"The largest global vaccination trial ever"

Pandemic policies review, part 1: The ethical primacy of valid consent

In part one of the pandemic policies review by Dystopian Down Under (Australia) x The Stark Naked Brief (UK):

They were wrong to flout the ethical primacy of valid consent, coercing the population into a medical experiment.

There are 3 ways in which our leaders denied the public the opportunity to give valid consent, which is a legal and ethical requirement for the administration of a vaccine:

1. The majority of the public was not made aware that they were taking part in an experiment

2. The government applied undue pressure and engaged in tactics of manipulation and coercion

3. The public was not sufficiently informed of the risks

Such glaring violations of the principle of valid consent should have prompted the medical fraternity to sound the alarm, with full-throated support by the news media. It’s notable that it is not only our governments that did us wrong on this. Our doctors, nurses, vaccinators and media were accomplices to this unconscionable breach of established medical ethics.

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1. The majority of the public was not made aware that they were taking part in an experiment

Australia’s Minister for Health at the time, Greg Hunt, said of the vaccine rollout in February 2021,

“The world is engaged in the largest clinical trial, the largest global vaccination trial ever, and we will have enormous amounts of data…”

This is an accurate statement. All four of the vaccines currently available in Australia and the UK are still in Phase 3 clinical trials. The completion dates of each are:

AstraZeneca – 24 February 2023 
Moderna -  29 Dec 2022  
Novavax – 30 June 2023
Pfizer – 15 February 2023

The Covid vaccines were rolled out concurrently with the Phase 3 trials. This is highly irregular, as new vaccines are generally required to complete trial phases 1-3 before receiving full approval by regulatory bodies, after which they are rolled out to the wider population. This process typically takes 7-10 years.

The conventional pathway of vaccine development is illustrated in this flow chart from Australia’s National Centre for Immunisation Research and Surveillance (NCIRS):

SOURCE

Compare this to the fast-tracked Covid vaccine development pathway at a pace described by the NSIRS as “pandemic speed” (presumably interchangeable for ‘the speed of science’) here:

SOURCE

The Phase 3 trials are still in progress and will not be completed until two or more years after the real world roll out began.

Some ‘fact checkers’ have quibbled with this statement, arguing that data has been published from all the Phase 3 trials (true) and that as the remainder of these trials is largely focused on safety monitoring (true), the trials are in fact complete because the safety monitoring component of Phase 3 trials doesn’t count as part of the trial (false). These ‘fact checkers’ would like to rewrite the book on how clinical vaccine trials work.¹

Phase 3 trials are the stage at which safety and immunogenicity are determined. As these trials are not complete, we do not have complete data on safety and immunogenicity, even at almost two years into the real world roll out.

It is this fact that presumably led world leaders, including Hunt (aforementioned), Barack Obama, and Pfizer’s Vice President Dr Philip Dormitzer to refer to the global vaccination rollout as a ‘trial’, or as ‘experimental.’

Governments justified this trade-off due to the urgency of finding a suitable vaccine for a deadly pandemic.

None of this so far undermines valid consent, provided that the public is informed that they are being invited to participate in a trial of a product for which safety and immunogenicity are yet to be completely determined.

However, that is not the message that the public received. No sir. Quite the opposite. Aside from the odd Freudian slip per the above video, the public messaging was overwhelmingly that:

• The Covid vaccines had been through all the same tests as all other licensed medicines, and,

• The Covid vaccines were, unequivocally, ‘safe and effective'.²

These assurances were misinformation, and still are. It is an egregious breach of all major international codes of medical ethics to trick people into participating in a medical experiment without their knowledge or informed consent.

2. The government applied undue pressure and engaged in tactics of manipulation and coercion

Australia’s Immunisation Handbook (AIH) states that valid consent is necessary for the administration of any vaccine (experimental, approved or otherwise). Consent can only be considered valid when given, “voluntarily in the absence of undue pressure, coercion or manipulation.” 

Similarly, The UK’s Greenbook outlines that consent, “must be given freely, voluntarily and without coercion by an appropriately informed person who has the mental capacity to consent to the administration of the vaccines in question”. 

Undue pressure and coercion was in fact the modus operandi of the vaccine rollout in Australia. Vaccination was mandated as a requirement to work in most industries, to travel across state and national borders, to use public facilities, to enter gyms and restaurants, and even to purchase alcohol. When asked why they took the jabs, many say that they ‘didn’t have a choice’ because they couldn’t work without it.

The fact is that though consent was technically given, in many cases it was not voluntary, as people viewed keeping their job as a necessity, not an optional luxury. That’s why a doctor’s surgery in Perth (Western Australia) was compelled to put this sign in place:

In the UK, the mandates were less extreme, due in part to strong and sustained push back from NHS workers. The pressure to vaccinate was largely social, with checkpoint hindrances to disincentivise remaining unvaccinated (eg: travel testing requirements for unjabbed only, or the short lived passport scheme for concerts, sport events and nightclubs). The UK government empowered companies to cut sick pay for unjabbed workers who were directed to self-isolate.

Nudge units were engaged to manipulate UK and Australian publics into getting vaccinated, a condition which renders consent invalid by the AIH definition of valid consent. A coalition of British psychologists declared the scare tactics employed by the UK government to be grossly unethical.

3. The public was not sufficiently informed of the risks

For consent to be considered valid per the AIH, the recipient must first have been informed of, “the potential risks and benefits of the relevant vaccine, the risks of not having it, and any alternative options.” This is in line with the Greenbook’s requirement that the vaccinee is, “appropriately informed.”

It was simply not possible at the time of the Covid vaccine rollouts for vaccinees to be appropriately informed of the associated risks, as the necessary studies had not been done.

For example, studies on the impacts of the vaccines on fundamental health outcomes such as men’s and women’s fertility, breast feeding and pregnancy had not been completed at the time that provisional approval was granted, as indicated in vaccine toxicology reports.

Human trials of mRNA vaccines are recent and few, and mRNA vaccine development has been plagued with safety concerns, particularly for individuals prone to autoimmune conditions.³ The public was not informed of the known risks associated with this novel vaccine technology.

Only recently was it confirmed that side effects in certain age cohorts are a greater risk than is the virus itself, a likely factor in Denmark, Sweden and Florida’s moves (along with some other Nordic countries) to restrict access to mRNA vaccines for younger age groups. Unfortunately, this information was only confirmed after billions of people had already been injected with the products.

In Australia and the UK, the public was told that the Covid vaccines were safe and effective, and that they were not experimental at the time of rollout, despite the safety and immunogenicity trials being nowhere near complete. Consent for Covid vaccination was given under conditions of coercion, undue pressure, and manipulation, and vaccinees were not appropriately informed of the risks associated with their vaccination. This is in breach of the Australian and UK governments’ own ethical and legal guidelines. It was wrong, and it should never happen again. 

THE PANDEMIC RECKONING, A SERIES
This post is Part 1 in the PANDEMIC RECKONING series, in which Dystopian Down Under and The Stark Naked Brief review the pandemic policies of the Australian and the UK governments. View the main post here:

LET'S DECLARE A PANDEMIC RECKONING

1. A vaccine development timeline explainer by Johns Hopkins University’s Coronavirus Research Centre states it clearly: ”assessing short- and long-term safety is also a major goal of phase 3 trials." To argue that the safety monitoring component of Phase 3 trials is irrelevant or is somehow complete before the trial end date is either stupid or willfully deceitful.

2. In many cases, politicians, health agencies and celebrity doctors outright lied to this effect. Take, for example, the NHS tweeting in March 2021 that, “The COVID-19 vaccine has been through the same clinical trials and safety checks that all other licensed medicines go through.” This is patently untrue.

Or take Australian celebrity doctor Dr Norman Swan who said, in this propaganda promo from the national broadcaster ABC: “We know what their side effects are already, there are no surprises round the corner,” a stunning claim in light of the fact that the trials monitoring safety and immunogenicity were barely halfway through at the time that this promo was circulated in late 2021.

3. Bear in mind that, prior to the provisional approval of these drugs, no mRNA vaccine had ever been taken to market. Prior to the provisional approval of its Covid vaccine Spikevax, Moderna had had to abandon any mRNA treatment that would require more than one dose due to toxicity concerns. Journalist Whitney Webb notes that there is no evidence that Moderna’s toxicity issue for multi-dose products has ever been resolved, flagging potential concerns arising from repeated administration of booster doses.