Vt. AstraZeneca Vaccine Trial Leader 'Optimistic,' Analysis Expected Within A Month
The rollout of coronavirus vaccines around the country continues to go slower than expected, but a third vaccine may soon be on the way. An inoculation developed by Oxford University and drug maker AstraZeneca is now being used in the United Kingdom, and its being tested, in part, in Vermont.
Although U.S. approval may not come for several more months, the new shot is cheaper and easier to use than some of its rivals. It doesn't require the super cold storage needed for the Pfizer vaccine, and the company claims it will be able to manufacture billions of doses this year.
VPR’s Henry Epp spoke with Dr. Beth Kirkpatrick, a specialist in infectious diseases at UVM Medical Center and the director of the Larner College of Medicine's Vaccine Testing Center. She is also one of the leaders of the local AstraZeneca trial. Their conversation has been edited and condensed for clarity.
Henry Epp: Let's start with the basics. Tell us a little bit about how this trial is set up. I understand participants are randomly assigned, either the vaccine or a placebo. Is that right?
Dr. Beth Kirkpatrick: Yeah, that's right. So, in this trial, it's what they call a two-to-one randomization. So, for every three volunteers, two will get vaccine and one will get placebo. Neither the volunteer nor the rest of the study staff will know who has which investigational product, either the vaccine or the placebo.
I don't know how much you can tell us right now or how much can be public, but I mean, how is the trial going here in Vermont so far?
We are finished enrolling here in Vermont. We finished on the 22nd of December. We enrolled 284 people. Most of our volunteers are now receiving their second dose of vaccine. So, we have completed our enrollment here.
At the same time, of course, multiple vaccines are now being administered around the country and this has developed really quickly. So, given that, should the participants in this trial, especially those who may be older or immunocompromised, should they be allowed to get a different vaccine during this time that they're in the trial?
Yeah, absolutely. You know, there's a really large conversation going on nationally about this exact issue: How do we make this ethically fair to these volunteers, some of whom have received a placebo?
So, what is happening now in the AstraZeneca trial is similar to what's happening in the other trial. When you're up in line and your group is ready to have the other vaccines that are already approved, the study actually unblinds you. So, you call our clinic and you say, "You know, I'm supposed to get the vaccine on Wednesday," and we actually tell you whether you got the AstraZeneca vaccine or you got a placebo.
OK, so that that could then change a person's decision making going forward, if they maybe have already been vaccinated.
That's right. So, if people have received a placebo, we say, "please go on and take the other vaccine." That's a pretty clear choice. We want people to be vaccinated. We want people to be protected. If they received the AstraZeneca vaccine, then we have a conversation with them and we talk about the risks and benefit of either choice.
And we'd like people to stay in the AstraZeneca trial no matter what they do, even if it just means coming back and followed up for safety and getting blood draws. And then if people, again, if they receive the actual AstraZeneca vaccine and they're given the option of another one, we work with them to try to make the right decision about what to do. And most people have opted to just stay and keep on with AstraZeneca trial and not take a second vaccine, only because we just don't know that well yet how they play together.
So, participants in this trial wouldn't necessarily be prohibited from getting a second vaccine even if they already got the vaccine under the trial?
No, they're not prohibited. You know, as in most clinical research, the volunteer, the subject, is the ultimate decider of whatever they want to do. So, we don't prohibit them from doing anything. They can leave the trial. They can take the second vaccine.
But it is really our job to sort of walk them through what we know that might help them make a decision that's, you know, in their best interests. So, they're not prohibited from taking a second vaccine. We've had a few people decide to do that.
What does that mean for the trial itself? If some participants are no longer going to be going with the plan as it was initially laid out for them, how does that change the data that you're getting?
You know, in losing some people, a few like this won't make a big difference in the big picture. You know, it's when we really get into the months and months down the road when we have the vaccine out in the general population, a very large number of people are looking at this. It does make things more complicated.
For this vaccine, because there is so much coronavirus circulating out there right now, I think this study will receive the answer it needs for how well the vaccine works, despite a few people taking a second vaccine or dropping out of the trial.
"I'm optimistic that with a combination of all these vaccines coming out, and the potentially really large impact of this many doses of AstraZeneca vaccine, is going to really help us turn the corner." — Dr. Beth Kirkpatrick
Well, as you're seeing the data come in around this AstraZeneca trial, do you have a sense of how well it works?
You know, I don't know that I would be able to tell that just looking at the group that we have in Vermont. But what I do know is, there's a lot of information in the media right now about the AstraZeneca vaccines, and it's actually quite confusing.
What I would say is the cleanest data on this AstraZeneca vaccine, as far as how well it works and how safe it is, is going to come from this United States-based trial. It's the largest trial that's done with the most uniform practices. And I expect the interim analysis will be done on this trial, hopefully by the end of January, early February.
Well, just zooming out to the bigger picture, everything is evolving quite quickly around the coronavirus pandemic. Vaccines are rolling out around the world. There's also this new variant we've been hearing about in recent weeks of the disease. It's being found in a number of countries, including the United States.
So, given both of those factors, what are your expectations as an infectious diseases expert for how this pandemic might progress in the coming year?
Oh, that's an excellent question. I guess let me start with the variant. The mutations we see in this coronavirus variant are not necessarily surprising. We expect the virus that's in this many people will have mutations, and we don't know yet that this is going to impact the vaccination at all. And the sense is probably it won't. We also don't know that the variant causes more severe disease, and then the modeling makes us think that it's more transmissible.
To your bigger question, I'm very hopeful that these vaccines will really start making an impact in 2021. The AstraZeneca vaccine, one of the big impacts this has on the whole landscape is really the massive manufacturing capacity of this company, and it really dwarfs Pfizer and Moderna. AstraZeneca thinks they can make 3 billion doses of this vaccine in 2021 alone.
And so, I'm optimistic that with a combination of all these vaccines coming out, and the potentially really large impact of this many doses of AstraZeneca vaccine, is going to really help us turn the corner.
That was going to be my final question. I mean, when we talk about turning the corner, is it a matter of a few months, six months, later in the year?
We won't be turning off the spigot. It won't go from lockdown to normal. But I do feel like the pressure will start coming off with the health care system, the deaths, the illnesses, and then we hopefully will just start walking back this epidemic. And my hope and wish is that we'll see that as early as the late winter.
Correction 1/12/2021 10:30 a.m.: This post has been updated with the correct spelling of Larner College of Medicine.
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