Pune: Serum Institute of India (SII) has identified four hospitals in the city – Sassoon General Hospital, KEM Hospital, Jehangir Hospital and Bharati Hospital – to conduct Phase II and III clinical trials of ‘COVISHIELD’, the Covid-19 vaccine candidate of Oxford University and AstraZeneca.
Before the actual clinical trials on humans start, each hospital’s ethics committee will have to give its approval for the proceedings to begin. Since the Drugs Controller General of India (DCGI) has given approval to SII on Monday (August 3), it is expected that each hospital ethics committee will give its go-ahead in the next two weeks for the trials to commence.
The Central Drugs Standard Control Organisation (CDSCO) expert committee had asked SII to make changes in its first proposal in eight parameters, including distribution of sites and dropout rate. The company had then sent the revised proposal within a few hours on July 31. The subject expert committee of CDSCO went through the data and protocol submitted for the trial. It was satisfied with the results and based on their opinion the DCGI permitted the phase 2 and 3 trials in the country.
Adar Poonawalla, Chief Executive Officer of SII, the largest vaccine manufacturer globally had earlier said that as soon as the DCGI grants permission, trials for the vaccine will begin in India. “We will soon start manufacturing the vaccine in large volumes,” Poonawalla had said. SII has taken a risk by starting manufacturing the vaccine even before the approvals in order to be ready with sizable volumes once the vaccine gets all permissions.
As per reports, the vaccine candidate will be tested on 1600 volunteers across India. Out of the 10 proposed locations for the clinical trials of Phase II and III in the country, four are from Pune. The first shot of the vaccine candidate is expected to be given to volunteering patients from Sassoon General Hospital and Jehangir Hospital at Pune Station Road, KEM Hospital and Research Centre in Rasta Peth and Bharti Hospital in Dhankawadi.