Update (0800ET): As the media (and the rest of the world) tries to figure out what exactly is going on with the AstraZeneca trial data, and whether the vaccine’s ability to protect the population from COVID truly does outweigh the risks, the company has just released a statement promising to release up-to-date results from the final phase of the trial within 48 hours.
AZ said yesterday’s trial conclusions were based on an “interim analysis” with all data received by the cutoff date of Feb. 17. Then, it promised to “immediately engage with the independent data safety monitoring board to share our primary analysis with the most up to date efficacy data.” Results of this primary analysis will be available within 2 days.
The numbers published yesterday were based on a pre-specified interim analysis with a data cut-off of 17 February.
We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis. We are now completing the validation of the statistical analysis.
We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data.
We intend to issue results of the primary analysis within 48 hours.
More academics complained about the optics of the situation.
“The last thing this vaccine needs is more concern when we kind of thought we were at that point now where we would put to bed all the other concerns,” said Paul Griffin, an associate professor of medicine at the University of Queensland in Brisbane, who is conducting clinical studies in Australia on four Covid-19 vaccine candidates.
And reporters complained that AstraZeneca’s explanation, and the whole back-and-forth between Astra and the NIH, seemed bizarre…