The initial findings into an ‘adverse event’ allegedly suffered by an Oxford COVID-19 vaccine trial participant in Chennai did not necessitate halting of the trials, the Centre said on Tuesday while clarifying that the ‘adverse event’ will not affect the timelines of vaccine rollout in any manner.
New Delhi: 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 Union Health Ministry further said that the ‘adverse event’ during SII trial was being reviewed by the DCGI to ascertain if there is any causal link between the event and the shot administered to him. Last week, a 40-year-old man, who was a volunteer in the third phase of the vaccine trial in Chennai, claimed to have suffered serious neurological and psychological symptoms after taking the experimental shot. He has sued the SII along with others and sought compensation of Rs 5 crore, besides seeking a halt to the trial. The SII, however, on Sunday rejected the charges as malicious and said it will seek damages in excess of Rs 100 crore.
The Pune-based vaccine manufacturer on Tuesday said that the vaccine is safe and immunogenic. “We would want to assure everyone that the vaccine won’t be released for mass use unless it is proven immunogenic and safe,” it said in a blog. ICMR Director General Balram Bhargava said adverse events occur with drugs or vaccines or any other health intervention.
“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 Union Health Ministry further said that the ‘adverse event’ during SII trial was being reviewed by the DCGI to ascertain if there is any causal link between the event and the shot administered to him. Last week, a 40-year-old man, who was a volunteer in the third phase of the vaccine trial in Chennai, claimed to have suffered serious neurological and psychological symptoms after taking the experimental shot. He has sued the SII along with others and sought compensation of Rs 5 crore, besides seeking a halt to the trial. The SII, however, on Sunday rejected the charges as malicious and said it will seek damages in excess of Rs 100 crore.
The Pune-based vaccine manufacturer on Tuesday said that the vaccine is safe and immunogenic. “We would want to assure everyone that the vaccine won’t be released for mass use unless it is proven immunogenic and safe,” it said in a blog. ICMR Director General Balram Bhargava said adverse events occur with drugs or vaccines or any other health intervention.
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