One of the words most frequently used when describing the events of the past 18 months is unprecedented. This is an unprecedented pandemic which is having an unprecedented impact on all of our daily lives, with unprecedented national lockdowns causing unprecedented economic disruption. And one of our most promising routes back to normality is the global roll-out of COVID-19 vaccines, which is taking place at a speed and a scale that is truly unprecedented.

To meet the challenge of ensuring these vaccines reach the most vulnerable in every country, the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi and WHO set up COVAX. Because of the unprecedented nature of the pandemic, this historic project – itself the first of its kind – has come up against hundreds of new complications and challenges that needed new solutions, all designed at the speed the pandemic required.

Serious injuries arising from vaccination are very rare. However, for the first time, anybody who does suffer from serious adverse events in lower-income countries now has a robust, transparent and fast way to get fair compensation.

Alongside other world firsts, such as the COVAX Humanitarian Buffer and the first global fair allocation principles, the COVAX No Fault Compensation Programme is the first and only global vaccine injury compensation mechanism. It has contributed to meeting one of the thorniest problems that needed to be overcome to successfully roll out COVID-19 vaccines worldwide: indemnity and liability. It is one of the key benefits for lower-income countries choosing to roll out COVID-19 vaccines through COVAX, limiting their financial risk. But how does it work, and why is it needed?

The problem

All vaccines rolled out to the general public have gone through rigorous testing, strict safety protocols and continuous monitoring to ensure they are safe and effective. COVID-19 vaccines are no exception. All vaccines made available or procured through the COVAX Facility have received regulatory approval or an emergency use authorisation to confirm their safety and efficacy. COVAX will not compromise on the safety and efficacy of COVID-19 vaccines supplied through the COVAX Facility and is, in addition to all the rigorous processes that are followed by COVAX, relying on regulatory authorities to ensure that is the case.

However, as with other vaccines, drugs and medical products, vaccines that are approved for general use may, in rare cases, cause serious adverse events in some individuals. Ordinarily, vaccine manufacturers would deal with this risk with tools such as product liability insurance, which can pay out compensation to the manufacturer in the event that an individual affected by these serious adverse events brings a claim against the manufacturer. However, the scale of the COVID-19 vaccine roll-out, with billions of people set to receive the jab, means these tools are now not available.

Instead, governments wishing to purchase COVID-19 vaccines are indemnifying manufacturers and other stakeholders against any financial losses they incur from the deployment and use of these vaccines, subject to very limited exceptions. For the governments of lower-income countries, 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.

The Program

Lower-income countries needed a solution that would remove the financial risk of rolling out COVID-19 vaccines. Over the past year a COVAX team led by WHO and Gavi has been hard at work developing this solution – the COVAX No-Fault Compensation Program.

The Program provides fair, no-fault, lump sum compensation to any individual in the 92 lower-income economies covered by the COVAX Advance Market Commitment (AMC) who suffers a serious adverse event from any vaccine procured or distributed through the COVAX Facility. The Program is designed to be fast, robust and transparent, making it easier for any individual affected to get fair compensation without having to go through a lengthy and expensive legal process.

This compensation will initially be funded by COVAX via donor contributions on the basis of a US$ 0.10 levy per dose for 2 dose vaccines and US$0.20 per dose for single dose vaccines, delivered by the mechanism. The Program is complemented with an insurance layer, providing insurance coverage for compensation payments.

How it works

Any individual in an AMC-eligible country who suffers from a serious adverse event following vaccination with a COVAX-supplied vaccine can file a claim via the Program’s web portal: www.covaxclaims.com. Managed and administered by an 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.

Once a claim is filed, it is assessed by an independent review panel of nurses and an appeals panel of nurses and physicians, appointed by ESIS. The administrator also has investigators to collect information related to claims locally. These panels are in turn guided by a scientific advisory committee of independent public health experts, who regularly review the evolving scientific literature on COVID-19 vaccine safety.

Unlike claims made through the court system, the size of the lump sum compensation is not dependent on the strength of the applicant’s legal team. Instead the level of compensation is based on a specific formula designed to be generous, fair and transparent, reflecting the cost of living in the country. The formula is as follows:

GDP per capita of the AMC-eligible economyin which the claimant resides x 12 x a harm factor ranging from 1.5 to 0.1 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.

Serious injuries arising from vaccination are very rare. However, for the first time, anybody who does suffer from serious adverse events in lower-income countries now has a robust, transparent and fast way to get fair compensation. This is unique to COVAX – vaccines purchased through bilateral deals cannot benefit from the Program – and could offer a model for future pandemics.

TOPICS: COVAXCOVID-19

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