Mandatory Infant & Childhood Immunization: Rationales, Issues and Knowledge Gaps

"If mandatory immunization is implemented, this needs to be tailored to fit the country's culture and the context."

Inadequate infant and childhood vaccine uptake rates have led several countries to enact, strengthen, or contemplate mandatory childhood immunisation legislation. This may happen, for example, when public health education campaigns and other interventions aimed at overcoming vaccine hesitancy do not lead to increased uptake rates, motivating public health and/or policymakers to move from persuasion and nudges to strategies that explicitly limit choice. This article presents an overview of mandatory immunisation, providing examples in two high- and one low-income countries to illustrate variations, summarise limited outcome data related to mandatory immunisation, and suggest key elements to consider when contemplating mandatory infant and/or child immunisation.

First, the article briefly defines mandatory immunisation programmes, describing the range of rigidity of these mandates from soft (i.e., flexible) to hard (i.e., rigid). One example would be Ontario, Canada, laws requiring parental education about immunisation (rather than immunisation itself); it is possible here to opt out with personal or philosophical objection if specific forms and notarisation are provided, and there is no penalty for noncompliance (medium-hard mandate, i.e., "informed consent" mandates). To illustrate the diversity of approaches, Table 1 summarises three frameworks: Australia (hard mandate), Slovenia (hard mandate), and Kenya (moderate-soft mandate).

Second, the authors consider the primary ethical issues inherent in mandatory immunisation. "At its core, mandatory immunization requires a principled calculus, a careful weighing of the indications, evidence and arguments, regarding the responsibilities of public authorities to act in support of the public good, and the potentially countervailing (but also potentially complimentary) rights and responsibilities of individuals."

Third, they explore key legal components for consideration in a mandatory immunisation framework and note the importance of tailoring these to fit a country's culture and the context.

Fourth, they offer some evidence of the effectiveness of hard mandates. One illustration given here is that of the 15 ethnic Republics that composed the former United Soviet Socialists Republic (USSR) and its communist neighbours, all of which had very strong centralised public health systems with mandatory vaccination that enabled enforcement without question and was associated with high uptake rates. By 2018, however, much had changed with respect to childhood immunisation in many of these countries The Ukraine now has the lowest childhood uptake rate in the WHO European Region, and Serbia and Poland are experiencing protests against mandatory immunisation. Context, history, and politics appear to have altered support for and acceptance of mandatory childhood immunisation in several of these countries.

Fifth, the authors examine evidence of unintended consequences. For example, in Serbia, the government responded to the decline in measles, mumps, and rubella (MMR) immunisation and the 2014/2015 outbreak of measles with substantial tightening of mandatory immunisation and harsher penalties. As they had not addressed the problem with the families and the general public, the response to the tightened law was heightened anti-vaccine sentiments and enhanced attention to negative vaccination messages in the media. This was an unexpected but predictable outcome due to failure in communication. Now, the vaccine uptake problem is compounded by low confidence in the programme, which may have been further undermined by the new harsher penalties.

Fifth, the article identifies key knowledge gaps regarding mandatory childhood immunisation. According to the authors, "the evidence for or against mandatory immunization for infants and children is meager. Not only is there no universal framework for mandatory immunization, but there is no compendium of examples of the different framework components, their value, costs and impact on uptake rates that countries that are contemplating mandating childhood immunization might examine." For example, "More work is needed in the area of knowledge, attitudes and behaviours of the community when mandatory immunization is introduced, and what cultural and contextual factors affect this. Similar work needs to be done to examine the knowledge, attitudes and behaviours of those who must implement and/or are required to enforce mandatory immunization in childhood."

Finally, the authors suggest that careful thought should be exercised before mandating childhood immunisation, as other interventions may be more effective and less intrusive. Governments need to assure financial sustainability, uninterrupted supply, and equitable access (and equitable extension of the benefits of vaccination and services) to all their child population before considering mandating immunisation. If mandatory immunisation is the preferred route, decision-makers are urged to devote careful thought, planning, and follow up - asking themselves questions including:

• Is there a problem with uptake rates? Or is it another problem that is being addressed?
• Is this the right solution at this time in this context?
• What components need to be in the mandatory framework?
• Do these components fit the culture, the context, and the specific problem that the mandatory programme is trying to solve at this time?
• Do other proven strategies need to be part of this change to the immunisation programme?
• Will the shift to a mandatory programme be accompanied by an increase in resources to the immunisation programme, and where will those resources come from (i.e., will other public health actions be compromised)?
• What might be the public response to such a change, especially if choice is restricted, and can this be effectively managed (e.g., through effective communication strategies)?
• Is there potential for harm to vulnerable populations (i.e., unintended consequences)?

A call for studies of the impact of mandatory immunisation (on programmes, practices, and outcomes) in high-, middle-, and low-income countries in different contexts concludes the article.