Human clinical trial of COVID-19 vaccine ‘Covaxin’ begins in Odisha

much-awaited human clinical trial of indigeusly developed Covaxin, a possible vaccine against vel coronavirus, began at an institute here on Monday, a senior official said.

human trial of BBV152 COVID-19 vaccine or Covaxin commenced at Institute of Medical Sciences (IMS) and SUM Hospital, one of 12 centres selected by Indian Council of Medical Research (ICMR) for conducting phase one and two of process, official at facility said.

Covaxin, which is being developed by Bharat Biotech, was administered to selected persons who had volunteered to be a part of trial, E Venkat Rao, principal investigator of trial process, told PTI.

Those who were administered vaccine have been kept under observation and all of m are "absolutely fine", he said.

Covaxin is first indigeus 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 preclinical as well as clinical development of this vaccine. It has already received approval for phase one and two by Drugs Controller General of India (DCGI).

selected volunteers will be given two doses within a gap of 14 days, Rao said.

y underwent a rigorous screening procedure. Those chosen after a thorough screening were administered vaccine strictly in accordance with protocols laid down by DCGI, he said.

Rao, who is a professor in hospital's department of community medicine, said re was a lot of enthusiasm among people who offered mselves to be volunteers for trial.

response from people has been extremely encouraging. Many people are still coming forward to be part of trial, he said.

ICMR, which is collaborating with pharma company for development of vaccine, has chosen 12 medical institutes in country where trial would be conducted. IMS and SUM Hospital is only institute in Odisha to be chosen for purpose.

Stating that process of screening is still on, Rao said those interested to volunteer for project may contact institute by registering online at ptctu.soa.ac.in.

volunteers need to be healthy and disease-free and can screen mselves through a simple questionnaire available at same website, he said.

Healthy volunteers d between 18 and 55 years having comorbid conditions or COVID-19 history are eligible to participate in clinical trials, he said.

Centre is going through profiles and conducting a thorough screening to choose suitable volunteers for trial.

"We are screening prospective volunteers and thoroughly evaluating ir health condition before administering m vaccine," he said.

trial centre is conducting physical and laboratory tests in accordance with ICMR protocol and is counseling volunteers who meet all criteria about possible risks. It is obtaining volunteers' consent before initiating process, Rao said.

trials are being conducted at a special laboratory-- Preventive and rapeutic Clinical Trial Unit (PTCTU) -- at institute, which is first such "dedicated human trial unit" in Odisha, he said.

PTCTU equipped with all modern amenities will focus on clinical trials involving preventive and rapeutic aspects such as vaccines, immuglobulins, preventive practices, chemoprophylactic drugs, educational/behavioural interventions and interventional nts or drugs.

(Photo credit for representation: PTI)