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Who’s aware of WHO’s vaccine redressal?

PT Jyothi Datta | Updated on August 22, 2021

Shield against a virus and the likely side-effects of inoculation   -  SUSHIL KUMAR VERMA

The global health body’s ‘no-fault’ compensation programme for Covid vaccine recipients needs a booster shot of visibility

Away from the public gaze on the vaccines deployed across the world, governments and companies are locked in discussions behind closed doors.

These powwows are over supplies, timelines and, among other things, the course of action when a vaccine does not have the desired outcome — when a side-effect is reported that could be linked to the vaccine, for example.

This is where it gets challenging for governments not inclined to provide indemnity to vaccine makers against vaccine-linked litigation. A situation that appears to be playing out closer home, as vaccines from companies like Pfizer await a passage to India.

Precisely to avoid such an impasse, a “global vaccine injury compensation mechanism” had been announced by the World Health Organization (WHO) in February. The scheme, though, is in need of a massive shot of visibility.

First of its kind

Explaining how it works, WHO’s Chief Scientist Dr Soumya Swaminathan says, “For vaccines that come through COVAX, there is a common indemnification language which is used in the contract and there is a no-fault compensation scheme... a global scheme to provide compensation to anybody who suffers a serious adverse event like injury or death due to the vaccine supplied through COVAX.”

It is for the first time such a system is in place globally, she says. And the reason: “All of these vaccines are used under emergency-use listing, which means when they were initially used there still wasn’t a lot of real-world data. So you cannot predict all the rare side-effects that could happen. As we have seen with each of these vaccines, there have been rare events which came to light only after millions of doses were administered. So, yes, the no-fault compensation covers those vaccines which are supplied through COVAX.”

But no one seems to have tapped into this programme. “It’s been operational for a couple of months. There is obviously time that is given to people to come forward. Because, if you suffer an adverse event, there is a procedure where it has to be investigated by the local safety committee, the cause of the event has to be found out, it has to be certified that it’s been due to a vaccine etc, and then people can apply for compensation,” explains Dr Swaminathan. Besides, “there is also, I think, a bit of awareness creation needed so that both individuals and governments are aware that they have this facility to fall back on,” she adds.

WHO worked with Chubb Limited to secure insurance coverage for the programme (valid till June 30, 2022). ESIS Inc (a Chubb company), the independent administrator of the programme, charges no fees to applicants, WHO said while announcing it.

Why indemnity?

Vaccine manufacturers seek indemnity from governments to limit financial exposure on account of adverse side-effects from the vaccine, says Kritika Agarwal, Associate Partner, Majmudar & Partners. While one of the reasons is that emergency approvals were given to Covid-19 vaccines in the face of a raging pandemic, another could be that “vaccine manufacturers may not want to spend time and money on defending any claims in all the countries where they supply and be subject to extensive litigation,” she points out,

The European Union, the UK, Latin America, Australia and the US “all offer indemnity in some form to vaccine makers, whether under legislation or supply contracts,” says Agarwal. WHO’s ‘no-fault compensation’ allows recipients to claim relatively quickly without litigation, she adds.

Extra protection
  • Compensation available in 92 low- and middle-income countries without need for litigation
  • Funded by a small levy on each dose supported by the Gavi COVAX Advance Market Commitment

Many developed economies have a ‘no-fault’ compensation scheme where anyone who has been injured from receiving a vaccine can file a claim against the government within an agreed time period, explains Sidharrth Shankar, Partner, J Sagar Associates.

In fact, WHO says, “By providing a no-fault lump-sum compensation in full-and-final settlement of any claims, the COVAX programme aims to significantly reduce the need for recourse to the law courts, a potentially lengthy and costly process.” A compelling enough point that begs attention from countries, in the interest of speedy redressal for vaccine recipients and manufacturers.

Published on August 22, 2021

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