Coronavirus (2021) thread

[shemnel]

so, are we saying that MHRA have approved AZ based on a really small sample of over 65s?

 

[Healdplace]

Ayrshire I agree that this seriously needs urgent action now as I suspect plenty of people who have had the AZ over 65 (which will be millions in the UK already) are going to demand the 'safe' one - which cannot happen as we have limited stocks.

God help us if someone who had the AZ vaccine dies of Covid as some lawyer will be on it like a hawk suing for millions anyone from AZ to Boris.

This could impact badly on the UK vaccination programme.

 

[Healdplace]

so, are we saying that MHRA have approved AZ based on a really small sample of over 65s?

That was known was it not, from previous discussions in here?

There is a difference between no proof of good efficacy and no evidence of lower or no efficacy. But that will not be understood widely.

I assume our authorities who approved it did so not under duress but on the basis of balance of risk.

But they need to speak out now as their judgement is effectively being called dangerously suspect.

Doubtless another press conference is looming.

 

[shemnel]

That was known was it not, from previous discussions in here?

i guess so, i perhaps hadnt had it so clear in my mind about the trial setup re age groups. I wonder why they are so confident at MHRA based on massive confidence intervals?

 

[BobKowalski]

The argument is purely based on low numbers in the age group tested not on any actual evidence of it not being safe. The sensible thing to have done would have been approve the vaccine and guide the government afterwards on its use until further test data.

Not approving it for all over 65s is like a two finger salute to the vaccine and will compromise its confidence around the world. I would think there is good law behind being able not to send a product to a purchaser who has clearly demonstrated their purpose is to damage global confidence in that product.

It’s likely the EMA will approve usage, but leave it to national Govts on the over 65’s.

The FDA haven’t authorised AZ either because of insufficient data and there was talk of domestic trials in the US, but not sure if they went ahead. Japan also want domestic trials.

The data issue was flagged back in December, so it’s not that big a surprise. All countries have their own criteria and will abide by it.

 

[AlgarveBlu]

Probably be labelled a doom monger for sharing this. But it's relevant to Germany's deicison today and why they've made it. Before anyone starts, this isn't me agreeing or disagreeing with it...it's just relevant to their decision and a big topic of discussion.

I think AZ trial results in USA in a much larger scale are due to be announced this month (someone correct me if I'm wrong?), so I suppose when that point comes it will clear up any confusion and we'll have a definitive outlook either way?

Collaborator!

 

[roubaixtuesday]

Very quick comment on the German over 65s story.

1. Not a surprise, and same approach taken by FDA in the US (actually FDA more stringent still and haven't approved in younger people either yet).

2. Problem is NOT that efficacy shown to be low but that insufficient older people in the dataset to show either way. Additional trial is being run to address the data gap.

3. Not a concern scientifically: the UK justification was
(i) Good efficacy shown in other age groups
(ii) Excellent immune response measured in older people, equivalent to that in younger, and as good (actually better IIRC) than Pfizer. Efficacy comes from immune response.

MHRA and several other authorities worldwide believe this shows sufficient benefit/ risk to approve. EMA/FDA require formal efficacy data.

Regulatory agencies taking different views on this sort of issue is not unusual.

Main issue is communication for people elsewhere taking the jab, not the decision itself.

My parents are due for vaccination today, based on all of this I'm delighted whichever they get.

 

[Healdplace]

Yes, we did know this from weeks ago and it was aired in here but there will be suspicions now this is in public domain media that the government pressured approval of the one vaccine we had good supply of in coming weeks because the consequence would otherwise be a roll our more like the EU than Israel and at the time there was still no EU deal in sight.

This can very easily turn into a scandal that will erode confidence in the vaccination programme and someone who has had it will likely be daft enough to start talking legal action egged on by Twitter .

 

[roubaixtuesday]

What’s the Oxford one then?

Just to acknowledge I was wrong about this - I thought uk capacity was just fill/ finish, but there's also API. Apologies.

 

[twosips]

I presume the UK medical bods who approved it for over 65s on the back of the same data will now be making an urgent statement as Germany are in effect telling them they risked lives of millions of people to get this out fast.

Yeah im very curious, because as lay-mans we see that stuff about only ONE infection being used as efficacy proof and it's hardly our fault to get 'eh?!' is it? I'm sure we'll hear more as this story develops though - it's too noisy to not play out publicly.