The government today said it had found no reason to stop the Oxford vaccine trials in India after reviewing a Chennai volunteer’s allegation of serious adverse effects, including memory loss and change in behavior.
The Adar Poonawalla-led Serum Institute of India (SII) also said the vaccine was “safe and immunogenic” and the Data and Safety Monitoring Board and the Ethics Committee had “independently cleared” the trials after examining the complaint.
”After initial causality assessment, findings did not necessitate stoppage of the Serum trials. SII vaccine trials have entered Phase 3. After reviewing all documents, SII has been given permission to conduct Phase 3 trials. Bharat Biotech also has been allowed to conduct Phase 3 trials,” said Rajesh Bhushan, Health Secretary.
The 40-year-old marketing professional was a volunteer for the third phase of the Covid vaccine trial and was administered a dose on October 1.
The wife of the volunteer said since he received a trial dose, he had lost an American project and had found it difficult to do simple tasks. The family has claimed ₹ 5 crore as compensation from the vaccine maker, but she denied any motive, financial or otherwise.
“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 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.
“Even after two weeks, simple things like online payments… he asks me to do. 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.”