No fault vaccine injury compensation after COVID-19: A systematic literature review and proposed typology

ABSTRACT

The COVID-19 pandemic brought about a unique and rapid period of global vaccine innovation. It revealed structural challenges not only in global vaccine affordability and distribution but in the liability and indemnity structures that can both impede access and affect fair outcomes for the small number of people who suffer severe side effects. This review examines vaccine injury and compensation mechanisms, including no-fault compensation schemes, aimed at addressing both the liability and indemnity concerns of developers and the compensation due those suffering severe side effects. The ultimate aim of the review is to provide a classification of systems for those countries that are considering adopting NFCS as part of their broader public health readiness and preparedness strategies.

Introduction

The COVID-19 pandemic first emerged in late 2019, and quickly became one of the most significant public health emergencies of the twenty-first century.¹ On January 30, 2020, the World Health Organization (“WHO”) officially declared COVID-19 a Public Health Emergency of International Concern (“PHEIC”) under the International Health Regulations (2005), marking the beginning of an urgent and accelerated global response.² The development and distribution of vaccines faced unprecedented challenges prompting global scientific institutions and pharmaceutical companies to rapidly develop, test, and deploy innovative vaccines, achieving breakthroughs in vaccine technologies in record time.³

However, alongside the rapid innovation in vaccine development, another critical issue emerged – ensuring equitable access to these vaccines, particularly for the low- and middle-income countries (“LMICs”).⁴ The global distribution of COVID-19 vaccines became a complex political and governance issue, rather than merely a public health challenge.⁵ Vaccine access is historically and inextricably intertwined with international relations, human rights, and global health equity.⁶ Vaccination is essential not only for curbing virus transmission but also for reducing mortality and morbidity.^7,8 Access to vaccines dictates outcomes both for human health and well-being and economic recovery in a state of public health emergency.⁹

However, the global distribution of vaccines faces multiple challenges, including affordability, accessibility, and the political dimensions of issues surrounding rights, obligations, liability, and accountability.¹⁰ A critical legal challenge in this context is the issue of liability for severe side effects, as vaccine manufacturers – still by volume rich companies located in rich countries – seek protection against potential claims arising from adverse events following immunization (AEFI).¹¹ Because the technologies used for COVID-19 vaccines had not been used at scale before, they posed special concerns that theretofore unanticipated side effects might surface at rates undetected by even gold standard Phase III trials.¹² How would vaccine developers deal with that risk, and how would those small numbers of people so affected be made whole? Indeed, these concerns materialized. The MRNA vaccines increased risks for heart inflammation, disproportionately in younger men.¹³ Adenoviral vector vaccines raised the risks of stroke, especially for women.¹⁴

Historically, compensation mechanisms for vaccine liability such as no-fault compensation schemes have played an important role in compensating those suffering rare severe side effects.¹⁵ The first such systems emerged after court decisions mandating compensation for those suffering side effects after compulsory smallpox vaccination.¹⁶ These systems have also assured vaccine manufacture and distribution during times of crisis, providing manufacturers with the risk tolerance necessary to accelerate development under uncertain circumstances.¹⁷ In some systems, the government assumes the whole of potential liability, while in others manufacturers contribute to its cost. There are, of course, default litigation systems under which those injured by a product may sue the manufacturer based on consumer protection, personal injury, or other theories of tort or delict.¹¹ The form of government and its relationship with private sector actors – where there is a licit private market sphere – is an essential factor in the design of such systems.

No-fault compensation mechanisms are designed to balance the need for vaccine development and access with the protection of individuals who may suffer adverse reactions. With pecuniary and legal indemnity for manufacturers, who may make ex ante contributions to a pooled fund of one sort or another, they accelerate industry-wide vaccine developments; concurrently, they offer safeguards for vaccine recipients, arguably increasing public confidence in health ministries and policies.¹⁸

No-fault compensation schemes (“NFCS”) have long been adopted by high-income countries (“HICs”) to address the risk of vaccine injury.¹⁹ The concept dates back to as early as 1953, when the German Supreme Court ruled that individuals injured by compulsory smallpox vaccinations were entitled to compensation.²⁰ Over the years, these schemes have proliferated based on mostly unresearched theories that they maintain public confidence in vaccination programs or more commonly a theoretical bargain between individuals who accept some compensated risk in exchange for society’s herd immunity. However, the situation is more complex at the international level due to concerns over sovereignty and differences in the social and legal structures between countries.²¹ While HICs can afford to implement robust compensation frameworks, many low-income countries (“LICs”) lack the fiscal capacity to do so. This discrepancy creates tensions, as LICs struggle to provide adequate protection for their citizens while facing challenges in accessing vaccines in the first place. This was particularly true for the novel vaccines introduced to address COVID-19.

The global nature of the COVID-19 pandemic highlighted the need for international collaboration on vaccine distribution and liability protection. Initiatives such as the CEPI-GAVI-WHO Vaccine Pillar “COVAX” – which created a centralized financing and distribution pool for the benefit of LICs – were implemented to ensure equitable vaccine access, but their deployment also brought to light significant legal and financial challenges.²² Compensating individuals injured by vaccines at the international level involves navigating complex sovereignty issues, as well as reconciling differences in national legal systems, health policies, and financial capabilities.²³

Indeed, these complexities have arisen again in the context of the recently adopted WHO Pandemic Agreement. For much of the treaty’s negotiating history, an entire article was dedicated to liability and risk mitigation, including the development of no-fault compensation systems. Even though that article was dropped before adoption of the final text, the parties are now negotiating an annex that will govern pathogen access-and-benefit sharing (“PABS”) as part of pandemic prevention, preparedness and response. Because the benefits anticipated from such a system are almost certainly pharmaceutical interventions, the need to prepare for severe side effects on a large scale remains significant.

Implementing effective no-fault compensation mechanisms at the international level largely remains a work in progress. While there have been some successes in establishing international frameworks, such as the COVAX initiative with ESIS, Inc., much more needs to be done to create a strong and universally acceptable system. The inability of the LICs to provide comprehensive indemnities has led to dissatisfaction among wealthier nations and may exacerbate vaccine inequities. Addressing these gaps will require a more nuanced and collaborative approach that balances pharmaceutical innovation with global health equity.

As the world prepares for future pandemics, it is crucial to identify and address the limitations of the existing vaccine injury compensation mechanisms. The lessons learnt from the COVID-19 vaccine rollout provide a timely opportunity to improve global health law and governance, ensuring that future public health emergencies are met with a more coordinated and equitable response. This Review identifies new no-fault vaccine injury compensation systems adopted pursuant to the COVID-19 pandemic. Together with existing systems, it outlines a typology by which those countries seeking to establish their own systems might refer. It therefore diverges from the methodologies that have prevailed since 1999, emphasizing type of administration, vaccines covered, funding, and losses eligible for compensation. Indeed, that literature remains rich, with Chu and coauthors publishing the most comprehensive study to date covering volume of claims, rates of compensation, and relative success rates for 12 countries, the internationally administered COVAX mechanism, and Hong Kong.

Instead, this Review, while updating the scope of knowledge of such systems, is instead oriented toward representative legal systems, administrative hierarchies, political environments, claim levels, compensation, and funding offices so as to facilitate more practical information for those countries considering adopting this form of access enhancing system. This new typology scheme differs from approaches adopted since the field of landscape review of NFCS was established in 1999, although it does contribute an updated state of knowledge under that conventional approach.

Materials and methods

Search strategy

This systematic literature review was conducted according to the method adopted by Mungwira et al.²⁴ and Halabi et al.¹⁵ which in turn was informed by early studies conducted by Evans²⁵ and Looker and Kelly.²⁰ Relevant articles published between 2020 and 2025 were identified by performing a literature search in PubMed, Embase, Academic Search Premier, JSTOR, and Westlaw. Keywords entered were vaccine AND injury AND compensation; “vaccine injury”; vaccine AND damage AND compensation; vaccine AND compensation; “vaccine policy”; “vaccine injury” AND international; and “vaccine injury” AND [country name].

Study selection and data extraction

From the articles retrieved, relevant references were selected using a three-step selection procedure, which involved screening titles and abstracts (step 1), screening the full text of articles (step 2), and screening during data extraction (step 3). At selection step 1, the following types of articles were excluded: (i) opinions or letters advocating the establishment of NFCS or stating cursory facts about them; (ii) studies on litigation alternatives to NFCS such as lawsuits brought under consumer protection laws; (iii) studies on NFCS that were proposed but never implemented; and (iv) articles citing incremental or immaterial changes to existing NFCS.

At selection step 2, articles were excluded if they: (i) did not contain data relevant to the review objective; (ii) were narrative reviews (e.g. lacked a methods section describing the procedure for literature selection); (iii) had insufficient methodological quality (or did not provide sufficient details to understand what had been done); and (iv) met other exclusion criteria as defined in selection step 1. In the preliminary phase, preparation work involved summarizing the historical evolutions and current policies of most vaccine indemnity schemes across jurisdictions, followed by parallel counterpart comparisons and longitudinal unifilar retrospective jurisprudence.

At selection step 3, further scrutiny during the data extraction phase led to the exclusion of articles which: (i) presented similar results from identical datasets, in which case only the most recently published article was selected; (ii) were systematic reviews or meta-analyses, though the original articles cited by them were included; (iii) reported and/or repeated descriptions of features of the WHO/the United Nations Children’s Fund (UNICEF) NFCS for vaccines procured through COVAX; (v) were correspondence letters; and (vi) were of poor-quality.

All titles and abstracts retrieved from searches were independently screened. The results were compared, deviations were discussed, and the selected references were included for full-text screening.

Results

Characteristics of the included studies

Of the 518 publications initially retrieved, 27 publications covering 28 countries containing data on NFCS were included. The majority of studies covered individual countries’ experiences. Rather than adopt the typology of comparison for national systems initiated by Evans (1999) and formalized by Looker and Kelley (2011) and Mungwira (2020), this Review endeavors to broadly classify NFCS by political structure, legal tradition, broad categories of compensation, and administrative hierarchy rather than by eligibility, administration, and other factors identified by the aforesaid studies. The aim is to provide an alternative way to understand how NFCS may be established, funded, and administered. There are few studies of global or regional approaches like COVAX/WHO/ESIS, AVAT, and UNICEF (we identified only three which provided cursory descriptions of the systems). The approach of these systems is represented by Canada, which contracts with a third-party, for-profit entity to administer its compensation system.

Global and regional compensation mechanisms for vaccine-related injuries

The scrutiny of existing international vaccine injury compensation frameworks is crucial as global public health preparedness continues to evolve.¹⁶ Global initiatives like COVAX, AVAT, and UNICEF and national compensation programs have drawn attention to the need for comprehensive mechanisms to address the risks associated with the rapid development and distribution of vaccines, especially during pandemics.⁵ Many of these initiatives highlight the inherent challenges in balancing public health objectives, pharmaceutical innovation, and the rights of individuals who may suffer from adverse vaccine effects. Understanding these existing models provides crucial insights into designing more equitable, accessible, and efficient international frameworks for vaccine-related injury compensation.

COVAX

COVAX was the “Vaccine Pillar” of the ACT Accelerator – four workstreams led by the World Health Organization to bring diagnostics, therapeutics, and vaccines to health systems which, as part of a separate pillar, were meant to be strengthened.²² Existing international adoptions, such as COVAX, rely on cooperative mechanisms involving stakeholders across sectors, including governments, pharmaceutical companies, and international organizations. Building on past financing instruments used by GAVI and its procurement agent UNICEF, COVAX leveraged funding and procurement terms with manufacturers with access and delivery to LICs. GAVI raised more than US$ 12 billion in donor funding for COVAX to support LICs in accessing COVID-19 vaccines.¹⁹ A unique component of this initiative was the creation of the first-ever international vaccine injury compensation mechanism.²³ Launched at the Global Vaccine Summit on 4 June 2020, COVAX ultimately developed an NFCS that aimed to limit the financial exposure for vaccines going to 92 low- and middle-income countries (“AMC countries”) under indemnity requirements and create a transparent process for individuals with serious adverse side effects to obtain compensation.²⁶ The Scheme was substantiated and solidified by an Agreement signed on 17 February 2021 between the WHO and Chubb Limited, and its subsidiary ESIS, Inc., for the administration of the no-fault compensation program.²³

Led by the GAVI and the WHO, the Scheme was established with two primary objectives: (i) reducing financial risks and mitigating economic burden for COVAX participants with potential vaccine-related liabilities by pooling compensation funds; (ii) ensuring fair and transparent compensation processes through providing access to compensation for all vaccine recipients, regardless of legal complexities or resource limitations. The Scheme features a streamlined compensation process that does not require proof of fault or negligence, thereby expediting claims resolution. Funding for the scheme is provided through a combination of donor contributions and vaccine sales revenues.

The Scheme was thus designed to provide rapid and transparent compensation to individuals who experience severe adverse effects after receiving COVID-19 vaccines, without requiring proof of fault by the manufacturer or administering entity. The Scheme covers countries receiving vaccines through COVAX, with funding primarily sourced from international donors and GAVI’s dedicated funds. Compensation claims are evaluated by an independent third party to ensure fairness and transparency.

Only three included studies analyzed the COVAX NFCS. Two studies broadly outlined the compensation mechanism. A third study found that the COVAX NFCS covered a high percentage of reviewed claims but received far fewer claims than comparator national systems. This finding is relevant given that the COVAX NFCS covered those receiving immunizations procured through COVAX in 142 countries.²⁷

AVAT and UNICEF

One study analyzed the broad components of both the African Vaccine Acquisition Trust (AVAT) and UNICEF’s NFCS. There is no additional analysis as to number of claims, percentage of claims paid, or other data relevant to these global or regional systems in the included studies. COVAX, AVAT, UNICEF, and the Government of Canada are distinguished in that they have dedicated the administration of their NFCS to a for-profit third party.

National compensation mechanisms for vaccine-related injuries

Two studies counted and analyzed the development of new national compensation systems developed before and during the COVID-19 pandemic, including in Australia (which created its system only for COVID-19 and closed it to new claims in September 2024) and Canada (the Quebec province of which had maintained a system since 1985, but there had theretofore been no national system).²⁸ The NFCS represented a significant advancement in addressing liability concerns for novel vaccines. The lack of a universal approach to compensation for vaccine-related injuries means that different countries have adopted varying models based on their legal and economic contexts. Some systems, like Sweden’s, are voluntary and industry-funded, while others, like the US Countermeasures Injury Compensation Program (CICP), rely on a per-emergency appropriation from the legislature (Congress) as well as, for COVID-19, a case-by-case analysis of claims.²⁹ Some countries, like Brazil and Honduras, legally established NFCS only to rescind them (Brazil) or never fully operationalize them (Honduras).³⁰

The COVID-19 pandemic exposed systemic inequities in global vaccine governance, primarily, through barriers related to intellectual property, distribution failures, and liability frameworks that placed disproportionate risks on vulnerable populations.³¹ A major issue has been the disparity in indemnity capacity between the HICs and LICs. HICs can absorb vaccine liability risks, as shown by the United States’ Countermeasures Injury Compensation Program (CICP), but LICs lack the legal and financial infrastructure to provide similar protections. This imbalance has been evident in initiatives like COVAX, which struggled to meet its goals due to prioritization of indemnified contracts by the manufacturers, favoring wealthier nations.

According to these studies, there are 28 national or provincial systems for vaccine injury compensation that stand apart from the global or regional NFCS outlined above. Table 1 sets forth these systems and their defining features according to the method adopted by Evans, Looker and Kelly, Wilson & Keelan, Mungwira, Halabi, and others. The design, funding, and administration of systems vary based on the legal and political traditions of the country in which they apply as well, inevitably, the size of the country. This table is updated from Wilson & Keelan’s 2011 summary table and the use of its data will be familiar to scholars of no-fault vaccine compensation dating to Evans.³²

Table 1.

Summary of jurisdictions identified with no fault vaccine injury compensation programs updated from Wilson & Keelan 2011, 2020.

Jurisdiction	Austria	Latvia	Nepal	Vietnam	Hungary
Year	1973	2013	2016	2016	2005
Administration	Ministry of Social Affairs	Zaju valsts agentura (ZVA) (State Medicines Agency)	Ministry of Health	Provincial Department of Health	Central government
Vaccines covered	All vaccines	All vaccines	Gov. recommended vaccines	Vaccines in the expanded national immunization program and vaccines against epidemics (Decree No. 104/2016/ND-CP, Article 15.1)	Mandatory or vaccines pro-actively recommended by law
Eligible comp. (e.g. unexpected injury, disability or death, etc.)	Severe bodily harm, death, disability	Serious or moderately serious harm that lasting for at least 26 weeks, or death	Physical losses (e.g. mutilation, death)	Only permanent injuries or death	No data
Types of comp. (e.g. medical costs, funeral, disability pension, death benefits, lost wages, etc.)	Both economic and non-economic losses; dependents excluded; disability pension only for people whose capability to work is reduced by over 20%	A lump sum payment calculated individually, with a maximum of EUR 142,290 and a minimum of EUR 5000	Set out under Vaccination Act 2016 No. 2072	Medical expenses, fixed amount equal to 30-month salaries, funeral expenses, mental suffering,loss of or reduced income	Medical, disability pension, funeral costs
Funding	Government funded	Central government	Government funded	Central government	Not specified, but likely government funded
Jurisdiction	Luxembourg	China	Finland	Rep. of Korea	Iceland
Year	2000	2006	1983	1995	2001
Admin	National Pension Fund Authority	Provinces, autonomous regions or municipalities directly under the Central Government	Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities	Korea Advisory Committee on Vaccine Injury Compensation	Icelandic Health Insurance (IHI)
Vaccines covered	Publicly recommended protective vaccination	Immunization program vaccines	EU approved vaccines administered in Finland and procured via the EU common procurement mechanism	Vaccines purchased by the Government and administered at public Health Centres	Vaccines against COVID-19 administered between 2020 and 2023 provided by the Icelandic health authorities
Eligible comp.(e.g. unexpected injury, disability or death, etc.)	Death or permanent physical disability	Severe disability or death directly attributable to vaccine	Loss of functionalability for at least 30 d, or incapacity to work, or permanent physical injury, or death	Moderate to severe adverse events (any vaccine injury where treatment cost more than 300,000 Korean won)	All injuries are potentially covered
Types of comp. (e.g. medical costs, funeral, disability pension, death benefits, lost wages, etc.)	Periodic payments (disability pension for the injured vaccinated person and survivor’s pension for surviving dependents)	Province-dependent	Unreimbursed medical costs, disability pension, death benefits, pain and suffering, additional losses arising from injury less statutory benefits, etc. (all are secondary to other sources of compensation)	Only economic losses of live recipients and estate of deceased recipients are compensated, including medical, nursing, funeral expenses, disability compensation, and death benefits.	Both economic and non-economic losses are compensated for live recipients; calculated individually with a cap value of ISK 5,000,000
Funding	Not specified, but likely government funded	Financial departments of the provinces, autonomous regions or municipalities	Insurance contributions levied on members of the Finnish Co-Operative for Pharmaceutical Injury Indemnities	Central government	State Treasury
Jurisdiction	South Africa	Canada (excluding Quebec)	Colombia (Partial NFCS)	Guatemala	Peru
Year	2021	2020	2020	2021	2021
Admin	National Department of Health	OXARO Inc (previously Raymond Chabot Grant Thornton Consulting Inc.)	COVID-19 Evaluation Council	Ministry of Public Health and Social Assistance	Ministry of Health
Vaccines covered	COVID-19 vaccines specified in Schedule 1 to the Directions no. 1987/2021	Nationally approved (Health Canada approved) COVID vaccine	Vaccines supplied by the State of Colombia	Nationally approved vaccines purchased by or donated to the state within 24 months from the entry into force of the Decree No.8–2021	Not specified whether including both vaccines approved for emergency use and standard approvals
Eligible comp. (e.g. unexpected injury, disability pension, death benefits, lost wages, etc.)	Severe injuries resulting in temporary or permanent physical or mental impairment, and death	Permanent and serious injuries resulting in persistent or significant disability or incapacity, or a congenital malformation or death	Not specified	Serious adverse reactions to a covered vaccine resulting in a significant impact on the injured person’s bodily functions	Permanent injuries or death from a severe adverse reaction resulting from a covered COVID-19 vaccination
Types of comp. (e.g. medical costs, funeral, disability pension, death benefits, lost wages, etc.)	Compensation is not available to the estate of a vaccine recipient but both economic and noneconomic payment	Both economic and non-economic losses are compensated as well as funeral expenses.	Not specified	Both economic and non-economic losses, a mixture of periodic payments and a lump sum payment	Both economic and non-economic losses, but excluding loss of earnings, and funeral expenses not specified
Funding	Central government (appropriated by an act of parliament) and donations	Federally funded, but excluding legal representation	Federally funded	Funding distributed from the central government	Funding comes from the central government
Jurisdiction	Australia	Hong Kong	Czech Republic	Estonia	Poland
Year	2021	2021	2020	2020	2021
Admin	Australian Government Department of Health and Aged Care	Axa China Region Insurance Company Limited	Czech Ministry of Health	Estonia Health Insurance Fund	Rzecznik Praw Pacjenta (public body)
Vaccines covered	Nationally approved (Therapeutic Goods Administration approved) COVID vaccines	Vaccines used as part of the Government’s COVID Vaccination Program, only for emergency use	Compulsory vaccines and COVID-19 vaccines acquired on the basis of a Commission Decision	EU approved vaccines used in Estonia	EU-approved vaccines for specified diseases
Eligible comp. (e.g. unexpected injury, disability pension, death benefits, lost wages, etc.)	Temporary or permanent injuries caused by listed COVID-19 vaccines, show specific conditions, and are diagnosed by a treating practitioner	Temporary and permanent injuries on the AEFI list or AESI list	Serious injuries causing pain and suffering, loss of earnings, and ‘deteriorated social position’	Severe injury resulting from vaccination lasting more than 4 months or death	Permanent or temporary injuries that result either in an emergency hospital visit for any period of time or a hospitalization of atleast 14 d
Types of comp. (e.g. medical costs, funeral, disability pension, death benefits, lost wages, etc.)	Any and all expenses resulting from injuries and valued over $1,000	The amount of compensation varies by the severity and duration of injury and is capped depending on age; no compensation is provided to dependents	Both economic and non-economic losses; dependents not necessarily awarded, but ‘a person close to the vaccinated person for mental suffering’ is offered compensation	Paid on scale of injury not on type of comp., however lost wages are not covered.	Lump sum payments based on duration of the stay with add on amounts for unpaid medical bills (e.g. for each surgical procedure).
Funding	Federally funded	National Government	Czech Government	Central government for the COVID vaccine compensation; a levy of €0.15 per dose for adverse events caused by other vaccines	1.5% tax on vaccine suppliers, local budgets and private donations
Jurisdiction	Russia	Slovenia	Israel	Thailand	Indonesia
Year	1998	2021	2020	2021	2021
Admin	Social Security Authorities	Slovenian Ministry of	Inbal Insurance	National Health Security	National Commission on
		Health	Company Ltd	Office	AEFI
Vaccines covered	Nationally approved vaccines for a pre-specified list of diseases	Mandatory vaccines and vaccines against COVID-19	Vaccines nationally approved for a pre-specified list of diseases	Vaccines administered by the state to ‘service recipients’ who are Thai citizens	All COVID-19 vaccines
Eligible comp. (e.g. unexpected injury, disability pension, death benefits, lost wages, etc.)	Russian legislation provides a list of instances when a person is eligible for social compensation due to post-vaccine complications (e.g. anaphylactic accident)	Covers only permanent injury resulting in “grave and permanent reduction in vital body functions”	Covers only permanent injuries or death	All injuries arising from receiving vaccination against COVID-19	Temporary or permanent injuries that cause disability or death and necessitate medical care
Types of comp. (e.g. medical costs, funeral, disability pension, death benefits, lost wages, etc.)	A fixed sum indicated in the statute (in cases of eligible post-vaccination complications, death or permanent disability) or individualized (in cases of temporary disability)	Lump sum amounting upto €60,000	Lump sum calculated by severity of the injury and age of victim – funeral expenses are not available	Lump sum payments distributed by nature of injury	Both economic and non-economic losses; dependents excluded; compensation amount determined by the evaluation committees
Funding	Federally funded	State budget	Internal Government Insurance Fund through a tax on each vaccine dose	National Health Security Fund	Central government
Jurisdiction	Malaysia	Philippines	Singapore
Year	2022	2021	2021
Admin	Malaysian Ministry of Health, and National Disaster Management Agency	Philippine Health Insurance Corporation	Ministry of Health
Vaccines covered	Vaccines received under the National COVID-19 Immunization Program (PICK)	Vaccines under the national inoculation program, only for emergency use	Privately administered vaccines are not covered
Eligible comp. (e.g. unexpected injury, disability pension, death benefits, lost wages, etc.)	Serious side effects evaluated by the Special Pharma covigilance Committee for the COVID-19	Serious case sidentified by PhilHealth and assessed to be ‘vaccine product-related reaction’ or ‘vaccine quality-defect reaction’ due to COVID-19 vaccines by causality assessment	Injuries that cause a serious side effect, which is defined as one that requires inpatient hospitalisation, or caused permanent severe disability, or is fatal
Types of comp.	Amount paid is determined based on certification by the	Hospital expenses and Permanent disabilities	A lump sum payment depending on the severity
(e.g. medical costs, funeral, disability pension, death benefits, lost wages, etc.)	administration, with a cap of 500,000 malaysian ringgit and no minimum sum.	Compensation – paid in lump sum	of side effect, with a maximum of $225,000 for death or serious disability and a minimum of $2,000
Funding	Central government	Central government	Central government

Table 2 provides an illustration of these differences and endeavors to provide a broad typology of them as distinguished from previous efforts. This typology, used for the first time here, identifies NFCS by legal tradition, political system, administrative hierarchy, claim level, compensation approach, and the interface agency.

Table 2.

Summary of Political, Legal, and Administrative Features of Representative NFCS Jurisdictions.

Jurisdictions	Germany	Mainland China	Sweden	U.K.	U.S.		Canada
Legal System	Civil law system			Common law system
Political Structure	Federal republic (parliamentary)	Socialist republic	Parliamentary representative constitutional monarchy	Parliamentary representative constitutional monarchy	Federal republic (presidential)		Parliamentary representative constitutional monarchy
Administrative Hierarchy	A federal government and 16 state governments	A central government supervising 32 provincial governments	Unitary state	A central government and three devolved governments	A federal government and autonomous states		A federal government and autonomous provinces
Claim Level	State (Social Affairs Offices)	Provincial (Health Commission)	Svenska Läkemedelsförsäkringen (LFF)	National (NHSBSA)	Federal (CICP)	Federal (VISP)
Compensation	A combination of periodic and lump sum payments.	Individually dependent	Individually dependent	A single lump-sum payout at £120,000	A combination of periodic and lump sum payments	A combination of periodic and lump sum payments
Funding Agency	State pension offices	Provincial financial departments	LFF government to non-profit third-party	Central government	Federal government	PHAC/OXARO federal government to for-profit third party

Discussion

Based on the criteria set forth above, this Review identified six representative jurisdictions in addition to providing the most updated table to date describing 28 NFCS under the methodology adopted by Evans in 1999 and followed thereafter. These jurisdictions were selected because they represent the legal traditions (civil versus common law), political organization (federal, monarchy, socialist, etc), claim level, compensation, and funding interface office most likely to be relevant for countries seeking to establish no-fault compensation systems. While the representative jurisdictions described below do not include low- or middle-income countries, those systems are included in Table 1 and our results suggest that the factors identified in Table 2 are more relevant than macroeconomic measures.

The representative systems are briefly described below, with features that may be adopted by other governments emphasized.

Canada

Although its province of Quebec had formed and administered a no-fault compensation system since 1986, no other Canadian province or territory nor the federal government established a no-fault vaccine injury compensation system until the COVID-19 pandemic. Canada’s pan-Canadian Vaccine Injury Support Program (VISP) was established through a federal government policy pronouncement, rather than a legislative act. The program was announced by the Prime Minister on December 10, 2020, and formally launched on June 1, 2021, to provide financial support for serious and permanent injuries resulting from Health Canada-authorized vaccines administered on or after December 8, 2020.

As of that date, those receiving vaccinations in Canada have access to VISP, other than those vaccinations administered in Quebec, who have access to its preexisting system. The Public Health Agency of Canada entered into an agreement with the private firm OXARO to undertake the program’s delivery, including assessment of claims and appeals of claims. OXARO is a former subsidiary of the Raymond Chabot Grant Thorton Group’s consulting arm that became a fully separate entity in 2023. It is still a member firm of the Grant Thorton Group as is Raymond Chabot Grant Thornton. In this respect, the Canadian system is representative of the approach adopted by COVAX, UNICEF, and AVAT, which also contract with for-profit third parties.

Claims are evaluated by a three person expert panel, the roster of which is maintained by OXARO. The standard of proof required by the scheme is that on the balance of probabilities the vaccination did cause the adverse event. This requires a majority decision by the three person panel using the WHO causality assessment “Causality assessment usually will not prove or disprove an association between an event and the immunization. It is meant to assist in determining the level of certainty of such an association. A definite causal association or absence of association often cannot be established for an individual event.” The system only compensates permanent injuries.

Consistent with its common law tradition, those seeking compensation may still sue in court to recover damages. However, if a litigant successfully sues after they have used the scheme, they must return payments the scheme has awarded them from their court-awarded damages.

Germany

Germany was the first country to establish an NFCS, in response to the 1953 German Supreme Court decision recognizing the right to compensation for injuries from compulsory vaccinations.¹⁶ The NFCS, governed by the Infection Protection Act (Infektionsschutzgesetz, “IfSG”), expanded to include injuries related to COVID-19 vaccines. It covers both mandatory and voluntary vaccines, including those authorized for emergency use.³³

The compensation system in Germany is decentralized. Each of the 16 federal states (Länder) administers and funds compensation claims through the Social Affairs Offices (Versorgungsämter), which collaborate with public health departments to assess the extent and causality of injuries. Claims can be made by anyone who suffers from temporary or permanent injuries exceeding standard post-vaccination reactions. Unlike the UK’s Vaccine Damage Payment Scheme detailed below, which imposes strict causation and eligibility criteria, Germany’s system is more accessible, without thresholds for disability or ceilings for compensation. The “balance of probabilities” standard is applied when assessing claims, meaning compensation is awarded if it is “more likely than not” that the vaccine caused the injury. The claimant-friendly approach contrasts with stricter systems like the UK’s, which requires stronger evidence of causation. In cases of uncertainty, the German system allows compensation even without definitive scientific proof, provided it is approved by the highest authority in the state responsible for war victims’ compensation.

Germany’s system also allows claimants to pursue additional legal recourse if claims are denied or exceed compensation limits, offering a limited pathway for further support. While the system provides coverage for both mandatory and voluntary vaccines, including COVID-19, there is limited transparency. There is no formal reporting on claim statistics, processing times, or financial performance.

The decentralized administration of Germany’s system, where states handle claims, could be adapted either by a national government for its subnational units or for a global system with regional or national claims management within a centralized framework. Germany’s claimant-friendly adjudication process, which includes a balance-of-probabilities analysis and provisions for cases with uncertain causality, could be considered for any international compensation scheme.

China

China’s NFCS dated from 24 March 2005, and integrated COVID-19 vaccines from 30 December 2020.³⁴ The China NFCS scheme was created under the Regulation on the Administration of Circulation and Vaccination of Vaccines 2005 (Order No. 668 of the State Council of 23 March 2005, which was updated in Order No 668 of the State Council of 23 April 2016). The main provisions for vaccine compensation are set out at Article 56 of the Vaccine Administration Law of the People’s Republic of China (2019).

Like Germany, each province, autonomous region or municipality administers their own scheme, although within the context of a socialist, single-party state. The national law establishes a broad framework. Within that framework, the financial departments of provinces, autonomous regions fund each scheme including compensation for compulsory vaccines given under the national immunization program. The purchase of commercial insurance to cover severe side effects is broadly encouraged.

Under the law, compensation for adverse reactions of immunization “shall be prompt, convenient and rational.” The scope, standards and procedures of compensation for adverse reactions of immunization are determined by the State Council, while the specific implementation measures are formulated by the provinces, autonomous regions or municipalities. There is no consistent application across China. Compensation is individualized – the 2019 Act specifies that the scope of compensation shall be adjusted based on the actual situation. However, the losses covered and the methods for quantifying loss differ by region. Fei and Peng report considerable variation between the types of damage compensated and quantification methods used.³⁴

Sweden

Sweden’s Pharmaceutical Insurance Scheme (“SPIS”) is a voluntary, industry-funded vaccine injury compensation scheme that offers no-fault compensation for injuries caused by vaccines. Established in 1978, SPIS covers injuries from nationally approved vaccines, including those authorized for emergency use, and has extended coverage to COVID-19 vaccine since December 2020. This scheme is managed by Svenska Läkemedelsförsäkringen, “LFF,” with participation from approximately 98% of pharmaceutical manufacturers in Sweden.³⁵

The Scheme is efficient, with claims typically resolved within 6 to 8 months. Claims are processed through a standardized form that grants LFF the authority to collect medical records, which are reviewed by claims experts. The standard of proof for compensation is set at a “preponderant probability,” meaning the injury must be predominantly caused by the vaccine.

SPIS is funded primarily through contributions from pharmaceutical companies, but when manufacturers are not members or the compensation cap is reached, the government indemnifies the program. The reliance on voluntary membership creates risks of coverage gaps and inconsistencies, especially when manufacturers choose not to participate.

The system is relatively transparent, with an external review board (The Pharmaceutical Injury Panel) offering an appeals process. The close ties between industry and the administering body, LFF, may raise concerns about conflict of interest that might influence compensation decisions.

SPIS demonstrates that a collaborative, industry-funded model can balance the need for compensation with the promotion of public health, especially in large-scale vaccination campaigns. However, its reliance on voluntary participation and the potential for conflicts of interest may pose challenges for universal applicability. A national or global NFCS could adopt the flexibility and efficiency of the Swedish model, while addressing its limitations, particularly by ensuring compulsory participation and independent oversight to guarantee fair compensation for all individuals, regardless of the manufacturer involved.

The model offers a useful reference for global compensation systems, showing that a non-adversarial, quickly resolved claims process can improve public trust in vaccines and help ensure that individuals injured by vaccines are adequately compensated. However, to ensure effectiveness and equity on a global scale, it would need to be adapted to prevent gaps in coverage and ensure comprehensive, transparent decision-making processes.

United Kingdom

The UK had an existing no-fault compensation scheme for vaccines created 22 March 1979, and which incorporated COVID-19 vaccines from 31 December 2020. This scheme was created under national legislation, the Vaccine Damage Payments Act 1979 and the Vaccine Damage Payments (Specified Disease) Order 2020. Since 1 November 2020 it has been administered by the NHS Business Services Authority (NHSBSA), who are a public body. Prior to that it was administered by the Department for Work and Pensions, a Government Department.

The funding for the scheme comes from central Government. The UK NFCS covers vaccines for specified diseases listed in Section 1(2) of the Act or added by a Statutory Instrument which are administered in the UK. It includes vaccines approved for emergency use and standard approvals.

The UK NFCS is distinguished by the approach it takes to both threshold for disability and corresponding compensation. The scheme will only recompense injuries which cause 60% or greater disablement. Payment under this scheme is fixed at £120,000.³⁶ This is a tax-free sum, but it may impact on some other social security benefits.

The UK NFCS provides models for simplicity and efficiency, although determining whether a person has crossed the disability threshold can involve costly medical assessment, some of which are outsourced to third party evaluators. Similarly, a set level of compensation lowers administrative costs for determining subcategories like loss of work, but risks inequitable outcomes or failure to make those injured whole. Moreover, the number of claims under this system exploded under COVID-19, a phenomenon that remains unexplained.³⁶ As a model for national or global systems, it provides possibilities for both administrative simplicity but also inequity.

United States

The United States maintains two NFCS. One covers routine immunizations recommended by its Centers for Disease Control and Prevention.³⁷ The second, the Countermeasures Injury Compensation Program (“CICP”), was established under the Public Readiness and Emergency Preparedness Act (“PREP Act”).³⁸ The CICP offers no-fault compensation for individuals injured by medical countermeasures, including vaccines and antiviral drugs.³⁹ The CICP aims to provide timely compensation without requiring the individual to prove negligence, thus providing a faster route to compensation during a time of crisis.

The CICP covers injuries from medical countermeasures authorized or licensed by the Food and Drug Administration (FDA), including vaccines and treatments under Emergency Use Authorizations (EUAs).⁴⁰ It compensates for medical expenses, lost wages, and death benefits but excludes attorney fees and pain-and-suffering damages. Importantly, the CICP’s effectiveness is dependent on proof of causal link. Injuries must be directly linked to the countermeasure, with compelling medical and scientific evidence. The program’s strict eligibility criteria and complicated claims process can sometimes delay or restrict compensation, leaving those affected in a limbo.

A notable advantage of the CICP is its streamlined administrative process. Claimants are required to submit a Request for Benefits form to the Health Resources and Services Administration (HRSA), which reviews the claim and compensates the individuals if they meet the criteria. This system does not involve courts, which accelerates the process compared to traditional legal approaches. However, the challenges it faces – limited coverage, rigid causality standards, and insufficient compensation – mirror limitations seen in other national systems, including those within the Global Vaccine Access frameworks, such as the GAVI COVAX AMC.

While the CICP has provided a model for rapid compensation during public health emergencies, its limitations underscore the need for more adaptable, comprehensive frameworks. The program’s strict eligibility criteria and casualty standards often leave individuals without recourse, particularly when injuries are long-term or complex. To address this, experts have proposed CICP could improve its performance through data-driven insights to identify inefficiencies and gaps in coverage. This approach could be expanded into an international framework for vaccine injury compensation.

Furthermore, as global vaccination campaigns continue, the CICP’s model could inspire an international NFCF that includes looser causality requirements, expanded injury definitions, and higher compensation caps to ensure broader coverage. This could address some of the inherent inequities in current systems, where many individuals, especially in LMICs, are left without adequate compensation due to rigidity eligibility or burdensome proof requirements.

Comparison

This literature review and featured NFCS typology provide insights into the expanding and diversifying models for NFCS. We focused on NFCS developed at the provincial or national level specifically in response to COVID-19 as the pandemic spurred new efforts to establish NFCS and nearly all countries with preexisting systems added COVID-19 immunizations to their schemes. The overall findings in Table 1 show that NFCS features such as eligibility, administration, funding, and classes of compensation varied widely based on political tradition and organization, funding source, and other factors captured in Table 2. While we report data for 28 countries, and feature 6 representative systems, comparisons between NFCS studies are made difficult because of factor bias (i.e. some studies focused solely on rate of compensation per number of claims), methodological differences between studies, country-specific factors, and lack of head-to-head comparison studies. The COVID-19 pandemic underscored the inherent challenges in managing global public health crises, particularly in terms of vaccine development, distribution, and compensation for vaccine-related injuries. While the COVID-19 pandemic is unlikely to be the last of its kind, it has provided many lessons into the systemic issues that need to be addressed to prepare for future global health emergencies. These include the need for equitable vaccine access, robust international collaboration, and critically, the establishment of effective vaccine injury compensation mechanisms.

We found important variations among countries’ NFCS. In Australia, which established a new system in response to COVID-19, a table of injuries divided into three tiers (Tier 1 for minor injuries, Tier 3 for significant injuries and death), guided the administration and compensation decisions of the system. In the United States CICP, compensation was significantly lower for all classes of claims, attributed to the responsibility of a single governmental office to evaluate the medical record according to a relatively stringent standard. The pace of review varied significantly with some NFCS reporting significant delays. German and Swedish models offer important lessons because they, respectively, emphasize local control and planning and putting “skin in the game” by manufacturers who reap profits from public health emergencies.

Similarly, using COVAX, AVAT, and UNICEF as models poses significant difficulties. The NFCS is based on a single experience (COVID-19) and there is limited information about how they functioned. They share with Canada the use of a third party for profit company to administer their claims.

We are skeptical that legal frameworks governing vaccine injury compensation can be harmonized at the international level. As it currently stands, the lack of consistency between jurisdictions brings into stark relief how approaches to compensation can reflect deeply held cultural, social, and economic norms. It may be possible to establish a global vaccine injury compensation fund, modeled after WHO’s existing mechanisms, governments and pharmaceutical companies can pool resources to provide financial support for vaccine-injured individuals in LMICs. The fund could be financed through a small levy on pandemic-related profits from pharmaceutical companies, ensuring long-term financial sustainability, but the approach more likely to provide fairness to populations is at the national or provincial level.

The recent amendments to the International Health Regulations have sparked heated debates, particularly regarding the lack of provisions empowering WHO to impose health measures, such as the vaccine distribution and state compensation, through legally meaningful mechanisms.⁴¹ On one hand, it appears that the WHO will continue to be limited in its capacity to require measures like NFCS. On the other hand, the principle of state sovereignty remains firmly entrenched so that a balance between persuasion and national leadership might be reached. As the WHO clarified in its response to an inquiry, no international agreement can unilaterally impose binding authority on signatory states, and it is ultimately up to the Member States’ themselves to decide in advance which aspects of legal preparedness to adopt based on context.⁴²

Similarly, the recently adopted WHO Pandemic Agreement does not provide for NFCS, although earlier versions of the agreement addressed liability and risk management and implicitly contemplated NFCS. The agreement as it stands contains implications for NFCS, especially national preparedness and the benefits that may follow PABS agreements.

National, no-fault schemes offer practical templates. The Swedish medical injury scheme, for example, utilizes: capped payouts and annual compensation linked to ongoing need, no legal fees and evidentiary thresholds (probable causation), and integration with existing social services to reduce overhead. While the Swedish model has been criticized for its cap limits (specifically in contrast to US models), it has been celebrated for its prioritization of sustainability, administrative simplicity, and equitable access – principles that are directly transferable to global frameworks. The inevitability of future pandemics strongly suggests countries adopt ethically grounded and financially sustainable approaches to vaccine injury compensation. An NFCS that balances corporate accountability, shared burdens, and inclusive governance is essential to preventing future inequities.

Conclusion

The COVID-19 pandemic has laid the bare profound inequities in global health law, highlighting the quadripartite challenges of affordability, distribution, liability and indemnity. These challenges underscore a system that often prioritizes commercial interests over fundamental fairness. NFCS are one method by which this imbalance may be addressed. This review has provided a set of models that countries may adopt or consider when constructing an NFCS.

While the COVID-19 response has driven significant innovations in vaccine development and distribution, it has also highlighted the urgent need for robust and equitable vaccine injury compensation mechanisms. The NFCS under GAVI COVAX AMC has been a critical starting point, but its shortcomings and failures offer valuable lessons for future improvements. In the face of an increasingly interconnected world, strengthened international collaboration and institutional innovation are essential at ensuring both vaccine access and fair compensation during future public health crises.

Countries have discretion to tailor their approach within a comparative framework like the one offered here. Critically, the global community must acknowledge that while no-fault compensation is not currently recognized as a universal human right, it is essential for balancing state responsibility with individual rights – especially where vaccination is mandated. States, as the primary duty bearers, must assume accountability within this framework. A human rights-based approach to global health must guide the development of mechanisms that support LICs in ensuring both vaccine access and fair compensation for affected individuals.

Ultimately, through global efforts to integrate international norms into national legal systems, we can achieve a world where health entitlements are accessible to all, including the most marginalized and vulnerable populations. The overarching goal is to guarantee the highest attainable standard of health remains a fundamental human right, available to every individual, regardless of race, religion, or socio-economic status, as enshrined in international health declarations. Only through such a unified approach can we build a more equitable, resilient, and just global health system for future generations.

Biography

Sam Halabi is the Bette Jacobs Endowed Professor in Georgetown University’s Department of Health Management and Policy and directs the Center for Transformational Health Law at the O’Neill Institute for National and Global Health Law. He is a global expert on no-fault vaccine injury compensation, having advised the COVAX Facility, international development banks, and governments on the issue as well as publishing research and analysis on no-fault vaccine injury compensation systems in JAMA, the New England Journal of Medicine, and the Lancet.

Funding Statement

The author(s) reported there is no funding associated with the work featured in this article.

Disclosure statement

No potential conflict of interest was reported by the author(s).