The COVID-19 vaccine evolved through the Jenner Institute, a component of the Nuffield Medicine Decomposer at the University of Oxford. The formulas are backed by AstraZeneca PLC, an Anglo-Swedish pharmaceutical company. AstraZeneca has partnered with Indian vaccine manufacturer Serum Institute of India to manufacture the COVID-19 vaccine for low- and middle-income countries.
Earlier this month, the Comptroller General of Medicines of India agreed to conduct complex trials in India. “The Phase 2/3 clinical trial will be a blind, randomized controlled examination of the protection and immunogenicity of Covishield (COVID-19 vaccine) in healthy Indian adults,” according to the study design.
The Pune-based drug manufacturer decided at 17 sites in India to conduct the trial. A total of 1,600 applicants will participate in the study.
These include: Andhra Medical College (Visakhapatnam), JSS Academy of Higher Education and Research, (Mysore), Seth GS Medical College and KEM Hospital (Mumbai), KEM Hospital Research Center (Vadu), BJ Medical College and Sassoon General Hospital (Pune), All India Institute of Medical Sciences (Jodhpur), Rajendra Memorial Research Institute of Medical Sciences, (Patna), Institute of Community Medicine (Madras), Post Graduate Institute of Medical Education – Research (PGIMER) Array Bharati , Jehangir Hospital (Pune), AIIMS (Delhi), ICMR – Regional Medical Research Center (Gorakhpur), TN Medical College – BYL Nair Hospital (Mumbai), Mahatma Gandhi Institute of Medical Sciences (Sewagram) and Government Medical College (Nagpur).
Of 1,600 candidates, 400 components will be components of the immunogenicity cohort and will be randomly assigned in a 3:1 report to obtain Covishield or Oxford / AZ-ChAdOx1 nCoV-19 respectively, while the remaining 1200 components participating in the safety cohort will be randomly selected. 3: 1 to get Covishield or Placebo respectively, according to ANI.
Each player will administer two doses within 4 weeks. The first dose will be given on day one and the dose of the moment will be scheduled for the 29th, depending on the study design.
“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 Phase 3 of the trial,” said Dr. Hemant Deshmukh of King Edward Memorial Hospital.
Two municipal hospitals in Mumbai, King Edward Memorial Hospital Parel and BYL Nair Hospitals, Central Mumbai, obtained approval from the Indian Medical Research Council to begin phase II and phase III clinical trials of the COVID-19 vaccine developed through Oxford University. Currently, the Brihanmumbai Municipal Corporation (BMC) is for volunteers to participate in the trial.
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