How come the UK are the only ones to approve the Oxford vaccine

[ForChristsSake]

Just wondering why the EU & USA aren't approving any time soon.

I'm based in EU myself

According to my friends in Brazil, this is the one they've been relying on and waiting for. I think they did a lot of our testing when we didn't have sufficiently high daily cases to do so.

Maybe it's for us and them - that would be a decent chunk of the world population!

The UK hasn't used the (US?) one, I don't think? Moderna?

The EU are asking for more data before approving. Presumably they feel the data is insufficient to approve it yet.

I heard in the US that it is beaurocracy that is slowing it all down.

Because we are the only ones who have had rolling data since its inception.

It's the price per dose.

I don't think theres overwhelming faith in it. After the cockup in the rush to 'win', naturally people want more data.

1. We are clearly pulling out all the stops to approve vaccines ASAP, as evidenced by the fact we were first with Pfizer.
2. Oxford AZ is a higher proportion of our portfolio than some others. Eg the US has some ordered but they also have loads of Moderna which we couldn’t get early access to.

So we are highly motivated.

The US doesn't need it so much as they have Moderna and Pfizer. We can't get Moderna for months. China and Russia have their own vaccines. It's really the EU who are deciding whether to approve it and we were just faster.

India have already manufactured 40 -50m doses of it prior to its approval. I'd say that's a good amount of faith, right?

Pride?

Ofgs. Two days ago posters were saying it was in doubt because it wasn't done quickly enough and now it's too quick and accelerated by pride??? Really? The bullshit on this board.

We approved Pfizer first too. It’s because we started the rolling approval quite a bit before others did. EU will approve it soon

Because we're really desperate?

I also think it's probably half decent and the one thing we've actually excelled at it vaccine approval processes. Unless of course it goes tits up

We are at pains to prove that we no longer need to wait for the EU. We can do everything faster than they can. Whether that is wise or not, remains to be seen, but basically we had to approve either before, or at exactly the same time as them, but certainly not after, or people would have complained.

EU took longer to approce the Pfizer one too.
I am positive they will approve Astra's too.

@FourTeaFallOut - India have already manufactured 40 -50m doses of it prior to its approval. I'd say that's a good amount of faith, right?

As far as I know, this was done for all of the vaccines once they reached the stage where they looked like they had potential to succeed. It was part of the accelerated development process.

This is the one we have ordered most doses of. Other countries have ordered more doses of other vaccines, so they don’t need this one as much.
Also we have had access to the data throughout, whereas other countries will only just be receiving it.

We authorised Pfizer first as well. Others will follow.

I mean, ok, good extra information.

Because it was the worst run trial anyone has seen for decades! The quality of the data is shocking and with viable alternatives why would they? Only fools would take that vaccine. Or ya know desperate people on an island with a regulatory body that got strong armed by the government because they didn't order enough of the vaccine with actual data.

@Cotti

Because it was the worst run trial anyone has seen for decades! The quality of the data is shocking and with viable alternatives why would they? Only fools would take that vaccine. Or ya know desperate people on an island with a regulatory body that got strong armed by the government because they didn't order enough of the vaccine with actual data.

And you know this how?

Provable evidence or I don't believe you.

The FDA will consider data from clinical trials that weren’t approved by them before commencing as “alien” data and may require additional US-based data before they will approve a drug. Some pharma companies will submit a clinical trial application to the FDA and wait for their approval, before commencing, even if they are only conducting trials in Europe, in order to avoid this. It may be that in this case, due to the rush to start trials and gain a licence, this was not done as it’s not required for other regions and the US isn’t the main target market. I don’t have any inside info, so could be wrong but it’s what I thought when I read that the FDA required more trial (I think US based) data.

Dunno. Why hasn't the UK approved the Russian one?

@knittingaddict

The control group were given two different treatments. Some got saline some got a different vaccine. This is a violation of everything we know about a well controlled study. They ALL should have got saline. They fucked up the dosing which means FDA will not consider that data because it wasn't done to the protocol as well they shouldn't! They will only consider ITT or intent to treat data. Fuck up data cannot be considered.

www.bmj.com/content/371/bmj.m4777

Between April and November 2020, 23 848 participants were enrolled to the trial. Half of the participants were given the covid-19 vaccine and the other half given a control (either a meningococcal conjugate vaccine or saline). After a dosing error led to a small group of participants receiving half a dose of the covid-19 vaccine, the researchers—with approval from the Medicines and Healthcare Products Regulatory Agency—added a half dose plus full dose group.2 This group, however, did not include adults over 55 years old as the low dose was given in an early stage of the trial, before older adults were recruited.

The UK regulators have been following the data for some vaccines, including Pfizer and AZ at each stage and digesting it as they go, rather than waiting for the developers to present them with all the data after completion. This speeds things up quite a lot. They also have prioritised the AZ because of the pre-order - that’s not suspicious, that’s sensible. They’ve clearly put the Moderna approval to the bottom of the To Do list because the UK won’t be getting any delivered until Spring regardless of approval so there’s no point doing it first. And as I understand it the UK agency don’t do the sort of drains up analysis of the raw data that the US do. It makes the US a bit slower but I personally find it reassuring to know they’re doing the gold plated approach - I’ll be pleased when and if they approve it as well.