Why Serum Institute Wants to Sue Vaccine Participant for Rs 100 Cr

SII plans to sue a vaccine trial participant after he claimed Rs 5 crore as compensation over alleged side effects.

(Photo: iStock)

While the vaccine against COVID-19, being developed by AstraZeneca and the University of Oxford, remains plagued by global questions over its efficacy, trouble seems to be brewing for the much talked-about vaccine at home as well. This time, over a series of side-effects, as alleged by a trial participant.

The saga of litigation and counter-litigation in this case has now led the Serum Institute of India, responsible for testing and manufacturing in India, to press for Rs 100 crore as damages.

Dismissing the participant’s claim, the institute has said that allegations made by the Chennai participant are “malicious and misconceived.”

WHY SHOULD YOU CARE?

Officially known as Covishield, the AstraZeneca vaccine is India’s best bet as it is being manufactured in the country by the Serum Institute of India, which has the capacity to produce 100 million doses by the end of December 2020.

• SII has the capacity to increase production to 400 million doses by April 2021
• The price of this vaccine is expected to hover around $2 per shot
• Unlike other promising vaccines, Covishield can be stored at 3 to 8 degree Celsius, and doesn’t require massive cold storage chains
• Moreover, since phase 3 trials were conducted in India, it better reflects efficacy of the virus within the Indian demography.

WHERE DID THE CONTROVERSY START?

On 29 November, a 40-year-old man from Chennai, who had participated in the Covishield vaccine trial, alleged that he had suffered serious side effects, including a “virtual neurological breakdown and impairment of cognitive functions,” reported news agency PTI.

Not only did the participant send a legal notice to the Serum Institute of India, demanding Rs 5 crore as compensation, he also asked the trial to be halted.

The candidate threatened to take further legal action if approvals given for the vaccine’s trial, manufacture and distribution were not cancelled.

WHAT EXACTLY HAS THE PARTICIPANT SAID?

According to the report, the man had signed up for the vaccine trial on 29 September, after the information provided to him in the Participant Information Sheet claimed that the vaccine being developed by AstraZeneca and Oxford was safe.

He was administered the vaccine on 1 October, after testing negative for COVID-19 antibodies a day before. This meant that at that stage, he did not have antibodies that one is likely to develop after recovering from the virus.

After ten days of stability, the participant went through severe episodes of vomiting and headache, following which a doctor had suggested that a Computer Tomography (CT) scan be done, the report said.

The participant alleged that after the Covishield vaccine was administered to him, he underwent several complications.

• He suffered acute encephalopathy and that an electroencephalogram had shown that his brain was partially affected.
• He could not recognise or speak to anyone and was shifted to the ICU on 26 October.
• Mild problems in verbal and visual memory functions were observed in a psychiatric evaluation.

WHAT IS THE SERUM INSTITUTE OF INDIA SAYING?

Dismissing allegations made by the Chennai participant as ‘malicious and misconceived’, the Serum Institute of India has said that there is no link between the vaccine and the participant’s medical condition.

While expressing sympathy with the participant over his medical condition, the Serum Institute of India has accused him of ‘falsely blaming’ the vaccine for his medical problems.

“The claim is malicious because the volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent. In spite of specifically being made aware of the same, he still chose to go public and malign the reputation of the company.”

Serum Institute of India

In counter litigation, the institute has said that it will press for Rs 100 crore as damages from the participant and will “continue to defend such malicious claims.”

In another clarification, the SII on Tuesday, 1 December, stated that the incident with the Chennai volunteer was not induced by the vaccine.

“All regulatory and ethical processes and guidelines were followed,” SII stated, reported ANI.

It also mentioned that Principal investigator, DSMB & Ethics had said that it was the non-related issue to vaccine trial.

WHAT HAVE THE LAWYERS OF THE PARTICIPANT SAID?

Meanwhile, lawyers representing the Chennai participant said that SII was attempting to intimidate their client.

The lawyers stated that their client is asking Rs 5 crore compensation for the health problems he is facing and to take care of his family.

“If you look at their statement it is clear that they are unwilling to even investigate what exactly happened and if the side-effects are due to the vaccine. Our client wants the manufacturing of the vaccine to be stopped because he fears others could get affected the same way," the lawyer added, according to The News Minute.

“Our client states that the severe trauma he went through from 11th October 2020, because of the “Acute Neuro Encephalopathy” that he suffered, is an extreme side-effect of the test vaccine that he took on 1st October 2020,” The News Minute quoted from the legal notice issued by the lawyers.