Friday 3 May 2024 – In response to the critical need to restore trust in vaccination programs [1, 2], the European Council proposed a series of actions in 2018 aimed at strengthening cooperation against vaccine-preventable diseases [3]. This led to a 2019 study funded by the European Health and Digital Executive Agency (HaDEA), which explored the feasibility of a European Vaccination Card (EVC) [4]. The study involved analysing existing vaccination documents, creating and evaluating EVC prototypes, assessing public acceptance, and developing strategies for potential EU-wide deployment [5, 6, 7] . Building on these efforts, EUVABECO is now launching EVC pilot projects in Latvia, Greece, Belgium, Germany, and Portugal. The EVC is designed to empower individuals by giving them control over their vaccination data, thus facilitating the management, review, and sharing of their vaccination records as needed. By providing citizens with accurate and current vaccination information, this tool aims to foster informed decision-making, enhance healthcare continuity, and reinforce confidence in both national and European vaccination strategies.
How and why will EUVABECO work with partners to pilot an EU-wide vaccination card?
While the HaDEA-funded study was progressing [8], the COVID-19 pandemic emerged, prompting the European Union to introduce the EU Digital COVID Certificate. This certificate, with over 2.3 billion issued, became a cornerstone of Europe’s pandemic management strategy by facilitating secure travel across the EU and enabling the coordinated relaxation of travel restrictions starting in August 2022 [9]. It also set a precedent for health innovations [10]. Following the expiration of its regulation on 30 June 2023, the World Health Organization (WHO) stepped in to establish the Global Digital Health Certification Network (GDHCN). This foundational digital public health infrastructure was created to meet the ongoing global need for a system that ensures the integrity and bilateral verification of health documents, thereby safeguarding against current and future health crises [11].
The EVC piloted by EUVABECO will use the GDHCN’s trust network, allowing Member States to bilaterally verify the authenticity of digital records through an interoperable trust architecture. While similar to the EU Digital COVID Certificate in being a portable vaccination record, the EVC serves a different purpose. Unlike the certificate, which often fulfilled legal or health mandates, the EVC is specifically designed to empower individuals by granting them control over their vaccination information. This empowerment is crucial for ensuring continuity of care for those crossing borders or transitioning between healthcare systems.
The EVC will be available in various formats—produced on-site, mailed, or digitally downloaded to a smartphone—making it easily accessible and displayable as needed. It will feature comprehensive vaccine history information, including detailed textual records, a scannable QR code, and downloadable embedded metadata. These digital elements, the QR code and metadata, will be securely signed to maintain their authenticity and integrity. Additionally, each vaccine record will be linked to an original master record maintained by a credible health organization, ensuring the data is reliable.
Upon implementation, the EVC will enable individuals to personally manage, access, and control the dissemination of their vaccination data, adhering to privacy regulations that mandate explicit consent for data sharing. Users will have the capability to present the card, which contains their vaccination details, to healthcare professionals and related personnel. Health professionals can then scan the QR code or access the metadata from the card file to include, evaluate, supplement, and confirm vaccination entries within their Electronic Health Record (EHR) system. This process ensures that individuals maintain full control over their health information while preserving the integrity and confidentiality of their medical records.
To realize this ambitious initiative, EUVABECO’s partner organizations in Latvia (Riga Stradins University), Greece (University of Thessaly), Belgium (Fratem), Germany (University of Saarland), and Portugal (General Health Directorate) are now working alongside EUVABECO’s EVC specialists. The successful rollout of the EVC system will depend on dynamic interactions among various stakeholders and system components, including an electronic Patient Information Leaflet (ePIL) server, a terminology server, a global registries directory, health jurisdiction registry, and a master records repository.
Each participating country brings unique resources to the table, such as existing Electronic Health Records, Immunisation Information Systems, and paper cards, each with differing vaccine terminologies. One significant challenge is the harmonization of vaccine terminology across these diverse healthcare settings, which will require developing a common syntax—a challenge EUVABECO is poised to tackle.
Acknowledging the varied healthcare landscapes in these countries, EUVABECO is committed to devising and refining implementation plans that are not only effective but also adaptable, and sustainable. The objective extends beyond the pilot phases, aiming for the broad adoption of the EVC across all EU Member States. This will involve the creation and dissemination of detailed workplans, the formulation of policy recommendations, and the development of strategies for outbreak response, alongside establishing criteria for evaluating the system’s impact and considering financial strategies for its widespread implementation.
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References
[1] European Commission (2020). State of Vaccine Confidence in the EU+UK 2020. doi:10.2875/06196 EW-03-20-831-EN-N (https://health.ec.europa.eu/document/download/33ad08ec-1f2c-46e8-be37-fc4c523447ab_en, accessed 6 April 2023)
[2] Guaraldi F, Montalti M, Gori D. The importance of mapping determinants, attitudes and beliefs of vaccine hesitancy in the great challenge of compulsory childhood vaccination: Comment on “Convergence on coercion: functional and political pressures as drivers of global childhood vaccine mandates.” Int J Health Policy Manag. 2023;12:7614. doi:10.34172/ijhpm.2023.7614 (https://pubmed.ncbi.nlm.nih.gov/37579365/, accessed 6 April 2023)
[3] European Commission (2018). COUNCIL RECOMMENDATION of 7 December 2018 on strengthened cooperation against vaccine-preventable diseases (2018/C 466/01). (https://eur-lex.europa.eu/legal-content/GA/TXT/?uri=OJ%3AJOC_2018_466_R_0001, accessed on 6 April 2023)
[4] European Commission (2019). Chafea/2019/Health/07 Concerning the Provision of Options and Recommendations for an EU Citizens’ Vaccination Card (https://ted.europa.eu/udl?uri=TED:NOTICE:40632-2020:TEXT:EN:HTML, accessed on 6 April 2023)
[5] European Commission (2022). Provision of options and recommendations for an EU citizen’s vaccination card. Annex 1, Data collection and mapping [report] (https://op.europa.eu/en/publication-detail/-/publication/6cf30f19-6a36-11ed-b14f-01aa75ed71a1/language-en/format-PDF, accessed 11 April 2024)
[6] European Commission (2022). Provision of options and recommendations for an EU citizen’s vaccination card. Annex 2, Design and testing of three dual templates [report] (https://op.europa.eu/en/publication-detail/-/publication/da6517a7-de58-11ed-a05c-01aa75ed71a1/language-en/format-PDF/source-search, accessed 11 April 2024)
[7] European Commission (2022). Provision of options and recommendations for an EU citizen’s vaccination card [report] (https://op.europa.eu/en/publication-detail/-/publication/111d0610-1c41-11ed-8fa0-01aa75ed71a1/language-en/format-PDF/source-search, accessed 11 April 2024)
[8] European Commission (2019). Chafea/2019/Health/07 Concerning the Provision of Options and Recommendations for an EU Citizens’ Vaccination Card (https://ted.europa.eu/udl?uri=TED:NOTICE:40632-2020:TEXT:EN:HTML, accessed on 6 April 2023)
[9] European Commission. EU Digital COVID Certificate [web portal] (https://commission.europa.eu/strategy-and-policy/coronavirus-response/safe-covid-19-vaccines-europeans/eu-digital-covid-certificate_en, accessed 11 April 2024)
[10] Kaag, F., and Koeck, JL (2021). EU COVID pass paves the way for digital vaccination card. Vaccines Today [news article] https://www.vaccinestoday.eu/stories/eu-covid-pass-paves-the-way-for-digital-vaccination-card/
[11] World Health Organization. Global Digital Health Certification Network [web portal] (https://www.who.int/initiatives/global-digital-health-certification-network, accessed 11 April 2024)
