Experimental Vaccines Require Informed Consent

In the U.S., vaccines granted Emergency Use Authorization by the FDA, as is the case with the Pfizer and Moderna COVID vaccines, are considered experimental. Administrators of emergency use vaccines are required by law to inform vaccine recipients of the potential risks.

With the mass vaccination program now in full swing, we are hearing of more and more reports suggesting this fundamental right and legal requirement is not being respected. The vast majority of people are simply not being given the opportunity to exercise this right that is a foundational principle of medical ethics and central to the concept of patient autonomy. Most people likely don’t even know what information they should be able to receive prior to vaccination.

Check out our video below (under 8 minutes in length), presented by Rob Verkerk Ph.D., including inputs from dentist, Dr. Zac Cox, from the World Doctors Alliance and integrative doctor, Dr. Anna Forbes, founder and director of the UK Medical Freedom Alliance.

You don’t need to sign something to give consent — baring your arm is sufficient.

In the case of vaccination, this is, in essence, your gesture that gives the vaccinator permission to touch you and inject you. Failure to seek your permission would typically be regarded, legally, as assault or battery.

The real problem therefore isn’t with the consent itself, but with the information that should precede the issue of consent.

The three prerequisites for informed consent

For consent to be valid you need 3 things:

1. It must be given voluntarily— without coercion or deceit.
2. It must be given by an individual who has mental capacity.
3. BEFORE giving consent, a person needs to have been fully informed about the issue. That includes being informed about what the risks and benefits of the treatment or vaccination are, as well as the risks and benefits of going without the treatment or vaccination, and what alternate options might be available.

Do health authority vaccine claims constitute deceit?

Health authorities around the world continue to claim that COVID-19 vaccines are “safe.” However, according to the Collins dictionary, this means that:

“Something that is safe does not cause physical harm or danger.”

“Safe” claims are routinely made by organizations like the UK NHS, the Centers for Disease Control in the USA and the World Health Organization.

A search we carried out of the VAERS database in the U.S. shows that nearly 8,000 adverse events have been reported to date (note: as many as 90% of adverse reactions often go unreported), and over 1.5% of these involved death. It is then arguably deceitful to refer to these experimental vaccines as “safe.”

Information chasm

Even if it can be argued that the existing safety claims, advertising campaigns or pressure from some sectors of the health professions are neither coercive nor deceitful, it is this last prerequisite concerning the provision of information where mass vaccination programs typically fall short.

Given the lack of vaccine transparency, vaccinators themselves are not properly informed so are generally not in any position to offer accurate information that might be available in the public domain, but is generally not well known.

Information that should be freely communicated includes the fact that the vaccines are experimental and unproven. Those considering giving consent should be told about the vaccines’ reliance on synthetic biology that has never been tested at scale. But it also includes information on known risks and benefits from Phase 3 trials, and that these trials are still under way and some won’t be complete for over 18 months (e.g. Jan. 31, 2023, for Pfizer mRNA vaccine).

Put simply – without vaccine transparency, informed consent is just not possible.

The very least we should expect is that every person gets to read the product information leaflet agreed between vaccine makers and regulators — before giving their consent. Even this isn’t happening. Where the information is being given — it’s often being handed to people as a passing gesture — a formality — after vaccination.

>>> Pfizer information leaflet, UK: Pfizer PIL      

>>> Pfizer fact sheet for recipients and caregivers, USA

>>> Pfizer fact sheet for healthcare providers administering the vaccine, USA

>>> AstraZeneca information leaflet, UK

>>> Moderna fact sheet for healthcare providers administering the vaccine, USA

>>> Moderna information leaflet, EU

>>> Moderna information leaflet

It’s time that those in charge of the vaccination programs begin to respect informed consent. And while they’re at it, recognise that they better change how they’re approaching informed consent because many are likely breaking the law by not allowing that right to be exercised.

The law on informed consent – present in nearly all jurisdictions – forms one of the central planks of medical ethics that’s the bedrock for the practice of ‘good medicine’ in civilised, democratised societies. Let’s not throw that to the wind.

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