Dhargal hospital to run clinical trials for COVID-19 vaccine

Panaji: The Dhargal-based Redkar Hospital and Research Centre is one of the 12 medical institutes across India selected by the Indian Council of Medical Research for conducting clinical trials to come out with an indigenous COVID-19 vaccine.

The RHRC is an advanced multi-speciality hospital handling acute emergency, rehabilitative care, diagnostic services and palliative care.

Dr Sagar Redkar of the research centre told ‘The Navhind Times’ that trials will be conducted on ‘healthy individuals’ suggested by the ICMR and the Clinical Research Organisation.

He, however, said the final approval for the trials is still awaited from the central authorities.

“We are yet to receive clearance by some authorities for the clinical trials. Paperwork and documentation have been underway.  Once that is completed they will provide us with vaccine. We will proceed under the supervision of the ICMR and the Clinical Research Organisation,” Dr Redkar explained.

The RHRC has its facility in Malvan in Sindhudurg district of Maharashtra.

After observing that many patients from Goa were travelling to the Malvan facility for treatment, the Redkar family decided to set up a similar facility in Goa. The Dhargal-based facility, which is located close to the Pernem railway station, was set up some five years ago. RHRC’s selection for the clinical trials of the COVID-19 vaccine could be based on the “population and geographical location”, Dr Redkar said, clarifying that the hospital is not admitting or treating COVID patients.

The ICMR has partnered with Bharat Biotech International Limited to fast track clinical trials for the indigenous COVID-19 vaccine (BBV152 COVID vaccine).

PTI ADDS FROM NEW DELHI: Contemplating launching an indigenous COVID-19 vaccine by August 15, the ICMR has written to select medical institutions and hospitals to fast-track clinical trial approvals for the vaccine candidate Covaxin being developed in collaboration with Bharat Biotech.

Twelve clinical trial sites have been identified and the apex health research body has asked the medical institutions and principal investigators to ensure that the subject enrolment is initiated no later than July 7.

COVID-19 vaccine candidate Covaxin, developed by the Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology, had recently got the nod for human clinical trials from the DCGI.

Noting that this was the first indigenous vaccine being developed by India, ICMR Director General Dr Balram Bhargava in his letter to principal investigators of the 12 sites said that it is one of the “top priority projects which is being monitored at the top-most level of the government”.

“It is envisaged to launch the vaccine for public health use latest by August 15 after completion of all clinical trials. BBIL is working expeditiously to meet the target, however, final outcome will depend on the cooperation of all clinical trial sites involved in this project,” Bhargava said in the letter.

“You have been chosen as a clinical trial site of the BBV152 COVID vaccine. In view of the public health emergency due to COVID-19 pandemic and urgency to launch the vaccine, you are strictly advised to fast track all approvals related to initiation of the clinical trial and ensure that the subject enrolment is initiated no later than July 7,” he said.

Meanwhile, Zydus on Friday said it has received approval from authorities to start human trials for its COVID-19 vaccine contender – the second Indian pharmaceutical firm to get such nod amid a surge in novel coronavirus infections worldwide.

The vaccine, ZyCoV-D, showed a “strong immune response” in animal studies, and the antibodies produced were able to completely neutralise the wild type virus, Zydus, part of Cadila Healthcare Ltd, said in a statement.

This comes within days of Bharat Biotech’s Covaxin vaccine getting approval of the drug regulator to start clinical trials.

Over seven vaccines are being researched in India and two of them have got go-ahead to start human clinical trials just this week.