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For the best vaccine information, you need to let the dust settle first



Much information comes and goes about the coronavirus and next steps for vaccines and treatments for COVID-19 – The edge There is even a newsletter.

But how do we evaluate all of this information in a logical way to avoid confusion, chaos or something worse? The edgeNilay Patel, Mary Beth Griggs and Nicole Wetsman spoke to Dr. Natalie Dean, Assistant Professor of Biostatistics at the University of Florida, on what we know so far about a COVID-19 vaccine schedule and the best way to assess the information overload comes in every day.

“I think if you want reliable information, let the dust settle down a bit,”

; explains Dr. Dean. “Because it’s not like the vaccine will be available to you tomorrow. Decisions are not made overnight. So get the full picture first. ”

Dr. Dean also talks about how biostatisticians work to gather the information needed to determine if vaccines are effective and safe, why it is important to maintain public confidence in such vaccines, and the next steps that are taken we are doing to bring the pandemic under control.

Below is a slightly edited excerpt from the interview.

Mary Beth Griggs: One of the things you mentioned is that we don’t know all the details of this particular case. And I saw that as a kind of criticism that we don’t see all of the data from all of these attempts. In such a situation, during a pandemic emergency, how important is it for people to exchange information? It feels like there’s a conflict there.

Dr. Natalie Dean: Yes, there is 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 logs and the process and what they decided, how to analyze the data, how things are defined. And we want to be able to compare notes across trials. We want to be able to understand differences. We want to be confident that the process you have established is appropriate. We agree that the required data will be generated.

There are very bare details available right now – there’s the clinical trial registry which gives you some basic information, and then there are press releases and the company websites themselves, but a lot of the details are missing so I think that’s really important. I think security data is very important to be transparent. This is very important for the public.

But it has to go through a real channel because I worry about the press leaking and being covered up – that can lead to a lot of confusion and chaos. I think people are confident that there is a process in which this information comes out through appropriate channels where it is reviewed by doctors and clinicians and interpreted in context. I think then people wouldn’t be so desperate to take everything apart. I’m just a little nervous about how the public reacts to things – just like what just happened. We don’t even know if it is vaccine-related, but it will definitely have some impact on confidence.

However, with regards to the effectiveness data, I have concerns that we are releasing the data too early. We have a lot of experience with other studies where people don’t know what to do with this information when something looks promising but isn’t final but then gets published. And sometimes this can cause attempts to stall. But then we have no way of collecting this information and arriving at a definitive answer so that we can end up in this limbo. So I have a different feeling about efficacy data than I feel about safety data. Efficacy data, I want it to go through the path of being fully reviewed and not released until there is a clear answer.

Nilay Patel: Let me be a little cynical and realistic. I don’t know that there is a lot of institutional trust in the United States right now. This is a big problem that affects everything. We see a lot of leaks. We see a lot of politically motivated data discussions. If you are an individual, smart person or a consumer, how should you rate the information overload that is coming your way?

I think it’s important for people to remember that this process is very quick, but it won’t happen overnight. So if a study is read aloud or we get something out of a study, that doesn’t mean you will have access to the vaccine tomorrow.

So let the dust settle a little, as it will take some time to get some data, to be reviewed by experts, to the time a government decision is made, to the time that They are available The vaccine becomes available, or even approved early, and then the time you can even access it. So there are these steps along the way.

Some very clever people – my colleagues – wrote this article for journalists a while ago [that] This information, which is a few days old, is more reliable than information today. And I really think that will be true because people are so voracious for information. But when it comes out in this strange way it can be very misleading.

I think if you want reliable information, let the dust settle a little, because it’s not like the vaccine will be available to you tomorrow like you don’t have to make your decision. Decisions are not made overnight. So get the full picture first.

MBG: One of the fascinating things is that this schedule is there and it’s longer than we expect when it comes to the vaccine. This is also so much faster than the vaccination process usually takes. Can you talk a little about how we got to the point where we are already in phase three? It seems to me – from the outside – pretty unprecedented when it comes to vaccine development.

It is absolutely unprecedented. I mean, it’s really just a real achievement for modern science. I’m just so impressed with how people got together and worked so quickly. I think it really shows when people are very committed – even when there is a lot of financial support – to achieve something, how quickly something can happen.

It was accomplished in several ways, some things could happen in parallel. Some of the vaccines were modified versions of existing vaccines so the process could be accelerated.

But then only eliminate a lot of downtime. There is usually some kind of period between attempts in which to decide what to do next. You are planning the next attempt. You will get it through the regulatory review. You get the ethical review. You take all of these steps. But now we’re planning the next step before we finish the first step. So you’re ready to get started right away.

And just like manufacturing, manufacturing will be increased in parallel while the trials are still ongoing. So you are running a higher financial risk because if something goes wrong and you decide you cannot continue, then you have wasted money, you have spent that money and you cannot get it back. But the advantage is, of course, that a product is available sooner.

So I find it comforting to see that this has been done in a way that does not compromise the evidence we have generated, as well as its safety and effectiveness. I think it will have an impact on how we evaluate future vaccines and what is possible if we really go all out towards a goal.


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