Mumbai’s KEM, Nair hospitals to conclude phase 2 of Oxford Covid-19 vaccine clinical trialUpdated: Nov 19, 2020, 00:44 IST
BYL Nair Hospital and King Edward Memorial (KEM) Hospital are set to conclude the second round of phase-2 human trials of the Oxford-AstraZeneca Covid-19 (Covishield) vaccine. Hospital authorities said they expect phase 3 of the trial to begin by the first week of December.
In August, the Indian Council of Medical Research (ICMR) selected the two hospitals to conduct the phases 2 and 3 clinical trials of Covishield vaccine. 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).
Nair Hospital was initially instructed to administer the first vial of the vaccine to 100 volunteers. Later, with a nod from ICMR, an additional 48 volunteers were selected for the first round of phase 2.
“A total of 148 volunteers have been given the first dose, of which 96 have been given the second dose. Phase 2 of the clinical trial will conclude in the next week,” said Dr Ramesh Bharmal, dean, BYL Nair Hospital.
According to sources, KEM Hospital is also in the last stage of the second round of phase 2 of the trial. “We have given the first vial to 100 volunteers. We have administered the second vial to more than 95 volunteers. In the next one to two days, it [phase 2] will conclude,” said a senior doctor from the hospital. Despite repeated calls, Dr Hemant Deshmukh, dean of KEM Hospital was unavailable for comment.
After phase 1 of the clinical trial, Covishield vaccine was found to induce 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.
“Phase 3 will mostly be initiated by the first week of December. The same volunteers will have to participate in the next phase,” said Dr Bharmal.
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 to manufacture the experimental Covid-19 vaccine candidate formulated at the University of Oxford, United Kingdom.