Serum faces Covishield volunteer's ire

Chennai: Life was sort of picture-perfect for the Chennai-based business consultant with a wife and two kids aged 12 and 7 and couple of business projects on hand, when it turned upside down in October 2020.

The city-based business consultant had developed severe neurological complications after first dose of vaccination of Covishield which is under development at the Pune-based Serum Institute of India, the volunteer's wife told IANS.

"He was in the intensive care unit (ICU) on his birthday battling severe neurological complications. Not only he had lost those business projects, he is not the normal person he used to be," she added.

According to her, the statement from Serum Institute that it would file a case claiming damages over Rs 100 crore was shocking, intimidating and also childish.

"My husband volunteered on his own for the Covishield trial. He faced very severe reaction after first dose of Covishield vaccination. The medical team at the Sri Ramachandra Institute of Higher Education and Research (formerly called Sri Ramachandra Medical College & Research Institute or SRMC) and others did not tell us what had happened to him and the proximate cause.

"As the hospital and others were silent for a very long time and with the vaccine trials continuing, we as socially concerned persons, went public with our experience. We had issued a legal notice to all the parties concerned. We are happy that the scientific community had supported us," she said. For two whole weeks in the hospital, the family was in the dark as to the reason for his neurological complications."My husband was in a state of 'coma' always sleeping and while awake used to be restless, screaming. He was fastened to the hospital bed," she added.

"While the Sri Ramachandra Institute doctors did not answer my questions through my friends and relatives, I had spoken to other doctors, neurologists who were of the view that the neurological problems suffered by my husband could be Covishield induced problems," the vaccine volunteer's wife added.

The Covishield volunteer was discharged from the hospital at her request on October 26, with the discharge summary stating that he had suffered "acute encephalopathy"-a brain disease.

According to her, several tests were done at the hospital which showed some dysfunction.

"Now he is getting better with the passing of each week. But he is unable to put his thought into words. He had some counselling sessions with a doctor," she added.

"A person losing his memory for nine long days is not a simple and small event," R Rajaram, one of the advocates for the family told IANS.

Queried whether the family is ready to go the long haul of fighting a court case for claiming compensation of Rs.5 crore she said: "Yes. Everything has changed for us after the Covishield vaccination. My husband is suffering from health complications. He has lost his projects. He is not normal now."

On coming to know about the call for volunteers for the third phase of human trial at Sri Ramachandra Institute for testing the Covid-19 vaccine developed by the Oxford University, the public spirit in him wanted to volunteer.

The volunteer had signed the consent form on September 29. As the test for antibodies against Covid-19 was negative, the Covishield study vaccine was given to him on October 1.

For 10 days after vaccination, there was no adverse reaction, but on October 11, the volunteer woke up at 5.30 a.m. with severe headache and went back to sleep and did not get up when his wife tried to wake him up at 9 a.m. At 2 p.m., he woke up and vomited and went back to sleep, saying he had severe headache.

There was a total behavioural change in him - he was not aware of his surroundings, he showed irritation towards light and sound, and was resisting any effort to make him get up from bed, the legal notice issued to Serum Institute and others said.

"Our client developed severe neurological health complications after he was given the test dose. We had sent a legal notice to the Serum Institute; Indian Council for Medical Research (ICMR); AstraZeneca, UK; Drugs Controller General of India; Andrew Pollard, Chief Investigator, Oxford Vaccine Trial; The Jenner Institute Laboratories, University of Oxford; and the Vice Chancellor of Sri Ramachandra Higher Education and Research," N G R Prasad, Advocate, Row & Reddy, told IANS.

A vaccine trial volunteer would be given two shots. The second shot will be about 28 days after the first one.

After the severe neurological complications that the volunteer suffered, the family was in a dilemma whether they should go for the second shot, failing which whether he would suffer further health complications.

When his wife checked with the doctors at Sri Ramachandra Institute they said there was no need for a second shot without giving any reason.

According to a family friend, the volunteer is well-read and very tech-savvy.

"He was our go to guy for all our technology issues. We were in tears when he was not even able to do some simple online transaction," the family friend preferring anonymity told IANS.

Meanwhile, Serum Institute had also said the serious adverse event (SAE) that happened to a city based volunteer though unfortunate was in no way induced by the vaccine without explaining the rationale for its assertion. (IANS)