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The Kerala High Court has directed the National Disaster Management Authority (NDMA) to expedite formulating a compensation policy framework for those dying due to the COVID-19 vaccine.
The order was passed September 1, 2022 and a time frame of three months has been set. This move sets a precedent since no such policy has been formulated so far.
This came after VG Arun stated he personally knew of at least three cases where people had allegedly succumbed to the after-effects of immunisation.
“Therefore, even if the numbers are very few, there are instances where people are suspected to have succumbed to the after-effects of immunisation. In such circumstances, respondents 2 (NDMA) and 8 (Ministry of Health) are bound to formulate a policy for identifying such cases and compensating the dependents of the victim,” the court said.
The case was heard after a widow sought compensation from the central and state authorities as her husband had passed away allegedly due to complications from immunisation.
The Bombay High Court has sought a response from the Serum Institute of India (SII), Microsoft founder Bill Gates and others in another similar case.
An Aurangabad resident has demanded Rs 1,000 crore in compensation claiming his daughter had died after taking the COVID-19 vaccine. The order was issued August 26 and the next hearing is to be held November 17.
In a third case, the Supreme Court September 1 had sought information from the Centre on the deaths of two women — aged 18 and 20 years — allegedly as an after-effect of the COVID-19 vaccine.
The SC observed that “ordinarily we would have considered relegating the petitioners to the appropriate regular remedies because the matter might involve determination of certain basic questions of fact so as to bring it within the four corners of a case of medical negligence.”
“… But, having regard to the post-mortem report filed with the additional documents, the submissions that the government has not responded to the petitioners’ representations and the nature of reliefs claimed, it appears appropriate to call upon the respondents to reply,” it added.
The Kerala HC has noted that documents shared “prima facie shows” adverse events after vaccination as the cause of death. However, experts maintained that proving causality was critical and not easy.
Dr Samiran Panda, former additional director general with the Indian Council of Medical Research, explained the three key factors involved in causality assessment:
“Cases of people dying after taking the COVID-19 vaccine should most definitely be brought to the notice of the legal framework. However, scientific discussion must take place to establish possible casualty. The question of compensation arises only after this,” Panda told Down To Earth.
A framework for compensation for those involved in a clinical trial under a controlled environment already exists. However, the cases being brought up in India’s high courts right now are after the vaccine has been given emergency use authorisation.
“In an approved product in the marketplace, it is in an uncontrolled environment and there could be varied factors causing the adverse effects or death. There is no mechanism to compensate anyone outside a clinical trial. The courts are the only recourse,” Dr Sanish Davis, president with the Indian Society for Clinical Research was quoted as saying in the news outlet BusinessLine.
More than 70,000 adverse events and 1,013 deaths have been reported following COVID-19 vaccination till January 30, 2022, the government told the Lok Sabha this February.
In a written reply, Union Minister of State for Health and Family Welfare Bharati Pawar underlined the operational guidelines for COVID-19 vaccination to provide guidance on classification, prevention, reporting and management of the aspects of the Adverse Events Following Immunisation (AEFI) framework.
However, the system is not as effective in practice, lacking a relief mechanism, despite being fleshed out on paper, an Economic Times report showed.
“One can make the argument that COVID-19 vaccines are being administered under Emergency Use Authorisation. In fact, Bharat Biotech’s homegrown Covaxin was initially being used in the clinical trial mode under which recipients would have to sign a consent form before taking the vaccine.
“People are taking a greater risk than they would have otherwise by taking these vaccines, and there is tremendous pressure to do so. All the more reason for them to demand compensation,” Sandhya Srinivasan, consulting editor at the Indian Journal of Medical Ethics, told DTE.
She further underlined huge gaps and malpractice in adverse event reporting and investigation, which is critical in establishing causalty.