Germany saying AZ vaccine only 8% effective in over 65s *MNHQ noting that this story has been widely debunked*

[dbIdb]

What fresh hell is this.

Why, why, why was the Oxford trial/data reporting so sloppy?

How has it come to this??

@HoldMeCloserTonyDanza

The writing has been on the wall for the approval for weeks now - it was reported in Austrian media days before any supply issues were even mentioned. It’s been obvious ever since the US FDA said they wouldn’t be approving AZ any time soon that there were troubling gaps in the data.

This has nothing to do with humility or feelings or pride or anything. Adequate data is just not there. People need to get a grip.

I suspect the data is there, we’re just waiting for them to release it. Pascal Soriot said they had clocked 200 cases as of a December update, and given the elderly were enrolled later there’s a strong chance there is more data on that age group in that.

[quote MRex]@Haffiana - the UK people and government already have waited for issues with their supply to be resolved, without throwing tantrums. You clearly don't know what Peter Liese said, a UK MP speaking in such an inflammatory way would be ripped apart in our media never mind here, and would expect party disciplinary action: "Darren McCaffrey on Twitter: "💥German MEP Peter Liese, who sits on the Health Committee, tells me European Union citizens will not be treated as second class If AstraZeneca don’t change course, it will face consequences and so will UK “better think twice” - including blocking Pfizer exports t.co/xaBLrisOH5" / Twitter" mobile.twitter.com/DarrenEuronews/status/1354483646602817540.[/quote]
'Tantrums'? Football teams again?

@HoldMeCloserTonyDanza - nobody cares! Everyone's just fascinated by the maybe public tantrum the EC are throwing over something that they are also saying they don't want. Don't want it, don't have it, the UK order can then be fulfilled really fast as well as the rest of Europe and set up a new cold chain supply to South America or Africa, wherever AZ feels needs it most.

*massive not maybe. It's definitely a tantrum.

@Haffiana -
tantrum
/ˈtantrəm/
noun

an uncontrolled outburst of anger and frustration

I've rechecked the dictionary, and yes it's definitely a tantrum.

@HoldMeCloserTonyDanza

This is another classic Boris strategy - just give the oldies the vaccine early in the hopes that it will work just as well for them. And if those stick in the mud Europeans balk at doing the same, smear them as being jealous of Brexit.

So many comments on this thread are straight-up delusional.

Now we must all just hope that the vaccine is still very effective, and avoid a humanitarian disaster that would greatly damage vaccine takeup in the future. Thanks Tory party! Such a pity you didn’t get that Union Jack on the vaccine box like you wanted!

At least there are no doubts at all about safety.

Although the efficacy of the AZ vaccine MAY be low the vaccine has been shown to reduce severe covid by 100% in all age groups. Surely this is the most important factor as this is what will impact on death rates.

The potentially low efficacy will be partially why we are having to social distance for longer as if it is low it will mean continuing mild cases and asymptomatic transmission until everyone is immunised but in the absence of a better alternative I think the UK is making a sensible compromise.

@soundofsilence1

I really hope you’re right, but please bear in mind there were only 2 cases in the placebo arm that met the WHO definition of severe. So the data on that is rather lacking too.

What is reassuring, though, is that the phase 2 trials showed a robust (and similar) immune response in all ages. www.ox.ac.uk/news/2020-11-19-oxford-coronavirus-vaccine-produces-strong-immune-response-older-adults

I agree that that is less robust than strong efficacy data in the 65+ age group. But it's enough for me to be happy that my elderly parents, who are having Oxford, can expect good protection.

Jesus!

Everyone commenting, journalists, SM, here, as thought the data gaps are something unusual, catastrophic etc.

We know that the very old and very young are not included in most research studies, that takes so.much longer to get through ethics. But we also know that there IS data coming from those later studies AND the vaccination programme.

They used standard practises to get a standard release from the MHRA.

This is the stuff that various European voices have called not doing additional testing and using the population as guinea pigs.

But they forget that the base information is well known, used for years.

It would be a major rewrite of our knowledge of the human immune system and vaccines if there was a non response in the older population.

And yet they wait, presumably to see if our octagenarians grow a second head or die in vast swathes.

Or course if any of that happens we really are in a strange new world!!!!

Curious completely agree

More info on the Belgian investigation ("raid") of Astrazeneca in this article; they are seriously auditing the Novasep factory that had the low yield to look for proof if that was the case or if AZ are fully lying. I actually can't quite believe they think Astrazeneca and Soriot himself would publicly lie about that, it's an incredible accusation:
"Vaccine factory inspected amid EU dispute with AstraZeneca - ABC News" abcnews.go.com/amp/Health/wireStory/vaccine-factory-inspected-amid-eu-dispute-astrazeneca-75534055
"France Dammel, a spokesperson for Belgium's health minister, said experts from the federal medicine agency inspected the Novasep site. They will now work with Dutch, Italian and Spanish experts before delivering a report in the coming days."

@mrex if I were AZ now I would tell the EU to screw it and divert the supply to developing countries that that are sitting waiting patiently for it.

@CuriousaboutSamphire It would be a major rewrite of our knowledge of the human immune system and vaccines if there was a non response in the older population.

I could not agree more. What happens when you reach 65? Your immune system suddenly starts working completely differently. The AZ jab is known tech. It is a pretty good bet that it will work in the same way in a 70 year old as it does in a 60 year old. We are in the middle of a goddamn pandemic. People are dying. You grab the data you have. You extrapolate based on common sense and previous data. And you run run run.

I wouldn't Blessex, I'd tell EC to screw it and let the individual EU countries buy the vaccine that can be made independently if they choose. At this point I might do it for 5* the price and contribute the profits to Covax. Because why not.

[quote MRex]@Motorina - yes, I saw that. Big pharma can play very rough commercially and it's a very unfair situation on Astrazeneca. I'd hinted a fair bit as well about the contract not being complete until EMA approval. I'd need to see the contract, but as AZ I'd be very tempted to say "Contract not workable. Here's how you've broken clauses on timeframes, working relationship and confidentiality. Here's how you've slandered our reputation for good measure. What we'll do now is withdraw from seeking EMA approval and return all funds effective today. Any EU27 can give emergency use authorisation, sign a contract this week in the same format for the number of vaccines they would otherwise get at the same cost plus an allowance for the legal bill you just caused, and we'll honour their vaccines. Any EU27 who don't want the vaccine is welcome to withdraw."
I don't think they will, but they may at least threaten, and I'd really enjoy it if they did.[/quote]
I quote this splendid post by @MRex here, and indulge in a moment of happy fantasy that it might just happen...

The EU is going to look mighty STUPID when the real world data comes through.

@mrex I wouldn't Blessex, I'd tell EC to screw it and let the individual EU countries buy the vaccine that can be made independently if they choose. At this point I might do it for 5 the price and contribute the profits to Covax. Because why not.*

Well yes that’s another option! But seems the EU countries don’t want it anyway.

@Blessex

The EU is going to look mighty STUPID when the real world data comes through.

They - or at least Germany - seem to be making the same mistake that got them into this pickle in the first place. Being over cautious and forgetting that this is a medical emergency and risks need to be taken that might not be taken in normal times. Same reason they dragged their heels over buying stocks of the AZ vaccine and still haven't got around to approving it.

Oh well. They'll always have Sanofi.

So the Belgians have inspected and they expect Spain, Italy and ?? to inspect the other 3 factories and to make a joint report?

Madness! Sheer lunacy!

That really is not how you treat Big Pharma when it is doing what it should be doing, fast research and manufacturing at cost!

This is what people have been asking about Big Pharma for years. Now they show that they will step up and do the right things the EU want to hammer them for what is, at worst, a mutual misunderstanding of the heart of a humanitarian contract!

Ridiculous!!!

The worry is that all those hundreds of thousands of grannies who have been receiving them in the last month may not actually be adequately protected at all

The clinical trial showed that over 65s showed similar immune responses after vaccination to under 65s. That isn't true of all vaccines, such as the flu jab, where over 65s have a weaker immune response so the vaccine efficacy is lower in that age group than in younger adults and children.

The trial suggested that the vaccine had 71.1% efficacy in the 18-64 age group with a 95% confidence interval of 56.3-80.9%. In layman's terms that means that the scientists are very sure the correct value is in that range.

In the over 65s, the vaccine had efficacy of 6.3% BUT with a 95% confidence interval of -1405-94.2%. Yes, minus 1405. In other words, the results are meaningless. The reason they are meaningless is because only 2 individuals in the over 65 cohort were diagnosed with COVID-19, probably because many of that group were being careful, staying at home etc so weren't exposed to the virus. There just isn't enough data to see what effect the vaccine had.

Dutch!!! Apologies!

There is culpability here right across the EU. We have Belgium, Spain, Netherlands and Italy involved in this ridiculous raid. France only getting the Sanofi factory offered up to Pfizer last week. Italy and Poland talking about suing Pfizer and Astrazeneca. Germany giving opinions on the vaccine seemingly at random and without caveats. German MEP, Cypriot Health Minister and German EC President threatening goods seizures and trade wars. It's crazy.

Do we know if Spain Italy and the Dutch have agreed?

I'm on my phone... all help on the research much appreciated.

Wow I can’t keep up. I’ve just read that now Nicola Sturgeon has waded in. This sounds very very bad to me.

And now the EU proposes imposing blocks on the export of vaccines. www.theguardian.com/world/2021/jan/28/belgium-launches-investigation-of-astrazeneca-vaccine-plant