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Vaccine - I’m seriously concerned about this

(79 Posts)
ayse Mon 31-Aug-20 17:22:08

CONSULTATION ON VACCINE ROLL-OUT: CALL TO ACTION

This consultation has just been launched, and we only have until 18th September to respond, via this survey consultations.dhsc.gov.uk/5f43b8aca0980b6fc0198f9f?fbclid=IwAR2l0heUZE7j0wknFftX1ckIe1RurcoZVvk0OFs1GduOHl60qSgtBerdxi0

Very important that as many people as possible respond.

I've read through quickly and have listed some of the main points of the consultation, with a few suggestions for arguments to make in response, to kick off a discussion. Please comment with further suggestions.

To summarise:

1) The Human Medicine Regulations already give the government the legal right to authorise an unlicensed COVID-19 vaccine. If a vaccine was available before the end of the transition period, but hadn't been licensed by the European Medicines Agency, it could be rolled out unlicensed BEFORE THE END OF 2020.

2) There is already reduced liability for manufacturers of unlicensed medicines:
"The current legal framework already recognises that if manufacturers or healthcare professionals are asked to supply an unlicensed medicine in response to a public health threat, it is unfair also to ask them to take responsibility for the consequences of the use of that medicine in the way that they normally would."

3) The government is proposing to "clarify" the legislation by extending this exemption from liability to pharmaceutical companies placing unlicensed products (ie vaccines) on the market, to give them the "assurance that they will not be exposed inappropriately to civil liability."

4) There is provision within the regulations to remove immunity for civil liability for "serious breaches" of conditions. The government is suggesting that there should be an "objective test" of whether the breach is serious enough for immunity to be removed. They are considering whether the "objective bystander" should be another pharmaceutical company (I kid you not 🙄) or "the man or woman in the street".

5) There will be an enormous expansion in the workforce legally allowed to administer vaccines, to include "midwives, nursing associates, operating department practitioners, paramedics, physiotherapists and pharmacists."

6) The government is proposing a relaxation of rules to allow advertising of unlicensed products, including the Covid-19 vaccine, and to allow promotion through national campaigns.

Ideas for inclusion in response:

1) Authorising an unlicensed vaccine could be detrimental to safety, and could potentially cause injury and death. This is a very dangerous proposal, and should be rejected.

2) The suggestion that the vaccine could possibly be rolled out before the end of the transition period has very worrying implications for safety. Vaccines normally take 8-10 years to develop.

3) Given the reduced time frame for safety testing, there should be no exemptions for liability. If pharmaceutical companies are encouraged to prioritise speed of development over safety, and are exempted from any liability if things go wrong, there could be disastrous consequences. The fast-tracked H1N1 vaccine caused serious lifelong side effects, including narcolepsy, to a significant number of people.

4) Given the history of bribery and corruption within the industry, pharmaceutical companies should not be designated "objective bystanders", in considering whether there has been a breach serious enough to remove immunity for civil liability. This should be the role of the "man or woman in the street", in keeping with the legal traditions of the UK.

5) Any advertising of the vaccine should carry a clear health warning that it has been fast-tracked and therefore not all the usual safety tests have been carried out. It should also state that it is unlicensed (if this proposal is adopted).

6) There will clearly be risks to taking this vaccine, so it should not be made mandatory, nor should access to the workplace or any other aspect of society be made conditional on taking it. Where there is risk, there must be choice. Forced medical procedures may be routine in totalitarian dictatorships, banana republics and police states, but they have no place in a democracy or any civilised society.

www.gov.uk/government/consultations/distributing-vaccines-and-treatments-for-covid-19-and-flu/consultation-document-changes-to-human-medicine-regulations-to-support-the-rollout-of-covid-19-vaccines?fbclid=IwAR1xQRP53_SMIfKMrUenLYDbgwJvoE2PYY8laU6BDvfXIbqScyPdP8PAqSQ#responding-to-this-consultation

ayse Mon 31-Aug-20 17:26:09

Where is the protection here for the public? I’d be so interested in others comments. Personally, I don’t think this is looking after us at all. Who will take responsibility if the vaccine causes damage?

Can anyone out there shed anymore light on these proposals?

NotSpaghetti Mon 31-Aug-20 17:32:22

What a mess!
I think most of us would be pleased to see a Covid-19 vaccine in production but this looks a bit like the wild west!

I think I need to mug up on this. Thanks for posting!

Alexa Mon 31-Aug-20 17:40:29

What is the probability of any vaccine's causing death or disability? Is there any reason the coronavirus vaccine even if untested will be any worse than ,say that for smallpox?

ayse Mon 31-Aug-20 17:40:58

Thanks Notspagetti. I’d welcome any comments either positive or negative

janeainsworth Mon 31-Aug-20 17:45:23

Thanks for flagging this up and summarising for us Ayse.
My initial reaction is that it is playing with fire.
But safety is not the only issue - efficacy is important too. What is the point of putting the population at risk with an unsafe vaccine, if it doesn’t work anyway?
I’d like to see the response of the BMA & similar organisations before commenting further.

ayse Mon 31-Aug-20 17:46:06

Alexa, that’s not really the point I’m making. I think it’s a dangerous precedent to set, apart from using unlicensed medicines. There were huge problems caused by thalidomide in the sixties which was licensed. The pill had hosts of problems attached over a huge number of years. Every drug has side effects and to be given something not rigorously tested is just asking for unforeseen difficulties.

ayse Mon 31-Aug-20 17:48:37

Hi Jeanainsworth, I didn’t do the summary, just pasted it in total from a message I received. Thus asking for comments. I’m hoping there are some medics out there who might read and comment

suziewoozie Mon 31-Aug-20 17:54:29

Thanks for posting - this is chilling.

biba70 Mon 31-Aug-20 18:09:56

Chilling indeed- and I ain't having it. I have always been pro vaccination for children, and have had the flu vaccine a few times - but I am sorry, I do NOT trust this Government one little bit, and I will refuse the vaccine until proper reassurance from Independent sources are clearly and unequivocally given.

Tweedle24 Mon 31-Aug-20 18:32:17

I would like to spend time perusing this.

I think it has been mentioned In another post but, I cannot understand the mention of allowing other medical professionals to administer the vaccine — midwives, nurses, pharmacists etc. They have always done this. Just another example of the ‘powers that be’ not knowing what goes on in real life.

TaraLee Mon 31-Aug-20 18:33:42

I would not want to be a guinea pig for this godforsaken virus. Vaccines take on average 10 years to develop and the record was 4 years for a mumps vaccine in the 60's, according to this:

www.globalcitizen.org/en/content/how-is-covid-vaccine-developed-how-long/

Call me a cynic, but I don't trust a word coming out about this virus, since 90% of everything seems politically slanted. It's been a crazy 2020.

But, the reason I'm here at all is I just found out I'm going to be a first-time GRANDMA! My daughter and her husband told us this weekend. It's still too early to tell everyone, but I don't know any of you and I have to tell someone! smile

This could not have come at a better time. This year has proven to "change" people a bit, what with all that's going on. For me, I was feeling a bit of depression, mainly because of the day in and day out Covid talk.

Now I have something happy to think about! Yayyy

Tweedle24 Mon 31-Aug-20 18:34:47

Ayse Doctors have long been giving unlicensed drugs with an explanation to the patient and the patient’s signed consent.

Oopsadaisy4 Mon 31-Aug-20 18:36:00

Unlicensed does not mean untested.

Oopsminty Mon 31-Aug-20 18:38:12

Extraordinary times call for extraordinary measures. As someone once said.

I agree that a rushed vaccine doesn't sound great but what else can be done?

MaizieD Mon 31-Aug-20 18:55:22

Oopsadaisy4

Unlicensed does not mean untested.

What does it mean, then?

Oopsminty Mon 31-Aug-20 19:00:30

A hypothyroid drug called Armour (NDT) is unlicensed in the UK.

Some NHS endocrinologists will prescribe it though

It's certainly been tested. That was all we used to use until the 70s and is still prescribed in the US.

ayse Mon 31-Aug-20 19:13:23

What if vaccination becomes mandatory? I understand the NZ government is considering vaccinating all those who enter the country at the border!

I have a choice with flu vaccine, the pneumonia vaccine etc. I believe this is the thin end of the wedge especially as Sweden seems to be recovering from Covid without all the palava that we have experienced. Sweden did as badly as us with respect to older people but the general population seems to be ok.

ayse Mon 31-Aug-20 19:18:41

Taralee. Congratulations and enjoy 💐. Thank you for the link to Global Citizen. I shall have a look.

janeainsworth Mon 31-Aug-20 19:27:35

Maizie this doesn’t really answer your question, but it’s the GMC guidance about the use of unlicensed medications
www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/prescribing-and-managing-medicines-and-devices/prescribing-unlicensed-medicines
It might be (slightly) reassuring.

MaizieD Mon 31-Aug-20 19:28:19

Oopsminty

A hypothyroid drug called Armour (NDT) is unlicensed in the UK.

Some NHS endocrinologists will prescribe it though

It's certainly been tested. That was all we used to use until the 70s and is still prescribed in the US.

There's a slight difference between a well established and proven drug, presumably with known side effects, and a rushed through vaccine, surely?

MaizieD Mon 31-Aug-20 19:29:38

Thnks for that link, janea, Ill have a look.

My gut instinct tells me to be very wary, though...

janeainsworth Mon 31-Aug-20 19:31:41

ayse What if vaccination becomes mandatory?

Some vaccinations already are.
Hepatitis B vaccination is mandatory for anyone doing ‘exposure-prone’ procedures, eg dentists and dental nurses.

I doubt if Covid vaccination could be made mandatory for the general population, but it could be for certain groups of workers or anyone wanting to travel.

janeainsworth Mon 31-Aug-20 19:48:31

www.hey.nhs.uk/patient-leaflet/unlicensed-off-label-medicines

Here’s another article. It sets out the reasons why a medicine may be unlicensed but still the right thing to prescribe (eg The medicine may be licensed only for adults, but in some circumstances it may be beneficial to prescribe it for a child)

What it doesn’t seem to say is that it’s ok to use an unlicensed vaccine because it’s been rushed through & isn’t fully tested, in order to suppress a virus mainly for societal reasons rather than for an individual’s benefit.

biba70 Mon 31-Aug-20 20:24:59

this, indeed.