"First Do No Harm". No-Fault Compensation Program for COVID-19 Vaccines as Feasibility and Wisdom of a Policy Instrument to Mitigate Vaccine Hesitancy
- PMID: 34696224
- PMCID: PMC8540114
- DOI: 10.3390/vaccines9101116
"First Do No Harm". No-Fault Compensation Program for COVID-19 Vaccines as Feasibility and Wisdom of a Policy Instrument to Mitigate Vaccine Hesitancy
Abstract
Vaccines are so far proven to be safe, although related adverse events cannot be excluded. The urgency for COVID-19 vaccines determined a dilution of the general expectations of safety and efficacy of vaccination (from safe and effective to safe and effective enough). In many countries, a no-fault program was established to compensate individuals who experienced serious vaccine-related injuries. The impressive number of administrations worldwide and the legal indemnity afforded to manufacturers of approved vaccines that cannot be pursued for compensation fed the debate about the availability of a compensation model for COVID-19 vaccine-related injuries. Several European countries have long introduced a system, Vaccine Injury Compensation Programs, to compensate people who suffer physical harm because of vaccination. In Europe, COVID-19 vaccination is strongly recommended for the general population and in many states is declared mandatory for healthcare workers. In 1992, Italy edited Law no. 210 providing legal protection for individuals who reported injuries after mandatory and recommended vaccinations as a no-fault alternative to the traditional tort system. Despite its recommended nature, COVID-19 vaccination is excluded from the no-fault model in several European states, and the Italian government is called to provide clear and firm instructions for the management of the many requests for compensation. The authors provide an overview of the existing compensation models in Europe and analyse available legislative proposals.
Keywords: COVID-19; adverse events; no-fault compensation; solidarity; vaccination; vaccine hesitancy.
Conflict of interest statement
The authors declare no conflict of interest.
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References
-
- D’Errico S., Turillazzi E., Zanon M., Viola R.V., Frati P., Fineschi V. The Model of “Informed Refusal” for Vaccination: How to Fight against Anti-Vaccinationist Misinformation without Disregarding the Principle of Self-Determination. Vaccines. 2021;9:110. doi: 10.3390/vaccines9020110. - DOI - PMC - PubMed
-
- Mungwira R.G., Guillard C., Saldaña A., Okabe N., Petousis-Harris H., Agbenu E., Rodewald L., Zuber P.L.F. Global landscape analysis of no-fault compensation programmes for vaccine injuries: A review and survey of implementing countries. PLoS ONE. 2020;15:e0233334. doi: 10.1371/journal.pone.0233334. - DOI - PMC - PubMed
-
- European Commission, Advance Purchase Agreement (“APA”) for the Production, Purchase and Supply of a COVID-19 Vaccine in the European Union. [(accessed on 27 July 2021)]. Available online: https://ec.europa.eu/info/sites/info/files/eu_apa_-_executed_-_az_redact....
-
- European Centre for Disease Prevention and Control COVID-19 Vaccine Tracker. [(accessed on 2 August 2021)]. Available online: https://vaccinetracker.ecdc.europa.eu/public/extensions/COVID-19/vaccine....
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