What exactly is happening with AstraZeneca?

Donald Trump · 27-01-2021 03:17PM

Melanchthon wrote: »

It's not simply first come first served though people are arguing about, it's that the UK signed a deal with better stricter terms than the EU did because they were quicker, the time scale also comes into play because it means the UK plant will have ironed out it's teething problems first, the UK may also have it as part of their deal that they have exclusive first preference on vaccines produced in the UK based plants which the EU does not in terms of its contract, simply a best effort clause.
All this hopefully will be out in the open soon if Astra Zeneca allow the contract to be released.

About the South Africa shipment, in their statement recently the EU was very specific that Humanitarian exports would not be impacted, so it might be that?

Do you think that signing a new contract, after 7th January 2021 (date of the article which indicated that they were about to agree to it), to deliver 1m doses when they knew that they were already a few hundred million doses short of fulfilling existing commitments, and then delivering that new 1m order first, would constitute "best efforts"? Really?

EU probably shouldn't really expect any vaccine from AZ then until 2022 or so - no? Because any other country that comes in now could leapfrog them. AZ has no incentive to deliver the EU order as it has their money and they have a motivation to deliver the new one because otherwise the new customer might buy elsewhere? Under your hypothesized rules.

9db3xj7z41fs5u · 27-01-2021 03:19PM

Melanchthon wrote: »

It's not simply first come first served though people are arguing about, it's that the UK signed a deal with better stricter terms than the EU did because they were quicker, the time scale also comes into play because it means the UK plant will have ironed out it's teething problems first, the UK may also have it as part of their deal that they have exclusive first preference on vaccines produced in the UK based plants which the EU does not in terms of its contract, simply a best effort clause.
All this hopefully will be out in the open soon if Astra Zeneca allow the contract to be released.

About the South Africa shipment, in their statement recently the EU was very specific that Humanitarian exports would not be impacted, so it might be that?

Your point falls down when you see that South Africa paid 2.5X the amount per vaccine versus Europe. How very "Humanitarian" of AZ

9db3xj7z41fs5u · 27-01-2021 03:20PM

monkeybutter wrote: »

you gotta assume that they aren't lying about it

Because a business never lied to its customer before...

Melanchthon · 27-01-2021 03:23PM

Evan Rich Storefront wrote: »

Be sure to link the two contracts so we can compare and contrast!

Yeah to be honest I am now not sure this explanation about priorities is going to work now as the EU seems to be pretty clear there was not those clauses in their contract. However the UK did seem to have a priority contract for 30 million doses in May for delivery in September. Things are going to get very messy.

https://mobile.twitter.com/EU_Commission/status/1354438254880321536

27-01-2021 03:27PM

Evan Rich Storefront wrote: »

I have a background in clinical trials.

1. Simply nonsense. You can look up any reputable website. The purpose of the approval is to safeguard individuals, with both effective and safe treatments. This is achieved by reviewing phase I-IV data - why have emergency approval at all then?
2. We gain what, 500,000 vaccines by spiting our European neighbours. And then we have to expect that everything will be just cool between us? - Doesn't seem to bother Germany - they have done exactly this with the Pfizer vaccine.
3. Why is the EU being disproportionately affected? Why have the supplies continued as normal to other areas? Even areas that ordered after us - Is it? Can you provide a source for that?
4. Provide evidence please? - See below, Denmark closest to using all their vaccines, the rest lagging to varying degrees.

eastie17 · 27-01-2021 03:27PM

Deleted User wrote: »

To respond to a few points above:

1. Emergency approval doesn't imply don't even look at the data or some sort of cowboy operation.

2. I heard Donnelly say this on Prime Time. Here's something a quick Google turned up:

https://www.irishtimes.com/news/ireland/irish-news/government-plans-to-vaccinate-700-000-people-by-end-of-march-donnelly-1.4457685

3. Production delays:
Both Pfizer and AZ have suffered from them. Hardly surprising since this is a massive unprecedented wartime scale effort, and the EU is huge. Yet the pile on from the EU is on AZ. Smells political to me.

4. EU slow rollout:
Even if we had an unlimited supply tomorrow, many EU countries aren't even able to use the supply they have. Ireland are actually doing very well on this front.

And how much credibility or leverage does McSharry think Ireland would have going it alone in a world where everyone wants the vaccine? Stick to not having to produce anything in the Dail and getting paid for it every month Marc, you'd go hungry in the real world.

On point 3, I cant see it being political, its a commercial issue imho from all the chat and commentary and quotes available on it. Maybe politics came into play on the UK side with some pressure coming from her majestys government but its up to AZ to try and resist that and honour their agreements.

McGiver · 27-01-2021 03:28PM

Melanchthon wrote: »

It did effect the UK too, they were meant to have millions of doses ready to go late last year.
The more I read details about figures it does seem your right though about Astra Zeneca did massively over promise to everyone.
I am not a process engineer though, sure there is people like that on boards though.

https://www.channel4.com/news/factcheck/factcheck-qa-how-much-coronavirus-vaccine-do-we-have

Thank you for admitting that.

I honestly don't see how all this is EU's fault.

The story is like this:
Health was not an EU competency so the Vaccine Alliance negotiated.

Then member states agreed together to move the negotiation to the EU level to the EC.

So then EC took over. This swap caused some alleged "delay" but not significant (delay defined as "contact signed later than the UK"). And it was on request of the member states to make this swap! Also note that this is the first time EU was involved in things like this on behalf of 27 countries and 450M market.

The EC on behalf of the member states and with their knowledge and approval tried to diversify the portfolio of vaccines as much as possible - because nobody knew what trials will end up when and with what results.

The EC negotiated deliveries of Pfizer, Moderna, AZ, Sanofi-GSK, J&J, CureVac, Novavax and Valneva vaccines. Preorder contracts were signed. Also funded R&D and production thereof (2.7 billion total).

Now AZ (which some 18% of the total EU portfolio) turns up two weeks before the first scheduled delivery and says "sorry we will deliver only 30% of the February delivery.

How is the EU at fault? In what way exactly?

Captain Hindsight, that's all that it is. Nobody knew, diversification of the portfolio was correct.

lucernarian · 27-01-2021 03:28PM

Evan Rich Storefront wrote: »

I have a background in clinical trials.

1. Simply nonsense. You can look up any reputable website. The purpose of the approval is to safeguard individuals, with both effective and safe treatments. This is achieved by reviewing phase I-IV data
2. We gain what, 500,000 vaccines by spiting our European neighbours. And then we have to expect that everything will be just cool between us?
3. Why is the EU being disproportionately affected? Why have the supplies continued as normal to other areas? Even areas that ordered after us
4. Provide evidence please?

I see your other points and question, but no. 4 does seem a bit disingenuous. There's an important distinction between "the EU" in the form of the EU institutions and the various individual countries that comprise it (and are responsible for the actual rollouts), that gets called "the EU" also.

27-01-2021 03:30PM

Donald Trump wrote: »

I don't think you have much of an argument from any angle.

Do you not understand the concept of selling something? If you sell me vaccines (and as part of that deal you will stockpile and store them temporarily for me) and I pay you, then they are my property. You can't later decide to sell them to someone else who might offer you more.

You can if you aren't going to be sued, or if the lawsuit is less than the amount of profit you will make from the other sale. It's a choice.

9db3xj7z41fs5u · 27-01-2021 03:32PM

Deleted User wrote: »

1. Emergency approval: I will refer you to the 1976 swine flu approval fiasco. Emergency approval does not mean removing all safeguards. It normally takes the FDA an average of 12 years to approve a drug. Now, doing this in 6-12 months is considerably less (i.e. emergency). However, imagine if the accumulating data prior to approval showed that it was not efficacious. Or worse, imagine if the data showed it was harmful. But nobody had reviewed the data. Whoops. Sorry to the people who were wrongly exposed to a harmful treatment. There has to be some basic safeguards, whatever the situation. Another analogy, imagine in an emergency, if the anaesthesiologist did not bother to read the label of the drug they were administering. That would be okay? Even if they gave a treatment that resulted in the patients death?
2. Further information on the Germany deal?
3. There are 1m doses going out to South Africa. The UK is managing to deliver on its vaccine targets. Check any credible news source
4. Has there been equal distribution to Denmark and the rest of the countries? The other EU countries are fairly concentrated. And tell me what is the benefit of not rolling out the vaccine for the country? And is it a fault of the EU, has the individual country manages its roll-out?

27-01-2021 03:34PM

Evan Rich Storefront wrote: »

Your point falls down when you see that South Africa paid 2.5X the amount per vaccine versus Europe. How very "Humanitarian" of AZ

So basically the EU are paying rock bottom price, haven't approved the vaccine yet, and signed a contract with more holes than a block of Swiss cheese.

Not surprising that AZ has put them to the back of the queue.

27-01-2021 03:39PM

Evan Rich Storefront wrote: »

1. Emergency approval: I will refer you to the 1976 swine flu approval fiasco. Emergency approval does not mean removing all safeguards. It normally takes the FDA an average of 12 years to approve a drug. Now, doing this in 6-12 months is considerably less. However, imagine if the accumulating data prior to approval showed that it was not efficacious. Or worse, imagine if the data showed it was harmful. But nobody had reviewed the data. Whoops. Sorry to the people who were wrongly exposed to a harmful treatment. There has to be some basic safeguards, whatever the situation. Another analogy, imagine in an emergency, if the anaesthesiologist did not bother to read the label of the drug they were administering. That would be okay? Even if they gave a treatment that resulted in the patients death?
2. Further information on the Germany deal?
3. There are 1m doses going out to South Africa. The UK is managing to deliver on its vaccine targets. Check any credible news source

1. So you are saying that the UK regulator who approved the emergency use of AZ didn't review any safety data? I find that extremely hard to believe. Also any side effects at year 2 won't show up in any of these approvals.
2. Germany's illegal Pfizer side deal:
https://www.politico.eu/article/germanys-coronavirus-vaccine-side-deal-at-odds-with-legally-binding-eu-pact/
3. How many did South Africa order? 1m doses is a small delivery. What are they paying (another poster says 2.5x the EU price)

IRISHSPORTSGUY · 27-01-2021 03:39PM

https://twitter.com/jonhenley/status/1354437257982341120

Pete_Cavan · 27-01-2021 03:40PM

McGiver wrote: »

Thank you for admitting that.

I honestly don't see how all this is EU's fault.

The story is like this:
Health was not an EU competency so the Vaccine Alliance negotiated.

Then member states agreed together to move the negotiation to the EU level to the EC.

So then EC took over. This swap caused some delay but not significant.

Where is the evidence this caused any delay at all? AZ confirmed in the middle of June that they had an an agreement to supply up to 400 million doses with deliveries starting by the end of 2020. The client may have changed slightly but AZ were still gearing up from then to supply the same number of units. By the time the contract was signed in August, if AZ knew that they couldn't meet that timeline because of delay in signing, they shouldn't have signed up or had the delivery schedule adjusted. They must have been confident at that time of meeting it.

9db3xj7z41fs5u · 27-01-2021 03:40PM

Deleted User wrote: »

So basically the EU are paying rock bottom price, haven't approved the vaccine yet, and signed a contract with more holes than a block of Swiss cheese.

Not surprising that AZ has put them to the back of the queue.

If I was an early investor, and bought the shares for pittance, and then the company goes global and the shares sky-rocket, can the company just sell my shares to somebody offering more money for them?

I hope that a) you specialise in contract law, b) you have read the contract between AZ and EU. Otherwise, you are just saying hollow statements for effect. Again, we paid the money for the product. The approval is arbitrary to the company

McGiver · 27-01-2021 03:44PM

Pete_Cavan wrote: »

Where is the evidence this caused any delay at all? AZ confirmed in the middle of June that they had an an agreement to supply up to 400 million doses with deliveries starting by the end of 2020. The client may have changed slightly but AZ were still gearing up from then to supply the same number of units. By the time the contract was signed in August, if AZ knew that they couldn't meet that timeline because of delay in signing, they shouldn't have signed up or had the delivery schedule adjusted. They must have been confident at that time of meeting it.

Agree - I will edit to "alleged delay". The "delay" is defined as "later than UK" and that's just nonsense. EU is 450M large confederation and Oxford is not an EU university. Obviously, UK with Oxford could do it faster and using this as an argument is very disingenuous. In fact, it's a demagogy.

9db3xj7z41fs5u · 27-01-2021 03:47PM

Deleted User wrote: »

1. So you are saying that the UK regulator who approved the emergency use of AZ didn't review any safety data? I find that extremely hard to believe. Also any side effects at year 2 won't show up in any of these approvals. The Pandemrix vaccine was used in 2009 and the link with narcolepsy was only proven in 2018.
2. Germany's illegal Pfizer side deal:
https://www.politico.eu/article/germanys-coronavirus-vaccine-side-deal-at-odds-with-legally-binding-eu-pact/
3. How many did South Africa order? 1m doses is a small delivery. What are they paying (another poster says 2.5x the EU price)

1. Other posters seemed to suggest that they did not not need to review any data. The UK took a risk. It reviewed Phase I-III data. However, phase IV data had not yet accumulated. They were lucky in a sense. But their luck does not mean that the EU approach is wrong (see Rofecoxib as an example of a drug that passed phases 1-3, and was withdrawn in phase IV).
2. That was not great on the part of Germany. But it does not make it right. And I think that in the grand scale of things, Ireland is a tiny dot on the map, and we have more power with the vaccines by acting in good faith.
3. 1m is still a lot of vaccines to fulfil, given that they have only offered the EU 31 million, and the EU has 10 fold greater population than South Africa

Bottom line, without the vaccines, more of us are going to die. The EU would be mad not to fight for the vaccine

27-01-2021 03:50PM

Evan Rich Storefront wrote: »

If I was an early investor, and bought the shares for pittance, and then the company goes global and the shares sky-rocket, can the company just sell my shares to somebody offering more money for them?

I hope that a) you specialise in contract law, b) you have read the contract between AZ and EU. Otherwise, you are just saying hollow statements for effect. Again, we paid the money for the product. The approval is arbitrary to the company

I was just replying to the previous post on face value. Let's see how it works out. The EU seem to think they have a claim.

And as for shares, you should look at what happened to some of the original Facebook investors.

9db3xj7z41fs5u · 27-01-2021 03:55PM

Deleted User wrote: »

I was just replying to the previous post on face value. Let's see how it works out. The EU seem to think they have a claim.

And as for shares, you should look at what happened to some of the original Facebook investors.

Not to go on a tangent, but the best mate who had his stock diluted (his name escapes me) successfully sued because of the disingenuous dilution of stuck.

I am putting my money on the EU.

27-01-2021 03:56PM

Evan Rich Storefront wrote: »

1. Other posters seemed to suggest that they did not not need to review any data. The UK took a risk. It reviewed Phase I-III data. However, phase IV data had not yet accumulated. They were lucky in a sense. But their luck does not mean that the EU approach is wrong. - There is only a limited about of phase IV data now. Still a risk.
2. That was not great on the part of Germany. But it does not make it right. And I think that in the grand scale of things, Ireland is a tiny dot on the map, and we have more power with the vaccines by acting in good faith. - I don't agree. It isn't a popularity contest. Germany and Hungary went on solo runs. Ireland needs to form alliances with other wealthy EU net contributors and stop being the good boys in class patted on the head by the likes of Nicolas Sarkozy. I'm pro EU but an EU of equals, not an EU where everything is a Franco German diktat.
3. 1m is still a lot of vaccines to fulfil, given that they have only offered the EU 31 million, and the EU has 10 fold greater population than South Africa

So the EU is getting 3x the amount per capita that SA is, despite SA paying 2.5x the price? Seems like the EU are being strongly favoured looking at those numbers.

9db3xj7z41fs5u · 27-01-2021 03:57PM

Deleted User wrote: »

So the EU is getting 3x the amount per capita that SA is, despite SA paying 2.5x the price? Seems like the EU are being strongly favoured looking at those numbers.

1. While yes, there is always the risk with phase IV data, the risk diminishes with the accumulating data, so our risk post-EMA approval is less than the UK one was. It is a calculated risk

2. This is about more than being good boys. If the EU wants to put us under pressure for the corporation tax, it can and will. we have to be strategic.

3. The EU funded the initial production. They paid before we had all the nice data saying that the vaccine was effective. So yes, the EU should reap the reward

Melanchthon · 27-01-2021 03:58PM

McGiver wrote: »

Thank you for admitting that.

Hahaha I note your completely avoiding the fact that you've provided absolutely nothing to refute the links I posted that there was a significant gap between the signing of contracts to support your claim about Pestons tweet in your rant about simpletons and trolls.

Can you supply information that supports your point that there was not a 3 month gap between the signing of contracts, if not will you retract that post

About the other point , after reading the interview with the CEO and seeing kyriakides press conference (which would seem to address the SA order too as an aside) I think this is going to involve a whole heap of lawyers.

27-01-2021 03:59PM

Evan Rich Storefront wrote: »

Not to go on a tangent, but the best mate who had his stock diluted (his name escapes me) successfully sued because of the disingenuous dilution of stuck.

I am putting my money on the EU.

Let's see what happens.

Suing the company that produces the only decent logistical and affordable vaccine anywhere near approval doesn't seem like a great move to me.

Working with them to do licenced production deals as Sanofi have done with Pfizer would seem a better tactic.

As a great businessman once said to me once the lawyers get involved, everybody loses.

27-01-2021 04:00PM

Evan Rich Storefront wrote: »

3. The EU funded the initial production. They paid before we had all the nice data saying that the vaccine was effective. So yes, the EU should reap the reward

And they are, getting 3x the allocation per capita.

27-01-2021 04:02PM

Donald Trump wrote: »

For all those people moaning about the EU and going on about it being ok to ignore later contracts in order to fulfill earlier contracts first

South Africa are expecting an imminent arrival of 1m doses https://www.theguardian.com/world/live/2021/jan/27/coronavirus-live-news-uk-to-quarantine-arrivals-from-high-risk-countries-as-global-covid-cases-pass-100m?page=with:block-601178dc8f08bf384c763acc#block-601178dc8f08bf384c763acc

You may also notice that there is an article from January 7th 2021 about SA ordering their first vaccines . https://apnews.com/article/africa-south-africa-coronavirus-pandemic-coronavirus-vaccine-22f3d4d4a9364ddd4c07b87f4d5294f8

Also another article here from 5 days ago about how much they are paying for it https://www.theguardian.com/world/2021/jan/22/south-africa-paying-more-than-double-eu-price-for-oxford-astrazeneca-vaccine

What do the "first-come-first-served" spoofers on here make of that?

You do realise the above isn't a contract with AZ? It is a contract with the SII who are producing the same vaccine under license from AZ/Oxford and branding it Covishield. The license granted was based on SII supplying poorer countries, don't think we can even import the vaccines produced in India as the manufacturer would need EMA approval.

brickster69 · 27-01-2021 04:08PM

I don't know what's going to be better to watch ?

EU - AZ Trial or the Trump Impeachment

Donald Trump · 27-01-2021 04:14PM

Deleted User wrote: »

You do realise the above isn't a contract with AZ? It is a contract with the SII who are producing the same vaccine under license from AZ/Oxford and branding it Covishield. The license granted was based on SII supplying poorer countries, don't think we can even import the vaccines produced in India as the manufacturer would need EMA approval.

https://www.seruminstitute.com/about_us.php

Vaccines manufactured by the Serum Institute are accredited by the World Health Organization, Geneva and are being used in around 170 countries across the globe in their national immunization programs, saving millions of lives throughout the world.

27-01-2021 04:27PM

Donald Trump wrote: »

https://www.seruminstitute.com/about_us.php

When you make a submission for approval for a new vaccine, that application will also include where the vaccine is to be produced and the manufacturing has to be reviewed and approved under the submission.

If the submission included the SII and has been approved then we could import, if it didn't it would be up to the SII to make a submission for manufacturing approval for that specific vaccine.

Melanchthon · 27-01-2021 04:39PM

brickster69 wrote: »

I don't know what's going to be better to watch ?

EU - AZ Trial or the Trump Impeachment

It's going to be such a mess if Astra Zeneca has signed a priority deal with the UK for production from the UK plants but didn't include this in the EU contract and are trying to cover it under Best Efforts.
Both sides could put export controls in as UK seems to have good production capacity for astra Zeneca now but is dependent on Belgium for Pfizer

9db3xj7z41fs5u · 27-01-2021 04:44PM

Melanchthon wrote: »

It's going to be such a mess if Astra Zeneca has signed a priority deal with the UK for production from the UK plants but didn't include this in the EU contract and are trying to cover it under Best Efforts.
Both sides could put export controls in as UK seems to have good production capacity for astra Zeneca now but is dependent on Belgium for Pfizer

Ultimately, AZ need the EU market. We are their best customers. And even after the Covid pandemic ends, they will be reliant on us

What exactly is happening with AstraZeneca?

Comments