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IOM Covid removing restrictions


Filippo

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8 minutes ago, Roger Mexico said:

This is pretty much complete bollocks from start to finish.  Covishield is the AstraZeneca vaccine (now branded in Europe as Vaxzevria).  To say the batches "contain no Covishield vaccines" [sic] is untrue insofar as it means anything at all.  Those batches are the same product made in the same manufacturing plants to the same specification as Covishield.  You can't change the contents by sticking it in a different box.

So the EMA is treating those batches as if they were Covishield and Covishield isn't authorised by the EMA.  The original EMA press release made this clear and explained why:

"This is because vaccines are biological products. Even tiny differences in the manufacturing conditions can result in differences in the final product, and EU law therefore requires the manufacturing sites and production process to be assessed and approved as part of the authorisation process."

The Amsterdam-based agency added: "Should we receive a marketing authorisation application for Covishield or should any change to the approved manufacturing sites for Vaxzevria be approved, we would communicate about it."

I can find no evidence that the EMA has changed their mind on this, most recently an article from four days ago when an EMA spokesman said:

[...]that Vaxzevria is “the only” AstraZeneca vaccine EMA currently authorises and for EU-authorisation purposes vaccines made by SII are not recognised as Vaxzevria.

He said: “EU law requires manufacturing sites and the production process to be assessed and approved as part of the authorisation process for vaccines used in the EU. Our product information for Vaxzevria shows on Annex II from page 13 a list of current approved manufacturing sites for this vaccine.”

And at the moment the Serum Institute of India does not appear in this list, though other sites outside the EU do.  There are no press releases or anything to indicate a change to the situation.

Now the SII have applied for approval for Covishield and hope to get approval by the end of July.  Obviously this a bigger problem than just 5 million Brits, Indians and Africans who have received that vaccine want to be able to travel freely as well and other countries such as Canada have received Indian-made batches.  But the whole thing remains a mess and seems unlikely to be resolved as quickly as it could be because the UK seems to think that just saying what you would like to happen will make it so.

Bloody EU and their requirement for consistent standards.

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2 hours ago, Numbnuts said:

Apparently NHS are massively behind with input of info and Wales are in the queue before us so hence this stopgap measure . 

This makes no sense to me.  Surely the data have already been input and the problem is converting to the correct format and getting it on the appropriate database.  There may be problems with the software or permissions, but that's different from what they are saying.  As so often with DHSC they just seem to be making up any old rubbish and not caring that it makes no sense - or even worse being fooled themselves.

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1 hour ago, AcousticallyChallenged said:

From the Gov’t Facebook page…

Bit of a trek if you’re at the other end of the Island mind. 

 

C1E98DD6-CFD4-4157-8A39-5371969909FE.jpeg

Every child, man, dog and his wife are being told to isolate, that's why!

Utterly ridiculous. Heads need wobbling here.

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4 hours ago, TerryFuchwit said:

Who?

You asked a simple question.

I provided an answer which you might or not agree with - or even have the faintest idea what is being referred to.

In everything else you certainly live up to your Fuchwit nom de plum.

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36 minutes ago, AlanShimmin said:

Bloody EU and their requirement for consistent standards.

The annoying thing is that it is't even that.  No one really doubts that the SII are capable of producing vaccines to the required standards, it's just that AZ didn't submit the appropriate paperwork. 

I'm not really sure why because they obviously did enough for the Chinese and South Korean manufacturers to get accepted (though they have to upgrade testing procedures by the end of July).  I can't help wondering if the UK Government asked them not to, in a belief that it would stop the EU getting any of 'our' vaccine.  Or maybe SII thought AZ would do it and vice versa.

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3 hours ago, AcousticallyChallenged said:

The point you miss is you are actively encouraged to request a test in absence of symptoms, if there are circumstances where you're likely to be passing something asymptomatic to you onwards.

Firstly - your fact checkers:

'These have been carefully constructed based on advice from our board and examples ranging from Amnesty International to the BBC' - well, there are 2 fine organisations with no agendas, positions to defend or have axes to grind whatsoever - not!

Re above - how can you, in the absence of symptoms, possibly know that you are passing on anything - if you've got no symptoms to start with?

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6 minutes ago, Roger Mexico said:

Are you saying that people have been told to self-isolate at Nobles A&E them?  Otherwise your comment makes no sense at all.

I am telling you many staff members at Nobles are being told to self isolate. I was with a senior nurse watching the football last night who is at a complete loss with the decision making (the demand on the A&E Dept. is no different to any other time).

Police also suffering.

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1 minute ago, Nom de plume said:

I am telling you many staff members at Nobles are being told to self isolate. I was with a senior nurse watching the football last night who is at a complete loss with the decision making.

But that's not what the Tweet says.  It says they "are currently experiencing extremely high demand within Noble’s Hospital Emergency Department", not that there are staff shortages.  (Though most of us have been completely at a loss with the decision making for years).

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1 minute ago, Roger Mexico said:

But that's not what the Tweet says.  It says they "are currently experiencing extremely high demand within Noble’s Hospital Emergency Department", not that there are staff shortages.  (Though most of us have been completely at a loss with the decision making for years).

The last bit - totally agree. Staggered by some of what I was told.

Of course they'll tell people to stay away.

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26 minutes ago, Roger Mexico said:

This makes no sense to me.  Surely the data have already been input and the problem is converting to the correct format and getting it on the appropriate database.  There may be problems with the software or permissions, but that's different from what they are saying.  As so often with DHSC they just seem to be making up any old rubbish and not caring that it makes no sense - or even worse being fooled themselves.

The NHS use a number of systems as stated on here by people that actually know, rather than guess.

So data input can be quite a legitimate reason.

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9 minutes ago, Declan said:

Should I be able to see my jab status on the NHS ap. Or is that another of the little differences that make us different.

I resolved this morning (but not 100%).

Had to go to local surgery (Village Walk, Onchan) and present ID. Was then issued individual login details for Patient Access (separate website) where I had to register.

Once done, immunisations and vaccines visible on NHS App which I'd already installed.

Only issue being the vaccine types and batch numbers are not listed. Not acceptable for foreign travel as it currently stands.

Therefore we need letters from our Surgery / Govt. clarifying vaccine date(s), types and batch numbers until such time the App is updated.

 

Edited by Nom de plume
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