• Previous research on SARS and MERS vaccines provided a head start for scientists working on the development of a vaccine for COVID-19.
  • The coronavirus vaccine likely won't be ready by winter, when a combo COVID-19/flu season is predicted to strike.
  • FDA authorization of a vaccine isn't the same as FDA approval, and rush authorization comes with lower standards of validation and research.
  • Point-of-care antibody testing that gives results in minutes is critical but such tests must be carefully validated for accuracy before they're made available to the public.

Video Transcript

JOHN WHYTE: Welcome to "Coronavirus in Context." I'm Dr. John Whyte, Chief Medical Officer at WebMD. There's a lot of talk about the vaccines and when they might be coming-- do we wait with our mitigation strategies until we have a vaccine? To tell us what's really going on with vaccine development, I've asked Dr. William Schaffner to join us. He is a professor of medicine in the Division of Infectious Disease. He's a professor of health policy and preventive medicine as well at Vanderbilt University. Dr. Schaffner, thanks for joining me.

WILLIAM SCHAFFNER: Good to be with you.

JOHN WHYTE: Let's start off with-- everyone is saying it's 12 months, it's 18 months until we have a vaccine. Realistically, how long does it take to develop a successful vaccine?

WILLIAM SCHAFFNER: Under normal circumstances, it can take up to a decade, but we had a head start here because the scientific backbone of this vaccine, at least the vaccine candidates that are out there, had already been established because people had worked on a SARS vaccine and a MERS vaccine. So they took that scientific homework that they had done and immediately began applying it to developing a coronavirus vaccine.

JOHN WHYTE: But in SARS, they stopped after a while when it went away. And viruses in general have been particularly challenging to get right-- the first, second, or third time. Look at where we are with shingles. We have challenges with HPV, HIV, influenza every year. Why now do we think we'll get everything right from the beginning?

WILLIAM SCHAFFNER: Well, I'm not so sure all of us think it will go in such a straightforward manner. We always have our fingers crossed in science. That's why they call it research instead of search.

JOHN WHYTE: That's a good point. That's a good point.

WILLIAM SCHAFFNER: As one of my friends likes to say. But in any event, there was sufficient experience with both SARS and with MERS so that people had a degree of confidence that this was a vaccine which, if they could get it together and it didn't have any unexpected adverse events, likely would be protective if it were used in coronavirus. So there was a kind of-- we started with a little more optimism than we usually have.

JOHN WHYTE: All right. Now, Dr. Gottlieb, former FDA commissioner, says we might have one available by the fall. Is that realistic?

WILLIAM SCHAFFNER: I think Dr. Gottlieb may be thinking about a British team that's working on a vaccine. They also had the backbone-- the scientific backbone of the vaccine well established. And they have told us that they are pushing their clinical trials with great intensity and likely would start manufacturing the vaccine even before the last clinical trial is finished-- the whole idea being we have so much optimism that we think we know what the results are going to be, and they're going to be good, if we start manufacturing the vaccine before the trial is finished, when the trial is finished, we'll have a lot of vaccine ready to go to put in arms.

JOHN WHYTE: But it's a big guess to get it right, because we sometimes make mistakes with influenza every year. So we are assuming that the stars are aligning to make some conclusions before we have all the data so we can start manufacturing.

WILLIAM SCHAFFNER: They're standing at the scientific roulette wheel, and they're pushing a lot of their chips onto the table. It's only money. If it doesn't work, well, we'll burn the vaccine and start over. I'm being a little bit--

JOHN WHYTE: I know.

WILLIAM SCHAFFNER: Frivolous. But the notion is that this is such an important problem, it's such a morbid problem, right, it's killing so many people that we need a vaccine in order to turn off the coronavirus. And we're really pushing our financial chips onto vaccine, and we're ready to make the bet that the vaccine is going to come out right. And we want to start administering it, we want to start putting it in arms just as soon as we get what we hope is a good result.

JOHN WHYTE: But every drug has risks and benefits. We know in the past with vaccines-- and we won't have all that post-market surveillance that otherwise, you know, we'd like to see to some degree. What are the risks, you know, in terms of vaccine issues?

WILLIAM SCHAFFNER: As with every new product, whether it's a drug or vaccine, there can be rare unintended effects-- side effects of the vaccine. And I know that here in the United States, and I suspect in the UK also and other countries, we will set up a surveillance system looking for potential adverse effects, and we'll have the analytical background to try to distinguish those from events that would have occurred anyway-- you know, just part of the background. So we'll be looking at that with great care.

JOHN WHYTE: I'm going to put you on the spot, because a lot of policy folks want to tie social distancing and mitigation strategies to the vaccine. And in many ways, they do have a very optimistic perspective. But are there concerns with saying we have to continue some intensity of mitigation until we have the vaccine? Should these be two different conversations? Because we do need a vaccine, absolutely. But if we're saying-- so what if it's three years? What if it's four years? We don't get it right the first time. What impact does that have?

WILLIAM SCHAFFNER: Well, if it's going to take three or four years for us to develop the vaccine, then that's clearly-- all of us--

JOHN WHYTE: Effective vaccine.

WILLIAM SCHAFFNER: --are in for the long haul, right? And we're going to have to maintain some mitigation activities regardless. Actually, there are some people who already think that the wearing of masks, social distancing, attention to hand hygiene-- that may come up again this flu season when, of course, we may anticipate getting more coronavirus again. And the question has been raised, gee, you know, they wear masks a lot in Asia. Why don't we start adapting that as a fashion-forward thing to do in the wintertime here in order to prevent influenza as well as coronavirus? So I think some of these mitigation efforts might well carry over to some extent.

JOHN WHYTE: Do you think we're further along in countermeasures-- different treatment options-- than we are in vaccines? Meaning we have a bunch of different potential agents.

WILLIAM SCHAFFNER: So we have clinical trials underway with vaccines and simultaneously with treatments. And we anticipate that within a period of a couple of months, some of these treatment clinical trials will have early data that will come in that will guide us much better in our treatment enterprises than waiting for the vaccine. The vaccine will take longer than getting information about the treatments, I think.

JOHN WHYTE: Are you concerned some of the trials aren't well-controlled and we have a lot of anecdotes and then social media promotes individual results?

WILLIAM SCHAFFNER: I think we can-- probably most of us agree that clear communication about many things about this coronavirus outbreak has not been characteristic. We need much more clear communication. Anecdotes are important. They get us excited. They raise the possibility of a good effect. But then we need evidence-based medicine so we can tell patients what they can expect and what side effects associated with that treatment might occur. After all, we're giving powerful medicines to very sick people.

And as you and I have just said, there always are side effects. And so we're always trying to balance those two. And we don't want to give a treatment that doesn't work. Nobody wants to do that.

JOHN WHYTE: Do you think we've got the nature of the disease right? Because in some ways when we're thinking about these different treatments, some are anti-malarial, a lot of anti-rheumatic drugs, which, in many ways, could perhaps relate to autoimmunity, we're talking about inflammatory agents. Those aren't the typical things we talk about in terms of treatments for viruses. Do you think those could be red herrings and we need to stick to some of these antiviral agents that we're exploring?

WILLIAM SCHAFFNER: Well, so we have two concepts here. We can develop antiviral drugs that try to actually either kill the virus or interrupt its multiplication. And that's been a-- that's what we do with influenza viruses. But it's thought that this coronavirus, once it gets into the lung, evokes an inflammatory response-- an immune response on the part of the body that's an over-response. And a lot of the lung damage we see is collateral damage.

So if we could modulate that immune response, that might help us-- or help the patients-- recover from the pneumonia. And so antiviral? Yes, we're interested in that. Immune modulation? We're interested in that also. They both deserve testing.

JOHN WHYTE: We've been hearing a lot about cytokine storm that we don't typically hear about, but that could be an underlying pathophysiology as well, correct?

WILLIAM SCHAFFNER: Sure. And that's what I'm thinking about-- that cytokine storm, which is the overreaction of the immune system. It plays a role in some pneumonia's that are complicating influenza, but it seems to play a much more dominant role in coronavirus.

JOHN WHYTE: Can I ask you to take out your crystal ball? I know everyone--

WILLIAM SCHAFFNER: I'll polish it up.

JOHN WHYTE: I know everyone is asking you-- where do you think we are six months from now in terms of countermeasures as well as vaccine development?

WILLIAM SCHAFFNER: Six months from now, that puts us in the winter once again-- or incipient winter. I think the coronavirus and influenza will both be out there trying to make us miserable. Apropos of treatments, I think we'll learn-- we will have learned a lot more about what effective treatment is. I'd love it for the British to be right, that we had an incipient vaccine. But I'm not counting on that. And I think vaccine probably won't be ready to be used quite then.

JOHN WHYTE: All right. How are we on antibody testing? Are these tests accurate enough to tell us whether we have protection? Because that's really what people want to know. They're associating the results with immunity, plus or minus, in these qualitative tests. But does that mean they're protected if we have a resurgence in the fall?

WILLIAM SCHAFFNER: John, I wish you hadn't asked. So there are lots of difficulties with these antibody tests. The first is a lot of them are coming on market just now that haven't been rigorously validated. And so there are people who are concerned that they may be providing false positives and false negatives. So we need validation of the tests.

JOHN WHYTE: As you know, they've come under an authorization rather than an approval from the FDA, which allows a lower standard. People don't always know those nuances.

WILLIAM SCHAFFNER: Right. So people are worried about how accurate they are. Number two, if they do detect antibodies, are those antibodies indicative of protection? They may well measure that you've been exposed to the virus and your body's responded to it. But does that correlate with protection? I'm ready to give them that because it's such a strong tradition in infectious diseases. And maybe I'm being overly optimistic.

But then there's something else-- if you get tested and you're certified as having antibody, I think you might well be protected. But I think we're going to be surprised that the penetration of this virus into the population is less than many laypersons anticipate. I'll grant you it'll be more in New York and New Orleans and maybe Detroit than Kansas City or Nashville, but even so, I think the studies-- the population-based studies-- will show that there are still many, many more people susceptible to this coronavirus than protected. And if that's true--

JOHN WHYTE: Why do you think that if we assume a high transmission rate?

WILLIAM SCHAFFNER: Yeah. No matter how high the transmission rate, I don't think half of us have already been exposed to this virus.

JOHN WHYTE: So no Herd immunity, in your mind.

WILLIAM SCHAFFNER: Herd immunity for a respiratory virus that's this contagious--

JOHN WHYTE: Yes.

WILLIAM SCHAFFNER: You need very high levels.

JOHN WHYTE: 60%, 70%.

WILLIAM SCHAFFNER: Or more-- 80% I would think.

JOHN WHYTE: Wow. OK. And then just one more question on the antibody testing since we have you. When you're saying the testing, are you relying on a point of care test, assume it works, qualitative? Or do you want that quantitative blood draw in the lab at Vanderbilt? What are you going to rely on?

WILLIAM SCHAFFNER: I think the answer is yes. For certain academic studies, I think the syringe and needle blood specimen sent to the laboratory kind of test is important. But there will be 21st century devices-- cartridges-- so that you can do a needle prick and actually get a readout on your device within about a minute or two. And that will be very important to the patient if those devices are validated as being accurate.

JOHN WHYTE: When can we get those validated, do you think? What's our timeline on that?

WILLIAM SCHAFFNER: Some of these tests are really going to be coming out on the market in May, and we'll have to see how much work the manufacturers have done to validate them. And then some of them will be taken into the academic environment and validation studies will be done. So we'll see them coming out late spring, early summer.

JOHN WHYTE: And I hope we can follow up with you at that time. It's been absolutely terrific to chat with you.

WILLIAM SCHAFFNER: My pleasure.

JOHN WHYTE: And thank you for watching "Coronavirus in Context." I'm Dr. John Whyte.