Tribune News Service
Chandigarh, October 21
The Post Graduate Institute of Medical Education and Research (PGI) today completed the first dose of vaccination of 100 volunteers for the late-phase human clinical trials of the Oxford-AstraZeneca vaccine, also known as Covishield in India.
The second dose is to be given after 28 days of the first dose, which will be on October 23. The institute has so far screened 143 candidates for the vaccine.
One among the vaccine volunteers is a 64-year-old senior doctor of the PGI. He said, “I have comorbidities such as hypertension and diabetes. I considered exposing myself to find out what effect the vaccine will have on elderly people with comorbidities like me. This is for the cause of mankind and I am willing to risk it even at the cost of my well-being.”
He said, “So far, I am doing well and have completed 23 days ever since the first dose. Initially, I developed fever and mild aches in the body, but recovered quickly. I feel fine ever since then.”
As per the protocol, Covishield or Placebo or Oxford/AZ-ChAdOx1 will be administered under a two-dose schedule on day one and 29 as 0.5 ml dose intramuscularly.
This is a phase two/three, observer-blind, randomised, controlled study in healthy adults in India for comparison of the safety of Covishield with Oxford/AZ-ChAdOx1 nCoV-19 and Placebo, and immunogenicity with Oxford/AZ-ChAdOx1 nCoV-19 in the prevention of the SARS CoV-2 infection.
Both Covishield and the Oxford/ChAdOx1 have the same virus protein but differ in their make — the exact nature of the difference has not been publicly disclosed. The trial also seeks to quantify these differences, if any.
The trial involves 1,600 volunteers in 17 cities across the country likely to be inoculated in the coming months in the combined phase two/three trials. These trials check whether the vaccine is safe and capable of producing an immune response to disarm future infections by the SARS-CoV-2 virus.
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