Re:Pfizer Covid vaccine approved for use next week in UK
by KingOfCoders on Wednesday December 02, 2020 @09:55AM
(#25276850)
How could numbers in a "controlled" trial be valid if they are arrived at by accident?
[ Parent
| on HN ]
Re:Pfizer Covid vaccine approved for use next week in UK
by Toenex on Wednesday December 02, 2020 @12:32PM
(#25278818)
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.
Re:Pfizer Covid vaccine approved for use next week in UK
by tgb on Wednesday December 02, 2020 @02:02PM
(#25280038)
I 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 [2] https://www.reuters.com/article/uk-health-coronavirus-astraz...
Re:Pfizer Covid vaccine approved for use next week in UK
by regularfry on Wednesday December 02, 2020 @11:34AM
(#25278056)
"Controlled" doesn't mean what you think.