Side effects

by George Santayana

Informed consent is one of the cornerstones of modern medicine and the foundation of the patient/doctor relationship. The principle of informed consent is a core part of the Nuremberg Code on human research ethics and states that consent for any medical treatment must come from the patient themselves who needs to understand both the benefits and risks. Likewise, the opposite, which we might call “informed refusal”, is just as important and a patient can refuse treatment or withdraw consent at any time.

The “informed’ part of informed consent can occur in a number of ways such as provision of written materials (the piece of paper you throw away when you open a packet of headache tablets) or a discussion with your doctor. Regardless, the information given to a patient needs to be accurate, balanced and cover both the benefits and risks.

Consent must also be given freely and without undue influence or coercion. Of course, a clinician can express their opinion and offer advice as to what course of action a patient might take, but ultimately the decision to proceed (swallow the pill, take the test, have the operation) resides with the patient.

Informed consent places the individual patient at the heart of clinical practice and given that they are the person receiving the treatment and taking any associated risks that intrinsically feels like the right thing. And so it used to be for vaccinations, where it was up to the individual whether they wished to have a specific vaccination or not. Yes, there were some specific situations where vaccination was deemed necessary (e.g. travelling to certain regions of the world) but in these situations the focus was on protecting the individual themselves. But then COVID-19 came along and suddenly this patient-centred view of the world was replaced by governments and the mainstream media with one where a treatment benefit was not just to the individual receiving the treatment but also to society… a change, which as I will discuss here, inexorably leads to the destruction of informed consent.

To understand why, let’s start by considering the benefit of a vaccination to an individual.

One of the peculiar things about vaccines as treatments is that their benefit is not the same as their effectiveness. This is because a vaccine works by generating immune “memory” of a specific pathogen. The effectiveness of the vaccine is therefore dictated by how good the immune response is to the immunisation and what type of immune memory it creates. The effectiveness is also to some extent dictated by the pathogen itself. So, for a virus like smallpox, vaccination was highly effective not least because the pathogen proved unable to evolve to evade vaccine induced immunity. In contrast, the parasites that cause malaria or sleeping sickness have evolved mechanisms to evade the immune system and so vaccinations against these pathogens have proven to be highly elusive. SARS-CoV-2 sits somewhere in the middle in that it appears susceptible to immunity from vaccination but can mutate and evolve variants that might be able to overcome this immunity.

However, having immune memory is of no benefit to the patient per se. The benefit to the patient only comes if, subsequent to vaccination, they become infected with the pathogen. At this point, because of the immune memory created by the vaccination, they raise a more robust, rapid and effective immune response, meaning that they will either not become ill, or if they do become ill, it will be with a milder form of the disease. In other words, infection by the pathogen is a pre-requisite of gaining the benefit from the vaccination, a benefit that only occurs if, in the absence of the vaccination, they would have developed significant disease. Vaccination is therefore a lot like insurance; you gain no benefit from having the insurance policy documents sitting in your filing cabinet; they only become useful when the thing you are insuring against actually happens.

This benefit of vaccination is captured in the concept of “number needed to vaccinate” or NNTV (i.e., how many individuals need to receive a vaccination in order for one of them to avoid developing serious disease). NNTV is therefore driven by two things: the prevalence of the pathogen within a population and the severity of the disease caused if someone was to be infected by the pathogen. The NNTV is why we don’t routinely vaccinate individuals against diseases such as yellow fever that are not prevalent in the U.K. and why we focus flu vaccinations on vulnerable individuals for whom the disease carries significant risk.

For SARS-CoV-2 and COVID-19, the seriousness of the disease is largely age related, meaning that the NNTV is also age-related. As a result, we might only need to vaccinate a few hundred over-60s for one to avoid having a serious case of COVID-19 while we would need to vaccinate thousands (if not tens or hundreds of thousands) of the under-20s to achieve the same outcome.

Unlike the benefit, the safety risks associated with SARS-CoV-2 vaccinations are not age dependent and include rare, serious adverse events including death. So, the balance of benefit and risk for their use also varies with age and is vastly different for a diabetic man in his 60s compared to a healthy young woman in her 20s. From the perspective of the benefit to the individual, there is therefore no way we should be considering vaccinating healthy young people using these vaccines. The likelihood of serious adverse effects may be small but then so is the likelihood of avoiding serious COVID-19 and so there is a very real possibility that a mass vaccination campaign of young people will produce more harm than benefit. In fact, the original strategy was to focus COVID-19 vaccinations on the over-50s for precisely this benefit/risk reason.

But somewhere along the way, COVID-19 vaccinations stopped being solely about the benefit to the individual and started to be about the benefit to society (i.e., the goal of achieving herd immunity). A brief reminder: herd immunity occurs when a sufficient proportion of a population is immune to a given pathogen in such a way that the likelihood of encountering an infectious person drops, as does the likelihood of an infectious person being able to pass the infection on to another individual who also becomes infectious. As a result, herd immunity protects individuals who are naïve to an infection simply because they are unlikely to ever encounter an infectious person and at the same time it means that an infection can no longer spread effectively through the population and may even die out.

Vaccinations can produce herd immunity and in the case of smallpox were so effective that they led to the elimination of the disease itself. But from an informed consent perspective there is one huge difference between vaccination campaigns that have historically produced herd immunity and that being pursued for COVID-19 and that is that historically the diseases concerned were of significant risk to those receiving the vaccination. For example, measles is a significant risk for young children and so we vaccinate young children. But young children often grow up to be adults and carry their measles immunity with them and so, as a result, measles herd immunity emerges as a consequence of measles vaccination… it is absolutely not its aim.

Achieving herd immunity is also when vaccine effectiveness comes into play, and this is because the vaccine must not only reduce the individual’s likelihood of developing serious disease but also produce “neutralising” immunity in the sense that infected, immune individuals are not infectious to others. As a result, the inclusion of “benefit to society” as a consideration for vaccinations against SARS-CoV-2 raises the bar as to what an effective vaccine looks like and it is becoming clear that the current Covid vaccinations almost certainly don’t jump over that bar. However, important as they are, I don’t want to focus on these technical aspects but instead come back to what the “benefit to society” addendum to vaccine benefit means for informed consent.

As soon as we aim to achieve herd immunity through vaccination, then we need to ensure that a sufficient proportion of the entire population are vaccinated. As discussed above, this happens naturally as a consequence of some vaccinations against childhood diseases but for SARS-CoV-2 and COVID-19 the benefit is to the more elderly population and not children and young people. As a result, to achieve herd immunity we need to vaccinate individuals who will receive minimal benefit from the treatment itself. We could treat this as a form of medical altruism and say, “We know that you won’t benefit personally, but for the good of society please have this treatment.” If we were to use this as the point of persuasion for individuals to have the vaccination, then this would not necessarily be a problem; people give blood as an altruistic act for the medical benefit of others all the time and encouraging them to do so isn’t unethical. However, it becomes an issue in this case because you need lots of young people (and the population in general) to be vaccinated in order to cross the magic threshold for herd immunity and purely relying on a sense of community or selflessness may not be sufficient to achieve the levels of vaccination required to achieve this societal benefit. So, to tackle this problem, and to use a horrendous Americanism, the population need to be incentivised to be vaccinated.

Let’s be completely clear: whatever form these incentives take they are coercion, and so utterly contrary to the principle of informed consent. This would be bad enough if the vaccinations were completely safe, but the fact that they carry even the small possibility of serious and even life-threatening risks makes this coercion even more egregious. Effectively, the benefit to the patient is no longer confined to the treatment itself, but whether they might win a prize, or be able to travel, or go to a nightclub, or watch a football match. Informed consent has been lost in a haze of rewards for the vaccinated.

Unfortunately, it gets worse. This is because it is a relatively simple logical step to move from seeing unvaccinated refuseniks as individuals to be cajoled or bribed into being vaccinated to treating them as a threat to the herd-immunity-through-vaccination project. Once we’ve taken this step, then the unvaccinated become hazards to the vaccinated; immune dementors who could suck the immunity from the rest of the population… or more specifically, variant factories whose every breath carries the risk of a new mutant virus able to evade vaccine-induced immunity.

Once we classify unvaccinated individuals as hazards, we can then deploy versions of the ‘passive smoking argument’ to move beyond coercion and into compulsion. Essentially the argument runs like this: we know that you as an (unvaccinated) individual have rights, but your (in)actions are also a hazard to broader (vaccinated) society and so we need to balance your rights as an (unvaccinated) individual with the rights of your fellow (vaccinated) citizens and as a result we must, reluctantly, remove your rights in order to protect the broader rights of others. This argument creates the necessary backdrop for policies to compel vaccination because it legitimises the removal of individual consent as a necessary evil to protect the broader (vaccinated) population.

However, unlike smoking in public, being unvaccinated is not something that can be switched on or off and so the only way to ensure that the unvaccinated hazard is contained is to separate it from the vaccinated population, which naturally leads to concepts such as vaccine passports and ‘No Jab, No Job’ policies. Voluntary fun activities like going to the pub or having a meal out – normal day-to-day existence – become harder and harder for those not having the vaccine, leaving many people with no choice but to take the medicine regardless of how they feel about it. And without choice how can there be consent?

They say that the road to hell is paved with good intentions, and so I believe it is with the Government’s COVID-19 vaccination policy. What starts out as a noble ambition to use COVID-19 vaccination as a tool to achieve a broader benefit to the population, logically ends up in the destruction of informed consent and the creation of medical apartheid. This is the inevitable consequence of shifting the focus of a medical treatment from the individual to broader society. It is also the thin end of a very unpleasant wedge because once we allow the principle that the state can have a direct stake in what is in the best interest of an individual’s health then where do we stop? Arguments that “the others” are a medical hazard to “us” have been deployed to justify some of the worse abuses of modern times and although I am absolutely not saying that current policies amount to anything like this, the resonance here should make even the most ardent proponent of vaccine compulsion uncomfortable. History teaches us that when governments, rather than individuals, decide on what is the best medical treatment this almost always leads to dire consequences – often for some of the most vulnerable in society. But with vaccine passports and NHS apps, it certainly feels like we’ve already started down this road and regardless of your views on COVID-19 vaccinations we should all be very worried about where this journey might lead.

George Santayana is the pseudonym of a senior executive in a U.K. pharmaceutical company.