EU may not allow those vaccinated with certain AZ batch numbers travel

[Ilovemypyjamas2021]

How likely is it that this will happen? Panicking slightly as I’m one of those who’s first vaccine was from one of these batch numbers & I travel to the EU for work a lot never mind seeing my family overseas in the EU
www.telegraph.co.uk/global-health/science-and-disease/eu-vaccine-passport-excludes-5m-britons-given-indian-made-astrazeneca/

[quote Heyelp]@cathyandclare ah cross posts. Thanks! Yes seems EU red tape strikes again.[/quote]
No.

The EU has (so far) decided that visitors must be vaccinated with vaccine that would have been licensed in the EU. This is reasonable.

The issue with these batches is simply that the SII manufacturing plant is named on the UK marketing authorisation but not on the EU marketing authorisation. I understand AZ applied to have the SII plant added and this has been approved by the MHRA (months ago) and is yet to be approved by the EMA.

Given that the UK voted to leave the EU, the EMA has no need to prioritise the UK’s interests in its work to licence the vaccines. If the EMA was still based in the UK and shared work with the MHRA I expect the EU licensing decision would have followed the MHRA’s.

Given that there are now reports of several of the individual EU countries’ regulators having already approved/ are in the process of approving vaccine from the SII plant (remember, all EU countries retain sovereignty despite what Vote Leave told you) I expect this will be a storm in a teacup.

[quote Heyelp]@Grellbunt you are implying there is something lesser about the vaccine made in India. Not helpful. Its the same vaccine. It’s red tape.[/quote]
It is the same formulation but it is manufactured in a different plant. Every plant used must be individually approved. This is not red tape. It’s about quality and safety.

As I said earlier, the EMA and the MHRA used to share resources and approvals. Now they can’t. The U.K. created that red tape.

This doesn't just affect the UK, many Canadians, Indians, South Americans, North Africans etc etc are using the Covishield Vaccine. It seems odd that WHO approved vaccines are not accepted for travelling, even if not for giving to the population.

If your batch number starts with PV does that mean it doesn't apply to you?
Can't read the articles to check thanks

I can see why Brexit happened.

And absolutely nothing to do with issues on either the safety of the vaccine or the standards of manufacture. India manufactures many of the drugs supplied to Europe (both EU and non-EU). It's an admin issue.

Again, no. The EMA cannot extrapolate from one manufacturing plant to another, and certainly not all Indian manufacturers are OK. There were many recalls a few years ago because of records falsification at several factories.

The SII itself is on the marketing authorisation for other vaccines, but I understand this is a new plant for this vaccine so has to be individually approved. The MHRA did this but the EMA has not (yet). Pre Brexit this assessment could have been a joint exercise.

It’s important that the original research behind a vaccine is sound to prove safety and efficacy. But it’s equally important that it has been manufactured in a safe and consistent way. Huge numbers of people have been killed over the years by manufacturing errors in theoretically safe drugs. Approval of factories is crucial.

In this case I’m not worried about my vaccine, because it has been approved elsewhere, but approval of manufacture is not just red tape.

It's fair enough not to approve manufacture without lots of red tape. It's another thing to demand that each worldwide visitor's vaccine has been made in a facility that the EMA has inspected and approved.

Again, no. The EMA cannot extrapolate from one manufacturing plant to another, and certainly not all Indian manufacturers are OK. There were many recalls a few years ago because of records falsification at several factories

I wasn't suggesting it should.

I was seeking to reassure those who may have had vaccines from these batches that it is safe and that it is not risky to take medicines that are manufactured in India simply because of place of manufacture.

Yes, you can get bad batches for all sorts of reasons, and that can happen to manufacturing plants wherever they are located.

There are no reported issues with the manufacture of the AZ vaccine in India

@daisypond

Mine is one of those too. One of my DC has had the Sinopharm vaccine and that’s not approved by the EU - ironic as she had both vaccines in a EU country.

Good point. Hungary has mostly rolled out Sputnik and sinopharm neither approved by the EMA (with some pfzier and AZ). Will the EU prevent Hungarians travelling in the EU??

The EMA is slow. The WHO and the MHRA have already approved it. The EMA will approve it. It is just slow. That in my book is…….red tape!

@RoseAndRose

Again, no. The EMA cannot extrapolate from one manufacturing plant to another, and certainly not all Indian manufacturers are OK. There were many recalls a few years ago because of records falsification at several factories

I wasn't suggesting it should.

I was seeking to reassure those who may have had vaccines from these batches that it is safe and that it is not risky to take medicines that are manufactured in India simply because of place of manufacture.

Yes, you can get bad batches for all sorts of reasons, and that can happen to manufacturing plants wherever they are located.

There are no reported issues with the manufacture of the AZ vaccine in India

Ah OK sorry - you’re completely right to point this out. I also would have had no concerns at all if I had had one of the SII batches.

Thanks Wise

It's very easy to make mistakes and write in ways that can be read in different ways to that intended, and good to be able to clarify!

@Heyelp

The EMA is slow. The WHO and the MHRA have already approved it. The EMA will approve it. It is just slow. That in my book is…….red tape!

No it is not red tape. Red tape is unnecessary regulatory or administrative hurdles. None of the regulatory hurdles in bringing a novel vaccine to market are unnecessary.

Speed (or lack of it) and alternative priorities are not red tape per se, although of course red tape could be a contributory factor.

@cathyandclare

This doesn't just affect the UK, many Canadians, Indians, South Americans, North Africans etc etc are using the Covishield Vaccine. It seems odd that WHO approved vaccines are not accepted for travelling, even if not for giving to the population.

This! This issue isn’t about Brexit and it’s barely even about the UK. Whether it is fair or ethical behaviour in a pandemic is a value judgment. But if you read the article, you will see who is most affected by it.

@RoseAndRose

Thanks Wise

It's very easy to make mistakes and write in ways that can be read in different ways to that intended, and good to be able to clarify!

Ain’t that the truth. 🙂

India hasn’t applied for approval yet

That’s why it’s not approved

Nothing to do with safety or effectiveness

And most countries accept it so let’s not scaremonger!

@sashagabadon
as a hungarian currently in hungary: yes, ppl with sinofarm and sputnik have diff travel restrictions.

I don't get the uproar. The point of this is to keep population safe. If the EMA has not approved something how could they possibly say, fine, come in, we believe you.... ?

Why does anyone believe that the manufacturing plant in India has been inspected and is up to standard?
I think that if companies can cut corners they will. And not because of spite or malice, just inherently how they work and it seems a good idea to them.

@Watapalava

India hasn’t applied for approval yet

That’s why it’s not approved

Nothing to do with safety or effectiveness

And most countries accept it so let’s not scaremonger!

There is one point I agree: don't scaremonger but I don't agree on the other point: the approval/regulatory process is there to make 100% sure that no contamination happens, everything is up to spec. Why should I believe that everything is fine because they say so? You'd never buy a car put together by joe smith in his back yard even if it had the Fiat emblem on it. Or fly on a plane type that is not approved by the FAA. Companies do not have people's best interest at heart usually. It's the profit and keeping the board happy that motivates them. Which means cutting corners.

Why does anyone believe that the manufacturing plant in India has been inspected and is up to standard? I think that if companies can cut corners they will. And not because of spite or malice, just inherently how they work and it seems a good idea to them.

Because the MHRA has inspected it and said it’s up to standard.

@WiseUpJanetWeiss
I would say fair enough, but lately I am questioning the MHRA and JCVI and other so called independent agency.
So, imo, the more agencies say fine, the more relaxed I will be. Just MHRA saying is not good enough.
Btw - is the detailed inspection report a public thing? don't google, I can do that, just if you know.

For travel it’s a non issue

@ATieLikeRichardGere

This does sound a little bit um…discriminatory? I was going to use a more serious word there but I stopped myself. But, like, this does seem like it will disadvantage some particular groups.

Racist.

It's a valid point that some people are discriminated for something that they didn't have a say in, fair point.
But on the other hand in most EU countries kids can't go to kindergarden until they have their full vax regiment up to date. Because it is not about individual discrimination, but public health measures. So is this. Unfair, but on a societal level needed.

Imo, I'd be more outraged at India manufacturer/AZ who didn't start the approval process or AZ who distributed these doses fully well knowing that they are not approved by EMA. Or gov not aligning with our closes neighbour.

There is quite a list of who should have done what to prevent this. It could have been avoided and to not disrupt ppls lives. But EU allowing an unapproved vacc should not be the talking point.

I don't think the headline is strictly true.

The EMA are saying one thing but national states are saying another in terms of what it means for British Citizens and are prepared to just count it as AZ rather than Covishield. (It sounds like Austria, Germany, Slovenia, Greece, Iceland, Ireland, Spain and Switzerland at least are fine with it).

The EMA don't actually have legal power to bar Brits and thats the significant part.

The other thing is that it depends on how the UK certify Brits. By the sound of it, they are recording all AZ vaccinated Brits under the Vaxzevria AstraZeneca brand so that you can't tell the difference between who has had the EMA approved EU manufactured vaccine and the Indian manufactured vaccine. Its unlikely to mention batch so no one at the border will be able to tell.

I think the situation with the US is more difficult as AZ isn't approved there and its apparent that talks to open a travel corridor with the US are stalling because the CDC hasn't approved AZ (or Covishield).

The UK has some more leverage here I suspect because I think this potentially would fall under the remit of the ECHR and there would be arguments on the basis of discrimination. Its worth noting that those who got the Indian batches will have been vaccinated in March / very early April so will be mainly those in their 50s. Thats going to include people who may need to travel for work too.

The key stumbling block is once you've had one vaccination, you can't exactly go back and take another one just to pass immigration.

So at some point there is going to have to be proper international cooperation on this - particularly with countries that have close links to each other.

I'm not particularly worried (I'm actually one of those affected). Its just needs so heads banging together on the paperwork.

Lets be honest, why on earth would tourist destinations that rely on British visitors want to stop fully vaccinated Brits (and importantly EU citizens resident in the UK) from coming just because they have the wrong batch number?

The MRHA is still highly respected and checked these batches coming in to British standards. Whilst we aren't in the EU, EU countries aren't out of their minds either - and not recognising Brits as fully vaccinated on the basis of batch numbers makes no sense to anyone whatsoever.