Five volunteers will be administered the first doses of a potential Covid-19 vaccine on Wednesday.
Serum Institute of India is manufacturing a #COVID19 vaccine. Five volunteers were tested for RT-PCR & antibodies, out of whom reports of three showed they have anti-bodies, hence the vaccine was administered to two: Medical Director of Bharti Vidyapeeth's Medical Hospital pic.twitter.com/TL7eu1894v
— ANI (@ANI) August 26, 2020
Doses of Covishield, developed by researchers at Oxford University and manufactured by the Pune-based Serum Institute of India (SII), arrived at Bharati hospital for phase-2 human clinical trials on Tuesday. The hospital is the first site in India to kick off the trial.
Bharati’s medical director Sanjay Lalwani, said, “Our hospital is the first site in India which has started the human trial by enrolling the first five volunteers from Pune. On Tuesday, we drew their swabs for an RT-PCR test to check for Covid infection and blood samples to find any past instances. These five volunteers will participate if they are found negative for both.”
The Drugs Controller General Of India (DCGI) had earlier this month given SII the nod to conduct phase 2 and phase 3 human clinical trials of Covishield vaccine in India.
About 1,600 people, all above 18, will be a part of the trials across 17 selected sites in India, including at four hospitals in Pune. From the 1,600 volunteers, 100 will undergo phase 2 human trials to assess the safety profile of the vaccine.
Lalwani said, “The first 100 volunteers from the phase 2 trial will be monitored for a week after vaccination to check for any adverse reaction. The phase 3 trial will begin immediately after the vaccine is found to be safe among the first 100. Our hospital will be enrolling 30 participants for the phase 2 trial and another 320 volunteers for phase 3 trial.”