Centre clears Oxford vaccine trials In India

Chennai, Dec 1: A Chennai volunteer whose allegations of adverse effects during the Oxford vaccine trials have led to a 100-crore lawsuit by Serum Institute of India (SII), lost an American project and has found it difficult to even make simple online payments, his wife has said.
The Adar Poonawalla-led Serum Institute said in a statement today that the Oxford coronavirus vaccine is “safe and immunogenic”. It also defended its legal notice to the volunteer, saying it wanted to “safeguard the reputation of the company which is being unfairly maligned.”

The volunteer’s wife denied the charge that there was any motive, financial or otherwise, in their legal notice to the vaccine-maker in November. The 40-year-old was a volunteer for the third phase of the Covid vaccine trial and was administered a dose on October 1. The family has claimed ₹ 5 crore as compensation.

“Our primary demand was to bring this to the notice of people. This vaccine is being called the option for India. We can’t stay quiet. We could have sold our silence, we could have just sent a notice and gained something…But our hearts wouldn’t let us do that,” the woman told NDTV on phone from Chennai.

She described her husband, a marketing professional, as a well-informed, creative person.

“His ability to write, present things in a creative manner were his plus points. Now he is unable to do his work,” she said, adding that though he was better, he still faced problems doing simple tasks.

“Even After two weeks, simple things like online payments…he asks me to do. He never does that. He got a good project during the pandemic; it was an American project that started on October 1. Apparently he has lost that. Because of his condition the clients have moved back. They wanted their work to be done quickly.”
The couple’s concern is that the trials were allowed to continue even after the volunteer complained.
“Our question was, why didn’t they halt the trial when such an adverse reaction was seen? At least until they were 100 per cent sure? How could they administer vaccine again to volunteers before informing them,” she said.
Serum has called the volunteer’s allegations “malicious and misconceived”.
“The COVISHIELD vaccine is safe and immunogenic. The incident with the Chennai volunteer though highly unfortunate was in no way induced by the vaccine and Serum Institute of India is sympathetic with the volunteer’s medical condition,” Serum Institute said in its statement.
The company said the Principal Investigator of the Data and Safety Monitoring Board and the Ethics Committee had “independently cleared and reckoned it as a non-related issue to the vaccine trial”.
“We would want to assure everyone that the vaccine won’t be released for mass use unless it is proven immunogenic, and safe. Taking into consideration the complexities and existing misnomers about vaccination and immunisation; the legal notice was sent therefore to safeguard the reputation of the company which is being unfairly maligned,” it said.

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