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Pay out amount and funding sources in different countries with well instituted vaccine injury compensation programs.
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Background: Vaccines have had a great impact on disease prevention and mortality reduction. Very rarely, vaccines also can result in serious adverse effects. In consideration of this fact, vaccine injury compensation programs have been implemented in many countries to compensate a vaccinee for associated adverse effects. The existing vaccine injury...
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Background: Vaccines have had a great impact on disease prevention and reducing mortality. Very rarely, vaccines also can result in serious adverse effects. In consideration of this fact, vaccine injury compensation programs have been implemented in many countries to compensate a vaccinee for associated adverse effects. The existing vaccine injury...
Citations
... These schemes provide a streamlined process for compensation, covering medical expenses, lost income, and noneconomic damages like pain and suffering. This approach also fosters public trust in vaccination programs by addressing adverse outcomes transparently and fairly [3]. ...
... [7] In Asia, countries like Japan and South Korea have well-established VICPs, offering comprehensive coverage for vaccine-related injuries. [3] However, a lack of standardization across these systems results in varying levels of protection and efficiency in compensating vaccine injuries globally. ...
... In Korea, high immunization rate of up to 95.9-100% among children has been recorded due to the availability of compensation against vaccine injury in National programs. [22] In our study, important determinants associated with COVID-19 vaccine acceptability [ Figure 3] include concerns about emerging variants of COVID-19, the availability of infor mation about vaccines through social media platforms (66%), positive perception and attitude on vaccine safety (59%) and efficacy (immunogenicity)(75%) of vaccine, positive attitude for accepting minor adverse effects of vaccine over the major benefit of protection of child to achieve normal social life, schooling (67%) and availing daycare facility (17%), [ Table 1] parent's own experience of receiving vaccine doses, concerns for physical and mental health of their children [ Figure 3]. The utmost desire not only to prevent infection and social damage but also to restore normal daily life emerged as a positive attitude, leading to high willingness for COVID-19 vaccine. ...
A BSTRACT
Purpose
COVID-19 was declared a global pandemic and all age groups were equally affected. Coronavirus had devastating effects worldwide due to the emergence of new variants till vaccination was adopted to eradicate the transmission of the virus and restore normalcy. However, children were not included in the initial phase of vaccination. The purpose of the study was to assess the level of perception, attitude, and practice among parents toward the COVID-19 vaccination drive in children 10–12 years of age.
Design and Study
The present research is a cross-sectional questionnaire-based survey including parents of children aged 10–12 years as participants. The survey was conducted between May 2022 and July 2022 with a sample size of 320.
Results
A high willingness (80%) among parents was found for getting their children vaccinated. COVID-19 vaccines were perceived to be safe by the parents (59%) and efficacious (75%) for their children. Parents (67%) felt that the benefits of getting their children vaccinated against COVID-19 prevail over the risks of the vaccine. Parents 214 (67%) feel the need of getting their child vaccinated for sending them to school followed by availing of daycare facilities after school 54 (17%) among working parents. A significant association ( P < 0.05) was seen between the variables of practice being followed by parents and their children as per COVID-19 norms. Parent’s negative attitude toward COVID-19 vaccination was associated with availability of no/unclear safety information (36%), fear of adverse effects of vaccine (3%), and false belief of having long-term immunity due to natural infection (32%). The positive attitude of parents was due to trust in positive information/news about the vaccine (42%), belief in the safety and efficacy of the vaccine (5%), acceptability for mild adverse effects (1%), and the necessity of vaccine to send children to schools (1%).
Conclusion and Recommendations
The awareness of parents regarding COVID-19 vaccination for children was limited, high level of acceptance for vaccination was seen in our study. We recommend to continuing educational programs through mass campaigns to increase increasing awareness among parents for getting COVID-19 vaccination for their children. Vaccine hesitancy including vaccine safety concerns of parents should be addressed by presenting myths and facts related to COVID-19 vaccine using television, radio, and social media platforms.
... Most of the existing VICPs are implemented at the central or federal level and are state-funded. The VICPs provide compensations covering medical expenses, disability pensions and death benefits (depending on the country) to individuals who experience injuries caused by vaccines licenced in the country [57,58]. The claims and decision-making processes are strictly administrative and non-civil and standards of proof linking vaccination and injury are required [57,59]. ...
Background
It has been established that the existing compensation mechanism is not the favoured platform for vaccine recipients with Adverse Effects Following Immunisation (AEFI). With the mass production of vaccines during the COVID-19 pandemic, intensified by the mandatory National COVID-19 Immunisation Programme in Malaysia, an alternative resolution mechanism for compensation is long overdue. This qualitative study aims to propose a viable alternative dispute resolution (ADR) mechanism for those who suffer AEFI from COVID-19 vaccination, particularly the economically disadvantaged, older people, and disabled individuals in Malaysia.
Methods
The researchers conducted an in-depth focus group discussion in September 2022 involving seven participants representing key stakeholders in vaccine compensations from governmental agencies, non-governmental organisations (NGOs), and private institutions who were experts in litigation and legislation, consumer protection, and medical practices in Malaysia. The study utilised ATLAS.ti 22 to conduct a thematic analysis.
Findings
The analysis yielded three themes: existing mechanisms and their challenges, the role of ADR, and the solution for a vaccine injury compensation mechanism. The participants shared their knowledge and experience regarding the existing vaccine compensation mechanisms in Malaysia, i.e. the common law of Tort and Consumer Protection Act 1999, and explained how each mechanism relates to specific challenges or arguments that provide the basis on which they are unable to accord fair compensation to the vaccine recipients. The participants debated the merits and disadvantages of the types of ADR for AEFI and unanimously proposed a specific healthcare centre for compensation (SHCC) as the most viable compensation mechanism for AEFI.
Conclusion
SHCC offers a new ADR to serve as a compensation mechanism for claimants affected by the COVID-19 vaccines while also contributing to achieving Sustainable Development Goal 16: peace, justice, and strong institutions.
... ZEPI has a policy of free treatment of all serious AEFIs that occur within 3 to 5 days post-vaccination with limited funding for vaccine injury compensation. Some HICs have however well-funded systems of vaccine injury compensation schemes (40). ...
Introduction: Functional national systems that monitor Adverse Events Following Immunization (AEFIs) are vital for implementing evidence-based vaccination policy while ensuring the safe access to these life-saving technologies. These systems can counteract vaccine hesitancy by increasing public trust and uptake in vaccination minimizing the burden of vaccine-preventable diseases (VPDs). Ensuring that these systems function optimally is a critical public health imperative. This is a novel study evaluating AEFI surveillance system including causality assessment, in Zimbabwe.
Aim:This study provides a review of Zimbabwe’s national AEFI surveillance system since its launch in 1998, highlighting strengths, weaknesses, and opportunities for improvement.
Method: We conducted an in-depth analysis of all AEFI reports received until 2021, assessing reporting trends and overall performance of the AEFI system in terms of investigation, causality assessment. The WHO Global Benchmarking Tool (GBT) was used to assess regulatory performance in terms of AEFI surveillance. Duplications were excluded and reports with evidence of AEFI(s) after vaccination were included.
Results: There was a steady increase of AEFI reports per annum particularly from 2006 to 2021 with a more dramatic increase during the COVID-19 epidemic with an AEFI reporting ratio of 43.46/million adults for COVID-19 vaccinations in 2021. The reporting ratio exceeded the WHO recommended minimum AEFI reporting ratio of 10 per 100000 surviving infants during eleven years (47.84%) out of the twenty-three years since inception of the surveillance. The GBT assessment demonstrated that the AEFI surveillance system evolved for all manufacturers or license holders.
Conclusion: Close partnership between the immunization program and regulatory authority has enhanced AEFI surveillance in Zimbabwe. Incomplete AEFI case investigations for and timely AEFI detection are challenges that need to be addressed. System strengthening should include consideration of digital innovations to improve detection, optimizing case investigation of serious AEFI including post-mortems and utilizing VigiPoint disproportionate analysis for signal detection.
Background Thailand implemented a no-fault compensation scheme (NFCS) for COVID-19 vaccine-related injuries during the pandemic as part of its Universal Health Coverage (UHC) framework. This policy aimed to promote vaccine confidence, reduce litigation and enhance healthcare system resilience. This study investigates the policy feedback effects of Thailand’s NFCS and its implications for healthcare governance in low- and middle-income countries (LMICs). Methods A qualitative multi-method approach was employed. Data sources included government policy documents, peer-reviewed literature, media content, official NHSO reports, five semi-structured interviews with key stakeholders and a focus group discussion with public health experts. Media content analysis included over 100 news reports published between March 2021 and October 2022. The analysis was guided by Policy Feedback Theory to identify self-reinforcing and self-undermining feedback loops. Results Between April 2021 and September 2023, 22,695 compensation claims were filed, with 84.0% approved. The NFCS reduced litigation risks, built public trust and contributed to high vaccine uptake. Self-reinforcing feedback effects were observed in administrative innovations, public engagement strategies and cross-scheme equity. However, self-undermining effects such as financial strain and increased public expectations emerged. Media narratives and public interviews confirmed the importance of rapid compensation and transparent communication in driving public acceptance. Conclusions Thailand’s NFCS illustrates how a well-designed compensation mechanism can enhance vaccine confidence and public trust during health emergencies. However, sustained political and financial commitment is necessary to mitigate unintended fiscal and administrative challenges. The findings offer relevant policy lessons for LMICs in designing resilient, inclusive compensation systems during future health crises.
Adverse events following immunization (AEFI) or vaccine injury is an issue of great concern in many nations, including Malaysia. This issue has long attracted the public's interest, but the emergence of COVID-19 disease has triggered greater interest as nations engaged in mass vaccination programs for their citizens. This is further exacerbated by the growing dissatisfaction with the traditional tort litigation system which necessitates exploring alternative ways to deal with vaccine injury cases. While the vaccine injury compensation program (VICP) has been implemented in several countries to compensate affected individuals following vaccination, not all VICP can cater to public health emergencies, especially regarding vaccine COVID-19. Malaysia, for example, has a similar program known as Special Financial Assistance Vaccine (SFA), which allows individuals to receive financial assistance if they suffer from AEFI COVID-19. Thus, this paper is intended to review and analyse the VICP in Southeast Asian countries and its implementation in Malaysia. This qualitative research was based on document review and comparative methodologies by exploring the VICP in Southeast Asia and similar mechanism in Malaysia to enrich the subject matter of the vaccine COVID-19 liability. The finding shows that the VICP program seems to be a great alternative in dealing with vaccine injury cases, especially in addressing the growing dissatisfaction with the traditional tort litigation system. Malaysia, Singapore and Thailand has its own VICP for affected individuals with COVID-19 vaccines while Myanmar, Cambodia, Timor-Leste, Indonesia, Vietnam, and the Philippines is under COVID-19 vaccine injury compensation scheme by COVID-19 Vaccines Global Access (COVAX) offered in 92 low- and middle-income nations.
Objectives
(1) Characterize the initial clinical characteristics and long-term outcomes of smallpox vaccine-associated hypersensitivity myocarditis and pericarditis (MP) in United States service members. (2) Describe the process of case identification and adjudication using the 2003 CDC nationally defined myocarditis/pericarditis epidemiologic case definitions to include consideration of case-specific diversity and evolving evidence.
Background
Between 2002 and 2016, 2.546 million service members received a smallpox Vaccinia vaccine. Acute MP is associated with vaccinia, but the long-term outcomes have not been studied.
Methods
Records of vaccinia-associated MP reported to the Vaccine Adverse Event Reporting System by vaccination date were adjudicated using the 2003 MP epidemiologic case definitions for inclusion in a retrospective observational cohort study. Descriptive statistics of clinical characteristics, presentation, cardiac complications, and time course of clinical and cardiac recovery were calculated with comparisons by gender, diagnosis and time to recovery.
Results
Out of over 5000 adverse event reports, 348 MP cases who survived the acute illness, including 276 myocarditis (99.6% probable/confirmed) and 72 pericarditis (29.2% probable/confirmed), were adjudicated for inclusion in the long-term follow-up. Demographics included a median age of 24 years (IQR 21,30) and male predominance (96%). Compared to background military population, the myocarditis and pericarditis cohort had a higher percentage of white males by 8.2% (95% CI: 5.6, 10.0) and age <40 years by 4.2% (95% CI: 1.7,5.8). Long-term follow-up documented full recovery in 267/306 (87.3%) with 74.9% recovered in less than a year (median ~3 months). Among patients with myocarditis, the percentage who had a delayed time to recovery at time of last follow-up was 12.8% (95% CI: 2.1,24.7) higher in those with an acute left ventricular ejection fraction (EF) of ≤50% and 13.5% (95% CI: 2.4,25.7) higher in those with hypokinesis. Patient complications included 6 ventricular arrhythmias (2 received implanted defibrillators) and 14 with atrial arrhythmias (2 received radiofrequency ablation). Three of 6 patients (50%) diagnosed with cardiomyopathy had clinical recovery at their last follow-up date.
Conclusions
Hypersensitivity myocarditis/pericarditis following the smallpox vaccine is associated with full clinical and functional ventricular recovery in over 87% of cases (74.9% <1 year). A minority of MP cases experienced prolonged or incomplete recovery beyond 1 year.
