What exactly is happening with AstraZeneca?

Strazdas · 12-03-2021 04:30PM

NeuralNetwork wrote: »

The previous panic was earlier on in the rollout of Pfizer, which amounted to nothing more than a misread of what was normal mortality statistics amongst very frail individuals.

There’s a huge, huge issue if there’s an impact on vaccine uptake. All it took was a few scare stories, based on misinterpreted stats on childhood vaccines that’s caused a huge mess with uptakes.

Absolutely do the reporting and research but stop running to the media with scare stories, without verifying anything every 5 minutes when there’s a huge audience out there who are looking for any excuse to fit with their conspiracy theories.

I think the general slew of negative press is not helping their cause. Stories about the vaccine's safety and efficacy are one thing, but giving the impression that they are a shoddy or unprofessional outfit is not doing anything to endear them to people or the vaccine.

Personally, I would take their vaccine without any hesitancy but they do seem to be inviting a lot of negative publicity onto themselves.

12-03-2021 10:46PM

astrofool wrote: »

I doubt it will effect supply (positive or negative) the most likely worst outcome (playing devils advocate, which I hate due to anti-vax idiots latching onto anything) would be that people with an underlying condition prone to blood clots take another vaccine, in my opinion it's much more likely that this was an event that happened unrelated to the vaccine, and it will be shown as completely safe once investigated.

that or it could be the Vioxx of Vaccines, let's just wait for the rest of the actual trials that still have not been handed over shall we. Then you can have you Salem trials on the Anti Vaxers all you like eh pet..

AngeloArgue · 12-03-2021 11:44PM

Strazdas wrote: »

I think the general slew of negative press is not helping their cause. Stories about the vaccine's safety and efficacy are one thing, but giving the impression that they are a shoddy or unprofessional outfit is not doing anything to endear them to people or the vaccine.

Personally, I would take their vaccine without any hesitancy but they do seem to be inviting a lot of negative publicity onto themselves.

I think that it's their manufacturing process that's slowing things down. It seems to me that the adenovirus vaccine process is the most trickiest and resource consuming. I think a lot of the problems we are seeing is the people in the sales and marketing side of the company making promises that the engineers, chemists and biologists cannot fulfil.

I also think that the NIAC made the right decision and following the EMA and WHO guidance in not making rash decisions that would delay the programme in suspending AZ vaccinations over a phenomena that is occurring at the expected natural rate in the population.

There is no evidence to suspect that the AZ vaccine is causing bloodclots. But now several countries have sown more doubt about receiving this vaccine.

Strazdas · 13-03-2021 01:57AM

AngeloArgue wrote: »

I think that it's their manufacturing process that's slowing things down. It seems to me that the adenovirus vaccine process is the most trickiest and resource consuming. I think a lot of the problems we are seeing is the people in the sales and marketing side of the company making promises that the engineers, chemists and biologists cannot fulfil.

I also think that the NIAC made the right decision and following the EMA and WHO guidance in not making rash decisions that would delay the programme in suspending AZ vaccinations over a phenomena that is occurring at the expected natural rate in the population.

There is no evidence to suspect that the AZ vaccine is causing bloodclots. But now several countries have sown more doubt about receiving this vaccine.

Yes, I don't think the vaccine is the problem at all and it is probably very safe.

Where they have messed up is in overpromising supplies. It's not a good look to be seen to mess a powerful political and trading bloc like the EU around (it will go down well with the Brexiteers of course, but they hate everyone). If AZ were giving the US the run around with deliveries instead, they would be having the exact same image problems.

Wolf359f · 13-03-2021 02:15AM

Strazdas wrote: »

Yes, I don't think the vaccine is the problem at all and it is probably very safe.

Where they have messed up is in overpromising supplies. It's not a good look to be seen to mess a powerful political and trading bloc like the EU around (it will go down well with the Brexiteers of course, but they hate everyone). If AZ were giving the US the run around with deliveries instead, they would be having the exact same image problems.

Brexiteers don't realise their wonderful AZ vaccine accounts for about 10-15% of the US stockpile, 20% of the EU's and about 40% of the UK.
Pfizer is leading the way in the Western world.

I know India is producing it under licence, but thankfully AZ hands ain't near that!

NeuralNetwork · 13-03-2021 02:43AM

Brexit has really cast a toxic haze over this, particularly in the anglophone media because to London journalists the assumption is that world revolves around Brexit and Tory politics.

You’re better to look at the AstraZeneca and EU issues without all that stuff.

As I see it AstraZeneca is not used to doing this kind of scale or production. It’s a very different product to what they normally produce and they are over promising and spinning. Pfizer/BioNTech and Moderna seem to be much less likely to spin positives and then not deliver.

The reality of it is the EU order is absolutely vast. The U.K. comparison isn’t comparing like with like. There are big supply bandwidth issues to get that volume.

I also think tbh that Trump was a big issue in how this panned out. If 2020 had been under a different administration, I think you may have seen US-EU coordination. Instead, you’re seeing fortress America, the legacy of America First and the EU based plants basically ending up supplying a lot of western countries like Canada, Israel and the U.K. etc without any US capacity being available.

It was fairly inevitable you were going to see extreme vaccine nationalism from the USA though. I mean Trump even floated the idea of buying BioNTech & CureVac to secure exclusive supplies for the US. He saw access to vaccines as a way of screwing over “enemies” basically. And his enemy list, rather bizarrely, included the EU and Canada ... European plants shouldn’t be shouldering that alone. I think it’s going to raise a lot of questions about future US acquisitions of EU biopharma and pharma too if the US isn’t really a friendly partner anymore. I think the days of friendly Uncle Sam may well be fading and the U.K. seems to be just getting weirder by the day.

I just find it rather shocking to see the EU being accused of being the nasty, vaccine hoarder when it’s been EU based plants facilitating supplies to countries that are rolling out faster than the EU itself, including the U.K. and Israel.

I don’t know what exactly Austria and Denmark were up to storming off to Israel, given two of the most likely successful second generation vaccines are both German / EU products mRNA vaccines from BioNTech & CureVac. It just looks like a big Eurosceptic, Brexity hissyfit.

I mean BioNTech, CureVac and Janssen / J&J vaccine are all EU based R&D.

The issue has been scaling up manufacturing capacity and maintaining domestic EU supply volumes, not any lack of technology.

It’s far from a perfect rollout but we need to be putting resources in, not turning into a bunch of countries shooting ourselves in the feet.

IRISHSPORTSGUY · 13-03-2021 03:18AM

News came that the UK audited the Serum institute for 10m extra doses on Feb 15th https://www.reuters.com/article/health-coronavirus-india-britain-exclusi-idUSKBN2AF1CG

The EU audit was reported on Feb 28th https://www.reuters.com/article/us-health-coronavirus-india-eu-exclusive/exclusive-eu-audits-indian-vaccine-maker-as-astrazeneca-looks-to-boost-supplies-to-the-bloc-source-idUSKCN2AT1J0?il=0

The UK will be getting those doses on Monday. Wishful thinking that they'll have 70m or so doses ready for the EU in 2 weeks?

Edit:

But spokespeople for both organisations confirmed in emails the EMA would need to approve the site and change marketing authorisation for the shot to be exported to the bloc.

That will take weeks/months, won't it?

TheRealPONeill · 13-03-2021 04:13AM

I for one am in awe at the posting stamina of NeuralNetwork in this forum.

Danzy · 13-03-2021 07:39AM

Wolf359f wrote: »

Yeah I seen that. I think that's just February figures. Looks to be for each 1 exported dose there's 1 for domestic EU use.
We could be twice as far into the vaccination program if they were not exporting, but then there would be so many countries that wouldn't have even started yet.

The Brits and Americans were very proactive in supporting companies making it. More than just throwing money at it. Very proactive in ordering, very proactive in rollout.

It's an enthusiasm gap more than anything.

Danzy · 13-03-2021 07:46AM

Wolf359f wrote: »

Brexiteers don't realise their wonderful AZ vaccine accounts for about 10-15% of the US stockpile, 20% of the EU's and about 40% of the UK.
Pfizer is leading the way in the Western world.

I know India is producing it under licence, but thankfully AZ hands ain't near that!

AZ isn't the Brexiteers vaccine, that's just jingoism from your side.

The lack of enthusiasm and belief we take for granted in vaccines is not the norm in continental Europe.

If the EU never existed, it would be the same problem.

It does and it's in charge of the process and it has botched the job. Even the most ardent supporters of it in European politics have said that.

They aren't being blind jingoists. Forget Brexiteers, it's about results and speed.

The damage another lost Summer will do to the wider economy in Western Europe doesn't bare thinking about.

Pete_Cavan · 13-03-2021 08:37AM

I'd love to know when AZ put forward supplying the EU from SII. Their contract with the EU certainly allows for the possibility of supplying from outside the EU, I would have thought AZ should have put forward any spare capacity elsewhere in order to make up for shortfalls as a minimum under "best reasonable efforts". Seems ridiculous that they can sell off this capacity while leaving an existing customer hugely short. Their excuse before was based around when contracts were signed, yet they sign new contracts which seem to be getting priority over the existing EU contract.

is_that_so · 13-03-2021 08:39AM

Pete_Cavan wrote: »

I'd love to know when AZ put forward supplying the EU from SII. Their contract with the EU certainly allows for the possibility of supplying from outside the EU, I would have thought AZ should have put forward any spare capacity elsewhere in order to make up for shortfalls as a minimum under "best reasonable efforts". Seems ridiculous that they can sell off this capacity while leaving an existing customer hugely short. Their excuse before was based around when contracts were signed, yet they sign new contracts which seem to be getting priority over the existing EU contract.

With the huge quantities "waiting" in the US, you'd wonder whether they factored that into their promises.

The chan chan man · 13-03-2021 08:39AM

I don’t trust this one at all. I’m not anti vax by any means, but this particular Astra Zeneca one sounds like a balls up. No thanks.

is_that_so · 13-03-2021 08:42AM

The chan chan man wrote: »

I don’t trust this one at all. I’m not anti vax by any means, but this particular Astra Zeneca one sounds like a balls up. No thanks.

The vaccine is good, the company trying to produce it here not so much. Best approach is to take what you're offered.

quartz1 · 13-03-2021 08:44AM

I am very much pro Vax but.whatever is going on with AZ it just feels like the vaccine is tainted . They have disrespected the populations of many Countries and it wouod be no harm if people were made aware of the other Drugs they manufacture so patients could return the compliment by using generics .

Danzy · 13-03-2021 08:44AM

The chan chan man wrote: »

I don’t trust this one at all. I’m not anti vax by any means, but this particular Astra Zeneca one sounds like a balls up. No thanks.

There is nothing wrong with the vaccine scientifically, politics.

The firm was too small for a big job.

dohouch · 13-03-2021 08:54AM

I think some of the producing countries are banning/restricting export of Astra Zenneca. So shortage!

robinph · 13-03-2021 09:06AM

quartz1 wrote: »

I am very much pro Vax but.whatever is going on with AZ it just feels like the vaccine is tainted . They have disrespected the populations of many Countries and it wouod be no harm if people were made aware of the other Drugs they manufacture so patients could return the compliment by using generics .

How is the vaccine tainted?

There is a disagreement over a contract and some supply issues.
Separately there is a coincidence of some people getting blood clots at the normal rate in the general population, but they happened to have had a vaccine recently. No indication that the vaccine is anything to do with that.

What are you seeing to suggest there is a problem with the vaccine, other than the name of the company is appearing in lots of news articles?

quartz1 · 13-03-2021 09:15AM

robinph wrote: »

How is the vaccine tainted?

There is a disagreement over a contract and some supply issues.
Separately there is a coincidence of some people getting blood clots at the normal rate in the general population, but they happened to have had a vaccine recently. No indication that the vaccine is anything to do with that.

Sparadic reports in the media where.countries have suspeded or restricted it's use. Shoddy chaotic deliveries and the fact 30 million doses are in storage but not approved it by the US. I believe the Vaccine is fine but it is becoming tainted in the Court of many peoples minds..

robinph · 13-03-2021 09:23AM

So not tainted then, just a lot of bad press being generated and fed back to us who would normally be oblivious to these stories about medical development and licensing.

Is Pfizer tainted by their trials being suspended in October after some people died for totally unrelated reasons? Or their supplies being reduced as they upgraded their plants this year?

Don't get the impression anything unusual is happening, other than we are getting told about these details in our news headlines.

is_that_so · 13-03-2021 09:30AM

robinph wrote: »

So not tainted then, just a lot of bad press being generated and fed back to us who would normally be oblivious to these stories about medical development and licensing.

Is Pfizer tainted by their trials being suspended in October after some people died for totally unrelated reasons? Or their supplies being reduced as they upgraded their plants this year?

Don't get the impression anything unusual is happening, other than we are getting told about these details in our news headlines.

Pfizer are really the heroes in all of this, ironic given their past. They also reported their production issues in a timely manner, issues that have not been repeated. The AZ problems are myriad from communications to mixed up trial data to contracts and deliveries. I can see it being a case study on future MBA courses!

robinph · 13-03-2021 09:35AM

is_that_so wrote: »

Pfizer are really the heroes in all of this,

For the rich countries probably. For the rest of the world unlikely.

Will be the cheaper and easier to distribute and use vaccines that solve the problem worldwide. Most of Europe may be vaccinated with the likes of Pfizer, most of the world will not be.

is_that_so · 13-03-2021 09:41AM

robinph wrote: »

For the rich countries probably. For the rest of the world unlikely.

Will be the cheaper and easier to distribute and use vaccines that solve the problem worldwide. Most of Europe may be vaccinated with the likes of Pfizer, most of the world will not be.

Without it, we'd be absolutely screwed in terms of any levels of vaccination, rich or not. The rest of the world depending on AZ is the problem as they cannot deliver reliably and one would hope the Oxford licenced partners turn out to be 100 times better at it.

JTMan · 13-03-2021 09:45AM

FT report on the latest on the AZ EU supply here (paywall):

- Dutch factory, run by subcontractor Halix, is yet to receive EU regulatory approval to supply the region. Commission has being encouraging the company to apply for authorisation.
- EU diplomats have grown increasingly agitated over how many vaccine doses Halix has actually manufactured in the meantime and what AstraZeneca is doing with the product.
-Concern is now growing that the British-Swedish company might also fail to deliver the 180m doses it had initially promised the EU for the second quarter of the year, half of which are due to come from outside the bloc.

Elessar · 13-03-2021 10:24AM

JTMan wrote: »

FT report on the latest on the AZ EU supply here (paywall):

- Dutch factory, run by subcontractor Halix, is yet to receive EU regulatory approval to supply the region. Commission has being encouraging the company to apply for authorisation.
- EU diplomats have grown increasingly agitated over how many vaccine doses Halix has actually manufactured in the meantime and what AstraZeneca is doing with the product.
-Concern is now growing that the British-Swedish company might also fail to deliver the 180m doses it had initially promised the EU for the second quarter of the year, half of which are due to come from outside the bloc.

Found the article via Google:

AstraZeneca’s struggle to ramp up vaccine supplies to the EU is partly because of the failure of one of the company’s key European manufacturing sites to deliver any doses to the bloc six months after the supply contract was agreed.

The Dutch factory, run by subcontractor Halix, is yet to receive EU regulatory approval to supply the region even though it was named in the deal signed between AstraZeneca and the European Commission in August.

EU officials said AstraZeneca was yet to provide sufficient data. The company said approval of the site remained “on track”.

The mystery of the Dutch factory underlines the growing questions over both AstraZeneca’s management of its EU contract and the bloc’s oversight. AstraZeneca has fallen far behind its planned vaccine deliveries to the EU, which has had a major effect on vaccination rollout.

The EU had administered 10.4 vaccine doses per 100 residents by Friday, compared with 29.7 in the US and 36.5 in the UK, according to data gathered by the Financial Times. Both the US and UK did deals with AstraZeneca earlier than the European Commission.

EU officials said this week that AstraZeneca would fall roughly 10m doses short of its target to deliver 40m doses by the end of March. That goal was already well below the original supply schedule of at least 100m shots by the end of the month. Thierry Breton, EU industry commissioner, said on Thursday that he did not believe AstraZeneca had made “best efforts” to meet its commitments — a reference to language in the August supply contract.

Concern is now growing that the British-Swedish company might also fail to deliver the 180m doses it had initially promised the EU for the second quarter of the year, half of which are due to come from outside the bloc. The US has so far refused to allow exports of any of the company’s US-based production, EU officials say. Supplying the EU from other countries in AstraZeneca’s worldwide production network could also be difficult.

The Halix factory is one of two facilities — along with the Belgian plant at Seneffe — named as main sources of so-called vaccine drug substance in AstraZeneca’s contract with the commission. Pascal Soriot, the company’s chief executive, explained in an interview with European newspapers in January that the vaccine drug substance is produced in Belgium and the Netherlands and then finished and packaged into vials at plants in Germany and Italy.

The Seneffe plant has struggled with lower-than-expected yields, while the Halix plant in the Netherlands’ Leiden Bio Science Park has produced vaccines but is still not authorised to supply them in the EU.

Last week Breton visited the Halix facility — which should produce at least 5m doses a month — as part of a tour of European vaccine manufacturing sites. Discussions over regulatory approval for the plant from the European Medicines Agency to supply the EU market were ongoing, the officials said.

Asked about the Halix situation, the commission said on Friday that the EMA was ready to fast-track authorisation of new production facilities once it received an application and the necessary information from AstraZeneca. “It is, however, the responsibility of the company to request plants to be covered by a marketing authorisation and to submit all necessary data to that effect,” it said. “The commission encourages the company to do so.”

A spokesman for AstraZeneca said: “The approval of the site with the EMA remains on track with our original plans and we can confirm that it forms part of our delivery plans.”

Halix did not respond to requests for comment.

EU diplomats have grown increasingly agitated over how many vaccine doses Halix has actually manufactured in the meantime and what AstraZeneca is doing with the product. Officials are counting on stockpiled vaccine to be released for use in the EU once the factory is authorised. In January, the bloc introduced new discretionary controls on vaccine exports to 31 high- and middle-income countries, which Italy has already used to prevent a shipment to Australia.

Brussels has clashed previously with both AstraZeneca and London over vaccine exports. EU officials have claimed the company has shipped vaccines produced in the EU to the UK. AstraZeneca has so far not sent doses in the other direction, even though two UK drug substance plants are referenced in the EU’s supply contract as potential sources of vaccine.

The Halix situation also raises the question of whether the European Commission and EU member states paid sufficient attention to tracking whether the plant was on schedule to deliver. Halix did not issue a press release announcing it had been contracted to produce vaccines until December, more than three months after it was named in the AstraZeneca contract with the commission.

“If it is the case that this facility is not producing for the EU then it is truly baffling,” said one EU diplomat. “It would mean that three of the four plants listed in the original EU contract are not providing doses to the EU.”

downcow · 13-03-2021 10:30AM

I see Arlene foster has called again for UK to look after Roi with our spare vaccines. I am confident this will happen as its in all our interests.
Does anyone know will vaccines he allowed to pass from UK into Eu?

Klonker · 13-03-2021 10:58AM

downcow wrote: »

I see Arlene foster has called again for UK to look after Roi with our spare vaccines. I am confident this will happen as its in all our interests.
Does anyone know will vaccines he allowed to pass from UK into Eu?

I think this will happen, it'll be good PR for the UK and the DUP but I can't see it happening until they have all their adults who want a vaccine vaccinated so looking at maybe June/July maybe. Even if they gave us 200k doses at that stage it would be a help.

13-03-2021 11:01AM

robinph wrote: »

So not tainted then, just a lot of bad press being generated and fed back to us who would normally be oblivious to these stories about medical development and licensing.

Is Pfizer tainted by their trials being suspended in October after some people died for totally unrelated reasons? Or their supplies being reduced as they upgraded their plants this year?

Don't get the impression anything unusual is happening, other than we are getting told about these details in our news headlines.

There has been two similar deaths in the uk after the Astra Zeneca vaccine and one after the Pfizer one. Same story with blood clots after both. I can’t help but thinking that the Astra Zeneca ones are being blown out of all proportion for nefarious reasons.

I would guess as well, that plants in Europe that could make the AZ vaccine do t want to, because there is no profit in it.

Happydays2020 · 13-03-2021 11:19AM

I cannot understand. We have introduced quarantining at the border and numbers are not tumbling down.

brickster69 · 13-03-2021 11:32AM

AZ has 4 places where they make it in the EU. Two of which make the material and two the fill and finish. The Dutch one is not producing because the site is not approved by the EMA. So basically the EU output is 50% of what it should be hence the delays.

It is the middle of March for God's sake

What exactly is happening with AstraZeneca?

Comments