Mandatory immunization and vaccine injury support programs: A survey of 28 GNN countries.

BACKGROUND: Despite the proposed ethical link between mandatory immunization and Vaccine Injury Support Programs (VISPs), relatively few jurisdictions, even those with mandatory immunization, have implemented such programs. Although it may be assumed that individuals injured by a vaccine in a non-VISP country receive less support than in countries possessing such programs, the extent of the discrepancy is not clear; nor is the nature of any discrepancy. METHODS: In our 2018 survey of 28 Global NITAG (National Immunization Technical Advisory Group) Network (GNN) countries, we asked respondents about mandatory immunization and the availability of VISPs. Responses were supplemented with desktop research and review of scholarly literature for further information regarding VISP availability and details. RESULTS: Although only two of 14 (14%) surveyed jurisdictions with mandatory immunization had formal VISPs, responses from additional countries suggested the presence of less formal avenues of compensation for serious Adverse Events Following Immunization (AEFIs); similarly, we found five of 15 (33%) of countries without mandatory immunization had implemented formal VISPs, but another three such countries suggested similar informal methods of compensation. CONCLUSIONS: From our data, it is evident that at least some countries with mandatory immunization may discharge their (perceived or actual) ethical obligation to provide financial assistance to vaccine-injured individuals through more informal avenues rather than structured VISPs, although the extent and impact of this practice is by its nature difficult to assess. Further, the nature of VISPs may vary significantly from jurisdiction to jurisdiction, and simple VISP/non-VISP classification of jurisdiction may fail to capture nuance in support for AEFI victims in many jurisdictions. Future assessments of VISPs should consider the possibility of these more informal avenues of support for vaccine injuries.

Immunization governance: Mandatory immunization in 28 Global NITAG Network countries.

International trends currently favour greater use of mandatory immunization. There has been little academic consideration or comparison of the existence and scope of mandatory immunization internationally. In this paper, we examine mandatory immunization in 28 Global NITAG (National Immunization Technical Advisory Group) Network (GNN) countries, including countries from every WHO region and World Bank income level classification. We found that although mandatory immunization programs, or mandatory elements within broader immunization programs, are relatively common, jurisdictions vary significantly with respect to the immunizations required, population groups affected, grounds for exemptions, and penalties for non-compliance. We also observed some loose associations with geography and income level. Based on these data, we categorized policies into a spectrum ranging from Narrow to Broad scope.

Strengthening vaccination frameworks: Findings of a study on the legal foundations of National Immunization Technical Advisory Groups (NITAGs).

In 2017, the Strategic Advisory Group of Experts on Immunization's Assessment Report of the Global Vaccine Action Plan noted the need to "better document the ways in which legislation and regulations have been used to promote or undermine immunization at the national level". Despite National Immunization Technical Advisory Groups (NITAGs) now existing in over 134 countries worldwide, there has been very little academic consideration of their legal underpinnings. In this paper, we compare the legal foundations and authority of 28 NITAGs from the six WHO Regions. All are members of the Global NITAG Network. We categorize the NITAGs based on their legal foundation and on the authority granted to them by their government, organizing them into a taxonomy of models. We then propose legal considerations for governments contemplating establishing or reforming a NITAG.

Mandatory infant & childhood immunization: Rationales, issues and knowledge gaps.

Globally, infant and childhood vaccine uptake rates are not high enough to control vaccine preventable diseases, with outbreaks occurring even in high-income countries. This has led a number of high-, middle-and low income countries to enact, strengthen or contemplate mandatory infant and/or childhood immunization to try to address the gap. Mandatory immunization that reduces or eliminates individual choice is often controversial. There is no standard approach to mandatory immunization. What vaccines are included, age groups covered, program flexibility and rigidity e.g. opportunities for opting out, penalties or incentives, degree of enforcement, and whether a compensation program for causally associated serious adverse events following immunization exists vary widely. We present an overview of mandatory immunization with examples in two high- and one low-income countries to illustrate variations, summarize limited outcome data related to mandatory immunization, and suggest key elements to consider when contemplating mandatory infant and/or child immunization. Before moving forward with mandatory immunization, governments need to assure financial sustainability, uninterrupted supply and equitable access to all the population. Other interventions may be more effective and less intrusive than mandatory. If mandatory is implemented, this needs to be tailored to fit the context and the country's culture.