Off Topic Coronavirus

Do you know that for a fact? Because my best mate works in the industry and told me differently. He said they are completely independent and wouldn't accept being pressured by the government.

 

Go and take your euro loving flag to Belgium Watford and ask them. I listened to the EuroNews report today and they even said said it was now easier for the UK. Sorry mate just accept and move on.

 

Maybe educate yourself rather than wallowing in **** Tory rhetoric.

 

It's got nothing to do with the Tories. Just try and be happy for once in your life that today we have done something good. I know it's hard for you Mr Doom and Gloom but today is a breakthrough and hopefully it will all go well and we can get back to normality.

 

I’m delighted. As ever it’s phenomenal work by the scientific community.

The point is that your lot are trying to link it to Brexit when it has nothing to do with it whatsoever, perhaps otherwise known as playing politics which I know you hate. This is covered by EU law for the rest of the year.

 

It isn't a fact. While EU countries choose to work together within the EMA via their national regulators, individual countries are entirely within their rights to approve a medicine not approved by the EMA. You can find a list of medicines approved by national regulators here: https://www.ema.europa.eu/en/medicines/national-registers-authorised-medicines

Until the end of this month EMA licenses are still valid in the UK, but the MHRA is [and always had been] able to approve medicines that the EMA is yet to make a decision on.

 

So are you saying we have broken the rules here?

 

mmm, until you mentioned the Brexit connection I was not wise to that information. Well if someone has connected it to Brexit then so be it. People like you will undoubtably see through those nasty Tory tricks. As being covered by EU law... have we not just broken it by saying we are rolling out next week and the EU haven't given it the go ahead?

 

Not at all, as I said, as a country which until the end of this month is adhering to EU rules we are allowed to authorise use of a medicine not approved centrally via the EMA. Germany could do the same if they wanted. It's not a criticism of the UK, it's great they've moved fast. It's simply false to say that we couldn't do this as an EU member - we've literally done this within the framework of EU law.

 

My original post you replied to was a tweet linking it to Brexit.

As I said, maybe go and educate yourself before going off on one.

 

Yeah I have just read that they EU will approve it next week. Probably still counting staples.

 

Has me quietly wondering if Windsor and Ellers talk to each other in their sleep - just saying

 

We’ll go for a pint once he’s been vaccinated.

 

Don’t think I’ve ever been involved in a UK only submission, never been enough cash in it. Cheers for the update.

 

What does your best mate do? You don’t need to tell me his name or the company he works for. The MRHA isn’t ‘completely independent’, it’s an executive agency, sponsored and reporting to the Department of Health. I’m pretty sure that the DoH, and by extension the politicians who are ministers in the department can set the MRHA’s objectives and priorities, and tell it to look at certain things quickly. I’d hope, and expect, that it couldn’t influence the professional assessments made, but I would not put it past them to try.

 

Business Secretary Alok Sharma said today “In years to come, we will remember this moment as the day the UK led humanity’s charge against this disease.”

For ****'s sake!

 

The target audience have bought it. Job done.

 

I despair.

Or I would if my expectations were any higher.

FFS indeed.

 

https://ted.europa.eu/udl?uri=TED:NOTICE:506291-2020:TEXT:EN:HTML&src=0


Anyone know what this is? The MRHA seeking to purchase a software/AI system to cope with the expected high volume of covid vaccine adverse drug reactions as the current system can’t be retrofitted to cope with expected volume.

 

I think you have answered your own question, it’s about volume. All drugs are subject to strict reporting of adverse events in those who take them (even if the adverse events are not related to the drug, they have to be recorded if reported). Vaccines would be included in this. But it’s very rare, in fact unprecedented I think, to give a new drug to tens of millions of people in this country in a very short space of time. So they need a reporting system which can cope with these huge numbers so that all those people who phone their GP because of a sore arm, or a brief fever, can be recorded.

It does not mean that they expect serious side effects, the trials would not suggest this, but the system is to protect future potential recipients if there are. Plenty of drugs (but a very small % of the total number properly assessed) have been withdrawn from the market because of side effects/adverse events.

If someone I’m talking to for some reason tells me that they are taking one of my company’s products, and, in a perhaps unrelated aside, mentions that they have had a few headaches, I am obliged to report this to my company, which would then pass the information on the the MRHA in this country. Any drug, like any food, has potential side effects and we need proper systems to make sure we manage these appropriately.