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Phase-3 Clinical Trial of Bharat Biotech’s Covid-19 Vaccine ‘Covaxin’ Begins in Kolkata

Representative image.

Representative image.

Dhankhar also commended the country's leadership in effectively handling the Covid-19 pandemic. “It happened due to visionary leadership in our country,” he added.

West Bengal Governor Jagdeep Dhankar on Wednesday inaugurated the launch of Phase-3 regulatory trial of Bharat Biotech’s Covid-19 vaccine ‘Covaxin’ at the Indian Council of Medical Research - National Institute of Cholera & Enteric Diseases (ICMR-NICED) in Kolkata.

The Governor said, “among many health care research centres, NICED has been chosen for the third phase trial of the indigenously developed Coronavirus vaccine. I am confident that the execution of the trial procedure will be smooth here.”

Dhankhar also commended the country's leadership in effectively handling the Covid-19 pandemic. “It happened due to visionary leadership in our country,” he added.

Dr Shanta Dutta, Director of ICMR-NICED, who was also present during the inaugural session, said, “The Phase-3 regulatory trial of ‘Covaxin’ was planned after satisfactory results were found during the first two trials. There are 24 centres where phase 3 trials have been started and we are one among those 24 centres.”

“There are a total 25,800 volunteers across India who will be given the vaccine dose in phase 3. In West Bengal, 100 volunteers will be participating,” she added.

As per reports, West Bengal Urban Development Minister and senior TMC leader Firhad Hakim is likely to be administered the first shot of the ‘Covaxin’ if he is found to be fit in the medical tests.

ICMR-NICED said that the regulatory trial is aimed to determine the protective efficacy of ‘Covaxin’ among the volunteers against Covid-19 infection. The final analysis of results will be available after one year of follow-ups post the second dose of vaccination.

On November 25 after promising results in the first and second phase, the Bharat Biotech’s Covid vaccine (Covaxin) arrived in Kolkata for the final round of clinical trials.

Meanwhile, West Bengal Health Department is also gearing up to set up the infrastructure to conduct clinical trials of other Covid-19 vaccines in the state.

“We have already declared the School of Tropical Medicine (STM) as the centre of excellence to conduct the clinical trials of Covid vaccine. We will conduct the trials in assistance with the ICMR. The School of Tropical Medicine would also conduct the trials of COVOVAX developed by Novavax, USA and the once which is developed by the Serum Institute of India in Pune. For Russian vaccine Sputnik V, we have set up facilities at the College of Medicine and Sagore Dutta Hospital,” a senior State health official said.

first published:December 02, 2020, 18:14 IST