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The half dose was an 'experimental endpoint'. Always planned but not seen as critical. FDA rules now stipulate you can only register on primary endpoints decla
by Toenex 6y ago
The half dose was an 'experimental endpoint'. Always planned but not seen as critical. FDA rules now stipulate you can only register on primary endpoints declared before the trial starts. I suspect AZ have argued that the accelerated nature of the process should take this into account.
- tgb 6y agoI don't think that gives an accurate picture of what happened. Even AstraZeneca themselves are calling the half-dosage a mistake. Their US trial of that vaccine does not currently contain a half-dose arm [1], though it likely will be amended to do so. As best I can read it, the dosage amount was planned but it was intended to represent the "full" dosage and not to be a half-dosage, but was updated when they noticed unusually mild physical symptoms in people receiving the vaccine. [2] I haven't seen anything to support the idea that a half-dosage was an intended endpoint, whether secondary or otherwise. Do you have a source for that? [1] https://clinicaltrials.gov/ct2/show/NCT04516746 https://clinicaltrials.gov/ct2/show/NCT04516746 [2] https://www.reuters.com/article/uk-health-coronavirus-astrazeneca-oxford/decades-of-work-and-half-a-dose-of-fortune-drove-oxford-vaccine-success-idUKKBN2832NG https://www.reuters.com/article/uk-health-coronavirus-astraz...