ONEStraZeneca’s relentless quest to develop a vaccine for Covid-19 stands out from what was otherwise an extremely simple process in the United States. adds confusion to an already confusing process.
Helen Branswell of STAT recently joined the “Readout Loud” podcast to talk about AstraZeneca’s current situation, the implications for confidence in the vaccine and how it affects the global effort to fight the pandemic by putting doses on the guns.
Excerpts from the conversation were slightly edited and condensed for clarity.
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When discussing AstraZeneca’s situation, experts consistently look for the word “unprecedented”. This is correct? And how shocking was this shuttle compared to the normal process of developing a vaccine?
I think it was quite shocking. I don’t know if I could go as far as something unprecedented. I didn’t look for, you know, precedents.
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But usually, when a sponsor of an experimental product, whether it’s a vaccine or a drug, and a DSMB [data and safety monitoring board] are coming and going, it happens behind the curtain. We don’t see that. And if there is a disagreement between the two on how to read the data, they resolve it before anyone publicly discloses the data. So having this situation in which AstraZeneca made its statement and then the DSMB made it clear that they disagreed with the analysis, or the way AstraZeneca did its analysis focusing only on previous cases, was quite an impressive rebuke. That sort of thing doesn’t usually happen in the public eye.
This week was a roller coaster ride. As of Thursday morning, it appears that the whole alarm was above a relative difference of 3 percentage points in vaccine effectiveness – 79% in AstraZeneca’s provisional data announced on Monday, against 76% of the most up-to-date analysis we obtained more recently. Who do you think is to blame for this bizarre news cycle going on: AstraZeneca for releasing outdated data or NIH for putting it all in the public record?
I don’t think it looks good on either side, to be honest. Given that they are only 3 percentage points, you would be tempted to say, oh, NIH looks worse with that. But there has been so much drama surrounding this vaccine, so much uncertainty about the data, that the company and the University of Oxford have generated … they had a lot of baggage going into this fight. So, I don’t think anyone would come out of this looking particularly good.
We knew that in 48 hours we would get 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 you scratch your head even more about why it happened?
I think I would say both, in a way. At the end of the day, we are all fascinated by this struggle, the drama. But the reality is that this is a very important vaccine and the world needs it and needs it to work. And what the data shows is that it works. And then 76% is a little better than the 62% that the Oxford group originally reported in its three phases 3, the ones they did in the UK, Brazil and South Africa. So this test gave us the information that we really need it and it’s really good news. So, in that regard, this is great.
“This vaccine project had more plot twists than an Agatha Christie novel.”
Helen Branswell, STAT Senior Writer on Infectious Diseases
But I would love to know more about why the DSMB, two days ago, thought that the most accurate number should be between 69 and 74. And why now? I mean, you know, there is a part of that story that we don’t know yet. And I am very curious to know what it is.
The American controversy over the vaccine comes just days after a series of European countries briefly stopped its distribution to investigate some rare potential side effects. Because this vaccine is being made at a non-profit price and is easier to store than many of the others, its inventors at Oxford University called it a “vaccine for the world”. So, from the perspective of the world, are these recent news damaging confidence in the vaccine?
It is certainly detrimental to confidence in the vaccine in North America, potentially in Europe.
Many countries have given emergency authorizations for this vaccine. If they are all following this to the same degree as we are, I don’t know. But certainly many people, friends of mine who are not journalists and who are not reporting on it, have asked me about this vaccine. Many of my family and friends are in Canada and many of them anticipate that this will be the vaccine that will be offered to them and feel they don’t really know what to believe, to be honest.
What should AstraZeneca do to rebuild part of trust and security? Or, more precisely, what can they do at this stage?
There is no more drama. This vaccine project had more plot twists than an Agatha Christie novel. What they need to do is just generate and disseminate good and reliable data. Obviously, this was done. From now on, they will submit an application for emergency use authorization. And the FDA will analyze your raw data and tell the world what it thinks about how well this vaccine works. And this will be an extraordinarily important step in the process of this vaccine.
Speaking of which, the trial we are talking about was intended to support this application to the FDA, but the vaccine is unlikely to be presented to the regulator until a month or two from now, at which point the US may have a sufficient supply of other Covid vaccines. -19 to meet your needs. So, what do you think is the probability that, despite all this contentious debate, the AstraZeneca vaccine will never actually be distributed in the United States?
You know, I think it’s a possibility. I don’t think I’m sure we know at this point. One of the things we have to see is that, at some point, people will have to start vaccinating children and trials will be needed to test the various vaccines and children. And there is a high likelihood, I think, that one or two of the vaccines may be more useful in children than others. If they are less reactive, for example. Parents don’t like to see their children having problems after getting the vaccine. So, if you can find a vaccine, one of the vaccines, or two of the vaccines that are less reactive in children, then these are probably the ones that would be used.
So, would I close the door on the possibility that this vaccine could have some use in the United States? No. Do I think it is a possibility that is not used or is not widely used in the United States? Yes, I think it is a possibility. Just from the point of view of what you said yourself, the United States may not need this vaccine or anything at all when it is available for use here.