Government proposal around distributing unlicensed covid-19 vaccine

[redferrari]

Government proposal around distributing unlicensed covid-19 vaccine

The government are running a public consultation up until 18th September 2020 around their proposal for authorising a temporary supply of unlicensed COVID-19 vaccines and the civil liability and immunity that is associated to this matter.

This impacts all of us however we have a say and can influence decision as we deem appropriate - ways to respond: Respond online (via link provided below) & comment on of the 5 areas offered* share your views on each aspect of the law they want to pass.

[[https://consultations.dhsc.gov.uk/5f43b8aca0980b6fc0198f9f]]

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

[Edited by MNHQ to remove capitals]

I hope it's ok to share this. I feel this is important information and more people should know about this to have a say

No need to shout.

They cant make any vaccine mandatory, its against human rights. Any suggestion that they would do so is ridiculous scaremongering. Not to mention, considering they cant even make enough tests for everyone, I fail to see how they would ever manage to make enough vaccine. If anything, itll be roled out like a flu jab for the elderly and otherwise vulnerable. If they manage to even make one that is.

I think it's scaremongering to imply that an untested vaccine is to be unleashed.
As I understand it from another thread, the proposal is just about getting it all in place while the formalities are completed.

I do apologize for upper case. I pasted from a whats app message and didn't realize it was all in upper case (loading dishes on one hand), Is there a way to request editing the heading?

@redferrari I agree with the government proposal thanks for the information, it’s positive news.

Isn't flu vaccine mandatory especially in schools?

They won’t make it mandatory as such, but they could potentially put restrictions on things like travel (can’t fly without a vaccine card) kids must have a vaccine to attend school etc.

I’m not one for a conspiracy theory, but they are ways of making the majority of the population have one without making it mandatory.

Flu vaccine isn't mandatory! Why on earth would you think that?

There’s already been a thread on this op

@redferrari

Isn't flu vaccine mandatory especially in schools?

Eh? Of course it isn't don't be ridiculous!

If they offer me a chance to remain healthy, keep my family healthy and ensure my lovely MiL lives into her 90s - fantastic.

This consultation is aimed at professionals in the pharmaceutical industry and in medicine who know what they're talking about.

I'm neither of those but I'm not scared of detail so I had a nose the other day after a similar thread was started. The legal framework already exists for unlicenced medicines to be distributed in certain conditions of public health threat.

The proposal is that these regulations are amended to make clear that conditions can be attached to this type of temporary authorisation:

To provide transparency, we propose to amend the HMRs to make it explicit that the supply of products, including COVID-19 vaccines, which is temporarily authorised under regulation 174 may be subject to conditions. The imposition of conditions enables the licensing authority to define the safeguards that are a pre-requisite for the safe supply and use of the product and without which authorisation would not be valid. This can range from specifying whom the product is suitable for, setting batch testing and quality assurance standards, and ensuring that appropriate storage is in place throughout the supply chain. Given its importance, it is appropriate to articulate this element of the licensing authority’s decision-making more fully in the legislation.

It will be the government who decides that a certain vaccine can be given a temporary authorisation, not the pharmaceutical companies or manufacturers. It's therefore only fair that the buck stops with the government. Why on earth would they agree to supply the UK with such a massive legal threat hanging over them if anything went wrong? It's not like they lack other markets around the world ...

To be clear, before any vaccine gets temporary authorisation while waiting to be licensed it will already have been through all the necessary trials to ensure it is safe and effective.

There's nothing in this about mandatory vaccination

Out of interest, how did you respond to this consultation OP?

Pp- the first bullet point in the first link. Though technically it's about not making it mandatory.

Unlicensed does not mean untested, and as a pp pointed out, prescribing unlicensed medicines is not a new thing.

www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/prescribing-and-managing-medicines-and-devices/prescribing-unlicensed-medicines

Woah fucking hell!

Making vaccines mandatory is not mentioned AT ALL in the consultation document but you're right - there it is as bullet point 1 on the response form:

Do not create powers to make receiving a COVID-19 vaccine mandatory for the UK population.

That whole list of bullet points reads very strangely when compared with the consultation document.

Did you actually read the documentation op?

@LangClegsInSpace

Woah fucking hell!

Making vaccines mandatory is not mentioned AT ALL in the consultation document but you're right - there it is as bullet point 1 on the response form:

Do not create powers to make receiving a COVID-19 vaccine mandatory for the UK population.

That whole list of bullet points reads very strangely when compared with the consultation document.

Aren't the bullet points just listing what the proposed changes don't do? Possibly because some people who are not the intended audience are posting links to it online and saying it's a consultation about unlicensed or mandatory Covid-19 vaccines?

I've now clicked through to the actual questions:
-------
Please provide comments on the area(s) of changes proposed, below.

Temporary authorisation of the supply of unlicensed products
Civil liability and immunity
Expansion to the workforce eligible to administer vaccinations
Vaccine promotion
Provisions for wholesale dealing of vaccines
---------
The questions relate to what is discussed in the consultation document. They bear no relation to the bullet points on the landing page:
---------
The proposals we are consulting on:

• Do not create powers to make receiving a COVID-19 vaccine mandatory for the UK population.
• Do not create powers to rush through development of a vaccine that has not been subjected to extensive clinical trials and a thorough assessment of the evidence.
• Do not create powers to rollout an untested vaccine for the UK population. Clinical situations can and do arise where the use of an unlicensed medicine is necessary in the absence of a licensed alternative. They are only recommended when the UK licensing authority is satisfied there is robust evidence to show the safety and efficacy standards for the medicine have been met.
• Do not create powers for untrained personnel to administer the vaccine.

---------

I bet you 2 bags of flour they have been hacked. This is what that landing page looked like on 2 September:

<a class="break-all" href="https://web.archive.org/web/20200902150211/consultations.dhsc.gov.uk/5f43b8aca0980b6fc0198f9f" rel="nofollow" target="_blank">web.archive.org/web/20200902150211/consultations.dhsc.gov.uk/5f43b8aca0980b6fc0198f9f

Isn't flu vaccine mandatory especially in schools?

Honestly, where on earth did you get that idea from.

As to the rest of your "info", I think that has already been shared multiple times on MN. It's the usual social media scaremongering bollocks.

Aren't the bullet points just listing what the proposed changes don't do? Possibly because some people who are not the intended audience are posting links to it online and saying it's a consultation about unlicensed or mandatory Covid-19 vaccines?

No, there are a near infinite number of things the proposed changes don't do. If they wanted to reassure people the consultation was nothing to do with making any vaccine mandatory they would have discussed it in the consultation document.

Look at the language used in that bullet list. It's extremely biased and bears very little relation to either the consultation document or the actual questions asked in the response form.

I have responded to an absolute fuckton of government consultations in the last few years (sad hobby) and none of them read like this. This is not normal.

If they haven't been hacked then someone at DHSC has gone very badly rogue.

Thanks a lot for those who explained this in detail. I do not have much knowledge about proposals by my interpretation was there could be distribution of unlicensed products if it's authorised?

In my area, schools we are chased to sign the flu jab consent form before the deadline. I forgot to do it once but got a call to remind me. I am not sure if it's the LA mandating it or teachers just wanting to be safe.

I have nothing against it but wondering how covid vaccine will be rolled out.

Look at the language used in that bullet list. It's extremely biased and bears very little relation to either the consultation document or the actual questions asked in the response form.

True. The language does seem a bit strangely written to my eyes aswell, I had to read it a few times to understand what was being said. I think it was the "do not" being in each bullet point, rather than at the end of the preceding sentence. I assumed it was just badly written but perhaps it's more than that.