"First Do No Harm". No-Fault Compensation Program for COVID-19 Vaccines as Feasibility and Wisdom of a Policy Instrument to Mitigate Vaccine Hesitancy.

Stefano D’Errico,Martina Zanon,Paola Frati,Matteo Scopetti,Monica Concato,Vittorio Fineschi,Michela Peruch

doi:10.3390/vaccines9101116

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.

Highlights

Despite their high safety profile, vaccine-related adverse events are reported, though rarely
In Europe, COVID-19 vaccination is strongly recommended for the general population and in many states is declared mandatory for healthcare workers
Debates around vaccine injury compensation programs have arguably taken on increased significance in the context of the COVID-19 pandemic, as billions of COVID-19 vaccines are intended for global administration, and manufacturers of approved COVID-19 vaccines are being afforded legal indemnity through purchase agreements, which means that they cannot be pursued for compensation for vaccine-related harm [4]

Summary

Introduction

Despite their high safety profile, vaccine-related adverse events are reported, though rarely. As indicated by the term “no-fault”, VICPs do not require injured parties or their legal representatives to prove negligence or fault by the vaccine provider, health care system, or the manufacturer before compensation. They seek to waive the need for accessing compensation for vaccine-related harms through litigation, where processes are lengthy and clear negligence can be difficult to prove. Debates around vaccine injury compensation programs have arguably taken on increased significance in the context of the COVID-19 pandemic, as billions of COVID-19 vaccines are intended for global administration, and manufacturers of approved COVID-19 vaccines are being afforded legal indemnity through purchase agreements, which means that they cannot be pursued for compensation for vaccine-related harm [4]

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Conclusion