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NEW DELHI: Serum Institute of India on Sunday said it will seek 100 crore in damages from a 40-year old participant in Chennai who claimed that the company’s covid-19 vaccine, which was given to him during its phase 3 trial, had caused a serious neurological side-effect.

“It is evident that the intention behind the spreading of such malicious information is an oblique pecuniary motive. The Serum Institute of India will seek damages in excess of (Rs) 100 crore for the same and will defend such malicious claims," a spokesperson for the company said in a statement.

The statement follows a legal notice seeking 5 crore in damages sent by the advocate of a 40-year-old participant from Chennai, who received a dose of the Covishield vaccine on 1 October at Sri Ramachandra Medical College & Research Institute (SRMC) in the city, but faced a serious adverse effect 10 days later. Mint has reviewed a copy of the legal notice dated 21 November.

On 11 October, the participant could not wake up in the morning due to a severe headache. He then went back to sleep and woke up in the afternoon and vomited. He was taken to SRMC that there, and from thereon was shifted to the intensive care unit (ICU) the following day.

After over a week in the ICU, he was shifted to the general ward on 20 October, and then discharged on 26 October. During his time in the hospital, the notice claims, the participant was made to go through a battery of tests, and diagnosed it as ‘acute neuro encephalopathy’, a condition where a change in your body or your brain alters a person’s mental status.

The changes in mental status include causing dizziness, headache and nausea, as well as potentially memory loss, small personality changes and increased irritability.

“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. Our client’s wife states that he is still not stable, has severe mood swings, has problems with comprehending and focusing on things, is finding it difficult to even do simple routine things like making online payments, leave alone focusing on work-related matters," the notice by the advocate R. Rajaram read.

However, Serum Institute in its statement said that, while the company is “sympathetic with the volunteer’s medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer".

It alleged that the volunteer is falsely laying the blame for his medical problems on the Covishield vaccine trial.

“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," the Serum Institute spokesperson said.

Serum Institute did not provide details on assessment of the participant by the site’s medical team, nor the process followed in coming to the conclusion that the vaccine was not the cause of the complications.

When asked for a comment, Rajaram said that the company in its statement has neither provided details about the medical conditions of the participant after receiving the vaccine, nor had provided any details then.

“They are saying the hospital had informed my client that it was not related to the vaccine, but nothing like that was done by them then," he said.

Serum Institute of India is on the verge of completing its 1,600-participant phase 2 and 3 clinical trial of Covishield in December. The company also plans to approach the Drug Controller General of India V.G. Somani for getting an emergency licensure for marketing the covid-19 vaccine, originally developed jointly by British firm AstraZeneca plc and University of Oxford.

The Covishield vaccine was seen as key not just to Serum Institute but also to India and other low-and middle-income countries, as it would be the first affordable vaccine for the world. However, the controversy has raised concern about safety of the vaccine, with some experts criticising the lack of transparency in the way adverse events were reported.

The Pune-based firm, the world’s largest vaccine manufacturer by volume, plans to use the interim data released by AstraZeneca earlier this month for seeking the emergency licensure. The data itself has been embroiled in controversy over lack of transparency.

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