Bhubaneswar, Jul 27 (PTI) The much-awaited human clinical trial of indigenously developed Covaxin, a possible vaccine against novel coronavirus, began at an institute here on Monday, a senior official said.
The human trial of BBV152 COVID-19 vaccine or Covaxin commenced at the Institute of Medical Sciences (IMS) and SUM Hospital, one of the 12 centres selected by the Indian Council of Medical Research (ICMR) for conducting phase one and two of the process, the official at the facility said.
Covaxin, which is being developed by Bharat Biotech, was administered to selected persons who had volunteered to be a part of the trial, E Venkat Rao, principal investigator of the trial process, told PTI.
Those who were administered the vaccine have been kept under observation and all of them are 'absolutely fine', he said.
Covaxin is the first indigenous vaccine developed by India against COVID-19 and is derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune.
ICMR and Bharat Biotech are jointly working for the preclinical as well as clinical development of this vaccine. It has already received the approval for phase one and two by the Drugs Controller General of India (DCGI).
The selected volunteers will be given two doses within a gap of 14 days, Rao said.
They underwent a rigorous screening procedure. Those chosen after a thorough screening were administered the vaccine strictly in accordance with the protocols laid down by the DCGI, he said.
Rao, who is a professor in the hospital's department of community medicine, said there was a lot of enthusiasm among people who offered themselves to be volunteers for the trial.
The response from the people has been extremely encouraging. Many people are still coming forward to be part of the trial, he said.
ICMR, which is collaborating with the pharma company for development of the vaccine, has chosen 12 medical institutes in the country where the trial would be conducted. IMS and SUM Hospital is the only institute in Odisha to be chosen for the purpose.
Stating that the process of screening is still on, Rao said 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 at the same website, he said.
Healthy volunteers aged between 18 and 55 years having no comorbid conditions or COVID-19 history are eligible to participate in the clinical trials, he said.
The Centre is going through the profiles and conducting a thorough screening to choose the suitable volunteers for the trial.
'We are screening the prospective volunteers and thoroughly evaluating their health condition before administering them the vaccine,' he said.
The trial centre is conducting physical and laboratory tests in accordance with the ICMR protocol and is counseling the volunteers who meet all criteria about the possible risks. It is obtaining the volunteers' consent before initiating the process, Rao said.
The trials are being conducted at a special laboratory-- Preventive and Therapeutic Clinical Trial Unit (PTCTU) -- at the institute, which is the first such 'dedicated human trial unit' in Odisha, he said.
The PTCTU equipped with all modern amenities will focus on clinical trials involving preventive and therapeutic aspects such as vaccines, immunoglobulins, preventive practices, chemoprophylactic drugs, educational/behavioural interventions and interventional agents or drugs.
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