KEM, Nair hospital to conclude phase 2 of Oxford COVID-19 vaccine trial

The BYL Nair Hospital and King Edward Memorial (KEM) Hospital are set to conclude the second round of Phase II human trials of the Oxford-AstraZeneca coronavirus (Covishield) vaccine. The hospital authorities said they expect phase III of the trial to begin by the first week of December.

The Indian Council of Medical Research (ICMR), in August, had selected Nair hospital along with the KEM hospital, Parel, to conduct the Phase II and III clinical trial of the promising vaccine Covidshield.

A total of 148 volunteers have been given the first dose, of which 96 are given second dose. 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.

The KEM and Nair hospital administration said that Phase II trial will conclude by next week.

According to reports, 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.

As per ICMR rules, after completion of 28 days from the first dose, volunteers are given the second dose, following which hospitals have to wait for another 28 days before starting phase 3 with the approval of the Central Drugs Standard Control Organisation (the national regulatory body for medicines).

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 have partnered to manufacture the experimental COVID-19 vaccine candidate formulated at the University of Oxford, United Kingdom.