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A healthcare worker prepares to administer a dose of the Oxford University-AstraZeneca vaccine, marketed by the Serum Institute of India (SII) as COVISHIELD. (REUTERS)
A healthcare worker prepares to administer a dose of the Oxford University-AstraZeneca vaccine, marketed by the Serum Institute of India (SII) as COVISHIELD. (REUTERS)

WHO inks pact with ESIS for no-fault compensation for vaccine SAEs under Covax

  • No-fault compensation may cover 97 million Covishield doses expected to be distributed in India through Covax

The World Health Organization (WHO) and US-based risk management services provider ESIS Inc signed an agreement on behalf of the Covax for the administration of a no-fault compensation programme for 92 low- and middle-income countries, including India, that are eligible to get vaccines paid through the facility.

The multilateral agency signed the agreement with the subsidiary of property and casualty insurance giant Chubb Ltd last week, a release by Gavi, the Vaccine Alliance said.

Covax is a facility aimed at equitable access to covid-19 vaccines globally and is jointly led by the WHO, Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi, the Vaccine Alliance. Under the facility’s Advance Market Commitment (AMC) programme, 92 countries will get the vaccine supported by Covax’s dedicated fund.

A no-fault compensation allows vaccine beneficiaries to receive compensation in case of a rare, but serious, adverse events associated with vaccines without making the beneficiaries to prove that the vaccine was the cause of the serious injury. While some countries ask companies to pay the compensation through an insurance, others like the US use a dedicated fund which makes the disbursal.

Covax’s no-fault compensation programme will be the first vaccine-injury compensation mechanism that would operate on an international scale, and will offer countries eligible under AMC the support to disburse compensation for rare but serious adverse events associated with Covax-distributed vaccines until 30 June next year.

“The no-fault compensation scheme not only gives #COVAX a clear advantage over bilateral deals for lower-income countries, giving them access to a legal mechanism and funds specifically for this issue, it gives us a model for future pandemics," Gavi chief executive officer Seth Berkley said on Twitter.

The no-fault compensation is also likely to help India, which is scheduled to get funding for over 97 million doses of Covishield through the Covax facility.

However, India itself neither has a compensation mechanism for serious vaccine injuries caused by the jabs, let alone a no-fault compensation mechanism. But if the vaccinee is part of clinical trial, then they are eligible for compensation from the sponsor, if they can prove that the vaccine was the cause.

Health secretary Rajesh Bhushan has earlier said that people who have serious adverse effects following vaccination will have to approach courts in the absence of a compensation mechanism.

Officials at Indian vaccine manufacturers, including Serum Institute of India, have also been seeking indemnity from the government for covid-19 vaccines. Indemnity is a form of insurance wherein the government pays the compensation in case of a side-effect following vaccination instead of the company.

At present, Serum Institute of India is not providing compensation for vaccine injuries from Covishield, but Bharat Biotech International has to provide the compensation as Covaxin is given an authorisation under “clinical trial" mode.

A compensation mechanism for serious side-effects, especially a no-fault compensation, is important to instil confidence in vaccines, various experts have said.

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