Serum Institute vax volunteer not ready to withdraw legal notice

A Chennai-based volunteer had developed severe neurological complications after first dose of vaccination of Covishield which is under development at Serum Institute

The advocate for the Chennai volunteer for Serum Institute of India's Covishield vaccine trial said his client has not agreed to the Pune-based vaccine maker Serum Institute of India's suggestion of withdrawing the legal notice issued earlier.

"The Serum Institute's advocate had told us to withdraw our legal notice to the company and they in turn would also do the same. We are not going to withdraw our legal notice. Our client is suffering due to the side effects of the vaccine.

"He has to be compensated for his sufferings. Further a detailed investigation has to be done on the ill effects of the Covishield vaccine," N.G.R. Prasad, Advocate, Row & Reddy, told IANS.

"We will be replying to this effect," Prasad added.

The Serum Institute's volunteer has asked the city-based Sri Ramachandra Institute of Higher Education and Research (formerly called Sri Ramachandra Medical College & Research Institute or SRMC) and the hospital to return all his medical records. As per the Indian Council of Medical Research (ICMR) norms, a patient is entitled to copies of all his medical records," R.Rajaram, one of the advocates for the family told IANS.

According to Rajaram, the hospital has called the volunteer for a review on December 11.

"We have asked the hospital to specify the purpose of the review. Based on the reply, the volunteer would go for the review," Rajaram added.

According to him, the volunteer is not able to focus and is not well.

"The company continues to maintain that the vaccine shot was not the reason for his clients health issues. But how they are saying that is not known. That has to be investigated," Rajaram said.

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

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," Prasad had told IANS.

The volunteer has claimed a compensation of Rs 5 crore for his neurological problems that cropped up after the vaccination.

On its part, the Serum Institute said that it would file a case claiming damages of over Rs 100 crore, which the volunteer's wife had termed as "shocking, intimidating and also childish".