Human Clinical Trial of Covaxin Begins in Bhubaneswar
The human clinical trial of ‘Covaxin’ has begun at the Institute of Medical Sciences and SUM Hospital in Bhubaneswar. IMS & SUM Hospital is one of the 12 centres chosen by the ICMR to conduct the first two phases of the clinical trials. It is the only institute in Odisha that has been selected for the purpose.
Dr E Venkat Rao, a professor of community medicine at the hospital, is assigned as the principal investigator. The tests are being conducted following the rules laid down by the Drugs Controller General of India (DCGI).
A specialised laboratory unit – Preventive and Therapeutic Clinical Trial Unit (PTCTU) – was inaugurated at the institute by Dean Gangadhar Sahoo. This is the first ‘designated human trial unit’ in Odisha equipped with all the medical amenities to conduct clinical trials. This includes preventive as well as therapeutic phases such as vaccines, immunoglobulins, preventive practices, chemoprophylactic drugs, educational/behavioural interventions and interventional agents or drugs.
Rao, in a briefing to the media, stated, “Those interested to volunteer for the project may contact the institute by registering online at ptctu.soa.ac.in. The volunteers need to be healthy and disease-free and can screen themselves through a simple questionnaire available on the same website. Healthy volunteers aged between 18 and 55 years having no comorbid conditions or COVID-19 history are eligible to participate in the clinical trials.”
Covaxin was approved for phase one and two of human clinical trials by the DCGI. The selected volunteers who have enlisted for the tests will be given two doses within a gap of 14 days.
Notably, Covaxin is the first indigenous vaccine produced in India against COVID-19. ICMR-National Institute of Virology in Pune had procured the vaccine by isolating a strain of the SARS-CoV-2 virus.