In barely a week, three Covid-19 vaccine-related cases have been reported from Courts across the country, putting the spotlight on adverse events following immunisation (AEFI) and compensation to aggrieved families, for deaths that are found to be linked to the vaccine.

At the Bombay High Court, a petitioner has sought compensation of ₹1,000 crore following the death of his daughter, allegedly due to vaccine side effects. In another case, the Kerala High Court recently directed the authorities to identify and compensate families of people who lost a family member due to vaccine side effects. And at the Supreme Court, stands another case involving the death of two girls, allegedly due to adverse effects of the vaccine.

But compensation is easier said than done, say experts, as it involves proving causality- or establishing that the adverse effect or death in these cases was directly linked to the vaccine.

Multiple phases

Dr Samiran Panda, former Additional Director General with the Indian Council of Medical Research told BusinessLine that a new product or vaccine completes multiple phases of clinical trials and is approved for marketing, only after its safety and efficacy are established. There are rules governing clinical trials and compensation, in case anything goes wrong during the trial. The problem of the volunteer participating in the trial is addressed and their medical tab (even if the person needed hospitalisation) is picked up by the sponsor or company sponsoring the trial.

Once the product is approved, it is under post-marketing surveillance. But if there is an adverse effect, the individual will have to approach the Court, and each case is decided on its merits and proof of causality, for example, he explained.

Causality will have to be established, agrees S. Srinivasan with the All India Drug Action Network. However, if several factors of causality are seen, the individual must be compensated

But Dr Sanish Davis, President with the Indian Society for Clinical Research points out that the laws are well defined. Compensation is outlined in clinical trials, as the environment is controlled and a product is being tested for safety and efficacy. But in an approved product in the market place, 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, he said, adding that the Courts are the only recourse.