One year after the start of the Corona outbreak, COVID-19 vaccines are about to arrive. These vaccines are new, and the distribution channels will also be new, given the necessity for mass vaccination on an unprecedented scale.
How can we track and trace who was vaccinated with what and when? A Commentary in the Medical Journal Vaccine, published on November 27, calls on stakeholders to get ready to ensure the proper documentation of vaccination administration.
It is vital that each administered COVID-19 vaccine should be precisely identified everywhere and anywhere across the world so that we can accurately monitor the effectiveness and safety of each type of vaccine.
Such a global, uniform registration requires an internationally agreed-on system, which can be based on globally-unique identification numbers. These should be connected to the existing national marketing authorisation and distribution numbers and be printed on the vaccine packages and on vials or syringes through scannable two-dimensional, information-rich barcodes.
These barcodes can contain data such as vaccine identification, date of production/expiration, lot number, and a check digit to guarantee the authenticity of the medicine. The person responsible for vaccination could scan each administered vaccine and automatically send the information to national vaccine registries, and forward the information to medical and pharmaceutical records and patient health records. Patients could receive a trustworthy vaccination certificate to be presented e.g. when travelling of in case of symptoms.
Industry and authorities have not yet taken all steps to roll out such a system which would allow to build public trust and maximise vaccine uptake.
Only with a robust registration system can we efficiently monitor the use, authenticity, efficacy and safety of Covid-19 vaccines. This should go hand in hand with respect for the crucial requirements of trustworthy health data handling.
Access to the Commentary: HTTPS://DOI.ORG/10.1016/J.VACCINE.2020.11.055
The Commentary authors: Vander Stichele RH, Hay C, Fladvad M, Sturkenboom M, Chen RT.
They work on this issue in the context of UNICOM, a European project in which i~HD is a partner, and in the Brighton Collaboration, an international task force on vaccine safety.
First author of this article, Professor Robert Vander Stichele, Department of Clinical Pharmacology at the University of Gent, is a senior researcher at i~HD.
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Dr Mats Sundgren, a founding member of our Institute, gave a presentation at SCOPE 2020 earlier this month on a new Pragmatic Clinical Trial (PCT) launched by AstraZeneca. In this PCT, they use real world registry data to establish the efficacy and safety of an existing drug for a new clinical indication.
This is the first-of-its-kind, indication-seeking PCT in the industry. It demonstrates an important use of routinely collected health data to generate evidence to the quality demanded by medicines regulators to extend the license of a drug to a new clinical indication.
The DAPA-MI trial that was presented, is a pioneering Registry-based Randomized Controlled Trial (R-RCT) and combines “gold standard” RCT elements with innovative, real-world trial elements.
Its unique trial design could ultimately lead to a higher recruitment rate and lower overall costs in comparison to conventional clinical trials. R-RCTs are more efficient clinical trials – allowing for immediate access to data, lower per patient cost and streamlined delivery – enabled by fewer trial visits and patient-centric digital solutions.
The mission of The European Institute for Innovation through Health Data (i~HD) is to enable, coordinate, and accelerate the efficient development and deployment of interoperable and seamless eHealth solutions and research strategies, towards achieving best practices and sustainable integrated person-centred health care, to optimise health and wellness in Europe, and beyond. It aims to guide and catalyse the best, most efficient and trustworthy uses of health data and interoperability, for optimising health and knowledge discovery.
i~HD has been established to tackle areas of challenge in the successful scaling up of innovations that critically rely on high quality and interoperable health data. It specifically addresses obstacles and opportunities to using health data by collating, developing and promoting best practices in information governance and in semantic interoperability. It is helping to sustain and propagate the results of health information and communication technology (ICT) research that enable better use of health data, assessing and optimising their novel value wherever possible.
i~HD has been formed after wide consultation and engagement of many stakeholders to develop methods, solutions and services that can help to maximise the value obtained by all stakeholders from health data. It supports innovations in health maintenance, health care delivery and in knowledge discovery, while ensuring compliance with all legal prerequisites, especially regarding the insurance of patient’s privacy protection. It unites multiple stakeholder groups to ensure that future solutions serve their collective needs and can be readily adopted affordably and at scale.