Mumbai: The BYL Nair Hospital has started the second round of the Phase II clinical trial of the Oxford Coronavirus vaccine Covidshield. So far, out of the 148 volunteers who were given the first vials, 96 have consumed the second vial at the Nair Hospital. After the completion of the process, the hospital will be authorized to start the Phase III of the trial.
In August, the Indian Council of Medical Research (ICMR) selected the hospital along with the King Edward Memorial (KEM) hospital, Parel, to conduct the Phase II and III clinical trial of the promising vaccine COVIDSHIELD. The Nair hospital was initially instructed to provide the first vial of the vaccine to 100 volunteers. But later with the permission of the ICMR, they selected another 48 volunteers for the first round of the Phase II trial.
“Around 148 healthy volunteers were given the first dose of the clinical trial, of which 96 volunteers have been given the second vial of the clinical trial after 28 days,” said Dr Ramesh Bharmal, dean of the hospital.
As per the rules of the ICMR, there are two rounds in the Phase II of the trial. After the completion of 28 days of the first vial, the volunteers are given the second vial. Then again, the hospital has to wait for another 28 days before starting the Phase III of the trial with the permission of the Central Drugs Standard Control Organisation (the national regulatory body for medicines). “All the volunteers are safe and healthy as we have not reported any side effects of the vaccines from the volunteers,” added Dr Bharmal.
The vaccine induces a strong immune response. It provokes a T cell (white blood cells that can attack cells infected with the coronavirus) response within 14 days of vaccination, and an antibody response within 28 days.
Pune-based Serum Institute of India (SII), which is the world’s largest manufacturer of vaccines in terms of volume, and British-Swedish pharmaceutical giant AstraZeneca partnered together to manufacture the experimental COVID-19 vaccine candidate formulated at the University of Oxford.
As per sources, the KEM hospital is also at the last stage of concluding the second round of the phase II of the trial. "We have given the first vial to 100 volunteers. We have completed the second vial to over 95 of them. In the next 1-2 days, it will be concluded," said a senior officer from the hospital.