Covaxin phase 3 trial begins in Kolkata; TMC's Firhad Hakim to receive first shot

Bharat Biotech's COVID-19 vaccine candidate Covaxin's phase 3 trials are scheduled to commence at Kolkata's National Institute of Cholera and Enteric Disease (NICED) from Wednesday, December 2 onwards. As per reports, TMC leader and Bengal Cabinet's Urban Development Minister Firhad Hakim is likely to be administered the first shot of the Covaxin phase 3 trial. Bharat Biotech and ICMR's Covaxin had earlier, successfully completed phase one and two trials. In Covaxin phase 3 trial in Kolkata, a total of 1,000 participants will be administered either placebo or vaccine shot. 

Speaking to PTI on Monday, a NICED official said, "State Urban Development Minister Firhad Hakim is likely to be the volunteer to take the first shot of Covaxin if everything goes according to plan and he is found to be fit in the medical tests."

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"Cannot have any comorbidities"

Speaking further, the official informed that all those who have volunteered for the Covaxin phase 3 trial have been asked to appear on December 2. He added that the vaccine will only be administered if the participants test fit as they cannot have any underlying health conditions. When asked if the TMC leader will receive a shot of the vaccine or the placebo, the official stated that the trial is a 'double-blinded placebo-controlled study' which means that no one knows what is being given to who. Following the first shot, the volunteers will be administered another shot after a period of four weeks. 

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"The phase III trials of Covaxin will be starting on December 2. We have requested some of the applicants, including Hakim, to appear for the trials on that day. They will be administered the vaccine only after they test fit for the trials. They cannot have any comorbidities. Following satisfactory results, the shots will be administered to them," said the NICED official. 

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"Since the phase III trial of Covaxin is a double-blinded placebo-controlled study, neither the volunteer nor the investigator will be able to know who is receiving what. Half of the volunteers will be receiving the first- candidate vaccines, indigenously developed by Hyderabad-based Bharat Biotech and the ICMR, while the rest will be given placebos," said the official when asked what TMC's Firhad Hakim will receive. 

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TMC leader and Mayor of Kolkata had earlier expressed his desire to volunteer for the Covaxin trials, which the NICED officials had welcomed. Speaking to the media, an official from the institute had said, "It is a great feat that he has expressed his willingness to be a part of the programme and we will be happy to enrol him. He requires to take a few screening tests, following which the next step will be decided."

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(With inputs from PTI)