A Consultation Document has just been published detailing Government proposals for rolling out unlicensed and untested vaccines. The first two paragraphs are incorrect.
The document also proposes no civil liabilities on pharmaceutical companies for adverse effects. Quote:
This will help to give companies willing to co-operate in the sort of mass vaccination programme under consideration for COVID-19, or mass distribution of treatments in other situations, some assurance that they will not be exposed inappropriately to civil liability.
The end date for the consultation is September 18th.
Here’s the link for responses:
I suggest you also contact your MP and ask how they will respond. Please share and encourage responses.
Thanks LivvyB. As this isn't an easy consultation for members of the public to respond to, please share ideas on the most appropriate evidence to submit.
Having read the GMC ethical guidance on consent https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/consent (paras 5, 27, 29, 32) and case law https://www.supremecourt.uk/cases/docs/uksc-2013-0136-judgment.pdf (paras 107 & 108), it appears to me that this proposed statutory instrument intends to remove consent.
Here's a copy of a response to the consultation from a UKColumn forum member:
1) Temporary authorisation of the supply of unlicensed products
Not needed – I refer you to PHE (that was) own definition of an HCID, and the assessment that covid-19 is not considered an HCID and hasn’t been since the 19th March 2020.
https://www.gov.uk/guidance/high-consequence-infectious-diseases-hcid#status-of-covid-19
and the ongoing ONS statistics of deaths in the UK showing very little cause for knee jerk reactions.
This current situation does not warrant any temporary or otherwise authorisation of unlicensed products.
2. Civil liability and immunity One could argue that there is no need to worry about immunity from prosecution because vaccines are safe and effective, therefore there is no reason to provide immunity to anyone manufacturing, purchasing or administering a vaccine.
However this is not the case and by its very nature ANY vaccine or medicine brought to the market will have untold possibilities for negative reactions, serious injury, death, side effects, long term health issues that will OBVIOUSLY not become apparent in the few months or years of testing.
Testing groups will always be limited and carefully controlled to ensure the maximum reduction of side effects. Testing will not be done on those who would be at most risk of side effects because it will not be in the interest of the manufacturer to do so, even though, those at most risk of side effects are probably those at most risk of the illness in the first place.
“The use of an ‘objective bystander’ in this situation could be a reasonable pharmaceutical company who might conceivably be in the same position as the company actually bringing the product to market” – I would argue there is no such thing as a reasonable pharmaceutical company, they have profit and vested interests at heart.
‘Alternatively, it would be possible to have as the ‘objective bystander’ any reasonable person – the man or woman in the street’ – I would here agree that possibly the man or woman in the street may not fully understand the technicalities of the treatment, testing or processes, however they should be able to be classed as objective, because it’s not in their interests to cover up the truth.
Any person with a biology A’ level or degree not employed anywhere in the industry or government could be classed as being able to understand the concepts discussed. They will not be worried about any future supply contracts or job prospects. They are much more of a bystander than any person employed in the pharmaceutical industry, medical, or government body.
You are also suggesting later in the document that the flu vaccine may be given at the same time, therefore I suggest it would be essential for ANY vaccine testing be done in combination with the current flu vaccines and not in isolation, because in all probability it will not be given in isolation. The same population that want the flu vaccine will want this one and will want them together therefore any claims of efficacy or safety will have to be shown in this context surely.
It will be completely negligent on the governments part to allow a ‘tested’ unlicensed vaccine to be administered at the same time as the flu vaccine and later say, well we couldn’t really foresee this problem when they were taken together!
3. Expansion to the workforce eligible to administer vaccinations There appears plenty of capacity withen the NHS at the moment, staff can be redeployed from all the treatment centres and departments where treatment has been cancelled or withdrawn because it appears the NHS has become a covid only service.
People can have a coronavirus vaccine if they want when they go to their local gp surgery to have their flu vaccine annually, because we are already being told that it probably won’t eliminate the virus it may need to be an annual one, so do it with the flu vaccine. No need to create more public panic, and no need to expand the workforce, use existing resources and do it at the same time.
4.Vaccine promotion There is already more than enough money spent in the UK and world promoting that vaccines are safe and effective. There has already been widespread coverage on the UK mass media that vaccines are safe, so there is no need to spend any additional money or time promoting them.
IF they are safe and effective people will want them. There will be no need to coerce, bully or threaten them to take them.
If you do change the regulations so that unlicensed vaccines and medications can be promoted then it should be made publicly clear and understandable to the person in the street that these treatments HAVE NOT undertaken the necessary testing route. The public will assume that anything their gp or surgery is recommending to them is completely safe because they have been told so, the level of trust the public has in the NHS will mean they will not think to question the advice. They are unable to imagine that anything promoted might harm them, so clear marketing of the fact it is unlicensed will be paramount. No vaccine should be licensed in this short time-period.
In this time of manufactured mass public panic it is important the public are made aware, you want this vaccine urgently, you can have it, but it hasn’t been as thoroughly tested as normal.
There is no need to mass vaccinate the UK with anything ever, and certainly not something which has not be fully tested. (The use of the word testing will be open to major manipulation in the face of ‘public safety and concern in the this global pandemic situation’, we know how double speak is used.)
Testing for a few weeks or months is not testing.
Testing without the use of the placebo is not testing (placebo – something inert and not therapeutic, ie not another vaccine – this is NOT a placebo, just for all the medical experts and vaccine labs that somehow think this is a valid definition of one.)
5. Provisions for wholesale dealing of vaccines This is the only section in the whole discussion document that I agree with. It makes perfect sense that the NHS should be able to move any medicine around within the UK as demand dictates. It is unbelievable that this has not been addressed before.
6. What could we do better?
Learn from history and understand that the pharmaceutical companies are not interested in public health, only profit, and their profits are such that they have money to work behind the scenes to influence others into buying and pushing their products in the name of public health.
As anyone in business will tell you, if you are able to keep your customers coming back year after year for your product, and if you are able to cross sell your products then you are onto a winner. The pharmaceutical corporations have the perfect business model however you look at it. Make a product ‘which saves lives’, sell it with no liability, ensure it needs to be bought every year, and profit from further sales of other products due to side effects of original product, rinse and repeat.
You people are supposed to work for the public benefit, not your own careers and not for profit of corporations, you could do better to really ask the right questions about whether this whole thing is a public health issue or a worldwide medical coup.
One of the best responses, Di. Thanks
This is very helpful, thank you so much for posting it, and I'm using it to draft my own response right now. Will post mine here as well in case anyone would like to use parts or all of it.
Thanks @LivvyB , I'd seen reference to the paper elsewhere (in the mirror project, interesting video with what sound like Sean Bean narrating:- https://www.mp-22.com/vax-petition?fbclid=IwAR3JKpS3QLOom30T_D7x2uCbnkniE7pwhPi8rK7lYijgS3mAHSUF7vMzdsQ), and this the response I've just sent to the government:-
'Dear sir/madam, I am writing as invited to make known my views on the proposed changes to the human medicine regulations to support the rollout of Covid 19 vaccines.
Firstly, to clarify, I will make the assumption that the term ‘Covid 19 vaccine’ is a term used to describe a vaccine to promote human immunity to the SARS-COV2 virus (please feel free to correct me if I have made an incorrect assumption).
With that said, I am extremely concerned at these proposed changes- I have seen the phase 2 testing results for one of the vaccine candidates and in that phase there were 2 (out of 43) subjects that experienced ‘severe systemic effects’, as well as numerous other less severe but notable side effects, yet this phase passed and was considered ‘safe’ to go to phase 3 trials. It would appear the definition of ‘safe’ in the context of vaccine safety testing has changed somewhat from the Oxford dictionary definition (which is:- ‘Protected from or not exposed to danger or risk; not likely to be harmed or lost’)- so one could summarise that safety testing has not been passed where any one individual has come to harm (suffered ill effects) during the safety testing phase. Pharmaceutical companies and their agents MUST be held liable for their actions, and to waive this requirement is surely very dangerous territory.
I am also extremely concerned that a VITAL part of the vaccine testing is being omitted- and that is the re-exposure of the subject to the contagion against which the vaccine is said to be protecting. Many past Coronavirus vaccine trials have proven successful at generating antibodies in the test subjects, but when the subjects (monkeys) have been re exposed to the ‘wild’ virus they have suffered severe autoimmune responses and died. If this key part of the testing process, along with the phase 1, 2 &3 human trials, is not completed and passed under the oxford definition of ‘safe’ then it cold not be said, it could not be proven, that the vaccine was/is indeed ‘safe’.
I am also concerned that the expansion of the workforce to allow ‘that someone other than a registered healthcare professional may actually be administering unlicensed vaccines’ (and that these people will not held liable for their actions) is a line that must not be crossed- in medical situation only a fully trained, qualified and registered healthcare professional should administer a vaccine and deviate from this stipulation is a far cry form the controlled and regulated (safe, and actually safe) regime that we currently have.
With all of the above taken into consideration, there is a very real risk that future litigation activities may well reveal that the proposed changes (incidentally, as well as temporary legislation currently in place) could well prove to be in contravention of human rights legislation and this would leave the UK Government in an indefensible position- and should the vaccine cause harm on a mass scale (unlikely I know but a very real possibility) the Government would be exposed to an almost limitless number and cost of claims from the populace, as well as the inevitable potential political fallout on the national and international stage. Not a risk I would suggest the UK Government should even consider taking in these difficult times.
Thank you for taking my views in to consideration'
Let's see if they send me a reply.
Brillant work Martin and thanks for the Mirror Project Link.
Here's my response:
False Premises
It seems clear this Consultation Paper is based on false premises.
Opening Paragraph
The opening paragraph of the paper states:
COVID-19 is the biggest threat this country has faced in peacetime history, which is why the UK government is working to a scientifically led, step-by-step action plan for tackling the pandemic – taking the right measures at the right time.
Can Covid19 be Considered the biggest threat in peacetime history or a pandemic?
Civid19 is one Infectious Disease amongst a great many:
Health Protection list of Infectious Diseases:
https://www.gov.uk/topic/health-protection/infectious-diseases
It is not, however, a high consequence infectious disease:
The latest information published, however, and last updated 20th June 2020, states that covid19 is no longer considered a high consequence infectious disease:
https://www.gov.uk/guidance/high-consequence-infectious-diseases-hcid
Worldwide deaths from COVID19 are currently claimed to be in excess of 800,000. Below are WHO stats for global deaths in 2016:
https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death
Heart Disease and related - 17.8 million
Cancer - 9 million
COPD - 3 million
Lower Respiratory Disease - 3 million
Digestive Disorders - 2.8 million
Alzheimers - 2.2 million
Diabetes - 1.6 million
Murder/Suicide - 1.5 million
Diarrhoea - 1.4 million
Tuberculosis - 1.3 million
Kidney disease - 1.2 million
HIV/AIDS - 1 million
Nutritional deficiencies - 0.45 million
In view of the above – how can covid19 be considered a pandemic?
Second Paragraph
The second paragraph states:
Effective COVID-19 vaccines will be the best way to deal with the pandemic. Any vaccine must first go through the usual rigorous testing and development process and be shown to meet the expected high standards of safety, quality and efficacy before it can be deployed.
Effective Covid 19 vaccines would be the best way of dealing with a pandemic, (a) if it is a pandemic (see above) and (b) effective therapeutics and treatments were not available.
Effective therapeutics and treatments
Hydroxychloroquine (HCQ)
A growing number of doctors worldwide believe HCQ combined with zinc and an anti-biotic prevents symptoms deteriorating (and therefore hospitalisation) if given in the early stages of covid19. It has also been shown HCQ in small doses is an effective prophylaxis. This drug has been used for 50 years as a treatment for malaria and the FDA (until recently) considered it one of the safest drugs on the market – it is routinely given to pregnant women and the elderly with no detrimental effects. Furthermore, there is evidence that countries in Africa, who take HCQ as a prophylaxis against malaria have been protected and have very low death rates.
This is supported by scientific research, which can be found in this link:
https://c19study.com/
Vitamin D3 and Calcifediol
I refer you to research showing how Vitamin D3 and Calcifidiol can improve the clinical outcome of subjects requiring hospitalization for COVID-19.
I agree the last sentence of the second paragraph regarding rigorous testing and development processes - yet the paper goes on to recommend the rolling out of unlicensed vaccines. If a vaccine was licenced it would have met the high standards of safety, quality and efficacy before being deployed. If it is unlicensed it would not.
The paper then proposes manufacturers will not be exposed ‘inappropriately’ to civil liability. It is difficult to understand what being exposed ‘inappropriately’ to civic liability means or why this adverb is necessary:
This will help to give companies willing to co-operate in the sort of mass vaccination programme under consideration for COVID-19, or mass distribution of treatments in other situations, some assurance that they will not be exposed inappropriately to civil liability.
This proposal does indeed offer some assurance to manufacturers of vaccines but, whilst doing so, offers no assurance to those receiving the vaccine. It is clear protection from civil liability would not motivate manufacturers to ensure vaccines are completely safe and hence may put the general public at risk.
In conclusion the proposals in this consultation paper should be rejected as it is clearly based on false premises. Furthermore, it is unethical to administer unlicensed vaccines, which have not been fully tested, to UK citizens, especially when manufacturers are protected from liablity for any adverse effects.
@LivvyB Just a note about the word pandemic. To most ordinary people it is associated with lots of death and world wide spread. However, WHO do not have a definition, or didn’t. The one they‘re using does not include lots of death.
Excellent response to consultation by former Pfizer VP: https://threadreaderapp.com/thread/1302725167588798467.html
This vaccine transparency letter contains useful points to include in the consultation response https://www.anhinternational.org/news/the-10-point-vaccine-transparency-approach/#user-heading-1
Just seen this link Di - more great info. Thanks
Here's my response
this is an excellent response Di, well done! Nice and factual. If it's ok I'll pinch some of it for my own response.
UK Column's 14 Sept programme focuses on the Human Medicine Regs consultation: https://www.ukcolumn.org/ukcolumn-news/uk-column-news-14th-september-2020
Even "tested" vaccines have a demonstrable record of causing harm:
Useful info - thaks V et L
I was just doing a quick Iatrogenesis search.
It looks like any research/data on this is likely to underestimate the condition, yet already by looking at hospital issues in the States it seems close numbers to covid deaths(which are likely overestimated).
https://europepmc.org/article/PMC/1070928
Here is my consultation response in case anyone would like to read and/or use it for their response:
1. Temporary authorisation of the supply of unlicensed products
The UK Government does not consider Covid-19 a dangerous disease (HCID) anymore: "As of 19 March 2020, COVID-19 is no longer considered to be a high consequence infectious disease (HCID) in the UK" (source: https://www.gov.uk/guidance/high-consequence-infectious-diseases-hcid). It is therefore not necessary to rush to supply unlicensed vaccines to the UK population at large, simply to avoid what is for over 85% people affected no more than a flu.
Furthermore, it is unethical to administer unlicensed vaccines, which have not been fully tested, to UK citizens, especially when manufacturers are protected from liablity for any adverse effects.
Thirdly, alternative treatments of Covid-19 such as through hydroxychloriquine, remzivir and other available and licensed medicines and treatments, but also complementary treatments such as through Traditional Chinese Medicine (see e.g. https://www.shiatsu.nl/wp-content/uploads/2020/03/novel-corona-virus-tcm-treatment.pdf) or administration of vitamin D, should be promoted in a health-setting rather than only focusing on an unproven and, so far, unavailable vaccine.
For the reasons stated above, I strongly suggest to DELETE the proposed amendments to the Human Medicines Regulations 2012, regulation 174A altogether.
2. Civil liability and immunity
It is vital that companies involved in the trials and manufacture of vaccines and adjuvants fully disclose all raw data to enable it to be independently assessed. Non-disclosure, omission or errors of relevant data or information relating to quality, safety or effectiveness, whether deliberate or the result of negligence should constitute a breach in the conditions of temporary authorisation.
Any parties with an interest in placing products on the market cannot be considered a “reasonable person”. This is the case for pharmaceutical companies, even if the company in question does not currently develop or produce its own Covid-vaccine. Pharmaceutical companies can therefore not be considered "objective bystanders".
It is also not likely that the average person on the street will be able to make an objective, i.e. not biased, and informative judgment on liability because they will not have the technical knowledge required to understand and judge the situation. I therefore suggest to create a committee composed of independent technical experts from the population (i.e. legal, medical and pharmaceutical experts) which can ascertain fairly whether a breach of reposnsibility has taken place or not and, consequently, whether an injury payment is due.
Furthermore, the Government must ensure that vaccine injury payments will be made to individuals injured by any approved Covid-19 vaccines, whether licensed or unlicensed, while also clarifying the level of proof required to establish causation and the statutory time limit for making such claims, prior to their administration to the public. Covid vaccines must be added to the Vaccine Damage Payment list .
3. Expansion to the workforce eligible to administer vaccinations
I strongly suggest to DELETE the proposed amendments to the Human Medicines Regulations 2012, regulation 8 "(c ) an operating department practitioner, a paramedic or a physiotherapist registered in Part 13, 8 or 9 of the Health and Care Professions Council register;(d ) a pharmacist;" since these professions are not properly trained to administer vaccines to humans. Since all vaccines have “unavoidable, adverse side effects” , only fully accountable authorised health care professionals should be allowed to vaccinate their patients. Doctors are trained to undertake a risk / benefit analysis for each individual; this cannot be delegated to non-health care professionals. Occupational health vaccinators are not health care professionals; they have no accountability or expertise in vaccine science and thus cannot obtain informed consent.
Moreover, there is no need to deploy a large number of untrained staff to administer a vaccine for large numbers of people as any COVID-vaccine, if effective at all, will only be helpful and sensible for a small part of the population, i.e. the old (80+) and immuno-compromised people such as cancer patients.
Current trials underway by pharmaceutical companies such as Astra Zeneca and Moderna, however, only test the Covid-vaccine on healthy dults between the ages of 18-55 years. The potential effect of these vaccines on the fragile population that would actually be the main beneficiaries of a Covid-vaccine is thus unknown. In addition, long-term effects on the healthy population as well as the more vulnerable people cannot be ascertained in a trial which only lasts a few months or a year.
4. Vaccine promotion
Advertising for medical products or treatments that are prescription-only "may not be advertised to the public" at all (ASA: https://www.asa.org.uk/type/non_broadcast/code_section/12.html). Advertising expedited unlicensed vaccines during a pandemic when full safety and efficacy data is still emerging would be negligent.
Advertising involves communication of claims, yet given the experimental nature of vaccines there is great uncertainty over claims. It would be wrong to provide immunity to civil liability to vaccine manufacturers allowing them to escape consumer protection laws that bind other advertisers.
Instead, positive natural health measures such as eating a balanced diet with sufficient vitamins C, D and zinc as well as breathing in sufficient clean oxygen (air), exposure to sunlight and exercising regularly to strengthen the immune system ought to be promoted by the government.
Also, the public must be informed of the extent of naturally-acquired immunity prior to public release of any - licensed - Covid-19 vaccines. In order to balance risk and utility, the public must be made aware of the extent of population herd immunity and have ready access to validated antibody tests so that individuals can assess their own state of immunity prior to giving consent for vaccination.
For these reasons I suggest to REMOVE the proposed amendments to the Human Medicines Regulations 2012, regulation 280(b) and 291A and any regulations related thereto altogether.
5. Provisions for wholesale dealing of vaccines
I suggest to DELETE the suggested amendments to the Human Medicines Regulations 2012, regulation 19(f), paragraphs 4A to 4C since the wholesale distribution of unlicensed vaccines must not be authorised under any circumstances in an effort to protect the population from physical harm.
It is unacceptable that the commercial interests of wholesalers are put before the health interests of the population. The provisions of the suggested amendments to this regulation should therefore NOT be facilitating the distribution of unlicensed medicines across the country.