This seems unconfirmed, and do note some sources in the story do not believe this account, but here goes:
AstraZeneca, whose Phase 3 coronavirus vaccine clinical trial has been on hold for more than a month, did not get critical safety data to the US Food and Drug Administration until last week, according to a source familiar with the trial.
The FDA is considering whether to allow AstraZeneca to restart its trial after a participant became ill. At issue is whether the illness was a fluke, or if it may have been related to the vaccine.
The source said the root of the delay is that the participant was in the United Kingdom, and the European Medicines Agency and the FDA store data differently.
“They had to convert data from one format to another format. It’s like taking stuff off a PC and putting it onto an Apple. They had to spend a lot of hours to get what they wanted,” the source said.
On Friday, a federal official hinted there might be some word this week on the trial’s future.
Or maybe they just fooled CNN with it?
Otherwise, good thing we are kept safe from such dangerous data formats! Would it really not be better to move to reciprocal recognition procedures? Not to mention a unified data format, or perhaps some FDA methods to read data produced for the EU?
For the pointer I thank Jackson Stone.