Informed consent?

Are covid vaccinators following GMC and NHS guidance?

Over the last 7 months, a group of health professionals and scientists have written repeatedly to the MHRA, the JCVI and the Chief Medical Officers regarding the safety data (or lack of) for covid-19 vaccinations for children. These letters have gone largely unanswered.  The main concern was that experimental gene-based vaccines with no long-term safety data were being rolled out under emergency use authorisation to younger and younger age groups without an accurate differentiation of the balance of benefit and risk. Clearly the risk from SARS-CoV-2

infection is inversely related to age, with healthy children often having no symptoms whatever and rarely requiring hospital admission.  Death rates for healthy children are less than one in a million. Conversely, vaccine side effects, especially myocarditis, are more common the younger the vaccinee.

There have been major advertising campaigns for the vaccines, largely based on the mantra ‘Safe & Effective’ and large scale vaccination hubs are not an environment for obtaining fully informed consent. Concerned at the lack of response to the open letters, the correspondence was all sent to the GMC with specific questions about potential breaches of good medical practice guidance and here is their reply. They clearly agree with our view that the requirements for decision making and obtaining informed consent are the same, regardless of whether this is a vaccine or any other medicine or medical procedure. The reply states, “discussions should be tailored to each individual patient – and will usually include the following:

• Recognised risks of harm that the doctor believes anyone in the patient’s position would want to know.

• The effect of the patient’s individual clinical circumstances on the probability of a benefit or harm occurring.

• Risks of harm and potential benefits that the patient would consider significant for any reason.

• Any risk of serious harm, however unlikely it is to occur.

• Expected harms, including common side effects and what to do if they occur.”

“Paragraph 24 also specifically mentions the patient’s ‘personalised risk’, which should take into account their ‘individual clinical and personal circumstances, compared with population level risk’.”

In response to the question of how informed consent can be obtained if long term outcomes are unknown they pointed out that this does not preclude obtaining consent for treatment but that “if the available evidence of benefits and harms of an option is unclear, you should explain this to the patient.”Discussions with many people working in the field and accounts from those who have suffered vaccine injuries suggests this guidance is not being universally followed.  It is certainly not being followed by the heavy advertising campaign nor by scapegoating of the unvaccinated.  If full information is not given or indeed any coercion occurs, then consent is not legally valid, putting not only the patient at risk of receiving a treatment they might have declined, but also putting at risk the doctor’s own registration if harm occurs and the patient claims they were not fully informed.  Food for thought for those involved in vaccination clinics, especially if vaccinating children and young people or vaccinating those who have already had SARS-CoV-2 infection and have their own naturally-acquired immunity. Consent is not consent unless fully informed and freely given.   

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