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Adverse events during vaccine trials do not require immediate statement from regulators, says Dr Gangandeep Kang

Updated : November 30, 2020 07:10 PM IST

There have been various developments on the COVID-19 vaccine front, with Prime Minister Narendra Modi visiting the Bharat Biotech facility, which is hoping to produce India's first indigenous vaccine. On the other hand, Serum Institute which has tied up with Oxford University and AstraZeneca to manufacture their vaccine, has hit back at a volunteer who sent the company a legal notice claiming adverse effects from its vaccine trials. The company has threatened to sue the 40-year-old for Rs 100 crores in damages. However, regulators have remained silent even as experts call for more transparency on the issue.

The government expects to vaccinate 30 crore people at a cost Rs 18,000 crore. Sources say that the cost to vaccinate per person is being pegged at Rs 600 and it would cost approximately Rs 50,000 crore vaccinate large number of people.

CNBC-TV18's Shereen Bhan gets in conversation with Professor at Christian Medical College Dr Gangandeep Kang, Former Director General at ICMR Dr NK Ganguly, senior virologist and Director at Ashoka University Dr Shahid Jameel and Director at Tata Memorial Care Dr CD Pramesh.

Discussing the adverse event during the Serum trials, Dr Kang said, "It is very important to understand that it is not necessary that every serious adverse event that happens in a clinical trial be disclosed to the media. It does need to be disclosed to the institutional ethics committee, to the data and safety monitoring boards (DSMBs) that is overseeing the trial, etc. The fact that there was one particular adverse event in the vaccine trial and that there is an adverse event in this trial does not necessarily require an immediate comment from the regulator. This should only be done if it is done at all once the information on the adverse event and all the relevant investigations have been completed and enough time has been given to the DSMB to ask for additional information and make its determination.”

NK Ganguly highlighted, "There is a process of transparency because trust in the vaccine is one of the paramount things. People should trust and there is a set international process and protocol for reporting an adverse event."

For more, watch the video.
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