No-fault compensation program for COVID-19 vaccines is a world first

Feb. 23, 2021

The World Health Organization (WHO) and Chubb Limited, through ESIS Inc., a Chubb company, signed an agreement on behalf of the COVAX Facility on Feb. 17, 2021 for the administration of a no-fault compensation program for the 92 low- and middle-income countries and economies eligible for support via the Gavi COVAX Advance Market Commitment (AMC) of the COVAX Facility, reported WHO in a news release.

As the first and only vaccine injury compensation mechanism operating on an international scale, the program will offer eligible individuals in AMC-eligible countries and economies a fast and transparent process to receive compensation for rare but serious adverse events associated with COVAX-distributed vaccines until June 30, 2022. By providing a no-fault lump-sum compensation in full and final settlement of any claims, the COVAX program aims to significantly reduce the need for recourse to the law courts, a potentially lengthy and costly process. ESIS, as the independent administrator of the program, was selected in accordance with WHO’s procurement rules and procedures and charges no fees to applicants.

All vaccines procured or distributed through the COVAX Facility receive regulatory approval or an emergency use authorization to confirm their safety and efficacy. But, as with all medicines, even vaccines that are approved for general use may, in rare cases, cause serious adverse reactions.

 “The unprecedented nature of the COVID-19 pandemic has been matched by the largest ever rollout of new vaccines under the ACT-Accelerator and its vaccines pillar, COVAX. This no-fault compensation mechanism helps to ensure that people in AMC-eligible countries and economies can benefit from the cutting-edge science that has delivered COVID-19 vaccines in record time,” said Dr. Tedros Adhanom Ghebreyesus, WHO Director-General.

“The No-Fault Compensation fund is a massive boost for COVAX’s goal of equitable global access to vaccines: by providing a robust, transparent and independent mechanism to settle serious adverse events it helps those in countries who might have such effects, manufacturers to roll out vaccines to countries faster, and is a key benefit for lower-income governments procuring vaccines through the Gavi COVAX AMC,” said Dr. Seth Berkley, CEO of Gavi.

The COVAX no-fault compensation program will be operationalized through its web portal (www.covaxclaims.com) by March 31, 2021, which will include resources such as the program’s protocol, Frequently Asked Questions (FAQs) and information on how to submit an application. Eligible individuals may apply for compensation under the program once the portal becomes operational, even if a COVAX-distributed vaccine is administered to them before March 31, 2021.

The program is financed initially through Gavi COVAX AMC donor funding, calculated as a levy charged on all doses of COVID-19 vaccines distributed through the COVAX Facility to the AMC eligible economies until 30 June 2022. WHO is working with Chubb to secure insurance coverage for the program with Chubb as lead insurer. The COVAX Facility aims, by the end of 2021, to deliver at least two billion doses of safe, effective and quality-assured vaccines to all participating countries, including at least 1.3 billion doses to the 92 AMC-eligible countries and economies, at the same time as wealthier nations.

WHO has the release. 

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