MHRA approves Pfizer jab for use in UK

[AuntieStella]

News just breaking on BBC

[quote purplefig]@MyPersona also if you’re referring to me I was on here this morning and just now, so I most certainly haven’t been posting links all day.[/quote]
Well you’re certainly making the most of the time you are here to foster dissent and spread misinformation, so let’s not get bogged down in semantics.

MarshaBradyo I can't comment on worldwide issues, but if I start on examples of undue pressure within the UK I'd be here all day
There's a useful link below - admittedly from 2016 and about regulators generally rather than just the health sector - which sheds some light on this. It's hellishly long, but even just the Executive Summary at the start underlines the need for a lack of complacency

assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/554817/Striking_the_Balance__web__-_v3_220916.pdf

www.theguardian.com/society/2020/dec/02/uks-triumph-at-approving-covid-vaccine-must-not-become-a-chest-thumping-exercise?CMP=Share_iOSApp_Other

That Guardian article fgs. God nothing useful to say just noise. Lady what is interesting about it to you?

Thanks Puzzled will read later

Actually, although not always a fan of the Guardian, I think that it summarises the situation very well.

As a former pharmaceutical industry professional some of the comments on here make my blood boil. A huge number of dedicated regulatory professionals at the MHRA have worked really hard to review the data as it came in (on a rolling review which means that you don't wait for a complete file) so that we can get a vaccine approved in record time, to hopefully put a limit on a major public health crisis which has so far resulted in 70000 deaths in the UK.

By all means don't have the vaccine if you don't want to, but do understand that your future freedom from risk will be as a result of others making a different choice.

But more importantly, don't make unfounded attempts to smear those hardworking regulatory staff, in an attempt to recruit others to your cause. This just demonstrates your complete lack of integrity.

@LadyBishyBarnaby

Actually, although not always a fan of the Guardian, I think that it summarises the situation very well.

In what way?

It’s just a leftist piece trying to find fault.

The safety profile is just as good, with nothing more than the likes of sore arms and headaches in some volunteers, which is normal for vaccines. The trials include 43,000 people, so there is a lot of data already in the use of this vaccine and most serious side-effects should have shown up by now if there are any.

But it’s confidence in the vaccine and willingness on the part of those at risk to take it that is at stake now. That is not helped by a fight to be first.

Do it all looks good but the only issue is we’re first. So what? Demand will outstrip supply.

@elastamum

As a former pharmaceutical industry professional some of the comments on here make my blood boil. A huge number of dedicated regulatory professionals at the MHRA have worked really hard to review the data as it came in (on a rolling review which means that you don't wait for a complete file) so that we can get a vaccine approved in record time, to hopefully put a limit on a major public health crisis which has so far resulted in 70000 deaths in the UK.

By all means don't have the vaccine if you don't want to, but do understand that your future freedom from risk will be as a result of others making a different choice.

But more importantly, don't make unfounded attempts to smear those hardworking regulatory staff, in an attempt to recruit others to your cause. This just demonstrates your complete lack of integrity.

Exactly

Agree with you @elastamum

@Retiremental How bloody dare you insinuate that I am lying about my grandma being ill with covid. Just how dare you! She is 91, is in the early stages of dementia and now has this to contend with, along with her existing health issues.

We are well aware exactly WHO has been in contact with my grandma, as the rehab unit have been totally transparent with the family member who is the point of contact.

I have NO idea why you have got such a bee in your bonnet, but the rehab unit are satisfied they know how my grandma caught covid and, unlike you, I trust their professionalism enough to believe them.

I have no idea WHAT your agenda is lady, but you are very, very wrong and bloody offensive in your insinuations.

MarshaBradyo - no, it’s not trying to find fault, it describes the situation as it is. I recognise that sometimes the Guardian can be accused of being “leftist” and can be its own worst enemy but that is a balanced article, which summarises the present situation well. One notable point is that the UK government had tried to portray this as a Brexit triumph but the drug has been approved for use under existing legislation that allows a national regulatory authority to approve a medicine for emergency use ahead of the EMA in an emergency situation, and the MHRA has emphasised that. Brexit has not enabled this but has made it more of a priority due to potential Brexit-related supply chain issues from 01/01/2021.

@LadyBishyBarnaby

MarshaBradyo - no, it’s not trying to find fault, it describes the situation as it is. I recognise that sometimes the Guardian can be accused of being “leftist” and can be its own worst enemy but that is a balanced article, which summarises the present situation well. One notable point is that the UK government had tried to portray this as a Brexit triumph but the drug has been approved for use under existing legislation that allows a national regulatory authority to approve a medicine for emergency use ahead of the EMA in an emergency situation, and the MHRA has emphasised that. Brexit has not enabled this but has made it more of a priority due to potential Brexit-related supply chain issues from 01/01/2021.

Yes they did and MHRA put that to rest and I’m completely ok with that.

But honestly could they not muster an ounce of positivity. This is it! We could be facing economic decline and further disaster beyond what we can imagine right now but now we are not. It’s a scientific triumph. But no just pick pick pick. Sod em. Radio has been better.

I'll have the vaccine thanks. But am in a low cohort so might not make the cut in the early stages.

A few things I think about are....

A. the lack of evidence that the vaccine will make the recipient immune, that is not known.
B. How long the effects of the vaccine will last, that is not known.
C. Two shot doses, and the logistics attached to that.

But look, no doubt it will all be ironed out soon enough. It is positive news, but honestly.... I can understand how some are wary, but hopefully they won't always be.

Cannot people understand that everything in life has a risk?

• driving a car, risk of dying in an accident
• eating chocolate, risk of choking
• smoking, risk of lung cancer
• take the dog for a walk, risk of getting tangled in its lead, falling and striking your head on the pavement

So stay at home on the sofa, and run the risk of a DVT because you’re sat on your arse all day.

NOTHING (including vaccines) is completely safe - everything is a trade off. Just use your common sense (I realise I’m overly hopeful judging from some of the comments on here).

I find it amazing that just a few months ago we were resigned to there never being a vaccine-like for AIDS- and now there IS a vaccine defying all odds, it is still apparently an overwhelmingly bad thing.

Aaargh I meant HIV.

1. MRNA vaccines have not been approved for use before (outside of clinical trials) They have been srudied for over a decade, developed for things like flu, Zika, rabies. It's just that this is the first application they've worked through. It carries no live virus, irt doesn't enter a cells nucleus. They have worked on this, developing new technology, delivery systems for a decade. It is new, not unknown!

2. We don’t know if this vaccine stops you getting the virus, just that it lessens the symptoms in some cases (so I’ve decided at this stage the benefit is not worth the risk for me) It won't be offered to you. As has been discussed her, forever it seems, it has some issues that restrict access.

3. I understand why this vaccine has been developed in record time (unlimited funding, and the brainiest brains working collectively etc.) but none of that replaces time. At this stage we just don’t know what the long term side effects are. Hope there won’t be any serious ones, but the fact remains we don’t know. OK! That's the same with every vaccine, every medication ever. There have been some trials, as deemed essential by the MHRA, EMA etc etc etc and have, apparently, met all the USUAL standards. Time is maybe not as important as you think in understadning the potential issues

This trial isn’t even scheduled to end until 2023. Don't do that! The extended timeline is to do what you say is currently lackng... to collect longitudinal data to support further testing, improvements etc.

There are legitimate issues to consider. But they seem to be around efficacy and longevity of the vaccine itself. Which will be the same for every vaccine currently in development. But there is a vast swathe of epidemiological data out there... I am sure any scientist involved in that part of the assessment and testing will have a best guess that will be far more informed than anyone posting heer, writing doom and gloom pieces in the media and anyone unravelling across SM!

The government has announced a campaign to stop misinformation about the vaccine. Mn would be a good place to start.

No one is going to force anyone to have the vaccine. It’s personal choice but don’t dismiss the life changing benefits. I’m in a low group to receive the vaccine but can’t wait. I want my life to return to normal. If others don’t, that’s their decision.

I am as left wing as they come, but I think it is very mean spirited of the Guardian. The fact that the vaccine has been approved is thanks to the hard work of people at the MHRA in utilising the temporary authorisation mechanism. The EMA has said it will make its decision by 29th December and will be on the basis of a full licence, hence the longer time scale.

If the Brexiteers want to chest beat about this, I really couldn't care less.

I suppose there will be a slight problem if the EMA finds a reason not to authorise the vaccine! But can't see that happening.

Completely disagree, lies need to be called out, just like misinformation.

Celebrate the vaccine, stop the lies, all lies.

I believe that you are lying about being told by the rehab unit, that an individual nurse has been named and confirmed as the source of the infection

Well @Retiremental you are very wrong indeed. I am not going to waste my time trying to persuade some sick random on the internet, that I would not lie about this. What the actual point of that would be, I have zero idea.

You believe what you like. It says so much about you that you have such unsubstantiated, ugly thoughts about others. Perhaps don't judge everyone by your standards of behaviour? Some of us like to aim higher than that. So much for #bekind!

TBF Retiremental, you are being a little naive if you seriously thing that all individuals within a care environment play things by the book. Someone I know had nightly conversations with someone from the carehome, when her DM was sick with Covid, feeding her with all sorts of details that she shouldn't have been given.

Different homes behave in different ways.

@Parker231

The government has announced a campaign to stop misinformation about the vaccine

And who should be judging what is classified as misinformation?

I've been reading all these threads and have seen utter misinformation being spouted by both sides (those ferviently supporting the vaccine and those who are cautious)