The Centre has refused to stall Oxford’s vaccine trials despite a Chennai-based volunteer’s allegation of serious side effects.
The Serum Institute of India, which has tied up with Oxford and AstraZeneca to develop Covishield vaccine, issued a statement saying its vaccine was “safe and immunogenic” and “independently cleared” by the Data and Safety Monitoring Board and the Ethics Committee.
Health Secretary Rajesh Bhushan said, “After reviewing all documents, Serum has been given permission to conduct Phase 3 trials. Bharat Biotech also has been allowed to conduct Phase 3 trials.” Bhushan said an “adverse incident” in a Serum Institute trial of the Covishield vaccine would not affect vaccine timelines in any way.
The Chennai-based complainant is a 40-year-old marketing professional. He had volunteered for the third phase of the COVID vaccine trial and was administered a dose on October 1.
The volunteer’s wife told media that since he received a dose, he had lost an American project and had found it difficult to do simple tasks. The family has sought ₹5 crore as compensation from Serum. “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,” she told NDTV.
The health ministry said trial subjects always signed a consent form and most of the trials were multi-site, conducted across various hospitals and states with an ethics committee at each site.
In a statement, the Serum Institute said: “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 and Bharat Biotech are likely to apply for authorisation to the government this month.