Mumbai hospital continues to wait for Covaxin to begin clinical trials

The Indian Council of Medical Research (ICMR) had selected Sion hospital for the third phase, pan India trial, of Covaxin.

More than a week after Lokmanya Tilak general hospital was granted an approval by its ethics committee to run clinical trials for India’s first indigenous vaccine candidate being developed by Bharat Biotech, the Sion-based hospital is still waiting to get Covaxin from the central government.

A medic administers Covaxin, an Indian government-backed experimental Covid-19 vaccine, to a health worker during its trials. (PTI Photo)

On November 26, the hospital got the green signal to conduct the third phase of the trial. “We have kept over 300 volunteers ready for the procedure. We will start the trial as soon as we get the vaccine from the government,” said Dr Mohan Joshi, hospital dean.

In the last week of October, the Indian Council of Medical Research (ICMR) selected the hospital for the third phase, pan India trial, of Covaxin. As many as 1,000 volunteers between 18 and 60 years will be included in the trial. Of this, 20% volunteers with co-morbidities will be selected and 5% will comprise medical health workers. Volunteers will be followed up for 12 months as per ICMR rules.

As per the official website of Bharat Biotech, Covaxin is developed in BSL-3 (Biosafety Level 3) high containment facility. The vaccine received Drugs Controller General of India (DCGI) approval for Phase I and II human clinical trials which commenced across India from July, 2020.

“Those who want to participate can contact us at the hospital. We have also started an Out Patient Department (OPD) for them. After thorough examination and tests, we select healthy volunteers. Also, we run Covid-19 tests to check if they have the pathogens of the virus or antibodies,” said Joshi.

Meanwhile, government-run JJ hospital, which has also received approval to start clinical trials for Covaxin, has started screening volunteers for the procedure.