HILL TIMES ARTICLE Vaccine hesitancy: the need for informed consent

 

Vaccine hesitancy: the need for informed consent

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By PETER C. COYTE      JULY 12, 2021

Informed consent requires that everyone be apprised of their unique risk profile for COVID-19 infection and associated outcomes as well as their risk profile for adverse events due to the vaccine.

A blanket statement that says that the “benefits of COVID-19 vaccination outweigh the risks” is meaningless as it does not consider the unique circumstances faced by each member of the public, writes Peter C. Coyte. Image courtesy of Pixabay

While the public has been informed that the benefits of COVID-19 vaccination outweigh the risks, a comprehensive and explicit risk assessment has neither been performed in Canada nor have any such assessments been communicated in detail to the public to allow for informed consent.

Informed consent requires an understanding of the risks and benefits of the choice to be taken. All actions, whether in medicine or elsewhere in life, entail costs and benefits.  While a therapy often yields a range of beneficial outcomes, such therapies may also pose a risk. In the context of COVID-19 vaccinations, the benefits vary from one clinical trial to another with some touted as reducing the severity of COVID-19 symptoms and others in the prevention of lab-confirmed COVID-19 cases. As such, the COVID-19 vaccine might, in some cases, be better classified as a prophylactic therapy, or a treatment for the symptoms that may arise from disease, rather than as a vaccine, or an intervention that prevents disease itself. This distinction is rarely highlighted in public discourse but is important in the transmissibility of COVID-19

The decision to accept or not to accept a COVID-19 vaccine entails a risk assessment wherein the costs and benefits of this choice are assessed. To undertake this exercise requires information on: the effectiveness of the vaccine in altering the course of COVID-19 disease; an assessment of the potential adverse events associated with the vaccine; and the values individuals attach to the consequences of COVID-19 infection as well as on the sequelae associated with adverse events due to the vaccine. Informed consent requires that the specific circumstances faced by each individual undertaking this choice be recognized as the risks, benefits, and values attached to these health outcomes vary among the population. A blanket statement that says that the “benefits of COVID-19 vaccination outweigh the risks” is meaningless as it does not consider the unique circumstances faced by each member of the public.

The challenge faced by individuals in undertaking this risk assessment cannot be underestimated. Informed consent requires that everyone be apprised of their unique risk profile for COVID-19 infection and associated outcomes as well as their risk profile for adverse events due to the vaccine and the associated sequalae.

The government, media, and scientific community have done a major disservice to the public by trivializing the choice without offering clarity on the key parameters to assess and value before deciding to accept vaccination. Under the simplest of circumstances, there are four main sets of parameters that people need to assess and value before a fully informed choice may be taken. The risk and cost of:

1. Premature mortality from COVID-19 infection;
2. The morbidity consequences from COVID-19 infection;
3. Premature mortality from the adverse events associated with COVID-19 vaccination; and
4. The morbidity consequences from the adverse events associated with COVID-19 vaccination.

Each of these four sets of parameters comprise a vast array of epidemiological and personal preference-based considerations, such as an assessment of remaining life expectancy, estimates of the quality of life, the value individuals attach to a forgone quality-adjusted life years, and the value of life following COVID-19 infection and/or adverse outcomes associated with vaccination.

Governments and others in authority have suggested that because the mortality and morbidity costs of COVID-19 infection are so large and the cost and risk of adverse events from COVID-19 vaccination are so small, all citizens, including those above 12 years of age, are assigned a pejorative labeled, “vaccine-hesitant,” if they refuse or postpone COVID-19 vaccination. But the absence of clear, detailed, and personalized information makes it impossible for the public to make an informed choice on this matter.

Despite general acceptance that value in health care is optimized when the public is making informed choices for themselves, the current situation is one in which governments and public health authorities are offering a one-size-fits-all recommendation.  It is important to reject such a singular collectivist recommendation and demand a more nuanced and individualistic approach. Advice to each member of the public should be informed by their unique risk profiles when contemplating vaccination and the idiosyncratic values that they attach to the resulting health outcomes. Once we return to this more individualistic approach to medicine that allows for informed consent, then we may have the potential to return value to health care.

Peter C. Coyte is a professor of Health Economics at the University of Toronto’s School of Public Health.

The Hill Times