30 June 2021
Open Letter from the UK Medical Freedom Alliance to General Practitioners / Vaccinators
Re: OBTAINING FULLY INFORMED CONSENT FOR ADMINISTRATION OF COVID-19 VACCINES, IN ORDER TO REDUCE PERSONAL LIABILITY
The UK Medical Freedom Alliance (UKMFA) is an alliance of UK medical professionals, scientists and lawyers who are campaigning for Medical Freedom, Informed Consent and Bodily Autonomy to be preserved and protected.
We wish to set out the legal requirements that apply to all medical practitioners, to obtain fully informed consent from a patient, prior to administering any Covid-19 vaccine. This information will help you to avoid any claims made by patients, that they did not fully understand the implications of receiving the vaccine. This is particularly pertinent in relation to population cohorts not represented in the ongoing regulatory vaccine trials, such as pregnant women and children.
The launch of the Covid-19 vaccines was welcomed by public authorities and hailed as an unequivocally safe and effective intervention. The vaccines have been given temporary authorisation for emergency use, prior to completion of the Phase 3 trials. Prompt and widespread implementation has been encouraged, with recent proposals for rollout to healthy children.
Despite all this publicity, it is vitally important to remember that Covid-19 vaccination is a medical procedure, which requires fully informed consent. The UK Medical Freedom Alliance have previously published guidance regarding the specific requirements for consent in the UK with reference to the GMC and the Montgomery rulingi. Anyone administering a Covid-19 vaccine is legally and ethically obliged to first ensure that ALL relevant information is provided, specifically with regards to safety and efficacy, and that this information is understood and accepted by the patient before proceeding. We would also suggest that providing information about treatments for Covid-19, as an alternative to vaccination, is a requirement.
We would like to highlight a few salient points which should always be covered when obtaining informed consent for Covid-19 vaccine administration:
1. Manufacturers’ claims of up to 95% effectiveness of the vaccines are based on evidence of effectiveness in preventing mild symptomsii. Outcomes such as severe disease, Long Covid, hospitalisation and death have NOT been assessed in the Covid-19 vaccine regulatory trialsiii iv.
2. Published claims of effectiveness were based on interim analyses of trial data, comprising an extremely small number of trial participants. This can be misleading to members of the public as the claims of 95% or similar effectiveness refer to relative risk reduction, whilst the absolute risk reduction to any individual is only in the region of 1%v. Some population groups, including the elderly, and certainly pregnant women and children, were not adequately represented, and therefore statistical significance of outcomes may not apply to themvi.
3. All Covid-19 vaccines are still in the Phase 3 clinical trials, which are not due to be completed till late 2022/early 2023. The vaccines are therefore still experimental. There is only limited short-term safety data and NO long-term safety data available, to rule out rare short-term side-effects or late-onset effects such as cancers, autoimmune diseases, infertility, neurological disorders etc.
4. Covid-19 has an infection fatality rate of <0.1% for most of the population (aged <70 years). Even in the elderly, the recovery rate from Covid-19 is in the range of the claimed effectiveness of the currently approved vaccinesvii viii.
5. There is currently no peer-reviewed evidence that the Covid-19 vaccines prevent infection with or transmission of the virus, so the recipient is still able to spread the virus to othersix.
6. A recently published paper “The Safety of COVID-19 Vaccinations – We Should Rethink the Policy”x calculated that the Number Needed to Vaccinate (NNTV) is between 200–700 to prevent one case of COVID-19 for the mRNA vaccine marketed by Pfizer, while the NNTV to prevent one death is between 9000 and 50,000 (95% confidence interval), with 16,000 as a point estimate. The number of cases experiencing adverse reactions has been reported to be 700 per 100,000 vaccinations. Currently, we see 16 serious side effects per 100,000 vaccinations, and the number of fatal side effects is at 4.11/100,000 vaccinations. They conclude that for every three deaths prevented by vaccination, we have to accept two inflicted by vaccination.
7. Covid-19 vaccines are based on a completely new gene-based biotechnologyxi. mRNA and DNA viral-vector vaccines have never previously received full regulatory approval for mass public use and are more akin to genetic manipulation/modification than traditional vaccination. Multiple concerns have been raised by scientists regarding possible short- and long-term adverse effects, specifically relating to the spike proteinxii xiii, which at this stage remain unrefuted due to lack of data.
8. There is a risk that Covid-19 vaccines may worsen clinical disease due to antibody-dependent enhancement (ADE), which has been observed in animal trials during previous attempts at developing a vaccine against coronavirusxiv xv xvi. Trials have so far not addressed this significant concern, and this information must be shared prior to vaccinationxvii xviii.
9. The Pfizer and Moderna vaccines contain polyethylene glycol (PEG). PEG is a known allergen which carries a risk of serious, potentially fatal allergic reactionsxix. The US Centre for Disease Control (CDC) has issued advice that anyone allergic to PEG or its close relative, Polysorbate, should not receive either of the currently available mRNA vaccinesxx.
10. Since the start of Covid-19 vaccine rollout to the population in December 2020, thousands of vaccine-related illnesses and deaths have been reported through databases in the US (VAERSxxi), Europe (Eudravigilancexxii) and the UK (MHRAxxiii) raising serious concerns about safety.
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11. It has emerged that some Covid-19 vaccines carry the risk of a rare blood clotting disorder “Vaccine-induced Immune Thrombotic Thrombocytopenia” (VITT). Recent UK government advice for young people is to avoid the AstraZeneca vaccine for this reason. VITT often presents as
ischemic strokes, including over 100 reported cases of the rare Cerebral Sinus Venous Thrombosisxxv. It is possible and plausible that this reaction could be a class effect caused by spike proteins and therefore not specific or limited to the AstraZeneca vaccinexxvi.
12. There is increasing concern over reports of myocarditis, especially in teenagers and young adults, following the mRNA Covid-19 vaccines. This appears to be more prevalent in young males. The risk of myocarditis following the Covid-19 vaccine seems to be 30-200x the normal background risk, as shown in a recent presentation by the US CDC’s Advisory Committee on Immunization Practices (ACIP), who are currently investigating 1200 cases of vaccine associated myocarditis and pericarditis in the USxxvii. In Israel the reported incidence of myocarditis following vaccination is estimated to be between 1/3000 to 1/6000 dosesxxviii. Although many of these cases are described as “mild” and resolve, myocarditis carries a long-term risk of heart failure, and also may require restricted exercise and medication for several months after recovery.
13. Other safety concerns are emerging as the vaccine is rolled out to the public, including Guillain-Barre Syndrome and Bell’s Palsy. More details and references are available in a recent report by HART in the UKxxix.
14. Covid-19 vaccine manufacturers demanded and were granted exemption from any liability for adverse effects caused by their productsxxx xxxi. There is therefore no recourse for compensation from the manufacturers, and only limited compensation (£120,000 lump sum) will be available to those injured, from the Government Vaccine Damage Payment schemexxxii, in the event of serious disability or death resulting from a Covid-19 vaccine. It is worth noting that between the inception of the scheme in 1979 until December 2014, only 931 vaccine damages payment awards were made, out of a total of 6,026 claims submittedxxxiii.
Conclusion and Recommendations
As manufacturers and distributors have been granted exemption from liability, there is the potential that claims for injury or death resulting from Covid-19 vaccines could be made against the individual administering the vaccine. The outcome is likely to rest on the question of whether all relevant information was provided to allow fully informed consent to be obtained, as per requirements laid down in law.
We recommend that the all the information presented above should be disclosed to patients and documented as part of the process of obtaining fully informed consent, with specific reference made to the fact that the end of the clinical trials needs to be awaited before Covid-19 vaccines may be declared safe.
We do hope that you find this letter and the recommendations made to be of assistance.
UK Medical Freedom Alliance
vi https://www.rki.de/DE/Content/Infekt/EpidBull/Archiv/2021/Ausgaben/02_21.pdf Page 27