Thread by @Calumets

Please DON'T IGNORE!
A government 'consultation' for unlicensed #vaccines non-medical staff can administer allowing no govt. liability if you're harmed ends next week! They've kept it quiet to avoid objections. Click the link & find the 'respond' line... gov.uk/government/con…

Reading the consultation documents and composing responses can be time-consuming as there are 5 areas to consider and respond to. If anyone wishes to use my responses (see this thread), please feel free to do so. It is a long thread, you'll need to cut and paste...

A) Temporary authorisation of the supply of unlicensed products

I object.

This is a dangerous idea, as we have already seen with at least one person falling ill from the Oxford University vaccine trial which has now been put on hold.

Vaccines must go through the most rigorous tests, and licensing comes as a result of successful completion of that process. Ignoring the licensing, when there are other options to keep people safe, such as lockdown and furlough, is reckless.

If the UK’s licensing authority was satisfied that there is sufficient evidence to demonstrate the safety, quality and efficacy of the vaccine, then it should be licensed in the usual way and not used until that happens.

This blanket immunity from prosecution of negative consequences of using an unlicensed vaccine would not be included in the consultation if what is being proposed was not dangerous (Regulation 345 of the Human Medicine Regulations transposes into UK law a requirement of...

EU law that key actors in the medicines supply chain cannot generally be sued in the civil courts for the consequences resulting from the use of an unlicensed product). The phrase 'or for any other disease that poses a serious risk to public health' leaves open the possibility...

that unlicensed vaccines could also be promoted for any other disease.

These measures would represent an outrageous precedent, and the current British government does not command the level of trust that would come close to granting this extraordinary request, particularly...

when they include clauses such as: ‘the conditions imposed on a regulation 174 authorisation for a COVID-19 vaccine are likely to be equivalent to requirements of a marketing authorisation, acknowledging that some flexibilities and pragmatic approaches may be required based on...

the situation’ (my emphasis).

The summary of this section of the consultation, given in the final paragraph of Part 1, seems disingenuous. In essence, this summary states that enabling the supply of drugs which have not been licensed will ensure patient safety. This is...

nonsensical.

Finally, the consultation later drops this little bombshell: ‘There is a possibility that both the flu vaccine and the COVID-19 vaccine will be delivered at the same time.’ The fact that the possibility of combining already unlicensed medicines has not been...

individually considered, suggests that the entire process is ill-conceived and potentially far more dangerous than the government itself understands. Just one more reason to withhold trust from this government and this proposal.

Next section coming up...

B) Civil liability and immunity

I object.

The following clause on liability is self-serving: ‘the producer has to be able to show that the objective state of scientific and technical knowledge at the time it was put on the market, including the most advanced level of such...

knowledge, was not such as to enable that defect to be discovered. By putting the most advanced state of scientific knowledge at the time the product is made available at the heart of the protection that is offered…’

The changes recommended in this consultation will allow producers to avoid liability by claiming that they couldn’t have known their product was harmful because there had not been evidence at the time it was distributed to suggest such.

However, the lack of evidence could well be due to the product being rushed out onto the market. In addition, the government proposes to further protect producers by withholding automatic civil liability for breach of conditions, preferring to refer to the views of a...

third party described both as an ‘independent bystander’ and as a ‘person [with an interest in placing medicinal products on the market],’ whilst also appearing to acknowledge this conflict by hedging their bets and suggesting a truly independent third party might be better.

This is entire section is, once again, ill-thought out and nonsensical.

Next section coming up...

C) Expansion of the workforce eligible to administer vaccinations

I object.

This proposal suggests expanding ‘the scope of patient group directions (PGDs) to allow the administration of any medicine’ (my emphasis), not just a Covid-19 vaccine, this includes...

any unlicensed medicine.

In addition, the consultation actually proposes this not as a temporary measure, but as a new ‘national protocol’, and requires ‘flexibility to define training and competence requirements.’

These proposals will achieve the exact opposite of the consultation’s stated intention to ‘ensure that all measures will be taken to ensure patient safety, including but not limited to clinical treatment of any potential reaction to the administered vaccine, such as...

anaphylactic shock.’ It is completely clear and obvious that patient safety will be better served by appropriate practitioners (doctors and other qualified prescribers) responding to potential reactions such as anaphylactic shock, rather than ‘nursing associates,...

physiotherapists and pharmacists.’

Next section coming up...

D) Vaccine promotion

I object.

This consultation intends to change the law to allow the promotion and advertising of any temporarily authorised product (that is, unlicensed product), both to the general public, and to medical practitioners.

This proposal is especially problematic when, as has been widely reported, the Cabinet Office has allowed contracts to be awarded to companies linked to prominent members of the government without any competitive tendering.

Although the policy and research company Public First (for example) is not a pharmaceutical producer, the award of these contracts has further diminished trust in the government, which cannot be trusted to refrain from rewarding other affiliated companies (including,...

potentially, pharmaceutical companies) for their political support (prominent members of the Tory government have, again, well-publicised relationships with numerous pharmaceutical and ‘health care’ companies, including: PepTcell, Infinite Percent, Eli Lilly, P&G and...

Genix Healthcare).

Last section coming up...

E) Provision for wholesale dealing of vaccines

I object.

It is reckless to propose the removal of the wholesale dealers’ licenses requirement for the transportation and transfer of vaccines which have controlled storage requirements such as strict temperature limits.

In addition, although the current proposals are temporary, they include the stated intention of considering long-term changes in this area. Current restrictions are in place to protect public safety, using the possible scarcity of (unlicensed) vaccines during a pandemic to...

reduce protections in the name of public safety is disingenuous at best, downright dangerous and deceitful at worst.

That's it. I hope it is helpful. I'm no anti-vaccer, but we have to stop this crazed bunch of hooligans endangering us all by removing existing safeguards.

Some sections had a bit 'my emphasis' which was where I underlined bits when drafting - I forgot these wouldn't show up on Twitter. Sorry about that.