The phase-I human clinical trials of Covaxin, India¡¯s first indigenously-developed coronavirus vaccine, began at AIIMS Delhi with the first dose given to a 30-year-old man.
Over 3,500 volunteers have registered themselves for the trial at AIIMS since last Saturday, of whom at least 22 are being screened, Dr Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS and the principal investigator of the study, said.
"The first volunteer, a resident of Delhi, was screened two days ago and all his health parameters were found to be within the normal range. He also does not have any co-morbid conditions.
"The first dose of 0.5 ml intramuscular injection was given to him around 1.30 pm. No immediate side-effects have been observed so far. He was under observation for two hours and will be monitored for the next seven days," Dr Rai said.
Few more participants will be given the vaccine on Saturday after their screening reports come in.
AIIMS-Delhi is among the 12 sites selected by the Indian Council for Medical Research (ICMR) for conducting the phase I and II of the randomised, double-blind, placebo-controlled clinical trials of Covaxin.
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In phase I, the vaccine will be tested on 375 volunteers and the maximum 100 of them will be from AIIMS. The second phase will include around 750 volunteers from all 12 sites together, Dr Rai said.
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COVID-19 vaccine candidate Covaxin, developed by the Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology (NIV), had recently got the nod for human clinical trials from the Drugs Controller General of India (DCGI).
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