It is the first and only vaccine injury compensation mechanism operating on an international scale, World Health Organization has launched the 'no-fault compensation' program for 92 low and middle income countries under its COVAX vaccine distribution plan. The program will offer eligible individuals compensation for any rare but serious adverse events associated with vaccines that are distributed by COVAX until June 30, 2022.
As COVID vaccination drives started world over, questions on how compensation claims would be handled if there are any serious side effects. And this has been on top of mind, especially for low and middle income countries.
Most countries, including India, still do not have a liability program for the vaccinations currently underway.
This lump-sum compensation, organised by WHO, is to be paid in full and final settlement of any claims. WHO said this will offer countries a fast, robust and transparent process to receive compensation and do away with any need for courts.
The vaccines procured or distributed through the COVAX facility are undergoing a regulatory scrutiny based on the data on efficacy and safety submitted by vaccine developers. However, the approvals are on an emergency use authorisation basis and WHO highlights that "as with all medicines, even vaccines that are approved for general use may, in rare cases, cause serious adverse reactions." In an eventuality, this needs to be compensated for.
The no-fault program has been funded through Gavi COVAX AMC donor funding as a small levy on each vaccine dose and ESIS Inc, a Chubb company, has been selected as independent administrator. The compensation program will be operationalised by March 31.
"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," Dr Tedros Adhanom Ghebreyesus, WHO Director-General said in a statement.
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Dr Seth Berkley, CEO of Gavi said, "This 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."
WHO has so far approved three vaccines, Pfizer's mRNA vaccine and two versions of Oxford-AstraZeneca vaccine, one from South Korea and other is Serum Institute's COVISHIELD. Supplies of Covishield to COVAX countries is expected to start in a few days.
By end 2021, COVAX aims to supply nearly 2 billion vaccine doses, including 1.3 billion doses to 92 low and middle income countries and this includes India. India is estimated to receive 97 million doses of Covishield under COVAX.
India through its own country vaccine distribution plan is distributing Bharat Biotech's Covaxin and Serum Institute's Covishield. Interestingly, beneficiaries receiving Covishield through the government procured lots will not be eligible for a compensation or liability claim, however those who receive the same vaccine under the COVAX supplied doses will be eligible.