To have become a Brexiteer yesterday?

[Mentum]

I was so Remain, I was devastated when we left. But the EU trying to steal our vac and casually invoking Article 16 has really left me aghast. I can't believe they are lashing out this way, I don't understand why.

Now that they have got there "extra" doses will they be sending the majority to the EU members suffering the worst?

@wonble

Now that they have got there "extra" doses will they be sending the majority to the EU members suffering the worst?

Sure they will but probably only after the EU big players have taken there cut🤔

There’s a report by Guido Fawkes today showing a number of Labour MPs past tweets saying how appalling that the UK was opting out of the EU vaccination scheme.

However at least Catherine West has had the decency to apologise.

@Andante57

There’s a report by Guido Fawkes today showing a number of Labour MPs past tweets saying how appalling that the UK was opting out of the EU vaccination scheme. However at least Catherine West has had the decency to apologise.

To be fair I think it worried everyone a little at the time. I am not a brexiteer but in love with the EU either. However thought at the time I hope this bloody gamble pays off

Yes descent to admit she was wrong. Shows a sense of responsibility in her behaviour that few politicians seem to have.

[quote Blessex]@Frazzled2207 Macron’s comments over the AZ vaccine are dangerous. How he can not understand that is baffling. He is not acting like a grown up. He is the leader of a large country. The MHRA and the EMA have both signed this vaccine off but no, Macron knows better than all those experts. The arrogance is astonishing.[/quote]
I don't think the MHRA have signed the vaccine itself off. That is why they were able to implement the emergency authorisation at the time they did, without further information. It is only by batches. I have no idea where liability lies.

The EMA has given an authorisation for the vaccine itself, not just batches. That is why it took longer; as they needed more data for this level of authorisation. The MHRA, by their own guidelines, will rubber-stamp this EMA decision.

The mechanism should never have been used. It was created to be used for difficulty for NI anyway. Not the EU. The only thing is the grownups came along. Barnier must have been flabbergasted.

Obviously, it will be a court thing between EU and AZ. I see reports of AZ signing the contract saying they had no prior obligations to any other party. Stated manufacturing as including UK sites. Other concerns they are sending the vaccines produced in EU to fulfil UK orders (despite stating they had no other party obligations ). Probably not helped by the chappie stating they would fill UK order first, despite what they stated on contract.

Dangerous for anyone to say that vaccines etc should not be shared across borders. What if China stopped their products? We'd all be sunk.

I see the EU are setting up an agency for these sort of situations in the future. Thank goodness for that. Pandemics may become more common.

The EMA has given an authorisation for the vaccine itself, not just batches. That is why it took longer; as they needed more data for this level of authorisation. The MHRA, by their own guidelines, will rubber-stamp this EMA decision

so the EMA do all the leg work, get criticised for taking so long, the MHRA rubber stamp their work and we can all say how quick & nimble we are?

no - just a process ....we didn't wait for them.

remapconsulting.com/the-uk-will-follow-ema-regulatory-decisions-for-2-years-after-brexit-and-is-looking-to-speed-up-regulatory-access-in-the-longer-term/

[quote Floppywin]no - just a process ....we didn't wait for them.

remapconsulting.com/the-uk-will-follow-ema-regulatory-decisions-for-2-years-after-brexit-and-is-looking-to-speed-up-regulatory-access-in-the-longer-term/[/quote]
No, that is misrepresenting what happened. What the MHRA did was not just a quicker process of what the EMA did. The MHRA are only giving temporary emergency authorisation for batches of an unlicensed vaccine. They did not give a marketing authorisation for a licensed vaccine. The MHRA did not have enough data for that as it was not available at that time; for anyone else either. Any EU member state could have done the same thing (emergency) but they agreed to do it the way they did. I don't know if liability came to play. I think the AZ date was delayed in any event and so the EMA had to wait for it to be made available to them to assess the vaccine for their approval of a marketing authorisation of a licensed vaccine.

The EMA are licensing the vaccine itself for use - a marketing authorisation for the vaccine itself, not just batches of it. It is conditional as more safety data comes in it will be reviewed. However, they had to wait on more data for the procedure of giving a licence for the vaccine itself.

So a different end point for EMA. It was more than the emergency temporary approval for an unlicensed medicine. I don't know if the MHRA has given a marketing authorisation for the vaccine yet based on the work and decision of EMA.

From the horse's mouth, here is the MHRA website. Now sometimes there appeared to have been political diktat placed by decree on their website, as before Brexit they stated that everything would probably remain the same. To steady the horses, I shouldn't wonder.

For a period of two years from 1 January 2021, when determining an application for a Great Britain Marketing Authorisations (MA), the MHRA may rely on a decision taken by the European Commission (EC) on the approval of a new MA in the centralised procedure.

Great Britain refers to England, Scotland and Wales.
The intended operation of the ECDRP is submission of the Marketing Authorisation Application (MAA) to the MHRA immediately on receipt of a positive Committee for Medicinal Products for Human Use (CHMP) opinion, although applications can be submitted any time after the approval of a European Union Marketing Authorisation.

The MHRA aims to determine the Great Britain MA as soon as possible after EC approval. A delay in submission may affect the delivery of a decision within the 67-day timeline.

www.gov.uk/guidance/european-commission-ec-decision-reliance-procedure

Cailleach1 that is very interesting, and to see how comprehensive the EU system is for approving medicines.

Just to understand this properly, did the MHRA allow emergency use of the AZ product in GB only or in NI too? For the emergency application I mean, not the conditional one?

Regardless its the end goal that matters and they got it approved and out and were quicker with Pfizer , even if just as emergency use as maybe thats all they can do for now

Also notice use of the word may

How to vaccinate the world was very interesting today - acceptance that sometimes "nationalism" can be positive and sometimes "collaboration" can be slow and unwieldy. Of course, the key is to pick the right tool/people/process for the job - one process does not fit all.

@donewithitalltodayandxmas

Regardless its the end goal that matters and they got it approved and out and were quicker with Pfizer , even if just as emergency use as maybe thats all they can do for now

Thats only true if the vaccine is safe & effective longer term, we could have rolled it out after the ph1 or 2 trials on the "we must get it out in arms" logic.

Personally, if i'm putting something in my body and my DC's i want it tested and approved, even if that means a 3 week delay.

i think the EMA's approach was the better one.

wasn't safer - just slower ........

We are approaching 10m people - know which I'm happier with and most others too.

There are still apologists for the EU here....

Well they can get together and send the vaccines they would have received in the UK to their friends in France and Germany.

Bluethrough

Maybe that is why we vaccinated the over 80s first. If they had all snuffed it over night. We basic science morons and gamblers know not to use it on the younger worker age groups. ( I AM BEING SARCASTIC BEFORE ANYONE FREAKS OUT)

@Truelymadlydeeplysomeonesmum

Bluethrough

Maybe that is why we vaccinated the over 80s first. If they had all snuffed it over night. We basic science morons and gamblers know not to use it on the younger worker age groups. ( I AM BEING SARCASTIC BEFORE ANYONE FREAKS OUT)

Sarcasm hides a multitude of truths lol!

🤦‍♀️🤣🤣🤣🤣🤣🤣🤣🤣🤣

🙈🙉🙊

@Greenfox500

Cailleach1 that is very interesting, and to see how comprehensive the EU system is for approving medicines.

Just to understand this properly, did the MHRA allow emergency use of the AZ product in GB only or in NI too? For the emergency application I mean, not the conditional one?

Yes, it covered NI too. It was the national use of the emergency authorisation, so covered the whole of the UK.

You can see it is not a marketing authorisation.

This authorisation is not a marketing authorisation for the purposes of Part 5 of the HMRs or Chapter 4 of Title III to the 2001 Directive.

The Certificate of Conformance generated by the QP for each batch also being supplied to the MHRA to assess effectively makes it batch by batch.

A Certificate of Conformance stating compliance with GMP and the conditions of this Regulation 174 authorisation must be generated by the releasing QP and supplied to the first receiver (only) in the supply chain and to MHRA, to provide evidence of its authorisation status, indicating it can be released for use from its quarantine status

www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca/conditions-of-authorisation-for-covid-19-vaccine-astrazeneca

I want to point out that the EMA cannot use the emergency authorisation route. Only the member states can do that for their own countries. If they chose to do that, the EU member states would have used their own national Regulatory bodies and these are (or were) the equivalent to the MHRA. The EMA is not the equivalent to the MHRA.

The EMA deals with centrally authorised products. If approved by the EMA, this authorisation is valid in all EU member states at the same time. Only some medicines are required to be dealt with by the centrally authorised procedure. So all oncology, diabetes, vaccines, neurodegenerative and innovative medicinal products. The difficult ones. These are the ones that the MHRA will rubber-stamp for the two year period. It will be interesting what will happen at the end of that two years.

Most 'ordinary' medicines in the EU do not go through the EMA. They go through member states own national agencies; these are like the MHRA. Efficiencies have happened. So pharmaceutical companies can apply at national level (certain countries only), decentralised procedure and mutual recognition procedure. So, if a product undergoes assessment and approval in one member state, it can be recognised by the other states (subject to conditions).

It is not a tit for tat on EMA and MHRA; for those who want to make goodies or baddies out of regulatory bodies. The UK carried out the emergency authorisation. Any EU state could have done likewise. The EU members agreed to go the centrally authorised procedure route and the EMA (which needed more details to give a conditional marketing authorisation as they cannot use the emergency authorisation).

Short article on EMA and the vaccine approval.
www.politico.eu/article/eu-regulator-rejects-need-for-emergency-authorization-of-coronavirus-vaccine/

Succinct article by bmj on how the Covid vaccine was approved in UK.
www.bmj.com/content/371/bmj.m4759

I think this explains the indemnity route the British gov't decided upon.

UK government grants Pfizer civil legal indemnity for COVID-19 vaccine

The UK government announced Thursday that it had granted Pfizer legal indemnity protecting the American pharmaceutical company from civil lawsuits due to any unforeseen complications arising from problems with its COVID-19 vaccine. The special legal indemnity was the result of an emergency government consultation in September, when the UK Department of Health & Social Care determined that changes to civil liability were necessary to better facilitate the widespread use of a COVID-19 vaccine in Britain.

The new regulation, Regulation 345 of the Human Medicines Regulations of 2012, prohibits civil liability against Pfizer or healthcare professionals distributing the vaccine for any damage that arises through use of the vaccine “in accordance” with its recommended use. The Pfizer COVID-19 vaccine will, however, be scheduled alongside other vaccines subject to the Vaccine Damage Payments Scheme, which authorizes one-time payments of £120,000 for individuals who have been disabled in the rare case that a vaccine produces highly damaging side effects to patients. Such scheduling should allow claimants to still receive damages in the very unlikely event that they suffer serious side effects from the vaccine.

You can read the full article below.

www.jurist.org/news/2020/12/uk-government-grants-pfizer-civil-legal-indemnity-for-covid-19-vaccine/