The Post Graduate Institute of Medical Education and Research (PGIMER) has been listed as one of the 17 trial sites for conducting the second and third phases of human clinical trials of Covishield, the potential vaccine developed by the Oxford University.
The trails would involve administration of the vaccine to 1,600 people healthy adults across trials at 17 sites.
PGIMER Director, Prof. Jagat Ram on Monday said, “The results of phase 1 trials in the UK have been optimistic and did not present any serious adverse side effects. Phase II and III trials will be done on a larger human population to see its efficacy and requisite protection against COVID-19 in humans.”
Elaborating, the Director said, “As the results of the trials will have far reaching impact, we will strengthen our capacities, wherever required, to come out with tangible outcomes. A core group will be constituted to work out the modalities and comprehensive plan along with timelines to meet the desired expectations of Drugs Controller General of India and contribute towards containing the pandemic to the best of our abilities.”
It’s an honour to be entrusted with this vital responsibility of being one of the sites for phase II, III trials on Covishield vaccine, he added.
Earlier, the PGIMER had begun trial of convalescent plasma therapy in patients with serious infection and had also assessed the safety of Mycobacterium w (Mw) in four hospitalized infected patients.
Notably, a committee of experts on COVID-19 under the aegis of Central Drugs Standard Control Organisation (CDSCO) had recommended the Drugs Controller General of India (DCGI) to grant approval to Serum Institute of India (SII) for conducting the Phase II and III trials. The permission was granted after Serum Institute satisfied certain requirements sought by the Drug Controller in the design of the proposal.
In addition to PGIMER, the other sites for trials 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.