On Tuesday, government said that it had found no reason to halt the Oxford vaccine trials in India after reviewing a Chennai volunteer’s allegation of serious adverse effects, including memory loss and change in behavior.
Serum Institute of India (SII) 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.
Health Secretary, Rajesh Bhushan 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 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.
The couple said it was hugely worrying that the trials continued even after their complaint.
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.
Health Secretary said: “This committee is independent of the government and of the vaccine manufacturer. Whenever in the course of a clinical trial, any adverse event happens, the institutional ethics committee takes note of it and within a period of 30 days gives its report to the Drugs Controller General of India.”
Serum has called the volunteer’s allegations malicious and misconceived.
SII 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.”
