COVAXIN Human Clinical Trials kick off at Bhubaneswar-based Institute
The human trials of India’s very own COVID-19 vaccine, COVAXIN, commenced at an institute in Bhubaneswar on Monday. The institute in focus here is the Institute of Medial Sciences and SUM Hospital. A senior official of the institute announced the beginning of human clinical trials of the BBV152 COVID-19 vaccine or COVAXIN.
According to the statement of the senior official, the Indian Council of Medical Research (ICMR) has shortlisted 12 centres for the phase one and two of the human clinical trials of COVAXIN.
Small Steps to Combat a Larger Problem
The principal investigator of the trial process, Dr. E Venkat Rao credited Bharat Biotech for the ongoing development of COVAXIN. In addition, Dr. Rao also stated that certain individuals who had volunteered for the trials were administered COVAXIN. He also informed that volunteers for the human trials of COVAXIN had to go through a comprehensively detailed screening procedure. Dr. Rao further added that administration of vaccines complies with protocols established by the Drugs Controller General of India (DCGI).
Other than the Institute of Medical Sciences and SUM Hospital in Bhubaneswar, the ICMR has selected institutes located in Visakhapatnam, Kanpur, Patna, Hyderabad, New Delhi, Goa, Gorakhpur, Rohtak, Arya Nagar, Belgaum, Kattankulathur and Nagpur for the clinical trials of COVAXIN.
Principal investigator of the vaccine trial, Dr. Savita Verma, announced that the initial part of the first phase of COVAXIN human trials concluded successfully at the Post-Graduate Institute of Medical Sciences in Rohtak. Dr. Verma stated that the 50 people across the country administered with COVAXIN showed promising results. She also added that six people were administered COVAXIN on Saturday in the second stage of phase-1 of the trials.
A Great Start for the Trials!
The first phase of the human clinical trials of COVAXIN kicked off on Friday at AIIMS Delhi. A man, supposed to be in his 30s, was the recipient of the first dose in the first COVAXIN trial. The principal investigator for the study, Dr. Sanjay Rai, stated that more than 3500 volunteers had registered for trials. He added that, with so many volunteers registering since Saturday, the screening process continues for at least 22 people presently. The ongoing first phase of COVAXIN trials would focus only on healthy people without any co-morbid conditions. The target age group for the first phase of COVAXIN trials would be 18 to 55 years.
The Director of AIIMS, Dr. Randeep Guleria, stated that the second phase would witness recruitment of at least 750 people. He also added that the age group of volunteers for the second phase would be 12 to 65 years.