The Centre on Tuesday, 1 December reviewed a Chennai volunteer’s allegation of serious adverse affects from the Oxford vaccine, and gave the trials clearance to resume, claiming that it found no reason to halt them, NDTV reported.
Rajesh Bhushan, Health Secretary, said, “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.”
The Health Ministry also brought to notice that all trial subjects signed a consent form, and the trials were conducted under the supervision of an ethics committee at each site.
The Serum Institute of India (SII) also claimed that Data and Safety Monitoring Board and the Ethics Committee had looked over the complaint, and ‘independently cleared” the trials.
Volunteer’s Wife Speaks Out
The 40-year-old man was a marketing professional was administered the dose on 1 October, 2020 and was part of the third phase of the Covid trials.
Speaking on his behalf, his wife said, “His ability to write, present things in a creative manner were his plus points. Now he is unable to do his work.”
“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 1 October. Apparently he has lost that. Because of his condition the clients have moved away. They wanted their work to be done quickly,” she added.
She stressed that her primary demand was to “bring this to the notice of people” as “this vaccine is being called the option for India”.
The volunteer has filed for a lawsuit and asked for a compensation of Rs 5 crore.
SII’s Statement on the Complaint
Headed by Adar Poonawalla, the SII has said that the vaccine is “safe and immunogenic.”
“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.”
The SII has also called the volunteer's allegations "malicious and misconceived".
(With inputs from NDTV)
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