On coronavirus vaccine in India, AIIMS Director hopeful of emergency use approval by December-end


With Covid-19 vaccines in the final stages of testing in India and the government working on a vaccine distribution plan, AIIMS Director is hopeful of a coronavirus vaccine by the end of this month or early January.

“In India, we now have vaccines which are in their final trial stage. 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 vaccine to public,” Dr Randeep Guleria, Director, AIIMS Delhi told news agency ANI on Thursday. Covid-19 Vaccine Latest Update

The AIIMS Director said work on a Covid-19 vaccine is going on war-footing both at Centre and state-level for vaccine distribution plan in terms of maintaining cold chain, having appropriate storehouses available, developing strategy, training vaccinators and availability of syringes.

On probe into allegations by Oxford vaccine trial volunteer

Speaking on the impact on vaccine during Chennai trial, Director of All India Institute of Medical Sciences (AIIMS) Dr Randeep Guleria told ANI that the case is an incidental finding rather than related to the vaccine candidate.

“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 Randeep Guleria said.

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 said.

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.

‘Decline in Covid-19 wave’

On the latest Covid-19 wave, Dr Guleria said, “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.”

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