of rushing out a vaccine. Follow all of WIRED’s coronavirus coverage here.

Megan recommends Bon Appétit’s Test Kitchen Talks video series. Lauren recommends Medea Giordano’s story about nonprofits, charities, and companies helping people in need during the pandemic. Mike recommends an episode of the Under the Scales podcast with writer Jesse Jarnow.

Megan Molteni can be found on Twitter @MeganMolteni. Lauren Goode is @LaurenGoode. Michael Calore is @snackfight. Bling the main hotline at @GadgetLab. The show is produced by Boone Ashworth (@booneashworth). Our executive producer is Alex Kapelman (@alexkapelman). Our theme music is by Solar Keys.

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Michael Calore: My cat is right here. I don't know if you can see her, but she's watching me.

[Intro theme music]

MC: Hi, everyone. Welcome to Gadget Lab. I'm Michael Calore, a senior editor here at WIRED. I am joined as always by my cohost, WIRED senior writer Lauren Goode.

Lauren Goode: Hello. This week you did not say that I'm there with you, or I'm joined here, because I think at this point our audience can officially assume that we are all recording this remotely, and at this point we'll notify you when that change,s if we somehow end up in person in studio again, but thanks Mike. It's great to be here again.

MC: And thank you for being here Lauren.

LG: Absolutely.

MC: We're also joined this week by staff writer Megan Molteni, who covers public health on the science desk here at WIRED. Megan, welcome back to the show.

Megan Molteni: Thanks for having me. Wish it were under better circumstances, but happy to be here wherever that is.

LG: Likewise.

MC: And thank you for joining us from your cloffice, your closet-office at home. We're lucky to have Megan with us this week because she has been covering the spread of the coronavirus ever since it was first identified in China back in January. Later on in the show, we're going to talk about the state of coronavirus testing in the US, but first we're going to focus on the ongoing search for a vaccine. We're going to look at what it takes to make a vaccine, who's working to create one, and why the process takes so long. Megan, let's start with the latest. We're recording this on Thursday, April 9th. Where do things currently stand with vaccines in this country?

MM: Yeah, so currently there are no approved vaccines against the coronavirus that causes Covid-19, but there are a handful that are already being tested in humans, and there are dozens more that are in earlier stages of development. So, vaccines all work on the same basic principles. Scientists try to make something that closely resembles a pathogen and then expose a person's immune system to it through a small dose administered usually as an injection, and ideally the immune system then develops a strong memory of that pathogen. So, the next time the person is exposed, their body will mount an attack before the infection can take hold. And the trick to doing this is to do that without making the person seriously ill from the vaccine itself. There are a few different methods for making vaccines, but they all have to strike this delicate balance of providing protection without actually making a person sick.

LG: So Megan, how did these efforts that we see right now to make some type of vaccine that can address Covid-19, how does it compare to prior efforts both in the US and globally to develop vaccines for some type of novel or relatively new disease?

MM: Yeah, this is the fastest that vaccines have ever gotten off the ground and then injected into humans, after the identification of the virus. So, this virus was sequenced in January, and it was already being tested in humans on March 15th. So, actually about two months, and that's actually pretty astonishing. And the reason for that is twofold. One of them has to do with just the fact that China was able to quickly identify the virus itself to sequence it. And that has to do with improvements in sequencing technologies, but it also has to do with the technology of the vaccine itself. Historically vaccines have consisted of either killed or weakened versions of a disease-causing a virus. Scientists have also started using just bits and pieces of a virus which they can produce inside genetically engineered bacteria and yeast. So, researchers at the University of Pittsburgh and Baylor College of Medicine in Houston used that technique to make a vaccine against SARS, which is a related virus.

And they now have an experimental vaccine that uses this technique, but they're waiting on permission from the US Food and Drug Administration to begin testing in people. The vaccines that are already in testing actually skip that step. So, what they do instead is they inject a little bit of the virus' genetic material, which codes for the protein that the virus uses to infect human cells. And the idea is that anyone who gets this vaccine, their body then absorbs this little bit of code, and some of their cells will then produce that single viral protein. And what should then happen is it should trigger their immune system to make antibodies that recognize it. And if all of this goes well, then those antibodies should theoretically protect those people from the real virus if they ever get exposed. And so, in the US, there's a Boston-based company called Moderna, and they started dosing patients with this vaccine March 15th, as I said earlier. And then there's another one developed by Inovio Pharmaceuticals, and they began injecting their first volunteers on Monday. Neither company has ever had a vaccine like this approved before. So it's really promising, and it can move really fast, but it's as of yet still untested technology.

MC: So even though things are moving quickly, as you say, we've heard time and again from our political leaders, from the reporting that you and your colleagues have been doing, and from the scientific community that a vaccine is going to take somewhere around a year to 18 months to be produced and be sent out to the general population. So how do these tests that you're talking about that are happening right now fit into that timeline?

MM: There's three phases typically of these human trials. The ones that have just started are what we call safety trials, they're phase one. All they're designed to do is just figure out if when you inject this into a person, does nothing bad happen? Subsequent phases are going to involve more people, and those will give scientists more statistical power to build a measure if the vaccine is actually working to prevent future infections. But then once you've done that ... So, that can take six months apiece, they're usually done one after the other, but then you've actually got to make the vaccine, distribute it, and that can take a lot of time to ramp up production. You have to build out these manufacturing facilities. Typically, the FDA also has to review all of the data that you've generated in these clinical trials.

That review process can sometimes take a year, but like we said, these are really atypical times. So, the FDA has been committed to speeding up that review process to move things along sooner. Just this week, Bill Gates announced that he's committing billions of dollars to building out manufacturing facilities for up to seven of the leading vaccine candidates. And what's important to remember is that it's likely they're not all going to work. The way these things work is that often you have to try a bunch of different things to find one that works, but what that means is that any of the ones that do actually seem to show good efficacy can then be cranked out right away and distributed. So those are the kinds of levers that can be pulled right now to try to speed this up.

LG: Megan, talk about this movement that has gotten a little bit of attention, there's certainly been some reporting on it, to have young people just be volunteers as part of this process. What are the ethics behind that? Are young people really showing to be any more protected than older people? Talk about that a little bit.

MM: This notion that you've brought up of doing these challenge trials, that's where you round up healthy young adults who are willing to volunteer to get the vaccine and then to be exposed to the virus in a controlled setting. It raises some ethical concerns specifically with this virus, because it's so new that there's a lot that we still don't understand about what puts some people at higher risk than others. There's a wide range of symptoms that people experience with this disease that range from mild to deadly. And we know that older age and underlying health conditions can make people's outcomes more grim or more deadly. But in the US, at least 750 people younger than 50 have already died from Covid-19, so there's a lot that we still don't really know. And so, asking people who might seem young and healthy now to volunteer for that, making sure that they're properly informed of the true risks, brings up some questions about whether we can really ask them to do that. Especially when you consider that they may see themselves as holding the weight of the world on their shoulders, almost literally.

MM: They may feel like this is something they have to do, and that may make it more difficult to weigh the risks in a responsible way. But there's a particular need to do trials that either go on long enough that people get exposed to the virus in the wild or that they get exposed in the lab. And that's because this coronavirus in particular belongs to a family of viruses for which we have to be concerned about something called antibody-dependent enhancement. Sometimes also called vaccine-induced immune enhancement. It's basically a phenomenon where the vaccine could actually make immunized people more susceptible to severe forms of the disease. This actually happened with SARS vaccines back in the mid 2000s, where animals that the SARS vaccine was tested on experienced worst symptoms if they had had the vaccine than if they hadn't. And like SARS, the worst symptoms of Covid-19 are thought to be caused not by the virus itself, but by an exaggerated immune response. So, researchers like Peter Hotez at Baylor College of Medicine has said that any trials really need to follow patients long enough to observe what happens when they get exposed to the virus to make sure that none of these vaccines have those negative effects.

LG: Do we have any sense right now if a vaccine is developed and proven to be effective, how long it will be effective for?

MM: That's a really good question that we don't know the answer to, and the reason we don't is because we don't really understand how long immunity lasts for a natural exposure to this disease. Some of the best data that we have comes from researchers who studied how long antibodies to SARS stuck around, and at least the preliminary data on those studies suggests that it could be up to three years. But we do know that for other families of coronaviruses that are endemic in the human population, we don't carry a lifelong immunity to them. We're probably looking at something that's in the years range, but probably not forever. So, people who are thinking about making vaccines are definitely considering the possibility that people will have to get booster shots periodically going forward.

MC: Let's talk about herd immunity, a term that many of us have heard, but maybe fewer of us actually understand. How does herd immunity come into play in the fight against this coronavirus?

MM: Herd immunity is when enough people have immunity to the virus that they're able to form a protective wall around people who remain vulnerable. So there's two ways to do that, either with natural exposure out in the environment or a vaccination campaign. And what we're really looking to do to be able to restart society, if we don't have a widely available vaccine, it's going to start little by little with people who've been exposed naturally. Once we have a vaccine that works and we can roll it out on a larger scale, then we're looking at trying to reach something like 80 percent, 85 percent of the population either receiving a vaccine or being able to demonstrate that they have antibodies against the coronavirus. That will give us enough protection that if a new case is imported from somewhere else, from some other hot spot, that there will be enough who are not able to get infected, that the virus doesn't spread through the community at the exponential rate that we're seeing right now.

LG: Megan, I think we're going to take a quick break shortly and then come back to you for the second half of the show. But I did want to ask you quickly about antibodies, because we're hearing a lot about this at the same time that we're hearing about vaccine development. And I imagine that there's some confusion for people who just are generally thinking about this as a cure for coronavirus. And of course, we know there is no cure currently, but what are the basics that people need to understand about the difference between blood plasma donations and how antibodies might help us counter the effects of coronavirus and what a vaccine would do?

MM: Yeah, that's a really good question and an important distinction to make. So, the antibodies that people would be receiving through a plasma donation would be from someone who has already been exposed to the virus. Those antibodies can prime that person's immune system and help them fight off the virus. So we should be thinking about it as a treatment. Those antibodies aren't going to last forever, they're going to eventually get broken down by that person's body. In order to have longer-lasting immunity, that person needs to have what are called B cells or memory cells that are actually producing their own antibodies. And that's a different process. That would basically involve either having a vaccine or being exposed to the virus directly to jump-start that pathway. So when we're talking about antibodies received through a plasma donation, think of it like a treatment that's on the order of—I believe we're talking about days to weeks

LG: Got it. Thank you for explaining that.

MC: All right, let's take a quick break and then when we come back, we're going to talk about testing.

[Break]

MC: Welcome back. While developing a vaccine for the coronavirus may be a drawn out, complicated effort, developing a test for the virus is much easier—or at least it should be. But there's been a shortage of tests here in the United States and issues with the reliability of tests on top of that. Megan, can you tell us why are we having such a difficult time with testing?

MM: Man, I wish I had an easy answer, but every week it's really something new. At first the bottleneck in testing was that the FDA had only approved a single testing protocol in the US, which was a test developed by the CDC in Atlanta. And what happened was, that test relies on a technology called RT-PCR, which has to happen in a lab. You have to have a PCR machine, you have to have people who know how to use it. And at first the CDC was the only lab that was doing that testing. After the FDA approved the CDC protocol under this emergency-use authorization, then the test from the CDC went out to all the public health labs in the US. Then there turned out to be a problem with those test kits; one of the reagents had an issue. It was not coming up with the right results, so that slowed things down a bit as well. Once the CDC issued new test kits, those went back out to the public health labs around the states, and they started trying to ramp up their production.

But by then there was a growing need for more testing capacity and growing pressure on the FDA to loosen its regulations. So then what the FDA did was say basically, anyone who has a certified lab in the US, if you're running one of these protocols, you can go out and do that with the FDA's blessing. Just make sure to send them your validation data within 15 days. That allowed these big testing labs like Quest and LabCorp to get into the game, and it made people optimistic that we were going to be able to test a lot of people. But what happened somewhat predictably is that there was a huge crush of demand from all of the hospitals all over the US that were already starting to see a large number of cases. And so a huge backlog developed at these big corporate labs.

The backlog we believe is because of reagent shortages, and there not being enough swabs. I think there weren't enough test tubes to hold the swabs. It's like every time you get one reagent, something else goes out. In the same way that we've seen states bidding against each other to get PPE, a lot of these labs are competing against each other on the market for all of the materials that you need to run these tests. A number of academic labs have also jumped into this testing race. We profiled a group at UC Berkeley a week or so ago that was ramping up to about 4,000 tests per day. They're being hampered by a completely other set of bureaucratic red tape, which is that the software that hospitals use to order tests and report back patient results aren't compatible with these academic centers, and it would take too long to get the right software vendor and basically make them interoperable. So now we have a number of academic centers that are able to contribute thousands of tests a day, and they're not being used because of that. So I think, all in all, people would say that a lot of these issues come down to a lack of coordination from the federal level to make all of these things run smoothly and be able to get tests out to people who need them.

MC: So, what about at-home tests? There's been a lot of talk about this, and I've actually seen some video and some photos of the tests being done. It looks like it involves a very long needle swab that goes uncomfortably far up into your nasal cavity. Will people really be able to get good samples if that is the test you need to do? Because it looks pretty unpleasant.

MM: There are definitely some concerns that these tests will not meet the kinds of standards that we need for getting samples that will be able to produce the right kinds of results. It's crucial not only to test people at the right time in the course of the infection, but also to get the sample from exactly the right place back in your nasal passages. That being said, at-home testing appears to be up in the air at this point. During the week of March 16th we heard from a number of companies that they were ready to distribute at-home tests. Those companies believed that they were operating under the FDA's emergency-use guidelines. But then a couple of days later, the FDA issued a warning letter against those companies, basically saying that those tests couldn't be authorized under that same guideline. And so now the FDA is working with those companies to develop a test that can be done at home. My understanding is that right now there are no home tests that are currently available by the FDA, and any that you might buy would be treated as fraudulent, since they are technically unauthorized under this emergency-use guideline.

LG: Megan, the recurring theme I'm hearing here is that there is an incredible lack of coordination happening at the federal level, and so a lot of the coordination we're seeing around Covid-19 is happening at the state level or in the private sector or in this case in specific labs. And I'm wondering what this means ultimately for the data we may or may not get around how many people in our country have this novel coronavirus. If testing efforts are happening on a state-by-state level or even a county-by-county level, what idoess that knowledge or lack of knowledge mean for the future about how we can actually address this pandemic?

MM: Yeah, I think it's a worthwhile question, and it's one that I posed to the head of the Association for Public Health Labs a few weeks ago, when a number of these tests were starting to come online from private labs and now these academic labs. About the ability to compare results across these different kinds of tests, and they all have different levels of specificity as well as sensitivity. So, how much virus they can pick up and how sure they are that what they're picking up is the right virus. At the time, what I was told was that it was more important to have tests out there, however they worked, than being worried about different levels of specificity or sensitivity from test to test. And I think we're still in that place where we're testing so few that we really don't understand where we are in the course of this epidemic specifically.

In the US, you have to think about testing is like looking back in time. It takes time for symptoms to develop, it takes time for test results to come back. So, when we see these numbers of new cases coming in every day, you can think about it as the number of people who got sick a week or 10 days ago. But we still don't have a good picture of who's gotten sick in the meantime. And there are reports, especially in New York where we're seeing that there are not enough tests available to test people who've died in the hospitals or people who've died in their homes. And so, there's a lot of ways in which the tests are just missing people across the board. And I think that's a much bigger concern than whether we're seeing a higher number of false negatives in some tests than others.

Obviously, that can be a problem if you have a false negative and then you go out and you infect a bunch of other people. But since most of us are in shelter at home situations right now, it's less of an issue. And I think the bigger issue is that the lack of testing overall, it certainly doesn't allow us to do contact tracing and it doesn't allow us to know how much of the population has really been exposed to this at this point. And that's the information we need to understand both to be able to allocate resources on this rolling basis as these outbreaks continue to develop new hotspots, and also to think about how we start to get people back to work.

LG: Right, and quite obviously this also will feed misinformation narratives as well because over the past few days we've seen how some pundits have suggested that the number of deaths is being over reported and that everything is leveling off. And it's this example of how partisanship is actually colliding with real science. Because as you mentioned, without the tests, we don't know exactly how many people who are dying in their homes right now or who are even dying in hospitals that are completely overwhelmed, how many people are being killed by coronavirus. And in reality, the numbers may be under reported at this point, but we're not going to know that without tests.

MM: Yeah, some epidemiologists I follow on Twitter talk about how as testing capacity in the US has ramped up more slowly relative to the number of cases that we're seeing, we're actually hitting or near to hitting a point where the number of cases are actually completely exceeding our ability to test. And so, when you see these leveling off, it may not truly represent that cases are actually falling off and that we're actually flattening the curve. But in some places at least, it may just represent that we have run out of the ability to test in that area and that there are actually many more cases that are not showing up in the data, right? So yeah, I think we're still in the moment of test, test, test, and I would say we'll still take whatever tests we can get.

MC: Are there any tests that exist for determining whether you had Covid in the past?

MM: Yeah, so these are what we call serological tests or antibody tests. And so, unlike the RTPCR tests, these tests don't measure active virus replication going on, but they measure the level of antibodies you have to the virus. These kinds of tests have just started to arrive, the FDA authorized its first one last week. My understanding is that the company that was authorized, Cellx, is in the process of getting 100,000 test kits shipped from China to New York City. There are at least 100 other companies that are asking the FDA to approve their antibody tests for emergency use. So, we may see more of those entering the market soon. I know that as of last week, 70 commercial labs had also notified the FDA that they have antibody tests available. As of yet, these tests are still tests that need to be ordered from your doctor.

If you had something in February and now you want to get that test, it's unlikely that you'll be able to at least at present time until more of these tests start actually hitting the market. But there are researchers at a number of academic centers that have already started experimenting with the serological testing. So, Stanford for example is collaborating with the Santa Clara County Department of Health to administer these tests to healthcare workers, so people can know if they have been exposed and have antibodies and can go back to work. So, I think this is a real area that people are trying to push forward and companies are trying to push forward right now, but I would say it's not something that's going to be available to the average person probably on the order of weeks to months.

MC: Well, Megan, thank you for joining the show this week and giving us all of this great information that people can hopefully use to help them navigate the medical frontier that they may be encountering soon. Although we hope that everybody is staying home and staying safe. We're going to take a quick break and then when we come back, we will do our recommendations and you're going to join us for that, right?

MM: Yeah.

MC: All right. We'll be right back.

[Break]

MC: All right, everybody, welcome back. Megan, guest gets to go first. Please tell us what is your recommendation for our listeners this week?

MM: Yeah, my recommendation, probably like a lot of people I've been cooking more at home, so I've been crushing Bon Appétit's YouTube channel. Specifically their series "Test Kitchen Talks." That's all your Bon Appétit folks making one thing. My favorite episode is when they all make their favorite egg preparations. There's this restaurant I love in Minneapolis called Grand Cafe, where they make this silky French omelet that literally brings me to tears and I'm so sad that I have not been able to eat it. And so, I've been trying to make it at home and it has been just a miserable failure after miserable failure. But I finally watched the episode where Sohla makes it and I think things clicked. I think I'm ready to try again. And the cocktail episode is pretty banging too, so I would highly recommend that for all your quarantine cooking.

MC: Nice. I like the solid shout out for our homeys over at Bon Appétit, the fellow Condé Nast brand.

LG: Yeah. Also, quarantine staples, right? Eggs and cocktails. What else do you really need?

MM: Literally nothing. Toilet paper.

LG: And toilet paper, yes. Maybe yeast.

MC: Lauren, what is your recommendation?

LG: My recommendation is our colleague, Medea Giordano, wrote a round up of all the nonprofits and companies that are helping people, either healthcare workers in the frontline or senior citizens who can't necessarily go out and do grocery shopping themselves. And it's a really comprehensive list, she includes of course mentions of organizations that we're all familiar with like Oxfam and the World Health Organization and The Red Cross, but also the World Central Kitchen, specific disaster relief funds. She goes through all of the grocery stores like Trader Joe's, Stop and Shop, Costco that have specific senior hours, so that people can go shop early and when things are less crowded. She also covers a bunch of different companies in the private sector that are pivoting, if you will, to helping make masks or are donating masks.

She wrote this ... Let's see, now it's been a week, feels like eight years of course, every week now feels so long. So, some of this has changed or evolved already, but it's just a really good comprehensive list if you were looking to help out people in some way or if you just need a break perhaps from some of the more dire news and just want to see how people are trying to do some good in the world right now. So, I recommend checking that out. The article is called "The Nonprofits and Companies Helping to Fight the Pandemic" by Medea Giordano and we'll include this in the show notes as well. Mike, what's yours?

MC: I am going to recommend a podcast episode of the show Under the Scales. It's on the Osiris network, which is a jammy music network of podcasts and Under the Scales is co-hosted by the lyricist for the band Phish. His name is Tom Marshall, so a content warning, I will be talking about the band Phish for the next 30 seconds. He has a show where he interviews prominent people in that scene and last week's episode featured Jesse Jarnow the writer, you may know him from WIRED, you may know him if you're in the Phish world or if you're just in the music world. Jesse talks a lot about his experience as a music writer, as a journalist, how he got into writing about music, why he writes about music, specifically why he writes about the topics that he writes about, which is Yola Tango, The Grateful Dead, Phish, the whole underground scene that revolves around that world. Jesse is a sweetheart. I'm his editor at WIRED, so I'm a little bit biased, but he's an excellent writer and it's just really refreshing to hear somebody talk about their profession passionately. So, I recommend that. Under the Scales, the episode that interviews Jesse Jarnow. Whether or not you like jam band music, it's still a good interview, I promise.

LG: Mike, that is both very on-brand and also, you're breaking away from the trend because Megan and I both recommended Condé Nast content, but that's okay. We forgive.

MC: Well, it's kind of Condé Nast because Jesse writes for WIRED quite often.

LG: That's true. He's a great writer.

MC: All right. That is our show for this week and I want to note that this is a milestone episode. It's number 450 which is just bananas if you think about it. Thank you Megan for joining us for this very big number.

MM: Thanks Mike and Lauren for having me.

MC: Of course, and we hope to have you back soon under better circumstances. Thank you all for listening. If you have feedback, you can find all of this on Twitter. Just check the show notes. This show was produced by Boone Ashworth and our executive producer is Alex Kapelman. Thank you and we'll be back next week.

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