We ask a biostatistician about the timeline of a COVID-19 vaccine
There’s a lot of information coming and going about the coronavirus, and the next steps for vaccines and treatments for COVID-19 — ThinkAuthority even has a newsletter dedicated to it.
But how do we assess all this information in a logical way, to prevent confusion, chaos, or something worse? ThinkAuthority’s Nilay, Mary Beth and Nicole talked to Dr. Natalie Dean, assistant professor of biostatistics at the University of Florida, about what we know so far about the timeline of a COVID-19 vaccine, and the best way to evaluate the flood of information coming in every day.
“I think if you want reliable information, then let the dust settle a little bit,” Dr. Dean explains. “Because it’s not like the vaccine is going to be available to you tomorrow. Decisions are not being made over overnight. So just getting the full picture first.”
Dr. Dean also talks about how biostatisticians work to collect the information needed to determine that vaccines are effective and safe, why it’s important to preserve public confidence in such vaccines, and the next steps we’re taking to get the pandemic under control.
Below is a lightly edited excerpt of the conversation.
Mary Beth: One of the things that you mentioned is we don’t know all the details of this particular case. And that’s something that I’ve been seeing as kind of criticism, that we’re not seeing all the data from all of these trials. How important is it during a situation like this, during an emergency in a pandemic, for people to be sharing information? It feels like there’s a conflict there.
Dr. Natalie Dean: Yeah, there’s a complicated balance in what should be shared and made available. Right, we are in this extreme situation.
One thing we should have more of is information about the protocols and the process and what they’ve decided, how they’re planning to analyze the data, how are things defined. And we want to be able to compare notes across trials. We want to be able to understand differences. We want to feel confident that the process they’ve laid out is reasonable. We agree that it will generate the data that we need.
Right now it’s kind of very bare bones details that are available — there’s the clinical trials registry that gives you some basic information, and then there’s press reports and there’s the company websites themselves, but there is a lot of detail that’s missing, and so I think that’s really important. I think safety data is very important to be transparent about it. That’s very critically important to the public.
But it does need to go through some proper channel, because I worry the leaking and getting covered by the press — that can lead to a lot of confusion and chaos. I think people feeling confident that there is a process — by which this information will come out through proper channels where it’s like been reviewed by doctors, clinicians, it’s interpreted in context — I think then people wouldn’t be as desperate to pick apart everything. I’m just a little nervous about how the public responds to stuff — like exactly what just happened. We don’t even know if it was related to the vaccine, but it definitely is going to have some impact on confidence.
And then with regards to the efficacy data though, I do have a concern that we’ll release data too early. We do have a lot of experience with other trials where if something looks promising but it’s not definitive but then it’s released, people do not know what to do with that information. And sometimes that can lead to trials grinding to a halt. But then we don’t have a pathway to collect that information and to get to a definitive answer, so we can end up in this limbo. So I have a different feeling about efficacy data than I do about safety data. Efficacy data, I want it to go through the pathway where it’s fully vetted and it’s only released when there’s a clear answer.
“DECISIONS ARE NOT BEING MADE OVER OVERNIGHT.”
Nilay: So let me be a little cynical, realistic. I don’t know that there’s a lot of institutional trust in the United States of America right now. This is a huge problem that affects everything. We are seeing a lot of leaks. We are seeing a lot of politically motivated data discussion. If you are an individual, smart person, consumer, how should you evaluate the flood of information that’s coming at you?
I think it’s important for people to remember that this process is moving really quickly, but it’s not going to happen overnight. So if a trial reads out or we get something out of a trial, it doesn’t mean that you’re going to be able to access the vaccine tomorrow.
So, you know, let the dust settle a little bit because it’ll take time from the time that you get some data, to the time it’s been reviewed by experts, to the time that there is a regulatory decision, to the time that the vaccine becomes available or early even approved, and then the time that you could even access it. So there are these steps along the way.
Some very smart people — my colleagues — wrote this article for journalists awhile back [that] said information that’s a few days old is more reliable than information today. And I really think that’s going to be true because people are so voracious for information. But when it comes out in these strange ways, it can tend to be very misleading.
I think if you want reliable information, then let the dust settle a little bit, because it’s not like the vaccine is going to be available to you tomorrow, like you don’t need to make your decision. Decisions are not being made over overnight. So just getting the full picture first.
MBG: One of the things that is fascinating about this is that there is this timeline and it is longer than we expect when it comes to the vaccine. This is also going so much faster than the vaccine process normally does. Can you talk a little bit about how we have gotten to this point where we’re in phase three trials already? It seems to me — from an outside perspective — pretty unprecedented when it comes to vaccine development.
It’s absolutely unprecedented. I mean, it’s really just a real feat for modern science. I’m just so impressed by how people have come together and worked so quickly. I think it really shows when people are very highly committed — well, also when there’s a lot of financial support — to achieve something, how quickly something can happen.
It’s been achieved in a few different ways, some things have been able to proceed in parallel. Some of the vaccines, they were modified versions of existing vaccines, and so that’s allowed the process to accelerate.
But then also just eliminating a lot of downtime. There’s usually kind of a period between trials where you’re deciding what you’re going to do next, you’re planning the next trial. You’re getting it through the regulatory review. You’re getting the ethical review. You’re doing all these steps. But now we’re sort of planning the next step before we’ve even finished the first step. So you’re kind of ready to go right away.
And just same with the manufacturing, increasing the manufacturing in parallel while the trials are still ongoing. And so you’re assuming more financial risk because if something goes wrong and you decide you can’t proceed, well, then you’ve wasted money, you’ve spent that money and you can’t get that back. But the advantage, obviously, is making a product available sooner.
So I think it’s reassuring to see that it’s been done in a way that doesn’t cut corners with respect to the evidence that we’re generating and the safety and efficacy. I think it will have implications for how we evaluate future vaccines and shows what’s possible if we really put everything towards a goal.