We're all a bit worried about the two neurological disorders seen in the AstraZeneca vaccine trial. In the media, one is being called multiple sclerosis; the other is being called transverse myelitis. These diseases can happen spontaneously, can happen as a result of a viral
infection (we think) and could possibly be an immune response to a vaccine. With the whole world watching and hoping, I have only sympathy for the trialists and sponsors and of course the participants. I'm seeing calls for "opening the books" and breaking blinds and increasing
transparency. I'm seeing people call for statistical tests to let us know the truth. But here's the thing: you can't make meaningful statistical claims about two events that may not even be the same. These serious adverse events are almost never so simple to figure out. Just as
a ballpark guess it would probably take 10 or more clear cases that fall only in the vaccine group to have real statistical confidence of causation rather than random luck. And breaking the blind publicly will likely make the trials difficult or impossible to perform in a
way that gives us meaningful information. We need large, well-conducted trials. We need safety boards working overtime on those trials. We need those safety boards to be able to do their jobs, which they can't do if they're having to unblind the entire world every time they
review an SAE. I know that some people feel like they can't trust federal agencies, and I know that those agencies are under intense political pressure right now. But I think our most rational move forward is to allow FDA and DSMBs to do their work, to strongly discourage
premature termination of trials over soft "efficacy" when we know that it's efficacy AND safety that are crucial to the success of a vaccine, and to continue to support good, focused science while we debate philosophically amongst ourselves about politics.
One specific thing that might help immediately would be to make freely/widely accessible prior vaccine trial datasets (flu etc) with annotated SAE rates in vaccine vs placebo groups. That's something that could be done immediately and would help the DSMBs to do their job.
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