It was in the fall of 1976. Spurred by the discovery of a novel swine flu virus among sick recruits in a military camp and the prediction that this virus would lead to a pandemic, the U.S. government ordered a national vaccination campaign. It was an administrative success with 48 million Americans getting vaccinated in less than three months.
However, records show that only one person actually had died of this virus and the anticipated pandemic never materialized. In addition, the vaccine was blamed for producing hundreds of cases of Guillain-Barré syndrome, a debilitating and otherwise rare neurological condition. The vaccination campaign was abruptly stopped after 25 people died of paralysis and respiratory failure.
The present scenario in the fall of 2009 is different from that of 1976. This swine flu virus has already caused a pandemic with more than 70 deaths in Canada and thousands of deaths around the world. Under these circumstances, a national vaccination campaign makes eminent sense and the federal government and its experts are to be congratulated for their foresight and efforts in securing an in-Canada vaccine production facility to meet national demand. However, if anything is to be learned from the 1976 “swine flu fiasco,” it is that such a campaign has many scientific, social and ethical aspects that require careful consideration.
Ethically speaking, a mass vaccination program should be guided at minimum by three basic ethical principles, namely, beneficence, respect for autonomy, and justice. In applying the principle of beneficence, the program’s goal ought to achieve a net benefit to the population, taking into account prevention of deaths and illnesses, as well as burdens and risks. By and large, routinely used vaccines, perfected over the years are safe and effective. But such assurance for the new pandemic vaccine must wait until it is fully tested, including clinical trials with volunteers. These tests have been scheduled, but the temptation is to do trials rapidly.
The longer the trials and the more volunteers involved, the more reliably can a vaccine’s safety and efficacy be determined, since some side effects can appear long after the injection. On the other hand, the sooner a safe vaccine is licensed for use, the more people can be protected.
We are told that trials will be done by November and vaccination across the country will start in December. Delays in scheduling require patience. Health authorities have the responsibility to assure themselves that the vaccine is reasonably effective and safe before asking millions of people to accept it. Safety is particularly important because the new vaccine will be offered to vulnerable populations, such as pregnant women, persons with chronic illnesses, and children.
The program also ought to be guided by the second ethical principle, the principle of respect for autonomy, which would enable people to make their own decisions about whether or not to accept vaccination, regardless of how strongly the heath authorities feel about the usefulness and safety of the vaccine. Respect for persons and their intrinsic dignity, requires no less.
In this regard, vaccination during a flu pandemic should not be different from any other medical procedure, which requires of the participant a voluntary informed consent. In order for the consent process to be informed, candidates for vaccination will need to be given estimates of anticipated benefits and foreseeable risks. A blanket reassurance such as, “trust me, it is good for you,” is not acceptable; people must be given the facts and figures acquired from new clinical trials and past historical experiences, and their questions should be responsibly answered.
Professionals responsible for vaccination need to ensure that participants understand the information. For example, vaccinated people may erroneously believe that a vaccine provides 100 per cent protection, while 60 to 80 per cent protection would be a more realistic expectation. If people sign the consent form with an incorrect impression, they may become careless and not take the usual precautions against infecting themselves or others.
Hopefully, somewhere there is a group of experts that is already composing a consent form that includes all relevant information that can assist people in making a decision about getting vaccinated.
In applying the third ethical principle, the principle of justice, the vaccination program must focus on a just and fair distribution and administering system. The federal decision to offer the vaccine to every Canadian has reduced concerns about unjust distribution. However, because the whole population cannot be vaccinated at once, the pandemic planners have established a needs-based distribution scheme by dividing the population into groups defined by occupation, level of risk, and age. To date, there is no federal-level recommendation about which of these subgroups will receive the vaccination first.
To determine priority group distribution, many factors will have to be considered, however it is important that the responsible authorities arrive at their decision in a very public, transparent and justified manner. Yet, creating appropriate groups and order of priority does not guarantee that justice is fully served.
It is also important that the method of delivery is just and fair. If, for example, persons with a high risk of complication from influenza are given priority for vaccination, it is necessary to identify them by name, based on their actual health condition, and they must be notified about the vaccination offer. Some will be in institutions, many in their homes, and some will lack the ability to go to vaccination clinics. Will home care agencies have the responsibility to contact these people and bring vaccination to their homes?
Vaccine administration will be further complicated when trying to administer to those with communication challenges or disabilities, and by individuals or groups who may try to gain an unfair advantage. Do we have enough people in the health care system who are designated for this task and getting ready to carry it out?
One group which justifiably may be given priority vaccination is front-line health care workers, but this will not be free of ethical problems. For example, if a health care worker receives priority vaccination, it would seem to create a reciprocal ethical obligation to serve.
How should we respond, if at the height of the pandemic such a person is unwilling to work? Even more problematic is the scenario where a physician or nurse refuses the pandemic vaccination. This is not an unlikely scenario, because more than 50 per cent of these professionals refuse the yearly flu vaccination which is highly recommended and promoted.
For health care workers, the decision to vaccinate is not just a personal decision. They are offered the vaccine not only to diminish their chance of disease and death, but also to maintain their health in order that they are available to serve. Even more importantly, vaccination will reduce the risk that of their transferring the virus from patients with the flu to patients that have other health problems. Unvaccinated health care workers at the height of a pandemic would likely put their patients at risk — an ethically most problematic situation.
Legal enforcement of vaccination is the last measure to consider. The first step is for all colleges of health care professions to consider if the acceptance of vaccination should or should not be declared an ethical obligation of the professionals they oversee.
Another important, justice-related issue is to consider offering compensation to people who are injured by vaccination. Even if the vaccine is reasonably safe, there is the possibility that of the many millions who receive it, some will experience adverse effects which at times can be debilitating. Is it fair that such people be burdened by both a personal injury and the economic consequences of such an event? Would it not be a further unfair burden, if a justified compensation would have to be won through the courts?
A good argument could be made that we all should share some of that risk and that parliament ought to adopt a law instituting a no-fault compensation system, similar to those for motor vehicle accidents. A number of American states, as well as the province of Quebec already have such a statute in place.
A great deal needs to be done so that a pandemic vaccination program can benefit the population to the greatest degree, be respectful of individuals, and be delivered with justice. During such a crucial time, an ethically sound pandemic vaccination program can foster solidarity and help us emerge from the pandemic crisis a more cohesive and humane society.
Jaro Kotalik is director of the Lakehead University Centre for Health Care Ethics