Standardization and simplification of vaccination records

Abstract

The majority of vaccines are administered during childhood. Vaccination records are important documents to be kept for a lifetime, but the documentation of immunization events is poorly standardized. At the point of care, paper records are often unavailable, making it impossible to obtain accurate vaccination histories. Vaccination records should include batch specifications to allow the tracking of licensed vaccines in cases of recall. The WHO have generated the International Certificate of Vaccination or Prophylaxis for the documentation of childhood and travel vaccinations as well as seasonal and booster immunizations. When moving vaccination records into the digital age, data standards and interoperability need to be considered. The ideal vaccination record should facilitate the interpretation of safety reports and promote a data continuum from pre-licensure trials to post-marketing surveillance. The current article describes which data elements are essential, and how vaccination documentation could be streamlined and simplified.

Keywords::

• AEFI
• certificate of immunization
• data interoperability
• m-health
• electronic health records
• harmonization
• pharmacovigilance
• simplification
• standardization
• vaccination record

Acknowledgements

The authors kindly thank A Khamesipour, R Tuttle, C Hoppe and the members of the Vienna Vaccine Safety Initiative think tank for their feedback on the manuscript.

Financial & competing interests disclosure

W Maurer received fees from different vaccine manufacturers for presentations in continuing medical education activities, but no funding for projects related to this article. Charité and CDISC are partners in the European IMI Joint Undertaking (IMI-JU) funded project “Biomarkers For Enhanced Vaccine Safety” (BioVacSafe). The remaining authors have no conflicts of interest to declare. There are no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Standardized vaccination records are needed on a global level.

• Standardized vaccination records should be universal, safe, flexible, durable and available in emergency situations.

• In order to increase accessibility retrieval/backup systems, electronic mirrors of vaccination records or linkage to national registries should be promoted.

• Simplified digital vaccination records provide significant advantage over paper-based systems, including universal access in cases of emergency.

• User-centered vaccination records should empower patients to keep track of their vaccination record and to ask for professional advice, when needed.

• Regulatory agencies and standards organizations should be involved in the development of digital records to ensure semantic interoperability.