Ethics Check-up of Public Health Immunization Programs in Canada
Noni E. MacDonald, Shawn Harmon, Janice E. Graham
Noni E MacDonald MD MSc FRCP 1, Shawn Harmon LLM, PhD 1,2, Janice E Graham PhD 1,3
1. Department of Pediatrics, Dalhousie University, IWK Health Centre, Halifax, Nova Scotia
2. Policy Analyst, Health Law Institute, Schulich School of Law, Dalhousie University, Halifax, Nova Scotia
3. Technoscience and Regulation Research Unit, Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia
The World Health Organization recognizes immunization as one of the most successful and effective public health interventions for saving lives (1). Its impact reaches far beyond the health and well-being of individuals and communities through improved social determinants of health affecting work productivity, equity, institutional stability, economic development, and innovation (see Figure 1). Nevertheless, immunization needs to be subject to independent scrutiny of vaccine research data and manufacturing practices, legal and ethical assurance of informed consent, and social justice issues including the right to access. In this Brief, we offer an ‘Ethics Check-up’ of Canada’s public health immunization programs and suggest some areas for further improvements.
Figure 1: Immunization and the Sustainable Development Goals ̶ adapted from GAVI, the Vaccine Alliance
The Check-up Criteria Used
According to the Canadian Medical Association, “ethical practice is understood as a process of active inquiry, reflection, and decision-making concerning what a physician’s actions should be and the reasons for these actions”(CMA Code of Ethics and Professionalism).
Immunization programs raise ethical concerns because they involve interventions in a wide range of communities that vary by age, disease burden, vulnerability, and immunization uptake rates. Some populations are seen as vulnerable (e.g., infants, children, pregnant women, immunocompromised, and the elderly) where the risks and benefits of immunization might vary. Isaacs has suggested seven ethical principles that should inform assessments of public health immunization programs in Australia (see Table 1) (2).
The National Advisory Committee on Immunization (NACI) for Canada and each of the provinces and territories make decisions on who is and is not eligible for specific vaccines by using an evidence-based framework. NACI is also now working to incorporate ethics, equity, feasibility, and acceptability into their national recommendations (National Advisory Committee on Immunization (NACI) workplan). Less attention has been paid to the ethical issues that arise at the front line, or the differences in immunization programs across the country, which raise ethical issues for the public. This CANVax Brief applies Isaacs’ criteria (Table 1) and draws attention to several issues of concern.
Table 1. The seven ethical principles for public health immunization programs applied in this Canadian context check-up.
Source: Adapted from Isaacs, 2012 (2).
Applying the Criteria
NACI provides evidence-based recommendations that take into account the population burden and risk of disease, including the safety and expected benefits of the vaccine in different populations in Canada. The provinces and territories then make their public health policy decisions about including (and paying for) the vaccine(s) in their immunization program, for whom it will be made available, how the program will be delivered, and whether catch-up programs will be introduced. Not all vaccines recommended by NACI are equally accessible across the country. Provincial differences in implementation can foster provider and public confusion, raising national equity and social justice concerns surrounding access. For example, the introduction of conjugated pneumococcal vaccine and varicella vaccine varied across the country, despite both vaccine-preventable diseases being prominent (3). The disparity in the timing of vaccine introduction continued, with Alberta introducing a school-based HPV vaccine program for girls in 2008 while Nunavut was only able to do this in 2010. Not all provinces and territories offer HPV vaccine catch-up programs for boys, and Nova Scotia’s approval of routine rotavirus vaccine in their infant program only occurred in 2019, years after other provinces (Provincial and territorial routine and catch-up vaccination schedule for infants and children in Canada). Thus, access to NACI’s recommended vaccines has varied in the past and into the present depending on where one lives in Canada, underscoring equity and social justice issues.
With respect to the benefits of immunization (i.e., vaccine-preventable disease [VPD] prevalence) and the risks of immunization (i.e., adverse events following immunization [AEFI]), both are tracked in Canada through surveillance systems. Canada has both passive and active AEFI (4) and VPD reporting systems, with VPD reporting from laboratories now more automated than in the past. VPD and AEFI summary findings are regularly reviewed and discussed within the province or territory where reported, as well as nationally with NACI and the Public Health Agency of Canada (PHAC). There are many examples where the introduction of a new vaccine across Canada has led to a marked decrease in the VPD (e.g., invasive Haemophilus influenzae type B (5) and pneumococcal-related diseases (6)), providing data on vaccine effectiveness in Canadian populations. IMPACT, Canadian Immunization Monitoring Program ACTive, is Canada’s pediatric hospital-based national active surveillance network that looks for vaccine failures, serious AEFI (i.e., hospitalization), and selected VPDs and infectious diseases, has provided much valuable data on the impact of pediatric vaccines over the past two decades. Similar data for adult vaccine impact are not routinely collected. The Serious Outcomes Surveillance (SOS) Network collects data on adults admitted to the hospital with influenza or pneumonia, but it does not track serious AEFI. Neither of these systems collects immunization uptake data for the specific region served by the reporting site, meaning that the effectiveness of the different vaccines locally can only be estimated. Beyond these active searches for AEFIs, there is an active VPD microbe reporting by microbiology laboratories across the country as they become automated, as well as passive VPD and AEFI reporting by health practitioners. Again, a gap in national immunization uptake data limits robust estimates of the national effectiveness of different vaccines. The principles of risk and effectiveness could be better addressed.
With respect to autonomy, school-based immunization programs raise unresolved consent and assent issues. While such programs are routinely offered across Canada, the age varies – from grade 4 (approximately 10- to 11-year-olds) to grade 9 (approximately 15- to 16-year-olds). Typically, parents sign a consent form for the vaccines to be administered. But if there is no consent and the student wants to be immunized, or if the consent and the student’s stated decision are at odds, public health practitioners may be unclear about how to proceed, and jurisdictional practices differ. In the case of positive parental consent with a student refusal, the vaccination is unlikely to proceed. But for the student who expresses a desire to be vaccinated in the face of parental refusal, there is more ambiguity. This uncertainty is confounded by variation across Canada at which age ‘capacity’ is assumed, and the differences in approaches to ‘mature minors’ (7). In Ontario, for example, there is no specific age at which a minor’s capacity is assumed; children are assessed on their capacity to give consent, which is informed less by their age and more by their understanding, and it is the latter which the health care provider must assess (8). Furthermore, some health care workers will not disregard the parental veto on immunization even if the minor appears to have capacity.
Another uncertainty associated with informed consent involves whether the given vaccine information is meeting user needs. In Canada, each province and territory develops its own patient/parent information packages. While these may draw on NACI’s information and advice, they often differ, leaving uncertainty as to whether the same vaccine is being described (9). For those seeking to make an informed decision, this can be confusing, if not off-putting, especially when proponents of no vaccination state that the provided information is inadequate. Better collaboration on vaccine information material development could not only make the area less confusing and contentious for those seeking information, but also improve coverage in populations where new data confirm safety and effectiveness.
Canada has a mixed picture of reciprocity for public health immunization programs. Hospital care costs associated with rare serious AEFI are covered by the publicly funded health care system. Any long-term disabilities caused by an AEFI may be supported, in part, by disability benefits offered through ministries of community and social services in the provinces and territories. However, these benefits usually do not cover lifelong loss of income due to inability to work. But vaccine causality is not always easy to assess. For example, causality assessment for narcolepsy incidents in Finland and Sweden post-pandemic H1N1 vaccine is confounded by the known increased risk of narcolepsy with H1N1 infection with the virus already circulating in the community when the immunization programs began (10). Disentangling the effect of natural infection concurrent with immunization is not simple. The onset of narcolepsy in childhood has a profound effect on education attainment, capacity for work, and many social, family and personal outcomes. There are strong ethical arguments that such serious AEFIs, when due to immunization, should be compensated, especially if vaccines are mandatory (i.e., not a choice) (11). In Canada, only Quebec has a vaccine injury compensation program – in place since 1987. This area needs further consideration to address reciprocity.
Issues of trust may arise for public immunization programs in a number of different areas. A cluster of AEFIs may undermine trust in the program and in the vaccine if their causality is not addressed quickly and satisfactorily. This occurred in Japan and in Denmark with the human papillomavirus vaccine (12, 13). It is unclear if all the provinces, territories and PHAC have serious AEFI rapid science procedures and communication templates in place, or if there is good co-ordination between the government levels across the country. Providing mixed messages on AEFIs and the vaccine can rapidly undermine public trust (Vaccination and trust (2017)). Trust concerns also arise when different vaccines are available for the same disease, but only some are funded and other ones are not (e.g., different influenza vaccines targeted at seniors) (14). This also raises ethical issues about cost-effectiveness assessment, social justice, and the valuation of equity. Again, science communication is key. Discussions about public values and priorities are needed, including voices from diverse communities. Moreover, evidence that these voices are valued and taken into consideration must be shown, or trust will be undermined.
Overall, this high-level ethics check-up of Canadian public health immunization programs suggests that Canada is generally on the right track. Although there is room for improvement, Canada has ‘passing marks’ in relation to principles such as benefits, risk, and effectiveness. There are gaps and uncertainties under other principles; however, examples such as equity, justice, autonomy, reciprocity, and trust speak to a need for greater attention to matters impacting other principles, including solidarity and transparency.
Universal solutions are not easy; given Canada’s size and health system structure, regional differences in disease prevalence and burden result in different decisions. Provincial and territorial priorities in health care also result in variation in implementation. Having acknowledged this, readily justifiable steps can be put into place in the short term that can improve collective coherence across Canadian immunization settings; fragmentation and duplication are problematic. For example, providing a simple ethics self-assessment questionnaire for provinces and territories might identify both common and region-specific challenges, and stimulate the development of effective shared tools and responses. Additionally, jointly developed best practices for issues such as consent and assent in school-based immunization programs would have country-wide benefits. Finally, a comprehensive review of serious AEFIs and the development of a template for AEFI crisis communication are undeniably valuable and within existing capacities. Obviously, leadership is needed to tackle these challenges so that the next ethics check-up – which might consider solidarity and transparency – might be improved.
- Strategic Advisory Group of Experts on Immunization. 2018 Assessment Report of the Global Vaccine Action Plan. 2018 Geneva, Switzerland: World Health Organization. https://www.who.int/immunization/global_vaccine_action_plan/en/.
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- Kellner JD, Canadian Paediatric Society, Infectious Diseases and Immunization Committee. Update on the success of the pneumococcal conjugate vaccine. Paediatrics & Child Health. 2011;16 (4): 233-236.
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- Steenbeek A, MacDonald N, Downie J, Appleton M, Baylis F. Ill-informed consent? A content analysis of physical risk disclosure in school-based HPV vaccine programs. Public Health Nursing. 2012;29 (1): 71-79.
- Sarkanen TO, Alakuijala APE, Dauvilliers YA, Partinen MM. Incidence of narcolepsy after H1N1 influenza and vaccinations: Systematic review and meta-analysis. Sleep Medicine Reviews. 2018; 38: 177-186.
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- Ikeda S, Hineno A, Ozawa K, Kinoshita T. Suspected adverse effects after human papillomavirus vaccination: A temporal relationship between vaccine administration and the appearance of symptoms in Japan. Immunologic research. 2018; 66(6):723-725.
- Baumann A, Andersen B, Østergaard L, Larsen M. Sense & sensibility: Decision-making and sources of information in mothers who decline HPV vaccination of their adolescent daughters. Vaccine X. 2019 Apr 4;2: 100020. doi: 10.1016/j.jvacx.2019.100020.
- Vaudry W, Zhao L, Stirling R on behalf of the National Advisory Committee on Immunization (NACI). Summary of the NACI Seasonal Influenza Vaccine Statement for 2018–2019. Can Commun Dis Rep 2018;44(6):123-8. https://doi.org/10.14745/ccdr.v44i06a01