PGI Chandigarh listed among 17 trial sites for phase 2, 3 trials on Covishield vaccine
In a major development, the Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh has been listed as one of the 17 trial sites for conducting the second and third phases of human clinical trials of a vaccine candidate — Covishield. It is developed by Oxford University. The trails would involve the administration of the vaccine to around 1,600 people healthy adults across trials at 17 sites.
PGI Director, Prof. Jagat Ram, said that “Its an honour to be entrusted with this vital responsibility of being one of the sites for phase 2, 3 trials on Covishield vaccine. The results of phase 1 trials in the UK have been optimistic and did not present any serious adverse side effects. Phase 2 and 3 trials will be done on a larger human population to see its efficacy and requisite protection against COVID-19 in humans.”
The Director added, “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 the Drugs Controller General of India and contribute towards containing the pandemic to the best of our abilities.”
Earlier, 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 the Serum Institute of India (SII) for conducting the Phase 2 and 3 trials. The permission was granted after the Serum Institute satisfied certain requirements sought by the Drug Controller in the design of the proposal.
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In addition to PGIMER Chandigarh, 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.
-PTC News
