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Authors: Ravi P. Rannan-Eliya, Institute for Health Policy
Why now?
The COVID-19 pandemic, which will remain a significant challenge for all health systems in the years ahead, should encourage countries to take a serious look at adopting national electronic immunization registers (EIRs). Until now, EIRs, which emerged only in the past two decades, have been largely the preserve of a few developed nations and a very small number of far-sighted developing nations such as Vietnam. For many developing countries, existing systems for tracking childhood vaccinations were sufficient to meet program management needs, and the potential benefits of an EIR were probably not sufficient to justify the challenges and costs of adoption, even if their development was feasible, which in many cases it was not.
COVID-19 has changed this fundamentally in two ways. First, it has created the need to track individual vaccination, especially in adults receiving COVID-19 vaccines. Second, individuals are increasingly being required to provide proof of their vaccination status as we seek to relax restrictions on normal life and travel between countries.
What is an Electronic Immunization Registry? And how is it different from what most countries do now?
Electronic Immunization Registries (EIRs) are computerized immunization registers that track vaccinations at the level of each individual person and allow access to each individual’s vaccine history in real time.1 Typically, national EIRs do this by tracking every individual within a country, usually from birth through their life-course. This requires the ability to maintain a near complete, centralized register of every individual in the country supported by a single personal identifier, with mechanisms to allow submission of vaccination events by any and all vaccination providers, and usually a public interface to allow individuals to access their own vaccination history when wanted.
EIRs differ from the immunization information systems in most countries, which may be computerized, but remain evolutions from local registers. These existing systems can do a good job at tracking and recording individual vaccinations at the local level, with providers entering and reporting aggregate data upwards to national program managers, either using paper-based reports or through electronic reporting systems, such as DHIS2. However, they primarily serve the needs of health care workers and program managers, supporting administrative, accountability and monitoring functions, and often requiring additional tools such as surveys, such as the Demographic and Health Surveys (DHS) to assess effective coverage.
Limitations in current systems
As national immunization strategies have become more ambitious in their targets and scope, there are several limitations of traditional systems that have increasingly become problematic for countries. One limitation is that they typically offer no data on who is not vaccinated, or on people who are vaccinated by providers who are not part of the primary child-based vaccination system. When faced with infections such as measles where even small numbers of unvaccinated individuals can drive new outbreaks, traditional immunization information systems cannot provide the coverage, detail and timeliness needed by public health officials. Surveys can fill the gap, but only partly and expensively, and rarely with the detail and frequency required during ongoing outbreaks to spot hidden gaps in coverage.
The other major limitation, which stems from the primary focus of existing systems on the needs of managers, is the ability to provide citizens with their personal vaccination history, something that people increasing expect and want. Portable vaccination cards and certificates which have often met this need, simply don’t provide a sufficiently responsive citizen-centric approach, nor do they provide a good solution to the inevitable problems that arise when documents get lost, or when they are needed daily. With the COVID-19 pandemic, this shortfall is no longer trivial or manageable. For at least the next few years, it is likely that many countries will want to impose restrictions on those who are not vaccinated, which cannot be done unless everyone can access and prove their vaccination history. Further, proof of vaccination is likely to be the norm for international travel, and if countries want their citizens to be able to travel, they will have no choice but to have systems that can provide robust, digital proof of their vaccination status, and this cannot be done without robust electronic systems for tracking vaccinations at the individual level.
The benefits and uses of EIRs
Once established, EIRs can provide all the functionality of current immunization information systems but offer far more benefits, both for the vaccinated individual, as well as programs and wider society.
First, by tracking every dose that is given—what, when, where and by whom—EIRs make it possible to track and monitor vaccine coverage for all individuals. This can be leveraged to track vaccine coverage in real time without the need for expensive surveys; to rapidly identify unvaccinated groups; to track who is due for a vaccination; and to pro-actively both notify providers and send reminders to the individuals themselves. For example, Spanish public health agencies have used EIRs to track immunization coverage during influenza epidemics and to identify high risk groups who needed special attention in boosting coverage.2 Such demands have become even more pressing during the COVID-19 pandemic, but countries without EIRs, like Sri Lanka, have often had to resort to expensive, labor intensive efforts to obtain such information.
The second benefit is the ability of EIRs to support the needs of other sectors that require vaccination data at the individual level, for example proving a child’s vaccination status to enter school. Instead of placing the burden on the family or maintaining a system of paper certificates, EIRs can directly report every child’s vaccination status directly to the school as is routinely done by Korea’s national immunization registry.3 An even more expansive use of this is Australia’s use of its registry to link payment of family cash benefits to proof of child vaccination.
A third use of EIR is to incentivize and track the performance of private providers by making payment of public funding conditional on providers submitting vaccination data to the register. This could be either an insurance reimbursement as in some countries, or simply an incentive to encourage general practitioners to maximize vaccination of their covered patients as in Australia.
From a program management perspective, EIRs also offer added advantages. These can include improving the robustness of provider reporting, for example, by picking up errors in the recording of dates and details of vaccination, detecting duplicate reporting, and tracing problems with individual vaccine lots, if the lot numbers are entered in the registry. This ability to link vaccine doses to individuals can also be a powerful tool to monitor vaccine safety. In Israel, during the COVID-19 pandemic, the EIR has been used to track the efficacy of vaccines in real time. EIRs also open significant avenues for operational research to support improving the performance and effectiveness of routine immunization systems.
The newest benefit of EIRs, that has become notably pertinent with COVID-19, is to support the provision of vaccine passports to citizens. For people to travel across borders or to limit access to specific venues based on vaccination status, vaccination certificates that are robust and cannot be easily forged are likely to become universal. Countries that can put in place domestic systems that can support such needs will inevitably reap significant benefits.
What has held up the introduction of EIRs?
Until recently, costs and technology have been major barriers to adopting EIRs, especially in developing countries. However, the falling costs of digital infrastructure, digital communications including smart phones, and development of indigenous IT capacity in many developing countries have rapidly reduced these barriers. Although external technical support and experience sharing can be helpful, the technical requirements for a digital EIR system are not so great that countries can’t develop their own systems, as shown by Vietnam’s successful local development of its national immunization register.4 And experience from many other countries indicates the costs of hardware are no longer so great for this to be a barrier. And even if these remain barriers for some, the significant global funding that has been made available to support COVID-19 vaccination infrastructure provides many opportunities for countries who want to leverage this funding to establish permanent EIRs that cover not only COVID-19 vaccines but all vaccines.
In practice, the biggest barrier to adoption of EIRs has probably not been cost or technology, but simply that existing systems were just good enough to meet basic needs leading to unwillingness to be more ambitious or difficulties in making a case to policymakers for investing more. But this is how COVID-19 can be a game changer for managers who want to seize the opportunity. The reality is that in many countries, governments are anyway rushing to implement digital platforms to support COVID-19 vaccination and vaccine passports with funding often not the biggest constraint. The social needs for this are so great and the resources that are being untapped so substantial, there is probably no better time to actively plan for an EIR than now.
What does it take to establish an EIR?
To be fair, EIRs are not an option for all countries, but increasingly it is for many developing countries. The basic requirement is essentially that the country has a unique personal identifier for every resident. This could be a national social insurance number, a national identity number, or even in some countries a ration number. It’s only if this is widely available and achieves universal coverage that it becomes feasible to then implement digital systems that link vaccination records uniquely to every individual.
But many developing countries, especially middle-income nations, do meet this requirement. Where it typically falls short though is in coverage of children. However, if a country already has a robust system for issuing these identifiers, it is not a big challenge to shift towards a system of issuing new numbers at birth or when initial vaccinations are given.
Internet connectivity and computers at health facilities are usually needed, but most existing systems don’t depend 100% on these being there. In practice, even advanced nations such as Australia, also have additional mechanisms to allow submission of vaccination data via paper records, whilst several developing countries, such as Vietnam, have demonstrated that mobile phones can suffice as the main provider-level interface. Almost all middle-income developing countries probably have sufficient digital infrastructure in place to do this, so the real barrier is the decision to adopt and developing a coherent plan for system development and implementation.
Implementation challenges
Many developing countries probably already do meet the minimum requirements to make an EIR feasible, and costs and technology as I have noted are no longer insurmountable barriers for most. There is also sufficient global experience with implementing EIRs for the common challenges to be well known and for mitigating solutions to exist.
The first and perhaps the most sensitive is the issue of confidentiality and data security. Many European countries have been slow to implement EIRs because of data protection laws.5 But even if such legal restrictions don’t exist, public confidence that data will be safeguarded is critical, so adequate measures will need to be put in place. This may involve giving the responsibility of handling the EIR to an independent agency that can guarantee confidentiality, such as in Australia.6 At the same time, it may also be necessary to implement new legislation or revise existing laws to fully support an EIR. But as the experience of Scandinavian countries, many of which have EIRs, demonstrates, finding a workable compromise between individual privacy concerns and program requirements is not impossible even in the most questioning societies.
The second challenge is to ensure that the EIR system and architecture is properly designed, and that any roll-out effectively integrates existing systems and data. Here most countries can benefit from looking first at the experience of others, obtaining technical advice where possible, and ensuring that there is a competent agency with sufficiently high level of oversight and ability to coordinate across sectors leading the effort.
Another challenge is how to ensure universal coverage of providers and of individuals. The first problem typically involves private providers, but their engagement can be tackled either through regulations and direct incentives, or indirectly by creating incentives for individuals to use providers that are in the system. This last approach is most feasible if there are incentives for individuals to be covered and registered in the system. For many countries, school vaccination requirements have often been sufficient, but again COVID-19 offers new opportunities to incentivize most adults to participate.
Finally, for many decentralized nations where immunization is a subnational responsibility, the issue will be who should lead the effort. Here the global experience is clear that achieving a fully effective system will require a national agency to take the lead, even if efforts start initially at a lower level. So, in Australia—probably the first country to establish a national EIR, EIRs initially developed at the state level, but it took the federal government to eventually link the state systems together and transition these to a single national platform.6 In contrast, in other countries where the efforts have not been led by the national government, decades of efforts have typically failed to establish an effective EIR, the United States, Canada and Italy being good examples of this.7 8
When is a good time?
I would argue that for many countries the best time to have made the shift to an EIR was yesterday, before COVID-19. For many countries, the operational challenges they are facing in rolling out COVID-19 vaccination could have been tackled more easily if they had an EIR in place, Vietnam being a good example of the benefits.
But the reality is that we are now in the middle of the COVID-19 pandemic, and there is huge pressure to deploy systems just to tackle the needs of COVID-19 vaccination. It would be easy to say that it’s best to leave existing systems as they are, and simply add on separate systems for COVID-19. Certainly, this route is likely to present fewer institutional challenges and does not require a change from business as usual. But I believe for many countries that would be a missed opportunity. In the long-run EIRs are likely to become commonplace, hastened by the pressures of the pandemic, and providing significant benefits to those countries who invest in them.
It’s also almost inevitable that governments will develop EIRs to manage COVID-19 vaccination, so the choice facing EPI managers is whether or not to seize this opportunity to modernize their approach to tracking routine immunizations.
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References
- Pan American Health Organization. Electronic Immunization Registry: Practical Considerations for Planning, Development, Implementation and Evaluation. Washington, D.C.: PAHO, 2017.
- Aguilar I, Reyes M, Martinez-Baz I, et al. Use of the vaccination register to evaluate influenza vaccine coverage in seniors in the 2010/11 influenza season, Navarre, Spain. Euro Surveill 2012;17(17) doi: 10.2807/ese.17.17.20154-en [published Online First: 2012/05/04]
- Kang M, Bae G, Kim H, et al. Korean resident registration system for universal health coverage. Health, Nutrition and Population (HNP) Discussion Paper. Washington, D.C.: World Bank, 2019.
- PATH. From paper to e-records: Vietnam’s digital immunization registry. Hanoi: PATH, 2017.
- Pebody R. Vaccine registers–experiences from Europe and elsewhere. Euro Surveill 2012;17(17) doi: 10.2807/ese.17.17.20159-en [published Online First: 2012/05/04]
- Chin LK, Crawford NW, Rowles G, et al. Australian immunisation registers: established foundations and opportunities for improvement. Euro Surveill 2012;17(16) [published Online First: 2012/05/04]
- Alfonsi V, D’Ancona F, Rota MC, et al. Immunisation registers in Italy: a patchwork of computerisation. Euro Surveill 2012;17(17) doi: 10.2807/ese.17.17.20156-en [published Online First: 2012/05/04]
- Laroche JA, Diniz AJ. Immunisation registers in Canada: progress made, current situation, and challenges for the future. Euro Surveill 2012;17(17) doi: 10.2807/ese.17.17.20158-en [published Online First: 2012/05/04]