The PGI Hospital in Chandigarh is among the 17 trial sites in India for conducting the second and third phases of human clinical trials of Covishield, the potential vaccine developed by Oxford University, its director said on Tuesday. The trials would involve administration of the vaccine to 1,600 healthy adults across 17 sites.
Postgraduate Institute of Medical Education and Research (PGIMER) Director Jagat Ram said, “It’s an honour to be entrusted with this vital responsibility of being one of the sites for phase two and three trials on Covishield vaccine.”
The COVID-19 vaccine developed by scientists at the Oxford University produces strong immune responses in both parts of the immune system, showed results of the Phase I/II trial, published in The Lancet medical journal, on Monday.
The vaccine provoked a T cell response within 14 days of vaccination — white blood cells that can attack cells infected with the SARS-CoV-2 virus — and an antibody response within 28 days — antibodies are able to neutralise the virus so that it cannot infect cells when initially contracted.
“The results of phase one trials in the UK have been encouraging and did not present any serious adverse side effects. Phase two and three trials will be done on a larger human population to see its efficacy and requisite protection against COVID-19 in humans.”
Further detailing, 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 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 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 two and three trials.
The permission was granted after the Serum institute satisfied certain requirements sought by the Drug Controller in the design of the proposal.
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 Mysuru.
The University of Oxford is working with the UK-based global biopharmaceutical company AstraZeneca for further development, large-scale manufacture and potential distribution of the Covid-19 vaccine, with plans for clinical development and production of the Oxford vaccine progressing globally.