Malta, Indian made Astra Zeneca and why the discrimination?

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fossyant

Ride It Like You Stole It!
Location
South Manchester
That's me out of travelling, not that I was going to :laugh::laugh:. So long as the Welsh don't kick me out as I'm only 45 miles from the border and my caravan is just the other side. First Vac at Etihad was the Indian one. I do, however, have rather good 5g reception from my arm, and my broadband is now super super fast. They do it all the right way over there.

Poor country, but has some of the fastest internetty stuff. That's me sorted.
 

stowie

Legendary Member
From my understanding, the manufacturing facility in India that was producing the Astra-Zeneca vaccine has not been through the EU approval process. I am purely guessing, but this might be because the EU and the Indian manufacturing plant didn't expect these vaccines to be used in the EU and so EU citizens would not be using it? The vaccine "passport" is a pretty recent thing.

Interesting side note - I learned quite recently that Astra-Zeneca have no vaccine manufacturing capability of their own. All of the vaccine production is done via third party manufacturing plants. So I guess each external plant would need certification. This is a model well used by the industry I am in (completely unrelated to pharmaceuticals), but it still was a bit of a surprise that pharmaceutical companies would employ the same model!
 
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Arrowfoot

Arrowfoot

Guru
From my understanding, the manufacturing facility in India that was producing the Astra-Zeneca vaccine has not been through the EU approval process. I am purely guessing, but this might be because the EU and the Indian manufacturing plant didn't expect these vaccines to be used in the EU and so EU citizens would not be using it? The vaccine "passport" is a pretty recent thing.

Interesting side note - I learned quite recently that Astra-Zeneca have no vaccine manufacturing capability of their own. All of the vaccine production is done via third party manufacturing plants. So I guess each external plant would need certification. This is a model well used by the industry I am in (completely unrelated to pharmaceuticals), but it still was a bit of a surprise that pharmaceutical companies would employ the same model!
Yes, all licensed to manufacturers around the the World. Presumed we would not have licensed an unknown sweatshop.

5 millions jabs of the Indian manufactured version were administered in the UK. I am stunned that TUI did not advise its passengers before hand. Manchester Airport authority did not provide any advisory and the UK Govt had no clue about it own product. Apparently Indian manufactured are identified by the batch numbers.

Even more interesting is the sudden U-Turn by Malta without any change in EU certification. EU's performance in vaccine manufacturing and allocation has been a balls-up from the word ago. Its bloody pandemic and not the usual testy fishing quotas!.
 

classic33

Legendary Member
Posted on the Covid Vaccine thread,
Simple in ways.
Like many medications, identical in every way, bar the brand name its licensed under, Covishield hasn't been tested let alone approved for use in Europe.

It's not something that has just been sprung on them.


Batch numbers* are:
4120Z001, 4120Z002 and 4120Z003.

*And should be on the card they gave you, as well as on your records.
 

Unkraut

Master of the Inane Comment
Location
Germany
Even more interesting is the sudden U-Turn by Malta without any change in EU certification.
Whilst a common approach to vaccination was agreed amongst the member states, a good thing imo, health is the responsibility of individual states who can if they wish do their own thing, and some of them have. Hungary, for example. Bavaria has reserved doses of the Russian vaccine.
EU's performance in vaccine manufacturing and allocation has been a balls-up from the word ago.
The EU could have done better with the Biontech vaccine, and was delayed because some members were bothered about the price, which had a knock-on effect on ordering and getting manufacturing set up. This did have a detrimental affect on production near the beginning, but this has long since been put right. I still think an enquiry into whether the EMA could have been quicker and whether von der Leyen could have done better should be made, but the programme has not been the disaster it appeared at first. I would also add the EU has exported large amounts of vaccine made in EU countries at a time when the Anglo-Saxons were basically exporting nothing.

Maybe the EMA knowing Britons would visit EU countries should have authorised the Indian manufactured dosage, but I don't think it had some moral obligation to do this. There are enough people refusing vaccination that it has to tread very carefully and cannot be seen to be simply accepting a vaccine without doing the necessary investigation of safety. To my mind this ought to be a rubber stamp job as the product has been injected millions of times, but then I don't have a problem with vaccination as some do.
 

stowie

Legendary Member
From reading a bit more on tinterwebs, there is some commentary that the EU haven't issued approval because the Indian manufacturer has not requested it.

As a total guess (since I have no experience in the sector), I wonder if most EU countries are accepting the vaccine under the emergency powers that the UK used with EU legislation to fast track our vaccine approvals but Malta was behind the curve in this.

It does make certain sense that the Indian manufacturer would not have applied for EU approval as I expect they weren't thinking their vaccine would be used in European countries seeing as Astra Zeneca had other manufacturing sites locally.
 
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Arrowfoot

Arrowfoot

Guru
Whilst a common approach to vaccination was agreed amongst the member states, a good thing imo, health is the responsibility of individual states who can if they wish do their own thing, and some of them have. Hungary, for example. Bavaria has reserved doses of the Russian vaccine.

The EU could have done better with the Biontech vaccine, and was delayed because some members were bothered about the price, which had a knock-on effect on ordering and getting manufacturing set up. This did have a detrimental affect on production near the beginning, but this has long since been put right. I still think an enquiry into whether the EMA could have been quicker and whether von der Leyen could have done better should be made, but the programme has not been the disaster it appeared at first. I would also add the EU has exported large amounts of vaccine made in EU countries at a time when the Anglo-Saxons were basically exporting nothing.

Maybe the EMA knowing Britons would visit EU countries should have authorised the Indian manufactured dosage, but I don't think it had some moral obligation to do this. There are enough people refusing vaccination that it has to tread very carefully and cannot be seen to be simply accepting a vaccine without doing the necessary investigation of safety. To my mind this ought to be a rubber stamp job as the product has been injected millions of times, but then I don't have a problem with vaccination as some do.
The U-turn without any action by the manufacturer or EU making any certification changes suggest that Malta had no clue what it was doing and depended on the EU. Not unexpected as smaller states do not have the means to establish their own standards independently.

EU unfortunately has form in this regard as other non-EU countries including the UK secured supply agreements earlier while the EU assumed that they had factories in Europe and waited far too long. Manufacturing companies in the EU are commercial entities and not vassal states and a formal agreement would be the first step.
 
As others have said, the Indian Vaccine wasn't certified by the EU, presumably because the company that made it didn't apply for certification: there's not a lot the EU can do about that

Even more interesting is the sudden U-Turn by Malta without any change in EU certification. EU's performance in vaccine manufacturing and allocation has been a balls-up from the word ago. Its bloody pandemic and not the usual testy fishing quotas!.
Malta, as an EU member is a sovereign country and can make up its own mind. They are part of the Schengen agreement that allows freedom of movement but during the pandemic that's been suspended temporarily by many countries, so if they allow someone in who other countries consider a risk, they'll be red listed.

The EU fell on its face at the start of the pandemic but things are getting back together now. Germany passed the UK for numbers of full vaccinations now, although it's still a lower percentage of the total population, other EU nations are not far behind.
 
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Arrowfoot

Arrowfoot

Guru
Malta, as an EU member is a sovereign country and can make up its own mind. They are part of the Schengen agreement that allows freedom of movement but during the pandemic that's been suspended temporarily by many countries, so if they allow someone in who other countries consider a risk, they'll be red listed.
But why the u-turn with nothing changed after the publicity. Does not look like it was well thought thru measure. No advisory to potential visitors either. Sounds poorly executed. Not a question of sovereignty but more towards incompetence.
 

roubaixtuesday

self serving virtue signaller
OK, so some points to clarify (I do work within the pharma sector).

First, to hopefully kill the "EU are being nasty" meme, note that the UK is not currently allowing any vaccination administered in the EU regardless of origin to be used to justify entry or quarantine relaxation. So we're far worse than any EU country on this.

Secondly, I believe the EU has a central scheme to recognise jabs and in order for vaccinations to count in that scheme, the jab has to be EMA (European Medicines Agency) authorised. That seems reasonable; would you trust a North Korean Vaccine?

Thirdly, in order for a product to be licensed, not only does the product need to be approved as safe and effective, but the specific supply chain and all sites within it have to be Good Manufacturing Practice (GMP) certified.

Fourthly, for the EU, if a company applies for a site to be included in the supply chain, the EU nominates one member state to do the GMP inspection, and the results then apply to all member states.

Fifth, AstraZeneca (AZ) has transferred the manufacturing process to Serum Institute India, which does not have EU GMP certification.

6th, the UK govt asked AZ to apply to the UK MHRA for GMP certification in order to boost supply. That happened earlier this year, three batches were subsequently imported, then India stopped exporting anywhere due to its own crisis. That GMP certification does not apply to the EU as the inspection was not under EMA and AZ had not applied to the EMA for certification of the Indian site. The ethics of diverting supply always intended for the developing world is obviously at question here too.

7th. So you can understand why Indian produced vaccine is NOT part of the EU central scheme.

8. However (shock horror) the EU is not a monolithic empire, and individual nation states control their external borders. Individual states do not have to use the central scheme, and can derogate from all or part of it. Many EU nations have chosen to recognise Indian produced AZ vaccine.

Hope that helps.
 
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