“As per the information available in the public domain, the Chennai trial case is an incidental finding rather than related to the vaccine. When we vaccinate a large number of people, some of them may have some other disease, which may not be related to the vaccine,” Dr Guleria told ANI here.
Talking about the safety of the vaccines Dr Guleria said there are data which supports that in short term vaccine is safe.
“There is good data available that the vaccines are very safe. Safety and efficacy of vaccine not compromised at all. About 70,000-80,000 volunteers were given the vaccine and no significant serious adverse effects seen. Data shows that in the short term vaccine is safe,” the AIIMS Director added.
Guleria also spoke about the Indian vaccines candidates and his assessment on the rollout where he said, “Hopeful that by the end of this month or early next month we should get emergency use authorisation from Indian regulatory authorities to start giving the vaccine to the public.”
Expressing his thoughts on the current COVID-19 wave, Guleria said, “Now, we’ve seen a decline in the current wave and I hope this will continue if we are able to have a good COVID-19 appropriate behaviour. We’re close to having a big change related to a pandemic if we manage this behaviour for the next three months.”
A Chennai-based volunteer has alleged serious side effects, including a neurological breakdown and impairment of cognitive functions, and has sought Rs 5 crore compensation in a legal notice to SII and others, besides seeking a halt to the testing, manufacturing, and distribution of the vaccine.
The participant was administered the vaccine at Chennai’s Sri Ramachandra Institute of Higher Education and Research (SRIHER), one of the trial sites, on October 1.
The participant claimed in his notice that the vaccine administered on him on October 1 was indeed Covishield, and not a placebo, as this was established from a positive test for antibodies against COVID-19 done after he was admitted to the hospital on October 11. He was admitted 11 days after receiving the vaccination.
However, Serum Institute of India, the clinical trial sponsor of the ‘Covishield’ vaccine in India, called the allegations in the notice “malicious and misconceived” and has threatened to seek damages in excess of Rs 100 crore. The company said that while it is sympathetic to the volunteer’s medical condition, there is absolutely no correlation between the vaccine trial and the medical condition of the volunteer.