By Raju Vernekar
Mumbai, Sept 21:
Over 300 volunteers will be administered the vaccine candidate dose in Pune and Mumbai this week in the final phase of human clinical trial of Oxford-Astrazeneca’s Covishield, following permission given by the Drugs Controller General of India (DCGI) to Serum Institute of India (SII),Pune to continue its trials.
Around 150 to 200 volunteers will be administered the vaccine candidate dose in Pune’s Sasson General Hospital, while 260 volunteers are expected to be given dosages in KEM and Nair Hospital in Mumbai. Nearly 350 volunteers have enrolled themselves with KEM, while 110 volunteers have enrolled at BYL Nair Hospital. About 100 volunteers will be given dosages at the Nair hospital. Although DCGI has given permission to conduct trails at KEM, the Nair Hospital is yet to receive such permission. However it is expected soon. All the volunteers will be provided a Rs 35 lakh insurance cover.
Some volunteers have already come forward for the trial and around 150 to 200 volunteers will be administered the vaccine candidate dose,” Dr Muralidhar Tambe, dean of Sassoon General Hospital said.
As per the study design, each subject will be administered two doses 4 weeks apart (First dose on Day 1 and Second dose on Day 29) following which the safety and immunogenicity will be assessed at predefined intervals.
A timeline of the Covishield trial in India is : On August 3, the Drug Controller General of India permitted SII to conduct the second and third phases of human clinical trials of Covishield, On August 25, SII began the second phase of trial, On September 8, Oxford and Astrazeneca confirmed that one person who was administered the shot reported illness, after which the trials in the UK were stalled on September 6, SII also stopped preparations for any further trial, On September 12, Astrazeneca announced that it is resuming the trial as the UK authorities have declared the vaccine shot safe, SII said it would wait for DGCI nod to resume the trials in India and DGCI gave a go-ahead to continue human clinical trial to SII on September 15. The Sassoon General Hospital began enrolling volunteers doe phase III from September 19.
Under phase-II, trials were conducted at Bharti Vidyapeeth Medical College and also KEM Hospital in Pune. The SII has partnered with British-Swedish pharma company AstraZeneca for manufacturing the COVID-19 vaccine candidate, developed by the University of Oxford.