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Re:Johnson and Johnson single-shot vaccine appears 66% effec... by mchusma on Friday January 29, 2021 @11:48AM (#25959313)
BTW - I do think it would be more helpful if you report on the numbers between vaccines to use your primary metric as "100% Effective at Preventing Death", then use 68% or whatever as your secondary metric. This better reflects the differences between the vaccines so far. All are amazing at protecting against what people care about most.
Re:Johnson and Johnson single-shot vaccine appears 66% effec... by GizmoSwan on Friday January 29, 2021 @11:47AM (#25959309)
Germany is approving Astrazeneca with some sort of limitation.
Re:Johnson and Johnson single-shot vaccine appears 66% effec... by eli on Friday January 29, 2021 @11:54AM (#25959421)
It was just approved by the EU and is already being distributed in the UK.
Re:Johnson and Johnson single-shot vaccine appears 66% effec... by GizmoSwan on Friday January 29, 2021 @12:01PM (#25959516)
Yes but they don't have sufficient data for older adults on it so that is the limitation.
Re:Johnson and Johnson single-shot vaccine appears 66% effec... by newacct583 on Friday January 29, 2021 @11:52AM (#25959372)
> In the US, this would allow us to end this thing within 90 days.

It... would not. We need half a million (edit: billion of course, oops) doses to "end this thing", and those just aren't going to be there from any combination of manufacturers. If that kind of result was really on the table, a new administration and congressional leadership would be moving mountains to get that win.

But yes: AZ should probably be approved faster than it is and I don't know what the delay is.

Re:Johnson and Johnson single-shot vaccine appears 66% effec... by tzs on Friday January 29, 2021 @02:20PM (#25961192)
The most direct reason for the delay in approving the AZ vaccine in the US is that as of early this month they had not submitted for approval.

They are waiting for the results from a larger US-based trial.

I'm not sure why they aren't going with the same trial data they used to submit requests elsewhere, but it could have something to do with the FDA approval process. The FDA evaluates drug approval requests the way a lot of people were saying the FAA should have evaluated Boeing's 737 Max certification application.

The FDA takes your trial data and then does their own analysis of safety and efficacy. They also have an independent advisory committee that looks over both the company's work and the FDA's work. Many other places, such as the UK, rely more on trusting the company's analysis.

The AZ vaccine was the one that had the error in running the trial that gave some people half of the dose they were suppose to get, and the results suggested that results were better for them than for those who got the full dose. The trial wasn't designed to test half dose vs full dose, and so the set of people who ended up getting half vs full are not really a good set to draw conclusions from.

Perhaps AZ thinks that submitting based on a later trial without that error will overall lead to faster approval than submitting an earlier trial that would probably take longer for the FDA and the independent advisory committee to analyze?

Re:Johnson and Johnson single-shot vaccine appears 66% effec... by fdiskl on Friday January 29, 2021 @11:58AM (#25959468)
i think you mean half a billion (or milliard).
Re:Johnson and Johnson single-shot vaccine appears 66% effec... by geuis on Friday January 29, 2021 @11:59AM (#25959479)
The issue with Astrazeneca is that they messed up part of their clinical trials.

The results weren’t even negative. A subset of their trial group received a different amount of vaccine which seemed to show greater efficacy later.

The issue, and thus the “mistrust”, is that if they messed up that rather critical part of their clinical trials then what else could they have messed up?

Re:Johnson and Johnson single-shot vaccine appears 66% effec... by UncleOxidant on Friday January 29, 2021 @11:48AM (#25959316)
Yeah, I don't get why the Astrazeneca vaccine approval in the US is being delayed till (reportedly) March. Is it because Pfizer and Moderna are US companies charging a lot more money vs. Oxford/Astrazeneca being UK and not making any money on their vaccine?
Re:Johnson and Johnson single-shot vaccine appears 66% effec... by sterlind on Friday January 29, 2021 @12:01PM (#25959509)
I think it's because of the transverse myelitis scare during AZ's Phase 3 tests, combined with AZ's dosage quality control issues making it really hard to interpret efficacy data.
Re:Johnson and Johnson single-shot vaccine appears 66% effec... by pkaye on Friday January 29, 2021 @07:18PM (#25964637)
The US trial got delayed but is due to complete by March I think. It will resolve some questions raised from the UK trial. Besides this, it looks like AZ is way behind on production anyway. With UK and EU fighting over the doses, the US may take a while to get any.
Re:Johnson and Johnson single-shot vaccine appears 66% effec... by Exmoor on Friday January 29, 2021 @11:54AM (#25959419)
I agree that the AZ vaccine was safe and should have been given US approval. That said, this data is for a single dose compared to AZ's two doses so it is a bit apples-to-oranges.