Chandigarh PGI among 17 trial sites
NEW DELHI: In less than a month after the Serum Institute applies to the Drug Controller General of India for permission to conduct phase 2 and 3 clinical trials of the Oxford University-Astra Zeneca vaccine candidate Covishield, the apex regulator has granted the permission.
The permission was given on Sunday after Adar Poonawala led Serum Institute satisfies certain requirements the drug Controller sought earlier this week in the design of the proposal.
PGI in Chandigarh is among the trial sites listed in the study, which will involve administration of the vaccine to 1,600 people healthy adults across trials at 17 sites.
Other sites include AIIMS in Delhi, ABJ Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, AIIMS in Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysore.
The design says every healthy human volunteer for the trial will be given two doses — the second one at a duration of four weeks.
If the first is administered today the second will be administered at day 29.
Then immunogenicity data will be assessed. The vaccine recently showed promising results in phase 1 trials in the UK and did not present any serious adverse side effects.
It’s safety was determined in phase 1 trials. Phase 2 and 3 trials are done on a larger human population to see if the vaccine produces the required protections against COVID-19 in humans.