KOLKATA: The institutional ethics committee of the School of Tropical Medical (STM) met on Tuesday, making the institute inch towards beginning the Phase III trial of Covid candidate vaccine Covovax. US- based Novovax, Serum Institute of India and ICMR are sponsoring the trial at STM. The institute has been preparing itself even while it was awaiting green signals from the regulatory authorities. Efforts are on so that the study can be rolled out by the third or fourth week of December.
While decks for the Phase III clinical trial of two different candidate vaccines for Covid — one in STM and another at NICED (National Institute of Cholera and Enteric Diseases) — have been cleared and a third one at College of Medicine and Sagore Dutta Medical Hospital (CMSDH) is on the anvil, some more Kolkata hospitals could be part of a study on a fourth candidate vaccine, said sources.
The pharmaceutical company that has developed this vaccine indigenously has approached more than half a dozen hospitals in the city for the phase III trial. Formalities and feasibilities are being worked out with these institutes. The pan-India multi-centric Phase III clinical trial of this vaccine is expected to kick off in early January.
Sources in the health department said it was looking into all good proposals and will fast track formalities.
“If everything goes smoothly, some city hospitals will also get to be part of the Phase III trial of a fourth candidate vaccine,” said a source in the state health department.
Earlier, the health department had appointed an expert committee to look into the proposal for the Sputnik V trial at College of Medicine and Sagore Dutta Medical Hospital (CMSDH). Even as the state-run medical college in Kamarhati might have missed conducting the Phase II trial of the Russian vaccine, health department officials are hopeful of CMSDH being a part of the Phase III trial. The ethics committee of the hospital is expected to meet soon on this. Dr Reddy’s is the Indian partner for this vaccine.
“We welcome the expedited process of approval from the concerned authorities for clinical trials. Otherwise, we may even lose being part of the trial as it is a competitive site selection process across the country,” said head of business development of site management organisation CliniMed LifeSciences Pvt Ltd, Snehendu Koner.
NICED, meanwhile, is expected to start its clinical trial on Indian made Covaxin by December first week. The Phase III trial of the Bharat Biothech’s candidate vaccine will have 1,000 volunteers — half will get the vaccine while half will get the placebo. The first lot of vials are likely to reach the institute with a week.