What to do with AstraZeneca vaccine data – and debate around them

AStraZeneca’s bottom-up quest to develop a vaccine for Covid-19 stands out from what has otherwise been a remarkably straightforward process in the United States and AstraZeneca’s latest vaccine twist, involving a controversial exchange with federal authorities, only adds confusion to an already confusing process.

Helen Branswell of STAT recently joined the ‘Readout Loud’ podcast to talk about AstraZeneca’s current predicament, the implications for vaccine confidence, and how this is affecting the global effort to fend off the pandemic by introducing doses in the arms.

Snippets of the conversation have been slightly edited and condensed for clarity.

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When discussing AstraZeneca’s situation, experts routinely search for the word “unprecedented”. Is it correct? And how shocking has this back and forth been compared to the normal process of vaccine development?

I think it was quite shocking. I don’t know if I could go as far as unprecedented. I didn’t look for, you know, precedents.

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But usually when a sponsor of an investigational product, be it a vaccine or a drug, and a DSMB [data and safety monitoring board] come and go, it happens behind the curtain. We don’t see that. And if there is a disagreement between the two of how to read the data, they resolve it before anyone releases the data. So having this situation where AstraZeneca made their statement and then the DSMB made it known that they disagreed with the analysis, or the way AstraZeneca had carried out their analysis focusing only on earlier cases, that was a rather astonishing reprimand. These kinds of things don’t normally happen in the public eye.

It’s been a bit of a roller coaster this week. On Thursday morning, it looks like all the alarm was above a 3 percentage point relative difference in vaccine effectiveness – 79% in AstraZeneca interim data announced on Monday, up from 76% in analysis more up to date than we got more recently. Who do you think will be blamed for this bizarre news cycle unfolding: AstraZeneca for releasing stale data or the NIH for putting it all on the public registry?

To be honest, I don’t think that’s good for either party. Considering that it’s only 3 percentage points, you’d be tempted to say, oh, the NIH looks worse from that. But there was so much drama surrounding this vaccine, so much uncertainty about the data, that the company and the University of Oxford generated… they had a lot of baggage in this fight. So, I don’t think anyone is stepping away from this particularly awesome look.

We knew within 48 hours we were going to have an updated set of results. When you saw that the results were only 3 percentage points different from the original results, did it make you feel better about what could have happened, or did it make you feel better? makes you scratch your head even more about the reasons for this situation?

I think I would say both, in a way. Ultimately, we are all fascinated by this fight, the drama. But the reality is, this is a really important vaccine and the world needs it and needs it to function. And what the data shows is that it works. And so 76% is a little better than the 62% that the Oxford group initially reported on their three phase 3s, the ones they did in the UK, Brazil and South Africa. So this essay has given us some information that we really need and that’s really good news. So in that regard, it’s great.

But I’d like to know more about why the DSMB thought two days ago that the most accurate number should have been between 69 and 74. And why now? I mean, you know, there’s a part of that story that we just don’t know about yet. And I’m really curious what it is.

The controversy in the United States over the vaccine comes just days after a host of European countries briefly suspended distribution to investigate some rare potential side effects. Because this vaccine is manufactured at a non-profit price and is easier to store than many others, its inventors at the University of Oxford called it a “vaccine for the world.” So from a world perspective, is this recent news hurting confidence in the vaccine?

Admittedly, this undermines confidence in the vaccine in North America, potentially in Europe.

Many countries have given emergency authorizations for this vaccine. If they all follow this to the same degree as we do, I don’t know. But certainly a lot of people, friends of mine who aren’t journalists and don’t report on this, have asked me about this vaccine. A lot of my family and friends are in Canada and a lot of them are planning that this will be the vaccine given to them and they feel like they don’t really know what to believe, to be honest.

What should AstraZeneca do to rebuild some of the trust? Or I guess more specifically, what can they do at this point?

No more drama. This vaccine project had more twists and turns than an Agatha Christie novel. What they need to do is simply generate and disseminate reliable, quality data. This has obviously been done. In the future, they will apply for an emergency use authorization. And the FDA is going to analyze their raw data and they will tell the world what they think about the effectiveness of this vaccine. And that will be an extremely important step in the process for this vaccine.

Speaking of which, the trial we’re talking about was intended to support this FDA claim, but the vaccine probably won’t be presented to the regulator for a month or two, by which time the United States may have enough of it. supply. other Covid-19 vaccines to meet its needs. So what do you think are the odds that despite all of this controversial debate, AstraZeneca is a vaccine never released in the United States?

You know, I think that’s a possibility. I guess I’m not sure we know at this point. One of the things that we have to see is that at some point people are going to have to start immunizing children and trials will have to be done to test the various vaccines and the children. And there’s a high likelihood, I think, that one or two of the vaccines might be more helpful in children than others. If they are less reactogenic, for example. Parents don’t like to see their children having difficulty after receiving a vaccine. So if you can find a vaccine, or one of the vaccines, or two of the vaccines that are less reactogenic in children, then those will most likely be the ones that will be used.

Would I close the door to the possibility that this vaccine could be used in the United States? No. Do I think it’s a possibility that it won’t be used or used a lot in the United States? Yeah, I think that’s a possibility. From the point of view of what you said yourself, the United States may not need much of this vaccine or any of these vaccines when it becomes available here.