The Indian pharmaceutical company Serum Institute of India has begun final trials of the Covid-19 vaccine developed through Oxford University at several Indian hospitals, adding the King Edward Memorial Hospital Parel and BYL Nair hospitals, Mumbai Central, which obtained approval from Indian Medical Research. ICMR Council to begin the trial.
India’s Comptroller General of Medicines has given the go-ahead for the initiation of complex vaccine testing in India. -19) in healthy Indian adults”, according to the design of the study.
It has been decided that 17 Indian sites will participate in these trials, while 1,600 applicants are expected to participate.
400 participants will be decided for the immunogenicity cohort and randomly assigned in a ratio of 3: 1 to administer the vaccine, Oxford AZD1222 nCoV-19 (formerly called ChAdOx1) or a placebo. The remaining 1,200 applicants will form the protective cohort and will also be randomly assigned in a 3:1 report to obtain the vaccine or a placebo.
Over a period of 4 weeks, applicants will get 2 doses, with the first dose administered on the first day of the trial and the moment dose on day 29.
“After the final touch of the Phase II trial, the reports will be sent to the Data Security Monitoring Board and then to the Central Standard Drug Control Organization for Stage 3 of the trial,” said Dr. Hemant Deshmukh of King Edward Memorial Hospital.
Brihanmumbai Municipal Corporation (BMC) has recently applied to participate in the trial after King Edward Memorial Hospital Parel and BYL Nair Hospitals, Central Mumbai obtained ICMR approval to begin the trial.
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