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]

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

Yes I’m sure it didn’t look like this the last time I looked. The webarchive isn’t loading for me at the moment.

There you go, the bullet list has disappeared:

consultations.dhsc.gov.uk/5f43b8aca0980b6fc0198f9f

Panic over

It’s back...

It’s very weird, but I wonder if it’s in response to misinformation and misunderstanding about the proposed changes?

The bullet list? It's not there now for me, I get this.

Sometimes unlicensed vaccines are imported from other countries where they are licenced. Eg, in the UK we dont have many (or any) multidose vials of vaccines ,but France does. I seem to recall getting unlicensed vaccine from France which was the same product as the UK product, but in a vial of 10 doses, to be used in used in one vaccination session.
So being unlicensed here does not mean untested. (it was fun consenting about 100 people who needed the vaccine though)
However if they were talking about importing the licenced Russian Covid vaccine which hasn't done phase 3 trials yet (and how does that work????) I would be VERY opposed.

I don't like the idea that pharmaceuticals won't be held responsible for adverse effects in the event of it being an unlicenced or temporarily authorised vaccine/medicine. It is probably only the thought of massive financial penalties and compensation that ensures vaccines and medicines are as safe as they are currently. Withdraw that and it removes some of the responsibility from the manufacturers of these products.

I planned to have the vaccine to help protect others but I won't be having a vaccine or a medicine for which the manufacturer won't accept any liability.

@LangClegsInSpace

The bullet list? It's not there now for me, I get this.

Sorry - was working. Yes the list is still there for me when I click on your link. Went looking on work computer in case I was somehow looking at cached version but it’s definitely still there.

@SpringFan

Sometimes unlicensed vaccines are imported from other countries where they are licenced. Eg, in the UK we dont have many (or any) multidose vials of vaccines ,but France does. I seem to recall getting unlicensed vaccine from France which was the same product as the UK product, but in a vial of 10 doses, to be used in used in one vaccination session. So being unlicensed here does not mean untested. (it was fun consenting about 100 people who needed the vaccine though) However if they were talking about importing the licenced Russian Covid vaccine which hasn't done phase 3 trials yet (and how does that work????) I would be VERY opposed.

Licensed in France is quite different from unlicensed anywhere in the world (or indeed licensed in Russia). Currently we have the same regulatory framework as France so I wouldn’t be at all concerned.

That said, I’m not particularly exercised about a nearly licensed U.K. vaccine provided the regulator has been all over it.

It all seems sensible to me, but I have seen some ignorant scare mongering posts about it on social media. The legislation is just to enable the vaccines to progress from successful testing to use without the potentially lengthy administrative step of licensing. And the immunity from civil action is a necessary step to enable this.

I don't think it's in anyone's interests to hear that the Oxford vaccine works in the next couple of months and then to hear that it's going to take 6 months of paper pushing for it to be licensed - it has no effect on the safety stage of testing, and doesn't increase the risk, vs many thousands more dying while waiting for a license - no brainer but some people will argue against anything!

Wise upJanetWeiss
Yep I know about regulatory frameworks etc , lived it for a while. That was my point - unlicensed is not always a total horror show if the product has been licensed in a comparable jurisdiction. (Long live the EMA) However a rush to licence without Phase 3 trials, which other countries have done/talking of doing would be a cause for concern, but I am not aware that UK is planning to do this.
The other point is that if people are being given an unlicensed vaccine, there will be a lot of effort needed to ensure informed consent is obtained.

Its not a public consultation.

Why on earth do people insist on posting something without having the slightest knowledge of what it is??

It says "To evaluate responses fully we need to ensure we reach a wide number of people from diverse backgrounds and experiences." It's also being shared quite a bit now since I last shared it

"The purpose of this consultation exercise is to engage directly with specific stakeholders that we have identified.... The consultees to whom this document is addressed are a specialist audience..."

The problem with sharing random links from Facebook (or the UsForThem fanatics) is that many people neglect to read or understand it.

The Oxford vaccine is the closest to completing stage 3 testing. Its currently being tested in the U.K, U.S, South Africa, Brazil and a couple of other places.
There are 2 pharmaceutical companies manufacturing a large stock of the vaccine.
The first vaccinated would be the most vulnerable.
That would be followed by first line workers.
Then it would be gradually given to the mass population.

Im happy to get it as soon as available.

Obviously it wont be compulsory.

@SpringFan

Wise upJanetWeiss Yep I know about regulatory frameworks etc , lived it for a while. That was my point - unlicensed is not always a total horror show if the product has been licensed in a comparable jurisdiction. (Long live the EMA) However a rush to licence without Phase 3 trials, which other countries have done/talking of doing would be a cause for concern, but I am not aware that UK is planning to do this. The other point is that if people are being given an unlicensed vaccine, there will be a lot of effort needed to ensure informed consent is obtained.

Totally agree, and I could tell you knew this stuff. Sorry, I didn’t mean to sound snippy.

And for avoidance of doubt, I’ll be happy if the MHRA is happy.