Covaxin Phase 3 trial starts in Kolkata; TMC's Firhad Hakim may get first shot
In the Covaxin phase 3 trial in Kolkata, a total of 1,000 participants will be administered either placebo or vaccine shot
Kolkata: The phase three trial of Covaxin — the vaccine for COVID-19 — at the National Institute of Cholera and Enteric Disease (NICED) in Kolkata will start from Wednesday, a senior official said.
State Urban Development Minister Firhad Hakim (62) 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, the official of the institute said on Monday.
"The phase III trials of Covaxin will be starting on 2 December. 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," the official said.
Hakim, also the chief of the Kolkata Municipal Corporation, had earlier expressed wish to be a volunteer for the trials.
"It is a great feat that he has expressed his willingness to be a part of the prorgamme and we will be happy to enrol him. He requires to take a few screening tests, following which the next step will be decided," the official added.
Asked whether the senior Trinamool Congress leader will be getting the vaccine or the placebo, he said that since the phase three 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, he said.
Another shot will be administered to each of the volunteers after four weeks of the first one. At least 1,000 volunteers will be administered the Covaxin in the phase III trials in Kolkata.
Find latest and upcoming tech gadgets online on Tech2 Gadgets. Get technology news, gadgets reviews & ratings. Popular gadgets including laptop, tablet and mobile specifications, features, prices, comparison.
COVID-19 vaccine shipments speed up ahead of inoculation drive; Delhi schools to reopen for classes 10, 12
Delhi chief minister Arvind Kejriwal said the AAP government will provide coronavirus vaccine free to the people of Delhi if the Centre fails to do so
Either pausing or cancelling approvals is not unheard of, and the CDSCO does have the authority to do so.
COVID-19 vaccine: DCGI grants approval to Covishield, Covaxin; Modi terms it 'decisive turning point'
The DCGI's approval was given on the basis of recommendations submitted by a COVID-19 subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO)