Unlicensed Vaccine Consultation - Warning

[WholemealTrapeze]

To worry about the government wanting to roll out an unlicensed vaccine with no one being responsible if things go wrong?

As well as thinking this is being sneaked through without the public realising?

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

You are definitely not being unreasonable I think more people need to read this.
They want the powers to give the vaccine unlicensed, via wholesaler who are not the usual supply chain by people.who have never given a vaccine before.

They want it done so that there will be no come back for them.
I mean what could go wrong?

This will only increase vaccine scepticism. For the process to work there must be trust

That's one step away from compulsory vaccination.

Can anyone that has voted that the op is bu comment on the first two points please.

I can understand why the UK Govt may want to do this. Until the end of this year, EU legislation requires such medicines to be authorised via the European Medicines Agency, but from next year the Brexit transition period will have ended. We need to have a mechanism in place to be able to quickly get out a vaccine to the masses.

If we can temporarily authorise unlicenced products (not unsafe, just unlicenced) then why can't we actually speed up licencing? I assume licencing has to take place before a medicine/vaccine can be given to the general public?

Why can't there be a temporary law that allows for anyone suffering adverse reactions from an unlicenced or temporarily-authorised medicine/vaccine to be able to claim compensation and why can't that compensation process be made very easy in the current unprecedented circumstances?

If pharmaceuticals aren't held to account (and the only way to hit them is financially) then there won't be the same onus on them to be extremely strict in determining the safety and efficacy of medicines/vaccines.

I will not be vaccinated by an unlicenced product or a temporarily-licenced one if there is no come-back on the manufacturers and/or distributors.

There has been discussion about this already: www.mumsnet.com/Talk/coronavirus/4010458-Government-Covid-19-Consultation.

The unlicensed product immunity relates to delay in getting EMA approval following successful testing, there is turning there that would allow roll-out before testing is approved. The unlicensed person immunity is to allow the armed forces to distribute, but adding a safeguard that they have to abide by restrictions (because the expected vaccine must be kept at lower temperatures, this is an addition to the law that probably should have been there before but just wasn't thought of because it wasn't applicable to other vaccines). Also immunity for those giving the vaccine would allow additional training (e.g. Army) or those with skills but not licensed to vaccinate humans (e.g. Vets, Dentists) to give vaccines.

*nothing not turning

In fairness, unlicensed medicines are already commonly in use. I have a rare condition for which there is no licensed treatment. I've been successfully treated with two different medications used off-licence. This definitely needs scrutiny but unlicensed doesn't necessarily mean untested or unsafe.

If I've read this properly then the government who ok the use of an unlicensed medicine or vaccine would be liable rather than the manufacturer or person who administer the drug/vaccine.
This is reasonable as the poor nurse who has to administer the vaccine should not be sued just for doing their job

Surprised there isn’t more reaction.
Perhaps people are just desperate for a vaccine and accept that it won’t be tested as long as others.

Isn't the point of the "moonshot" to create a "1st class citizen's passport": you can only go out & go to work IF you tested negative that day. Everyone else will be allowed only restricted movement until they get a clear test.

As for unlicensed vaccine, meh. Doesn't worry me.

@WholemealTrapeze - says that the vaccine must have completed testing and be waiting for licensing. So that doesn't apply.

I don’t see the problem personally. All they’re trying to do is temporarily remove the red tape aspect of the process to allow the vaccine to be used at the earliest opportunity. It will have been stringently safety and efficacy tested. Do we really want to delay the administration of a safe and efficient vaccine to those most at risk, when instead we could potentially have families together at Christmas and stop people dying from this horrible virus? For what purpose? So that the paperwork can be rubber stamped? Imagine how you’d feel if your loved one missed out on the vaccine by 2 weeks for the sake of a piece of paper?

Why can't we just have informed consent for the initial doses? Adults with capacity should get to choose between the risk of a nearly ready but not quite gone through all the protocols vaccine, or the risk of Covid. They could sign a disclaimer.