Of the 10-15 planned sites across the country, at least four in Pune are likely to be involved in human clinical trials of the Oxford University AstraZeneca Covid-19 vaccine. On Monday, the Union Ministry of Health and Family Welfare tweeted that the Drug Controller General of India (DCGI) had given Serum Institute of India the approval to conduct Phase 2 and 3 clinical trials of the Oxford University AstraZeneca Covid-19 vaccine (COVISHIELD).
The four likely sites in Pune are — KEM Hospital and Research Centre at Vadu, Bharati Hospital, Jehangir Hospital and the government-run B J Medical College and Sassoon General Hospital. The Indian Council of Medical Research’s Regional Medical Research Centre at Gorakhpur and Rajendra Memorial Research Institute of Medical Sciences at Patna are among several other sites that have been considered for the trials.
ICMR officials told The Indian Express that they were in the process of finalising trial sites, and an estimated 1,600 volunteers will be involved in the human clinical trials. The vaccine candidate is officially known as AZD1222 and has been developed by the Jenner Institute – a part of the Nuffield Department of Medicine at the University of Oxford.
The formulation has been backed by the pharmaceutical firm AstraZeneca PLC. According to reports, the Oxford Covid-19 vaccine has gone in phase 3 trials in South Africa and Brazil. The Serum Institute of India has supported these efforts for a vaccine against Covid-19, and had earlier told The Indian Express that it will be able to fill a global demand of 100 million doses in the next two to three years.
The DCGI gave the nod after a revised proposal for the study was submitted by the Serum Institute. The phase 2 and 3 trials will be an observer-blind randomised controlled study to determine the safety and immunogenicity of the Oxford vaccine on healthy Indian adults. Meanwhile, Serum Institute of India officials said that the revised protocol will have to be approved by the ethics committee of each of the proposed trial sites.
At Bharati Hospital, medical director Dr Sanjay Lalwani said that it will take at least a week or so to get approval from the ethics committee.
Pathik Divate, director of Jehangir Clinical Development Centre, said the centre’s ethics committee will also meet soon to check and approve revised protocols.
According to Dr Ashish Bawdekar, principal investigator at the KEM Hospital’s clinical trial site, a minimum of 160 participants will be enrolled. It is likely that each clinical trial site can get more than 200 participants each. However, the entire process may well take another two weeks, following which the trial is expected to start.
Adar Poonawalla , CEO of Serum Institute of India, had earlier told The Indian Express that the institute hoped to embark on phase 2 and 3 human clinical trials with the Oxford University vaccine candidate by August, and the vaccine should be out by the year-end if all goes well.
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