AZN is evaluating their vaccine in multiple trials across the world, yet these are not embedded under a unified protocol. In fact, the trials seem to be quite different by country, in terms of populations, subgroups, etc. Based on the publicly available details I've seen. 2/5
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With the exception of the US-based trial, I am not aware of details on how these trials are being monitored. Is there a centralized DSMB? Are they combining the accrued data? They seem to have combined events across Brazil and UK. Why not the other countries? 3/5
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And reporting out a secondary analysis that was not pre-specified (since it seems to be based on a dosing error) is not desirable. If they seek to get the half-dose approved, they should wait until they have a compelling result. Otherwise, we can land in "evidence limbo." 4/5
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All of this to say, I really don't know what to make of the results, but as
@Dereklowe and others have said, I'm glad this is not the first vaccine to read out, because it is awfully confusing for experts and non-experts alike. 5/5Show this thread
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Are they evaluating the same vaccine with same dosage in other countries or is it different too?
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On their press release it looked like the half dose was only U.K.
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@hildabast is an expert on reporting on this particular trial. -
My article is in the final editing round, so coming soon I hope.
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As someone who has worked for 15 years in biopharma ... this whole thing seems just ridiculously amateurish. Just mind boggling.
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