Once again reinforcing that while their science may be solid, their management of the regulatory process is awful. If this was a disagreement they had with their DSMB and the results are basically the same including the new data (as they claim in that press release) then surely they should have just included that in the press release originally?

Instead they've now caused another round of noise.

You seem to imply it's AZ's fault, when in fact it's clearly a systemic FDA issue here.

AZ's vaccine has been proven safe and effective multiple times in multiple studies.

The FDA has banned banned everyone from choosing to voluntarily get it if they wish. It's not based on ANY bona-fide scientific concern, it's ban is solely based on red tape. This event proves it. If the FDA was in the business of helping people, they would find a way to lift this ban.

They have found a way to "lift this ban". The company simply has to conduct a well run trial, submit the trial data to the FDA, and ask for an emergency use authorization. Once they do that, it takes two or three weeks for the FDA to processes it. That two or three weeks is not red tape--it is the FDA having their own scientists and independent scientists go over all the data and do the safety and efficacy calculations themselves.

This worked fine for Pfizer, Moderna, and Johnson & Johnson.

Part of AZ's job is to manage their relationship with their DSMB (which is not the FDA). Even if they've done the science correctly and developed a good vaccine (I happen to think the evidence supports this view) they are also supposed to manage these relationships to stop this kind of disagreement becoming public.

Either one of two things has happened:

1) Their independent DSMB have conspired to screw them for reasons unknown - I think this is pretty unlikely.

2) They have mismanaged the communications with the DSMB and released results which it was their job to know the DSMB did not agree with.

Something not being approved is not the same thing as a ban. You and I might think there is enough evidence, given the context of the pandemic, to have started using this vaccine in the US but I am not qualified to assess that.