Usually, when you run a vaccine experiment, there’s tons of red tape. There are ethical boards to consult and subjects to recruit. Then you have to convince people with money that your research is important enough to move forward at all. But now, there’s none of that. A vaccine for the coronavirus is at the top of the priority list, and everyone’s moving as fast as they can.
Dr. Kirsten Lyke is the lead investigator on COVID-19 vaccine trials at the University of Maryland’s Center for Vaccine Development and Global Health. She’s worked on vaccines for years—some have panned out, and some haven’t. She knows trials like this one can take a long time, and she also knows that the vaccine she’s testing may not work at all. But she’s optimistic anyway, and hoping to have a vaccine in just a few short months.
On Thursday’s episode of What Next, I asked Lyke how this is even possible, and spoke with her about the accelerated timeline for the COVID-19 vaccine. Our conversation has been edited and condensed for clarity.
Mary Harris: Right now, your vaccines are at the very earliest phase of human testing, called Phase 1.
Kirsten Lyke: A straightforward Phase 1 study is usually 40 to 50 subjects: volunteers who agreed to participate. And it may take anywhere from 12 to 18 months from the time we decide to do a study to ramp it up.
How does that compare with what you’re doing now?
We got a call from Pfizer around April 10 right requesting that we consider participation. We had our first Zoom meeting that Wednesday. It was essentially two weeks of round-the-clock work to get the study up and running, and then last week we put out the call to volunteers asking for recruits.
So are you saying that normally a process that could take a year took four weeks?
A month. That’s exactly what I’m saying.
Can you describe the room where you’re giving the vaccinations? Like, do you have a basement bunker?
It looks like your regular doctor’s office, where we have several individual rooms where we can put one volunteer at a time. But these are really unusual times. So everyone who comes to campus here in Maryland has to wear a mask. We meet them at the door and do a prescreening. We ask them if they’ve been exposed to COVID-19 or if they’ve had COVID 19, go through a list of questions to discern if they have any symptoms of COVID-19, and then do their temperature. Only then are they allowed to get a little golden ticket that allows them to enter the vaccine area.
For vaccination, it’s a process. The very first thing we do before is a nasal-pharyngeal swab, just like everyone around the country is getting. So within 45 minutes, we’ve determined whether they’re shedding the virus, and if they’re negative, we can go ahead and randomize and enter them into the system so that we can get them on the docket for vaccination.
It sounds like you feel like you’re on a clock.
We are on a clock. We’re on a very rapid sprint overlaying a marathon because every single week we have to recruit a number of volunteers to fill our docket for next week’s dose escalation. So we’re vaccinating this particular round while simultaneously recruiting for next week’s round, when we’ll go to the next dose.
How many vaccines a week are you giving?
We’re actually testing four different vaccines at three different dose levels. We’re also doing young people up to age 55. Then we’ll move to older people. Every one of those permutations needs 15 people. This is just, at this stage, a safety and immunity study. We’re looking at immune responses and testing the safety of each of these permutations of the vaccine.
The overarching design of the study is to test people from ages 18 to 85 and ultimately those with all sorts of risk factors for COVID-19: diabetes, hypertension, lung disease. But right now, in these very, very early stages, we’re testing just the 18- to 55-year-olds who are healthy. Come June, we’ll move to the older age group. Come July, we’re going to move to people who have other comorbidity conditions. And as we work our way along the ladder, we’ll cover the full panoply of people who are most at risk and need to have a vaccine.
One of the things that is helping for this particular scenario is that everything is shut down. At our center, it’s called severe restriction: We’re not allowed to do other studies or invite volunteers for any of our other ongoing studies. It’s prioritized as COVID-19 studies only.
So this is all you can work on.
For the most part, everything has been stalled. Anyone who has expertise in what we do is declared essential and allowed to be on campus to continue research. Everyone has been freed up of their day-to-day work to have time to concentrate on just doing this trial.
How do you speed things up without cutting corners? Even if you pour people into something, it still takes a toll to move so fast.
Obviously a COVID-19 vaccine has not been in people and has not really been in a lot of preclinical studies, where they go into different animals and officials do exhaustive testing. Mice have been injected and we have very limited data, but most of the data that was given to the FDA to move forward on this was with companion vaccines that had been made with the same platform but weren’t necessarily COVID-19-based vaccines.
So it’s the same method, but it’s not the same virus.
Right. So that may not fly in ordinary situations. But the FDA has agreed that the preponderance of evidence established that this was safe. We have safety data, but to some degree, it might not be the mountains of data that are typically generated before moving forward.
What kind of people are volunteering for this? I know you pay them, so there’s an incentive, but who’s going up and saying, “I want to be on the front lines of testing a pretty unproven vaccine”?
The good thing is that there are a lot of people at home who wanted to do something. Obviously there are people who need some money. But I would say overwhelmingly it’s not people looking for any compensation. Most tell me they’re going to donate their checks. It’s people from the community. It’s people maybe associated with the university but who aren’t in direct patient care.
Are you even really testing for how effective the vaccine is, or is it mostly just safety? I know that in a Phase 1 trial, you may look for a little bit of effectiveness, but you’re mostly just saying, can we do this?
Right now we’re interested predominantly in safety and also whether the immune response that’s mounted is actually specific to the virus and in a petri dish can neutralize the antibodies. We are collecting data so that if people develop COVID-like symptoms, we’ll have them do a self-swab and send it to us so we can collect all of that data. The length of the trial for people participating right now is actually 26 months, even though we hope we’ll have picked a vaccine and it’s gone into production well before that. You know, as early as this autumn, they’re still going to be participating and coming in for blood draws so we can see how long their antibody response lasts.
Like a lot of things when it comes to this coronavirus, with this vaccine, we are going to be learning a lot on the fly. Even if it’s proved safe and goes into production in the next few months, we might not know exactly how effective it is until after it gets released. There’s an element of taking it on faith. So what does effectiveness look like in a vaccine like this? I get the chickenpox vaccine and I don’t get that condition. Do you think we’re going to be able to promise that a vaccine we’re working on so quickly for a condition we’re really just learning the contours of?
There are so many unknowns that it’s impossible to say. I can say that this is what we hope for: that the vaccine we’re developing today is going to work and it’s going to cover people for a reasonable amount of time. And that is where what is reasonable to me may not be reasonable to someone else. Everyone has experience with the flu vaccine—every year we have to make a new crop of vaccines. The total overall efficacy differs year after year, 70 percent, 50 percent.
Sometimes it’s zero percent efficacy.
Sometimes it’s not effective at all. And that would not be acceptable. I mean, we’re hoping for a high level of protective efficacy in a virus that’s not mutating. That’s a lot to ask. We just don’t know how this is going to all play out. All we know is that there are other coronaviruses circulating, like the common cold—which isn’t a deathly illness. Hopefully this will morph into that. But I don’t think we want to wait the amount of time that it takes for society at large to develop immunity.
In you pre-pandemic work, you focused on diseases like dengue, which is caused by a virus, and malaria, which is caused by a parasite. We’ve been looking for a vaccine for those for years, and we still haven’t found anything, really.
That’s absolutely correct. Half a million people die of malaria a year. And there is no sense of urgency anywhere up and down the levels of vaccine development.
I wonder if it kind of makes you humbled looking at this coronavirus, with folks saying we want a vaccine in 18 months. You know how hard the work is.
Malaria is a different beast. It is very, very difficult to develop a vaccine because it’s so complicated. The beauty of viruses is they’re so simple—they can’t even replicate themselves. HIV is an exception because it morphs and changes genetically. It’s constantly evolving, so it’s hard to keep up. But Ebola, for example, is a simple virus. It can’t mutate that quickly because it typically ended up killing people before it had a chance to mutate. So it was relatively easy to make a vaccine, and we’re kind of hoping the same thing with COVID-19, not to minimize the difficulty.
You sound so confident!
Well, I think we’re going to get it. I mean, there are a hundred companies claiming they have a vaccine that they want to bring to fruition. We just happen to have been part of a process that had the financial means and the infrastructure to get it off the ground very quickly. So I hope this one works, but I also hope other vaccines work because by the time we get to autumn and start ramping up production, I don’t think one company is going to be able to develop worldwide mass production immediately.