Did you know about this back door vaccine consultation?

[tinkywinkyshandbag]

Doing the rounds on social media. I've responded. Whichever side of the vaccine debate you sit on this is important.

After 18th Sept, The Government are going to say they consulted the public and because there were no objections, we all want and consent to the rollout of unlicensed #vaccines, and that we are happy for non-medical staff to administer them and happy to accept we will not have the ability to ask for compensation if we face damage to our health.

They are going to say, you agreed to it (because no one saw this #Consultation request to share their opinion of course), this request is not being seen by many and has not been promoted widely enough.

Please don’t fall into apathy and then complain when it’s too late.

NB: click on the photo and then look for the blue ‘respond on line’, click on the words to go to the right place to share your views on each aspect of the potentially harmful new law they want to pass.

Please reshare this and make sure you contribute!

www.gov.uk/government/consultations/distributing-vaccines-and-treatments-for-covid-19-and-flu

The proposals would expand the workforce that can administer COVID-19 and flu vaccinations under an NHS or local authority occupational health scheme so that it also includes midwives, nursing associates, operating department practitioners, paramedics, physiotherapists and pharmacists.

Every winter in hospitals across the country we have “peer vaccinators” administering the flu vaccine to colleagues. They are trained and have to complete a pgd but all those in the jobs listed above are allowed to vaccinate their colleagues. This is completely normal so get a grip and stop scaremongering!

@PinkSparklyPussyCat our vet is more friendly than most nurses I’ve met

Many parents I know are reluctant to agree to fast tracked novel vaccines, the vast majority of whom happily followed the normal vaccination schedule for the children. The government definitely shouldn’t assume that it’s a small group of anti-Vaxers who have qualms.

They will need to really up the trust levels and the quality of their information if they want mass compliance.

I was not aware of this and I do not agree with it.

Whose partner has had to give them blood thinning injections after a c-section? Mine has, twice. He’s not medically trained, squeamish, and a bit crap on detail (shit at DIY, for instance). I am
still here. If the thing doesn’t have to actually go into a vein, anyone can do it - it’s finding veins that’s more tricky. I think most vaccines go into muscle.

@everythingthelighttouches

I don’t know why everyone is focussing in the actual immunisation by someone trained to deliver it.

I’ve read the consultation document and the bit I’m trying to understand better is that it will be given in mass vaccination program without being licensed.

I understand the need to speed things up wherever possible and I’m totally comfortable with the overlapping phI-III trials. I also understand that governments are taking the risks and mass manufacturing already.

Approval by a regulatory authority l, like the FDA in America or the EMA in Europe is standard practice for all drugs and devices.

Here, the U.K. authority (MHRA) will be able to give the go ahead without formally licensing the drug.

So what step is missing? What is not being done that would normally be done in the assessment for licensing?

They say the MHRA still need to be satisfied on safety and efficacy, but that’s exactly what the approval process does, so us this “licensing lite” ???

Can anyone more in the know explain?

Yes I’d like to know this. It seems to go hand in hand with the civil liability act as well. Do basically if the vaccine fucks you up you can’t sue!!

Children are still being paid out from developing narcolepsy to the swine flu vaccine - no chance!

I have the free flu vaccine yearly and often get it done at the chemist to save waiting too long for a nurse appointment at the GP practice.

taking blood is a lot more difficult (especially mine ask my phlebotomist) than doing an injections -

The issue is not who will be giving the injection but the proposal is:

“-authorising temporary supply of an unlicensed product
-civil liability and immunity”

An unlicensed product could be injected in to you, and you will have no recourse against the manufacturer of that product.

This should be of concern to everyone imo

This is what doesn't sit well with me... from that BBC article posted earlier:

"In addition, the consultation - which seeks to amend the Human Medicine Regulations 2012 - will look into ways to protect companies that manufacture and distribute the vaccine, should it cause any harm.

This is to prevent them from bearing the risk caused by decisions made by government to roll out unlicensed vaccines, in order to protect the health of the public."

Basically the government want to be able to give us an unlicensed vaccine with no recourse should there be serious health implications afterwards. They are playing on our fear of the virus and assuming we will all want a vaccine no matter what the cost. I hope they don't bundle it in with the flu vaccine.
This should have had far more publicity and if they only wanted relevant comments from clinical researchers etc, they shouldn't be calling it a public consultation. We all have a vested interest in this.

Exactly what you said @RelapsedChocoholic its scary they are even considering this

I work in medicine regulation and my company are one of the front runners making a vaccine. Believe me there is no back door option. The development and approval process is being fast tracked but no corners are being cut. And the vaccine sales will be non-profit. So no pharma bashing please. We're doing a great job!

Isn’t this the second thread on this topic just this week??

@Scottishgirl85

Not everyone trusts pharma, the sector is not always snow white. This vaccine is so important there will have to be transparency and trust.

It would be naive of government to dismiss vaccine fears, we need to understand why it exists and engage early.

Apparently 50% of Greek citizens not keen to have the vaccine we could easily see similar issues here without care taken to engage with and explain to the public.

They're not planning on co-opting your bin man to give you a vaccine on his way out the gate with the bins FGS. If you read the paper properly, almost all the people on the list will probably already know how to administer a needle - midwives, paramedics pharmacists etc., and it doen't take long to train someone how to administer a vaccination.

And the product will be 'unlicensed' not untested - it just means that due to the severity of the situation they want to be able to roll the vaccine out without having to spend a long time on the paperwork. The vaccine will be as stringently tested as any other vaccine. They are not going to roll out a vaccine that will adversely affect millions.

The science needs to be properly explained so everyone knows exactly what's happening, but please stop listening to some idiot on Facebook over the medics and scientists, the epidemiologists who have made the study of vaccines their life's work.

The crud being spouted on social media will likely be the cause of the world crumbling in a heap because too few people will have the vaccine and we'll all be suffering for far longer than we need to, more people will die of Covid, more people will have their mental health seriously damaged by the restrictions and the economy going down the pan.

the NHS uses 50 odd unlicensed drugs, as well as loads off label which aren't licensed for that particular condition. Licensing doesn't mean it hasn't been tested.

As for administering it is they've been trained, fine. My 72 year old dad injects himself every week, and 11 year old kids manage their insulin injections. There'll be someone medical on hand to oversee and deal with adverse reactions.

Fb , before I deactivated last week, was full of hyperbole about making it compulsory because it says something like 'manage and organise the vaccination programme' , which if course needs managing and organising. And that noone would be able to fly out get a passport without it. Did my head in. Nothing would surprise me with this shower, but they couldn't do that based on this act.

One of the groups who will be authorised to give vaccines are vets - as they manage to vaccinate squirming pets and angry bulls, I think they are more than qualified to prick my arm!

The unlicensed products are most likely to be drugs tested in other parts of the world - to get licenced in the U.K. they have to run trials specific to us normally.

Scottishgirl85

“I work in medicine regulation and my company are one of the front runners making a vaccine. Believe me there is no back door option. The development and approval process is being fast tracked but no corners are being cut. And the vaccine sales will be non-profit. So no pharma bashing please. We're doing a great job!”

Can you explain what is the difference between a drug being licensed and what will happen in this instance?

@everythingthelighttouches Marketing authorisation applications are not yet filed, as phase 3 trials only just started. In normal situations the vaccine would be at least a few years from license approval at this stage. The European Medicines Agency is looking at lots of ways to speed this up. Options include rolling review of data as it becomes available from the trials (rather than waiting for all data to be available and submitting all at once), and conditional approvals where less comprehensive data is needed upfront with commitment to provide in near future from ongoing trials, but benefit-risk analysis must already be proven positive. There is a lot of information on the EMA website. Testing will be thorough, it is the way we get the license agreed with EMA and European Commission that needs to be adapted.

Of course Brexit will be interesting, as UK will not be under the EU Medicines Legal Framework from 01 January... The impact to access to medicines has in my opinion always been the worst aspect of Brexit...

@RelapsedChocoholic

The issue is not who will be giving the injection but the proposal is:

“-authorising temporary supply of an unlicensed product
-civil liability and immunity”

An unlicensed product could be injected in to you, and you will have no recourse against the manufacturer of that product.

This should be of concern to everyone imo

I am not sure that’s quite true

I haven’t looked into it in much detail but I had thought if there was negligence you could still take action. Drugs and vaccines have strict liability (ie without proof of negligence) and I think it’s THAT that’s proposed to be removed. I have a feeling this has also been done for other drugs and/or vaccines but maybe someone who works in the field can clarify?