Serum Institute seeks Rs 100 cr in damages from trial subject

Experts feel trust is broken as trial was not halted; Chennai resident had sought Rs 5 cr in compensation

As questions mount on Oxford-AstraZeneca vaccine trials in India after a 40-year-old participant fell sick and sought damages of Rs 5 crore, Serum Institute of India (SII) has said the allegations in his legal notice are “malicious and misconceived”, and the firm will ask for damages in excess of Rs 100 crore for them.

The SII Chief Executive on Saturday indicated the company would apply to the regulator in two weeks for an emergency use authorisation (EUA) of the vaccine.

The volunteer fell sick 10 days after he was given a shot on October 1 in the clinical trial of Covishield (it could be the vaccine or the placebo). Since follow-up tests showed he had developed antibodies for the Sars-CoV-2 virus, there is a high probability that he was given the vaccine. On October 11, the person reported a severe headache and vomited. After CT scans, Covid-19 tests, and MRI scans, he was shifted to the ICU of a hospital. He was released after 11 days, and the discharge summary says he had suffered “acute encephalopathy”. The person is still disoriented and agitated.

A law firm has, on his behalf, sent legal notice to SII, seeking compensation of Rs 5 crore. The notice, which Business Standard has seen, said the participant “must be compensated in the least for all the sufferings that he and his family have undergone and are likely to undergo in future”.

Advocates Row & Reddy and R Rajaram, who sent the notice, told Business Standard that no one had borne his medical expenses. “The participant’s information sheet says compensation will be paid if there are side-effects but do not quantify the extent,” the lawyers said.

A Serum spokesperson said: “While Serum is sympathetic, there is absolutely no correlation with the trial and the medical condition of the volunteer. The volunteer is falsely laying the blame on the Covid vaccine trial.”

The volunteer was informed that the complications had no connection with the trial. “He still chose to go public and malign the company. Serum will seek damages in excess of Rs 100 crore,” the spokesperson said.

The clinical trial site — the Sri Ramachandra Institute of Higher Education and Research in Chennai — refused to comment. The Chennai resident, who is married and has two children, volunteered for the third phase of the trial. He has urged the Indian Council of Medical Research to not approve the vaccine.

Does this event cloud trials?

Experts say there are clear guidelines. The sponsor is supposed to inform the ethics committee at the site, Drug Controller General of India (DCGI), and Drug Safety and Monitoring Board (DSMB). Ideally, the sponsor has to take a call if trial is to be halted. “In the UK, the sponsor, not the regulator, halted the trial. Investigation found the matter was related to the vaccine. The DSMB will get the data from the sponsor,” said a government official, adding the lead investigator could not stop the trial without a decision by the sponsor.

Drug Regulator General of India V G Somani and S R Ramakrishnan, the lead investigator for the Chennai arm of the trial, could not be reached.

Virologist Jacob John said such incidents did destroy trust. It is not clear if the DSMB has submitted its reports to the DCGI. In September, the DCGI had issued show-cause notice to SII for not informing it about its vaccine partner, AstraZeneca, pausing trials in other countries and also for not submitting a casualty analysis.