COVAX No-Fault Compensation Program: Explained
Employees packing boxes with COVID-19 vaccine at the packaging and dispatch department in Pune, Maharashtra, India, on Tuesday, Feb. 23, 2021.
The COVID-19 pandemic has had a huge toll on everyone’s physical, mental and financial health. Millions have died or fallen ill. Millions more have been pushed into poverty. Vaccination is one of the key tools to end the pandemic and help to reduce the spread of the SARS CoV-2 virus.
By getting vaccinated, people help to protect themselves from the likelihood of death and severe disease with the possible long-term health implications and hospitalisation that can result from a COVID-19 infection.
When a person is vaccinated, they not only protect themselves, but also contribute to protecting their loved ones and their community, especially the most vulnerable people in their community. The benefits of vaccination far outweigh the risk of very rare serious adverse events that may be related to vaccination.
COVID-19 vaccines have been extensively tested in clinical trials and are continually monitored to ensure they are safe for use. Furthermore, over 12 billion COVID-19 vaccine doses have been administered globally, as of 1st July 2022.
As with any medical product, in very rare cases, someone who has received a COVID-19 vaccine may suffer a serious adverse reaction related to the vaccine or its administration. In such cases, these persons should receive compensation in recognition of the impact on their lives. COVAX No-Fault Compensation Program for Advance Market Commitment (AMC) Eligible Economies (the “Program”) recognises that individuals who get vaccinated, put themselves at a very small risk of injury following vaccination, for the wider benefit of the community, and acknowledges that in the very rare cases where a vaccine causes permanent impairment or death, affected individuals deserve compensation. It acts as a kind of social contract. This Program has been established for eligible individuals in the 92 AMC Eligible Economies who have received a COVID-19 vaccine distributed through COVAX.
The Program is an important part of COVAX’s commitment to vaccine equity. It reduces the financial exposure for AMC Eligible Economies by minimizing the number of instances in which these economies may be required to indemnify manufacturers, and ensures that affected eligible individuals have access to fair compensation. The Program also reduces the risk of litigation for manufacturers.
What is COVAX No-Fault Compensation Program?
The Program is the first vaccine injury compensation mechanism operating on an international scale.
The purpose of the Program is to provide a mechanism to compensate those individuals in AMC Eligible Economies who suffer from certain serious adverse events that are confirmed to be associated with vaccines earmarked for delivery through the COVAX Facility for use in AMC Eligible Economies until 30 June 2023, or the administration of such vaccines.
The Program is designed to be fast, robust and transparent, making it easier for any affected individual to get fair compensation, without having to go through a lengthy and expensive legal process.
Who is eligible to receive compensation from the No-Fault Compensation fund?
The Program is open to all eligible individuals - citizens, residents, refugees and other populations of concern (as defined by the Inter-Agency Standing Committee) in an AMC Eligible Economy, who have suffered a serious adverse event resulting in permanent impairment or death following the administration of a COVID-19 Vaccine received through the COVAX Facility until 30 June 2023.
Why is the Program needed?
As with other vaccines, drugs and medical products, vaccines that are approved for general use may, in very rare cases, cause serious adverse events in some individuals.
In light of the scale of the pandemic and the number of people being vaccinated, governments wishing to purchase COVID-19 vaccines are being required to indemnify manufacturers against any financial losses they may incur from the deployment and use of these vaccines. For the governments of AMC Eligible Economies, this kind of financial exposure could present too much risk for already-stretched health budgets, potentially delaying or even limiting the roll-out of COVID-19 vaccines to a large proportion of the global population..
While applying for compensation under the Program is voluntary, the Program aims to significantly reduce the need for individuals in the AMC Eligible Economies to seek compensation for serious adverse events through the national court system. Court litigation for such cases is often lengthy, complex and expensive, and has a higher burden of proof and therefore a more uncertain outcome. A reduction in litigation through the court system will in turn reduce the burden on AMC Eligible Economies to indemnify manufacturers for any losses they may incur as a result of any possible court awards arising from such litigation..
What is unique about the Program?
This is the first international vaccine injury compensation program.
Vaccines are a key tool to end the pandemic. The establishment of the Program acknowledges that vaccines serve a wider benefit to society as well as to individuals, and that in the very unlikely event of serious injury, affected individuals deserve compensation.
One of the vital elements of COVAX’s work is to protect the most vulnerable in society and ensure that vaccines reach the global population quickly and efficiently. By reducing the instances in which an AMC Eligible Economy needs to indemnify manufacturers, the Program has accelerated access to vital, life-saving vaccines.
Does the fact that there needs to be a compensation mechanism mean that the vaccines available through COVAX are not safe?
No, absolutely not.
All vaccines rolled out through the COVAX Facility to the public meet the highest international standards of safety and efficacy as set out by the WHO. The vaccines have gone through rigorous testing, strict safety and quality protocols, and have received regulatory approval or an emergency use authorization to confirm their safety and efficacy. In addition, they are the subject of continuous monitoring by WHO and national regulators to ensure that they are safe and effective.
COVAX will not compromise on safety and efficacy of COVID-19 vaccines supplied through the COVAX Facility. Billions of COVID-19 vaccine doses have already been administered through the COVAX Facility, resulting in a very small number of very rare serious adverse events reported. The risk of severe illness or death from COVID-19 infection is substantially higher than the risk of very rare serious adverse events arising from immunization with a COVID-19 vaccine. In the very rare cases where immunization with a COVID-19 vaccine distributed through the COVAX Facility does result in permanent impairment or death, the COVAX No Fault Compensation Program provides eligible individuals in AMC Eligible Economies with access to fair compensation.
For more information about vaccine safety, please consult the WHO COVID-19 vaccine safety pages.
How can eligible injured individuals submit an application for compensation?
Eligible individuals in the AMC Eligible Economies who have suffered a serious adverse event resulting in permanent impairment or death associated with a COVID-19 vaccine procured or distributed through the COVAX Facility, or the administration of such a vaccine can submit applications for compensation, using publicly available forms available at the Program’s web portal: www.covaxclaims.com.
Applications must be submitted with supporting evidence provided by registered healthcare providers.
The Program is managed and administered by an experienced independent claims administrator, ESIS, Inc. The process is designed to be as easy as possible for applicants. Regional assistance is being offered, as well as email and telephone helplines.
No fee will be charged by the Program’s Administrator to submit an application.
Detailed information about the Program and how to submit an application is made available through the How to Submit an Application instructions and the Frequently Asked Questions (FAQs) and Answers about the Program. If questions are not answered by these documents, individuals can contact the Program’s Administrator through the contact us page.
What happens when an application is submitted?
If an application meets the Program’s requirements, it will be assessed by an independent review panel of nurses and as applicable, an appeals panel of nurses and physicians, appointed by ESIS. These panels are guided by a scientific advisory committee of independent public health experts.
The administrator also has investigators to collect information locally. Within the clearly defined timelines outlined in the Program’s protocol, ESIS will acknowledge all applications, and will respond to applicants at each stage of the application process (e.g. requesting additional information, informing the applicant of the outcome, and the process of appeal should an applicant wish to appeal a rejected application, etc.)
How is compensation calculated?
The level of compensation is based on a specific formula designed to be generous, fair and equitable, reflecting the cost of living across the AMC Eligible Economies.
The formula is as follows:
Gross Domestic Product (GDP) per capita of the AMC-Eligible Economy in which the claimant resides x 12 x a harm factor ranging from 0.1 to 1.5 dependent on the nature of the injury and level of impairment, as evaluated based upon the most recently published edition of the American Medical Association’s (AMA) Guides to the Evaluation of Permanent Impairment.
The harm factor is based on the level of impairment suffered by the individual. Impairment percentages or ratings contained in the AMA’s Guides have been developed by medical specialists and are consensus-derived estimates that reflect the severity of the medical condition and the degree to which the impairment decreases an individual’s ability to perform common activities of daily living.
In addition, a daily in-hospital benefit of $100.00 per day, up to a maximum of 60 days, will be paid for each day of hospitalization or prolongation of existing hospitalization. This hospital benefit is a flat rate, which applies to all eligible individuals in all the AMC Eligible Economies.
How is the Program funded?
The Program’s capital is funded by COVAX via donor contributions.
This page was updated on the 7 July 2022 to update figures and dates.