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IOM Covid removing restrictions


Filippo

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2 hours ago, Roger Mexico said:

Well it wasn't really an argument, was it?  More a cry for help.  Or of despair.

I'm afraid I've long since given up trying to understand what the actual regulations surrounding isolation, testing and quarantine say, never mind whether they make any sense.  They were a bit incoherent to start with and have just got worse as the Manx government tried to mirror the ever-more nonsensical decisions of the UK. 

It's not that they're over-lax or unnecessarily restrictive, it's that they frequently manage to be both at the same time.  And so badly presented that no one understands them and ends up doing whatever they want.  The appropriate regulations (if they even exist) will probably be so badly drafted that they will be unusable, so there will be no comeback.

The most depressing thing about the last 18 months or so has been the way in which hardly anyone seems to have learnt anything.  Rather than accepting some failures are inevitable and learning from them, they just pretend they never happened and repeat the same mistakes even more enthusiastically.

There is still a major inconsistency in the advice on the Gov website

I expect it will be sorted soon.

Basically if you have 2+2 you do not need to isolate if there has been a close contact ....unless the test and trace tell you to. This is despite the vaccine exemption stating that you are exeempt

2 hours ago, TerryFuchwit said:

Certainly worth avoiding any form of testing unless you have absolutely no choice.

 

Yes indeed. There is nothing in it for anyone to be so honest as to go and have a test.

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1 hour ago, Roger Mexico said:

It's not the media's fault, they are merely quoting from what the IOM Government press release says.

Technically they may be correct because it says "no doses branded Covishield have been administered on the Island" which will be true as they will have been branded the same as all the other AZ vaccines received.  But it's not the name on the box that is the problem, but where they were made.  So they are providing reassurance about something that wasn't required.

It's true that, based on this BBC piece from six days ago, that the UK DoH claimed the 'three SII batch numbers [...] were being "assessed and are treated as Covid-19 Vaccine AstraZeneca"'.  And  "All AstraZeneca vaccines given in the UK are the same product and appear on the NHS Covid Pass as Vaxzevria. The European Medicines Agency has authorised this vaccine and we're confident travel will not be affected."

But of course they can't dictate to the EU what the EU will or won't accept and the system doesn't seem to be working yet anyway, though individual EU counties may well accept them, just as they are accepting Russian or Chinese vaccines.

It's just bullshit. Sometimes it's like listening to a child talk when Ashford is quoted. It's a needlessly obtuse answer which will confuse an already confusing situation.

Were these vaccines made in India and rebranded as Vaxzevria? Yes.

Will these batches of vaccines stop people from being able to travel into certain European countries? Yes.

Why on earth did they feel the need to release this statement?

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1 hour ago, Major Rushen said:

As usual…. Cannot answer the primary question. Why are these batch numbers not approved by the EMA, what is being done about it, and when will it be fixed.

I did explain when this first came to public attention, it’s lost somewhere above.

Both the MHRA and EMA emergency authorisation was for a named vaccine manufactured by a specified manufacturer, in a specified country and factory. In each case UK and Belgium. Not India. The authorisations are on line. 

In February there was a slow down in supply as the production lines were temporarily scaled back to allow expansion. MHRA then issued a further emergency authorisation which specifies India, the Serum Institute of India and one of their factories. That’s where the batch Z001, 2 and 3 come from. EMA didn’t. 

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On 7/9/2021 at 5:07 PM, Major Rushen said:

Thank you.

The issue for me is that IOM  GOV  have made a statement alluding that the India vaccines are ok for Europe but does not advise that the Batch Numbers are not accepted. 

 

 

They’ve made two apparently conflicting statements. They’ve not squared the circle. In fact both are correct. Covishield  isn’t approved by MHRA or EMA. OxfordAZ is. Covishield and OxfordAZ are supposed to be identical. MHRA recognises Oxford AZ manufactured in India as long as it has an AZ label, not if it has a Covishield  label. No one in UK or IOM got Covishield . They got OxfordAZ from the three batches Z001, 2 & 3. Recognised in UK by MHRA but not in EU by EMA.

9 European countries have agreed to accept vaccines from those batches. The rest haven’t, yet.

Not that it’s important to Manxies at the moment. We can’t get the digital QR pass yet, where the batch number is recorded. And the scanning of info doesn’t get done on arrival but as you check in or embark.

So airlines, harbour or rail staff. They’ve not got the digital pass readers or printed bar code scanners up and running, yet. But there are stories going around about passengers with a dose from those batches being refused travel.

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2 hours ago, swoopy2110 said:

Especially when she was travelling to Malta which is saying that it will accept:

“NHS COVID Pass “– NHS Coronavirus (COVID-19) vaccination record – full course of vaccination with 14 days after last dose

without any extra provisos.

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14 minutes ago, Major Rushen said:

Thank you.

The issue for me is that IOM  GOV  have made a statement alluding that the India vaccines are ok for Europe but does not advise that the Batch Numbers are not accepted. 

 

 

The issue is the statement says that none of the batches were used on the IoM when they clearly were

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3 minutes ago, Roger Mexico said:

Especially when she was travelling to Malta which is saying that it will accept:

“NHS COVID Pass “– NHS Coronavirus (COVID-19) vaccination record – full course of vaccination with 14 days after last dose

without any extra provisos.

If you get a letter from your GP or use your Vaccination card the batch numbers are there for all to see and that is what the Airlines and travel agents are recording for onward transmission to your destination. If you were to arrive in Malta with an unapproved batch, the airline will be responsible for taking you back.

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12 minutes ago, kevster said:

The issue is the statement says that none of the batches were used on the IoM when they clearly were

Actually it doesn't say that exactly.  The actual wording is:

Five million doses were, however, manufactured by the Serum Institute of India.  Regardless of the place of manufacturer, all AstraZeneca COVID-19 vaccines administered in the Isle of Man and the UK are theChAdOx1-S [recombinant] which is approved by the EMA.

The trouble is that the EMA doesn't agree.  As John points out it has its own procedures for approving use which includes place and manufacturer and it can't over-ride them on the say-so of an individual country, especially a non-EU one. 

If the UK had thought to do so they could probably have got the batches approved back in the Spring, but they didn't.  And now, like so many dealings with the EU they are hoping that pretending there isn't a problem will make it go away.  Because that's worked so well for them so far.

So the press release isn't exactly untrue, it's just confusing and pointless.  And trying to mislead people that's everything is OK when it clearly isn't.  Presumably to try to absolve themselves from actually needing to do something about it.

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24 minutes ago, Major Rushen said:

If you get a letter from your GP or use your Vaccination card the batch numbers are there for all to see and that is what the Airlines and travel agents are recording for onward transmission to your destination. If you were to arrive in Malta with an unapproved batch, the airline will be responsible for taking you back.

Yes that's the danger.  Airlines will always be ultra-cautious over this, even if the arrival country would be happy to let people in.  They want to keep things simple for check-in staff.  Unfortunately the UK government may be more interested in having rows with the EU, so they can blame them for things going wrong,  rather than getting things fixed.  Though 5 million people may be less impressed.

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24 minutes ago, Roger Mexico said:

Yes that's the danger.  Airlines will always be ultra-cautious over this, even if the arrival country would be happy to let people in.  They want to keep things simple for check-in staff.  Unfortunately the UK government may be more interested in having rows with the EU, so they can blame them for things going wrong,  rather than getting things fixed.  Though 5 million people may be less impressed.

Tempting though it is to blame the UK authorities and the Brexit debacle, getting EMA approval has nothing to do with them. Serum Institute of India would have to apply. As the EU has not contracted to buy any Indian product that’s not something they’re going to do.

Its a wider point, recognising the authorisations of other countries. J&J not authorised in UK, but is in Europe.

EMA recognises

Comirnaty ( previously pfizer )

Spikevax (previously COVID-19 Vaccine Moderna)

Vaxzevria (previously COVID-19 Vaccine AstraZeneca)

COVID-19 Vaccine Janssen

They are reviewing, but haven’t authorised

CVnCoV

NVX-CoV2373

Sputnik V (Gam-COVID-Vac)

COVID-19 Vaccine (Vero Cell) Inactivated

Russia has been playing soft diplomacy and providing Sputnik to lots of countries, including some former Eastern European, but now EU, states who have authorised it outside the EMA framework. Quite what will happen to Hungarians and Slovaks wishing to travel isn’t quite clear. I don’t think Sputnik V can be uploaded to the EU Covid passport

 

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4 minutes ago, John Wright said:

Tempting though it is to blame the UK authorities and the Brexit debacle, getting EMA approval has nothing to do with them. Serum Institute of India would have to apply. As the EU has not contracted to buy any Indian product that’s not something they’re going to do.

I would have thought as it was AZ who were getting SII to manufacture the vaccine on their behalf, so it would have been AZ who would have had to get the approval - though SII would have needed to co-operate.  But the UK could in any case made it part of the conditions of their contract with AZ that such approval by the EMA was required. 

The annoying this is that there is probably not a great deal of work needed to get the required paperwork sorted out - no one seriously believes there is a problem with those batches.

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Jason Moorhouse MHK is asking Tynwald to create, fund and maintain a Covid memorial Garden in the South of the Island according to the 58 item Order Paper for next weeks Tynwald.

Not clear why the South but could that be due to Abbotswood being in his neck of the woods ? 

 

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