India to start trial of Oxford COVID-19 vaccine

Phase II and III clinical trials of Astra Zeneca vaccine by the Oxford University

• India’s top drug regulatory body DCGI has given green signal to Serum Institute
  of India (SII) for phase II and III clinical trial of Oxford COVID 19 trial
• SII will conduct phase II and III clinical trials of Astra Zeneca vaccine developed
  by the Oxford University against coronavirus disease
• The firm has to submit safety data, evaluated by the Data Safety Monitoring
  Board (DSMB), to the CDSCO before proceeding to phase 3 clinical trials

Approval by DCGI of trial to SII

• The SII had submitted a revised proposal after the expert panel had asked it to
  revise its protocol for the phase II and III clinical trials
• The firm has to submit safety data, evaluated by the Data Safety Monitoring
  Board (DSMB), to the CDSCO before proceeding to phase 3 clinical trials
• The panel had recommended that the human trial sites for the study should be
  distributed across the country
• SII is to conduct phase II and III human trial for the COVID-19 vaccine
  developed by the University of Oxford

Phase II and III trial India

•  Around 1,600 people will participate in the clinical trial proposed to be
  undertaken at 17 selected institutes across the country
• Volunteers must be above 18 years old to take part in the study
• Serum Institute has selected 17 institutions to conduct the advanced trial
• These sites are AIIMS-Delhi, B J Medical College in Pune, Rajendra Memorial
  Research Institute of Medical Sciences (RMRIMS) in Patna, Post Graduate
  Institute of Medical Education and Research in Chandigarh, AIIMS-Jodhpur,
  Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and
  JSS Academy of Higher Education and Research in Mysore
• As per the study design, each subject will be administered two doses four weeks
  apart (first dose on day one and second dose on day 29) following which the
  safety and immunogenicity will be assessed at predefined intervals
• According to the application, it would conduct an observer-blind, randomised
  controlled study to determine the safety and immunogenicity of ‘Covishield’ on
  healthy Indian adults

Astra Zeneca vaccine by Oxford University

• The COVID-19 vaccine candidate has been developed by the Unversity of Oxford
  and British-Swedish firm AstraZeneca
• At present, phase II and II clinical trials of the Oxford vaccine candidate is going
  on in the United Kingdom, phase II clinical trial in Brazil and phase I and II
  clinical trials in South Africa
• AstraZeneca has partnered with SII to develop COVID-19 vaccine for India and
  low-to-middle income countries
• Oxford’s coronavirus vaccine as it has already shown promising results in the
  first phase of clinical human trial
• The researchers said that they found their experimental COVID-19 vaccine
  produced a dual immune response in people aged 18 to 55

Other Vaccine developments

• Currently, at least 26 vaccines are in a clinical evaluation with six of them in
  late-stage, phase 3 trials according to WHO
• WHO’s draft of the landscape of COVID-19 vaccine shows that nearly 139
  candidate vaccines are in preclinical evaluation
• Several large-scale studies are in pipeline to assess the safety and efficiency of
  some of the most advanced vaccine candidates
• It includes the Moderna mRNA vaccine, Pfizer-BioNTech candidate, and
  Oxford’s Astra Zeneca COVID-19 vaccine etc
• Amidst all this progress a report from Russia claims that preparation of mass
  vaccination against CVOID-19 is set to be completed by October
• However, the country is yet to release any scientific data on its vaccine trials

Pic courtesy : livemint.com